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

–

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.

-

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

-

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.

—

German Translation by CSN:

60 Wissenschaftler und NGOs appellieren an EFSA

International Appeal from Wuerzburg

The European Academy for Environmental Medicine (EUROPAEM) invited many renowned national and international scientists and health care professionals to a medical conference held in Wuerzburg, Germany from April 23 to April 25, 2010. These professionals were from the fields of environmental medicine, toxicology, immunology, neurology and genetics and other health fields as well as physicians and dentist. Also in attendance were representatives of patient initiatives. The theme of this international medical conference was Science Meets Practice. It dealt specifically with the issues of Neuro- Endocrine- Immunology and their importance in environmental medicine.

Greatly concerned, participants noted the increasing prevalence of chronic multisystem illnesses such as multiple chemical sensitivity (MCS), chronic fatigue syndrome (CSF), fibromyalgia (FMS) as well as cardiovascular diseases, metabolic syndrome, neurodegenerative diseases, auto immune diseases, and cancer.

At the conference it was impressively demonstrated that these chronic diseases are based on similar pathological mechanisms. Common mechanisms are chronic inflammatory processes influenced by environmental factors including chemical pollutants, biological infectious agents, and electromagnetic field (EMF) triggers.

Chronic diseases mean long-term patients and such patients require consecutive higher medical costs. This often leads to social exclusion of the affected people. Facing the appalling reports of Europe´s growing financial constraints, especially in public health, a further increase of chronic illnesses will accelerate the ongoing collapse of the National Health Service and medical insurance companies in Europe. Remedy is only possible with a change of priorities from today´s unilaterally symptomatic oriented medicine to causally oriented medicine focusing on cost-effective primary prevention.

Conference participants addressed an urgent appeal to the European environment and health ministers, to the European Commission, the European parliamentarians, national governments and to the directors of social and private insurance companies. They urge them to take these findings and developments into serious consideration, stressing and weighting financial investments primarily in prevention, precaution and best early detection and diagnosis of these chronic and environmentally related illnesses.

All over Europe this requires the full awareness of these research findings of the practicing physicians of environmental medicine and their integration into university research and teaching. The European governments are asked to finally implement the already ratified decisions of the Fourth Ministerial Conference on Environment and Health Ministers held in Budapest in 2004.

This appeal was unanimously adopted by the congress.

Wuerzburg April 25, 2010

For the board of EUROPAEM,

Jean Huss, Vice-Chairman

Dr. Kurt Mueller, Chairman

Dr. Peter Ohnsorge, Managing Chairman

Dr. Hans-Peter Donate, Press, Responsible

• German Version – International Appeal from Wuerzburg
• Japanese Version – International Appeal from Wuerzburg / Thanks to Takeshi for translation.

International Journal of Occupational and Environmental Health Features Discovery of Asbestos-Related Pain Origin from Scientists at the Karmanos Cancer Institute in Detroit 

Scientists at the Barbara Ann Karmanos Cancer Institute’s National Center for Vermiculite and Asbestos-Related Cancers (NCVAC) have discovered a probable reason for the unrelenting chest pain experienced in certain patients with asbestos-related diseases and cancers. The findings, featured in the July 20, 2009 edition of the International Journal of Occupational and Environmental Health, were published in an academic peer-reviewed manuscript by principal author Michael Harbut, M.D., MPH, co-director of the NCVAC and chief of the Center for Occupational and Environmental Medicine, affiliated with Wayne State University.  

Harbut reported the findings after studying a patient who was exposed to taconite dust as a child.  

Using a new radiography approach developed by Carmen Endress, M.D., FACR, associate professor of Radiology, Wayne State University School of Medicine and radiologist at the NCVAC, there was a documented increase in pleural plaques, causing erosion on the interior wall of the ribs. 

“This action of the pleural plaque against the covering of the bone and the bone itself is a biologically plausible and an anatomically logical explanation of the unrelenting pain which some patients experience,” said Dr. Harbut.

This new imaging approach involves enhancing images obtained on the 64-slice high resolution CT scan using the Vitrea(R) imaging software program by Vital Images. By using this imaging approach, Dr. Harbut was able to demonstrate that: 

Evidence based on the CT findings, the physical examination, pulmonary function studies, epidemiology and history of the patient’s intractable pleural pain meets the criteria for diagnosis of asbestosis. Combined with the known science of taconite dust, a link between the mine where the patient’s father worked and the patient’s disease was established.  

