BPA among new substances of very high concern

EU names bisphenol-A among new SVHCs

Helsinki, 12 January 2017 – The European Chemicals Agency (ECHA) has added four new SVHCs to the Candidate List – now containing 173 substances, including BPA – based on proposals by France, Sweden, Germany and Austria, following the SVHC identification process with involvement of the Member State Committee.

The European Chemicals Agency is the driving force among regulatory authorities in implementing the EU’s groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness. ECHA helps companies to comply with the legislation, advances the safe use of chemicals, provides information on chemicals and addresses chemicals of concern.

The Candidate List is a list of substances that may have serious effects on human health or the environment. Substances on the Candidate List are also known as “substances of very high concern“. The aim of publishing such a list is to inform the general public and industry that these substances are candidates for possible inclusion in the Authorisation List. Once they are on the Authorisation List, industry will need to apply for permission to continue using the substance after the sunset date.

Regarding bisphenol A (BPA) , the reason for inclusion was : “Toxic for reproduction“(Article 57c).

Companies may have legal obligations resulting from the inclusion of the substance in the Candidate List. These obligations may apply to the listed substance on its own, in mixtures or in articles. In particular, any supplier of articles containing a Candidate List substance above a concentration of 0.1% (weight by weight) has communication obligations towards customers down the supply chain and consumers. In addition, importers and producers of articles containing the substance have six months from the date of its inclusion in the Candidate List (12 January 2017) to notify ECHA. Information on these obligations and related tools are available on the ECHA website.

Brexit and The Future of Chemicals Regulation

Will Brexit risk our health and our environment?

The Environmental Audit Committee is launching a second inquiry into the future of environmental law and policy following the result of the EU Referendum. It will focus on the future of the European Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Please send written submissions using this form.

The EU has adopted several pieces of legislation on chemicals, which are primarily ‘trade regulations’ harmonising the conditions under which chemicals can be placed on the market. The aim of REACH is to protect human health and the environment. REACH shifts the responsibility from public authorities to industry with regards to assessing and managing the risks posed by chemicals and providing appropriate safety information for their users. REACH is constantly evolving, having been amended 38 times since it was enacted in 2006. REACH is enforced by the European Chemicals Agency (ECHA) and relatively little of its regulation has been transposed into UK law.

The Future of Chemicals Regulation after the EU Referendum, parliament uk, 21 December 2016.

Will Brexit risk our health? UK MPs start inquiry into chemicals regulation after the EU referendum, chem trust, JANUARY 11, 2017.

Image credit Javier Díaz Barrera.

It has been estimated that the chemicals industry is the UK’s largest manufacturing exporter. The industry produces products which are fundamental to many other sectors of the economy – from energy to clothing, motor manufacturing to agriculture, food standards to children’s toys.

The Prime Minister has said that leaving the EU will involve converting the body of EU law into British law (via a “Great Repeal Bill”). However, the Government has said that up to a third of EU environmental law cannot be simply ‘copy pasted’ into UK law and will require additional work to ensure that the UK maintains the current level of environmental protection. REACH was cited in the evidence to our Future of the Natural Environment inquiry as one of these challenging areas.

This inquiry will examine the future of chemicals regulation in the UK after the Referendum result, with a particular focus on the possible impacts on environmental protection, public safety and the UK chemicals industry.

The Committee invites submissions on some or all of the questions below:

Transposition

  • What particular challenges will the UK Government face when it seeks to transpose REACH into UK law through the “Great Repeal Bill”?
  • How far will the UK’s ability to effectively transpose REACH depend on negotiations with other Member States and the nature of the UK’s future relationship with the EU (e.g. Single Market membership)?
  • What role should the devolved administrations play in setting the regulatory environment in this area? How should any divergences in policy be managed?

Administrative, Policy and Regulatory Implications

  • How should administrative and enforcement responsibilities, which are currently being carried out by the European Commission or EU Agencies (such as ECHA), be transferred to domestic bodies?
  • What are the likely implications for industry in terms of regulation, environmental and safety standards?
  • Does the UK Government have the requisite expertise and resources to take on these tasks?

