Requirements for the Special Packaging of Household Substances
Federal RegisterJul 21, 1995
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SUMMARY: The Commission amends its requirements under the Poison
Prevention Packaging Act of 1970 (``PPPA'') for child-resistant
packaging to change the child and adult tests under which child-
resistant packaging is evaluated.
The revisions to the adult test will substitute 100 older adults,
from 50 through 70 years old, for the current panel of 100 18-45 year-
olds. The senior adults are tested to see if they can properly use the
package in two test periods, 5-minutes and 1-minute. These changes will
increase the use of child-resistant packaging by making it easier for
adults to use properly. The revisions to the adult test do not apply to
products that must be packaged in metal containers or in aerosol form,
which will remain subject to the present 18-45 test panel and single 5-
minute test period requirements.
The revisions to the child test include sequential testing, which
can reduce the number of children that have to be tested in order to
determine whether a package is child-resistant.
For all tests, the number of subjects tested by any one tester and
the number of subjects tested at any one site are limited. Also,
standardized instructions are required for the child and senior-adult
tests.
DATES: Revised Secs. 1700.15(b)(2), 1700.20(a)(3), and 1700.20(a)(4)
will become effective July 22, 1996. There will be an additional 18-
month blanket exemption from compliance with the new senior-adult
requirements. Accordingly, packaging will not be required to comply
with the senior-adult test until January 21, 1998.
Revised Secs. 1700.20(a) (1) and (2), will become effective January
24, 1996.
New Sec. 1700.20(d), will become effective August 21, 1995.
ADDRESSES: Documents relating to this rulemaking proceeding may be
obtained from the Office of the Secretary, Consumer Product Safety
Commission, Washington, DC 20207.
FOR FURTHER INFORMATION CONTACT: Michael Bogumill, Division of
Regulatory Management, Directorate for Compliance, Consumer Product
Safety Commission, Washington, DC 20207; telephone (301) 504-0400, ext.
1368.
SUPPLEMENTARY INFORMATION:
Preamble--Table of Contents
I. The Current PPPA Regulations
A. Child Test and Criteria
B. Adult Test and Criteria
C. Noncomplying Packaging
II. CPSC's Changes to the PPPA Protocol
A. Procedural Background
B. Changes to the Adult Test Panel
Older adults.
Age groups.
Sequential Adult Test
Senior adult use effectiveness (``SAUE'').
Screening tests.
Homogeneity.
C. Adult Test Times
D. Changes to Simplify the Child Test
E. Changes to Ensure Test Consistency
F. Adult-Resecuring Test
III. Comments on the Proposal
A. Child Test Protocol Changes
Consent forms.
Test sites.
Sample preparation.
Child test instructions.
Seating.
Use of teeth.
B. Unit Packaging--Non-Reclosable
Child-resistance.
Senior-adult use effectiveness.
Failure for unit packaging.
C. ``Innovative''or Novel Packaging
D. Senior Test
Normal adults.
Gender distribution.
Age range of participants.
Test should reflect the age of users of the product.
Screening test.
Age groups.
Eliminate participants who stop trying.
Number of tests per participant.
Sites.
Sequential test.
Senior consent forms.
Instructions.
E. Effectiveness of the Senior Protocol--Safety v. Convenience
F. ISR Testing
G. Household Chemicals
H. Comments on Statutory Findings
I. 1-Year Effective date, Blanket 18-Month Exemption from
Compliance, and Additional Temporary Stays of Enforcement
J. Miscellaneous Comments
Carpal tunnel syndrome.
Exemption for large-diameter packages.
Need for additional comment.
IV. Economic Issues
A. General
B. Economic Comments
V. Statutory Requirements for Issuing PPPA Standards
A. General
B. Availability to Children
C. Technical Feasibility
Introduction.
Continuous-threaded packaging.
Lug-type packaging.
Snap-type packaging.
Pouches and blister packaging.
Aerosols and pumps.
D. Practicability
E. Appropriateness for the substances
F. Conclusion
VI. Effective Date
VII. Environmental Protection Agency
VIII. Regulatory Flexibility Analysis
A. General
B. Closure Manufacturers
C. Household Product Manufacturers and Packagers
D. Pharmaceutical Packagers
E. Pharmacies
F. Conclusion
IX. Environmental Considerations
I. The Current PPPA Regulations
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 ``special
packaging,''hereafter referred to as child-resistant (``CR'')
packaging. The PPPA defines CR packaging as ``packaging that is
designed or constructed to be significantly difficult for children
under five years of age to open * * * and not difficult for normal
adults to use properly.''15 U.S.C. 1471(4) (emphasis added). Under the
PPPA, the Commission has defined and established standards for CR
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 CR packaging. 16 CFR 1700.14. The existing requirements were
developed before the widespread use of CR packaging (``CRP'') and,
therefore, without the benefit of the actual use experience and test
data that since have become available.
A. Child Test and Criteria
The current child-test protocol (16 C.F.R. 1700.20(a) (1), (2), and
(3)) specifies testing with 200 children, ages 42 through 51 months,
distributed in 10 groups by specific ages. Each age group consists of
approximately one-half boys and one-half girls. A pair of children are
given test packages and asked to open them. If both children open their
packages, the test is stopped. If at least one child has not opened his
or her package after 5 minutes, the opening test is stopped and the
children are given a single visual demonstration of the method of
opening the package. If the children did not attempt to use their teeth
to open the package during the first 5 minutes, they also are told at
this time that they may use their teeth to open the package if they
wish. Then, the opening test is resumed and continues for another 5
minutes.
For a package to meet the PPPA effectiveness criteria, at least 85
percent
[[Page 37711]]
of the children must be unable to open the package within the first 5
minutes, and at least 80 percent of the children must be unable to open
the package by the end of the second 5-minute period. 16 C.F.R.
1700.15(b)(1).
B. Adult Test and Criteria
The current adult test protocol, 16 C.F.R. 1700.20(a)(4) and (5),
specifies a test panel of 100 adults, ages 18 through 45 years. Seventy
percent of the adults must be females and 30 percent must be males. For
a package to meet the PPPA effectiveness criteria, at least 90 percent
of the adults must be able to open and, if appropriate, properly close
the package within the 5-minute test period. 16 C.F.R. 1700.15(b)(2).
C. Noncomplying Packaging
The Congress was concerned that some elderly or disabled persons
would be unable to open CRP. Therefore, the PPPA was drafted to permit
substances subject to CRP requirements to be marketed in non-CR
packages (``non-CRP'') in certain circumstances.
Section 4(a) of the PPPA, 15 U.S.C. 1473(a), allows the
manufacturer or packer to package a nonprescription product subject to
special packaging standards in one size of non-CRP only if (1) the
manufacturer (or packer) also supplies the substance in CRP of a
popular size and (2) the non-CRP bears conspicuous labeling stating:
``This package for households without young children.'' 15 U.S.C.
1473(a). If the package is too small to accommodate this label
statement, the package may bear a label stating: ``Package not child-
resistant.''16 CFR 1700.5(b). The right of the manufacturer or packer
to market a single size of the product in noncomplying packaging under
these conditions is termed the ``single-size exemption.'' Section 4
specifies that the reason for allowing non-CR packages is to make
substances subject to CR standards ``readily available to elderly or
handicapped persons unable to use such substance when packaged in (CR
packaging).''
The Commission may restrict the right to market a single size in
noncomplying packaging if the Commission finds that the substance is
not also being supplied in popular size packages that comply with the
standard. 15 U.S.C. 1473(c). In this case, the Commission may, after
giving the manufacturer or packer an opportunity to comply with the
purposes of the PPPA and an opportunity for a hearing, order that the
substance be packaged exclusively in CRP. To issue such an order, the
Commission must find that the exclusive use of special packaging is
necessary to accomplish the purposes of the PPPA.
Furthermore, prescription substances subject to special packaging
standards may be dispensed in non-CRP if directed by the prescriber or
requested by the purchaser. PPPA Sec. 4(b), 15 U.S.C. 1473(b).
Thus, persons who find CRP unduly difficult to use may purchase the
single size of a nonprescription product that may be provided in
noncomplying packaging or may request that his or her prescriptions be
supplied in noncomplying packaging, thereby eliminating the protection
that CRP provides against poisoning.
II. CPSC's Changes to the PPPA Protocol
A. Procedural Background
Many consumers find CRP to be too difficult to use. When given the
choice, therefore, many consumers purchase products in conventional
packaging rather than CRP. [29] 1 Consumers are also making a
substantial number of CRP ineffective after bringing them home, such as
by leaving the package cap off or loose or by placing the package's
contents in a non-CR container. [29] This failure to use or misuse of
CRP is a substantial cause of accidental poisonings of young children.
\1\ Numbers in brackets indicate the number of a relevant
supporting document in the ``List of Relevant Documents'' in
Appendix I to this notice.
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On January 19, 1983, the Commission published an advance notice of
proposed rulemaking (``ANPR'') outlining its concerns in this area and
explaining possible actions to increase the proper use of CRP, simplify
the test procedures, and make the test procedures less affected by
possible variables. 48 FR 2389. After considering comments on the ANPR
and other available information, the Commission decided to propose
amendments to the protocol to address this problem. Also, the proposed
amendments would change the protocol to make the test results more
consistent and make the child test easier to perform. The Commission
published its initial proposal in the Federal Register of October 5,
1990. 55 FR 40856.
The original period for written comments on the proposal expired
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 commenter suggested certain
changes to the proposed adult test. The Commission preliminarily
concluded that this suggestion might have merit and requested comment
on it. 56 FR 9181 (March 5, 1991).
The Commission received a number of comments in response to the
proposed rule and the additional request for comment. The Commission
also contracted for additional testing to obtain information to address
the comments received on the proposed 5-minute/1-minute test. The
Commission then published a further request for comment on additional
information used to address comments and on the changes to the test
procedures that the Commission preliminarily concluded were
appropriate. 59 FR 13264 (March 21, 1994). The Commission denied three
requests for extension of the 60-day comment period on that notice.
On January 5, 1995, the Commission approved an amendment of its
requirements for child-resistant packaging to change the child and
adult tests under which child-resistant packaging is evaluated. Then,
on February 6, 1995, the Commission approved a Federal Register notice
to implement these changes. Immediately thereafter, the Commission was
provided with comments on the final rule that had not previously been
submitted to the agency during the course of the rulemaking. These
comments were circulated by the Coalition for Responsible Packaging
(the ``Coalition''), a recently formed ad hoc industry group.
The Commission voted on February 9, 1995, to withhold publication
of the final rule in order to consider these new arguments. In order to
provide interested parties with every reasonable opportunity to comment
on the new issues, the Commission provided for both written and oral
submissions. Written comments on these issues were to be submitted to
the Commission by March 7, 1995 (60 FR 9654, February 21, 1995). The
Commission also held a hearing on March 16, 1995, to receive oral
presentations. The hearing was announced in the Federal Register of
March 6, 1995 (60 FR 12165). After
[[Page 37712]]
considering these comments, the Commission voted on June 15, 1995, to
issue the revisions to the PPPA test protocols described in this
notice.
The following sections of this notice describe the revisions that
were proposed and the revisions that have been included in the final
rule. Where the final rule differs from the proposal, the reasons for
the changed provisions are stated in this notice.
There have been multiple opportunities for public comment in this
proceeding, and providing another such opportunity is unnecessary and
would substantially delay implementation of this important safety rule.
Accordingly, the Commission concludes that the final rule should be
issued without an additional opportunity for public comment.
B. Changes in the Adult Test Panel
Older Adults
The PPPA has helped to significantly reduce the number of childhood
poisonings. However, after more than 20 years, many children are still
being injured and killed by accidental ingestion of harmful products.
In 1994 alone, an estimated 130,000 children under 5 years old were
treated in hospital emergency rooms for suspected or actual poisonings.
In 1993, poison control centers received reports of more than 6,300
poisonings of young children with effects that were either ``moderate''
(i.e., pronounced and prolonged, generally requiring treatment) or
``major'' (i.e., life-threatening). In addition, 42 children died in
these tragic accidents in 1992, the most recent year for which the
Commission has complete death data.
The Commission's data show that many CR packages are difficult for
many if not most adults to use and that this is a substantial factor in
accidental poisonings of young children. In a survey of about 3000
consumers, difficulty in use was the reason given by 42% of the 313
people who left the CR cap off, by 43% of the 389 people who
transferred the contents to another container, and by 59% of the 232
who replaced a CR cap with a non-CR cap. [15]
This difficulty in using CR packaging is confirmed by other data in
the record. Typical reclosable CR packaging that passes the current
adult protocol was considered difficult to use by 22 to 64% of 800
people aged 18-45, depending on package type. [27, 28] Thus, reclosable
CR packaging does not fully implement the PPPA's requirement that such
packaging not be difficult for normal adults to use properly.
Furthermore, the data show that the improper use of CR packaging is
involved in a substantial number of accidental ingestions by young
children. For example, one statistical study of the accidental
ingestion of medicines by young children showed that 17% of the
medicines had been supplied in CR packaging but were not in properly
secured CR packaging when ingested. [112] An additional 40% of the
medicines in this study were not purchased in CR packaging.
In another study of about 2000 accidental pediatric drug
ingestions, 18% of the reclosable containers had caps that were off or
loose prior to the ingestion. [29, 92] Of the cases involving toxic
drugs, about 6% involved CR closures that were left off or loose, about
17% involved contents transferred from one container to another, and
about 18% involved non-CR packages.
Based on this type of data, the Commission concluded that reducing
the misuse of CR packaging by adults would reduce the number of
accidental poisonings among children, and that this could be
accomplished by making CR packaging easier for adults to use.
Accordingly, the Commission began a rulemaking proceeding in 1983 to
achieve these goals.
The Commission concluded that substituting a panel of older adults,
who as a group are less able to open traditional CRP, would exclude the
more difficult-to-use designs that now can pass the test with the
younger panel. 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. Test participants were limited to those who could
demonstrate the ability to open and resecure non-CRP. The Commission's
rationale for this conclusion is discussed in more detail in section
V(C) of this notice.
Age Groups
In the originally 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% of the
participants being in the 71-75 year-old age group. 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 devised modifications to the test procedure that divided 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. For the reasons discussed below, the Commission decided to
change the adult test to a panel of 50-70 year-old adults. Testing
conducted in 1991-1993 confirmed that the 60-64 year-old group and the
65-70 year-old group tend to perform similarly. [184, 160] See 55 FR
40858, [27]. Because there was no statistically significant difference
between the performance of the 60-64 and 65-70 age groups, they are
combined in the final rule into one group covering ages 60 to 70. As
discussed below, to reduce the risk that the test results of 50 to 59
year-olds will vary significantly with age, the Commission has decided
to divide that group into two groups, one of ages 50-54 and the other
of ages 55-59.
Sequential adult test.
