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.

1

Poison Prevention Packaging

Act

2

Issue regulations requiring special packaging for household substances 15 U.S.C. § 1472(a)

Other statutes provide for enforcement of PPPA regulations Consumer Product Safety Act Federal Hazardous Substances Act

3

Child-resistant ◦ significantly difficult for children <5 to open or obtain a toxic or harmful amount of the substance within a reasonable time

Adult (Senior) Friendly ◦ not difficult for normal adults to use properly

15 U.S.C. § 1471(4)

4

Customarily produced or distributed for sale for consumption or use, or customarily stored, by individuals in or about the household, and which is

◦ a hazardous substance as defined by the Federal Hazardous Substances Act (FHSA);

◦ a food, drug, or cosmetic as defined by the Food, Drug and Cosmetic Act (FD&CA); or

5

◦ substance intended for use as fuel when stored in a portable container and used in the heating, cooking, or refrigeration system of a house.

15 U.S.C. § 1471(2)

6

The child-resistance requirements apply to the immediate container or wrapping.

Not a shipping container Not outer wrapping

15 U.S.C. § 1471(3)

7

The Act contains provisions to ensure that elderly or handicapped individuals unable to use special packaging can obtain regular packaging

Section 4 allows for limited use of non-complying packaging to achieve this

15 U.S.C. § 1473

8

Manufacturer (or packer) may supply non-prescription substance in a single non-complying size package

Label: For households without young children

Physician can specify non-CR packaging in prescription

Patient can request non-CR packaging when filling prescription

15 U.S.C. § 1473

9

Commission findings: special packaging is required to protect

children from serious personal injury or serious illness resulting from handling, using, or ingesting household substances.

special packaging is technically feasible, practicable, and appropriate for those substances.

15 U.S.C. § 1472(a)

10

The Commission must consider: Reasonableness of the standard Available scientific, medical, and engineering data

Manufacturing practices of affected industry

Nature and use of the substance

15 U.S.C. § 1472(b)

11

Cannot prescribe specific packaging designs, product content, package quantity, or (with one exception) labeling

15 U.S.C. § 1472(d)

12

Can prohibit packaging that is “unnecessarily attractive” to children

15 U.S.C. § 1472(d)

13

Notice and comment rulemaking (15 U.S.C. § 1474(a))

No cost benefit analysis is required (15 U.S.C. § 1472(e))

14

Not sooner than 180 days unless Commission finds it is in the public interest

Not later than 1 year Applies to products packaged on or after effective date

15 U.S.C. § 1471n

15

Not customarily used in/around the household

Specifically exempted at 16 CFR § 1700.14(a) Bulk packages of drugs sold to pharmacies

that will be repackaged by pharmacist before being dispensed

Bulk chemicals sold to industry Containers of 5 gallons or more (unless

otherwise indicated in a regulation)

16

Public Law 114-116 Jan. 28, 2016

17

Any nicotine provided in a liquid nicotine container sold, offered for sale, manufactured for sale, distributed in commerce, or imported into the United States shall be packaged in accordance with the standards provided in 16 CFR § 1700.15.

This requirement shall be treated as a

standard for special packaging of a household substance under the PPPA.

18

Act provided that requirement would take effect 180 days after enactment

July 26, 2016

19

Food and Drug Administration has issued final regulations concerning electronic cigarettes and related products and components, 81 FR 28974 (May 10, 2016).

Currently, no FDA regulations on packaging of liquid nicotine.

20

Child Nicotine Poisoning Prevention Act has savings clause that would allow FDA to issue regulations or take other action regarding liquid nicotine (including child-resistant packaging) in the future.

Act calls for consultation and coordination between CPSC and FDA.

21