Feature Article Archive

Is Food Packaging a Blind Spot in Chemical Regulation?

#90b, December 2015. Food contact materials in the EU are not regulated under the REACH chemical laws but instead by legislation which came into force in November 2004, governing “materials and articles intended to come into contact with food”. The problem is, the EU has only finalised regulation of six of the total of 17 groups of FCMs.

EDCs, Scientific Review & the “Manufacture of Uncertainty”

#88b, October 2015. Studies which investigate potential risks to health posed by chemicals vary in design, methodological quality, populations studied, and exposure and health outcomes considered. Even very large, highly-cited studies will be challenged or refuted over time, which is why decision-making (if it is to be based on the best available evidence) requires on-going reconciliation of studies which give different answers to the same question.

Chemicals in the circular economy

#86b, August 2015. The “circular economy” is a generic term for a restorative industrial economy whereby economic activity conserves and increases resource rather than depleting it, via two circular flows of biological and technical feedstocks. Here we describe some of the challenges which chemicals present in making the transition to a circular economy.

Separating fact from fiction in chemical risk assessments: how reliable are evidence reviews?

#84b, June 2015. In which the preliminary findings of new research suggests that the methods used for evaluating evidence for health risks from chemicals may, from the point of view of providing accurate accounts of what is and is not known about chemical toxicity, be in need of serious overhaul.

The uncertainty factor

#82b, April 2015. For a prominent feature of risk assessment, uncertainty factors attract few publications in the peer-reviewed literature. According to Web of Science, there are only 79 toxicology citations with “uncertainty factor” in the title. A number of these are conference abstracts rather than full journal papers. Of these publications, 50% have been cited 7 times or fewer. Only 25 have been published since 2003.

Sense about scientific advisers part 3: science, politics, innovation and controversy

#80b, February 2015. Here we leave behind specific problems with the current delivery of science advice in Europe to examine how scientific research can be better employed for resolving disagreement about what constitutes sustainable environmental policies in the EU. We caution against artificially reductive and risk-driven approaches to analysing the relative merits of different innovation pathways which may be on offer at any given time.

Sense about scientific advisers part 2: three recommendations

#79b, January 2015. Here we present three lessons we believe should be learned from the controversy about the CSA role, before making three recommendations as to how the on-going debate should be framed.

Scientific advice, innovation and the Precautionary Principle

#76b, October 2014. While unambiguous scientific advice in areas of political and scientific controversy is appealing, in reality it is probably unattainable. There is therefore a need for extra-informational decision-making mechanisms, of which the Precautionary and Innovation Principles are two examples. Often seen as existing in opposition, in the right policy environment precaution exists in unison with innovation. Furthermore, benefits of an Innovation Principle may be overstated due to underestimation of the cost of failure to anticipate potential harm and society’s ability to solve the challenges of implementing precautionary approaches to chemical risk management.

Sense About Scientific Advisors Part 1: A Recent History

#75b, September 2014. Here we document how the role of Chief Scientific Advisor (CSA) is currently conceived by the European Commission and implemented by Anne Glover, namely CSA as “Philosopher-King”. Via recent historical examples we show how this conception of CSA both challenges the democratic foundations of decision-making, by allowing the decisions of policy-makers to be opposed or over-ridden by an unelected official, and fails to ensure evidence-based policy by putting too much influence on a position which is vulnerable to the attention of lobbying efforts. These considerations bring into question the desirability of the role of CSA.

Making sense of chemical stories: some considerations for chemists

#72b, July 2014. Last month Sense About Science re-published its 2008 guide Making Sense of Chemical Stories, a report intended to address misconceptions promulgated by “lifestyle commentaries” that chemicals “cause only harm to health and damage to the environment”. The document was lauded by the American Chemistry Council as “a guide to help put to bed the all-too-common myths about chemicals in our daily lives” – but is it? Or does it make the same sort of mistakes as the “lifestyle” commentators it aims to correct?

Organic food: does eating it cut cancer risk?

