CHEMICAL 

ASSESSMENTS 

Challenges Remain 

with EPA’s Integrated 

Risk Information 

System Program 

Report to the Ranking Member,

Subcommittee on Energy and 

Environment, Committee on Science, 

Space, and Technology, House of 

Representatives 

December 2011 

GAO-12-42 

United States Government Accountability Office

GAO 
United States Government Accountability Office

Highlights of GAO-12-42, a report to the 

Ranking Member, Subcommittee on Energy 

and Environment, Committee on Science, 

Space, and Technology, House of 

Representatives 

December 2011 

CHEMICAL ASSESSMENTS

Challenges Remain with EPA's Integrated Risk 

Information System Program 

Why GAO Did This Study

The Environmental Protection 

Agency’s (EPA) Integrated Risk 

Information System (IRIS) Program 

supports EPA’s mission to protect 

human health and the environment by 

providing the agency’s scientific 

position on the potential human health 

effects from exposure to various

chemicals in the environment. The 

IRIS database contains quantitative 

toxicity assessments of more than 550 

chemicals and provides fundamental 

scientific components of human health 

risk assessments. In response to a 

March 2008 GAO report on the IRIS 

program, EPA revised its IRIS 

assessment process in May 2009.

GAO was asked to evaluate (1) EPA’s 

progress in completing IRIS 

assessments under the May 2009 

process and (2) the challenges, if any, 

that EPA faces in implementing the 

IRIS program. To do this work, GAO 

reviewed and analyzed EPA 

productivity data, among other things, 

and interviewed EPA officials.

What GAO Recommends

GAO recommends, among other 

things, that EPA assess the feasibility 

of the established time frames for each 

step in the IRIS assessment process 

and make changes if necessary, 

submit for independent review to an 

entity with scientific and technical 

credibility a plan for how EPA will 

implement the National Academies’ 

suggestions, and ensure that current 

and accurate information on chemicals 

that EPA plans to assess through IRIS 

is available to IRIS users. EPA agreed 

with GAO’s recommendations and 

noted specific actions it will take to 

implement them.

What GAO Found

EPA’s May 2009 revisions to the IRIS process have restored EPA’s control of the 

process, increased its transparency, and established a new 23-month time frame 

for its less challenging assessments. Notably, EPA has addressed concerns 

GAO raised in its March 2008 report and now makes the determination of when 

to move an assessment to external peer review and issuance—decisions that 

were made by the Office of Management and Budget (OMB) under the prior IRIS 

process. In addition, EPA has increased the transparency of the IRIS process by 

making comments provided by other federal agencies during the interagency 

science consultation and discussion steps of the IRIS process available to the 

public. Progress in other areas, however, has been limited. EPA’s initial gains in 

productivity under the revised process have not been sustained. After completing 

16 assessments within the first year and a half of implementing the revised 

process, EPA completed 4 assessments in fiscal year 2011. Further, the 

increase in productivity does not appear to be entirely attributable to the revised 

IRIS assessment process and instead came largely from (1) clearing the backlog 

of IRIS assessments that had undergone work under the previous IRIS process 

and (2) issuing assessments that were less challenging to complete. EPA has 

taken longer than the established time frames for completing steps in the revised 

process for most of its less challenging assessments. However, EPA has not 

analyzed its established time frames to assess the feasibility of the time frame for 

each step or the overall 23-month process. The agency’s progress has also been 

limited in completing assessments that it classifies as exceptionally complex and 

reducing its ongoing assessments workload. Beyond the 55 ongoing IRIS 

assessments, the backlog of demand for additional IRIS assessments is unclear. 

With existing resources devoted to addressing its current workload of ongoing 

assessments, EPA has not been in a position to routinely start new assessments. 

EPA faces both long-standing and new challenges in implementing the IRIS 

program. First, EPA has not fully addressed recurring issues concerning the 

clarity and transparency of its development and presentation of draft IRIS 

assessments. For example, as part of its independent scientific review of EPA’s 

draft IRIS assessment of formaldehyde, the National Academies provided 

suggestions for improving EPA’s development and presentation of draft IRIS 

assessments in general, including that EPA use a standardized approach to 

evaluate and describe study strengths and weaknesses and the weight of 

evidence. EPA announced that it planned to respond to the National Academies’ 

suggestions by implementing changes to the way it develops draft IRIS 

assessments. Given that many of the issues raised by the National Academies

have been long-standing, it is unclear whether any entity with scientific and 

technical credibility, such as an EPA advisory committee, will have a role in 

conducting an independent review of EPA’s planned response to the 

suggestions. In addition, EPA has not addressed other long-standing issues 

regarding the availability and accuracy of current information to users of IRIS 

information, such as EPA program offices, on the status of IRIS assessments, 

including when an assessment will be started, which assessments are ongoing, 

View GAO-12-42. For more information, and when an assessment is projected to be completed. contact David C. Trimble at (202) 512-3841 or 

trimbled@gao.gov. 
Page i GAO-12-42 Chemical Assessments 

Letter 1 

Background 4

EPA’s Progress in Completing Assessments under Its Revised 

Process Has Been Limited 10

EPA Faces Long-standing and New Challenges in Implementing the 

IRIS Program 19

Conclusions 27

Recommendations for Executive Action 28

Agency Comments and Our Evaluation 29

Appendix I Scope and Methodology 31 

Appendix II Status of Chemicals in the IRIS Assessment Development 

Process, as of September 30, 2011 33 

Appendix III Information on Chemicals of Key Concern 34 

Appendix IV Projected Completion Dates for IRIS Assessments Currently in the 

Assessment Development Process, as of September 30, 2011 41 

Appendix V Comments from the Environmental Protection Agency 42 

Appendix VI GAO Contact and Staff Acknowledgments 47

Tables 

Table 1: EPA’s May 2009 IRIS Assessment Process Steps and 

Established Time Frames 8

Table 2: Completed IRIS Assessments from May 2009 through 

September 2011 14

Table 3: Ongoing IRIS Assessment Workload Balance 15

Contents 
Page ii GAO-12-42 Chemical Assessments 

Table 4: May 2009 IRIS Process Step Time Frames and Actual 

Completion Times for Each Step 18

Figures 

Figure 1: National Academies’ Risk Assessment Model Used by 

EPA 5

Figure 2: Number of Completed IRIS Assessments, Fiscal Years 

2002-2011 12

Abbreviations 

ATSDR Agency for Toxic Substances and Disease Registry 

BBP butyl benzyl phthalate 

BOSC Board of Scientific Counselors 

CEQ Council on Environmental Quality 

CERCLA Comprehensive Environmental Response, Compensation, 

and Liability Act of 1980 

DBP dibutyl phthalate 

DEHA di(2-ethylhexyl) adipate 

DEHP di(2-ethylhexyl) phthalate 

DIBP diisobutyl phthalate 

DINP diisononyl phthalate 

DIPE diisopropyl ether 

DOD Department of Defense 
Page iii GAO-12-42 Chemical Assessments 

DPP dipentyl phthalate 

EGBE ethylene glycol monobutyl ether 

EPA Environmental Protection Agency 

ETBE ethyl tertiary butyl ether 

FDA Food and Drug Administration 

HHS Department of Health and Human Services 

IRIS Integrated Risk Information System 

IRISTrack IRIS Substance Assessment Tracking System 

MTBE methyl tert-butyl ether 

NASA National Aeronautics and Space Administration 

NCEA National Center for Environmental Assessment 

NCEH National Center for Environmental Health 

NIOSH National Institute for Occupational Safety and Health 

NTP National Toxicology Program 

OIRA Office of Information and Regulatory Affairs 

OMB Office of Management and Budget 

ORD Office of Research and Development 

PAH polycyclic aromatic hydrocarbon 

PART Program Assessment Rating Tool 

PBPK physiologically based pharmacokinetic 

PCBs polychlorinated biphenyls 

PFOA perfluorooctanoic acid-ammonium salt 

PFOS perfluorooctane sulfonate-potassium salt 

RDX hexahydro-1,3,5-trinitro-1,3,5-triazine 

RfC inhalation reference concentration 

RfD oral reference dose 

TAEE tertiary amyl ethyl ether 

TAME tertiary amyl methyl ether 

TCDD 2,3,7,8-tetrachlorodibenzo-p-dioxin 

TCE trichloroethylene 

TCP trichloropropane 

THF tetrahydrofuran 

TSCA Toxic Substances Control Act 

This is a work of the U.S. government and is not subject to copyright protection in the 

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Page 1 GAO-12-42 Chemical Assessments 

United States Government Accountability Office

Washington, DC 20548 

December 9, 2011 

The Honorable Brad Miller 

Ranking Member 

Subcommittee on Energy and Environment 

Committee on Science, Space, and Technology 

House of Representatives 

Dear Mr. Miller: 

The Environmental Protection Agency’s (EPA) Integrated Risk 

Information System (IRIS) Program supports EPA’s mission to protect 

human health and the environment by providing the agency’s scientific 

position on the potential human health effects that may result from 

exposure to various chemicals in the environment. IRIS was created in 

1985 to help EPA develop consensus opinions within the agency about 

the health effects from chronic exposure to chemicals, and its importance 

has increased over time. The IRIS database contains quantitative toxicity 

assessments of the health effects of more than 550 chemicals and 

provides fundamental scientific components—qualitative hazard 

identification and quantitative dose-response assessment—of human 

health risk assessments.1

 EPA’s IRIS Program develops new IRIS 

assessments and, as needed, updates existing IRIS values contained in 

the IRIS database. These IRIS assessments, in turn, provide scientific 

input for risk management decisions, such as whether EPA should 

establish air or water quality standards to protect the public from 

exposure to toxic chemicals or set cleanup standards for hazardous 

waste sites. Consequently, IRIS assessments are a critical component of 

EPA’s capacity to support scientifically sound decisions, policies, and 

regulations. State and local environmental programs and some 

international regulatory bodies also rely on IRIS for managing their 

environmental protection programs. 

 

1

As we have previously reported, the Toxic Substances Control Act (TSCA) requires EPA 

to demonstrate that certain health or environmental risks are likely before it can require 

companies to test the approximately 700 new chemicals introduced into commerce 

annually or take action to control unreasonable risks by placing restrictions on the tens of 

thousands of chemicals already in the agency’s TSCA inventory. 

 
 

Page 2 GAO-12-42 Chemical Assessments 

In 2008, we reported that the IRIS database was at serious risk of 

becoming obsolete because the agency had not been able to keep its 

existing assessments current, decrease its ongoing assessments 

workload to a manageable level, or complete assessments of the most 

important chemicals of concern.2

 In addition, we reported that as of 

December 2007, most of the ongoing assessments being conducted at 

that time had been in process for more than 5 years and that some 

assessments of key chemicals—chemicals that are likely to cause cancer 

or other significant health effects—had been in process even longer. For 

example, the formaldehyde and dioxin assessments had been ongoing 

for 11 and 17 years, respectively.3

 We also reported that new Office of 

Management and Budget (OMB)-required reviews of IRIS assessments 

by OMB and other federal agencies—called interagency reviews—were 

conducted in a manner that limited the transparency and credibility of the 

assessments and hindered EPA’s ability to manage the IRIS assessment 

process. Because of these issues, we recommended that EPA revise its 

IRIS assessment process to develop the timely chemical risk information 

the agency needs to effectively conduct its mission and to better ensure 

the development of transparent, credible chemical assessments. 

EPA issued a revised process in April 2008 that we concluded, in 

testimony before Congress, would further exacerbate the timeliness and 

credibility concerns we had identified.4

 Because the agency had not 

developed sufficient chemical assessment information to limit public 

exposure to many chemicals that may pose substantial health risks—and, 

in particular, because of EPA’s lack of responsiveness to our March 2008 

recommendations—in January 2009, we added EPA’s processes for 

assessing and controlling toxic chemicals to our list of areas at high risk 

 

2

GAO, Chemical Assessments: Low Productivity and New Interagency Review Process 

Limit the Usefulness and Credibility of EPA’s Integrated Risk Information System, 

GAO-08-440 (Washington, D.C.: Mar. 7, 2008). 

