Chemical Assessments: Low Productivity and New Interagency Review
Process Limit the Usefulness and Credibility of EPA's Integrated 
Risk Information System (07-MAR-08, GAO-08-440).		 
                                                                 
The Environmental Protection Agency's (EPA) Integrated Risk	 
Information System (IRIS) contains EPA's scientific position on  
the potential human health effects of exposure to more than 540  
chemicals. IRIS is a critical component of EPA's capacity to	 
support scientifically sound environmental decisions, policies,  
and regulations. GAO was asked to examine (1) the outcome of	 
steps EPA has taken to ensure that IRIS contains current,	 
credible chemical risk information, to address the backlog of	 
ongoing assessments, and to respond to new requirements from the 
Office of Management and Budget (OMB); and (2) the potential	 
effects of planned changes to the IRIS assessment process on	 
EPA's ability to ensure that IRIS provides current, credible risk
information. To do this work, GAO reviewed and analyzed EPA data 
and interviewed officials at relevant agencies. 		 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-08-440 					        
    ACCNO:   A81228						        
  TITLE:     Chemical Assessments: Low Productivity and New	      
Interagency Review Process Limit the Usefulness and Credibility  
of EPA's Integrated Risk Information System			 
     DATE:   03/07/2008 
  SUBJECT:   Chemical agents					 
	     Chemical exposure					 
	     Chemical regulation				 
	     Chemical research					 
	     Chemicals						 
	     Data integrity					 
	     Health hazards					 
	     Information disclosure				 
	     Information infrastructure 			 
	     Information management				 
	     Interagency relations				 
	     Policy evaluation					 
	     Program evaluation 				 
	     Public health					 
	     Regulatory agencies				 
	     Reporting requirements				 
	     Risk assessment					 
	     Risk management					 
	     Transparency					 
	     Assessments					 
	     EPA Integrated Risk Information System		 

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GAO-08-440

   

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

United States Government Accountability Office: 
GAO: 

March 2008: 

Chemical Assessments: 

Low Productivity and New Interagency Review Process Limit the 
Usefulness and Credibility of EPA's Integrated Risk Information System: 

GAO-08-440: 

GAO Highlights: 

Highlights of GAO-08-440, a report to the Chairman, Committee on 
Environment and Public Works, U.S. Senate. 

Why GAO Did This Study: 

The Environmental Protection Agencyï¿½s (EPA) Integrated Risk Information 
System (IRIS) contains EPAï¿½s scientific position on the potential human 
health effects of exposure to more than 540 chemicals. IRIS is a 
critical component of EPAï¿½s capacity to support scientifically sound 
environmental decisions, policies, and regulations. GAO was asked to 
examine (1) the outcome of steps EPA has taken to ensure that IRIS 
contains current, credible chemical risk information, to address the 
backlog of ongoing assessments, and to respond to new requirements from 
the Office of Management and Budget (OMB); and (2) the potential 
effects of planned changes to the IRIS assessment process on EPAï¿½s 
ability to ensure that IRIS provides current, credible risk 
information. To do this work, GAO reviewed and analyzed EPA data and 
interviewed officials at relevant agencies. 

What GAO Found: 

EPAï¿½s actions since 2000 to ensure that IRIS contains current, credible 
risk information, to address its backlog of 70 ongoing assessments, and 
to respond to new OMB requirementsï¿½including increasing funding and 
revising the assessment processï¿½have not enabled EPA to routinely 
complete credible IRIS assessments or decrease its backlog. Although in 
fiscal years 2006 and 2007 EPA sent 32 assessments to OMB for the first 
of three required external reviews, EPA finalized only 4 assessments 
during this period. This low level of productivity jeopardizes the 
viability of the IRIS database. Further, an EPA analysis indicated that 
many existing assessments may need to be updated, and EPA program 
offices and other IRIS users have requested assessments of hundreds of 
chemicals not yet in IRIS. Factors contributing to EPAï¿½s inability to 
complete IRIS assessments in a timely manner include new OMB-required 
reviews of IRIS assessments by OMB and other federal agencies; certain 
EPA management decisions, such as delaying some assessments to await 
new research; and the compounding effect of delaysï¿½even one delay can 
have a domino effect, requiring the process to essentially be repeated 
to incorporate changing science. As of December 2007, most of the 70 
ongoing assessments had been in progress for over 5 years. 
 
Regarding new OMB requirements, the IRIS assessment process now 
includes two OMB/interagency reviews of draft assessments. These 
reviews have resulted in involvement of other federal agencies in EPAï¿½s 
IRIS assessment process in a manner that limits the credibility of IRIS 
assessments and hinders EPAï¿½s ability to manage them. That is, the 
OMB/interagency reviews lack transparencyï¿½OMB considers agenciesï¿½ 
comments on IRIS assessments to be internal executive branch documents 
that may not be made public. Given the importance of IRIS assessments, 
it is essential that input from all parties, including other federal 
agencies, be part of the public record. Transparency is especially 
important because agencies providing input include those that may be 
affected by the assessments should they lead to regulatory or other 
actions. Also, without communicating its rationale for doing so, OMB 
directed EPA to terminate five assessments that for the first time 
addressed acute, rather than chronic, exposureï¿½even though EPA 
initiated this type of assessment to help it implement the Clean Air 
Act. Most OMB/interagency reviews completed to date have added 6 or 
more months to the IRIS time frames. 

Such delays and credibility concerns would likely be exacerbated by 
further changes EPA is planning to respond to continuing concerns of 
other federal agencies, such as providing them with an expanded role in 
EPAï¿½s IRIS assessment process and discretion to suspend assessments to 
develop new studies for some chemicals. EPA estimates that such 
assessments would take up to 6 years, an estimate GAO believes is 
conservative in light of the assessment time frames under the current 
process. Suspending assessments is inefficient; alternatively, with 
longer-term planning, EPA could provide agencies and the public with 
more advance notice of assessments, enabling them to complete relevant 
research before IRIS assessments are started. 

What GAO Recommends: 

GAO recommends that EPA (1) clearly define and document an IRIS 
assessment process that, among other things, can be conducted within a 
time frame that minimizes the need for rework and (2) ensure that it 
can develop transparent, credible assessments by, for example, 
determining the types of IRIS assessments it will conduct based on EPA 
program needs and defining the appropriate role of other federal 
agencies in its IRIS assessment process. EPA agreed to consider GAOï¿½s 
recommendations in revising the IRIS assessment process. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-440]. For more 
information, contact John B. Stephenson at (202) 512-3841 or 
[email protected]. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

EPA's Efforts to Improve the IRIS Assessment Program Have Not Produced 
the Desired Results: 

While Appropriate Coordination with Federal Agencies Could Help EPA 
Resolve IRIS Assessment Controversies More Efficiently, EPA's Proposed 
Expansion of Agencies' Roles in IRIS Assessments Would Cause Further 
Delays and Limit Their Credibility: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Objectives, Scope, and Methodology: 

Appendix II: Broad Outline of EPA's Current IRIS Assessment Process: 

Appendix III: Information on OMB/Interagency Reviews of IRIS 
Assessments: 

Appendix IV: Comments from the Environmental Protection Agency: 

Appendix V: Comments from the Office of Management and Budget: 

Appendix VI: GAO Contact and Staff Acknowledgments: 

Figures: 

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

Figure 2: Funding for the IRIS Program, Fiscal Years 2000-2007: 

Figure 3: Number of Completed IRIS Assessments, Draft Assessments to 
OMB, and IRIS Staff in Full-Time Equivalents, Fiscal Years 2000-2007: 

Figure 4: December 2007 Status of IRIS Assessments That EPA Reported as 
Ongoing in Fiscal Year 2007: 

Figure 5: EPA's Draft Proposed IRIS Assessment Process: 

Figure 6: Status of IRIS Assessments Sent to OMB for the First OMB/ 
Interagency Review Starting in Fiscal Year 2004, as of December 1, 
2007: 

Abbreviations: 

ATSDR: Agency for Toxic Substances and Disease Registry: 

DOD: Department of Defense: 

DOE: Department of Energy: 

EPA: Environmental Protection Agency: 

IARC: International Agency for Research on Cancer: 

IRIS: Integrated Risk Information System: 

NASA: National Aeronautics and Space Administration: 

NCEA: National Center for Environmental Assessment: 

NCI: National Cancer Institute: 

NIOSH: National Institute of Occupational Safety and Health: 

OMB: Office of Management and Budget: 

ORD: Office of Research and Development: 

PART: Program Assessment Rating Tool: 

PBPK: physiologically based pharmacokinetic: 

RfC: inhalation reference concentration: 

RfD: oral reference dose: 

TCE: trichloroethylene: 

[End of section] 

United States Government Accountability Office:
Washington, DC 20548: 

March 7, 2008: 

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

Dear Madam Chairman: 

The Environmental Protection Agency's (EPA) Integrated Risk Information 
System (IRIS)--a database integral to the agency's mission of 
protecting human health and the environment--contains EPA's scientific 
position on the potential human health effects that may result from 
exposure to various chemicals in the environment. IRIS data provide the 
fundamental scientific components needed to develop human health risk 
assessments. These health risk assessments, in turn, provide the 
foundation for risk management decisions, such as whether EPA should 
establish air and water quality standards to protect the public from 
exposure to toxic chemicals or set cleanup standards for hazardous 
waste sites. In addition, state and local environmental programs, as 
well as some international regulatory bodies, rely on IRIS health 
effects information in managing their environmental protection 
programs. Although the information in IRIS is a critical primary 
component of EPA's capacity to support scientifically sound decisions, 
policies, and regulations, many IRIS assessments are outdated, and few 
assessments have been completed in recent years. This has resulted in a 
significant backlog of incomplete chemical assessments and a growing 
number of outdated assessments. Further, while EPA's IRIS database 
currently includes about 540 chemicals, every year approximately 700 
new chemicals enter commerce, any number of which could pose 
significant human health risks. 

Overall, the goal of the IRIS assessment process is to produce 
quantitative estimates of cancer and noncancer effects from chronic 
(long term) exposure to the chemicals assessed. One impact of not 
having current and complete IRIS assessments of many potentially 
harmful chemicals is that some chemicals that pose health risks to the 
public may not be regulated under, for example, air or drinking water 
statutes, or are regulated by standards that may not sufficiently take 
into account the best available science on human health effects. For 
example, trichloroethylene (TCE), a solvent widely used as a degreasing 
agent in industrial and manufacturing settings, is the most frequently 
reported organic contaminant in groundwater and has been linked to 
cancer and other health hazards, according to the National 
Academies.[Footnote 1] Yet, because of questions raised by peer 
reviewers about the IRIS cancer assessment for TCE, EPA withdrew the 
assessment from IRIS in 1989, did not initiate a new TCE assessment 
until 1998, and likely will not complete that assessment until 2010 or 
later. This delay represents an information gap of at least 21 years. 
Without completed IRIS assessments reflecting current risk data, EPA 
lacks assurance that its regulatory decisions concerning this 
widespread chemical reflect the best available science on its potential 
health effects. 

While the IRIS assessment process includes numerous individual steps or 
activities, major assessment steps include (1) a review of the 
scientific literature; (2) preparation of a draft IRIS assessment; (3) 
internal EPA reviews of draft assessments; (4) two Office of Management 
and Budget (OMB)/interagency reviews, managed by OMB that provide for 
input from OMB as well as from other federal agencies, including those 
that may be affected by the IRIS assessments if they lead to regulatory 
or other actions; (5) an independent peer review conducted by a panel 
of experts; and (6) the completion of a final assessment that is posted 
to the IRIS Web site. EPA's assessment process has undergone a number 
of formal and informal changes during the past several years. The 
agency is planning further changes--particularly in the areas of 
external reviews and scientific data gaps--largely to address concerns 
of other federal agencies, such as the Department of Defense (DOD). 
Some of the assessment process changes have raised concerns about EPA's 
ability to keep its scientific assessments separate from its risk 
management decisions, as the National Academies recommends and EPA 
policy endorses. 

In this context, this report examines (1) the outcome of steps EPA has 
taken to ensure that IRIS contains current, credible chemical risk 
information, to address the backlog of IRIS assessments, and to respond 
to new requirements from OMB; and (2) the potential effects of EPA's 
planned changes to the IRIS assessment process on EPA's ability to 
ensure that IRIS provides current, credible risk information. 

In conducting our work, we obtained and analyzed information on EPA's 
productivity, including the number of new and completed IRIS 
assessments, for fiscal years 2000 through 2007; the status of IRIS 
assessments, as of December 1, 2007, that were in progress during 
fiscal year 2007; the status of IRIS assessments that have been sent to 
OMB for OMB/interagency review; the number of assessments in the IRIS 
database that may need to be updated; the resources provided to the 
program for fiscal years 2000 through 2007; and user needs and EPA's 
assessment completion goals. We interviewed EPA's National Center for 
Environmental Assessment officials who manage the IRIS assessment 
program, as well as officials from other EPA program offices and 
federal science and health agencies that are involved in the IRIS 
assessment process, to obtain their perspectives on, among other 
things, the current IRIS assessment process, the potential effects of 
the proposed changes to the process, the extent to which EPA has made 
progress in completing assessments and meeting user needs, and 
challenges EPA faces in completing assessments. In addition, we also 
interviewed officials from the Department of Defense, the Department of 
Energy (DOE), the National Aeronautics and Space Administration (NASA), 
and OMB to obtain their perspectives on the OMB/interagency review 
process and on the planned changes to the IRIS assessment process. We 
did not evaluate the scientific content or quality of IRIS assessments. 
(See app. I for a more detailed description of the methodology we 
employed.) We conducted our work from October 2006 to March 2008 in 
accordance with generally accepted government auditing standards, which 
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. 

Results in Brief: 

EPA has taken a number of steps to help ensure that IRIS contains 
current, credible chemical risk information, to address its backlog of 
ongoing assessments, and to respond to new OMB requirements. However, 
to date, these changes--including increasing funding, centralizing 
staff conducting assessments, and revising the assessment process--have 
not enabled EPA to routinely complete credible IRIS assessments or 
decrease the backlog. That is, although EPA sent 32 draft assessments 
for external review in fiscal years 2006 and 2007, the agency finalized 
only 4 IRIS assessments during this time. Several key factors have 
contributed to EPA's inability to achieve a level of productivity that 
is needed to sustain the IRIS program and database: new OMB-required 
reviews of IRIS assessments by OMB and other federal agencies; the 
growing complexity and scope of risk assessments; certain EPA 
management decisions and issues, including delaying completion of some 
assessments to await new research or to develop enhanced analyses of 
uncertainty in the assessments; and the compounding effect of delays. 
Regarding the last factor, even a single delay in the assessment 
process can eventually lead to the need to repeat the assessment 
process to take into account changes in science and methodologies. A 
variety of delays have impacted the majority of the 70 assessments 
being conducted as of December 2007--causing them to be in process for 
more than 5 years. These time frames are problematic because of the 
substantial rework such cases often require to take into account 
changing science and methodologies before they can be completed. 
Further, because EPA staff time continues to be dedicated to completing 
these assessments, EPA's ability to both keep the more than 540 
existing assessments up to date and initiate new assessments is 
limited. Importantly, EPA program offices and state and local entities 
have requested assessments of hundreds of chemicals not yet in IRIS, 
and EPA data as of 2003 indicated that the assessments of 287 chemicals 
in the database may be outdated--that is, new information could change 
the risk estimates currently in IRIS or enable EPA to develop 
additional risk estimates for chemicals in the database. In addition, 
because EPA's 2003 data are now more than 4 years old, it is likely 
that more assessments may be outdated now. 

One of the factors that has contributed to EPA's inability to complete 
assessments in a timely manner--the new OMB/interagency review process-
-also limits the credibility of the assessments because it lacks 
transparency.[Footnote 2] Specifically, neither the comments nor the 
changes EPA makes to the scientific IRIS assessments in response to the 
comments made by OMB and other federal agencies, including those whose 
workload and resource levels could be affected by the assessments, are 
disclosed. According to OMB, the comments it provides to EPA and EPA's 
disposition of them are considered internal executive branch 
communications that may not be made public. Further, OMB has not 
communicated its rationale for directing EPA to discontinue work on 
five IRIS assessments that EPA had sent to OMB for OMB/interagency 
review. These assessments, initiated to meet EPA program needs, were 
the first EPA IRIS assessments of short-term (acute) risks of exposure; 
the IRIS program historically has evaluated long-term (chronic) risks. 

The additional assessment process changes EPA is planning would likely 
exacerbate delays in completing IRIS assessments and further affect 
their credibility. Specifically, despite the informal OMB/interagency 
review process that OMB required EPA to incorporate into the IRIS 
assessment process in 2005, certain federal agencies continue to 
believe they should have greater and more formal roles in EPA's 
development of IRIS assessments. Consequently, EPA has been working for 
several years to establish a formal IRIS assessment process that would 
expand the role of federal agencies in the process--including agencies 
such as DOD, which could be affected by the outcome of IRIS 
assessments. Some of these agencies and their contractors could face 
increased cleanup costs and other legal liabilities if EPA issued an 
IRIS assessment for a chemical that resulted in a decision to regulate 
the chemical to protect the public. Under EPA's planned changes, these 
potentially affected agencies would be able, at several points in the 
assessment process, to subject particular chemicals of interest to 
additional process steps. EPA estimates that these assessments would 
take up to 6 years to complete because, for example, at the discretion 
of these agencies, EPA would suspend the assessment process for up to 
18 months so the agencies could conduct additional research to fill 
data gaps, rather than proceeding with currently available data. While 
it is important to ensure that assessments consider the best science, 
EPA has acknowledged that waiting for new data can result in 
substantial harm to human health, safety, and the environment. Further, 
although coordination with other federal agencies about IRIS 
assessments could enhance the quality of the assessments, increasing 
the role of agencies that may be affected by IRIS assessments in the 
process itself reduces the credibility of the assessments if that 
expanded role is not transparent. In this regard, while EPA planned to 
include federal agencies' comments in the public record, the process 
changes have been delayed since early 2007 in part because of OMB's 
view that agencies' comments about IRIS assessments represent internal 
executive branch communications that may not be made public--a view 
that is inconsistent with the principle of sound science that relies 
on, among other things, transparency. 

We are making recommendations to the EPA Administrator to require the 
Office of Research and Development to re-evaluate its draft proposed 
changes to the IRIS assessment process in light of the issues raised in 
this report and ensure that any revised process, among other things, 
clearly defines and documents an IRIS assessment process that will 
enable the agency to develop the timely chemical risk information it 
needs to effectively conduct its mission. In addition, we are 
recommending that the EPA Administrator take steps to better ensure 
that EPA has the ability to develop transparent, credible IRIS 
assessments, including determining the types of assessments it needs to 
support its programs; defining the appropriate role of external federal 
agencies in EPA's IRIS assessment process; and managing an interagency 
review process in a manner that enhances the quality, transparency, 
timeliness, and credibility of IRIS assessments. 

We provided EPA and OMB with a draft of this report for review and 
comment. EPA agreed to consider our recommendations in revising the 
IRIS assessment process. However, EPA stated that it believed the 
productivity and transparency issues discussed in the draft report were 
misrepresented in the title and body of the report. We disagree and 
believe we have fairly represented IRIS productivity and transparency 
issues related to the IRIS assessment process. We did, however, clarify 
that the transparency issues highlighted in our report focus on the 
IRIS assessment process rather than on the content of IRIS assessments, 
and we revised the report title. In its comments, OMB did not 
specifically address the recommendations we made to EPA but disagreed 
with some aspects of the report, such as our characterization of the 
purpose and effect of the OMB-managed interagency reviews of IRIS 
assessments and our conclusion that interagency comments should be 
transparent. We disagree with OMB and believe that we have fairly 
represented the OMB/interagency review process as well as the 
importance of making input from all parties publicly available to 
alleviate concerns of potential bias. EPA's and OMB's letters and our 
detailed responses are discussed further at the end of this report and 
in appendixes IV and V. 

