A new and more stringent federal safety standard for phthalates in children’s toys and certain child care articles was proposed by the U.S. Consumer Product Safety Commission (“CPSC” or “Commission”) on Dec. 30, 2014. See Consumer Product Safety Commission, Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates, 79 Fed. Reg. 78324 (Dec. 30, 2014) (amending 16 C.F.R. § 1307). This proposed rule on phthalates (the “proposed rule”) would establish a new federal standard on the use of specified phthalates in children’s toys and child care articles and expand the list of permanently banned phthalates under current law.
Background and Current Prohibitions on Certain Phthalates in Children’s Toys and Child Care Articles
“Phthalates” is a class of chemicals generally used as plasticizers for PVC or cosmetic products. Phthalates have been used in plastic toys, baby teethers, home furnishings, air fresheners, car interiors, cosmetics, drugs and medical equipment, among other products.
The CPSC permanently prohibits three types of phthalates from use in children’s toys and child care articles; specifically, di (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and butyl benzyl phthalate (BBP). See Consumer Product Safety Improvement Act (“CPSIA”) of 2008, Pub. L. No. 110-314, § 108, 122 Stat. 3036 (2008). Section 108(a) of the CPSIA, which went into effect February 2009, sets out the permanent prohibition that makes it unlawful to manufacture for sale, offer for sale, distribute in commerce, or import into the United States any children’s toy or child care article that contains concentrations of more than 0.1 percent of DEHP, DBP, or BBP.
For certain phthalates that required further proof of health risks, the CPSIA issued an interim rule, which will terminate if the Commission’s proposed rule becomes final. Section 108(b)(1) of the CPSIA prohibits, on an interim basis, the manufacture for sale, offer for sale, distribution in commerce, or importation into the United States of “any children’s toy that can be placed in a child’s mouth” or “child care article” containing concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DNOP).
The CPSIA defines a “children’s toy” as “a consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays” and a “child care article” as “a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething” CPSIA §§ 108(g)(1)(B)-(C). The interim prohibition applies to children’s toys if any part of the toy can actually be brought to the mouth by a child so that it can be sucked and chewed. If the toy or toy part can only be licked, then it is not considered as able to be “placed in mouth.” The CPSIA further specifies that if a toy or part of the toy in one dimension is smaller than 5 centimeters, then it is considered as being able to be placed in mouth by a child. CPSIA § 108(g)(2)(B). The interim prohibitions remain in effect until the Commission issues a final rule determining whether to make the interim prohibitions permanent. The Commission was required to promulgate a final rule based on the recommendations from the Chronic Hazard Advisory Panel (“CHAP”). CPSIA § 108(b)(3).
The CPSIA directed the establishment of the CHAP “to study the effects on children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles” and to make a recommendation to the CPSC as to whether any “phthalates (or combinations of phthalates)” (other than those already banned) should be prohibited as banned hazardous articles. CPSIA § 108(b)(2). Specifically, the Commission is required to determine whether to continue the interim prohibition of DINP, DIDP, and DNOP. On July 18, 2014, the CHAP released its report and recommended the following actions:
- That the permanent ban on DBP, BBP, and DEHP remain in place and unchanged;
- That the interim ban on the use of DINP in children’s toys and child care articles at levels greater than 0.1% be made permanent;
- That the current bans on DNOP and DIDP be lifted;
- That no action be taken by the CPSC on dimethyl phthalate (DMP) or diethyl phthalate (DEP). (However, the CHAP recommended that federal agencies responsible for DEP exposure from a number of items including food, pharmaceuticals and personal care products perform risk assessments with an eye to supporting risk management procedures.)
- That diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP) should be permanently banned from use in children’s toys and child care articles at levels greater than 0.1%;
- That diisooctyl phthalate (DIOP) be subject to an interim ban from use in children’s toys and child care articles at levels greater than 0.1% until sufficient toxicity and exposure data are available to assess the potential risks; and
- That the CPSC obtain additional information on the phthalate alternatives that the CHAP studied; specifically ATBC, DEHT, DINX, TPIB, DEHA and TOTM.