Many comments on the originally proposed 100-member adult panel
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%, the probability of these packages passing
consistently was unknown. The commenters stated that SAUE of 95% in 1
test is required to assure that the package will pass consistently at
90%. Commenters stated that the protocol must be designed to avoid
failing an effective package with a true proportion a little greater
than 90%, or passing a package with a true proportion a little less
than 90%. 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%. However, neither of these changes would
address the variability of results with ``borderline'' packages.
To address these comments, the CPSC's staff developed a sequential
testing scheme. That test would have maintained the age range of 60-75
years of age and the acceptance criterion of 90, while assuring a high
level of confidence for passing packages. [174] The adults, under the
staff's plan, would be tested sequentially, in panels of 100, until a
statistically reliable pass/fail determination can be made or a total
of 400 adults (4 panels of 100) was tested. Providing for a larger
number of adults to be tested for packages that perform near the 90
percent criterion would
[[Page 37713]]
increase the likelihood of making the correct decision of passing or
failing. The sequential testing procedure was published for comment in
the Federal Register of March 21, 1994. 59 FR 13264.
Many of the subsequent comments indicated that the sequential
testing scheme would produce a much greater testing burden on industry.
For the reasons stated in section III(D) of this notice, the Commission
agreed and reverted in the final rule to the current 100-adult test
panel.
Senior Adult Use Effectiveness (``SAUE'')
Successful participants are those who open the test package within
the first, 5-minute, period and also open and properly resecure the
test package within the second, 1-minute, period. In the proposal of
March 21, 1994, the proportions of success for the 60-64, 65-70, and
71-75 year-old age groups were calculated separately and averaged so
that the larger 71-75 year-old age group was not more heavily
represented. The SAUE was compared to the acceptance criteria for the
sequential test to see whether the package has passed or failed or
whether another panel of 100 should be tested. The SAUE was calculated
in the same manner for 100, 200, 300, or 400 participants.
In the final rule, as noted above, the Commission specifies that
the adult test panel shall consist of 100 adults of ages 50 through 70,
inclusive.2 The specified age categories within the 50 to 70 range
are weighted according to sample size allocation. Accordingly, there is
no longer a need to calculate the proportions of the age groups
separately and average them. Therefore, if 90 or more of the adults on
the test panel are able to properly use a package, it passes the adult
test.
\2\ Elsewhere in this notice, the terms ``50 to 70'' and ``50-
70'' mean ``50 through 70, inclusive.'' The same sort of terminology
applies to the other age ranges mentioned in this notice, e.g., 18-
45.
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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-CRP. The packages used for screening purposes are a
non-CR snap and a continuous-threaded package. The participants have to
open and to resecure the two non-CR 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-CR 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 to open the CRP 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 amended the test
procedures to incorporate this change.
Homogeneity
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 CRP. The CPSC staff statistically analyzed the
homogeneity of the three age groups, using the results of tests with
reclosable and non-reclosable packages. [187, 188] 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. Therefore, no changes to the test procedures are
required with respect to the homogeneity of the age groups within the
60 to 70 age range. As noted, the age range of the adult panel in the
final rule is 50-70. The data discussed above show there is homogeneity
in the 60-70 age range. To reduce the practical effect of any potential
lack of homogeneity in the 50-59 age range, the Commission specified
that 25 persons would come from the 50-54 age range and that another 25
would come from the 55-59 age range.
C. Adult Test Times
The 5-minute test time of the current adult test probably greatly
exceeds the time that consumers are willing to spend attempting to open
a CR package. The frustration level experienced by persons trying to
open a package depends on both the effort and time required to do so.
[132] The Commission proposed that the effort required to open and, if
appropriate, resecure CRP should be reduced by requiring that closures
can be opened and resecured by adults older than the currently required
18-45 age group. In order to ensure that CRP is not so difficult to use
that adults must spend an unreasonable amount of time trying to open
and close the packaging, the Commission proposed to reduce the time
period for the adult test to 1 minute. Shortening the test time will
help ensure that CRP is acceptable to users and will therefore be used
properly.
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
could use to become familiar with how the package operates. During the
original comment period, 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 were successful in opening the package during the
familiarization period would then be tested to see if they could then
open and, if appropriate, 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 might have merit and requested comment
on it. 56 FR 9181. The final rule incorporates this suggestion.
D. Changes to Simplify the Child Test
Other proposed amendments were intended to simplify the current
child-test procedures, without reducing the ability of the test to
determine child-resistance. These proposed amendments included 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 CR 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% of the children in each age group,
respectively, instead of the current 10 age groups between 42 and 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, as in the original proposal. The commenter indicated that ``near
age'' makes it possible to calculate a child's age plus
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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 revisions as originally proposed.
The CR 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 March 21, 1994, proposal included a
calculation for near age as part of the child-test procedure.
These child-test changes are procedural and are not expected to
change the test results. Accordingly, these changes will have no effect
on the ability of currently available CRP to meet the effectiveness
criteria.
E. Changes to Ensure Test Consistency
Other proposed amendments were intended to ensure that the test
protocol produces more consistent results. These amendments are: to add
an optional 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% of the children
or 35% of the adults (in both the senior- and younger-adult tests); to
limit the children in each group who are tested at or obtained from any
given site to not more than 20%; to limit the percentage of the total
number of senior adults tested who are tested at or obtained from any
given site to not more than 24%; to limit the total number of younger
adults obtained or tested at any one site to 35%, and to issue
guidelines for standardized instructions to be used when testing.
The current PPPA regulations do not include the test instructions
used by CPSC for the child and adult test. The Commission originally
proposed adding a recommendation to Sec. 1700.20 for the use of
standardized instructions as voluntary guidelines for conducting the
child and adult tests. The Commission received comments supporting
standardization of the test procedures.
The Commission agreed that the procedures and instructions for the
senior and child tests should be followed closely to ensure the
statistical reliability of these tests and to control variability.
Accordingly, the Commission's March 21, 1994, Federal Register notice
proposed to include standardized instructions for the child and senior-
adult tests in the rule.
F. Adult-Resecuring Test
The PPPA requires that adults be able to use CRP properly, which
includes both opening the package and resecuring it to a CR condition.
The adult-resecuring test proposed by CPSC can be used to determine
whether packages have been properly resecured when an objective
determination that this has occurred (e.g., visual or mechanical)
cannot otherwise be made.
When such packages have been opened and appear to be resecured
during the adult test, they are given to children to open according to
the child-test protocols. If more than 20% of these children succeed in
opening the packages, the number of children in excess of 20% count as
failures to resecure by adults.
III. Comments on the Proposal
Thirty-six commenters submitted information and comments in
response to the March 21, 1994, Federal Register notice. The comments
focused on several areas, including the availability of test subjects,
the cost of package development and testing, and the effective date for
implementation. In addition, the Commission received 21 comments in
response to the February 21, 1995, Federal Register notice concerning
the issues that had not been raised previously in the rulemaking.
(These issues are: (i) Older adults are not ``normal adults'' under the
statute and therefore must be excluded from the adult test panel, and
(ii) the revised protocol allegedly addresses convenience rather than
safety.) Also, nine persons spoke at the oral hearing on March 16,
1995. Furthermore, more data and arguments concerning the new issues
were provided in correspondence and meetings after these opportunities
for comment. The Commission's response to these comments and to other
comments received previously but not addressed, is given below.
Comments on economic issues are addressed separately in section IV of
this notice.
A. Child Test Protocol Changes
The only change to the previously-proposed child test protocols by
the March 21, 1994, Federal Register notice was to make the
standardized test procedures part of the rule rather than suggested
guidelines. The Commission received comments on the standardized test
procedures and also received comments on aspects of the child test that
have been in effect for over 20 years. The comments on the child test
protocols, and the Commission's responses, are described below.
Comments made about child testing of unit packaging are addressed in
section III(B), below.
Consent Forms
Several commenters indicated that the mandatory use of informed
consent for child protocol testing will decrease the population of
children available for testing and increase the time and cost of
testing. Commenters contended that the Commission tried to require
informed consent in the late 1970's but withdrew the proposal based
upon the comments that were received at that time. Some commenters
requested that all mention of consent for children be eliminated from
the revised protocol. Other commenters indicated that the protocol
should state that informed consent should be required only if required
by the contracting party or testing agency.
In 1972, the Commissioner of the Food and Drug Administration
(``FDA'') proposed amending the CR test procedure to require informed
consent (37 FR 26833). This proposal was withdrawn in 1979 by the
Commission because general U.S. Government regulations for the
protection of human subjects made specific PPPA human subject
requirements unnecessary (44 FR 55310). The CPSC is required by the
regulations for the Protection of Human Subjects (16 CFR 1028) to use
informed consent in all human testing conducted by or for the agency.
Therefore, the statement that each child's parent or guardian should
read and sign a consent form prior to testing was included in the rule
to ensure that the test specified in the standard is the same procedure
that CPSC must use for compliance purposes.
Because informed consent must be used in CPSC-sponsored testing,
the Commission does not believe that the statement about informed
consent should be deleted from the test protocols as requested by one
commenter. Commenters stated that most child testing is done without
informed consent. The Commission has no data showing whether there are
differences in test results conducted with and without informed
consent. Therefore, the final rule differs from the proposal in that
the final rule states that the Commission will not disregard results of
child tests performed by other parties simply because the tests were
conducted without informed consent.
Test Sites
The proposed child test procedure states that the testing should be
done in a location that is familiar to the children; for example, their
customary nursery school or regular kindergarten.
[[Page 37715]]
No more than 20% of children in each group shall be tested at or
obtained from any one site.
Commenters requested that child testing be allowed to be performed
at one or more central locations, provided the children are drawn from
a variety of locations within the geographic area and the children are
made to feel comfortable at the test site.
Although this approach might make it easier to conduct the tests,
the Commission has concerns about the effect of unfamiliar surroundings
on CR package testing. The current regulations contain the requirement
for familiarity; therefore, all data collected for the past 20 years
were collected from tests conducted in familiar surroundings. It is not
known what influence unfamiliar surroundings might have on a child's
participation in the test, and the commenter did not provide data on
this issue. For example, a child may be distracted during testing
because of being separated from a parent in a strange place, or by
being paired with another child who is a stranger rather than a
classmate. Therefore, testing will continue to be conducted at five
sites familiar to the children.
Sample Preparation
Commenters indicated that the sample preparation sections of the
child and senior tests should be consistent. The Commission agrees and
has modified section 1700.20(a)(2)(iv)(1) of the child test
instructions to state:
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.''
Application torques must be recorded in the test report.
The proposed child-test instructions also stated that reclosable
packages shall be opened and properly resecured one time by the tester
who will be conducting the test. Commenters requested that testers
resecure torque-dependent packages to a specified torque prior to
testing the samples with children. Commenters voiced concern that test
results would depend on the strength of the tester and not on only the
child/package interaction.
The Commission opposes resecuring packages that are to be child
tested to a specified torque, because the preparation of samples is
designed to mimic the situation found in the home. Testing packages
with a specific application torque only represents the child-resistance
at that torque and above. Machine application torques only represent
the first opening and not how the package will be available to the
children in the household most of the time. Having people resecure the
packages prior to testing better mimics the home situation. The
commenters provide no information about what criteria would be
necessary to determine the appropriate torque in this case. The
Commission agrees, however, with comments stating that it is not
necessary for the same tester who conducts the test to open and
resecure the packages before testing, and has modified the instructions
in the final rule accordingly.
The commenters also indicated that test instructions should include
a test to determine that a CR package will continue to function for the
number of openings and closings customary for its size and contents, as
required by the current PPPA regulations. The Commission agrees with
this comment and has added the standard procedure for multiple
openings/resecurings used by CPSC in Instruction 3 of the Child Test
Instructions.
Child Test Instructions
Several comments were received regarding the child test
instructions. Most of these comments requested clarifications of the
instructions printed in the March 1994, Federal Register notice.
Several minor changes to wording of the instructions have been made by
the Commission in response to these requests and suggestions.
Seating
One comment concerned the statement in the instructions that
children are required to sit in chairs. It was requested that this
statement be deleted because chairs are not practical for testing large
or tall containers. The Commission agrees that chairs may make it
difficult for children to handle large or tall containers. Therefore,
the Commission has changed instruction 6 of the child test to read
``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.''
It is important, however, that tests be conducted consistently. If
a large or tall package is tested, all the children tested should sit
on the floor. If a table and chairs are used, all children tested
should be tested at tables and chairs. This does not restrict the
children from freedom of movement during the test as indicated in the
test instructions. The Commission recommends that testing agencies note
on the data sheets and in the test report whether children have been
tested on the floor or in chairs.
Use of Teeth
Children often use their teeth to try to open packages when they
are at home. It is therefore important to determine whether CR
packaging can be opened by children when they use their teeth. However,
children may feel inhibited about doing so during the test.
Accordingly, the current child test procedure states that 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'' before the start of the second 5-minute test
period. Some commenters requested that the instruction to use teeth be
given before the demonstration instead of after. These commenters
request moving the statement because when the instruction is given
immediately before the second 5-minute test period, the children do not
try to open the packages as the tester demonstrates but put the
packages immediately into their mouths. The commenters contend that the
present order of instructions minimizes the effect of the demonstration
and emphasizes the permission to use teeth. The commenters want to
separate the instruction that teeth can be used from the demonstration
of how to open the package.
The Commission disagrees with the solution proposed by these
commenters. The suggested change would simply reverse the impact by
giving the statement that teeth can be used at the end of the first
test period, after children have put the package down. The subsequent
demonstration may negate the effect of the permissive statement.
There may be better ways to address these commenters'' concern that
the teeth-using instruction be separated from the demonstration so the
children will have an opportunity to model the tester's actions. For
example, the timing, rather than the order, of the instruction
regarding teeth could be altered (e.g., one minute after the
demonstration). [234] However, it is not known whether this would
actually better mimic the situation that exists in the home.
Furthermore, the effect of this modification on test results is
unknown, since a shorter time period would be available for children to
use their teeth. For unit packaging, this could affect the quantity of
product children access during testing. As with the commenters'
proposal, such a change could result in future test outcomes which
differ significantly from those obtained in the past.
The Commission concludes that the stringency of the child-
resistance test should not be increased or decreased
[[Page 37716]]
without a demonstrated need to do so. Should data become available in
the future to clarify the impact of such a change to this portion of
the protocol, the Commission can consider this issue further.
Some commenters requested that, after the test, the tester 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.'' The Commission considers
this to be acceptable. However, testers must remember to modify this
statement if the children used their teeth before the demonstration.
The child-test instructions in the final rule incorporate these
changes.
B. Unit Packaging--Non-Reclosable
Several comments were received regarding the proposed test
protocols as they relate to unit packaging. A commenter indicated that
it is not possible to make senior-friendly unit-dose packaging that is
CR. Commenters provided alternative suggestions: maintaining the
existing 18- to 45-year-old test group for unit packaging, amending the
child test protocols to eliminate the use of teeth, or reducing the age
of children tested. The Commission does not believe that these
commenters' suggestions are necessary or warranted. Responses to
individual issues related to unit packaging are addressed below.
