User:Oceanflynn/sandbox/Integrated Risk Information System

The  Integrated Risk Information System 'IRIS' "is a program within the United States Environmental Protection Agency (EPA) whose scientific reports are "used by the EPA and states to draft regulations to rid air, water or soil of toxic chemicals." The IRIS "is responsible for developing toxicologic assessments of environmental contaminants." In cases where the assessments are complex and they involve regulatory policies, the EPA requests that the National Research Council undertake an independent scientific review of IRIS's reports.

National Research Council (NRC)
In the case of IRIS assessments of complex issues that affect regulatory decisions, the EPA may request that the NRC undertake an independent scientific review of the IRIS assessment. The NRC identified deficiencies in "some of EPA's general approaches and specific methods" and in 2011 Congress directed EPA to implement the recommendations in the NRC's report. These changes were to be monitored by the NRC.

According to the NRC publication Alternatives for Managing the Nation's Complex Contaminated Groundwater Sites there are "at least 126,000 sites across the U.S. still have contaminated groundwater, and their closure is expected to cost at least $110 billion to $127 billion. About 10 percent of these sites are considered "complex," meaning restoration is unlikely to be achieved in the next 50 to 100 years due to technological limitations. At sites where contaminant concentrations have plateaued at levels above cleanup goals despite active efforts, the report recommends evaluating whether the sites should transition to long-term management, where risks would be monitored and harmful exposures prevented, but at reduced costs."

The NRC claims that, "across the United States, thousands of hazardous waste sites are contaminated with chemicals that prevent the underlying groundwater from meeting drinking water standards. These include Superfund sites and other facilities that handle and dispose of hazardous waste, active and inactive dry cleaners, and leaking underground storage tanks; many are at federal facilities such as military installations. While many sites have been closed over the past 30 years through cleanup programs run by the U.S. Department of Defense, the U.S. EPA, and other state and federal agencies, the remaining caseload is much more difficult to address because the nature of the contamination and subsurface conditions make it difficult to achieve drinking water standards in the affected groundwater."

IRIS Assessments
"An IRIS assessment contains hazard identifications and dose-response assessments of various chemicals related to cancer and noncancer outcomes. Although the program was created to increase consistency among toxicologic assessments within the agency, federal, state, and international agencies and other organizations have come to rely on IRIS assessments for setting regulatory standards, establishing exposure guidelines, and estimating risks to exposed populations."

History
In 2004 Iris released its assessment of naphthalene.

From 2005 to 2015 the National Research Council (NRC) has reviewed some of the "more complex and challenging IRIS assessments" including those of formaldehyde, dioxin, and tetrachloroethylene.

Tetrachloroethylene assessment
In June 2008, the EPA released its draft toxicological review of Tetrachloroethylene (Perchloroethylene) (CAS No. 127-18-4) in support of the IRIS assessment.

In 2010 the NRC released its review of the EPA's draft IRIS assessment of tetrachloroethylene.

""Tetrachloroethylene is a volatile, chlorinated organic hydrocarbon that is widely used as a solvent in the dry-cleaning and textile-processing industries and as an agent for degreasing metal parts. It is an environmental contaminant that has been detected in the air, groundwater, surface waters, and soil. ...The draft IRIS assessment provides quantitative estimates of cancer and noncancer effects of exposure to tetrachloreothylene, which will be used to establish air quality and water-quality standards to protect public health and to set cleanup standards for hazardous waste sites.""

- NRC 2010

""At the request of EPA, the National Research Council conducted an independent scientific review of the draft IRIS assessment of tetrachloroethylene from toxicologic, epidemiologic, and human clinical perspectives. The resulting book evaluates the adequacy of the EPA assessment, the data and methods used for deriving the noncancer values for inhalation and oral exposures and the oral and inhalation cancer unit risks posed by tetrachloroethylene; evaluates whether the key studies underlying the draft IRIS assessment are of requisite quality, reliability, and relevance to support the derivation of the reference values and cancer risks; evaluates whether the uncertainties in EPA's risk assessment were adequately described and, where possible, quantified; and identifies research that could reduce the uncertainty in the current understanding of human health effects associated with tetrachloroethylene exposure.""

- NRC 2010

Formaldehyde assessment
"Formaldehyde is ubiquitous in indoor and outdoor air, and everyone is exposed to formaldehyde at some concentration daily. Formaldehyde is used to produce a wide array of products, particularly building materials; it is emitted from many sources, including power plants, cars, gas and wood stoves, and cigarettes; it is a natural product in come foods; and it is naturally present in the human body as a metabolic intermediate. Much research has been conducted on the health effects of exposure to formaldehyde, including effects on the upper airway, where formaldehyde is deposited when inhaled, and effects on tissues distant from the site of initial contact."

In 1990 and 1990 the EPA "released noncancer and cancer assessments of formaldehyde for its IRIS.

In 1998 the EPA "began reassessing formaldehyde in 1998."

In June 2010 the EPA released a draft IRIS assessment in June 2010.

In 2011 the National Research Council (NRC) released independent scientific review of the draft IRIS formaldehyde assessment. The EPA had requested the NRC review "given the complexity of the issues and the knowledge that the assessment will be used as the basis of regulatory decisions."

Controversies
In 2014 the EPA had considered Michael Dourson to direct IRIS. Dourson who runs a company Toxicology Excellence for Risk Assessment (TERA) "which does substantial work for chemical and drug companies." He was not named as director.

By December 2014, largely because of pressure from Congress and the strong chemical industry lobby groups, President Obama was unable to increase the number of IRIS assessments, some of which like arsenic, formaldehyde and hexavalent chromium have been delayed for over a decade.