Chemical Assessments: An Agencywide Strategy May Help EPA Address Unmet Needs for Integrated Risk Information System Assessments
Released: 2013-06-10T00:00:00


Highlights: section_title: Why GAO Did This Study
paragraphs: EPA created the IRIS database in 1985 to help develop consensus opinions within the agency about the health effects from chronic exposure to chemicals. The health effects information in IRIS--referred to as IRIS toxicity assessments--provides fundamental scientific information EPA needs to develop human health risk assessments. GAO was asked to review the effectiveness of EPA's implementation of its IRIS toxicity assessment process. This report determines the extent to which (1) EPA has evaluated demand for IRIS toxicity assessments from users inside and outside EPA; (2) EPA's process for nominating and selecting chemicals for IRIS toxicity assessment accurately reflects demand; and (3) EPA has implemented a strategy for addressing any unmet agency needs when IRIS toxicity assessments are not available, applicable, or current. To do this work, GAO reviewed and analyzed IRIS nomination data, among other things, and interviewed EPA officials. GAO did not evaluate the scientific content or quality of IRIS toxicity assessments.

section_title: What GAO Found
paragraphs: The Environmental Protection Agency (EPA) has not conducted a recent evaluation of demand for Integrated Risk Information System (IRIS) toxicity assessments with input from users inside and outside EPA. Specifically, EPA issued a needs assessment report in 2003, which estimated that 50 new or updated IRIS toxicity assessments were needed each year to meet users' needs. However, GAO did not find sufficient support for the estimate. In addition, IRIS Program officials recognize that the 2003 estimate does not reflect current conditions, but the agency does not plan to perform another evaluation of demand. Without a clear understanding of current demand for IRIS toxicity assessments, EPA cannot adequately measure the program's performance; effectively determine the number of IRIS toxicity assessments required to meet the needs of IRIS users; or know the extent of unmet demand.

The IRIS Program's chemical nomination and selection process, which the agency uses to gauge interest in the IRIS Program from users inside and outside of EPA, may not accurately reflect current demand for IRIS toxicity assessments. The 75 chemicals that were nominated in response to EPA's most recent 2011 nomination period may not reflect demand for a number of reasons. For example, given the long-standing challenges the IRIS Program has had in routinely starting new assessments, according to some EPA IRIS users, they chose not to nominate new chemicals for assessment. Also, EPA has not clearly articulated how the IRIS Program applies the criteria it uses to prioritize the selection of chemicals for IRIS toxicity assessment--including how it determines the circumstances under which an IRIS toxicity assessment is or is not needed. Consequently, for chemicals that were nominated but not selected for assessment, it is not clear how many, if any, were excluded from consideration because they did not meet the IRIS Program's selection criteria because the IRIS Program determined that an IRIS toxicity assessment was not needed--or, alternatively, if they were not selected due to resource constraints or other reasons.

EPA has not implemented an agencywide strategy for addressing the unmet needs of EPA program offices and regions when IRIS toxicity assessments are not available, applicable, or current. Specifically, EPA does not have a strategy for identifying and filling data gaps that would enable it to conduct IRIS toxicity assessments for nominated chemicals that are not selected for assessment because sufficient data from health studies are not available. IRIS Program officials stated that no agencywide mechanism exists for EPA to ensure that chemicals without sufficient scientific data during one nomination period will have such information by the next nomination period or even the one after that. These officials acknowledged that better coordination across EPA and with other federal agencies could help address the issue. EPA also does not have agencywide guidance for addressing unmet needs when IRIS toxicity assessments are not available, applicable, or current. In the absence of agencywide guidance, officials from select EPA offices stated that they used a variety of alternatives to IRIS toxicity assessments to meet their needs, including using toxicity information from other EPA offices or other federal agencies.

section_title: What GAO Recommends
paragraphs: GAO recommends that EPA evaluate demand for IRIS assessments; document how the agency applies its selection criteria, including the circumstances under which an IRIS toxicity assessment is or is not needed and; develop an agencywide strategy including, at a minimum, coordination across EPA offices, as well as with other federal agencies, to identify and fill data gaps, and providing guidance that describes alternative sources of toxicity information. EPA agreed with the first two recommendations and partially agreed with the third.

section_title: Letter
paragraphs: The Environmental Protection Agency’s (EPA) Integrated Risk  Information System (IRIS)—a database integral to the agency’s mission  of protecting human health and the environment—contains EPA’s  scientific position on the potential human health effects that may result  from exposure to various chemicals in the environment. EPA created the  IRIS database in 1985 to help it develop consensus opinions within the  agency about the health effects from chronic exposure to chemicals and  currently includes information on more than 550 chemicals. The health  effects information in the IRIS database—referred to as IRIS toxicity  assessments—provides fundamental scientific information EPA needs to  develop human health risk assessments on particular chemicals. These  human health risk assessments, in turn, provide the foundation for EPA’s  risk management decisions, such as whether EPA should establish air  and water quality standards to protect the public from exposure to  particular toxic chemicals. EPA’s IRIS Program develops new IRIS  toxicity assessments and, as needed, updates information in existing IRIS  toxicity assessments contained in the IRIS database. The importance of  EPA’s IRIS Program has increased over time as EPA program offices and  regions have increasingly relied on IRIS toxicity assessments in making  environmental protection and risk management decisions. In addition,  state and local environmental programs, as well as some international  regulatory bodies, rely on IRIS toxicity assessments in managing their  environmental protection programs.

Although the information in the IRIS database is a critical primary  component of EPA’s capacity to support scientifically sound decisions,  policies, and regulations, we have reported previously on EPA’s difficulty  producing timely, credible IRIS toxicity assessments. Specifically, in  March 2008, we reported that the IRIS database was at serious risk of  becoming obsolete because EPA had not been able to (1) keep its  existing assessments current or (2) complete assessments of the most  important chemicals of concern. Further, we reported that because EPA  staff time continued to be dedicated to completing ongoing assessments,  EPA’s ability to both keep existing assessments (at that time more than  540) up to date and initiate new assessments was limited. We also  reported that, although the number of program staff quadrupled from 8 to  37 and program funding increased from $1.7 million to $9.6 million for  fiscal years 2000 to 2007, EPA had on average completed about five  assessments annually during this period. For these and other reasons, in  2009 we added EPA’s processes for assessing and controlling toxic  chemicals to our list of areas at high risk for waste, fraud, abuse, and  mismanagement or in need of broad-based transformation. In response  to our 2008 report and subsequent high-risk designation, EPA revised its  IRIS toxicity assessment process in May 2009.

In December 2011, we reported, among other things, that EPA’s initial  productivity gains under the May 2009 revised process had not been  sustained and that the agency continued to face challenges in  implementing the IRIS Program. For example, from May 2009 through September 2011, EPA completed 20 IRIS toxicity assessments—more  than doubling the total productivity it achieved during the two fiscal years  immediately preceding the adoption of the revised process. However, 16  of these toxicity assessments were completed in the first year and a half  of implementing the revised process, and productivity fell sharply during  fiscal year 2011, with EPA issuing 4 IRIS toxicity assessments. We  reported that, even if EPA were to overcome the significant productivity  difficulties it has experienced in recent years and met its goal of  completing 40 assessments in fiscal year 2012, it was not clear that this  level of productivity would meet the needs of IRIS users inside and  outside EPA. We noted that beyond EPA’s ongoing assessments, and  some that were on hold, the demand for additional IRIS toxicity  assessments was unclear.

With tens of thousands of chemicals listed with EPA for commercial use  in the United States, and about 1,000 new chemicals listed for  commercial use each year, demand for IRIS toxicity assessments is  potentially very high. In this context, you asked us to review the  effectiveness of EPA’s implementation of its IRIS toxicity assessment  process. Our objectives were to determine the extent to which (1) EPA  has evaluated demand for IRIS toxicity assessments from users inside  and outside EPA; (2) EPA’s process for nominating and selecting  chemicals for IRIS toxicity assessment accurately reflects demand; and  (3) EPA has implemented a strategy for addressing any unmet needs of  EPA program offices and regions when IRIS toxicity assessments are not  available, applicable, or current.

To determine the extent to which EPA has evaluated demand for IRIS  toxicity assessments, we reviewed EPA’s 2003 evaluation of demand for  IRIS toxicity assessments. We also interviewed officials at the National  Center for Environmental Assessment, which manages the IRIS Program  and develops IRIS toxicity assessments (henceforth IRIS Program  officials). Specifically, we interviewed these officials to determine whether  they had conducted other evaluations of demand since 2003, how they  derived the 2003 estimate, and whether that estimate reflects current  conditions. We reviewed the report to determine its basis for estimating  IRIS demand and the number of assessments it needed to conduct in  order to meet demand.