3

Formaldehyde is a gas widely used in such products as pressed wood, paper, 

pharmaceuticals, leather goods, and textiles. In addition, the term “dioxin” applies to a 

family of chemicals that are often the byproducts of combustion and other industrial 

processes. Complex mixtures of dioxins enter the food chain and human diet through 

emissions into the air that settle on soil, plants, and water. For more information on 

formaldehyde and dioxin, see appendix III. 

4

GAO, Toxic Chemicals: EPA’s New Assessment Process Will Increase Challenges EPA 

Faces in Evaluating and Regulating Chemicals. GAO-08-743T (Washington, D.C.: Apr. 

29, 2008). 
 

Page 3 GAO-12-42 Chemical Assessments 

for waste, fraud, abuse, and mismanagement or in need of broad-based 

transformation.5

In response to our 2008 report and subsequent high-risk designation, 

EPA revised its IRIS assessment process in May 2009 to, among other 

things, restore EPA’s control of the process and increase its 

transparency. Our biennial review of high-risk areas in 2011 concluded 

that the EPA Administrator needs to continue to demonstrate a strong 

commitment to and support of the IRIS Program to ensure that EPA’s 

2009 reforms are implemented effectively and that the program can 

routinely provide timely, transparent, and credible assessments.6

 In this 

context, you asked us to review EPA’s IRIS assessment process. Our 

objectives were to evaluate (1) EPA’s progress in completing IRIS 

assessments under the May 2009 process and (2) the challenges, if any, 

that EPA faces in implementing the IRIS program. 

In conducting our work, we analyzed EPA’s May 2009 assessment 

process; data from fiscal year 1999 through September 30, 2011, on IRIS 

productivity, such as the number of IRIS assessments initiated and 

completed; the status of IRIS assessments that are currently in progress; 

and EPA’s goals for completing assessments. To assess the reliability of 

the data, we conducted interviews and e-mail exchanges with EPA 

officials about the data system, the method of data input, and internal 

data controls and documentation, among other things. We found the data 

to be sufficiently reliable for the purposes of our report. We also 

interviewed officials from EPA’s Office of Research and Development’s 

(ORD) National Center for Environmental Assessment (NCEA), which 

manages the IRIS Program. In addition, we interviewed officials from 

other federal agencies involved in the IRIS process—including OMB and 

the Department of Defense (DOD)—and groups that have knowledge of 

the IRIS Program. We did not evaluate the scientific content or quality of 

IRIS assessments, but we reviewed the suggestions to EPA in peer 

review reports on overall improvements to the development of IRIS 

assessments and information on other issues affecting the IRIS Program. 

 

5

GAO, High-Risk Series: An Update, 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 (TSCA). 

6

GAO, High-Risk Series: An Update, GAO-11-278 (Washington, D.C.: Feb. 16, 2011). We 

also concluded that the EPA Administrator needed to continue to support the agency’s 

TSCA initiatives. 
 

Page 4 GAO-12-42 Chemical Assessments 

A more detailed description of our scope and methodology is presented in 

appendix I. 

We conducted this performance audit from July 2010 to December 2011 

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. 

This section discusses EPA’s risk assessment and risk management 

practices and the May 2009 IRIS process. 

EPA’s IRIS Program is an important source of information on health 

effects that may result from exposure to chemicals in the environment. As 

figure 1 shows, the toxicity assessments in the IRIS database fulfill the 

first two critical steps of the risk assessment process—providing 

qualitative hazard identification and dose-response assessment (see 

definitions below).7

 IRIS information can then be used with the results of 

exposure assessments (typically conducted by EPA’s program or regional 

offices) to provide an overall characterization of the public health risks for 

a given chemical in a given situation. EPA defines a risk assessment, in 

the context of human health, as the evaluation of scientific information on 

the hazardous properties of environmental agents (hazard 

characterization), the dose-response relationship (dose-response 

assessment), and the extent of human exposure to those agents 

(exposure assessment). In final form, a risk assessment is a statement 

regarding the probability that populations or individuals so exposed will be 

harmed and to what degree (risk characterization). The development of 

risk assessments is directly dependent on the development of toxicity 

assessments such as those developed by the IRIS Program. 

 

7

EPA uses the model presented by the National Academies in Science and Decisions: 

Advancing Risk Assessment (Washington, D.C.: The National Academies Press, 2009). 

This publication is also known as the Silver Book. 

Background 

Risk Assessment and Risk 

Management 
 

Page 5 GAO-12-42 Chemical Assessments 

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

Note: 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. 

A typical IRIS toxicity assessment is based on two sequential analyses: 

qualitative hazard identification and quantitative dose-response 

assessment. Among other things, a hazard identification identifies health 

hazards that may be caused by a given chemical at environmentally 

relevant concentrations; this identification describes the potential 

noncancer and cancer health effects of exposure to a chemical that 

research studies have suggested or determined. For cancer effects, EPA 

describes the carcinogenic potential of a chemical in a narrative which 

includes one of five weight-of-the-scientific-evidence descriptors, ranging 

from “carcinogenic to humans” to “not likely to be carcinogenic to 

humans.” The second analysis is the dose-response assessment, which 

characterizes the quantitative relationship between the exposure to a 

chemical and the resultant health effects; this assessment describes the 

magnitude of hazard for potential noncancer effects and increased cancer 

risk resulting from specific exposure levels to a chemical or substance. 

The quantitative dose-response analysis relies upon credible research 

data, primarily from either animal (toxicity) or human (epidemiology) 

studies. The noncancer dose-response assessments may include 
 

Page 6 GAO-12-42 Chemical Assessments 

 an oral reference dose (RfD)—an estimate 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 (RfC)—an estimate of the daily 

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. 

The focus of IRIS toxicity assessments has been on the potential health 

effects of long-term (chronic) exposure to chemicals. According to OMB, 

EPA is the only federal agency that develops qualitative and quantitative 

assessments of both cancer and noncancer risks of exposure to 

chemicals, and EPA does so largely under the IRIS Program.8

The risk characterization information, which is derived from toxicity and 

exposure assessments—exposure assessments identify the extent to 

which exposure actually occurs—can be used to make risk management 

decisions designed to protect public health. For example, IRIS 

assessments support scientifically sound decisions, policies, and 

regulations under such key statutes as the Clean Air Act, the Safe 

Drinking Water Act, and the Clean Water Act, as well as for setting 

Superfund cleanup standards of hazardous waste sites.9

 Risk 

management, as opposed to risk assessment, involves integrating the 

risk characterization information with other information—such as 

economic information on the costs and benefits of mitigating the risk, 

technological information on the feasibility of managing the risk, and the 

concerns of various stakeholders—to decide when actions to protect 

public health are warranted. More specifically, an initial risk management 

decision would be to determine whether the health risks identified in a 

chemical risk assessment warrant regulatory or other actions. As a result, 

 

8

OMB, Fiscal Year 2006 Program Assessment Rating Tool (PART) assessment of EPA’s 

Human Health Risk Assessment Program. 

9

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 

(CERCLA) requires federal agencies to respond to certain releases or threatened releases 

of hazardous substances on lands they administer. CERCLA also created a trust fund—

the Superfund—to provide for certain cleanup activities at nonfederal sites. Under 

CERCLA, EPA established the Superfund program to address the threats that 

contaminated sites pose. 
 

Page 7 GAO-12-42 Chemical Assessments 

the development of IRIS assessments is of key interest to stakeholders, 

such as other federal agencies and their contractors, chemical 

companies, and others who could be affected if regulatory actions were 

taken. That is, stakeholders could face increased cleanup costs and other 

legal liabilities if EPA issued an IRIS assessment for a chemical that 

resulted in a risk management decision to regulate the chemical to protect 

the public. 

EPA’s process for developing IRIS assessments—established in May 

2009—consists of seven steps. In announcing its revised process in May 

2009, EPA noted that the new process would ensure that the majority of 

assessments would be completed within 2 years (23 months)—a 

significantly shorter time than the estimated completion time frame of 

about 6 to 8 years under the previous process. We note that the seven 

steps are preceded by a literature search and data call-in, which is not 

included as part of the process or its time frames. Results of the literature 

search are posted on the IRIS website and announced in the Federal 

Register, along with a request for information—the data call-in—about 

any pertinent studies not listed. According to EPA officials, the literature 

search and data call-in are not part of the process because the agency 

does not dedicate full-time staff to them. EPA officials told us that after 

the literature search, they place IRIS assessments in one of three 

categories—standard, moderately complex, or exceptionally complex10—

on the basis of such factors as the number of available scientific studies 

on the chemical, the number of potential health effects identified in these 

studies, the staff resources required to complete the assessment, and the 

level of stakeholder interest. However, this process, as written, does not 

distinguish among different types of assessments with varying complexity. 

Table 1 outlines the steps in the IRIS assessment process, along with the 

planned time frames established by EPA. 

 

10EPA refers to a standard assessment as a tier 1 assessment, a moderately complex 

assessment as tier 2, and an exceptionally complex assessment as tier 3. 

The May 2009 IRIS Process 
 

Page 8 GAO-12-42 Chemical Assessments 

Table 1: EPA’s May 2009 IRIS Assessment Process Steps and Established Time Frames 

Step Action Time frame 

1—IRIS draft assessment completed Assessment drafted 345 days 

2—Internal agency review Draft assessment reviewed by EPA program and regional 

offices 

60 days 

3—EPA-managed interagency science 

consultation 

Interagency science consultation on draft assessment 

coordinated by EPA (White House officesa

 and other 

federal agenciesb

) 

45 days 

4—External peer review Draft assessment posted on IRIS website for independent 

peer reviewc

 and peer review meeting announced in 

Federal Register; concurrently, public comment period and 

public listening session announced in Federal Registerd

105 days 

5—Draft assessment revised Draft assessment revised in response to peer review and 

public comments and document prepared responding to 

comments 

60 days 

6a—Internal agency review; 

6b—EPA-led interagency science discussion 

Draft assessment reviewed by EPA program and regional 

offices concurrent with interagency science consultation 

on draft assessment coordinated by EPA (White House 

offices and other federal agencies) 

45 days 

7—Final IRIS assessment Final assessment, including summary, toxicological 

review, and response to comments, posted on IRIS 

websitee

30 days 

Total 690 days (23 months) 

Source: GAO analysis of EPA process. 

a

The White House offices participating include OMB’s Office of Information and Regulatory Affairs 

(OIRA) and the Council on Environmental Quality (CEQ). 

b

Other federal agencies participating include DOD, the Department of Health and Human Services 

(HHS), and the National Aeronautics and Space Administration (NASA). 

c

EPA decides the type of independent peer review an IRIS 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. 

d

The public listening session is announced concurrently with the peer review meeting in the Federal 

Register and provides an opportunity for interested parties to present scientific and technical 

comments on draft IRIS assessments. 

e

http://www.epa.gov/IRIS. 

All IRIS assessments undergo external peer review, but exceptionally 

complex assessments are generally peer reviewed by EPA’s Science 

Advisory Board panels and in some cases by National Academies 
 

Page 9 GAO-12-42 Chemical Assessments 

panels.11 These peer reviews typically require more planning and take 

longer than the reviews for less complicated assessments.12 Peer reviews 

for all other assessments are typically conducted by expert panels that 

are independently assembled by an EPA contractor. All panel members, 

including Science Advisory Board and National Academies panels, are 

composed of individuals with expertise in various scientific and technical 

disciplines who retain their primary involvement in academia, industry, 

state government, and environmental organizations. 

As we reported in 2008, an overarching factor that can affect EPA’s ability 

to complete IRIS assessments in a timely manner is the compounding 

effects of delays.13 Once a delay in the assessment process occurs—for 

example, suspending work on an assessment to wait for additional 

studies—work that has been completed can become outdated, 

necessitating rework of some or all of the steps in the assessment 

process. Even a single delay can have far-reaching, time-consuming 

consequences, in some cases requiring that the assessment process 

essentially start over.14

 

11Congress established EPA’s Science Advisory Board in 1978 and gave it a broad 

mandate to advise the agency on technical matters. The Science Advisory Board’s 

preliminary work is done by subcommittees or panels focused on various environmental 

science topics. These groups are chaired by Science Advisory Board members, and their 

recommendations are transmitted to the Science Advisory Board for discussion and 

deliberation. Recommendations are forwarded to EPA only if the Science Advisory Board 

determines that it is appropriate. 

