Last month, EPA published for public comment a draft “framework” for human health risk assessment. It is the culmination of years of work done by EPA staff who are part of the Risk Assessment Forum, a select team of experts from various offices throughout the agency whose efforts were overseen by the Office of the Science Advisor. Billed as a response to the National Research Council’s Science and Decisions: Advancing Risk Assessment (a.k.a. the “Silver Book”), the Framework really only addresses one of NRC’s recommendations. And it proposes policy changes that threaten scientific integrity.
The Silver Book’s Chapter 8 looks innocuous at first glance, suggesting that improvements in EPA’s risk assessment process should include reforms that “[make] risk assessments more useful for informing risk-management decisions.” But the simple utilitarian façade masks a proposal that would induce a revolutionary shift in the way EPA risk assessments are conducted. To make risk assessments more useful, NRC proposed a process wherein risk managers (the agency policymakers with the closest ties to political appointees) would sit down with risk assessors (the agency scientists who read the scientific studies and interpret their meaning in terms of potential risks to the public) before the risk assessment begins, with an objective of defining the scope of the risk assessment. The concept of risk assessors and risk managers working together is not unreasonable, but as with any practical effort to put in place a general recommendation, the devil is in the details.
How best to maintain protective distance between risk assessors and risk managers is a controversial subject. Without independence from policymakers and their agendas, risk assessors are extraordinarily vulnerable to manipulation. The high profile case of the Fish and Wildlife Service’s Julie MacDonald, a Bush Administration political appointee who tampered with scientific evidence behind endangered species listings shows just how far these problems can go.
Full textThe White House’s message on its program for retrospectively reviewing existing regulations just shifted a little further away from recognizing the need for protective regulations for health, safety, and the environment. First the White House said it was interested in "expanding" certain existing regulations, if appropriate. Then it said it was interested in hearing ideas from the public on expanding regulations, but officially considers those ideas to be a lower priority than ideas that would weaken regulations. Now today, a new website launched by the White House pushes the notion of any balance in regulatory review further off the table.
Let me step back. Executive Order 13,563, issued by President Obama in January of 2011, announced the regulatory look-back program we’ve discussed a lot here:
To facilitate the periodic review of existing significant regulations, agencies shall consider how best to promote retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.
A key word there was expand. If agencies were to divert some of their current staff from working on needed new public protections to re-evaluate existing ones (the White House has never sought, let alone received, any new funding for the look-back programs at the agencies), at least it might, in theory, be a somewhat balanced exercise that could identify needed expansions to existing rules. Cass Sunstein, the Administrator of OIRA, has himself publicly noted the importance of the word “expand.” The process, we hoped, might not be simply weakening existing rules.
Full textYesterday, the U.S. Food and Drug Administration (FDA) announced that it would amend an existing food additive regulation to prohibit the use of Bisphenol A (BPA) in “infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups).” BPA, a chemical commonly added to polycarbonate resins (a fancy word for plastics), continues to raise concerns over its low-dose, endocrine-disrupting health effects. Despite these health and safety concerns, the FDA’s decision to ban BPA in these limited items responds to a petition from the American Chemistry Council (ACC), which cites abandonment as the reason for the regulation amendment—not safety.
The good news about FDA’s BPA ban: FDA finally took an affirmative step toward protecting some of the public from BPA. The bad news: the step is a meager one that establishes little more protection than state legislatures and grass-roots campaigns have already achieved through state bans and market pressures. FDA, in other words, permanently banned BPA from products that already have removed it.
As I explained in a previous blog posting concerning CPR Member Scholar Noah Sach’s and my comments on the ACC’s petition and in CPR’s previous white paper on BPA regulatory options, FDA can take much larger and more meaningful steps to protect the public. These steps begin with recognizing the safety and health risks associated with BPA and include implementing broader bans without regard to age and use limitations and mandating BPA labeling requirements.
