The EPA announced yesterday that they’re changing the way they treat manufacturers’ claims that certain information about toxic chemicals should be kept secret.
Richard Denison of EDF has a useful explanation and analysis of this good news.
Rena Steinzor and Matt Shudtz explored the dangers of secrecy in chemical science in a 2007 CPR white paper, Sequestered Science: Secrets Threatening Public Health.
Full textMy family has gotten a lot smaller lately. My mother died in 2004, my father in 2007, and my uncle in 2008.
I’ve done the five stages of grief, as introduced by Elisabeth Kübler-Ross in 1969, but not exactly as she described. It’s true that I initially felt denial: “I’m a lucky person; this can't be happening.” Then I was angry and felt sorry for myself. Then, at least during my mother’s struggle with pancreatic cancer, I hit the bargaining table. Mom was a Sunday school teacher when I was little, so I pleaded with God: “Please let the diagnosis be wrong, please let the chemo work, please don’t let the good die young.” To hedge my bets, I occasionally promised, “if she can beat the odds, I’ll volunteer at the local cancer center and I’ll donate my life savings to research.” It didn’t work. In less than four months, she was dead.
Depression crept in, and this stage held me in its grip for a long time. I gained acceptance a year or two after my mother’s death—she would’ve wanted me to—but this stage eluded me with the loss of my father and my uncle. Now, I’m just angry. Outraged, in fact.
My father had stomach cancer. My uncle had prostate cancer. Both were farmers.
Full textOn Monday, OMB Director Peter Orszag sent a letter to Rep. Ed Markey, responding to Congressman Markey’s concerns about OMB’s involvement in EPA’s Endocrine Disruptor Screening Program. Orszag’s letter -- released by Markey's office Wednesday -- explains, in no uncertain terms, that OMB is done meddling in EPA’s scientific determinations about endocrine-disrupting chemicals. It’s a step in the right direction for Orszag and OIRA Administrator Cass Sunstein, who have their work cut out for them if they are going to -- I hope -- work to halt OMB’s historical penchant for interfering in EPA’s work.
Congressman Markey’s concerns about OMB involvement in the EDSP were stoked by the same events that prompted the letter that CPR Board Member Robert Glicksman and I sent to Mr. Sunstein and his colleague Dr. John Holdren of the OSTP. We saw a trail of documents suggesting that OMB was pressuring EPA to revise the procedures through which it would allow pesticide manufacturers to avoid EPA orders to test their products for potential endocrine-disrupting effects. (See CPR Policy Analyst Matthew Shudtz’s October 20 post for details.)
In his letter to Rep. Markey, Mr. Orszag wisely avoided delving into the scientific underpinnings of the EDSP. And in testimony before the House Energy and Commerce Committee’s Subcommittee on Commerce, Trade, and Consumer Protection on Tuesday, EPA’s Steve Owens testified that, after numerous conversations with Mr. Sunstein, it is his understanding that OMB’s terms of clearance for the EDSP Paperwork Reduction Act Information Collection Request “in no way” limits EPA’s discretion under the program.
OMB’s course correction on this issue is great news for scientific integrity. Unfortunately, it cannot undo the mistakes of the past – in particular, the Bush-era changes to the EDSP that opened the floodgates for industry to claim that their old test data are adequate to replace a full battery of new tests that EPA would prefer that they undertake. EPA’s procedures for dealing with “Other Scientifically Relevant Information” aren’t perfect, but the past is behind us, and the future is looking up.
Full textCPR President Rena Steinzor and board member Robert Glicksman sent a letter today to White House Science Adviser John Holdren and OIRA Administrator Cass Sunstein regarding OMB's role in EPA science decisions. The letter concerns two recent episodes involving OMB that we wrote about this week: one regarding the EPA's Endocrine Disrputor Screening Program (EDSP) and the other regarding the agency's Integrated Risk Information System (IRIS). From the letter:
Both of these episodes pre-date Professor Sunstein’s confirmation and may well be the product of staff steeped in the culture of OMB regulatory review under the Bush Administration. The episodes represent a direct assault on scientific integrity because they involve attempts to reverse conclusions by agency experts at the behest of regulated industries whose central objections were rooted in concerns about potential future compliance costs, not the accuracy of EPA’s science. Compounding the offensiveness of this interference is the fact that the decisions that were derailed involved efforts to analyze scientific research that were preliminary to any regulation of industry activities.