Due to the clarity and definition of this new imaging approach, it is more likely to detect asbestos-related diseases and cancer at an earlier stage.  

Earlier detection will allow the possibility for additional treatment options to manage the pain caused by pleural plaque beyond the narcotics often prescribed for patients with advanced stages of asbestos disease. This includes exploring other forms of traditional and nontraditional methods to control pain.  

The patient, studied since 2004 and currently 55 years of age, was exposed as a child to taconite dust unknowingly by her father, a taconite miner from 1962 – 1969, who carried the taconite dust on his work clothes. Taconite is used in the production of steel and road-patching material. It has been mined in Michigan and Minnesota. 

The patient has experienced increasing pain on her right side for the past 31 years, a persistent cough and wheezing. As the pain increased so did her medication. Using the new imaging approach, Dr. Harbut was able to show the progression of the patient’s pleural plaque over a three year period, from 2005 – 2008. The patient’s pleuritic pain, as well as the findings of her pulmonary function, physical exam and symptomology are consistent with those diagnosed with asbestosis and pleural plaques, as established by the American Thoracic Society.  

These findings also support earlier human and animal reports that dusts produced by taconite mining can evoke the same biological responses as do other fibers already defined as asbestos or asbestiform materials. 

Harbut added, “Patients often require a lifetime of narcotics to allow functioning, but we are hopeful that with this new imaging technology, more selective pain management approaches with fewer side effects can be instituted resulting in a better quality of life.”

Finally, the report supports the identification of taconite, which has not yet been categorized as asbestos but causes a disease consistent with asbestosis, and recommends a reevaluation of the definition of asbestos. This is especially important within the context of legislative efforts to prohibit the use of asbestos. 

Karmanos scientists are continuing their series of patient studies and will submit similar findings for peer review later this summer.  

In addition to Dr. Harbut, co-authors of the report include Carmen Endress, M.D., FACR; John J. Graff, Ph.D., MS, assistant professor, Wayne State University School of Medicine, and chief, Cancer Surveillance Research at the Barbara Ann Karmanos Cancer Institute; Christopher Weis, Ph.D., National Enforcement Investigations Center, United States Environmental Protection Agency; and Harvey Pass, M.D., director, New York University’s Division of Thoracic Surgery.  

About the National Center for Vermiculite and Asbestos-Related Cancers (NCVAC at Karmanos)  

In response to the United States Environmental Protection Agency’s (EPA) identification of major sources of public asbestos exposure in Michigan, and to address the need for early diagnosis and aggressive treatment of asbestos-related diseases, the Barbara Ann Karmanos Cancer Institute and the Center for Occupational and Environmental Medicine (COEM) affiliated with Wayne State University established Karmanos’ National Center for Vermiculite and Asbestos-Related Cancers. The NCVAC is co-directed by Michael Harbut, M.D., MPH, Karmanos Cancer Institute and Chief of the Center for Occupational and Environmental Medicine; and John J. Graff, Ph.D. MS, chief of Cancer Surveillance Research, Karmanos Cancer Institute and assistant professor, Department of Family Medicine and Public Health Sciences, Wayne State University School of Medicine. 

Reference: Barbara Ann Karmanos Cancer Institute, International Journal of Occupational and Environmental Health Features Discovery of Asbestos-Related Pain Origin from Scientists at the Karmanos Cancer Institute in Detroit , US Newswire, DETROIT, July 20, 2009.

Bitumen fumes consist essentially of polycyclic aromatic hydrocarbons (PAHs) and their derivatives, some of which are known to be carcinogenic or cocarcinogenic in humans. The aim of this study was to investigate exposure to asphalt fumes among Turkish asphalt workers and determine whether any effects could be detected with genotoxic tests.  

The study included 26 asphalt workers and 24 control subjects. Sister chromatid exchange (SCE) and micronucleus (MN) were determined in peripheral lymphocytes. Urinary 1-hydroxypyrene (1-OHP) excretion was used as a biomarker of occupational exposure to PAHs.  

The asphalt workers had a significant increase in SCEs and MN (for each, p < 0.001). A positive correlation existed between the duration of exposure and rates of SCE or MN frequencies (r = 0.49, p < 0.05; r = 0.53, p < 0.05, respectively). The concentration of 1-OHP in urine was higher for the asphalt workers than for the controls (p < 0.001). However, we found that there was no statistically significant correlation between the urinary 1-OHP concentration and SCEs or MN frequencies (r = 0.25, p > 0.5; r = 0.17, p > 0.5, respectively).  

