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 l Independent federal regulatory agency that was created in 1972 by Congress in the Consumer Product Safety Act. l “Protect the public against unreasonable risks of injuries and deaths associated with consumer products.” l Jurisdiction over about 15,000 types of consumer products

Acts Under CPSC’s Jurisdiction l Consumer Product Safety Act l Flammable Fabrics Act l Refrigerator Safety Act l Federal Hazardous Substances Act (FHSA) l 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 § l Ethylene glycol l Fluoride l Furniture polish l Glue removers containing acetonitrile l Hydrocarbons l Kindling and/or illuminating preparations l Methacrylic acid l Methyl alcohol l Mouthwash containing ethanol l Permanent wave neutralizer containing sodium or potassium bromate l Sodium and Potassium hydroxide l Solvents for paint or other coating material l Sulfuric acid l Turpentine

Drugs included in 16 CFR § (a) l acetaminophen l aspirin l controlled drugs l dibucaine l diphenhydramine l ibuprofen l iron-containing drugs and dietary supplements l ketoprofen l lidocaine l loperamide l methyl salicylate l minoxidil l mouthwash l naproxen l oral prescription drugs l OTC-switched drugs

Oral Rx Drug Regulation l 16 C.F.R. § (a)(10) l 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

Clinical Trial Drugs l 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 l Not Used In/Around the Household s Institutional Use èHospitals, Nursing Homes s Professional Use

CR Packaging Exceptions (continued) l Rx Drugs s Bulk Drugs to be Repackaged by the Pharmacist s Requested by Patient or Physician s Exempted (16 CFR § 1702) è16 CFR § (a)(10)(i)-(xxi)

CR Packaging Exceptions (continued) l OTCs - Household Products s One size s Labeled (16 CFR §1700.5) è“This Package For Households Without Young Children” è“Package Not Child-Resistant” s Other popular sizes are CR s Imposed exclusive CR s Drain cleaners (16 CFR )

Petitions for Exemption l 16 CFR part 1702 l Requirements - Procedural – 16 CFR § Substantive – 16 CFR §

Petitions for Exemption (Cont.) l Justification – 16 CFR § Lack of toxicity - CR packaging not technically feasible, practicable, or appropriate - CR package is incompatible with substance

Petitions for Exemption (Cont.) l Information and Data Submission - Human experience èChild èAdult - Experimental data - Packaging and labeling èSamples

Examples of Exempted Products l Powdered unflavored aspirin l Effervescent aspirin l Powdered cholestyramine l Oral contraceptives l Hormone replacement therapy l Powdered iron preparations l Effervescent acetaminophen l Hydrocarbon- containing products where the liquid cannot flow freely.

Physician Samples l Oral prescription drugs require special packaging. 16 CFR § (a)(10) l Section 4 of the PPPA grants physicians the authority to order non-CR packaging for their patients in the written prescription.

Special Packaging l “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 l “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 l Child Test - 16 FR§ (a)(2) s Panels of 50 children (42-51 months) s Tester restriction - 30% children s Site restriction - 20% children s 5 minute - demo - Teeth - 5 minute s Sequential Pass/Fail Table è16 CFR§ (a)(2)(iii) è80% after 200 children

SEQUENTIAL TEST

Unit Packaging Failure l “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 l 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.

Toxicological Data l 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: l Suzanne Barone l l Geri Smith l l John Boja l l Website:

Packaging Test Methods l Senior Test - 16 FR§ (a)(3) s 100 adults (50-70 years old) s Site restriction (24%) s Tester restriction (35%) s 5 minute/1 minute test period s Screening s 90% Effectiveness

Packaging Test Methods l Metal cans/metal closures and aerosols. èUse 100 Adults aged years èOne 5 minute time period è90% effectiveness