Bisphenol A becomes officially recognised as an endocrine disruptor

Bisphenol A is recognised by ECHA for its endocrine-disrupting properties, based on a proposal by France

Member State Committee unanimously agrees that Bisphenol A is an endocrine disruptor

ECHA/PR/17/12 – The Member State Committee (MSC) supported the French proposal to additionally identify Bisphenol A as a substance of very high concern because of its endocrine disrupting properties which cause probable serious effects to human health. The committee also agreed to identify the substance PFHxS as an SVHC.

Helsinki, 16 June 2017 – The Member State Committee (MSC) unanimously agreed on the identification as substances of very high concern (SVHCs) of:

  • 4,4′-isopropylidenediphenol (bisphenol A, BPA) (EC 201-245-8, CAS 80-05-7), proposed by France, due to its endocrine disrupting properties for human health;
  • Perfluorohexane-1-sulphonic acid and its salts (PFHxS), proposed by Sweden, due to their very persistent and very bioaccumulative (vPvB) properties.

Bisphenol A is already listed in the Candidate List due to its toxic for reproduction properties. At the MSC meeting earlier this week, MSC unanimously agreed on its additional identification as an SVHC because of its endocrine disrupting properties which cause probable serious effects to human health which give rise to an equivalent level of concern to carcinogenic, mutagenic, toxic to reproduction (CMRs category 1A or 1B) substances.

ECHA will include PFHxS in the Candidate List and will update the current entry for BPA accordingly by the end of June 2017. Companies may have legal obligations with respect to these substances upon publication of the updated Candidate List.

Bisphenol A is recognised by ECHA for its endocrine-disrupting properties, based on a proposal by France

In February 2017, ANSES submitted a proposal to the European Chemicals Agency (ECHA) to classify bisphenol A (BPA) as a substance of very high concern (SVHC) within the framework of the European REACh regulation, based on its “endocrine-disrupting” properties which cause probable serious effects to human health. This proposal has just been adopted by ECHA’s Member State Committee. The decision means that industry players must notify ECHA of the presence of bisphenol A in all imported or manufactured items and must also inform buyers when items contain the substance. The inclusion of BPA on ECHA’s list of substances of very high concern also means that it may be submitted to authorisation as a substance, with its uses subject to the granting of a temporary, renewable authorisation.

Bisphenol A is a synthetic chemical which has been used for over 50 years, mainly in the plastics industry. ANSES has identified close to sixty business sectors that are potential users of the substance in France. Studies by ANSES on the uses and health effects of bisphenol A, conducted as part of the National Endocrine Disruptor Strategy, led the Agency to recommend, as of September 2011, a reduction in population exposure to the substance through its substitution in food contact materials in particular. Therefore since 1 January 2015 bisphenol A has been banned in food containers in France, and has led to a significant reduction in exposure levels.

Furthermore, in 2012, in the framework of implementation of the European regulation on the labelling of chemical substances (CLP regulation), ANSES submitted a proposal to ECHA for amending the classification of bisphenol A in order to include it in category 1B – substances toxic to reproduction (fertility). This proposal was adopted by the European Commission in July 2016.

Following this, a measure restricting BPA use in certain widely available items such as receipts made of thermal paper, was also adopted by the European Commission in December 2016, based on a dossier filed by ANSES with ECHA as part of the REACh regulation.

Identification of bisphenol A as a substance of very high concern

The REACh regulation specifies that substances that may have serious and often irreversible effects on human health and the environment can be identified as substances of very high concern (SVHC). In February 2017, ANSES submitted a proposal to ECHA for identifying BPA as an SVHC based on its “endocrine disrupting” properties which cause probable serious effects to human health.

This proposal has just been adopted by the Member State Committee of ECHA. As a direct result of BPA’s identification as an SVHC, industry players will now have to notify ECHA of the presence of bisphenol A in all imported or manufactured items and must also inform buyers, upon request, when items contain the substance.

