The Integrated Risk Information System (IRIS) is an environmental assessment program operated by the U.S. Environmental Protection Agency (EPA). The IRIS program is focused on risk assessment, and not risk management (those decision processes involving analysis of regulatory, legal, social and economic considerations related to the risks being studied). [1]
Initially, in the 1980s, the IRIS program established a database of human health assessments about the impacts of chemicals in the environment. EPA created the database to provide a consistent approach to risk assessment practices across the various environmental laws that the Agency implemented and enforced.[ citation needed ]
The program was created by the EPA in 1985. Initially, the goal of the program was to foster consistency's in the agency's evaluation of chemical toxicity. [1] The IRIS database was first made publicly available in 1987. In 1996, the EPA implemented a new process for building intra-agency consensus and improving efficiency within the IRIS database. The same year, the EPA introduced the IRIS Toxicological Review, which presented the first agency-wide health assessment document. In March 1997, the IRIS database was uploaded to the internet. In 2004, the IRIS process was changed to add an interagency review led by the Office of Management and Budget (OMB) and to place a higher emphasis on outside peer review of IRIS assessments.[ citation needed ]
The IRIS program was once again revised in April 2008. Among other things, the newly revised program provided opportunity for research to close data gaps on mission critical chemicals. The following year, the process was changed to streamline a review schedule so that a majority of assessments would be posted to the IRIS database within two years of the start date. In 2013, the EPA announced that it would be making enhancements to the IRIS process in order to improve transparency, efficiency, and the scientific foundation of the agency's assessments. [2] That same year, the program's Toxicological Review documents were restructured to make them more clear, systematic and consistent. In December 2015, the IRIS program released its first ever multi-year agenda, which identified the top chemical assessments the program would focus on in the following years.[ citation needed ]
In 2016 the EPA faced criticism for changing the risk description of Ethylene Oxide from "probably carcinogenic to humans" to "carcinogenic to humans," based on Ethylene Oxide's IRIS value. The American Chemistry Council found shortly after that the EPA had grossly misestimated the IRIS value, finding it to be 19,000 times lower than natural levels of EO in the human body, and comparably lower than the levels of EO in ambient air. [3] Consequently, in 2017 the Texas Commission on Environmental Quality (TECQ) performed its own analysis of the cancer risk proposed by EO and found it initially to be 65 times lower than the IRIS value, before releasing a later assessment with a value 3,500 times lower in 2019. [4] In 2022, despite calls to review the IRIS value or to adopt the TECQ risk value, the EPA elected to continue to use the 2016 IRIS value and decline the TECQ proposed value. [5]
The IRIS process takes about 26 to 39 months to complete, depending on the complexity of the assessment, with the review part of the process taking between 15 and 24 months. [6] The process begins with what the EPA refers to as the "Planning and Scoping" stage. [7] During this stage, risk assessors will consider the scope and possible legal limitations as well as how the information will be used. After the Planning and Scoping Stage, the EPA uses a seven-step risk assessment review program that starts with a draft assessment and ends in publication on an IRIS website. The review process proceeds as follows:
The IRIS opens a draft review for experts to review in order to assess the course of action needed for the corresponding issue. Action is taken by legislative bodies after assessing the risk and the level of action needed to be taken for the corresponding issue. The relationship between IRIS and an environmental impact assessment (EIA) is that IRIS provides a database used in the EIA process. External parties (scientists, scholars, legislation) make decisions based on the IRIS database. Support for these decisions comes from backing[ further explanation needed ] from programs such as Strategic environmental assessment (SEA) and OMB.[ citation needed ]
The Office of Management and Budget (OMB) is the largest office within the Executive Office of the President of the United States (EOP). OMB's most prominent function is to produce the president's budget, but it also examines agency programs, policies, and procedures to see whether they comply with the president's policies and coordinates inter-agency policy initiatives.
The Environmental Protection Agency (EPA) is an independent agency of the United States government tasked with environmental protection matters. President Richard Nixon proposed the establishment of EPA on July 9, 1970; it began operation on December 2, 1970, after Nixon signed an executive order. The order establishing the EPA was ratified by committee hearings in the House and Senate.
Butanone, also known as methyl ethyl ketone (MEK) or ethyl methyl ketone, is an organic compound with the formula CH3C(O)CH2CH3. This colorless liquid ketone has a sharp, sweet odor reminiscent of acetone. It is produced industrially on a large scale, but occurs in nature only in trace amounts. It is partially soluble in water, and is commonly used as an industrial solvent. It is an isomer of another solvent, tetrahydrofuran.
