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June 30, 2015 by Lisa Heinzerling

Michigan v. EPA: Costs Matter, But Everything Else Is Up For Grabs

In Michigan v. EPA, the Supreme Court reviewed the Environmental Protection Agency's decision to regulate power plants under section 112 of the Clean Air Act. Section 112 is the provision regulating toxic air pollutants, such as mercury. The question before the Court was whether EPA reasonably interpreted the Clean Air Act to allow EPA to decline to consider costs in deciding whether to regulate power plants under section 112. The Court held that it was not reasonable to interpret the Act in this way. Thus, from the Court's decision, we know that EPA must consider costs in deciding whether to regulate power plants under section 112. There are, however, important questions that remain:

1. We do not yet know what happens to EPA's rule while EPA does the analytical work the Court has required of it. The Supreme Court reversed the judgment of the D.C. Circuit and remanded the case for further proceedings consistent with its opinion. The case will go back to the D.C. Circuit for it to figure out how to address the Supreme Court's ruling. Certainly the case will eventually have to return to EPA; the D.C. Circuit itself will …

June 26, 2015 by Lisa Heinzerling
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The Supreme Court's decision in King v. Burwell is, of course, most important for its central holding that the Affordable Care Act's federal subsidies are available even on federally established health exchanges. The decision preserves health insurance subsidies for millions of people who have begun to benefit from them and avoids the ridiculous spectacle of taking the subsidies away based on four words ("established by the State") in a lengthy and complicated statute.

But for those who, like me, are not health care experts but teach and write in environmental law, the majority opinion by Chief Justice Roberts is principally worth studying for its approach to statutory interpretation. Especially for those following EPA's impending regulation of greenhouse gases from power plants under section 111 of the Clean Air Act, which has already drawn attacks based on a purported lack of statutory authority, the Court …

Aug. 4, 2014 by Lisa Heinzerling
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Imagine a government warning on tobacco products that gave nearly equal prominence to both the pleasures and pains of using tobacco products. The "warning" would tell citizens that whether they should use tobacco products or not was – despite the government's long practice of recommending against such use – actually a pretty close case. Tobacco use is just so pleasurable, it turns out, that its risks – of bad health, of early death – might be worth it.

Or imagine a parent saying the same thing to her child: here are the risks of using tobacco products, she'd say, but here on the other side are the wonderful pleasures. You make the call; it's too close for me to judge.

Despite its strangeness, this is exactly the kind of statement the White House and the Food and Drug Administration have collaborated in propounding in the 

context of a …

Jan. 6, 2014 by Lisa Heinzerling
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The Food and Drug Administration (FDA) recently recommitted itself to its lame proposal to address the profligate use of antibiotics in livestock by enlisting the voluntary participation of the drug companies that make the antibiotics.  Two documents issued last month reveal the details of the agency’s current plans.   The first is a final guidance document describing the FDA’s process for handling drug sponsors’ voluntary efforts to phase out “production uses” of antibiotics in animal feed and water and to bring the remaining uses under the oversight of a veterinarian. The second is a draft rule relaxing the requirements for veterinarians in exercising this oversight.  Production uses are aimed at promoting growth and improving feed efficiency, not at treating active infections.  The FDA will continue to allow mass medication of whole herds and flocks of livestock for purposes of preventing infection.

The FDA has, in internal …

Dec. 12, 2013 by Lisa Heinzerling
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In  2001, a group of private citizens, public health groups, and medical organizations petitioned the Food and Drug Administration (FDA) to approve nonprescription status for the emergency contraceptive Plan B and its generic cousins.  Under the Food, Drug, and Cosmetic Act, the FDA’s decision was supposed to turn on whether these drugs could be taken safely and efficaciously without the assistance of a licensed health professional.  Instead, an investigation by the Government Accountability Office (GAO) and fact-finding by the district court handling litigation over the controversy made clear that the FDA bowed to political pressure, first by delaying any decision as long it could and then by being as stingy as possible in granting nonprescription access to emergency contraceptives.

