Comments to the FDA Regarding Representative Edward J. Markey’s filing of a Food Additive Petition

September 17, 2012

Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Comments of Members of the Patient, Consumer, and Public Health Coalition
Regarding Representative Edward J. Markey’s filing of a Food Additive Petition
[Docket No. FDA-2102-F-0728]

As members of the Patient, Consumer, and Public Health Coalition, we offer our strong support for Representative Edward J. Markey’s petition to the Food and Drug Administration to ban Bisphenol A (BPA) in packaging for infant formula because these uses have been permanently and completely abandoned.  The ban will also protect this vulnerable population from BPA’s adverse health effects.

Earlier this year, FDA banned  BPA in baby bottles and children’s drinking cups and even before the ban, due to consumer concerns, the major manufacturers of baby bottles, infant feeding cups, infant formula and baby food all offer products that do not use packaging with BPA.  However, BPA is still used in many food containers, including the epoxy coating on the inside of many food and beverage cans and the lids of glass food jars.   Congressman Markey’s petition would provide extra safeguards to protect all babies and children.  We know the focus of this “Notice of petition” is on amending regulations because BPA use has been abandoned in packaging for infant formula, but we encourage the FDA to release its separate assessment of the safety of BPA.

BPA leaches out of the plastic or epoxy lining into the liquid or food in the container.  The Centers for Disease Control and Prevention found BPA in the bodies of more than 93 percent of the U.S.population studied.[i]

BPA was originally developed as a synthetic estrogen, and it mimics and interferes with estrogen in the body.  Estrogen is an important hormone that is in all males and females, but with higher levels in females, and it affects reproduction and development.[ii]   Scientists are concerned about BPA’s behavioral effects on fetuses, infants, and children at current exposure levels, and whether it can affect the prostate gland, brain, and behavior.[iii]  There is also considerable concern about the impact of BPA on the mammary gland and its ability to trigger early puberty in girls, as well as possibly increasing the long-term risk of breast cancer.

BPA is called an “endocrine disruptor” because it can affect various hormonal functions in the body, causing symptoms such as weight gain, infertility, and erectile dysfunction. Exposure to BPA at low doses is paradoxically related to more severe symptoms, so even minimal contact with BPA-containing products is a very serious issue.

BPA levels are especially high in the bodies of infants and children,3 and children are especially vulnerable to BPA.  So it makes sense to focus first on children. But, there are many other vulnerable populations—pregnant women, chemotherapy patients, and adults at-risk for heart disease—who may also be harmed by BPA.

BPA and Heart Disease
A study based on a major government data set, the NHANES, found that adults with higher levels of BPA in their urine were more likely to have heart disease, even when other variables were statistically controlled.[iv]  That study replicated the findings of an earlier study published in the Journal of the American Medical Association, which found a link between BPA levels and diabetes and heart disease, even when obesity was statistically controlled.[v]  This shows that BPA in adults is potentially very harmful, causing deadly diseases that can start with health problems in childhood.

Alternatives Available
Japanhas reduced BPA in consumer products, such as canned beverages and plastic tableware.[vi] Canada, China, the European Union, and the United Arab Emirates have all banned BPA from baby bottles.[vii]  Several cities and 11 states have restricted the use of BPA in infant food packaging.  In 2009, SUNOCO, a BPA manufacturer, announced it would not sell BPA to companies making products for children under 3 years of age.[viii]

Keeping Consumers Safe
There is a growing body of evidence that the cumulative exposures to BPA is endangering our children and probably also adults.  More than 100 well-designed studies, many conducted by independent researchers without conflicts of interest, have raised doubts about the safety of BPA.  And, safer alternatives to BPA are available. However, children, pregnant women and all of the public are still exposed to BPA at high levels.   If we want to protect our babies and children, then it is important to ban BPA in infants’ and children’s products.

For the above reasons, members of the Patient, Consumer, and Public Health Coalition strongly support Representative Markey’s petition to the Food and Drug Administration to ban Bisphenol A (BPA) in packaging for infant formula.

Breast Cancer Action
National Consumers League
NationalResearchCenterfor Women & Families / Cancer Prevention and Treatment Fund
Our Bodies Ourselves
U.S. PIRG
WoodyMatters
 

For more information, contact Paul Brown at (202) 223-4000 or pb@center4research.org.

 


[i] Hileman, B. (2007, April). Bisphenol A on Trial. Chemical & Engineering News Government & Policy, Vol. 85, Number 16.  http://pubs.acs.org/cen/government/85/8516gov2.html

[ii]  Schierow, L., Lister,S.A. (2008, May). Bisphenol A (BPA) in Plastics and Possible Human Health Effects.
Congressional Research Service Report for Congress, The Library of Congress.

[iii] National Toxicology Program. U.S. Department of Health and Human Services (HHS). (2008, September). NTP-CEHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A.  http://cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.pdf

[iv] Melzer, D., Rice, N.E., Lewis, C., Henley, W.E., and Galloway, T.S. (2010, January).  Association of Urinary Bisphenol A Concentration with Heart Disease:  Evidence from NHANES 2003/06. PLoS ONE, 5(1), e8673. http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0008673

[v] Lang I.A., Galloway T.S., Scarlett A. et al. (2008). Association of Urinary Bisphenol A Concentration With Medical Disorders and Laboratory Abnormalities in Adults. Journal of American Medical Association 300(11), 1303-1310.

[vi] Advanced Industrial Science and Technology. (2007). Risk Assessment Document: Bisphenol A.

[vii]  ConsumerReports.org (2011, June 1). China bans BPA from plastic baby bottles.   http://news.consumerreports.org/safety/2011/06/china-bans-bpas-from-plastic-baby-bottles.html

[viii] Rust, S. and Kissinger, M. (2009, March 12). Maker acknowledges BPA worries. JSOnline. Milwaukee Wisconsin Journal Sentinelhttp://www.jsonline.com/watchdog/watchdogreports/41186522.html