Child-Resistance
Commenters indicated that the test for child-resistance is too
stringent for unit-dose packaging because the children are told to use
their teeth, and the children tested are much older than 2-year-olds
(the average age of the children ingesting substances).
The Commission disagrees with these comments. Children use their
teeth to open packaging. However, they are less likely to do so in
front of an adult stranger. [234] Therefore, the statement about teeth
is an important part of the test because it may lessen the inhibition a
child may feel while being watched by a stranger. The commenters have
provided no information to support eliminating the statement about
teeth from the child-test protocol.
The commenters indicated that the children tested are older than
the at-risk population of 2-year-olds who are involved in almost half
of the poisoning incidents. The commenters state that the best way to
have senior-friendly packages is to test only the population of
children most at risk. Alternatively, the commenters request that the
test with older children be ``calibrated'' by decreasing the time of
the test or changing the pass/fail rates.
The Commission disagrees with these comments. The PPPA is intended
to protect children less than 5 years of age from serious injury from
handling, using, or ingesting hazardous household chemicals. 15 U.S.C.
1471(4). Changing the age of the children to 2-year-olds would leave
the older children unprotected. The current protocol, which has been
used for the past 20 years, already excludes children 52 to 59 months
old, who are the most capable children in the population at risk. The
test also allows a liberal 20% failure rate. Lessening the CR standards
by decreasing the age of the children tested, lessening the time of the
test, or decreasing the standard for child-resistance would lessen the
protection that the PPPA was intended to provide.
Several commenters indicated that unit-dose packaging is inherently
CR because children have to open individual blisters. The commenters
cite the European standards, which allow opaque blister packaging to be
considered CR. Commenters indicated that these packages are easy for
adults to open and do not endanger children.
The definition of child-resistance for unit packaging under the
current PPPA regulations can depend on the toxicity of the product
being packaged. A test failure for unit packaging is any child who
opens or gains access to the number of units that constitute the amount
that may produce serious personal injury or illness or to more than 8
units, whichever number is lower. 16 CFR 1700.20(a)(3).
Test data with different ``non-CR'' unit packaging types indicate
that 80-90% of children can access at least one unit. If this unit
contains a product toxic enough to cause serious effects in a child,
there is no child-resistance. These products do exist. This point was
illustrated by Rosanne Soloway, representing the American Association
of Poison Control Centers, at the December 5, 1990, presentation of
oral comments. Ms. Soloway described scenarios where accidental
ingestion by children of only one tablet of certain medicines resulted
in coma and brain damage. Unit packaging that will not pass the tests
for child-resistance is not inherently CR.
Commenters state that it is important that seniors have packaging
to help them take their medications. One commenter indicated that unit
packaging is an important mechanism of patient compliance and gave
mnemonic oral contraceptive packaging as an example of successful
packaging. These hormone-containing products were exempted from the CR
requirement or oral prescription drugs because they have low toxicity.
49 FR 44455. However, children do ingest these products despite their
being marketed in unit-dose packaging. Poison control centers report
that almost 10,000 children a year ingest birth control pills without
serious problems. [263] To define all unit packaging as CR would
sacrifice the protection of children in order to promote better drug
compliance. The Commission believes that a better approach is to
improve unit packaging so that both purposes can be achieved.
Senior-Adult Use Effectiveness
Some commenters requested that unit packaging should be exempted
from the senior test because there is no ``effective technology to
deliver blister/pouch security without adult tool usage.'' The
Commission does not agree with this statement. A blister package and
pouch that do not require the use of a tool to open were tested by 60
to 75 year-olds as part of the CPSC testing program. [157, 159, 194]
The results, which appeared in the March 21, 1994, Federal Register
notice, demonstrate that it is possible to make senior-friendly, CR,
unit packaging that does not rely on the use of a tool. Furthermore,
the Commission is not averse to the tool concept, because many package
types, especially food packaging, require the use of a tool to open.
Rather than exempting unit packaging from the revised adult test
requirements, the Commission believes that a better approach is to give
proper instructions for opening a package, especially when a tool is
required.
Some commenters claimed that the amount of time it takes older
adults to open CR blisters contradicts CPSC's statement that the
majority of participants thought these packages were ``easy to use.''
The statement that the majority of participants thought that the
test packages were ``easy to use'' was derived from asking the
participants to rate the package on a scale of 1 to 5 following the
test. [194] The ease-of-use determination is based on the opinion of
the participant and not on the actual time to open the package. The
average opening times for the blister package were 40 seconds and 20
seconds for the first and second test periods, respectively. The
commenters compared this to the average time for seniors to open a non-
CR unit packaging, which was approximately 20 and 10 seconds for the
two test periods. It should be noted that, although the times to open
non-CR blister packages averaged 20
[[Page 37717]]
seconds, the actual times ranged from 2 to 90 seconds. The Commission
believes that ease of use of unit packaging can be improved by giving
clear opening instructions.
Failure for Unit Packaging
Some commenters requested that the limitation of more than eight
units be eliminated from the child test definition of failure.
The current regulations state that a test failure for unit
packaging is any child who opens or gains access to the number of
individual units that 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. 16 CFR 1700.20(a)(3). The
original PPPA regulations defined five units as a failure. This was
established to provide the packaging industry with parameters for the
development of unit packaging, but it was found to be too restrictive.
The number of units was changed to eight in 1973 (93 FR 12738). The
concern at that time was the uncertainty of determining the amount of a
product that produces serious personal injury or illness to a child.
The commenters did not provide any test or other parameters for
determining what amount of product in excess of eight units would cause
serious effects in children. This would have to be done before this
comment could be implemented. If such information becomes available in
the future, the Commission may reconsider this issue.
Certain commenters requested clarification of the term ``opens or
gains access.'' A unit-dose packaging trade association proposed a
definition of failure for solid dosage forms in unit-dose blister
packaging. The suggested definition would not cover liquids or items
that can cause significant harm to children in small amounts. The
suggested definition focuses on the absolute amount of the product
removed from the package during the test and not the potential for
removal. A blister with the backing removed and the pill totally
exposed but not removed would pass, according to the commenters'
definition. However, in that case, the product would be accessible to
children. A puncture made by a child's tooth in a blister that contains
a hard tablet may not allow the child access to the pill. However, the
same tooth puncture in a blister with a tablet that can be easily
pulverized and sucked out by the child is accessible.
The Commission is not adopting the commenter's proposed definition,
but the test results can be interpreted in accordance with the
discussion given above. The Commission is including the following
language to clarify the meaning of ``opens or gains access to'': ``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.'' This is a modified version of language submitted
by a another commenter. If companies have questions concerning
individual products, the Commission's Office of Compliance is available
to discuss these issues.
C. ``Innovative'' or Novel Packaging
Several commenters indicated that a separate test method should be
employed for novel or innovative packaging. Failure of novel designs to
pass the 5-minute/1-minute senior test is interpreted by these
commenters as a flaw of the test because it does not take into account
the unfamiliarity of the package. Other commenters indicated that, for
novel packages, participants should be told that the packages they are
testing are not like the ones they have at home and that they should
follow directions very carefully.
The purpose of the PPPA protocol revisions is to ensure the
availability of CRP that normal adults, including older adults, can use
without difficulty. It is contrary to the purpose of the regulation to
adopt a separate, less stringent, test procedure to promote new designs
that do not meet the minimum standards.
Giving participants the information that the packages they are
testing may be unfamiliar to them is reasonable. However, additional
emphasis on the instructions for novel designs, or admonitions to
follow them very carefully, are inappropriate since this situation
would not occur in the home.
It is better to present the information, that the designs may be
unfamiliar, in a standard format. The description of the test in the
consent form is appropriate for this purpose. Accordingly, the
Commission is adding the following sentence to the consent form: ``You
may or may not be familiar with the packages we are testing.''
D. Senior Test
A number of comments were received regarding the senior test. These
comments are discussed below.
Normal Adults
One of the two new comments that were received after February 6,
1995, was that older adults are not ``normal adults'' under the statute
and therefore must be excluded from the adult test panel. This issue is
discussed below.
1. Introduction and background. The PPPA was enacted in 1970 to
reduce the number of deaths and injuries to young children who
accidently ingest poisonous products. It authorized the Department of
Health, Education, and Welfare (``HEW'') to issue CR packaging
requirements for such substances. In 1973, this authority was
transferred to the newly-created CPSC.
In addition to providing that special packaging must be
significantly difficult for children under age 5 to open, section 2 of
the PPPA requires that the packaging must be ``not difficult for normal
adults to use properly'' (emphasis added).3 This adult requirement
reflects Congress' concern that if CR packaging were difficult to use,
people would fail to put the caps back on correctly or would transfer
the contents to non-CR containers. The PPPA also accommodates those
adults who are unable to use CR packaging by allowing companies to make
non-CR packaging for such individuals in certain circumstances.4
\3\ 15 U.S.C. 1471(4).
\4\ 15 U.S.C. 1473.
---------------------------------------------------------------------------
The PPPA itself does not define the term ``normal adults,'' nor
does it establish any procedure to determine difficulty of adult use.
However, the PPPA's legislative history defines the term ``normal
adults'' as ``the broad range of the adult population not having
handicaps hindering their [proper] use of special packaging'' (emphasis
added). S. Rep. No. 91-845, 91st Cong., 2d Sess. 9 (1970) (``S. Rep.
No. 91-845''). To avoid limiting the development of technology, the
PPPA contemplated that performance standards would be established to
evaluate the child-resistance and adult-use effectiveness of child-
resistant packaging designs.5 As the Senate Report notes, the
statutory definition of child-resistant packaging expressly leaves it
to the Commission to determine the parameters of special packaging in
each case.6
\5\ Thus, the law prohibits the Commission from specifying
specific package designs, product content, or package quantity. 15
U.S.C. 1472(d).
\6\ S. Rep. No. 91-845 at 9.
---------------------------------------------------------------------------
The current protocol attempts to ensure that CR packages are not
difficult for normal adults to use by requiring that the packages must
be able to be opened and, if appropriate, properly closed within 5
minutes by 90% of a panel of 100 persons, 18 to 45 years of age, with
no overt physical or mental handicaps. 16 CFR 1700.15, 1700.25.
The test protocol adopted by the Commission, which tests whether
50-70
[[Page 37718]]
year-olds are able to open CR packages, is a surrogate for whether
normal adults of all ages will have difficulty using such packaging.
Certain commenters contended, however, that it would be unlawful to
include older adults on the panel because they allegedly are not
``normal adults'' under the statute. These commenters further argued
that section 4 of the PPPA exempts the ``elderly'' and ``handicapped''
7 from being considered as ``normal adults.'' The Commission
disagrees with these claims that older people are not normal adults or
that the proposed panel is unlawful.8
\7\ The term ``handicapped'' is hereafter referred to as
``disabled,'' except where context requires the use of the statutory
term.
\8\ It should be noted that the Coalition for Responsible
Packaging and its members were the proponents of this argument with
respect to the previously proposed panel of 60-75 year-olds.
However, the Coalition has publicly endorsed the Commission's
decision to adopt a panel of 50-70 year-olds. [299] Thus, these
industry commenters apparently now agree that the adult panel
adopted by the Commission is permissible under the PPPA.
---------------------------------------------------------------------------
2. The term ``normal adults'' does not exclude all ``elderly''
persons. The statute does not define ``normal adults.'' However, the
legislative history of the PPPA indicates that the term normal adults
is not limited to the 18-45 year-olds who make up the current test
panel.
``The definition of special packaging leaves it to the Secretary
[of Health, Education, and Welfare, now the Commission] to determine
specifically the parameters of special packaging in each case. The
[Senate] Committee [on Commerce], however, set limits to the
parameters by specifying that special packaging must be
significantly difficult [for children] to open . . ., that it need
not keep out all children, that it not be difficult for normal
adults--the broad range of the adult population not having handicaps
hindering their use of special packaging to use properly, and that
the target age-group is children under six [five, as enacted] years
of age.''
S. Rep. No. 91-845 at 9 (emphasis added). Any claim that the term is
limited to persons age 45 and below is inconsistent with this
description of normal adults. Furthermore, the description of ``normal
adults'' as including ``the broad range of the adult population''
implies that there will be considerable variation in the abilities of
persons across that range.
In addition, human factors considerations also indicate that the
broad range of normal adults includes the elderly. The Division of
Human Factors notes that there is considerable overlap in the physical
capabilities of younger and older adults. [287]
One industry commenter appeared to equate normal adult with the
``norm'' of the adult population, and questioned how that can be
determined if only the ``extremes'' of the population are tested. The
Commission's Human Factors staff noted that the commenter
inappropriately applied the concept of norm. The term norm, as used by
the commenter, is a point value and cannot be used to determine the
qualities of a range, such as the capabilities of normal adults. If
norm were interpreted only as the average (i.e., mean) value, it would
be age 41 for the U.S. adult population. If norm were interpreted as
the most common age, it would be age 29 for the U.S. adult population.
Under either interpretation, structuring a test panel comprised only of
subjects of a single age would be impracticable and uninformative about
large segments of the population. Moreover, the age chosen could change
with each census. Another commenter similarly described ``normal'' as
only those of average or better capabilities. Because average is
typically the halfway point, this commenter would exclude half the
population from being considered normal. Congress could not have
intended such results.
Also, the 60-75 test panel does not consist of the upper extreme,
which generally is considered to be the 95th percentile of the studied
population. According to Human Factors, the 95th percentile of U.S.
adults is above age 75. Thus, the revised protocol specifically
excludes the extreme.
3. Section 4 of the PPPA does not limit the meaning of ``normal
adults'' in section 2. Some commenters argued that section 4 of the
PPPA, in effect, defines normal adults to exclude the ``elderly'' or
``handicapped.'' This is incorrect.
As explained above, section 4 allows manufacturers and packagers to
market regulated substances in non-CR packaging in certain
circumstances. The reason for this exemption is to make ``any household
substance which is subject to a standard * * * readily available to
elderly or handicapped persons unable to use such substance when
packaged in compliance with such standard.'' 15 U.S.C. 1473(a)
(emphasis added).
There will always be people who, regardless of the adult test
protocol in force, cannot use CR packaging. This is the segment of the
population--whose size is determined not by age but by the state of the
art of CR packaging and the degree of difficulty allowed by the
standard--that non-CR packaging is intended to serve. Section 4 simply
assures that companies will be permitted to make non-CR packaging
available to these people. It does nothing more.
Certain industry commenters interpreted section 4 to mean that the
statute divides the entire adult population into three distinct groups:
``normal adults,'' the elderly, and the disabled. These commenters
argue that section 4 defines ``normal adults'' to exclude elderly
people, and that they therefore may not be on the test panel. This
argument is based on the premise that section 4 defines the term
``normal.'' However, it does no such thing.