Background: 

EPA's Integrated Risk Information System (IRIS) is an important source 
of information on health effects that may result from exposure to 
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 as EPA program offices and the states have increasingly 
relied on IRIS information in making environmental protection 
decisions. Today, the IRIS database--which currently contains 
assessments of more than 540 chemicals--is heavily relied upon by EPA, 
state and local environmental programs, international regulatory 
bodies, academia, industry, and others to support risk-based decision 
making to protect public health and the environment. According to EPA, 
national and international users access the IRIS database approximately 
9 million times a year. EPA's Assistant Administrator for the Office of 
Research and Development has described IRIS as the premier national and 
international source for qualitative and quantitative chemical risk 
information; other federal agencies have noted that IRIS data is widely 
accepted by all levels of government across the country for application 
of public health policy, providing benefits such as uniform, 
standardized methods for toxicology testing and risk assessment, as 
well as uniform toxicity values. Similarly, a private-sector risk 
assessment expert has stated that the IRIS database has become the most 
important source of regulatory toxicity values for use across EPA's 
programs and is also widely used across state programs and 
internationally. 

As shown in figure 1, the toxicity assessments in the IRIS database 
fulfill the first two critical steps of the risk assessment process-- 
providing hazard identification and dose-response assessment. 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. The risk characterization information 
can be used to make risk management decisions designed to protect 
public health. The development of risk assessments is thus directly 
dependent on the development of toxicity assessments such as those 
developed in the IRIS program. 

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

[See PDF for image] 

This figure is an illustration of the National Academies' Risk 
Assessment and Risk Management Model Used by EPA. The following 
information is depicted: 

Risk assessment: 

* IRIS toxicity assessment: 
1. Hazard identification; 
2. Dose-response assessments. 
* Exposure assessment; 
* Together these assessments form: 
Risk characterization. 

Risk management: 

* Development of regulatory options; 
* Evaluation of public health, economic, social, and political 
consequences of regulatory options; 
* Added together with risk characterization, these yield: 
* Agency decisions and actions. 

Source: National Academies. 

{End of figure] 

Risk management, as opposed to risk assessment, involves integrating 
the risk characterization information generated from the risk 
assessment 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 how to protect public health. An initial risk 
management decision would be to determine whether the health risks 
identified in a chemical risk assessment warrant regulatory or other 
actions. Examples of subsequent risk management decisions that could 
stem from a determination that action is necessary to protect public 
health include deciding (1) how much of a chemical a company may 
discharge into a river; (2) which substances may be stored at a 
hazardous waste disposal facility; (3) the extent to which a hazardous 
waste site must be cleaned up; (4) permit conditions for treatment, 
storage, or disposal of hazardous waste; (5) levels for air emissions; 
and (6) allowable levels of contamination in drinking water. Thus, as 
EPA has recognized, although IRIS assessments are not regulatory in 
nature, the quantitative IRIS values may influence many environmental 
decisions and may serve as a basis for regulatory consideration. 

A typical IRIS assessment contains a qualitative hazard identification 
description and quantitative dose-response assessments. Among other 
things, a hazard identification description identifies the potential 
noncancer and cancer health effects of exposure to a chemical that 
research studies have suggested or determined. For example, for cancer 
effects, EPA describes the potential health risk using one of five 
weight-of-the-scientific-evidence descriptors, ranging from 
"carcinogenic to humans" to "not likely to be carcinogenic to humans." 
The quantitative assessments also address noncancer and cancer health 
effects and are developed if there are sufficient credible research 
data, primarily from either animal (toxicity) or human (epidemiology) 
studies to support this type of analysis. The noncancer dose-response 
assessments may include: 

* an oral reference dose (RfD)--an estimate of the daily 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, and: 

* an inhalation reference concentration (RfC)--an estimate of the daily 
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 quantitative cancer toxicity assessments include estimates of a 
chemical's carcinogenic potency--a "cancer slope factor" and "unit 
risks." Both the cancer slope factor and unit risks are estimates of 
the increased cancer risk (e.g., 1 in 100 people getting cancer, 1 in 
1,000, 1 in 1 million, etc.) from a lifetime of exposure to a given 
chemical. However, the unit risk is an estimate of the increased risk 
for lifetime exposure at a standard concentration of a chemical in air 
or water (1 microgram per cubic meter of air or 1 microgram per liter 
in water), whereas the cancer slope factor is an estimate of the 
increased risk per unit dose (calculated using a dose-response curve, 
or a graph that shows the relationship between a dose and the 
proportion of exposed persons or animals that have a biologically 
significant response).[Footnote 3] 

Historically and currently, the focus of IRIS toxicity assessments has 
been on the potential health effects of long-term (chronic) exposure to 
chemicals. According to OMB,[Footnote 4] 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. Other federal agencies develop qualitative 
cancer assessments or quantitative estimates of noncancer effects of 
exposure to chemicals in the environment. For example, the Agency for 
Toxic Substances and Disease Registry (ATSDR) develops quantitative 
estimates of the noncancer effects of exposures to chemicals in the 
environment for exposures of up to 14 days (acute); more than 14 days 
but less than a year (subchronic); and 365 days and longer (chronic). 
While ATSDR's toxicological profiles include information from other 
agencies' cancer assessments, including EPA's quantitative IRIS cancer 
assessments, ATSDR does not develop quantitative cancer assessments. 
ATSDR toxicological profiles also include qualitative cancer 
assessments developed by the Department of Health and Human Services' 
National Toxicology Program and the World Health Organization's 
International Agency for Research on Cancer (IARC). While these latter 
assessments provide information on the effects of long-term exposures 
to chemicals, they only provide qualitative assessments of cancer risks 
(e.g. known human carcinogen, likely human carcinogen, etc.) and not 
quantitative estimates of cancer potency, which are required to conduct 
quantitative risk assessments. 

As the IRIS database became more widely used and accepted, EPA took 
steps, beginning in the early 1990s, to improve and maintain the IRIS 
program and database. For example, the agency created an IRIS Quality 
Action Team that produced a report in 1994 outlining a number of 
recommendations for improvement, and EPA implemented a pilot program 
from 1995-1997 to test new operational procedures for the IRIS program. 
Changes under the pilot program included developing a standard 
toxicological review document to support each IRIS summary, 
incorporating peer review into the assessment process, and establishing 
a standing group of 18 senior health scientists to conduct the internal 
agency review of all IRIS draft assessments. The standing group, now 
called the IRIS Agency Review Committee, includes representatives from 
the program offices and regions. EPA also formed an IRIS implementation 
strategy team that developed recommendations in 1997 to improve the 
IRIS program and database. Key recommendations addressed the need to 
(1) update IRIS information, (2) establish an annual agenda for the 
program, (3) form a central IRIS staff to be responsible for the 
database and to coordinate with the program and regional offices 
leading individual IRIS assessments, (4) provide Internet access to the 
IRIS database, and (5) conduct more outreach to users. 

In response, EPA formed a small centralized IRIS staff in the Office of 
Research and Development, National Center for Environmental Assessment 
(NCEA), which has implemented many of these recommendations. For 
example, EPA placed the IRIS database on its Web page, set up a hot 
line service to improve outreach with users, and started developing an 
annual IRIS agenda that identifies the chemicals to be assessed during 
the fiscal year (new and ongoing assessments) and providing this agenda 
to the public in a notice in the Federal Register. EPA also responded 
to the recommendations by posting external peer review drafts of IRIS 
assessments on EPA's Web page and considering public comments received 
on these drafts. As discussed below, EPA has continued to evaluate its 
IRIS assessment process and make changes in an effort to improve it. 

EPA's Efforts to Improve the IRIS Assessment Program Have Not Produced 
the Desired Results: 

In response to criticisms and in an effort to meet the needs of the 
programs and entities that rely on IRIS information, EPA has continued 
to make a number of IRIS assessment process changes aimed at improving 
the timeliness, quality, consistency, and transparency of IRIS 
assessments. However, even with process changes and increased program 
funding and staffing, EPA has not been able to routinely complete 
credible assessments or decrease its backlog of ongoing assessments. 
Several key factors have contributed to EPA's inability to achieve a 
level of productivity that is needed to sustain the IRIS program and 
database, including the OMB/interagency review process managed by OMB, 
certain management decisions and issues regarding the IRIS program, and 
the compounding effect of delays. In addition, because the OMB/ 
interagency review process is not transparent, this change also limits 
the credibility of IRIS assessments. 

EPA Efforts to Improve IRIS Continue: 

Despite the many steps that EPA took throughout the 1990s aimed at 
improving the IRIS assessment process, the agency has continued to face 
criticism that the risk information in the database is outdated and of 
varying quality. For example, according to congressional testimony in 
2000 by a risk assessment expert and a representative of a chemical 
industry association, the outdated and inconsistent information in IRIS 
represented a serious limitation that undermined the accuracy of risk 
assessments and risk management decisions. In addition, external 
parties--notably entities that may be affected by the IRIS assessments, 
including other federal agencies and industry--have criticized the IRIS 
assessment process as lacking transparency and have sought earlier 
input into EPA's assessment process. Further, as a result of continuing 
concerns that EPA and state regulators were relying on scientific 
information that was potentially outdated, in 2000, a Senate 
appropriations committee report directed EPA to conduct an assessment 
to determine the need to both update and add new assessments to IRIS. 

In response to the criticisms and in an effort to meet the needs of the 
programs and entities that rely on IRIS information, EPA has continued 
to make a number of IRIS assessment process changes aimed at improving 
the timeliness, quality, consistency, and transparency of IRIS 
assessments. For example, EPA further centralized the assessment 
process, hiring additional scientists in the Office of Research and 
Development to lead individual IRIS assessments; in the past, chemical 
managers in various program offices and regions had led the assessments 
on a voluntary basis. EPA made this change to improve the timeliness of 
assessments and to address concerns about the inconsistency of 
assessments that the different offices were producing. In addition, EPA 
changed its peer review requirements, opting for peer review panels, 
whose meetings the agency has opened to the public, rather than 
obtaining written peer review comments from several experts. According 
to EPA, these steps were taken to provide the best possible scientific 
review of each assessment and to make the review process more 
transparent. 

EPA also decided to conduct its internal agency review of assessment 
drafts earlier in the process. That is, the 18-member IRIS Agency 
Review Committee comprising EPA senior health scientists now comments 
on draft assessments before they are released for external review, as 
well as after external review comments are incorporated in the 
assessments. In the past, the review by the IRIS Agency Review 
Committee had taken place once, following the external reviews. 
According to EPA, this change was made to enhance peer reviews by 
identifying key science issues and providing external reviewers with 
drafts that had already been thoroughly vetted within EPA. Prior to 
this change, IRIS assessments had been internally peer reviewed by 
three or four scientists with relevant expertise in the Office of 
Research and Development, program offices, or regions before the 
assessments were sent to external peer review.[Footnote 5] EPA has also 
added formal briefings of draft assessments to the Assistant 
Administrator, Office of Research and Development, at various stages in 
the assessment process. In addition, EPA informally elevated final IRIS 
assessment approval authority to the Assistant Administrator, Office of 
Research and Development. EPA has also delayed or suspended some 
assessments to await new or scientific studies. 

Another key change that EPA has incorporated into the IRIS assessment 
process at OMB's request is an OMB/interagency review process that is 
managed by OMB. The purpose of these reviews is to obtain input from 
OMB and other federal agencies that OMB has determined have an interest 
in particular IRIS assessments as they are being developed in order to 
help ensure and increase their quality. The reviews occur at two points 
in the IRIS assessment process--first, after the internal agency review 
but before the external peer review; and second, after EPA has 
incorporated input from the external peer review. According to EPA 
officials, this OMB/interagency review process has evolved from an ad 
hoc review of selected IRIS assessments of interest to OMB and other 
federal agencies to a process that now requires, for all assessments, 
OMB's determination that EPA has satisfactorily addressed all OMB/ 
interagency comments. This determination must be made both before EPA 
can provide draft assessments to external peer reviews and before EPA 
can finalize and post assessments on the IRIS database. 

Although the IRIS assessment process continues to evolve, it currently 
typically includes the following steps (see app. II for a flow chart of 
the process): 

* solicitation of chemical nominations from EPA program and regional 
offices, federal agencies, and the public. 

* selection of chemicals to be assessed during the fiscal year 
(referred to as the annual agenda). 

* publication of a Federal Register notice announcing EPA's annual 
agenda--the specific chemical assessments the agency intends to 
conduct--and requesting scientific information about these chemicals, 
thereby giving the public and other federal agencies an opportunity to 
identify relevant studies. 

* a review of the scientific literature. 

* development of draft IRIS toxicological reviews and summaries 
containing qualitative and, if sufficient information is available, 
quantitative risk estimates, that have undergone internal peer 
consultation--a peer review by three or four EPA scientists with 
relevant expertise. 

* initial internal agency review, which includes review and comment 
from the 18-member EPA IRIS Agency Review Committee. 

* OMB/interagency review by other federal agencies, such as DOD, DOE, 
and NASA, coordinated by the Office of Management and Budget; OMB 
informs EPA when EPA has adequately addressed interagency comments. 

* external peer review by a group of independent experts, convened by 
an EPA contractor, the Science Advisory Board, or the National 
Academies, and public comment. 

* a second internal agency review. 

* a second OMB/interagency review; OMB informs EPA when EPA has 
adequately addressed interagency comments. 

* EPA management review and approval. 

* posting of IRIS assessments on the IRIS database, available on EPA's 
Web site. 

In addition to EPA continuing to revise its IRIS assessment process, 
since fiscal year 2000, funding for the IRIS program has increased-- 
from $1.7 million to $9.6 million in fiscal year 2007 (see fig. 2). The 
need for increased resources to accomplish significant IRIS 
improvements had been noted in the February 1997 IRIS Implementation 
Strategy Team Report. 

Figure 2: Funding for the IRIS Program, Fiscal Years 2000-2007: 

[See PDF for image] 

This figure is a line graph depicting the following data: 

Fiscal year: 2000; 
Funding for the IRIS Program: $1.7 million. 

Fiscal year: 2001; 
Funding for the IRIS Program: $1.9 million. 

Fiscal year: 2002; 
Funding for the IRIS Program: $6.7 million. 

Fiscal year: 2003; 
Funding for the IRIS Program: $2.3 million. 

Fiscal year: 2004; 
Funding for the IRIS Program: $6.9 million. 

Fiscal year: 2005; 
Funding for the IRIS Program: $8.2 million. 

Fiscal year: 2006; 
Funding for the IRIS Program: $8.4 million. 

Fiscal year: 2007; 
Funding for the IRIS Program: $9.6 million. 

Source: GAO analysis of EPA data. 

Note: In fiscal year 2002, a congressional appropriations conference 
committee designated $5 million to accelerate the development of new 
IRIS values and to update current IRIS values. According to EPA 
officials, this funding was provided to various EPA program offices to 
support the IRIS assessments that program offices were leading at that 
time. In addition, EPA has reprogrammed funds from some of its other 
programs to expand the IRIS program to support the development of IRIS 
assessments, especially high-priority chemicals. 

[End of figure] 

Process Changes and Increased Resources Have Not Enabled EPA to 
Routinely Complete IRIS Assessments and Meet Users' Needs: 

As shown in figure 3, EPA has continued to take steps to improve the 
IRIS assessment process and increased program funding and staffing, but 
the agency has not made progress in completing IRIS assessments and 
reducing its backlog of ongoing assessments. Although the number of 
program staff has quadrupled from 8 to 37 between 2000 and 2007, EPA 
has, on average, completed about five IRIS assessments per year--and in 
fiscal years 2006 and 2007, completed only two each year. However, EPA 
sent 16 draft assessments to OMB for OMB/interagency review in both 
fiscal years 2006 and 2007 and plans to provide 16 draft assessments to 
OMB annually in fiscal years 2008 through 2012. Further, in its fiscal 
year 2008 budget justification documents, EPA said it plans to complete 
8 IRIS assessments in fiscal year 2008, noting that completion of 
assessments, rather than providing drafts to OMB, is the most important 
outcome. 

Figure 3: Number of Completed IRIS Assessments, Draft Assessments to 
OMB, and IRIS Staff in Full-Time Equivalents, Fiscal Years 2000-2007: 

[See PDF for image] 

This figure is a multiple line graph depicting the following data: 

Fiscal year: 2000; 
IRIS staff levels in full-time equivalents: 7.8; 
IRIS assessments completed: 5. 

Fiscal year: 2001; 
IRIS staff levels in full-time equivalents: 7.8; 
IRIS assessments completed: 7. 

Fiscal year: 2002; 
IRIS staff levels in full-time equivalents: 7.8; 
IRIS assessments completed: 3. 

Fiscal year: 2003; 
IRIS staff levels in full-time equivalents: 12.8; 
IRIS assessments completed: 11. 

Fiscal year: 2004 (Year OMB/interagency review initiated); 
IRIS staff levels in full-time equivalents: 27; 
IRIS assessments completed: 4; 
Draft IRIS assessments to OMB for OMB/interagency review: 1. 

Fiscal year: 2005; 
IRIS staff levels in full-time equivalents: 37; 
IRIS assessments completed: 4; 
Draft IRIS assessments to OMB for OMB/interagency review: 5. 

Fiscal year: 2006; 
IRIS staff levels in full-time equivalents: 37; 
IRIS assessments completed: 2; 
Draft IRIS assessments to OMB for OMB/interagency review: 16. 

Fiscal year: 2007; 
IRIS staff levels in full-time equivalents: 37; 
IRIS assessments completed: 2. 
Draft IRIS assessments to OMB for OMB/interagency review: 16. 
	
Source: GAO analysis of EPA data. 

[End of figure] 

During fiscal year 2007, EPA had 77 ongoing IRIS assessments. As of 
December 1, 2007, 70 of these were still in progress--2 were completed 
in fiscal year 2007 and 5 were discontinued at the direction of 
OMB.[Footnote 6] Representing EPA's first efforts to develop IRIS 
assessments covering acute (short-term) exposure to chemicals, EPA 
initiated them in 2004 to meet EPA program needs, including, for 
example, to help it implement the Clean Air Act. In November 2007, EPA 
officials told the members of the Board of Scientific Counselors 
committee evaluating EPA's health risk assessment program that OMB did 
not explain to EPA why it was directing the agency to terminate these 
IRIS assessments. 

Of the 70 assessments still in progress as of December 1, 2007, 48 have 
been in progress for more than 5 years, and 12 of those for more than 9 
years. As figure 4 shows, many of these assessments are either being 
drafted or are undergoing internal agency review. Additionally, 19 
assessments are undergoing one of the two OMB/interagency reviews 
managed by OMB, and 5 of the assessments have been suspended by EPA for 
various reasons, including waiting for new research studies that have 
yet to be completed. 

Figure 4: December 2007 Status of IRIS Assessments That EPA Reported as 
Ongoing in Fiscal Year 2007: 

[See PDF for image] 

This figure is a vertical bar graph depicting the following data: 

Type: Suspended[A]; 
Number of assessments: 5. 

Type: Draft development[B]; 
Number of assessments: 31. 

Type: Formal EPA agency review[C]; 
Number of assessments: 6. 

Type: First interagency review managed by OMB[D]; 
Number of assessments: 14. 

Type: Assessments discontinued per OMB direction[E]; 
Number of assessments: 5. 

Type: Assessments delayed per EPA direction[F]; 
Number of assessments: 1. 

Type: External peer review[G]; 
Number of assessments: 8. 

Type: Second interagency review managed by OMB[H]; 
Number of assessments: 5. 

Type: Preparation of final assessment/web posting[I]; 
Number of assessments: 0. 

