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United States Government Accountability Office: 
GAO: 

Report to the Chairman, Committee on Environment and Public Works, 
U.S. Senate: 

May 2013: 

Chemical Assessments: 

An Agencywide Strategy May Help EPA Address Unmet Needs for Integrated 
Risk Information System Assessments: 

GAO-13-369: 

GAO Highlights: 

Highlights of GAO-13-369, a report to the Chairman, Committee on 
Environment and Public Works, U.S. Senate. 

Why GAO Did This Study: 

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. 

What GAO Found: 

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. 

What GAO Recommends: 

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. 

View [hyperlink, http://www.gao.gov/products/GAO-13-369]. For more 
information, contact J. Alfredo Gómez at (202) 512-3841 or 
gomezj@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

EPA's Most Recent Evaluation of Demand for IRIS Toxicity Assessments 
Is a Decade Old: 

EPA's Chemical Nomination and Selection Process May Not Accurately 
Reflect Current Demand for IRIS Toxicity Assessments: 

EPA Has Not Implemented an Agencywide Strategy for Addressing Unmet 
Needs for IRIS Toxicity Assessments: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Scope and Methodology: 

Appendix II: Summary of Approaches Used by Select EPA Program Offices 
and Regions to Address Toxicity Assessment Needs: 

Appendix III: Comments from the Environmental Protection Agency: 

Appendix IV: GAO Contact and Staff Acknowledgments: 

Figures: 

Figure 1: National Academies' Risk Assessment Model Used by EPA: 

Figure 2: Number of IRIS Toxicity Assessments EPA Issued, Fiscal Years 
2002 to 2012: 

Abbreviations: 

ATSDR: Agency for Toxic Substances and Disease Registry: 

Cal/EPA: California Environmental Protection Agency: 

CAS: Chemical Abstracts Service: 

DIPE: diisopropyl ether: 

EPA: Environmental Protection Agency: 

ETB: Eethyl tertiary butyl ether: 

GPRA: Government Performance and Results Act of 1993: 

IRIS: Integrated Risk Information System: 

MTB: Emethyl tertiary butyl ether: 

OMB: Office of Management and Budget: 

PART: Program Assessment Rating Tool: 

PPRTV: Provisional Peer Reviewed Toxicity Value: 

TAME: tertiary amyl methyl ether: 

TBA: tertiary butyl alcohol: 

[End of section] 

United States Government Accountability Office: 
Washington, DC 20548: 

May 10, 2013: 

The Honorable Barbara Boxer: 
Chairman: 
Committee on Environment and Public Works: 
United States Senate: 

Dear Madam Chairman: 

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.[Footnote 
1] 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.[Footnote 2] 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.[Footnote 3] 
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.[Footnote 4] 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.[Footnote 5] 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.[Footnote 6] 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.[Footnote 7] 
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.[Footnote 8] 
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. 
[Footnote 9] 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. 

Background: 

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. 

EPA's Human Health Risk Assessment and Risk Management Practices: 

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.[Footnote 10] This model 
includes four components: (1) hazard identification, (2) dose-response 
assessment, (3) exposure assessment, and (4) risk characterization 
(see figure 1). 

Figure 1: National Academies' Risk Assessment Model Used by EPA: 

[Refer to PDF for image: illustration] 

IRIS toxicity assessment:
1. Hazard identification; 
2. Dose-response assessment. 

and: 

Exposure assessment. 

Combine to indicate: 

Risk characterization. 

Sources: GAO presentation of the risk assessment component of the 
National Academies’ risk assessment and risk management model
used by EPA. 

[End of figure] 

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.[Footnote 
11] 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."[Footnote 12] 

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/m3 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.[Footnote 13] 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.[Footnote 14] 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.[Footnote 15] 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.[Footnote 
16] 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. 
[Footnote 17] 

* 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.[Footnote 18] 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. 

EPA's Process for Soliciting Nominations and Selecting Chemicals for 
New and Updated IRIS Toxicity Assessments: 

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.[Footnote 19] 

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.[Footnote 20] 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. 

EPA's Most Recent Evaluation of Demand for IRIS Toxicity Assessments 
Is a Decade Old: 

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.[Footnote 21] In response to the Senate request, EPA 
conducted a needs assessment--the results of which are discussed in 
its September 2003 report, Needs Assessment for U.S. EPA's Integrated 
Risk Information System.[Footnote 22] 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.[Footnote 23] 
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.[Footnote 24] 
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.[Footnote 25] In addition, we 
have previously reported that, in developing new initiatives, agencies 
can benefit from following leading practices for strategic 
planning.[Footnote 26] Congress enacted the Government Performance and 
Results Act (GPRA) in 1993 to improve efficiency and accountability of 
federal programs.[Footnote 27] 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.[Footnote 28] 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. 

