NRDC Sues Food and Drug Administration for Failure to Regulate Toxic Chemical

WASHINGTON – - The Natural Resources Defense Council filed a lawsuit against the Food and Drug Administration for its failure to act on a petition to ban the use of bisphenol A (BPA) in food packaging, food containers, and other materials likely to come into contact with food. BPA, a hormone-disrupting chemical linked to serious health problems, poses a particular risk to fetuses, infants and young children. NRDC filed today’s lawsuit in U.S. Court of Appeals for the D.C. Circuit.

In October 2008, NRDC petitioned the FDA to prohibit the use of BPA in food packaging to prevent the toxic chemical from contaminating food. The FDA has failed to take action in response to the petition for more than 18 months, although the agency expressed concern about the effects of early life exposure to BPA on brain development and the prostate gland of fetuses, infants, and children.

BPA is found in wide variety of products, including the lining of liquid infant formula cans, soda or beer cans, fruit or vegetable cans, and pizza boxes as well as consumer products made from polycarbonate plastics, including baby bottles, sippy cups, and reusable water bottles. More than 93 percent of the general population has some BPA in their bodies, primarily from exposure through food contamination and other preventable exposures.

“BPA-free alternatives are already available and on the market. The FDA has no good reason to drag their feet on banning it,” said Dr. Sarah Janssen, a senior scientist in the Environment and Public Health program at NRDC. “It’s upsetting that food is most people’s primary source of exposure to BPA. The FDA should act now to eliminate this unnecessary risk.”

A growing amount of scientific research has linked BPA exposure to altered development of the brain and behavioral changes, a predisposition to prostate and breast cancer, reproductive harm, diabetes, obesity, and cardiovascular disease.

“The FDA has failed to safeguard the food supply and protect the public from harm,” said Aaron Colangelo, an attorney with NRDC. “The FDA’s failure to regulate this chemical in food packaging in unjustified, and so we are forced to ask the court to intervene and order the agency to take action

Literature:

NRDC, Natural Resources Defense Council, Release – Lawsuit Seeks to Ban BPA from Food Packaging, WASHINGTON, June 29, 2010.

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The Natural Resources Defense Council is a national, nonprofit organization of scientists, lawyers and environmental specialists dedicated to protecting public health and the environment. Founded in 1970, NRDC has 1.3 million members and online activists, served from offices in New York, Washington, Chicago, Los Angeles, San Francisco and Beijing.

The study confirms previous research in which study author Stephen G. Grant, Ph.D., associate professor of environmental and occupational health at Pitt’s Graduate School of Public Health, discovered evidence of abnormalities in the HPRT gene located on the X chromosome in cord blood from newborns of non-smokers exposed to environmental tobacco smoke.

In the current study, Dr. Grant confirmed smoke-induced mutation in another gene called glycophorin A, or GPA, that is representative of oncogenes – genes that transform normal cells into cancer cells and cause solid tumors. The GPA mutation was the same level and type in newborns of mothers who were active smokers and of non-smoking mothers exposed to tobacco smoke. Likewise, the mutations were discernable in newborns of women who had stopped smoking during their pregnancies, but who did not actively avoid secondhand smoke.

“These findings back up our previous conclusion that passive, or secondary, smoke causes permanent genetic damage in newborns that is very similar to the damage caused by active smoking,” said Dr. Grant. “By using a different assay, we were able to pick up a completely distinct yet equally important type of genetic mutation that is likely to persist throughout a child’s lifetime. Pregnant women should not only stop smoking, but be aware of their exposure to tobacco smoke from other family members, work and social situations.”

Literature: University of Pittsburgh Schools of the Health Sciences, Exposure to secondhand smoke in the womb has lifelong impact, June 30, 2010

Related Environmental Medicine Matters Articles:

• Secondhand Smoke Exposure and Depressive Symptoms
• Second Hand Smioking results in Liver Disease, UCLA Study finds
• Male Reproductive Organs are at Risk from Environmental Hazards
• Majority of US hospitals will have smoke-free campuses by end of year
• 2009 edition of the Tobacco Atlas catalogues catastrophic toll of tobacco worldwide

Scientists and NGOs concerned about the health impacts of bisphenol A

PRESS RELEASE, 23rd JUNE 2010

An unprecedented 60 scientists and international environment, health and women’s organisations from around the globe have jointly written to the European Food Safety Authority (EFSA) stating that

“action is necessary to reduce the levels of Bisphenol-A (BPA) exposure, particularly in groups at highest risk, namely young infants and pregnant mothers.”

[Quotes from some of the participating scientists and NGOs can be found towards the end of this release.]

In total, 41 NGOs and 19 scientists from 15 countries from across the globe (including 9 from the UK) have signed the letter. The letter comes on the eve of a new scientific opinion to be released by the EFSA on the safety of Bisphenol A in food contact materials expected in early July 2010. EFSA was requested by the European Commission to assess the latest science on Bisphenol A, and if necessary, to update the existing Tolerable Daily Intake (TDI) (a specific amount in food or drinking water that can be ingested (orally) over a lifetime without an appreciable health risk).

Bisphenol A is a mass produced chemical used in the manufacture of polycarbonate plastics that are clear and nearly shatter-proof. It can be found in plastics used for food and beverages, such as baby bottles, sports water bottles, as an epoxy resin in canned food and drinks, plastic food storage containers, tableware and in other products, including dental sealants, and has been found to leach into food and drink.

