Transcript POISON PREVENTION PACKAGING ACT

THE POISON PREVENTION
PACKAGING ACT
Suzanne Barone, Ph.D.
Project Manager for Poison Prevention
The views expressed in this presentation are those of the CPSC staff, have not been
reviewed or approved by, and may not necessarily reflect the views of, the
Commission.
CPSC’s Mission
Independent federal regulatory agency
that was created in 1972 by Congress in
the Consumer Product Safety Act.
 “Protect the public against unreasonable
risks of injuries and deaths associated
with consumer products.”
 Jurisdiction over about 15,000 types of
consumer products

Acts Under CPSC’s
Jurisdiction
Consumer Product Safety Act
 Flammable Fabrics Act
 Refrigerator Safety Act
 Federal Hazardous Substances
Act (FHSA)
 Poison Prevention Packaging
Act (PPPA)

Poison Prevention Packaging
Act
To protect children from serious personal
injury or serious illness resulting from
handling, using or ingesting hazardous
substances including household
chemicals, pharmaceuticals, and
cosmetics.
Substances included in 16 CFR § 1700.14
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Ethylene glycol
Fluoride
Furniture polish
Glue removers
containing
acetonitrile
Hydrocarbons
Kindling and/or
illuminating
preparations
Methacrylic acid
Methyl alcohol
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Mouthwash
containing ethanol
Permanent wave
neutralizer containing
sodium or potassium
bromate
Sodium and
Potassium hydroxide
Solvents for paint or
other coating material
Sulfuric acid
Turpentine
Drugs included in 16 CFR § 1700.14(a)
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acetaminophen
aspirin
controlled drugs
dibucaine
diphenhydramine
ibuprofen
iron-containing
drugs and dietary
supplements
ketoprofen
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lidocaine
loperamide
methyl salicylate
minoxidil
mouthwash
naproxen
oral prescription
drugs
OTC-switched
drugs
Oral Rx Drug Regulation
16 C.F.R. §1700.14(a)(10)
 CR packaging is required for any drug
for human use that is in a dosage form
intended for oral administration and that
is required by Federal law to be
dispensed only by or upon an oral or
written prescription of a practitioner
licensed by law to administer such drug
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Clinical Trial Drugs
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Oral drugs for human use when they
are dispensed during a clinical trial
(investigational drugs) for use in the
household (outpatient) are regulated
under the oral prescription drug
regulation because they are dispensed
by or at the order of a licensed
practitioner.
CR Packaging Exceptions
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Not Used In/Around the Household
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Institutional Use
Hospitals, Nursing Homes
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Professional Use
CR Packaging Exceptions
(continued)
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Rx Drugs
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Bulk Drugs to be Repackaged by
the Pharmacist
Requested by Patient or
Physician
Exempted (16 CFR § 1702)
16 CFR §1700.14(a)(10)(i)-(xxi)
CR Packaging Exceptions
(continued)
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OTCs - Household Products
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One size
Labeled (16 CFR §1700.5)
“This Package For Households
Without Young Children”
“Package Not Child-Resistant”
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Other popular sizes are CR
Imposed exclusive CR
Drain cleaners (16 CFR 1500.17)
Petitions for Exemption
16 CFR part 1702
 Requirements
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- Procedural – 16 CFR § 1702.2
- Substantive – 16 CFR § 1702.3
Petitions for Exemption
(Cont.)
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Justification – 16 CFR § 1702.7
- Lack of toxicity
- CR packaging not technically
feasible, practicable, or appropriate
- CR package is incompatible with
substance
Petitions for Exemption
(Cont.)
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Information and Data Submission
- Human experience
Child
Adult
- Experimental data
- Packaging and labeling
Samples
Examples of Exempted
Products
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Powdered
unflavored aspirin
Effervescent aspirin
Powdered
cholestyramine
Oral contraceptives
Hormone
replacement therapy
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Powdered iron
preparations
Effervescent
acetaminophen
Hydrocarboncontaining products
where the liquid
cannot flow freely.
Physician Samples
Oral prescription drugs require
special packaging. 16 CFR §
1700.14(a)(10)
 Section 4 of the PPPA grants
physicians the authority to order
non-CR packaging for their patients
in the written prescription.
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Special Packaging
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“Packaging that is designed or
constructed to be significantly
difficult for children under five
years of age to open or obtain a
toxic or harmful amount of
substance contained therein within
a reasonable time and not difficult
for normal adults to use properly..”
Special Packaging
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“Nothing in this Act shall authorize
the Secretary to prescribe specific
packaging designs, product content,
package quantity, or with the
exception of authority granted in
section 4(a)(2) of this Act, labeling.”
Packaging Test Methods
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Child Test - 16 FR§1700.20(a)(2)
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Panels of 50 children (42-51 months)
Tester restriction - 30% children
Site restriction - 20% children
5 minute - demo - Teeth - 5 minute
Sequential Pass/Fail Table
16 CFR§1700.20(a)(2)(iii)
80% after 200 children
SEQUENTIAL TEST
Test Panel # Children
Tested
Package Openings (10 minutes)
Pass
1
2
3
4
50
100
150
200
Continue
0-5 6-14
6-15 16-24
16-25 26-34
26-40
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Fail
15+
25+
35+
41+
Unit Packaging Failure
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“A test failure shall be any child who
opens or gains access to the number of
individual units which constitute the
amount that may produce serious
personal injury or serious illness, or a
child who opens or gains access to
more than 8 individual units, whichever
is lower, in 10 minutes of testing.”
Determining “F”
Serious Injury / Serious Illness
 The determination of the amount of
a substance that may produce
serious personal injury or serious
illness shall be based on a 25pound child.
Toxicological Data
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Manufacturers or packagers
intending to use unit packaging for
a substance requiring special
packaging are requested to submit
such toxicological data to the
CPSC Office of Compliance.
If you have questions
about PPPA:
Suzanne Barone 301-504-7256
 e-mail [email protected]
 Geri Smith 301-504-7529
 e-mail [email protected]
 John Boja 301-504-7300
 e-mail [email protected]
 Website: www.cpsc.gov
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Packaging Test Methods
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Senior Test -16 FR§1700.20(a)(3)
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100 adults (50-70 years old)
Site restriction (24%)
Tester restriction (35%)
5 minute/1 minute test period
Screening
90% Effectiveness
Packaging Test Methods
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Metal cans/metal closures and
aerosols.
Use 100 Adults aged 18-45 years
One 5 minute time period
90% effectiveness