EPA's Chemical Nomination and Selection Process May Not Accurately 
Reflect Current Demand for IRIS Toxicity Assessments: 

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 figure 2). EPA has issued from 2 
to 11 IRIS toxicity assessments annually since fiscal year 2002. 

Figure 2: Number of IRIS Toxicity Assessments EPA Issued, Fiscal Years 
2002 to 2012: 

[Refer to PDF for image: vertical bar graph] 

Fiscal year: 2002; 
IRIS toxicity assessments issued: 3. 

Fiscal year: 2003; 
IRIS toxicity assessments issued: 11. 

Fiscal year: 2004; 
IRIS toxicity assessments issued: 4. 

Fiscal year: 2005; 
IRIS toxicity assessments issued: 4. 

Fiscal year: 2006; 
IRIS toxicity assessments issued: 2. 

Fiscal year: 2007; 
IRIS toxicity assessments issued: 2. 

Fiscal year: 2008; 
IRIS toxicity assessments issued: 5. 

Fiscal year: 2009; 
IRIS toxicity assessments issued: 7. 

Fiscal year: 2010; 
IRIS toxicity assessments issued: 10. 

Fiscal year: 2011; 
IRIS toxicity assessments issued: 4. 

Fiscal year: 2012; 
IRIS toxicity assessments issued: 4. 

Source: GAO analysis of EPA data. 

Note: EPA's Integrated Risk Information System (IRIS) contains 
toxicity assessments that provide fundamental scientific information 
EPA needs for assessing the risks chemicals pose to human health 
(i.e., develop human health risk assessments). 

[End of figure] 

In addition, as we reported in December 2011, EPA fell short of its 
productivity goal in fiscal year 2011--completing 4 of the 20 IRIS 
toxicity assessments it had originally planned to complete that year. 
[Footnote 29] Similarly, in completing 4 IRIS toxicity assessments in 
fiscal year 2012, EPA fell short of its fiscal year 2012 goal of 
completing 40 assessments. Given the challenges the IRIS Program has 
experienced issuing IRIS assessments, for many chemicals, the IRIS 
Program is not fulfilling the goal of providing a common scientific 
foundation for decision making within EPA programs--which is the 
stated purpose of an IRIS toxicity assessment according to EPA's 
strategic planning document for human health risk assessment research. 
[Footnote 30] Instead, because the IRIS Program has been 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. 
[Footnote 31] 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.[Footnote 32] 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. 

EPA Has Not Implemented an Agencywide Strategy for Addressing Unmet 
Needs for IRIS Toxicity Assessments: 

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. 

EPA Does Not Have a Strategy for Identifying and Filling Data Gaps: 

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.[Footnote 33] One of the chemicals dropped 
from consideration due to insufficient data was nominated in 2005, 
2007, and 2011.[Footnote 34] 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.[Footnote 35] 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).[Footnote 36] 

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.[Footnote 37] 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. 

IRIS Program officials told us that no mechanism exists for EPA to 
ensure that chemicals without sufficient health studies during one 
nomination period will have those data gaps filled by the next 
nomination period or even the one after that. As discussed earlier, as 
part of its solicitation process, the IRIS Program circulates an 
annotated list of chemical nominations that specifies the degree to 
which health studies are available for each chemical. However, 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.[Footnote 38] Other agencies within the 
Department of Health and Human Services 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. 

EPA Does Not Have Agencywide Guidance for Addressing Unmet Needs: 

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.[Footnote 39] 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.[Footnote 40] 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.[Footnote 41] 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.[Footnote 42] 