There have been long standing concerns about the health impacts of bisphenol A, due to scientific studies that have shown it has hormone disrupting effects at extremely low levels of exposure. Human bio-monitoring studies have shown that the vast majority of people in developed countries are exposed to Bisphenol-A.

EFSA’s previous opinions in 2007 and 2008 predominantly relied upon a handful of industry backed scientific papers that have expressed no concerns about our levels of BPA exposure. The letter from scientists and NGOs highlights scientific criticism in academic journals regarding these papers as compared to the “several hundred peer reviewed scientific papers have been published that have highlighted potential adverse health effects associated with BPA exposures”

The letter also draws attention to some of the new studies which have raised risks of exposure relating to a potential increased likelihood of developing ‘diabetes’, ‘developmental programming’ and ‘breast cancer’. Bisphenol A exposure at environmentally relevant levels commonly found in the environment in developed countries has also been repeatedly linked by independent university – based scientists to a number of other serious chronic health conditions.

Despite EFSA’s pivotal position in setting chemical food safety levels across the EU, Sweden and Germany have become the third and fourth most recent EU member states, alongside France and Denmark, to take action ahead of the EFSA review.

Andreas Carlgren, Sweden’s Environment Minister stated, on 11th May 2010, that

“If the EU will not quickly forbid the hormone disrupting substance bisphenol in baby-bottles Sweden will precede with a national prohibition.”

The President of the German Federal Environment Agency on the 9th June also broke from EFSA policy by issuing new guidance calling on

“manufacturers, importers and users of bisphenol A to use alternative substances that pose less risk to human health and the environment in all areas of use that significantly contribute to exposure”.

Regulators in Canada and the USA have already taken action to limit BPA exposure, for example in its use in baby bottles. As yet there has been no similar action at the European Union level.

A number of EU member states continue to back a common approach across the EU on bisphenol A. Tim Smith, the head of the UK Food Standards Agency, declared in an internal FSA report on the 12th May, 2010 that he ‘considers it important to have an agreed position across the EU’ and that the FSA will only ‘revise our position in line with it the EFSA Review if it is considered necessary’, despite the action that is being taken elsewhere across the EU.

The EFSA have already delayed publication of its review, as explained on its website:

To give the European Commission an up-to-date overview of the safety of BPA, EFSA will now deliver a scientific opinion in early July rather than end of May. This is due to the need for the Panel to consider hundreds of studies in its review and analysis of the most recent scientific literature.

The letter from scientists and organisations opens by ‘welcoming this announcement’ issued at the 11th hour that EFSA has finally agreed to examine hundreds of non-industry backed scientific papers.

The letter was drafted by Breast Cancer UK and Prof. Fredrick vom Saal, Curators Professor of Biological Sciences, University of Missouri-Columbia who has been awarded by his peers for his work on Bisphenol-A and is a recognised leader in this field. The effort was also coordinated by the Brussels based Health and Environment Alliance (HEAL).

Prof. vom Saal stated in response to the publication of the letter that:

“At the heart of the debate over BPA lies an outdated set of guidelines used by regulatory agencies that are based on approaches to evaluating the safety of chemicals established over 50 years ago. Thus, 21st century research approaches have provided overwhelming scientific evidence of harm in hundreds of published reports, but these findings are being rejected for consideration because they do not conform to the outdated testing guidelines.

“This has left regulatory agencies to rely entirely on industry-funded research that used ‘approved’ testing methods that are crude and insensitive, and it is not surprising that 100% of these industry-funded studies conclude that BPA causes no harm.

“The only rational path for European regulators is to take decisive action to reduce human exposure to BPA. The overwhelming nature of the total scientific evidence mandates this as a priority.”

Clare Dimmer, Chair of Trustees Breast Cancer UK and former breast cancer patient stated:

“Breast cancer is the most common cancer across Europe and has been increasing rapidly regardless of the costly and expensive efforts made by Governments to improve screening, treatment, and increase research. It must now be time that regulators act on the science and begin to take a precautionary approach to hazardous chemicals like bisphenol-A found in our everyday products.”

Lisette van Vliet, Ph.D. the Toxics Policy Advisor at HEAL said:

“It is high time that EFSA caught up to the overwhelming science showing genuine reasons for concern about our daily exposure to BPA.”

Participating scientists and organisations were given the opportunity to provide a quote for this press release; those that responded have been included below. This does not preclude participating organisations providing their own releases, supporting statements and additional comments.

Prof. Andrew Watterson, Occupational and Environmental Health Research Group, University of Stirling, said:

“It’s worrying, considering the weight of the scientific evidence, that strong action to reduce human exposure is yet to be taken. Hundreds of academic studies have explicitly raised the risks of developmental harm to foetuses and young children from exposure to BPA and this should dictate a strong precautionary policy response from European regulators. If this is not forthcoming, the UK Government must intervene as other European countries are already doing so.”

Daniela Hoffmann, Chemicals Expert, GLOBAL 2000/Friends of the Earth Austria:

“EFSA has to finally acknowledge the overwhelming scientific evidence concerning the risk BPA poses to human health.”

Sarah Häuser, Chemicals Expert BUND / Friends of the Earth Germany:

“The existing Tolerable Daily Intake for BPA does not protect human health. In animal experiments and biomonitoring studies, BPA doses much smaller than those estimated as being safe by EFSA were linked to chronic conditions health damages like diabetes and cardiovascular diseases. It’s time to take action now.”

