[Federal Register Volume 68, Number 115 (Monday, June 16, 2003)]
[Proposed Rules]
[Page 35614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15064]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700


Petition Requesting Amendment to Child-Resistance Testing Pass/
Fail Criterion for Unit Dose Packaging (Petition No. PP 03-1)

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of petition.

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SUMMARY: The current regulatory definition of a child-resistance test 
failure for unit dose, i.e., non-reclosable packaging under the Poison 
Prevention Packaging Act (PPPA), is a child gaining access to the 
number of individual unit doses that constitute the amount that ``may 
cause serious personal injury or serious illness'' or more than eight 
individual unit doses, whichever is less. The Commission has received a 
petition (Petition No. PP 03-1) requesting that the Commission amend 
that requirement to eliminate the first criterion related to the 
toxicity of the substance to be packaged and define a unit dose 
packaging failure to be a child gaining access to more than eight 
individual unit doses. The Commission solicits written comments 
concerning the petition.

DATES: The Office of the Secretary must receive comments on the 
petition by August 15, 2003.

ADDRESSES: Comments on the petition, preferably in five copies, should 
be mailed to the Office of the Secretary, Consumer Product Safety 
Commission, Washington, DC 20207, telephone (301) 504-0800, or 
delivered to the Office of the Secretary, Room 501, 4330 East-West 
Highway, Bethesda, Maryland 20814. Comments may also be filed by 
facsimile to (301) 504-0127 or by email to [email protected]. Comments 
should be captioned ``Petition PP 03-1, Petition for Amendment of the 
Child-Resistance Testing Requirements for Unit Dose Packaging.'' A copy 
of the petition is available for inspection at the Commission's Public 
Reading Room, Room 419, 4330 East-West Highway, Bethesda, Maryland. The 
petition is also available on the CPSC Web site at http://www.cpsc.gov.

FOR FURTHER INFORMATION CONTACT: Rockelle Hammond, Office of the 
Secretary, Consumer Product Safety Commission, Washington, DC 20207; 
telephone (301) 504-6833; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: By letter of March 17, 2003, and 
supplemental information provided by letter of May 5, 2003, the 
Healthcare Compliance Packaging Council (HCPC) requests a change to the 
Commission's regulatory requirements under the PPPA for testing the 
ability of unit dose child-resistant, i.e., ``special'' packaging to 
resist attempts by children to open it. The HCPC request addresses the 
portion of the requirements defining a testing failure for unit dose 
packaging. Unit dose packaging is non-reclosable packaging typically 
including a limited number of tablets (usually one or two) per unit, 
e.g., blister, strip or pouch packaging.
    The HCPC members include companies involved in the manufacture of 
pharmaceutical-grade plastic films, aluminum, and paperboard used to 
produce unit dose blister and strip packaging, as well as manufacturers 
of machinery used to create unit dose formats. HCPC corporate members 
include firms that provide packaging services to the pharmaceutical 
manufacturers on a contract basis, as well as companies that purchase 
bulk quantities of drug products from pharmaceutical manufacturers and 
re-package those products into unit dose and other formats for use by 
hospitals, clinics, and other similar facilities.\1\
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    \1\ March 17, 2003 HCPC letter at 3.
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    The child resistance testing requirements were promulgated under 
authority of the PPPA. The testing requirements are the mechanism for 
assessing the ability of a particular form of ``special packaging'' to 
resist attempts by children to gain access to its contents. The 
definition of a child-resistance test failure for unit dose packaging 
is a child gaining access to the number of individual unit doses that 
constitute the amount that may cause ``serious personal injury or 
serious illness'' or more than eight individual unit doses, whichever 
is less.\2\
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    \2\ 16 CFR 1700.20(a)(2)(ii).
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    The HCPC's specific request is as follows. ``The definition of test 
failure for unit dose packaging should be an objective standard, i.e., 
`any child who opens or gains access to more than 8 individual units 
during the full 10 minutes of testing.' '' The HCPC asserts that ``unit 
dose packaging is inherently safer than cap-and-vial closures'' and 
that ``the current regulation creates a disincentive for pharmaceutical 
manufacturers and packagers to use safer unit dose packaging.''\3\
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    \3\ March 17, 2003 HCPC letter at 3-5.
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    The HCPC request has been docketed as petition number PP 03-1. The 
Commission is particularly interested in receiving comments on the 
petition from: (1) Consumers; (2) dispensing physicians; (3) poison 
control centers; (4) pharmaceutical manufacturers; (5) chain drug 
store, government, independent, and hospital pharmacies; and (6) drug 
repackagers, wholesalers and distributors.
    Interested parties may obtain a copy of the petition by writing or 
calling the Office of the Secretary, Consumer Product Safety 
Commission, Washington, DC 20207; telephone (301) 504-0800. The 
petition is available on the CPSC World Wide Web site at http://www.cpsc.gov. A copy of the petition is also available for inspection 
from 8:30 a.m. to 5 p.m., Monday through Friday, in the Commission's 
Public Reading Room, Room 419, 4330 East-West Highway, Bethesda, 
Maryland.

    Dated: June 10, 2003.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 03-15064 Filed 6-13-03; 8:45 am]
BILLING CODE 6355-01-P