CPSC Requests Comments on CPSIA Phthalates Policy Statement, Issues New Test Method
The Consumer Product Safety Commission has issued a Federal Register notice announcing the availability of a Policy Statement establishing CPSC's position with respect to testing children's toys and child care articles for compliance with the phthalates bans1 of the Consumer Product Safety Improvement Act of 2008 (CPSIA2).
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CPSC has also issued a new method for testing such children's products for phthalates.
In addition, both Chairman Tenenbaum and Commissioner Nord expressed interest in receiving comments on issues unaddressed by the Policy Statement that would help CPSC in formulation of a proposed rule. (See below for details.) All comments are due by September 16, 2009.
(The Policy Statement and Test Method were previously posted by CPSC. See ITT's Online Archives or 08/04/09 and 08/10/09 news, 09080410 and 09081005, for BP summaries.)
Highlights of the policy statement and test method include (partial list):
Testing Should be Limited to Plasticized Component Parts
Phthalate testing of children's toys and child care articles should be limited to those plastic parts or other product parts which could conceivably contain phthalates (plasticized component parts), rather than the entire product.
Alternative approaches may be used if they satisfy the requirements of the CPSIA.
(Note that in February 2009, CPSC issued a one year stay of enforcement, until February 10, 2010, of CPSIA testing and certification requirements, including for phthalates, though not underlying product compliance. See ITT's Online Archives or 02/02/09 news, 09020205, for BP summary.)
CPSC Lab to Use New Method to Test Phthalates Compliance
CPSC staff has also developed a new test method (CPSC-CH-C1001-09.2) that will be used by the CPSC testing lab for the analysis of phthalate content in children's toys and child care articles.
This test method replaces CPSC's February 2009 method (CPSC-CH-C1001-09.1). (See ITT's Online Archives or 02/11/09 news, 09021110, for BP summary.)
General approach. The general approach of the new test method is to grind the plasticized component part sample to a powder by cryogenic milling, dissolve it completely in tetrahydrofuran, precipitate any polyvinyl chloride (PVC) polymer with hexanes, filter and then dilute the solution with cyclohexane, and analyze by Gas Chromatography-Mass Spectrometry (GC-MS). (See link below for further details.)
Adjustments may be necessary. CPSC staffhas concluded that this test method is sufficient to determine the concentration of the six regulated phthalates in most consumer products. However, adjustments may be necessary for products made from certain materials, and should be based on sound chemistry and materials science knowledge as well as appropriate solvents for the materials.
(CPSC explains that testing the phthalate content of an entire children's toy or child care article, as it previously advocated, lost favor as it may: (i) lead to dilution of phthalate concentrations and not be as protective for children; (ii) cause confusion by differing from similar regulations issued by other jurisdictions (including the European Commission and the state of California); and (iii) be prohibitively expensive.)
Identifying Plasticized Component Parts
In the Policy Statement, CPSC notes that phthalates are primarily used as plasticizers (softeners) in PVC plastics and that PVC is used in many products including, toys, floor and wall coverings, household furnishings, building materials, wire and cable insulation, footwear, rainwear, and automobile interiors. However, not all plastics contain phthalates.
Materials that may have phthalates. Examples of materials that CPSC states may contain phthalates are:
PVC and related polymers, such as polyvinylidene chloride (PVDC) and polyvinyl acetate (PVA). (These materials should always be tested.)
Soft or flexible plastics, except polyolefins.
Soft or flexible rubber, except silicone rubber and natural latex.
Foam rubber or foam plastic, such as PU.
Surface coatings, non-slip coatings, finishes, decals, and printed designs.
Elastic materials on apparel, such as sleepware.
Adhesives and sealants.
Electrical insulation.
Materials that normally do not have phthalates. Examples of materials that CPSC states do not normally contain phthalates are:
Unfinished metal.
Natural wood, except for coatings and adhesives added to wood.
Textiles made from natural fibers, such as cotton or wool, except for printed decorations, waterproof coatings or other surface treatments, back coatings, and elastic materials (especially sleepwear).