Future of Chemical Industry

  • What scope is there for the UK to pursue a divergent approach to chemicals regulation from the EU once the process of leaving has been completed?
  • What principles should a UK chemicals regulation regime follow?
  • What are the likely practical implications of having a UK-only chemicals regulatory policy for:
    1. The Environment?
    2. Public Safety?
    3. UK Industry
  • What key features should any new regime have to ensure these are not compromised?

CHEM Trust will be submitting its views on this important issue, emphasising :

  • the importance for public health & the environment of having effective regulation of chemicals;
  • the role of REACH as a world-leading regulation system, even though it is not perfect;
  • potential risks from the UK becoming detached from REACH, and the challenges of creating a new regulatory system.

Can glyphosate residues in food cause fatty liver disease, obesity, diabetes and ‘metabolic syndrome’ ?

Multiomics reveal non-alcoholic fatty liver disease in rats following chronic exposure to an ultra-low dose of Roundup herbicide

2017 Study Abstract

The impairment of liver function by low environmentally relevant doses of glyphosate-based herbicides (GBH) is still a debatable and unresolved matter.

Previously we have shown that rats administered for 2 years with 0.1 ppb (50 ng/L glyphosate equivalent dilution; 4 ng/kg body weight/day daily intake) of a Roundup GBH formulation showed signs of enhanced liver injury as indicated by anatomorphological, blood/urine biochemical changes and transcriptome profiling.

Roundup residues in food cause fatty liver disease, the ecologist, 9th January 2017.

Image credit chafermachinery.

Here we present a multiomic study combining metabolome and proteome liver analyses to obtain further insight into the Roundup-induced pathology. Proteins significantly disturbed (214 out of 1906 detected, q < 0.05) were involved in organonitrogen metabolism and fatty acid β-oxidation. Proteome disturbances reflected peroxisomal proliferation, steatosis and necrosis. The metabolome analysis (55 metabolites altered out of 673 detected, p < 0.05) confirmed lipotoxic conditions and oxidative stress by showing an activation of glutathione and ascorbate free radical scavenger systems. Additionally, we found metabolite alterations associated with hallmarks of hepatotoxicity such as γ-glutamyl dipeptides, acylcarnitines, and proline derivatives.

Overall, metabolome and proteome disturbances showed a substantial overlap with biomarkers of non-alcoholic fatty liver disease and its progression to steatohepatosis and thus confirm liver functional dysfunction resulting from chronic ultra-low dose GBH exposure.

Could prenatal test results decide for treatments to help reduce the effects of a genetic disorder?

Universal Haplotype-Based Noninvasive Prenatal Testing for Single Gene Diseases

Together, single-gene disorders are more common than Down’s syndrome. A fast test for genetic disorders means parents could learn about the future health of their baby as early as six weeks into pregnancy.

November 2016 Study Abstract

Background
Researchers have developed approaches for the noninvasive prenatal testing of single gene diseases. One approach that allows for the noninvasive assessment of both maternally and paternally inherited mutations involves the analysis of single nucleotide polymorphisms (SNPs) in maternal plasma DNA with reference to parental haplotype information. In the past, parental haplotypes were resolved by complex experimental methods or inferential approaches, such as through the analysis of DNA from other affected family members. Recently, microfluidics-based linked-read sequencing technology has become available and allows the direct haplotype phasing of the whole genome rapidly. We explored the feasibility of applying this direct haplotyping technology in noninvasive prenatal testing.

Simple blood test can detect genetic diseases early in pregnancy, New Scientist, Magazine issue 3107, 7 January 2017.

Universal Haplotype-Based Noninvasive Prenatal Testing for Single Gene Diseases, American Association for Clinical Chemistry, DOI: 10.1373/clinchem.2016.268375, December 2016.

Icarus (Henri Matisse,1947) credit doomsteaddiner.

Methods
We first resolved the haplotypes of parental genomes with the use of linked-read sequencing technology. Then, we identified SNPs within and flanking the genes of interest in maternal plasma DNA by targeted sequencing. Finally, we applied relative haplotype dosage analysis to deduce the mutation inheritance status of the fetus.

Results
Haplotype phasing and relative haplotype dosage analysis of 12 out of 13 families were successfully achieved. The mutational status of these 12 fetuses was correctly classified.

