Apr 29: The Senate Environment and Pubic Works Committee, Chaired by Senator Barbara Boxer (D-CA), held an Oversight Hearing on EPA Toxic Chemical Policies. Witnesses testifying at the hearing include James Gulliford, EPA Assistant Administrator for Pesticides, Prevention, and Toxic Substances; the U.S. Government and Accountability Office (GAO); and representatives of the Gynecology & Reproductive Sciences Department, University of California, San Francisco; the WELL Network; Fanwood Chemical, Inc. on the behalf of the Synthetic Organic Chemicals Manufacturers Association; Integrative Biostrategies, LLC; and Occupational and Environmental Health, Johns Hopkins University. Senator Boxer and Ranking Member James Inhofe also delivered opening statements.
In her remarks, Senator Boxer said the hearing would reveal "some disturbing news about the White House and the Bush Administration’s efforts to corrupt EPA’s toxic chemical risk assessment process. By placing politics before science, the Bush Administration is putting the public in harms way. This according to the GAO and EPA scientists." Boxer said, EPA regulates toxic chemicals in the environment under several laws but the overall toxic chemicals law, the Toxic Substances Control Act, or “TSCA,” was adopted in 1976 and was supposed to help assure that toxic chemicals would be restricted or banned if they were hazardous. She said, "TSCA puts the burden on the government to prove a toxic chemical is a risk. That is unlike the European program, called REACH [Registration, Evaluation and Authorization of Chemicals (REACH), See WIMS 3/19/08, See EcoBizPort REACH]. REACH puts the burden on the chemical industry -- where it should be -- to show that their chemicals are safe."
On April 10, U.S. EPA's Office of Research and Development, announced that the Integrated Risk Information System (IRIS) database and process for developing chemical assessments would undergo several changes "to increase its transparency and efficiency." EPA said the changes include: an expanded process for recommending a substance be assessed; the earlier involvement of other agencies and the public; hosting “listening sessions” to allow for the broader participation and engagement of interested parties; and an even more rigorous scientific peer review of IRIS assessments [See WIMS 4/10/08]. EPA’s IRIS program is a chemical evaluation program that is a critical component of EPA’s capacity to support scientifically sound environmental regulations and policies. The IRIS database contains EPA’s scientific position on the potential human health effects of exposure to more than 540 chemicals.
Senator Boxer released a GAO report entitled, Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA's Integrated Risk Information System (GAO-08-440, March 7, 2008). She said the report "criticizes the Bush Administration changes to the risk assessment process and makes clear the danger faced by the public when political interference and the influence of polluters affects EPA’s ability to address the risks of toxic chemicals. Under EPA’s new approach politics can be -- and already has been -- injected into multiple stages in the process. Even worse, the new procedure effectively requires the White House the Department of Defense (DOD) -- which contracts out much of its weapons programs -- to agree with EPA on any risk assessment before it goes forward and is made public. The entire process of White House and interagency debate is kept secret, which GAO and EPA scientists say undermines the credibility of EPA’s scientific assessments. That is because EPA scientists are being pushed aside by White House operatives and polluters."
In its review GAO found, among other items, that the IRIS database is at serious risk of becoming obsolete because EPA has not been able to routinely complete timely, credible assessments or decrease its backlog of 70 ongoing assessments -- a total of 4 were completed in fiscal years 2006 and 2007. In its testimony GAO said that EPA’s new process is largely the same as the draft GAO evaluated [prior to the April 10 release], and some key changes also are likely to further exacerbate the productivity and credibility concerns GAO identified. GAO testified, "GAO continues to believe it is critical that input from all parties—particularly agencies that may be affected by the outcome of IRIS assessments—be publicly available. As recommended in GAO’s March 2008 report, to effectively maintain IRIS, EPA must, among other things, streamline its lengthy assessment process and adopt transparency practices that provide assurance that IRIS assessments are appropriately based on the best available science and that they are not inappropriately biased by policy considerations. Since EPA’s new process is not responsive to GAO’s recommendations, the viability of this critical database has been further jeopardized."
Access the hearing website with links to all testimony, opening statements, the full 89-page GAO report, related letters & documents and a webcast of the hearing (click here). Access an EPA release on it new IRIS process (click here). Access the IRIS website (click here). Access links to contacts, a 9-page EPA description of the process revisions, and a 5-page FAQ document (click here). [*Toxics]
Showing posts sorted by relevance for query IRIS. Sort by date Show all posts
Showing posts sorted by relevance for query IRIS. Sort by date Show all posts
Tuesday, April 29, 2008
Thursday, June 12, 2008
Frustration Mounts With Integrated Risk Assessment System Delays
Jun 12: House Science & Technology Committee, Investigations & Oversight Subcommittee, Chaired by Representative Brad Miller (D-NC), held a second hearing on EPA’s Integrated Risk Assessment System -- IRIS. The hearing was entitled, Toxic Communities: How EPA’s IRIS Program Fails the Public. Witnesses testifying at the hearing included representatives from: Jerome Ensminger, retired from the Marine Corps; Center for Public Environmental Oversight; Natural Resources Defense Council; and the Medical University of South Carolina.
In an opening statement Representative Miller expressed his ongoing frustration and said, "The glacial pace at which EPA is completing assessments of chemicals has real consequences for public health and tragic consequences for individuals and their families. Completion of an IRIS assessment is just the first step in the process protecting people from dangerous exposures to toxic chemicals. With an IRIS assessment in place, it is easier to deal with the cleanup of chemical contamination of the air or water, to adopt safer practices in the workplace and to consider steps to regulate toxic substances that can harm our children and our communities."