Type: Completed assessments[J]; 
Number of assessments: 2. 

Source: GAO analysis of EPA information. 

[A] EPA has suspended five IRIS assessments for several reasons, 
including waiting for additional research, reevaluating the need for an 
assessment, and potentially broadening the scope of an assessment. 

[B] This phase includes conducting literature searches, drafting 
assessments, and incorporating comments from an internal peer review 
process; it is concluded when the IRIS Program Director provides the 
draft and support documents for review by EPA's IRIS Agency Review 
Committee. 

[C] This phase includes the review by EPA's IRIS Agency Review 
Committee and revisions in response to the review; it is concluded when 
the NCEA Associate Director for Health transmits a draft to OMB. 

[D] This phase encompasses the first OMB/interagency review managed by 
OMB; revisions in response to the review; negotiations among EPA, OMB, 
and other federal agencies over changes to the draft and the content of 
the charge questions for the external peer reviewers; and briefing of 
the Assistant Administrator for the Office of Research and Development 
(ORD). It is concluded when OMB informs EPA that issues have been 
resolved and the assessment can proceed to the next step--external peer 
review. 

[E] In November 2007, EPA said that in 2006 OMB requested and then in 
2007 directed EPA to discontinue the five IRIS assessments covering 
acute exposures that EPA had sent to OMB for OMB/interagency review 
from July to September 2006. 

[F] One assessment has been delayed by EPA for almost 2 years pending 
the development of an acceptable uncertainty analysis. 

[G] This phase encompasses public review and comment, the external peer 
review conducted by an independent panel, and incorporation of draft 
revisions in response to peer review and public comments. It is 
concluded when the NCEA Associate Director for Health transmits a 
revised draft to OMB for the second OMB/interagency review it manages. 

[H] This phase encompasses the second review by EPA's IRIS Agency 
Review Committee; the second OMB/interagency review managed by OMB; 
revisions in response to comments received from agency and OMB/ 
interagency review; negotiations among EPA, OMB, and the other federal 
agencies over changes; and briefing of the Assistant Administrator for 
ORD. It is concluded when ORD, the IRIS Agency Review Committee, and 
other federal agencies resolve all issues, OMB informs EPA that issues 
have been resolved, and a revised IRIS assessment is sent for 
preparation of a final IRIS assessment. 

[I] This phase encompasses the final preparation of the IRIS summary 
and toxicological review and the review and clearance by the NCEA 
Director. It is concluded when the assessment is posted on the IRIS Web 
site after the Assistant Administrator, ORD, approves a fact sheet 
about the assessment prepared by the chemical manager. 

[J] EPA completed two assessments in July and September 2007. 

[End of figure] 

In addition to the current backlog of 70 ongoing and suspended IRIS 
assessments, EPA data from 2001 through 2003 indicated that 287 of the 
chemicals in the IRIS database may potentially need to be updated. 
Specifically, EPA reviewed the scientific literature on the 460 
chemicals in the database not being reassessed to identify assessments 
that may need to be updated in light of new studies or information that 
could potentially change the risk estimates currently in the IRIS 
assessments. In addition, while conducting these literature reviews, 
EPA identified new studies or information that would enable the agency 
to develop additional risk estimates (e.g., add an estimate, such as an 
RfD or cancer potency estimate, for assessments lacking such 
estimates). EPA's "screening level review" found new information that 
could potentially (1) change an existing risk estimate for 169 
chemicals and/or (2) allow EPA to develop additional risk estimates for 
210 chemicals. Although EPA identified these chemicals as candidates 
for reassessment, as of fiscal year 2007, the agency had initiated 
reassessments of only a few of these chemicals. Further, because the 
screening levels were completed more than 4 years ago, it is likely 
that more assessments may now be outdated. 

EPA officials said they have initiated another screening level review 
that they expect to be completed by July 2008. Importantly, in its 
performance assessment of EPA's human health risk assessment program, 
which includes IRIS, OMB considers health assessment values in IRIS as 
out of date if they were developed more than 10 years ago and where new 
scientific information has been identified that could change the health 
assessment value. This designation highlights the need for EPA to 
become productive in completing its IRIS assessments if it is to remain 
a viable and credible assessment resource. We note that EPA recently 
formed a new working group that will specifically address chemical 
assessments that are over 10 years old and for which new information is 
available. This group's efforts are currently in the planning stages, 
and an EPA official involved in this group indicated that the agency 
expects to begin work on this effort by March 2008. 

Although EPA has stated its intent that the IRIS database be updated 
and expanded to include new assessments requested by IRIS users as soon 
as "practically possible," the current backlog continues to present a 
practical impediment to doing so. Because of the backlog, for example, 
EPA did not initiate new assessments in fiscal years 2006 and 2007. 
[Footnote 7] In fact, key IRIS users--two EPA program offices-- 
specifically requested that the IRIS program management focus its 
resources on expediting the completion of ongoing IRIS assessments 
important to their regulatory and cleanup responsibilities rather than 
initiating new assessments in fiscal year 2007. For example, the Office 
of Solid Waste and Emergency Response identified 29 assessments that 
were important to that office and asked EPA to finish these IRIS 
assessments before initiating others. In addition, the Office of Air 
identified 28 high-priority IRIS assessments that it needed to fulfill 
its regulatory mandates,[Footnote 8] 14 of which it identified as being 
of the "highest priority" and the other as "high priority;" IRIS 
reviews for 12 of the chemicals of highest priority are in progress, 
but most of these assessments are still either being drafted or are 
undergoing an internal agency review. In terms of new assessments that 
will be needed for EPA's air toxics program, an official in the Office 
of Air and Radiation said there were about 12 to 20 air toxics of 
concern nationwide for which IRIS risk information is needed and about 
50 or so uncommon air toxics emitted in isolated "hot spots" (e.g., 
near a chemical plant in sparsely populated areas) where a small number 
of people who live nearby--perhaps 200 or so--are exposed to relatively 
high doses of these air toxics. He said it is more difficult to get 
approval for assessments of such chemicals because of the small number 
of people potentially affected, even though these chemicals may be very 
harmful to human health and the environment. 

Moreover, as discussed above, EPA program offices and state and local 
entities have identified needs for assessments of hundreds of chemicals 
not yet in IRIS. For example, in its 2003 needs assessment report, EPA 
reported that about half of the chemicals and chemical classes that 
IRIS users had nominated for assessment were not included in IRIS. 
[Footnote 9] Reasons that IRIS users nominated these chemicals included 
to support anticipated rule making, to support agency or state 
implementation priorities, to address children's health concerns, and 
to address the widespread occurrence of a chemical at contaminated 
sites and in groundwater. Unmet IRIS needs affect IRIS data users both 
within and outside EPA. For example, EPA's Office of Research and 
Development noted in its 2003 Air Toxics Multi-Year Plan that 
quantitative assessment values (for noncancer and cancer health 
effects) for many high-priority air toxics that are needed to support 
site-specific efforts and regulatory decisions are "missing." Along 
these same lines, in its Office of Solid Waste Integrated Research and 
Development Plan for the Hazardous Waste Identification Rule, EPA's 
Office of Research and Development identified 460 chemicals of 
potential concern and reported that roughly 200 of these lack 
quantitative assessment values (estimates of the risk of cancer and 
noncancer effects of the chemicals). Non-EPA users also are affected by 
the lack of IRIS values. According to the preliminary results of an EPA 
project aimed at determining how IRIS is used by non-EPA decision 
makers,[Footnote 10] non-EPA users have one primary criticism regarding 
IRIS--they are frustrated by the lack of new assessments, particularly 
for "controversial" chemicals. These users reported that the absence of 
an IRIS assessment creates enormous challenges for state regulatory 
agencies and significant uncertainty for regulatory parties. 

Although EPA's 2003 needs assessment report had identified a potential 
need to complete 50 IRIS assessments annually to meet user needs, the 
agency has not finalized more than 11 assessments a year during the 
past 10 years. As figure 3 shows, productivity has, in fact, declined 
since 2003, with EPA completing 4 assessments in fiscal year 2005 and 2 
each in fiscal years 2006 and 2007. EPA's updated multiyear plan 
estimates incremental increases in the number of IRIS assessments EPA 
will complete in fiscal years 2008 through 2011, at which point EPA's 
annual goal is to complete 16 IRIS assessments.[Footnote 11] We note 
that even if EPA were to overcome the significant productivity 
difficulties it has experienced in recent years and meet this goal of 
completing 16 assessments a year beginning in 2011, it is not clear 
that this level of productivity would meet the needs of EPA program 
offices and other users, given the current status of the database. For 
example, in November 2007, the Deputy Administrator of EPA's Region 2 
told the Board of Scientific Counselors panel reviewing EPA's human 
health risk assessment program that even 16 IRIS assessments per year 
would not meet their chemical assessment needs. Although funding for 
the IRIS program has increased since 2000, we note that fiscal year 
2007 funding of $9.6 million represents approximately 0.1 percent of 
EPA's $7.3 billion annual budget. 

It is a positive step that EPA delivered 32 IRIS assessments to OMB for 
OMB/interagency review in fiscal years 2006 and 2007. However, in 
general, the IRIS assessments sent to OMB during this period were on 
less controversial chemicals. In its December 2005 multiyear plan, EPA 
specified 10 major assessments that would be sent for external review 
in fiscal years 2006 and 2007. As of December 1, 2007, only 2 of these 
assessments had been sent for OMB/interagency review.[Footnote 12] In 
order to meet user needs and therefore enable EPA to more effectively 
protect public health, it will be important for EPA to make progress on 
the assessments of the more controversial chemicals, which tend to be 
those to which people are more widely exposed. 

Lastly, while EPA's assessment process changes have resulted in EPA 
providing the public with more information about IRIS assessments, some 
of the information provided in Federal Register notices and in the IRIS 
database itself is not accurate or is incomplete. For example, some 
assessments that have been suspended have continued to be identified as 
ongoing, and information on the status of the individual assessments 
provided in a system called IRIS Track has not been kept up to date. 
Regarding this latter point, we found that more EPA chemical managers 
started updating this database as a result of our review. Nonetheless, 
some of the milestone estimates remained outdated, and the milestones 
in IRIS Track did not reflect the current assessment process. We note 
that in November 2007, EPA created a new IRIS Web page, updating and 
consolidating some of the milestones to better reflect the current 
process. However, two key milestones--the second OMB/interagency and 
EPA internal agency reviews--are still not identified. 

EPA's Productivity Problems Stem from Several Key Factors: 

In our view, several key factors have contributed to EPA's inability to 
achieve a level of productivity that is needed to sustain the IRIS 
program and database. These factors that have hindered EPA's efforts to 
improve productivity are: 

* the OMB/interagency review process managed by OMB, 

* the growing complexity and scope of risk assessments, 

* certain management decisions and issues regarding the IRIS program, 

* congressional action that has delayed some assessments with 
potentially significant economic effects, and: 

* the compounding effect of delays. 

OMB/Interagency Review Process: 

One factor that has made it more difficult for EPA to complete IRIS 
assessments in a timely manner is the OMB-managed interagency review 
process, initiated in 2004 at OMB's direction. According to OMB, the 
purpose of OMB/interagency reviews is to ensure that federal agencies 
are aware of draft IRIS assessments in which they have an interest and 
that these agencies have the opportunity to be involved with the IRIS 
assessments as they are being developed in order to help ensure and 
increase their quality. This process, initially conducted on an ad hoc 
basis, was put in place in response to interagency conflicts that EPA 
faced when it attempted to finalize some IRIS assessments for chemicals 
that became highly controversial, such as perchlorate, naphthalene, and 
TCE--chemicals that are or have been considered by some federal 
agencies, including DOD, DOE, and NASA, to be integral to their 
missions. Notably, EPA's IRIS assessments of these chemicals could lead 
to regulatory actions that could, among other things, restrict the use 
of these chemicals, require agencies to provide protective gear to 
their employees exposed to the chemicals at work, or require agencies 
or their contractors to carry out or pay for cleanup of contamination 
at federal sites. The interagency conflicts about these IRIS 
assessments have contributed to their delays--resulting, for example, 
in EPA having to essentially restart the naphthalene assessment after 
it had been drafted and peer reviewed. 

The OMB/interagency review process has evolved over time, but it 
remains an informal process with OMB generally communicating its review 
requirements verbally. OMB has not provided EPA with written guidance, 
directives, policies, or procedures on this significant review program. 
In 2005, OMB started requiring EPA to send OMB all draft IRIS 
assessments for an OMB/interagency review before the assessments are 
provided to external peer review panels. In addition, OMB requires EPA 
to send the assessments to OMB a second time, after EPA has addressed 
the external peer review comments and recommendations. According to EPA 
officials, in 2007, OMB informed EPA that it cannot send its draft 
assessments for external peer review or post final EPA assessments on 
the EPA IRIS database until OMB verbally informs EPA that it has 
satisfactorily addressed OMB/interagency comments. OMB has not 
specified which authority or authorities it is using to review IRIS 
assessments. Because IRIS assessments are not regulations, they are not 
covered by Executive Order 12866 which provides for OMB review of 
proposed regulations, among other things. In addition, although in 
January 2007, Executive Order 13422 amended Executive Order 12866 by 
establishing a role for OMB in reviewing "significant guidance" 
documents, which could potentially include IRIS assessments, OMB 
officials told us that OMB has not formally classified IRIS assessments 
as significant guidance documents within the meaning of this executive 
order.[Footnote 13] These officials said that OMB had the authority to 
review IRIS assessments prior to the issuance of Executive Order 13422 
and was continuing to use this general authority. We note that these 
executive orders address only OMB's reviews of two specific categories 
of agency documents and that OMB has not identified IRIS assessments as 
falling into either of these categories. 

Under the OMB/interagency review process for IRIS assessments, OMB 
identifies the federal agencies from which it will seek comments on the 
assessments and provides comments and questions to EPA from OMB and the 
other federal agencies. EPA then revises the assessments to address the 
comments and questions and also provides OMB with a document discussing 
how it has addressed each of the issues raised. According to EPA 
officials, this step is concluded when OMB verbally informs EPA that 
all of the issues are resolved. Thus, before EPA can provide its draft 
assessments to external peer reviewers, EPA, OMB, and the other federal 
agencies must reach agreement on (1) EPA's revised IRIS assessment and 
(2) the scope of the external peer review, including specific questions 
reviewers will be asked. 

The OMB reviews have primarily been conducted by a policy analyst in 
the Office of Information and Regulatory Affairs who, according to OMB 
officials, has a toxicology background and is qualified to conduct 
these reviews. If EPA does not agree with some of the proposed changes 
or peer review requirements, OMB officials said the assessment could be 
elevated to higher management levels within EPA for resolution. Thus, 
the framework of the OMB/interagency review process can essentially 
give more weight to OMB and the other federal agencies than to EPA 
chemical managers who have prepared the assessments and the many 
scientists and experts who have peer reviewed them. Further, in 
commenting on OMB's proposed risk assessment bulletin in 2007, the 
National Academies stated its concern that scientific issues may be 
superseded by policy considerations to the extent that the technical 
aspects of risk assessments would be overseen by OMB and not by the 
peer review process or by agency technical managers. Similarly, an EPA 
official noted that the farther removed the scientists and experts who 
have prepared or peer reviewed the assessments are from the 
negotiations and decisions over assessment changes requested by OMB and 
other federal agencies, the decisions are based more on political 
rather than scientific considerations. 

According to EPA officials, some of the OMB/interagency reviews have 
provided valuable input. However, they said the reviews have also added 
a significant amount of time to the assessment process, in part because 
the reviews are not subject to any specific time frames or deadlines 
and because responding to OMB comments in some cases has required 
several iterations to address nonsubstantive issues involving minor 
clarifications, semantics, and organization. (We note that according to 
the executive order under which OMB reviews regulatory actions, OMB 
must generally complete such reviews within 90 days.) In terms of time 
frames, our analysis of EPA data as of December 1, 2007, indicate that 
of the 36 assessments sent to OMB for the first OMB/interagency review, 
16 have completed this process. While 4 completed the process in less 
than 6 months, 12 of them were in the review process for 6 or more 
months. Moreover, five additional assessments--the previously discussed 
assessments of acute exposure--were discontinued at the direction of 
OMB after a year in the OMB/interagency review stage. 

In addition, as of December 1, 2007, 5 of 10 draft assessments had 
completed the second OMB/interagency review, which OMB officials said 
is conducted by OMB to ensure that EPA has adequately considered the 
comments from external peer review panels. These assessments were at 
the second OMB/interagency review stage for periods ranging from 10 
days to almost 4 months. According to EPA, while agencies should only 
point out major scientific issues that would warrant halting the 
release of the assessment, some comments submitted to them from the 
second OMB/interagency reviews by OMB have gone beyond their intended 
purpose of identifying only major scientific concerns and thus have 
unnecessarily added time to the assessment process. (See app. III for 
additional information about the time frames for the OMB/interagency 
reviews.) Further, EPA officials noted that the OMB/interagency review 
process can delay not only the IRIS assessments undergoing OMB/ 
interagency review but also the other assessments that the EPA chemical 
managers would be working on or starting if they were not engaged in 
responding to the OMB/interagency comments. 

Overall, the two OMB/interagency reviews managed by OMB have introduced 
a significant level of uncertainty into the time frames for completing 
IRIS assessments. This fact was reflected in EPA's December 2005 Human 
Health Risk Assessment Multi-Year Plan, which identified EPA's annual 
performance goals for fiscal years 2006 through 2012. The goals did not 
include the number of IRIS assessments completed and posted on the IRIS 
Web page--the performance goal that would be expected--but instead the 
number of assessments provided to OMB for the first OMB/interagency 
review. While EPA's annual performance goal for IRIS assessments had 
been the number of completed assessments, during the Program Assessment 
Rating Tool (PART) review by OMB, it was agreed that the number of 
assessments provided to OMB for OMB/interagency review was the most 
appropriate annual measure of performance because EPA "relinquishes 
direct control of production dates" when it sends draft IRIS 
assessments to OMB. 

In addition to adding time to the IRIS assessment process, the OMB/ 
interagency review process also affects the credibility of assessments 
primarily because the review process lacks transparency. According to 
EPA's Risk Characterization Policy and Handbook, the risk assessment 
process--which includes the hazard identification and dose-response 
analysis that constitutes IRIS assessments--should be transparent and 
its products should be clear, consistent, and reasonable. Transparency 
is particularly important in cases such as this when potentially 
affected parties are providing input into, and in some cases 
questioning, EPA's scientific analyses supporting its IRIS assessments. 
Specifically, a transparent process allowing IRIS users and the public 
to see the comments from OMB and other federal agencies--including 
those potentially impacted by the IRIS assessments--as well as EPA's 
responses to them, could help alleviate concerns about potential bias 
in the assessments. 

However, under the OMB/interagency review process managed by OMB, the 
comments EPA receives from OMB and other federal agencies and EPA's 
responses to them are not available to the public. OMB does not 
authorize their disclosure to the public on the basis that these 
communications are internal deliberations of the executive branch. 
Overall, because the rationale for changes to EPA's scientific 
assessments stemming from OMB and the interagency review process are 
not disclosed, the credibility of the IRIS assessments is reduced. We 
note that the former Assistant Administrator for the Office of Research 
and Development has emphasized the importance of transparency in the 
IRIS assessment process. Specifically, he stated that the best cure for 
controversy surrounding IRIS assessments "is early and frequent visits 
to the experts, second opinions, and lots of sunshine" (that is, 
transparency). 