For further information please contact:

Hratche Koundarjian, Campaign Manager, Breast Cancer UK, Charity No: 1088047, T: 07905 911 039, E: hratche@breastcanceruk.org.uk, W: www.breastcanceruk.org.uk / www.nomorebpa.org.uk

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Letter and Signatories:

Prof. Klaus-Dieter Jany, Chair of the CEF Panel

European Food Safety Authority

Largo N. Palli 5/A, 43121 Parma, Italy

23rd June 2010

Dear Prof. Jany,

We are writing to welcome the announcement on the European Food Safety Authority (EFSA) website that the CEF panel will be considering ‘hundreds of studies in its review and analysis of the most recent scientific literature’ in its review of the TDI of bisphenol-A in food contact products.

Over the last decade and a half, a substantive body amounting to several hundred peer reviewed scientific papers, have been published that have highlighted potential adverse health effects associated with BPA exposures, at internal doses relevant to levels of biologically active BPA found in humans.

As a March 2010 Review (Vandenberg et al) of 80 bio-monitoring studies of BPA in Environmental Health Perspectives makes clear;

‘The two toxicokinetic studies performed to date, which suggest that human exposure is negligible, have significant flaws and are therefore not reliable for risk assessment purposes.’

However, in its prior risk assessments of BPA, EFSA only relied on a small number of studies rather than the much larger number that the United States Food and Drug Administration recently recognised as valid and of high utility in its risk assessment of BPA, and which led the FDA to express concern about the health hazards posed by BPA.

Only a tiny minority of studies have articulated that BPA exposure is completely safe, and many of these research papers have been criticised in academic commentaries and responses as having serious flaws, but it is these few flawed studies that EFSA previously relied on to declare BPA safe.

For example, a letter co-authored by 24 scientists published in the February 2010 edition of Toxicological Sciences states;

‘Publishing studies that conclude no harm in response to low doses of endocrine disrupting chemicals, when the studies did not include a positive control (Tyl et al., 2002), included inappropriate doses of positive controls (Ryan et al., 2009; Tyl et al., 2008), or included positive controls that showed no effect (Cagen et al., 1999), is inappropriate in peer-reviewed journals (Myers et al., 2009a,b; vom Saal and Welshons, 2006). Such studies violate basic principles of study design.’

Many scientific studies are now calling into question the safety of BPA. For example, a recent study has highlighted that BPA may contribute to metabolic disorders relevant to glucose homeostasis, and suggests that BPA may be a risk factor for diabetes (Alonso-Magdalena et al., 2010). Moreover, experiments at Yale university report that BPA may induce altered developmental programming (Bromer et al.,2010), and Doherty et al (2010) of Yale university have published a study which raises the concern about epigenetic effects of BPA on the regulation of the mammary gland, with potential implications for breast cancer risk. Endometriosis is also a concern as work by Signorile et al (2010) highlights that pre-natal exposure of mice to bisphenol-A causes an endometriosis-like response in female offspring.

It is therefore our opinion that any objective and comprehensive review of the scientific literature will lead to the conclusion that action is necessary to reduce the levels of BPA exposure, particularly in groups at highest risk, namely young infants and pregnant mothers.

There are an increasing number of countries that are either already committed to this course of action, or have signalled that they will soon be undertaking similar measures.

We share the concerns of these Governments and regulators and believe that reducing BPA exposure to these groups is both scientifically sound and in the best interest of public health.

As such, we call on you as the Chair of the CEF panel and the CEF Committee Members in their ongoing review to include all relevant studies, including bio-monitoring studies, and based on that evidence we conclude that there is a strong scientific mandate for action.

Yours sincerely,

1. Benson Akingbemi, Associate Professor, Department of Anatomy, Physiology and Pharmacology, Auburn University, Auburn, USA.
2. Prof. Dr. Ibrahim Chahoud, Institute of Clinical Pharmacology and Toxicology, Dept. of Toxicology, Charité – Universitätsmedizin Berlin
3. André Cicolella, Dipl Eng chemist-toxicologist.
4. Prof. Patricia Hunt, Meyer Distinguished Professor, School of Molecular Biosciences, Washington State University
5. Prof. Maricel V. Maffini. Ph.D. Research Assistant Professor. Department of Anatomy and Cellular Biology, Tufts University School of Medicine
6. Jane Muncke, Ph.D, Environmental Toxicologist, Emhart Glass SA, Switzerland.
7. John Peterson Myers, Ph.D., Chief Scientist, Environmental Health Sciences, Charlottesville VA.
8. Angel Nadal, PhD, Professor of Physiology, Instituto de Bioingeniería and CIBERDEM, Universidad Miguel Hernández de Elche, Spain.
9. Dr John Newby, Medical Information Scientist for the Cancer Prevention Society and Former Member of the Developmental Toxico-Pathology Research Group, Department of Human Anatomy & Cell Biology, Faculty of Medicine, University of Liverpool.
10. Prof. Jörg Oehlmann, Goethe University Frankfurt am Main, Institute for Ecology, Evolution and Diversity.
11. Prof. Gail S. Prins, PhD, Professor of Physiology, Department of Urology, University of Illinois at Chicago.
12. Prof. Fredrick vom Saal, Curators Professor of Biological Sciences, University of Missouri-Columbia.
13. Prof. Pietro Giulio Signorile, President of the Italian Endometriosis Foundation.
14. Prof. Ana M Soto, MD, Department of Anatomy and Cell Biology, Tufts University, School of Medicine.
15. Prof. Hugh S. Taylor, M.D., Professor of Molecular, Cellular and Developmental Biology, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University.
16. Laura N. Vandenberg, PhD, Postdoctoral Fellow, Center for Regenerative and Developmental Biology, Tufts University.
17. Prof. Cheryl S. Watson, PhD, Professor, Biochemistry & Molecular Biology Dept. University of Texas, Medical Branch, Galveston.
18. Prof. Andrew Watterson, Occupational and Environmental Health Research Group, University of Stirling.
19. Prof. R. Thomas Zoeller, Biology Department, Morrill Science Center, University of Massachusetts.