The Government Accountability Office’s recent report on IRIS [See WIMS 4/29/08] concluded that EPA’s process for initiating and completing IRIS assessments resulted in proposals that are in preparation for more than 5 years, with some assessments taking more than a decade. Miller said, "The new process that EPA and OMB instituted just this past April will add additional years to IRIS assessments. The years of added study and discussion regarding IRIS assessments come on top of a regulatory process that is burdened with very time consuming steps for a complete risk assessment, cost-benefit analyses, and internal and external reviews as laid down in Executive Orders and statute. Even after a regulation is finalized, it can be challenged in court and sent back to the Agency for revision. When finally established a new regulation usually includes some time, often many years, for the affected parties to “transition” away from the practices that are being regulated."
Miller cited the fact that EPA has been working on a revised TCE assessment since 1989. Two years ago, following interventions by NASA, the Department of Energy, the Department of Defense and OMB, the National Academy reviewed EPA’s draft IRIS assessment and the science available on TCE and said that: “evidence on carcinogenic risk and other health hazards from exposure to trichloroethylene has strengthened since 2001. … Priority should be given to finalizing the risk assessment so that risk management decisions can be made expeditiously.”
Miller said, "Expeditiously? Expeditious is not a word that describes this situation. GAO estimates that EPA will not complete their TCE assessment until 2010 – that’s twenty one years from their original start date. If they complete the assessment in 2010, we will still be years away from regulatory action. People will have been exposed to a known toxic substance for decades, for a generation, while the government engages in study after study. Have we become so obsessed with getting the science right that we have lost sight of our real goal -- protecting public health? Or, is getting the science right a pretext for obstruction? This system defies common sense. It is broken, and it is condemning people to future health problems."
On June 11, Miller sent a letter to the White House asking for all documents related to the long-delayed assessment of TCE. Miller said, "Politics should have no role in deciding what toxic effect a chemical may have. The White House Office of Management and Budget (OMB) has effectively blocked the Environmental Protection Agency (EPA) from posting new health assessments of hazardous chemicals by prolonging the assessments because of inevitable uncertainties about the interaction of chemicals and human health. . ."
Access the hearing website for extensive background and links to all testimony (click here). Access a release and link to Representative Miller's letter to OMB (click here). [*Toxics]
In an opening statement Representative Miller expressed his ongoing frustration and said, "The glacial pace at which EPA is completing assessments of chemicals has real consequences for public health and tragic consequences for individuals and their families. Completion of an IRIS assessment is just the first step in the process protecting people from dangerous exposures to toxic chemicals. With an IRIS assessment in place, it is easier to deal with the cleanup of chemical contamination of the air or water, to adopt safer practices in the workplace and to consider steps to regulate toxic substances that can harm our children and our communities."
The Government Accountability Office’s recent report on IRIS [See WIMS 4/29/08] concluded that EPA’s process for initiating and completing IRIS assessments resulted in proposals that are in preparation for more than 5 years, with some assessments taking more than a decade. Miller said, "The new process that EPA and OMB instituted just this past April will add additional years to IRIS assessments. The years of added study and discussion regarding IRIS assessments come on top of a regulatory process that is burdened with very time consuming steps for a complete risk assessment, cost-benefit analyses, and internal and external reviews as laid down in Executive Orders and statute. Even after a regulation is finalized, it can be challenged in court and sent back to the Agency for revision. When finally established a new regulation usually includes some time, often many years, for the affected parties to “transition” away from the practices that are being regulated."
Miller cited the fact that EPA has been working on a revised TCE assessment since 1989. Two years ago, following interventions by NASA, the Department of Energy, the Department of Defense and OMB, the National Academy reviewed EPA’s draft IRIS assessment and the science available on TCE and said that: “evidence on carcinogenic risk and other health hazards from exposure to trichloroethylene has strengthened since 2001. … Priority should be given to finalizing the risk assessment so that risk management decisions can be made expeditiously.”
Miller said, "Expeditiously? Expeditious is not a word that describes this situation. GAO estimates that EPA will not complete their TCE assessment until 2010 – that’s twenty one years from their original start date. If they complete the assessment in 2010, we will still be years away from regulatory action. People will have been exposed to a known toxic substance for decades, for a generation, while the government engages in study after study. Have we become so obsessed with getting the science right that we have lost sight of our real goal -- protecting public health? Or, is getting the science right a pretext for obstruction? This system defies common sense. It is broken, and it is condemning people to future health problems."
On June 11, Miller sent a letter to the White House asking for all documents related to the long-delayed assessment of TCE. Miller said, "Politics should have no role in deciding what toxic effect a chemical may have. The White House Office of Management and Budget (OMB) has effectively blocked the Environmental Protection Agency (EPA) from posting new health assessments of hazardous chemicals by prolonging the assessments because of inevitable uncertainties about the interaction of chemicals and human health. . ."
Access the hearing website for extensive background and links to all testimony (click here). Access a release and link to Representative Miller's letter to OMB (click here). [*Toxics]
Friday, September 19, 2008
Hearing On "Science Under Siege" At U.S. EPA
Sep 18: The House Energy & Commerce Committee, Subcommittee on Oversight and Investigations, Chaired by Representative Bart Stupak (D-MI) held a hearing entitled, Science Under Siege: Scientific Integrity at the Environmental Protection Agency. Witnesses testifying at the hearing included: U.S. Government Accountability Office (GAO); Union of Concerned Scientists (UCS); State of Maine Department of Environmental Protection; Glynn Environmental Coalition; Natural Resources Defense Council (NRDC); American Chemistry Council; Marcus Peacock, Deputy Administrator U.S. EPA [Prepared testimony was not submitted]; and George Gray, Ph.D., Assistant Administrator U.S. EPA Office Research and Development.
Full Committee Chairman, Representative John Dingell (D-MI), delivered an opening statement saying, "Scientific integrity is an essential ingredient of nearly every decision the Environmental Protection Agency (EPA) makes. Unfortunately, there is a substantial question as to whether that is always the case under the current Administration. There is growing evidence that Congress, State and local governments, the public, and even other countries cannot rely on EPA for honest science.