Growing Complexity of Risk Assessments and Risk Assessment Methods and 
Models: 

Another factor that affects the length of time it takes to complete 
IRIS assessments is the growing scientific complexity of the 
assessments. For example, according to John Graham, the former director 
of both Harvard's Center for Risk Analysis and OMB's Office of 
Information and Regulatory Affairs, more and different types of 
scientific data have made the IRIS assessment of health effects more 
challenging.[Footnote 14] As a result, EPA chemical managers and 
scientists need to explore new methods of analyses and evaluate a wider 
variety of potential health effects (e.g., multiple disease endpoints) 
than in the past. In addition, chemical managers responsible for the 
assessments are working with a growing body of complex risk assessment 
guidelines, such as EPA's 2005 Guidelines for Carcinogen Risk 
Assessment (final revised cancer assessment guidelines) and its 
supplement relating to children, Supplemental Guidance for Assessing 
Susceptibility from Early Life to Exposure to Carcinogens. In addition, 
chemical managers must increasingly analyze studies using state-of-the- 
art physiologically based pharmacokinetic (PBPK) models, which improve 
the estimation of doses across species and routes of exposure and 
provide insights on uncertainty.[Footnote 15] Before EPA relies on PBPK 
models intended for risk assessments, the agency needs to evaluate 
them. Such evaluations include a review of the model purpose, 
structure, mathematical representation, parameter estimation 
(calibration), and computer implementation. EPA has established 
criteria for acceptance of a PBPK model for risk assessment purposes in 
one of two detailed reports issued in 2006, Approaches for the 
Application of Physiologically Based Pharmacokinetic (PBPK) Models and 
Supporting Data in Risk Assessment. The other 2006 report on PBPK 
models is the Use of Physiologically Based Pharmacokinetic (PBPK) 
Models to Quantify the Impact of Human Age and Interindividual 
Differences in Physiology and Biochemistry Pertinent to Risk. In fiscal 
years 2008 and 2010, EPA plans to issue additional information on PBPK 
modeling for use in risk assessments. 

The chemical managers are also called upon to use some new methods and 
models of risk assessment that are being developed or being applied for 
the first time in the absence of guidelines. For example, uncertainty 
analysis is a method in the early stages of development and use in 
risks assessments, for which EPA has not yet developed guidance. 
[Footnote 16] However, chemical managers are having to develop and 
apply new approaches to quantify and communicate uncertainty. According 
to EPA, these approaches include identifying alternative studies and 
endpoints for the application of uncertainty factors in noncancer risk 
assessment and the application of alternative dose- response models for 
cancer risk assessment. Important cutting-edge assessment models 
relevant to IRIS assessments include biologically based dose-response 
models, which are based on the modes of action of chemicals--that is, 
analysis of physiological, chemical, and biological information that 
helps identify a chemical agent's role in the development of tumors. 
These highly complex models can analyze multiple modes of action and 
can be responsive to EPA's 2005 guidelines for cancer assessment that 
emphasize mode-of-action evaluation. According to EPA, the agency has 
extensive experience in qualitative mode-of- action analysis but more 
limited experience in the quantitative evaluation of multiple modes of 
action. 

EPA Management Decisions and Issues: 

Some of the IRIS assessment process changes that EPA management has 
implemented in recent years have made it more difficult for the agency 
to complete assessments in a timely manner. These changes were aimed 
primarily at improving the quality of the assessments. It is too early 
to determine whether or to what extent the changes have enhanced the 
scientific credibility of the assessments,[Footnote 17] but it is clear 
they have contributed to assessment delays overall. Changes that have 
affected the time frames for IRIS assessments include waiting for 
additional scientific studies to be completed, waiting for the 
development of an acceptable methodology for presenting qualitative and 
quantitative uncertainty analysis in the IRIS assessments, and numerous 
process changes. 

Waiting for additional scientific studies: EPA management's decision in 
some cases to suspend ongoing IRIS assessments while waiting for 
additional scientific studies to be completed has contributed to EPA's 
lack of productivity. According to a former IRIS program director, 
EPA's general approach in the 1990s was to use only information from 
completed scientific studies available at the time of the assessment-- 
e.g., the reviews were based on the best available science. However, 
EPA has awaited the results of new and ongoing studies before 
completing some IRIS assessments, which has resulted in delaying them 
for years. Examples of key chemical assessments that have been delayed 
while EPA waits for new studies include those for formaldehyde and 
Royal Demolition Explosive,[Footnote 18] discussed later. Other delayed 
assessments include those for tetrahydrofuran, perfluorooctane 
sulfonate-potassium salt (PFOS), and perfluorooctanoic acid-ammonium 
salt (PFOA). We understand that there may be exceptional circumstances 
for which it may be appropriate to wait for the results of an important 
ongoing study, such as a major epidemiological study that will provide 
new, critical data for an assessment. According to EPA officials, this 
is the case with research they are awaiting for its IRIS assessment of 
asbestos. However, as a general rule, requiring that IRIS assessments 
be based on the best science available at the time of the assessment, 
as had been the prior practice, is a standard that would best support a 
goal of completing assessments within reasonable time periods and 
minimizing the need to conduct significant levels of rework. 

Developing an acceptable uncertainty analysis for IRIS assessments: 
Another management decision that has delayed the completion of IRIS 
assessments is to incorporate comprehensive uncertainty analysis into 
the IRIS assessments. Peer reviews of EPA's assessments by the National 
Academies and others have sometimes recommended additional uncertainty 
analysis; the Assistant Administrator, Office of Research and 
Development, has made the inclusion of qualitative and quantitative 
uncertainty analyses in IRIS assessments a high priority to, among 
other things, support better decisions and guide EPA's research agenda. 
Such analyses require the use of state-of-the-art tools to quantify 
uncertainty. That is, comprehensive--and, in particular, quantified-- 
uncertainty analysis, is an emerging analytic tool. For example, EPA's 
August 2007 Human Health Risk Assessment Multi-Year Plan estimates 
releasing an external review draft report on methods for analyzing and 
characterizing uncertainty in hazard and dose-response assessments in 
2010; the plan--which covers 2006 through 2012--does not estimate a 
final report date for this important guidance on uncertainty analysis. 
In the interim, EPA chemical managers have had to try to develop 
complex uncertainty estimates in draft assessments in the absence of 
agency guidance or protocols. As discussed later, this requirement has 
delayed the completion of an important assessment (tetrachloroethylene) 
for almost two years. Moreover, because EPA is now requiring all IRIS 
assessments to include basic or enhanced uncertainty analysis, other 
significant assessments that have been drafted have also been delayed, 
pending approval by the Assistant Administrator, Office of Research and 
Development, of an acceptable template for uncertainty analysis for 
significant assessments. Further, external peer reviewers of IRIS 
assessments containing quantified uncertainty analyses will need to 
have specialized expertise to assess the quality and reliability of 
these cutting-edge analyses--which themselves contain uncertainties and 
incorporate numerous assumptions. Evaluating the uncertainty 
assessments will be challenging, given their complexities and the lack 
of guidance on this emerging method. Along these lines, members of the 
Board of Scientific Counselors[Footnote 19] have questioned whether 
expert peer reviewers of EPA's IRIS assessments will have the necessary 
expertise in this emerging method. Finally, effectively communicating 
the results of complex uncertainty analyses may be challenging--in 
fact, some have questioned whether highly detailed quantitative 
uncertainty analysis enhances the values of risk assessments. For 
example, in commenting on a proposed OMB bulletin that would have 
provided risk assessment guidance to federal agencies, the Department 
of Health and Human Services noted that "characterization of every 
possible uncertainty or extensive evaluation of each assumption . . . 
could result in a confusing, less straight-forward document . . . that 
would not serve the public or the risk assessment community well." 
[Footnote 20] Similarly, in its review of the proposed bulletin, the 
National Academies concluded that "there is a serious danger that 
agencies will produce ranges of meaningless and confusing risk 
estimates, which could result in risk assessments of reduced rather 
than enhanced quality and objectivity." 

Continuous process changes, outdated standard operating procedures, and 
management issues: EPA's continual changes to the IRIS assessment 
process present a challenge to the chemical managers who are 
undertaking the assessments. Further, a number of changes have been 
implemented informally since the last update to the agency's standard 
operating procedures for fiscal year 2006 reviews. According to EPA, 
these changes have been made in order to continually improve the 
assessment process and to respond to changing requirements, such as the 
OMB-managed OMB/interagency review and the need to incorporate emerging 
risk assessment methods. Chemical managers have told us that there is 
much confusion about the process, including who needs to be briefed on 
the draft assessments and who has approval authority to move an 
assessment to the next step. In fact, in the absence of current 
operating procedures to guide chemical managers on basic procedures and 
program management responsibilities for the development, review, and 
finalization of IRIS assessments, EPA chemical managers recently took 
the initiative to develop a detailed graphic providing their best 
understanding of the process. One aspect of the IRIS assessment process 
that has become particularly unclear is the steps required to obtain 
approvals to move draft assessments through various stages (e.g., to 
OMB, external peer review, or final issuance). For example, until 2004, 
EPA used an agencywide consensus process to reach either unanimous or 
substantial agreement on draft assessments among members of the IRIS 
Agency Review Committee; if agreement could not be reached by the 
committee, the operating procedures had provided a detailed process for 
resolving contentious issues. When EPA moved from the consensus 
approach to an "agency resolution" approach, however, the guidance said 
only that final decisions on any contentious issues were to be resolved 
by either the NCEA Director or the Agency Science Advisor.[Footnote 21] 
In addition, while approval to move draft assessments to external peer 
review had been made by the NCEA Director, according to EPA officials, 
in 2006, the Assistant Administrator started approving drafts for the 
first of three external reviews of IRIS assessments--the initial OMB/ 
interagency review. However, this change occurred informally and was 
not reflected in the existing standard operating procedures.[Footnote 
22] We also note that, starting in 2004, chemical managers were 
required to provide a fact sheet on final IRIS assessments to the 
Assistant Administrator for review and approval before the assessments 
could be posted on the Web site.[Footnote 23] Raising the level at 
which various approvals are made has added time to the process because 
it involves additional briefings, additional revisions and negotiations 
over revisions, and, at times, delays due to scheduling difficulties. 
As a result, it is important for EPA to both articulate and evaluate 
its internal review process to help ensure the appropriate balance 
between product quality and timeliness. 

Finally, in addition to process and approval clarifications, it also 
appears that the IRIS program could benefit from more rigorous 
management attention and oversight. For example, the risk assessment 
for chloroform--identified as one of the highest-priority assessments 
requested by the EPA Office of Air and Radiation--was first announced 
in a January 1998 Federal Register notice; however, the chemical 
manager for the chloroform assessment retired from the agency in late 
2004, and a new chemical manager was not assigned to this assessment 
until early 2007.[Footnote 24] Although EPA continued to identify this 
assessment as ongoing, it was actually unstaffed and therefore 
suspended for at least 2 years. In addition, a relatively simple, less 
controversial assessment of 2,2,4-trimethylpentane, which concluded 
that there were insufficient scientific data to either quantify the 
noncancer health risks associated with the chemical or to assess its 
potential to cause cancer, took more than 4 years to complete. EPA 
officials could not explain why this assessment--which should have 
taken less than a year to complete--took so long, aside from noting 
that the responsible staff had been given other high-priority 
assignments during this time. EPA needs to ensure that its IRIS 
assessments are given high priority and adequately staffed so that 
costly delays are avoided. 

Congressional Actions: 

Another factor that can delay the completion of IRIS assessments is the 
potential for congressional involvement in assessments that become 
controversial, such as those with potentially significant economic 
effects. Because of the potential for such assessments to lead to 
regulatory actions that can significantly affect certain industries or 
federal agencies, it is particularly important that these assessments 
effectively and appropriately use the best available science. Even 
assuming the best available science, however, uncertainties remain an 
inherent aspect of complex chemical risk assessments. As the National 
Academies has noted, "A risk assessment usually involves incomplete 
data, scientific uncertainty, and the need for expert judgment" and 
"almost every risk assessment is open to challenge on one ground or 
another."[Footnote 25] As a result, the assessments may be questioned 
on various scientific and technical grounds and subjected to intense 
national scrutiny by many individuals and organizations, including the 
media. Constituents may contact their elected representatives with 
their concerns, and politicians are likely to become involved, either 
supporting the content of the assessments or challenging it. Because of 
this debate, Members of the Congress, congressional committees, or the 
Congress as a whole may direct EPA to take certain steps before 
finalizing a particular assessment. While the intense scrutiny to which 
some chemical assessments are subjected can result in improved 
assessments, all uncertainties cannot be eliminated and controversies 
can continue beyond the point at which additional analysis is helpful. 
Further, addressing questions and concerns about assessments often 
involves considerable rework and takes a significant amount of time. 
EPA strives to balance the desire for the best possible assessment with 
its responsibilities for protecting the public health, which it can 
only do with timely assessments of chemicals. That being said, it can 
be challenging for EPA to both identify and achieve the proper balance 
between these competing goals. 

In the case of certain controversial chemical assessments, actions by 
congressional committees and individual members have led EPA to, for 
example, postpone completion of the IRIS assessment of formaldehyde for 
years until an update of an epidemiological study that had just been 
released was completed. Another response to congressional concerns is 
EPA's decision to reconsider the quantitative noncancer assessment of a 
chemical, dibutyl phthalate, that had completed all internal and 
external reviews and was ready to be released in 2007. The noncancer 
assessment, an update to the assessment completed in 1990, would have 
allowed more exposure to dibutyl phthalate than the earlier assessment. 
In 2000, the Department of Health and Human Services' National 
Toxicology Program concluded that dibutyl phthalate may adversely 
affect human reproduction or development if exposures are sufficiently 
high. This chemical, regulated under the Clean Air Act's air toxics 
program, is used in many consumer products, such as cosmetics, nail 
polishes, fragrances, wood stains, and toys; the European Union has 
banned its use in cosmetics and restricted its use in children's toys 
containing concentrations of phthalates in excess of 0.1 percent. 
Similarly, after January 1, 2009, a California statute enacted in 2007 
will prohibit the manufacture, sale, or distribution of certain toys 
and child care articles if the products contain concentrations of 
phthalates exceeding 0.1 percent.[Footnote 26] Because of congressional 
questions and comments from the Natural Resources Defense Council 
about, among other things, the adequacy of the uncertainty factors used 
in the analysis and the lack of consideration in the draft assessment 
of cumulative exposure to multiple phthalates (similar chemicals in the 
same class) that have similar health effects, EPA has suspended the 
assessment. In December 2007, an EPA official said that EPA has decided 
to seek advice from the National Academies on whether the agency should 
develop a new type of assessment for this chemical--one that would 
assess a class of related chemicals. If EPA decides to develop a new, 
cumulative IRIS assessment, it will likely be many years before an 
updated IRIS assessment addressing dibutyl phthalate is completed. 
[Footnote 27] 

Compounding Effect of Delays: 

An overarching factor that affects EPA's ability to complete IRIS 
assessments in a timely manner is that once a delay in the assessment 
process occurs, work that has been completed can become outdated, 
necessitating rework throughout some or all of the assessment process. 
For example, delays often require repeating reviews of the scientific 
literature on a chemical to take into account the time that has passed 
since the literature review was completed; this, in turn, may require 
detailed analyses of any new studies found to be relevant. Moreover, 
new risk assessment guidelines and cutting-edge methodologies that the 
agency has started applying to other assessments may now need to be 
applied to an assessment being reworked to meet current assessment 
requirements and standards and the expectations of peer reviewers. Once 
these analyses are complete, the draft will likely need to be revised 
and again subjected to internal reviews, OMB/interagency reviews, and 
scientific peer review. In addition, the longer an assessment is in 
progress, the more likely it becomes that staff will change due to 
retirements and resignations; in turn, newly assigned chemical managers 
face a learning curve in reviewing often voluminous data and analyses. 
For example, at least four chemical managers have been assigned to the 
nitrobenzene assessment since it was started in 1998. Overall, even a 
single delay can have a domino effect--having far-reaching, time- 
consuming consequences, in some cases, requiring that the assessment 
process essentially start over. In addition, because chemical managers 
must continue to devote time and attention to assessments that 
experience delays--often repeating prior steps to update the 
assessments--their ability to work on other ongoing assessments and 
undertake new ones is limited. 

Key IRIS Assessments Have Been Delayed by Some of These Factors: 

Some key IRIS assessments have been in progress for a number of years, 
in part because of delays stemming from one or more of the factors 
discussed above. Examples include the following: 

Naphthalene. EPA started the IRIS assessment of cancer risks stemming 
from the inhalation of naphthalene in 2002. Naphthalene is used in jet 
fuel and in the production of widely used commercial products such as 
moth balls, dyes, insecticides, and plasticizers. According to a 
presentation delivered at the 2007 annual meeting of the Society for 
Risk Analysis by an Army Corps of Engineers toxicologist,[Footnote 28] 
"The changing naphthalene regulatory environment includes a draft EPA 
risk assessment that if/when finalized, will change naphthalene's 
status from 'possible' to 'likely' human carcinogen."[Footnote 29] 
Thus, according to this presentation, one potential impact of this IRIS 
assessment on DOD is that DOD would need to provide many employees 
exposed to naphthalene with equipment measuring their exposure to the 
chemical. In addition, because many military bases are contaminated 
with naphthalene, a component of jet fuel (approximately 1 percent to 3 
percent) used by all DOD services, DOD could face extensive cleanup 
costs. By 2004, 2 years after starting the assessment, 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.[Footnote 
30] 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.[Footnote 31] According to EPA, 
this added 6 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 this time, the naphthalene assessment had been in 
progress for over 4 years; EPA decided that the IRIS noncancer 
assessment, issued in 1998, was outdated and needed to be revisited. 
Thus, EPA expanded the IRIS naphthalene assessment to include both 
noncancer and cancer assessments. As a result, 6 years after the 
naphthalene assessment began, it is now back at the drafting stage. The 
assessment now will need to reflect relevant research completed since 
the draft underwent initial external peer review in 2004, and it will 
have to undergo all of the IRIS assessment steps again, including 
additional internal and external reviews that are now required. This 
series of delays has limited EPA's ability to conduct its mission. For 
example, the Office of Air and Radiation has identified the naphthalene 
assessment as one of its highest-priority needs for its air toxics 
program. In addition, the Office of Solid Waste and Emergency Response 
considers the naphthalene assessment a high priority for the Superfund 
program--naphthalene has been found in at least 654 of Superfund's 
current or former National Priorities List sites.[Footnote 32] Although 
EPA currently estimates that it will complete the assessment in 2009, 
meeting this revised estimate will be challenging, given all of the 
steps that are yet to be completed and the extensive external scrutiny 
to which it will continue to be subjected. 

Royal Demolition Explosive. This chemical, also called RDX or hexahydro-
1,3,5-trinitrotriazine, 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. Royal Demolition Explosive 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 
is the case with naphthalene, the IRIS assessment could potentially 
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. Although EPA started an IRIS assessment of 
Royal Demolition Explosive in 2000, it has made minimal progress on the 
assessment because EPA agreed to a request by DOD to wait for the 
results of DOD-sponsored research on this chemical. In 2007, EPA began 
to actively work on this assessment, although some of the DOD-sponsored 
research is still outstanding. 