#71, May 2014. A recent study published in the British Journal of Cancer (BJC) found that, in a group of over 600,000 British middle-aged women followed for just over 9 years, no decrease in cancer risk could be observed between women who described themselves as “always” or “usually” eating organic food, and women who described themselves as “never” eating organic food (Bradbury et al. 2014).

Fire safety and environmental risk: what next?

#70, April 2014. The use of flame retardants in consumer goods is a very good example of how difficult it can be to ensure that as few people as possible are harmed by a given risk (in this case, house fires), while also being sure that as few people as possible are harmed by the steps being taken to reduce that risk (which here would be the use of flame retardant chemicals to meet fire safety standards).

The TV fire and flame retardant controversy: deconstructing the data

#69, March 2014. Tom Muir, an independent researcher and former employee of Environment Canada (retired), explains how flaws in derivation of fire risk from underlying Swedish data ultimately results in failure to demonstrate a need for an ignition standard in televisions.

The “junk science threat” to free trade

#68, February 2014. In January 2014, MEP Julie Girling contributed an opinion piece to the Wall Street Journal in which she decried “the EU’s expanding embrace of ‘precautionary’ regulation” of endocrine disrupting chemicals (EDCs), equating this to a “junk science” approach to policy-making. Since this piece promulgates a number of misconceptions about the legal and scientific underpinnings of precautionary policy-making, we felt it was worth deconstructing some of the points she presents.

The Substitution Principle: any case for scepticism?

#67, January 2014. Campaigns to substitute toxic chemicals for safer alternatives recently received a shot in the arm from new initiatives announced by Walmart and Target. Walmart is prioritising 10 problem compounds for phase-out from the goods they sell, while Target is introducing a system for scoring the environmental performance of its range of goods, heavily weighted towards the toxicity of constituent chemicals. The programmes are intended to encourage the suppliers of Target and Walmart to develop greener formulations for their products.

Everyone’s research problem: assessing the methodological quality of a study

#66, December 2013. While we understand that tests of the potential toxicity of compounds such as BPA have to be fair, as a society it seems we are not necessarily very good at understanding that the process by which we evaluate bodies of published research for methodological quality should also follow the same principles which define a fair test in a laboratory.

Who can you believe when it comes to chemical safety?

#65, November 2013. With the diversity of expert opinion about the safety of BPA, you could be forgiven for being unsure as to whose opinion it is you are supposed to believe? And with over 6000 published studies, it is unlikely that you have the personal time or resources to get sufficiently familiar with the research into BPA to decide for yourself who is most likely to be right. So how do you pick the opinion which is most likely to be correct?

A tale of two colleges: is it really controversial to advise mothers about potential health effects of chemical exposures?

#64, October 2013. This month, ACOG published a Committee Opinion about exposure to toxic environmental agents. It describes “reducing exposure to toxic environmental agents” as a “critical area of intervention”. A similar paper was published on the same theme in the United Kingdom in June this year, when the UK equivalent of ACOG, the Royal College of Obstetricians and Gynaecologists (RCOG), issued a Scientific Impact Paper titled “Chemical Exposures During Pregnancy”. For a short paper intended for internal use by members of RCOG, the publication brought on a storm of criticism and press interest, with almost all major printed media outlets picking up on the story.

Eight questions for toxicologists against proposals for new EU chemicals laws

#63, September 2013. Normally a reclusive subject rarely sighted in the media, the intersection between science and chemicals policy has been unusually prominent this summer, with the editors of journals of toxicology, endocrinology and other related fields publishing combative editorials about how endocrine disrupting chemicals should be regulated. According to the commentaries and editorials, the journal editors have a number of questions to answer. Eight of them are as follows.

A Health & Environment retrospective.

#62, August 2013. Highlights from 5 years of H&E.

Arguing about nothing? “Science-based” regulation of endocrine disruptors

#61, July 2013. In discussions about chemical regulation, calls for “science-based policy” are regularly heard in the debate around the appropriate legal and testing framework for identification and control of endocrine-disrupting chemicals (EDCs). Exactly what “science-based policy” amounts to, however, is difficult to pin down.