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1. Action for Breast Cancer, Malta
2. Alliance for Cancer Prevention, UK
3. Arnika, Czech Republic
4. Association for Environmental and Chronic Toxic Injury, Italy
5. Austrian section of ISDE (International Society of Doctors for the Environment), Austria
6. Breast Cancer Fund, USA
7. Breast Cancer UK, UK
8. BUND / Friends of the Earth Germany, Germany
9. Cancer Prevention and Education Society, UK
10. ChemSec –International Chemical Secretariat, International
11. CHEM Trust, UK
12. Chemical Sensitivity Network, Germany
13. Clean Air Action Group, Hungary
14. Comité pour le Développement Durable en Santé, France
15. Danish Consumer Council, Denmark
16. The Danish Ecological Council, Denmark
17. Eco-Accord Program on Chemical Safety, Eastern Europe, Caucasus and Central Asia
18. EcoAid, Germany
19. Ecologistas en Acción, Spain
20. Environmental Health Fund, USA
21. Environment Illinois, USA
22. European Environmental Bureau, EU
23. Finnish Association for Nature Conservation, Finland
24. Friends of the Earth Spain, Spain
25. Global 2000 / Friends of the Earth Austria, Austria
26. Health and Environmental Network, Europe
27. Health Care Without Harm, International
28. Indiana Toxics Action, USA
29. Instituto Sindical de Trabajo Ambiente y Salud, Spain
30. The Irish Doctors’ Environmental Association, Ireland
31. Italian Endometriosis Foundation, Italy
32. Plastic Planet, Austria
33. Rachel’s Friends Breast Cancer Coalition, USA
34. Réseau Environnement Santé, France
35. Society for Sustainable Living, Czech Republic
36. Unison, UK
37. VHUE e.V., Germany
38. Women in Europe for a Common Future, Europe
39. Women’s Environmental Network, Scotland
40. Women’s Voices for the Earth, USA
41. WWF European Policy Office, Europe

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References

• Vandenberg LN, Chauhoud I, Heindel JJ, Padmanabhan V, Paumgartten FJ, Schoenfelder G 2010. Urinary, Circulating and Tissue Biomonitoring Studies Indicate Widespread Exposure to Bisphenol A. Environ Health Perspect :-. doi:10.1289/ehp.0901716
• vom Saal FS, Akingbemi BT, Belcher SM, Crain DA, Crews D, Guidice LC, Hunt PA, Leranth C, Myers JP, Nadal A, Olea N, Padmanabhana V, Rosenfeld CS, Schneyer A, Schoenfelder G, Sonnenschein C, Soto AM, Stahlhut RW, Swan SH, Vandenberg LN, Wang H, Watson CS, Welshons WV and Zoeller RT. 2010. Flawed Experimental Design Reveals the Need for Guidelines Requiring Appropriate Positive Controls in Endocrine Disruption Research. Toxicological Sciences 2010 115(2):612-613; doi:10.1093/toxsci/kfq048
• Alonso-Magdalena P, Vieira E, Soriano S, Menes L, Burks D, Quesada I, et al. 2010. Bisphenol-A Exposure during Pregnancy Disrupts Glucose Homeostasis in Mothers and Adult Male Offspring. Environ Health Perspect :-. doi:10.1289/ehp.1001993
• Bromer JG, Zhou Y, Taylor MB, Doherty L, Taylor HS. Bisphenol-A exposure in utero leads to epigenetic alterations in the developmental programming of uterine estrogen response. FASEB J. 2010 Feb 24. [Epub ahead of print] PubMed PMID: 20181937.
• Doherty L, Bromer JG, Zhou Y, Aldad TS and Taylor HS. In Utero Exposure to Diethylstilbestrol (DES) or Bisphenol-A (BPA) Increases EZH2 Expression in the Mammary Gland: An Epigenetic Mechanism Linking Endocrine Disruptors to Breast Cancer. Hormones and Cancer. DOI: 10.1007/s12672-010-0015-9.
• Signorile PG, Spugnini EP, Mita L, Mellone P, D’Avino A, Bianco M, Diano N, Caputo L, Rea F, Viceconte R, Portaccio M, Viggiano E, Citro G, Pierantoni R, Sica V, Vincenzi B, Damiano G. Mita DG, Baldi F and Baldi A. Pre-natal exposure of mice to bisphenol A elicits an endometriosis-like phenotype in female offspring. General and Comparative Endocrinology. doi:10.1016/j.ygcen.2010.03.030.

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German Translation by CSN:

60 Wissenschaftler und NGOs appellieren an EFSA

Berkeley — Pregnant women with higher blood levels of a common flame retardant had altered thyroid hormone levels, a result that could have implications for fetal health, according to a new study led by researchers at the University of California, Berkeley.