To determine the extent to which EPA’s process for nominating and  selecting chemicals for IRIS toxicity assessments accurately reflects  current demand, we reviewed data provided by the IRIS Program and  from the IRIS Program’s website on the number of IRIS toxicity  assessments completed annually from fiscal years 2002 through 2012. In  addition, we analyzed all chemical nomination forms submitted by EPA  program offices and regions to the IRIS Program from 2005, 2007, and  2011—which were the last three times that the IRIS Program solicited  nominations for new and updated IRIS toxicity assessments. For  additional perspective on user needs, we reviewed non-EPA IRIS users’  chemical nomination forms from 2011. In addition, we reviewed the IRIS  Program’s processes for soliciting nominations and selecting chemicals  for toxicity assessments, including the agency’s selection criteria. We also  reviewed agency guidance and interviewed IRIS Program officials to  better understand the chemical nomination and selection process.

To determine the extent to which EPA has implemented a strategy for  addressing any unmet needs of EPA program offices and regions when  IRIS toxicity assessments are not available, applicable, or current, we  reviewed the IRIS Program’s efforts to analyze IRIS user chemical  nominations. For context, we interviewed IRIS Program officials. For  additional perspective, we interviewed officials using a standard set of  questions from a nonprobability sample of three EPA program offices and  one region: the Office of the Administrator, the Office of Water, the Office  of Solid Waste and Emergency Response, and EPA’s Region 2. We selected these program offices and region because they submitted 78  percent of the chemical nominations to the IRIS Program during the  period we reviewed—2005, 2007, and 2011. These offices and region  ranked the highest in terms of the number of chemical nominations  submitted and, in some cases, nominated chemicals more than once  during different nomination years. Because this is a nonprobability  sample, it is not generalizable to all EPA program offices and regions, but  it can provide illustrative examples of the experience of those EPA  program offices and one region that nominated 78 percent of chemical  nominations for IRIS toxicity assessment during the period we reviewed.  For example, we received information from officials from these offices  about how EPA program offices and one region nominate chemicals for  IRIS toxicity assessment, how the IRIS Program meets the needs of  these offices and region over the course of nomination periods, and what  alternative toxicity assessments these offices and region turn to when  IRIS toxicity assessments are not available.

Separately from our nonprobability sample, we also interviewed officials  from the Office of Pollution Prevention and Toxics, within the Office of  Chemical Safety and Pollution Prevention, because it did not nominate  any chemicals for IRIS toxicity assessment for any of the last three  nomination periods. We did not evaluate the scientific content or quality of  IRIS toxicity assessments. A more detailed description of our scope and  methodology can be found in appendix I. For a summary of approaches  used by selected EPA program offices and regions to address their unmet  needs regarding IRIS toxicity assessments, see appendix II.

We conducted this performance audit from April 2012 to May 2013 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: This section discusses EPA’s human health risk assessment and risk  management practices and its processes for soliciting nominations and  selecting chemicals for new and updated IRIS toxicity assessments.
subsections: section_title: EPA’s Human Health Risk Assessment and Risk Management Practices
paragraphs: EPA’s ability to effectively implement its mission of protecting public  health and the environment is critically dependent on credible and timely  assessments of the risks posed by chemicals. Such assessments are the  cornerstone of scientifically sound environmental decisions, policies, and  regulations under a variety of statutes, such as the Safe Drinking Water  Act, the Toxic Substances Control Act, and the Clean Air Act. EPA  assesses the human health risks of chemicals using a model from the  National Academies. This model includes four components: (1) hazard  identification, (2) dose-response assessment, (3) exposure assessment,  and (4) risk characterization (see fig. 1).

For some, but not all chemicals, EPA conducts the first two sequential  analyses of a human health risk assessment—that is, the hazard  identification and dose-response assessment—under its IRIS Program.  Taken together, these two steps are commonly referred to as IRIS toxicity  assessments. EPA’s IRIS Program—managed by EPA’s National Center  for Environmental Assessment within the Office of Research and  Development—develops new IRIS toxicity assessments and updates  existing IRIS toxicity assessments if revisions are warranted on the basis  of newly published peer-reviewed studies.

EPA program offices and regions combine information from IRIS toxicity  assessments with the results from chemical exposure assessments to  characterize risk, which provides information on the probability that the  adverse effects described in hazard identification will occur under the  conditions described in the exposure assessment. These four steps— hazard identification, dose-response assessment, exposure assessment,  and risk characterization—comprise human health risk assessments,  which EPA offices use to make risk management decisions. Risk  management, as opposed to risk assessment, involves integrating the  risk assessment information with other information—such as economic  information on the costs and benefits of mitigating a risk, technological  information on the feasibility of managing the risk, and the concerns of  various stakeholders—to determine whether the health risks identified in  a chemical risk assessment warrant EPA taking regulatory or other risk  management actions.

A typical IRIS toxicity assessment contains a qualitative hazard  identification and quantitative dose-response assessment. The qualitative  hazard identification identifies noncancer and cancer health effects that  may be caused by exposure to a given chemical. For cancer effects, EPA  qualitatively describes the carcinogenic potential of a chemical in a  narrative that includes selecting a weight-of-evidence descriptor, ranging  from “carcinogenic to humans” to “not likely to be carcinogenic to  humans.”

Following hazard identification, a dose-response assessment is  conducted for both noncancer and cancer effects assuming adequate  data are available. A quantitative dose-response assessment  characterizes the quantitative relationship between the exposure to a  chemical and the resultant health effects. The quantitative dose-response  assessment relies on experimental data, primarily from either animal  (toxicity) or human (epidemiology) studies. The noncancer dose-response  assessment may include the following: an oral reference dose—an estimate (with uncertainty spanning  perhaps an order of magnitude) of the daily oral exposure to a  chemical that is likely to be without an appreciable risk of deleterious  effects during a person’s lifetime—expressed in terms of milligrams  per kilogram per day, and an inhalation reference concentration—an estimate (with uncertainty  spanning perhaps an order of magnitude) of the continuous inhalation  exposure to a chemical that is likely to be without an appreciable risk  of deleterious effects during a person’s lifetime—expressed in terms  of milligrams per cubic meter.

According to EPA officials, the quantitative cancer dose-response  assessment typically includes estimates of a chemical’s carcinogenic  potency by both the oral and inhalation routes of exposure. For oral  exposures, the “oral slope factor” is an estimated 95 percent upper bound  on the increased cancer risk per increased unit of exposure (in mg/kg- day) to a chemical over a lifetime. For inhalation exposures, the  “inhalation unit risk” is an estimated 95 percent upper bound on the  increased cancer risk per increased unit of exposure (in µg/m in air) to a  chemical over a lifetime. The toxicity values derived in both noncancer  and cancer dose-response assessments—that is, the oral reference  dose, inhalation reference concentration, oral slope factor, and inhalation  unit risk—are often referred to as IRIS values.

IRIS toxicity assessments estimate the potential health effects of lifelong  (chronic) exposure to chemicals. According to the Office of Management  and Budget (OMB), the IRIS Program is the only federal program that  provides qualitative and quantitative assessments of both cancer risks  and noncancer effects of chemicals. In addition, according to EPA’s  Human Health Risk Assessment Strategic Research Action Plan, no other  federal health assessment program has (1) a similar mission and scope  or (2) internal and external peer review processes that are as rigorous.  Specifically, the IRIS toxicity assessment process includes internal EPA  review; two interagency reviews by other federal agencies and White  House offices (e.g., OMB); public review and comment; and a rigorous,  independent, external peer review. However, IRIS is not the only source  of toxicity information available to EPA program offices and regions. For  many chemicals, IRIS toxicity assessments are not available, applicable,  or current; therefore, in some cases, EPA program offices and regions  rely on toxicity information from other sources. Other sources include, but  are not limited to the following:

Toxicological Profiles and Minimal Risk Levels. The Agency for Toxic  Substances and Disease Registry (ATSDR)—a federal public health  agency of the U.S. Department of Health and Human Services— prepares Toxicological Profiles for hazardous substances in response  to statutory requirements under the Comprehensive Environmental  Response, Compensation, and Liability Act, commonly known as  Superfund. ATSDR’s Toxicological Profiles typically evaluate three  different exposure durations—acute (14 days or less), intermediate  (15-364 days), and chronic (365 days or more). According to  ATSDR’s website, during the development of toxicological profiles, if  the agency determines that reliable and sufficient data exist to identify  the specific health effects that result from exposure to a hazardous  substance, the agency will derive Minimal Risk Levels. Minimal Risk  Levels are an ATSDR estimate of daily human exposure to a  hazardous substance at or below which that substance will likely not  pose a measurable risk of adverse noncancerous effects—such as  neurological, respiratory, and reproductive effects—over a specified  time period. Minimal Risk Levels are substance-specific estimates,  which according to ATSDR’s website are intended to serve as  screening levels used by ATSDR health assessors and others to  identify contaminants and potential health effects that may be of  concern at hazardous waste sites. According to ATSDR’s website, for  non-carcinogens, ATSDR adopted a practice similar to that of EPA’s  oral reference dose and inhalation reference concentration. Unlike  EPA’s IRIS Program, however, ATSDR does not develop quantitative  cancer toxicity values.