Formaldehyde. EPA began an IRIS assessment of formaldehyde in 1997 
because the existing assessment was determined to be outdated.[Footnote 
33] Formaldehyde is a colorless, flammable, strong-smelling gas used to 
manufacture building materials, such as pressed wood products, and used 
in many household products, including paper, pharmaceuticals, and 
leather goods. While EPA currently classifies formaldehyde as a 
probable human carcinogen, the International Agency for Research on 
Cancer (IARC), part of the World Health Organization, classifies 
formaldehyde as a known human carcinogen. Since 1986, studies of 
industrial of workers have suggested that formaldehyde exposure is 
associated with nasopharyngeal cancer, and possibly with leukemia. For 
example, in 2003 and 2004, the National Cancer Institute (NCI) and the 
National Institute of Occupational Safety and Health (NIOSH) released 
epidemiological studies following up on earlier studies tracking about 
26,000 and 11,000 industrial workers, respectively, exposed to 
formaldehyde; the updates showed exposure to formaldehyde might also 
cause leukemia in humans, in addition to the cancer types previously 
identified. According to NCI officials, the key findings in their 
follow-up study were an increase in leukemia deaths and, more 
significantly, an exposure/response relationship between formaldehyde 
and leukemia--as exposure increased, the incidence of leukemia also 
rose. As with the earlier study, NCI found more cases of a rare form of 
cancer, nasopharyngeal cancer, than would usually be expected. The 
studies from NCI and NIOSH were published in 2003 and 2004,[Footnote 
34] around the time that EPA was still drafting its IRIS assessment. In 
November 2004, the Chairman of the Senate Environment and Public Works 
Committee requested that EPA delay completion of its IRIS assessment 
until an update to the just-released NCI study could be conducted, 
indicating that the effort would take, at most, 18 months. EPA agreed 
to wait--and more than 3 years later, the NCI update is not yet 
complete. As of December 2007, NCI estimates that the study will be 
completed in two stages, one in mid-2008 and the second one later that 
year. An NCI official said that the additional leukemia deaths 
identified in the update provide "greater power" to detect associations 
between exposure to formaldehyde and cancer. EPA's inability to 
complete the IRIS assessment it started more than 10 years ago in a 
timely manner has had a significant impact on EPA's air toxics program. 
Specifically, when EPA promulgated a national emissions standard for 
hazardous air pollutants covering facilities in the plywood and 
composite wood industries in 2004, EPA's Office of Air and Radiation 
took the unusual step of not using the existing IRIS estimate but 
rather decided to use a cancer risk estimate developed by an industry- 
funded organization, the CIIT Centers for Health Research (formerly, 
the Chemical Industry Institute of Toxicology) that had been used by 
the Canadian health protection agency. The IRIS cancer risk factor had 
been subject to criticism because it was last revised in 1991 and was 
based on data from the 1980s. In its final rule, EPA stated that "the 
dose-response value in IRIS is based on a 1987 study, and no longer 
represents the best available science in the peer-reviewed literature." 
The CIIT quantitative cancer risk estimate that EPA used in its health 
risk assessment in the plywood and composite wood national emissions 
standard indicates a potency about 2,400 times lower than the estimate 
in IRIS that was being re-evaluated and that did not yet consider the 
2003 and 2004 NCI and NIOSH epidemiological studies. According to an 
EPA official, an IRIS cancer risk factor based on the 2003 and 2004 NCI 
and NIOSH studies would likely be close to the current IRIS assessment, 
which EPA has been attempting to update since 1997. The decision to use 
the CIIT assessment in the plywood national emissions standard was 
controversial, and officials in EPA's National Center for Environmental 
Assessment said the center identified numerous problems with the CIIT 
estimate. Nonetheless, the Office of Air and Radiation used the CIIT 
value, and that decision was a factor in EPA exempting certain 
facilities with formaldehyde emissions from the national emissions 
standard. In June 2007, a federal appellate court struck down the rule, 
holding that EPA's decision to exempt certain facilities that EPA 
asserted presented a low health risk exceeded the agency's authority 
under the Clean Air Act.[Footnote 35] Further, the continued delays of 
the IRIS assessment of formaldehyde--currently estimated to be 
completed in 2010 but after almost 11 years still in the draft 
development stage--will impact the quality of other EPA regulatory 
actions, including other air toxics rules and requirements. 

Trichloroethylene. Also known as TCE, this chemical is a solvent widely 
used as a degreasing agent in industrial and manufacturing settings; it 
is a common environmental contaminant in air, soil, surface water, and 
groundwater. TCE has been linked to cancer, including childhood cancer, 
and other significant health hazards, such as birth defects. TCE is the 
most frequently reported organic contaminant in groundwater, and 
contaminated drinking water has been found at Camp Lejeune, a large 
Marine Corps base in North Carolina. TCE has also been found at 
Superfund sites and at many industrial and government facilities, 
including aircraft and spacecraft manufacturing operations. In 1995, 
the International Agency for Research on Cancer classified TCE as a 
probable human carcinogen, and in 2000, the Department of Health and 
Human Services' National Toxicology Program concluded that it is 
reasonably anticipated to be a human carcinogen. Because of questions 
raised by peer reviewers about the IRIS cancer assessment for TCE, EPA 
withdrew it from IRIS in 1989 but did not initiate a new TCE cancer 
assessment until 1998. In 2001, EPA issued a draft IRIS assessment for 
TCE that proposed a range of toxicity values indicating a higher 
potency than in the prior IRIS values and characterizing TCE as "highly 
likely to produce cancer in humans." The draft assessment, which became 
controversial, was peer reviewed by EPA's Scientific Advisory Board and 
released for public comment. A number of scientific issues were raised 
during the course of these reviews, including how EPA had applied 
emerging risk assessment methods--such as assessing cumulative effects 
(of TCE and its metabolites) and using a physiologically based 
pharmacokinetic model--and the uncertainty associated with the new 
methods themselves.[Footnote 36] To help address these issues, EPA, 
DOD, DOE, and NASA sponsored a National Academies review to provide 
guidance. The National Academies report, which was issued in 2006, 
concluded that the weight of evidence of cancer and other health risks 
from TCE exposure had strengthened since 2001 and recommended that the 
risk assessment be finalized with currently available data so that risk 
management decisions could be made expeditiously. The report 
specifically noted that while some additional information would allow 
for more precise estimates of risk, this information was not necessary 
for developing a credible risk assessment. Nonetheless, 10 years after 
EPA started its IRIS assessment, the TCE assessment is back at the 
draft development stage. EPA estimates this assessment will be 
finalized in 2010. More in line with the National Academies' 
recommendation to act expeditiously, five senators introduced a bill in 
August 2007 that, among other things, would require EPA to both 
establish IRIS values for TCE and issue final drinking water standards 
for this contaminant within 18 months. 

Tetrachloroethylene. EPA started an IRIS assessment of 
tetrachloroethylene--also called perchloroethylene or "perc"--in 1998. 
Tetrachloroethylene is a manufactured chemical widely used for dry 
cleaning of fabrics, metal degreasing, and making some consumer 
products and other chemicals. Tetrachloroethylene is a widespread 
groundwater contaminant, and the Department of Health and Human 
Services' National Toxicology Program has determined that it is 
reasonably anticipated to be a carcinogen. The IRIS database currently 
contains a 1988 noncancer assessment based on oral exposure that will 
be updated in the ongoing assessment. Importantly, the ongoing 
assessment will also provide a noncancer inhalation risk and a cancer 
assessment. The IRIS agency review of the draft assessment was 
completed in February 2005, the draft assessment was sent to OMB for 
OMB/interagency review in September 2005, and the OMB/interagency 
review was completed in March 2006. EPA had determined to have the next 
step, external peer review, conducted by the National Academies--the 
peer review choice reserved for chemical assessments that are 
particularly significant or controversial. EPA contracted with the 
National Academies for a review by an expert panel, and the review was 
scheduled to start in June 2006 and be completed in 15 months. However, 
as of December 2007, the draft assessment has not yet been provided to 
the National Academies. After verbally agreeing with both the noncancer 
and cancer assessments following briefings on the assessments, the 
Assistant Administrator, Office of Research and Development, 
subsequently requested that additional uncertainty analyses--including 
some quantitative analyses--be conducted and included in the assessment 
before the draft was released to the National Academies for peer 
review. As discussed above, quantitative uncertainty analysis is a risk 
assessment tool that is currently being developed, and although the 
agency is working on developing policies and procedures for uncertainty 
analysis, such guidance currently does not exist. The draft 
tetrachloroethylene assessment has been delayed since early 2006 as EPA 
staff have gone back and forth with the Assistant Administrator trying 
to reach agreement on key issues such as whether a linear or nonlinear 
model is most appropriate for the cancer assessment and how uncertainty 
should be qualitatively and quantitatively characterized. EPA officials 
and staff noted that some of the most experienced staff are being used 
for these efforts, limiting their ability to work on other IRIS 
assessments. In addition, the significant delay has impacted the 
planned National Academies peer review because the current contract, 
which has already been extended once, cannot be extended beyond 
December 2008. The peer review was initially estimated to take 15 
months. As a result, a new contract and the appointment of another 
panel may be required. 

Dioxin. The dioxin assessment is an example of an IRIS assessment that 
has been, and will likely continue to be, a political as well as a 
scientific issue. 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. EPA's initial dioxin assessment, published in 1985, 
focused on the dioxin TCDD (2,3,7,8-tetrachlorodibenzo-p-dioxin) 
because animal studies in the 1970s showed it to be the most potent 
cancer-causing chemical studied to date. Several years later, EPA 
decided to conduct a reassessment of dioxin because of major advances 
that had occurred in the scientific understanding of dioxin toxicity 
and significant new studies on dioxins' potential adverse health 
effects. Initially started in 1991, this assessment has involved 
repeated literature searches and peer reviews. For example, a draft of 
the updated assessment was reviewed by a scientific peer review panel 
in 1995, and three panels reviewed key segments of later versions of 
the draft in 1997 and 2000. In 2002, EPA officials said that the 
assessment 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 
meats, fish, and dairy products, which contain minute traces of 
dioxins. These foods contain dioxins because animals eat plants and 
commercial feed and drink water contaminated with dioxins, which then 
accumulate in animals' fatty tissue. It is clear that EPA's dioxin risk 
assessment could have a potentially significant impact on consumers and 
on the food and agriculture industries. As EPA moved closer to 
finalizing the assessment, in 2003 the agency was directed in a 
congressional appropriations conference committee report to not issue 
the assessment until it had been reviewed by the National Academies. 
The National Academies provided EPA with a report in July 2006. In 
developing a response to the report, which the agency is currently 
doing, EPA must include new studies and risk assessment approaches that 
did not exist when the assessment was drafted. EPA officials said the 
assessment will be subject to the IRIS review process once its response 
to the National Academies' report is drafted. As of 2008, EPA has been 
developing the dioxin assessment, which has potentially significant 
health implications for all Americans, for 17 years. 

While Appropriate Coordination with Federal Agencies Could Help EPA 
Resolve IRIS Assessment Controversies More Efficiently, EPA's Proposed 
Expansion of Agencies' Roles in IRIS Assessments Would Cause Further 
Delays and Limit Their Credibility: 

Although an interagency review process managed by OMB was informally 
incorporated into the IRIS assessment starting in 2004, federal 
agencies continue to believe they should have greater and more formal 
roles in EPA's development of IRIS assessments given the potential 
impact of the assessments on either their missions or their budgets, 
such as the need to redesign systems to eliminate hazardous materials 
or to clean up contaminated sites. These agencies--including DOD, DOE, 
the Department of Homeland Security, the Department of Transportation, 
and NASA--have sought earlier, more formal involvement in IRIS 
assessments than is currently provided through the OMB/interagency 
review process and the other avenues for input that currently exist, 
which include nominating chemicals for assessment and providing 
relevant studies for planned or ongoing assessments. Officials from 
DOD, NASA, and DOE told us there is a lack of formality and 
transparency about how they can provide input and when it is 
appropriate to do so. For example, they seek a more formal process for 
nominating chemicals and providing relevant studies for planned or 
ongoing assessments, and they want to help decide questions for the 
peer reviews of IRIS assessments. They said that reducing the 
scientific uncertainty in IRIS assessments is important because some 
assessments can have significant impacts on their operations and 
budgets. Also, the officials said that their involvement with IRIS 
assessments occurs too late in the process, leading to disagreement 
among EPA and the agencies after the assessments are drafted, and 
unnecessarily delaying certain assessments, such as naphthalene, TCE, 
and dioxin. 

Along these lines, we concluded in a 2006 report that EPA could help 
ensure consistent, transparent, and high-quality risk assessments by 
working with stakeholders early and periodically throughout the process 
to identify, among other things, key issues and studies that need to be 
considered in the analysis.[Footnote 37] Nonetheless, we believe that 
if EPA is to increase the involvement of DOD and other potentially 
affected federal agencies in the IRIS assessment process, it is 
important to do so in a way that enables EPA to balance the benefits of 
increased interagency coordination with EPA's need to improve the 
timeliness of its IRIS assessments and to ensure their credibility with 
proper controls. 

In response to the continuing concerns of some federal agencies 
regarding the IRIS assessment process, EPA has, for several years, been 
working to develop a formal IRIS assessment process that would give 
other federal agencies a more significant role in the process.[Footnote 
38] EPA consulted with an Interagency Work Group on the IRIS Process, 
which includes officials representing potentially affected agencies 
such as DOD, DOE, and NASA, as well as officials from other agencies 
that develop health assessments of chemicals, such as the Department of 
Health and Human Services' ATSDR. OMB, the Department of Homeland 
Security, and the White House Office of Science and Technology Policy 
are also represented on the working group. 

EPA developed a draft process in early 2007 that the agency believed 
would be acceptable to the interagency work group. One of the key 
aspects of EPA's draft process is an increased role for other agencies-
-including those whose operations and resource levels could be affected 
by the results of the assessments--in providing input to IRIS chemical 
assessments. Specifically, federal agencies would have the opportunity 
to be involved, or provide some form of input, at almost every step of 
EPA's IRIS assessment process. Most significantly, the draft proposed 
process would provide federal agencies with several opportunities 
during the IRIS assessment process to identify chemicals of interest to 
them as "mission critical." As defined in the draft process, a mission- 
critical chemical is one that is "an integral component to the 
successful and safe conduct of an agency's mission in any or all phases 
of operations." Potential impacts on the use of mission-critical 
chemicals assessed under the IRIS program include "cessation or 
degradation of the conduct of the mission and/or unacceptable resource 
constraints."[Footnote 39] A mission-critical designation would add 
requirements to the assessment process, providing other federal 
agencies with increased involvement in IRIS assessment decisions. As 
outlined, this designation could add 2 or more years to the process 
(see shaded boxes in fig. 5 for these additional requirements). 

Figure 5: EPA's Draft Proposed IRIS Assessment Process: 

[See PDF for image] 

This figure is an illustration of EPA's Draft Proposed IRIS Assessment 
Process, as follows: 

1. Annual request for nomination of IRIS chemicals for assessment[A]. 

2. Determine the annual agenda and publish it in the Federal 
Register[A]. 

3. Scientific literature search. 

4. Federal Register notice/data call-in[A]. 

5. Development of a draft qualitative assessment. Is the chemical 
mission critical? If yes, go to step 6; if no, go to step 10. 

6. Public review of draft qualitative assessment[B]. 

7. Review of public comments[B]. 

8. Interagency evaluation to close data gaps[B]. Is there interest in 
conducting research to close data gaps? If yes, go to step 9; if no, go 
to step 10. 

9. Federal agency development of new studies[B]. 

10. Development of a complete draft IRIS assessment (qualitative and 
quantitative), including internal peer consultation. Is the chemical 
mission critical? If yes, go to step 11; if no, go to step 12. 

11. EPA consults with federal agencies to determine level and scope of 
peer review[B]. Go to step 13. 

12. EPA determines the level and scope of the peer review. 

13. Internal agency review by the 18-member IRIS Agency Review 
Committee. 

14. Revised draft IRIS assessment. Return to step 13 if necessary. 

15. OMB/interagency review coordinated by OMB[C]. 

16. Revised draft IRIS assessment. Return to step 15 if necessary. 

17. Independent external peer review and public comment[C]. 

18. Revised draft IRIS assessment. 

19A. Second internal agency review by the 18-member IRIS Agency Review 
Committee. Return to step 18 if necessary. 

19B. Second OMB/interagency review coordinated by OMB[C]. Return to 
step 18 if necessary. 

20. Completion of IRIS assessment, EPA management review and approval, 
and posting on IRIS. 

[A] Additional steps, under EPAï¿½s planned changes, to its assessment 
process and indicate steps where EPA has provided additional 
opportunity for input from potentially affected federal agencies for 
mission-critical chemicals. 

[B] Indicate steps where EPA has provided additional opportunity for 
input from potentially affected federal agencies for all chemicals. 

[C] Indicate steps where potentially affected federal agencies already 
had an opportunity for input. 

Source: GAO analysis of EPA information. 

[End of figure] 

The additional requirements for assessments of mission-critical 
chemicals that would lengthen the IRIS assessment process include the 
following: 

* The opportunity for federal agencies and the public to identify any 
additional information that is available on a chemical and to correct 
any errors on EPA's new first assessment draft--a draft qualitative 
assessment.[Footnote 40] EPA estimates that the public comment period 
alone would add 45 days to the assessment process. 

* An opportunity for potentially affected federal agencies to review 
public comments made during the error correction step and initiate a 
meeting with EPA if they want to discuss a particular set of comments. 
EPA estimates that this step, which includes EPA's review and analysis 
of the public comments, would add 30 days to the process. 

* An opportunity for potentially affected federal agencies to fill a 
data gap or eliminate an uncertainty factor that is identified in the 
qualitative draft. If an agency believes it can sponsor research to 
fill a significant data gap, EPA would then suspend the assessment 
process for up to 18 months to allow that agency time to conduct 
research and have the completed study peer reviewed. 

In addition, the draft proposed process would give other federal 
agencies a formal role in helping EPA determine the level of 
independent peer review assessments for mission-critical chemicals-- 
that is, whether the peer reviews would be conducted by EPA Science 
Advisory Board panels, National Academies' panels, or panels organized 
by an EPA contractor. In addition, the other federal agencies would be 
able to help determine the panel members' areas of scientific expertise 
as well as the scope of the peer reviews and the specific issues they 
would address. 

Finally, the draft proposed process would also formalize the roles of 
other federal agencies in nominating chemicals for assessment, helping 
EPA determine the chemicals it would assess, and providing scientific 
information (reports, studies, etc.) for the assessments EPA 
undertakes. In the past, EPA sought such information in public notices 
in the Federal Register, and federal agencies could have provided their 
input either in response to these notices or by contacting EPA 
officials directly. However, in response to criticisms that EPA's 
approach to seeking input from the public was not appropriate for other 
federal agencies, under the proposed process, EPA would directly reach 
out to other federal agencies for this input by separately 
communicating these requests to them at the time it publishes its 
notices in the Federal Register. The draft proposed IRIS process would 
also formalize the OMB/interagency reviews, which provide other federal 
agencies with the opportunity to provide comments on IRIS draft 
assessments both before and after the draft assessments are provided to 
external peer reviewers. The OMB/interagency reviews would continue to 
be managed by OMB. 

EPA has acknowledged that the additional steps and opportunities for 
input from other federal agencies that its draft proposed process would 
provide will add more time to an already lengthy process. Specifically, 
under the proposed process we reviewed, EPA officials estimated that 
IRIS assessments for standard chemicals would take roughly 2-1/2 years 
to complete and that an additional 2 to 3 years would be needed for 
mission-critical chemicals. In February 2008, the Assistant 
Administrator, Office of Research and Development, updated these time 
frames, estimating that most assessments would take between 3 and 4-1/ 
2 years to complete, while assessments of mission-critical chemicals 
would take up to 6 years. However, these estimates appear to be 
optimistic considering the length of time ongoing assessments--which 
have not been subject to additional process steps--have been in 
progress: most for more than 5 years and many for more than 9 years. 
Further, when assessments take longer than 2 years, they can become 
subject to substantial delays stemming from the need to redo key 
analyses to take into account changing science and assessment 
methodologies. 