“This is the first study with a sufficient sample size to evaluate the association between PBDE flame retardants and thyroid function in pregnant women,” said the study’s lead author, Jonathan Chevrier, a UC Berkeley researcher in epidemiology and in environmental health sciences. “Normal maternal thyroid hormone levels are essential for normal fetal growth and brain development, so our findings could have significant public health implications. These results suggest that a closer examination between PBDEs and these outcomes is needed.”

PBDEs, or polybrominated diphenyl ethers, are a class of organobromine compounds found in common household items such as carpets, textiles, foam furnishings, electronics and plastics. U.S. fire safety standards implemented in the 1970s led to increased use of PBDEs, which can leach out into the environment and accumulate in human fat cells.

Studies suggest that PBDEs can be found in the blood of up to 97 percent of U.S. residents, and at levels 20 times higher than those of people in Europe. Because of California’s flammability laws, residents in this state have some of the highest exposures to PBDEs in the world.

“Despite the prevalence of these flame retardants, there are few studies that have examined their impact on human health,” said the study’s principal investigator, Brenda Eskenazi, UC Berkeley professor of epidemiology and of maternal and child health. “Our results suggest that exposure to PBDE flame retardants may have unanticipated human health risks.”

The new study, to be published June 21 in the journal Environmental Health Perspectives, is the second study to come out this year from Eskenazi’s research group linking PBDEs to human health effects. Eskenazi was the principal investigator on the earlier study that found that women with higher exposures to flame retardants took longer to get pregnant.

In the new study, the researchers analyzed blood samples from 270 women taken around the end of their second trimester of pregnancy. The women in the study were part of a larger longitudinal study from the Center for the Health Assessment of Mothers and Children of Salinas (CHAMACOS) that examines environmental exposures and reproductive health.

The researchers measured concentrations of 10 PBDE chemicals, two types of thyroxine (T4) and thyroid-stimulating hormone (TSH). They controlled for such factors as maternal smoking, alcohol and drug use, and exposure to lead and pesticides.

Analysis focused on the five PBDE chemicals that were detected most frequently and are components of a mixture called pentaBDE. The researchers found that a 10-fold increase in each of the PBDE chemicals was associated with decreases in TSH ranging from 10.9 percent to 18.7 percent. When the five PBDEs were analyzed together, a tenfold increase was linked to a 16.8 percent decrease in TSH.

The study did not find a statistically significant effect of PBDE concentrations on levels of T4. With one exception, all the women in the study with low TSH levels had normal free T4 levels, which corresponds to the definition of subclinical hyperthyroidism. The study found that odds of subclinical hyperthyroidism were increased 1.9 times for each tenfold increase in PBDE concentrations.

“Low TSH and normal T4 levels are an indication of subclinical hyperthyroidism, which is often the first step leading toward clinical hyperthyroidism,” said Chevrier. “Though the health effect of subclinical hyperthyroidism during pregnancy is not well understood, maternal clinical hyperthyroidism is linked to altered fetal neurodevelopment, increased risk of miscarriage, premature birth and intrauterine growth retardation.”

Exactly how flame retardants influence TSH levels is unclear, the researchers said, but animal studies have shown that certain PBDEs can mimic thyroid hormones.

In addition to the commercial mixture pentaBDE, octaBDE and decaBDE have been developed for use as commercial flame retardants. PentaBDE and octaBDE have both been banned for use by the Stockholm Convention on Persistent Organic Pollutants, the European Union and eight U.S. states, including California, but they are still present in products made before 2004.

The production of decaBDE by major manufacturers is scheduled to be phased out in the United States by 2013. However, pentaBDE and decaBDE are being replaced by new brominated and chlorinated compounds whose impact on human health is not yet clear, the researchers noted.

Literature: University of California – Berkeley, Flame retardant linked to altered thyroid hormone levels during pregnancy, June, 21, 2010.

Senator Feinstein, others demand BPA ban in Food Safety Bill

(Washington, DC ) Senator Dianne Feinstein stood with environmental health advocates today on Capitol Hill to release a new report that demonstrates alarming levels of bisphenol A (BPA) in common canned foods. BPA is a synthetic sex hormone and exposure to low doses has been linked to abnormal behavior, diabetes and heart disease, infertility, developmental and reproductive harm, and obesity, which raises the risk of early puberty, a known risk factor for breast cancer.

Senator Feinstein has introduced legislation that would ban BPA in cans, in addition to other food and beverage containers. The Senator is hopeful that the Food Safety Act will include language that protects consumers from BPA exposure.

“We found in our analysis that if someone is eating just one meal with at least one canned food product, their levels of BPA are as much as those that have been shown to cause health effects in laboratory animal studies,” says Bobbi Chase Wilding of Clean New York, co-author, of No Silver Lining, An Investigation Into Bisphenol A in Canned Foods, by The National Workgroup for Safe Markets, a coalition of U.S. public health- and environmental health-focused organizations.

“Six states have taken crucial first steps this year to get this hormone mimicking chemical out of our children’s food, but this report shows that there is much more to be done. Senator Feinstein’s bill will protect much more of our food from this toxic contamination,” said U.S. Public Interest Research Group Public Health Advocate Elizabeth Hitchcock.

“BPA is a bad actor chemical that should not be in contact with food we eat,” says Laura Vandenberg, PhD, Tufts University, a leading BPA researcher. “Hundreds of independent peer-reviewed scientific studies have found harm from low doses of BPA and its inexcusable the chemical is still used in food cans.”

