[Federal Register Volume 60, Number 140 (Friday, July 21, 1995)]
[Rules and Regulations]
[Pages 37710-37744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17436]




[[Page 37709]]

_______________________________________________________________________

Part II





Consumer Product Safety Commission





_______________________________________________________________________



16 CFR Part 1700



Requirements for the Special Packaging of Household Substances; Final 
Rule

  Federal Register / Vol. 60, No. 140 / Friday, July 21, 1995 / Rules 
and Regulations  

[[Page 37710]]


CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700


Requirements for the Special Packaging of Household Substances

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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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

[[Page 37714]]
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 senior adults indicated the package was 
easy to use. [195] There is no reason to believe that other sizes of 
this design CRP cannot be made senior-friendly.
Pouches and Blister Packaging
    The non-reclosable single-use CR pouch and blister packaging are 
used for a variety of products and can be used for most regulated 
products. Four commercially available packages containing product, two 
CR pouches and two CR blisters, were tested by CPSC under contract as 
received from the manufacturer. The packages tested are as follows:
    A CR ASTM type IVA foil pouch with internal (hidden) tear notch 
opening was tested with 400 seniors and had a SAUE of 0.981 after the 
first 100 adults tested, and 80.5% of the senior adults indicated the 
package was easy to use. [194] This package design is presently used 
for many products.
    The same type of foil pouch was also tested with instructions to 
use scissors to open. [194] In this case, it is classified as a CR ASTM 
type IVC foil pouch. The CR pouch, opened with a tool, had a SAUE of 
1.000 after the first 100 adults tested, and 99% of participants 
indicated the package was easy to use. Id. Test results show that 
senior adults can successfully open CR pouches with a tool (scissors) 
and find it easy to do.
    A CR ASTM type VIIID, semi-rigid blister with peel and push out 
opening, blister card (3  x  4 = 12 blisters) was tested with 400 
seniors and had a SAUE of 0.961 after the first 100 adults tested, and 
81% of participants indicated the package was easy to use. [194] This 
package design is used for a number of products at this time.
    The ASTM/ISR conducted senior adult testing (n=1600) on the same 
type of semi-rigid blister from the same manufacturer and containing 
the same product as the Commission had tested using four protocol 
testing firms. [211] 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 proposed standards after the 
first test of 100 senior adults.
    A CR ASTM type VIIIE, semi-rigid blister with internal tear notch 
and instructions to use scissors to open, blister card (2  x  3 = 6 
blisters) was tested with 400 seniors and had a SAUE of 0.942 after two 
sets of 100 adults were tested. [194] Eighty-four percent of the 
participants indicated the package was easy to use. Id. This design 
package is used for a number of products at this time that are 
regulated, i.e., hazardous, at the one- or two-unit level. Test results 
show that senior adults can successfully open CR blisters with a tool 
(scissors) and find it easy to do.
    Tests with commercially available products show there is senior-
friendly CR pouch and blister packaging on the market. [194] Such 
packaging is, therefore, technically feasible. Some products using CR 
pouch and blister packaging presently include the option of using a 
tool (scissors) to open the package. Data show that the use of a tool 
(scissors) increases the number of seniors able to open the package and 
the ease with which they open the package. Id.
Aerosols and Pumps
    Currently, a few PPPA-regulated substances, such as oven cleaners, 
use this type of packaging. Products that must be in aerosol form are 
not subject to the new senior-friendly requirements. They will be, 
however, subject to the revised child test requirements and will remain 
subject to the current adult-test requirements.
    One CRP manufacturer has advertised its CR overcap--ASTM type VIID, 
a permanently attached hinged overcap that requires a tool (coin) to 
open--to be senior-friendly. [232, Ref. 15] This design can be used for 
aerosols and certain mechanical pump dispensers. Based upon past 
experience with such designs, the Commission believes that this overcap 
could be developed so it would be both child-resistant and senior-
friendly. If a tool is required to open the package, it will likely 
comply with the CR effectiveness standards. With the leverage afforded 
when using a tool (e.g., a coin) and with the proper opening force a 
senior-friendly package can be accomplished.
    Developing CR, SAUE packaging for the small capacity mechanical 
pump package may require more time than other package types. A CR 
overcap with

[[Page 37732]]
a tool-assisted opening feature can ensure child-resistance. However, 
making this cap senior-friendly is more difficult.
    The Commission concludes that the available information support the 
finding that senior-friendly mechanical pump packaging is technically 
feasible.

D. Practicability

    For ASTM types I, II, III, IV and VIII, (CT, lug, snap, pouch, 
blister, and mechanical dispensers) senior-friendly CRP are presently 
being used by some companies for regulated products. [232, 240] These 
companies use assembly line and mass production techniques in their 
manufacturing processes. This shows that it is practicable to package 
regulated products in special packaging. No major problems are 
anticipated in this change from the manufacturing standpoint.
    Two CRP manufacturers state that ASTM types VII (hinged overcap) 
and IX (mechanical pump, with a CR overcap) senior-friendly special 
packaging can be made commercially available and are practicable. [232] 
This is supported by one manufacturer that supplies its CR overcap 
commercially. [232, Ref. 16] Modifications would need to be made to the 
assembly line to include the CR overcap feature, and production 
techniques may require modifications to obtain a satisfactory 
manufacturing process. This special package can be implemented into a 
product manufacturer's assembly line and production manufacturing 
process. Therefore, it is practicable to package products in aerosol 
and mechanical pump special packaging with overcaps.
    Also, the Commission is aware of an aerosol design that can be 
actuated by an adult-sized finger but not by a child's. [216, 240 Ref. 
12] Like the CR overcap design, this package can be used with assembly 
line and mass production techniques and is therefore practicable. For 
the reasons discussed above, however, products that must be packaged in 
aerosol form or in metal cans are not required to meet the senior-
friendly requirements in the rule.

E. Appropriateness for the Substance

    Some companies are presently using senior-friendly ASTM types I, 
II, III, IV and VIII special packaging for their products. Companies 
can use existing CRP designs and materials that have proven not to be 
detrimental to the integrity of the substance and have not interfered 
with its storage or use. The implementation of senior-friendly 
packaging should not affect shelf-life and integrity, because it is 
anticipated that the same packaging materials could be used in contact 
with the product. FDA or DOT approval may be required if a switch in 
packaging is required for a particular product. However, the record 
information supports the finding that senior-friendly CRP of ASTM types 
I, II, III, IV, and VIII are appropriate for the packaged substances.
    Available information also supports the finding that senior-
friendly CRP of ASTM types VII and IX is appropriate for the packaged 
substances. The CR overcap method of packaging has successfully been 
used. [232] The CR overcap concept does not affect the integrity of the 
substance or interfere with its storage or use, because the CR overcap 
is separate from the product container. Product shelf-life and 
integrity would not be expected to change, as it is anticipated that 
the same packaging materials could be used in contact with the product.

F. Conclusion

    The Commission concludes that the revised protocols will ensure 
that special packaging will be significantly difficult for children 
under age 5 to open or obtain a toxic or harmful amount of the contents 
within a reasonable time and will not be difficult for normal adults to 
use properly. The Commission also finds that for the products covered 
by the revised rule, special packaging is technically feasible, 
practicable, and appropriate for the substances.

VI. Effective Date

    Section 8 of the PPPA, 15 U.S.C. 1471n, requires that the effective 
date of a special packaging standard ``shall not be sooner than one 
hundred and eighty days or later than one year from the date such 
regulation is final, unless the [Commission], for good cause found, 
determines that an earlier effective date is in the public interest and 
publishes in the Federal Register [the] reason for such finding, in 
which case such earlier date shall apply.'' As explained below, the 
Commission is establishing different effective dates for some of the 
amendments being issued.
    With regard to the revised requirements for the senior-adult test 
panel, senior-adult test times, and standardized senior-adult 
instructions, there are regulated PPPA products on the market with ASTM 
type IA, IB, IIA, IIIA, IVA, IVC, VIIID, and VIIIE CRP that comply with 
the SAUE requirements. This is demonstrated by CPSC and ASTM/ISR 
senior-adult protocol test results.
    Most PPPA-regulated substances could be packaged in senior-friendly 
CRP in 1 year. [232, 240] Additional time may be required for others. 
To serve the market, over 3 billion senior-friendly CRP need to be 
manufactured per year. The CRP design modifications, mold changes, 
protocol testing, and, in some cases, FDA stability or DOT performance 
testing all require time to complete before commercial production of 
senior-friendly CRP can begin. Companies that currently make senior-
friendly CRP do not presently have the production capacity to meet the 
entire demand.
    Two CR overcap manufacturers have indicated that, with adequate 
time, they can make suitable ASTM type VII and IX senior-friendly CR 
overcaps. [232, Refs. 15 and 16] This type of CR feature can be used 
with packaging using mechanical pumps. Additional time may be required 
for the two CR overcap manufacturing companies to redesign for new 
sizes, obtain molds, protocol test, and start commercial production. 
More than 1 year may be needed to ensure adequate supplies of new 
senior-friendly and CR packaging.
    Therefore, the Commission is allowing the maximum time permitted by 
statute, 1 year, as the effective date for the senior-adult test panel, 
senior-adult test times, senior-adult standardized instructions, and 
limitations on sites and testers for the younger-adult test. The 
Commission is also granting an 18-month blanket exemption from 
compliance after the effective date in order to ease the burden on 
industry. In addition, the Commission is implementing a procedure 
whereby companies unable to comply within that time, despite their 
good-faith efforts to do so, may apply for temporary enforcement stays. 
These temporary enforcement stays are described in section III(I) of 
this notice, concerning the Commission's response to comments on the 
effective date.

    The child-test amendments concerning sequential testing, three age 
groups, standardized instructions, and the limitations on sites and 
testers are not expected to change the results of these tests. However, 
to allow time for companies to complete ongoing studies and plan future 
studies, these amendments will become effective January 24, 1996.

    The amendments to publish the suggested guidelines for an 
appropriate resecuring test will become effective August 21, 1995. The 
Commission finds that this effective date is in the public interest 
because the guidelines provide additional options for achieving 
reliable test results, yet, since they are not mandatory, do not impose 
new obligations on companies. Therefore,

[[Page 37733]]
there is no reason why these guidelines should not become effective as 
quickly as possible.

VII. Environmental Protection Agency

    The Environmental Protection Agency (``EPA'') enforces the Federal 
Insecticide, Fungicide and Rodenticide Act (``FIFRA''), as amended (7 
U.S.C. 136-136y). Under that Act, EPA has the authority to protect 
people and the environment from the adverse effects of pesticides by 
ensuring that pesticide products are applied, stored, and disposed of 
in a manner consistent with the product registration.
    The Administrator of EPA is authorized to establish standards with 
respect to the package, container, or wrapper in which a pesticide or 
device is enclosed for use or consumption, in order to protect children 
and adults from serious injury or illness resulting from accidental 
ingestion or contact with pesticides or devices regulated by FIFRA. 
FIFRA specifies that the standards established by EPA must be 
consistent with those established under the authority of the PPPA. 
Thus, packages that comply with the PPPA regulations would also comply 
with the standards established by EPA for products regulated under 
FIFRA. However, EPA would retain the authority to exempt products, 
either completely or under stated conditions, from the requirement that 
products regulated under FIFRA have CRP.
    Since the Commission is amending its regulations under the PPPA, 
EPA can be expected to make any necessary amendments to its regulations 
for packaging so that EPA's regulations will be consistent with those 
established by the Commission. However, the Commission is not in a 
position to fully assess how the changes may affect all the products 
subject to regulation by EPA under FIFRA. For example, some of the 
containers subject to FIFRA are much larger, and have much larger and 
more massive closures, than do the household products regulated by CPSC 
under the PPPA. Such products, that comply with the present PPPA 
requirements, may not be able to comply with the senior-adult test 
panel or reduced testing times being proposed for products subject to 
the PPPA. However, if necessary, EPA has the option of allowing certain 
containers to comply with a standard incorporating a 5-minute test of 
the 18-45 age group.