Provisional Peer Reviewed Toxicity Values (PPRTV). PPRTVs are  toxicity values that EPA’s National Center for Environmental  Assessment ordinarily prepares on an ongoing basis to support  cleanup decisions at Superfund sites. PPRTVs are derived for chronic  and subchronic exposure durations in instances where IRIS toxicity  assessments are not available, and are sometimes derived for  subchronic exposure durations when an IRIS toxicity assessment on  chronic exposure exists. Also, while PPRTVs receive internal review by EPA scientists and external peer review by independent scientific  experts, they differ from IRIS values in that they do not undergo the  same rigorous process of peer review and public participation.

California Environmental Protection Agency (Cal/EPA) Toxicity  Assessments. Cal/EPA prepares toxicity assessments, which are  peer-reviewed and provide quantitative values for both cancer and  noncancer effects. According to Cal/EPA’s website, Cal/EPA’s Office  of Environmental Health Hazard Assessment is responsible for  developing and providing managers in state and local government  agencies with toxicological and medical information relevant to  managing risks and making decisions involving public health. The  office develops procedures and practices for performing health risk  assessments for those involved in environmental health issues,  including policymakers, businesspeople, members of community  groups, news reporters, and others with an interest in the potential  health effects of toxic chemicals. Specifically, the office publishes “A  Guide to Health Risk Assessment,” which outlines in a generalized  form the four risk assessment steps in the National Academies model  described above.

section_title: EPA’s Process for Soliciting Nominations and Selecting Chemicals for New and Updated IRIS Toxicity Assessments
paragraphs: EPA’s IRIS Program invites IRIS users to submit nominations for  chemicals to be considered for new or updated IRIS toxicity assessments.  The IRIS Program solicits nominations from EPA program offices and  regions and other federal agencies by issuing a memorandum and solicits  nominations from the public by publishing a solicitation in the Federal  Register. Generally, the IRIS Program includes a list of criteria that the  agency plans to use to prioritize chemicals for selection as part of the  solicitation. The IRIS Program included the following criteria in its most  recent 2011 nomination solicitation: (1) potential public health impact; (2)  EPA statutory, regulatory, or program-specific implementation needs; (3)  availability of new scientific information or methodology that might  significantly change the current IRIS information; (4) interest to other  governmental agencies or the public; (5) availability of other scientific  assessment documents that could serve as a basis for development of an  IRIS toxicity assessment; and (6) other factors such as widespread  exposure to the chemical.

After receiving nominations, IRIS Program staff conducts a preliminary  literature search to determine whether there is sufficient information to  develop toxicity values for the chemicals nominated. According to IRIS  Program officials, the purpose of the literature search is to determine if  there is sufficient scientific data from health studies that could be used to  develop new IRIS toxicity assessments or update existing assessments.  Following the preliminary literature search, the IRIS Program separates  the nominated chemicals into two groups: (1) those for which health  studies are available and could be used to develop or update an IRIS  toxicity assessment and (2) those for which there are not enough data to  develop an assessment. Next, according to IRIS Program officials, they  provide EPA program offices and regions with an annotated list of  chemical nominations that specifies the degree to which health studies  are available for each chemical and ask for feedback regarding which  chemicals are the highest priorities. After considering such feedback, the  IRIS Program selects chemicals for new or updated IRIS toxicity  assessments. The IRIS chemical nomination and selection process  culminates in the publication in the Federal Register of the IRIS agenda— which contains, among other things, a list of chemicals for which the IRIS  Program intends to initiate IRIS toxicity assessments, as well as a list of  ongoing IRIS toxicity assessments. For example, the most recent IRIS  agenda, published in May 2012, lists 15 IRIS toxicity assessments—with  planned start dates ranging from fiscal year 2012 to fiscal year 2014—as  well as a list of the 52 IRIS toxicity assessments that were already under  way. According to the IRIS agenda, EPA considers its own resources  and the availability of guidance, guidelines, and policy decisions in  deciding when to start assessments for the selected chemicals.

section_title: EPA’s Most Recent Evaluation of Demand for IRIS Toxicity Assessments Is a Decade Old
paragraphs: EPA has not done a recent evaluation of demand for IRIS toxicity  assessments with input from users inside and outside the agency. EPA  conducted its most recent evaluation of demand for IRIS toxicity  assessments in September 2003, which included input from users inside  and outside EPA, but it has not performed a similar review since that  time. Without a clear understanding of current demand for IRIS toxicity  assessments, EPA cannot adequately measure the program’s  performance; effectively determine the number of IRIS assessments  required to meet the statutory, regulatory, and programmatic needs of  IRIS users; or know the extent to which unmet demand exists.

EPA conducted its last evaluation of demand in 2003 at the request of  Congress. In September 2000, due to concerns that EPA and state  regulators were relying on potentially outdated scientific information, the  Senate Committee on Appropriations requested that EPA conduct a  needs assessment with public input to determine the need for increasing  the annual rate of new and updated IRIS toxicity assessments.response to the Senate request, EPA conducted a needs assessment— the results of which are discussed in its September 2003 report, Needs   In  Assessment for U.S. EPA’s Integrated Risk Information System.  According to the report, EPA estimated that 50 new or updated IRIS  toxicity assessments a year were needed to meet user needs.  Specifically, EPA estimated that completing 50 assessments annually  would allow the agency to routinely update existing toxicity assessments  in the IRIS database, as well as respond to immediate user needs for new  or updated assessments. This estimate, according to the report, was  based on EPA’s past experience soliciting nominations from EPA  program offices and regions and information obtained through a July  2001 query of EPA program offices and regions and the public that  requested information on which chemicals they considered priorities for  assessment. However, based on our review of the report, we did not  find sufficient support for the estimate. Specifically, the report did not  describe how EPA’s past experience or its 2001 query were used to  derive the report’s estimate that about 50 IRIS toxicity assessments per  year were needed to meet demand. In addition, the report stated that  because EPA received a small number of responses to the agency’s  2001 query, it is not clear if the responses received are necessarily  representative of the broad range of IRIS users.

Although EPA’s 2003 needs assessment is a decade old, EPA officials  told us that the agency does not currently have plans to perform another  evaluation of demand for the IRIS Program and that, due to changing  conditions over the last 10 years the 2003 evaluation was not applicable  to current conditions. IRIS officials stated that the IRIS Program’s primary  mechanism for monitoring the needs of EPA’s program and regional  offices at present is to perform outreach with EPA program offices and  regions, such as holding quarterly meetings with program office  representatives from each EPA program office and holding internal  scoping meetings with representatives from EPA program offices and  regions for certain chemicals. In response to our questions regarding  current demand, IRIS Program officials told us that the annual need for  IRIS toxicity assessments may likely be in the hundreds, though officials  did not describe how they derived this number.

We have previously reported on the need for EPA to comprehensively  analyze its workload and workforce to effectively carry out its strategic  goals and objectives. Specifically, in July 2011, we reported that the  agency did not have a workload analysis to help determine the optimal  numbers and distribution of staff among its laboratory enterprise—which  is responsible for providing the scientific research, technical support, and  analytical services that underpin its policies and regulations. In addition,  we have previously reported that, in developing new initiatives, agencies  can benefit from following leading practices for strategic planning.  Congress enacted the Government Performance and Results Act (GPRA)  in 1993 to improve efficiency and accountability of federal programs. We  have reported that these requirements also can serve as leading  practices for strategic planning at lower levels within federal agencies,  such as planning for individual divisions, programs, or initiatives. Of  these leading practices, it is particularly important for agencies to define  strategies that address management challenges that threaten their ability  to meet long-term goals—including a description of the resources needed  to meet established goals. Without an evaluation of current demand for  IRIS toxicity assessments that takes into account resource constraints,  the IRIS Program risks not being able to develop a plan that lays out  realistic goals based on current conditions.

section_title: EPA’s Chemical Nomination and Selection Process May Not Accurately Reflect Current Demand for IRIS Toxicity Assessments
paragraphs: The IRIS Program’s chemical nomination and selection process, which  the agency uses to gauge interest in the IRIS Program from users inside  and outside of EPA, may not accurately reflect current demand for IRIS  toxicity assessments. Our analysis of IRIS Program data indicates that  the IRIS Program received nominations for 75 chemicals from EPA and  non-EPA IRIS users in response to its most recent 2011 nomination  period. However, the 75 chemicals received for the 2011 nomination  period may not accurately reflect current demand for IRIS toxicity  assessments. As about 1,000 new chemicals are listed for commercial  use each year, demand for IRIS toxicity assessments is potentially very  high, but the number of chemicals nominated may either overstate or  understate actual demand. For example, it is not clear how many  chemicals IRIS users did not nominate due to concerns that the IRIS  toxicity assessment would not be completed in a timely manner. Officials  from EPA’s Office of Water told us that even though they may need an  IRIS toxicity assessment, they sometimes develop their own chemical  toxicity assessments to meet their urgent or time-critical needs, such as  meeting statutory deadlines.