12Since May 2009, 1 assessment has been externally peer reviewed by the National 

Academies (formaldehyde), 3 have been externally peer reviewed by the Science 

Advisory Board (trichloroethylene [TCE], Polycyclic aromatic hydrocarbon [PAH] mixtures, 

and Tetrachlorodibenzo-p-dioxin, 2,3,7,8-[dioxin]), and 14 have been externally peer 

reviewed by expert panels that are independently assembled by an EPA contractor 

(dichloromethane, hexachloroethane, urea, hexavalent chromium, halogenated platinum 

salts, 1,4-dioxane [oral route], pentachlorophenol, ethyl tertiary butyl ether [ETBE], 

hydrogen cyanide, tetrachloroethane-1,1,2,2, dichloroethylene -1,2-cis-, dichloroethylene -

1,2-trans-, trichloroacetic acid, and chloroprene). 

13GAO-08-440. 

14The National Academies’ Silver Book observes that “delays in the process of assessing 

risks may increase overall exposure to risk when decisions are delayed.” The Silver Book 

notes that “the design of a risk-assessment process should balance the pursuit of 

individual attributes of technical quality in the assessment and the competing attribute of 

timeliness of input into decision-making.” Science and Decisions: Advancing Risk 

Assessment. 
 

Page 10 GAO-12-42 Chemical Assessments 

EPA’s May 2009 IRIS assessment process addresses some of the 

problems we identified in our March 2008 report. However, progress in 

other areas has been limited. EPA’s initial gains in productivity under the 

revised process have not been sustained. EPA has not significantly 

reduced its workload of ongoing assessments, which would enable the 

agency to routinely start new assessments and keep existing 

assessments current. EPA has not met established time frames for IRIS 

assessment process steps. 

EPA has addressed concerns we raised in our March 2008 report 

regarding the transparency of the IRIS process. Since May 2009, all 

federal agency and White House office comments from both the 

interagency science consultation and discussion (steps 3 and 6b of the 

IRIS process) are available to the public on EPA’s IRIS website. In 

addition, EPA has made publicly available documents that show EPA’s 

responses to selected “major” interagency comments for all draft IRIS 

assessments that have completed an interagency review step since June 

2011. As we have previously reported, we believe that interagency 

coordination can enhance the quality of EPA’s IRIS assessments. 

Previously, OMB considered its comments and changes, and those of 

other federal agencies, to be “deliberative”—that is, they were not part of 

the public record. We believe the input from other federal agencies is now 

obtained in a manner that better ensures that EPA’s scientific analysis is 

given appropriate weight. As a result, stakeholders, including EPA 

regional and program offices, the public, and industry, can now see which 

other federal agencies comment and the nature of their comments, 

making IRIS assessments more transparent. Transparency is especially 

important because agencies providing input, such as DOD and NASA, 

may have a vested interest in the outcome of the assessment should it 

lead to regulatory or other actions. For example, these agencies may be 

affected by the potential for increased environmental cleanup costs and 

other legal liability if EPA issued an IRIS assessment that resulted in a 

decision to regulate a chemical to protect the public. Officials we spoke 

with from other federal agencies—including DOD, NASA, and the 

Department of Health and Human Services (HHS)—all agreed that 

making their comments publicly available was a good practice. 

In addition, EPA now manages the interagency science consultation and 

discussion (steps 3 and 6b of the IRIS process, formerly OMB-managed 

interagency reviews). As we recommended in 2008, the process now 

includes time limits for all parties, including OMB and other federal 

agencies, to provide comments to EPA on draft assessments. Prior to 

EPA’s Progress in 

Completing 

Assessments under Its 

Revised Process Has 

Been Limited 

Improvements to the IRIS 

Process 
 

Page 11 GAO-12-42 Chemical Assessments 

May 2009, OMB managed these steps, and EPA was not allowed to 

proceed with assessments until OMB notified EPA that it had sufficiently 

responded to comments from OMB and other federal agencies. EPA has 

also streamlined its IRIS process, as we recommended in our 2008 

report, by consolidating some process steps and eliminating others that 

had provided opportunities for other federal agencies to suspend IRIS 

assessments to conduct additional research.15

Shortly after it implemented its revised IRIS assessment process in May 

2009, EPA experienced a surge of productivity in terms of the number of 

IRIS assessments it issued. Specifically, from May 2009 through 

September 30, 2011, EPA completed 20 IRIS assessments—more than 

doubling the total productivity it achieved during fiscal years 2007 and 

2008.16 However, 16 of these 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 assessments (see fig. 2). 

 

15GAO-08-440. 

16In fiscal year 2007 EPA issued 2 IRIS assessments. In fiscal year 2008 EPA issued 5 

assessments—4 of which were assessments of related chemicals assessed and peer 

reviewed together but finalized individually. In addition, in February 2009—3 months 

before the revised IRIS process was announced—EPA issued an assessment for 

nitrobenzene. 

Initial Gains in 

Productivity under the 

Revised Process Have Not 

Been Sustained 
 

Page 12 GAO-12-42 Chemical Assessments 

Figure 2: Number of Completed IRIS Assessments, Fiscal Years 2002-2011 

In completing 4 IRIS assessments in fiscal year 2011, EPA fell significantly 

short of its original plan to complete 20 assessments—a goal that it had 

revised to 9 as of August 2011. In addition, EPA is unlikely to meet its fiscal 

year 2012 goal of completing 40 assessments.17 As of September 30, 

2011, 12 of the 40 assessments that EPA plans to complete in fiscal year 

2012 are still being drafted (step 1 of the IRIS process). See appendix II for 

the status of chemicals in the IRIS assessment process as of September 

30, 2011. On the basis of the planned time frames EPA established under 

its revised process, once these 12 IRIS assessments are drafted, EPA will 

require at least 345 days, or 111⁄2 months, to complete the remaining IRIS 

process steps and issue the assessments—making it unlikely these will be 

completed in 2012. 

 

17This goal includes assessments remaining from fiscal year 2011. EPA originally planned 

to issue 20 IRIS 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 goals. 
 

Page 13 GAO-12-42 Chemical Assessments 

The increased productivity occurring after May 2009 does not appear to 

be entirely attributable to the revised IRIS assessment process. 

According to our analysis of EPA data, the agency’s ability to complete 

more assessments was not due to a fundamental gain in how quickly 

assessments are completed, but rather to EPA’s ability to clear up the 

backlog of assessments that had undergone work under the previous 

IRIS process and had been delayed for multiple reasons. Most of the 

assessments completed from May 2009 through September 2011 had 

been in process 5 years or longer and thus had already passed through 

some key process steps prior to the implementation of the revised 

process. In addition, most of these completed IRIS assessments were for 

standard and moderately complex assessments—that is, they were less 

challenging to complete than those for more complex chemicals. 

Specifically, 17 of 20 assessments issued from May 2009 through 

September 30, 2011, were in process for 5 years or longer, and 2 of the 

20 were for exceptionally complex assessments (see table 2). For 

example, 1 exceptionally complex assessment that EPA did complete 

was for trichloroethylene (TCE). For information on TCE, as well as on 

some other key chemicals for which EPA has not completed IRIS 

assessments, see appendix III. 
 

Page 14 GAO-12-42 Chemical Assessments 

Table 2: Completed IRIS Assessments from May 2009 through September 2011 

IRIS assessment Level of complexitya Assessment completion date 

Length of time to 

complete assessment 

Trichloroacetic acid Moderately complex Sept. 30, 2011 7 years, 9 months 

Trichloroethylene (TCE) Exceptionally complex Sept. 28, 2011 13 years, 9 months 

Hexachloroethane Standard Sept. 23, 2011 6 years 

Urea Standard July 13, 2011 3 years, 6 months 

Chloroprene Moderately complex Sept. 30, 2010 11 years, 10 months 

Dichloroethylene -1,2-Cis- Standard Sept. 30, 2010 6 years, 8 months 

Dichloroethylene -1,2-Trans- Standard Sept. 30, 2010 6 years, 8 months 

Pentachlorophenol Moderately complex Sept. 30, 2010 12 years, 9 months 

Tetrachloroethane-1,1,2,2 Standard Sept. 30, 2010 5 years 

Hydrogen cyanide Standard Sept. 28, 2010 7 years, 6 months 

Dioxane-1,4—(oral route) Moderately complex Aug. 11, 2010 6 years, 6 months 

Carbon tetrachloride Moderately complex Mar. 31, 2010 10 years, 3 months 

Ethylene glycol monobutyl ether (EGBE) Moderately complex Mar. 31, 2010 6 years, 2 months 

Acrylamide Exceptionally complex Mar. 22, 2010 9 years, 1 month 

Bromobenzene Standard Sept. 30, 2009 6 years, 8 months 

Thallium Standard Sept, 30, 2009 7 years, 9 months 

Trichloropropane-1,2,3 (TCP) Moderately complex Sept, 30, 2009 6 years, 5 months 

Cerium Oxide Standard Sept, 29, 2009 4 years, 3 months 

Hexanone-2 Standard Sept, 25, 2009 4 years, 8 months 

Chlordecone (kepone) Standard Sept, 22, 2009 6 years, 8 months 

Average time to complete 7 years, 6 months 

Source: GAO analysis of EPA data. 

a

EPA determines the level of complexity for IRIS assessments. 

As of September 30, 2011, EPA had 55 IRIS assessments ongoing and 

14 on hold—down from the 88 assessments that were in various stages 

of development when it implemented its revised IRIS assessment process 

in May 2009. Since May 2009, EPA has undertaken 6 new assessments, 

dropped 5 assessments that it determined were no longer required, 

completed 20 assessments, and continued to have 14 assessments on 

hold (see table 3). According to EPA officials, assessments that have 

been put on hold will be resumed when the agency has resources 

available to staff them. 

EPA Has Not Significantly 

Reduced Its Ongoing 

Assessment Workload, 

Which Would Enable the 

Agency to Start New 

Assessments 
 

Page 15 GAO-12-42 Chemical Assessments 

Table 3: Ongoing IRIS Assessment Workload Balance 

Beginning workload, May 2009 88

New assessments undertakena 6

Dropped from agendab (5)

Completedc (20)

On holdd (14)

Ending workload, September 30, 2011 55

Source: GAO analysis of EPA data. 

a

Since May 2009, EPA has started 3 new IRIS assessments (n-butanol, diethyl phthalate, and 

polychlorinated biphenyls [PCBs]–noncancer). In addition, EPA decided to split the assessments for 3 

chemicals (chromium VI, 1,4-dioxane, and methanol), effectively adding 3 assessments to its list of 

ongoing assessments. It split the latter assessment into assessments of the cancer and noncancer 

effects of methanol, and the former 2 assessments into assessments of the effects of oral and 

inhalation exposure. 

b

As indicated in the Federal Register (75 Fed. Reg. 63827, October 18, 2010), EPA stopped work on 

(or “dropped”) the IRIS assessments of perfluorooctane sulfonate-potassium salt (PFOS) and 

perfluorooctanoic acid-ammonium salt (PFOA) because it is focusing on these chemicals as part of its 

chemicals management program under the Toxic Substances Control Act (TSCA). In the same 

Federal Register notice, EPA announced that it had stopped work on the IRIS assessment of 

weathered toxaphene because of lack of data to support an IRIS assessment, and that it had revised 

its approach to the IRIS assessment of asbestos, deciding to focus exclusively on a certain type of 

asbestos—Libby amphibole asbestos—in order to respond to the needs of the agency and the mining 

community of Libby, Montana. Under the revised approach, EPA dropped its plans to assess 

asbestos other than Libby amphibole asbestos. In August 2011, EPA decided to drop a fifth 

assessment, the draft assessment of mirex, because of its relatively low priority EPA-wide. 

c

For a list of the 20 completed IRIS assessments from May 2009 through September 2011, see table 2. 

d

The following 14 assessments remain on hold as of September 30, 2011: manganese, ethylene 

dichloride, tungsten, tertiary-amyl-methyl ether (TAME), ethylbenzene, alkylates, antimony, carbonyl 

sulfide, diisopropyl ether (DIPE), tertiary amyl ethyl ether (TAEE), bisphenol A, refractory ceramic 

fibers, isopropanol, and ethanol. 