One of these commenters has also argued that section 4 is designed
to make packaging available not only to the elderly or disabled, but to
all adults for whom ``child resistant packages would be difficult * * *
to open.'' [277, pp. 2-3] While it is true that section 4 is designed
to assist anyone who cannot open CR packaging, this is inconsistent
with the argument that section 4 defines the term ``normal adult.''
That is, if section 4 defined ``normal'' and if it excluded the
elderly, disabled, and anyone else who had difficulty using CR
packaging, then each of these groups would have to be excluded from the
test panel. However, this would mean that every CR package would pass
the adult test with a score of 100% because anyone who had difficulty
opening the package would, by definition, be ineligible to test it.
The debate between the two houses of Congress concerning the scope
of the exempt size provision of the act also provides insight
concerning the population of adults that Congress regarded as being
normal. The House of Representatives favored a provision that would
have made CRP the exception rather than the rule, requiring CRP for
only one size intended for use in households with young children. This
position was based on data indicating that 75% of all U.S. households
had no children between the ages of 1 and 5. According to the House
rationale, requiring members of these households to purchase products
in CRP would be illogical. H.R. Rep. No. 1642, 91st Cong., 2d Sess. 6
(1970). Thus, the adults whom the House expected to use child-resistant
packaging were those who actually had children, i.e., adults roughly 18
to 45 years of age.
The Senate, on the other hand, recognized that the problem of
accidental poisoning was not limited to the immediate households in
which children reside. It therefore favored legislation that would
generally require CRP for all products subject to CR standards, with a
limited exception providing non-CRP for those individuals physically
unable to use products in CRP. S. Rep. No. 91-845 at 11. Under
[[Page 37719]]
this scheme, since virtually all product sizes would be child-
resistant, adults of all ages, as opposed to only those who had
children, were the expected purchasers. Incapacity, not age alone,
determined the parameters of the exempt size provision. Ultimately, the
law as enacted adopted the Senate approach. Thus, the Congress clearly
intended that ``normal adults'' include persons older than persons
expected to have young children in their homes.
4. Even if section 4 did limit the meaning of ``normal adult,''
only those persons unable to use CR packaging would be excluded. To
argue that all elderly or handicapped persons are excluded from being
``normal adults'' is to ignore the statute's qualifying phrase that
section 4 is for persons ``unable'' to use CR packaging. Thus, even if
section 4 were a limitation on the meaning of normal adult, which it is
not, only those elderly or disabled persons who lack the capability to
use CR packaging would be excluded.
Some commenters claimed the Commission's interpretation of ``normal
adults'' eliminates the concept of age from the definition of ``normal
adult,'' in contravention of the use of the term ``elderly'' in section
4. This argument is incorrect. The term ``elderly * * * unable to use''
in section 4 acknowledges that the sorts of ailments that may be
associated with or caused by advanced age can render people unable to
use CR packaging. However, section 4 simply cannot be read to exclude
all elderly adults from being normal adults.
An industry commenter also argued that if the test panel is to
include older adults, it must at least ``exclude those elderly persons
who could not open'' CR packaging. [277, p. 4] This could be
accomplished, according to the commenter, through a pre-test by
``giv[ing] the panel member the CR package * * * and exclud[ing] those
elderly persons, who could not open it from the test group.'' [277,
p.4] However, as discussed above with respect to another comment, if
all older adults who failed to open the CR package were excluded from
the panel, every package could, and in fact would be guaranteed to,
pass with a perfect score.
Even in the 18-45 age group, there are persons who are disabled to
the point that they cannot open CR packaging. The current test
protocol, issued by the FDA in 1971, specifies that the adults on the
panel shall have ``no overt physical or mental handicaps.'' 36 Fed.
Reg. 22151 (November 20, 1971); 21 C.F.R. Part 295 (1972), now codified
at 16 CFR 1700.20(a)(4). This prohibition of overt disabilities was the
only condition in the original test protocol that would bar the
participation of ``handicapped'' persons within the specified age
range. Accordingly, people are permitted to participate in the current
adult test even if they have disabilities that are not overt--e.g.,
certain forms of arthritis--but may still affect their ability to open
CR packages. Thus, FDA did not feel compelled by the reference to the
``handicapped'' in section 4 to exclude all disabled persons from the
category of normal adults. Similarly, even if section 4 limited the
definition of ``normal,'' not all older adults would have to be
excluded from the adult panel.9
\9\ The revised protocol adopted by the Commission contains more
conditions for participation by adult panelists than does the
original protocol. The revised protocol requires that the
participants shall: (1) ``Have no obvious or overt physical or
mental disability''; (2) have no ``permanent or temporary illness,
injury, or disability which would interfere with his/her effective
participation''; (3) be able to open and close two types of non-CR
packages in a 1-minute screening test; and (4) read and sign a
consent form. Sec. 1700.20(a)(3) (i) and (iii). Persons with
disqualifying disabilities, whether caused by advanced age or other
factors, are disqualified as test participants. This adequately
guards against any arguable limitation imposed by section 4 that the
panel not consist of elderly people unable to use special packaging.
---------------------------------------------------------------------------
Finally, a commenter argued that the greater difficulty older
adults have in opening traditional CR packaging proves that they are
inherently disabled compared to younger adults and therefore cannot be
considered ``normal'' adults. As explained above, however, just because
the older participants'capabilities may be somewhat diminished in the
use of traditional CR packages does not mean those adults fall outside
the ``broad range'' of the adult population. Moreover, the commenter's
argument overlooks the fact that the older adult panel can perform at a
very high level--scoring 95% and above in CPSC tests--with packages
that pass the revised protocol. Thus, under any interpretation, older
adults do not have a less than normal ability to open the new type of
CR packages.
5. The Commission is vested with broad discretion to establish the
test protocol and criteria to determine whether packaging is not
difficult for normal adults to use. Obviously, there is no one
performance criterion that establishes a single point at which
packaging transforms from difficult to not difficult for normal adults
to use. Nor does the statute specify a point at which packaging will be
deemed ``not difficult for normal adults to use.'' Congress gave the
Commission broad discretion to address these issues.
The Senate Report specifically acknowledged the Commission's power
``to determine specifically the parameters of special packaging.''
10 Additionally, the preamble to FDA's initial test protocol
states that ``if experience in application of this protocol indicates a
need for change, it may be appropriately amended at that time.''
11 This is exactly what the rule now issued by the Commission
accomplishes.
\10\ S. Rep. No. 91-845 at 9 (1970).
\11\ 36 FR 22151, 22152. The group that developed the original
protocol similarly expected that there would be regulatory changes
in the future based upon experience and advances in CR technology.
This joint industry-FDA committee was led by Dr. Edward Press, who
expected that the standard would ``be improved, revised, [and]
expanded within a year or two.'' [295, p. 65] He further foresaw
``that, as new data become available, the [FDA, now the Commission]
will establish standards which may differ from those recommended by
the [Joint Industry-FDA] Committee.'' [295, p. 111]
---------------------------------------------------------------------------
The PPPA and its legislative history provide further support for
CPSC's authority to adopt CR standards that require companies to
improve their packages to meet the state of the art. CPSC's packaging
standards must be ``technically feasible, practicable, and appropriate
. . .'' 15 U.S.C. 1472(a)(2). According to the legislative history,
packaging is ``technically feasible'' if ``technology exists to produce
packaging conforming to the standard . . . However, this requirement
does not mean that the [Commission] must establish standards that can
be met by the lowest, or even the average, level of packaging
technology extant in the industry.''
S. Rep. No. 91-845 at 10 (emphasis added).
And, a standard is ``practicable'' when special packaging for the
covered products is adaptable to modern mass production and assembly-
line techniques. Id. at 10. In addition, Congress made clear that it
``did not desire to limit in any way the development of new forms of
special packaging.'' Id. at 9.
Thus, CPSC is not required to gear PPPA regulations to the lowest
common denominator in the industry. As the state of the art in
packaging technology continues to change, so may CPSC's requirements.
Industry's argument to the contrary would freeze CR packaging
requirements based on the packaging technology that was available 25
years ago. This would require Congress to rewrite the PPPA to account
for engineering advances that now allow packages to be both highly
child-
[[Page 37720]]
resistant and not difficult for normal adults of all ages to open. It
is illogical and inconsistent with the statutory framework and its
legislative history to think that Congress intended that result.
6. The current rule does not adequately measure difficulty for
normal adults; a test using senior adults is better for this purpose.
Whatever the boundaries of the category of normal adults (discussed
above), the present test with a panel of 18 to 45 year-olds is, at
best, a poor measure of whether the packaging is not difficult to use
properly. What the test measures is whether, in the 5 minutes allotted
time, at least 90% of the panel members can open and, if applicable,
properly resecure the packaging. The fact that a person can open a
package does not mean that he or she does not find it difficult to do
so. Moreover, 5 minutes is probably a much longer time than most
adults, even those 18 to 45 years old, will spend attempting to open a
package.
The Commission's data show this to be the case. As noted above,
from 22 to 64% of persons of ages 18 to 45, depending on package type,
found typical CR packaging ``difficult'' to open. [27, 28] No one
disputes that, whatever the outer boundaries of the category of
``normal adult'' may be, it surely includes adults of ages 18 to 45
with no overt physical or mental disabilities. Thus, the available data
show that much of the currently available CR packaging is difficult for
``normal adults'' to use, even if (as some commenters argued) that term
included only the most capable portion of the adult population. Thus,
typical CR packaging fails to accomplish the statutory objective, and
the Commission is fully justified in changing the test protocol to
eliminate difficult-to-use packages from the market.
The present protocol fails to enforce the ``not difficult''
requirement because it tests only whether 90% of the most able half of
the population can use packages. The options to address this flaw in
the current protocol are few. One alternative would be to survey the
adult test participants to see if they found the package not difficult
to open. According to the Commission's Human Factors Division, however,
this option would make the test less objective and verifiable, and
would increase the variability of the results.
The older adult panel retains the ``can use'' criterion that is
more objective and verifiable. According to the Commission's Human
Factors staff, the ``seniors-able-to-use'' criterion is a reasonable
surrogate measure for ``difficulty of use'' in at least a substantial
proportion of the population. The requirement for packaging that older
adults can use virtually guarantees that CR packaging will not be
difficult to use for substantially larger segments of the ``normal''
adult population than in the past, including those 18-45 year-olds who
consider traditional CR packaging ``difficult'' to use. Thus, even if
people age 50-70 were not ``normal adults'' (and they are), the ability
of these older persons to open packaging is a more reasonable surrogate
for ``lack of difficulty'' in younger adults than is the present adult
test.
As discussed below, the Commission has changed the age range of the
adult panel from the proposed 60-75 to 50-70 in the final rule. The
Commission continues to believe that it would be lawful to use a panel
of 60-75 year-olds. However, the Commission agreed to change the panel
because the rule will still save children's lives and, as adopted,
reduces the burden of compliance on the regulated industry.
Gender Distribution
A commenter indicated that equal numbers of males and females
should be tested, and not the 70% females that was proposed and that is
in the current adult test, because children are allegedly exposed
equally to products used by males and females. The gender ratio was
maintained for the senior test because child care activities are still
predominantly performed by females, both in the home and elsewhere.
More important, differences in strength between males and females
persist in older age groups, and it is appropriate to shift the test
sample toward users who represent the lower limits of strength-based
performance.
Age Range of Participants
Some commenters claimed that the adult panel should represent the
ages of grandparents, who have a mean age of 51 years old. The purpose
of the senior test is to provide CRP that can be used without
difficulty by a larger portion of the population than packaging that
has been available for the past 20 years. The age range for the adult
test was not chosen as a representation of the ages of grandparents.
Other commenters requested that the 71-75 year age group be dropped
due to variability. Any greater variability of results for people in
this age group could be compensated for by allocating a larger portion
of the sample to the 71-75 year-old participants and weighting their
results so that age group is not overrepresented. However, this point
is moot because the Commission decided to adopt a panel of 50-70 year-
old adults.
After the most recent comment period, the Commission reexamined its
data on tests performed in the 1980's on persons between the ages of 18
and 75. Briefing package, May 25, 1995, Tab G. In those tests, all the
packages that scored over 90% with the 61-75 age group also did so with
the 51-70 age group. Similarly, all the packages that scored below 90%
with the 61-75 age group also did so with the 51-70 group (although one
package scored about 85% with the 61-75 age group and just under 90%
with the 51-70 age group). Overall, the performance of the 51-70 age
group was closer to the 61-75 age group than it was to the 18-45 age
group. This was especially so for the packages that older adults found
were the hardest to open. For example, the two hardest packages scored
95.3% and 92.5% when tested with the 18-45 group. However, they
respectively scored 76.3% and 76.0% with the 61-75 group and 79.8% and
76.8% with the 51-70 group.
These test results indicate that there is a substantial safety
benefit associated with using an adult test panel made up of persons of
ages 50 to 70, compared to using the present adult test panel of 18-45
year-olds. It is possible that some borderline packages that would fail
with the 60-75 age group would pass with the 50-70 age group. However,
it is unlikely that this would occur with the hardest-to-open packages
that have been marketed previously and that are of the greatest concern
to the Commission. The Commission concludes that such hard-to-open
packages can be eliminated from the market by a test using either 50-70
year-olds or 60-75 year-olds.
The Commission believes that the required statutory findings--that
packaging meeting the standard is technically feasible, practicable,
and appropriate for the substances for which it is required--can be
made with either a 50-70 year-old panel or a 60-75 year-old panel.
However, adopting the 50-70 age range could reduce the burden on
industry in complying with the rule. And, the Commission believes that
a panel of 50-70 year-olds, like a panel of 60-75 year-olds, will
reduce the misuse of CRP. Accordingly, the Commission decided to
accommodate industry's requests, and incorporated the 50 to 70 age
range for the senior adult test panel in the final rule.
Test Should Reflect the Age of Users of the Product
Several commenters argued that the ages of the test subjects should
reflect the ages of the consumers using the
[[Page 37721]]
individual products. What these commenters suggested would result in
different test populations for different products. None of the products
regulated by the PPPA are restricted from being purchased or used by
the population in general. Furthermore, the same type of package also
is often used for different products. These commenters did not indicate
how the ages of the consumers who use the products would be determined,
and, if adopted, this suggestion would be a never-ending source of
dispute and uncertainty. Thus, the Commission will use the same test
population and test procedure to define child-resistance and senior-
adult use effectiveness for all regulated products.
Screening Test
Some commenters requested modification of the screening test so
that the packages used for screening participants are similar in size,
type, and weight to the package being tested. The purpose of the
screening test is to ensure that the participating seniors have some
baseline ability, including the ability to read, to sign a consent
form, and to open two types of non-CR packages. It is unnecessary to
change the screening test with each type of package. Therefore, the
screening procedures of the senior protocol remain as proposed.
