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

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

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

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

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.

CR Packaging Exceptions

Not Used In/Around the HouseholdInstitutional Use

Hospitals, Nursing Homes

Professional Use

CR Packaging Exceptions (continued)

Rx DrugsBulk Drugs to be Repackaged by

the PharmacistRequested by Patient or

PhysicianExempted (16 CFR § 1702)

16 CFR §1700.14(a)(10)(i)-(xxi)

CR Packaging Exceptions (continued)

OTCs - Household ProductsOne 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)

Petitions for Exemption

16 CFR part 1702 Requirements

- Procedural – 16 CFR § 1702.2

- Substantive – 16 CFR § 1702.3

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

Petitions for Exemption (Cont.)

Information and Data Submission- Human experience

ChildAdult

- Experimental data

- Packaging and labeling Samples

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.

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.

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..”

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.”

Packaging Test Methods Child Test - 16 FR§1700.20(a)(2)

Panels of 50 children (42-51 months)

Tester restriction - 30% childrenSite restriction - 20% children5 minute - demo - Teeth - 5 minuteSequential Pass/Fail Table

16 CFR§1700.20(a)(2)(iii)80% after 200 children

SEQUENTIAL TEST

Package Openings (10 minutes)Test Panel # ChildrenTested

Pass Continue Fail

1 50 0-5 6-14 15+2 100 6-15 16-24 25+3 150 16-25 26-34 35+4 200 26-40 - 41+

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.”

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.

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.

If you have questions about PPPA:

Suzanne Barone 301-504-7256 e-mail sbarone@cpsc.gov Geri Smith 301-504-7529 e-mail gsmith@cpsc.gov John Boja 301-504-7300 e-mail jboja@cpsc.gov Website: www.cpsc.gov

Packaging Test Methods

Senior Test -16 FR§1700.20(a)(3)

100 adults (50-70 years old)Site restriction (24%)Tester restriction (35%)5 minute/1 minute test periodScreening 90% Effectiveness

Packaging Test Methods

Metal cans/metal closures and aerosols.

Use 100 Adults aged 18-45 yearsOne 5 minute time period90% effectiveness