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Aug. 13, 2009 by Rebecca Bratspies

Paterson's Executive Order: Win for Industry, Loss for Public Health and Safety

This is one of two posts today by CPR member scholars evaluating NY Gov. David Paterson's recent executive order on regulations; see also Sid Shapiro's post, "New York Governor Channels Ronald Reagan: Governor Paterson’s Flawed Plan to Review Regulations."

It is open season on environmental, health, and safety regulations in New York. Last Friday, August 7, Governor Paterson issued an Executive Order directing his public safety agencies to review all of their regulations with an eye toward eliminating any that are “unnecessary, unbalanced, unwise, duplicative or unduly burdensome.

This language could have been lifted directly from anti-regulation lobbying groups. The Governor's press release actually touts: "Streamlined Regulations Will Better Protect the Health, Safety and Welfare of all New Yorkers." Nothing could be further from the truth.

The Order requires each agency to conduct a 60 day comment period and then select at least two regulations to designate for further review, the selection to be based on which regulations have generated the most widespread or substantive criticism and opposition.

Think about what this means.

Paterson’s Executive Order gives well-financed, well-organized business groups a second bite at the apple on a host of regulatory battles that …

Aug. 11, 2009 by Holly Doremus
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This item cross-posted by permission from Legal Planet.

When it comes to climate change, lawyers and policymakers (and scientists too) have been guilty of emphasizing greenhouse gas emission reduction, almost to the exclusion of everything else. Adapting to climate change has taken a distant back seat, even as it has become increasingly clear that the world is already committed to some pretty dramatic changes.

That’s beginning to change. Earlier this summer, the U.S. Global Change Research Program issued a major report detailing the present and expected future impacts of climate change in the U.S. Scientific studies with troubling data continue to pile up, like this one published this week by researchers from the US Geological Survey’s Western Ecological Research Center finding that large-diameter trees are declining in Yosemite National Park, an effect they attribute primarily to water stress and expect to accelerate as …

Aug. 11, 2009 by Shana Campbell Jones
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One of the ongoing tensions in environmental law is the conflict between uniformity and flexibility, constancy and change. Many of the environmental successes over the past thirty years derive from uniform standards that are straightforward to administer and enforce. The Clean Water Act’s requirement, for example, that all industrial polluters are obligated to utilize the same end-of-pipe, technology-based pollution controls is responsible for dramatically cleaning up our waters.

There are, of course, still more low-hanging fruit to be addressed under our existing laws, but building upon the environmental gains we have made is also challenge. The remaining problems are often complex, the pollution sources more dispersed, ecosystems change. Developing policies to clean up or prevent a particular mess is one thing, but developing policies that respond to new scientific information and promote ecosystem health more broadly is quite another. Environmental managers, regulators, and policymakers are thus …

Aug. 10, 2009 by Wendy Wagner
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On 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 …

Aug. 10, 2009 by Matthew Freeman
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CPR's Sid Shapiro is interviewed in this week's edition of Living On Earth, the environment-focused public radio show heard in 300 markets around the nation.  The subject is David Michaels's nomination to head the Occupational Safety and Health Administration.   Says Shapiro:  "David Michaels has his job cut out for him. I think it's fair to say that OSHA is one of the most dysfunctional agencies in Washington. For example, Congress had a plan how to regulate toxic chemicals in the workplace. And OSHA has been almost unable in the last ten years or so to fulfill that plan. In fact, it's only issued three health regulations in roughly the last 10 to 15 years."   Text of the interview is here.  It's downloadable, here.  And streamed, here.

Aug. 6, 2009 by Alexandra Klass
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One of many approaches to combating climate change is “Carbon Capture and Geologic Sequestration” (CCS). It’s a pretty straightforward idea: capture climate-change-causing carbon emissions and lock them up underground, rather than letting them float up into the atmosphere where they would contribute to global warming.

The concept may be simple, but the actual engineering of it is as complicated as you might guess. The first problem is capturing and transporting CO2 emissions to their “resting place.” And then comes the second, injecting the CO2 into a deep geologic formations that will trap it underground for hundreds to thousands of years. Suitable homes for such captured CO2 include oil and gas fields (they’re already drilling deep down anyway), saline aquifers, and deep coal seams. As it happens, several CCS projects are underway in Norway, Algeria, and Canada and more are planned in the United States, China …

Aug. 5, 2009 by Matt Shudtz
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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 …

Aug. 4, 2009 by Ben Somberg
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CPR Member Scholar Thomas McGarity testified this afternoon at a hearing of the Senate Committee on Health, Education, Labor, and Pensions on the issue of medical device safety (written testimony, press release).

Currently, individuals injured by a faulty medical device generally cannot sue the device manufacturer in state courts if that device was fully approved by the FDA, even if the manufacturer was aware of new research showing faults in the product. The Senate is considering a bill that would exempt state common law claims from the express preemption clause in the Medical Device Amendments to the Food, Drug and Cosmetics Act. The House is considering a similar bill.

"The implicit assumption in preempting medical device injury claims in state courts is that the FDA can and is performing its job perfectly, but that's just not the case," McGarity says. "Common law still has an important …

Aug. 3, 2009 by James Goodwin
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Today, I joined CPR Member Scholars Mary Jane Angelo, Holly Doremus, and Dan Rohlf in submitting comments to the U.S. Fish and Wildlife Service (FWS)—one of the agencies charged with primary responsibility for executing the Endangered Species Act (ESA)—suggesting several ways to improve the regulations for implementing interagency consultations under the Act. Under Section 7 of the ESA, which governs interagency consultations, any time that a federal agency like the Department of Defense or the Department of Transportation wants to take an action that will potentially harm an endangered species or its habitat, that agency must consult with either FWS or the National Marine Fisheries Service (NMFS)—depending on what kind of species is involved—to determine whether and how the action will affect the species or its habitat. Through this consultation, the agency is supposed to determine how to alter its action to …

Aug. 3, 2009 by Shana Campbell Jones
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Today, the Senate Environment & Public Works Committee's Subcommittee on Water and Wildlife is holding a hearing entitled “A Renewed Commitment to Protecting the Chesapeake Bay: Reauthorizing the Chesapeake Bay Program." Here's something that should be on Congress's agenda: making the Bay-wide TMDL (“pollution cap”) enforceable to ensure that it is actually implemented.

First, some background: Congress created the Bay Program in 1983, establishing it under the Clean Water Act. The regional partnership, which now includes several federal agencies in addition to Maryland, Virginia, Pennsylvania, Delaware, West Virginia, New York and the District of Columbia, is world-renowned for the quality of its science and its monitoring capabilities. Yet, although approximately $4 billion has been spent on restoration efforts since 1995, the Chesapeake Bay remains “severely degraded.” While population growth in the region has certainly made Bay restoration efforts more difficult, the critical problem lies …

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