Parabens: endocrine disruptors in cosmetics and food?

#60, June 2013. Parabens are esters of p-hydroxybenzoic acid and are widely used as preservatives in cosmetics. They have appeared in the news because of concern about their endocrine-disrupting potential, in particular their ability to mimic oestrogen, with a study in 2012 finding parabens in almost 100% of breast samples from breast cancer patients.

However, people may be less aware of the use of parabens in foodstuffs, identifiable on labelling as additives E214-219. The most commonly-used parabens in food are methylparaben (food additive E218) and ethylparaben (E214) with the European Food Safety Authority setting in 2004 an Acceptable Daily Intake (ADI) of a sum total of 0-10mg/kg bodyweight per day for methyl- (E218) and ethylparaben (E214).<

Why regulatory definitions of chemical hazards are important

#59, May 2013. One of the longest lists of potential endocrine disrupting chemicals (EDCs) so far produced is 870 compounds in length. Assembled by the Endocrine Disruption Exchange (TEDX), a chemical makes the list if a published, verified citation from the primary scientific literature demonstrates it has an effect either on the endocrine system or on the signalling cascades governing any of the body’s systems.

We can use this list as the basis for a conceptual, qualitative stress-test for elements of the various proposed regulatory definitions of “endocrine disrupting chemical”.

The gulf between identification of endocrine disruptors and regulatory restrictions being placed on their use

#58, April 2013. It is often presented as though a chemical being identified as an EDC means being banned systematically. In fact, there is a lengthy and complex process between something being identified as presenting a certain type of hazard, and something being banned (or in REACH vocabulary, the chemical not being authorised for a proposed use) because it is deemed to pose too great a threat to health.

Triclosan or soap and water?

#57, March 2013. Despite its widespread use, only a relatively small amount of research into the potential health effects of triclosan has been published. Much of the evidence for potential harm from triclosan comes from in vivo amphibian and fish studies and in vitro mammalian studies.

Are hazard-based approaches to chemical regulation unscientific and anti-business?

#56, February 2013. Should chemical regulation be based on the intrinsic potential for a substance to cause harm, or should further account be taken of the probability that they will actually cause harm? This is a question of increasing importance in European chemical regulation, as disputes about the safety of chemicals heat up and regulators seek to reassure the general public that what they are exposed to is safe, or if not safe, that chemical hazards are at least an issue which is under control.

Debating the environmental costs and safety gains of use of flame retardants

#55, January 2013. Changes in regulations with implications for FR use are of strong financial interest to the FR industry, while environmental health concerns about FRs suggest there may be substantial gains to be made from limiting their use. The debate has evolved to become highly polarised between the industry and environmental lobbies, as one side is accused of promoting false information about fire safety and promoting chemophobia, and the other of downplaying the harmfulness of FRs and exaggerating their efficacy in preventing fire deaths.

False alarms or missed hazards: how should regulators define “endocrine disruptor”?

#54, November 2012. It might sound absurd to say that the definition of “endocrine disruptor” should be unscientific, but in fact there are important trade-offs entailed in how we define, for regulatory purposes, a chemical as an endocrine disruptor. These trade-offs should make us very cautious about conflating the purpose of a regulatory definition of EDC with the purpose of a scientifically correct definition of EDC, and may even show us that the process of defining EDC is a democratic matter which cannot be decided by expert committees alone.

Epigenetics and the developmental origins of disease

#53, October 2012. It is a rare research initiative which does not announce itself with bold claims. And the Developmental Origins of Adult Disease (DoHAD) hypothesis is no rarity, claiming in a recent white paper to “provide insight into new strategies for research and disease prevention, while being robust enough to require a public health and policy response”. Should we be as excited as the authors?

Regulatory challenges presented by endocrine disruptors

#52, September 2012. If we are to have any hope of sensibly regulating EDCs in a scientifically-credible way, then we have to look to endocrinology for guidance when it comes to developing testing strategies which will identify EDCs and evaluate the risk they pose to health.