Styrene is an organic compound with the chemical formula C6H5CH=CH2. Its structure consists of a vinyl group as substituent on benzene. Styrene is a colorless, oily liquid, although aged samples can appear yellowish. The compound evaporates easily and has a sweet smell, although high concentrations have a less pleasant odor. Styrene is the precursor to polystyrene and several copolymers, and is typically made from benzene for this purpose. Approximately 25 million tonnes of styrene were produced in 2010, increasing to around 35 million tonnes by 2018.
Vinyl chloride is an organochloride with the formula H2C=CHCl. It is also called vinyl chloride monomer (VCM) or chloroethene. This colorless compound is an important industrial chemical chiefly used to produce the polymer, poly(vinyl chloride) (PVC). Vinyl chloride monomer is among the top twenty largest petrochemicals (petroleum-derived chemicals) in world production. The United States remains the largest vinyl chloride manufacturing region because of its low-production-cost position in chlorine and ethylene raw materials. China is also a large manufacturer and one of the largest consumers of vinyl chloride. Vinyl chloride is a flammable gas that has a sweet odor and is carcinogenic. It can be formed in the environment when soil organisms break down chlorinated solvents. Vinyl chloride that is released by industries or formed by the breakdown of other chlorinated chemicals can enter the air and drinking water supplies. Vinyl chloride is a common contaminant found near landfills. Before the 1970s, vinyl chloride was used as an aerosol propellant and refrigerant.
Environmental remediation is the cleanup of hazardous substances dealing with the removal, treatment and containment of pollution or contaminants from environmental media such as soil, groundwater, sediment. Remediation may be required by regulations before development of land revitalization projects. Developers who agree to voluntary cleanup may be offered incentives under state or municipal programs like New York State's Brownfield Cleanup Program. If remediation is done by removal the waste materials are simply transported off-site for disposal at another location. The waste material can also be contained by physical barriers like slurry walls. The use of slurry walls is well-established in the construction industry. The application of (low) pressure grouting, used to mitigate soil liquefaction risks in San Francisco and other earthquake zones, has achieved mixed results in field tests to create barriers, and site-specific results depend upon many variable conditions that can greatly impact outcomes.
The National Environmental Policy Act (NEPA) is a United States environmental law designed to promote the enhancement of the environment. It created new laws requiring U.S. federal government agencies to evaluate the environmental impacts of their actions and decisions, and it established the President's Council on Environmental Quality (CEQ). The Act was passed by the U.S. Congress in December 1969 and signed into law by President Richard Nixon on January 1, 1970. To date, more than 100 nations around the world have enacted national environmental policies modeled after NEPA.
In organic chemistry, ethoxylation is a chemical reaction in which ethylene oxide adds to a substrate. It is the most widely practiced alkoxylation, which involves the addition of epoxides to substrates.
The Toxic Substances Control Act (TSCA) is a United States law, passed by the 94th United States Congress in 1976 and administered by the United States Environmental Protection Agency (EPA), that regulates chemicals not regulated by other U.S. federal statutes, including chemicals already in commerce and the introduction of new chemicals. When the TSCA was put into place, all existing chemicals were considered to be safe for use and subsequently grandfathered in. Its three main objectives are to assess and regulate new commercial chemicals before they enter the market, to regulate chemicals already existing in 1976 that posed an "unreasonable risk of injury to health or the environment", as for example PCBs, lead, mercury and radon, and to regulate these chemicals' distribution and use.
The U.S. National Ambient Air Quality Standards are limits on atmospheric concentration of six pollutants that cause smog, acid rain, and other health hazards. Established by the United States Environmental Protection Agency (EPA) under authority of the Clean Air Act, NAAQS is applied for outdoor air throughout the country.
The National Priorities List (NPL) is the priority list of hazardous waste sites in the United States eligible for long-term remedial investigation and remedial action (cleanup) financed under the federal Superfund program. Environmental Protection Agency (EPA) regulations outline a formal process for assessing hazardous waste sites and placing them on the NPL. The NPL is intended primarily to guide EPA in determining which sites are so contaminated as to warrant further investigation and significant cleanup.