In the absence of agencywide guidance, officials from the three EPA 
program offices and one region we met with said they used a variety of 
different approaches to meet their needs when an IRIS toxicity 
assessment was not available or current. That is, EPA offices operate 
in much the same way as they operated before the IRIS Program was 
formed to develop consensus opinions within the agency about the 
health effects from chronic exposure to chemicals. For example, when 
IRIS toxicity assessments are not available or current, Office of 
Solid Waste and Emergency Response officials stated that their office 
refers to a hierarchy of toxicity values it established to perform 
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 in order of preference 
as: (1) IRIS toxicity values, (2) 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.[Footnote 43] Similarly, Region 2 officials told us 
that they generally follow the Office of Solid Waste and Emergency 
Response's hierarchy of values to guide their decisions regarding 
other toxicology sources to meet their needs when an IRIS toxicity 
assessment is not available. For example, Region 2 officials told us 
that there are a number of chemicals for which their office has used 
PPRTVs and values from ATSDR and Cal/EPA to address high-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.[Footnote 44] 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).[Footnote 45] 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.[Footnote 46] 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.[Footnote 47] 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.[Footnote 48] While EPA agreed with our 
recommendation, it has not 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. 

Conclusions: 

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. 

Recommendations for Executive Action: 

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. 

Agency Comments and Our Evaluation: 

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.[Footnote 49] 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 [hyperlink, 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. 

Sincerely yours, 

Signed by: 

J. Alfredo Gómez: 
Director, Natural Resources and Environment: 

[End of section] 

Appendix I: Scope and Methodology: 

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.[Footnote 50] 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.[Footnote 51] 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. 

[End of section] 

Appendix II: Summary of Approaches Used by Select EPA Program Offices 
and Regions to Address Toxicity Assessment Needs: 

Office of Solid Waste and Emergency Response: 

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.[Footnote 52] 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).[Footnote 53] 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. 

EPA Region 2: 

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.[Footnote 54] Officials also told us that there are 
number of high-profile chemicals where the office has used PPRTVs and 
values from ATSDR and Cal/EPA, because an IRIS toxicity assessment is 
not available. However, officials noted that ATSDR does not develop 
cancer values. 

Office of Water: 

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. 

Office of the Administrator: 

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.[Footnote 55] 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. 

Office of Pollution Prevention and Toxics: 

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. 

[End of section] 

Appendix III: Comments from the Environmental Protection Agency: 

Note: GAO comments supplementing those in the report text appear at 
the end of this appendix. 

United States Environmental Protection Agency
Washington, D.C. 20460
Office of the Administrator: 

April 16, 2013: 

Mr. Alfredo Gomez: 
Director: 
Natural Resources and Environment: 
U.S. Government Accountability Office: 
Washington, D.C. 20548: 

Dear Mr. Gomez: 

Thank you for the opportunity to review and comment on the U.S. 
Government Accountability Office's 13-369 draft report, Chemical 
Assessments: An Agency-wide Strategy May Help EPA Address Unmet Needs 
for Integrated Risk Information System Assessments. The U.S. 
Environmental Protection Agency appreciates the GAO's analysis of the 
agency's effectiveness in implementing its Integrated Risk Information 
System, known as IRIS, toxicity-assessment process. 

In the report, the GAO identifies several areas of concern and 
recommends that the EPA address those concerns at two levels. 

First, to ensure that the 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, the GAO recommends 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; and; 

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

Second, to maximize resources and address unmet needs for IRIS 
toxicity assessments, the GAO recommends that the Deputy 
Administrator, in coordination with the EPA's science advisor, develop 
an agencywide strategy to identify and fill data gaps that preclude 
the EPA from conducting IRIS toxicity assessments, and develop 
guidance describing alternative sources of toxicity information and 
procedures for preparing toxicity assessments when IRIS values are not 
available, applicable or current. 

The EPA appreciates that the GAO recognizes the importance of the IRIS 
program and agrees there is a need to identify and evaluate the demand 
for IRIS assessments, including improving the transparency of 
decisions to select or not select chemicals for IRIS assessment 
development. One of our priorities is to improve the IRIS program's 
productivity and to increase the number of assessments. Understanding 
the needs of IRIS users and responding to their expectations enables 
the EPA and external stakeholders to better assess the program's 
productivity and the need for new or different steps to improve program
results. To obtain current and accurate information on IRIS users' 
needs and expectations. ORD this year win evaluate the potential 
future demand for IRIS toxicity assessments and the resources required
to meet that demand. As the GAO suggested. the EPA will then use the 
evaluation outcome to estimate the number and types of IRIS 
assessments required to meet the needs of the EPA and external IRIS
users. 