However, this tally of IRIS assessments does not reflect the true extent of 

EPA’s workload or the backlog of demand for IRIS assessments. Beyond 

the 55 ongoing IRIS assessments and 14 on hold, the demand for 

additional IRIS assessments is unclear. With existing resources devoted 

to addressing its current workload of ongoing assessments, EPA has not 

been in a position to routinely start new assessments. In late 2010, for the 

first time since 2007, EPA solicited nominations for new IRIS 

assessments from EPA program and regional offices, as well as from the 

public and federal agencies that participate in IRIS interagency reviews. 

However, as of September 30, 2011, EPA officials had not decided which 

chemicals to include on the IRIS agenda and thus include in their 
 

Page 16 GAO-12-42 Chemical Assessments 

workload.

18 Moreover, instead of nominating new chemicals for 

assessment in 2010, one regional office requested that the IRIS Program 

focus its efforts on completing assessments currently under way. In 

addition, in 2007, the Office of Air and Radiation—which develops 

national programs, policies, and regulations for controlling air pollution 

and radiation exposure—requested that ongoing assessments be 

expedited for 28 chemicals that it identified as high-priority and required 

to fulfill its regulatory mandates. As of September 30, 2011, 17 of the 28 

assessments the office identified are ongoing, and 3 are on hold. See 

appendix IV for EPA’s expected completion dates for IRIS assessments 

currently in the assessment process. 

In addition, other assessments in the IRIS database may need to be 

updated. As we reported in March 2008, EPA data from 2001 through 

2003 indicated that 287 of the assessments in the IRIS database at that 

time may need to be updated. In October 2009, EPA announced in the 

Federal Register the establishment of the IRIS Update Project. The stated 

purpose of the project was to update IRIS toxicity values, such as oral 

reference doses or inhalation reference concentrations, that are more 

than 10 years old. However, according to EPA officials, since the project 

was announced, little progress has been made toward updating these 

assessments. We note that even if EPA were to overcome the significant 

productivity difficulties it has experienced in recent years and meet its 

goal of completing 40 assessments in fiscal year 2012, it is not clear that 

this level of productivity would meet the needs of EPA program offices 

and other users. 

IRIS assessments have taken longer than the time frames established 

under the revised IRIS process. Since implementing the revised process, 

most IRIS assessments have exceeded the established time frames for 

each step of the process. EPA officials, however, told us that the time 

frames established for the steps in the revised IRIS assessment process 

apply only to standard assessments—and not to moderately or 

exceptionally complex assessments. While EPA officials have said that 

they are trying to hold moderately complex assessments to the established 

time frames, EPA does not have a written policy that describes the 

applicability of these time frames or written criteria for designating IRIS 

 

18The IRIS agenda lists chemicals that are to be assessed during a given fiscal year. 

EPA Has Not Met 

Established Time Frames 

for IRIS Assessment 

Process Steps 
 

Page 17 GAO-12-42 Chemical Assessments 

assessments as standard, moderately complex, or exceptionally complex. 

Consequently, it is unclear how IRIS users will know which assessments 

are standard, moderately complex, or exceptionally complex and what time 

frames will be required to complete them. 

According to EPA officials, NCEA management, including IRIS Program 

management, is tracking the time it takes for each IRIS assessment to 

complete the various steps in the IRIS process. However, EPA has not 

yet analyzed these data to determine whether the time frames 

established for each step or the overall 23-month process are realistic. 

According to EPA officials, they do not yet have the data needed to draw 

conclusions regarding completion time frames. 

On the basis of our analysis of EPA data, however, we determined how 

long each IRIS process step was taking on average compared with the 

time frames established for each step under the May 2009 revised 

process. We performed this analysis for the 55 assessments that were 

ongoing, as of September 30, 2011, and the 20 assessments that were 

completed after May 2009. Because none of the 20 IRIS assessments 

completed from May 2009 through September 2011 were initiated after 

the revised process was implemented, it was not possible to fully evaluate 

the extent to which EPA is adhering to the new 23-month time frame. 

Further, we combined our analysis of steps 4 and 5 because EPA data do 

not indicate when step 4 ends and when step 5 begins, and we combined 

steps 6 and 7 for the same reason. According to our analysis, on 

average, assessments of all types have taken longer than the established 

time frames for every step in the IRIS process (see table 4). 
 

Page 18 GAO-12-42 Chemical Assessments 

Table 4: May 2009 IRIS Process Step Time Frames and Actual Completion Times for Each Step 

Average completion timea 

(Number of assessments that completed the step)

IRIS process steps and established 

EPA time framesb

 Standard assessments 

Moderately complex 

assessments 

Exceptionally complex 

assessments 

Step 1–IRIS draft assessment 

completedc

(345 days)

675 days 

(1 assessment) 

352 days 

(1 assessment) 

506 days 

(1 assessment) 

Step 2–Internal agency review 

(60 days)

91 days 

(4 assessments) 

141 days 

(2 assessments) 

109 days 

(4 assessments) 

Step 3–EPA-led interagency science 

consultation 

(45 days)

73 days 

(8 assessments) 

69 days 

(3 assessments) 

114 days 

(8 assessments) 

Step 4–External peer review, and 

Step 5–Draft assessment revised 

(165 days combinedd

)

294 days 

(6 assessments) 

442 days 

(4 assessments) 

523 days 

(2 assessments) 

Step 6a—Internal agency review, 

Step 6b—EPA-led interagency science 

consultation and discussion, and 

Step 7–Final IRIS assessment posted 

(75 days combinede

)

80 days 

(11 assessments) 

92 days 

(7 assessments) 

155 days 

(2 assessments) 

Source: GAO analysis of EPA data. 

a

We calculated average completion times, rounded to the nearest day, using EPA-provided data. In 

our calculations, we considered only assessments that began and completed a step under the May 

2009 process. This included the 55 ongoing assessments and the 20 completed since May 2009. For 

example, some assessments completed multiple steps since May 2009, while others completed only 

one or two. 

b

According to EPA officials, the time frames established for the steps in the IRIS assessment process 

apply to standard assessments. EPA officials told us they are trying to hold moderately complex 

assessments to the 23-month time frame, and the process time does not apply to exceptionally 

complex assessments. 

c

As of September 30, 2011, 23 other assessments were still in step 1, and 21 of these had already 

exceeded the 345-day time frame for the step. These 21 assessments had been started prior to 

EPA’s implementation of the May 2009 IRIS process. 

d

We combined steps 4 and 5 because the EPA data do not indicate when step 4 ends and when step 

5 begins. 

e

We combined steps 6 and 7 because the EPA data do not indicate when step 6 ends and when step 

7 begins. 

Some other federal agencies that participate in interagency reviews 

expressed concern that in some cases time and resource constraints 

present challenges as they try to meet EPA’s time frames for the two 

interagency review steps. In addition to the time limits established under the 

revised process, in an effort to increase productivity and complete more IRIS 

assessments, EPA officials said that, beginning in April 2011, the agency 
 

Page 19 GAO-12-42 Chemical Assessments 

began to accelerate the number of draft assessments sent through the 

interagency review steps. However, officials from other federal agencies—

including HHS and DOD—told us that they have advised EPA that the 

accelerated pace of interagency reviews in the second half of fiscal year 

2011 strained their resources. In addition, the official from NASA told us that 

not only are the increased pace of reviews straining the agency’s resources, 

but that it has also affected the ability to provide in-depth independent 

technical reviews and interagency comments. EPA officials also told us that 

the interagency reviewer at NASA is so concerned with the pace of the 

interagency reviews under the revised process that NASA officials have 

asked OMB to form an interagency work group to discuss the reviews. 

EPA faces both long-standing and new challenges in implementing the 

IRIS Program. First, the National Academies has identified recurring 

issues with how the IRIS Program develops and presents its 

assessments and has suggested improvements. Second, EPA has not 

consistently provided reliable information on ongoing and planned IRIS 

assessments to IRIS users. Third, unresolved discussions with OMB 

regarding EPA’s responses to Data Quality Act challenges may impede 

EPA’s ability to issue completed IRIS assessments. 

The National Academies and EPA’s Science Advisory Board have 

identified several recurring issues with how EPA develops and presents 

IRIS assessments. For example, in April 2011, the National Academies in 

its independent scientific review of EPA’s draft IRIS assessment of 

formaldehyde provided a critique of EPA’s development and presentation 

of draft IRIS assessments. Overall, the National Academies noted some 

recurring methodological problems in the draft IRIS assessment of 

formaldehyde.19 In addition, in the report the National Academies also 

identified recurring issues concerning clarity and transparency with EPA’s 

development and presentation of its draft IRIS assessments. 

The National Academies and Science Advisory Board have identified 

similar clarity and transparency issues in peer review reports over the 

 

19We did not evaluate the scientific content or quality of IRIS assessments. 

EPA Faces Longstanding and New 

Challenges in 

Implementing the 

IRIS Program 

The National Academies 

Has Identified Recurring 

Issues with How the IRIS 

Program Develops and 

Presents Its Assessments 
 

Page 20 GAO-12-42 Chemical Assessments 

past 5 years.20 Some of these reports stated that EPA should more clearly 

explain its reasons for including or excluding the scientific studies 

supporting draft IRIS assessments. In addition, some reports stated that 

EPA should more transparently present its justifications for its 

methodological approaches. Independent of its review of the 

formaldehyde assessment, the National Academies also provided a 

“roadmap for revision” that made suggestions for improvements to the 

IRIS draft development process, during which EPA selects and evaluates 

evidence (the literature search) and drafts an assessment (step 1). The 

National Academies’ “roadmap for revision” suggested that EPA take the 

following steps, among others: 

 use clear, standardized methods to identify and select study evidence; 

 use a standardized approach to evaluate and describe study 

strengths and weaknesses and the weight of evidence, describe and 

justify the assumptions and models used, and adopt a standardized 

approach to characterizing uncertainty factors;21 and

 present methodology and findings more clearly and more concisely 

through better use of graphics and tables and use a template to 

facilitate a consistent description of the approach to study selection.

The National Academies’ report on the draft IRIS assessment of 

formaldehyde specifically noted that EPA should not delay the finalization 

of the assessment in order to implement any of the suggestions it made 

regarding the overall IRIS process. As of September 30, 2011, according 

to EPA officials, the agency is revising the assessment in response to the 

National Academies’ suggestions, but the status page on EPA’s website 

for formaldehyde lists “TBD”—to be determined—as the posting date for 

the final assessment. 

 

20In addition to reviewing the National Academies’ peer review report on the draft IRIS 

assessment of formaldehyde, we reviewed National Academies peer review reports on the 

draft assessments of tetrachloroethylene (2010) and dioxin (2006) and the Science 

Advisory Board peer review reports on the draft assessments of trichloroethylene (TCE) 

(2011), acrylamide (2008), ethylene oxide (2007), dioxin (2011), polycyclic aromatic 

hydrocarbon (PAH) mixtures (2011), and inorganic arsenic (2011). 

21EPA uses uncertainty factors in the derivation of IRIS values to account for uncertainty 

due to, among other things, variability in susceptibility to a chemical among humans, the 

extrapolation of animal study data to humans, and the extrapolation of a chemical’s effects 

over a lifetime. 
 

Page 21 GAO-12-42 Chemical Assessments 

In July 2011, EPA announced that it planned to respond to the National 

Academies’ suggestions by implementing changes to the way it develops 

draft IRIS assessments. In announcing the planned changes, EPA stated 

that it would take the following actions: 

 enhance its approach to identifying and selecting scientific study 

evidence; 

 provide more complete documentation of its approach to evaluating 

scientific study evidence and indicate which criteria were most 

influential in its evaluation of the weight of evidence; and 

 concisely state the criteria used to include or exclude studies, 

continue to use existing IRIS guidelines to enhance the clarity and 

transparency of its data evaluation and presentation of findings and 

conclusions, eliminate the need for some report text using 

standardized tables, and portray toxicity values graphically. 