The social cost of carbon (SCC) is the marginal cost of the impacts caused by emitting one extra tonne of carbon emissions at any point in time. The purpose of putting a price on a ton of emitted CO2 is to aid policymakers or other legislators in evaluating whether a policy designed to curb climate change is justified. The social cost of carbon is a calculation focused on taking corrective measures on climate change which can be deemed a form of market failure. Latest studies calculate costs of more than US$300 per ton of CO2. The only governments which use the SCC are in North America. Because of politics the SCC is different from a carbon price. The Intergovernmental Panel on Climate Change suggested that a carbon price of $100/tCO2 could reduce global GHG emissions by at least half the 2019 level by 2030.
The Food Quality Protection Act (FQPA), or H.R.1627, was passed unanimously by Congress in 1996 and was signed into law by President Bill Clinton on August 3, 1996. The FQPA standardized the way the Environmental Protection Agency (EPA) would manage the use of pesticides and amended the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food Drug and Cosmetic Act. It mandated a health-based standard for pesticides used in foods, provided special protections for babies and infants, streamlined the approval of safe pesticides, established incentives for the creation of safer pesticides, and required that pesticide registrations remain current.
The United States Global Change Research Program (USGCRP) coordinates and integrates federal research on changes in the global environment and their implications for society. The program began as a presidential initiative in 1989 and was codified by Congress through the Global Change Research Act of 1990, which called for "a comprehensive and integrated United States research program which will assist the Nation and the world to understand, assess, predict, and respond to human-induced and natural processes of global change."
The Hazardous Substances Data Bank (HSDB) was a toxicology database on the U.S. National Library of Medicine's (NLM) Toxicology Data Network (TOXNET). It focused on the toxicology of potentially hazardous chemicals, and included information on human exposure, industrial hygiene, emergency handling procedures, environmental fate, regulatory requirements, and related areas. All data were referenced and derived from a core set of books, government documents, technical reports, and selected primary journal literature. Prior to 2020, all entries were peer-reviewed by a Scientific Review Panel (SRP), members of which represented a spectrum of professions and interests. Last Chairs of the SRP are Dr. Marcel J. Cassavant, MD, Toxicology Group, and Dr. Roland Everett Langford, PhD, Environmental Fate Group. The SRP was terminated due to budget cuts and realignment of the NLM.
Pesticide regulation in the United States is primarily a responsibility of the Environmental Protection Agency (EPA). In America, it was not till the 1950s that pesticides were regulated in terms of their safety. The Pesticides Control Amendment (PCA) of 1954 was the first time Congress passed guidance regarding the establishment of safe limits for pesticide residues on food. It authorized the Food and Drug Administration (FDA) to ban pesticides they determined to be unsafe if they were sprayed directly on food. The Food Additives Amendment, which included the Delaney Clause, prohibited the pesticide residues from any carcinogenic pesticides in processed food. In 1959, pesticides were required to be registered.
Tissue residue is the concentration of a chemical or compound in an organism's tissue or in a portion of an organism's tissue. Tissue residue is used in aquatic toxicology to help determine the fate of chemicals in aquatic systems, bioaccumulation of a substance, or bioavailability of a substance, account for multiple routes of exposure, and address an organism's exposure to chemical mixtures. A tissue residue approach to toxicity testing is considered a more direct and less variable measure of chemical exposure and is less dependent on external environmental factors than measuring the concentration of a chemical in the exposure media.
Toxicological databases are large compilations of data derived from aquatic and environmental toxicity studies. Data is aggregated from a large number of individual studies in which toxic effects upon aquatic and terrestrial organisms have been determined for different chemicals. These databases are then used by toxicologists, chemists, regulatory agencies and scientists to investigate and predict the likelihood that an organic or inorganic chemical will cause an adverse effect on exposed organisms.
Michael L. Dourson is an American toxicologist and Director of Science at the nonprofit organization, Toxicology Excellence for Risk Assessment. He was formerly a senior advisor to the Administrator of EPA, and prior to that, a professor at the Risk Science Center at the University of Cincinnati College of Medicine. Prior to joining the University of Cincinnati, he was founder and president of the nonprofit Toxicology Excellence for Risk Assessment. Earlier in his career, he was employed by the Environmental Protection Agency Environmental Criteria and Assessment Office, among other assignments.
The CompTox Chemicals Dashboard is a freely accessible online database created and maintained by the U.S. Environmental Protection Agency (EPA). The database provides access to multiple types of data including physicochemical properties, environmental fate and transport, exposure, usage, in vivo toxicity, and in vitro bioassay. EPA and other scientists use the data and models contained within the dashboard to help identify chemicals that require further testing and reduce the use of animals in chemical testing. The Dashboard is also used to provide public access to information from EPA Action Plans, e.g. around perfluorinated alkylated substances.
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