As recommended, the EPA 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 a full IRIS assessment. For 
those chemicals not selected for IRIS assessment specifically because 
data gaps preclude undertaking an assessment, the EPA will identify the
data gaps and research needs and will make these known to EPA 
researchers, the administrators of the EPA's external research grant 
program, other EPA programs. other federal research agencies such as the
National Institute of Environmental Health Sciences and the public. 
Also, as the GAO has recommended, the EPA win ensure that these 
efforts do not impede the progress of ongoing assessments. 

We understand and support the goal of the GAO's recommendation that 
the EPA develop an "agencywide strategy... to help identify and fill 
data gaps that preclude development of IRIS toxicity assessment." 
Where data gaps prevent an informed assessment of the health effects 
of an IRIS candidate chemical, filling those data gaps should be a 
priority both to support the IRIS program and to improve the public's 
understanding of chemical risks. The EPA's limited resources" however, 
preclude the agency from substantial investments in health-effects 
research on individual chemicals. We must, therefore, look to other 
federal agencies, academic institutions and chemical-products 
producers to fund such research. The EPA 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. 

We urge the GAO to clarify more precisely the extent to which the EPA 
must rely on others to conduct research to fill data gaps on IRIS 
chemicals and can best encourage that research by publicizing data
gaps and working with other organizations with research capabilities 
rather than use our own limited resources to conduct testing. In 
addition, recognizing that necessary research can take many years to
conduct and publish. it is important that the GAO recommendations 
emphasize more strongly that, in some cases, IRIS assessment 
development may need to proceed on the basis of available information
and should not be held in abeyance awaiting new research. This will 
create an incentive for manufacturers and others to anticipate the 
needs of the IRIS program and not wait until assessments are imminent 
before investing in needed research. [See comment 1] 

The GAO should also note that one tool available to the EPA, the ToxiC 
Substances Control Act, is limited in its ability to require industry 
to submit available data on chemicals and to conduct health effects 
testing to nit data~gaps. As the Obama Administration has articulated 
in its goals for TSCA reform, manufacturers should provide the EPA 
with the necessary information to conclude that new and existing 
chemicals are safe and do not endanger public health or the 
environment TSCA reform, combined with robust collaboration between 
the IRIS and TSCA programs, could improve the EPA's ability to develop 
chemical assessments in a timely manner. [See comment 2] 

The EPA also understands the GAO's interest in the agency developing 
"guidance that describes alternative sources of toxicity information 
and procedures for preparing toxicity assessments when IRIS values are 
not available, applicable or current." We agree that such guidance 
might be helpful but believe its development is best left to 
individual EPA programs. many of which are already meeting the
need described by the GAO. [See comment 3] 

As the GAO recognizes, IRIS assessments, while important and 
influential, are not the only authoritative sources of hazard 
information on chemicals and need not be available in all instances to 
meet the needs of the public and government agencies. The draft report 
itself recognizes that there are already such alternate sources as 
documented in the recent EPA's Office of Inspector General report 
summarizing a survey of EPA national-program offices and regions about 
their use of IRIS and other toxicity information. 

Moreover, the EPA's programs and offices do not currently lack 
"procedures for preparing toxicity assessments when IRIS values are 
not available, applicable or current." The draft report already points 
out some of these procedures such as toxicity assessments produced by 
the EPA's Office of Pollution Prevention and Toxics. Others not 
mentioned in the report include the health effects support documents 
for drinking-water contaminants, published by EPA's Office of Water, 
and the Superfund program's guidance in identifying a hierarchy of 
toxicity values, in addition to those in IRIS, to support cleanup 
decisions. As these efforts reflect, EPA programs at times have 
targeted, special-purpose needs that can be satisfied without the 
comprehensive literature reviews and toxicity evaluations in IRIS 
assessments. 

The EPA is responsible for assessing and managing environmental risks 
based on many laws with different requirements. The recommendation to 
develop guidance "describing alternative sources of toxicity 
information" suggests a uniformity in risk-management requirements 
that does not exist. That said, while the EPA believes relevant 
offices and programs are already aware of the range of internal and 
external sources of toxicity information, the EPA will take steps to 
ensure EPA national programs and regions are well-informed about the 
results of the OIG survey and the availability of IRIS and other 
toxicity information. [See comment 4] 

We urge the GAO to consider refining these two recommendations.
In the meantime, I thank you once more for enabling the EPA to review 
and comment on the GAO's draft report. We at the EPA fully recognize 
the IRIS program's importance and value to our critical mission and to 
the work of many public-health agencies and organizations. The EPA 
remains committed to strengthening the IRIS program and to addressing 
the agency's needs for toxicity assessments, and we are grateful for 
the GAO's thoughts and recommendations. 

