April 15, 2015
Office of the Secretary
Consumer Product Safety Commission, Room 820
4330 East West Highway
Bethesda, MD 20814
Comments of members of the Patient, Consumer, and Public Health Coalition
on the Consumer Product Safety Commission’s proposed rulemaking
“Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates”
[Docket No. CPSC-2014-0033]
We are writing these comments as members of the Patient, Consumer, and Public Health Coalition, which includes patients, consumer advocates, scientists, and physicians, regarding the Consumer Product Safety Commission’s (CPSC) proposed rule on the “Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates.” We are pleased to see that it mirrors most of the 2014 recommendations of the Chronic Hazard Advisory Panel (CHAP). Although we support most of the proposed rule, we have several concerns which we have detailed below.
We agree with the CPSC that the three permanently banned phthalates—dibutyl phthalate (DBP), butyl benzyl phthalate (BBP), and di(2-ethylhexyl) phthalate (DEHP)—should remain banned.
We agree with CPSC that the interim ban on diisononyl phthalate (DINP) (at levels greater than 0.1%) for use in children’s toys and child care articles should be made permanent. We also agree with CPSC that the permanent DINP ban apply to “all children’s toys and child care articles, rather than only children’s toys that can be mouthed…because exposure occurs from handling children’s toys, as well as from mouthing.” It should also be noted that in 2013, California declared DINP a carcinogen.
We agree with the CPSC proposed rule to ban four additional phthalates: diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP), which are associated with adverse effects on male reproductive development. Also, applying the CPSC chronic hazard guidelines, the four phthalates are considered “probably toxic to humans.”1 One of those phthalates, DIBP, is in a small percentage of toys and child care articles, according to CPSC staff. We agree with the CPSC that banning the four phthalates is necessary because it would prevent the future use of the phthalates in toys and child care articles.1
We strongly disagree with the CPSC’s decision not to ban diisooctyl phthalate (DIOP) on an interim basis as was recommended by the CHAP scientists. The CPSC stated that “CPSIA did not provide for an interim prohibition as an option,” and cited a lack of studies on DIOP as justification for leaving it on the market. However, the National Institute of Health’s Pub Chem notes that DIOP exposure in laboratory animals led to “a significant increase in…the percentage of fetuses with malformations…with dosing as low as 0.05%.” Exposure to high doses resulted in “abnormal sperm, and sperm concentration in males.” Also, antiandrogenic effects are possible from DIOP.1 In its final rule, the CPSC should protect the public—including the most vulnerable such as children under 6 and pregnant women—from possible health risks from DIOP. If an interim ban is not possible, the CPSC should err on the side of safety and recommend a permanent ban on DIOP.
We also disagree with the proposal by the CHAPS and CPSC to lift the interim bans on di-n-octyl phthalate (DNOP) and diisodecyl phthalate (DIDP). The CHAP stated that DNOP and DIDP are not associated with antiandrogenicity and do “not contribute to the cumulative risk from other phthalates.”1 However, both DNOP and DIDP are “associated with toxicological effects, including liver toxicity and developmental effects.”1 Regarding DIDP, it is also associated in animal studies with kidney toxicity and developmental effects such as too many ribs. During the interim ban, manufacturers have not used DNOP and DIDP in toys and children’s products; therefore, we suggest that the CPSC continue the ban on these phthalates, especially in light of the toxic effects associated with them.
The CHAP did not recommend prohibitions on dimethyl phthalate (DMP), di(2-propyl) heptyl phthalate (DPHP), and diethyl phthalate (DEP) but recommended additional studies or assessments on them. It also recommended additional studies on the six phthalate alternatives it reviewed. These studies are important because four of the alternatives are used in children’s toys and childcare articles. In the final rule, there should be a timeline for when these additional studies will be done.
We have been very surprised by industry critics who claimed the CHAP is not sufficiently objective or transparent. We strongly disagree. As you know, CPSI required the CHAP to “consist of seven independent scientists” selected by the CPSC from a list provided by the National Academy of Sciences. This ensured that an unbiased panel was created to review phthalates and their alternatives. Also, four independent scientists peer-reviewed the draft CHAP report. The CHAP solicited public and industry comments and held 13 public meetings (six by teleconference), and to allow access to as many as possible and to be as transparent as possible, the meetings were webcast.