Conclusions
High-throughput linked-read sequencing followed by maternal plasma-based relative haplotype dosage analysis represents a streamlined approach for noninvasive prenatal testing of inherited single gene diseases. The approach bypasses the need for mutation-specific assays and is not dependent on the availability of DNA from other affected family members. Thus, the approach is universally applicable to pregnancies at risk for the inheritance of a single gene disease.

Indépendance des facultés de médecine à l’égard de l’industrie pharmaceutique

Classement Formindep des facultés de médecine indépendantes des labos pharma

Interview de Paul Scheffer diffusée sur France Info le 10 janvier 2017 suite à la publication d’une étude sur la question de l’indépendance des facultés de médecine française à l’égard de l’industrie.

Sur le même sujet

Breast cancer screening not associated with a reduction in the incidence of advanced cancer

Mammograms tied to overdiagnosis of breast cancer

The current study offers fresh evidence linking routine screening to over-diagnosis of non-aggressive tumors because it compares outcomes over a single time period in two regions of Denmark – one that offered biennial mammography for women aged 50 to 69 and one that didn’t.

January 2017 Study Abstract

Background
Effective breast cancer screening should detect early-stage cancer and prevent advanced disease.

Objective
To assess the association between screening and the size of detected tumors and to estimate overdiagnosis (detection of tumors that would not become clinically relevant).

Design
Cohort study.

Breast Cancer Screening in Denmark: A Cohort Study of Tumor Size and Overdiagnosis, Annals of Internal Medicine, DOI: 10.7326/M16-0270, 10 JANUARY 2017.

Philips Mammography Truck, Brazil via philips_newscenter.

Setting
Denmark from 1980 to 2010.

Participants
Women aged 35 to 84 years.

Intervention
Screening programs offering biennial mammography for women aged 50 to 69 years beginning in different regions at different times.

Measurements
Trends in the incidence of advanced (>20 mm) and nonadvanced (≤20 mm) breast cancer tumors in screened and nonscreened women were measured. Two approaches were used to estimate the amount of overdiagnosis: comparing the incidence of advance and nonadvanced tumors among women aged 50 to 84 years in screening and nonscreening areas; and comparing the incidence for nonadvanced tumors among women aged 35 to 49, 50 to 69, and 70 to 84 years in screening and nonscreening areas.

Results
Screening was not associated with lower incidence of advanced tumors. The incidence of nonadvanced tumors increased in the screening versus prescreening periods (incidence rate ratio, 1.49 [95% CI, 1.43 to 1.54]). The first estimation approach found that 271 invasive breast cancer tumors and 179 ductal carcinoma in situ (DCIS) lesions were overdiagnosed in 2010 (overdiagnosis rate of 24.4% [including DCIS] and 14.7% [excluding DCIS]). The second approach, which accounted for regional differences in women younger than the screening age, found that 711 invasive tumors and 180 cases of DCIS were overdiagnosed in 2010 (overdiagnosis rate of 48.3% [including DCIS] and 38.6% [excluding DCIS]).

Limitation
Regional differences complicate interpretation.

Conclusion
Breast cancer screening was not associated with a reduction in the incidence of advanced cancer. It is likely that 1 in every 3 invasive tumors and cases of DCIS diagnosed in women offered screening represent overdiagnosis (incidence increase of 48.3%).

Are Medical Faculty Students protected from Pharma Industry Influence during their Training?

Conflict of Interest Policies at French Medical Schools

January 2017 Study Abstract

Background
Medical faculties have a role in ensuring that their students are protected from undue commercial influence during their training, and are educated about professional-industry interactions. In North America, many medical faculties have introduced more stringent conflict of interest (COI) policies during the last decade. We asked whether similar steps had been taken in France. We hypothesized that such policies may have been introduced following a 2009–2010 drug safety scandal (benfluorex, Mediator) in which COIs in medicine received prominent press attention.

Methods
We searched the websites of all 37 French Faculties of Medicine in May 2015 for COI policies and curriculum, using standardized keyword searches. We also surveyed all deans of medicine on institutional COI policies and curriculum, based on criteria developed in similar US and Canadian surveys. Personal contacts were also consulted. We calculated a summary score per faculty based on 13 criteria. [range 0–26; higher scores denoting stronger policies]

Conflict of Interest Policies at French Medical Schools: Starting from the Bottom, PLOS one, dx.doi.org/10.1371/journal.pone.0168258, January 9, 2017.

