Comments on Estimated Phthalate Exposure and Risk to Pregnant Women and Women of Reproductive Age

August 7, 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 document “Estimated Phthalate Exposure and Risk to Pregnant Women and Women of Reproductive Age as Assessed Using Four NHANES Biomonitoring Data Sets

Docket No. CPSC-2014-0033

We are commenting 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) document “Estimated Phthalate Exposure and Risk to Pregnant Women and Women of Reproductive Age as Assessed Using Four NHANES Biomonitoring Data Sets.”

The June 15, 2015 Report

We agree with the CPSC that the number of pregnant women in NHANES data sets after 2005/2006 “were too small to generate statistical estimates for this subpopulation” and “can not be used for statistical estimates.”[1]   We believe that pregnant women’s daily exposures to phthalates since 2005-6 are likely to be similar to other women of reproductive age (WORA).  The new report indicates that some of those exposures have increased and others have decreased, presumably reflecting changes in products more than changes in women’s habits. It is alarming that the daily intake of DINP has increased.  The report states that DINP is replacing DEHP proportionally in total hazard indices, and that it is less potent than DEHP. But less potent does not mean DINP is safe. California declared it a carcinogen in 2013, and we strongly support the plan to make the interim ban on DINP a permanent one.

It is important to note that NHANES looked at phthalate data on “participants aged 6 years and older,”[2] which is not the most vulnerable population that is affected by phthalates.  Prenatal exposure and exposure of young children are of greater concern but NHANES does not capture that.[3], [4], [5]  Fortunately, “the CHAP used several data sources for human biomonitoring analysis” not just the NHANES 2005/2006 data.[6]  For example, the Study for Future Families found that “roughly 5% of mothers and their infants in the United States had HI [Hazard Indices] greater than one.”6 When HI values exceed one, there is concern of adverse health effects.

Most important, researchers have shown that, unlike other chemicals, phthalates may have more serious effects at lower levels than at higher levels.[7] 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 based on levels of exposure, even though “science has moved on.”[8]

Conclusions

CPSIA required the CPSC to convene a CHAP “to study the effects on children’s health of all phthalates and phthalate alternatives used in children’s toys and child care articles” and to promulgate a final rule.1  The Commission has issued a proposed rule—it should finalize that rule.

The new analysis of more recent NHANES data supports the recommendations of the previous CHAP report that the interim ban on diisononyl phthalate (DINP) for use in children’s toys and child care articles should be made permanent, and should apply to “all children’s toys and child care articles, rather than only children’s toys that can be mouthed.”[9] The new analysis is also consistent with the CHAP proposal 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.

Research indicates that boys exposed to phthalates prenatally may be more likely to develop smaller genitals and incomplete descent of the testicles.[10]  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[11] (their risk is lessened if they get corrective surgery before age 13[12]).  A 2015 University of Pittsburgh[13] study reinforces studies done by Harvard researchers that show phthalates may alter human sperm DNA and semen quality.[14], [15], [16]

We strongly urge the CPSC to protect the public health by doing all it can to reduce prenatal and childhood exposures to phthalates that could be harmful to human health.

Annie Appleseed Project
Connecticut Center for Patient Safety
Jacobs Institute of Women’s Health
Kids In Danger
MISSD
MRSA Survivors Network
National Center for Health Research
U.S. PIRG
WoodyMatters

The Patient Consumer and Public Health Coalition can be reached through Paul Brown at pb@center4research.org or (202) 223-4000

[1] Consumer Product Safety commission (June 2015).  Estimated Phthalate Exposure and Risk to Pregnant Women and women of Reproductive Age as Assessed Using four NHANES Biomonitoring Data Sets (2005/2006, 2007/2008, 2009/2010, 2011/2012).  http://www.cpsc.gov/Global/Regulations-Laws-and-Standards/CPSIA/CHAP/NHANES-Biomonitoring-analysis-for-Commission.pdf

[2] 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

[3] 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

[4] 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

[5] Miodovnik A., Engel S.M., Zhu C., et al. (2011). Endocrine disruptors and childhood social impairment, Neurotoxicology Mar;32(2):261-7.

[6] Consumer Product Safety Commission (July 2014).  Chronic Hazard Advisory Panel On Phthalates and Phthalate Alternatives.

[7] 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.

[8] 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

[9] 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

[10] 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.

[11] Toppari J., Kaleva M. Maldescendus testis. Horm Res 1999;51:261-9.

[12] Pettersson A. et al. (2007) Age at surgery for undescended testis and risk of testicular cancer. New England Journal of Medicine 356:1835-41

[13] 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

[14] 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

[15] 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.

[16] 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