Sincerely, 

Signed by: 
Bob Perciasepe: 
Acting Administrator: 

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,[Footnote 56] 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,[Footnote 57] 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.[Footnote 58] 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. 

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. 

[End of section] 

Appendix IV: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

J. Alfredo Gómez, (202) 512-3841 or gomezj@gao.gov: 

Staff Acknowledgments: 

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. 

[End of section] 

Footnotes: 

[1] Under its IRIS Program, EPA (1) identifies a chemical's toxicity, 
or hazardous properties, which are the potential noncancer and cancer 
human health effects of exposure to a chemical, and (2) assesses the 
dose-response relationship between exposure to a chemical and the 
resultant health effects, which describes the magnitude of hazard for 
potential noncancer effects and increased cancer risk. 

[2] A human health risk assessment characterizes the nature and 
magnitude of health risks to humans from exposure to chemical 
contaminants that may be present in the environment. IRIS toxicity 
assessments are used along with other information to prepare human 
health risk assessments. Toxicity represents the degree to which a 
chemical is harmful. In this report, the terms toxicity and hazard are 
used synonymously. 

[3] According to IRIS Program officials, new assessments are added to 
the IRIS database after an evaluation of the available scientific 
literature, and existing assessments are revised based on an 
evaluation of new studies that have been published since the original 
assessment was completed. 

[4] GAO, Chemical Assessments: Low Productivity and New Interagency 
Review Process Limit the Usefulness and Credibility of EPA's 
Integrated Risk Information System, [hyperlink, 
http://www.gao.gov/products/GAO-08-440] (Washington, D.C.: Mar. 7, 
2008). 

[5] GAO, High-Risk Series: An Update, [hyperlink, 
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: Jan. 22, 
2009). This high-risk area addresses EPA's implementation of the IRIS 
Program, as well as implementation of the Toxic Substances Control Act. 

[6] GAO, Chemical Assessments: Challenges Remain with EPA's Integrated 
Risk Information System Program, [hyperlink, 
http://www.gao.gov/products/GAO-12-42] (Washington, D.C.: Dec. 9, 
2011). 

[7] For purposes of this report, "IRIS users" represent EPA program 
offices and regions and non-EPA entities that submit chemical 
nominations to the IRIS Program. Such non-EPA entities include other 
federal agencies, White House offices, and the public. 

[8] According to IRIS Program documents, the IRIS Program solicits 
opinions from EPA offices, other federal agencies, and the public on 
an annual basis. However, since 2004, the IRIS Program has solicited 
nominations from IRIS users three times: in 2004, 2006, and 2010. In 
their nomination forms, IRIS users send EPA the names of chemicals and 
the reasons for requesting that IRIS toxicity assessments be developed 
or updated, among other information. In 2004, the IRIS Program 
solicited nominations only from EPA program offices and regions. In 
2006 and 2010, the IRIS Program solicited nominations from all IRIS 
users. The IRIS Program refers to these nomination periods as being 
for fiscal years 2005, 2007, and 2011, which are the years we also 
refer to in this report. 

[9] We interviewed officials both at the Office of Policy and the 
Office of Children's Health Protection, which are suboffices within 
the Office of the Administrator. We also received a written response 
from the Office of Underground Storage Tanks, which is a suboffice 
within the Office of Solid Waste and Emergency Response. 

[10] The National Academies comprise four organizations: the National 
Academy of Sciences, the National Academy of Engineering, the 
Institute of Medicine, and the National Research Council. EPA uses the 
model that was initially outlined in the 1983 National Academies' 
National Research Council, Risk Assessment in the Federal Government 
(commonly known as the Red Book). The National Research Council's 
subsequent 2009 report presented by the National Academies in Science 
and Decisions: Advancing Risk Assessment (Washington, D.C.: The 
National Academies Press, 2009) reiterated this process. This 
publication is also known as the Silver Book. 

[11] Exposure represents the magnitude, frequency, and duration of 
contact with a chemical. 

[12] According to IRIS Program officials, one of the following five 
descriptors is selected based on the extent of human and animal data 
available: (1) "carcinogenic to humans," (2) "likely to be 
carcinogenic to humans," (3) "suggestive evidence of carcinogenic 
potential," (4) "inadequate information to assess carcinogenic 
potential," or (5) "not likely to be carcinogenic to humans." 