BPA’s inclusion on the list of substances of very high concern means that its uses may be limited and subject to the granting of a temporary, renewable authorisation.

Sources
  • MSC unanimously agrees that Bisphenol A is an endocrine disruptor, ECHA, 16 June 2017.
  • Bisphenol A is recognised by ECHA for its endocrine-disrupting properties, based on a proposal by France, ANSES, 16/06/2017.
  • Image credit Percy.

60 MiNueTs : Toxic Research

UCSF Program on Reproductive Health and the Environment, 2017

The University of California San Francisco (UCSF) Program on Reproductive Health and the Environment (PRHE)’s mission is to create a healthier environment for human reproduction and development through advancing scientific inquiry, clinical care and health policies that prevent exposures to harmful chemicals in our environment.

PRHE is housed within the Department of Obstetrics, Gynecology and Reproductive Sciences, in the UCSF School of Medicine, one of the nation’s most prestigious medical schools. The Department is renowned for promoting cutting-edge reproductive science research, extending the frontiers of multidisciplinary women’s health care and professional education, advocating for women’s health at local, state and national levels, and engaging community involvement.

More Information

60 MiNueTs : Toxic Chemicals

UCSF Program on Reproductive Health and the Environment, 2017

The University of California San Francisco (UCSF) Program on Reproductive Health and the Environment (PRHE)’s mission is to create a healthier environment for human reproduction and development through advancing scientific inquiry, clinical care and health policies that prevent exposures to harmful chemicals in our environment.

PRHE is housed within the Department of Obstetrics, Gynecology and Reproductive Sciences, in the UCSF School of Medicine, one of the nation’s most prestigious medical schools. The Department is renowned for promoting cutting-edge reproductive science research, extending the frontiers of multidisciplinary women’s health care and professional education, advocating for women’s health at local, state and national levels, and engaging community involvement.

More Information

60 MiNueTs : Toxic Bodies

UCSF Program on Reproductive Health and the Environment, 2017

The University of California San Francisco (UCSF) Program on Reproductive Health and the Environment (PRHE)’s mission is to create a healthier environment for human reproduction and development through advancing scientific inquiry, clinical care and health policies that prevent exposures to harmful chemicals in our environment.

PRHE is housed within the Department of Obstetrics, Gynecology and Reproductive Sciences, in the UCSF School of Medicine, one of the nation’s most prestigious medical schools. The Department is renowned for promoting cutting-edge reproductive science research, extending the frontiers of multidisciplinary women’s health care and professional education, advocating for women’s health at local, state and national levels, and engaging community involvement.

More Information

A Mitochondrial Etiology of Neuropsychiatric Disorders

This Viewpoint explores the hypothesis that mitochondrial dysfunction is associated with neuropsychiatric disorders

Abstract

Enormous resources have been invested in the analysis of neuropsychiatric disorders using powerful genomics techniques, including genome-wide association studies (GWAS), whole-exome sequencing (WES), and whole-genome sequencing, to search for nuclear DNA (nDNA) gene variants associated with these disorders.

Yet, no coherent pathophysiological etiology for psychiatric disorders has emerged. For example, after analysis of thousands of autism cases by GWAS and WES, numerous copy number variants and loss-of-function mutations have been identified, but no single variant accounts for a significant proportion of cases.

Moreover, the genes that have been found to harbor loss-of-function mutations in patients with autism overlap with those associated with congenital heart disease and metabolic disorders.

What do “brain” diseases have to do with congenital heart disease and metabolic disorders?

Environmental Endocrine Disruption Crisis of Epidemic Proportions

AutismOne Conference 2017

Presented by Leslie Carol Botha, WHE,
uploaded on SlideShare. Watch it full screen.

Endocrine Disruptors

Postdischarge Opioid Use After Cesarean Delivery

Too Many Opioids After Cesarean Delivery

Doctors may be overprescribing opioids to women who have had cesarean sections, a new study found, and it’s not so simple as ‘just use less’, the lead author said:

”About a quarter of the women used all their pills and still reported they had pain”

2017 Study Abstract

OBJECTIVE
To characterize postdischarge opioid use and examine factors associated with variation in opioid prescribing and consumption.