This study shows that Turkish asphalt workers have an increased exposure to PAHs from bitumen fumes, and genotoxic effects could be detected by SCEs and MN tests. 

Reference: Karaman A, Pirim I., Exposure to bitumen fumes and genotoxic effects on Turkish asphalt workers, Department of Medical Genetics, State Hospital, Erzurum, Turkey, Clin Toxicol (Phila). 2009 Apr;47(4):321-6.

Selenium is an essential trace element with antioxidative, antimutagenic, antiviral and anticarcinogenic properties.  

There is increasing evidence that the dietary selenium intakes are sub-optimal in the populations of many countries and that human cancer mortalities would significantly decline if additional selenium was made available either through supplementation or the fortification of certain foods. An important property of selenium is its interaction with other elements that may be present in foods, the water, the workplace and the environment, e.g. As, Cu, Ni, Co, Cr, Mn, Zn, Cd, Sn, Pb, Hg, Bi, Mo, Ag, Au, etc.  

The sequestration of elements by selenium represents an efficient natural detoxification mechanism for some of these elements but also results in the physiological inactivation of selenium.  

Animal experiments confirm that the chronic exposure to low levels of these elements abolishes the cancer-protective effect of selenium. Human cancer is likewise significantly determined by the interactions of selenium with other elements, as evidenced by epidemiological, ecological and case-control studies. Cadmium, for example, is a key risk-increasing element for prostate cancer; for breast cancer, Cd, Cr, Zn are mainly contributing; for bronchial cancer (in smelter workers), Cd, As, Cr, Sb, Co, La, all these elements are in a reciprocal relationship with Se.  

While selenium remains the key cancer-protective trace element, the interpretation of its mode of action necessitates consideration of the effects of selenium antagonistic elements. 

Reference: Schrauzer GN., Selenium and selenium-antagonistic elements in nutritional cancer prevention, Department of Chemistry and Biochemistry, University of California-San Diego, La Jolla, CA, USA., Crit Rev Biotechnol. 2009;29(1):10-7

EPA to Move Aggressively on Cleanup and HHS to Assist Area Residents with Medical Care  

WASHINGTON – U.S. Environmental Protection Agency Administrator Lisa P. Jackson today announced the agency has determined that a public health emergency exists at the Libby asbestos site in northwest Montana.  Over the past years, hundreds of asbestos-related disease cases have been documented in this small community, which covers the towns of Libby and Troy. The announcement was made today at a joint press conference with Department of Health and Human Services Secretary Kathleen Sebelius and U.S. Sens. Max Baucus and Jon Tester.  

This is the first time EPA has made a determination under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) that conditions at a site constitute a public health emergency.  This determination recognizes the serious impact to the public health from the contamination at Libby and underscores the need for further action and health care for area residents who have been or may be exposed to asbestos. Investigations performed by the Agency for Toxic Substance and Disease Registry have found the incidence of occurrence of asbestosis, a lung condition, in the Libby area staggeringly higher than the national average for the period from 1979-1998. EPA is working closely with the Department of Health and Human Services, which is making available a short-term grant to provide needed asbestos-related medical care to Libby and Troy residents.  

During her Senate confirmation hearing, Administrator Jackson committed to review the situation at the Libby asbestos site based on current site information, sound science and EPA’s legal authorities. As a result of her review, the Administrator has decided that conditions at the site present a significant threat to public health and that making a public health emergency determination is appropriate.  

“This is a tragic public health situation that has not received the recognition it deserves by the federal government for far too long. We’re making a long-delayed commitment to the people of Libby and Troy. Based on a rigorous re-evaluation of the situation on the ground, we will continue to move aggressively on the cleanup efforts and protect the health of the people,” said EPA Administrator Lisa P. Jackson. “We’re here to help create a long and prosperous future for this town.” She added, “Senator Max Baucus has been a tireless advocate for the people living in Libby and Troy who have confronted this public health tragedy for generations and we commend him for his work. We look forward to working with him and Senator Tester who has been working diligently since being elected to the Senate to bring much needed support to these communities.”  

“Senator Baucus and Senator Tester have powerfully brought the voices of the people of Libby and Troy to Washington so the nation could hear and understand what happened. They refused to give up on finding the best ways to help those who have suffered so much. Today’s announcement reflects our Administration’s concern for the residents of Lincoln County and our intention to act decisively to protect and improve their health and quality of life,’ said Secretary Sebelius. “The Department of Health and Human Services has been working closely with the EPA and the residents of Lincoln County for a number of years to conduct screenings and help provide access to care. Now, we have come together with Senator Baucus and Senator Tester, Administrator Jackson, and agencies across HHS, to offer a new grant to provide short-term medical assistance for screening, diagnostic and treatment services in a comprehensive and coordinated manner in partnership with local officials on the ground in Lincoln County. “  

Sen. Max Baucus, a long-time advocate on this issue, consistently sought out a determination of a public health emergency in this region.  