Also, given the long-standing challenges the IRIS Program has had in  routinely starting new assessments, according to some EPA IRIS users,  they chose not to nominate new chemicals for assessment and instead  nominated chemicals that were already listed on the IRIS agenda as  under way. For example, according to officials from EPA’s Office of Solid  Waste and Emergency Response, due to the large number of chemicals  already listed on the IRIS agenda and the IRIS Program’s limited  resources, in some cases, they reiterated support for chemicals that were  already listed on the agenda as under way rather than nominate new  chemicals. IRIS Program officials told us that, although EPA program  offices and regions and other IRIS users would like to see the IRIS  Program produce more IRIS toxicity assessments each year, current  resources constrain the speed at which the IRIS Program can complete  them. For example, EPA issued 4 IRIS toxicity assessments in fiscal year  2012 (see fig. 2). EPA has issued from 2 to 11 IRIS toxicity assessments  annually since fiscal year 2002. unable to keep up with demand for IRIS toxicity assessments, the agency  had to prioritize its selection of chemicals for IRIS toxicity assessment.

Furthermore, EPA has not clearly articulated under what circumstances  IRIS toxicity assessments are not needed, and the IRIS Program’s  process for prioritizing chemicals does not provide clarity regarding why  specific chemicals are selected for assessment and others are not.  According to IRIS Program officials, some chemicals may not need IRIS  toxicity assessments. While the IRIS Program has developed criteria that  are used to prioritize its selection of chemicals for IRIS toxicity  assessment, it is not clear how it applies these criteria—including how it  determines the circumstances under which program offices and regions  may or may not need an IRIS toxicity assessment. As discussed earlier,  the IRIS Program published its chemical selection criteria when it solicited  nominations for IRIS toxicity assessment for its 2011 nomination period.  However, in announcing that it had selected 15 IRIS toxicity assessments  in its 2012 IRIS agenda, the IRIS Program did not explain and has not  published information on, how the agency applied its selection criteria.  OMB’s implementing guidance for internal control requirements for  federal agencies emphasizes the need for agencies to develop policies  that ensure the effectiveness and efficiency of their operations and, as  part of that, emphasizes that information related to guidance should be  communicated to relevant personnel at all levels within an organization  and outside the agency in a relevant, reliable, and timely manner. In  August 2012, IRIS Program officials told us that they were working to  develop a better description of the nomination and selection process that  will clarify how the agency applied the six criteria but, as of March 2013,  had not done so. Consequently, for the chemicals that were nominated  during the most recent 2011 nomination period, but not selected, it is not  clear how many, if any, were excluded from consideration because they  did not meet the IRIS Program’s selection criteria, because the IRIS  Program determined that an IRIS toxicity assessment was not needed— or, alternatively, if they were not selected because of resource constraints  or other reasons.

section_title: EPA Has Not Implemented an Agencywide Strategy for Addressing Unmet Needs for IRIS Toxicity Assessments
paragraphs: EPA has not implemented an agencywide strategy for addressing the  unmet needs of EPA program offices and regions when IRIS toxicity  assessments are not available, applicable, or current. Specifically, EPA  does not have (1) a strategy for identifying and filling data gaps that would  enable it to conduct IRIS toxicity assessments for nominated chemicals  that were not selected for IRIS toxicity assessment due to insufficient data  and (2) agencywide guidance for addressing unmet needs when IRIS  toxicity assessments are not available, applicable, or current—which is  consistent with findings reported recently by EPA’s Inspector General and  Science Advisory Board.
subsections: section_title: EPA Does Not Have a Strategy for Identifying and Filling Data Gaps
paragraphs: EPA does not have a strategy for identifying and filling data gaps that  would enable it to conduct IRIS toxicity assessments for nominated  chemicals that were not selected for IRIS toxicity assessment because of  insufficient scientific data from health studies. As discussed earlier, as  part of the IRIS chemical nomination and selection process, IRIS Program  officials separate nominated chemicals into two groups: (1) those for  which sufficient scientific data from health studies exist that could be used  to develop or update an IRIS toxicity assessment and (2) those for which  sufficient data do not exist for developing an assessment. For example,  as a part of its most recent 2011 nomination period, the IRIS Program  dropped 11 of the 75 chemicals nominated from consideration because  sufficient scientific data from health studies were not available to develop  an IRIS toxicity assessment. One of the chemicals dropped from  consideration due to insufficient data was nominated in 2005, 2007, and  2011. The chemical—iso-octane, or 2,2,4-trimethylpentane, which is a  constituent of motor fuels—was nominated, according to officials with  EPA’s Office of Underground Storage Tanks, within the Office of Solid  Waste and Emergency Response, so that the office can determine  appropriate cleanup levels for leaking underground storage tank sites.  Moreover, Section 1505 of the Energy Policy Act of 2005 directed the  EPA Administrator to, among other things, conduct a study on the effects  on public health (e.g., the effects on children, pregnant women, minority  or low-income communities, and other sensitive populations) of increased  use of iso-octane and six other fuel additives as substitutes for methyl  tertiary butyl ether (MTBE).

While the IRIS Program prepared and issued an IRIS toxicity assessment  that contained the qualitative hazard identification description of iso- octane in 2007, it was unable to derive quantitative IRIS values due to  insufficient data on the chemical’s health effects in humans. According to  EPA’s 2007 IRIS assessment of iso-octane, the IRIS Program did not  develop quantitative estimates of noncancer and cancer risks because  the studies needed to support such estimates were not available.Consequently, EPA’s Office of Underground Storage Tanks nominated  iso-octane again in 2011. In response, according to IRIS Program  officials, the IRIS Program evaluated the literature since the 2007 IRIS  toxicity assessment was completed and determined that no new studies  were available to support development of quantitative IRIS values.  Therefore, iso-octane was not considered for an IRIS toxicity assessment  in 2011. According to officials with the Office of Underground Storage  Tanks, they meet with IRIS Program officials regularly, and the IRIS  Program is aware of their need for IRIS toxicity assessments related to  these chemicals. However, should officials with the Office of Underground  Storage Tanks nominate iso-octane again; EPA cannot ensure that the  data needed to prepare an IRIS toxicity assessment that includes  quantitative IRIS values will be available and thus, allow EPA to address  this unmet need. Without quantitative IRIS toxicity values for these  chemicals, it is unclear how EPA will conduct a study of these chemicals  on the effects on public health as required by the Energy Policy Act of  2005.

The National Toxicology Program was created in 1978 as a cooperative effort to  coordinate toxicology testing programs within the federal government, strengthen the  science base in toxicology, develop and validate improved testing methods, and to provide  information about potentially toxic chemicals to health, regulatory, and research agencies,  scientific and medical communities, and the public. may also be a potential research source. Without such research—which  is necessary to fill data gaps needed to develop IRIS toxicity  assessments—the agency will be unable to ensure that it can respond to  unmet EPA program offices’ and regions’ programmatic and public health  needs in the future.

section_title: EPA Does Not Have Agencywide Guidance for Addressing Unmet Needs
paragraphs: EPA does not have agencywide guidance for addressing the needs of its  program offices and regions when IRIS toxicity assessments are not  available, applicable, or current. IRIS Program officials told us that, while  there is no agencywide guidance, they work with staff from program  offices and regions on a case-by-case basis to find alternatives to IRIS  toxicity assessments. For example, IRIS Program officials told us that, in  some cases, the Superfund Technical Support Center may be able to  partially address the needs of the Office of Solid Waste or Emergency  Response or regions by summarizing peer reviewed studies. In other  cases, they said that they may work with the Office of Solid Waste and  Emergency Response, as well as other program offices and regions, to  determine if a PPRTV would meet their needs. In 2008, EPA’s Board of  Scientific Counselors recommended that EPA consider using PPRTVs as  an interim measure to meet its needs for some chemicals, if an IRIS  toxicity assessment was not available, and recommended that well- developed PPRTVs be considered as a source of prioritization in the  development of full IRIS documents. However, it is unclear how  frequently program offices and regions use PPRTVs to support their  statutory, regulatory, or programmatic needs—beyond their use in  Superfund risk assessments—because EPA does not collect information  on or have agencywide guidance on when a PPRTV, or other toxicity  assessment, might be an appropriate alternative to an IRIS toxicity  assessment. Without such guidance, EPA cannot ensure that it has a  consistent approach for addressing the needs of program offices and  regions when IRIS toxicity assessments are not available, applicable, or  current. Under federal standards of internal control, agencies are to  clearly document in writing internal control in management directives,  administrative policies, or operating manuals and have it readily available  for examination.

Other non-EPA sources of toxicity information include ATSDR Minimal Risk Levels and  Cal/EPA toxicity values. Although the Office of Solid Waste and Emergency Response  developed the hierarchy of toxicity values specifically for the Superfund Program, officials  stated that the hierarchy is generally used by all suboffices within the Office of Solid  Waste and Emergency Response when IRIS toxicity assessments are not available or  current. profile issues in their region because an IRIS toxicity assessment was not  available. However, the officials noted that ATSDR does not develop  cancer values.