METHODS
We conducted a prospective observational cohort study by recruiting all women undergoing cesarean delivery during an 8-week period, excluding those with major postoperative morbidities or chronic opioid use. Starting on postoperative day 14, women were queried weekly regarding number of opioid pills used, amount remaining, and their pain experience until they had stopped opioid medication. Demographic and delivery information and in-hospital opioid use were recorded. The state Substance Monitoring Program was accessed to ascertain prescription-filling details. Morphine milligram equivalents were calculated to perform opioid use comparisons. Women in the highest quartile of opioid use (top opioid quartile use) were compared with those in the lowest three quartiles (average opioid use).

RESULTS
Of 251 eligible patients, 246 (98%) agreed to participate. Complete follow-up data were available for 179 (71% of eligible). Most women (83%) used opioids after discharge for a median of 8 days (interquartile range 6-13 days). Of women who filled their prescriptions (165 [92%]), 75% had unused tablets (median per person 75 morphine milligram equivalents, interquartile range 0-187, maximum 630) and the majority (63%) stored tablets in an unlocked location. This amounts to an equivalent of 2,540 unused 5-mg oxycodone tablets over our study period. Women who used all prescribed opioids (n=40 [22%]) were more likely to report that they received too few tablets than women who used some (n=109 [61%]) or none (n=30 [17%]) of the prescribed opioids (33% compared with 4% compared with 5%, P<.001). The top quartile was more likely to be smokers than average users and consumed more opioid morphine milligram equivalents per hour of inpatient stay than average opioid users (1.6, interquartile range 1.1-2.3 compared with 1.0, interquartile range 0.5-1.4, P<.001).

CONCLUSION
Most women-especially those with normal in-hospital opioid use-are prescribed opioids in excess of the amount needed.

More Information
  • Postdischarge Opioid Use After Cesarean Delivery, The American College of Obstetricians and Gynecologists, doi: 10.1097/AOG.0000000000002095, June 06, 2017.
  • Too Many Opioids After Cesarean Delivery, nytimes, JUNE 14, 2017.

Sex and gender : you should know the difference

1. The dictionary
2. The intersection of sex and gender: lessons learned and improving LGBT health care
3. A call to action

Embryos do not have a “gender”; rather, they have a “sex.” Gender refers to social and cultural distinctions between sexes, not biological ones. An embryo’s “maleness” or “femaleness” should therefore be defined by its biological sex (i.e., sex chromosome pair).

We recognize that “sex” and “gender” are often synonyms in regular speech. But, as reproductive medicine specialists who might tout services in “gender selection/determination” or even care for patients who are transgender, it is imperative that we dictate the use of the proper terminology, not just among ourselves, but also during dialogue with patients, policymakers, and other stakeholders. Failing to do so may have unintended consequences that we will attempt to point out.

1. The dictionary, World Health Organisation (WHO), American Congress of Obstetricians and Gynecologists (ACOG), Food and Drug Administration, American Society of Reproductive Medicine (ASRM), and personhood

The rise of “gender,” and its interchangeability with “sex” is well documented both in academia and in the public arena, as is its criticism. Ultimately, while various academic specialties define the terms differently, it is important for us to reflect on current definitions to guide our call to action.

