October 1, 2012
Office of the Secretary
U.S. Consumer Product Safety Commission
4330 East West Highway
Bethesda, MD 20814
Comments of the Patient, Consumer and Public Health Coalition
“Children’s Toys and Child Care Articles Containing Phthalates
Proposed Guidance on Inaccessible Component Parts”
[Docket No. CPSC-2012-0040]
As members of the Patient, Consumer, and Public Health Coalition, we are writing to support most of the Consumer Product Safety Commission’s proposed guidance regarding phthalates in inaccessible component parts of children’s toys and child care articles.
The Consumer Product Safety Improvement Act of 2008 (CPSIA) permanently prohibits the sale of children’s toys or child care articles that contain more than 0.1% of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and benzyl butyl phthalate (BBP). It also prohibits on an interim basis toys that can be placed in a child’s mouth or child care articles containing more than 0.1% of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP) and di-n-octyl phthalate (DnOP).
The CPSIA, as amended in 2011, allows for exclusion for certain products containing inaccessible phthalates component parts and the CPSC was directed to draft a rule providing guidance on which components will be considered inaccessible or “adopt the same guidance with respect to inaccessibility that was adopted by the Commission with regard to accessibility of lead.”
We generally support CPSC’s proposed guidance to adopt “the same guidance with respect to inaccessibility for phthalates that was adopted by the Commission with regards to accessibility of lead.”1 The guidance would use the same clear definitions and tests used in the rule regarding accessibility of lead-containing parts. The guidance states that a component part is inaccessible “if it is not physically exposed, by reason of a sealed cover or casing, and does not become physically exposed through reasonably foreseeable use and abuse of the product, including swallowing, mouthing, breaking, or other children’s activities, and the aging of the product.”1
We support the CPSC’s clear language in the proposed guidance that states: “Lead, paint, coatings, and electroplating may not be considered a barrier that would render phthalate-containing component parts of toys and child care articles inaccessible.”1 Paint, coatings and electroplating should never be considered a barrier to phthalates, because phthalates are sometimes added to paints and coatings, and because paint and coatings and electroplating can chip away over time, leaving the phthalates exposed.
Regarding phthalates in vinyl covered mattresses or sleep surfaces for young children, we agree with CPSC that they should not be considered to be made inaccessible through the use of fabric covering. CPSC notes that “young children typically spend more than half of each day sleeping or resting” and if the mattress has phthalates, the infant can end up breathing in the dust, licking the mattress cover, or be exposed when liquids, including beverages or urine, have spilled on the mattress and facilitated phthalate migration through the fabric.
We support the Commission’s proposed guidance for accessibility probes specified for sharp points or edges. These probes are designed to mimic how a child’s fingers touch a product. We support determining accessibility based on the “use and abuse” tests for the different children’s age brackets, but question why the bite test is excluded and urge its inclusion in appropriate circumstances.
In addition, whether the component is small enough (smaller than 5 centimeters) to be swallowed is relevant to lead safety but not to exposure to phthalates, and therefore the size of the component should not be considered for the phthalate accessibility standards. Phthalates component parts that are covered by fabric that pass the use and abuse tests should not be considered inaccessible to a child (whether they are smaller or larger than 5 centimeters), because dust from phthalates can pass through the fabric and be inhaled by the child. We are aware that the law that amended the CPSIA (Public Law 112-28) contains a strong public health provision regarding phthalates, which may deal with this potential problem, but it would be better to prevent the problem from the beginning by not allowing fabric covers. The law states that the CPSC “may revoke any or all exclusions granted based on the inaccessible component parts provision…at any time…if the Commission finds, based on scientific evidence, that such compliance is necessary to protect the public health or safety.” Nevertheless, it would be better to explicitly protect children by not assuming fabric covers are adequate protection against phthalates.
Phthalates are called “endocrine disruptors” because they affect the body’s hormones by mimicking them or blocking them. They interfere with the body’s natural levels of estrogen, testosterone, and other hormones. Hormones can increase the risk of some cancers and other serious diseases, whether those hormones are natural or synthetic. Research indicates that boys exposed to phthalates may be more likely to develop smaller genitals and incomplete descent of the testicles. Boys who are born with undescended testicles are 2-8 times more likely to develop testicular cancer as young men than men born with both testicles descended. Other human studies have found an association of higher phthalate levels with lower scores on brain and motor development tests, behavior problems, and a link to obesity and phthalates.,, Lab animals exposed to phthalates are more likely to develop liver cancer, kidney cancer, and male reproductive organ damage. Researchers have also noted that, unlike other chemicals, phthalates appear to have more serious effects at lower levels that at higher levels. We support most of the proposed guidance because it will help to protect the public, especially children, from the adverse effects of phthalates.
Consumer Federation of American
Kids in Danger
National Research Center for Women & Families
For more information, contact Paul Brown at (202) 223-4000 or email@example.com
 Main KM, Skakkebaik NE, Virtanen HE, Toppari J (2010). Genital anomalies in obys and the environment. Best Pract Res Clin Endocrinol Metab. Apr: 24(2): 279-89.
 Toppari J, Kaleva M. Maldescendus testis. Horm Res 1999;51:261-9.
 Yeni Kim Y, Eun-Hee Ha, Eui-Jung Kim, et al. (2011). Prenatal Exposure to Phthalates and Infant Development at Six Months: Prospective Mothers and Children’s Environment Health (MOCEH) Study, Environmental Health Perspectives.
 Whyatt Rm, Liu X, Rauh VA, Calafat AM, Just AC, Hoepner L, Diaz D, et al. (2012). Maternal prenatal urinary phthalate metabolite concentrations and child mental, psychomotor and behavioral development at age three years. Environmental Health Perspectives 120(2): 290-5.
 Teitelbaum SL, Mervish N, Moshier EL, Vangeepruam N, Galvez MP, Calafat AM, Silva MJ, Brenner BL, Wolff MS. (2012). Associations between phthalate metabolite urinary concentrations and body size measures in New York City children. Environmental Research 112:186-193.
 Vastag, B (2001). CDC Unveils First Report on Toxins in People, JAMA 285(14): 1827-1828.
 Vanderberg et al. (2012). Hormones and Endocrine Disrupting Chemicals: Low-dose Effects and Nonmonotonic Dose Responses. Endocrine Reviews. Firs published ahead of print March 14, 2012 as doi:10/1210/er.2011-1050.