"The landmark survey of EPA scientists conducted by the Union of Concerned Scientists (UCS) confirms what many had feared -- the Bush Administration’s political interference with EPA scientists is pervasive and frequent. The UCS survey found that more than 500 EPA scientists knew of “many or some” cases where EPA political appointees had interfered with scientific decisions. Nearly 100 EPA scientists identified the White House Office of Management and Budget as the primary source of external interference. And more than 500 scientists said they feared retaliation for speaking candidly about EPA’s scientific work. Clearly, we are not talking about an isolated incident.
"The testimony we will hear today exposes a broad pattern of political meddling by the Bush Administration, directed at EPA scientists and science. A prime example is the Administration’s recent changes to the Integrated Risk Information System (IRIS) process, under which chemicals are evaluated to determine the extent to which they may be hazardous to human health. . . Under this new system, the two largest polluters in the United States -- the Department of Defense and the Department of Energy -- are permitted to provide secret comments to OMB, which then has the final say on what goes into the IRIS system. Even EPA is not permitted to see these comments. And, because all of this is now done in secrecy, it is not entirely clear who else may have a hand in the process. . ."
At the hearing GAO released a new report entitled, New Assessment Process Further Limits the Credibility and Timeliness of EPA's Assessments of Toxic Chemicals (GAO-08-1168T, September 18, 2008). In the report, GAO found, "In March 2008, GAO concluded that the IRIS database was at serious risk of becoming obsolete because EPA had not been able to complete timely, credible assessments or decrease its backlog of 70 ongoing assessments -- a total of 4 were completed in fiscal years 2006 and 2007. In addition, assessment process changes EPA had recently made, as well as other changes EPA was considering at the time of GAO’s review, would further reduce the credibility and timeliness of IRIS assessments."
GAO said, "EPA issued its revised IRIS assessment process in April 2008. The new process is largely the same as the draft GAO evaluated and does not respond to the recommendations in GAO’s March 2008 report. Moreover, some key changes are likely to further exacerbate the productivity and credibility concerns GAO identified. . . Instead of streamlining the process, as GAO recommended, EPA has institutionalized a process that from the outset is estimated to take 6 to 8 years. This is problematic because of the substantial rework such cases often require to take into account changing science and methodologies. . . Little or no progress has been made on assessments of chemicals highlighted in our report, including naphthalene, formaldehyde, and trichloroethylene (TCE)."
Access the hearing website for links to all testimony and a webcast (click here). Access the complete statement from Chairman Dingell (click here). Access the GAO report (click here). Access multiple WIMS-eNewsUSA blog postings on the IRIS issue (click here). [*Toxics]
Full Committee Chairman, Representative John Dingell (D-MI), delivered an opening statement saying, "Scientific integrity is an essential ingredient of nearly every decision the Environmental Protection Agency (EPA) makes. Unfortunately, there is a substantial question as to whether that is always the case under the current Administration. There is growing evidence that Congress, State and local governments, the public, and even other countries cannot rely on EPA for honest science.
"The landmark survey of EPA scientists conducted by the Union of Concerned Scientists (UCS) confirms what many had feared -- the Bush Administration’s political interference with EPA scientists is pervasive and frequent. The UCS survey found that more than 500 EPA scientists knew of “many or some” cases where EPA political appointees had interfered with scientific decisions. Nearly 100 EPA scientists identified the White House Office of Management and Budget as the primary source of external interference. And more than 500 scientists said they feared retaliation for speaking candidly about EPA’s scientific work. Clearly, we are not talking about an isolated incident.
"The testimony we will hear today exposes a broad pattern of political meddling by the Bush Administration, directed at EPA scientists and science. A prime example is the Administration’s recent changes to the Integrated Risk Information System (IRIS) process, under which chemicals are evaluated to determine the extent to which they may be hazardous to human health. . . Under this new system, the two largest polluters in the United States -- the Department of Defense and the Department of Energy -- are permitted to provide secret comments to OMB, which then has the final say on what goes into the IRIS system. Even EPA is not permitted to see these comments. And, because all of this is now done in secrecy, it is not entirely clear who else may have a hand in the process. . ."
At the hearing GAO released a new report entitled, New Assessment Process Further Limits the Credibility and Timeliness of EPA's Assessments of Toxic Chemicals (GAO-08-1168T, September 18, 2008). In the report, GAO found, "In March 2008, GAO concluded that the IRIS database was at serious risk of becoming obsolete because EPA had not been able to complete timely, credible assessments or decrease its backlog of 70 ongoing assessments -- a total of 4 were completed in fiscal years 2006 and 2007. In addition, assessment process changes EPA had recently made, as well as other changes EPA was considering at the time of GAO’s review, would further reduce the credibility and timeliness of IRIS assessments."
GAO said, "EPA issued its revised IRIS assessment process in April 2008. The new process is largely the same as the draft GAO evaluated and does not respond to the recommendations in GAO’s March 2008 report. Moreover, some key changes are likely to further exacerbate the productivity and credibility concerns GAO identified. . . Instead of streamlining the process, as GAO recommended, EPA has institutionalized a process that from the outset is estimated to take 6 to 8 years. This is problematic because of the substantial rework such cases often require to take into account changing science and methodologies. . . Little or no progress has been made on assessments of chemicals highlighted in our report, including naphthalene, formaldehyde, and trichloroethylene (TCE)."