Just the ticket? Safety of alternatives to BPA in receipt paper

#51, August 2012. Although there is not much information about the environmental performance of potential substitutes, the Swedish Chemicals Agency (KEMI) has nonetheless proposed banning the use of BPA in thermal paper. Here we outline some of the problems with securing data on chemicals used in manufactured goods, and why KEMI believes a ban on BPA is warranted even though information on alternatives is lacking.

Does discussion of environmental causes of cancer cause cancer?

#50, July 2012. There is no obvious reason why the 2010 US President’s Cancer Panel examination of chemicals as potential, under-discussed causes of cancer should have caused so much controversy. The report was hardly unheralded, and the recommendations were in line with much existing cancer prevention strategy. The conclusion that one is forced to, is critics of the report must believe that discussing environmental causes of cancer undermines cancer prevention strategy: in other words, that talk about environmental causes of cancer causes cancer.

Is everything we think we know about chemical toxicity wrong?

#49, May 2012. Yes,  if the first comprehensive review of the issue in a decade is correct in concluding that low doses of chemicals can harm health.

Opportunities for cancer prevention: lifestyle choices vs. unavoidable exposures

#48, April 2012. Cancer prevention strategies are based on what is known about attributable causes of cancer. But does focusing on existing knowledge advance or hamper efforts to reduce cancer incidence? We evaluate two opposing perspectives to conclude that demanding highly robust data may in fact limit our ability to prevent cancers beyond the proportion caused by lifestyle choices.

Are moves toward threshold-based chemicals risk assessment premature? (TTCs part 3)

#47, March 2012. Because of the possible far-reaching consequences of their adoption, the adoption of thresholds of toxicological concern (TTCs) in regulatory risk assessment needs to be discussed in a broad, democratic environment where all affected parties are involved in a final decision. Moves to implement TTCs should not be made in isolation by small committees in single European authorities.

Are TTCs the best way to reduce animal testing? (Part 2)

#46, February 2012. it is far from clear that risk assessors should approve the use of TTCs in chemicals risk assessment: not only is there substantial evidence that thresholds are set at a level which will fail to protect population health; without specific chronic toxicity data, the potential magnitude of effect of a chemical exposure on a population cannot be anticipated.

Thresholds of Toxicological Concern: Evaluating an Initiative to Reduce Animal Testing. (Part One)

#45, January 2012. One rationale for reducing the burden of chemical toxicity testing is the application of thresholds of toxicological concern (TTCs), a pragmatic, probabilistic approach to risk assessment of substances for which toxicity data are unavailable. It holds that if a substance is unlikely enough to pose a risk to health, then toxicological testing of the substance is not required.

PFCs: A case study in favour of the precautionary principle

#44, December 2011. PFCs are an example of how production and marketing of a substance can outpace scientific research into its safety and placing regulatory restrictions on its use. In the case of PFCs, this has resulted in 3 generations of people being exposed to an unknown hazard while a complex consensus, based on weak data and economic interests, develops around restricting their use.

Impasse on BPA: different facts – or different values?

#43, November 2011. Expert committees with substantial scientific expertise are clearly divided in opinion between those who believe BPA is safe, at least at current exposure levels, and those who believe exposure to BPA should be reduced. They all have access to roughly the same data, which they should be able to analyse objectively, so the question is: how has this happened? Perhaps the place to look for the reason for the impasse is in each side’s conception of what counts as adequate science in evaluating and responding to the possible threat to health posed by BPA.

Swamping Part 2: Affinity is only part of the picture

#42, September 2011. We look at why it is wrong to claim that potential EDCs cannot have a health effect if they have a much lower affinity for a receptor than natural hormones, and examine why this means standard toxicological testing protocols are unhelpful for assessing possible harm from EDCs.

Are EDCs too swamped by the body’s own hormones to pose a threat to health?

#41, August 2011. It is sometimes argued that endocrine disrupting chemicals (EDCs) pose negligible threat to human health because any effect they might have is swamped by the presence of endogenous hormones and the natural signalling processes happening in the body.

