The ?pure science? bottleneck
Some 700 new chemicals hit the market each year, adding to the tens of thousands already in use. Yet the EPA has assessed only 557 chemicals since the IRIS program began in 1985. A typical review takes six to eight years, sometimes much longer. It took 27 years for the agency to issue a partial assessment of dioxin, a byproduct of plastics manufacturing and burning.
The Government Accountability Office (GAO) concluded in 2008 that the IRIS program was so bogged down that it was in danger of becoming obsolete.
In 2009, EPA Administrator Jackson made bold promises within her first weeks in office to fix the program. She?pledged?to finish many more assessments and to try to complete each one within two years. Since May 2009, the EPA said it completed 24 IRIS assessments, ?double the number? completed in the same time period prior to May 2009.
Yet its overall progress remains slow, and in the past two years, the program produced as few assessments as ever. Last year, the EPA planned to complete 40 assessments. It finished three.
The reasons for the logjam are complex. But it has become common for industry and its allies inside the federal government to push for?delay. ?Even a single delay can have far-reaching, time-consuming consequences, in some cases requiring that the assessment process essentially start over,? the GAO reported.
In the case of chromium (VI), evidence shows that industry worked closely with the EPA as the agency conducted its assessment. On Oct. 8, 2009, a scientist at a law firm representing chemical companies complained in an email that the EPA was pushing ahead on its assessments without waiting for studies to address ?gaps? in the science.
?EPA moved Chrom VI up by about two years after ?we? entered into a process of planning research with them to address gaps,? wrote Richard Canady, a former scientist at the White House?s Office of Management and Budget (OMB), who was then working at the private law firm of McKenna, Long & Aldridge. ?I?d like to make a case for EPA planning ahead in cooperation with industry.?
Canady?s email was sent to Nancy Beck, a toxicologist at OMB who reviewed the EPA?s findings. Beck referred Canady to an American Chemistry Council official for help in gathering data. A 2009?investigation?by a subcommittee of the House Science and Technology Committee criticized Beck for improperly interfering with IRIS assessments during the George W. Bush administration. Beck now works for the ACC. She did not return a call last week seeking comment; an ACC spokesman said Tuesday?he would seek her perspective.
In a recent interview, Canady said he could not recall the precise details from his email and declined to reveal clients for which he was working. But Canady said he thought the process of planning research with the EPA ?wasn?t that formal.? Instead, industry scientists would call EPA scientists to find out what new data would help them in their chromium (VI) assessment, he said.
His 2009 email also said, ?Peter made a point to me the other day about how boron and methylene chloride were good examples of working together on developing data ahead of assessments in ways that influenced the outcome.?
Canady said this was a reference to Peter Preuss, then the director of the EPA?s National Center for Environmental Assessment, which oversees IRIS.
The EPA originally planned to issue its chromium (VI) assessment last summer, giving the ACC time to finish its new studies. However, under Jackson?s imperative to quicken assessments, the EPA moved up its timeline by six to nine months.
When the EPA?s Cogliano rebuffed the ACC?s request for a delay, the trade association turned its attention to the peer review panel.
Critics say the industry uses comments on chemicals that are under review to overwhelm the agency.
?There?s a very elaborate process that involves multiple opportunities for industry to pick away and blast away and confuse and overload the staff of IRIS, and the IRIS staff reacts by trying to address each and every one of industry?s concerns,? said law professor Steinzor.
?The chemical industry has made IRIS its leading target, one of its leading targets, for spoil in the current age of greed,? Steinzor said
Of the 49 public comments submitted to the EPA on chromium before the peer-review panel met, the American Chemistry Council and its research partners authored 29 of them, totaling 1,661 pages. In addition, 10 other comments totaling 137 pages came from industry urging the EPA to wait for the ACC studies.
As the EPA stood poised to announce potential new safeguards for chromium (VI), the ACC had hired a scientific consulting firm, ToxStrategies, to manage the $4 million studies of mice and rats given the chemical for 90 days.
The panel met May 12, 2011, at a Hilton hotel near Reagan National Airport. Patierno was highly critical of the EPA?s findings and suggested the agency ?absolutely consider the extensive new data being provided.? Hamilton and Wise agreed.
In a recent interview, Wise said he wasn?t entirely familiar with ToxStrategies? findings, which hadn?t yet been published. But he assumed the delay would be short, only a few months. The EPA initially said the delay would take four years. Later, the agency said the assessment would be done this year.
Anatoly Zhitkovich, a professor at Brown University who chaired the EPA peer review panel, was upset with the results and wrote his own review published in the journal?Chemical Research in Toxicology, according to Costa, a close colleague. Zhitkovich declined an interview request, but his?article?supported the findings of the EPA.
In lobbying for delay, the American Chemistry Council quietly enlisted the help of a small office within the U.S. Small Business Administration.
SBA Chief Counsel for Advocacy Winslow Sargeant, an electrical engineer by training, submitted a comment to the EPA on Oct. 5, 2011, challenging its scientific conclusions and urging it to delay its chromium assessment pending completion of the ACC studies. Winslow cited the peer review comments from Hamilton and Wise to support his argument.
But emails obtained through FOIA by the advocacy group Center for Effective Government revealed that the ACC helped shape the SBA letter. An ACC lobbyist, Randy Schumacher, sent an email to Sargeant?s office on June 28, 2011, asking for its help.
?Administrator Jackson calling upon her to stop the Cr6 risk assessment process to do exactly as EPA?s peer reviewers deemed advisable,? Schumacher wrote. ?Since it appears EPA needs to hear from more constituents for it to listen to its own peer review team, would SBA be willing to send a letter to Ms. Jackson to weigh in on this matter??
Later emails from Schumacher suggested editing changes to Sargeant?s letter. The SBA official has not responded to interview requests.
Source: http://www.publicintegrity.org/2013/02/13/12184/epa-unaware-industry-ties-cancer-review-panel
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