EPA Action Plan To Address MDI and TDI Hazards Under TSCA

U.S. Environmental Protection Agency (EPA) has released action plans to address the potential health risks of methylene diphenyl diisocyanate (MDI), toluene diisocyanate (TDI), and related compounds, used in certain applications such as spray foam insulation, sealing concrete or finishing floors. The plans identify a range of actions the agency is considering under the authority of the Toxic Substances Control Act (TSCA).

Actions to address concerns associated with TDI, MDI, and related compounds include issuing rules to call in data on any past allegations of significant adverse effects, obtain unpublished health and safety data from industry sources, require exposure monitoring studies for consumer products, and possibly ban or restrict consumer products containing uncured MDI or TDI. EPA plans to continue to work with other federal agencies, the polyurethanes industry, and others to improve labeling and to provide product safety information for polyurethane products containing uncured compounds, especially in consumer products.

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IRIS Assessments Continue for Methanol, MTBE, ETBE, Acrylonitrile

U.S. Environmental Protection Agency (EPA) announced its plan to address the four draft Integrated Risk Information System (IRIS) assessments that were placed on hold in June 2010, pending a review of some of the underlying studies relied on in the assessments. The four assessments were for methanol, methyl tertiary-butyl ether (MTBE), ethyl tertiary-butyl ether (ETBE), and acrylonitrile.

EPA put the assessments on hold because of a report written by the National Toxicology Program (NTP), a program administered by the National Institute of Environmental Health Sciences (NIEHS). The report outlined a review of research completed by the Ramazzini Institute, a lab in Italy that conducts animal testing to evaluate the potential cancer-causing effects of chemicals. The report recommended that further pathology reviews be carried out to resolve differences of opinion between NTP scientists and the Ramazzini Institute in the diagnoses of certain cancers reported in the study.

EPA and NIEHS have decided to jointly sponsor an independent Pathology Working Group (PWG) review, in cooperation with the Ramazzini Institute, of selected studies, including the methanol cancer assessment study. The review has begun and will continue over the next several months. The results will be made public and the cancer assessment for methanol will remain on hold until its completion.

The Ramazzini Institute diagnosed leukemias, lymphomas, or tumors in studies of MTBE and ETBE, and acrylonitrile. Based on other available data, EPA has determined that reliance on Ramazzini Institute study results is not necessary to continue with assessment development for MTBE, ETBE and acrylonitrile, including an assessment of cancer risks. Therefore, work on the assessments for the three chemicals will continue during the PWG review. When the four assessments (methanol, MTBE, ETBE, acrylonitrile) were put on hold in June 2010, two completed and publicly posted assessments (vinyl chloride and 1,1-dichloroethylene) were also identified as relying substantially on Ramazzini data. EPA plans to evaluate the results of the PWG review to inform conclusions about Ramazzini Institute tumor findings for these two assessments.

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New Robot Screening System Released To Predict Chemical Effects

Several federal agencies have unveiled a new robot screening system that will test 10,000 different chemicals for potential toxicity, including chemicals found in industrial and consumer products, food additives and drugs. The robot system, which is located at the National Institutes of Health Chemical Genomics Center (NCGC), was purchased as part of the Tox21 collaboration established in 2008 between the U.S. Environmental Protection Agency (EPA), the National Institute of Environmental Health Sciences National Toxicology Program, and NCGC, and U.S. Food and Drug Administration (FDA) in 2010. Tox21 merges existing research, funding and testing tools to develop ways to more effectively predict how chemicals will affect human health and the environment.

Tox21 has already been used to screen more than 2,500 chemicals for potential toxicity using robots and other innovative chemical screening technologies, including different types of oil spill dispersants used during the BP oil spill in the Gulf of Mexico.

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New Contaminants Proposed For SDWA Monitoring

U.S. Environmental Protection Agency (EPA) is proposing 30 currently unregulated contaminants for monitoring in water systems. Under the authority Safe Drinking Water Act (SDWA), EPA currently regulates more than 90 contaminants in drinking water. The SDWA requires that EPA identify up to 30 unregulated contaminants for monitoring every five years. This current proposal is the third Unregulated Contaminant Monitoring Regulation and includes requirements to monitor for two viruses and 28 chemical contaminants that could be present in drinking water and do not currently have health-based standards.

EPA is requesting public comment on the proposed list of 30 contaminants until May 2, 2011. Following the comment period, EPA will consider input and finalize the list in 2012, with sampling to be conducted from 2013 to 2015. Sampling will take place at all systems serving more than 10,000 people and at a representative sampling of systems serving less than 10,000 people.

