Poison Prevent Packaging Act and Child Nicotine Poisoning Prevention Act of 2015 - Overview of the Acts

1. 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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2. Poison Prevention
Packaging
Act
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3.  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
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4.  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)
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5.  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
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6. ◦ 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)
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7.  The child-resistance requirements
apply to the immediate container or
wrapping.
 Not a shipping container
 Not outer wrapping
15 U.S.C. § 1471(3)
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8.  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
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9.  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
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10. 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)
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11. 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)
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12.  Cannot prescribe specific
packaging designs, product
content, package quantity, or
(with one exception) labeling
15 U.S.C. § 1472(d)
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13.  Can prohibit packaging that is
“unnecessarily attractive” to
children
15 U.S.C. § 1472(d)
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14.  Notice and comment rulemaking
(15 U.S.C. § 1474(a))
 No cost benefit analysis is required
(15 U.S.C. § 1472(e))
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15.  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
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16.  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)
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17. Public Law 114-116
Jan. 28, 2016
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18.  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.
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19.  Act provided that requirement would
take effect 180 days after enactment
 July 26, 2016
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20.  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.
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21.  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.
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