VIII. Regulatory Flexibility Analysis [236]

A. General

    The Regulatory Flexibility Act (Pub. L. No. 96-345) requires 
agencies to prepare and make available for public comment an initial 
regulatory flexibility analysis describing the impact of the rule on 
small businesses and other small entities, when a notice of proposed 
rulemaking is published in the Federal Register. In its proposal to 
revise the protocol for testing CRP under the PPPA, the Commission made 
an initial determination that the effect of the revisions depended upon 
the amount of package testing needed and the potential cost of research 
and development and equipment modification, if necessary, to enable 
closures/packages to meet the revised test protocol. The potential cost 
of meeting marketing requirements of other government agencies was also 
unknown.
    CPSC received comments on the proposal that provided information on 
anticipated impacts on companies. Some comments were specific to an 
individual company; some comments were more generalized and came from 
trade associations representing small and large businesses. The types 
of businesses impacted by the proposed revisions include: closure/
package manufacturers; household product manufacturers/packagers, 
pharmaceutical packagers, and pharmacies.
    Estimates of the number of businesses in the various market 
segments are based on data from government sources, trade associations, 
and trade publications. These sources did not provide specific 
information on the size of the firms. Small entities that are 
unaffiliated with trade organizations and that did not comment on the 
proposal are included in the estimates only to the extent that they 
reported (anonymously) to government sources.

B. Closure Manufacturers

    The Bureau of the Census reported 1991 CR shipment data from 40 or 
fewer manufacturers (none by name). However, CPSC staff identified 
about 70 manufacturers of CR closures, many of which were likely 
included in the Census data. According to industry spokespersons, the 
CR closure segment of the market is highly concentrated, with the 4 
largest manufacturers of plastic closures accounting for an estimated 
80% of the CR closure market. [236] Few, if any, of the more than 60 
other manufacturers (an unknown number of which may be small) produce 
CRP as a primary product line, since the CR market is itself only a 
small fraction of the closure market.
    At a minimum, closure manufacturers will incur the costs of testing 
existing packages for SAUE. Failing packaging cannot be filled after 
the expiration of the 18-month exemption from compliance (unless an 
additional temporary stay of enforcement is granted), but such 
packaging may be modified or redesigned if economically feasible. The 
costs of changes are expected to fall on the customer and, in most 
cases, to pass through to the consumer. It is unlikely that a 
substantial number of small firms will experience severe or permanent 
adverse impacts as a consequence of the final rule.
    CPSC received only one comment from a self-identified small 
business that expected ``onerous and undue hardship.'' CR closures 
account for 20% of this company's business. One aspect of the burden 
concerns timing, which the Commission has addressed by granting an 18-
month exemption from compliance after the effective date. In addition, 
the company can apply for an additional temporary stay of enforcement 
if good-faith efforts do not enable compliance by the expiration of the 
18-month exemption.

C. Household Product Manufacturers and Packagers

    Two trade associations, representing over 900 firms, commented on 
the proposal. One association said about 65% of its members (almost 
300) were small businesses; the other association (representing about 
500 members) did not respond to a staff request for this information. 
Comments from the associations and from several large household product 
manufacturers centered around the cost of testing, the availability of 
packaging, and the timing of the implementation of the rule. CPSC did 
not receive comments from individual self-identified small household 
product manufacturers or packagers. The manufacturers and packagers of 
household products that must be packaged in metal containers or aerosol 
form will benefit from the Commission's decision not to include these 
products within the scope of the products subject to the senior-
friendly requirements of the revised rule.
    Small household product manufacturers will incur the costs of 
testing proprietary packages, if they use such packaging. Economic 
considerations will guide decisions by small companies on whether to 
pursue SAUE package development (if proprietary packages fail the 
revised

[[Page 37734]]
protocol), to use standard (supplier stocked, on-the-shelf) SAUE 
packaging, or to reformulate or withdraw a product. Some SAUE packaging 
is available now; other SAUE package types, including those for 
products having formulations that impose unusual requirements on 
packaging, are expected to become available. Changes in packaging may 
require associated equipment purchases or modifications. Costs of 
testing some products to meet the requirements of government agencies 
other than CPSC may be required if packaging is changed. Incremental 
costs associated with new SAUE packaging should not add materially to 
the costs of a product and are expected to be passed on to the 
consumer.
    CPSC does not anticipate that any substantial number of small 
businesses will be significantly affected, however, because of the 
current and expected future availability of SAUE packaging for all 
types of product formulations. If necessary, companies can apply for a 
temporary stay of enforcement to comply with the rule.

D. Pharmaceutical Packagers

    There are an estimated 1,200 pharmaceutical packagers, according to 
an FDA spokesperson, an unknown number of which are small. [236] Also 
unknown is the number of small firms that provide consumer-ready 
pharmaceuticals; some firms provide products only in bulk packages. The 
Commission expects that many of the small firms can use standard SAUE 
packaging. However, firms that use reclosable packaging may have to 
find new suppliers, and may also have to pay more for SAUE packaging. 
Films, foils, and other materials used for SAUE non-reclosable 
packaging also may cost more than the materials used for existing CRP. 
No comments were received from any small company regarding the possible 
need for stability testing to meet FDA requirements. Incremental costs 
for new packaging are expected to be modest and most likely will be 
passed on to users. CPSC does not anticipate that a significant number 
of packagers will be severely or permanently affected.

E. Pharmacies

    There are over 40,000 independent pharmacies, according to a 
representative of the National Association of Retail Druggists, most of 
which are small businesses. [236] (There are an additional 25,000 chain 
pharmacies, including those associated with drug and food stores and 
mass merchandisers. Id.) Retail establishments may have to find new 
suppliers if old suppliers abandon the market or do not offer 
acceptable sizes of containers. Pharmacies may also have to pay more 
for SAUE packaging than for existing CRP. Pharmacy staff probably will 
spend additional time instructing customers in the use of new 
packaging. Modest incremental costs for SAUE packaging and for staff 
time are likely to be passed on to the consumer, and there should not 
be a big impact on most pharmacies.

F. Conclusion

    The Commission concludes that the action to revise the testing 
protocol for special packaging under the PPPA will not have a 
significant adverse impact on a substantial number of small businesses.

IX. Environmental Considerations

    Pursuant to the National Environmental Policy Act, and in 
accordance with the Council on Environmental Quality regulations and 
CPSC procedures for environmental review, the Commission has assessed 
the possible environmental effects associated with the revisions to the 
PPPA protocols.
    The Commission assessed the possible environmental effects of 
rulemaking associated with the revisions to the protocol for testing 
CRP under the PPPA and presented its findings in a paper dated April 2, 
1990. [123, Tab D] Reassessment of the possible environmental effects 
confirms the original determination that the rule will have no 
significant effects on the environment. [236] The revisions to the rule 
involve a test method and establish new test standards. They will not 
change the number of CRP in use. Since the rule will not become 
effective until 1 year after its publication and there will be a 
subsequent 18-month blanket exemption from compliance, there is time to 
use up existing inventories of unfilled non-SAUE packaging. 
Additionally, SAUE packaging is made of basically the same materials 
and in basically the same way as older styles of CRP. Much of the 
existing equipment involved in the production and filling of non-SAUE 
packaging can be modified to produce SAUE packaging, rather than 
replaced.

EFFECTIVE DATES: Revised Secs. 1700.15(b)(2), 1700.20(a)(3), and 
1700.20(a)(4) are effective July 22, 1996. Until then, current 
Secs. 1700.15(b)(2), 1700.20(a)(4), and 1700.20(a)(5) remain in effect.
    Revised Secs. 1700.20(a) (1) and (2) are effective January 24, 
1996. Until then, current Secs. 1700.20(a)(1)-(3) remain in effect.
    New Sec. 1700.20(d) is effective August 21, 1995.
    For mandatory provisions, the effective dates specified above apply 
to all products subject to the respective sections that are packaged on 
or after the effective date.

List of Subjects in 16 CFR Part 1700

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

V. Conclusion

    For the reasons given above, the Commission amends 16 CFR 1700.20 
as follows:

PART 1700--[AMENDED]

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

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

    2. Section 1700.15(b)(2) is revised to read as follows:


Sec. 1700.15  Poison prevention packaging standards.

* * * * *
    (b) * * *
    (2) Ease of adult opening. (i) Senior-adult test. Except for 
products specified in paragraph (b)(2)(ii) of this section, special 
packaging shall have a senior adult use effectiveness (SAUE) of not 
less than 90% for the senior-adult panel test of Sec. 1700.20(a)(3).
    (ii) Younger-adult test. (A) When applicable. Products that must be 
in aerosol form and products that require metal containers, under the 
criteria specified below, shall have an effectiveness of not less than 
90% for the younger-adult test of Sec. 1700.20(a)(4). The senior-adult 
panel test of Sec. 1700.20(a)(3) does not apply to these products. For 
the purposes of this paragraph, metal containers are those that have 
both a metal package and a recloseable metal closure, and aerosol 
products are self-contained pressurized products.
    (B) Determination of need for metal or aerosol container.
    (1) Criteria. A product will be deemed to require metal containers 
or aerosol form only if:
    (i) No other packaging type would comply with other state or 
Federal regulations,
    (ii) No other packaging can reasonably be used for the product's 
intended application,
    (iii) No other packaging or closure material would be compatible 
with the substance,

[[Page 37735]]

    (iv) No other suitable packaging type would provide adequate shelf-
life for the product's intended use, or
    (v) Any other reason clearly demonstrates that such packaging is 
required.
    (2) Presumption. 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.
    (3) Justification. A manufacturer or packager of a product that is 
in a metal container or aerosol form that the manufacturer or packager 
contends is not required to comply with the SAUE requirements of 
Sec. 1700.20(a)(3) shall provide, if requested by the Commission's 
staff, a written explanation of why the product must have a metal 
container or be an aerosol. Manufacturers and packagers who wish to do 
so voluntarily may submit to the Commission's Office of Compliance a 
rationale for why their product must be in metal containers or be an 
aerosol. In such cases, the staff will reply to the manufacturer or 
packager, if requested, stating the staff's views on the adequacy of 
the rationale.
    3. Section 1700.20(a) is revised to read as follows:


Sec. 1700.20 Testing procedure for special packaging.

    (a) Test protocols. (1) General requirements.
    (i) Requirements for packaging. As specified in Sec. 1700.15(b), 
special packaging is required to meet the child test requirements and 
the applicable adult test requirements of this Sec. 1700.20.
    (ii) Condition of packages to be tested. (A) Tamper-resistant 
feature. Any tamper-resistant feature of the package to be tested shall 
be removed prior to testing unless it is part of the package's child-
resistant design. Where a package is supplied to the consumer in an 
outer package that is not part of the package's child-resistant design, 
one of the following situations applies:
    (1) In the child test, the package is removed from the outer 
package, and the outer package is not given to the child.
    (2) In both the adult tests, if the outer package bears 
instructions for how to open or properly resecure the package, the 
package shall be given to the test subject in the outer package. The 
time required to remove the package from the outer package is not 
counted in the times allowed for attempting to open and, if 
appropriate, reclose the package.
    (3) In both the adult tests, if the outer package does not bear any 
instructions relevant to the test, the package will be removed from the 
outer package, and the outer package will not be given to the test 
subject.
    (B) Reclosable packages--adult tests. In both the adult tests, 
reclosable packages, if assembled by the testing agency, shall be 
properly secured at least 72 hours prior to beginning the test to allow 
the materials (e.g., the closure liner) to ``take a set.'' If assembled 
by the testing agency, torque-dependent closures shall be secured at 
the same on-torque as applied on the packaging line. Application 
torques must be recorded in the test report. All packages shall be 
handled so that no damage or jarring will occur during storage or 
transportation. The packages shall not be exposed to extreme conditions 
of heat or cold. The packages shall be tested at room temperature.
    (2) Child test. (i) Test subjects. (A) Selection criteria. Use from 
1 to 4 groups of 50 children, as required under the sequential testing 
criteria in Table 1. No more than 20% of the children in each group 
shall be tested at or obtained from any given site. Each group of 
children shall be randomly selected as to age, subject to the 
limitations set forth below. Thirty percent of the children in each 
group shall be of age 42-44 months, 40% of the children in each group 
shall be of age 45-48 months, and 30% of the children in each group 
shall be of age 49-51 months. The children's ages in months shall be 
calculated as follows:
    (1) Arrange the birth date and test date by the numerical 
designations for month, day, and year (e.g., test date: 8/3/1990; birth 
date: 6/23/1986).
    (2) Subtract the month, day, and year numbers for the birth date 
from the respective numbers for the test date. This may result in 
negative numbers for the months or days. (e.g.,
[GRAPHIC] [TIFF OMITTED] TR21JY95.000

