Matt Shudtz on CPRBlog {Bio}
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EPA's Coming Announcement on BPA

In response to a question at a National Press Club appearance on Monday, Lisa Jackson said that the EPA would be finalizing an action plan on BPA in the "very near future."

As I noted here in January, the EPA had announced in September that it would be releasing action plans on a number of chemicals, including BPA, but when the first group of plans was released in late December, BPA was not among them. I raised a red flag because EPA had sent six draft chemical action plans to White House's Office of Information and Regulatory Affairs (OIRA) on December 14, OIRA hosted a meeting with BPA industry lobbyists a week later, then the BPA action plan was absent from the list of plans released on December 30. OIRA had no business reviewing the chemical action plans in the first place since they are not regulatory actions covered by EO 12,866.

Last week, Sen. Chuck Schumer put some pressure on EPA and OIRA, asking Administrator Jackson for a written explanation regarding the “confounding decision” to hold back the BPA action plan. Now that the BPA action plan has been released from OIRA’s grip (Inside Story, 3/4/10) and delivered to EPA for publication, what can we expect it to say?

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Stakeholders Speak, and OSHA Listens

Today the top brass from OSHA opened their doors to the many stakeholders who have something to say about how the agency is doing in its efforts to protect U.S. workers. Of course, they got an earful.

The event marks a new path for OSHA, in that the head of the agency and top career staff took the time to sit face-to-face with occupational health experts, workers, worker representatives, and even the families of victims of workplace accidents, not just the usual cast of characters from the industry lobbying firms.

And it wasn’t just a cattle call. OSHA head David Michaels, Debbie Berkowitz (Chief of Staff), Richard Fairfax (Director of Enforcement), and Dorothy Dougherty (Director of Standards) engaged the speakers in a way that showed they not only cared about what the speakers were saying but are genuinely interested in taking action to protect workers from occupational hazards – hazards we know about as well as emerging hazards.

My testimony, based on our recent report, Workers at Risk: Regulatory Dysfunction at OSHA, can be found here.

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Eye on OIRA: Meddling with IRIS Again, Now on Arsenic

Add arsenic to the list of carcinogenic chemicals that will see delayed regulation from EPA as a result of OMB’s meddling. Last week, after almost seven years’ work, EPA released a draft assessment of the bladder and lung cancer risks posed by arsenic in drinking water. But the release of the final arsenic risk assessment is being delayed while EPA’s Science Advisory Board is asked to take yet another look at agency scientists’ work. As Jonathan Strong wrote in InsideEPA (sub. req'd) last week, the recursive review by SAB is “emboldening” activists who want to delay any potential new drinking water regulations.

Demanding external peer review of EPA scientists’ work on just about anything is a standard tactic industry uses to bide time before they have to shell out the money to clean up the messes they’ve made. Witness Sen. David Vitter’s hold on President Obama’s nominee for the head of EPA’s Office of Research and Development (the people responsible for IRIS assessments). Senator Vitter kept the hold on Dr. Anastas for months, until Administrator Jackson agreed to send the long-delayed formaldehyde IRIS assessment to the National Academy of Sciences for Review. That guaranteed Sen. Vitter’s constituents in the formaldehyde industry at least another 18 months of regulatory delay – more, if they can pull a few choice words from NAS’s eventual report and claim that they undermine the draft assessment.

A Senate hold on a presidential nominee isn’t the only way to ensure delay, though. Strong encouragement from people within the Executive Office of the President is another, and that’s just what the opponents of arsenic regulation got. In October 2008, EPA released an early draft of the arsenic IRIS reassessment for “interagency” review. OMB weighed in, as usual, with a set of comments that ask some highly scientific questions. As we’ve noted many times before in this space, OIRA’s small staff, with their expertise in economics and general regulatory policy and responsibility for overseeing the entire Executive Branch, should not be delving deep into the pre-regulatory science at one agency.

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Next Up on BPA: EPA's Chemical Action Plan?

FDA scientists have had a chance to develop an assessment of the risks of BPA in food contact applications using a fuller body of low-dose studies and concluded last week that there’s some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children (for a helpful analysis of the context of FDA’s decision, see Sarah Vogel’s post at The Pump Handle). Now, it’s time to look at what EPA is doing with respect to the ubiquitous endocrine-disrupting chemical.

In late September, Lisa Jackson announced that EPA’s Office of Pollution Prevention and Toxics would develop “action plans” for four chemicals or groups of chemicals, outlining potential future regulatory actions aimed at protecting the public and the environment from unreasonable risk. BPA was one of the candidates for an action plan, but when EPA released its four plans on December 30, BPA’s was not among them. EPA’s reason for delaying the BPA action plan was that it was waiting on FDA’s newest analysis and the results of $30 million worth of new studies being conducted under various grants from NIEHS.

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EPA Proposes New Lead Monitoring Requirements

EPA today took an important step toward reversing one of the Bush Administration’s “midnight regulations,” announcing a proposed rule that would improve monitoring standards for airborne lead. Under EPA’s new proposal, any establishment that emits lead into the air at a rate of a half a ton per year or more could be required to have a monitoring station.

In a previous post I noted that EPA finalized a rule in late 2008 that only required monitoring at sites with emissions topping 1 ton per year, after a last-minute entreaty from the lead battery industry and some of their accomplices at OMB. EPA had originally proposed a threshold somewhere in the 0.2 to 0.6 tons per year range.

After President Obama took over the White House and put Lisa Jackson in charge of the EPA, several environmental and public health groups petitioned the agency to reconsider the lead monitoring requirements. The newly proposed monitoring requirements are EPA’s response to the petition.
Monitoring stations that detect airborne lead are important to EPA because they help the agency determine whether existing emissions controls are keeping lead below the health-based ambient air quality limits set under the Clean Air Act.

