IRIS Update: EPA Announces New Program to Revise Old Chemical Profiles
In 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 …
Greenwire and the Los Angeles Times ran pieces last week shining a light into a dark corner where staff at the Office of Information and Regulatory Affairs once again meddled in scientific regulatory programs where they do not belong, second-guessing EPA’s administration of the Endocrine Disruptor Screening Program (EDSP). The program, mandated by Congress under the Food Quality Protection Act, is designed to identify pesticides like DDT that cause profound changes in wildlife and, potentially, people, through the ubiquitous application of pesticides. Both articles highlighted the key problem, which is that the OMB-promoted changes to the EDSP would undercut EPA’s attempt to get a full suite of new test data on 67 chemicals’ potential endocrine-disrupting effects. But there's an additional important issue: OMB’s meddling, under the auspices of its power to enforce the Paperwork Reduction Act, shifted a heavy burden from industry’s shoulders …
Granite, like most natural stones, contains radioactive material. While this isn’t much of a concern for a person who spends a few hours in a kitchen with granite countertops every day, new research by David Bernhardt, Linda Kincaid, and Al Gerhart suggests that the workers who fabricate those countertops might have reason to worry.
When they cut granite slabs to fit a room and to have nice edges, corners, and cut-outs for sinks and appliances, workers’ saws can create a lot of dust, and that dust can contain uranium, thorium, and other radioactive materials. If the dust isn’t properly controlled and the workers are not wearing the right protective equipment, they can inhale the dust, where it can cause real damage to the vulnerable tissues in their lungs. Based on limited sampling and some conservative assumptions about control equipment and exposure duration, Bernhardt, Kincaid, and …
Earlier this month, EPA released for public comment a new white paper on probabilistic risk assessment, marking the Obama Administration’s first major foray into the contentious debate about EPA's evolving risk assessment methods. Back in May, EPA Administrator Lisa Jackson announced changes to the way the Office of Research and Development (ORD) will update risk assessments for the IRIS database, but that announcement was made without any real public input and it only implicated the inner workings of one program office (albeit an important one). The public comment period on the new white paper presents the first opportunity for the various stakeholders who usually weigh in on EPA’s risk assessment policies to have some say in the new administration’s policies.
The new white paper, Using Probabilistic Methods to Enhance the Role of Risk Analysis in Decision Making, focuses on one of the fundamental …
On Monday, the big news out of FDA was the announcement that they’re going to publish a new assessment of the risks posed by BPA in food packaging, due out by the end of November. Jesse Goodman, FDA’s Chief Scientist, made the announcement at a meeting of the agency’s Science Board, which also heard two presentations by scientists from different offices within FDA working on the new assessment.
Last year, FDA formed a task force to assess the risks of BPA and the task force quickly concluded that “there is a large body of evidence that indicates that FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects.” Given the rapid development of new studies on BPA in the diet, it …
Following up on Ben’s post about Tuesday’s Senate HELP Committee hearing on medical device preemption, I’d like to respond to three issues that came up during the question-and-answer session.
Innovation: Senators Harkin and Hatch had a bit of a disagreement about whether the possibility of tort liability stifles innovation by medical device firms. Peter Barton Hutt, who Senator Hatch lauded as the “dean of all FDA lawyers,” noted that he sits on the board of ten small biotech firms and that “decisions made by venture capitalists based upon such issues as potential liability directly affect every one of those companies.”
Two points here. First, it is a good thing that investors take into account potential tort liability. In the context of FDA-approved medical devices, tort law simply ensures that companies are operating according to a duty of care defined by a standard of reasonableness …
Last 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 …
The Bush Administration’s anti-regulatory henchmen in the Office of Management and Budget are at it again – fighting to keep EPA and state environmental agencies in the dark about how much pollution is being emitted into the air.
On October 16, EPA announced that it was slashing the National Ambient Air Quality Standard for lead from 1.5 micrograms per cubic meter (µg/m³) to 0.15 µg/m³. (Side note: EPA’s 90-percent reduction in permissible lead levels is good, but it’s still on the high side of the 0.05 – 0.2 µg/m³ that its scientific advisory board suggested.) In order to enforce the new standard, EPA included in the rule new requirements for the number and location of lead monitoring stations. EPA requires a lead monitor for any facility that produces more than one ton of airborne lead per year.
But the …
On 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 …
While his colleagues (and former colleagues) jockey for the healthcare reform limelight, Rep. Frank Pallone is quietly busy making sure that, regardless of who pays for healthcare, the sick and injured will have safe and effective solutions to their problems. Last Thursday, Rep. Pallone held a hearing to assess FDA’s ability to properly oversee the medical device industry. The testimony outlined a troubling picture.
GAO has been closely monitoring FDA’s medical device program for years. On Thursday, Marcia Crosse, the head of the government watchdog’s health care division, testified about three serious shortcomings in FDA’s work. To begin, FDA isn’t necessarily reviewing high-risk devices according to the most stringent premarket review processes, meaning the devices might reach the market without adequate review of their inherent dangers, putting patients at increased risk. That problem leads to the second flaw GAO identified – FDA is …