    (3) Multiply the difference in years by 12 to obtain the number of 
months in the difference in years, and add this value to the number of 
months that was obtained when the birth date was subtracted from the 
test date (i.e., 4 x 12= 48; 48+2= 50). This figure either will remain 
the same or be adjusted up or down by 1 month, depending on the number 
of days obtained in the subtraction of the birth date from the test 
date.
    (4) If the number of days obtained by subtracting the days in the 
birth date from the days in the test date is +16 or more, 1 month is 
added to the number of months obtained above. If the number of days is 
-16 or less, subtract 1 month. If the number of days is between -15 and 
+15 inclusive, no change is made in the number of months. Thus, for the 
example given above, the number of days is -20, and the number of 
months is therefore 50-1=49 months.
    (B) Gender distribution. The difference between the number of boys 
and the number of girls in each age range shall not exceed 10% of the 
number of children in that range. The children selected should have no 
obvious or overt physical or mental handicap. A parent or guardian of 
each child shall read and sign a consent form prior to the child's 
participation. (The Commission staff will not disregard the results of 
tests performed by other parties simply because informed consent for 
children is not obtained.)
    (ii) Test failures. A test failure shall be any child who opens the 
special packaging or gains access to its contents. In the case of unit 
packaging, however, a test failure shall be any child who opens or 
gains access to the number of individual units which constitute the 
amount that may produce serious personal injury or serious illness, or 
a child who opens or gains access to more than 8 individual units, 
whichever number is lower, during the full 10 minutes of testing. The 
number of units that a child opens or gains access to is interpreted as 
the individual units from which the product has been or can be removed 
in whole or in part. The determination of the amount of a substance 
that may produce serious personal injury or serious illness shall be 
based on a 25-pound (11.4 kg) child. Manufacturers or packagers 
intending to use unit packaging for a substance requiring special 
packaging are requested to submit such toxicological data to the 
Commission's Office of Compliance.
    (iii) Sequential test. The sequential test is initially conducted 
using 50 children, and, depending on the results, the criteria in Table 
1 determine whether the package is either child-resistant or not child-
resistant or whether further testing is required. Further testing is 
required if the results are inconclusive and involves the use of one or 
more additional groups of 50 children each, up to a maximum of 200 
children. No individual shall administer the test to more than 30% of 
the children tested in each group. Table 1 gives the acceptance (pass), 
continue testing, and rejection (fail) criteria to be

[[Page 37736]]
used for the first 5 minutes and the full 10 minutes of the children's 
test. If the test continues past the initial 50-child panel, the 
package openings shown in Table 1 are cumulative.

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

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

Standardized Child Test Instructions

    1. Reclosable packages, if assembled by the testing agency, 
shall be properly secured at least 72 hours prior to the opening 
described in instruction number 3 to allow the materials (e.g., the 
closure liner) to ``take a set.'' Application torques must be 
recorded in the test report.
    2. All packages shall be handled so that no damage or jarring 
will occur during storage or transportation. The packages shall not 
be exposed to extreme conditions of heat or cold. The packages shall 
be tested at room temperature.
    3. Reclosable packages shall be opened and properly resecured 
one time (or more if appropriate), by the testing agency or other 
adult prior to testing. The opening and resecuring shall not be done 
in the presence of the children. (In the adult-resecuring test, the 
tester must not open and resecure the package prior to the test.) If 
multiple openings/resecurings are to be used, each of four (4) 
testers shall open and properly resecure one fourth of the packages 
once and then shall open and properly resecure each package a 
second, third, fourth, through tenth (or other specified number) 
time, in the same sequence as the first opening and resecuring. The 
packages shall not be opened and resecured again prior to testing. 
The name of each tester and the package numbers that he/she opens 
and resecures shall be recorded and reported. It is not necessary 
for the testers to protocol test the packages that they opened and 
resecured.
    4. The children shall have no overt physical or mental 
handicaps. No child with a permanent or temporary illness, injury, 
or handicap that would interfere with his/her effective 
participation shall be included in the test.
    5. The testing shall take place in a well-lighted location that 
is familiar to the children and that is isolated from all 
distractions.
    6. The tester, or another adult, shall escort a pair of children 
to the test area. The tester shall seat the two children so that 
there is no visual barrier between the children and the tester.
    7. The tester shall talk to the children to make them feel at 
ease.
    8. The children shall not be given the impression that they are 
in a race or contest. They are not to be told that the test is a 
game or that it is fun. They are not to be offered a reward.
    9. The tester shall record all data prior to, or after, the test 
so that full attention can be on the children during the test 
period.
    10. The tester shall use a stopwatch(s) or other timing devices 
to time the number of seconds it takes the child to open the package 
and to time the 5-minute test periods.
    11. To begin the test, the tester shall hand the children 
identical packages and say, ``PLEASE TRY TO OPEN THIS FOR ME.''
    12. If a child refuses to participate after the test has 
started, the tester shall reassure the child and gently encourage 
the child to try. If the child continues to refuse, the tester shall 
ask the child to hold the package in his/her lap until the other 
child is finished. This pair of children shall not be eliminated 
from the results unless the refusing child disrupts the 
participation of the other child.
    13. Each child shall be given up to 5 minutes to open his/her 
package. The tester shall watch the children at all times during the 
test. The tester shall minimize conversation with the children as 
long as they continue to attempt to open their packages. The tester 
shall not discourage the children verbally or with facial 
expressions. If a child gets frustrated or bored and stops trying to 
open his/her package, the tester shall reassure the child and gently 
encourage the child to keep trying (e.g., ``please try to open the 
package'').
    14. The children shall be allowed freedom of movement to work on 
their packages as long as the tester can watch both children (e.g., 
they can stand up, get down on the floor, or bang or pry the 
package).
    15. If a child is endangering himself or others at any time, the 
test shall be stopped and the pair of children eliminated from the 
final results.
    16. The children shall be allowed to talk to each other about 
opening the packages and shall be allowed to watch each other try to 
open the packages.
    17. A child shall not be allowed to try to open the other 
child's package.
    18. If a child opens his/her package, the tester shall say, 
``THANK YOU,'' take the package from the child and put it out of the 
child's reach. The child shall not be asked to open the package a 
second time.
    19. At the end of the 5-minute period, the tester shall 
demonstrate how to open the package if either child has not opened 
his or her package. A separate ``demo'' package shall be used for 
the demonstration.
    20. Prior to beginning the demonstration, the tester shall ask 
the children to set their packages aside. The children shall not be 
allowed to continue to try to open their packages during the 
demonstration period.
    21. The tester shall say, ``WATCH ME OPEN MY PACKAGE.''
    22. Once the tester gets the children's full attention, the 
tester shall hold the demo package approximately two feet from the 
children and open the package at a normal speed as if the tester 
were going to use the contents. There shall be no exaggerated 
opening movements.
    23. The tester shall not discuss or describe how to open the 
package.
    24. To begin the second 5-minute period, the tester shall say, 
``NOW YOU TRY TO OPEN YOUR PACKAGES.''
    25. If one or both children have not used their teeth to try to 
open their packages during the first 5 minutes, the tester shall say 
immediately before beginning the second 5-minute period, ``YOU CAN 
USE YOUR TEETH IF YOU WANT TO.'' This is the only statement that the 
tester shall make about using teeth.
    26. The test shall continue for an additional 5 minutes or until 
both children have opened their packages, whichever comes first.
    27. At the end of the test period, the tester shall say, ``THANK 
YOU FOR HELPING.'' If children were told that they could use their 
teeth, the tester shall say, ``I KNOW I TOLD YOU THAT YOU COULD USE 
YOUR TEETH TODAY, BUT YOU SHOULD NOT PUT

[[Page 37737]]
THINGS LIKE THIS IN YOUR MOUTH AGAIN'' In addition, the tester shall 
say, ``NEVER OPEN PACKAGES LIKE THIS WHEN YOU ARE BY YOURSELF. THIS 
KIND OF PACKAGE MIGHT HAVE SOMETHING IN IT THAT WOULD MAKE YOU 
SICK.''
    28. The children shall be escorted back to their classroom or 
other supervised area by the tester or another adult.
    29. If the children are to participate in a second test, the 
tester shall have them stand up and stretch for a short time before 
beginning the second test. The tester shall take care that the 
children do not disrupt other tests in progress.

    (3) Senior-adult panel. (i) Test subjects. Use a group of 100 
senior adults. Not more than 24% of the senior adults tested shall be 
obtained from or tested at any one site. Each group of senior adults 
shall be randomly selected as to age, subject to the limitations set 
forth below. Twenty-five percent of the participants shall be 50-54 
years of age, 25% of participants shall be 55-59 years of age, and 50% 
of the participants shall be 60-70 years old. Seventy percent of the 
participants of ages 50-59 and ages 60-70 shall be female (17 or 18 
females shall be apportioned to the 50-54 year age group). No 
individual tester shall administer the test to more than 35% of the 
senior adults tested. The adults selected should have no obvious or 
overt physical or mental disability.
    (ii) Screening procedures. Participants who are unable to open the 
packaging being tested in the first 5-minute time period, are given a 
screening test. The screening tests for this purpose shall use two 
packages with conventional (not child-resistant (CR) or ``special'') 
closures. One closure shall be a plastic snap closure and the other a 
CT plastic closure. Each closure shall have a diameter of 28 mm 
 18%, and the CT closures shall have been resecured 72 
hours before testing at 10 inch-pounds of torque. The containers for 
both the snap- and CT-type closures shall be round plastic containers, 
in sizes of 2 ounce  \1/2\ ounce for the CT-type closure 
and 8 drams  4 drams for the snap-type closure. Persons who 
cannot open and close both of the screening packages in 1-minute 
screening tests shall not be counted as participants in the senior-
adult panel.
    (iii) SAUE. The senior adult use effectiveness (SAUE) is the 
percentage of adults who both opened the package in the first (5-
minute) test period and opened and (if appropriate) properly resecured 
the package in the 1-minute test period.
    (iv) Test procedures. The senior adults shall be tested 
individually, rather than in groups of two or more. The senior adults 
shall receive only such printed instructions on how to open and 
properly secure the special packaging as will appear on or accompany 
the package as it is delivered to the consumer. The senior-adult panel 
is tested according to the procedure incorporated in the following 
senior-adult panel test instructions:

Test Instructions for Senior Test

    The following test instructions are used for all senior tests. 
If non-reclosable packages are being tested, the commands to close 
the package are eliminated.
    1. No adult with a permanent or temporary illness, injury, or 
disability that would interfere with his/her effective participation 
shall be included in the test.
    2. Each adult shall read and sign a consent form prior to 
participating. Any appropriate language from the consent form may be 
used to recruit potential participants. The form shall include the 
basic elements of informed consent as defined in 16 CFR 1028.116. 
Examples of the forms used by the Commission staff for testing are 
shown at Sec. 1700.20(d). Before beginning the test, the tester 
shall say, ``PLEASE READ AND SIGN THIS CONSENT FORM.'' If an adult 
cannot read the consent form for any reason (forgot glasses, 
illiterate, etc.), he/she shall not participate in the test.
    3. Each adult shall participate individually and not in the 
presence of other participants or onlookers.
    4. The tests shall be conducted in well-lighted and distraction-
free areas.
    5. Records shall be filled in before or after the test, so that 
the tester's full attention is on the participant during the test 
period. Recording the test times to open and resecure the package 
are the only exceptions.
    6. To begin the first 5-minute test period, the tester says, ``I 
AM GOING TO ASK YOU TO OPEN AND PROPERLY CLOSE THESE TWO IDENTICAL 
PACKAGES ACCORDING TO THE INSTRUCTIONS FOUND ON THE CAP.'' (Specify 
other instruction locations if appropriate.)
    7. The first package is handed to the participant by the tester, 
who says, ``PLEASE OPEN THIS PACKAGE ACCORDING TO THE INSTRUCTIONS 
ON THE CAP.'' (Specify other instruction locations if appropriate.) 
If the package contains product, the tester shall say, ``PLEASE 
EMPTY THE (PILLS, TABLETS, CONTENTS, etc.) INTO THIS CONTAINER.'' 
After the participant opens the package, the tester says, ``PLEASE 
CLOSE THE PACKAGE PROPERLY, ACCORDING TO THE INSTRUCTIONS ON THE 
CAP.'' (Specify other instruction locations if appropriate)
    8. Participants are allowed up to 5 minutes to read the 
instructions and open and close the package. The tester uses a 
stopwatch(s) or other timing device to time the opening and 
resecuring times. The elapsed times in seconds to open the package 
and to close the package are recorded on the data sheet as two 
separate times.
    9. After 5 minutes, or when the participant has opened and 
closed the package, whichever comes first, the tester shall take all 
test materials from the participant. The participant may remove and 
replace the closure more than once if the participant initiates 
these actions. If the participant does not open the package and 
stops trying to open it before the end of the 5-minute period, the 
tester shall say, ``ARE YOU FINISHED WITH THAT PACKAGE, OR WOULD YOU 
LIKE TO TRY AGAIN?'' If the participant indicates that he/she is 
finished or cannot open the package and does not wish to continue 
trying, skip to Instruction 13.
    10. To begin the second test period, the tester shall give the 
participant another, but identical, package and say, ``THIS IS AN 
IDENTICAL PACKAGE. PLEASE OPEN IT ACCORDING TO THE INSTRUCTIONS ON 
THE CAP.'' (Specify other instruction locations if appropriate.) If 
the package contains product, the tester shall say, ``PLEASE EMPTY 
THE (PILLS, TABLETS, CONTENTS, etc.) INTO THIS CONTAINER.'' After 
the participant opens the package, the tester says, ``PLEASE CLOSE 
THE PACKAGE PROPERLY, ACCORDING TO THE INSTRUCTIONS ON THE CAP.'' 
(Specify other instruction locations if appropriate.)
    11. The participants are allowed up to 1 minute (60 full 
seconds) to open and close the package. The elapsed times in seconds 
to open and to close the package are recorded on the data sheet as 
two separate times. The time that elapses between the opening of the 
package and the end of the instruction to close the package is not 
counted as part of the 1-minute test time.
    12. After the 1-minute test, or when the participant has opened 
and finished closing the package, whichever comes first, the tester 
shall take all the test materials from the participant. The 
participant shall not be allowed to handle the package again. If the 
participant does not open the package and stops trying to open it 
before the end of the 1-minute period, the tester shall say, ``ARE 
YOU FINISHED WITH THAT PACKAGE, OR WOULD YOU LIKE TO TRY AGAIN?'' If 
the participant indicates that he/she is finished or cannot open the 
package and does not wish to continue trying, this shall be counted 
as a failure of the 1-minute test.
    13. Participants who do not open the package in the first 5-
minute test period are asked to open and close two non-child-
resistant screening packages. The participants are given a 1-minute 
test period for each package. The tester shall give the participant 
a package and say, ``PLEASE OPEN AND PROPERLY CLOSE THIS PACKAGE.'' 
The tester records the time for opening and closing, or 61 seconds, 
whichever is less, on the data sheet. The tester then gives the 
participant the second package and says, ``PLEASE OPEN AND PROPERLY 
CLOSE THIS PACKAGE.'' The time to open and resecure, or 61 seconds, 
whichever is less, shall be recorded on the data sheet.
    14. Participants who cannot open and resecure both of the non-
child-resistant screening packages are not counted as part of the 
100-seniors panel. Additional participants are selected and tested.
    15. No adult may participate in more than two tests per sitting. 
If a person participates in two tests, the packages tested shall not 
be the same ASTM type of package.

[[Page 37738]]

    16. If more adults in a sex or age group are tested than are 
necessary to determine SAUE, the last person(s) tested shall be 
eliminated from that group.

    (4) Younger-adult panel. (i) One hundred adults, age 18 to 45 
inclusive, with no overt physical or mental handicaps, and 70% of whom 
are female, shall comprise the test panel for younger adults. Not more 
than 35% of adults shall be obtained or tested at any one site. No 
individual tester shall administer the test to more than 35% of the 
adults tested. The adults shall be tested individually, rather than in 
groups of two or more. The adults shall receive only such printed 
instructions on how to open and properly resecure the special packaging 
as will appear on the package as it is delivered to the consumer. Five 
minutes shall be allowed to complete the opening and, if appropriate, 
the resecuring process.
    (ii) Records shall be kept of the number of adults unable to open 
and of the number of the other adults tested who fail to properly 
resecure the special packaging. The number of adults who successfully 
open the special packaging and then properly resecure the special 
packaging (if resecuring is appropriate) is the percent of adult-use 
effectiveness of the special packaging. In the case of unit packaging, 
the percent of adult-use effectiveness shall be the number of adults 
who successfully open a single (unit) package.
    4. Add a new Sec. 1700.20(d), reading as follows.


Sec. 1700.20  Testing procedure for special packaging.

* * * * *
    (d) Recommendations. The following instructions and procedures, 
while not required, are used by the Commission's staff and are 
recommended for use where appropriate.
    (1) Report format for child test.

A. Identification

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

B. Procedures

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

C. Results

    1. Openings in each 5-minute period and total openings for males 
and for females in each age group.
    2. Opening methods (e.g., normal opening, teeth, etc.).
    3. Mean opening times and standard deviation for each 5-minute 
test period.
    4. The percentage of packages tested at each site as a 
percentage of total packages.
    5. The percentage of packages tested by each tester as a 
percentage of total packages.
    6. Child-resistant effectiveness for the first 5-minute period 
and for the total test period.

    (2) Standardized adult-resecuring test instructions. CPSC will use 
the adult-resecuring test where an objective determination (e.g., 
visual or mechanical) that a package is properly resecured cannot be 
made. The adult-resecuring test is performed as follows:

Adult-Resecuring Procedure

    1. After the adult participant in either the senior-adult test 
of 16 CFR 1700.20(a)(3) or the younger-adult test of 16 CFR 
1700.20(a)(4) has resecured the package, or at the end of the test 
period (whichever comes first), the tester shall take the package 
and place it out of reach. The adult participant shall not be 
allowed to handle the package again.
    2. The packages that have been opened and appear to be resecured 
by adults shall be tested by children according to the child-test 
procedures to determine if the packages have been properly 
resecured. The packages are given to the children without being 
opened or resecured again for any purpose.
    3. Using the results of the adult tests and the tests of 
apparently-resecured packaging by children, the adult use 
effectiveness is calculated as follows:
    a. Adult use effectiveness.
    1. The number of adult opening and resecuring failures, plus the 
number of packages that were opened by the children during the full 
10-minute test that exceeds 20% of the apparently-resecured 
packages, equals the total number of failures.
    2. The total number of packages tested by adults (which is 100) 
minus the total number of failures equals the percent adult-use 
effectiveness.

    (3) Report format for adult-resecuring test.

A. Identification

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

B. Procedures

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

C. Results

Adult Test

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

Child Test

    1. Openings in each 5-minute period, and total openings, for 
males and females in each age group.
    2. Opening methods.
    3. Mean opening times and standard deviation for each 5-minute 
test period.
    4. The percentage of packages tested at each site as a 
percentage of total packages.
    5. The percentage of packages tested by each tester as a 
percentage of total packages.
    (4) Consent forms. The Commission uses the following consent 
forms for senior-adult testing reclosable and unit-dose packaging, 
respectively.
    1. Reclosable packages.

[Testing Organization's Letterhead]

Child-Resistant Package Testing

[[Page 37739]]


    The U.S. Consumer Product Safety Commission is responsible for 
testing child-resistant packages to make sure they protect young 
children from medicines and dangerous household products. With the 
help of people like you, manufacturers are able to improve the 
packages we use, keeping the contents safe from children but easier 
for the rest of us to open.
    Effective child-resistant packages have prevented thousands of 
poisonings since the Poison Prevention Act was passed in 1970. The 
use of child-resistant packages on prescription medicines alone may 
have saved the lives of over 350 children since 1974.
    As part of this program, we are testing a child-resistant 
package to determine if it can be opened and properly closed by an 
adult who is between 50 and 70 years of age. You may or may not be 
familiar with the packages we are testing. Take your time, and 
please do not feel that you are being tested--we are testing the 
package, not you.

Description of the Test

    1. I will give you a package and ask you to read the 
instructions and open and properly close the package.
    2. I will then give you an identical package, and ask you to 
open and properly close it.
    3. I may ask you to open some other types of packages.
    4. The packages may be empty or they may contain a product.
    5. I will ask you whether you think the child-resistant package 
was easy or hard to use.

Consent Form for Child-Resistant Package Testing

    The Consumer Product Safety Commission has been using 
contractors to test child-resistant packages for many years with no 
injuries to anyone, although it is possible that a minor injury 
could happen.
    I agree to test a child-resistant package. I understand that I 
can change my mind at any time. I am between the ages of 50 and 70, 
inclusive.
Birthdate--------------------------------------------------------------
Signature--------------------------------------------------------------
Date-------------------------------------------------------------------
Zip Code---------------------------------------------------------------

Office Use

Site:------------------------------------------------------------------
Sample Number:---------------------------------------------------------
Test Number:-----------------------------------------------------------
Package Number:--------------------------------------------------------
    2. Unit-dose packages.

[Testing Organization's Letterhead]

Unit Dose Child-Resistant Package Testing

    The U.S. Consumer Product Safety Commission is responsible for 
testing child-resistant packages to make sure they protect young 
children from medicines and dangerous household products. With the 
help of people like you, manufacturers are able to improve the 
packages we use, keeping the contents safe from children but easier 
for the rest of us to open.
    Effective child-resistant packages have prevented thousands of 
poisonings since the Poison Prevention Act was passed in 1970.
    The use of child-resistant packages on prescription medicines 
alone may have saved the lives of over 350 children since 1974.
    As part of this program, we are testing a child-resistant 
package to determine if it can be opened by an adult who is between 
50 and 70 years of age. You may or may not be familiar with the 
packages we are testing. Take your time, and please do not feel that 
you are being tested--we are testing the package, not you.

Description of the Test

    1. I will give you a package and ask you to read the 
instructions, open one unit, and remove the contents.
    2. I will then give you an identical package, and ask you to 
open one unit and remove the contents.
    3. I may ask you to open some other types of packages.
    4. I will ask you whether you think the child-resistant package 
was easy or hard to use.

Consent Form for Child-Resistant Package Testing

    The Consumer Product Safety Commission has been using 
contractors to test child-resistant packages for many years with no 
injuries to anyone, although it is possible that a minor injury 
could happen.
    I agree to test a child-resistant package. I understand that I 
can change my mind at any time. I am between the ages of 50 and 70, 
inclusive.
Birthdate--------------------------------------------------------------
Signature--------------------------------------------------------------
Date-------------------------------------------------------------------
Zip Code---------------------------------------------------------------

Office Use

Site:------------------------------------------------------------------
Sample Number:---------------------------------------------------------
Test Number:-----------------------------------------------------------
Package Number:--------------------------------------------------------


Sec. 1700.14  [Amended]

    5. Section 1700.14(a) introductory text is amended by inserting 
``meeting the requirements of Sec. 1700.20(a)'' after ``is such that 
special packaging''.

    Dated: July 11, 1995.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.