The letter asks Holdren and Sunstein to clarify the extent of OMB’s role in reviewing agency science.
Full textIn Wednesday's Federal Register, EPA unveiled a new, streamlined process through which agency scientists will systematically review old chemical profiles in the IRIS database and update them with the latest toxicological information. With everything from Clean Air Act residual risk determinations about hazardous air pollutants to Superfund site cleanup standards to Safe Drinking Water Act regulations turning on the toxicological profiles housed in the IRIS database, it is a huge step in the right direction for EPA to be proactively screening old profiles to make sure they are up-to-date.
In 2003, the Eastern Research Group conducted a literature review to determine which chemicals in the IRIS database had been the subject of new toxicity or carcinogenicity studies since their last significant IRIS update. The researchers identified new health effects information for 169 chemicals (37% of those reviewed) that, if evaluated in detail, could possibly result in a change to an existing value. Additionally, the researchers found studies that could possibly fill data gaps for 281 chemicals (61% of those reviewed) whose IRIS entries were incomplete. Only a handful of chemical profiles made it through the Bush Administration’s IRIS assessment process, so it is unlikely the numbers have changed much since the Eastern Research Group’s study was published.
The IRIS Update Project, as described in Wednesday’s Federal Register notice, will focus on revising toxicological profiles that are more than 10 years old and will prioritize those chemicals that are most important for Clean Air, Superfund, and Clean Water program staff. The seven-step process that EPA has laid out seems reasonable enough, although the announcement is a bit thin on details for a majority of the seven steps. Here is how EPA describes the process:
Wednesday’s announcement does not get into the details of Steps (3) through (7), and, of course, these are the aspects of the program that are most likely to lead to the heated debates that can derail an IRIS assessment. But it is good to see that EPA will be utilizing the FACA framework to engage external peer reviewers. FACA is not perfect, but it will provide a degree of transparency and protection from bias that will benefit the IRIS Update Program.
Full textSen. Charles Grassley (R-IA), of late in the news for his role as power player in the health care debate, has long enjoyed a reputation as a Republican maverick. One reason for that reputation is his highly publicized crusade to improve ethics in the medical profession, specifically with respect to “ghost writing” of medical journal articles. In recent years, it’s become disturbingly common for pharmaceutical companies to hire public relations firms to write summaries of scientific research supporting their products and then pay hefty fees to high-profile academic researchers who sign the drafts and submit them for publication without disclosing their affiliation with their corporate sponsors.
Grassley’s campaign was first featured on the front page of the New York Times in June 2008, with an exposé on a Harvard child psychiatrist who failed to disclose the money he earned from manufacturers of antipsychotic medicines for pushing their use for children. The newspaper has also reported on a spate of ghost-written articles pushing the use of hormone replacement therapy for women. On Wednesday, it was Grassley’s demand that the National Institutes of Health crack down on the practice. Specifically, he wants to know what that august institution plans to do about its own individual researchers, as well as the primary investigators on its grants who have violated “medical ethics.”
Ghost-writing is a troubling practice in the context of academic research, and the failure to disclose such affiliations violates the policies of leading medical journals such as the New England Journal of Medicine, the Lancet, and the Journal of the American Medical Association. Universities should craft policies on the practice and educate their faculty members on its ramifications. Scientists who are careless about what they do and don’t disclose run the risk of compromising their reputations, not least of all with their peers.
But as reported by the media, Grassley’s crusade has taken on characteristics of a witch hunt, especially because the senator, who is himself well-funded by the pharmaceutical industry, seems much more interested in exposing individual scientists who have crossed his line in the sand than criticizing the companies for sponsor the ghost-writing. It’s hard to muster much sympathy for a prominent research scientist who takes millions in payments from drug companies, forgets to mention those affiliations when reporting on supposedly dispassionate research, and then gets challenged by his fellow scientists. But implying that an arm of the federal government should take steps to establish a process for punishing those individuals could degenerate into persecution, especially because analogous efforts to challenge the integrity of individual researchers have such a troubling history.