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Confidential Business Information CBI Eligibility Denied By EPA

The U.S. Environmental Protection Agency has notified five companies that the identities of 14 chemicals associated with a number of health and safety studies submitted under the Toxic Substances Control Act (TSCA) and claimed as confidential are not eligible for confidential treatment. Last year, EPA put in place a plan to review confidentiality claims for the name of chemicals addressed in health and safety studies. Under these new procedures EPA is moving to declassify many chemical identities so they are no longer secret. EPA expects that more chemical names connected with health and safety studies will be released in the future. The agency plans to deny confidentiality claims for chemical identity in health and safety studies provided to the agency under TSCA unless the chemical identity contains process or mixture information that is expressly protected by the law.

Under TSCA, companies may claim that information they submit to EPA should be treated as confidential business information (CBI) and not be disclosed to the public. Companies that manufacture, process, or distribute chemicals are required to immediately provide notice to EPA if they learn that a chemical presents a substantial risk of injury to health or the environment. The reports are made available on EPA’s website, but when the identity of the chemical has been claimed confidential by a company, the name of the chemical has been removed from the copy of the report that is made public.

EPA has begun reviewing past CBI claims for chemical identity in health and safety studies. Where EPA determines that the information is not eligible for confidential treatment under the law, the agency will notify companies of the determination and that EPA will make the information public on the 31st day after receiving the determination unless the company challenges the disclosure in federal court.

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EPA Proposing Adding Vapor Intrusion To CERCLA Hazard Ranking

U.S. EPA is proposing to amend the ranking system used to assess potential “Superfund” sites to include potential vapor intrusion. The Hazard Ranking System (HRS), required by the Superfund statute, is the primary mechanism used by EPA to assess the relative threat associated with actual or potential releases of hazardous substances. Sites that score 28.50 or greater under the HRS are eligible for inclusion on the National Priorities List (NPL). The NPL is intended primarily to guide the EPA in determining which sites warrant further investigation. A score of 28.50 does not represent a specified level of risk but is a cutoff point that serves as a screening-level indicator of the highest priority releases or threatened releases.

The HRS includes four scoring pathways - ground water, surface water, air and soil exposure. Additional pathways have been identified by EPA as posing significant threats to human health and the environment, and one such pathway is vapor intrusion. Vapor intrusion occurs when contaminants enter into indoor spaces, generally residences, from environmental sources such as contaminated ground water or contaminated soil.

Historically, EPA's Superfund program has responded to vapor intrusion contamination by two mechanisms: (1) through its emergency response program at sites not on the NPL, or (2) through sites placed on the NPL because of other pathway-related risks. In May 2010, the Government Accountability Office (GAO) issued a report that concluded that if vapor intrusion sites are not assessed and, if needed, listed on the NPL, some seriously contaminated hazardous waste sites with unacceptable human exposure may not otherwise be cleaned up. In response, EPA is proposing to add a new HRS pathway so that sites with vapor intrusion contamination can be evaluated for inclusion on the NPL.

EPA initiated rulemaking in January 2011, and current expects final rules to be completed by January 2012.

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Perchlorate and VOC Standards For Drinking Water Supplies

U.S. Environmental Protection Agency has announced the agency’s decision to develop to regulate perchlorate in drinking water. The decision will lead to the development of the first-ever national standard for perchlorate. In a separate action, the agency also plans to establish a drinking water standard to address a group of up to 16 toxic chemicals that may pose risks to human health. According to EPA, scientific research indicates that perchlorate may disrupt the thyroid’s ability to produce hormones that are critical to developing fetuses and infants. Monitoring data show more than 4% of public water systems have detected perchlorate and 5 - 17 million people may be served drinking water containing perchlorate. Perchlorate is both a naturally-occurring and man-made chemical that is used in the manufacture of rocket fuel, fireworks, flares and explosives, and may be present in bleach and in some fertilizers. This decision reverses a 2008 preliminary determination by the previous administration. EPA expects to continue to evaluate potential perchlorate health effects and occurrence in public water systems. The agency will also evaluate the feasibility and affordability of treatment technologies to remove perchlorate and examine the costs and benefits of potential standards. EPA will also be developing one regulation covering as many as 16 volatile organic compounds (VOCs), includes trichloroethylene (TCE) and tetrachloroethylene (PCE) as well as other regulated and some unregulated contaminants that are discharged from industrial operations. The VOC standard will be developed as part of EPA’s new strategy for drinking water to address contaminants as groups rather than individually in order to provide public health protections more quickly and also allow utilities to more effectively and efficiently plan for improvements.

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