“This is a great day for Libby. This is a town that was poisoned by W.R. Grace, then had to wait year after year as the last administration failed to determine that public health emergency exists. But today is a new day,” said Sen. Baucus. “Today is the day that Administrator Jackson did the right thing and made this vital determination. Today is the day that Secretary Sebelius declared that people in Libby will get the health care they need. Today is the day that after years of work we were able to succeed in getting this done. Yet, we won’t stop here. We will continue to push until Libby has a clean bill of health.”  

“This is a long-overdue, common-sense decision that will go a long way for Libby and the thousands of folks who were poisoned there,” Sen. Tester said. “This decision will help make quality health care more accessible and it will open the door to get new resources on the ground.  We still have a long way to do right by the folks in Libby.  Working together with the Department of Health and Human Services and the Environmental Protection Agency, we’re making very good progress.”   

Secretary Sebelius tasked two HHS agencies – the Health Resources and Services Administration and the Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry – to help county residents. These two agencies will support a new grant to assist affected residents who need medical care. Local officials are currently putting together a grant proposal that will lay out options for provision of medical care that will work for the residents of Lincoln County. HHS anticipates that this grant can be awarded in August 2009.  

The Libby asbestos site has been on the EPA’s Superfund National Priorities List since 2002, and cleanup has taken place since 2000.  EPA has made progress in helping to remove the threat of asbestos in the land and air, and with it, the increased risks of lung cancer, asbestosis, and other respiratory problems. While EPA’s cleanup efforts have greatly reduced exposure, actual and potential releases of amphibole asbestos remain a significant threat to public health in that area.  

The Libby asbestos site includes portions of the towns of Libby and Troy and an inactive vermiculite mine seven miles northeast of the town. Gold miners discovered vermiculite in Libby in 1881; in the 1920s the Zonolite Company formed and began mining the vermiculite.  In 1963, W.R. Grace bought the Zonolite mining operations. The mine closed in 1990. It is estimated that the Libby mine was the source of over 70 percent of all vermiculite sold in the United States from 1919 to 1990.  

More information: http://www.epa.gov/libby 

EPA, EPA Announces Public Health Emergency in Libby, Montana,  June 17, 2009  

PHILADELPHIA – Has the key to reducing breast cancer gotten lost in the race for a cure? A new book, No Family History, presents compelling evidence that exposure to everyday products such as cosmetics and toiletries, hormones in food, household cleaners and pesticides is behind the dramatic increase in breast cancer and argues that the solution is simple: prevention.  

“Every three minutes, one woman in the United States is diagnosed with breast cancer. Yet, most women with breast cancer defy most or all of the risk factors, including weight, diet, whether they gave birth and breast fed, and family history,” says No Family History author Sabrina McCormick, Ph.D., a Robert Wood Johnson Foundation Health & Society Scholar at the University of Pennsylvania. 

The incidence of breast cancer has increased at an alarming rate over the past 60 years. In 1940, around one in 24 women who lived to be 80 was afflicted. By 2006, that number rose to one in eight.  

In her book, McCormick cites compelling evidence showing that the reason for this dramatic increase is the rise in the production and use of cancer-causing chemicals women are exposed to on a daily basis.  

Breast cancer “hot spots” from Long Island, N.Y., to Northern California have two common threads—industrial pollution and agricultural pesticides. These “hot spots” are pockets of the United States where breast cancer has risen six times faster than the national rate. In Long Island, the incidence of breast cancer is 200 percent higher than the national average. 

“In our race for a cure for breast cancer, we have ignored the overwhelming body of evidence that demonstrates a link between products from cosmetics to pesticides and breast cancer,” McCormick says. “We must focus on prevention by demanding safer products, reducing our exposure to chemicals and urging our policymakers to ban cancer-causing chemicals in everyday products.” 

European governments responded to this scientific evidence by banning cosmetic products with certain chemicals from being sold in their countries. According to No Family History, one American cosmetics company known as much for its “pink ribbon” marketing campaigns as for its pink lipstick removed these chemicals from products sold in Europe, but these same chemicals remain in the products the company sells in the United States. 