Textiles made from common synthetic fibers, such as polyester, acrylic, and nylon, except for printed decorations, waterproof coatings or other surface treatments, and elastic materials. (However, any textiles containing PVC or related polymers must be tested).
Polyethylene and polypropylene (polyolefins).
Silicone rubber and natural latex.
Mineral products such as play sand, glass, and crystal.
Manufacturer/Importer Failure to Comply with CPSIA Phthalates Provisions a Prohibited Act
CPSC's Policy Statement notes that failure to comply with the CPSIA phthalates bans is a prohibited act under section 19 of the Consumer Product Safety Act (CPSA) and can result in civil and criminal penalties. Likewise, failure to have a product that is subject to the bans tested by an accredited third-party laboratory and have the appropriate certification for that product (once CPSC's testing and certification stay expires on February 10, 2009) is also a prohibited act under section 19.
Comments Sought on Policy Statement & Unaddressed Issues for Rulemaking
Both Chairman Tenenbaum and Commissioner Nord, in their statements approving the policy, express interest in receiving comments on issues unaddressed by the Policy Statement that would help CPSC in formulation of a proposed rule3. In particular, the Commissioners seek comments on:
accessible vs. inaccessible component parts, even though the CPSIA does not reference those terms for phthalates;
for "toys that can be placed in a child's mouth", whether only the parts that can be placed in a child's mouth should be tested;
what reliance those who have used CPSC's previously posted test method can place on such results, especially given the retroactive impact of the statute;
studies and other information that would be helpful in drafting a proposed rule; etc.
1The CPSIA imposed both permanent and interim bans on certain phthalates in specified children's products beginning February 10, 2009 as follows: (1) children's toys or child care articles containing more than 0.1% of benzyl butyl phthalate (BBP), dibutyl phthalate (DBP), or di-(2-ethylhexyl) phthalate (DEHP) were permanently prohibited; and (2) children's toys that can be placed in a child's mouth or child care articles containing more than 0.1% of diisodecyl phthalate (DIDP), diisononyl phthalate (DINP), or di-n-octyl phthalate (DnOP) were prohibited, on an interim basis until the CPSC determines whether to continue the ban.
''Children's toy'' means 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.
''Child care article'' means 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.
A toy is considered a "toy that can be placed in a child's mouth" if any part of the toy can actually be brought to the mouth and kept in the mouth by a child so that it can be sucked and chewed. If the children's product can only be licked, it is not regarded as able to be placed in the mouth. If a toy or part of a toy in one dimension is smaller than 5 centimeters, it can be placed in the mouth.
2Enacted as Public Law 110-314 on August 14, 2008.
3Commissioner Nord states that the proposed rule would deal with component parts and states that presumably, phthalates testing would be discussed as well. Chairman Tenenbaum does not indicate what the proposed rule would address.
(See ITT's Online Archives or 03/26/09 news, 09032620, for BP summary of a CPSC public meeting on CPSIA phthalates provisions.
See ITT's Online Archives or 03/12/09 news, 09031205, for BP summary of CPSC request for panel members to consider if the CPSIA phthalates bans should be expanded, etc.
See ITT's Online Archives or 02/17/09 news, 09021710, for BP summary of CPSC interim enforcement plan for the CPSIA phthalate bans.)
CPSC contact - Michael A. Babich (301) 504-7253
CPSC notice (D/N CPSC-2009-0063, FR Pub 08/17/09) available at http://edocket.access.gpo.gov/2009/pdf/E9-19664.pdf
CPSC "Statement of Policy: Testing of Component Parts With Respect To Section 108 of the CPSIA" available at http://www.cpsc.gov/about/cpsia/componenttestingpolicy.pdf
CPSC Test Method (CPSC-CH-C1001-09.2, dated 07/27/09) available at http://www.cpsc.gov/about/cpsia/CPSC-CH-C1001-09.2.pdf
CPSC Chairman Tenenbaum's statement on her vote available at http://www.cpsc.gov/pr/tenenbaum08072009phthcomptest.pdf
CPSC Commissioner Nord's statement on her vote available at http://www.cpsc.gov/pr/nord08072009phthcomptest.pdf