Access the hearing website for links to all testimony and a webcast (click here). Access the complete statement from Chairman Dingell (click here). Access the GAO report (click here). Access multiple WIMS-eNewsUSA blog postings on the IRIS issue (click here). [*Toxics]
Wednesday, May 07, 2014
WIMS Environmental HotSheet 5/7/14
National / International News
<> Take Your Pick! News Roundup for 3rd National Climate Assessment from Climate Nexus – Links to all the coverage from various media sources
- U.S. National Climate Assessment: Resources and media - The 2014 National Climate Assessment: Climate Change Impacts in the
<> EIA releases complete Annual Energy Outlook 2014 report - (Wed, 07 May 2014) The U.S. Energy Information Administration will release today the full content of the Annual Energy Outlook 2014 ((AEO2014)
<> Americans Deserve a Broad Debate on Energy, But Senate Democrats Won't Allow It - U.S. Senate Republican Leader Mitch McConnell made the following remarks on the Senate floor calling on Senate Democrats to allow energy proposals that focus on helping the Middle Class: "Once again. . .
<> Substantial Improvements Made in EPA's IRIS Program - A new congressionally mandated report from the National Research Council says that changes EPA has proposed and implemented into its Integrated Risk Information System (IRIS) process are "substantial improvements."
- National Research Council Releases Report Praising EPA's IRIS Program Enhancements - Today, the U.S. Environmental Protection Agency's (EPA) actions to improve its Integrated Risk Information System (IRIS) program, which provides information on the health effects of environmental. . .
<> EPA Releases EnviroAtlas Ecosystem Mapping Tool - The U.S. Environmental Protection Agency (EPA) today released EnviroAtlas, a web-based interactive tool that integrates over 300 separate data layers, helps decision makers understand the implications of. . .
<> DOE Issues Request for Information on Fuel Cell Research and Development Needs - May 5, 2014DOE Issues Request for Information on Fuel Cell Research and Development Needs. . .
<> Leading Environmental and Conservation Groups and Deepwater Wind Announce Agreement to Protect Endangered Whales at Deepwater ONE Offshore Wind Farm Site - Agreement Will Reduce Noise Impacts on North Atlantic Right Whales
<> Agriculture Secretary Tom Vilsack Announces Continued Progress on 2014 Farm Bill Implementation - May 7, 2014 — Agriculture Secretary Tom Vilsack today announced continued progress during the first 90 days of implementing the Agricultural Act of 2014 (the 2014 Farm Bill), which President Obama signed. . .
<> May Updates to the Climate Litigation Charts - Update #62 May 2014 Each month, Arnold & Porter and the Center for Climate Change Law collect and summarize developments in climate-related litigation, which we also add to our U.S. and non-US climate litigation charts.
<> Secretary Jewell to Make Major Announcements Related to Tribal Energy Development - As part of President Obama's Climate Action Plan to cut carbon pollution and create clean energy jobs, on Wednesday, May 7, 2014, Secretary of the Interior Sally Jewell will make several major announcements related to energy. . . 1:00 pm MST – Announcement
<> Does "global warming" mean it's warming everywhere? – NOAA: It's only when we "zoom out" to the planet-wide scale that trends in surface temperature are obvious: despite a few, rare areas experiencing cooling, the vast majority of places across the globe are warming.
<> Top 10 Things You Didn't Know About Offshore Wind Energy - Top 10 Things You Didn't Know About Offshore Wind Energy Learn more about efforts to develop America's vast offshore wind resources.
<> Oil-by-rail exports to the US up by 900 per cent - May 7, 2014 - 9:48am The Globe and Mail reports, "New National Energy Board figures show that oil-by-rail exports have risen more than 900 per cent in less than two years...
<> Plan Bee: we can live without pesticides! - Today Greenpeace launched a solutions report, Plan Bee - living without pesticides. It illustrates concrete ways to protect our bees and agriculture and proves the large-scale feasibility of ecological farming.
Federal Register Highlights
The following is an alert of Environmental Federal Register announcements that may be of interest for: Wednesday, May 7, 2014. (Click here to access today's complete Federal Register index with links to complete announcements).
1. Nothing We're Tracking Today (click for the complete Energy & EPA announcements)
Tuesday, July 12, 2011
Sen. Hearing On Unregulated Drinking Water Contaminants Program
Jul 12: The Senate Environment and Pubic Works (EPW) Committee, Chaired by Senator Barbara Boxer (D-CA) , with Ranking Member James Inhofe (R-OK) held a hearing entitled, "Oversight Hearing on the Environmental Protection Agency's Implementation of the Safe Drinking Water Act's Unregulated Drinking Water Contaminants Program." Witnesses testifying at the hearing included the: Government Accountability Office; U.S. EPA; American Public Health Association; West Valley Water District; Joseph Cotruvo & Associates, LLC; George Washington University Cancer Institute; and Department of Public Health and Community Medicine Tufts University.
Chairman Boxer indicated in an opening statement, "In order to ensure that enough is being done to protect our nation from emerging contaminants, I, along with Representatives Waxman and Markey, asked the Government Accountability Office (GAO) to investigate the unregulated contaminant program. This report is being released today. . . the GAO report shows the development of new standards for unregulated drinking water contaminants, such as perchlorate, were derailed in a process that failed to use the best available science and was driven by factors other than the protection of public health. Scientific information has shown that certain emerging contaminants in our drinking water, such as perchlorate and chromium-6, could be harmful to children and families across the nation. . . EPA needs to have a process that vigorously addresses these contaminants to help ensure the safety of the nation's drinking water. . ."
Ranking Member Inhofe said, "At the cornerstone of the Safe Drinking Water Act is the idea that we should be controlling those substances that pose risks to public health. Unfortunately, the system that EPA uses to determine health risks, the Integrated Risk Information System (IRIS), has a decade's long issues in crafting risk assessments. The National Academy of Sciences (NAS) has recently pointed out that IRIS assessments have suffered from a lack of transparency, inconsistency, and problems with evaluating studies and the weight of evidence. . . As analytical techniques continue to improve, we are able to detect constituents at increasingly lower levels. This ever increasing ability to detect will allow the numbers of chemicals in our water to increase infinitely. However, it is important that we do not associate any detection with risk. In nearly every case, the extremely low levels we are detecting are well below the dosage that would affect public health. To be perfectly clear, exposure does not mean there is risk. . ."
