[Federal Register Volume 60, Number 34 (Tuesday, February 21, 1995)]
[Proposed Rules]
[Pages 9654-9655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4307]



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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]
BILLING CODE 6355-01-P