Over a twelve-year period, the agency resorted to extreme measures to avoid answering the statutorily dictated question: whether women and girls could safely and efficaciously take emergency …

Nov. 18, 2013 by Lisa Heinzerling
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The Food and Drug Administration recently announced its tentative determination that most of the trans fatty acids in our diets – specifically, partially hydrogenated oils (PHOs) – are not “generally recognized as safe” within the meaning of the Food, Drug, and Cosmetic Act, and thus must be regulated as food additives. If the FDA finalizes this determination, then food manufacturers would need to obtain the approval of the FDA before selling PHOs in any food or as food ingredients. Approval would then depend, in turn, on a determination by the FDA that PHOs were safe after all. In this way, a final determination by the FDA that PHOs are not “generally recognized as safe” would effectively amount to a ban on their use in food.

The FDA’s proposed finding is a huge deal for public health. The agency estimates that eliminating PHOs from the food supply could prevent …

Nov. 14, 2013 by Lisa Heinzerling
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One of the healthiest things a person can do is to eat lots of fruits and vegetables. Unless they’re contaminated with dangerous pathogens, that is. Contaminated produce has been responsible for an alarming number of deaths and illnesses in recent years, from Listeria-tainted cantaloupes that killed up to 43 people in 2011 to a Cyclospora outbreak linked to salad mix and cilantro that sickened 631 people in 25 states this past summer. 

For this reason, the Food Safety Modernization Act (FSMA) directed the Food and Drug Administration (FDA) to set standards to ensure the safety of the fruits and vegetables in our food supply.   The FDA’s proposed rule on produce safety would address some of the most likely sources of contamination on farms, including tools and equipment, water used in agricultural activities, and worker health and hygiene. At the Center for Progressive Reform we …

Sept. 30, 2013 by Lisa Heinzerling
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This coming Friday marks the 20th anniversary of a little-known but remarkably important document: Executive Order 12866, issued by President Bill Clinton in 1993. Executive Order 12866 replaced an order issued by President Ronald Reagan in 1981. Both of these documents set out a process whereby the White House – acting through the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) – would review major agency rules before they were issued.

Executive Order 12866, and the Reagan order before it, ushered in a new era in administrative law, one in which the White House would become the dominant force in administrative rulemaking and in which cost-benefit analysis would become the overarching framework for evaluating the wisdom of rules. Professional career staff in the agencies, steeped in the technical fields relevant to the agencies’ work, would see their work product changed, sometimes dramatically …

June 25, 2013 by Lisa Heinzerling
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At a speech this afternoon at Georgetown University, President Obama outlined a series of aggressive steps aimed at curbing greenhouse gas emissions and preparing the nation to adapt to the now unavoidable effects of climate change. Center for Progressive Reform Member Scholar Lisa Heinzerling issued the following reaction:

The President’s speech offered exactly what many of us have been waiting to hear from him: A solid commitment to use the tools available to the EPA to finally get the federal government out of slow gear on climate change. In particular, by extending emissions limits to existing power plants, he’s taking dead aim at the most severe environmental problem facing the planet. Protests from industry and its allies on the Hill overlook an important reality: The Clean Air Act already gives the EPA authority to adopt such rules, and the Supreme Court has so ruled.

Heinzerling …

June 11, 2013 by Lisa Heinzerling
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The Obama Administration’s announcement that it will comply with a district court’s order that it make emergency contraceptives available to all women and girls without a prescription comes as a welcome development in a long-running administrative-law fiasco. But the Administration’s specific suggestions as to how it will set things right, set forth in letters sent yesterday to the district court and to the citizen petitioners who originally asked for nonprescription access to emergency contraceptives, are inadequate in several respects.

First, under the government’s approach, we will all have to wait for Teva Branded Pharmaceutical Products R&D, Inc. — the sponsor of the one-pill emergency contraceptive, Plan B One-Step — to submit a new application asking for full over-the-counter status for its product before anything can happen to implement the court’s ruling. The government’s letter to the court announcing its compliance with the court …

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