GAO submitted 26-pages of testimony and a 146-page report entitled, Safe Drinking Water Act: EPA Should Improve Implementation of Requirements on Whether to Regulate Additional Contaminants (GAO-11-254, May 27, 2011). GAO was asked to: (1) evaluate the extent to which EPA's implementation of the 1996 amendments has helped assure the public of safe drinking water; and, (2) review the process and scientific analyses used to develop the 2008 preliminary regulatory determination on perchlorate. GAO analyzed relevant statutory provisions and regulatory determination documents and interviewed EPA officials.
GAO found that, "Systemic limitations in EPA's implementation of requirements for determining whether additional drinking water contaminants warrant regulation have impeded the agency's progress in assuring the public of safe drinking water. EPA's selection of contaminants for regulatory determination in 2003 and 2008 was driven by data availability -- not consideration of public health concern. EPA does not have criteria for identifying contaminants of greatest public health concern and based most of its final determinations to not regulate 20 contaminants on the rationale of little or no occurrence of the contaminants in public water systems. Moreover, EPA's testing program for unregulated contaminants--which can provide key data to inform regulatory determinations--has fallen short in both the number of contaminants tested and the utility of the data provided because of management decisions and program delays. . ."
GAO's 17 recommendations include that the EPA Administrator require: (1) development of criteria to identify contaminants that pose the greatest health risk; (2) improvements in its unregulated contaminants testing program; and, (3) development of policies or guidance to interpret the broad statutory criteria. According to GAO, EPA agreed with 2 recommendations but took the position that developing guidance and taking the other recommended actions are not needed. GAO believes EPA needs to adopt all of the recommendations to better assure the public of safe drinking water.
EPA testified that, "Strong science and the law are the foundation of our decision-making at EPA. Under the Safe Drinking Water Act (SDWA), EPA identifies priority contaminants that are known or anticipated to occur in public water systems and then evaluates whether new drinking water standards are warranted for these contaminants. . . GAO's report expresses concern that EPA's past decisions have been driven not by considering the greatest health concern but by considering available data. EPA agrees that we can improve our process to better focus on contaminants that may be of public health concern. The improved approach in the most recent CCL [Contaminant Candidate List] was a substantial step forward in achieving this by using a rigorous scientific process to better ensure that the contaminants on the list are the ones that should be of highest priority for public health protection. . .
"In response to the GAO recommendations, EPA will also consult with an independent panel of scientists on the regulatory determinations, specifically on the evaluation of the contaminants against the first and second criteria defined by SDWA, the use of best available science to develop the determination, and whether the determination focuses on the greatest public health risk. We will post the regulatory determination process publicly and review the process every five years as we conduct the regulatory determination cycle. . ."
Access the hearing website with links to all testimony, a webcast and Chairman Boxer's statement (click here). Access the statement from Sen. Inhofe (click here). Access the complete GAO report (click here). [*Drink]
Monday, February 06, 2012
House Hearing On EPA & Fostering Quality Science
Feb 3: The House Committee on Science, Space, and Technology, Subcommittee on Energy and Environment, Chaired by Representative Andy Harris (R-MD) held a hearing entitled, "Fostering Quality Science at EPA: Perspectives on Common Sense Reform – Day II." Witnesses included representatives from the Health Effects Institute; EPA's Science Advisory Board; American Chemistry Council; Regulatory Checkbook; Department of Civil and Environmental Engineering, University of Iowa; and the National Institute of Statistical Sciences.
In a release from the Ranking Member Brad Miller (D-NC) it was noted that the first hearing of this series, held last November, was intended to serve as an opportunity to evaluate EPA's research enterprise, but instead the discussion focused on hydraulic fracturing. The second hearing was intended to inform the subcommittee on structural and substantive concerns of external stakeholders related to EPA's research activities, but the witness panel was primarily made up of representatives from right-wing think tanks.
In a brief opening statement, Chairman Harris said, "Unfortunately, the Environmental Research, Development and Demonstration Authorization Act, or ERDDAA, which is the statute authorizing R&D at EPA as well as the Science Advisory Board, was last reauthorized for fiscal year 1981. I think we can all agree that our fiscal, environmental, and economic priorities have changed dramatically over the last 30 years, and we should have statutes and a Congressional role in environmental policy that reflects these changes. As we have held nearly a dozen oversight hearings on specific EPA issues during this Congress, we have seen patterns of behavior that suggest the need for significant reforms.
At day one of this hearing, we received testimony from several witnesses with decades of experience. . . They provided specific recommendations on reforming scientific activities at EPA, including the need to separate science and policy, to quantify uncertainties, to ensure greater transparency in the data, models, and assumptions used in regulatory decisions, to prioritize environmental problems and solutions, and to stop overly alarmist approaches to benefit-cost analysis."
Representative Miller said, "I am pleased to see that we have some panelists with the experience and knowledge required to address in detail critical improvements that can make EPA's research enterprise more effective, efficient, and transparent. At the least, this is not just a panel of witnesses armed only talking points and flailing criticism meant to undermine or dismantle the one agency charged with protecting our citizens and the environment from unlawful pollution. . . As I have stated before, I approach this task hoping to work with my Republican counterparts in pursuing reforms that will lead to better research practices that help EPA accomplish its mission. . . I understand the amount of research, stakeholder conversations, and thought that must take place to write legislation as important and ambitious as the reauthorization of ERDDA."