Exactly what it means to be “swamped”, however, is not always clear. We examine whether or not the argument stands up to scrutiny given new findings about oestrogen signalling, and outline some of the policy implications.

Assessing Risk Posed by Chemicals in Mixtures

#40, July 2011. Chemical risk assessment has to change in order to understand and manage the risk that multiple, everyday exposures may pose to health. As things stand, it is not up to the job, so we examine some proposals for overhauling risk assessment so it can deal with mixtures.

Relevance bias model for chemical risk assessment

#39, June 2011: This month, we expand on the idea that RA might be subject to what we dubbed a “relevance” bias. Here, we present a simple model to illustrate how this bias might consistently distort reviews of chemical safety.

Could “Relevance” be a Source of Bias in Risk Assessment?

#38, May 2011: Bias, the inclination to hold a partial perspective at the expense of possibly equally valid alternatives, has plagued analysis of information since time immemorial: like lodestone to an explorer’s compass, bias invisibly guides analysis off course from fact and into the realms of falsehood and belief. We look at whether or not there is a structural bias in the risk assessment process.

Research practice and chemicals policy: how science makes life difficult for regulators

#37, April 2011: There is a great deal of controversy and argument around whether or not the way chemicals are assessed for safety in the EU is adequately responsive to evidence that they may be causing harm. Leaving to one side lobbying by commercial and public-interest organisations, here we look at whether or not scientific practice produces the data regulators feel they need in order to make decisions about restricting the use of chemicals – and if not, then what can be done about it.

The Obesogen Hypothesis

#36, March 2011: The full set of reasons as to why someone might become obese must be more complex than loss of control over energy balance is, otherwise treatment of obesity through diet and lifestyle changes alone would be successful more often than in just 2-20% of cases. We look at the hypothesis that some chemicals may have a role to play in promoting energy imbalance.

Chemicals as an emerging risk factor in developing type-2 diabetes: a short history

#35, February 2011: New research suggests that obese persons who do not have elevated POPs levels are not at elevated risk of diabetes, suggesting that the POPs rather than the obesity per se is responsible for the association. We examine the evidence and the implications.

Is there a better way of assessing the risks which chemicals may pose to human health?

#34, January 2011: The adequacy of the process for assessing risk to human health posed by chemicals is coming under increasing scrutiny. In this month’s feature article, we examine some of the criticisms of risk assessment and the relative merits of moving towards a more hazard-based approach to chemical regulation.

Issue 33 – The significance of different standards of evidence in determining the safety of pharmaceuticals against the safety of chemicals

What are the differences between how pharmaceuticals are tested for health as compared to chemicals? Does this limit the evidence which we can draw on to decide if a chemical is safe and set policies to protect health by restricting its use and marketing?

Issue 32 – Science and the safety of BPA: Of mice and men

New evidence comparing how mice, monkeys and humans metabolise BPA suggests that not only does it take longer for the body to excrete it than EU regulators currently believe, human exposure to BPA may also be much higher than currently thought, and non-dietary exposure more important than currently suspected.

Issue 31 – The role of DEHP in inflammation and compromised immune responses in neonates

Phthalates are still widely-used in medical devices, though alternatives are increasingly available for almost all uses except blood bags. Premature infants undergoing total parenteral nutrition (TPN) have been found to be less likely  to suffer from cholestasis, a condition in which the bile duct becomes blocked and for which inflammation is a risk factor, after substitution of DEHP-containing equipment for a PVC-free alternative.

Issue 30 – Why potential for chemicals to disrupt thyroid function is causing concern

Can chemicals in the environment alter thyroid homeostasis, potentially lowering thyroid hormone levels to a point at which they can harm health? Who is likely to be most vulnerable? What are the biological mechanisms? And which chemicals are causing concern?

Issue 29 – BFRs explained

Brominated flame retardants are a controversial class of chemical. Several types of BFR have already been banned in Europe; this year the European Parliament has been considering whether or not BFRs should be banned entirely from electronics goods.

Manufacturers argue they are essential for saving lives; environment groups and manufacturers of non-halogenated fire retardants say they pose unnecessary environmental hazards and should be phased out in favour of greener alternatives.