  • The Oxford English Dictionary defines “sex” as “either of the two main categories (male and female) into which humans and many other living things are divided on the basis of their reproductive functions.
  • The WHO defines “sex” as the “biological and physiological characteristics that define men and women.” The WHO further defines “gender” as the “socially constructed roles, behaviors, activities and attributes that a given society considers appropriate for men and women.”
  • In the 2011 Committee Opinion on “Healthcare for Transgender Individuals,” the ACOG defines “sex” as the “designation of a person at birth as male or female based on anatomy and biology”.
  • Prior to 2011, the FDA used the term “gender” to refer to the physiological differences between male and female but changed position, distinguishing “sex” as a biological classification and “gender” as a “person’s self-representation as male or female, or how that person is responded to by social institutions”.
  • The ASRM Ethics Committee uses the term “sex” when discussing selection/determination of embryos. This 2015 document replaced two documents titled “Sex selection and PGD [sic]” and “Preconception gender selection for nonmedical reasons” from 2008 and 2004, respectively. Currently (at the time of this writing), on the ASRM website, the terminology remains “Gender/Sex Selection,” implying that the two terms are synonyms and highlighting the evolution of the Ethics Committee’s sensitivity to distinguishing between these two terms.

A recent PubMed query identified 51 scientific publications with the term “gender selection” in the title. This term is inaccurate because we are unable to determine the gender of an embryo, or a neonate for that matter, only its chromosomal sex. For those clinics, physicians, and/or laboratories offering couples the option of choosing embryos based on sex chromosomes, the term “sex selection” or “sex determination” should be used instead.

While one could take this academic convention further, we will concede our efforts beyond the embryo stage and stop short of calling for “gender reveal” celebrations to be renamed “sex reveal” celebrations. We understand that parents may have ingrained convictions about the future gender identity of a fetus.

Furthermore, ASRM should consider, perhaps within its Ethics Committee document on sex selection, formally adopting definitions of sex and gender that are in step with its peer organizations. Doing so may be important in further policy refinements and testimony preparation when ASRM or individual members testify regarding personhood measures. Admittedly, using the terms interchangeably is a nuance that might escape most policymakers, but consistently referring to an embryo’s sex is more aligned with ASRM’s stance on personhood measures.

2. The intersection of sex and gender: lessons learned and improving LGBT health care

It is important to take a moment to highlight the origin of the medical community’s wariness of exerting a paternalistic force in “gender determination.” Beginning in the 1950s and continuing for many decades, physicians promoted the assignment of “gender” at birth for intersex infants or those with ambiguous genitalia. This often involved “genital corrective surgeries” to attempt to match the anatomy to the assigned gender. Examples include clitorectomies in virilized XX infants with congenital adrenal hyperplasia and removal of a micropenis in XY infants with creation of a neovagina. Many children with a Y chromosome were assigned a female gender, given that it was easier to create a vagina than a functional penis. Initial protests to this approach came from intersex advocacy groups, citing a lack of long-term data and significantly high levels of psychological stress in those subjected to nonconsensual surgery.

In the late 1990s, the issue entered the mainstream media with the case of David Reimer, an XY infant who underwent gender reassignment surgery at 22 months old after a circumcision procedure resulted in inadvertent penile amputation. He was raised from that point on as female but struggled with gender dysphoria and transitioned to living as a male at the age of 15. He suffered from depression and committed suicide at the age of 38.

The interplay between sex and gender is complex and involves genetic, hormonal, and sociocultural factors. The principles of patient autonomy and nonmaleficence dictate that we, as physicians, should not assign gender. Based on this philosophy, and given our ability with embryo biopsy and aneuploidy screening, we believe that one can “select” and/or “determine” only the sex of an embryo. The gender cannot be determined until later.

Finally, this distinction has consequences as it relates to our care of LGBT patients and our position as proponents and providers of assisted reproductive technologies. We are often involved in the care of transgender and gender-nonconforming patients. This may include hormonal management during transition or assistance in fertility preservation or family building. We should welcome these patients, and understanding a distinction between biologically defined “sex” and one’s self represented “gender” is the first step in improving their health care experience.

3. A call to action

In summary, we call on our peers and stakeholders to use, and advocate for, the use of “sex” instead of “gender” when discussing the chromosomal makeup of an embryo in academic, public policy, and lay-media settings. We also recommend adopting definitions similar to our complimentary medical societies and mainstream health care agencies and attempting to have our literature to conform to the above.