A GOP release indicated that witnesses repeatedly emphasized the need for greater transparency of scientific data and research results. Dr. Stanley Young, Assistant Director for Bioinformatics at the National Institute of Statistical Sciences said, "On publication of a paper, where research is funded by the EPA, the data should be made public. When the EPA proposes a regulation based on science, it should name the papers it is depending on and it should make data sets used in those papers publicly available. . . Claims are more likely to be valid and the resulting policy sensible. Let normal science help in the vetting process. Make the data available."
Michael Walls, Vice President of Regulatory and Technical Affairs at the American Chemistry Council said, "At the heart of the problem in the Federal government's processes for assessing risks to environment and human health is the lack of a consistent, coherent, science-based framework that binds the agencies to an appropriate and transparent approach for weighing evidence, considering uncertainty, and keeping up with advances in the field. The processes for considering scientific information and data and the standards and criteria used in risk assessment need to be modernized and streamlined to meet both today's needs and greater challenges of the future."
To demonstrate how the quality of science has eroded, Walls pointed to problems with the EPA's Integrated Risk Information System (IRIS) assessments of n-butanol and dioxin as well as with the evaluation of formaldehyde and styrene in the 12th Report on Carcinogens (RoC). He said, "Why do we need to get this right? About 80% of IRIS assessments haven't been updated for more than 15 years. 90% are now at least 10 years old. Meanwhile, the science that informs our understanding of chemicals and exposures has continued to advance by leaps and bounds. That new science should surely inform our regulatory and policy decisions."
The Chairwoman of EPA's Science Advisory Board, appointed in 2008 by EPA Administrator Stephen Johnson summarized saying, ". . .we are supportive of these changes at ORD. More could be done, more is being done, but I believe, and our reports have indicated, that ORD is moving in the right direction." She said, "The best available science is essential to sound decision‐making, but is not the only aspect to sound policy decisions. What is "best available science"? While hard to provide a simple one‐size‐fits‐all definition, generally it is scientific results, conclusions, and technical information that has been produced using proven methods, that has been peer‐reviewed, where hypotheses are tested with objective and unbiased approaches, and that has support for its conclusions from other independent studies. EPA cannot possibly do all of the science needed by the Program Offices and Regional Offices. Some of this needed science is conducted within EPA, and some science is used from outside research to verify, supplement, and in general add to the collective body of knowledge used to inform a given decision. . ."
She continued saying, "For purposes of maximum transparency and quality assurance, we usually advise the Agency not to include reports that have not been peer‐reviewed, or journal manuscripts in preparation or draft form but not yet published. As a researcher who has received funding from EPA and many other agencies, I have found that EPA has very high standards for data quality and assurance. . . It [EPA] is sorely short of resources to provide the capacity needed for all the science questions at the Agency, and yet there is no other agency where such environmentally focused and directed science is being done to fill the unique mission of protecting the public's health and the environment on which they depend. Investing in EPA science is a wise investment. . ."
Access a Republican release on the hearing (click here). Access the Republican hearing website for links to statements, testimony and webcast (click here). Access a Democratic release on the hearing (click here). Access the Democrats website for the hearing (click here).
GET THE REST OF TODAY'S NEWS (click here)
32 Years of Environmental Reporting for serious Environmental Professionals
32 Years of Environmental Reporting for serious Environmental Professionals
Tuesday, September 11, 2012
GAO Finds Security Problems With High-Risk Radiological Sources
Sep 10: The U.S. Government Accountability Office (GAO) released a report entitled, Nuclear Nonproliferation Additional Actions Needed to Improve Security of Radiological Sources at U.S. Medical Facilities (GAO-12-925, Sep 10, 2012). The report was requested by Senator Daniel Akaka (D-HI), Chairman Subcommittee on Oversight of Government Management, the Federal Workforce, and the District of Columbia of the Committee on Homeland Security and Governmental Affairs.
In background information GAO indicates that in the hands of terrorists, radiological material, such as cesium-137, could be used to construct a "dirty bomb." Such material -- encapsulated in steel or titanium and called a sealed source -- is commonly found in equipment used by U.S. medical facilities to treat, among other things, cancer patients. The Nuclear Regulatory Commission's (NRC) is responsible for regulating the commercial use of sealed sources and has relinquished its regulatory authority to 37 states, known as Agreement States. In 2008, the National Nuclear Security Administration (NNSA) established a program to provide security upgrades to U.S. hospitals and medical facilities that use radiological sources. GAO was asked to determine: (1) the extent to which NRC's requirements ensure the security of radiological sources at U.S. medical facilities; and (2) the status of NNSA's efforts to improve the security of sources at these facilities. GAO reviewed relevant laws, regulations, and guidance; interviewed Federal agency and state officials; and visited 26 hospitals and medical facilities in 7 states and Washington, DC.
GAO found that the NRC requirements do not consistently ensure the security of high-risk radiological sources at the 26 selected hospitals and medical facilities GAO visited. One reason for this is that the requirements are broadly written and do not prescribe specific measures that hospitals and medical facilities must take to secure medical equipment containing sealed sources, such as the use of cameras or alarms. Rather, the requirements provide a general framework for what constitutes adequate security practices, which is implemented in various ways at different hospitals. Some of the medical equipment in the facilities visited was more vulnerable to potential tampering or theft than that of other facilities because some hospitals developed better security controls than others. Some examples of poor security GAO observed included: an irradiator, used for medical research and containing almost 2,000 curies of cesium-137, was stored on a wheeled pallet down the hall from, and accessible to, a loading dock at one facility; at a second facility, the combination to a locked door, which housed an irradiator containing 1,500 curies of cesium- 137, was clearly written on the door frame; and at a third facility, an official told GAO that the number of people with unescorted access to the facility's radiological sources was estimated to be at least 500. In addition, some NRC and Agreement State inspectors said the training NRC requires is not sufficient.