According to officials from EPA and some of the potentially affected 
federal agencies, the key goals of the draft proposed changes to the 
IRIS assessment process are to (1) fill data gaps to reduce uncertainty 
in the IRIS assessments and (2) prevent disagreements among EPA and 
other federal agencies about assessments late in the IRIS assessment 
process. As discussed earlier, disagreements have arisen late in the 
process in the past and have significantly delayed the completion of 
some assessments. These goals are important, and it is appropriate for 
EPA and the federal agencies to find ways to achieve them. However, 
some of the proposed changes would result in assessments being caught 
in a continuous cycle of updates and revisions--delaying the completion 
of assessments of chemicals with potentially significant health impacts 
for many years. As discussed above, delays for any reason--including 
waiting for new research to fill data gaps--can have a compounding 
effect on time frames because delays often require extensive rework, 
such as updates to reflect other studies that have come out in the 
interim, performing additional analyses to reflect the current state of 
the science of risk assessment tools, and other rounds of interagency 
or external peer reviews because of changes in the assessments. Thus, 
changing from a reliance on the best available scientific data at the 
time an assessment is conducted to a reliance on research that has 
either not yet started or been completed in order to fill scientific 
data gaps is a decision that can have a significant impact on 
assessment completion dates. 

Further, although EPA has said that IRIS assessments would only be 
suspended to wait for shorter-term studies, such as those assessing 
modes of action, we and several agency officials we spoke with believe 
that the time needed to plan, conduct, and complete research that would 
address significant data gaps, and have it peer reviewed, would likely 
take longer than the 18 months EPA would allow under its draft proposed 
IRIS process. In addition, although the draft process would set a limit 
on the time the assessments can be suspended to await studies, the 
enforcement of such time frames could prove to be difficult when 
research schedules slip. And not waiting for study results beyond the 
18-month limit could, in fact, undo all of the efforts expended to 
avoid disagreements in the later stages of the assessments. Also, EPA's 
prior experience with waiting for studies, such as in the case of the 
formaldehyde assessment discussed earlier, shows that estimates of 
completion dates for these studies can stretch out from months to 
years. Finally, the extent to which new research would provide 
information that would actually reduce key scientific uncertainties in 
the IRIS assessments is not known until the research is completed and 
peer reviewed. 

In discussing with us the need for additional time to conduct new 
research to fill scientific data gaps for chemicals defined as mission 
critical, DOD officials emphasized that the federal agencies believe it 
is important that scientific uncertainties are reduced to the maximum 
extent practical within a reasonable time frame before IRIS assessments 
of mission-critical chemicals with high uncertainty are completed. The 
potential impacts of IRIS assessments on DOD--should risk assessments 
using the IRIS data lead to regulatory actions--could include the need 
to (1) conduct research and development of material substitutes; (2) 
redesign systems and processes to eliminate hazardous materials; (3) 
conduct research and development of treatment or cleanup technologies; 
(4) improve personal protective clothing, equipment, and procedures; 
and (5) provide for special handling and storage of chemicals. 

However, the reality is that scientific data gaps will almost always 
exist. EPA, whose mission includes protecting the public and the 
environment from harmful chemicals, must decide whether to use 
assumptions and estimates to address data gaps or to wait for research 
that could potentially fill some of the data gaps. On this issue, in 
discussing the fact that EPA must address many environmental risks with 
incomplete data and a lack of consensus about assumptions, the agency 
has stated that it seeks to strike a balance among fairness, accuracy, 
and efficient action because not acting until data quality improves can 
result in substantial harm to human health, safety, and the 
environment. Along these lines, as discussed earlier, a National 
Academies panel recently reported on a chemical of interest 
(trichloroethylene) to several federal agencies that would likely be 
defined as mission critical under the proposed IRIS process. The 
National Academies' report recommended that the risk assessment be 
finalized with currently available data, rather than waiting for 
additional information to address scientific uncertainties, so that 
risk management decisions can be made expeditiously because the 
evidence on risks to human health have strengthened. The National 
Academies specifically noted that while some additional information 
would allow for more precise estimates of risk, this information is not 
necessary at this time for developing a credible risk assessment. EPA 
started the assessment in 1998, and it has been subject to multiple 
independent peer reviews. However, EPA is currently preparing another 
assessment draft that will need to undergo the IRIS assessment process 
a second time. As such, the draft will be to subject to the OMB/ 
interagency reviews and another independent peer review before it can 
be finalized. We note that if EPA's proposed IRIS process is 
implemented, DOD and other federal agencies could designate 
trichloroethylene as a mission-critical chemical and have the 
assessment suspended for 18 months for research aimed at reducing 
scientific uncertainties. 

EPA could potentially minimize or eliminate requests to suspend ongoing 
assessments to fill in scientific data gaps by better coordinating with 
DOD's emerging contaminants program--established in 2006--that leads 
and supports the Materials of Emerging Regulatory Interest Team 
(MERIT).[Footnote 41] The intent of the emerging contaminants program 
is to help DOD proactively manage chemicals DOD uses or has used in its 
operations that (1) are a perceived or real threat to human health or 
the environment and (2) lack a published health standard and/or have 
new information available about their sources or effects. The program 
seeks to identify chemicals of importance to DOD's mission that are on 
the regulatory horizon so that the agency can begin to make changes or 
identify areas of research that may minimize the impact that 
regulations of a particular chemical would have on the agency and its 
mission. 

Of particular relevance to the IRIS program is the scanning component 
of the emerging contaminants program, which consists of a regular 
review of the scientific literature, periodicals, and regulatory 
communications for chemicals that have, or are likely to have, changing 
human health values or regulatory standards. DOD then further screens 
those chemicals that are, were, or will be used by DOD to determine 
whether a potential impact to DOD's mission exists. After screening, 
DOD conducts impact assessments to determine the severity of risk to 
DOD functional areas, which include environment, safety, and health 
protection; research and development; production, operation and 
maintenance, and disposal; training and readiness; and cleanup. Through 
these efforts, DOD seeks to identify cost-effective opportunities to 
proactively manage future unacceptable risks. One research area the 
emerging contaminants program has identified as a potentially good 
investment is DOD-funded health effects research aimed at filling 
important data gaps for mission-critical chemicals with high 
uncertainty factors.[Footnote 42] 

DOD's ongoing actions in monitoring scientific literature and 
identifying research that could reduce scientific uncertainties could 
be more effectively put to use. Specifically, enhanced coordination and 
collaboration between EPA and DOD's emerging contaminants program have 
the potential to proactively reduce some scientific uncertainties 
associated with chemicals that EPA is not yet assessing--as opposed to 
the current reactive focus on ongoing IRIS assessments. That is, under 
the draft proposed IRIS process changes we reviewed, DOD and other 
federal agencies would be able to designate ongoing chemicals as 
mission critical at several stages in the assessment process--and have 
their assessments suspended for up to 18 months to address data gaps. 
However, enhanced coordination and collaboration between DOD and EPA 
could change this essentially reactive approach to a model that is more 
proactive and effective. If, for example, EPA provided 2 years' notice 
of its intent to assess specific chemicals, rather than simply 
announcing the list of chemical assessments it plans to initiate during 
a given fiscal year, DOD and other agencies could use this time to 
sponsor and complete the studies they deem necessary, rather than 
waiting to initiate them after an IRIS assessment had started. Giving 
agencies 2 years' notice (which would provide them with more than 18 
months to conduct additional research) would be more effective and 
efficient than delaying ongoing IRIS assessments for 18 months to await 
research, given the compounding effect of delays on IRIS assessments. 
We note that, to date, the emerging contaminants action list--the list 
of chemicals that DOD has assessed and judged to have a significant 
potential impact on people or the DOD mission--has focused largely on 
chemicals that EPA's IRIS program is already assessing. However, with 
some adjustments in the emerging contaminants program's focus or scope, 
DOD could widen its scope and help EPA with its planning process by 
earlier identification of the mission-critical chemicals of concern to 
DOD for which IRIS assessments are needed. Finally, when the emerging 
contaminants program identifies health research needs for chemicals 
considered mission critical, DOD could meet its research needs more 
effectively and quickly by sponsoring research as needs are identified, 
rather than waiting until IRIS assessments are started. 

Lastly, we note that while increased coordination with potentially 
affected federal agencies on IRIS assessments could enhance the 
assessments and facilitate their completion, giving potentially 
affected federal agencies formal roles in some IRIS assessment 
decisions reduces the credibility of the assessments if proper 
controls, such as ensuring transparency, are not in place. While we 
recommended in our 2006 report on human health risk assessment that EPA 
consistently involve stakeholders as appropriate to the risk 
assessment, we made this recommendation in the context of improving the 
overall quality, consistency, and transparency of risk assessments. 
However, one aspect of EPA's draft proposed IRIS process that has 
proven to be controversial involves transparency. Specifically, EPA's 
early 2007 draft proposal included making the comments from OMB and 
other federal agencies provided during the OMB/interagency review 
process part of the public record; according to EPA, this requirement 
has been removed from the latest draft proposal because of concerns 
raised by OMB. These concerns have delayed the implementation of the 
planned process changes, and as of December 2007, EPA was planning to 
send a revised draft back to the interagency work group for review and 
approval. 

According to DOD officials, OMB did not support certain aspects of the 
draft process EPA presented to the Interagency Work Group on the IRIS 
Process in early 2007, expressing concerns about how the proposal would 
address the concerns of states, industry, and environmental entities 
and the requirement to have agencies' comments part of the public 
record. The latter concern stemmed from the precedent it might set and 
because OMB believes that doing so would erode the effectiveness of the 
deliberative process among EPA and the agencies. However, because the 
agencies' comments on IRIS assessments are to be scientific in nature, 
it is unclear why agencies might not candidly comment on an IRIS 
assessment even if their comments would become part of the public 
record. In fact, officials from DOD, DOE, and NASA told us they did not 
object to EPA's plan to make interagency comments part of the public 
record because they would be scientific in nature and not part of a 
policy discussion. 

While OMB officials would not comment directly on this issue as it 
relates to objections they might have to EPA's draft proposed process, 
one official told us that generally OMB believes that effective 
deliberations among federal agencies are important and that if 
agencies' deliberative comments are part of the public record, agency 
officials will not be as frank and candid as they would be under the 
protection of confidentiality. 

However, transparency in the IRIS assessment process can provide 
assurance that these scientific assessments are appropriately based on 
the best available science and that they are not impacted by policy 
issues and considerations. Under the National Academies' risk 
assessment and risk management paradigm, policy considerations are 
relevant in the risk management phase, which occurs after the risk 
assessment phase that encompasses IRIS assessments.[Footnote 43] Some 
of the federal agencies that would be given formal roles in some IRIS 
assessment decisions are particularly interested in risk management 
issues as they would likely face adverse consequences, such as 
increased cleanup costs and other legal liabilities, if EPA issues an 
IRIS assessment for a given chemical that results in a risk management 
decision to regulate the chemical to protect the public.[Footnote 44] 
Consequently, to ensure credibility of the IRIS assessments, the input 
of these agencies into the assessment process should be transparent. 

Further, when EPA and other agencies propose regulations or other 
actions on the basis of health risk assessments, the proposals 
represent policy choices. Through the rule-making process and other 
interagency working groups, federal agencies have the opportunity to 
participate in policy dialogues. Such discussions can appropriately 
address risk management concerns that, by definition, involve 
integrating risk characterization information (based, in part, on 
information in IRIS) with other information[Footnote 45] to decide how 
to protect public health. In contrast, the input of federal agencies 
into the IRIS assessments, part of the risk assessment process, should 
be based solely on science issues, not policy concerns. 

Conclusions: 

The IRIS database, one of the most significant tools that EPA has 
developed to effectively support its efforts to protect people and the 
environment from harmful chemical exposures, is at serious risk of 
becoming obsolete because the agency has not been able to keep its 
existing assessments current or complete assessments of the most 
important chemicals of concern. Although EPA has taken important steps 
to improve the IRIS program and productivity since 2000 and has 
developed a number of draft assessments for external review, its 
efforts to finalize the assessments have been thwarted by a combination 
of factors: the imposition of external requirements, the growing 
complexity and scope of risk assessments, and certain EPA management 
decisions. Each of these factors has led to delays in the completion of 
individual IRIS assessments. In addition, an overarching factor--the 
compounding effect of delays--has had a particularly profound impact on 
productivity: Even a single delay can create a cascading series of 
delays with far-reaching, time-consuming consequences. In fact, in some 
cases, it is necessary to essentially start the assessment process over 
because of the need to incorporate science and methodologies that have 
evolved since the assessments began. To effectively meet its diverse 
user needs, EPA must both keep the IRIS database up to date and 
undertake assessments of potentially dangerous chemicals not yet 
evaluated. Achieving these objectives will require EPA to complete IRIS 
assessments in a timely fashion that minimizes rework--an outcome that 
cannot occur unless EPA's IRIS assessment process is streamlined to 
routinely support timely completion of assessments. When assessments 
take longer than two years, they can become subject to substantial 
delays stemming from the need to redo key analyses to take into account 
changing science and assessment methodologies. 

However, the manner in which other federal agencies are involved in the 
IRIS assessment process prevents EPA from effectively streamlining and 
managing its assessments. Under the current process, EPA is required to 
send draft assessments to OMB at two key points in the assessment 
process. Although the OMB/interagency reviews have no time frames or 
deadlines, EPA is not allowed to proceed with the assessment process 
until OMB agrees that EPA has sufficiently responded to agencies' 
comments; and OMB has also directed EPA to terminate five assessments. 
Further, OMB's view that disagreements between EPA and other agencies 
should simply be elevated to senior EPA executives for resolution is 
inefficient and causes delays. That is, an effective IRIS assessment 
process would not require the constant intervention of top-level 
executives, whose time is already at a premium. Moreover, the current 
process elevates the goal of reaching interagency agreement above 
achievement of IRIS program objectives and, in doing so, fails to 
adequately acknowledge the expertise of EPA scientists and the many 
other scientific experts who have prepared and reviewed the 
assessments. We believe that interagency coordination can enhance the 
quality of EPA's IRIS assessments. However, this goal would more likely 
be achieved if the input from other federal agencies was obtained in a 
manner that better ensured that EPA's scientific analyses were given 
appropriate weight and that provided time frames to avoid indefinite 
delays. Because an integral part of EPA's mission is to assess the 
risks associated with exposures to chemicals, the agency is best 
situated to establish how--and at what level--to best resolve IRIS 
assessment issues raised by other federal agencies. Until EPA can 
establish time frames for various assessment steps--including the OMB/ 
interagency review process--and determine (1) how it will resolve 
interagency conflicts, (2) when assessments are ready for either 
independent peer review or completion, and (3) the scope of the 
assessments needed to support EPA programs, EPA will continue to be 
hampered in its ability to develop timely and credible IRIS assessments 
that meet its needs and protect the environment. 

Importantly, the lack of transparency of the OMB/interagency review 
process reduces the credibility of EPA's IRIS assessments. Because the 
agencies' comments and the changes EPA makes in response are treated as 
internal executive branch documents not subject to release outside the 
executive branch, the OMB/interagency reviews occur in what amounts to 
a black box. Specifically, the first assessment drafts that become 
publicly available--those provided to independent peer reviews-- 
incorporate changes from federal agencies that may be affected by the 
assessments without identifying or providing reasons for the changes. 
Moreover, the changes EPA is proposing to its current assessment 
process would provide potentially affected federal agencies with a 
formalized opportunity to provide input at almost every step in the 
assessment process without addressing the extent to which agencies' 
input would be made part of the public record. Given the importance and 
sensitivity of IRIS assessments, it is critical that input from all 
parties, particularly agencies that may be affected by the outcome, be 
publicly available to alleviate concerns of potential bias in the 
assessments. 

In addition, EPA's draft proposed changes to its IRIS assessment 
process--which would further expand the role of other federal agencies 
in the process, including the option to suspend assessments of key 
chemicals for up to 18 months to develop new studies--would add to the 
already unacceptable level of delays in completing IRIS assessments. 
Under its draft proposed changes, EPA estimates that assessments of 
certain key chemicals may take up to 6 years. Assessments of this 
duration are problematic--they tend to get caught in a perpetual cycle 
of updates and revisions. Further, we believe EPA's time estimate for 
assessments under its draft proposal are optimistic, as most IRIS 
assessments currently in progress have already been in the works for 
more than 5 years, including 12 that have been in progress for more 
than 9 years. Yet these assessments have not been subject to the 
additional steps and requirements under the draft proposed process. 

An alternative, more efficient approach to suspending assessments while 
waiting for new research would be for EPA to give agencies and the 
public more advance notice of planned assessments, thereby providing 
external parties with an interest in conducting additional research on 
a given chemical the ability to complete their work prior to the start 
of the IRIS assessment. This is important because effectively 
maintaining the IRIS database depends on strict adherence to time 
frames using the best available science. In addition, we note that OMB 
has raised questions about whether the proposed process sufficiently 
addresses the needs of private entities. Along these lines, we believe 
that if EPA grants special rights to other federal agencies to suspend 
IRIS assessments to conduct new research, it is likely that the agency 
would face pressure to do so for numerous other entities, including 
industries and individual companies that could be impacted by IRIS 
assessments should the assessments lead to regulatory actions. 

Further, while we believe it is appropriate for EPA to identify key 
uncertainties in IRIS assessments and to continue to work on developing 
methodologies for conducting more sophisticated and meaningful 
uncertainty analyses, continuing to delay IRIS assessments in order to 
develop and test enhanced methodologies and strategies for 
communicating them can conflict with EPA's stated goal of seeking 
balance among fairness, accuracy, and efficient action. More 
specifically, EPA has acknowledged that not acting until data quality 
improves can result in substantial harm to human health, safety, and 
the environment. Also, as EPA continues to incorporate uncertainty 
analysis in its assessments, ensuring that the information is clear and 
useful to decision makers is important. Along these lines, the National 
Academies and others have warned that producing "ranges of meaningless 
and confusing risk estimates" could result in assessments of reduced, 
rather than enhanced, quality and objectivity. 

Lastly, while it is difficult to overstate the importance of the IRIS 
program to EPA's ability to effectively conduct its mission of 
protecting human health and the environment, this program currently 
uses about 0.1 percent of EPA's annual appropriations--specifically, in 
fiscal year 2007, the program received about $9.6 million of EPA's $7.3 
billion budget. EPA's current estimate that it will be able to complete 
16 assessments a year by 2011 would represent a substantial increase 
over recent productivity; however, it is not clear that this level will 
be sufficient to maintain the viability of the IRIS database. 

Recommendations for Executive Action: 

To develop timely chemical risk information that EPA needs to 
effectively conduct its mission, we are recommending that the 
Administrator, EPA, require the Office of Research and Development to 
re-evaluate its draft proposed changes to the IRIS assessment process 
in light of the issues raised in this report and ensure that any 
revised process: 

* clearly defines and documents a streamlined IRIS assessment process 
that can be conducted within time frames that minimize the need for 
wasteful rework and carefully considers the trade-off between the 
benefits of changes that involve additional steps and time--including 
the development of enhanced uncertainty analyses and other emerging 
assessment methods--and the impacts of these changes on EPA's ability 
to complete timely chemical assessments; 

* establishes a policy that endorses conducting IRIS assessments on the 
basis of peer-reviewed scientific studies available at the time of the 
assessment and develops criteria for allowing assessments to be 
suspended to await the completion of scientific studies only under 
exceptional circumstances; 

* establishes IRIS assessment needs to provide at least 2 years' notice 
of assessments that are planned, including criteria for making 
exceptions to the advance notifications, if needed; 

* sets time limits for all parties, including OMB and other federal 
agencies, to provide comments to EPA on draft IRIS assessments; and: 

* periodically assesses the level of resources that should be dedicated 
to this significant program to meet user needs and maintain a viable 
IRIS database. 