[13] OMB, Fiscal Year 2006 Program Assessment Rating Tool (PART) 
assessment of EPA's Human Health Risk Assessment Program. 

[14] EPA Office of Research and Development, Human Health Risk 
Assessment Strategic Research Action Plan 2012-2016, EPA 601/R-12/007, 
June 2012. 

[15] EPA decides the type of independent peer review an IRIS toxicity 
assessment will undergo. The peer reviews are conducted by (1) a peer 
review panel assembled by an EPA contractor, (2) EPA's Science 
Advisory Board, or (3) the National Academies. 

[16] 42 U.S.C. § 9604 (i)(3). 

[17] Toxicity values are a numerical expression of a substance's 
exposure-response relationship that is used in risk assessments. 

[18] The specific definition for each exposure duration category may 
vary depending on the source of the toxicity value being used. In 
general, subchronic is used to describe periods of repeated exposure 
by the oral, dermal, or inhalation route for more than 30 days up to 
approximately 90 days in laboratory animals or 10 percent of the life 
span in humans. 

[19] The IRIS Program also included these criteria, with slight 
variation, for the 2005 and 2007 nomination solicitations. 

[20] Of the 15 IRIS toxicity assessments listed in the 2012 IRIS 
agenda, 7 were updates of assessments already in the IRIS database. Of 
the 52 IRIS toxicity assessments that were already under way, 34 were 
updates of assessments already in the IRIS database. 

[21] S. Rep. No. 106-410 at 90 (2000). 

[22] EPA, Needs Assessment for U.S. EPA's Integrated Risk Information 
System (Washington, D.C.: September 2003). 

[23] For example, the report called for developing a schedule for 
updating potentially outdated assessments at least once every 10 years 
and updating some every 5 years. 

[24] EPA received responses from 10 EPA program offices, 7 EPA 
regions, and 22 public and private organizations. Non-EPA respondents 
included the U.S. Army, state agencies, industries, trade 
organizations, public interest and nonprofit organizations. 

[25] GAO, Environmental Protection Agency: To Better Fulfill Its 
Mission, EPA Needs a More Coordinated Approach to Managing Its 
Laboratories, [hyperlink, http://www.gao.gov/products/GAO-11-347] 
(Washington, D.C.: July 25, 2011). 

[26] GAO, Environmental Protection: EPA Should Develop a Strategic 
Plan for Its New Compliance Initiative, [hyperlink, 
http://www.gao.gov/products/GAO-13-115] (Washington, D.C.: Dec. 10, 
2012); GAO, Environmental Justice: EPA Needs to Take Additional 
Actions to Help Ensure Effective Implementation, [hyperlink, 
http://www.gao.gov/products/GAO-12-77] (Washington, D.C.: Oct. 6, 
2011). 

[27] We have reported in the past that, taken together, the strategic 
planning elements established under GPRA and associated OMB guidance, 
and practices identified by GAO provide a framework of leading 
practices in federal strategic planning. For example, see GAO, 
Executive Guide: Effectively Implementing the Government Performance 
and Results Act, [hyperlink, 
http://www.gao.gov/products/GAO/GGD-96-118] (Washington, D.C.: June 1, 
1996); GAO, Tax Administration: IRS Needs to Further Refine Its Tax 
Filing Season Performance Measures, [hyperlink, 
http://www.gao.gov/products/GAO-03-143] (Washington, D.C.: Nov. 22, 
2002); and GAO, Managing for Results: Strengthening Regulatory 
Agencies' Performance Management Practices, [hyperlink, 
http://www.gao.gov/products/GAO/GGD-00-10] (Washington, D.C.: Oct. 28, 
1999). 

[28] Leading practices in federal strategic planning include defining 
mission and goals, defining strategies that address management 
challenges and identify resources needed to achieve goals, ensuring 
leadership involvement and accountability, involving stakeholders, 
coordinating with other federal agencies, and developing and using 
performance measures. 

[29] [hyperlink, http://www.gao.gov/products/GAO-12-42]. EPA 
originally planned to issue 20 IRIS toxicity assessments in fiscal 
year 2011: 4 were issued, 1 was dropped, 2 were given "TBD"--to be 
determined--completion dates, and 13 were added to the fiscal year 
2012 completion goal, bringing it to 40 assessments. 

[30] EPA Office of Research and Development, Human Health Risk 
Assessment Strategic Research Action Plan 2012-2016, EPA 601/R-12/007, 
June 2012. 