“Women and girls should not have to check the ingredients in every stick of lipstick and each bottle of moisturizer. Better regulation to ensure that these products are safe would go a long way to reducing the incidence of breast cancer,” McCormick says. 

Many companies that profit from “pink” marketing campaigns or breast cancer treatments, McCormick argues, are the same ones fighting against tougher regulations of cancer-causing chemicals in everyday products. McCormick dubs this the “political economy” of breast cancer.

“In the case of breast cancer, many activists have unwittingly bought into campaigns leading down the road away from a cause, and instead into more and more breast cancer,” McCormick writes in her book. 

No Family History: The Environmental Links to Breast Cancer (Rowman & Littlefield) is a provocative glimpse into environmental links to breast cancer, profiling research as well as women’s stories. McCormick recommends that women reduce their exposure to many cosmetics and toiletries and urges policymakers to strengthen regulations to ban cancer-causing chemicals from being used in everyday products. 

Reference: Robert Wood Johnson Foundation Health & Society Scholars, Are everyday products from cosmetics to household cleaners causing the high rates of breast cancer? June, 15, 2009 

For more information on the book (in stores in June) and a documentary McCormick produced on the subject, visit www.nofamilyhistory.org

A study involving 678 individuals who apply pesticides, culled from a U.S. Agricultural Health Study of over 50,000 farmers, recently found that exposure to certain pesticides doubles one’s risk of developing an abnormal blood condition called MGUS (monoclonal gammopathy of undetermined significance) compared with individuals in the general population. The disorder, characterized by an abnormal level of a plasma protein, requires lifelong monitoring as it is a pre-cancerous condition that can lead to multiple myeloma, a painful cancer of the plasma cells in the bone marrow. The study will appear in the June 18 issue of Blood, the official journal of the American Society of Hematology.  

“Previously, inconclusive evidence has linked agricultural work to an increased multiple myeloma risk. Our study is the first to show an association between pesticide exposure and an excess prevalence of MGUS,” said lead author Ola Landgren, MD, PhD, of the National Cancer Institute (NCI), which is part of the National Institutes of Health, U.S. Department of Health and Human Services. “This finding is particularly important given that we recently found in a large prospective cancer screening study that virtually all multiple myeloma patients experienced a MGUS state prior to developing myeloma.”  

“As several million Americans use pesticides, it’s important that the risks of developing MGUS from the use of pesticides is known,” added senior study author and NCI investigator Michael Alavanja, DrPH. 

The blood of study participants, who were individuals licensed to apply restricted-use pesticides, was assessed for MGUS prevalence. The median age of participants was 60 years (range 30-94 years), and all lived in either Iowa or North Carolina. Participants also completed questionnaires providing comprehensive occupational exposure information for a wide range of pesticides, including information such as the average number of days of pesticide use per year, years of use, use of protective gear while applying pesticides, and pesticide application methods. Information on smoking and alcohol use, cancer histories of the participants’ first-degree relatives, and other basic demographic and health data were also obtained. Individuals with prior histories of lymphoproliferative malignancies (such as multiple myeloma or lymphoma) were excluded. Cancer incidence and mortality were monitored annually, and, after five years, follow-up interviews were conducted to update the information about participants’ occupational exposures, medical histories, and lifestyle factors. 

For comparison, data were obtained from a large MGUS-screening study conducted by the Mayo Clinic, and the results from the pesticide-exposed group were compared with the assessments of 9,469 men from the general population of Olmsted County, Minnesota. The two groups were similar in terms of age, race, and educational attainment. Because of the low prevalence of women among workers who apply pesticides, women were excluded from the study.  

In the pesticide-exposed group, no MGUS cases were observed among those who were less than 50 years of age, but the prevalence of MGUS in those older than 50 was 6.8 percent, which is 1.9 times higher than the general population study group of men in Minnesota. 

The researchers also evaluated the potential association between MGUS prevalence and 50 specific pesticides for which usage data were known. Of the chemicals studied, a significantly increased risk of MGUS was observed among users of dieldrin (an insecticide), carbon-tetrachloride/carbon disulfide (a fumigant mixture), and chlorothalonil (a fungicide). The MGUS risk for these agents increased 5.6-fold, 3.9-fold, and 2.4-fold, respectively. Several other insecticides, herbicides, and fungicides were associated with MGUS, but not significantly.  