See U.S. Consumer Product Safety Commission Directorate for Health Sciences, Report to the U.S. Consumer Product Safety Commission by the Chronic Hazard Advisory Panel on Phthalates and Phthalate Alternatives (July 2014).
Under federal law, current permanent and interim CPSIA prohibitions on phthalates are only applicable to children’s toys and child care products with concentrations of the phthalates in amounts more than 0.1 percent. Other children’s products, including rainwear, footwear, backpacks, some school supplies and clothing items containing elastic waistbands as well as printed T-shirts and sweatshirts are not children’s toys or child care products under the CPSIA and as such, are not subject to the CPSIA’s prohibition of phthalates. While beyond the scope of this bulletin, certain states restrict phthalates in children’s products and have different, and sometimes broader, restrictions and/or definitions of what constitutes a “children’s product.” See, e.g., Wash. Rev. Code 70.240.020 (“Prohibition on the manufacturing and sale of children’s products containing lead, cadmium, or phthalates”) and 70.240.010 (defining “children’s product”).
The Proposed Rule and Impacts on Different Parties
The CPSC’s proposed rule adopts all recommendations by the CHAP – with the notable exception that it rejects the proposed interim ban on DIOP and does not propose any prohibition for this phthalate – and thus expands the category of permanently banned phthalates under Section 108(a) of the CPSIA. In addition to the existing ban of DEHP, DBP and BBP at levels of greater than 0.1 percent, the CPSC also proposes to make it unlawful to manufacture for sale, offer for sale, distribute in commerce, or import into the United States any children’s toy or child care article that contains concentrations of more than 0.1 percent, computed individually, of DINP, DIBP, DPENP, DHEXP, and DCHP.
If adopted, the CPSC’s proposed rule will result in major changes. First, the DINP prohibition will be extended from children’s toys that can be placed into a child’s mouth to all “children’s toys.”
Second, DIDP and DNOP are no longer prohibited under the proposed rule.
Third, the proposed rule would prohibit children’s toys and child care articles containing four phthalates that are not currently prohibited under the CPSIA; specifically, DIBP, DPENP, DHEXP, and DCHP.
If finalized, the proposed rule will require changes and compliance efforts among children’s toys and child care article manufacturers, importers, and testing laboratories. Manufacturers may be required to remove or reduce the level of DINP, DIBP, DPENP, DHEXP, and DCHP in all parts – including the non-mouthable parts – of the children’s toys and child care articles they produce. Testing laboratories may need to expand their testing protocols to include the newly added phthalates. Additionally, importers of goods that fall within the jurisdiction of the CPSC, will have to review their auditing, certification and testing procedures aimed at identifying the types and level of phthalates in imported children’s toys and child care articles. If the proposed rule is adopted, affected parties will have 180 days to implement the new requirements after publication of the final rule in the Federal Register.
We also note that phthalates are faced with stricter regulations issued by federal agencies other than the CPSC. The U.S. Environmental Protection Agency (“EPA”) issued a significant new use rule (SNUR) in December 2014 for a number of chemicals including Di-n-pentyl phthalate (DnPP), a phthalate that the EPA advises is no longer in use. The SNUR requires any company manufacturing, processing or importing the chemicals (including DnPP) to notify the EPA 90 days before starting or resuming new uses of the chemical (excluding use as a chemical standard for analytical experiments) so the agency can evaluate their intended use and, if necessary, take action to prohibit or limit the activity. See Environmental Protection Agency, Benzidine-Based Chemical Substances; Di-n-pentyl Phthalate (DnPP); and Alkanes, C12-13, Chloro; Significant New Use Rule, 79 Fed. Reg. 77891 (Dec. 29, 2014).
Comments on the proposed CPSC rule on phthalates can be submitted until March 16, 2015.