Full textOn Wednesday, the Bipartisan Policy Center's Science for Policy Project released its report (press release, full report) on the use of science in regulation-making. I was on the panel and thus am a bit biased, but I think the report makes a terrific contribution. It significantly narrows the range of positions that can be credibly debated about the appropriate level of oversight needed to ensure the quality of regulatory science. At the same time, it introduces some important new ideas for improving science-policy, like creating incentives for scientists to provide stronger peer review. In the process of finalizing the report, we all had to make some concessions. Rather than feeling that the resulting recommendations were of the lowest-common-denominator type, however, I believe the entire panel felt that the report contains a lot of specific details that, if implemented, would be dramatic improvements on the status quo. Hopefully the report will be useful to OSTP’s work and other highly respected groups, like CPR, will agree with many of the recommendations.
Full textLast Thursday, EPA announced (pdf) that they would reconsider a rule on monitoring lead in the air that was published in the waning days of the Bush Administration. I wrote about the original announcement, criticizing EPA for turning its back on children in neighborhoods like mine, where certain sources of airborne lead wouldn’t be monitored because of some questionable lobbying by the lead battery industry. Long story, short: After originally proposing and asking the public to comment on lead monitoring thresholds between 200 and 600 kilograms per year, EPA changed its mind at the last minute and finalized a rule requiring monitors only at sources of airborne lead with outputs above 1000 kilograms per year.
This is an important issue because airborne lead has well known adverse impacts on neurological development. In its recitation of the justifications for regulating lead, EPA notes that manifestations of lead neurotoxicity include sensory, motor, cognitive, and behavioral impacts. Lead has been linked to lower scores on IQ tests and negative impacts on attention, memory, learning, and visuospatial processing. In the understated language of a federal agency, “Poor academic skills and achievement can have ‘enduring and important effects on objective parameters of success in real life,’ as well as increased risk of antisocial and delinquent behavior.”
Of course, kids in my neighborhood weren’t the only ones EPA would have been neglecting under the Bush-era rule, so back in January representatives of several local, state, and national organizations formally requested that EPA reconsider the rule. Their request shows, in stark terms, the struggle between OMB’s politically driven staff and EPA decisionmakers who were dutifully working to protect the public health. In one exchange after OMB requested that EPA double the threshold for “source-oriented” monitors, EPA staff sent back an e-mail informing them “that if OMB wants a 1 ton threshold, it would have to provide a rationale for that point of view,” emphasizing that the rationale should be “a technical rationale, and not policy views.”
Full textOn March 9, President Obama announced a science integrity initiative aimed at taking the politics out of science. In his memorandum that day, he laid out the broad principles and instructed the director of the Office of Science and Technology Policy (OSTP) to “develop recommendations for Presidential action designed to guarantee scientific integrity throughout the executive branch” - and to have the recommendations within 120 days. John Holdren has since been confirmed as OSTP Director.
Yesterday, Tuesday July 7, was 120 days after March 9. But there’s been no announcement of what Holdren is recommending.
CPR scholars have written extensively about the clean science initiative, lauding the initial announcement, sending initial ideas to Holdren and asking him to open the process to public comment, and lauding the White House when they did just that. In May, we submitted our comments to OSTP with our full recommendations on science integrity.
Let’s hope Holdren's recommendations are almost ready and will be made available for public scrutiny soon.
Andrew Freedman of washingtonpost.com's Capital Weather Gang has a nifty catch: the Heartland Institute, the people cluttering up my newspaper this week with climate-change-denying ads, have officially changed tack on their lobbying policy. Back in March, the group told Freedman:
"Our purpose is to bring scientists, economists, and policy experts together to address issues overlooked or ignored by the IPCC [the United Nations Intergovernmental Panel on Climate Change] .... If we really wanted to influence policy we would have held the event in Washington, not New York - as many of the policy wonks at the conference have urged us to do, but we resist."
But the group ended up holding its conference in Washington this month. Now they tell Freedman:
"The reason we moved up the date, changed the location, and presented a shorter schedule ... was to bring our message to elected officials in Washington D.C. in time to inform the debate over climate and energy policy."
Inform, right.
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