[31] As discussed earlier, EPA's IRIS Program was originally created 
to develop consensus across the Agency regarding health effects 
resulting from chronic exposures to chemicals. IRIS Program officials 
have recently told us that IRIS no longer formally requires Agency 
consensus for its assessments, but consensus is still sought and often 
achieved through the existing Agency review process. 

[32] OMB, Memorandum to the Chief Financial Officers, Chief Operation 
Officers, Chief Information Officers, and Program Managers, December 
21, 2004. 

[33] As discussed earlier, the IRIS Program has not published 
information on how the agency applied its selection criteria but, upon 
request, provided us with information regarding chemicals dropped from 
consideration due to insufficient data. 

[34] 2,2,4-Trimethylpentane (iso-octane). 

[35] According to EPA's website, 2,2,4-trimethylpentane is released to 
the environment through the manufacture, use, and disposal of products 
associated with the petroleum and gasoline industry. During an 
accident, 2,2,4-trimethylpentane penetrated the skin of a human which 
caused necrosis of the skin and tissue in the hand and required 
surgery. No other information is available on the acute (short-term) 
effects in humans. Irritation of the lungs, edema, and hemorrhage has 
been reported in rodents acutely exposed by inhalation and injection. 
No information is available on the chronic (long-term), reproductive, 
developmental, or carcinogenic effects of 2,2,4-trimethylpentane in 
humans. Kidney and liver effects have been observed in rats 
chronically exposed via gavage (experimentally placing the chemical in 
the stomach) and inhalation. 

[36] 42 U.S.C. § 7545(b)(4). These substances are (1) ethyl tertiary 
butyl ether (ETBE); (2) tertiary amyl methyl ether (TAME); (3) 
diisopropyl ether (DIPE); (4) tertiary butyl alcohol (TBA); (5) 
ethanol; (6) iso-octane (2,2,4-trimethylpentane); and (7) alkylates. 
According to EPA's website, MTBE is a fuel additive made by combining 
methanol and isobutylene and has been used since 1979 in the United 
States as an octane-enhancing replacement for lead. According to the 
website, the use of MTBE in gasoline sold in the United States has 
virtually ceased in recent years. According to IRIS Program officials, 
ETBE, TAME, DIPE, TBA, and ethanol are currently on the IRIS agenda in 
the draft development step. The ETBE assessment is being revised 
because important new data became available after the external peer 
review. New schedules for ETBE and TBA were posted on the IRIS website 
in February 2013. Taking into account the complexity of the ethanol 
dataset, IRIS Program officials told us that they are considering 
various approaches to conducting the ethanol assessment and will 
revisit the priority of the ethanol assessment in fiscal year 2013. 
Alkylates were added to the IRIS agenda in 2007 but were withdrawn in 
2012 because there are multiple chemicals in this class, many with 
limited databases. If individual alkylates with sufficient data to 
support an IRIS assessment are nominated in the future, the IRIS 
Program will consider these nominations individually. 

[37] According to EPA's 2007 IRIS assessment on iso-octane, no 
subchronic or chronic oral or inhalation studies were identified that 
demonstrated a dose-response effect that could be used to determine 
the noncarcinogenic risk for iso-octane and no studies were available 
on the carcinogenic effects of iso-octane on which to base a cancer 
assessment. 

[38] 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. 

[39] According to officials at the Office of Solid Waste and Emergency 
Response, summaries of toxicity literature are more useful than no 
information about toxicity of a particular chemical, but typically the 
summaries do not completely address the needs of the program offices 
of regions. 

[40] PPRTVs are developed for EPA's Superfund program and, therefore, 
the Superfund program determines the chemicals that are nominated for 
development. Other EPA program offices are not included in the 
nomination process in the same fashion as they are for the IRIS 
nomination process. However, once a PPRTV is posted to the Office of 
Solid Waste and Emergency Response's Superfund website, they are 
publicly available. 

[41] EPA Board of Scientific Counselors, Review of the Office of 
Research and Development's Human Health Risk Assessment Program at the 
U.S. Environmental Protection Agency: Final Report, April 1, 2008. 

[42] GAO, Standards for Internal Control in the Federal Government, 
[hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1] 
(Washington, D.C.: November 1999). 

[43] 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. 