Dr. George Lundgren, a Minnesota family physician who was biomonitored and discovered BPA in his own body, has seen an increase in suspected BPA linked health effects in his patients: “The cases of diabetes and obesity are increasing at such a rate in my own practice that diet and lack of exercise alone just can’t explain it away. And the fact that there are no labels on the products that are exposing us to a chemical that may be linked to these serious health problems and other illness is disturbing.”

“Anyone who reads this report would agree that getting BPA out of food is an urgent food safety issue that demands immediate congressional action,” said Janet Nudelman, policy director at the Breast Cancer Fund. “Fortunately the Senate has the opportunity to address this problem right now by including strong protections against food-based exposures to BPA in the Food Safety Modernization Act. This is our best chance to protect Americans, especially our kids, from this toxic chemical.”

“We commissioned this study to see what level of BPA might be consumed from canned foods in a typical, everyday American diet,” explains Mia Davis from Clean Water Action, another of the report’s co-authors, “We wanted to know if the amount of BPA found in canned foods and beverages would be enough to affect a person’s health, or the health of their child if they are pregnant.”

Mike Schade from Center for Health, Environment & Justice, also a co-author, says, “General Mills just announced that it is removing BPA from its organic tomatoes’ cans, so we know that companies that want to do the right thing, will, but we need the FDA to insure a basic level of protection for consumers.”

Sarah Janssen, MD, PhD, staff scientist, Natural Resources Defense Council says,“The levels of BPA in our food supply have been associated with a wide range of health effects. Dozens of independent scientists, including the Director of NIEHS, have advised reducing BPA exposure. It’s time for FDA to act on their advice.” NRDC filed a petition in October, 2008 asking FDA to revoke the approval of and ban BPA as a food additive. FDA has yet to rule on this petition.

BPA in canned foods is just one of thousands of ways we are exposed to dangerous chemicals in everyday products,” said Andy Igrejas, national campaign director for Safer Chemicals, Healthy Families, a coalition of 200 environmental and public health groups. “The proposed Safe Chemicals Act needs to be strengthened and passed so that people, especially children, are not bombarded with such hazards.”

Highlights:

• Levels in canned food that are the same or similar to levels of BPA found in the urine of over 90% of Americans by the Center for Disease Control and Prevention, and cord blood of newborn babies.
• One can of Del Monte green beans had the highest levels of BPA ever found in canned food, at 1140 parts per billion; EPA presumes BPA is safe at 50 parts per billion per day.
• The study tested 50 cans from 19 states and Ontario, Canada for BPA contamination, including cans with fish, fruits, vegetables, beans, soups, tomato products, sodas, and milks, which together represent common ingredient and meal options for a wide range of North American consumers.
• Test results showed there is inconsistency across brands and types of food, which prevents consumers from avoiding BPA just by looking at a label. In one case, two different cans of peas from two separate lots had an extreme difference: on had six parts per billion, while the other had over 300 parts per billion.

BPA has been banned from baby bottles and children’s sippy cups in six states (Connecticut, Maryland, Minnesota, Washington, Wisconsin, and Vermont), three counties in New York and the City of Chicago. Only Connecticut and Vermont restrict the use of BPA in cans of baby food.

Denmark has recently become the first country to enact a BPA ban and Canada has banned BPA in baby bottles while the French Senate is working to impose restrictions. Japan asked manufacturers for voluntary restriction of BPA from canned food in 1998 and saw a decline in their population’s levels of contamination.

Literature: Chemical Safety Workgroup, Release, May 18, 2010.

Read full report: NO SILVER LINNING (pdf)

Related Article:

• Why BPA leached from ’safe’ plastics may damage health of female offspring
• Plastics chemical retards growth, function of adult reproductive cells
• Public Health Advisory Regarding Bisphenol A (BPA)

Diethyl phthalate (DEP) and di-n-butyl phthalate (DnBP) are used extensively in personal care products, including fragrances (DEP) and nail polish (DnBP).

Between May 2003 and July 2006, we gathered questionnaire data on the use of seven product categories (deodorant, perfume, hair spray, hair gel, nail polish/polish remover, liquid soap/body wash, and lotion/mist) over 48 h during the third trimester of pregnancy from 186 inner-city women.

A 48-h personal air sample was collected and analyzed for DEP and DnBP; a maternal spot urine sample was collected and analyzed for their monoester metabolites, monoethyl phthalate (MEP) and mono-n-butyl phthalate (MnBP), respectively. In all, 97% of air samples and 84% of urine samples were collected within +/-2 days of the questionnaire.

During the 48 h, 41% of women reported perfume use and 10% reported nail polish/polish remover use. In adjusted analyses, no association was seen between nail product use and air DnBP or urine MnBP concentrations.

Women reporting perfume use had 2.3 times higher (95% CI 1.6, 3.3) urinary MEP concentrations. Personal air DEP increased by 7% for each 25% increase in a composite indicator of the six other product categories (P<0.05), but was not associated with perfume use. Air DEP was correlated with urine MEP concentrations only among non-perfume users (r=0.51, P<0.001). Results suggest that perfume use is a significant source of DEP exposure.