As of March 2012, NNSA had spent $105 million to complete security upgrades at 321 of the 1,503 U.S. hospitals and medical facilities it identified as having high-risk radiological sources. Of the 26 hospitals and medical facilities that GAO visited, 13 had volunteered for the NNSA security upgrades and had received security upgrades, such as remote monitoring systems, surveillance cameras, enhanced security doors, iris scanners, motion detectors, and tamper alarms; three others were in the process of receiving upgrades. However, NNSA does not anticipate completing all such security upgrades until 2025, leaving a number of facilities potentially vulnerable. In addition, the program's impact is limited because, among other things, it is voluntary, and facilities can decline to participate. To date, 14 facilities, including 4 in large urban areas, have declined to participate in the program. Combined, those 14 facilities have medical equipment containing over 41,000 curies of high-risk radiological material. According to police department officials in a major city, one hospital with a blood irradiator of approximately 1,700 curies has declined the NNSA upgrades due in part to cost concerns, even though the police department considers it to be a high-risk facility.
GAO recommends, among other things, that NRC strengthen its security requirements by providing medical facilities with specific measures they must take to develop and sustain a more effective security program. NRC neither agreed nor disagreed with the recommendation and stated that its existing security requirements are adequate. GAO continues to believe that implementing its recommendation would contribute to increased security at U.S. hospitals and medical facilities.
Access the complete 56-page report (click here). [#Haz/Nuclear]
GET THE REST OF TODAY'S NEWS (click here)
32 Years of Environmental Reporting for serious Environmental Professionals
32 Years of Environmental Reporting for serious Environmental Professionals
Tuesday, May 06, 2008
Senate Hearing On Perchlorate And TCE In Water
May 6: Senate Environment and Pubic Works Committee, Chaired by Senator Barbara Boxer (D-CA) held a hearing entitled, Perchlorate and TCE in Water. Witnesses testifying at the hearing included: Benjamin Grumbles, Assistant Administrator for Water, U.S. EPA; representatives of the California EPA; Ohio EPA; the Association of State Drinking Water Administrators (ASDWA); Massachusetts Department of Environmental Protection; a State of New York legislator; HealthRisk Strategies; Medical University of South Carolina; and the Environmental Working Group. Additionally, Senator Boxer and Ranking Member James Inhofe delivered opening statements.
Senator Boxer said, "In fact, today we will hear about EPA’s particularly disturbing failures to address significant risks to our families from two widespread drinking water contaminants: perchlorate and trichloroethylene, usually just called 'TCE.' Perchlorate is used to make rocket fuel, but when it gets into drinking water, this toxic chemical can interfere with the thyroid and affect hormone systems, which control the way the body develops. Infants and pregnant women are especially vulnerable to perchlorate. Researchers have found that over 20 million Americans’ drinking water supplies contain perchlorate. GAO found in 2005 that there were nearly 400 sites in 35 states contaminated with perchlorate. My state of California had 106 sites. . . And we know that we are exposed to perchlorate from many sources, not just drinking water. A January 2008 study by the FDA found perchlorate in 74% of all foods tested, including baby food."
Boxer said that EPA had done "very little" to address the problem. She said, "I told EPA last week that if the Bush Administration failed to protect our people, Congress would step in. I have two bills to protect people from perchlorate contamination. The first bill, the “Perchlorate Monitoring and Right to Know Act,” S. 24, says that EPA is to restore the rule requiring that drinking water be tested for perchlorate, and that the results of those tests must be disclosed to the public. My second bill, the “Protecting Pregnant Women and Children from Perchlorate Act,” S. 150, requires EPA to quickly set a perchlorate standard for drinking water that protects pregnant women and children. In addition, Senator Clinton, Senator Dole, myself, and several colleagues have a bill, the “TCE Reduction Act,” S. 1911, that would protect people exposed the TCE."
Senator Inhofe indicated that he was opposed to all three of these pieces of legislation mentioned by Senator Boxer. He said, "Each bill assumes that the scientific data and findings are complete and that they require the Environmental Protection Agency to establish a Maximum Contaminant Level, or MCL, within a specified amount of time for both perchlorate and TCE. My concern isn’t that these chemicals may be harmful to human health at a certain level, but rather that politicians feel compelled to introduce legislation forcing EPA’s hand on what could become a 'contaminant of the month' scenario without scientific backing. It should also be noted that TCE already has a set MCL based on principals outlined in the Safe Drinking Water Act. . .
"The legislative approach taken in S. 24, S. 150, and S. 1911 is simply politicians meddling in the scientific process clearly laid out in the Safe Drinking Water Act. Mike Baker from the Ohio Environmental Protection Agency will speak on behalf of the Association of State Drinking Water Administrators about the current process and the concern of legislating contaminants rather than following the process outlined in the Safe Drinking Water Act. . ." [See WIMS 1/3/07]
EPA testified that the Agency has been working on the science related to perchlorate for more than ten years. "In 2003, EPA sent its January 2002 external review draft of the perchlorate risk assessment to the National Academy of Sciences (NAS) for review. The NAS panel released a report in January 2005 which recommended that the Agency use a reference dose (RfD) of 0.0007 mg/kg/day (0.7 µg/kg/day) based on a human study (Greer et al., 2002). The RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of adverse effects during a lifetime. EPA endorsed their recommendation and used the NAS panel report "Health Implications of Perchlorate Ingestion” as the basis for establishing its RfD which was subsequently posted to the Integrated Risk Information System (IRIS) database in February 2005."
He said in January 2006, EPA issued guidance for contaminated sites which recommended a revised preliminary remediation goal (PRG) of 24.5 ppb perchlorate in water. The PRG was calculated from EPA’s RfD using standard exposure values of 70 kg body weight and 2 liters of water consumed per day. This calculation provides the drinking water equivalent level, assuming
no other sources of perchlorate exposure." He also said, "In addition, if a state has promulgated a drinking water standard for perchlorate (e.g., Massachusetts adopted 2 ppb as a drinking water standard), that value would be considered an Applicable or Relevant and Appropriate Requirement (ARAR) and used as the ground water cleanup level for sites in that state."