Issue 28 – Rethinking the origins of breast cancer

Understanding how endocrine disruptors might cause cancer could, in fact, have profound implications for our understanding of what causes tumours to appear in the body: if a chemical does not cause genetic mutation, how can it cause breast cancer – and what does this mean for understanding carcinogenesis?

Issue 27 – Are there hazards lurking in common bottle plastic?

Some research suggests that PET plastic, widely used in packaging and assumed to be safe, might be leaching toxic chemicals into food and drink. H&E follows the trail of evidence – but it leads only to a mass of uncertainty and confusion. So we ask: what can be done to ensure PET is safe?

Issue 26 – Green Chemistry

As controversy around society’s use of chemicals grows, green chemistry is getting more attention as a way of lessening the impact of chemicals on the environment and health.

Issue 25 – The bad science? Epidemiology under the spotlight

  • Association, causation, and the usefulness of epidemiology
  • Criticism of speed of EU chemical safety law
  • New studies on mechanism of harm of BPA

Issue 24 – Are all things poison? Rethinking safety standards for low doses of chemicals

  • Are all things poison? Rethinking safety standards for low doses of chemicals
  • Scientific society urges changes to basic principles of risk assessment
  • New studies associate non-stick chemicals with high cholesterol and thyroid disorders

Issue 23 – Environmental health science vs. clinical research

  • How to make environmental health science relevant to clinicians
  • US companies volunteer to phase out controversial chemicals
  • Researchers uncover link between BPA exposure and heart disease.

Issue 22 – The new science of epigenetics

  • Lamarckianism and the epigenetic revolution in environmental health
  • 75 new chemicals in US biomonitoring survey
  • UN orders bisphenol-A safety summit

Issue 21 – Chemical interference in thyroid function

  • Spot the difference: can the body distinguish between thyroid hormones and chemical imitators?
  • American Medical Association commits to protecting public from hormone disruptors
  • Study raises fresh concerns about feminising effects of phthalate exposure

Issue 20 – Mental health and environmental contaminants

  • Toxicant exposure and mental health: opportunities for treatment?
  • American Cancer Society plans to examine environmental factors behind disease
  • Doctors tested for exposure to hazardous chemicals common in healthcare

Issue 19 – Time is of the essence

  • A question of when: can timing of conception affect child health?
  • Swedish County Councils plan to stimulate development of PVC-free blood bag
  • Differences in breast milk may hold clues to high cancer rates in Danes

Issue 18, September 2009 – Fear of a fat planet

  • Fear of a fat planet: closing the gaps in understanding obesity
  • Media reporting misses key point of organic study
  • France could be first European country to ban BPA

Issue 17, August 2009 – Rising cancer rates

  • Rising cancer rates: Attention on the environment in struggle to explain increased incidence
  • Medical society recommends action to limit risks posed by hormone-like chemicals
  • Materials in medical devices found to contribute to health complications for premature infants

Issue 16, July 2009 – Limitations of risk assessment

  • Risky assessments: how chemical safety testing fails to anticipate harmful effects on health and the environment
  • Animal research associates BPA exposure with vaginal cancer
  • Three phthalates among the seven chemicals EU agency describes as being of “very high concern”

Issue 15, June 2009 – Night work and health

  • Night time work environment contributes to increased cancer risk for workers
  • Danish girls found to be starting puberty earlier
  • Male monkey behaviour feminised by pre-natal BPA exposure

Issue 14, May 2009 – Antibiotic resistance

  • Are infection control measures contributing to antibiotic resistance?
  • French government agency advises against use of phthalates in medical devices
  • New studies link pesticide use to Parkinson’s Disease and childhood brain cancer

Issue 13, April 2009 – Endocrine disrupting chemicals

  • Sending the wrong signals: the danger to long-term health posed by endocrine disruptor exposure during developmental windows
  • High bisphenol-A levels found in hospitalised premature infants
  • Cleaning chemicals put nurses at up to 70% increased risk of asthma

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