EPA Axes Panel Chair at Request of Chemical Industry Lobbyists: Review Panel Timeline

Documents obtained by EWG reveal that EPA dismissed the chair of their high-profile external review panel at the request of the American Chemical Council (ACC) representing the interests of the companies who produce the toxic fire retardants under consideration (BFRIP). EPA’s move is in conflict with their own voluntary guidance documents. These require, at a minimum, that their handling of allegations of bias be transparent and well documented for the public (EPA 2006).

Timeline of EPA and industry actions

EPA is updating its 1989 Deca safety standard, and creating new standards for other PBDE fire retardants as well, including Tetra, Penta, and Hexa PBDE. The process began with a literature review in 2002. In late 2006, EPA posted their draft risk calculations for public comment and announced the expert review meeting (EPA-NCEA 2007d).

12/22/2006	EPA posts their draft health standards for Deca and other PBDEs in the Federal Register, and announces the first expert panel meeting.
mid-Feb 2007	Dr. Rice of Maine CDC testifies before Maine Legislature on the need for use restrictions on Deca.
2/22/2007	PBDE Expert Panel convenes, with Dr. Rice as chair.
3/22/2007	EPA posts final Expert Panel report as a pdf file. The document includes Dr. Rice's comments.
5/3/2007	ACC demands that EPA kick Dr. Rice off the expert panel.
6/15/2007	ACC meets with EPA to discuss their concerns with the process.
8/13/2007	EPA kicks Dr. Rice off of the panel, strips her comments from the Expert Panel report, and republishes the altered version. The document contains no mention of Dr. Rice and no record of EPA's actions to remove her comments.
9/21/2007	ACC writes EPA. They request that EPA post the reasons for removing Rice on EPA's website.
11/26/2007	EPA posts 3rd version of Expert Panel comments. This version adds a disclaimer about the removal of Dr. Rice, and notes that EPA is not considering her comments in its final safety standard for Deca.
1/8/2008	EPA responds to second ACC letter
3/28/2008	EPA is expected to issue its final safety standard for Deca.

In January and February 2007, before the External Review panel met, Dr. Rice's agency, Maine CDC, released a joint report with Maine EPA, reviewing the need for use restrictions for Deca PBDE and the suitability of alternative fire retardants. Dr. Rice was a co-author. The report concluded that "safer alternatives are available to meet flammability standards for TVs, mattresses and residential upholstered furniture" (Rice 2007a).

Dr. Rice was asked to testify before the Maine Legislature and offer her opinion about a bill that would restrict Deca in products sold in Maine. She presumably echoed the Agency conclusion in testimony in February 2007. Dr. Rice was in a unique position to make such comments as she was the co-author of a low dose study (Rice 2007b) that confirmed the neurological deficits observed in the principal study used to derive the reference dose for Deca PBDE (Viberg 2003).

2/22/2007 PBDE Expert Panel convenes.
The EPA contractor convened the advisory panel of 5 scientists to provide EPA with a rigorous review of the scientific basis for the agency's proposed health standards. Expert reviewers were asked to answer a set of questions from EPA regarding the completeness of the Agency's literature review, the adequacy of data and the appropriate use of uncertainty factors in EPA’s derivation of a daily safe exposure level, or Reference Dose (RfD) (EPA-NCEA 2007e).

3/22/2007 EPA posts Expert Panel comments.
The document contains the individual comments from 5 reviewers (EPA 2007a). Dr. Rice is listed as panel chair. She raises several issues that others did not address. Nonetheless the 5 expert reviewers are generally in agreement with EPA’s selection of low dose studies and the general steps taken to translate those to daily safe exposures that do not risk human health.

5/3/2007 ACC demands that EPA remove Dr. Rice from the Deca panel.
ACC’s Sharon Kneiss wrote to ORD Assistant Administrator George Gray a former head of a consultant group that receives ACC funding, to ask that he personally intervene in the process (ACC 2007). ACC, acting on behalf of BFRIP, the Brominated Flame Retardant Industry Partnership, alleges that the panel is not an “independent, third-party review” because Dr. Rice is a “fervent advocate of banning deca-BDE.” In an interview with a local paper Dr. Rice stated that “there is no question” that Deca PBDE should be eliminated from commerce because it was a persistent toxin that accumulates in the food chain. ACC alleged that, “[T]here is no doubt that [Dr. Rice] has taken a very public position concerning a regulatory determination that is fundamental to the very issues presented to the panelists in the draft IRIS Toxicological Reviews” (ACC 2007).

ACC fails to note that Dr. Rice’s testimony was solicited by the legislature and offering her expert opinion was in fact a requirement of her job. However, unlike industry-employed scientists (who often serve in this capacity) Dr. Rice has no direct or indirect financial incentive to sway panel findings.

6/15/2007 ACC meets with EPA in person to express concerns about Dr. Rice and the proposed risk values.
There is no public record of the discussion during this closed door meeting.