According to officials with the Office of Water—which is responsible for  implementing, among other mandates, the Clean Water Act and Safe  Drinking Water Act—they develop toxicity assessments for chemicals to  meet statutory deadlines. For example, under the 1996 amendments to  the Safe Drinking Water Act, every 5 years, EPA is to determine for at  least five unregulated contaminants, including chemicals, whether  regulation is warranted, considering those that present the greatest public  health concern. Because of the limited number of IRIS toxicity  assessments the IRIS Program can select and develop at one time, the  Office of Water created the scheme to prioritize and nominate for IRIS  toxicity assessment those chemicals that are the most controversial and  high-profile, have a high economic impact, and will take more time and  staff to complete. The Office of Water can then, according to officials from  that office, develop its own assessments for chemicals that have less  controversy surrounding them and take less time and staff to complete in  order to meet some of its programmatic needs. Officials from the Office of  Water told us that the office develops its own assessments for some  chemicals because the IRIS Program would not be able to complete most  of the needed toxicity assessments in time to meet the office’s statutory  deadlines.

Similarly, the Office of Pollution Prevention and Toxics, within the Office  of Chemical Safety and Pollution Prevention, has developed its own  toxicity assessments. The Office of Pollution Prevention and Toxics is  responsible for implementing the Toxic Substances Control Act, which  provides EPA with the authority to obtain more information on chemicals  and to regulate those chemicals that the agency determines pose  unreasonable risks to human health or the environment. In February  2012, the office announced plans to develop risk assessments on 83  chemicals. While the office has not nominated any chemicals for IRIS  toxicity assessment over the past three nomination periods through the  formal nomination process, according to EPA officials with the office, in  developing its risk assessments, it plans to incorporate information from  IRIS toxicity assessments to the extent such information is available,  recent, and relevant. These officials told us that the risk assessments  they are conducting in support of the Toxic Substances Control Act are  often based on intermittent exposure to workers and consumers who are  subject to chemicals contained in products. However, they also told us  that, while the IRIS values contained in the database may not always be  applicable, often other data available in the IRIS database are applicable,  such as toxicity information for shorter term exposure scenarios that have  long-lasting/persistent effects (e.g., development toxicity). In these  cases, they said that they have used the hazard and dose-response  information described in an IRIS toxicity assessment for a particular  chemical to develop their own toxicity assessment. IRIS Program officials  said that they are working with the Office of Pollution Prevention and  Toxics and other EPA offices to find other options for assessing toxicity,  such as PPRTVs, when IRIS toxicity assessments are not available,  applicable, or current. While IRIS toxicity assessments may not be  applicable in all situations, EPA does not have agencywide guidance that  outlines the circumstances under which program offices and regions may  or may not need IRIS toxicity assessments, or describes appropriate  alternative sources to IRIS toxicity assessments.

Our finding concerning the various approaches EPA program offices and  regions use to address their need for toxicity assessments is consistent  with findings reported recently by EPA’s Inspector General and Science  Advisory Board. EPA’s Office of the Inspector General conducted a  survey of 300 respondents from EPA program offices and regions in  January 2013. The survey found that 34 percent of the 300 survey  respondents indicated that they had experienced a situation in which they  or their team researched a substance that was listed in IRIS but used  toxicity values from another source instead of those available in IRIS. Of  those respondents, 68 percent indicated that one of their top three  reasons for doing so was because the alternate system source is more  up-to-date with current scientific practice or other information.  Additionally, 28 percent of all survey respondents indicated that they had  experienced a situation in which they or their team developed their own  toxicity values. However, more than a third of respondents indicated that  there were no standard operating procedures or other guidance regarding  how to choose a source of toxicity values for their office’s work.

EPA’s Science Advisory Board has also reported on differences across  the agency regarding the use of scientific information for decision  making. For example, in July 2012, the Science Advisory Board  reported that available resources for developing toxicity assessments, the  number of scientific staff engaged in the work, and the institutional and  legal framework supporting these assessments differ across the  agency. The report also noted that some EPA programs and regions do  not have the infrastructure required to generate all assessments needed  to support their own activities and that scientists in these offices work  within statutory constraints, often on an extremely short timetable and  with limited budgets. Within those constraints, according to the report,  they either assess available scientific information themselves or rely on  the Office of Research and Development, other parts of EPA, or other  federal or state agencies for the science assessments needed to support  decision making.

We have also reported on EPA’s fragmented and largely uncoordinated  science activities. Specifically, in July 2011, we reported that EPA had not  fully addressed the findings and recommendations of five independent  evaluations over the past 20 years regarding long-standing planning,  coordination, or leadership issues that hamper the quality, effectiveness,  and efficiency of EPA’s science activities, including its laboratory  operations. We recommended, among other things, that EPA establish a  top-level science official with the authority and responsibility to  coordinate, oversee, and make management decisions regarding major  scientific activities throughout the agency, including the work of all  program, regional, and Office of Research and Development  laboratories.fully implemented it. In particular, while EPA expanded the responsibilities  of the agency’s science advisor to coordinate, oversee, and make  recommendations to EPA’s Administrator regarding the agency’s major  scientific activities, as of March 2013, the agency had not given this  official the authority to make management decisions regarding scientific  activities across EPA as we recommended. In the absence of such  authority, there is no agency mechanism for understanding and  addressing the unmet needs for IRIS toxicity assessments. As a result,  EPA may not be maximizing its limited resources or addressing the  statutory, regulatory, and programmatic needs of EPA program offices  and regions in a consistent manner.

section_title: Conclusions
paragraphs: With tens of thousands of chemicals listed with EPA for commercial use  in the United States and about 1,000 new chemicals listed for commercial  use each year, demand for IRIS toxicity assessments is potentially very  high. EPA’s IRIS Program develops new toxicity assessments and, as  needed, updates information on existing toxicity assessments contained  in the IRIS database. EPA has not evaluated demand for IRIS toxicity  assessments with input from users inside and outside the agency since  2003, and although IRIS Program officials recognize that the 2003  estimate does not reflect current conditions, the agency does not plan to  perform another evaluation of demand. Without a clear understanding of  current demand for IRIS toxicity assessments, EPA cannot measure the  program’s performance; determine the number of IRIS assessments  required to meet the statutory, regulatory, and programmatic needs of  IRIS users; or know the extent of unmet demand.

The IRIS Program’s chemical nomination and selection process, which  the agency uses to gauge interest in the IRIS Program from users inside  and outside EPA, may not accurately reflect current demand for IRIS  toxicity assessments. For example, it is not clear how many chemicals  IRIS users did not nominate due to concerns that the IRIS toxicity  assessment would not be completed in a timely manner. Furthermore,  EPA has not clearly articulated how the IRIS Program applies the criteria  it uses to prioritize the selection of chemicals for IRIS toxicity  assessment—including how it determines the circumstances under which  program offices and regions may or may not need an IRIS toxicity  assessment. Consequently, for chemicals that are nominated, but not  selected for IRIS toxicity assessment, it is not clear how many, if any, are  excluded from consideration because they do not meet the IRIS  Program’s selection criteria, because the IRIS Program determined that  an IRIS toxicity assessment was not needed—or, alternatively, if they are  not selected because of resource constraints or other reasons.

EPA has not implemented an agencywide strategy for addressing the  unmet needs of EPA program offices and regions when IRIS toxicity  assessments are not available, applicable, or current. Specifically, EPA  does not have a strategy for identifying and filling data gaps that would  enable it to conduct IRIS toxicity assessments for nominated chemicals  that were not selected for assessment due to insufficient data. Because  EPA does not have a process in place for identifying and filling research  gaps, it is unable to ensure it can respond to any unmet EPA program  offices’ and regions’ programmatic and public health needs in the future.  Also, EPA does not have guidance that outlines the circumstances under  which program offices and regions may or may not need an IRIS toxicity  assessment, or that describes appropriate alternative sources to IRIS  toxicity assessments. Without guidance, EPA cannot ensure a consistent  approach for addressing the needs of program offices and regions when  IRIS toxicity assessments are not available, applicable, or current.

section_title: Recommendations for Executive Action
paragraphs: We are making three recommendations to the EPA Administrator.

To ensure that EPA can measure the IRIS program’s performance and  determine the number of IRIS toxicity assessments required to meet the  statutory, regulatory, and programmatic needs of IRIS users, we  recommend that the EPA Administrator direct the Office of Research and  Development to implement the following two actions without impeding the  progress of ongoing assessments:  Identify and evaluate demand for the IRIS Program to determine the  number of IRIS toxicity assessments and resources required to meet  users’ needs.

Document how EPA applies its IRIS toxicity assessment selection  criteria, including the circumstances under which program offices and  regions may or may not need an IRIS toxicity assessment.