Our field has long pushed beyond the social stigmas of infertility, miscarriage, menopause, and sexual dysfunction to provide compassionate care for our patients. This issue provides an opportunity for us to continue in that tradition.

Sources and DES Studies

La santé : du public à l’intime

Le 1er chapitre est dédié au Distilbène

Dans la période contemporaine, plus que jamais, les expériences de la santé, de la maladie, de la vieillesse et du handicap se constituent à l’intersection des sphères privée et publique. D’un côté la santé publique “dé-privatise” les actes et les préoccupations de santé, de l’autre, les pratiques individuelles façonnent certains dispositifs institutionnels et/ou législatifs et en même temps se “dé-singularisent“. Les individus doivent à la fois se réapproprier le message institutionnel et être en capacité de donner à une expérience intime un caractère public.

Le 1er chapitre – Des malades rendus visibles par le droit ? L’expérience judiciaire individuelle et collective des victimes du Distilbène – est dédié au Distilbène.

Si la sociologie de la santé s’est amplement développée depuis les années 1970, l’interface public-privé et la porosité de ses frontières a été peu interrogée. Les analyses de cet ouvrage apportent un nouveau regard sur ce qui circule entre les sphères privée et publique afin de rendre intelligibles les mécanismes sociaux qui sous-tendent cette interface.

– Comment s’opère le mouvement de dé-privatisation de la santé, selon quels ressorts, enjeux, limites ?
– Comment le privé s’immisce-t-il, façonne-t-il, imprègne-t-il la sphère publique de la santé ?
En partant des situations empiriques les plus représentatives, cet ouvrage invite sociologues, étudiants, professionnels de santé, usagers et citoyens à porter leur attention sur l’articulation public/privé dans le champ de la santé.

Sources

Le Distilbène DES, en savoir plus

L’expérience judiciaire individuelle et collective des victimes du Distilbène

Des malades rendus visibles par le droit ?
La santé : du public à l’intime – chapitre 1

Résumé

Lors de la plupart des catastrophes sanitaires en France, la transformation de problèmes de santé privés en affaires de santé publique a été laissée à l’initiative des victimes et de leur engagement judiciaire, notamment dans le cas du sang contaminé et de l’amiante.

Le Distilbène ne fait pas exception : l’histoire française de ce médicament est celle d’oublis et de négligences répétés de la part des pouvoirs publics et de la profession médicale. Il a souvent fallu les témoignages de victimes dans les médias et les premières décisions de justice dans les années 2000 pour que les personnes concernées se saisissent, non plus comme des malades isolés, mais comme un groupe exposé, pouvant légitimement demander raison de son malheur.

Pour autant, les tribunaux peuvent-ils être le lieu d’une action collective, spécialement en matière de santé publique ? Pour répondre à cette question, nous avons développé trois stratégies d’enquête :

  1. le recueil des trajectoires individuelles des victimes,
  2. l’explicitation des politiques judiciaires associatives,
  3. l’analyse de la jurisprudence.

Dans cet article,

  • nous décrivons d’abord le dossier du Distilbène dans le contexte français des catastrophes sanitaires sérielles, qui ont profondément bouleversé les modalités politiques, administratives et scientifiques de traitement de la santé publique, et qui ont aussi donné lieu à des développements judiciaires à multiples rebondissements.
  • Nous analysons ensuite le passage par l’action judiciaire comme une voie possible d’élaboration d’une cause collective, en dépit de procédures individualisées.
  • Enfin, nous observons les objectifs assignés par les victimes et leurs associations aux décisions de justice, et les évaluations contrastées quant à la pertinence de leur publicisation.

Sources

  • La santé : du public à l’intime, ouvrage collectif, est paru aux Presses de l’EHESP.
    Le 1er chapitre, rédigé par Emmanuelle Fillion et Didier Torny, est dédié au Distilbène.
  • Des malades rendus visibles par le droit ? L’expérience judiciaire individuelle et collective des victimes du Distilbène, halshs.archives-ouvertes, 2015-01.
Le Distilbène DES, en savoir plus