Chapter 8.A.2 (6.A.2) Risk Assessment and Regulatory Competence
Notes: Risk Assessment by Legislatures, Agencies, and Courts
Note 2. Administrative Competence.
Former University of Chicago Professor Cass Sunstein, who has now been confirmed as President Obama’s Administrator of the Office of Information and Regulatory Affairs in the Office of Management and Budget, see http://www.whitehouse.gov/omb/inforeg/, has argued that greater transparency and accountability for the administration of OSHA could be achieved if the statute were construed as requiring the agency to balance costs and benefits before issuing standards. See Cass R. Sunstein, Is OSHA Unconstitutional?, 94 Va. L. Rev. 1407 (2008).
To what extent should we allow political pressure to influence risk assessment for public health policy-making purposes? Lobbyists and advocacy groups may push the government to recognize emerging health risks (for example, consumer protection groups). However, they may also pressure the government to ignore or play down threats to public health (for example, lobbyists for asbestos, tobacco, and drug companies). See, Jock McCulloch and Geoffrey Tweedale, Defending the Indefensible (New York: Oxford University Press, 2008) (arguing that industry influence explains why “nearly 80 per cent of world asbestos production in the twentieth century was produced after the world learned that asbestos could cause mesothelioma”).
Note 3. Risk Assessment Literature.
For an article discussing the disparate regulatory controls in health care (juxtaposing drug regulation with the lack of regulation of innovative surgical procedures) and proposing a regulatory regime that includes professional self-regulation, institutional control and broad disinterested oversight, see Amer S. Ahmed, The Last Twist of the Knife: Encouraging the Regulation of Innovative Surgical Procedures, 105 Colum. L. Rev. 1529 (2005).
Problem: State Law, Disaster-Planning and Bioterrorism Preparedness
The Centers for Law and the Public’s Health, a collaborative project of Johns Hopkins and Georgetown Universities, tracked international, national, state, and local legal responses to the 2009 swine flu crisis. The Centers’ website includes information on international, federal, state, territorial, and regional declarations of emergency or public health emergency. To view the list, see The Centers for Law and the Public’s Health, Swine Flu Legal Preparedness, http://www.publichealthlaw.net/Projects/swinefluphl.php.
For an update on the legislative status of the Model State Emergency Health Powers Act in states across the U.S., see Centers for Law and the Public’s Health, Model Laws, http://www.publichealthlaw.net/ModelLaws/index.php.
Declarations of emergency
On April 26, 2009 the U.S. declared the swine flu outbreak a public health emergency. See Donald G. McNeil’s article, U.S. Declares Public Health Emergency over Swine Flu, NY Times, April 26, 2009. Many states and local governments have also made declarations of emergency. For updates on declarations of emergency in U.S. states and territories, see The Centers for Law & the Public’s Health, Swine Flu Legal Preparedness, http://www.publichealthlaw.net/Projects/swinefluphl.php (last visited October 19, 2010). Consider the implications of this declaration within jurisdictions which have implemented the Model State Emergency Powers Act through the remainder of Chapter 8’s discussion of public health powers.
New Problem: Climate Change as a Public Health Threat
The WHO has studied and reported the public health implications of global climate change. See WHO, Climate Change and Human Health, at: http://www.who.int/globalchange/en/ (last visited October 19, 2010). The U.S. CDC has a similar program. The CDC’s Policy on Climate Change and Public Health states:
There is widespread scientific consensus that the world’s climate is changing. Some of the effects of climate change are likely to include more variable weather, heat waves, heavy precipitation events, flooding, droughts, more intense storms such as hurricanes, sea level rise, and air pollution. Each of these changes has the potential to negatively affect health. While climate change is recognized as a global issue, the effects of climate change will vary across geographic regions and populations.
Although scientific understanding of the effects of climate change is still emerging, there is a pressing need to prepare for potential health risks. This public health preparedness approach is applied to other threats in the absence of complete data, such as terrorism and pandemic influenza. A wide variety of organizations (federal, state, local, multilateral, private and nongovernmental) are working to address the implications of global climate change. Despite this breadth of activity, the public health effects of climate change remain largely unaddressed.
To view the full text of the CDC Policy on Climate Change and Public Health, which includes a list of the ways in which climate change may impact health, see National Center for Environmental Health: Climate Change and Public Health, http://www.cdc.gov/climatechange/policy.htm.
What are the advantages and disadvantages of addressing global warming as a public health issue? What effect does framing the issue in this way have on federal and state government’s ability to regulate human activities that contribute to global warming?
For an example of how climate change’s dual nature (as both an environmental and human health problem) may lead to regulatory confusion, see Massachusetts, et al. v. Environmental Protection Agency et al., 549 U.S. 497 (2007). In that case, a number of states, local governments, and private organizations challenged the EPA’s refusal to regulate air pollutants from new motor vehicles. The Clean Air Act (CAA) states that the EPA is required to regulate emissions from new vehicles that may be “reasonably…anticipated to endanger public health or welfare.” Id. at 506. EPA argued that this provision did not authorize the agency to set mandatory emissions standards for new vehicles, as the link between emissions and global climate change “was not unequivocally established.” Id. at 497. The EPA also contended that even if it was authorized to make such regulations, such a task should be left to the President and executive branch to coordinate policies. Id.
Justice Stevens, writing for the majority of the U.S. Supreme Court, held that the EPA was authorized to regulate such emissions under the CAA. The Court rejected the EPA’s argument that it would be unwise or inappropriate for the agency to get involved in the regulation of greenhouse gas emissions:
EPA no doubt has significant latitude as to the manner, timing, content, and coordination of its regulations with those of other agencies. But once EPA has responded to a petition for rulemaking, its reasons for action or inaction must conform to the authorizing statute. Under the clear terms of the Clean Air Act, EPA can avoid taking further action only if it determines that greenhouse gases do not contribute to climate change or if it provides some reasonable explanation as to why it cannot or will not exercise its discretion to determine whether they do… To the extent that this constrains agency discretion to pursue other priorities of the Administrator or the President, this is the congressional design.
Id. at 533. Following this decision, the EPA issued a proposed finding that six greenhouse gases (including carbon dioxide) pose a threat to human health, and that emissions from new motor vehicles add to the atmospheric concentration of such gases. This finding could lead to increased regulations being placed on the motor vehicle industry. See, U.S. Environmental Protection Agency, Endangerment and Cause or Contribute Findings for Greenhouse Gases under the Clean Air Act, available at: http://epa.gov/climatechange/endangerment.html; and U.S. Environmental Protection Agency, Transportation and Climate, Regulations and Standards, available at http://www.epa.gov/oms/climate/regulations.htm (last visited October 24, 2010).