According to EPA officials, in implementing these changes, EPA will 

subject those assessments that are in earlier stages of development to 

more extensive changes than those in later stages of development. It will 

change the latter “as feasible” without repeating steps in the overall IRIS 

process. However, EPA has not provided a more detailed description of 

how the National Academies’ suggestions will apply to each of the 

assessments in its current inventory of IRIS assessments. Without a more 

precise description of which drafts would be considered “in the earlier 

stages of development” or what “more extensive changes” would entail, it 

is too soon to provide a comprehensive assessment of EPA’s approach. 

In addition, it is not transparent to stakeholders and other interested 

parties which assessments will be subject to these changes and which 

will not. EPA established the Board of Scientific Counselors (BOSC), an 

advisory committee composed of non-EPA technical experts from 

academia, industry, and environmental communities, to provide 

independent advice, information, and suggestions to the Office of 

Research and Development (ORD) research program—which houses the 

IRIS Program.22 Part of BOSC’s mission is to evaluate and provide advice 

concerning the utilization of peer review within ORD to sustain and 

 

22Members of the BOSC Executive Committee and subcommittees constitute a 

distinguished body of scientists and engineers who are recognized experts in their 

respective fields. 
 

Page 22 GAO-12-42 Chemical Assessments 

enhance the quality of science in EPA. It is unclear if BOSC will have a 

role in reviewing EPA’s response to the National Academies’ suggestions. 

We reviewed two IRIS assessments—one completed and one still in draft 

form—that reflect changes EPA has made in response to the National 

Academies’ suggestions.23 First, for its assessment of urea, finalized in 

July 2011, EPA streamlined the report by moving sections of text from the 

body to an appendix, which shortened the body of the assessment from 

89 to 57 pages, making it more concise. In addition, we reviewed the draft 

IRIS assessment of diisobutyl phthalate (DIBP), which EPA provided to 

us, that was undergoing agency review (step 2) and reflects some of the 

National Academies’ suggestions regarding presentation. For example, it 

includes (1) descriptive and pictorial explanations of the study selection 

methods used; (2) tables that, among other things, give side-by-side 

comparisons of studies considered in determining the oral reference dose 

for the chemical; and (3) brief descriptions of the strengths and 

weaknesses of various studies considered. For these two assessments, it 

appears that EPA has begun to enhance the readability of its 

assessments by making changes that appear to be in line with the 

suggestions made by the National Academies. 

EPA uses two primary mechanisms—the IRIS agenda and a website 

feature known as IRISTrack—to make information on the status of IRIS 

assessments available to EPA program and regional offices, other federal 

agencies, and the public.24 EPA has not effectively used these two 

mechanisms, or a third that we recommended in March 2008—that the 

agency provide a 2-year notice of its intent to assess specific chemicals—

to consistently provide reliable information on IRIS assessments to 

stakeholders and other interested parties.25

 

23According to EPA, these two assessments were changed based on the National 

Academies’ suggestions for improvement. We chose one assessment because it was 

completed during our review and EPA provided us the other assessment, which it said 

reflected changes made based on the National Academies’ suggestions. These two 

assessments may not be representative of all assessments, but are examples of 

assessments that EPA has changed based on the National Academies’ suggestions. 

24EPA’s IRIS assessment tracking system is formally called the IRIS Substance 

Assessment Tracking System. 

25GAO-08-440. 

EPA Has Not Consistently 

Provided Reliable 

Information on Planned 

and Ongoing IRIS 

Assessments to IRIS Users 
 

Page 23 GAO-12-42 Chemical Assessments 

First, EPA has not published an IRIS agenda in the Federal Register—

identifying the chemicals that EPA plans to assess (both new and 

ongoing assessments)—since it announced its 2008 IRIS agenda in 

December of 2007. EPA started developing an annual IRIS agenda and 

providing it to the public in a notice in the Federal Register in 1997.26 In 

late 2010, EPA began to solicit nominations for its fiscal year 2011 IRIS 

agenda from its program and regional offices, as well as from the public 

and federal agencies that participate in IRIS interagency reviews. 

However, as of September 30, 2011, EPA had not published its fiscal 

year 2011 agenda. In addition, some of the information provided in the 

Federal Register notices about the IRIS agenda has been incomplete. For 

example, an October 2010 Federal Register notice contained a list of 

chemicals currently on the IRIS agenda but did not distinguish between 

chemicals the agency was actively assessing and those it had designated 

for future assessment.27 We reported on similar issues in March 2008—

noting that EPA had identified some assessments that had been 

suspended as ongoing.28

Second, EPA has not kept information on the status of the individual 

ongoing assessments up to date in IRISTrack—an issue we also reported 

on in 2008.29 EPA’s IRISTrack, a feature of its website, is intended to 

provide stakeholders and other interested parties with information on draft 

IRIS assessments—specifically, estimated start and end dates for steps 

in the IRIS process.30 For example, officials from the Office of Water 

indicated that that their office relies heavily on IRISTrack for information 

about the status of IRIS assessments. In addition to not updating 

IRISTrack, EPA recently removed some key information presented in 

IRISTrack. Now, in some cases, the IRISTrack date for the beginning of 

draft development (step 1) understates the actual duration of an 

assessment—sometimes by many years. For example, IRISTrack 

indicates that draft development for the dioxin assessment began in the 

 

26EPA also uses the Federal Register to announce other IRIS-related developments, such 

as public meetings of peer review panels and public listening sessions, at which interested 

parties are invited to give comments on draft IRIS assessments. 

27Federal Register (75 Fed. Reg. 63827, October 18, 2010). 

28GAO-08-440. 

29GAO-08-440. 

30IRISTrack provides estimated start and end dates by fiscal year quarter. 
 

Page 24 GAO-12-42 Chemical Assessments 

first quarter of fiscal year 2009; in fact, as we have reported, EPA has 

been assessing dioxin since 1991.31 IRISTrack also understates the 

duration of assessments of other chemicals of key concern—for 

formaldehyde, naphthalene, and TCE. Therefore, current and accurate 

information regarding when an assessment will be started, which 

assessments are currently ongoing, and when an assessment is 

projected to be completed is presently not publicly available. 

Third, EPA does not provide at least 2 years’ notice of its intent to assess 

specific chemicals, as we recommended the agency should do in our 

March 2008 report to give agencies and other interested parties the 

opportunity to conduct research needed to fill any data gaps.32 In 

commenting on our report, EPA agreed to consider our recommendation, 

and EPA officials recently stated that they continue to agree with it, but as 

of September 30, 2011, the agency still had not taken steps to implement 

our recommendation. 

Discussions between EPA and OMB officials regarding Data Quality Act 

challenges related to specific draft IRIS assessments have been ongoing 

for over a year without resolution. If these unresolved discussions 

continue, they could contribute to delays of IRIS assessments. According 

to EPA officials, OMB would like to return to its role in the prior 

assessment process, in which it managed interagency reviews and made 

the final determination as to whether EPA has satisfactorily responded to 

comments from OMB and officials in other federal agencies. 

The Information Quality Act, commonly called the Data Quality Act, 

requires OMB to issue governmentwide guidelines to “ensure and 

maximize the quality, objectivity, utility, and integrity of information, 

including statistical information,” disseminated to the public.33 In addition, it 

required agencies to issue their own guidelines, set up administrative 

mechanisms to allow affected parties to seek the correction of information 

they considered erroneous, and report periodically to OMB information 

about Data Quality Act challenges (“requests for correction” of agency 

 

31GAO-08-440. 

32GAO-08-440. 

33Consolidated Appropriations–Fiscal Year 2001, Pub. L. No. 106-554, § 515, 114 Stat. 

2763A-153 to 2763A-154 (2000) (44 U.S.C. § 3516 note). 

Unresolved Discussions 

between EPA and OMB 

Could Contribute to Delays 
 

Page 25 GAO-12-42 Chemical Assessments 

information) and how the agencies addressed them.34 Under its data 

quality guidelines, when EPA provides opportunities for public participation 

by seeking comments on information, such as during a rulemaking, the 

agency uses the public comment process rather than EPA guidelines to 

address concerns about EPA’s information. This is consistent with OMB’s 

data quality guidelines, which encourage agencies to incorporate data 

quality procedures into their existing administrative practices rather than 

create new and potentially duplicative or contradictory processes. 

According to EPA’s data quality guidelines, the public comment period 

serves the purposes of the guidelines, provides an opportunity for 

correction of information, and does not duplicate or interfere with the 

orderly progression of draft documents through an established process—in 

this case, the IRIS assessment process. That is, the external peer review 

and associated public comment period provide the public with the 

opportunity to raise questions regarding the quality of the information being 

used to support an IRIS assessment. According to EPA officials, federal 

agency responses to data quality challenges must be cleared by OMB 

before EPA sends responses to the parties filing challenges—although no 

law or guidance specifically provides for such reviews. 

In June and July 2010, EPA received Data Quality Act challenges 

regarding two draft IRIS assessments. According to EPA officials, in its 

draft responses to these data quality challenges, EPA declined to review 

the challenged data because, according to agency policy, draft IRIS 

documents are not subject to data quality challenges. EPA used the same 

approach in 2006 when responding to and declining a similar challenge 

regarding a draft IRIS assessment; at that time, OMB approved the EPA 

response. EPA sent its draft responses for the two more recent 

challenges to OMB for approval in September 2010 and January 2011. 

EPA’s data quality guidelines set a goal of responding to Data Quality Act 

challenges within 90 days, but EPA officials said that they still await a 

decision by OMB. According to EPA officials, OMB is delaying a decision 

because OMB would like to return to its role in the prior assessment 

process, in which it managed interagency reviews and made the final 

 

34OMB’s data quality guidelines recognize that “information quality comes at a cost,” and 

that agencies should weigh the costs and benefits of increasing information quality. 67 

Fed. Reg. 8453 (February 22, 2002). OMB has stated that its involvement in the IRIS 

process increases the quality of the assessments, but it has produced no cost-benefit or 

other analysis supporting that statement, nor has it disclosed the performance measures it 

uses to evaluate assessment quality. 
 

Page 26 GAO-12-42 Chemical Assessments 

determination as to whether EPA has satisfactorily responded to 

comments from OMB and officials in other federal agencies. 

EPA officials told us that as of September 30, 2011, the issues regarding 

data quality challenges had not delayed the progress of draft IRIS 

assessments.35 Meanwhile, OMB staff told us that they had sent 

comments to EPA on the draft responses and await EPA’s reply to their 

comments. It appears to GAO that the discussions of these issues 

between EPA and OMB officials, which have been ongoing for over a 

year without resolution, have highlighted the agencies’ differences 

regarding the revised IRIS process. If these differences persist, they 

could contribute to the compounding effects of delays in the IRIS process, 

discussed here and in our earlier work. For example, in August 2011, 

EPA received a third data quality challenge on an assessment that EPA 

had expected to be finalized at the end of fiscal year 2011.36 For reasons 

that remain unclear, EPA now projects that this assessment will not be 

finalized until fiscal year 2012. We note that the assessment had entered 

the interagency science discussion (step 6b) in July 2011. EPA asked 

interagency reviewers to submit written comments by August 26, 2011, 

but as of September 2011, OMB reviewers have not yet submitted 

comments. 

 

35One of the challenged assessments, the draft inorganic arsenic cancer assessment, is 

currently undergoing post-peer review EPA revisions (step 5). The other challenged 

assessment, the draft cancer assessment of methanol, is currently on hold while EPA 

reviews some of the data underlying the findings of the draft assessment. 

36On August 1, 2011, the International Platinum Group Metals Association filed a request 

for correction on the IRIS assessment for Halogenated Platinum Salts and Platinum 

Compounds. In addition, The National Academies has observed that “reaching consensus 

on all aspects of the scope and conduct of a risk assessment among decision-makers and 

stakeholders representing diverse interests will not always be feasible. In addition, it is not 

necessarily in the public interest to delay the risk assessment where consensus is difficult 

to achieve.” Science and Decisions: Advancing Risk Assessment (Washington, D.C.: The 

National Academies Press, 2009). Moreover, EPA has noted in its data quality guidelines 

that “most environmental statutes obligate EPA to act to prevent adverse environmental 

and human health impacts. For many of the risks that we must address, data are sparse 

and consensus about assumptions is rare. In the context of data quality, we seek to strike 

a balance among fairness, accuracy, and efficient implementation. Refusing to act until 

data quality improves can result in substantial harm to human health, safety, and the 

environment.” 
 

