EDF Health

Very little, very late: EPA still lacks data on safety of widely used flame retardant chemicals

Lindsay McCormick is a Research Analyst.  Richard Denison, Ph.D., is a Lead Senior Scientist.

[This is Part One of a two-part series.  Here is a link to Part Two.]

Last summer, EPA released a Problem Formulation and Data Needs Assessment describing the inadequacy of data available to conduct risk assessments on a group of brominated phthalate flame retardants – two of which are major components in widely used Firemaster products. 

This is the first of two blog posts on the comments EDF recently submitted to EPA on this document.  In this post, we discuss the growing public health and environmental concerns over use of Firemaster products and the recommendations we made to EPA on steps it needs to promptly take to address these concerns.  In our second post, we’ll lay out our serious concerns about the lack of transparency, limited data access, and allowance of unwarranted confidentiality claims that our review of EPA’s document brought to light.

 

First, a brief history

In the mid-2000s, Great Lakes Chemicals Corporation (now Chemtura) agreed to phase out production of polybrominated diphenyl ether (PBDE) flame retardants due to mounting evidence of their health effects and their persistence and accumulation in people and the environment.  Soon after, the use of the company’s replacement Firemaster products skyrocketed.

The two main components of Firemaster products, 2-Ethylhexyl 2,3,4,5- tetrabromobenzoate (TBB) and bis(2-Ethylhexyl) -3,4,5,6- tetrabromophthalate (TBPH), are  high production volume (“HPV”) chemicals – each produced at more than one million pounds annually.

Unfortunately, use of these chemicals rose to such levels – replacing PBDEs in consumer products like polyurethane foam-based furniture and electronics – without sufficient data and review to establish their safety.   Read More »

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New Wristband Technology Illuminates Chemical Asthmagens in our Environment

Lindsay McCormick is a Research Analyst.

Asthma presents a huge public health challenge.  Over the past few decades, asthma rates in the U.S. have nearly tripled – increasing from 3.1% in 1980 to 8.4% in 2010. Today, more than 25 million people suffer from this chronic respiratory illness.

While air pollution and allergens like pet dander are clearly big triggers for asthma, we know that certain chemical exposures play an important role as well.  A number of chemicals used in everyday consumer products – from household cleaners and building materials to shampoos and cosmetics – are known or suspected “asthmagens”– environmental agents that cause or exacerbate asthma.  Unfortunately, such chemicals are poorly regulated and we, as individuals, rarely have any way of knowing which ones are lurking in our environment.

EDF recently conducted a pilot project to explore which chemicals we are exposed to in our day-to-day lives.  The project employed simple chemical-detecting wristbands that absorb certain chemicals present in the environment.  We enlisted 28 volunteers to become “environmental sensors” for a week by wearing the wristbands.

Among the results:  Over the course of that week, the participants came into contact with a total of 57 potentially hazardous chemicals, 16 of which are linked to respiratory health effects such as asthma.   Read More »

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Evidence grows linking DEHP exposure to reproductive toxicity: What is the state of regulation?

Lindsay McCormick is a Research Analyst.

Phthalates are chemical plasticizers found in a wide array of industrial and consumer products, including polyvinyl chloride (PVC) piping and tubing, cosmetics, medical devices, plastic toys, and food contact materials.  Because phthalates are often not strongly chemically bound to these products, they can leach out of those products and into the environment around us. Given this, it may not be surprising that phthalates and their metabolites can be measured in the bodies of nearly all people tested.

This post reports on important new research on DEHP and summarizes the state of regulation of the chemical in the U.S. and abroad.   Read More »

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ECHA keeps the ball rolling on Authorisation under REACH

Alissa Sasso is a Chemicals Policy Fellow.

In our last update on the European Union’s Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), we noted a major milestone under the “A” of REACH, as the first application for an authorisation was passed to and is awaiting decision by the European Commission. The authorisation process is continuing to move along: as of May 19th, ECHA has received 13 applications for 35 uses of six different substances on the Authorisation list. Interest in ECHA’s authorisation work is also increasing, eliciting a greater variety of stakeholder input than in the first round.  Read More »

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Getting the data on chemicals is just the beginning

Jennifer McPartland, Ph.D., is a Health Scientist.

Common sense tells us it’s impossible to evaluate the safety of a chemical without any data. We’ve repeatedly highlighted the scarcity of information available on the safety of chemicals found all around us (see for example, here and here).  Much of this problem can be attributed to our broken chemicals law, the Toxic Substances Control Act of 1976 (TSCA).

But even for those chemicals that have been studied, sometimes for decades, like formaldehyde and phthalates, debate persists about what the scientific data tell us about their specific hazards and risks.  Obtaining data on a chemical is clearly a necessary step for its evaluation, but interpreting and drawing conclusions from the data are equally critical steps – and arguably even more complicated and controversial. 

How should we evaluate the quality of data in a study? How should we compare data from one study relative to other studies? How should we handle discordant results across similar studies?  How should we integrate data across different study designs (e.g., a human epidemiological study and a fruit fly study)? These are just a few examples of key questions that must be grappled with when determining the toxicity or risks of a chemical.  And they lie at the heart of the controversy and criticism surrounding chemical assessment programs such as EPA’s Integrated Risk Information System (IRIS). 

Recently, a number of efforts have been made to systematize the process of study evaluation, with the goal of creating a standardized approach for unbiased and objective identification, evaluation, and integration of available data on a chemical.  These approaches go by the name of systematic review

Groups like the National Toxicology Program’s Office of Health Assessment and Translation (OHAT) and the UCSF-led Navigation Guide collaboration have been working to adapt systematic review methodologies from the medical field for application to environmental chemicals.  IRIS has also begun an effort to integrate systematic review into its human health assessments. 

Recently a paper in Environmental Health Perspectives (EHP) by Krauth et al. systematically identified and reviewed tools currently in use to evaluate the quality of toxicology studies conducted in laboratory animals.  The authors found significant variability across the tools; this finding has significant consequences when reviewing the evidence for chemical hazard or risk, as we pointed out in our subsequent commentary (“A Valuable Contribution toward Adopting Systematic Review in Environmental Health,” Dec 2013). 

EDF applauds these and other efforts to adopt systematic review in the evaluation of chemical safety.  Further elaboration of EDF’s perspective on systematic review can be found here

 

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Stymied at every turn: EPA withdraws two draft TSCA proposals in the face of endless delay at OMB

Richard Denison, Ph.D., is a Senior Scientist.

The Environmental Protection Agency (EPA) has withdrawn two draft rules it had developed under authority of the Toxic Substances Control Act (TSCA).  EPA originally sent the proposed rules to the White House for its review way back in 2010 and 2011. 

Despite a clear requirement that White House reviews of draft proposed rules be completed within 90 days, the Office of Information and Regulatory Affairs (OIRA) [which is part of the Office of Management and Budget, OMB] sat on these two draft proposals for 1,213 and 619 days, respectively.  Faced presumably with the reality that OIRA was never going to let EPA even propose the rules for public comment, EPA decided to withdraw them.  Read More »

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