To ensure that EPA maximizes its limited resources and addresses the  statutory, regulatory, and programmatic needs of EPA program offices  and regions when IRIS toxicity assessments are not available, we  recommend that the EPA Administrator direct the Deputy Administrator, in  coordination with EPA’s Science Advisor, to implement the following  action:

Once demand for the IRIS Program is determined, develop an  agencywide strategy to address the unmet needs of EPA program  offices and regions that includes, at a minimum:  coordination across EPA offices and with other federal research  agencies to help identify and fill data gaps that preclude the  agency from conducting IRIS toxicity assessments, and guidance that describes alternative sources of toxicity information  and when it would be appropriate to use them when IRIS values  are not available, applicable, or current.

section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft of this report to EPA for its review and comment.  EPA’s written comments and our detailed response to them are  presented in appendix III.  EPA also provided technical comments on our  draft report, which we incorporated, as appropriate.

In its written comments, EPA agreed with our findings and two of our  recommendations and partially agreed with our third recommendation.  Specifically, EPA agreed with our recommendations that the Office of  Research and Development (1) identify and evaluate demand for the IRIS  Program to determine the number of IRIS toxicity assessments and  resources required to meet users’ needs and (2) document how EPA  applies its IRIS toxicity assessment selection criteria, including the  circumstances under which program offices and regions may or may not  need an IRIS toxicity assessment. In its written comments, EPA stated  that the Office of Research and Development this year will evaluate the  potential future demand for IRIS toxicity assessments and the resources  required to meet that demand. EPA also stated that it will better describe  for internal and external stakeholders and the public the nomination and  selection process for chemicals for IRIS toxicity assessments, including  the rationale for not selecting nominated chemicals for IRIS assessment.

With respect to our third recommendation, that EPA develop an  agencywide strategy to address unmet need for IRIS toxicity  assessments, in its written comments, EPA requested that we provide  additional clarification and consider refining our recommendation.  Specifically, EPA stated that it understood and supported the goal of  developing an agencywide strategy to help identify and fill data gaps that  preclude the agency from conducting IRIS toxicity assessments, but  urged us to clarify more precisely the extent to which it must rely on  others to conduct research to fill data gaps on IRIS chemicals. As we note  in the report, IRIS Program officials told us that they do not have a  process in place for filling research gaps and acknowledged that better  coordination across EPA offices and with other federal research  agencies, such as the Department of Health and Human Services’  National Toxicology Program, could help address this issue. We  acknowledge that EPA has limited resources, which may preclude the  agency from making substantial investments in research into how  individual chemicals affect human health. As such, to ensure that the  agency maximizes its limited resources, we have recommended that EPA  develop a strategy to coordinate with other federal research agencies to  help identify and fill data gaps. In this context, EPA acknowledged that it  must look to other federal agencies, academic institutions, and chemical  product producers to fund research into how chemicals affect human  health, as we have recommended. EPA also stated, in its written  comments, that the agency can and will do a more effective job to make  data needs known to relevant federal agencies and nonfederal  organizations that either fund or conduct chemical research.

Also regarding our third recommendation that EPA develop an  agencywide strategy to address unmet needs for IRIS toxicity  assessments, based on technical comments provided by EPA officials  prior to receiving the agency’s letter dated April 16, 2013, we refined the  wording of our third recommendation. The original text recommended that  EPA develop guidance that describes alternative sources of toxicity  information and procedures for preparing toxicity assessments when IRIS  values are not available, applicable, or current.  We refined the wording of  this recommendation to read: guidance that describes alternative sources  of toxicity information and when it would be appropriate to use them when  IRIS values are not available, applicable, or current.  The revised  language more accurately reflects the intent of our recommendation. In  addition, in its written comments, EPA stated that it understood our  interest in the agency developing guidance that describes alternative  sources of toxicity information and agreed that such guidance might be  helpful. However, EPA stated that the development of such guidance is  best left to individual EPA programs. We disagree. In the absence of  agencywide guidance that addresses unmet demand for IRIS  assessments, EPA offices operate in much the same way they operated  before the IRIS Program was formed to develop consensus opinions  within the agency about the health effects from chronic exposure to  chemicals. As we note in this report, we have previously reported on  EPA’s fragmented and largely uncoordinated science activities and  recommended, among other things, that EPA establish a top-level  science official with the authority and responsibility to coordinate,  oversee, and make management decisions regarding major scientific  activities throughout the agency. Consistent with our prior report and  recommendation, we believe that guidance regarding major scientific  activities should also come from a top-level science official. However, as  we note in our current report, EPA has not provided its Science Advisor  with the authority to make management decisions regarding scientific  activities across EPA as we previously recommended. Therefore, we  believe that agencywide guidance should come from EPA’s Deputy  Administrator in coordination with EPA’s Science Advisor.

As agreed with your office, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies to the Acting Administrator of  EPA, the appropriate congressional committees, and other interested  parties. In addition, this report will be available at no charge on the GAO  website at http://www.gao.gov.

If you or your staff members have any questions about this report, please  contact me at (202) 512-3841 or gomezj@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made key contributions to this  report are listed in appendix IV.

section_title: Appendix I: Scope and Methodology
paragraphs: To determine the extent to which the Environmental Protection Agency  (EPA) has evaluated demand for IRIS toxicity assessments, we reviewed  EPA’s 2003 evaluation of demand for IRIS toxicity assessments. We also  interviewed IRIS Program officials to determine whether they had  conducted other evaluations of demand since 2003, how they derived the  2003 estimate, and whether that estimate reflects current conditions.  Because the 2003 evaluation did not provide sufficient information on its  methodology, we were unable to fully assess its estimate. We  corroborated EPA officials’ assertion that the 2003 assessment no longer  reflects current conditions based on our understanding of the IRIS  Program. As we discussed earlier, the importance of EPA’s IRIS Program  has increased over time as EPA program offices and regions have  increasingly relied on IRIS toxicity assessments in making environmental  protection and risk management decisions. In addition, as about 1,000  new chemicals are listed for commercial use each year, potential for  changes in demand over time are likely.

To determine the extent to which EPA’s process for nominating and  selecting chemical for IRIS toxicity assessment accurately reflects current  demand, we reviewed data provided by the IRIS Program and from the  IRIS Program’s website on the number of IRIS toxicity assessments it  completed annually from fiscal years 2002 through 2012. In addition, we  analyzed all chemical nomination forms submitted by EPA program  offices and regions to the IRIS Program from 2005, 2007 and 2011— which were the last three times that EPA solicited nominations for new  and updated IRIS toxicity assessments. For additional perspective on  user needs, we reviewed non-EPA IRIS users’ chemical nomination forms  from 2011. To select and count the number of nominations, two analysts  reviewed information EPA provided us to determine which documents to  include in our analysis. We used the following inclusion and exclusion  criteria to determine which documents to include in our analysis:

Documents labeled as being a nomination were included while  documents labeled as being another document were excluded. For  example, some documents were the IRIS Program’s request for  nominations or Federal Register Notices, which were not included in  our analysis. In other instances, a nominating entity indicated that the  chemicals were being prioritized and not nominated (i.e., they clearly  stated “this is a list of our priorities”), and were not included in our  analysis.

We included individual nomination sheets for our analysis, but we did  not include nomination cover sheets or separate documents that IRIS  Program officials sent us separately from the individual nomination  sheets.

We did not include the nomination form if the nominating entity  indicated on the form that there was no new nomination and instead  was a reiteration of support for a previous nomination.

In some instances, EPA program offices and regions nominated two  chemicals on one nomination form or listed two chemicals together.  Chemicals were counted as a single nomination if they had the same  Chemical Abstracts Service (CAS) registry number and as separate  nominations if they had different CAS registry numbers. According to the  CAS registry website, the CAS registry is the most authoritative collection  of disclosed chemical substance information, containing more than 70  million organic and inorganic substances and 64 million sequences. In  cases where it was not clear to both analysts whether to include a  document in our analysis, IRIS Program officials provided confirmation.  While we used this methodology to determine the number of nominations  in the 2005, 2007, and 2011 nomination periods, using a different  methodology might result in a different number of nominations. As about  1,000 new chemicals are listed for commercial use each year, the  chemicals nominated may either overstate or understate actual demand.  In addition, we reviewed the IRIS Program’s processes for soliciting  nominations and selecting chemicals for IRIS toxicity assessments,  including the agency’s selection criteria. We also reviewed agency  guidance and interviewed IRIS Program officials to better understand the  chemical nomination and selection process.