Page 27 GAO-12-42 Chemical Assessments 

The IRIS process reforms EPA began implementing in May 2009 have 

restored EPA’s control of the process and increased its transparency. 

Notably, EPA has addressed concerns we raised in our March 2008 

report regarding the transparency of comments from both the interagency 

science consultation and discussion steps in the IRIS process. Making 

these comments publicly available is especially important because 

agencies providing input may have a vested interest in the outcome of the 

assessment should it lead to regulatory or other actions. As a result, 

stakeholders, including EPA regional and program offices, the public, and 

industry, can now see which other federal agencies comment and the 

nature of their comments, making IRIS assessments more transparent. In 

addition, EPA now manages the interagency science consultation and 

discussion steps and has streamlined the IRIS process. 

Progress in other areas, however, has been more limited. For example, 

even for its less challenging assessments, EPA took longer than its 

established time frames for accomplishing steps in the revised process—

calling into question the feasibility and appropriateness of the established 

time frames in the IRIS assessment process for standard assessments. 

Thus, the established time frames may not be feasible. It is also unclear 

whether the established time frames apply to moderately complex 

assessments because EPA does not have a written policy that describes 

the applicability of the time frames, although EPA officials said they are 

trying to hold moderately complex assessments to the 23-month time 

frame. Similarly, EPA does not have written criteria for designating IRIS 

assessments as standard, moderately complex, or exceptionally complex. 

We note that EPA has not analyzed the time frames to determine whether 

the actual time taken for each step of the overall 23-month process is 

realistic. Such an analysis would provide more accurate information for 

EPA to use in establishing time frames for these assessments. Not 

having established time frames for these assessments also creates 

uncertainty for many stakeholders with significant interest in IRIS 

assessments. 

EPA also faces both long-standing and new challenges in implementing 

the IRIS Program. Notably, the National Academies and Science Advisory 

Board have identified recurring issues of clarity and transparency of draft 

IRIS assessments. Consequently, as part of its independent scientific 

review of EPA’s draft IRIS assessment of formaldehyde, the National 

Academies also provided suggestions in a “roadmap for revision” that 

included suggestions for improving EPA’s development and presentation 

of draft IRIS assessments in general. The report identified recurring 

methodological issues with how the IRIS Program develops and presents 

Conclusions 
 

Page 28 GAO-12-42 Chemical Assessments 

its assessments and suggested improvements. EPA announced that it 

intends to address the issues raised in the National Academies’ report but 

has not publicly indicated how these proposed changes would be applied 

to its current inventory of IRIS assessments. Many of the issues raised in 

the National Academies’ report have been brought to the agency’s 

attention previously. It is unclear whether any independent entity with 

scientific and technical credibility, such as EPA’s Board of Scientific 

Counselors, will have a role in reviewing EPA’s planned response to the 

National Academies’ suggestions to ensure that EPA addresses these 

long-standing issues. 

In addition, EPA has not addressed other long-standing issues regarding 

the accuracy and availability of information on the status of IRIS 

assessments to IRIS users—including stakeholders such as EPA program 

and regional offices, other federal agencies, and the public. For example, 

since 2007, EPA has not published in the Federal Register an IRIS agenda 

that includes information on chemicals the agency is actively assessing or 

when it plans to start assessments of other listed chemicals. The agency 

also has not updated IRISTrack to display all current information on the 

status of assessments on the IRIS agenda, including estimated start dates 

and end dates of steps in the IRIS process. In addition, EPA has recently 

removed some key information presented in IRISTrack that showed the 

duration of IRIS assessments. Now, in some cases, the IRISTrack date for 

the beginning of draft development underestimates the actual duration of 

an assessment—sometimes by many years. Therefore, current and 

accurate information regarding when an assessment will be started, which 

assessments are currently ongoing, and when an assessment is projected 

to be completed is presently not publicly available. Finally, as we 

recommended the agency should do in our March 2008 report, EPA does 

not provide at least 2 years’ notice of its intent to assess specific chemicals, 

which would give agencies and other interested parties the opportunity to 

conduct research needed to fill any data gaps. 

To improve EPA’s IRIS assessment process, we are making the following 

six recommendations: 

To better ensure the credibility of IRIS assessments by enhancing their 

timeliness and certainty, we recommend that the EPA Administrator 

require the Office of Research and Development to 

 assess the feasibility and appropriateness of the established time 

frames for each step in the IRIS assessment process and determine 

Recommendations for 

Executive Action 
 

Page 29 GAO-12-42 Chemical Assessments 

whether different time frames should be established, based on 

complexity or other criteria, for different types of IRIS assessments, and 

 should different time frames be necessary, establish a written policy 

that clearly describes the applicability of the time frames for each type 

of IRIS assessment and ensures that the time frames are realistic and 

provide greater predictability to stakeholders. 

To better ensure the credibility of IRIS assessments by enhancing their 

clarity and transparency, we recommend that the EPA Administrator 

require the Office of Research and Development to submit for 

independent review to an independent entity with scientific and technical 

credibility, such as EPA’s Board of Scientific Counselors, a plan for how 

EPA will implement the National Academies’ suggestions for improving 

IRIS assessments in the “roadmap for revision” presented in the National 

Academies’ peer review report on the draft formaldehyde assessment. 

To ensure that current and accurate information on chemicals that EPA 

plans to assess through IRIS is available to IRIS users—including 

stakeholders such as EPA program and regional offices, other federal 

agencies, and the public—we recommend that the EPA Administrator 

direct the Office of Research and Development to 

 annually publish the IRIS agenda in the Federal Register each fiscal 

year; 

 indicate in published IRIS agendas which chemicals EPA is actively 

assessing and when EPA plans to start assessments of the other 

listed chemicals; and 

 update IRISTrack to display all current information on the status of 

assessments of chemicals on the IRIS agenda, including projected 

and actual start dates, and projected and actual dates for completion 

of steps in the IRIS process, and keep this information current. 

We provided a draft of this report to the Administrator of EPA for review 

and comment. In written comments, which are included in appendix V, EPA 

agreed with the report’s recommendations. EPA also provided technical 

comments, which we incorporated into the report as appropriate. 

Specifically, EPA agreed that it should (1) assess the feasibility and 

appropriateness of the established time frames for each step in the IRIS 

assessment process by using available program performance measures 

Agency Comments 

and Our Evaluation 
 

Page 30 GAO-12-42 Chemical Assessments 

collected since the current IRIS process was established to evaluate 

determine whether different time frames should be established, based on 

complexity or other criteria, for different types of IRIS assessments, (2) 

determine if different time frames are necessary, establish a written policy 

that clearly describes the applicability of the time frames for each type of 

IRIS assessment and ensures that the time frames are realistic and provide 

greater predictability to stakeholders, (3) continue to implement the 2011 

suggestions for improving IRIS assessments in the “roadmap for revision” 

presented in the National Academies’ peer review report on the draft 

formaldehyde assessment and seek independent review through the 

Science Advisory Board to ensure that the agency is addressing the 

recommendations, (4) annually publish the IRIS agenda in the Federal 

Register each fiscal year, (5) indicate in published IRIS agendas which 

chemicals EPA is actively assessing and when EPA plans to start 

assessments of the other listed chemicals, and (6) update IRISTrack to 

display all current information on the status of assessments of chemicals 

on the IRIS agenda, including projected and actual start dates, and 

projected and actual dates for completion of steps in the IRIS process, and 

keep this information current. 

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 Administrator of EPA, 

the appropriate congressional committees, and other interested parties. In 

addition, the report will be available at no charge on the GAO website at 

http://www.gao.gov. 

If you or your staff members have any questions about this report, please 

contact me at (202) 512-3841 or trimbled@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 major contributions to 

this report are listed in appendix VI. 

Sincerely yours, 

David C. Trimble 

Director 

Natural Resources and Environment 
Appendix I: Scope and Methodology 

Page 31 GAO-12-42 Chemical Assessments 

This appendix details the methods we used to assess the Environmental 

Protection Agency’s (EPA) management of its Integrated Risk Information 

System (IRIS). For this review, our objectives were to evaluate (1) EPA’s 

progress in completing IRIS assessments under the May 2009 process and 

(2) the challenges, if any, that EPA faces in implementing the IRIS Program. 

To address these objectives, we reviewed relevant EPA documents, 

including documents outlining the April 2008 and the May 2009 versions of 

the IRIS assessment process; documents related to IRIS performance 

metrics; chemical nomination forms submitted by EPA regional and 

program offices, federal agencies, and others; and documents and other 

information on the public EPA website, including the IRIS database and 

IRISTrack, the assessment tracking system available at the IRIS website. 

In addition, we reviewed other relevant documents, including Federal 

Register notices announcing, among other things, IRIS agendas, as well as 

documents related to EPA’s meetings with other federal agencies involved 

in interagency reviews of draft IRIS assessments. We did not evaluate the 

scientific content or quality of IRIS assessments; however, we did review 

the National Academies’ peer review report on the draft IRIS assessment 

of formaldehyde to evaluate their suggestions for overall improvements to 

the development of IRIS assessments and other peer review reports by the 

National Academies and EPA’s Science Advisory Board to evaluate their 

suggestions for improvements to draft IRIS assessments. In addition, we 

interviewed officials from EPA’s National Center for Environmental 

Assessment (NCEA) who manage the IRIS Program, including the Acting 

Center Director, the Associate Director for Health, and the IRIS Program 

Acting Director, to obtain their perspectives on, among other things, the 

May 2009 IRIS process and the effects of changes from the April 2008 IRIS 

process, the extent to which EPA has made progress in completing timely, 

credible chemical assessments, challenges EPA faces in completing 

assessments, and EPA’s process for responding to Data Quality Act 

challenges. We interviewed officials from EPA’s Office of Environmental 

Information to obtain their perspectives on EPA’s process for responding to 

data quality challenges. We also attended two Board of Scientific 

Counselors (BOSC) meetings to understand the board’s role in providing 

advice, information, and recommendations about the Office of Research 

and Development (ORD) research programs, including IRIS. 

For the first objective, we obtained and analyzed data from fiscal year 

1999 through September 30, 2011, including data, spreadsheets, project 

plans, and other documents used in IRIS assessment planning, 

development, and completion. From the data we gathered, we analyzed 

information on IRIS productivity, including information on the number of 

Appendix I: Scope and Methodology 
Appendix I: Scope and Methodology 

Page 32 GAO-12-42 Chemical Assessments 

IRIS assessments completed and initiated, the status of IRIS 

assessments that are currently in progress or on the IRIS agenda, and 

the completion dates and durations of IRIS assessment process steps 

completed or currently in progress for given chemical assessments. In 

addition, we assessed the reliability of the data we received from EPA for 

our first objective. Our assessment consisted of interviews and e-mail 

exchanges with EPA officials about the data system, the method of data 

input, and internal data controls and documentation, among other areas. 

We also corroborated the data with other sources, where possible. For 

example, we verified the information provided in tables of IRIS 

assessment start dates and completion dates of IRIS assessment 

process steps through interviews and e-mail exchanges with the NCEA 

officials responsible for maintaining these data. Through our assessment, 

we determined that the data were sufficiently reliable for our purposes. 

For the second objective, we interviewed the chair of the National 

Academies Committee to Review EPA’s Draft IRIS Assessment of 

Formaldehyde to obtain his perspective on the National Academies’ 

suggestions for improvements to the IRIS assessment process. We 

interviewed officials from the Office of Management and Budget’s (OMB) 

Office of Information and Regulatory Affairs (OIRA) to obtain their 

perspectives on interagency review of draft IRIS assessments, OMB’s 

process for responding to EPA with regard to Data Quality Act challenges, 

and OMB’s process for reviewing and approving EPA guidance documents. 

