THE POISON PREVENTION PACKAGING ACT

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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.

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CPSCs 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

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Acts Under CPSCs Jurisdiction

• Consumer Product Safety Act
• Flammable Fabrics Act
• Refrigerator Safety Act
• Federal Hazardous Substances Act (FHSA)
• Poison Prevention Packaging Act (PPPA)

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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.

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Substances included in 16 CFR 1700.14

• Ethylene glycol
• Fluoride
• Furniture polish
• Glue removers containing acetonitrile
• Hydrocarbons
• Kindling and/or illuminating preparations
• Methacrylic acid
• Methyl alcohol

• 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

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Drugs included in 16 CFR 1700.14(a)

• acetaminophen
• aspirin
• controlled drugs
• dibucaine
• diphenhydramine
• ibuprofen
• iron-containing drugs and dietary supplements
• ketoprofen

• lidocaine
• loperamide
• methyl salicylate
• minoxidil
• mouthwash
• naproxen
• oral prescription drugs
• OTC-switched drugs

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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

• 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.

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CR Packaging Exceptions

• Not Used In/Around the Household
• Institutional Use
• Hospitals, Nursing Homes
• Professional Use

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CR Packaging Exceptions (continued)

• Rx Drugs
• 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)

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CR Packaging Exceptions (continued)

• OTCs - Household Products
• One size
• Labeled (16 CFR 1700.5)
• This Package For Households Without Young
  Children
• Package Not Child-Resistant
• Other popular sizes are CR
• Imposed exclusive CR
• Drain cleaners (16 CFR 1500.17)

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Petitions for Exemption

• 16 CFR part 1702
• Requirements
• - Procedural 16 CFR 1702.2
• - Substantive 16 CFR 1702.3

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Petitions for Exemption (Cont.)

• Justification 16 CFR 1702.7
• - Lack of toxicity
• - CR packaging not technically feasible,
  practicable, or appropriate
• - CR package is incompatible with substance

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Petitions for Exemption (Cont.)

• Information and Data Submission
• - Human experience
• Child
• Adult
• - Experimental data
• - Packaging and labeling
• Samples

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Examples of Exempted Products

• Powdered unflavored aspirin
• Effervescent aspirin
• Powdered cholestyramine
• Oral contraceptives
• Hormone replacement therapy

• Powdered iron preparations
• Effervescent acetaminophen
• Hydrocarbon-containing products where the liquid
  cannot flow freely.

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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

• 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..

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Special Packaging

• 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.

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Packaging Test Methods

• Child Test - 16 FR1700.20(a)(2)
• 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 CFR1700.20(a)(2)(iii)
• 80 after 200 children

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SEQUENTIAL TEST
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Unit Packaging Failure

• 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.

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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 25-pound
  child.

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Toxicological Data

• 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.

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If you have questions about PPPA

• Suzanne Barone 301-504-7256
• e-mail sbarone_at_cpsc.gov
• Geri Smith 301-504-7529
• e-mail gsmith_at_cpsc.gov
• John Boja 301-504-7300
• e-mail jboja_at_cpsc.gov
• Website www.cpsc.gov

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Packaging Test Methods

• Senior Test -16 FR1700.20(a)(3)
• 100 adults (50-70 years old)
• Site restriction (24)
• Tester restriction (35)
• 5 minute/1 minute test period
• Screening
• 90 Effectiveness

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Packaging Test Methods

• Metal cans/metal closures and aerosols.
• Use 100 Adults aged 18-45 years
• One 5 minute time period
• 90 effectiveness