Appendix I--List of Relevant Documents

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

    1. Woodson, W.E. & Conover, D.W. (1964). Human Engineering Guide 
for Equipment Designers. (2d. ed). Berkeley: University of 
California Press.
    2. Sheffner, A. Leonard, PhD, ASTM IV A, Non-Reclosable CR pouch 
with internal (hidden) tear notch opening Packaging, Child and Adult 
Protocol Tests, Foster D. Snell, Inc, Florham Park, New Jersey 
07932, December 1, 1972. (May contain confidential information.)
    3. Breault, H.J., ``Five Years with 5 Million Child-Resistant 
Containers,'' Windsor Poison Control Center, Windsor, Ontario, 
Canada, Clinical Toxicology 7(1), pp. 91-95, 1974.
    4. Sheffner, A. Leonard, PhD, ASTM IV A, Non-Reclosable CR pouch 
(PP/PE/F/PE) with internal (hidden) tear notch opening Packaging, 
Child and Adult Protocol Tests, Foster D. Snell, Inc, Florham Park, 
New Jersey 07932, March 10, 1975. (May contain confidential 
information.)
    5. Dershewitz, R.A. & Williamson, J.W. (1977). Prevention of 
childhood household injuries: A controlled clinical trial. American 
Journal of Public Health, 67(12), 1148-1153.
    6. Sheffner, A. Leonard, PhD, ASTM IV A, Non-Reclosable CR pouch 
with internal (hidden) tear notch opening Packaging, polyester/LDPE, 
Child Protocol Tests, Foster D. Snell, Inc, Florham Park, New Jersey 
07932, January 9, 1978.
    7. Sheffner, A. Leonard, PhD, ASTM IV A, Non-Reclosable CR pouch 
with internal (hidden) tear notch opening Packaging, polyester/LDPE, 
Child and Adult Protocol Tests, Foster D. Snell, Inc, Florham Park, 
New Jersey 07932, March 28, 1978.
    8. Wilbur, C.J., ``Determination of the minimum time to open and 
close CR packaging,'' CPSC, Health Sciences, January 1979.
    9. Sherman, Dr. F.T., et al, Child-Resistant Containers for the 
Elderly, Journal of American Medical Association, March 9, 1979.
    10. Howes, D.R., ``Analyses of Poison Packaging Protocol Test 
Data,'' CPSC Engineering Sciences, March 1979.
    11. Madison, R., ``A Confirmation Test of a Child-Resistant 
Closure,'' CPSC, Engineering Sciences, June 1979.
    12. Market Facts, Inc., ``A Pilot Study of Effectiveness and 
Functionality of Child-Resistant Containers and Related User 
Attitudes'', CPSC-C-77-0095, Market Facts, Inc., Washington, D.C., 
20006, October 1979.
    13. Associated Testing Laboratories, Inc., Wayne, New Jersey, 
07470, ``Child-Resistant Blister 2 x 4 tablets, Peel Back and Push 
Out, ASTM-VIII-D, Protocol Test Report, No. T3999-001,'' November 
19, 1979.
    14. Dershewitz, R.A. (1979). Will Mothers use free household 
safety devices? American Journal of the Diseases of Childhood, 133, 
61-64.
    15. Survey of Consumers' Use of Products Regulated under the 
Poison Prevention Packaging Act, Chilton Research Services, May 
1980.
    16. McCormick, E.J., & Sanders, M.S. (1982). Human Factors in 
Engineering and Design. (Fifth Edition). New York: McGraw-Hill Book 
Company.
    17. Williams, A.F. (1982). Passive and active measures for 
controlling disease and injury: The role of health psychologists. 
Health Psychology, 1(4), 399-409.
    18. Proceedings of the Human Factors Society, 27th Annual 
Meeting, Norfolk VA, Volume 1, October 10-14, 1983.
    19. Orzech, D., CPSC, ``Summary of Comments Received Re: ANPR 
Protocol Revisions,'' October 14, 1983.
    20. Spungen, H.S. and Schuirmann, D.J. ``Accessibility of Tamper 
Resistant Packaging to the Elderly,'' FDA, Center for Drugs and 
Biologies, 1984.
    21. Thein, W.M.A., Rogmans, W.H.J., ``Testing Child-Resistance 
for Access by

[[Page 37740]]
Infants and the Elderly,'' Consumer Safety Institute, Amsterdam, The 
Netherlands, Accid, Anal. & Prev., Vol. 16, No. 3, pp. 185-190, 
1984.
    22. Robbins L.J. et al, ``Child-Resistant Packaging and the 
Geriatric Patient,'' JAOGS, Vol. 32, No. 6, June 1984.
    23. Proceedings of the Human Factors Society, 28th Annual 
Meeting, Volume 1, October 22-26, 1984.
    24. Wilbur, C.J., ASTM D10.31 Child-Resistant Packaging Sub-
Committee Meeting Minutes pertaining to CPSC Protocol Revisions and 
Institute of Standards Research, (ISR) Senior Friendly Testing, 
1985-1994.
    25. Dawson, C., CPSC, Workshop: ``Special Issues: Poison 
Prevention Packaging and Older Consumers,'' 1985.
    26. Product Manufacturer, Personal Communication, CR Blister 
Adult Protocol Test Results, Age Groups 18-45 and 46-70, Document 
Numbers 110685, November 1985.
    27. Wilbur, C.J., ``Special Packaging Requirements Suggested 
Changes,'' CPSC, Health Sciences, November 1985. pp. 11-14.
    28. Wilbur, C.J., CPSC, ``Special Packaging Requirements 
Suggested Changes,'' February 12, 1986.
    29. Jacobson, B.J., et al, ``Prescription Drug Ingestion 
Study,'' CPSC, Health Sciences, September 10, 1986.
    30. Sterndal, B., Bobbink S., Robertson, W.O., ``Poisoning From 
Samples,'' Seattle Poison Center, Seattle, Washington, Vet Hum 
Toxicol, 28(6), December 1986.
    31. Sterndal, B., Bobbink, S., Robertson, W., ``Poisoning from 
Samples,'' Seattle Poison Center, Vet Hum Toxicol, Vol. 28, December 
1986.
    32. Wogalter, M.S. Godfrey, S.S., Fontenelle, G.A., Desaulniers, 
D.R., Rothstein, P.R., & Laughery, K.R. (1987). Effectiveness of 
warnings. Human Factors, 29(5), 599-612.
    33. Perritt, Alex, PhD, ASTM VIII I, Non-Reclosable CR Blister 
with Internal (hidden) Tear Notch Opening, 10 Tablet (2x5) Blister 
Card, Child and Adult Protocol Tests, Perritt Laboratories, Inc, 
Hightstown, New Jersey, 08520, No. 1118-002, 2/23/87. (May contain 
confidential information.)
    34. Wilbur, C.J., CPSC, ``ANPR Protocol Revisions Responses to 
Comments Received,'' February 25, 1987.
    35. Simpson, G., ``Cost Effects of the Proposed Revised 
Protocols for Testing Child Resistant Closures,'' March 24, 1987.
    36. Wiseman, H.M., et al, ``Accidental Poisoning in Childhood: A 
Multicentre Survey. 1. General Epidemiology 2. The Role of Packaging 
in Accidents Involving Medications,'' Human Toxicology, Vol. 6, No. 
4, pp 303-314, July 1987.
    37. Wilbur, C.J., CPSC, ``Protocol Revisions: Health Sciences 
Recommendations,'' July 7, 1987.
    38. Ewell, H., CPSC, ``Revisions to PPPA Protocol--VOTE SHEET,'' 
July 22, 1987.
    39. Summary of Comments on Advance Notice of Proposed 
Rulemaking, July 22, 1987.
    40. White, V.A., CPSC, ``Briefing Package on Recommendations for 
Revision to the Poison Prevention Packaging Act (PPPA) Testing 
Protocol,'' July 22, 1987.
    41. White, V.A., CPSC, ``Supplemental Package to the Briefing 
Package on Recommendations for Revision to the Poison Prevention 
Packaging Act (PPPA) Testing Protocol,'' July 23, 1987.
    42. Dunn, S., Secretary, CPSC, Minutes of Commission Meeting, 
``Revisions to Poison Prevention Packaging Act (PPPA) Testing 
Protocol,'' August 6, 1987.
    43. White, V.A., CPSC, ``Schedule for Briefing Package on Draft 
Proposal for PPPA Protocol Revisions,'' August 24, 1987.
    44. Madison, R., ``Sequential Testing for Child-Resistant 
Packaging,'' CPSC, Engineering Sciences, August 25, 1987.
    45. Letter from Myers, C.E., American Society of Hospital 
Pharmacists, to C. Wilbur, CPSC, October 8, 1987.
    46. Letter from White, V., to C.E. Myers, ASHP, October 1987.
    47. Wilbur, C.J., HSPS, Log of Meeting with ASTM Committee 
D10.31, October 29, 1987.
    48. Letter from Vander, N., Closure Manufacturers Association, 
to V. White, December 22, 1987.
    49. Letter from Myers, C.E., American Society of Hospital 
Pharmacists, to V. White, CPSC, December 23, 1987.
    50. ASTM, Standard Classification Child-Resistant Packages, D-
3475-88, 1988, ASTM, 1916 Race Street, Philadelphia, PA. 19103.
    51. Wogalter, M.S., McKenna, N.A., & Allison, S.T. (1988). 
Warning compliance: Behavioral effects of cost and consensus. 
Proceedings of the Human Factors Society 32nd Annual Meeting, 2, 
901-904.
    52. Wilbur, C.J., CPSC, Health Sciences, ``PPPA, Protocol 
Revisions--Manufacturers Preview,'' January 1988.
    53. Letter from Vander, N., Brockway Plastics, to V. White, 
CPSC, January 12, 1988.
    54. Wind, M., CPSC, ``Protocol Revisions Back-up Document,'' 
February 9, 1988.
    55. Letter from Sanzo, K., Morgan, Lewis & Bockius, to V. White, 
CPSC, February 9, 1988.
    56. White, V.A., Log of Meeting with Closure Manufacturers 
Association, February 10, 1988.
    57. Letter from Sawyer, S.F., Registrations Plus, to V. White, 
February 12, 1988.
    58. Wilbur, C.J., ``PPPA Proposed Protocol Revisions--Technical 
Feasibility, Practicability, and Appropriateness,'' CPSC, Health 
Sciences, March 1988.
    59. Letter from Vander, N., Closure Manufacturers Association, 
to Chairman Scanlon, CPSC, May 4, 1988.
    60. White, V.A., CPSC, ``Final Reports on Grants for Innovative 
Child-Resistant Packaging,'' May 4, 1988.
    61. Butts, S., ``Submissions on Priorities for FY 1990,'' May 
11, 1988.
    62. Letter from Scanlon, T., CPSC, to N. Vander, May 25, 1988.
    63. Letter from Tinsworth, E., EPA, to V. White, August 2, 1988.
    64. Letter from Vander, N., Closure Manufacturers Association, 
to Chairman Scanlon, CPSC, August 31, 1988.
    65. Agenda, CPSC/EPA Meeting on Economic Survey for CRP Protocol 
Testing Changes, September 30, 1988.
    66. Gross, R., Consumer Product Safety Commission and 
Environmental Protection Agency Child-Resistant Packaging Meeting 
Minutes, November 9, 1988.
    67. Hunter, M.M., Hunter, R.M., ``Cognitive Skill Based Child-
Resistant Medicine Container,'' U.S. Department of Health and Human 
Services, National Institute of Child Health and Human Development, 
Yellowstone Environmental Science, Bozeman, Montana, January 1989.
    68. Letter from Hunter, M.M. and Hunter R.M., Yellowstone 
Environmental Science, to P. Scheidt, NIH, January 30, 1989.
    69. White, V., ``Status and Outlook for Protocol Revisions 
Project,'' January 30, 1989.
    70. Prunella, W.J., ``Briefing Package on Proposed Rule for PPPA 
Protocol Revisions,'' February 27, 1989.
    71. Letter from Gross, R., United States Environmental 
Protection Agency, to V. White, CPSC, February 27, 1989.
    72. Letter from Hunter, M., Yellowstone Environmental Science, 
to M. Millonig, March 1, 1989.
    73. White V.A., ``Briefing Package on Proposed Rule for PPPA 
Protocol Revisions,'' March 2, 1989.
    74. Letter from White V., CPSC, to R. Gross, EPA, March 16, 
1989.
    75. Letter from Wilbur, C.J., CPSC, to M.M. Hunter, March 27, 
1989.
    76. Letter from Vogel, P.E., Department of Health and Human 
Services ,to Mary M. Hunter, March 30, 1989.
    77. Erb, C., ``Heading Off Headaches,'' Futures, Mich. State 
Univ., Vol. 7, No. 2, Spring/Summer 1989.
    78. Letter from Kimm, V., EPA, to M.M. Hunter, April 14, 1989.
    79. Letter from Koop, E., Department of Health and Human 
Services, to M.M. Hunter, May 11, 1989.
    80. Letter from Baucus, M., United States Senate, to B .Hunter, 
May 11, 1989.
    81. Letter from Williams, T.F., MD, Department of Health and 
Human Services, to M.M. Hunter, May 12, 1989.
    82. Letter from Hunter, B., Yellowstone Environmental Science, 
to Acting Chairman Graham, CPSC, May 25, 1989.
    83. Letter from Hunter, B., Yellowstone Environmental Science, 
to Commissioner Dawson, CPSC, May 25, 1989.
    84. Letter from Lott, T., U.S. Senate, to Mr. and Mrs. Hunter, 
May 31, 1989.
    85. Closure Manufacturers Association, ``Closure Manufacturers 
Association Position Statement On Proposed Changes In Child-
Resistant Packaging Protocol,'' June 1989.
    86. Letter from Johnson, J.B., U.S. Senate, to Mr. and Mrs. 
Hunter, June 2, 1989.
    87. Letter from Bryan, R.H., U.S. Senate, to Mr. and Mrs. Bob 
Hunter, June 5, 1989.
    88. Letter from Hollings, E., U.S. Senate, to Mr. and Mrs. 
Hunter, June 12, 1989.
    89. Wilbur, C.J., Log of Meeting with Yellowstone Environmental 
Science, June 16, 1989.
    90. Letter from Hunter, M.M., Yellowstone Environmental Science, 
to C.E. Koop, National Safe Kids Campaign, June 23, 1989.
    91. Wilbur, C.J., ``Older Adult Use Effectiveness, Child 
Resistant Effectiveness,'' CPSC, July 1989.
    92. Jacobson, B.J., et al, ``Accidental Ingestions of Oral 
Prescription Drugs: A Multicenter Survey,'' AJPH, Vol. 79, No. 7, 
pp. 853-856, July 1989.