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Regulatory Highs and Lows of 2009: OSHA and Toxics

CPRBlog asked some of our regular bloggers to give us some suggestions for the high and low points of the regulatory year. We began by taking the Bush Administration’s “midnight regulations” off the table, so that we could focus in on the Obama Administration’s impact to date. CPR Policy Analyst Matt Shudtz offers up a number of items, below, focusing on the positive:

At OSHA, several high points: 

  • The leadership of David Michaels (as Assistant Secretary, the head of OSHA) and Jordan Barab (as Deputy Assistant Secretary), both of whom seem intent on putting OSHA back on task – protecting workers – after years of agency wheel-spinning.

  • OSHA’s enforcement sweep of construction sites in Texas, in which the agency brought inspectors from other regions to conduct unannounced inspections. Actual enforcement of the laws! Texas earned the honor because it has the highest rate of construction fatalities in the nation.

  • Assessing meaningful fines. OSHA proposed the largest fine in its history this year. Under the proposal, BP would pay $87.4 million for safety violations and its failure to correct hazards at the Texas City refinery, where an explosion killed 15 workers and injured 170 in 2005.

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FDA Needs More Time for its Report on BPA

Yesterday came and went with no announcement from the FDA on the safety of BPA in food packaging. The agency had created a self-imposed November 30 deadline for releasing a new finding, and in the intervening months, a number of new studies on the health effects of BPA have been released and FDA has brought in an outside expert to head up the review. These developments have understandably slowed the review process.

The question before FDA is whether BPA is safe for its intended use in food contact applications -- the lining inside cans, for example. So Kaiser Permanente’s recent headline-grabbing study that showed an increased likelihood of erectile dysfunction and problems ejaculating among workers who were highly exposed to BPA in a Chinese plant might not be very useful in making that determination. But the many studies showing correlations between various exposures to BPA and other adverse health effects might be more important.

As Meg Kissinger reports in the Milwaukee Journal-Sentinel, FDA’s review panel – now headed by Lynn Goldman of the Johns Hopkins School of Public Health, a renowned expert on endocrine-disrupting chemicals – must make its safety determination amidst a whirlwind of other developments, including voluntary restrictions on certain uses of BPA by the chemical’s manufacturers, local laws banning BPA use in baby bottles, and petitions from public health NGOs for new product labels, warnings, and temporary bans on specific uses of BPA.

The intertwined policy developments and evolving science on BPA’s toxicology have created a difficult environment for FDA to communicate a clear statement to the public about the health concerns connected to BPA. But slow reactions to experts’ warnings on public health threats have plagued FDA in recent years (e.g., suicides linked to antidepressants, dangers posed by children’s use of over-the-counter cough and cold medicines). The BPA review presents an opportunity for FDA to show it can be on the leading edge for a change.

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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 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:

  1. Publish an annual Federal Register notice announcing EPA’s IRIS Update Project agenda and calling for scientific information from the public regarding assessments on the agenda;
  2. Conduct a comprehensive search of the current scientific literature on each assessment;
  3. Develop draft health assessment documents using state of the science methods and guidelines;
  4. Conduct a combined simultaneous review of the draft assessment documents by EPA and other Federal Agencies via the Federal Standing Science Committee;
  5. Solicit public comments on draft assessments, followed by independent external peer review under the Federal Advisory Committee Act (FACA);
  6. Prepare final IRIS assessments that reflect public comments and independent expert review; and
  7. Replace the existing assessments with the final updated IRIS assessments on the IRIS website.

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.

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Sunstein Watch: OMB Meddling on Endocrine Disruptor Screening Program Means Shifting a Key Burden From Industry to EPA

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 to EPA’s.

Put another way, Obama’s OIRA snuck through the back door changes that industry had failed to get through the front door of the normal administrative process during the Bush Administration, ultimately forcing changes that threaten to completely undermine the EDSP, which has been moving at a snail’s pace in the face of ferocious industry opposition for well over a decade. Once again, like the episode we reported yesterday ("Don't OMB Economists Have Better Things to Do Than Channel Industry Opposition to EPA Science?"), this particular bit of mischief was a fait accompli before Cass Sunstein was confirmed as OIRA Administrator. And, once again, the episode shows how much work Sunstein will have to do to transform and redirect an institution that in far too many ways continues to behave as if George W. Bush and his anti-regulatory appointees were still running the government.

Aware that chemicals used as active and “inert” ingredients in pesticides have the potential to disrupt the delicate balance of estrogen, androgen, and thyroid hormones, Congress mandated that EPA develop a research program that would help government regulators better understand the effect of pesticides on such systems. After years of advisory committee meetings, stakeholder input, and internal study, EPA in late 2007 proposed a two-tiered strategy for implementing the EDSP. First, EPA would issue test orders to pesticide registrants requiring them to put certain chemicals through a series of assays, screening to see which chemicals have the potential to interact with estrogen, androgen, and thyroid hormones (“Tier 1 Screening”). EPA would then require that the chemicals that exhibited a potential to interact with the hormones be run through a series of more demanding tests to determine how they actually interact (“Tier 2 Testing”).

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New Research on Radioactive Granite, and OSHA's Response

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 Gerhart suggest that stone cutters could potentially be exposed to radiation levels many times greater than recommended exposure levels for the general public.

Granite’s radiation problem is not new, and the Marble Institute of America, one of the industry’s main trade associations, was quick to commission its own study to challenge the worker exposure research. The MIA-commissioned study questioned Bernhardt et al.’s sampling techniques and statistical analysis. And the MIA, for its part, argued that it is standard practice within the industry to use wet-cutting techniques (which would limit dust but weren’t used when Kincaid and Gerhart did their sampling). But by the MIA’s own account, over 25 percent of stone fabricators don’t use those techniques.

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