[Federal Register Volume 60, Number 43 (Monday, March 6, 1995)]
[Proposed Rules]
[Pages 12165-12166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5502]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1700
Requirements for the Special Packaging of Household Substances;
Opportunity for Oral Comment
AGENCY: Consumer Product Safety Commission.
ACTION: Opportunity for presentation of oral public comments.
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SUMMARY: The Commission announces an opportunity for the presentation
of oral comments on two issues that were recently raised concerning
amendments the Commission is considering to its regulations 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.
Immediately after issuing a rule amending the PPPA test protocol,
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. 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.
The Commission has provided that written comments, limited to these
two issues, may be submitted until March 7, 1995. In addition, the
Commission is providing the opportunity for interested parties to
present oral comments, on these two issues alone, limited to a maximum
of 10 minutes per commenter.
DATES: Oral comments limited to the new issues described below may be
presented to the Commission at a Commission hearing beginning at 10:00
a.m., March 16, 1995. A request to present oral comments and an outline
or text of the comments must be received by the Commission on or before
March 10, 1995.
ADDRESSES: The hearing will be held in the Commission's Hearing Room,
4330 East-West Highway, 4th Floor, Bethesda, MD 20814. Requests to
present comments and outlines or text of the comments should be mailed
to the Office of the Secretary, Consumer Product Safety Commission,
Washington, DC 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.
Congress provided that 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
Commission's existing regulations 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 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 CFR 1700.15(b)(2).
Although the PPPA has significantly reduced the number of
poisonings of young children, deaths and injuries resulting from these
accidental ingestions continue to be a substantial problem. For
example, in 1993 alone, approximately 140,000 children under 5 years
old were treated in hospital emergency rooms for suspected or actual
poisonings. Also in 1993, poison control centers received reports of
more [[Page 12166]] than 6,000 poisonings of young children with
``moderate'' or ``major'' (life-threatening) effects. In addition, 42
children died in these accidents in 1992, the last year for which the
Commission has complete data.
During the more than 20 years since the PPPA was adopted, the
Commission has found that, contrary to requirements of the PPPA,
``normal'' adults of all ages have difficulty using typical CRP.
Moreover, the Commission's data indicate that the difficulty in using
CRP results in a substantial number of accidental ingestions by young
children because adults purchase hazardous substances in non-CRP or
disable CRP by leaving the caps off or loose or transferring the
package contents to another container.
Accordingly, the Commission sought to address the safety hazard
created by difficult to open CRP. On January 19, 1983, the Commission
published an advance notice of proposed rulemaking (``ANPR'') outlining
its concerns in this area and explaining and seeking comment on
possible actions to increase the proper use of CRP, to simplify the
test procedures, and to make the test procedures less affected by
possible variables. 48 FR 2389.
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 indicated that older adults, ages from 60-75
years, could be substituted for the current panel of 100 18-45-year-
olds.
After considering comments on the ANPR and other available
information, the Commission proposed amendments to the protocol to
address this problem. The proposed amendments would also 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, for public comment. 55 FR
40856.
In addition to the requests for comments in January 1983 and
October 1990 noted above, the Commission announced additional comment
periods on March 5, 1991, (56 FR 9181) and March 21, 1994 (59 FR
13264). The Commission's staff evaluated the comments received in
response to each of these requests.
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, the Coalition for Responsible Packaging, an
industry group, raised concerns about the Commission's action. Most 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.
On February 21, 1995, the Commission published a Federal Register
notice announcing that written comments, limited to these two issues
only, could be submitted until March 7, 1995. 60 FR 9654. The
Commission has now decided to also receive oral comments on these two
new issues. Oral comments on these new issues alone may be presented to
the Commission at a Commission hearing beginning at 10:00 a.m., March
16, 1995.
A request to present oral comments and an outline or text of the
comments must be received by the Commission on or before March 10,
1995. The oral comments shall be limited to 10 minutes per commenter.
The Commission reserves the right to further limit repetitious
comments. Comments addressing other issues will not be considered.
The hearing will be held in the Commission's Hearing Room, 4330
East-West Highway, 4th Floor, Bethesda, MD 20814. Requests to present
oral comments and outlines or text of the comments shall 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.
Dated: March 1, 1995.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
[FR Doc. 95-5502 Filed 3-2-95; 11:42 am]
BILLING CODE 6355-01-P