To determine the extent to which EPA has implemented a strategy for  addressing any unmet needs of EPA program offices and regions when  IRIS toxicity assessments are not available, applicable, or current, we  reviewed the IRIS Program’s efforts to analyze IRIS user chemical  nominations. For context, we interviewed officials from EPA’s National  Center for Environmental Assessment, which manages the IRIS Program  and develops IRIS toxicity assessments. For additional perspective, we  interviewed officials using a standard set of questions from a  nonprobability sample of three EPA program offices and one region: the  Office of the Administrator, the Office of Water, the Office of Solid Waste  and Emergency Response, and EPA’s Region 2. We selected these  program offices and region because they submitted 78 percent of the  chemical nominations to the IRIS Program during the period we  reviewed—2005, 2007, and 2011. These offices and region ranked the  highest in terms of the number of chemical nominations submitted, and, in  some cases, nominated chemicals more than once during different  nomination years. Because this is a nonprobability sample, it is not  generalizable to all EPA program offices and regions, but it can provide  illustrative examples of the experience of those EPA program offices and  one region that nominated 78 percent of chemicals for IRIS toxicity  assessment during the period we reviewed. For example, we received  information from officials from these offices about how EPA program  offices and one region nominate chemicals for IRIS toxicity assessment,  how the IRIS Program meets the needs of these offices and region over  the course of nomination periods, and what alternative toxicity  assessments these offices and region turn to when IRIS toxicity  assessments are not available. For a summary of approaches used by  selected EPA program offices and regions to address their IRIS toxicity  assessment needs, see appendix II.

Separately from our nonprobability sample, we also interviewed officials  from the Office of Pollution Prevention and Toxics, within the Office of  Chemical Safety and Pollution Prevention, because it did not nominate  any chemicals for IRIS toxicity assessment for any of the last three  nomination periods. We did not evaluate the scientific content or quality of  IRIS toxicity assessments.

We conducted this performance audit from April 2012 to May 2013 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

section_title: Appendix II: Summary of Approaches Used by Select EPA Program Offices and Regions to Address Toxicity Assessment Needs
subsections: section_title: Office of Solid Waste and Emergency Response
paragraphs: According to officials at the Office of Solid Waste and Emergency  Response, the office nominated 18 chemicals over the course of the  2005, 2007, and 2011 nomination periods. The Office of Solid Waste and  Emergency Response provides policy, guidance, and direction for the  agency’s emergency response and waste programs, including managing  the Superfund Program, which responds to abandoned and active  hazardous waste sites and accidental oil and chemical releases. IRIS  toxicity assessments are used by the Office of Solid Waste and  Emergency Response to, among other things, support mandated  regulatory actions. For example, the Office of Underground Storage  Tanks, within the Office of Solid Waste and Emergency Response,  submitted chemicals during the 2011 nomination period to support the  requirement under Section 1505 of the Energy Policy Act of 2005 that the  EPA Administrator conduct a study on the effects on public health of  increased use of iso-octane and six other fuel additives as substitutes for  methyl tertiary butyl ether (MTBE). When IRIS toxicity assessments are  not available or current, Office of Solid Waste and Emergency Response  officials stated they rely on other toxicity values to meet their  programmatic needs. For example, officials at the Office of Underground  Storage Tanks stated that, in the absence of IRIS values, states must  resort to other sources for toxicological information, and this can lead to  inconsistencies state-to-state. Officials also stated that, when an IRIS  toxicity assessment is not available, the office refers to a hierarchy of  toxicity values to be used in performing human health risk assessments  for Superfund sites. In 2003, the Office of Solid Waste and Emergency  Response updated this hierarchy, which is intended to help risk  assessors identify appropriate sources of toxicology information and lists  the sources as: (1) IRIS toxicity values, (2) Provisional Peer Reviewed  Toxicity Values (PPRTVs), and (3) other EPA and non-EPA sources of  toxicity information—with priority given to those sources of information  that are the most current, publicly available, and peer reviewed. Such  values include the Agency for Toxic Substances and Disease Registry  (ATSDR) Minimal Risk Levels and California Environmental Protection  Agency (Cal/EPA) toxicity values. Although developed specifically for the  Superfund Program, officials stated that this guidance is generally used  by all suboffices within the Office of Solid Waste and Emergency  Response.

section_title: EPA Region 2
paragraphs: According to Region 2 officials, the region nominated 22 chemicals over  the course of the 2005, 2007, and 2011 nomination periods. EPA’s  Region 2 serves New Jersey, New York, Puerto Rico, the U.S. Virgin  Islands, and eight tribal nations. Region 2 nominates chemicals for IRIS  assessment on behalf of risk assessors throughout their region—that is,  EPA and officials throughout the region, primarily at Superfund sites, that  evaluate chemical risks. For example, Region 2 stated in its chemical  nomination form for the 2011 nomination period that it needed IRIS  toxicity assessments to support cleanup decisions for chemicals present  in residential properties and in groundwater. Region 2 officials indicated  that, when IRIS toxicity values are not available, they may rely on other  toxicity values to meet their programmatic needs and follow the Office of  Solid Waste and Emergency Response’s hierarchy of values in  consultation with the IRIS Program as appropriate.

Region 2 officials stated that in some cases, other organizations such as ATSDR or  Cal/EPA may develop a quantitative value before the IRIS toxicity assessment is revised.  In that case, the Region would consider the use of the quantitative value based on  discussions with the IRIS program.

section_title: Office of Water
paragraphs: According to Office of Water officials, the office nominated 23 chemicals  over the course of the 2005, 2007, and 2011 nomination periods. EPA’s  Office of Water is responsible for drinking water safety, and it restores  and maintains oceans, watersheds, and their aquatic ecosystems. The  Office of Water is responsible for implementing, among other mandates,  the Clean Water Act and Safe Drinking Water Act. For example, in its  chemical nomination form for the 2011 nomination period, the Office of  Water stated that it needed IRIS toxicity assessments to develop  regulations. The Office of Water develops assessments for chemicals it  needs to meet statutory deadlines. Because of the limited number of IRIS  toxicity assessments the IRIS Program can select and develop at one  time, the Office of Water created the scheme to prioritize those chemicals  that are the most controversial and high-profile, have a high economic  impact, and will take more staff and time to complete. The Office of Water  can then develop its own assessments for chemicals that have less  controversy surrounding them and take less time and staff to complete in  order to meet some of its programmatic needs. Officials stated that  developing the office’s own assessments for some chemicals was based  on the reality that the IRIS Program would not complete most of the  needed toxicity assessments in time to meet the office’s statutory  deadlines.

section_title: Office of the Administrator
paragraphs: According to officials at the Office of the Administrator, the office  nominated 26 chemicals over the course of the 2005, 2007, and 2011  nomination periods. EPA’s Office of the Administrator provides executive  and logistical support for the EPA Administrator. The office supports the  leadership of EPA’s programs and activities to protect human health and  the environment. An official from the Office of Policy, within the Office of  the Administrator, stated that rationales for nominating chemicals varied  widely—for example, the increasing or widespread exposure to a  chemical or the availability of new data to develop a new or update an  existing IRIS toxicity assessment. The official noted that the Office of  Policy’s programmatic needs differed from other EPA offices’ needs in  that it does not develop regulations or risk assessments. Instead, the  office provides assistance for other EPA offices’ assessments and  reviews assessments that other offices perform. In the absence of an  IRIS toxicity assessment, the Office of Policy relied on the original  literature, review articles, and assessments prepared by other agencies.  Such values include the ATSDR Minimal Risk Levels and Cal/EPA toxicity  values. An official with the Office of Children’s Health Protection, also  within the Office of the Administrator, stated that most of its nominations  were for chemicals that were under the Toxic Substances Control Act or  the Safe Drinking Water Act and were based on children’s health  concerns. The official stated that, in the absence of an IRIS toxicity  assessment, the Office of Children’s Health Protection goes directly to the  literature or work done by other government agencies or programs, such  as the National Toxicology Program.

section_title: Office of Pollution Prevention and Toxics
paragraphs: The Office of Pollution Prevention and Toxics is responsible for  implementing the Toxic Substances Control Act, which provides EPA with  the authority to obtain more information on chemicals, and to regulate  those chemicals that the agency determines pose unreasonable risks to  human health or the environment, announced in February 2012 its plans  to develop risk assessments on 83 chemicals. While the office has not  nominated any chemicals for IRIS toxicity assessment over the past three  nomination periods through the formal nomination process, according to  EPA officials with the Office of Pollution Prevention and Toxics, in  developing its risk assessments, it plans to incorporate information from  IRIS toxicity assessments to the extent such information is available,  recent, and relevant. Officials at the Office of Pollution Prevention and  Toxics, and senior staff of the Office of Research and Development,  which houses the IRIS Program, have compared the list of existing and  ongoing IRIS toxicity assessments in order to share relevant literature  and hazard reviews for upcoming risk assessments related to the Toxic  Substances Control Act. These officials told us that the risk assessments  they are conducting in support of the Toxic Substances Control Act are  often based on intermittent exposure to workers and consumers who are  subject to chemicals contained in products. However, they also told us  that, while the IRIS values contained in the database may not always be  applicable, often other data available in the IRIS database are applicable,  such as toxicity information for shorter term exposure scenarios that have  long-lasting/persistent effects (e.g., development toxicity). In these cases,  they said that they have used the hazard and dose response information  described in an IRIS toxicity assessment for a particular chemical to  develop their own toxicity assessment.