[44] This focus is consistent with the fact that media-specific 
environmental laws such as the Clean Air Act and Clean Water Act are 
available to limit the concentration of contaminants in water or the 
ambient air, and the Toxic Substances Control Act requires EPA to 
defer action to such other laws if the agency determines that it can 
use them to adequately address a given risk. However, information on 
such continuous exposures is still critical for regulation under the 
Toxic Substances Control Act. For example, to promulgate a rule under 
section 6 of the Toxic Substances Control Act, EPA must have 
information on, among other things, the effects of the chemical on 
human health and the magnitude of human exposure to the chemical. 

[45] IRIS toxicity values are generally used to estimate risks 
associated with continuous exposures to a pollutant in the air or 
water. In most cases, the information used to develop the dose-
response assessments is based on intermittent exposures to workers or 
animals in a controlled environment. IRIS assessments include an 
adjustment to continuous exposure in the derivation of toxicity values. 

[46] EPA's Science Advisory Board is a federal advisory committee 
established by Congress in 1978 with a broad mandate to advise the 
agency on technical matters. 

[47] Science Advisory Board, Science Integration for Decision Making 
at the U.S. Environmental Protection Agency, EPA-SAB-12-008 
(Washington, D.C.: July 6, 2012). 

[48] [hyperlink, http://www.gao.gov/products/GAO-11-347]. 

[49] [hyperlink, http://www.gao.gov/products/GAO-11-347]. 

[50] According to IRIS Program documents, the IRIS Program solicits 
opinions from EPA offices, other federal agencies, and the public on 
an annual basis. However, since 2004, the IRIS Program has solicited 
nominations from IRIS users three times: in 2004, 2006, and 2010. In 
2004, the IRIS Program solicited nominations only from EPA program 
offices and regions. In 2006 and 2010, the IRIS Program solicited 
nominations from all IRIS users. The IRIS Program refers to these 
nomination periods as being for fiscal years 2005, 2007, and 2011, 
which are the years we also refer to in this report. 

[51] We interviewed officials both at the Office of Policy and the 
Office of Children's Health Protection, which are suboffices within 
the Office of the Administrator. We also received a written response 
from the Office of Underground Storage Tanks, which is a suboffice 
within the Office of Solid Waste and Emergency Response. 

[52] The Office of Solid Waste and Emergency Response has suboffices 
including the Office of Underground Storage Tanks, which submitted 
separate nominations (inclusive of the 18 chemicals) to the IRIS 
Program. 

[53] 42 U.S.C. § 7545(b)(4). These substances are (1) ethyl tertiary 
butyl ether (ETBE); (2) tertiary amyl methyl ether (TAME); (3) 
diisopropyl ether (DIPE); (4) tertiary butyl alcohol (TBA); (5) 
ethanol; (6) iso-octane (2,2,4-trimethylpentane); and (7) alkylates. 
According to EPA's website, MTBE is a fuel additive made by combining 
methanol and isobutylene and has been used since 1979 in the United 
States as an octane-enhancing replacement for lead. According to the 
website, the use of MTBE in gasoline sold in the United States has 
virtually ceased in recent years. According to IRIS Program officials, 
ETBE, TAME, DIPE, TBA, and ethanol are currently on the IRIS agenda in 
the draft development step. The ETBE assessment is being revised 
because important new data became available after the external peer 
review. New schedules for ETBE and TBA were posted on the IRIS website 
in February 2013. Taking into account the complexity of the ethanol 
dataset, IRIS Program officials told us that they are considering 
various approaches to conducting the ethanol assessment and will 
revisit the priority of the ethanol assessment in fiscal year 2013. 
Alkylates were added to the IRIS agenda in 2007 but were withdrawn in 
2012 because there are multiple chemicals in this class, many with 
limited databases. If individual alkylates with sufficient data to 
support an IRIS assessment are nominated in the future, the IRIS 
Program will consider these nominations individually. 

[54] 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. 

[55] The Office of the Administrator has suboffices including the 
Office of Policy and the Office of Children's Health Protection, which 
each submitted separate nominations (inclusive of the 26 chemicals) to 
the IRIS Program. 

[56] [hyperlink, http://www.gao.gov/products/GAO-08-440]. 

[57] GAO, Toxic Substances: EPA Has Increased Efforts to Asses and 
Control Chemical but Could Strengthen Its Approach, [hyperlink, 
http://www.gao.gov/products/GAO-13-249] (Washington, D.C.: Mar. 22, 
2013). 

[58] [hyperlink, http://www.gao.gov/products/GAO-11-347]. 

[End of section] 

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