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Good news for the Arctic! “I believe there will not be an oil spill”—this according to Ken Salazar, the nation’s Secretary of Interior and, now, environmental crystal-gazer. As someone still fretting about BP’s mess in the Gulf, I want to believe; but it’s hard. So let me back up.
Earlier this week, Secretary Salazar said it was “highly likely” that his agency would grant Shell Oil permits to begin drilling exploratory wells in Arctic waters north of Alaska, despite opposition from many environmental groups. While acknowledging the many challenges presented by such an operation, the Secretary recalled his department’s new permitting standards and expressed confidence in a new oil containment device that was recently tested in Washington’s Puget Sound.
Then: “I believe there will not be an oil spill. . . . If there is, I think the response capability is there to arrest the problem very quickly and minimize damage. If I were not confident that would happen, I would not let the permits go forward.”
Full textMember Scholar Noah Sachs and Policy Analyst Aimee Simpson have sent a letter to the EPA nominating the chemical Bisphenol A (BPA) to be included on the “Fourth Contaminant Candidate List” for possible regulation. They write:
Pursuant to the Safe Drinking Water Act Amendments of 1996 (SDWA), the U.S. Environmental Protection Agency (EPA) must compile a list of unregulated contaminants that are known or anticipated to occur in public water systems and may require regulation under the SDWA. EPA then must make a decision about whether or not to regulate a least five of the contaminants on the list. EPA recently issued a notice and request for nomination of chemical and microbial contaminants for possible inclusion in the fourth drinking water Contaminant Candidate List (CCL 4). Under existing guidelines, EPA selects contaminants for a CCL based on a scoring system that addresses two primary factors: health effects and occurrence in water supplies. BPA received a low score on this scale during deliberations on the CCL3 and was not included on that list. We believe that new information published since the CCL3 deliberations will change BPA’s score. It deserves your close attention, and BPA should be added to the CCL 4.
Sachs and Simpson explain that the scientific research on BPA has advanced significantly, particularly with regard to low-dose impacts. They write: “these low-dose health effects are not properly accounted for in current risk assessments of BPA and CCL evaluations.” The full letter is here.
Full textThe end of the school year always leaves me wishing that I could have lectured more clearly or somehow covered more in my classes on environmental law and policy. There was really just too much to discuss. How does one do justice to all those doubtful arguments in support of the Keystone XL pipeline? It’s a job creator! A gasoline price cap! A floor wax! Or the continuing saga of how the Obama administration should reorganize the offshore drilling responsibilities assigned to the MMS, I mean BOEMRE, I mean BOEM/BSEE. And there is never enough time to test it all.
This year I’ve assembled a few questions that have been on my mind this semester but that didn’t make it onto the exam. (Answers are posted at the bottom of this page). By the way, if you’re a regular reader of CPRBlog, this should be a snap: All of the answers can be found in CPRBlog entries from the last five months.
So find a quiet spot, sharpen that No. 2 pencil, and test your knowledge.
1. Last year, when the EPA began limiting emissions of CO2 from coal-burning power plants and other sources, the energy industry blew a fuse. Affected companies publicly argued that greenhouse gas regulation had gone too far. But last February during oral argument before the U.S. Court of Appeals, lawyers for some of those same companies argued that the agency’s rule was invalid because it did not go far enough. According to them, what was wrong with the rule?
Full textTwo years ago tomorrow, Saturday, EPA sent a seemingly modest idea over to the White House for a quick review. The agency wanted to establish a simple list of “chemicals of concern.” These weren’t chemicals that were necessarily going to be subject to bans or other restrictions, but they present significant enough hazards and are distributed widely enough in the environment to raise some eyebrows among EPA’s toxics staff. Among the chemicals that were being proposed for inclusion on the list: phthalates, PBDEs, and BPA. The rule wasn’t expected to cost much, but EPA sent it to the White House anyway, probably because this was the first time the agency would use a particular statutory authority Congress first granted in 1972. But two years after EPA sent the proposal to the White House, it is still sitting on a desk somewhere at OIRA, and I think it’s time to say it: OIRA has killed this rule.
