PPPA Workshop October 25, 2016 Bethesda, Maryland John W. Boja, Ph.D. Team Lead, Chemical Hazards Views expressed in this presentation are those of the staff and do not necessarily represent the views of the Commission
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PPPA Workshop
October 25, 2016 Bethesda, Maryland
John W. Boja, Ph.D. Team Lead, Chemical Hazards
Views expressed in this presentation are those of the staff and do not necessarily represent the views of the Commission
Manufacturers and importers of products requiring special packaging must certify in a General Certificate of Conformity (GCC) that their product(s) comply with the special packaging requirements.
A manufacturer or importer must support its GCC with records from a test of each product or a reasonable testing program.
15 U.S.C. § 2063(a)(1)
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The PPPA requires special packaging for certain substances.
Special packaging must meet the performance specifications of 16 C.F.R. § 1700.15.
Therefore, the importer or the domestic party that packages any substance that requires special packaging must certify that the special packaging meets the performance specifications of 16 C.F.R. § 1700.15.
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1. Identification of the product 2. Citation to each CPSC product
safety regulation applicable 3. Identification of the U.S. importer
or domestic manufacturer 4. Contact information for the
individual maintaining records of test results
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5. Date and place where the product was manufactured
6. Date and place where the product was tested for compliance with the regulation(s) cited above
7. Identification of any laboratory on whose testing the certificate depends
For complete instructions and more information see: https://www.cpsc.gov/Business--Manufacturing/Testing-Certification/General-Certificate-of-Conformity-GCC
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Describe the product(s) covered by the certification in enough detail to match the certificate to each product it covers and no others.
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Performance specification in 16 C.F.R. § 1700.15
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Provide the name, full mailing address, and telephone number of the importer or U.S. domestic manufacturer certifying the product.
The importer must issue the GCC for products manufactured overseas, and the U.S. manufacturer must issue the GCC for products manufactured domestically.
(See 16 C.F.R. part 1110)
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Provide the name, full mailing address,
e-mail address, and telephone number of the person maintaining test records in support of the certification.
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Date and place where the package was filled, not the date and place where the container was manufactured.
For the date(s) when the product was filled, provide at least the month and year. For the place of manufacture provide at least the city and country where the product was manufactured.
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Provide the date(s) and place when the packaging was tested for compliance with the 16 C.F.R. § 1700.15.
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Identification of the entity that conducted the testing upon which the certificate depends.
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Section 102 Certification and the Poison Prevention Packaging Act
https://www.cpsc.gov/Regulations-Laws--Standards/Statutes/Poison-Prevention-Packaging-Act/PPPA-FAQ
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The importer or the domestic party that packages a PPPA-regulated substance in special packaging must issue the general conformity certificate (GCC).
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Protocol data obtained in accordance with the procedures described under 16 C.F.R. § 1700.20 may be used by the importer or domestic packager to support its certification. The packager can rely upon this data as the basis for the reasonable testing program.
Commission staff does not consider the European tests (ISO 8317, EN 14375, and EN862) to be the equivalent of the tests required by the CPSC regulations.
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There is no expiration date on these tests and no requirement to retest so long as the tests adequately reflect the current packaging used.
Retesting should be conducted when a material change has been made to the packaging. A material change is a change that the manufacturer makes to the packaging's design, manufacturing process, or to the source of component parts for the packaging, which could affect the package's ability to comply with the performance specification of 16 C.F.R. § 1700.15.
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No. The empty container is not subject to the special packaging requirements of the PPPA and does not require certification.
However, a packing manufacturer may certify a package as having met the performance specifications under 16 C.F.R. § 1700.15.
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CPSC does not regulate children’s drugs and their accompanying dosing devices such as dosing cups or separate dosing droppers. These products are excluded from the definition of "consumer product" under the Consumer Product Safety Act. However, the CPSC regulates the child-resistant packaging for certain drugs as required by the Poison Prevention Packaging Act (PPPA).
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No. Bulk drugs provided to pharmacies are not subject to the special packaging requirements of the PPPA and therefore no certificate is required.
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