By Michelle L. Butler –
On December 16, 2009, the Consumer Product Safety Commission (“CPSC” or “Commission”) posted on its website a draft Federal Register notice that would announce the Commission’s decision to revise the terms of its stay of enforcement of certain testing and certification requirements under section 14 of the Consumer Product Safety Act (“CPSA”), as amended by section 102(a) of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”). The Commission must vote on whether to issue the notice before it is published in the Federal Register.
Of particular relevance for manufacturers of products regulated under the Poison Prevention Packaging Act (“PPPA”), such as drugs and dietary supplements containing iron, the Federal Register notice would lift the stay of the certification requirement for products required to be in special packaging under the PPPA and 16 C.F.R. Part 1700. See Draft Notice, at 14. Testing based upon a “reasonable testing program” will be required, and “the manufacturers will need to issue a certificate of general conformity to these statutes or regulations (‘general conformity certificate’) beginning on February 10, 2010 for all products manufactured after that date.” Id. at 15.
We note, however, that there is some ambiguity regarding this section of the draft Federal Register notice. CPSIA required general conformity certificates for PPPA-regulated products through the addition of language that a certificate is required for a product that is “subject to a consumer product safety rule under [the CPSA] or similar rule, ban, standard, or regulation under any other Act enforced by the Commission.” CPSA § 14(a)(1) (emphasis added). The PPPA is enforced by the Commission, and the CPSC staff have viewed the PPPA special packaging requirements as subject to the general conformity certificate requirements.
The ambiguity arises with regard to the definition of a “consumer product.” By statutory definition, a “consumer product” does not include drugs, devices, cosmetics, or foods. See CPSA, § 3(a)(5)(H), (I). However, the discussion in the draft Federal Register notice regarding lifting the stay for the testing and certification requirements for PPPA-regulated products comes under a heading titled “Consumer Products Where the Commission is Lifting the Stay of Enforcement and for Which General Conformity Certification Will Become Necessary.” Draft Notice, at 14 (emphasis added). The question here is whether the Commission intends to draw a distinction between PPPA-regulated products that are also consumer products (such as turpentine, see 16 C.F.R. § 1700.14(a)(6)) and PPPA-regulated products that are not consumer products (such as drugs, see, e.g., 16 C.F.R. 1700.14(a)(10)) and lift the stay as to the former but not the latter. [Note also that the that language in the section of the draft notice describing the action the Commission would take also refers to “consumer products” – “Thus, as of February 11, 2010, except as stated above in part II, manufacturers (including importers) and private labelers of consumer products and children’s products must comply with the testing and certification requirements set forth in paragraphs 14(a)(1), (a)(2), (a)(3), and (g) of the CPSA, as amended by section 102(a) of CPSIA.” Draft Notice, at 20-21 (emphasis added).] That said, given the facts that the CPSC staff have consistently taken the position that PPPA-regulated products, including drugs, are subject to the general conformity certificate requirements and that the PPPA and its implementing regulations are specifically identified in the draft notice as requirements for which the stay will be lifted, it seems unlikely that the draft Federal Register notice intended to suggest that the stay would be lifted only as to the subset of PPPA-regulated “consumer products,” but the language as currently drafted may leave open that possibility.
The draft notice also states that “[t]he Commission has concluded that general conformity certificates are not required for labeling requirements under the Federal Hazardous Substances Act because those requirements are not sufficiently similar to consumer products safety standards or bans to warrant certification.” Draft Notice, at 15.
Other types of standards for non-children’s products for which the Commission would lift the stay include:
- ban on lead in paint in paint and on furniture (16 C.F.R. Part 1303);
- requirements for child-resistance on portable gas containers;
- ban on extremely flammable contact adhesives (16 C.F.R. Part 1302);
- ban of unstable refuse bins (16 C.F.R. Part 1301); and
- standard for refrigerator door latches (16 C.F.R. Part 1750).
See id. at 14.
Over the past year, the Commission has issued many documents pertaining to implementation of CPSIA, including proposed, interim, and final rules, statements of policy, and guidance documents. The Commission has issued two notices of requirements for accreditation of laboratories for testing of children’s products. The Federal Register notice would lift the stay of enforcement as to the following:
- children’s products as of February 10, 2010:
- bicycle helmets (16 C.F.R. Part 1203);
- bunk beds (16 C.F.R. Part 1513);
- rattles (16 C.F.R. Part 1510 and §§ 1500.18(a)(15) and 1500.86(a)(7), (8)); and
- dive sticks (16 C.F.R. §§ 1500.18(a)(9), 1500.86(a)(7), (8)).
See id. at 11.
The Federal Register notice would lift the stay for certain other products on a delayed basis. For example, due to current insufficient testing laboratory capacity, the stay for bicycles (16 C.F.R. Part 1512) would be kept in effect until August 10, 2010. See id. at 11-12. With regard to total lead content in children’s products, in order “to allow component testing to form the basis for certifications for lead content and to permit the staff to complete an interpretative rule on the meaning of the term “children’s product,” testing by a third party laboratory and certification based on that testing should begin on products manufactured after August 10, 2010. See id. at 12.
The Federal Register notice would continue the stay of enforcement until further notice for a variety of other children’s products:
- carpets and rugs (16 C.F.R. Parts 1630 and 1631, except with regard to guarantees under the Flammable Fabrics Act);
- vinyl plastic film (16 C.F.R. Parts 1611, except with regard to guarantees under the Flammable Fabrics Act);
- wearing apparel (16 C.F.R. Parts 1610, except with regard to guarantees under the Flammable Fabrics Act);
- caps and toy guns (16 C.F.R. § 1500.18(a)(5));
- phthalates (section 108 of CPSIA);
- ASTM F963 (Consumer Safety Specifications for Toy Safety) (section 106 of CPSIA);
- clacker balls (16 C.F.R. §§ 1500.18(a)(7), 1500.86(a)(5));
- baby walkers;
- bath seats;
- children’s sleepwear (16 C.F.R. Parts 1615 and 1616);
- electronic toys (16 C.F.R. § 1500.18(b) and Part 1505); and
- durable infant products (section 104 of CPSIA).
See id. at 15-16.
The Commission stated when it issued the stay last year that all certification requirements in its regulations that existed prior to enactment of CPSIA would remain in effect (e.g., the pre-CPSIA requirements for testing and certification of mattresses), and that remains the case. The draft Federal Register notice identifies categories of products that were subject to pre-existing testing, labeling, recordkeeping, or certification requirements that may need to modify their certifications to include additional information required by CPSIA. See id. at 19-20.
The Commission recently conducted a two-day workshop regarding testing and certification requirements, including the contours of “reasonable testing programs” and component testing. A webcast of the discussion can be found here. On December 16, 2009, the Commission posted a draft Federal Register notice regarding “Interim Enforcement Policy on Component Testing and Certification of Children’s Products and Other Consumer Products to the August 14, 2009 Lead Limits.” In the coming days, we can expect to see additional notices and other documents issued by CPSC as they work to provide regulations and guidance on implementation of the certification and testing requirements, and will continue to monitor and report on developments.