Medical image credit thomashawk.

Results
In total, we found that 9/37 (24%) of French medical schools had either introduced related curriculum or implemented a COI-related policy. Of these, only 1 (2.5%) had restrictive policies for any category. No official COI policies were found at any of the schools. However, at 2 (5%), informal policies were reported. The maximum score per faculty was 5/26, with 28 (76%) scoring 0.

Conclusion
This is the first survey in France to examine COI policies at medical faculties. We found little evidence that protection of medical students from undue commercial influence is a priority, either through institutional policies or education. This is despite national transparency legislation on industry financing of health professionals and limits on gifts. The French National Medical Students Association (ANEMF) has called for more attention to COI in medical education; our results strongly support such a call.

In conclusion, the AAMC and others organizations have called for a profound cultural change in the medical profession that must begin with medical education. This is all the more important in that students who have the most contacts with industry are also those who tend to have the most positive attitudes to these relations and to believe themselves to be invulnerable to influence. Policies that restrict interactions contributing to conflict of interest have been shown to reduce industry influence on practice. Medical faculties in France have a responsibility to protect and educate their students and to support the best possible care, in the interests of patient and public health.

Semen quality in young men has been clearly declining over the past 15 years

First study to examine a very large population of sperm donors within the same laboratory over a long observation period

January 2017 Study Abstract

Objective
To provide information of semen quality among young Chinese men in the past 15 years.

Design
Retrospective cross-sectional study.

Setting
Sperm bank.

Patient(s)
A total of 30,636 young adult men who applied to be sperm donors at the Hunan Province Human Sperm Bank of China in 2001–2015 were included in the study.

Decline in semen quality among 30,636 young Chinese men from 2001 to 2015, Fertility and Sterility: dx.doi.org/10.1016/j.fertnstert.2016.09.035, January 2017 (Volume 107, Issue 1), Pages 83–88.e2.

The Sperm Bike credit bikecitizens.

Intervention(s)
Physical examination and analysis of blood and semen samples.

Main Outcome Measure(s)
Semen parameters, such as semen volume, sperm concentration, total sperm count, progressively motile sperm count, sperm progressive motility, sperm morphology, and round cells.

Result(s)
Many of the semen parameters showed a decreasing trend over the 15-year observation period. The sperm concentration and percentage of sperm with normal morphology decreased from 68 × 106/mL to 47 × 106/mL and from 31.8% to 10.8%, respectively. Although sperm progressive motility showed irregular variation, the progressively motile sperm count decreased from 34 × 106 to 21 × 106 over the 15-year period. Furthermore, the rate of qualified donors fell from 55.78% in 2001 to 17.80% in 2015, and the rate for 2015 was approximately threefold lower than the corresponding rates in 2001.

Conclusion(s)
This is the first study to investigate the semen quality of a large population within the same laboratory in China over a long observation period. Our data clearly illustrate that the semen quality among young Chinese men has declined over a period of 15 years, especially in terms of sperm concentration, total sperm count, sperm progressive motility, and normal morphology. Moreover, the percentage of qualified donors also showed a decreasing trend during this time period. Although bulk semen parameters (reflected by 95% confidence intervals) overlap substantially throughout the study period, overall, these findings are a serious reproductive health warning, and further studies are warranted to confirm the findings of this study in China and to determine the factors causing this phenomenon.

Initially potable groundwater used by several households contaminated by high-volume hydraulic fracturing

Fracking Chemicals Detected in Pennsylvania Drinking Water

Significance

New techniques of high-volume hydraulic fracturing (HVHF) are now used to unlock oil and gas from rocks with very low permeability. Some members of the public protest against HVHF due to fears that associated compounds could migrate into aquifers.

Fracking Chemicals Detected in Pennsylvania Drinking Water, nytimes, MAY 4, 2015.

Image credit vshioshvili.

We report a case where natural gas and other contaminants migrated laterally through kilometers of rock at shallow to intermediate depths, impacting an aquifer used as a potable water source. The incident was attributed to Marcellus Shale gas development.

