Poison Prevention Packaging Act (PPPA) Updated guidance on substances not intended for household use
WASHINGTON, February 18, 2022 /PRNewswire/ — https://www.cpsc.gov/s3fs-public/PPPA-Updated-Guidance-on-Substances-Not-Intended-for-Household-Use.pdf?VersionId=gX6jSWqq.JcrTGz2vAnUoPoZBeGlUqfv
The U.S. Consumer Product Safety Commission’s (CPSC or Commission) Office of Compliance and Field Operations issues guidance to clarify that the CPSC does not recognize an “institutional use” exception for household substances that require special packaging under the Poison Prevention Packaging Act (“PPPA”). or “the Law”). Products that meet the definition of a “domestic substance” must comply with special packaging requirements under the PPPA, regardless of how the substance is labeled. Even substances intended for institutional use only and labeled as such must be in special packaging unless the packaging meets one of the recognized limited exceptions. Although CPSC staff may consider certain factors, discussed below, when determining whether to request corrective action, no general “institutional use” exception exists for covered products. These guidelines are effective immediately and supersede all prior agency guidelines for institutional use.
Market changes affecting compliance with the PPPA
In recent years, the distribution, sale and marketing channels for almost all consumer products, including substances subject to the PPPA, have changed dramatically. Distribution channels for many products now involve extensive, multi-level distribution and retail networks, and the manufacturer often no longer sells directly to individuals or through a physical retailer. Additionally, the phenomenal growth of online marketplaces is making a greater variety of products available to consumers than ever before.
These changes have given consumers better online access to purchase and consume household substances at home in non-childproof packaging. Although the manufacturer or repackager may not sell or otherwise introduce into commerce a substance in nonconforming packaging directly, nor sell it directly to consumers, such nonconforming products are nevertheless accessible to consumers. This access goes against the preventive objective of the PPPA and endangers the young children it aims to protect.
Adopted in 1970 and found at 15 USC § 1471, et seq., the PPPA requires that certain household substances be packaged in accordance with special packaging standards found in 16 CFR § 1700.15. Under the Act, a “household substance” is defined as “any substance that is customarily produced or distributed for consumption or use, or customarily stored, by persons inside or outside the household” and that is: a hazardous substance1 (defined in 1261 USC § 1(f)); a food, drug, or cosmetic (defined in 21 USC § 321); or a substance intended for use as a fuel when stored in a portable container and used in a home’s heating, cooking or refrigeration system. A list of substances requiring special packaging can be found in the PPPA regulations at 16 CFR § 1700.14. In general, special packaging, often referred to as “child-resistant packaging”, must be designed or constructed in such a way that it is very difficult for children under the age of five to open or obtain a toxic or harmful amount of the substance they contain within a reasonable time. time while maintaining the effectiveness of such packaging for the duration of normal use. 16 CFR § 1700.15 (child protocol testing for special packaging under PPPA).
The PPPA contains two statutory exceptions to compliance for household substances requiring special packaging. The first is a “one-time exception” for household substances, including over-the-counter (“OTC”) medicines for elderly or disabled people who might have difficulty opening child-resistant packaging. 15 USC § 1473(a). Under this exception, the PPPA allows only one nonconforming size of a substance, provided that the substance is also supplied in packaging that meets the PPPA’s special packaging standards. The one size should not be the most popular size and should also bear the prominent warning “this package for households without young children”. See 15 USC §1473(a) and (c); 16 CFR § 1700.5. The “single exception” does not apply to prescription drugs. The second exception applies to prescription drugs dispensed by a pharmacist in packaging that is not childproof and must be directed by a prescribing physician or requested by the purchaser. See 15 USC §1473(b); 16 CFR § 1701.
In addition, the Commission recognized that bulk packs of prescription drugs intended to be repackaged by the pharmacist before being dispensed to consumers do not need to use special packaging. However, if the immediate packaging in which the drugs are distributed by the manufacturer is intended to be the packaging in which the drugs are distributed to the consumer, then it must be in a special packaging. See 43 Fed. Reg. 11,979 (March 23, 1978); 16 CFR § 1701.
Notably, the PPPA contains no other statutory exceptions to compliance for substances requiring special packaging. Thus, there is no exception for substances used in “institutional” settings (for example., hospitals, nursing homes, construction sites and other commercial environments).
Compliance Guidelines Update
CPSC staff recognize that substances subject to the PPPA are also used in commercial and institutional settings, where the risk to children is reduced. Therefore, when determining whether to request corrective action for nonconforming products intended for use in commercial and institutional environments, CPSC staff will consider a variety of factors, including:
how and where the product is advertised, marketed, sold, labeled and distributed;
the nature and extent of surveillance exercised by a company over its supply chain;
packaging configuration, type and size;
if the additional instructions provided on the packaging [such as for storage, handling, or use] are intended for consumers; and
product reviews and other evidence demonstrating the nature and extent of consumer use.
These factors are not exhaustive. CPSC staff recognizes that other changes in the marketplace may require other factors to be considered.
To the extent that these guidelines are inconsistent with previously distributed materials, these guidelines supersede those materials. Again, the law provides no “institutional use” exception to the PPPA.
For more information on these updated guidelines, please contact [email protected]
1 The CPSC regulations at 16 CFR § 1701.3 interpret “domestic substance”, stating that, except as otherwise stated in 16 CFR § 1700.14(a), the Commission has determined that the term “domestic substance” applies only hazardous substances packed in containers with a capacity less than 5 gallons.
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SOURCE US Consumer Product Safety Commission