[[Page 37741]]

    93. Letter from White, V.A., to M.M. Hunter, Yellowstone 
Environmental Science, July 5, 1989.
    94. Taillefer, R., Consumer and Corporate Affairs Canada, 
``Reports of Meetings and Other Information,'' July 7, 1989.
    95. Letter from Burns, C., U.S. Senate, to Dr. Duane Alexander, 
NIH, July 10, 1989.
    96. Letter from Williamson, D.J., Closure Manufacturers 
Association, to Acting Chairman Graham, CPSC, July 18, 1989.
    97. Letter from Hunter, M.M., Yellowstone Environmental Science, 
to V. White, CPSC, July 28, 1989.
    98. Hunter, M.M. et. al., ``Child-Resistant Packaging Can Be 
Easy For Older Adults To Use,'' July 28, 1989.
    99. Letter from Williamson, D.J., Closure Manufacturers 
Association, to V. White, September 6, 1989.
    100. White, V., ``Log Meeting on Status of Protocol Revisions 
Project,'' September 7, 1989.
    101. White, V., Log of Meeting with Closure Manufacturers 
Association, September 15, 1989.
    102. Letter from Clark, D.E., Department of Health and Human 
Services, to R.M. Hunter, September 27, 1989.
    103. Letter from Hunter, M.M., Yellowstone Environmental 
Science, to V. White, October 11, 1989.
    104. Letter from Hunter, M.M., Yellowstone Environmental 
Science, to C.J. Wilbur, October 11, 1989.
    105. Unified Agenda, Item 3781, 54 FR 45525 (October 30, 1989).
    106. Letter from Hunter, M.M., Yellowstone Environmental 
Science, to D.E. Clark, NIH, November 9, 1989.
    107. Peirson, J., ``Form & Function,'' Wall Street Journal, 
December 1, 1989.
    108. Letter from Hunter, M.M., Yellowstone Environmental 
Science, to V. White, CPSC, December 15, 1989.
    109. Dychtwald, K. and Flower, J., ``Age Wave: The Challenges 
and Opportunities of an Aging America,'' 1989.
    110. LeBailly, S.A., Fleming, G.V., Freel, K., Hicks-Bartlett, 
S., Kirschenman, J., Ritts-Benally, K., & Sasicki, J. (1990). The 
Children's Safety Research Project (Contract No. R49/CCR5022-02-1). 
Prepared for the American Academy of Pediatrics and the Centers for 
Disease Control.
    111. Letter from Williamson, D.J., Closure Manufacturers 
Association, to Chairman Jones-Smith, January 8, 1990.
    112. Schacter, L., ``Unintentional Ingestions of Medications by 
Children Under 5 years of Age (January-March 1989),'' CPSC, 
Epidemiology, February 10, 1990.
    113. Wilbur, C.J., Closure Testing Equipment (CTE) Studies, Non-
Child Resistant (NCR), Snap Type Packaging, Status Report, CPSC, HS, 
March 1990.
    114. Wilbur, C.J., Closure Testing Equipment (CTE) Studies, Non-
Child Resistant (NCR), Continuous Threaded Type Packaging, Status 
Report, CPSC, HS, March 1990.
    115. Letter from Hunter, F.T., to President George Bush, March 
1, 1990.
    116. Letter from Hunter, M.M., Yellowstone Environmental 
Science, to B. Bush, The White House, March 3, 1990.
    117. Initial Regulatory Flexibility Analysis, CPSC, Economics, 
March 15, 1990.
    118. Gross, R., EPA, ``CPSC Proposed Rule on Requirements for 
the Special Packaging of Household Substances,'' March 20, 1990.
    119. Letter from Hellander, I. and Wolfe, S.M., Public Citizen, 
to Secretary, CPSC, March 21, 1990.
    120.``Environmental Impact of Effects Associated with the 
Proposed Revisions to the Poison Prevention Packaging Act (PPPA) 
Protocols, CPSC Directorate for Economics, April 2, 1990.
    121. Wilbur, C.J., ``Adult, 60-75 & 18-45 Years of Age, Protocol 
Tests with Child Resecuring Verification and a 200 Child Protocol 
Test, Innovative Child Resistant Packaging System (ICRPS), 38 mm 
ASTM, IA Screw Type CR Package with Cap Tool Slot on a Square 
Plastic 125 ML Container--Status Report,'' CPSC, Health Sciences, 
April 1990.
    122. Gross, R., EPA, ``Consumer Product Safety Commission 
Proposed Rule on Requirements for the Special Packaging of Household 
Substances,'' April 5, 1990.
    123. White, V.A., ``Draft Proposal to Revise the Poison 
Prevention Packaging Act (PPPA) Testing Protocol,'' CPSC, Program 
Management, April 10, 1990.
    124. Letter from Hunter, M., Yellowstone Environmental Science, 
to Chairman Jones-Smith, CPSC, April 18, 1990.
    125. Letter from Hunter, R., Yellowstone Environmental Science, 
to Chairman Jones-Smith, CPSC, April 25, 1990.
    126. Letter from White, V., CPSC, to Wolfe, S. and Hellander, 
I., Public Citizen, April 26, 1990.
    127. Wilbur, C.J., ``PPPA Protocol Revisions--Manufacturers 
Preview--Effective Date,'' CPSC, Health Sciences, May 1990.
    128. Ewell, H., ``Changes to Draft Federal Register Notice to 
Propose PPPA Protocol Revisions,'' May 1, 1990.
    129. Robins, M.P., ``Commission Request for Child-Resistant 
Closure Market Share Information,'' CPSC, Economics, May 14, 1990.
    130. Schacter, L.A., ``Response to Commission Questions and 
Comments from the PPPA Protocol Revisions Briefing (May 2, 1990),'' 
CPSC, Epidemiology, May 22, 1990.
    131. Robins, M.P., ``Effective Date for Implementation of the 
Proposed Protocol Revisions,'' CPSC, Economics, May 23, 1990.
    132. Deppa, Shelley W., ``Human Factors Issue Raised in 
Commission Briefing on PPPA Protocol Revisions,'' CPSC, 
Epidemiology, May 24, 1990.
    133. Letter from Williamson, D.J., Closure Manufacturers 
Association, to Chairman Jones-Smith, May 25, 1990.
    134. Eberle, S., ``Protocol Revisions: Additional Information in 
Response to Commission Questions,'' CPSC, Program Management, May 
25, 1990.
    135. Dunn, S.E., CPSC, Minutes of Commission Meeting, May 31, 
1990.
    136. Wilbur, C.J., Final Report (CPSC-C-88-1226), June 11, 1990.
    137. Letter from Paolello, P., Calmar Inc., to S. Eberle, CPSC, 
June 14, 1990.
    138. White, V.A., ``Request for Closed Meeting with Closure 
Manufacturer,'' June 29, 1990.
    139. Wilbur, C.J., ``PPPA Protocol Revisions One Minute Test 
Period Technical Feasibility, Practicability, Appropriateness,'' 
CPSC, Health Sciences, July 1990.
    140. Letters from 85 Consumers to Acting Chairman Graham, CPSC, 
July 1990.
    141. Gross, R., EPA, ``CPSC Proposed Rule on Requirements for 
the Special Packaging of Household Substances,'' July 3, 1990.
    142. White, V.A., ``Draft Proposed Rule on PPPA Protocol 
Revisions,'' CPSC, July 13, 1990.
    143. Ewell, H., ``Changes to PPPA Protocol Revision FR,'' July 
18, 1990.
    144. White, V.A., Log of Meeting with Sunbeam Plastics Corp., 
July 18, 1990.
    145. Gross, R., ``CPSC Proposed Rule on Requirements for the 
Special Packaging of Household Substances,'' July 20, 1990.
    146. Letter from Paolello, P., Calmar, Inc., to M. Robins, CPSC, 
July 20 1990.
    147. White, V.A., ``Draft Proposed Rule on Protocol Revisions 
under the PPPA,'' July 20, 1990.
    148. Robins, M., Log of Meeting with Calmar, Inc., July 25, 
1990.
    149. Ewell, H., ``EPA Comments on Draft Federal Register Notice 
to Revise the PPPA Test Protocol,'' July 25, 1990.
    150. Letter from Williamson, D.J., Closure Manufacturers 
Association, to T. Stevenson, CPSC, July 27, 1990.
    151. White, V., ``Final Contract Report on Innovative Child-
Resistant Packaging Systems,'' July 31, 1990.
    152. Letter from Paolello, P., Calmar, Inc., to M. Robins, CPSC, 
August 3, 1990.
    153. Comments on proposed rule. On file in the Office of the 
Secretary, October 5, 1990.
    154. Ward, W. A., ASTM IV A, Non-Reclosable CR Pouch with 
internal (hidden) Tear Notch Opening Packaging, Foil two tab pouch, 
Child and Adult Protocol Tests, Perritt Laboratories, Inc, 
Hightstown, New Jersey, 08520, No. 1186-002, November 30, 1990. (May 
contain confidential information.)
    155. Transcript of oral comments--December 5, 1990.
    156. Dingus, T. A., Hathaway, J.A., & Hunn, B.P. (1991). A most 
critical warning variable: Two demonstrations of the powerful 
effects of cost on warning compliance. Proceedings of the Human 
Factors Society 35th Annual Meeting, 2, 1034-1038.
    157. Wilbur, Charles, J., Laboratory Report, Form 221, Semi-
Rigid CR Blister ASTM VIIID, Peel & Push Opening, Blister Card (3 x 
4 = 12 Blisters), M-400-0311, CPSC, Health Sciences, March 12, 1991.
    158. Whitmore, R., Kelly, J., Reading, P., ``National Home and 
Garden Pesticide Use Survey,'' Draft Final Report, EPA, June 24, 
1991.
    159. Wilbur, Charles, J., Laboratory Report, Form 221, Foil CR 
Pouch ASTM IVA with Hidden Tear Notch Opening or Scissor Opening, M-
400-0731, CPSC, Health Sciences, July 31, 1991.
    160. CPSC, Child-Resistant Packaging Testing for PPPA Protocol 
Revisions Support, CPSC-P-91-1135, September 11, 1991 and 
amendments.
    161. Transcript of oral comments--September 12, 1991.
    162. Wilbur, Charles, J., Laboratory Report, Form 221, 35mm CR 
ASTM IIA Lug 13 Dram

