Requirements for the Special Packaging of Household Substances; Reconsideration of Final Rule; Opportunity for Written Comment

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700

Requirements for the Special Packaging of Household Substances;

Reconsideration of Final Rule; Opportunity for Written Comment

AGENCY: Consumer Product Safety Commission.

ACTION: Reconsideration of final rule; notice of opportunity for

additional written public comment.

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SUMMARY: The Commission on February 6, 1995, approved a Federal

Register notice amending its requirements under the Poison Prevention

Packaging Act of 1970 for child-resistant packaging to change the child

and adult tests under which child-resistant packaging is evaluated.

Immediately thereafter, the Commission became aware of comments on the

final rule that had not previously been submitted to the agency during

the course of the rulemaking. As a result, the Commission on February

9, 1995, voted to withhold publication of the final rule in order to

consider these new arguments.

The new arguments can be summarized as follows. First, in

establishing an adult test panel consisting of adults aged 60-75, the

Commission allegedly exceeded its statutory authority to require that

child-resistant packaging not be difficult for ``normal adults'' to use

properly. Second, the rule allegedly addresses consumer convenience,

rather than safety, which the comment claims is not properly the

subject of a Commission regulation.

DATES: Written comments limited to the new issues described below may

be submitted on or before March 7, 1995.

ADDRESSES: Written comments should be mailed to the Office of the

Secretary, Consumer Product Safety Commission, Washington, D.C. 20207,

or delivered to the Office of the Secretary, Consumer Product Safety

Commission, Room 501, 4340 East-West Highway, Bethesda, MD 20814.

FOR FURTHER INFORMATION CONTACT: Suzanne Barone, Ph.D., Project

Manager, Consumer Product Safety Commission, Washington, DC 20207;

telephone (301) 504-0477, ext. 1196.

SUPPLEMENTARY INFORMATION:

The Poison Prevention Packaging Act of 1970 (``PPPA''), 15 U.S.C.

1471-1476, authorizes the Consumer Product Safety Commission to issue

requirements that certain household substances be sold in child-

resistant (``CR'') packaging. Under the PPPA, the Commission has

defined and established standards for such ``special'' packaging. 16

CFR 1700.1(b)(4), 1700.3, 1700.15, and 1700.20. The Commission has also

determined which household substances are required to have the special

packaging. 16 CFR 1700.14.

To comply with the special packaging requirements, a package must

resist entry by most young children and must be ``not difficult'' for

``normal adults'' to open and properly resecure, within specified time

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

The current adult test protocol, 16 CFR 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

[[Page 9655]] males. The test period is 5 minutes. The adults are given

the test package and asked to open and then properly close the package.

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).

In enacting the PPPA, the Congress was concerned that the elderly

or individuals with disabilities 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.''

Furthermore, prescription substances subject to special packaging

standards may be dispensed in non-CRP if directed by the prescriber or

requested by the purchaser. PPPA Sec. 4(b), 15 U.S.C. 1473(b).

Thus, persons who find CRP unduly difficult to use may purchase the

single size of a nonprescription product that may be provided in

noncomplying packaging or may request that his or her prescriptions be

supplied in noncomplying packaging, thereby eliminating the protection

that CRP provides against poisoning. 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. The Commission was concerned that these

consumer actions, all caused at least in part by packaging that is

difficult for normal adults to use properly, were exposing children to

avoidable poisonings.

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.

Older adults typically have the most difficulty with CRP.

Therefore, in order to eliminate the currently-marketed CR package

designs that are most difficult for ``normal adults'' of all ages to

open, the Commission proposed to substitute older adults, ages from 60-

75 years, for the current panel of 100 18-45 year-olds.

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

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). On December 20, 1994, the Commission was briefed by

its staff on the comments on the proposed rule and the changes

recommended by the staff.

On January 6, 1995, the Commission met and decided to approve the

rule recommended by the staff, but to exclude from the scope of the

rule those products that must be packaged in metal cans or aerosol

form. The staff made appropriate changes to the draft Federal Register

notice that would issue the final rule, and that notice was approved by

the Commission on February 6, 1995. Immediately thereafter, certain

portions of the packaging industry raised concerns about the

Commission's action. Some of these concerns already had been addressed

in the rulemaking proceeding. Two concerns, however, had not been the

subject of specific comments by interested parties in this rulemaking.

Specifically, the new comments can be summarized as follows. First,

in establishing an adult test panel consisting of adults aged 60-75,

the Commission allegedly exceeded its statutory authority to require

that child-resistant packaging not be difficult for ``normal adults''

to use properly. Second, the rule allegedly addresses consumer

convenience, rather than safety, which the comment claims is not

properly the subject of a Commission regulation. In addition, the

second comment contends that to the extent that child-resistant

packages exist that will pass the ``senior friendly'' test approved by

the Commission, market forces will be an adequate and more appropriate

mechanism to ensure that the more convenient packaging will be adopted.

The Commission wanted to assure that it had an opportunity to

consider these new arguments that had not previously been raised in the

rulemaking. Accordingly, on February 8, 1995, the Commission voted

unanimously to withhold publication of the Federal Register notice that

would have issued the final rule, to consider the new arguments.

Written comments, limited to these two issues only, may be submitted

until March 7, 1995. The Commission will consider any new information

and arguments received on these issues alone, and will resolve these

points as quickly as possible. Comments addressing other issues will

not be considered.

Dated: February 16, 1995.

Sadye E. Dunn,

Secretary Consumer Product Safety Commission.

[FR Doc. 95-4307 Filed 2-17-95; 8:45 am]

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