He indicated that the Agency has "significant concerns with the bills introduced by Senators Boxer and Clinton. With respect to drinking water our primary concern with these bills is that they return the Agency to the time before 1996 when Congress dictated the drinking water regulations developed by the Agency." He concluded saying, the Agency is "working expeditiously to address potential risks from perchlorate and to evaluate the need for and feasibility of a stronger standard for TCE using this framework. We believe this framework is sound, and respectfully request that you allow us time to complete the required analyses and determinations to ensure appropriate science-based protection of public health from these and other contaminants, as envisioned in the 1996 amendments. As noted above, we are committed to making a final regulatory determination for perchlorate by the end of 2008, and for TCE as soon as the necessary analyses have been completed."
Access the hearing website for links to all testimony, opening statements and a webcast (click here). [*Water/Drink, *Toxics]
Senator Boxer said, "In fact, today we will hear about EPA’s particularly disturbing failures to address significant risks to our families from two widespread drinking water contaminants: perchlorate and trichloroethylene, usually just called 'TCE.' Perchlorate is used to make rocket fuel, but when it gets into drinking water, this toxic chemical can interfere with the thyroid and affect hormone systems, which control the way the body develops. Infants and pregnant women are especially vulnerable to perchlorate. Researchers have found that over 20 million Americans’ drinking water supplies contain perchlorate. GAO found in 2005 that there were nearly 400 sites in 35 states contaminated with perchlorate. My state of California had 106 sites. . . And we know that we are exposed to perchlorate from many sources, not just drinking water. A January 2008 study by the FDA found perchlorate in 74% of all foods tested, including baby food."
Boxer said that EPA had done "very little" to address the problem. She said, "I told EPA last week that if the Bush Administration failed to protect our people, Congress would step in. I have two bills to protect people from perchlorate contamination. The first bill, the “Perchlorate Monitoring and Right to Know Act,” S. 24, says that EPA is to restore the rule requiring that drinking water be tested for perchlorate, and that the results of those tests must be disclosed to the public. My second bill, the “Protecting Pregnant Women and Children from Perchlorate Act,” S. 150, requires EPA to quickly set a perchlorate standard for drinking water that protects pregnant women and children. In addition, Senator Clinton, Senator Dole, myself, and several colleagues have a bill, the “TCE Reduction Act,” S. 1911, that would protect people exposed the TCE."
Senator Inhofe indicated that he was opposed to all three of these pieces of legislation mentioned by Senator Boxer. He said, "Each bill assumes that the scientific data and findings are complete and that they require the Environmental Protection Agency to establish a Maximum Contaminant Level, or MCL, within a specified amount of time for both perchlorate and TCE. My concern isn’t that these chemicals may be harmful to human health at a certain level, but rather that politicians feel compelled to introduce legislation forcing EPA’s hand on what could become a 'contaminant of the month' scenario without scientific backing. It should also be noted that TCE already has a set MCL based on principals outlined in the Safe Drinking Water Act. . .
"The legislative approach taken in S. 24, S. 150, and S. 1911 is simply politicians meddling in the scientific process clearly laid out in the Safe Drinking Water Act. Mike Baker from the Ohio Environmental Protection Agency will speak on behalf of the Association of State Drinking Water Administrators about the current process and the concern of legislating contaminants rather than following the process outlined in the Safe Drinking Water Act. . ." [See WIMS 1/3/07]
EPA testified that the Agency has been working on the science related to perchlorate for more than ten years. "In 2003, EPA sent its January 2002 external review draft of the perchlorate risk assessment to the National Academy of Sciences (NAS) for review. The NAS panel released a report in January 2005 which recommended that the Agency use a reference dose (RfD) of 0.0007 mg/kg/day (0.7 µg/kg/day) based on a human study (Greer et al., 2002). The RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of adverse effects during a lifetime. EPA endorsed their recommendation and used the NAS panel report "Health Implications of Perchlorate Ingestion” as the basis for establishing its RfD which was subsequently posted to the Integrated Risk Information System (IRIS) database in February 2005."
He said in January 2006, EPA issued guidance for contaminated sites which recommended a revised preliminary remediation goal (PRG) of 24.5 ppb perchlorate in water. The PRG was calculated from EPA’s RfD using standard exposure values of 70 kg body weight and 2 liters of water consumed per day. This calculation provides the drinking water equivalent level, assuming
no other sources of perchlorate exposure." He also said, "In addition, if a state has promulgated a drinking water standard for perchlorate (e.g., Massachusetts adopted 2 ppb as a drinking water standard), that value would be considered an Applicable or Relevant and Appropriate Requirement (ARAR) and used as the ground water cleanup level for sites in that state."
He indicated that the Agency has "significant concerns with the bills introduced by Senators Boxer and Clinton. With respect to drinking water our primary concern with these bills is that they return the Agency to the time before 1996 when Congress dictated the drinking water regulations developed by the Agency." He concluded saying, the Agency is "working expeditiously to address potential risks from perchlorate and to evaluate the need for and feasibility of a stronger standard for TCE using this framework. We believe this framework is sound, and respectfully request that you allow us time to complete the required analyses and determinations to ensure appropriate science-based protection of public health from these and other contaminants, as envisioned in the 1996 amendments. As noted above, we are committed to making a final regulatory determination for perchlorate by the end of 2008, and for TCE as soon as the necessary analyses have been completed."
Access the hearing website for links to all testimony, opening statements and a webcast (click here). [*Water/Drink, *Toxics]
Subscribe to:
Posts (Atom)