[[Page 37742]]
on a Amber Round Prescription Vial, M-803-0603, CPSC, Health 
Sciences, October 7, 1991.
    163. Wilbur, Charles, J., Laboratory Report, Form 221, Semi-
Rigid CR Blister ASTM VIIIE, Scissor Opening, Not internal Tear 
Notch Opening, Blister Card (2  x  3 = 6 Blisters), M-400-0909, 
CPSC, Health Sciences, October 31, 1991.
    164. Wilbur, C. J., Laboratory Report, Form 221, 28mm CR ASTM IA 
Continuous Threaded Cap with Liner on a White Round Bottle, P-400-
1201, CPSC, Health Sciences, December 2, 1991. {Contains possibly 
confidential information}
    165. Woodson, W.E., Tillman, B. & Tillman, P. (1992). Human 
Factors Design Handbook: Information and Guidelines for the Design 
of Systems, Facilities, Equipment, and Products for Human Use. (2d 
ed.). New York: McGraw-Hill, Inc.
    166. Hunter, R.M., Hunter, M.M., Rivara, F., et al., ``Cognitive 
skill-based child-resistant medicine container: Phase II Final 
Report,'' US Department of Health and Human Services, National 
Institute of Child Health and Human Development: Yellowstone 
Environmental Science, Bozeman, Montana: 1992.
    167. Wind, M., Health Sciences, ``ASTM Proposal for a Joint 
Project on PPPA Protocol Revisions,'', January 21, 1992.
    168. Kissinger, T. L., CPSC, Epidemiology, ``The Appropriateness 
of the Statistical Analytical Methods of ASTM for the Child-
Resistant Closure Study,'' March 19, 1992.
    169. Wilbur, Charles, J., Laboratory Report, Form 221, 33mm CR 
ASTM IIIA Snap Cap with Liner and Foil TAC on a White Round Bottle, 
P-400-0406, CPSC, Health Sciences, April 10, 1992.
    170. Wilbur, Charles, J., Laboratory Report, Form 221, ASTM 
VIID, Reclosable Aerosol Overcap Requires Device to Open, P-400-
0703, No. 1047, CPSC, Health Sciences, July 7, 1992.
    171. Wilbur, C. J., Laboratory Report, Form 221, 35mm CR ASTM IB 
Continuous Threaded Cap, No Liner on a Handled 50 oz. HDPE Bottle, 
P-400-0706, CPSC, Health Sciences, July 8, 1992.
    172. Kissinger, T.L., CPSC, Epidemiology, ``Critique of the ASTM 
Proposal for a Joint Study on Interlaboratory Variability in the CRC 
Project,'' July 13, 1992.
    173. Cudney, S. and Hunter, M., Danger! Grandparents' Drugs May 
Be Lethal to Children, Geriatric Nursing, July/August 1992, pp 222-
224.
    174. Kissinger, T., CPSC, Epidemiology, ``The Sequential 
Hypothesis Testing Procedure in the Older Adult Testing of Child-
Resistant Packaging,'' September 18, 1992.
    175. Perritt, Alex, PhD, ASTM IA, Reclosable, 38mm, Push Down & 
Turn to Open Child Resistant Packaging, Perritt Laboratory, No. 
1110-038, SAUE Five Minute/one minute & Child Resecuring 
Verification Test, Perritt Laboratory, Hightstown, New Jersey, 
October 27, 1992. (May contain confidential information.)
    176. Letter from Charles Kumkumian, FDA to S. Barone, November 
19, 1992.
    177. Barone, S. Health Sciences, ``ASTM/ISR Proposal for Inter-
Laboratory Testing of the Proposed Revised Child-Resistant Packaging 
Protocols of the Poison Prevention Packaging Act,'' (OS# 5776), 
December 4, 1992.
    178. Letter from Jacqueline Jones-Smith, Chairman CPSC to Ms. 
Kathleen Riley and Mr. Edward Saylor, ASTM Institute for Standards 
Research, December 8, 1992.
    179. Christophersen, E.R. (1993). Improving compliance in 
childhood injury control. In N.A. Krasnegor, L. Epstein, S.B. 
Johnson, & S.J. Yaffe (Eds.), Developmental Aspects of Health 
Compliance Behavior. Hillsdale, NJ: Lawrence Erlbaum Associates, 
Publishers.
    180. Johnstone, N., ASTM IV A, Non-Reclosable CR pouch with 
internal (hidden) tear notch opening Packaging, polyester/LDPE, 
Child and Adult Protocol Tests, Associated Testing Laboratories, 
Wayne, New Jersey, 07470, No. T29758-002, January 29, 1993. (May 
contain confidential information.)
    181. Letter from Barone, S., to M. Buie, Child Related Research, 
Inc., February 5, 1993.
    182. Letter from Barone, S. to H. Lockhart, Michigan State 
University, February 25, 1993.
    183. Wilbur, C. J., Laboratory Report, Form 221, 35mm Overcap, 
ASTM VIID, Requires Use of Key or Device to Open (Actuates Normally) 
on a Round Metal Aerosol, 202 (dia) x 406, CPSC, Health Sciences, P-
400-0703, June 30, 1992, R-400-0428, April 28, 1993, and R-400-0517, 
May 17, 1993. (May contain confidential information.)
    184. Kissinger, T., CPSC, Epidemiology, ``The Derivation of the 
30:30:40 Sample Size Allocation Scheme Used in Testing of Senior 
Adults with CR Packaging,'' June 28, 1993.
    185. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized 
Squeeze Force Must BE Applied To A Designated Location, Senior 
Protocol, Perritt Laboratories, Hightstown, NJ, No 1089-119, Aug 03, 
1993. (May contain confidential information.)
    186. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized 
Squeeze Force Must BE Applied To A Designated Location, Senior 
Protocol, Perritt Laboratories, Hightstown, NJ, No 1089-120, Aug 03, 
1993. (May contain confidential information.)
    187. Kissinger, T., CPSC, Epidemiology, ``Application of the 
Sequential Testing Procedure for Senior Adults to Data for Four 
Reclosable Child-Resistant Packages and Related Analysis,'' August 
4, 1993.
    188. Kissinger, T., CPSC, Epidemiology, ``Application of the 
Sequential Testing Procedure for Senior Adults to Four Non-
Reclosable Child-Resistant Packages and Related Analysis,'' August 
4, 1993.
    189. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized 
Squeeze Force Must BE Applied To A Designated Location, Child 
Protocol, Perritt Laboratories, Hightstown, NJ, No 1089-118, Aug 10, 
1993. (May contain confidential information.)
    190. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized 
Squeeze Force Must BE Applied To A Designated Location, Child 
Protocol, Perritt Laboratories, Hightstown, NJ, No 1089-117, Aug 11, 
1993. (May contain confidential information.)
    191. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized 
Squeeze Force Must BE Applied To A Designated Location, Child 
Protocol, Perritt Laboratories, Hightstown, NJ, No 1089-116, Aug 11, 
1993. (May contain confidential information.)
    192. Kissinger, T.L., CPSC, Epidemiology, ``Evaluation of Test 
Data From Two Different Testing Agencies with Senior Adult Subjects 
Using ASTM Type IIA Child-Resistant Packaging,'' August 12, 1993.
    193. Kissinger, T., CPSC, Epidemiology, ``Tests of Significance 
for the Difference in Mean Opening Times in CPSC Senior Adult 
Testing of Child-Resistant Packaging,'' August 26, 1993.
    194. Wilbur, C., and Barone, S., ``PPPA Senior Adult Use 
Effectiveness Protocol Tests--Non-reclosable Packaging,'' September, 
1993.
    195. Wilbur, C. and Barone, S., ``PPPA Senior Adult Use 
Effectiveness Protocol Tests--Reclosable Packaging,'' September, 
1993.
    196. Perritt, Alex, PhD, Child Resistant Trigger Sprayer, ASTM 
Type IX, Mechanical Dispensers, Perritt Laboratory, No. 1126-006, 
SAUE Five Minute Test & 50 Count Child Protocol Test, Perritt 
Laboratory, Hightstown, New Jersey, 10-12-93. (May contain 
confidential information.)
    197. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized 
Squeeze Force Must BE Applied To A Designated Location, Senior 
Protocol, Perritt Laboratories, Hightstown, NJ, No 1089-121, Oct 12, 
1993. (May contain confidential information.)
    198. Bogumill, M., CERM, ``CPSC's interpretation on allowing use 
of a tool in protocol testing of child-resistant packaging,'' 
October 15, 1993. (May contain confidential information.)
    199. Wilbur, C. J., Laboratory Report, Form 221, 1-1/4'' Metal 
Cap (Plastic/Metal), ASTM IA, Push Down & Turn to Open Child 
Resistant Cap for Metal Containers, CPSC, Health Sciences, S-400-
1108, November 8, 1993. (May contain confidential information.)
    200. Barone, S. Health Sciences, ``Child-Resistant Packaging 
Test Data Generated in Response to Public Comment,'' (OS # 3588) 
December 20, 1993.
    201. Memorandum from Rosalind Gross, EPA, to Suzanne Barone, 
CPSC, with comments on FR notice, January 31, 1994.
    202. Letter from Stephen S. Kellner, Chemical Specialties 
Manufacturers Association, to Chairman Jacqueline Jones-Smith, 
February 8, 1994.
    203. Letter from Peterson, E. to Anne McKlindon, ISR, February 
9, 1994.
    204. Letter from Edward Saylor, ASTM to Commissioners Jones-
Smith and Gall, February 16, 1994.
    205. Letter from Hugh Lockhart, Institute for Standards 
Research, to Commissioners Jones-Smith and Gall, March 2, 1994.
    206. Letter from James A. Thomas, ASTM to Commissioners Jones-
Smith and Gall, March 4, 1994.
    207. Letter from Darla Jean Williamson, Closure Manufacturers 
Association, to Chairman Jacqueline Jones-Smith, March 8, 1994.
    208. Letter from CPSC's General Counsel, Jerry G. Thorn, to 
Doris S. Freedman, Acting Chief Counsel for Advocacy, Small Business 
Administration, concerning initial regulatory flexibility analysis, 
March 11, 1994.

[[Page 37743]]