In addition, according to IRIS program officials, they have compared the  list of chemicals for which the Office of Pollution Prevention and Toxics  plans to conduct risk assessments with the list of existing and ongoing  toxicity assessments and shared relevant literature and hazard reviews.  IRIS program officials also said that the Office of Pollution Prevention and  Toxics participates with other EPA offices in prioritizing their needs for  ongoing IRIS toxicity assessments. IRIS toxicity values are generally  used to estimate risks associated with continuous exposures to a  pollutant in the air or water. In most cases, according to IRIS Program  officials, the information used to develop the dose-response assessments  is based on intermittent exposures to workers or animals in a controlled  environment, and IRIS assessments include an adjustment to continuous  exposure in the derivation of toxicity values. IRIS Program officials said  that they are working with the Office of Pollution Prevention and Toxics  and other EPA offices to find other options for assessing toxicity, such as  PPRTVs, when IRIS toxicity assessments are not available, applicable, or  current.

section_title: Appendix III: Comments from the Environmental Protection Agency
subsections: section_title: See comment 4.
paragraphs: The following are GAO’s comments on the letter from the Environmental Protection  Agency dated April 16, 2013.  1.  In this report, we do not discuss the challenges associated with suspending the  development of an ongoing IRIS toxicity assessment to await new research and,  therefore, our recommendations are not aimed at addressing this issue. Instead,  our report is concerned with data gaps that preclude EPA from starting an IRIS  assessment. However, we have addressed issues concerning suspending the  development of an ongoing IRIS assessment in a prior report. Specifically, in our  2008 report on EPA’s IRIS Program, we note that, as a general rule, requiring  that IRIS assessments be based on the best science available at the time of the  assessment is a standard that would best support a goal of completing  assessments within reasonable time periods and minimizes the need to conduct  significant levels of rework. In our 2008 report, we recommended that EPA  establish a policy that endorses conducting IRIS assessments on the basis of  peer-reviewed scientific studies available at the time of the assessment and  develop criteria for allowing assessments to be suspended to await the  completion of scientific studies only under exceptional circumstances. As of the  date of this report, EPA has not implemented our 2008 recommendation.  2.  We have reported in the past that EPA has found many provisions of the Toxic  Substances Control Act difficult to implement, and we have suggested that  Congress consider making statutory changes to strengthen EPA’s authority to  obtain toxicity information from the chemical industry. However, as we note in our  March 2013 report on the Toxic Substances Control Act, EPA has not pursued all opportunities to obtain chemical data using its existing authorities under the  law. We agree that robust collaboration between the IRIS and Toxic Substances  Control Act Programs could improve EPA’s ability to develop chemical  assessments in a timely manner.  3.  We continue to believe that agencywide guidance is needed that describes  alternative sources of toxicity information and when it would be appropriate to  use them when IRIS values are not available, applicable or current. As we note in  this report, we have previously reported on EPA’s fragmented and largely  uncoordinated science activities and recommended, among other things, that  EPA establish a top-level science official with the authority and responsibility to  coordinate, oversee, and make management decisions regarding major scientific  activities throughout the agency.recommendation, we believe that guidance regarding major scientific activities  should also come from a top-level science official. However, as we note in our  current report, EPA has not provided its Science Advisor with the authority to  make management decisions regarding scientific activities across EPA as we  previously recommended. Therefore, we believe that agencywide guidance  should come from EPA’s Deputy Administrator in coordination with EPA’s  Science Advisor.

Consistent with our prior report and  4.  We recognize that EPA is responsible for assessing and managing  environmental risks based on many laws with different requirements and that  program offices and regions may not always need IRIS toxicity assessments.  However, as we note in our report, EPA has not clearly articulated under what  circumstances IRIS toxicity assessments are not needed. Moreover, in cases  where program offices and regions have indicated a need for an IRIS toxicity  assessment, but an assessment is not available, applicable, or current, EPA  does not have guidance that describes alternative sources of toxicity information  and when it would be appropriate to use them.

section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact

section_title: Staff Acknowledgments
paragraphs: In addition to the individual named above, Diane G. LoFaro, Assistant  Director; Summer Lingard-Smith; and Marie Webb made key  contributions to this report. Important contributions were also made by  Mark Braza, Janice Ceperich, Nirmal Chaudhary, Richard Johnson,  Cynthia Norris, Aaron Shiffrin, and Kiki Theodoropoulos.


Question-summary annotations: questions: question: What is the status of EPA's evaluation of demand for IRIS toxicity assessments?
answer: The Environmental Protection Agency (EPA) has not conducted a recent evaluation of demand for Integrated Risk Information System (IRIS) toxicity assessments with input from users inside and outside EPA.
child_questions: question: What have recent evaluations considered?
answer: Specifically, EPA issued a needs assessment report in 2003, which estimated that 50 new or updated IRIS toxicity assessments were needed each year to meet users' needs.
child_questions: question: How did GAO assess the estimate?
answer: However, GAO did not find sufficient support for the estimate.

question: What is the stance of IRIS Program officials regarding the 2003 estimate?
answer: In addition, IRIS Program officials recognize that the 2003 estimate does not reflect current conditions, but the agency does not plan to perform another evaluation of demand.

question: What are the risks of EPA's lack of a current IRIS toxicity assessment?
answer: Without a clear understanding of current demand for IRIS toxicity assessments, EPA cannot adequately measure the program's performance; effectively determine the number of IRIS toxicity assessments required to meet the needs of IRIS users; or know the extent of unmet demand.

questions: question: What is the status of IRIS Program's chemical nomination and selection process?
answer: The IRIS Program's chemical nomination and selection process, which the agency uses to gauge interest in the IRIS Program from users inside and outside of EPA, may not accurately reflect current demand for IRIS toxicity assessments. The 75 chemicals that were nominated in response to EPA's most recent 2011 nomination period may not reflect demand for a number of reasons.
child_questions: question: What is one reason why the selection process may not reflect current demand?
answer: For example, given the long-standing challenges the IRIS Program has had in routinely starting new assessments, according to some EPA IRIS users, they chose not to nominate new chemicals for assessment.

question: How does EPA's stance affect this issue?
answer: Also, EPA has not clearly articulated how the IRIS Program applies the criteria it uses to prioritize the selection of chemicals for IRIS toxicity assessment--including how it determines the circumstances under which an IRIS toxicity assessment is or is not needed.

question: What is the implication of this lack of data?
answer: Consequently, for chemicals that were nominated but not selected for assessment, it is not clear how many, if any, were excluded from consideration because they did not meet the IRIS Program's selection criteria because the IRIS Program determined that an IRIS toxicity assessment was not needed--or, alternatively, if they were not selected due to resource constraints or other reasons.

questions: question: How has EPA addressed the unmet needs of EPA program offices?
answer: EPA has not implemented an agencywide strategy for addressing the unmet needs of EPA program offices and regions when IRIS toxicity assessments are not available, applicable, or current.
child_questions: question: How has EPA addressed data gaps?
answer: Specifically, EPA does not have a strategy for identifying and filling data gaps that would enable it to conduct IRIS toxicity assessments for nominated chemicals that are not selected for assessment because sufficient data from health studies are not available.

question: What is IRIS Program's stance regarding the data gap?
answer: IRIS Program officials stated that no agencywide mechanism exists for EPA to ensure that chemicals without sufficient scientific data during one nomination period will have such information by the next nomination period or even the one after that. EPA also does not have agencywide guidance for addressing unmet needs when IRIS toxicity assessments are not available, applicable, or current.

question: How has EPA met their needs in the absence of agencywide guidance?
answer: In the absence of agencywide guidance, officials from select EPA offices stated that they used a variety of alternatives to IRIS toxicity assessments to meet their needs, including using toxicity information from other EPA offices or other federal agencies.

question: What would help address the issue?
answer: These officials acknowledged that better coordination across EPA and with other federal agencies could help address the issue.

questions: question: Why was the IRIS database created?
answer: EPA created the IRIS database in 1985 to help develop consensus opinions within the agency about the health effects from chronic exposure to chemicals.
child_questions: question: What information do IRIS toxicity assessments provide?
answer: The health effects information in IRIS--referred to as IRIS toxicity assessments--provides fundamental scientific information EPA needs to develop human health risk assessments.

question: What was GAO asked to evaluate?
answer: GAO was asked to review the effectiveness of EPA's implementation of its IRIS toxicity assessment process.
child_questions: question: What does this report assess?
answer: This report determines the extent to which (1) EPA has evaluated demand for IRIS toxicity assessments from users inside and outside EPA; (2) EPA's process for nominating and selecting chemicals for IRIS toxicity assessment accurately reflects demand; and (3) EPA has implemented a strategy for addressing any unmet agency needs when IRIS toxicity assessments are not available, applicable, or current.

question: How did GAO conduct its evaluation?
answer: To do this work, GAO reviewed and analyzed IRIS nomination data, among other things, and interviewed EPA officials. GAO did not evaluate the scientific content or quality of IRIS toxicity assessments.