37710 - Federal Register / Vol. 60, No. 140 / Friday, July 21, 1995

37710

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

CONSUMER PRODUCT SAFETY

COMMISSION

16 CFR Part 1700

Requirements for the Special

Packaging of Household Substances

AGENCY

: Consumer Product Safety

Commission.

ACTION

: Final rule.

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 §§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 §§1700.20(a) (1) and (2), will

become effective January 24, 1996.

New §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

37711

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

Numbers in brackets indicate the number of a

relevant supporting document in the ‘‘List of

Relevant Documents’’ in Appendix I to this notice.

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 §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]

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.

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

37712

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

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

37713

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

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.

increase the likelihood of making the

correct decision of passing or failing.

The sequential testing procedure was

published for comment in the Federal

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.

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.

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

37714

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

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 §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

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.

37715

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

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

37716

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

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

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

37717

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

15 U.S.C. 1471(4).

15 U.S.C. 1473.

Thus, the law prohibits the Commission from

specifying specific package designs, product

content, or package quantity. 15 U.S.C. 1472(d).

S. Rep. No. 91–845 at 9.

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).

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.

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.

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.

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

37718

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

The term ‘‘handicapped’’ is hereafter referred to

as ‘‘disabled,’’ except where context requires the

use of the statutory term.

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.

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’’

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.

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

37719

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

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.

§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.

S. Rep. No. 91–845 at 9 (1970).

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]

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.

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.’’

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.’’

This is exactly what the rule

now issued by the Commission

accomplishes.

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-

37720

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

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

37721

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

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

37722

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

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.

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 §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

§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.

However, the information in the record

indicates that the senior-friendly adult

test will have significant safety benefits

and will not compromise child-

resistance.

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%

37723

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

The Commission previously received another

industry comment in which the SAUE scores were

all calculated incorrectly, assuming the age group

proportions were correct.

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).

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.

The failure to

provide these data makes it impossible

to make a thorough or meaningful

assessment of this commenter’s

submission.

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.

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.

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

37724

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

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,

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

37731

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

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

⁄

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

(

)

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 × 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 × 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

37732

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

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,

37733

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

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

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

37734

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

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

§§1700.15(b)(2), 1700.20(a)(3), and

1700.20(a)(4) are effective July 22, 1996.

Until then, current §§1700.15(b)(2),

1700.20(a)(4), and 1700.20(a)(5) remain

in effect.

Revised §§1700.20(a) (1) and (2) are

effective January 24, 1996. Until then,

current §§1700.20(a)(1)–(3) remain in

effect.

New §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:

§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 §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 §1700.20(a)(4).

The senior-adult panel test of

§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,

37735

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

(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 §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:

§1700.20 Testing procedure for special

packaging.

(a) Test protocols. (1) General

requirements.

(i) Requirements for packaging. As

specified in §1700.15(b), special

packaging is required to meet the child

test requirements and the applicable

adult test requirements of this §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.,

8 03 1990

6 23 1986

2 20 4

/ /

/ /−

−

(3) Multiply the difference in years by

12 to obtain the number of months in

the difference in years, and add this

value to the number of months that was

obtained when the birth date was

subtracted from the test date (i.e., 4×12=

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

37736

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

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.

ABLE

1—N

UMBER OF

PENINGS

: A

CCEPTANCE

ASS

), C

ONTINUE

ESTING

AND

EJECTION

AIL

) C

RITERIA FOR THE

IRST

5 M

INUTES AND THE

ULL

10 M

INUTES OF THE

HILDREN

’

ROTOCOL

EST

Test panel

Cumu-

lative

number

of chil-

dren

Package openings

First 5 minutes Full 10 minutes

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

37737

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

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 ±

⁄

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

§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.

37738

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

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 §1700.20(d), reading as

follows.

§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

37739

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

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:

§1700.14 [Amended]

5. Section 1700.14(a) introductory text

is amended by inserting ‘‘meeting the

requirements of §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

37740

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

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.

37741

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

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

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

37742

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

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 × 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.

37743

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

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.

37744

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

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