In addition, we interviewed officials from the Department of Defense (DOD), 

the National Aeronautics and Space Administration (NASA) and the 

Department of Health and Human Services (HHS)—including 

representatives from the Centers for Disease Control and Prevention’s 

National Center for Environmental Health (NCEH)/ Agency for Toxic 

Substances and Disease Registry (ATSDR), National Institute for 

Occupational Safety and Health (NIOSH). We also interviewed HHS officials 

from the Food and Drug Administration (FDA); the National Institute of 

Environmental Health Sciences/National Toxicology Program and the Office 

of the Secretary. We also interviewed representatives from a chemical 

industry group and a nonprofit research and educational organization. 

We conducted this performance audit from July 2010 to December 2011 

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. 
Appendix II: Status of Chemicals in the IRIS 

Assessment Development Process, as of 

September 30, 2011 

Page 33 GAO-12-42 Chemical Assessments 

Step 1–Draft 

development 

(24 assessments 

in step)

Step 2–EPA 

internal review 

(8 assessments 

in step)

Step 3–

Interagency 

science 

consultation 

(2 assessments 

in step)

Step 4–External 

peer review and 

public comment

(9 assessments in 

step)

Step 5–EPA 

draft revision 

(7 assessments 

in step)

Step 6a and 

b–Final EPA 

review / 

Interagency 

science 

discussion 

(1 assessment 

in step)

Step 7–

Completion and 

posting 

(4 assessments 

in step)

Acetaldehyde 

Arsenic, inorganic 

(noncancer) 

Beryllium (cancer) 

Butanol, tCadmium 

Chloroethane 

Chromium VI 

(inhalation) 

Cobalt 

Copper 

Di(2-ethylhexyl) 

adipate (DEHA) 

Ethyl tertiary butyl 

ether (ETBE) 

Hexabromocyclododecane 

Hexachlorobutadiene 

Hexahydro-1,3,5-

trinitro-1,3,5-

triazine (RDX) 

Methyl tert-butyl 

ether (MTBE) 

Naphthalene 

Nickel (soluble salts) 

Phthalates 

(cumulative) 

Phthalates: 

-Dibutyl (DBP) 

-Di(2-ethylhexyl) 

(DEHP) 

-Diethyl (DEP) 

Styrene 

Uranium 

Vinyl acetate 

Ammonia 

Chloroform 

Phthalates: 

-Butyl benzyl (BBP) 

-Diisobutyl (DIBP) 

-Diisononyl (DINP) 

-Dipentyl (DPP) 

Trimethylbenzene, 

1,2,4- 

Trimethylbenzene, 

1,3,5- 

Benzo[a]pyrene

Polychlorinated 

biphenyls (PCBs) 

(noncancer) 

Acrylonitrile

Biphenyl 

Butanol, nChromium VI (oral)

Dioxane, 1,4- 

(inhalation) 

Libby amphibole 

Asbestos (cancer) 

Methanol (cancer)a

Methanol 

(noncancer) 

Vanadium 

pentoxide 

Arsenic, 

inorganic 

(cancer) 

Dichlorobenzene, 1,2- 

Dichlorobenzene, 1,3- 

Dichlorobenzene, 1,4- 

Formaldehyde 

Polycyclic 

aromatic 

hydrocarbon 

(PAH) mixtures 

Tetrachlorodibenzo-p-dioxin, 

2,3,7,8- (dioxin) 

Platinum Dichloromethane 

Ethylene oxide 

(cancer) 

Tetrachloroethylene 

(perchloroethylene or perc) 

Tetrahydrofuran 

(THF) 

Source: GAO analysis of EPA data. 

a

The draft cancer assessment of methanol is on hold pending the results of a National Toxicology 

Program (NTP) review of data from the Italian Ramazzini Institute, on which, according to EPA, the 

assessment “relied substantially.” In 2010, an NTP report on a Ramazzini Institute animal study of 

methanol revealed differences of opinion between NTP scientists and the institute regarding 

diagnoses of certain cancers.

Appendix II: Status of Chemicals in the IRIS 

Assessment Development Process, as of 

September 30, 2011 
Appendix III: Information on Chemicals of Key 

Concern 

Page 34 GAO-12-42 Chemical Assessments 

 Trichloroethylene (TCE). In September 2011, EPA finalized and 

posted an IRIS assessment of TCE, 13 years after initiating it. A 

degreasing agent used in industrial and manufacturing settings, TCE 

is a common environmental contaminant in air, soil, groundwater, and 

surface water. TCE has been found in the drinking water at Camp 

Lejeune, a large Marine Corps base in North Carolina. It has also 

been found at Superfund sites and many industrial and government 

facilities, including aircraft and spacecraft manufacturing operations. 

TCE has been linked to cancer, including childhood cancer, and other 

significant health hazards, such as birth defects. In 1995, the 

International Agency for Research on Cancer, part of the World 

Health Organization, classified the chemical as “probably carcinogenic 

to humans,” and in 2000, the Department of Health and Human 

Services’ National Toxicology Program concluded that TCE is 

“reasonably anticipated to be a human carcinogen.” However, 

between 1989 and September 2011, the IRIS database contained no 

quantitative or qualitative data on TCE. Because of questions raised 

by peer reviewers about the IRIS cancer assessment for TCE, EPA 

withdrew it from the IRIS database in 1989 and did not initiate a new 

TCE cancer assessment until 1998. In 2001, EPA issued a draft IRIS 

assessment of TCE that characterized TCE as “highly likely to 

produce cancer in humans.” The draft assessment was peer reviewed 

by a Science Advisory Board panel and released for public comment. 

In the course of these reviews, issues arose concerning, among other 

things, EPA’s use of emerging risk assessment methods and the 

uncertainty associated with these new methods.1

 To help address 

these issues, EPA and other agencies sponsored a National 

Academies peer review panel to provide guidance. The National 

Academies panel recommended in its 2006 report that EPA finalize 

the draft assessment using available data, noting that the weight of 

evidence of cancer and other health risks from TCE exposure had 

strengthened since 2001. Nonetheless, the TCE assessment was 

returned to draft development. It then underwent a third peer review, 

again through Science Advisory Board, which issued its report in 

January 2011. EPA revised the draft in response to the Science 

 

1

Emerging new methods included cumulative assessment of TCE and its metabolites and 

the use of a physiologically based pharmacokinetic (PBPK) model. PBPK models are a 

class of dosimetry models—models that measure doses—that are useful for predicting 

internal doses to target organs. With the appropriate data, these models can be used to 

extrapolate across species and exposure scenarios and address various sources of 

uncertainty in risk assessments. 

Appendix III: Information on Chemicals of 

Key Concern 
Appendix III: Information on Chemicals of Key 

Concern 

Page 35 GAO-12-42 Chemical Assessments 

Advisory Board’s comments and, in September 2011, finalized and 

posted the TCE assessment. 

 Dioxin. The term “dioxin” applies to a family of chemicals that are 

often the byproducts of combustion and other industrial processes. 

Complex mixtures of dioxins enter the food chain and human diet 

through emissions into the air that settle on soil, plants, and water. 

When animals ingest plants, commercial feed, and water 

contaminated with dioxins, the dioxins accumulate in the animals’ fatty 

tissue. EPA’s initial assessment of dioxin, which was published in 

1985, focused on the dioxin TCDD (2,3,7,8-tetrachlorodibenzo-pdioxin), which animal studies dating to the 1970s had shown to be the 

most potent cancer-causing chemical studied to date. EPA began 

work on updating this assessment in 1991. From 1995 through 2000, 

the revised draft assessment underwent a full peer review, as well as 

three peer reviews of key segments of the draft. As we have reported 

previously, EPA officials said in 2002 that the version of the revised 

assessment then in progress would conclude that dioxin may 

adversely affect human health at lower exposure levels than had 

previously been thought, and that most exposure to dioxins occurs 

from eating such American dietary staples as meat, fish, and dairy 

products.2

 EPA was moving closer to finalizing the assessment when, 

in 2003, a congressional appropriations committee directed the 

agency not to issue the assessment until it had been peer reviewed 

by the National Academies. The National Academies issued its peer 

review report in July 2006. EPA then revised the draft assessment in 

response to the National Academies’ recommendations, releasing it 

for public comment in May 2010 and sending it to the Science 

Advisory Board for another peer review. In August 2011, the Science 

Advisory Board panel issued its peer review report. Having been 

tasked with evaluating EPA’s responses to the National Academies 

review and its incorporation of studies that have become available 

since 2006, the panel concluded that the draft IRIS assessment of 

dioxin was “generally clear, logical, and responsive to many but not all 

of the suggestions of the NAS.”3

 Among other things, the Science 

 

2

GAO-08-440. 

3

U.S. Environmental Protection Agency, Office of the Administrator, Science Advisory 

Board. “SAB Review of EPA’s Reanalysis of Key Issues Related to Dioxin Toxicity and 

Response to NAS Comments (May 2010)” (EPA-SAB-011-014). Washington, D.C.: 

August 26, 2011. 
Appendix III: Information on Chemicals of Key 

Concern 

Page 36 GAO-12-42 Chemical Assessments 

Advisory Board panel recommended that EPA discuss both linear and 

nonlinear models for cancer risks associated with dioxin exposure in 

its revised report. Three days after the Science Advisory Board issued 

its report, EPA announced that it would split the dioxin assessment 

into two parts, completing the noncancer portion of the assessment 

first and then addressing the Science Advisory Board’s comments and 

completing the cancer portion of the assessment. EPA expects to 

complete the noncancer portion of the dioxin assessment by January 

2012, and states that it will complete the cancer portion as 

expeditiously as possible thereafter. The effort to update the 

assessment of dioxin, which could have significant health implications 

for all Americans, has been ongoing for 20 years. 

 Formaldehyde. Formaldehyde is a gas widely used in such products 

as pressed wood, paper, pharmaceuticals, leather goods, and textiles. 

The IRIS database currently lists formaldehyde as a “probable human 

carcinogen”; however, the International Agency for Research on 

Cancer classifies it as “carcinogenic to humans.” In June 2011, the 

Department of Health and Human Services’ National Toxicology 

Program classified formaldehyde as “known to be a human 

carcinogen” in its Report on Carcinogens.

4

 The report stated that 

epidemiological studies “have demonstrated a causal relationship 

between exposure to formaldehyde and cancer in humans”—

specifically, nasopharyngeal cancer, sinonasal cancer, and myeloid 

leukemia. The current IRIS assessment of formaldehyde dates to 

1989, when the cancer portion of the assessment was issued, and 

1990, when the noncancer portion was added. The last significant 

revision of the formaldehyde assessment dates to 1991. As we have 

reported previously, EPA began efforts to update the IRIS 

assessment of formaldehyde in 1997.5

 In 2004, EPA received a 

congressional directive to await the results of a National Cancer 

Institute study that was expected to take, at most, 18 months before 

finalizing the draft assessment. That study was completed in May 

2009, and in June 2010, EPA released the draft assessment, which 

assessed both cancer and noncancer health effects, to the National 

Academies for peer review. In May 2011, the National Academies 

published its peer review report. As of September 30, 2011—14 years 

 

4

U.S. Department of Health and Human Services, Report on Carcinogens, Twelfth Edition 

(2011). 

5

GAO-08-440. 
Appendix III: Information on Chemicals of Key 

Concern 

Page 37 GAO-12-42 Chemical Assessments 

after EPA began work to update the IRIS formaldehyde assessment—

the agency had indicated no timetable for finalizing the assessment. 

Continued delays in the revision of the IRIS assessment of 

formaldehyde have the potential to affect the quality of EPA’s 

regulatory actions. For example, in August 2011, EPA announced a 

proposed rule under the Clean Air Act related to certain emissions 

from natural gas processing plants. Because a newer IRIS 

assessment of formaldehyde has not been completed, the proposed 

rule relies on the existing IRIS value for formaldehyde, last updated in 

1991. EPA had expected to complete the formaldehyde assessment 

by the end of fiscal year 2011, but withdrew the projected completion 

date from the IRIS website after the publication of the National 

Academies’ peer review report on the draft assessment. As of April 

2011, EPA expected to complete the formaldehyde assessment in the 

fourth quarter of fiscal year 2011. However, as of September 30, 

2011, the IRIS website provided no projected completion date for the 

assessment. 

