Manufacturers, regulators, retailers and consumers have a shared responsibility to ensure products are used safely and properly. This is done in numerous ways, including effective labeling, educational outreach and child-resistant packaging, which is the focus of this month’s column.
Child-resistant packaging is required for consumer products that can pose a hazard to children under the Poison Prevention Packaging Acti (PPPA), which was signed in 1970. The PPPA outlines the specificationsii for child-resistant packaging, as well as the ease of adult opening through a senior-adult testiii—and the testing protocolsiv that must be followed for both. While the U.S. Consumer Product Safety Commission (CPSC) regulates consumer products that require child-resistant packaging, it’s also important to note that both the U.S. Environmental Protection Agency (EPA) and U.S. Food & Drug Administration (FDA) have child-resistant packaging requirements for products under their jurisdictions.
Like most things since March 2020, the COVID-19 pandemic has also had an impact on child-resistant packaging. During an open public meeting in May 2020, PPPA testing firms informed CPSC that testing for child-resistant certification had halted as a result of the pandemic. Children and adults were not available to participate in the testing, nor could testing firms comply with the public health guidance for social distancing to even conduct the testing. As a result of this public meeting, CPSC issued a PPPA Enforcement Discretion Testing Advisory Letterv that stated the CPSC would temporarily accept the following alternatives to ease the interruption of testing certification:
• Testing protocol data to the methods described under the international standards ISO 8317, ISO 14375, EN 862, CSA Z76.1 and CSA Z76.2, in lieu of the method described under 16 CFR § 1700.20
• Transparent barriers between the tester and test subjects (children or adults) and, in the cases of the child test, between children
• Single-site child and adult testing under 16 CFR § 1700.20
When using these allowed alternatives, the general certificate of conformity (GCC) and testing protocol data for any regulated products in child-resistant packaging must be sent to CPSCvi before distribution into commerce.
The Household & Commercial Products Association (HCPA) requested two extensions of the enforcement discretion—both of which were grantedvii, viii —and manufacturers can use the alternative test methods through Dec. 31, 2021 to ensure that critical products make it to the marketplace. The first extension letter also expanded the enforcement discretion to accept the use of the adult-resecuring data as the basis to determine whether a package meets the child-resistant requirements in order to reduce the total number of children needed for testing.
While CPSC has not specified a date or timeframe by which alternative testing must be completed, it expects testing to be prompt. Additionally, packaging certified using an international standard during the enforcement discretion period is not required to be retested once the enforcement discretion period ends, unless there is a material change in the packaging, the product within the packaging or there is a change in the manufacturing process.
Companies are encouraged to inform the HCPA of their current experiences in obtaining certification for child-resistant packaging during the enforcement discretion period, whether using the testing protocols under the PPPA or international standards so that the information can be shared with CPSC. It is of the utmost important that stakeholders, including CPSC, understand what the industry is doing to ensure that products are safe, not only when used according to the label directions, but also when stored in homes and out of the reach of children.
For more information on the PPPA or enforcement discretion, please contact me at [email protected]. SPRAY
i Title 16 CFR parts 1700–1702
ii 16 CFR § 1700.15(b)
iii 16 CFR § 1700.15(b)(2)(i)
iv 16 CFR § 1700.20
vi Email [email protected]
vii The first extension letter can be found here
viii The second extension letter can be found here