September 19, 2016
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Comments of members of the Patient, Consumer, and Public Health Coalition
The Food Additive Petition Filed by Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, Learning Disabilities Association of America, and Natural Resources Defense Council;
[Docket No. FDA-2016-F-1253]
Members of the Patient, Consumer, and Public Health Coalition strongly support the food additive petition to amend or revoke food additive regulations regarding food processing and packaging involving specific phthalates.[i] We strongly urge the FDA to ban the use of these ortho-phthalates for use in the production, storage, and packaging of food.
More commonly known as phthalates, ortho-phthalate metabolites are detectable in nearly everyone in the U.S.,[ii] primarily because of the food we eat.[iii] While exposures to specific phthalates may be low for many individual foods, they are present in a wide variety of foods and so the cumulative level is much higher.[iv], [v], [vi]
Phthalate exposure can have diverse and long-lasting harms. Phthalates such as DEHP are probable human carcinogens.[vii] Exposure before birth and during early life has been linked to numerous problems with brain development. These include Attention Deficit Hyperactivity Disorder (ADHD) related behaviors, impaired social behavior, aggression, depression, and lower IQ.[viii] Increased exposure causes reproductive problems for both sexes, including abnormal testicle development and preterm birth.[ix]
Eleven phthalates have been found to affect reproductive, developmental and endocrine health, and the remaining substances do not have sufficient evidence to judge their safety As such, it is impossible to conclude that there is “reasonable certainty of no harm.” We agree with the petitioners that phthalates should be addressed as a class because if phthalates are considered on an individual basis, one harmful phthalate will likely replace another harmful one. Phthalates contaminate food at different stages of production and storage.[x] We support the extensive scope of the petition to cover all of the steps in processing and packaging of food.
We note that government agencies have already banned or limited the use of certain phthalates covered by this food additive petition. The Consumer Product Safety Commission has banned the use of six of these phthalates from children’s toys and other products due to these health concerns for this vulnerable population.[xi] The FDA already limits/warns about the use of DEHP in medical devices[xii] and DEHP and DBP in drugs.[xiii] Clearly, the same chemicals in our food is potentially even a greater risk.
Our Coalition and member groups have commented or testified to the FDA on phthalates and food contact issues for several years. In 2010, members of our coalition submitted comments in support of the FDA’s proposed rule regarding allowable DEHP levels in bottled water (see Docket NO. FDA-1993-N-0259).
The National Center for Health Research’s Dr. Anna Mazzucco spoke at the December 9, 2014 FDA meeting on expanding the Redbook to enhance the safety of food and products. Dr. Mazzucco noted that “Current evaluation of food additives for carcinogenic activity is narrowly focused on genotoxic mechanisms of action. She added that the FDA should add tests for endocrine disruption to its toxicological evaluation of food contact substances and additives to ensure that all food contact substances, both old and new, are safe.”
In summary, we agree with the March 18, 2016 letter from the Natural Resources Defense Council and other groups to the Center for Food Safety and Applied Nutrition. The letter states that “there is no longer a reasonable certainty of no harm for the food contact use of the 30 phthalates.” We echo their concerns that exposure levels to U.S. citizens of these phthalates are above the tolerance for the class of chemicals. The FDA should ban the use of phthalates for use in the production and storage of food.
American Medical Student Association
American Medical Women’s Association
Breast Cancer Action
Breast Cancer Consortium
Mothers Against Medical Error
MRSA Survivors Network
National Center for Health Research
National Consumers League
National Organization for Women
Our Bodies Ourselves
Washington Advocates for Patient Safety
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at firstname.lastname@example.org or at (202) 223-4000.
[i] Federal Register (May 20, 2016). Food and Drug Administration, notice of petition. Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition.
[ii] National Health and Nutrition Examination Survey (NHANES) (October 2014). Phthalates and plasticizers metabolites- Urine (PHTHTE_G); years of content 2011-2012. http://wwwn.cdc.gov/Nchs/Nhanes/2011-2012/PHTHTE_G.htm
[iii] Consumer Product Safety Commission (July 2014). Chronic Hazard Advisory Panel On Phthalates and Phthalate Alternatives.https://www.cpsc.gov/PageFiles/169876/CHAP-REPORT-FINAL.pdf
[iv] Sathyanarayana S et al (2013). Unexpected results in a randomized dietary trial to reduce phthalate and bisphenol A exposures. J Expo Sci Environ Epidemiol. 23(4):378-384.
[v] Schecter A et al (2013). Phthalate concentrations and dietary exposure from food purchased in New York State. Environ Health Perspect. 121(4):473-479. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3620091/
[vi] Serrano SE, Braun J, Transande L, Dills R, Sathyanarayana S (2014). Phthalates and diet: a review of the food monitoring and epidemiology data. Environ Health 13:43.
4 Agency for Toxic Substances and Disease Registry (2002). Toxicological profile for di (2-ethylhexyl) phthalate. Update. Atlanta, GA: U.S. Department of Health and Human Services, Public Health Service.
[viii] Ejaredar M, Nyanza EC, Ten Eycke K, Dewey D (2015). Phthalate exposure and children’s neurodevelopment: A systematic review. Environ Res 142:51-60.
[ix] Marie C, Vendittelli F, Sauvant-Rochat MP (2015) Obstetrical outcomes and biomarkers to assess exposure to phthalates: A review. Environ Int. 83:116-136.
[x] Fierens T, Van Holderbeke M, Willems H De Henauw S, Sioen I (2013). Transfer of eight phthalates through the milk chain — A case study. Environ Int. 51:1-7.
[xi] US Consumer Product Safety Commission. (July 2015). Phthalates. http://www.cpsc.gov/en/Business–Manufacturing/Business-Education/Business-Guidance/Phthalates-Information.
[xii] US Food and Drug Administration (July 2002). FDA public health notification: PVC devices containing the plasticizer DEHP. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062182.htm.
[xiii] US Food and Drug Administration (December 2012). Limiting the use of certain phthalates as excipients in CDER-regulated products. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm330792.htm