    209. Suzanne Barone, HS, ``Response to the Requests by the 
Institute for Standards Research of the ASTM and the Closure 
Manufacturers Association for an extension of the comment period and 
a public meeting on the CPSC child-resistant packaging test data and 
analysis,'' March 19, 1994.
    210. Comments on March 21, 1994, proposed rule. On file in the 
Office of the Secretary.
    211. Wilbur, C. J., ASTM Institutes for Standards Research 
(ISR), 4 lab protocol test SAUE with Lug IIA CRP and Blister VIIID 
CRP, March 25, 1994.
    212. Letter from Brett Kaufman, Beery Plastics, to John Woods, 
DowBrands, April 29, 1994.
    213. Publication, Sunbeam Inc, A Rexham Company, ``Contributions 
to the Safety of Children & Developments to Make Safety Closures 
Adult Friendly,'' April 1994.
    214. Suzanne Barone, HS, ``Response to the Request by the ASTM 
Subcommittee D10.31 on Child-resistant Packaging for an extension of 
the comment period and a public meeting on the CPSC child-resistant 
packaging test data and analysis,'' April 4, 1994.
    215. Angel, Joe, Publisher, ONSTREAM Column, ``Safety 
Innovation, P & G's new safety cap a winner'', Packaging World, 
Chicago IL, p 71, May 1994
    216. Log of Meeting with representatives from the Chemical 
Specialty Manufacturers Association, May 5, 1994.
    217. Log of Meeting with Perritt Laboratories, June 27, 1994.
    218. Complaint, child-resistant package testing without informed 
consent, July 1, 1994.
    219. Log of Meeting with representatives from ASTM D10.31, July 
19, 1994.
    220. Log of Meeting with representatives from the Chemical 
Specialty Manufacturers Association, July 25, 1994.
    221. Wilbur, Charles, J., Laboratory Report, Form 221, Non-CR 
Finger Mechanical Pump Spray with Overcap, 2 fl. oz., S-400-0802, 
No. 1860, CPSC, August 2, 1994.
    222. Log of Meeting with representatives from the Institute for 
Standards Research, August 11, 1994.
    223. Wilbur, C. J., Personal Communications, Major CRP (ASTM IA) 
Manufacturer, Memo Record, 247, May 5, 1994 and August 16, 1994.
    224. Log of meeting with Poly-Seal Corporation and Great Lakes 
Marketing on August 30, 1994.
    225. Letter from John Craig, Bordentown Township Senior Citizens 
Club, to Suzanne Barone, CPSC, October 4, 1994.
    226. Letter from Suzanne Barone, CPSC, to John Craig, Bordentown 
Township Senior Citizens Club, October 18, 1994.
    227. Letter from Hugh Lockhart, ISR Project Director, to Suzanne 
Barone, October 20, 1994.
    228. Log of Meeting with representatives from the Chemical 
Specialty Manufacturers Association, October 20, 1994.
    229. Letter from Alexander M. Perritt, Perritt Laboratories, to 
Suzanne Barone, November 1, 1994.
    230. Terry L. Kissinger, EPHA, ``Testing Protocol for Child-
Resistant Packaging: Response to Public Comments Received after 
Publication of the Notice of Proposed Rulemaking,'' November 3, 
1994.
    231. Letter from Michael S. Buie, Child Related Research, Inc., 
to Suzanne Barone, November 9, 1994.
    232. Charles Wilbur, HS ``Technical Feasibility, Practicability, 
and Appropriateness Determination for the Final Rule to Require SAUE 
Special Packaging for the PPPA Regulated Products,'' November 10, 
1994
    233. Letter from Ralph Engel, Chemical Specialties Manufacturers 
Association, to Commissioner Gall, November 17, 1994.
    234. Catherine A. Sedney, EPHA, ``Responses to Written Comments 
on Proposed Revisions to Child-Resistant Packaging Protocol,'' 
November 17, 1994.
    235. Charles Wilbur, HS, ``Temporary Enforcement Exemption 
Request Procedure,'' November 18, 1994.
    236. Fay H. Dworkin and Marcia Robins, EC, ``Protocol Revisions: 
Final Economic Reports,'' November 18, 1994.
    237. Suzanne Barone, HS, ``Response to Comments Related to the 
Proposed Effective Date of the Revised Child-Resistant Test 
Protocols,'' November 22, 1994.
    238. Log of meeting with Chemical Specialties Manufacturers 
Association, November 28, 1994.
    239. Suzanne Barone, HS, Briefing Package--Final Rule to Require 
Changes to Child-Resistant Packaging Test Protocols, December 6, 
1994.
    240. Charles Wilbur, HS, ``Supplemental Information Concerning 
the Final Rule to Require Senior Adult Use Effective Special 
Packaging for the Poison Prevention Packaging Act Regulated 
Products,'' December 16, 1994.
    241. Memorandum from Rosalind Gross, EPA, to Suzanne Barone, 
CPSC, with comments on briefing package, December 19, 1994.
    242. Letter from Ralph Engel, Chemical Specialties Manufacturers 
Association, to Chairman Ann Brown, December 19, 1994.
    243. Terry Kissinger, EPHA, ``Analysis of Data from Closure 
Manufacturers Association,'' December 19, 1994.
    244. Wilbur, C. J., Personal Communications, Major CR Overcap 
Manufacturer, Memo Record, 247, December 19, 1994.
    245. Wilbur, C. J., Laboratory Report, Form 221, 28mm plastic/
PET CR cap on a one gallon F Style metal can with handle, ASTM IA, 
T-400-1243, #1917, December 19, 1994.
    246. Suzanne Barone, HS, ``Response to Closure Manufacturers 
Association's Points of Concern,'' December 19, 1994.
    247. Suzanne Barone, HS, ``Additional Information on the 
Availability of Senior-Friendly Child-Resistant Packaging and the 
Ability of Most Substances to Meet the Effective Date,'' December 
19, 1994.
    248. Wilbur, C. J., Laboratory Report, Form 221, ASTM VIID, 
Requires Use of a Key or Device to Open (Actuates Normally), Metal 
Aerosol 211 x 604, T-400-1241, #1913, December 20, 1994.
    249. Wilbur, C. J., Laboratory Report, Form 221, ASTM IA with 
tool assist option ASTM IE, Key or Device Open, Plastic over Metal 
CR Cap on a one quart F Style Metal Can, T-400-1240,, #1912, 
December 20, 1994.
    250. Letter from Kathleen Sanzo, Morgan, Lewis, and Bockius, to 
the Office of the Secretary, December 23, 1994.
    251. Wilbur, C. J., Laboratory Report, Form 221, ASTM IA with 
tool Assist Option ASTM IE, Key or Device Open, Plastic Over Metal 
CR Cap with Top Tab Tool Assist Opening Feature for metal F Style 
Metal Containers, T-400-1238, #1910, December 23, 1994.
    252. Letter from William Bradley, Nonprescription Drug 
Manufacturers Association, to Chairman Ann Brown and Commissioner 
Mary Sheila Gall, January 3, 1995 Senior Adult Resecuring Test 
Compliance Period.
    253. Letter from Christopher S. Bond, U.S. Senate, to Chairman 
Ann Brown and Commissioner Mary Sheila Gall, January 3, 1995.
    254. Letter from William Bradley, Nonprescription Drug 
Manufacturers Association, to Chairman Ann Brown and Commissioner 
Mary Sheila Gall, January 3, 1995 Increased Risk to Children if 
Senior Adult Test Protocol is Implemented.
    255. Letter from Ralph Engel, Chemical Specialties Manufacturers 
Association, to Office of the Secretary, January 3, 1995.
    256. Wilbur, C.J., Laboratory Report, Form 221, Metal Aerosol 
211 x 703, with ASTM VII Thomas, Hold Fitment Still While Turning 
(Actuates Normally), T-400-0151, #1916, January 4, 1995.
    257. Wilbur, C. J., Laboratory Report, Form 221, ASTM IIIA 
Prescription Vial with an EZ Open Extended Thumb Tab, T-400-0150, # 
1915, January 4, 1995.
    258. Letter from Darla J. Williamson, Closure Manufacturers 
Association, to Chairman Ann Brown, January 4, 1995.
    259. Letter from John Rother, American Association of Retired 
Persons, to Chairman Ann Brown, January 4, 1995.
    260. Letter from Chairman Ann Brown, CPSC, to Senator 
Christopher Bond, January 6, 1995.
    261. Wilbur, C. J., Laboratory Report, Form 221, Metal Aerosol 
211x602, with ASTM VIIG, Shell child Protector-Top (Hood), Requires 
Finger Longer than that of Child, (Actuates Normally), T-400-0159, 
#1930, January 4, 1995.
    262. Wilbur, C. J., Personal Communications, Major CR Capping 
Equipment Manufacturer, Memo Record 247, October 27, 1994.
    263. Product Code 06800 oral contraceptives, from data tapes 
purchased from AAPCC 1984-1993.
    264. Industry Position Paper, ``The Consumer Product Safety 
Commission's New `Senior Friendly' packaging Mandate: Congress 
Should Act to Reverse This Counter-Productive, Unauthorized 
Expansion of CPSC Authority,'' January 30, 1995.
    265. Letter from John McMackin and J. Steven Hart representing 
the Coalition for Responsible Packaging to Robert Wager, February 
10, 1995.
    266. Summary of CPSC Staff Response to the Industry Position 
Paper on the Recent PPPA Protocol Revisions, February 17, 1995.
    267. Reconsideration of Final rule: notice of opportunity for 
additional written public comment, 60 FR 9654, February 21, 1995.
    268. Letter from Margie Lawlor, ASTM to Charles Wilbur, February 
23, 1995.

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    269. Letter from Jeffrey Minnette, Sunbeam Plastics, to Robert 
Wager, February 23, 1995, CONFIDENTIAL.
    270. Memorandum from Terry L. Kissinger, EPHA, ``Response to 
Letter from the Nonprescription Drug Manufacturers Association Dated 
January 3, 1995,'' February 27, 1995.
    271. Requirements for the special packaging of household 
products, opportunity for oral comments, 60 FR 12165, March 6, 1995.
    272. Comments on additional two issues. On file in the Office of 
the Secretary, March 7, 1995.
    273. Transcript of oral comments--March 16, 1995.
    274. Logs of meetings with Coalition for Responsible Packaging, 
March 22, 1995, March 29, 1995, April 5, 1995, April 25, 1995, May 
18, 1995 and June 1, 1995.
    275. Letter from William Bradley, Nonprescription Drug 
Manufacturers Association, to Suzanne Barone, March 22, 1995.
    276. Letter from Ralph Engel, Chemical Specialties Manufacturers 
Association, to Chairman Brown, March 22, 1995.
    277. Letter from Coalition for Responsible Packaging, 
``Additional comment on `unable-to-use.' April 4, 1995.
    278. Letter from William Bradley, Nonprescription Drug 
Manufacturers Association, to Suzanne Barone, April 5, 1995.
    279. Memorandum from Terry L. Kissinger, EPHA, ``Response to 
Letter from the Nonprescription Drug Manufacturers Association Dated 
March 22, 1995,'' May 5, 1995.
    280. Letter from William Bradley, Nonprescription Drug 
Manufacturers Association, to Eric Rubel, May 10, 1995.
    281. Memorandum from Terry L. Kissinger, EPHA, ``Response to 
Letter from the Nonprescription Drug Manufacturers Association Dated 
April 5, 1995,'' May 11, 1995.
    282. Ward, Richard A, ASTM IA, 38mm CR cap on 60cc Bottle, 
Senior Friendly Protocol Test, Ages 60-75 with Child Resecuring 
Verification, Perritt Laboratories, Inc, Hightstown, NJ, January 30, 
1992. Submitted May 11, 1995 CONFIDENTIAL.
    283. Ward, Richard A, ASTM IA, 38mm CR cap on 60cc Bottle, 
Senior Friendly Protocol Test, Ages 18-70 with Child Resecuring 
Verification, Perritt Laboratories, Inc., No.1085-045, Hightstown, 
NJ May 20, 1991. Submitted May 11, 1995 Confidential.
    284. Ward, Richard A, ASTM IA, 38mm CR cap on 60cc Bottle, 
Senior Friendly Protocol Test, Ages 60-75 with Child Resecuring 
Verification, Perritt Laboratories, Inc, Hightstown, NJ, May 20, 
1991. Submitted May 11, 1995 CONFIDENTIAL.
    285. Johnstone, N, ASTM IA, P/P, 38mm CR cap on Bottle, Adult 
Protocol Test, Ages 18-45 with Child Resecuring Verification, 
Associated Testing Laboratories, Inc., Wayne, NJ, T29425-001 April 
21, 1992. Submitted May 11, 1995 CONFIDENTIAL.
    286. Letter from Daniel Gerner, Healthcare Compliance Packaging 
Council, to Robert Wager, May 12, 1995.
    287. Memorandum from Catherine A. Sedney, EPHA, ``Responses to 
Written Comments on Proposed Revisions to Child-Resistant Packaging 
Protocol,'' May 18, 1995.
    288. Memorandum from Eric A. Rubel, OGC, ``PPPA Protocol 
Revisions,'' May 22, 1995.
    289. Memorandum from Terry L. Kissinger, EPHA, ``Comparison of 
60-75 Age Range with Alternate Age Ranges for Adult Protocol 
Testing,'' May 24, 1995.
    290. Suzanne Barone, ``Response to Additional Comments on the 
Proposal to Revise the Child-Resistant Packaging Test Protocols,'' 
May 25, 1995.
    291. U.S. Population Estimates, by Age Sex, Race, and Hispanic 
Origin: 1990 to 1994. Kevin Deardorff, Frederick Hollmann, Patricia 
Montgomery, U.S. Bureau of the Census.
    292. Letter from 25 State Attorneys General to CPSC Chairman Ann 
Brown, May 31, 1995.
    293. Letter from Coalition for Responsible Packaging to CPSC 
General Counsel Eric Rubel, June 14, 1995.
    294. Memorandum of Record, E. Press, April 11, 1967.
    295. Safety Packaging in the '70's--Proceedings of a Conference 
Sponsored by the Scientific Development Committee, The Proprietary 
Association, December 9, 1970.
    296. Letter from Edward Press, M.D., to Michael Gidding, March 
20, 1995.
    297. Memorandum from Terry L. Kissinger to Suzanne Barone, 
``Probabilities of Scoring 90 Percent or Higher in Adult Protocol 
Testing with a Single Homogeneous Age Group,'' June 5, 1995.
    298. Memorandum from Ronald L. Medford and Suzanne Barone to the 
Commission, ``Poison Prevention Packaging Act Protocol Revisions--
Sequential Test Method for Measuring Adult-Use-Effectiveness,'' June 
6, 1995 (forwarding No. 297).
    299. Press release, Coalition for Responsible Packaging, June 
15, 1995.
    300. Letter from James D. Cope, President, NDMA, to CPSC 
Chairman Ann Brown, June 15, 1994.
    301. Letter from Charles Jacobson to CPSC Chairman Ann Brown, 
June 16, 1995.
    302. Letter from CPSC Chairman Ann Brown to Charles Jacobson, 
June 21, 1995.

[FR Doc. 95-17436 Filed 7-20-95; 8:45 am]
BILLING CODE 6355-01-P