Age Groups
Several commenters requested that the 60-64 and 65-70 age groups be
combined to decrease the testing burden. CPSC staff analyses indicate
that there was not a significant difference in performance between the
60-64 age group and the 65-70 age group for the package types tested by
CPSC, as reported in the March 1994 proposal. [187, 188] This was
verified by data submitted by ASTM's Institute for Standards Research
(``ISR'') involving senior adult testing of two packages at four
different testing agencies. Because there is no significant difference
in performance between these two age groups, it is reasonable to reduce
the testing burden by combining the two age groups. Therefore, the
final rule specifies that sampling be done so that, for each panel, 50
persons are selected for the 60-70 age group.
However, the currently available data do not support the conclusion
that adults in the upper and lower ends of the 50-59 age range will
perform similarly to one another. Accordingly, as explained in section
II(B) of this notice, 25 persons are selected for each of the 50-54 and
55-59 age groups to reduce the practical effects of any lack of
homogeneity in the 50-59 age group.
Eliminate Participants Who Stop Trying
Another commenter suggested that participants be eliminated from
the test if they stop trying less than 2 minutes into the 5-minute test
period. This would introduce a bias towards a package passing by
eliminating participants who cannot operate it within 2 minutes and
cease trying. The sample of adults would be skewed toward those who are
most capable and/or most persistent. This comment was rejected because
persons who quit trying in a test situation are likely also to do so in
real life. These persons thus probably are the most likely to misuse
CRP. Thus, adopting this suggestion could significantly reduce the
beneficial effect of the rule.
Number of Tests Per Participant
Several comments were received regarding the number of tests in
which a senior may participate. Commenters requested clarification of
the CPSC's position on this point. The March 1994 proposal states, in
the test instructions for the senior test, ``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.'' Some
commenters requested that the term ``per sitting'' be added to the
first sentence of this instruction to avoid an implication that no
person could test more than two packages in a lifetime. Another
commenter proposed adding the language ``in a 24-hour period'' to the
statement.
The purpose of the statement is not to limit testing individuals to
two packages per lifetime. The statement in the test instructions is
meant to eliminate any effects of continuous testing using the same
people, who may tire, gain expertise, or otherwise perform differently
after testing several different packages. The term ``per sitting'' does
clarify the intent of the restriction and has been added to the adult-
test instructions.
One commenter indicated that since adults have had a lifetime of
learning how to open CRP, subsequent testing at another time is not a
concern. The Commission has concerns about repeated testing by
individuals and the potential for abuse. The Commission does not intend
that the same participant have multiple ``sittings'' within a short
period of time. The Commission does not intend that a panel of people
be in effect trained to open packaging.
Neither does the Commission intend that test participants be drawn
from a ``pool'' of experienced test participants. There is the
potential that people who have failed in the past will not consent to
be tested again, thus creating by default a panel of able participants,
who bias the test results. This potential exists if testers go
frequently to the site where the same people are likely to be found.
Although the length of time between testing needed to ensure that these
sorts of problems do not occur is unknown, the Commission recommends
against testing at sites containing a defined group more than 3 to 4
times a year.
The potential for abuse could be partially eliminated by specifying
a time period between testing the same individual. However, it is
difficult to identify the proper length of time between tests. In
addition, it would be impossible to measure compliance with such a
requirement, unless participant data bases and reporting were also
required. It was also suggested that the participant, rather than the
test agency, be responsible for the frequency of testing. It was
suggested that this could be done by including a statement on the
consent form, such as ``I am between the ages of 50 and 70 and, to the
best of my knowledge, I have not tested a child-resistant package
within (insert a time).'' This would place an additional and
unnecessary burden on the participants. Also, there are no data showing
that participants would have a sufficient recollection of the time
since they were last tested to make this a practical way to deal with
the problem.
Sites
Several comments were received regarding the sites used for
testing. The proposed rule states that no more than 24% of adults
should be tested at any one site. This would require that a minimum of
five sites be used. Commenters requested that the number of sites
required be lowered to four.
In the March 1994 proposal, the Commission analyzed the sites
grouped together by geographic area (3 digit zip code), not by the zip
code of the participants, as many of the commenters stated. [187, 188]
The sites were grouped together geographically because there were
inadequate numbers of participants tested at each site for any
meaningful analysis of site variability. This geographic analysis
showed that there was no variability among the groups of sites in
CPSC's tests, which all used the five-site minimum. There are no test
data on the effect on test results of decreasing the required number of
sites. Accordingly, there is no basis for
[[Page 37722]]
reducing the number of required sites from five to four.
Another commenter suggested that the definition of site be changed
from a location to a group of panelists at a specific location under a
group name. The commenter stated that test results could differ
dramatically between different groups of people based on the
characteristics of a group and not the actual location of the group.
This comment would allow testing at only one geographic site if a
sufficient number of different groups were tested.
Defining a site as a group of people would limit testing to defined
groups, such as a bridge club or a senior citizens meeting on a
particular day. This would eliminate sampling from a mall or other area
where people are not congregated for a central purpose. There is no
information on how this change would affect test results. The
Commission concludes that by selecting a variety of geographic sites
there is a likelihood that senior adults will be selected with diverse
interests and backgrounds.
Another commenter requested that central location testing be
permitted as long as adults were not drawn from the same geographic
area. This commenter submitted data indicating that selecting senior
adults from large central locations, such as shopping malls, can result
in geographic diversity, as measured using residential zip codes. CPSC
staff agrees that large central locations can provide geographic
diversity in the selection of subjects, and that this type of diversity
is desirable. However, there is no information on whether the use of
large central locations has an effect on actual test data. Factors
other than geographic diversity may be important. By selecting a
variety of sites, there is a likelihood that senior adults are selected
with diverse interests and diverse backgrounds. Therefore, the
Commission concludes that senior testing should continue with the
requirement of a minimum of five test sites. However, the Commission's
consent forms are being amended to collect information about
participant's residential zip code, so this suggestion can be evaluated
in the future.
Sequential Test
Several comments were received about the proposed sequential test
and about its alleged effects on the standards for passing the senior
test. Several commenters complained that the CPSC increased the
stringency of the test since, with the sequential adult test, a SAUE of
0.951 would have been required to pass after testing the first panel of
100 seniors. The proposed sequential test would not have increased the
test's stringency, however, since the pass/fail criterion would have
remained 0.900.
The main advantage of a sequential test would be to increase the
probability of making the correct pass/fail decision for those packages
that perform in the ``borderline'' (near 0.900) range. This is
accomplished by increasing the number of people tested for borderline
packages. Thus, the sequential test would have required testing more
adults for packages that perform near the 0.900 pass/fail criterion.
However, borderline packages are not the hardest-to-open packages
that are of the greatest concern to the Commission. The Commission
believes that the hardest packages to use will be eliminated by a panel
of 50-70 year-olds, even without a sequential test.
Therefore, the Commission believes that it can use nonsequential
testing, which may reduce the burden on industry, without compromising
the safety benefits of the rule. Accordingly, both the senior- and
younger-adult tests will use a single 100-member panel.
Senior Consent Forms
Several commenters requested that the actual language of the adult
consent form be included in the rule to further standardize the test.
It was also requested that different forms be used for reclosable and
non-reclosable packages, that participants be told about the time
limits of the test, and that participants be informed that they may be
asked to open other types of packages (i.e., those used for screening
purposes).
The Commission agrees that the consent form should be standardized;
the consent forms used in Commission testing are now included in the
rule as a recommended example. In current testing, separate forms are
used for reclosable and non-reclosable packages. In addition, language
about the potential to be asked to test screening packages has been
added to the consent form.
However, the Commission disagrees that participants should be
advised of the time limits of the test (e.g., ``you have 1 minute'').
Time pressure is a potentially influential factor, and emphasizing a
time limit may induce anxiety unnecessarily among participants.
Instructions
Comments were received that the sample preparation sections of the
child test and the senior test were not consistent. The Commission
agrees and has modified Sec. 1700.20(a)(3)(iv)(A) of the senior test.
Several requests for further standardization of the instructions
were received. Commenters requested standardization of the commands to
participants in the screening test to reflect what is said in the
regular test. Some commenters also indicated that standardized language
should be added to the procedure to help confirm whether a participant
has given up. The Commission agrees with these changes and has amended
the test procedure in Sec. 1700.20 to include additional standardized
language.
E. Effectiveness of the Senior Protocol--Safety v. Convenience
A number of commenters attacked the basic premise of the revisions,
that easier-to-open packages will result in increased proper use of CRP
by adults and that this will increase the safety of children. Some
commenters cast this argument as follows: If (as the commenters
contended) the rule does not increase safety, it perforce addresses
only convenience and is not a proper subject for a Commission
regulation.12 However, the information in the record indicates
that the senior-friendly adult test will have significant safety
benefits and will not compromise child-resistance.
\12\ Given that the Coalition for Responsible Packaging, which
represents the proponents of this argument, now endorses the rule as
adopted [299], it appears that these claims no longer apply.
---------------------------------------------------------------------------
The Rule Will Cause Beneficial Changes in Adult Behavior
Large numbers of adults are currently relegated to using non-CR
packages because of the difficulty in using traditional CR packages.
For example, CPSC test results show that up to 44% of 61-75 year old
adults could not open CR packages that pass the current protocol. [37]
However, under the revised protocol, these adults will be able to use
CR packaging and thereby reduce the risk of accidental poisonings.
The likelihood that people will defeat a safety measure through
error, misuse, or avoidance increases with the degree of actual or
perceived effort and inconvenience required to use the measure. [234,
287] This is evidenced by the current problems with CRP, i.e.,
difficult-to-use containers often are used improperly or not at all.
Conversely, research findings indicate that when the degree of effort
or inconvenience associated with safe behavior is reduced, the
likelihood of compliance increases. [287]
The protocol revisions directly address the capability of the
general population to use a given type of CR package by requiring that
at least 90%
[[Page 37723]]
of test participants of ages 50 to 70 be able to use them. Recent test
results with older adults showed that 95% to 99% of the 60 to 75 year-
olds sampled were able to use the newer types of reclosable packages
tested. [195] Furthermore, the majority of participants rated the
packages ``easy to use.'' [195] Similar results were obtained for non-
reclosable packaging. [194] These results would almost certainly hold
or be even stronger for the 50-60 age group.
The Commission concludes that packaging that older adults can use,
and which they perceive to be easy to use, has a higher likelihood of
being used correctly by the general population than packaging they
cannot use, or which they perceive to be difficult to use.
The Revised Protocols Will Not Compromise Child Safety
Several commenters argued that the proposed changes will lead to a
reduction in child-resistance. Their argument is that packages that
currently pass at, e.g., 95% CR effectiveness may be replaced with
packages that pass at a lower effectiveness after the revised protocols
are adopted. However, the Commission's tests of senior-friendly
packages have shown that packages which are easier for senior adults to
open need not be easier for children to open. Child-resistance
effectiveness levels with the reclosable senior-friendly packages
tested by CPSC varied from 97% to 100%, which are as child-resistant as
the most effective of traditional CR packaging. [195]
One commenter submitted graphs depicting test data purportedly
showing that modifications to CR packaging to make them more adult
accessible result in less child-resistance. [275, 278] The commenter
did not identify the packages tested, describe in detail the changes
that were made to the packages, or provide the raw data for the tests.
Indeed, for two of the five graphs purporting to reflect industry
testing, no backup information was presented. The Commission cannot
determine for any of the graphs whether the appropriate protocol was
adequately followed or whether the effectiveness scores were calculated
properly.13 The failure to provide these data makes it impossible
to make a thorough or meaningful assessment of this commenter's
submission.
\13\ The Commission previously received another industry comment
in which the SAUE scores were all calculated incorrectly, assuming
the age group proportions were correct.
---------------------------------------------------------------------------
Moreover, two of the five packages in these graphs purportedly
scored at least 96% in both the child and adult tests. Thus, the
limited information supplied by this commenter shows, at most, that
some packages may need further modification or may need to be replaced
with commercially available packages having both high adult-
effectiveness and high child-resistance.
Another argument raised by these commenters was that each
percentage point of reduction in true child-resistance would result in
a potential 32 million product failures. This figure apparently was
obtained by dividing 100 into the estimated 3.2 billion CR packages
produced each year. This argument overlooks the fact that even a
package for which child-resistance has been slightly reduced to make it
easier for adults to open will still be far more child-resistant than
one where the cap has been left off or loose because it was difficult
to open. A package that is not child-resistant or that is misused is
less than 9% child-resistant, versus at least 80% child-resistant for
packages that pass the protocol.14 Thus, each additional unit that
is purchased in CR packaging and used properly because it is less
difficult for adults to use can be over 10 times more child-resistant
than non-CR packaging or misused CR packaging.
\14\ Wilbur, C.J., ``Closure Testing Equipment Studies, Status
Reports, Non-Child Resistant, Snap Type Packaging and Continuous
Threaded Type Packaging, CPSC,'' CPSC Directorate for Health
Sciences (March 1990).
---------------------------------------------------------------------------
The Commission is unable to quantify the number of poisonings that
will be prevented by the new rule, and such a calculation is not
statutorily required. However, the record evidence--including survey
data, human factors analysis, and other information--indicates that
this rule will increase the proper use of CR packaging, reduce
injuries, and save children's lives.
One commenter argued that persons who start using CR packaging
because it is easier to open may let their guard down and not be as
vigilant about keeping the products out of the reach of children. The
commenter claimed that this will result in increased poisonings.
However, it is speculative whether caregivers will likely get a false
sense of security if they switch from non-CR packaging to CR packaging.
And, the Commission is not aware of any evidence that this occurred
when CR packages were first introduced.
Because no CR packaging is childproof, it will always be important
to endeavor to keep hazardous products out of the reach of children.
Although it may well still be important to educate people about the
need to keep hazardous products away from children, the rationale for
the PPPA is that education alone is inadequate to address the problem
of accidental childhood poisonings:
Efforts at public education are based on the premise that
poisonings are caused by parental negligence and that poisonings can
be prevented by stimulation of greater parental care. The Committee,
however, believes that parental negligence is not the primary cause
of poisonings. There are too many potentially hazardous products in
the modern home to hope that all of them can be kept out of the
reach of children. Special packaging will accomplish what previous
efforts have not b[y] attempting to create positive separation
between young children and hazardous substances. Special packaging
is intended simply to make the environment of young children safer.
S. Rep. No. 91-845 at 3.
Finally, the Commission has addressed through discretionary
enforcement stays the possibility that a manufacturer may have
difficulty maintaining the child-resistance of packaging while
complying with the new protocol. Specifically, as discussed below, one
of the grounds for such stays is that more time is needed to develop
CRP that will meet the new protocol and not significantly reduce the
child-resistance of the package.
