Requirements for the Special Packaging of Household Substances; Opportunity for Oral Comment

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