“There is great concern regarding the increase in frequency in mature B-cell malignancies in the Western world and what may be the cause of this. A number of reports in the past have linked exposure to pesticides with increased risk of these types of cancers, but the present study is the first to link agricultural work to a pre-malignant condition,” said John G. Gribben, MD, DSc, Professor of Experimental Cancer Medicine at Barts and the London School of Medicine, who is not affiliated with the study. “It is vital to assess the risk of workplace exposure and disease, and the results lend further support to providing safe workplace practices to limit exposure to potential carcinogens.”

“Our findings are intriguing,” stated Dr. Landgren. If replicated in a larger sample from our study and other large studies, further work should focus on gaining a better understanding of the molecular basis of MGUS and multiple myeloma. Ultimately, this will result in the identification of novel molecular targets involved in the progression from MGUS to multiple myeloma and in the development of targeted therapies.”   

Reference: American Society of Hematology, Individuals Who Apply Pesticides Are Found to Have Double the Risk of Blood Disorder, Press Release, WASHINGTON, June 12, 2009

Patients with curable early-stage breast cancer died from chemotherapy solvent

A new study from the Research on Adverse Drug Events and Reports (RADAR) pharmacovigilance program at Northwestern University Feinberg School of Medicine identified 287 unique cases of hypersensitivity reactions submitted to the FDA’s Adverse Event Report System between 1997 and 2007 with 109 (38 percent) deaths in patients who received Cremophor-based paclitaxel, a solvent-administered taxane chemotherapy.

Adverse event reports generally only represent from 1 to 10 percent of actual incidence, so the number of hypersensitivity reactions and deaths is likely significantly higher. The severe allergic reactions are believed to be caused by Cremophor, the chemical solvent – a derivative of castor oil — that is used to dissolve some insoluble drugs before they can be injected into the blood stream.

Two patients who died from an allergic reaction had early-stage breast cancer, which had been surgically removed, and were being treated with Cremophor-containing paclitaxel to prevent the cancer from coming back. Both of these patients had received medications before the chemotherapy to reduce the risk of hypersensitivity reactions.

The study was led by Charles Bennett, M.D., RADAR program coordinator and a professor of hematology/oncology at Northwestern’s Feinberg School, and Dennis Raisch, a professor of pharmacy at the University of New Mexico.

“The deaths of women with early-stage breast cancer are particularly disturbing because without the adverse reaction, they could have likely had 40 years of life ahead of them,” Bennett said.

RADAR investigators also found that 22 percent of all fatalities occurred in patients despite patients having received premedication to prevent hypersensitivity reactions, while another 15 percent of such patients experienced life-threatening respiratory arrest.

The report was presented at the 45th Annual Meeting of the American Society of Clinical Oncology held recently in Orlando, Fla.

Cremophor-containing paclitaxel has been associated with hypersensitivity reactions, with responses ranging from mild skin conditions to more severe effects, including anaphylaxis and cardiac collapse. Current U.S. product labeling for Cremophor containing paclitaxel includes a black-box warning alerting physicians and patients of potential toxicity and recommending the use of corticosteroids and other medications before chemotherapy administration to reduce the risk of hypersensitivity reactions.

“The results of our review suggest that physicians should be vigilant in monitoring the safety of their patients undergoing chemotherapy treatment,” said Bennett, who also is the A.C. Buehler Professor in Economics and Aging at the Feinberg School and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

“Patients receiving Cremophor-based paclitaxel should be given medications to prevent hypersensitivity reactions, but what is sobering, as the study has shown and as the black-box warning indicates, women suffer anaphylaxis despite receiving steroid premedication,” Bennett said. “Physicians should be diligent in reporting adverse events to regulatory agencies to better monitor the impact of Cremophor on patient safety. Physicians may also want to consider exploring other alternative chemotherapy options that do not include Cremophor.”

In addition to the two women with early-stage breast cancer who died after treatment with the Cremophor-based paclitaxel, four other women with early-stage breast cancer experienced life-threatening anaphylaxis reactions. Each of them had received prior medications to prevent the reactions.

“The fatal outcomes observed in patients with early-stage breast cancer were particularly striking as this is a patient population with a good prognosis that is generally treated with curative intent,” said Raisch.

For the report, Bennett and Raisch reviewed adverse event reports submitted to regulatory agencies in the U.S., Europe and Japan. The most common cancer diagnosis for these patients with allergic reactions was lung cancer followed by breast cancer and ovarian cancer.

Reference: Northwestern University, Common chemotherapy drug triggers fatal allergic reactions, Press Release, 8-Jun-2009