In addition, we recommend that the EPA Administrator take steps to 
better ensure that EPA has the ability to develop transparent, credible 
IRIS chemical assessments--an ability that relies in large part on 
EPA's independence in conducting these important assessments. Actions 
that are key to this ability include ensuring that EPA: 

* can determine the types of IRIS assessments to conduct on the basis 
of the needs of EPA's program offices and other users; 

* can define the appropriate role of external federal agencies in EPA's 
IRIS assessment process and manage an interagency review process in a 
manner that enhances the quality, transparency, timeliness, and 
credibility of IRIS assessments, including determining when interagency 
issues have been appropriately addressed; and: 

* has the ability to provide comments by OMB and other federal agencies 
on draft IRIS assessments to decision makers, the Congress, and the 
public. 

Agency Comments and Our Evaluation: 

In commenting on a draft of this report, EPA's Assistant Administrator 
for Research and Development agreed to consider our recommendations in 
revising the IRIS assessment process. However, EPA stated that it 
believed the productivity and transparency issues discussed in the 
draft report were misrepresented in the title and body of the report. 
We disagree and believe we have fairly represented IRIS productivity 
and transparency issues related to the IRIS assessment process. We did 
clarify that the transparency issues highlighted in our report focus on 
the IRIS assessment process rather than on the content of IRIS 
assessments, and we revised the report title. In addition, EPA 
emphasized that the proposed changes to the IRIS assessment process are 
still subject to change. Along these lines, we made our recommendations 
with the intent that they would be integrated into any revised process. 
In its response, EPA also estimated that under the new process, most 
assessments would take between 3 and 4-1/2 years; mission-critical 
assessments would take up to 6 years. These estimates differ from the 
time frames EPA officials provided during our review, and we have 
revised the report to reflect this. However, we believe an IRIS 
assessment process built around such time frames is problematic. As we 
state in our draft and final reports, when assessments take longer than 
2 years, they can become subject to substantial delays stemming from 
the need to redo key analyses to take into account changing science and 
assessment methodologies. Finally, EPA asserted that the new process 
will lead to increased productivity. We disagree and have concluded 
that the proposed revisions would add to the already unacceptable level 
of delays in completing IRIS assessments. 

In its comments, OMB did not specifically address the recommendations 
we made to EPA but disagreed with some aspects of the report, primarily 
regarding our characterization of the OMB-managed interagency reviews 
and their effects on IRIS assessments. For example, OMB indicated that 
it disagreed with our conclusions that the OMB/interagency reviews make 
it more difficult for EPA to complete IRIS assessments in a timely 
manner, that these reviews affect the credibility of the assessments, 
and that interagency comments should be transparent. We disagree with 
OMB and believe that we have fairly represented the OMB/interagency 
review process as well as the importance of input from all parties 
being publicly available. Given the importance and sensitivity of IRIS 
assessments, it is critical that input from all parties, particularly 
agencies that may be affected by the outcome, be publicly available to 
alleviate concerns of potential bias in the assessments. EPA's and 
OMB's comments and our detailed responses appear in appendix IV and 
appendix V. 

As agreed with your office, unless you publicly announce the contents 
of this report earlier, we plan no further distribution of this report 
until 30 days from the report date. At that time, we will send copies 
to the Administrator, EPA; the Director, OMB; and appropriate 
congressional committees and other interested parties. We will also 
make copies available to others on request. In addition, the report 
will be available at no charge on the GAO Web site at [hyperlink, 
http://www.gao.gov]. 

If you or your staff have any questions about this report, please 
contact me at (202) 512-3841 or [email protected]. 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, 

Signed by: 

John B. Stephenson: 
Director, Natural Resources and Environment: 

[End of section] 

Appendix I: Objectives, Scope, and Methodology: 

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, we determined (1) the outcome of steps 
that EPA has taken to ensure that IRIS contains current, credible 
chemical risk information, to address the backlog of IRIS assessments, 
and to respond to new requirements from the Office of Management and 
Budget (OMB); and (2) the potential effects of EPA's planned changes to 
the IRIS assessment process on EPA's ability to ensure that IRIS 
provides current, credible risk information. 

To address these two objectives, we reviewed relevant EPA and other 
documents, including EPA's 2003 IRIS Needs Assessment, the Office of 
Research and Development's multiyear plans, numerous documents 
outlining the IRIS assessment process and draft proposed changes to the 
assessment process, EPA budget justification documents, and OMB's 
Program Assessment Rating Tool assessment that covered the IRIS 
program. We interviewed officials from EPA's National Center for 
Environmental Assessment who manage the IRIS assessment program, 
including the Center Director, the Associate Director for Health, and 
the IRIS Program Director; officials from other EPA program offices, 
including the Office of Air and Radiation; and officials from federal 
science and health agencies that are involved in the IRIS assessment 
process, to obtain their perspectives on, among other things, the 
current IRIS assessment process, the potential effects of the draft 
proposed changes to the process, the extent to which EPA has made 
progress in completing assessments and meeting user needs, and 
challenges EPA faces in completing assessments. In addition, we 
interviewed officials from the Department of Defense, the Department of 
Energy, and the National Aeronautics and Space Administration who have 
served on the interagency working group on the IRIS assessment process, 
and OMB officials in the Office of General Counsel and the Office of 
Information and Regulatory Affairs to obtain their perspectives on the 
OMB/interagency review process and on the planned changes to the IRIS 
assessment process. We also interviewed officials from the Department 
of Health and Human Services' Agency for Toxic Substances and Disease 
Registry (ATSDR), an agency that assesses the potential noncancer 
health effects of exposure to some chemicals, to obtain information on 
ATSDR's assessment process. In addition, we attended the Board of 
Scientific Counselors Human Health Risk Assessment (HHRA) Subcommittee 
meetings in November 2007. During these meetings, the Subcommittee 
reviewed the EPA Office of Research and Development's HHRA program-- 
specifically, its relevance, quality, performance, and scientific 
leadership. 

For the first objective, we obtained and analyzed several data sets, 
including data from EPA's IRIS database; EPA's IRIS Track--a 
compilation of status reports for IRIS assessments in progress; Federal 
Register notices announcing annual IRIS agendas; a spreadsheet that EPA 
uses to track the IRIS assessments sent to OMB for the OMB/interagency 
reviews; EPA's 2003 screening level reviews report--its efforts to 
identify assessments that may need to be updated; and EPA's 2003 IRIS 
Needs Assessment. From the data we gathered, we analyzed information on 
EPA's productivity, including the number of new and completed IRIS 
assessments, for fiscal years 2000 through 2007; the status of IRIS 
assessments, as of December 1, 2007, that were in progress during 
fiscal year 2007; the status of IRIS assessments that have been sent to 
OMB for OMB/interagency review and the time elapsed during those 
reviews; the number of assessments in the IRIS database that may need 
to be updated; the resources provided to the program for fiscal years 
2000 through 2007; and user needs and EPA's assessment completion 
goals. We also interviewed chemical managers, who are responsible for 
managing the IRIS assessments in progress, to obtain further 
information on the 77 chemicals in progress during fiscal year 2007. We 
did not evaluate the scientific content or quality of IRIS assessments. 

In addition, we conducted a reliability review of the data we received 
from EPA for our first objective. Through our review, we determined 
that the data we used were sufficiently reliable for our purposes. Our 
assessment consisted of interviews with officials about the data system 
and elements and the method of data input, among other areas. We also 
corroborated the data with other sources, where possible. For example, 
we verified the information provided in EPA's IRIS Track system with 
the chemical managers responsible for each of the 77 chemicals in 
progress during fiscal year 2007, and updated the information as 
appropriate. Similarly, we ensured that status information presented in 
IRIS Track was consistent with the status information presented in the 
spreadsheet that EPA uses to track draft assessments provided to OMB 
for the OMB/interagency review. In addition, EPA attempted to 
corroborate its data on the status of IRIS assessments that have been 
sent to OMB for OMB/interagency review and the time elapsed during 
those reviews, providing OMB with its tracking spreadsheet for review. 
OMB chose not to respond. Consequently, we relied on EPA's data and 
assessed its reliability, based on information including the source of 
the data and method of input. 

We conducted this performance audit from October 2006 to March 2008 in 
accordance with generally accepted government auditing standards. Those 
standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives. 

[End of section] 

Appendix II: Broad Outline of EPA's Current IRIS Assessment Process: 

Note: This outline does not include the individual activities, 
including internal reviews and briefings, encompassed within many of 
the broad IRIS assessment categories. 

1. Annual request for nomination of IRIS chemicals for assessment. 

2. Determine the annual agenda and publish it in the Federal Register, 
along with a call for scientific information from the public on select 
chemicals. 

3. Scientific literature search. 

4. Development of a complete draft IRIS assessment (qualitative and 
quantitative), including internal peer consultation. 

5. Internal agency review by the 18-member IRIS Agency Review 
Committee. 

6. Revised draft IRIS assessment. 

7. OMB/interagency review coordinated by OMB. 

8. Revised draft IRIS assessment. 

9. Independent external peer review and public comment. 

10. Revised draft IRIS assessment. 

11A. Second internal agency review by the 18-member IRIS Agency Review 
Committee. Return to step 10 if necessary. 

11B. Second OMB/interagency review coordinated by OMB. Return to step 
10 if necessary. 

12. Completion of IRIS assessment, EPA management review and approval, 
and posting on IRIS. 

Source: GAO analysis of EPA information. 

Note: This outline does not include the individual activities, 
including internal reviews and briefings, encompassed within many of 
the broad IRIS assessment categories. 

[End of section] 

Appendix III: Information on OMB/Interagency Reviews of IRIS 
Assessments: 

As of December 1, 2007, EPA has sent 36 draft IRIS assessments to OMB 
for the first OMB/interagency review managed by OMB, and the reviews of 
16 assessments were completed. As shown in figure 6, the OMB/ 
interagency review of 4 assessments was completed in less than 6 months 
and 12 of these assessments added 6 or more months to the IRIS 
assessment process. 

Figure 6: Status of IRIS Assessments Sent to OMB for the First OMB/ 
Interagency Review Starting in Fiscal Year 2004, as of December 1, 
2007: 

[See PDF for image] 

This figure is a vertical bar graph depicting the following data: 

Number of assessments: 
Status: Completed interagency review in less than 6 months; 
Number of assessments: 4. 

Status: Completed interagency review in 6 or more months; 
Number of assessments: 12. 

Status: Assessment suspended, now being redone; 
Number of assessments: 1. 

Status: Assessment discontinued after a year in OMB/interagency review; 
Number of assessments: 5. 

Status: OMB/Interagency review ongoing for 6 months to a year; 
Number of assessments: 1. 

Status: "Interagency review ongoing for 2 to 4 months[A]; 
Number of assessments: 13. 

Source: GAO analysis of EPA data. 

[A] These 13 assessments were submitted to OMB in the last quarter of 
fiscal year 2007. 

[End of figure] 

Moreover, as also shown in figure 6, five assessments that assessed 
acute exposure were discontinued at the direction of OMB after a year 
in the OMB/interagency review stage,[Footnote 46] and one assessment 
was suspended and is now being redone (naphthalene). Finally, 14 
assessments were at the OMB/interagency review stage as of December 1, 
2007: Of these, 1 had been at this stage for 9-ï¿½ months, and the 
remaining 13 had been submitted to OMB in the last quarter of fiscal 
year 2007 and had been at the OMB/interagency review stage for 2 to 4 
months. While OMB officials said that EPA does not have to provide a 
document addressing every OMB/interagency comment, EPA officials said 
that a detailed disposition of comments document was, in fact, 
necessary in order to get OMB's agreement that EPA had satisfactorily 
addressed all comments. There are no time frames for this iterative 
process. 

OMB officials said that the second OMB/interagency review is conducted 
by OMB to ensure that EPA has adequately considered the comments from 
the external peer review panel. As of December 1, 2007, 10 assessments 
had been sent to OMB for the second OMB/interagency review, and 5 of 
these assessments completed the review. The time frames for these five 
assessments ranged from 10 days to almost 4 months. 

[End of section] 

Appendix IV: Comments from the Environmental Protection Agency: 

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

United States Environmental Protection Agency: 
Office Of Research And Development: 
Washington, D.C. 20460: 
[hyperlink, http://www.epa.gov]: 

February 21, 2008 

John B. Stephenson, Director: 
Natural Resources and Environment: 
Government Accountability Office: 
441 G Street NW, Room 2135: 
Washington, DC 20548: 

Dear Mr. Stephenson: 

Thank you for the opportunity to review and comment on the Government 
Accountability Office's (GAO) draft report, "Low Productivity and Lack 
of Transparency Limit the Usefulness and Credibility of EPA's 
Integrated Risk Information System" (IRIS). Recognizing that EPA will, 
in all probability, respond to the final version, I would like to 
comment briefly on the productivity and transparency issues that are 
discussed in the draft report, which we believe are misrepresented in 
the report's title and throughout the report. 

Since GAO raised many issues already recognized by EPA, the Agency has 
been actively working on revisions to its IRIS process. We believe 
these revisions will improve the productivity and transparency of IRIS. 
It should be noted that although GAO discusses some of the aspects of 
EPA's ongoing efforts to update the IRIS process, and comments on the 
potential effects of the proposed changes to the process, the GAO draft 
report refers to an outdated draft (internal) document. [See comment 1] 
Consequently, some of the steps or procedures presented by GAO in its 
draft report have changed or will no longer be relevant in the final 
process. GAO's draft report should acknowledge that they were working 
from a draft internal document, and therefore that GAO's conclusions 
and recommendations may be erroneous when compared to the final IRIS 
process. [See comment 2] Nonetheless, EPA will consider each of the 
GAO's recommendations in light of the new IRIS process, even though 
these recommendations were based on the outdated draft document. 

Under the new process, EPA's increased involvement of other agencies 
and the public will help us identify scientific issues earlier and 
foster better communication and sharing of information, which will 
ultimately help streamline the IRIS process. [See comment 3] It is 
worth noting that under the new process, specific time limits for each 
step in the process will improve the timeliness of completed 
assessments. For example, public and interagency review periods will be 
for fixed and relatively short durations. Interagency and public review 
will therefore represent only a small fraction of the total time 
required to complete an IRIS assessment. For most chemicals, the IRIS 
process will take between three and four and a half years. For the 
small number of mission-critical chemicals, the process may take an 
extra one to one and a half years. EPA believes the new IRIS process, 
in combination with the increased resources for the program provided in 
recent years, will lead to increased productivity in achieving 
completed assessments. [See comment 4] 

Although only briefly recognized in GAO's draft report, today's IRIS 
assessments are much more sophisticated, complex, and of higher 
scientific quality than at any other time in the program's history. 
[See comment 5] The increased complexity of chemical assessments often 
leads to extensive public comments and more rigorous levels of internal 
and external peer review, which is one of the most important reasons 
for delays in the IRIS process. Additionally, recent external peer 
reviews by EPA's Science Advisory Board (SAB) and the National Academy 
of Sciences (NAS) have requested that even more sophisticated analyses, 
such as quantitative uncertainty analysis, be performed and presented 
in some IRIS assessments. These issues, and EPA's responsiveness to 
them, are given too little attention or are unfairly criticized in the 
GAO draft report. [See comment 6] 

Also, the IRIS program has increased the rigor of its scientific peer 
review. Specifically, the external peer review process has been changed 
from letter reviews to face-to-face panel peer reviews that are open to 
the public. This has encouraged public interaction with the peer 
reviewers. Members of our Board of Scientific Counselors (BOSC) that 
recently reviewed the IRIS program indicated that "the extent of peer 
review for IRIS...exceeds most other examples with which the 
subcommittee members were familiar." [See comment 7] 

Transparency is critical to an effective IRIS process. It is equally 
important that scientists and policymakers be able to have full and 
frank discussions. Clearly, the quality of government decisions is 
better and stronger when healthy skepticism is not discouraged. [See 
comment 8] The current IRIS process strikes a balance between these two 
principles by encouraging open discussion of science and science policy 
questions, while appropriately protecting the deliberative process. 
Enhancing transparency through these and other measures necessarily 
means bringing many parties into the IRIS process. However, increased 
participation does not diminish EPA's accountability as the final 
decision-maker in establishing IRIS health values. All final IRIS 
assessments must also stand on their own merit by undergoing public and 
external peer review. It is noteworthy that in addition to having a 
transparent process, it is important to ensure transparency in the 
content of IRIS assessments (e.g., the rationale for relying on or 
using specific data sets, assumptions, or models). The GAO draft report 
does not comment on this facet of transparency, which directly bears on 
the content and quality of IRIS assessments. [See comment 9] 

We have taken a number of specific steps to enhance transparency in the 
IRIS program. For example: 

* We created IRIS Track on our web site to let everyone know the status 
of every chemical being worked on by EPA. This step opened up the 
process to all stakeholders, provided much greater transparency than 
before, and enabled interested parties to follow the progress of an 
assessment. [See comment 10] 

* Final documents are now published on the IRIS public web site. This 
includes all external public comments received and all the responses to 
the comments. The entire record of the assessment available to the 
public. [See comment 11] 

* IRIS has expanded the nomination process for new assessments to 
include a Federal Register Notice to allow the public to nominate 
chemicals, as well as a direct request to EPA Offices and other federal 
agencies asking for their nominations as well. [See comment 12] 

Like GAO, the Environmental Protection Agency highly values the IRIS 
Program, which stands as a model for: the international scientific 
community of unbiased, public, external peer review; the application of 
new scientific advancements in risk assessment; and focusing government 
efforts on priority chemical risk issues. According to the most recent 
review of the IRIS program by BOSC, "The comprehensiveness, 
transparency, and consistency of the IRIS approach has made it into the 
internationally-recognized standard in hazard characterization." 

EPA is committed to continual enhancement of the IRIS Program, and in 
that spirit, we appreciate your attention to the program. If you have 
any comments or questions on our response, please contact me or Kevin 
Teichman, Deputy Assistant Administrator for Science, at (202) 564-
6620. 

Best regards, 

Signed by: 

George Gray: 
Assistant Administrator: 

The following are GAO's comments on the Environmental Protection 
Agency's letter dated February 21, 2008. 

GAO Comments: 

1. Our analysis of the draft proposed changes to the IRIS assessment 
process does not support EPA's assertion that the revised process EPA 
is developing will improve the productivity and transparency of IRIS. 
In fact, as discussed in our draft and final reports, the draft 
proposed process would exacerbate existing productivity and 
transparency concerns. 

2. EPA emphasizes that our draft report includes information on 
proposed revisions to the IRIS assessment process that "have changed or 
will no longer be relevant" in the final version. Our draft and final 
reports clearly indicate that we are providing information on EPA's 
current assessment process as well as on proposed changes to the IRIS 
process that EPA has been developing for years--but has not yet 
finalized. For example, the draft and final reports state that "as of 
December 2007, EPA was planning to send a revised draft back to the 
interagency work group for review and approval." Moreover, in the draft 
and final reports, the graphic outlining the proposed changes is titled 
"EPA's Draft Proposed IRIS Assessment Process." Further, we made our 
recommendations with the intent that they be considered and integrated 
into any revised process that EPA finalizes. Finally, we note that EPA 
did not identify any significant changes it has made to the proposed 
process we outline in the draft and final reports, either when it 
commented on the draft report or on a December 2007 statement of facts 
provided to EPA for review for factual accuracy. However, to ensure 
clarity, we have added "draft" prior to our use of the term "proposed 
process" in a number of places. 

3. EPA states that "under the new process," the increased early 
involvement of other agencies and the public in identifying scientific 
issues and sharing information will ultimately help streamline the IRIS 
process. We note that other agencies and the public have the 
opportunity for early involvement in IRIS assessments under the current 
process. We do not believe that simply formalizing their involvement 
will, in fact, streamline the process or improve the timeliness of 
completed assessments. 