The Commission May Issue Safety Rules That Improve Convenience
One commenter also argued that the Commission could not issue the
proposed rule because an ease-of-use regulation, even if it had a
safety rationale, would not be a ``safety standard'' under the Consumer
Product Safety Act (``CPSA''). As an example, the commenter claimed
that the Commission could not use the CPSA to issue a convenience
standard for lawn mowers.
The fact that the PPPA contains a specific ease-of-use requirement
(that the packaging be not difficult for normal adults) is sufficient
to refute this contention, regardless of what might be done under the
CPSA. As regards the example of lawn mowers, however, the Commission's
Safety Standard for Walk-Behind Power Lawn Mowers (issued under the
CPSA), actually does contain a safety provision linked to convenience.
See 16 CFR 1205.5(a)(iv). Thus, even under the CPSA, the Commission may
issue standards fashioned to ensure safe behavior by consumers, even if
that standard addresses the ``convenience'' of a safety feature.
Market Forces Have Failed To Eliminate Difficult-To-Use Packaging
Finally, a number of commenters argued that ease of use would be
best
[[Page 37724]]
addressed by market forces. However, in the 20-plus years the PPPA has
been in effect, there has been only minimal market penetration by
packages thought to meet the new protocol.
At the presentation of oral comments, a commenter argued that it
would be different in the future now that senior-friendly packaging
that is highly child-resistant has been introduced to the market. He
explained that as soon as other companies developed such packaging,
they would be forced by competitive forces to use it. The commenter
presented no data or evidence to support this optimistic scenario.
There is no reason to believe that, in this case, large segments of
the market will make needed safety changes unless such changes are
mandatory. For the most part, industry has shown no willingness to
spend money and time voluntarily to make significant improvements in
the performance of CR packages. Consumers may not even realize that
easy-to-use packaging can be produced. Also, consumers can purchase
packaging without a CR feature, and consumers have ``solved'' the
problem of difficult packaging by leaving caps off or loose or putting
the contents in another container.
Many packaging manufacturers are apparently reluctant to make a
substantial capital investment to produce easier to open packaging that
will then have to compete with established lines. As a CR package
manufacturer stated in commenting on the proposed rule:
[A]s long as we don't encourage manufacturers to produce good,
effective child-resistant closures, they will never get around to
doing it. And as long as we continue to allow these so-called child
resistant products that require force or tools to be acceptable, no
one can get on the market with a good child-resistant closure. It
would be foolish for any individual or company to invest millions of
dollars when that type of competition is present and allowed.
[Comment CP1-91-1]
Indeed, at the oral hearing, another commenter stated that interest
in a new aerosol package he is developing decreased by 50% over the 2
months since the Commission had excluded aerosol packages from the
rule. [273, p. 104]
In short, there is no basis in the record to conclude that market
forces will ensure the adoption of senior-friendly CR packaging.
Education
One commenter stated that a carefully designed and executed
education program has the potential to reduce childhood poisonings far
more than changing the test protocol for CRP. Other commenters
concluded that the problem is one of adult responsibility; they contend
that education of the senior population is as important as, or more
important than, package changes.
The Commission agrees that education efforts will be a necessary
concomitant to the revised standards to publicize the availability of
easy-to-use packaging and to remind people about the importance of
keeping hazardous products out of the reach of children. However,
education is unlikely to solve this problem as effectively as changes
in available packages. As noted above, in adopting the PPPA, Congress
recognized that education alone could not solve the problem of
accidental poisonings of children. S. Rep. No. 91-845 at 3. Certainly,
education alone cannot address the issue of adult responsibility for
the adults who cannot use some of the CRP currently on the market.
Participation by the industry in this type of education campaign is
welcomed by the Commission.
F. ISR Testing
The Institute for Standards Research (``ISR''), a subsidiary of the
ASTM, sponsored tests to measure the interlaboratory variability
expected when conducting CR package tests according to the proposed
protocols. The ISR testing program involved testing two package types,
ASTM Type IIA (lug) and Type VIIID (blister), by four different testing
agencies. Four senior panels were run at each agency for each package.
Both the ISR and the ISR project manager commented on the results
of the ISR testing and on the comparison of the ISR results with those
obtained from CPSC-sponsored testing conducted by a single testing
agency. [210, Refs. 17 and 35]
In the CPSC-sponsored testing of each of these two package types, a
pass determination was made within the first three test panels,
regardless of the order in which the panels were considered, indicating
that the probability of these packages ever failing was very low. [187]
The same results were obtained in the ISR-sponsored testing.
Additionally, no package tested in either CPSC-sponsored or ISR-
sponsored testing had a calculated effectiveness below 90% for any test
panel, indicating that no package was ever close to failing the senior
adult test. [187, 230]
The ISR noted that there was a statistically significant difference
in the senior-adult use effectiveness among agencies for the lug
package. [210, Ref. 17] A high pass rate for the lug package at one
testing agency was responsible for this conclusion. [230] The reason
for this difference is unknown. It may be because the ISR study was not
standardized sufficiently at the various testing agencies, so that the
study was conducted differently at one testing agency from the way it
was conducted at the other testing agencies. [230] Since CPSC staff did
not observe the actual testing, there is no way for the Commission to
determine if this was the case. In any event, however, the results of
the ISR-sponsored testing verified the proposed CPSC test method.
G. Household Chemicals
Several commenters requested that household chemical products be
regulated separately from pharmaceutical products. Commenters argued
that household chemical products should be excluded from the proposed
test method because the CPSC allegedly has not demonstrated a
significant rate of serious personal injury or illness from poisoning
incidents where CR closures were left off household products by the
elderly. Commenters also claimed that the Commission inappropriately
generalized NEISS data pertaining to injuries to children in the
pharmaceutical category to all regulated household products within its
jurisdiction, including chemical specialty products.
These commenters are referring to a study conducted from NEISS
cases that investigated poisonings from only pharmaceutical products.
[112] While the Commission has no comparable data on household
chemicals, the Commission is aware of ingestions and deaths of children
from PPPA-regulated household products. Household chemicals regulated
under the PPPA include oven cleaners, furniture polish, turpentine,
kindling and illumination preparations, ethylene glycol, solvents for
paint or other similar surface-coating materials, glue removers
containing acetonitrile, and permanent wave neutralizers containing
sodium bromate or potassium bromate. The CPSC staff monitors ingestions
and deaths from these products. (If cleaning products are registered
pesticides, they are regulated by the Environmental Protection Agency
and not the CPSC.)
Many specialty cleaning products are toxic following ingestion. One
published article calculates hazard factors for household products
through an analysis of data from the American Association of Poison
Control Centers (AAPCC) pertaining to reported exposures of children
under 6 years of
[[Page 37725]]
age. [230, Ref. 6] A hazard factor was derived from the number of
serious exposures for a substance, normalized to the overall rate of
major effects and deaths.
Hazard factors for many of these products, including acid and
alkali drain cleaners, alkali oven cleaners, and ethylene-glycol-based
products, were found to be significantly higher than the hazard factor
for all other reported cases, despite the fact that CRP is already
required for these substances. Thus, children are exposed to these
toxic household chemicals.
It is expected that CRP capable of passing the senior adult test
will be easier for adults to use correctly, and the availability of
such packaging will encourage adults to purchase the products in CRP
and properly use the packaging. It seems particularly important to make
such a requirement for these household products, because data submitted
by one commenter showed low senior-adult test scores for household
chemical products. Senior test data submitted by this commenter for 12
different packages showed that 10 packages had senior effectiveness
below 90%. Two packages had senior-effectiveness below 50%. [210, Ref.
15] Since many of the household chemical products are quite toxic, it
is reasonable to require that such products be in CRP that adults are
capable of opening and resecuring properly.
The majority of packaging for household chemicals (approximately
65%) uses the same CRP types used for pharmaceutical products. [233]
For these products, it is just as feasible to provide improved CRP for
household products as it is for pharmaceutical products. For the
remaining household products, primarily products in metal cans or
aerosol dispensers, there are no test data demonstrating that currently
commercially available packages are senior-friendly.
Senior-friendly packaging may be developed for metal cans,
especially if the cap is designed for the use of a tool to aid in
opening. A tool is especially useful for this application since the
caps for products in metal cans often are applied initially with a high
torque to prevent leakage during shipment. After the initial opening,
the option for a tool is available if needed. The Commission is aware
of one promising prototype of a cap for metal cans that has senior-
friendliness as a design goal. [213, 245, 251] Any applications that
use both a metal can and a metal closure would probably take the
longest to develop and implement senior-friendly packaging. [232, 240]
As to aerosols, various types of senior-friendly overcaps show
promise. [232, 240] In addition, designs that use a tool to remove an
overcap may be developed. [170, 183, 232 Ref. 15, 240 Ref. 11, 248]
There is an existing design that places the aerosol actuating button in
a narrow recess that is deep enough that the button can be reached by
an adult's finger, but not by a child's. [240 Ref. 12, 261] Another
design uses an annular ring that is mounted around the aerosol can so
that it can rotate but is not removable. [256] The overcap screws into
the upper portion of the rotatable ring. If one holds the body of the
can and tries to unscrew the overcap, the ring rotates and the overcap
will not unscrew. To remove the overcap, the ring must be held so it
does not rotate while the cap is being unscrewed. Although both of
these designs are promising, the Commission does not know whether they
have been subjected to either the child or senior-adult tests.
The Commission concludes that there are currently a substantial
number of ingestions by children of household chemicals and that a
significant portion of seniors cannot open and resecure existing
packages. Thus, improving the packages will reduce the likelihood that
the CR package will be defeated or not resecured. Therefore, the
Commission decided to include household chemicals as a group in the
requirement for senior-friendly packaging.
Nevertheless, as noted above, aerosols and metal packages with
metal closures are likely to take the longest time to implement senior-
friendly packaging, and to present the most difficulties. Excluding
these two types of packaging from the revised requirements at this time
will also reduce the potential competition for the services of testing
organizations during the 30-month period before compliance with the
revised adult test will be required for other products.
The Commission's technical staff believes that senior-friendly
packaging for all products, including those in metal containers and in
aerosols, can be produced eventually. Nevertheless, excluding products
that require metal or aerosol containers from the revised requirements
will enable the Commission to monitor the further development and
testing of these limited types of packaging before making any
subsequent decision about whether or not to require such packages to be
senior-friendly.
Accordingly, the Commission concludes that products that must be
packaged in metal packages with metal closures, or in aerosols, will
not be subject to the senior-adult test that is issued below. However,
the Commission will monitor the development of senior-friendly versions
of these types of packages and revisit this issue at a later time.
These metal and aerosol containers will be subject to the revised child
test and will remain subject to the current younger-adult test. All
other products presently subject to special packaging requirements
under the PPPA will be subject to the revised child and senior-adult
requirements.
A product will be deemed to require metal containers or aerosol
form if:
1. No other packaging type would comply with other state or Federal
regulations,
2. No other packaging can reasonably be used for the product's
intended application,
3. No other packaging or closure material would be compatible with
the substance,
4. No other suitable packaging type would provide adequate shelf-
life for the product's intended use, or
5. Any other reason clearly demonstrates that such packaging is
required.
In the absence of convincing evidence to the contrary, a product
shall be presumed not to require a metal container if the product, or
another product of identical composition, has previously been marketed
in packaging using either a nonmetal package or a nonmetal closure. If
requested by the Commission's staff, the manufacturer or packager of a
product packaged in a non-senior-friendly metal or aerosol container
will provide a justification of why, under the criteria specified
above, the product requires such packaging.
H. Comments on Statutory Findings
Many commenters claimed that the Commission did not have sufficient
information to make the statutory findings that technically feasible,
practicable, and appropriate senior-friendly CRP is available for all
substances regulated under the PPPA.
Some commenters seem to believe that in order for a package to be
technically feasible, practicable, and appropriate, it must be
commercially available. This is not the case. These findings mean that
senior-friendly CR packages can be made and mass produced that are
compatible with the substances to be packaged. The CPSC presented data
in the March 1994 Federal Register notice on many different packages
that are commercially available and have passed the senior-friendly
protocol. In addition, closure manufacturers have indicated that other
types of senior-friendly packaging can
[[Page 37726]]
be developed. Manufacturers and packagers may also consider alternative
packaging. The lack of commercial availability of a closure for a
particular specialty package does not mean that a closure cannot be
developed for that package or that other packages would be
inappropriate for the product. A detailed discussion of the
Commission's findings is in section V of this notice.
I. 1-Year Effective Date, Blanket 18-Month Exemption from Compliance,
and Additional Temporary Stays of Enforcement
In the October 5, 1990, Federal Register notice, the Commission
proposed 1 year after promulgation as the effective date for the
proposed senior-adult test. This is the longest effective date
authorized in the PPPA. The Commission requested information about the
economic effect of the effective date.
Alternatives to a 1-Year Effective Date
Commenters voiced concern about the limited availability of testing
firms and senior-friendly packaging in the proposed 1-year period. The
commenters suggested alternative approaches, including grandfathering
existing CRP, phasing-in by product class, phasing-in by package type,
and corporate averaging. Commenters also requested the formation of a
CRP conversion task force for determining appropriate effective dates.
Another commenter requested that the Commission issue a compliance
policy guide.
1. Grandfathering existing CRP. If adopted, this comment could
negate the objective of the regulation, which is to ensure that
currently marketed hard-to-open CRP is removed from the market. The
objective of grandfathering for a limited period of time is achieved by
the 18-month blanket exemption from compliance being provided by the
Commission. This is discussed in more detail below.
2. Limited testing facilities. Commenters argued that there is
insufficient capacity for testing CRP to enable all products to be
tested in time to comply with a 1-year effective date. Although the
current capacity of testing organizations may be insufficient to
provide enough tests of CRP to ensure that all products can be tested
and senior-friendly packaging implemented within 1 year, these firms do
plan to increase their capacity as much as possible to take advantage
of the increase in demand for their services.
In addition, the revised procedures are specified in enough detail
that some manufacturers and packagers could conduct their own tests for
compliance with the revised protocol. This was shown by the ISR tests,
which used one laboratory that had no previous experience in conducting
CR package tests. Also, it is expected that additional testing
laboratories will form to meet this need. The CPSC's staff has had many
inquiries from marketing groups and universities interested in
providing testing services.
The Commission's 18-month exemption from compliance, discussed
below, also will accommodate delays caused by any lack of appropriate
test facilities.
3. Phase-in by product class. Many commenters suggested that the
revised requirements be phased in by product class. Various suggestions
were made as to which product classes should go first.
The Commission does not agree that this phase-in approach is an
efficient way to obtain the most complying CRP in a short but
reasonable time. In most product categories, some packaging has been
developed that will comply with the revised protocol. Thus, regulating
by product class would have given many companies more time to comply
than is necessary.
