People must be protected from exposure to fragrance ingredients that may cause cancer or fetal, hormonal or reproductive toxicity, the Cancer Prevention Coalition warned today. But federal agencies are not regulating these ingredients, leaving the public at risk due to the “recklessly irresponsible” behavior of the fragrance industry, says CPC Chairman Samuel S. Epstein, M.D.

Protection of the public would be implemented by passage of Senator Frank Lautenberg’s Safe Chemicals Act of 2010, Dr. Epstein advises. This bill requires manufacturers to provide information on “chemicals of concern” in consumer products.

The bill would provide the public with information on the dangers of these products, especially, says Dr. Epstein, “as the U.S. Food and Drug Administration (FDA) has recklessly failed to do so since passage of the 1938 Federal Food, Drug, and Cosmetic Act.”

Perfumes and fragrances are the single largest category of cosmetic and personal care products, especially products used on the hair, face, and eyes. These products represent nearly 50 percent of all prestige beauty dollars now spent in the United States. Fragrances are also extensively used in a wide range of everyday household cleaning products.

Exposure to toxic ingredients in cosmetics and personal care products is predominantly through the skin. In contrast, exposure to toxic ingredients in household cleaning products is predominantly through inhalation.

The FDA has direct authority under the terms of the 1938 Federal Food Drug and Cosmetic Act to regulate toxic ingredients in cosmetics and personal care products. However, seven decades later, it has still failed to do so. Similarly, the U.S. Environmental Protection Agency has also still failed to regulate these toxic ingredients in household cleaning products.

“In the disturbing absence of any federal regulations,” Dr. Epstein says, the policies and practices of the cosmetics and personal care products industries are determined by its International Fragrance Association (IFRA). This is an international trade organization of over 100 perfume and fragrance manufacturers, representing fifteen regions including the U.S., Europe, South America, Australia, and the Far East.”

The primary objective of IFRA is to protect the self-regulatory practices and policies of the industry by the development of a Code of Practices and safety guidelines, Dr. Epstein says. However, these include maintaining the “trade secret” status of perfume and fragrance ingredients, and pre-empting international legislative labeling and safety initiatives.

Of the more than 5,000 ingredients used in the fragrance industry, approximately 1,300 have so far been evaluated by the industry’s International Research Institute for Fragrance Materials. This institute is a “non-profit” organization, created by IFRA in 1966 to conduct research and testing of fragrance ingredients.

“However,” Dr. Epstein warns, “this testing is minimal and restricted to local effects on human skin, and short-term toxicity tests in rodents.”

Evaluation of ingredient safety is then made by a board of toxicologists, pharmacologists, and dermatologists, identified by the institute as “independent” without disclosure of their qualifications, let alone conflicts of interest.

Their findings are presented to IFRA’s Scientific Advisory Board, and then published in its trade journal, Food and Chemical Toxicology. The information reported in this journal is the basis on which IFRA formulates its own “safety guidelines.” However, Dr. Epstein points out, due to the “trade secret” status of fragrances, manufacturers are still not required by the FDA to disclose their ingredients on product labels or in any other way.

“These ingredients include a wide range of allergens. They also include synthetic musks, particularly tonalide and galaxolide, designed to mimic natural scents derived from musk deer and ox,” Dr. Epstein explains. “They are persistent and bioaccumulate in the body, have toxic hormonal effects, and have been identified in breast milk.”

In 1973, in efforts at damage control, IFRA created a Code of Practice listing prohibited ingredients, based on its own safety analyses. This listing has been periodically updated.

In May 1999, in response to repeated complaints of respiratory, neurological, and other toxic effects following the use of Calvin Klein’s Eternity perfume, the Environmental Health Network of California hired two testing laboratories to identify the ingredients in the perfume.

Analysis of these results by the Cancer Prevention Coalition, summarized in Dr. Epstein’s 2009 book Toxic Beauty, reveal the following:

• 26 ingredients whose “Toxicological properties have not been investigated,” or “toxicology properties have not been thoroughly investigated.”
• 25 ingredients that are “Irritants.”
• 5 ingredients that are “Skin sensitizers,” or allergens.
• 3 ingredients that show “Fetal, hormonal, and reproductive toxicity.”
• 2 ingredients that “May cause cancer.”

In efforts at damage control, IFRA agreed that information on allergenic ingredients in perfumes like Eternity should be made available, but only on request from dermatologists, for diagnostic purposes. “This “Fragrance On-Call List” action denies the public its right to know,” Dr. Epstein warns.

More disturbingly, Dr. Matthias Vey, president of IFRA, failed to respond to repeated warnings from August to October 2003 from the Cancer Prevention Coalition. These urged “all fragrance products be labeled to the effect that, apart from the absence of known skin and respiratory allergens, they contain no known carcinogens, gene damaging, hormonal, or otherwise toxic ingredients.”