An industry association has criticized the CHAP because more recent National Health and Nutrition Examination Survey (NHANES) data “show a marked decrease in overall phthalate exposure” in people. That is only part of the story. A 2014 study looking at data over a ten-year period (2001– 2010) found that exposures to some phthalates have declined while others have increased. Americans’ exposure to three substances permanently banned in toys and children’s products—DEHP, DBP and BBP—has declined. The decreased phthalate exposure should be interpreted as showing that the law is working, not that it is no longer needed.
Unfortunately, exposure to other phthalates such as DINP and DIBP, as measured in urine, has increased. The higher levels of DIBP and other phthalates “suggest that manufacturers may be using them as substitutes for other phthalates even though the US EPA has expressed concern about their use.”2 That is why we support the CPSC’s proposed rule that would ban DIBP. It is worrisome that DINP exposure has gone up since it was banned on an interim basis from children’s toys and children’s products.
Perhaps the most important reason CPSC should not give credence to industry’s point about NHANES is because NHANES looked at phthalate data on “participants aged 6 years and older,”which is not the most vulnerable population that is affected by phthalates. Prenatal exposure and exposure of young children are of greater concern., , 
Evidence of Adverse Health Effects
The CHAP report noted that the phthalate syndrome in rats resembles the “testicular dysgenesis syndrome” (TDS) in humans.1 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 later on than men born with both testicles descended (their risk is lessened if they get corrective surgery before age 13). A new University of Pittsburgh study reinforces studies done by Harvard researchers that show phthalates may alter human sperm DNA and semen quality., , 
Researchers have shown that, unlike other chemicals, phthalates appear to have more serious effects at lower levels than at higher levels. Usually, it is assumed that the higher the dose or exposure, the greater the harm, but that is not the case with endocrine disruptors. The director of the National Institute of Environmental Health Sciences, Linda Birnbaum, says that chemical manufacturers are asking “old questions” when they test for safety even though “science has moved on.”
Scope of Phthalate Prohibitions
We are disappointed that the CPSC is not proposing to expand the scope of the phthalates prohibitions to include other children’s items such as raincoats, footwear, backpacks, school supplies, and clothes.1 The CPSC justifies this by stating, “limited information available suggests that increased exposure to phthalates from most children’s products outside children’s toys and child care articles would be negligible.”1 The key phrase is “limited information.” Lack of data does not mean we should assume that there is no problem, especially since the Centers for Disease Control and Prevention researchers “found measurable levels of many phthalate metabolites in the general population,” and that some phthalates affect the reproductive system of animals and more research is needed “to assess the human health effects of exposure to phthalates.”
For the reasons we’ve stated above, the coalition strongly supports most provisions of the proposed rule on the “Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates.” However, we are disappointed with some of the provisions described above and strongly disagree with the CPSC regarding DIOP. In the final rule we recommend that the CPSC protect the health of consumers by permanently banning DIOP.
American Medical Women’s Association
Association for Pelvic Organ Prolapse Support
Breast Cancer Action
Connecticut Center for Patient Safety
Consumers United for Evidence-Based Healthcare (CUE)
Jacobs Institute of Women’s Health
Kids In Danger
MRSA Survivors Network
National Center for Health Research
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or pb@center4research.
 Federal Register (December 30, 2014). Consumer Product Safety Commission. Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates. Docket No. CPSC-2014-0033. http://www.gpo.gov/fdsys/pkg/FR-2014-12-30/pdf/2014-29967.pdf
 Lee SM, (January 15, 2014). Banned chemicals replaced by worrisome ones, UCSF study shows.SFgate.com (San Francisco Chronicle). http://www.sfgate.com/health/article/Banned-chemicals-replaced-by-worrisome-ones-UCSF-5144291.php
 National Institutes of Health Pub Chem. Diisooctyl Phthalate. http://pubchem.ncbi.nlm.nih.gov/compound/Diisooctyl_phthalate#section=Top
 Six phthalate alternatives: acetyl tributyl citrate (ATBC), di(2-ethylhexy) terephthalate (DEHT), 1,2-cyclohexanedicarboxylic acid, diisonoyl ester (DINX), 2,2,4-trimethyl-1,3 penatanediol diisobutyrate (TPIB), di(2-ethylhexyl) adipate (DEHA), and tris(2-ethylhexyl) trimelliate (TOTM).
