[Federal Register: June 16, 2003 (Volume 68, Number 115)]
[Proposed Rules]
[Page 35614]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jn03-17]
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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 cpsc-os@cpsc.gov. 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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: rhammond@cpsc.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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