4. Phase-in by package type. Another option suggested for a phase-
in approach was to phase in by package types. The Commission did not
adopt this approach, because it could have unnecessarily delayed use of
senior-friendly packaging. If a package design truly presents unusual
problems in complying, the procedure for temporary stays of enforcement
can be used.
5. Corporate averaging. One commenter stated that corporate
averaging would be an appropriate system for phasing in the effective
date. A specified percentage of a company's products would have to
comply with the new regulations by a specified time, and the rest of
its products would be phased in by percentage over time.
The Commission does not believe this would be an efficient way to
implement the regulation. Many companies use only one type of
packaging, and additional time is not necessary. Also, the Commission
would be unable to monitor compliance with the regulation since the
CPSC would not know what particular products or packages should comply.
Even if industry undertook to keep the Commission fully advised, the
burden on both industry and the Commission would be enormous.
6. Task force. One commenter suggested that a task force,
consisting of CPSC staff, industry, closure suppliers, and testing
agencies, determine compliance time frames. The Commission rejected
this approach as impractical and unnecessary. No procedure was
described to resolve disagreements on such a task force or to insure
that the public interest would be adequately represented. Furthermore,
there is no mechanism to enforce the determinations of a task force
except the time-consuming one of additional rulemaking proceedings by
the Commission.
7. Compliance policy guide. One commenter requested that the
Commission issue a compliance policy guide (``CPG'') concerning its
enforcement of the new standards. The commenter suggests that the
Commission develop a policy statement which establishes criteria by
which a manufacturer would be considered to have demonstrated a good
faith effort to comply with the standards. CPSC then would not take
action against packaging not meeting the standards if the manufacturer
had satisfied the criteria specified in the policy.
This CPG approach is less practical than the procedure for an 18-
month compliance exemption. Rather than trying to anticipate all the
possible ways in which a good faith effort could be thwarted, it will
be much more efficient to deal with such situations through a time-
limited exemption, followed by additional individual temporary
enforcement stays, where justified.
None of the approaches suggested by the commenters provides an
efficient method to obtain the largest amount of senior-friendly
packaging on the market in the shortest reasonable time. The Commission
estimates that most products subject to the requirements could comply
within 1 year. However, as discussed below, an 18-month compliance
exemption is established to address many of the cost factors involved
in a 1-year effective date.
8. Exemption from compliance. The PPPA requires that the effective
date of a regulation establishing a special packaging standard shall
not be later than 1 year after the date that the regulation is final
(i.e., is published in the Federal Register as a final rule). Having
found that designs of child-resistant packaging that meet the
requirements of the revised testing protocol are technically feasible,
practicable, and appropriate, the Commission has allowed the statutory
maximum one year for the revisions to the testing protocol to go into
effect. Data available to the Commission indicate that sufficient
quantities of these designs could be manufactured within a year to meet
the demand for packages that comply with the revised testing
requirements.
[[Page 37727]]
The Commission recognizes that the revised standard may affect as
many as 3 billion packages annually. This will require action on the
part of closure manufacturers, as well as packagers of products subject
to regulations, manufacturers of bottles and containers, mold
manufacturers, and other firms involved in the packaging and
distribution of products subject to PPPA regulations. In adopting these
protocol revisions, the Commission wants to (i) minimize any commercial
disruption, (ii) allow for a more orderly transition to packaging that
complies with the revised requirements, and (iii) help assure that--
consistent with the results of CPSC testing on certain currently
available packages--any other new packaging designs or modifications
provide ease of adult use without sacrificing child resistance.
Therefore, the Commission is granting companies a blanket exemption
from having to comply with the revised adult protocol for 18 months
after it goes into effect. The exemption from the senior-adult
requirement will apply only to products that comply with the younger-
adult requirement.
The Commission believes that the additional 18 months will provide
adequate time for affected firms to make any necessary changes to their
packages or machinery, and to place orders for complying packaging in a
timely manner that assures delivery well in advance of the effective
date. The Commission also recognizes, however, that unique
circumstances may arise that require additional time for individual
firms to comply. The Commission will therefore also consider requests
for additional reasonable enforcement stays after the expiration of the
18-month exemption.
The Commission, through appropriate staff, shall grant a request
for an enforcement stay that demonstrates, based upon supporting
information and documentation, (i) a good-faith effort to obtain
packaging that complies with the revised standards during the period
after publication of the final rule in the Federal Register, and (ii)
compliance with one of the following criteria:
1. Delay in Protocol Testing. Protocol testing likely will not
be completed within the time required to enable complying packages
to be used by the applicable deadline. Estimated dates upon which
testing will be completed and complying products will be produced
shall be submitted. (Several protocol testing firms should be
contacted to obtain the earliest completion date.)
2. Product Testing. Required FDA testing likely will not be
completed within the time required to enable complying packages to
be used by the applicable deadline. Estimated dates by which testing
will be completed and complying products will be produced shall be
submitted.
3. Equipment. Necessary manufacturing equipment will likely not
be available within the time required to manufacture finished
products in compliance with the revised requirements. The estimated
date by which equipment will be in use and complying CRP will be
produced shall be submitted.
4. CRP Availability. Where CRP is claimed to be unavailable, an
explanation shall be provided of why currently available,
alternative CRP cannot reasonably or practicably be used. An
estimated date by which complying CRP will be obtained and produced
shall also be submitted.
5. Redesigned/New CRP: Maintaining Child Resistance. Where a
claim is made that CRP will have to be redesigned or developed, an
explanation shall be provided of why commercially available
packaging cannot reasonably or practicably be used. The rationale
for a temporary enforcement stay under this provision may include,
among other reasons, that more time is reasonably needed to develop
a CRP that will meet the new adult protocol and not significantly
reduce the child resistance of the package. An estimated date by
which complying CRP will be obtained and produced shall also be
submitted.
6. Other. Other substantial reasons demonstrating that
additional time is reasonably necessary to comply with the amended
protocol. An estimated date by which complying CRP will be obtained
and implemented shall be submitted.
The Commission, through appropriate staff, shall issue a decision
granting or denying the request for a temporary stay of enforcement
within 30 days after receipt of the request and appropriate supporting
material. All requests for enforcement stays, including any supporting
data or information, for which claims of confidentiality are made,
shall be considered confidential and exempt from public disclosure to
the extent allowable by law.
J. Miscellaneous Comments
Carpal Tunnel Syndrome
Comments were received by groups representing pharmacists that
requested that the Commission and manufacturers consider the need for a
design of CRP that reduces the incidence of repetitive motion injuries,
such as carpal tunnel syndrome, among pharmacists. Letters were
received from pharmacists with carpal tunnel syndrome.
Carpal tunnel syndrome is caused by compression of the nerves in
the wrist. It is associated with occupations that require repeated
forceful wrist bending. Some of the pharmacists attribute their
repetitive motion injuries to opening and closing certain designs of
CRP.
The CPSC is prohibited by the PPPA from prescribing specific
package designs, and the Commission is unaware of any performance test
for CRP that would have the effect of reducing carpal tunnel syndrome.
However, packages that are easier for seniors to use should be easier
for everyone, including pharmacists, to use. The effect this will have
on the development of carpal tunnel syndrome in pharmacists is unknown.
Exemption for Large-Diameter Packages
One commenter, a manufacturer of swimming pool chemicals, requested
that large diameter packages, over 110 mm, be exempted from the senior
test. The manufacturer provided test data on the packaging used
currently by the firm. In all cases, the packages failed the proposed
senior test.
It should be noted that this specific manufacturer makes products
regulated by the Environmental Protection Agency (EPA) and not by the
CPSC. The decision on whether to exempt this product thus will be the
EPA's responsibility.
In general, however, the Commission does not believe that failing
data on existing packages is reason enough for a permanent exemption
from the revised protocol. The Commission believes that senior-friendly
CRP for all CPSC-regulated products is technically feasible,
practicable, and appropriate. Removing existing CRP from the market
that cannot be used properly by the senior panel is the purpose of the
revisions.
Need for Additional Comment
After the Commission voted to issue the revised protocol containing
the older-adult test panel of 50-70 year-olds, an individual wrote to
the Commission suggesting that the changes from the proposal should
have been published so that those particular changes could be commented
on by the public. The Commission does not believe such action is either
legally required or sound policy. All the changes from the proposal are
within the range of issues discussed in earlier Federal Register
notices. Furthermore, the final rule is a logical outgrowth of the
previous notices and the comments received in the rulemaking. Thus, an
additional opportunity for public comment is not required and would
significantly delay the substantial safety benefits of the rule.
IV. Economic Issues [236]
A. General
More than 20 categories of substances require special
packaging.15 These include oral prescription drugs; aspirin,
acetaminophen, ibuprofen, and
[[Page 37728]]
loperamide in OTC drugs; potassium and sodium bromates in permanent
wave neutralizers; low-viscosity mineral seal oil and/or other
petroleum distillates in furniture polish; and turpentine, sodium and/
or potassium hydroxide, methyl alcohol, sulfuric acid and ethylene
glycol in various household products. Product formulations include
liquids, gels, solids, flakes, granules, and powders.
\15\ The substances are specified at 16 CFR 1700.14.
---------------------------------------------------------------------------
Oral liquid pharmaceuticals are either prepackaged by the
manufacturer or pharmacy-dispensed using reclosable continuous-threaded
(``CT'') closures. Some liquids are available in non-reclosable unit-
dose packages. Most oral solid dosages (tablets and capsules) are
either prepackaged in plastic bottles with CT or snap closures or are
pharmacy-dispensed in vials with CR lug-finish closures. However, the
number of solid dosage preparations that are prepackaged by the
manufacturer in non-reclosable blisters or pouches is growing,
according to an industry study from Leading Edge Reports.16
\16\ Drug and Pharmaceutical Packaging Materials, May 1991.
---------------------------------------------------------------------------
Household products are supplied in a greater variety of container
shapes and in larger volume sizes than are drug preparations. According
to commenters, approximately 65% of household products use styles
similar or identical to those used for drug products. [233] CRP for
household products include plastic, glass, fiberboard, and metal
containers with plastic, metal, or combination metal/plastic closures
or dispensers. CR closure styles include CT, overcap, and various
specialty designs unique to a particular product/container. Some
household products are supplied in single-use non-reclosable pouches or
bags. Larger packages (5 gallons or more) of household substances are
not required to meet special packaging requirements. (16 CFR 1701.3)
17
\17\ Certain household products that meet the size exemption may
require special packaging by the Environmental Protection Agency
(EPA). EPA, Prevention, Pesticides and Toxic Substances [7506C],
EPA-735-F-94-003, For Your Information.
---------------------------------------------------------------------------
Closures are seals or lids, typically made of plastic or metal. The
closure and the container together make a package. Plastic CR closures
(SIC 3089) make up only a small portion of the total closure market
(CRP and non-CRP).18 In 1991, 73 firms shipped 39.2 billion
closures, of which only 3.0 billion units (8%) were CR. Prescription
drugs accounted for 29% (0.9 billion) of CR closures, while the
remaining 71% (2.1 billion) were used on ``All Other,'' a category that
includes OTC drugs. Census data do not provide a breakout for OTC drugs
and other products.
\18\ In the Initial Regulatory Flexibility Analysis, 1986 Bureau
of Census closure shipment data for companies using Standard
Industrial Classification (SIC) 3089 (Plastic Products, Not
Elsewhere Classified were cited. The latest available shipment data
appear in Bureau of Census, Closures for Containers, MQ34H(92)-5,
Summary for 1991, issued July 1992, after which Census discontinued
publishing the report due to withdrawal of trade association
funding.
---------------------------------------------------------------------------
According to the Census Bureau, 14 of the 73 closure manufacturers
ship CR closures for prescription drugs and 26 of the 73 ship CR
closures for all other products. It is likely that the 14 manufacturers
of CR closures for prescription drugs also manufacture CR closures for
other regulated products (i.e., are a subset of the 26 other CR closure
manufacturers). It is likely, too, that a substantial number of the CR
closure manufacturers also produce non-CR closures and numerous other
plastic products. Industry spokespersons estimate that the four largest
manufacturers of plastic closures account for over 80% of the CR
closure market.
Metal and metal composite closures are also available for use on
products requiring CRP. However, they comprise an even smaller part of
the market than plastic closures. The companies producing them are
classified in SIC 3466, Crown and Closures. In 1991, 27 companies
shipped an estimated 17.5 billion metal and metal composite closures.
About 0.5 billion units (3%) were manufactured by 10 companies and used
on medicine packages. Census data do not provide a breakout by use for
CR metal closures.
Firms involved in providing the materials for non-reclosable
packages (e.g., films, foils, and adhesive-coated paperboard backings)
are a diverse group of suppliers of packaging materials and equipment.
Their products are used by pharmaceutical and household product
manufacturers for non-reclosable packages such as blister
configurations and pouches that are fabricated at the time they are
filled. Packages can readily be fabricated as CR or non-CR, depending
upon the characteristics of the materials used.
The revised protocol will likely cause many changes in the
packaging of products subject to the PPPA. The changes are both
expected and desirable, since the widespread availability and use of
senior-friendly packaging will help to minimize the number of
accidental poisonings of young children. In the short run, however,
achieving a more senior-friendly universe of CRP also will entail costs
or other effects to industry. The Final Regulatory Flexibility Analysis
in section VIII of this notice includes more detail regarding impacts
on small entities. There are also effects on consumers.
In general, most firms should be able to comply with the revised
rule with modest cost effects on themselves or their customers, because
complying closures are known to exist and to be available at low
incremental costs. However, there are several categories of effects of
the revised PPPA protocols, especially where firms undertake to develop
new or modified packaging. These effects include: design and
development of new or modified closures; testing to determine
compliance with the CR protocol requirements and, if needed, the
requirements of other agencies; testing to ensure product integrity or
to meet other standards, such as strength or stability; testing for
consumer acceptance, if desired; modification of packaging equipment to
accommodate the new packaging; production costs; and other
miscellaneous effects. Production costs, which would be ongoing, will
not be significant. The remaining costs are one-time, up-front
expenditures.
B. Economic Comments
Many commenters expressed concern that the revised regulations will
result in increased costs in several areas. The response to specific
comments is presented below.
Test costs. Some commenters claimed that the cost of testing will
increase because of the requirement of informed consent for the child
test and the increased numbers of seniors tested in the sequential
senior test.
As was discussed previously, the CPSC is required to use informed
consent in all human testing. However, data obtained from child tests
conducted without informed consent will not be disregarded based on the
lack of informed consent alone. Since there is no requirement for
testing, it is the package or product manufacturer's decision to test
either with or without informed consent.
With respect to the cost of sequential testing, the issue of
increased costs is moot because, as discussed above, the Commission has
decided not to adopt this approach.
Cost-benefit comments. Several commenters claimed that the
Commission was required by the PPPA to assess the economic impact of
the revisions and had not done so. One commenter argued that the
statutory
[[Page 37729]]
terms ``practicable,'' appropriate,'' and ``reasonable'' require the
agency to justify the standards on cost-benefit grounds.