 American Chemistry Council (February 17, 2015). Letter to U.S. Consumer Product Safety Commission Chairman Elliot F. Kaye.
 Zota A.R., Calafat A.M., and Woodruff T.J. (March 2014). Temporal Trends in Phthalate Exposures: Findings from the National Health and Nutrition Examination Survey, 2001–2010. Environ Health Perspect; DOI:10.1289/ehp.1306681 http://ehp.niehs.nih.gov/1306681/
 National Health and Nutrition Examination Survey (NHANES) (November 2013). Urinary Phthalates and Plasticizers Metabolites (PHTHTE_G); years of content 2011-2012. http://www.cdc.gov/nchs/nhanes/nhanes2011-2012/PHTHTE_G.htm
 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 Environmental Health (MOCEH) Study, Environmental Health Perspectives. Retrieved September 14, 2011 athttp://ehp03.niehs.nih.gov/article/info%3Adoi%2F10.1289%2Fehp.1003178
 Whyatt R.M., 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
 Miodovnik A., Engel S.M., Zhu C., et al. (2011). Endocrine disruptors and childhood social impairment, Neurotoxicology Mar;32(2):261-7.
 Main K.M., Skakkebaek N.E., Virtanen H.E., Toppari J. (2010). Genital anomalies in boys 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.
 Pettersson A. et al. (2007) Age at surgery for undescended testis and risk of testicular cancer. New England Journal of Medicine 356:1835-41
 University of Pittsburgh Schools of the Health Sciences (March 5, 2015). Pervasive Chemical Potentially Alters Levels of a Pregnancy Hormone that Influences Sex Development (Press Release). http://www.upmc.com/media/NewsReleases/2015/Pages/adibi-phthalate-fetal-development.aspx
 Duty S. M., M. J. Silva, et al., (2003). Phthalate exposure and human semen parameters. Epidemiology14(3): 269-77. http://www.ncbi.nlm.nih.gov/pubmed/?term=Duty%2C+S.+M.%2C+M.+J.+Silva%2C+et+al.%2C+(2003)Epidemiology+14(3)%3A+269-77
 Duty S. M., N. P. Singh, et al., (2003). The relationship between environmental exposures to phthalates and DNA damage in human sperm using the neutral comet assay. Environ Health Perspect 111(9): 1164-9. http://www.ncbi.nlm.nih.gov/pubmed/?term=Duty%2C+S.+M.%2C+N.+P.+Singh%2C+et+al.%2C+(2003).+The+relationship+between+environmental+exposures+to+phthalates+and+DNA+damage+in+human+sperm+using+the+neutral+comet+assay.+Environ+Health+Perspect+111(9)%3A+1164-9.
 Duty S. M., A. M. Calafat, et al., (2004). The relationship between environmental exposure to phthalates and computer-aided sperm analysis motion parameters. J Androl 25(2): 293-302. http://www.ncbi.nlm.nih.gov/pubmed/?term=Duty%2C+S.+M.%2C+A.+M.+Calafat%2C+et+al.%2C+(2004).+The+relationship+between+environmental+exposure+to+phthalates+and+computer-aided+sperm+analysis+motion+parameters.+J+Androl+25(2)%3A+293-302
 Vandenberg et al. (2012). Hormones and Endocrine Disrupting Chemicals: Low-dose Effects and Nonmonotonic Dose Responses. Endocrine Reviews. First published ahead of print March 14, 2012 as doi:10.1210/er.2011-1050.
 Cone M. and Environmental Health News. Low Doses of Hormone-Like Chemicals May Have Big Effects. Scientific American. March 15, 2012. http://www.scientificamerican.com/article.cfm?id=low-doses-hormone-like-chemicals-may-have-big-effects
 Centers for Disease Control and Prevention (CDC). Phthalates fact sheet. http://www.cdc.gov/biomonitoring/Phthalates_FactSheet.html