Phthalates are widely used in some types of plastic to make the plastic more pliable and flexible. In recent years, certain phthalates have been subjected to increased scrutiny as possible human carcinogens and reproductive and developmental toxicants and their use have been banned or otherwise restricted by a number of regulations worldwide, including the Consumer Product Safety Improvement Act of 2008 (CPSIA). The CPSIA banned the use of phthalates in any "children's toy" or "child care article" and mandated third-party testing to ensure compliance. While the CPSIA's ban on the manufacture and sale of children's toys and child care articles containing phthalates has been in effect since February 2009, the Consumer Product Safety Commission (CPSC) stayed enforcement of the third-party testing requirements to give manufacturers, importers and private labelers ("manufacturers") time to put testing programs in place. Following its recent meeting, the CPSC published a Notice of Requirements (NOR) that lifts the stay as of December 31, 2011; beginning January 1, 2012, manufacturers will be required to have each "plasticized component" of children's toys and child care articles tested by an accredited third party laboratory in order to certify that each plasticized component is in compliance with the phthalate regulations.
Although the NOR provides that "only those plastic parts which could conceivably contain phthalates ["plasticized component parts"] should be tested for phthalates," the NOR provides scant further guidance on this issue: "Untreated/unfinished wood, metal, natural fibers, natural latex and mineral products are not expected to inherently contain phthalates and need not be tested or certified provided that these materials have neither been treated [n]or adulterated with the addition of materials that could result in the addition of phthalates into the product or material."
This lack of clear guidance compounds the ambiguity in the regulations occasioned by the failure of CPSC to address the many questions that have arisen since 2008 with respect to the definitions of "children's toy" and "child care article." CPSC continues to rely on the definitions that appear in its "Guidance for Small Manufacturers, Importers, and Crafters of Children's Products" issued on February 10, 2009:
- A "children's toy" is a product intended for a child 12 years of age or younger for use when playing. General use balls, bath toys/bath books, dolls and inflatable pool toys are examples of toys that are covered by the law and might contain phthalates. Bikes, playground equipment, musical instruments, and sporting goods (except for their toy counterparts) are not considered toys and therefore not affected by the ban.
- A "child care article" is a product that a child under 3 would use for sleeping, feeding, sucking or teething. Bibs, child placemats, child utensils, feeding bottles, cribs, booster seats, pacifiers and teethers are child care articles that are covered by the law and might contain phthalates.
Further guidance from CPSC is much needed. As one CPSC commissioner acknowledged, "Definitions determine how broadly or narrowly a law or rule applies, so it was and is important that we get it right. Manufacturers need to know which products they are supposed to test for phthalates; CPSC staff needs to know for enforcement action." Unfortunately for manufacturers, further guidance does not appear likely in the near term.
Compliance with the CPSIA phthalate testing requirements will likely be time-consuming and costly for manufacturers, but non-compliance carries the real risk of significant civil and criminal penalties. It may be prudent for a manufacturer to seek advice on strategies for increasing the likelihood of compliance with the CPSIA phthalate regulations. This advice may include strategies for product identification, testing and labeling. One bright spot is that manufacturers who comply with the CPSIA phthalate regulations may insulate themselves from liability for phthalates in tested products under California A.B. 1108 and Proposition 65: "Proposition 65 applies to products regulated by both A.B. 1108 and CPSIA and will continue to do so after those two statutes take effect, but we expect that it will have little practical significance because products that comply with A.B. 1108 and CPSIA would not, with a few possible exceptions, require a Proposition 65 warning. Thus, Proposition 65 actions should become largely unnecessary for products that comply with the other laws."
Orrick attorneys have been advising manufacturers on strategies for compliance with the Consumer Product Safety Act, Proposition 65 and other product regulations for over 20 years.