Literature:

Just AC, Adibi JJ, Rundle AG, Calafat AM, Camann DE, Hauser R, Silva MJ, Whyatt RM., Urinary and air phthalate concentrations and self-reported use of personal care products among minority pregnant women in New York city, Journal of Exposure Science and Environmental Epidemiology advance online publication, 31 March 2010; doi:10.1038/jes.2010.13.

Yale scientists show how bisphenol A induces epigenetic changes in pregnant mice that cause hormonal imbalance in the later life of female progeny

Here’s more evidence that “safe” plastics are not as safe as once presumed: New research published online in The FASEB Journal suggests that exposure to Bisphenol A (BPA) during pregnancy leads to epigenetic changes that may cause permanent reproduction problems for female offspring. BPA, a common component of plastics used to contain food, is a type of estrogen that is ubiquitous in the environment.

“Exposure to BPA may be harmful during pregnancy; this exposure may permanently affect the fetus,” said Hugh S. Taylor, Ph.D., co-author of the study from Yale University School of Medicine in New Haven, Connecticut. “We need to better identify the effects of environmental contaminants on not just crude measures such as birth defects, but also their effect in causing more subtle developmental errors.”

Taylor and colleagues made this discovery by exposing fetal mice to BPA during pregnancy and examining gene expression and DNA in the uteruses of female fetuses. Results showed that BPA exposure permanently affected the uterus by decreasing regulation of gene expression. These epigenetic changes caused the mice to over-respond to estrogen throughout adulthood, long after the BPA exposure. This suggests that early exposure to BPA genetically “programmed” the uterus to be hyper-responsive to estrogen. Extreme estrogen sensitivity can lead to fertility problems, advanced puberty, altered mammary development and reproductive function, as well as a variety of hormone-related cancers. BPA has been widely used in plastics and other materials. Examples include use in water bottles, baby bottles, epoxy resins used to coat food cans, and dental sealants.

“The BPA baby bottle scare may be only the tip of the iceberg.” said Gerald Weissmann, M.D., Editor-in-Chief of The FASEB Journal. “Remember how diethylstilbestrol (DES) caused birth defects and cancers in young women whose mothers were given such hormones during pregnancy. We’d better watch out for BPA, which seems to carry similar epigenetic risks across the generations. ”

Author: FASEB* – Federation of American Societies for Experimental Biology, Why BPA leached from ’safe’ plastics may damage health of female offspring, 25-Feb-2010.

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* FASEB comprises 23 societies with more than 90,000 members, making it the largest coalition of biomedical research associations in the United States

A new study led by Mount Sinai researchers in collaboration with scientists from Cornell University and the U.S. Centers for Disease Control and Prevention, has found higher prenatal exposure to phthalates—manmade chemicals that interfere with hormonal messaging—to be connected with disruptive and problem behaviors in children between the ages of 4 and 9 years. The study, which is the first to examine the effects of prenatal phthalate exposure on child neurobehavioral development, will be published January 28, on the Environmental Health Perspectives website.

“There is increasing evidence that phthalate exposure is harmful to children at all stages of development,” said Stephanie Engel, PhD, lead study author and Associate Professor of Preventive Medicine at Mount Sinai School of Medicine. “We found a striking pattern of associations between low molecular weight phthalates – which are commonly found in personal care products – and disruptive childhood behaviors, such as aggressiveness and other conduct issues, and problems with attention. These same behavioral problems are commonly found in children diagnosed with Attention-Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder, or Conduct Disorder.”

Phthalates are part of a group of chemicals known as endocrine disruptors, that interfere with the body’s endocrine, or hormone system. They are a family of compounds found in a wide range of consumer products such as nail polishes, to increase their durability and reduce chips, and in cosmetics, perfumes, lotions and shampoos, to carry fragrance. Other phthalates are used to increase the flexibility and durability of plastics such as PVC, or included as coatings on medications or nutritional supplements to make them timed-release.

“Recently, the government instituted regulations limiting certain phthalates in things like child care articles or toys that a young child might put in their mouth,” continued Dr. Engel. “But it’s their mother’s contact with phthalate-containing products that causes prenatal exposure. The phthalates that we found most strongly related to neurodevelopment were those commonly found in cosmetics, perfumes, lotions and shampoos. Current US regulations do not address these kinds of phthalates.”

For the study, phthalate metabolite levels were analyzed in prenatal urine samples of a multiethnic group of 404 women who were pregnant for the first time. The women were invited to participate in follow-up interviews when their children were between the ages of 4 and 9. The mothers were not informed of their phthalate metabolite levels and the researchers were unaware of their exposures when testing the children.

Follow-up visits were completed by 188 of the women and their children. At each follow-up visit, the mothers completed validated questionnaires designed to assess their behavior and executive functions. The researchers found that mothers with higher concentrations of low molecular weight phthalates consistently reported poorer behavioral profiles in their children. The strongest trends were in the categories of conduct and externalizing problems, characteristics typically associated with Oppositional Defiant Disorder, Conduct Disorder and ADHD.

“These are high level, chronic exposures that start before the child is even born, but continue throughout their life. More research is needed to examine the effects of cumulative exposure to phthalates on child development. But what this study suggests is that it’s not enough to regulate childhood exposure to these chemicals. The regulations need to include products that moms use,” said Dr. Engel.

Reference: The Mount Sinai Hospital / Mount Sinai School of Medicine, Mount Sinai finds prenatal exposure to certain chemicals affects childhood neurodevelopment, Jan. 28, 2010

Male reproductive disorders that are of interest from an environmental point of view include sexual dysfunction, infertility, cryptorchidism, hypospadias and testicular cancer.