8/13/2007 EPA posts 2nd version of Expert Panel comments as a pdf file. All of Dr. Rice’s comments are omitted.
In August, EPA posts an identically formatted document that omits Dr. Rice’s name and all of her comments (EPA 2007d). The new pdf file was placed on the same webpage, and the title page still listed the date of the report to be February 2007 (EPA-NCEA 2007b).

9/21/2007 Nancy Sandrof of ACC writes EPA on behalf of Bromine producers (BFRIP).
ACC writes a second letter requesting that EPA post the reason for removing Rice on EPA's website and take steps to assure that Dr. Rice's comments not influence the other reviewers or the overall outcome. They ask that EPA not use the Viberg study--showing neurological impacts to mice given a single dose of Deca--for the risk assessment and request a delay in the publication of final values.

11/26/2007 EPA posts 3rd version of Expert Panel comments as a pdf file. Document contains 4 reviewers, EPA discloses Rice's removal.
In November, EPA posted a third version of the Expert Panel comments with a new disclaimer that reads: "Notice: EPA modified this report in August, 2007 to include only four of the five reviewers’ comments. One reviewer’s comments were excluded from the report and were not considered by EPA due to the perception of a potential conflict of interest" (EPA-NCEA 2007c). The new pdf file was placed on the same webpage as the previous 2 versions. However the webpage now has a similar disclaimer. The report title page still lists the report date of February 2007.

1/8/2008 George Gray of EPA responds to ACC.
Dr. Gray writes the Bromine Manufacturers via ACC to confirm that they have posted a disclaimer about the removal of Dr. Rice. An EPA review showed that she did not influence the other panelist. He confirms that EPA will continue to use the Viberg study as a point of departure for their RfDs, as every external reviewer agreed with this decision. He hints that a yet-to-be-published EPA study has confirmed low-dose neurotoxicity after single or repeat doses. Finally, he clarifies that the IRIS assessments have been delayed to provide time to address final interagency review comments.

3/28/2008 Final RfD expected.

It is unclear what effect removing Dr. Rice and her comments will have on the final PBDE values. EWG’s line-by-line comparison of the panel report before and after EPA stripped Dr. Rice’s comments from the document shows that the altered document is now missing at least two major concerns relevant to Deca’s risks to humans (EPA 2007a):

• Dr. Rice noted that EPA had provided no scientific basis for its assumption that the single-day exposure for PBDE-induced brain damage demonstrated in animal studies could be used to predict daily PBDE exposures to humans. EPA had used single-day exposures as sub-chronic (multi-day) exposures and had used an uncertainty factor of 3 rather than 10 to translate them to the PBDEs that impact humans from conception through adulthood. EPA’s rationale was that the study targeted a “unique critical window of vulnerability.” However their only citation was a university thesis that cited a 1968 publication identifying post-natal day 10 in rodents as a critical day.

Dr. Rice objected to this, and cited a review article she co-authored in Environmental Health Perspectives that discussed many periods of brain vulnerability to developmental toxicants. EPA’s recognition of this data gap would result in an additional factor of safety applied to the Agency’s safe dose (the reference dose, or RfD). Now Dr. Rice's comment and publication exposing the Agency’s baseless assumption is completely missing from the panel review document.

• Dr. Rice noted that health risks of PBDEs would be additive. Tetra, Penta and Hexa congeners are exclusively sold and used in mixtures and it would be impossible for a person to be exposed to them independently. Deca and the other congeners are commonly detected in people and household samples, which indicate daily exposure to all 4 types. Each group shows the same pattern of low dose toxicity after single day exposures. Health risks from these fire retardants would be additive. This comment reflects a view of additive chemical risks widely accepted across the scientific community but absent from EPA’s proposed methods for assessing Deca risks. Dr. Rice was the only panelist to note this important deficiency in EPA’s method. Because the agency removed her comments, the panel review document no longer reflects this important point. EPA’s failure to consider additive risks will result in a vastly less protective health standard for each chemical.
• Dr. Rice suggested different combinations of Uncertainty Factors be used in the translation of single day rodent exposures to daily safe ingestion values for humans. The overall impacts are concentrations 3 to 35 times lower than proposed by EPA.

Other tactics of the bromine manufacturers to protect the use of their toxic products have recently come under scrutiny. On January 26th, 2008 the Washington Post published an exposé linking tobacco companies' efforts to fight fire-safe cigarettes with the same bromine-producing chemicals who had converging interests, as both benefited from an increased reliance on chemical fire retardants to combat cigarette ignitions. The Washington Post reported that a single lobbyist, Peter Sparber, represented both tobacco and bromine producers, and funneled money to the National Association of State Fire Marshalls, who for more than a decade fought for increased use of chemical fire retardants in place of less toxic methods to control ignition sources like cigarettes (Shin 2008).

EPA has now acceded to demands of the bromine industry to alter documents that will be used to set agency health standards. The result of these actions could compromise public health protections from these ubiquitous and toxic pollutants.