As reported in “What’s That Smell,” a June 2010 report by Women’s Voices of the Earth, faced with continuing criticism of unresponsiveness, IFRA initiated a “compliance program” in 2007. “However,” Dr. Epstein warns, “this is based on testing of a mere 50 fragranced products from the global market place to detect prohibited ingredients.”

A fragrance may be restricted by IFRA on a variety of grounds. These include: use in products at higher-than-recommended concentrations, sensitization, photosensitization, phototoxicity, allergenicity, neurotoxicity, carcinogenicity, undefined biological effects, and inadequate data.

“This restriction, though, works better in theory than in practice,” Dr. Epstein emphasizes. “There is no pre-approval process for ingredient safety other than that claimed by the Research Institute for Fragrance Materials.”

Literature: Cancer Prevention Coalition, Reckless Self-Interest Of The Fragrance Industry, CHICAGO, IL, June 28, 2010

Related Articles:

• Secret Chemicals revealed in Celebrity Perfumes, Teen Body Sprays
• Household detergents, Shampoos may harmful substance in wastewater
• Phthalate Concentrations and Use of Personal Care Products among Pregnant Women
• Open Letter: Perfumed Stamps constrain People with Disabilities

Chronic Fatigue Syndrome a medically determinable impairment

One of the battles often fought by persons with CFS trying to obtain Social Security Disability Insurance and SSI benefits was resolved with the adoption of Social Security Ruling 99-2p. In this binding Ruling the Social Security Administration set out guidelines for adjudicators and judges to follow for claims based upon Chronic Fatigue Syndrome. This Ruling removes at least one of the barriers faced by Claimants.

What Was the Issue?

The Social Security Act allows for SSDI or SSI benefits to be paid to persons unable to work by reason of any medically determinable physical or mental impairment (or combination of impairments)….” (emphasis added) The Act and Regulations define the phrase “medically determinable” as a condition that can be established by medical evidence consisting of signs, symptoms and laboratory findings. It cannot be based only on the Claimant’s description of symptoms.

In claims based upon CFS there are obviously a lack of medical signs, symptoms and laboratory findings. Therefore many claims were denied on the failure to prove the existence of a “medically determinable impairment.”

What Does the Ruling Say?

The Ruling states unequivocally that CFS can be a medically determinable impairment. It specifies medical signs and laboratory findings that will now constitute proof of a medically determinable impairment for persons suffering from CFS. However, whether the Claimant is actually “totally disabled” is a separate determination based upon the severity of functional limitations caused by the disease. That is the same as in any claim based upon any other medical problem.

This Ruling requires that any of the following medical signs, which are clinically documented over a period of at least 6 consecutive months, can establish a medically determinable impairment:

• palpably swollen or tender lymph nodes on physical examination;
• nonexudative pharyngitis;
• persistent, reproducible muscle tenderness on repeated examinations, including the presence of positive tender points; or,
• other medical signs consistent with medically accepted clinical practice which are consistent with the other evidence in the case record.

The following laboratory findings can establish a medically determinable impairment for individuals with CFS:

• an elevated antibody titer to Epstein-Barr virus capsid antigen equal to or greater than 1:5120, or early antigen equal to or great than 1:640;
• an abnormal MRI brain scan;
• neurally mediated hypotension as shown by tilt table testing or another clinically accepted form of testing; or,
• other laboratory findings consistent with medically accepted clinical practice such as abnormal sleep studies and abnormal exercise stress tests that are consistent with other evidence in the case record.

Finally, mental impairments documented by mental status examinations or psychological testing can also establish the presence of a medically determinable impairment.

What Evidence Can Be Used to Show these Signs and Findings?

As in any claim for disability benefits the focus is upon the medical evidence, especially the clinical records and test results from treating sources. SSA will try to obtain all medical records, generally beginning 12-months prior to the month of application. The Ruling notes that conflicts in the medical evidence are not unusual in cases involving CFS and clarification should be sought first from the treating sources. Treating source opinions about the severity of the impairment should be given deference if they are well supported by medically acceptable clinical and laboratory techniques and are not inconsistent with other evidence in the records. It is noted that any information regarding functional abilities before and after the onset of the impairment is helpful in evaluating the claim. Finally third-party sources may be useful in determining the credibility of the Claimant.

As in any claim, the focus is upon a longitudinal view of all of the medical evidence. Claimants must be actively treating with medical providers and must be completely describing all symptoms each time they see the doctor. The doctors must keep careful, legible, notes during each visit so that the signs and findings noted above can be documented. In addition, the physician should be willing to provide a written opinion to SSA regarding the patient’s ability to sustain even sedentary work activity on an 8 hour per day, 5 days per week basis.

SSR 99-2p does not provide that every claim based upon CFS should be approved. It does, however, set forth guidelines for evaluation of these claims so that Claimants, physicians and representatives can be assured of a fair evaluation of the impairment and its impact on the individual.