Several reports suggest declining sperm counts and increase of these reproductive disorders in some areas during some time periods past 50 years. Except for testicular cancer this evidence is circumstantial and needs cautious interpretation. However, the male germ line is one of the most sensitive tissues to the damaging effects of ionizing radiation, radiant heat and a number of known toxicants.

So far occupational hazards are the best documented risk factors for impaired male reproductive function and include physical exposures (radiant heat, ionizing radiation, high frequency electromagnetic radiation), chemical exposures (some solvents as carbon disulfide and ethylene glycol ethers, some pesticides as dibromochloropropane, ethylendibromide and DDT/DDE, some heavy metals as inorganic lead and mercury) and work processes such as metal welding. Improved working conditions in affluent countries have dramatically decreased known hazardous workplace exposures, but millions of workers in less affluent countries are at risk from reproductive toxicants. New data show that environmental low-level exposure to biopersistent pollutants in the diet may pose a risk to people in all parts of the world.

For other noxicants the evidence is only suggestive and further evaluation is needed before conclusions can be drawn. Whether compounds as phthalates, bisphenol A and boron that are present in a large number of industrial and consumer products entails a risk remains to be established. The same applies to psychosocial stressors and use of mobile phones.

Finally, there are data indicating a particular vulnerability of the fetal testis to toxicants – for instance maternal tobacco smoking. Time has come where male reproductive toxicity should be addressed form entirely new angles including exposures very early in life.

Literatur:
Bonde JP., Male reproductive organs are at risk from environmental hazards, Department of Occupational and Environmental Medicine, Bispebjerg University Hospital, Copenhagen, Denmark, Asian J Androl. 2009 Dec 7.

If it hadn’t been for the Big Macs that Joannie ate pretty much three times a week, she wouldn’t have gotten fat.  If she hadn’t been exposed while in her mother’s womb to chemicals x, y and z, Joannie wouldn’t have had the propensity to get fat.  And if Joannie’s mom had eaten more sensibly, both waistlines would be slimmer.

Fat people most likely are programmed to become fat before taking their first sip of milk.

Today’s news is, that pesticides are among the chemicals responsible for this reprogramming.

Two of three U.S. adults are now classified as overweight.  Type II diabetes has increased in like measure over the same decades, and so has heart disease.  This is not a coincidence.  These illnesses share common characteristics: they are triggered while in the womb by exposure to the same kinds of chemicals and the outcomes show up in adulthood.  Scientists now call this pattern “the fetal origins of adult diseases”.

The most likely culprits are chemicals now grouped together under the rubric “endocrine disrupters.” It’s been known for about two decades, though disputed by the manufacturers, that these chemicals alter the normal signaling pathways of hormones.  Think of Bisphenol A (BPA), right now the nation’s most celebrated endocrine disruptor.

Pesticides, though not specifically thought of as endocrine disruptors nor regulated as such, can similarly knock normal development off track.  Research has just found that a family of pesticides among the most widely used in the world is connected to these three adult illnesses.  This is the family of organophosphates, concocted from petroleum with an addition of phosphoric acid.

When lab rats are exposed to these pesticides through the mother’s diet, at a time in their development equivalent to a human baby’s second trimester in the womb, their metabolism changes in two ways: their cholesterol and triglycerides rise.  These abnormal and lasting changes resemble the major factors that predict and lead, later in life, to obesity, diabetes and cardiovascular heart disease (specifically, atherosclerosis, a condition in which fatty material collects along the arteries and hardens artery walls).

These changes in metabolism happen at low levels, within the levels we are uniformly exposed to, which the Environmental Protection Agency declares as “safe” but are evidently not.  The changes are the strongest when the mother rats are fed a high-fat diet.  Human babies may even be underweight at birth (and there’s an epidemic of underweight babies in the U.S.), but quickly become overweight

Humans run into these pesticides in our food and water.  Of course, children continue to be exposed once they are born and are in fact exposed more than adults because they eat and drink more in relation to their body weight and have a higher ratio of skin.

The other groups of people exposed most to organophosphates and other pesticides are the same groups with the highest rates of obesity – people who live in run-down inner-city neighborhoods, the poor, and farmworkers.  Again, not a coincidence but a connection, a trigger.

Dr. Ted Slotkin of Duke University, the researcher responsible for these discoveries, found another compelling clue: exposure caused harm to the rodent’s brain, as well as its metabolism.  Once the exposed lab animal was born and started to eat at will, its consumption of a high-fat diet reduced the adverse symptoms in its brain functioning.  As Dr. Slotkin muses, “If you’ve got neurofunctional deficits, and they can be offset by continually eating Big Macs, then you will naturally (but unconsciously) select that kind of food because it will make you feel better.”  Unfortunately, increased fat will further harm the animal’s, or human’s, metabolism.

What this means for you:

Particularly while trying to conceive, during pregnancy, while nursing, and for your children, avoid pesticides; eat organic foods.

For information about endocrine disruptors, read the new booklet published by the nonprofit Learning and Developmental Disabilities Initiative.

Author: Alice Shabecoff for CSN – Chemical Sensitivity Network, November 5, 2009

Alice Shabecoff is the co-author with her husband Philip of Poisoned Profits: The Toxic Assault on our Children, published by Random House last year.  See their website, www.poisonedprofits.com

Related article from Alice Shabecoff:

• Our planet, our children – How are your children doing?