 Tetrachloroethylene (Perc). Tetrachloroethylene—also called 

perchloroethylene or perc—is a manufactured chemical used in, for 

example, dry cleaning, metal degreasing, and textile production. Perc 

is a widespread groundwater contaminant and the National 

Toxicology Program has determined that it is “reasonably anticipated 

to be a human carcinogen.” Currently, the IRIS database contains 

only a noncancer assessment based on oral exposure to perc, posted 

in 1988; it gives no information on potential cancer effects or potential 

noncancer effects associated with inhalation of perc. EPA began work 

to update this assessment, and to include information on cancer and 

noncancer inhalation risk, in 1998. As we have reported previously, 

EPA completed its internal review of the draft perc assessment in 

February 2005 and the interagency review in March 2006.6

 However, 

when the Assistant Administrator of EPA’s Office of Research and 

Development requested that additional analyses be conducted, EPA 

was delayed in sending the draft assessment to the National 

Academies for peer review. In June 2008, EPA sent the draft 

assessment to the National Academies, which released its peer 

review report in February 2010. EPA is in the process of responding 

to the National Academies’ suggestions, 13 years after the agency 

began work on the draft perc assessment. As a result, IRIS users, 

 

6

GAO-08-440. 
Appendix III: Information on Chemicals of Key 

Concern 

Page 38 GAO-12-42 Chemical Assessments 

including EPA regional and program offices, continue to lack both 

cancer values and noncancer inhalation values to help them make 

decisions about how to protect the public from this widespread 

groundwater contaminant. EPA had expected to complete the perc 

assessment by the end of fiscal year 2011, but as of September 30, 

2011, it had not done so. 

 Naphthalene. Naphthalene is used in jet fuel and in the production of 

such widely used commercial products as moth balls, dyes, 

insecticides, and plasticizers. The current IRIS assessment of 

naphthalene, issued in 1998, lists the chemical as a “possible human 

carcinogen”; since 2004, the National Toxicology Program has listed it 

as “reasonably anticipated to be a human carcinogen.” As we have 

reported previously, EPA began updating the cancer portion of its 

naphthalene assessment in 2002.7

 By 2004, EPA had drafted a 

chemical assessment that had completed internal peer reviews and 

was about to be sent to an external peer review committee. Once it 

returned from external review, the next step, at that time, would have 

been a formal review by EPA’s IRIS Agency Review Committee. If 

approved, the assessment would have been completed and released. 

However, in part because of concerns raised by DOD, OMB asked to 

review the assessment and conducted an interagency review of the 

draft. In their 2004 reviews of the draft IRIS assessment, both OMB 

and DOD raised a number of concerns about the assessment and 

suggested to EPA that it be suspended until additional research could 

be completed to address what they considered to be significant 

uncertainties associated with the assessment. Although all of the 

issues raised by OMB and DOD were not resolved, EPA continued 

with its assessment by submitting the draft for external peer review, 

which was completed in September 2004.8

 However, according to 

EPA, OMB continued to object to the draft IRIS assessment and 

directed EPA to convene an additional expert review panel on 

genotoxicity to obtain recommendations about short-term tests that 

OMB thought could be done quickly.9

 According to EPA, this added 6 

 

7

GAO-08-440. 

8

As we have previously reported, according to DOD, EPA did not specifically ask the peer 

reviewers to address some of the technical questions DOD had raised and wanted the 

peer review to address. 

9

Genotoxic substances are a type of carcinogen, specifically those capable of causing 

genetic mutation and of contributing to the development of tumors. This includes both 

certain chemical compounds and certain types of radiation. 
Appendix III: Information on Chemicals of Key 

Concern 

Page 39 GAO-12-42 Chemical Assessments 

months to the process, and the panel, which met in April 2005, 

concluded that the research that OMB was proposing could not be 

conducted in the short term. Nonetheless, EPA officials said that the 

second expert panel review did not eliminate OMB’s concerns 

regarding the assessment, which they described as reaching a 

stalemate. In September 2006, EPA decided, however, to proceed 

with developing the assessment. By 2006, the naphthalene 

assessment had been in progress for 4 years, and EPA decided that 

the noncancer portion of the existing IRIS assessment was outdated 

and needed to be revisited. Having made this decision, the agency 

returned both portions of the assessment, cancer and noncancer, to 

the drafting stage. We reported in March 2008 that EPA estimated a 

2009 completion date for the naphthalene assessment.10 As of 

September 30, 2011, however, the assessment remained in the draft 

development stage, even though EPA program offices had identified 

the naphthalene assessment as a high-priority need for the air toxics 

and Superfund programs. As of September 30, 2011, EPA expects to 

complete the naphthalene assessment in the third quarter of fiscal 

year 2013. 

 Royal Demolition Explosive. This chemical, also called RDX or 

hexahydro-1,3,5-trinitro-1,3,5-triazine, is a highly powerful explosive 

used by the U.S. military in thousands of munitions. Currently 

classified by EPA as a “possible human carcinogen,” this chemical is 

known to leach from soil to groundwater. RDX can cause seizures in 

humans and animals when large amounts are inhaled or ingested, but 

the effects of long-term, low-level exposure on the nervous system 

are unknown. As we reported in March 2008, as is the case with 

naphthalene, the IRIS assessment of RDX could require DOD to 

undertake a number of actions, including steps to protect its 

employees from the effects of this chemical and to clean up many 

contaminated sites.11 We reported at that time that EPA had started 

an IRIS assessment of RDX in 2000, but it had made minimal 

progress on the assessment because EPA had agreed to a request 

by DOD to wait for the results of DOD-sponsored research on this 

chemical. In 2007, EPA resumed work on the assessment, although 

some of the DOD-sponsored research was still outstanding at the 

time. EPA decided to suspend work on the assessment in 2009 in 

 

10GAO-08-440. 

11GAO-08-440. 
Appendix III: Information on Chemicals of Key 

Concern 

Page 40 GAO-12-42 Chemical Assessments 

order to focus on assessments that were further along in the IRIS 

process. According to EPA’s project plan for RDX, in March 2010, 

EPA received a letter from DOD requesting that EPA complete the 

assessment. In addition, in 2010, EPA’s Superfund Program labeled 

the RDX assessment as a high priority because of the presence of the 

chemical at federal facilities. In June 2010, EPA renewed work on the 

RDX assessment, but as of September 30, 2011, it remained in the 

draft development stage (step 1). An EPA official told us in October 

2011 that EPA plans to contact DOD officials to confirm that the draft 

assessment of RDX adequately captures the findings of the DODsponsored research. In addition, the EPA official said that the agency 

plans to contact officials at HHS’s Agency for Toxic Substances and 

Disease Registry to ensure that the two agencies have coordinated 

research efforts on this chemical. EPA projects that it will finalize the 

assessment of RDX in the first quarter of fiscal year 2013. 
Appendix IV: Projected Completion Dates for 

IRIS Assessments Currently in the 

Assessment Development Process, as of 

September 30, 2011 

Page 41 GAO-12-42 Chemical Assessments 

Fiscal year 2011 

(4 assessments completed, 20 initially 

projected)

Fiscal year 2012 

(40 assessments)

Fiscal year 

2013 

(12 assessments)

Fiscal year 

2014 

(1 assessment) 

TBD—To be 

determined 

(2 assessments)

Initial fiscal year 

2011 projection: 

20 completed 

assessments 

————- 

April 2011 

projection: 

15 completed 

assessments 

————— 

August 18, 2011 

projection: 

9 completed 

assessments 

————— 

September 30, 

2011: 

4 actual 

completed 

assessments 

Benzo[a]pyrene 

Formaldehyde 

Methanol (cancer) 

Polycyclic aromatic 

hydrocarbon (PAH) 

mixtures 

Tetrachlorodibenzo-pdioxin, 2,3,7,8- 

(dioxin) 

————- 

Arsenic, inorganic 

(cancer) 

Chromium VI (oral) 

Dichlorobenzene, 1,2- 

Dichlorobenzene, 1,3- 

Dichlorobenzene, 1,4- 

Mirex (dropped from 

IRIS agenda in 

August 2011) 

————— 

Dichloromethane 

Ethylene oxide 

(cancer) 

Platinum 

Tetrachloroethylene 

(perchloroethylene or 

perc) 

Tetrahydrofuran 

(THF) 

————— 

Hexachloroethane 

Trichloroacetic acid 

Trichloroethylene 

(TCE) 

Urea

Acetaldehyde 

Acrylonitrile 

Ammonia 

Arsenic, inorganic (cancer) 

Benzo[a]pyrene 

Beryllium (cancer) 

Biphenyl 

Butanol, nButanol, tChloroform 

Chromium VI (oral) 

Di(2-ethylhexyl) adipate (DEHA) 

Dichlorobenzene, 1,2- 

Dichlorobenzene, 1,3- 

Dichlorobenzene, 1,4- 

Dichloromethane 

Dioxane, 1,4- (inhalation) 

Ethylene oxide (cancer) 

Hexabromocyclododecane 

Hexachlorobutadiene 

Hexahydro-1,3,5-trinitro-1,3,5-

triazine (RDX) 

Methanol (noncancer) 

Methyl tert-butyl ether (MTBE) 

Phthalates (cumulative) 

Phthalates: 

-Dibutyl (DBP) 

-Diethyl (DEP) 

-Diisobutyl (DIBP) 

-Diisononyl (DINP) 

-Dipentyl (DPP) 

-Butyl benzyl (BBP) 

-Di(2-ethylhexyl) (DEHP) 

Platinum 

Polycyclic aromatic hydrocarbon 

(PAH) mixtures 

Tetrachlorodibenzo-p-dioxin, 

2,3,7,8- (dioxin) 

Tetrachloroethylene 

(perchloroethylene or perc) 

Tetrahydrofuran (THF) 

Trimethylbenzene, 1,2,4- 

Trimethylbenzene, 1,3,5- 

Uranium 

Vanadium pentoxide 

Arsenic, inorganic 

(noncancer) 

Cadmium 

Chloroethane 

Chromium VI 

(inhalation) 

Cobalt 

Copper 

Ethyl tertiary butyl 

ether (ETBE) 

Libby amphibole 

asbestos (cancer) 

Naphthalene 

Nickel (soluble salts)

Polychlorinated 

biphenyls (PCBs) 

(noncancer) 

Vinyl acetate 

Styrene Methanol (cancer) 

Formaldehyde 

Source: GAO analysis of EPA data. 

Appendix IV: Projected Completion Dates for 

IRIS Assessments Currently in the Assessment 

Development Process, as of September 30, 2011 
Appendix V: Comments from the 

Environmental Protection Agency 

Page 42 GAO-12-42 Chemical Assessments 

Appendix V: Comments from the 

Environmental Protection Agency 
Appendix V: Comments from the 

Environmental Protection Agency 

Page 43 GAO-12-42 Chemical Assessments 
Appendix V: Comments from the 

Environmental Protection Agency 

Page 44 GAO-12-42 Chemical Assessments 
Appendix V: Comments from the 

Environmental Protection Agency 

Page 45 GAO-12-42 Chemical Assessments 
Appendix V: Comments from the 

Environmental Protection Agency 

Page 46 GAO-12-42 Chemical Assessments 
Appendix VI: GAO Contact and Staff 

Acknowledgments 

Page 47 GAO-12-42 Chemical Assessments 

David C. Trimble, (202) 512-3841 or trimbled@gao.gov

In addition to the individual named above, Diane LoFaro, Assistant 

Director; Christine Fishkin, Assistant Director; Summer Lingard; Mark 

Braza; Jennifer Cheung; Nancy Crothers; Lorraine Ettaro; Robert Grace; 

Gary Guggolz; Richard P. Johnson; Michael Kniss; Nadia Rhazi; and Kiki 

Theodoropoulos made key contributions to this report. Also contributing to 

the report were Tim Bober, Michelle Cooper, Anthony Pordes, Benjamin 

Shouse, Jena Sinkfield, and Nicolas Sloss. 

Appendix VI: GAO Contact and Staff 

Acknowledgments 

GAO Contact 

Staff 

Acknowledgments 

(361203)
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