Literature: Jeffrey A. Rabin & Assoc, CFS Finally Recognized As ‘Medical Impairment’ Under Guidelines, 24-7, June 26, 2010

Article provided by Jeffrey A. Rabin & Assoc, Visit at www.rabinsslaw.com

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Related Articles:

• CFS – Chronic Fatique Syndrome: FDA and NIH confirm ‘XMRV findings’
• MCS – Multiple Chemical Sensitivity recognized as physical disease at ICD-10 in Japan
• The Department of Health of the Austrian Government recognizes MCS – Multiple Chemical Sensitivity as a physical disease
• MCS recognized as physical disease in Germany

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

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.

Dioxins and similar compounds, such as dioxin-like polychlorinated biphenyls (PCBs), include a range of toxic substances which are formed by burning – e.g. through waste incineration or forest fires – and some industrial processes. Their presence in the environment has declined since the 1970s, following concerted efforts at the EU level.

Dioxins are found at low levels in many foods. They do not cause immediate health problems, but long-term exposure to high levels of dioxins has been shown to cause a range of effects, including cancer. Their persistence and the fact that they accumulate in the food chain, notably in animal fat, therefore continues to cause some safety concerns.

The highest average levels of dioxins and dioxin-like PCBs in relation to fat content were observed for liver and liver products from animals. The highest average levels in relation to total product weight were for fish liver and products derived from fish liver. In animal feed, the highest average levels were found in fish oil.

Overall, 8% of the samples exceeded the different maximum levels set out in EU legislation. However, some of these samples clearly originated from targeted sampling during specific contamination episodes. There were also large variations between different groups of food and feed in terms of the proportion of samples which exceed maximum levels.

The report concludes that no clear trend can be established regarding changes in background levels of dioxins and related substances in food and feed over time, as there were increases in some categories but decreases in others. Furthermore, occasional contamination episodes and a lack of information on which samples resulted from targeted or random sampling make it difficult to assess such trends.

The current EU method for measuring overall dioxin levels is based on toxicity values for different types of dioxins recommended by the World Health Organisation (WHO) in 1998. EFSA was also asked to assess the impact on total dioxin levels of using toxicity values set out in WHO recommendations from 2005, which downgraded the relative toxicity of certain types of dioxins. The report finds that using the new values would reduce overall dioxin levels by 14%, although the extent of this reduction was very different across food and feed categories.

Finally, the report recommends continuous random testing of a sufficient number of samples in each food and feed group to ensure accurate assessments of the presence of dioxins and dioxin-like PCBs.

Author; EFSA, EFSA publishes European overview of dioxin levels in food and feed, March 31, 2010

• Full Report
• Results of the monitoring of dioxin levels in food and feed
• European Commission – Food Contaminants – Dioxins and PCBs

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.

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.

Just like Germany, Austria is now classifying Chemical Sensitivity / MCS – Multiple Chemical Sensitivity as a physical disease under the code T78.4 of the ICD-10 (the register of diseases). The news comes from a recent letter by the Department of Health of the Austrian Government.

MCS in the ICD-10 in Germany

In a letter dated September 4, 2008 the DIMDI, the Cooperation Partner for Germany of the WHO, wrote that MCS – Multiple Chemical Sensitivity was classified in the register ICD-10 GM which is valid in Germany:

MCS – Multiple Chemical Sensitivity

T78.4…Allergy, not otherwise specified;

Chapter 19 (Injuries, Intoxication and certain other outcomes), Article T66-T78 (Other and unspecified injuries caused by external causes).

MCS in Austria recognized as physical disease

With a letter dated June 24, 2009 regarding “Chemical Sensitivity / MCS – Multiple Chemical Sensitivity (T78.4)”, the Department of Health of the Austrian Government declares that:

In response to your letter dated 4/14/2009 to the Minister of Health Mr. Stoerger, we inform you that the WHO ICD-10 Code modified for Germany from DIMDI is used in Austria as well.

Also in Austria MCS is not a psychological disease

It should be emphasized that the German Institute for Medical Documentation and Information (DIMDI) declared explicitly that there is not any allocation of MCS in Chapter 5 (Mental and behavioural disorders) of the ICD-10-GM. Thus, the debate about MCS as mental illness is at an end.

In Germany doctors who document the diagnosis and the hospital administrations work under the Social Security Code V, which states that the diagnoses have to be made according to the systematic list of ICD-10-GM. Thus, the ICD-10 classification is legally binding.

The Department of Health of the Austrian Government refers in the letter that MCS – Multiple Chemical Sensitivity is recognized in Austria as a physical disease, because also there it will have the code T78.4 in the ICD-10.

Author: Silvia K. Müller, CSN – Chemical Sensitivity Network, 26. June 2009

References:

Bundesministerium für Gesundheit, Chemikalien-Sensitivität / MCS – Multiple Chemical Sensitivity (ICD-10 T78.4), 24.06.2009, Wien, Österreich.

DIMDI Letter to CSN, MCS ICD-10, 04.09.2008

DIMDI Letter, 04.09.2008

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