The terms ``practicable'' and ``appropriate'' are found in the
findings that the Commission is required to make under section 3(a)(2)
of the PPPA. 15 U.S.C. 1472(a)(2). Whatever these terms may mean in
other contexts, they are specifically described in the legislative
history of the PPPA:
In order to find that special packaging is ``practicable'', the
[Commission] must determine, for example, whether special packaging
meeting the standard would be susceptible to modern mass-production
and assembly-line techniques. Finally, in order to find that special
packaging is ``appropriate for such substance'', the [Commission]
must examine the substance under consideration and find that
packaging complying with the standard is not detrimental to the
integrity of the substance and does not interfere with its storage
or use.
S. Rep. No. 91-845 at 10. Thus, these terms do not require cost-
benefit findings.
Section 3(b) of the PPPA requires the Commission to consider the
``reasonableness'' of any PPPA standard it issues. However, the
legislative history of the PPPA states, with respect to section 3(b),
the Commission
Is not required to make a formal finding regarding these issues.
This paragraph is intended to prevent the [Commission] from ruling
out available evidence on these issues and to insure consideration
of that evidence.
S. Rep. No. 91-845 at 10 (emphasis added).
Thus, the Commission is not statutorily required to ``justify''
PPPA standards on cost-benefit grounds, as contended by this commenter.
Nevertheless, the Commission is always concerned about the potential
costs of its actions. The Commission seeks to fulfill its
Congressionally-mandated mission in the most cost-effective manner.
Accordingly, the Commission had its staff present the available
information on costs and benefits for consideration. [236] That
information, which is discussed in detail below, included the likely
costs to industry to comply with an older-adult test protocol.
Significantly, those costs are overwhelmingly one-time, up-front
expenses.
By comparison, the $500 million annual societal costs of accidental
childhood ingestions provide a tremendous potential for ongoing
benefits from the rule. While the costs of the rule will largely be
incurred before the rule's effective date, the substantial benefits of
the rule will continue for the foreseeable future.
Moreover, the Commission has taken several actions to potentially
reduce the cost of the final rule. These include using an adult panel
of ages 50-70, instead of 60-75, and eliminating the sequential test
which, in some cases, could require testing up to 400 adults.
Accordingly, the Commission concludes that the costs of the rule
are justified in view of the benefits that it will achieve.
For additional discussion of the findings that the Commission is
required to make in order to issue this rule, and of the other matters
the Commission is required to consider but not make formal findings on,
see section V of this notice.
Another commenter indicated that the Commission has not complied
with Executive Order 12866, which requires that certain agencies
provide the Office of Management and Budget with analyses of the costs
and benefits of proposed significant regulatory actions and their
alternatives.
Executive Order 12866 imposes a number of requirements on
``agencies,'' as that term is defined in the order. However, under the
Order, the term ``agency'' generally does not include independent
regulatory agencies, such as the Commission, as that term is defined in
44 U.S.C. 3502(10). Thus, except for preparing a Regulatory Plan and
Regulatory Agenda (which the Commission does), the requirements of
Executive Order 12866 do not apply to the Commission. Accordingly, the
comments relating to the Commission's responsibilities under this Order
are inapplicable.
V. Statutory Requirements for Issuing PPPA Standards
A. General
Section 3(a)(1) of the PPPA, 15 U.S.C. 1472(a)(1), authorizes the
Commission to issue standards for the special packaging of any
household substance if it finds that ``the degree or nature of the
hazard to children in the availability of such substance, by reason of
its packaging, is such that special packaging is required to protect
children from serious personal injury or serious illness resulting from
handling, using, or ingesting such substance.'' As noted previously,
special packaging is packaging that is significantly difficult for
children under 5 years of age to open and not difficult for normal
adults to use properly. 15 U.S.C. 1471(4).
Section 3(a)(2) of the PPPA, 15 U.S.C. 1472(a)(2), requires the
Commission to find that the amended standard ``is technically feasible,
practicable, and appropriate for [the substances to which it will
apply].'' ``Technically feasible'' means that package designs that
would meet the requirements of 16 C.F.R. 1700.15(b), and that would be
suitable for use with the products subject to the rule, are or can be
available. S. Rep. No. 91-845 at 10. A standard is ``practicable'' when
special packaging for the products covered by the rule is adaptable to
modern mass production and assembly line techniques. Id. A standard is
``appropriate'' where special packaging can be made available in forms
that are not detrimental to the integrity of the substance and do not
interfere with its storage or use. Id.
The Commission's staff developed data to support these statutory
findings with respect to the 60-75 age group, rather than the
participants of ages 50-70 in the panel specified in the final rule.
However, these data also support the findings for the 50-70 age group,
because packaging that achieves passing results with a 60-75 panel will
also meet the 50-70 panel requirement.
Under section 3(b) of the PPPA, 15 U.S.C. 1472(b), the Commission,
in issuing a PPPA standard, also is required to consider (a) the
reasonableness of the standard, (b) available scientific, medical, and
engineering data concerning special packaging and concerning childhood
accidental ingestions, illness, and injury caused by household
substances, (c) the manufacturing practices of industries affected by
the PPPA, and (d) the nature and use of the household substance. In
issuing this rule, the Commission has considered these factors.
B. Availability to Children
As noted above, in order to issue a CRP standard, the Commission
must find that ``the degree or nature of the hazard to children in the
availability of such substance, by reason of its packaging, is such
that special packaging is required to protect children from serious
personal injury or serious illness resulting from handling, using, or
ingesting such substance.'' 15 U.S.C. 1472(a)(1). The Commission
previously made this finding for the substances listed in 16 C.F.R.
1700.14 when it required that they meet the standards and testing
procedure currently specified in 16 C.F.R. 1700.15 and 1700.20. Insofar
as those findings relate to the toxicity of the substances and to the
general accessibility of the packages to children in the household,
these findings are still applicable.
Even though these substances are now marketed in CRP, changes to
the adult protocol are needed to adequately protect children from the
serious personal injury or serious illness presented by these
substances. As explained above, the noncomplying
[[Page 37730]]
provision of the PPPA, 15 U.S.C. 1473(a), specifically allows packagers
to supply nonprescription regulated products in one size of
conventional packaging. 16 C.F.R. 1700.5. In addition, 15 U.S.C.
1473(b) allows regulated prescription products to be provided in non-
CRP when requested by the purchaser or directed by the prescriber. Many
people exercise these options to obtain packaging that is not CR, and
this exposes a significant number of young children to toxic products.
A 1989 CPSC study [112] analyzed a statistical sample of ingestions
of medications by children under age 5 that were treated by hospital
emergency rooms reporting to the National Electronic Injury
Surveillance System (NEISS). This study showed that 44% of the
prescription medicines in the study were not dispensed in a CR package.
This study also showed that about 40% of the medications (prescription
or nonprescription) in the study were not originally packaged in a CR
container at the time of purchase and that about 17% of the medications
were originally packaged in a CRP but were not in a secured (returned
to the CR mode) CRP at the time of the ingestion. The 17% that were no
longer in secured CRP consisted of (i) cases where the medication had
been removed from the container before the ingestion (about 9%), (ii)
cases where the medication was in a CR package but the top was left
open (about 6%), and (iii) cases where the medication was in a
container with a different top (about 2%).
Further, a 1986 study conducted by the CPSC in conjunction with the
AAPCC demonstrated the occurrence of pediatric drug ingestions
involving disabled CRP or non-CR packaging. [29] The study involved 9
poison control centers and about 2,000 pediatric drug ingestions. The
study showed that, for all medicines in prescription containers other
than a unit-dose package, 18% (n=234) had a cap that was loose or off
prior to the ingestion. Of those cases involving toxic drugs,
approximately (i) 6% involved a CRP with the closure left off or loose,
(ii) 17% involved contents transferred from one container to another,
and (iii) 18% involved a non-CR package. Thus, improper use of CRP
apparently is involved in a substantial number of ingestions by
children.
The available information also shows that much of this misuse is
caused by regarding the CRP as too difficult to open. This was
demonstrated by a 1980 CPSC report of the results of a telephone survey
of about 3,000 consumers concerning how they used both drugs and
chemical specialty items. [15] In that survey, the primary reason for
improper use of CRP for about 42% of the persons who said they left the
CR cap off was that it was too difficult to open or close. This was
also the primary reason given by 43% of those who said they transferred
contents from one container to another and by 59% of those who said
they replaced the CR cap with a non-CR cap. These data demonstrate that
a major reason why consumers use CR packaging improperly is that the CR
packaging is too difficult to open or close.
The problem of operating CRP has a special impact on older
consumers, who as a group have more difficulty opening these packages.
A survey of 120 non-institutionalized older persons showed that 60%
acknowledged having difficulty opening or closing CR medication
containers. [9] Sixty-four percent of the women (average age, 70 years)
and 36% of the men (average age, 67 years) admitted to having
difficulty.
The difficulties experienced by older persons in using CRP, and the
resultant tendency to avoid using such packaging, expose children to
risk. Data acquired since the 18-45 age panel was selected have shown
that there is substantial exposure of young children to adults older
than age 60. In the 1989 CPSC NEISS study [112], 16% of the
prescription medicines ingested belonged to a grandparent. The
percentage of the prescription drugs ingested that belonged to persons
age 60 or above was also 16%. These data demonstrate the importance of
assuring that older adults can operate CRP by substituting a panel of
older persons.
Commission tests [121] show that the inclusion of an older-adult
test as part of the PPPA human performance test protocol also will
improve the ability of all adults to use CRP. If CRP were easier to
use, there would be less motivation to seek out non-CR packaging. Thus,
fewer conventional packages would be available to young children who
live with or are otherwise exposed to the purchasers. In addition, if
complying packages were easier to open and resecure, the packages would
more likely be properly resecured after use. Accordingly, substituting
a panel of older adults will help protect children by increasing
consumer willingness to use CRP and to keep the package properly
resecured. This conclusion is supported by the available information.
The Commission has received at least 76 form letters stating that
the sender has trouble with CRP, supporting the 60-75 age panel
requirement, and pledging that the writer would use CRP if it were
inexpensive and easy to use. [140] The Commission also is aware of one
study showing that easy-to-use CRP would result in increased proper
resecuring of caps. [21]
Previously-available packaging was considered to be difficult to
open by 22 to 64% of people from ages 18 to 45, depending on package
type. [27, 28] Among people 61 to 75 years old, 27 to 69% found the
packages difficult to open. Recent test results with older adults with
more senior-friendly packaging differ markedly from the tests cited
above. These latter results showed 95 to 99% of the adults (ages 60 to
75) were able to use the reclosable packages tested, and 84 to 91% of
the adults rated the packages as ``easy to use.'' [195] Similar results
were obtained for non-reclosable packaging.
Thus, the data support the conclusions that a panel of older
persons will make CRP easier for normal adults to use; that this will
result in more persons buying CRP and using it properly, and that this
will ultimately result in fewer accidental poisonings of young
children.
For the above reasons, the Commission finds that the degree and
nature of the hazard to children in the availability of the substances
specified in 16 C.F.R. 1700.14, by reason of packaging that does not
comply with the revised protocol, is such that issuance of the revised
protocol is required to protect children from serious personal injury
or serious illness from handling, using, or ingesting such substances.
C. Technical Feasibility
Introduction
As noted above, technically feasible means that packaging meeting
the new standard can be produced. Based on testing done under
Commission contract and other information in the record from industry
sources, the Commission concludes that special packaging meeting the
revised test protocols is technically feasible for all products now
required to be in CRP that will be covered by the revised protocols.
The discussion below shows how the Commission reached this
conclusion for various categories of packaging as established by ASTM.
It is important to note, however, that manufacturers need not continue
to use the same type of package that they have in the past. In some
cases, it may be easier or less costly to switch to another type of
package that is senior-friendly than to obtain or develop a senior-
friendly package of the same type that was used previously.
Continuous-Threaded Packaging
Most of the regulated products use or can use this type of CRP.
Commercially
[[Page 37731]]
available CR ASTM Type IA CT 28mm caps with liner and tamper resistant
shrink neck band, on white round plastic 50-tablet bottles [195] were
tested under a CPSC contract. This package requires a push down and
turn force to open. The CRP has a SAUE of 0.953 (n=100) and a CR
effectiveness (CRE) of 100% (n=50), and 90% of the senior adults
indicated the package was easy to use. Id. The package manufacturer has
supplied CPSC with older-adult protocol test data that show other sizes
of this type of special packaging also meet the proposed SAUE and CRE
requirements. [240]
In addition, a commercially available CR ASTM Type IB CT 35mm cap
without liner on a 50-ounce plastic-handled bottle with two locking
notches [195] was tested under CPSC contract. The package requires a
squeeze and turn force to open. This CRP had a SAUE of 0.983 (n=100)
and a CRE of 100% (n=100), and 84% of the senior adults indicated the
package was easy to use. Id. CPSC has senior protocol test data from
the manufacturer showing other sizes of this design CRP also meet the
proposed SAUE and CR effectiveness requirements. [240]
For those products requiring metal containers and closures for
product stability purposes, one manufacturer has an InterLok plastic
over metal 1\1/4\ inch standard alpha nozzle CR cap, requiring a tool
to open, that is suitable for use with metal containers. [213] The
manufacturer indicated the package likely complies with proposed SAUE
and CRE requirements.
Lug-Type Packaging
This type of CRP is typically used for dispensing prescription
drugs. A commercially available CR ASTM Type IIA lug, 13 dram, 35mm cap
with insert liner on a round amber prescription polypropylene vial
without product was tested by CPSC under contract. [160, 195] The
package requires a push down and turn force to open. The package had a
SAUE of 0.961 (n=100) and a CRE of 100% (n=100), and 89% of the senior
adults indicated the package was easy to use. [195] The package
manufacturer has supplied CPSC with older adult protocol test data that
show other sizes of this type of special packaging would also meet the
proposed SAUE and CRE requirements. [240]
The ASTM's Institute for Standards Research (``ISR'') conducted
senior adult testing (n=1600) using four protocol testing firms. [211]
The CRP tested was the same type from the same company as that tested
by CPSC, but with a different production date. Test data from all four
testing firms showed the CRP complying with the proposed SAUE
requirements. Three of the four testing firms reported compliance with
the proposed standards after testing the first set of 100 senior
adults.
Snap-Type Packaging
This type of CRP is typically used for prescription drugs and over-
the-counter (OTC) nonliquid products, i.e., tablets, capsules, powders,
etc. A commercially available CR ASTM Type IIIA snap 33 mm cap with
liner and tamper resistant shrink neck band, and foil inner seal on a
white round plastic bottle (9) was tested under CPSC contract.
[160, 195] This package requires arrows to be lined up and an upward
force applied to open. This CRP had a SAUE of 0.992 (n=100), a CRE of
97% (n=100), and 91% of the
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