It’s troubling that such a small thing as a list of dangerous chemicals could be dashed by the White House. In 2009, GAO added EPA’s toxics program to its list of “high-risk programs warranting attention from Congress and the executive branch.” Surely, this is not the kind of attention GAO had in mind. GAO’s auditors have noted that
Full textEPA has a limited ability to provide the public with information on chemical production and risk because of TSCA's prohibitions on the disclosure of confidential business information. About 95 percent of the notices companies have provided to EPA on new chemicals contain some information claimed as confidential.
With considerable media flourish, the Department of Justice (DOJ) announced Tuesday the first and so far only criminal charges related to the BP Deepwater Horizon catastrophe that killed 11 workers, and did profound violence to the Gulf of Mexico and the local economies dependent up on it. One Kurt Mix, 50, an engineer involved in designing the failed “top kill” remedy, was indicted for obstruction of justice. More specifically, he's accused of deleting text messages from his phone that he knew were to be collected as evidence in the case..
Prosecutors made Mix do a perp walk for reporters, with the New York Times reporting that he “surrendered” in Houston, “wearing a light purple shirt and pair of khakis without a belt.” Several legal experts, including Professors Richard Lazarus (former executive director of the Oil Spill Commission) and David Uhlmann (former chief DOJ environmental crimes prosecutor) predicted that the arrest of Mix would help prosecutors build cases against those further up the food chain. With all due respect to these hopeful—really wishful—predictions, it’s way too soon for DOJ to take a victory lap.
For one thing, Attorney General Eric Holder has amassed an underwhelming track record in prosecuting perpetrators of unspeakable and fatal health, safety, and workplace crimes, including Don Blankenship, former chief executive officer of Massey Energy, whose obsession with “digging coal” without pausing to ensure safety requirements are met, led to extraordinarily hazardous working conditions at the Upper Big Branch mine, where 29 miners died in the worst disaster in 40 years; and Stewart Parnell, the chief executive of the Peanut Corporation of America, whose decision to ship peanut paste that tested positive for salmonella killed nine and sickened hundreds. Elsewhere in the regulatory arena, Holder has not yet delivered on prosecuting financial crimes documented in two dozen books, television programs, and movies.
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I spent last Friday – the second anniversary of the BP Blowout – in the vast basement of the Orleans Parish Criminal District Court building, shifting in my metal chair, ignoring the talk-show chatter from the flat screens, and keeping an eye on the red digit counter to know when my number was up.
I'd been called for jury duty.
Whether I will eventually be deployed is up to the gods, but until then I had resolved to study (with the help of this building's creaking Wi-Fi system) all 2,000 pages of the proposed multibillion-dollar settlement in the Deepwater Horizon case – the settlement made public last week by BP and thousands of Gulf Coast residents and businesses. (I blogged earlier when the broad outline of this settlement was first announced here.)
Now some of you may wish to savor the details, poring over the documents page-by-page between sips of Courvoisier. But for the rest, I've got the bottom line [SPOILER ALERT]: The proposed settlement rewards plaintiffs' hard bargaining, puts a crimp in federal and state hopes for a speedy trial, and demonstrates once again that despite the size of this deal, the main course is yet to come, in the form of federal civil fines and possible criminal prosecution.
Full textCPR Member Scholar Noah Sachs and I submitted comments yesterday to FDA regarding the American Chemistry Council’s (ACC) petition to the agency on BPA. In September, the ACC petitioned FDA to remove approval for the use of BPA in “infant feeding bottles and certain spill-proof cups” (Rena Steinzor and I explained at the time the story behind the seemingly counter-intuitive move).
In our comments this week, we advocate for FDA to utilize its full rulemaking authority and take broader regulatory action to protect the public against BPA. Specifically, we propose:
As we explain in the comments, convincing scientific evidence supports these broader measures because of the demonstrated low-dose effects of BPA and other endocrine disrupting chemicals. These low-dose effects are not properly accounted for in current risk assessments of BPA and it is the role of FDA to act on behalf of all consumers' safety.
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