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.  

Since their expansion in the market, concern has increased about exposure to and potential health effects of Firemaster products.  Recent research has linked exposure to these flame retardants to health effects ranging from reduced fertility to hormone disruption and DNA damage.  Furthermore, several researchers as well as government entities, including EPA, have noted the similarity in structure of the brominated phthalate flame retardants to di(ethylhexyl)phthalate (DEHP) – listed as a known carcinogen  and developmental toxicant under California’s Proposition 65 and banned by the Consumer Product Safety Commission (CPSC) for use in children’s toys and other products due to its reproductive toxicity.

Like their PBDE predecessors, it turns out that the brominated phthalate components of Firemaster products also persist and build up in the environment and in living organisms.   Today, these chemicals are showing up around the world – in everything from indoor house dust and wastewater sewage sludge to animals like polar bears and dolphins.

But EPA missed all this when it reviewed one of these chemicals, TBB, prior to its entry onto the market.  TBB was initially given a cursory review by EPA through its New Chemicals Program and effectively cleared for use in the mid-1990s.  Once it became clear that Firemaster 550 was to be the main replacement for pentaBDE as it was phased out, EPA again rushed to judgment.  In a 2003 press release it stated: “EPA has recently completed a preliminary assessment of a Penta substitute, Firemaster® 550, and concluded that this alternative chemical is not persistent, bioaccumulative or toxic to aquatic organisms.”

While that review was shrouded in secrecy and it’s never been clear on what evidence EPA based this sweeping claim, it is clear that EPA got it wrong.  Just a year later, in 2004, mounting concerns about brominated flame retardants led EPA to initiate a second review of TBB, though again it appears EPA misjudged the magnitude of the problem.

Fast-forward to 2012, when EPA Assistant Administrator Jim Jones testified before a Senate Committee explaining that EPA had originally missed the persistence and bioaccumulation potential of TBB:

EPA first reviewed a new flame-retardant component of several products in 1995 for use in polyurethane foam and was unable to identify that a component of flame retardants [TBB] was persistent, bioaccumulative and toxic. Later, after the chemicals were in commerce, information became available that showed the chemicals were being found in humans and the environment.

The Agency’s mistake did not go unnoticed: A 2012 Chicago tribune article called EPA out on allowing Firemaster products onto the market without a thorough review of their safety.

 

EPA’s Data Needs Assessment and our recommendations

In 2013, EPA began considering a cluster of five structurally similar brominated phthalate flame retardants (including TBB and TBPH) for risk assessment through its existing chemicals Work Plan Chemicals Program (along with several other clusters of flame retardants, about which we blogged recently).  Unfortunately, after a preliminary problem formulation, EPA concluded that it lacks adequate data to move forward with quantitative risk assessment of any of the brominated phthalate flame retardants and instead released a Data Needs Assessment in August, 2015.

It is deeply troubling (though perhaps not surprising) that – two decades after the chemical’s initial market entry and a decade after EPA’s second review – EPA maintains it still has insufficient data to conduct a risk assessment on a chemical like TBB.

Recently, EDF submitted comments to EPA on its Data Needs Assessment both supporting the Agency’s general efforts to evaluate the brominated phthalates and providing considerable critical feedback.  Below we summarize our major recommendations to EPA.

Prioritize assessment of commercial mixtures in widespread use

In its Data Needs Assessment, EPA has focused on data needs for individual brominated phthalate chemicals – primarily TBB and TBPH – with the apparent aim of assessing their individual risks.  We argue that EPA should shift its focus to data needed to assess the risk of exposure to Firemaster products containing the brominated phthalates, given that humans and the environment are being widely exposed to these chemicals primarily (or in the case of TBB, exclusively) through ongoing use of these commercial mixtures.  The importance of evaluating the risks of the chemical mixtures to which people are actually being exposed is well-accepted in the scientific community (including among EPA scientists).

We recommend that EPA’s focus should especially be aimed at Firemaster 550.  Not only is it the most ubiquitous Firemaster product (formulated as the main replacement for PBDEs in polyurethane foam products), but it may have additional toxicity compared to other Firemaster products.  That’s because Firemaster 550 includes two aryl phosphate components (TPP and ITPP) in addition to the two brominated phthalate components (TBB and TBPH); new research – not considered by EPA – suggests that Firemaster 550's toxicity may be driven in significant part by its aryl phosphate components.

Despite the public health urgency of understanding the risk posed by widespread use of Firemaster 550, EPA excluded data development and risk assessment of the aryl phosphates (and, by default, Firemaster 550) as “outside the scope” of its current assessment.

We argue that EPA should not base its risk assessment scoping decisions on artificial clustering of related chemicals where that leads to a failure or delay in assessing real-world exposures to chemical mixtures actually in use and their public health impact. Recognizing that the data currently available on Firemaster 550 are likely inadequate to conduct such a risk assessment, we strongly urge EPA to prioritize obtaining the data needed to assess the risks of the Firemaster 550 mixture.

Obtaining needed data

In order to promptly move forward with risk assessment, EPA must act, without delay, to obtain any data on hazard and exposure it needs.  In its Data Needs Assessment, however, EPA has taken a passive approach to filling data gaps:  Not only has it failed to clearly state the priority data needs, but it does not identify any next steps it intends to take to obtain these data.

We urge EPA to take aggressive steps to gather additional data in order to expedite risk assessments of Firemaster 550 and other Firemaster products in use.  In our comments, we proposed a detailed process for quickly obtaining these data through simultaneous use of data requests and regulatory actions (e.g., TSCA Section 4 test rules).

In addition to pursuing data from the manufacturer of Firemaster products, EPA needs to consider all available published, peer-reviewed literature.  Through our own limited review of the published literature, we identified substantial additional data on both Firemaster products and their individual components that EPA appears to have missed or ignored (see, for example, here, here, and here).  As researchers continue to uncover evidence that Firemaster products present environmental and public health threats, EPA should do its part to assess and manage its risks as soon as possible.

 

In our next post, we’ll turn to the very serious problems our review of EPA’s Data Needs Assessment uncovered with respect to transparency, data access, and allowance of unwarranted confidentiality claims.

For more detail, please see the comments we filed on the Brominated Phthalate Cluster Problem Formulation and Data Needs Assessment.

 

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