The organic contaminants—likely derived from drilling or HVHF fluids—were detected using instrumentation not available in most commercial laboratories. More such incidents must be analyzed and data released publicly so that similar problems can be avoided through use of better management practices.

Abstract

Evaluating a groundwater supply contamination incident attributed to Marcellus Shale gas development, National Academy of Sciences, doi: 10.1073/pnas.1420279112, April 2, 2015.

High-volume hydraulic fracturing (HVHF) has revolutionized the oil and gas industry worldwide but has been accompanied by highly controversial incidents of reported water contamination. For example, groundwater contamination by stray natural gas and spillage of brine and other gas drilling-related fluids is known to occur. However, contamination of shallow potable aquifers by HVHF at depth has never been fully documented.

We investigated a case where Marcellus Shale gas wells in Pennsylvania caused inundation of natural gas and foam in initially potable groundwater used by several households. With comprehensive 2D gas chromatography coupled to time-of-flight mass spectrometry (GCxGC-TOFMS), an unresolved complex mixture of organic compounds was identified in the aquifer. Similar signatures were also observed in flowback from Marcellus Shale gas wells. A compound identified in flowback, 2-n-Butoxyethanol, was also positively identified in one of the foaming drinking water wells at nanogram-per-liter concentrations. The most likely explanation of the incident is that stray natural gas and drilling or HF compounds were driven ∼1–3 km along shallow to intermediate depth fractures to the aquifer used as a potable water source. Part of the problem may have been wastewaters from a pit leak reported at the nearest gas well pad—the only nearby pad where wells were hydraulically fractured before the contamination incident. If samples of drilling, pit, and HVHF fluids had been available, GCxGC-TOFMS might have fingerprinted the contamination source. Such evaluations would contribute significantly to better management practices as the shale gas industry expands worldwide.

Hydraulic Fracturing

Cancer Risk after Fat Transfer: A Multicenter Case-Cohort Study

Fat Transfer After Mastectomy, is it Safe?

2017 Study Abstract

Background
Fat transfer is an increasingly popular method for refining postmastectomy breast reconstructions. However, concern persists that fat transfer may promote disease recurrence. Adipocytes are derived from adipose-derived stem cells and express adipocytokines that can facilitate active breast cancer cells in laboratory models. The authors sought to evaluate the association between fat transfer to the reconstructed breast and cancer recurrence in patients diagnosed with local or regional invasive breast cancers.

Methods
A multicenter, case-cohort study was performed. Eligible patients from four centers (Memorial Sloan Kettering, M. D. Anderson Cancer Center, Alvin J. Siteman Cancer Center, and the University of Chicago) were identified by each site’s institutional tumor registry or cancer data warehouse. Eligibility criteria were as follows: mastectomy with immediate breast reconstruction between 2006 and 2011, age older than 21 years, female sex, and incident diagnosis of invasive ductal carcinoma (stage I, II, or III). Cases consisted of all recurrences during the study period, and controls consisted of a 30 percent random sample of the study population. Cox proportional hazards regression was used to evaluate for association between fat transfer and time to recurrence in bivariate and multivariate models.

Cancer Risk after Fat Transfer: A Multicenter Case-Cohort Study, AMERICAN SOCIETY OF PLASTIC SURGEONS, Plastic & Reconstructive Surgery, January 2017 – Volume 139 – Issue 1 – p 11–18, doi: 10.1097/PRS.0000000000002838.

Results
The time to disease recurrence unadjusted hazard ratio for fat transfer was 0.99 (95 percent CI, 0.56 to 1.7). After adjustment for age, body mass index, stage, HER2/Neu receptor status, and estrogen receptor status, the hazard ratio was 0.97 (95 percent CI, 0.54 to 1.8).

Conclusion
In this population of breast cancer patients who had mastectomy with immediate reconstruction, fat transfer was not associated with a higher risk of cancer recurrence.

In this video published on 29 Dec 2016 bu the PRSJournal channel, Rod J. Rohrich, MD, Editor-in-Chief of “Plastic and Reconstructive Surgery” discusses the safety of Fat Transfer after Mastectomy vs. traditional reconstruction surgery.