4. We have revised the report to add the updated estimated time frames 
for IRIS assessments under EPA's proposed revisions to the process 
provided in EPA's letter. With most assessments estimated to take up to 
4-1/2 years to complete, it appears unlikely that the IRIS program will 
be able to produce quality assessments in a timely manner. As discussed 
in our draft and final reports, when assessments take longer than 2 
years, they can become subject to substantial delays stemming from the 
need to redo key analyses to take into account changing science and 
assessment methodologies. Further, although EPA states that only a 
small number of IRIS assessments will be designated as mission- 
critical, we note that the chemicals with this designation are likely 
to be those posing widespread public health concerns that need to be 
addressed expeditiously. As we state in the draft and final reports, 
effectively maintaining the IRIS database will depend on strict 
adherence to time frames using the best available science. 

In addition, we believe that if EPA grants special rights to other 
federal agencies to, among other things, suspend IRIS assessments to 
conduct new research, it is likely that the agency would face pressure 
to do so for other entities, including industries and individual 
companies that could be impacted by IRIS assessments should they lead 
to regulatory actions. Therefore, while EPA's stated intent is to limit 
the number of mission-critical designations made by other federal 
agencies, the number is likely to increase over time. 

5. While EPA states that the draft report only briefly recognizes that 
IRIS assessments are more sophisticated and complex, our draft and 
final reports identify the growing complexity of risk assessments and 
risk assessment methods and models as one of five key factors 
contributing to EPA's inability to complete IRIS assessments in a 
timely manner. 

6. EPA states that external peer reviews have requested that more 
sophisticated analyses, such as quantitative uncertainty analysis, be 
performed and presented in some IRIS assessments. EPA further states 
that its responsiveness to these requests is given too little attention 
or is unfairly criticized in the draft report. In fact, our draft and 
final reports clearly state that peer reviews of EPA's assessments have 
sometimes recommended additional uncertainty analysis. Further, while 
we conclude that it is appropriate for EPA to identify key 
uncertainties in IRIS assessments and to continue to work on developing 
methodologies for conducting more sophisticated and meaningful 
uncertainty analyses, the methodologies are not yet developed. That is, 
our draft and final reports indicate that EPA plans to release draft 
reports in 2010 on methods for analyzing and characterizing uncertainty 
in hazard and dose response and in physiologically based 
pharmacokinetic models. Thus, we believe that continuing to delay IRIS 
assessments to develop and test enhanced methodologies and strategies 
for communicating them conflicts with EPA's stated goal of seeking 
balance among fairness, accuracy, and efficient action. Specifically, 
it is unclear how EPA's ongoing, nearly 2-year delay of the assessment 
of tetrachloroethylene (perc)--a widespread groundwater contaminant-- 
pending the development of an acceptable uncertainty analysis 
represents an appropriate balance between accuracy and efficient 
action. 

7. The draft and final reports discuss the changes EPA has made to its 
IRIS assessment process, including the one highlighted in EPA's letter-
-a change from letter peer reviews to panel peer reviews open to the 
public. 

8. EPA states that the current IRIS process strikes a balance between 
transparency and having full and frank discussions by encouraging open 
discussion of science and science policy questions while appropriately 
protecting the deliberative process. We disagree that such a balance 
exists because the OMB/interagency review process is not transparent at 
all. In its comments, EPA dismisses any impact of the opaque OMB/ 
interagency review process, emphasizing that all IRIS assessments 
undergo public and external peer review. However, the presence of 
transparency at a later stage of IRIS assessment development does not 
excuse or explain its absence earlier. Further, the National Academies 
have stated that the dialogue between risk assessors and risk managers 
should not bias or otherwise color the risk assessment conducted, and 
risk assessment and risk management activities should remain distinct. 
Transparency in the IRIS assessment process can provide assurance that 
these scientific assessments are appropriately based on the best 
available science and that they are not impacted by policy issues and 
considerations. Finally, because federal agencies' comments on IRIS 
assessments provided via the OMB/interagency process are to be 
scientific in nature, it is unclear why agencies would not candidly 
comment on an IRIS assessment even if their comments would become part 
of the public record. 

9. EPA's comments note that transparency is applicable to both the 
assessment process and the content of IRIS assessments (e.g., the 
rationale for relying on or using specific data sets, assumptions, and 
models). We have revised our report to recognize that transparency is 
relevant to both the assessment process and the content of IRIS 
assessments and to be clear that the transparency issues we discuss 
primarily relate to the process. We note that many of the process 
changes EPA has made beginning in the 1990s are aimed at improving the 
transparency of the content of IRIS assessments as well as the process. 

10. This information on EPA process improvements is provided in the 
draft and final reports. 

11. EPA stated that final IRIS documents are now published on the IRIS 
public Web site and that the entire record is available to the public. 
This statement is not accurate because the record of the OMB/ 
interagency review comments and EPA's responses to them are not made 
available to the public. 

12. The draft and final reports provide information on EPA's nomination 
process for new assessments, which includes a Federal Register notice. 

[End of section] 

Appendix V: Comments from the Office of Management and Budget: 

Executive Office Of The President: 
Office Of Management And Budget: 
Washington, D.C. 20503: 

February 21, 2008: 

Mr. John B. Stephenson: 
Director, Natural Resources and Environment: 
U.S. Government Accountability Office: 
441 G Street, N.W., Room 2075: 
Washington, D.C. 20548: 

Dear Mr. Stephenson: 

Thank you for the opportunity to comment on the Government 
Accountability Office's (GAO) draft report titled, "Chemical 
Assessments: Low Productivity and Lack of Transparency Limit the 
Usefulness and Credibility of EPA's Integrated Risk Information System" 
(GAO-08-440). 

We applaud your efforts to evaluate the EPA Integrated Risk Information 
System (IRIS) as we believe this is a very important EPA program. As 
your report states, funding for the IRIS program has increased-from 
$1.7 million in FY 2000 to $9.6 million in FY 2007; OMB has supported 
changes that will improve the quality and efficiency of the IRIS 
program. 

However, the draft GAO report fundamentally misunderstands the purpose 
of interagency review and, unfortunately, could leave readers with a 
false impression of the role of OMB/interagency review in the IRIS 
process. We discuss below our most important concerns with the draft 
report. [Footnote 47] [See comment 2] 

First, the draft report mischaracterizes OMB's role by alleging that 
OMB has imposed an OMB-managed interagency review process of IRIS risk 
assessment documents that has resulted in a loss of EPA control. [See 
comment 1][Footnote 48] In fact, however, only EPA has the authority to 
finalize an EPA assessment and only EPA has authority to determine when 
a draft may be sent for external peer review. The interagency review 
process is a dialogue that helps to ensure the quality (including 
objectivity and transparency) of agency documents. Input from 
scientists throughout the Federal government (including, for example, 
HHS, DOD, DOE, NASA, DOL, and USDA within the context of the IRIS 
process) helps inform and improve the quality of IRIS assessments. 
These reviews address the objectivity, clarity, and transparency of the 
work, identifying key science policy issues for EPA's consideration, 
and scientific issues for external peer review. [Footnote 49] Simply 
put, the interagency review process works as follows: OMB oversees an 
interagency process that is part of a broader EPA process. During the 
interagency process, EPA works collaboratively with OMB and other 
agencies to achieve resolution and completion of interagency reviews. 
These discussions have sometimes required resolution by the EPA Science 
Advisor, who is also the EPA Assistant Administrator of the Office of 
Research and Development. When this review process is complete, OMB 
concludes interagency review. At that time, EPA moves to the next 
step - generally, release of the risk assessment for public comment and 
an external peer review by a group of independent experts. [Footnote 
50] To be clear, EPA is entirely responsible for the content of 
information on IRIS. 

Second, the draft report alleges that the fact that OMB manages and 
directs the review process has "made it more difficult for EPA to 
complete IRIS assessments in a timely manner." [Footnote 51] [See 
comment 3] The draft report asserts that the OMB/interagency review 
adds significant time to IRIS time frames. It is our experience, 
however, that the interagency commenters have generally provided 
comments in a very timely manner. We are not aware of delays over 
"nonsubstantive issues" as alleged in the draft report. [Footnote 52] 
We also note that the draft report does not provide specific examples 
on which we can comment. [Footnote 53] [See comment 6] In addition, we 
believe the draft report is seriously flawed in that it does not 
consider whether interagency review operates to improve the quality of 
IRIS assessments, both by addressing the objectivity, clarity, and 
transparency of the work as well as identifying key science policy 
issues for EPA consideration and technical issues for peer review. 
[Footnote 54] [See comment 4] The draft report's focus on timeliness, 
without consideration of quality of the end product, presents a 
misleading and incomplete picture. 

Third, the draft report alleges that "the OMB/interagency review 
process also affects the credibility of assessments primarily because 
the review process lacks transparency." [Footnote 55] [See comment 5] 
To address this supposed issue, the draft report recommends that EPA 
make public comments by OMB and other Federal agencies to decision 
makers, the Congress, and the public. However, the draft report fails 
to acknowledge that, in the case of documents that involve interagency 
deliberations, these documents are covered by the deliberative process 
privilege, a well-recognized privilege that has been affirmed by the 
Congress in the Freedom of Information Act (5 U.S.C. 552(b)(5)) and by 
the Supreme Court in such cases as NLRB v. Sears, Roebuck & Co., 421 
U.S. 132 (1975), and EPA v. Mink, 410 U.S. 73 (1973). [Footnote 56] 
[See comment 8] Accordingly, protection of internal Executive Branch 
communications is not "inconsistent with the principle of sound 
science," contrary to the erroneous conclusions of the draft report. 
[Footnote 57] In fact, the National Academy of Sciences, which is 
recognized as a leader in scientific reviews, uses a multi-step review 
process that includes deliberations that are withheld from the public. 
[Footnote 58] [See comment 9] 

Finally, the draft report discusses at some length a draft document 
that it alleges serves to establish a "formal IRIS assessment process" 
that EPA has been developing over the past two years. [Footnote 59] 
[See comment 7] The discussion in the draft GAO report is misleading to 
readers; EPA's draft document is not a final document. [Footnote 60] 
[See comment 10] EPA has not completed the development of this process. 
Indeed, the process will not be complete until EPA circulates its draft 
to the public for comments and then releases a final product that is 
responsive to those comments. 

Thank you again for the opportunity to review and comment on your draft 
report. We hope you take these comments into account in preparing your 
final report. 

Sincerely, 

Signed by: 

Kevin F. Neyland: 
Deputy Administrator: 
Office of Information and Regulatory Affairs: 

The following are GAO's comments on the Office of Management and 
Budget's letter dated February 21, 2008. 

GAO Comments: 

1. OMB states that the draft report mischaracterizes OMB's role by 
alleging that OMB has imposed an OMB-managed interagency review process 
of IRIS risk assessment documents that has resulted in a loss of EPA 
control. We believe that we have appropriately described the OMB/ 
interagency review process and identified the time frame and assessment 
content limitations it has placed on EPA. First, as discussed in the 
draft and final reports, OMB has limited EPA's ability to determine the 
types of assessments it will conduct to meet its program needs by 
requiring EPA to terminate five IRIS assessments. Second, while EPA's 
annual performance goal for IRIS assessments had been the number of 
completed assessments, during the Program Assessment Rating Tool review 
by OMB it was agreed that the number of assessments provided to OMB for 
OMB/interagency review was the most appropriate annual measure of 
performance because EPA "relinquishes direct control of production 
dates" when it sends draft IRIS assessments to OMB. Third, our draft 
and final reports are clear that EPA officially determines when drafts 
are sent for external peer review or are finalized, but they are also 
clear that prior to taking these steps, EPA must be notified by OMB 
that EPA has adequately addressed interagency comments. Thus, the 
current process elevates the goal of reaching interagency agreement 
above achieving IRIS program objectives and in doing so fails to 
adequately acknowledge the expertise of EPA scientists and the many 
other scientific experts who have prepared and reviewed the 
assessments. Importantly, the fact that the first assessment drafts 
that become publicly available--those provided to independent peer 
reviewers--incorporate changes from federal agencies that may be 
affected by the assessments without identifying these changes or the 
reasons they were made weakens the credibility of the assessments. 
Finally, because the negotiations over OMB/interagency comments are not 
disclosed, OMB's assertion that EPA is entirely responsible for the 
content of information on IRIS is open to question. 

2. GAO provides statements of facts to agencies to confirm the factual 
accuracy of statements upon which reports are based. OMB commented that 
we did not incorporate its concerns about the draft statement of facts 
we provided to OMB. We considered OMB's comments that addressed factual 
information and, in response, made some revisions as appropriate. 
However, many of OMB's comments did not address facts but were focused 
on broader issues, such as the scope and methodology of our review. We 
disagreed with OMB's broad comments and thus did not make certain 
changes OMB suggested. For example, OMB expressed concern that our 
report discusses the development of proposed revisions to EPA's IRIS 
assessment process, which has not been released for public comment. As 
we discuss further in comment 10, GAO audits and reviews include those 
providing prospective analyses of possible or planned agency actions. 

3. OMB takes issue with our conclusion that the OMB/interagency review 
has made it more difficult for EPA to complete IRIS assessments in a 
timely manner. Our draft and final reports show that the initial OMB/ 
interagency reviews that had been completed as of December 1, 2007, 
added 6 months or more to the IRIS assessment process. The average 
length of time for these initial reviews was 7-1/2 months. Given the 
impact of delays on IRIS assessments and the staff time needed to 
respond to OMB/interagency comments, we believe such delays are 
significant. Further, our report discusses five key factors that make 
it difficult for EPA to complete assessments in a timely manner--one of 
which is the OMB/interagency review process. 

4. OMB states its belief that the draft report is seriously flawed 
because it does not consider whether interagency reviews improve the 
quality of IRIS assessments. As OMB notes, our draft report states that 
we did not evaluate the scientific content or quality of IRIS 
assessments. However, as the draft and final reports state, the Board 
of Scientific Counselors--an independent board of experts appointed by 
EPA to assess its programs--reviewed the effectiveness of the IRIS 
program (as part of its review of EPA's human health risk assessment 
program) in November 2007. A report is expected to be finalized in 
early 2008. In response to our congressional request and to avoid 
duplication of effort, we focused on the timeliness and credibility of 
IRIS assessments in the context of the current assessment process and 
proposed revisions to it. Our draft report also noted that it is too 
early to determine whether or to what extent the IRIS assessment 
process changes EPA has implemented in recent years have enhanced the 
scientific credibility of the assessments--for example, only four 
assessments were finalized in fiscal years 2006 and 2007. Importantly, 
because OMB/interagency comments and EPA's response to them are not 
disclosed, the extent to which the comments added value or caused EPA 
to revise its risk estimates cannot be determined. However, the status 
of the IRIS assessment of dibutyl phthalate raises questions about the 
extent to which the OMB/interagency reviews improve the quality of IRIS 
assessments. Specifically, this key assessment had cleared both OMB/ 
interagency reviews and was in the process of being finalized in July 
2007. However, because of methodology concerns raised by the Natural 
Resources Defense Council and the Chairman, Senate Committee on 
Environment and Public Works, EPA suspended the assessment pending a 
review by the National Academies. 

5. OMB asserts that "the draft report fails to acknowledge that, in the 
case of documents that involve interagency deliberations, these 
documents are covered by the deliberative process privilege," and that 
"accordingly, protection of internal Executive Branch communications is 
not 'inconsistent with the principle of sound science.'" Contrary to 
OMB's assertion, the report specifically acknowledges that OMB 
considers the documents at issue to be protected from disclosure 
because of their deliberative nature. Moreover, OMB's assertions 
concerning the deliberative process privilege are misleading and 
illogical. That is, OMB's comments fail to note that the deliberative 
process privilege protects internal and interagency communications from 
judicially compelled disclosure, an issue irrelevant to our 
report.[Footnote 65] The privilege in no way prevents agencies from 
voluntarily disclosing such information.[Footnote 66] OMB is thus 
arguing that because the scientific comments at issue might generally 
be protected from discovery in civil litigation, refusal to disclose 
them voluntarily in this specific context is necessarily consistent 
with the principles of sound science. OMB provides no citation or other 
support for this conflation of judicial and scientific procedures. 

Moreover, OMB's comments that the deliberative process privilege was 
affirmed in the Freedom of Information Act (FOIA) fails to acknowledge 
that FOIA requires federal agencies to disclose factual material in 
documents covered by the deliberative process privilege if the factual 
material can be reasonably segregated from the deliberative 
material.[Footnote 67] OMB's comment appears to assume that because a 
document passes from one agency to another all of its contents may be 
withheld from disclosure, a legally unsupportable assertion that courts 
have uniformly rejected, particularly in the context of attempts to 
withhold scientific information.[Footnote 68] Indeed, to the extent 
that interagency comments on IRIS assessments reflect political and 
policy concerns rather than discussions of scientific issues, they 
would be easier to withhold from disclosure in court but harder to 
justify as part of the IRIS scientific assessment process. 

In addition, OMB's comments do not distinguish between risk assessment 
and risk management decisions, such as the formulation of regulations. 
As discussed in the draft and final reports, IRIS assessments are not 
themselves regulations, and OMB and other agencies will have 
opportunities to engage in deliberative policy debates during, for 
example, interagency reviews that occur during rule makings. These are 
points in the process where it is appropriate to address policy 
questions, such as the implications for other agencies of a specific 
regulatory decision. 

Finally, under the interagency process as currently contemplated, some 
IRIS assessment reviewers--representatives of federal agencies-- 
essentially are given favored status. OMB fails to explain why certain 
scientific views should be given added consideration and protected from 
the critical scientific scrutiny all other comments will receive simply 
because the reviewers providing the comments are federal employees. 

6. OMB stated general disagreement with information presented in our 
discussion of the naphthalene assessment but did not cite the specific 
information with which it disagreed. Instead, OMB referred readers to 
the charge and report from the second peer review EPA had conducted on 
this chemical at OMB's direction. In our draft and final reports, we 
report EPA officials' description of the purpose and conclusions of 
this peer review. Specifically, EPA officials said (1) the agency 
convened an additional expert review panel on genotoxicity to obtain 
recommendations about short-term tests that OMB thought could be done 
quickly and (2) the panel concluded that such research could not be 
conducted in the short term. The questions posed to the peer reviewers 
and the summary of results in the report cited by OMB are consistent 
with EPA's description. 

7. OMB says that the draft report is misleading to readers because 
EPA's "draft document is not a final document." The report clearly 
identifies the proposed IRIS assessment changes that EPA has been 
working on. For example, the graphic outlining the proposed changes is 
titled "EPA's Draft Proposed IRIS Assessment Process." The draft and 
final reports also state that "as of December 2007, EPA was planning to 
send a revised draft back to the interagency work group for review and 
approval." However, to ensure clarity, we have added "draft" prior to 
our use of the term "proposed process" in a number of places. 

8. We did not assert that the OMB/interagency process is equivalent to 
peer review, and we agree with OMB that this review process happens 
before any external peer review occurs. However, because the OMB/ 
interagency process is opaque, neither peer reviewers nor the public 
are privy to the changes EPA made to the draft assessments or the 
charge questions to the peer review panels in response to the comments 
from OMB and other federal agencies. The presence of transparency at a 
later stage of IRIS assessment development does not excuse or explain 
its absence earlier. 

9. It is unclear why OMB attempts to rely on the Federal Advisory 
Committee Act Amendments of 1997 to defend the lack of transparency in 
the interagency IRIS review process. The transparency procedures 
applicable to the National Academies' committees to which OMB refers 
far exceed those that exist under the OMB/interagency IRIS process. For 
example, under the legislation OMB cites, National Academies' 
committees must (1) provide the names, biographies, and conflict of 
interest disclosures of committee appointees; (2) provide an 
opportunity for the public to comment on the proposed committee member 
appointments; (3) ensure that meetings focused on data gathering are 
generally open to the public; (4) provide the names of reviewers of 
draft committee reports; and (5) provide summaries of any closed 
committee meetings. 5 U.S.C. App. 2, ï¿½ 15. The interagency portion of 
the IRIS process does none of these things. Moreover, while the act 
authorizes a National Academies' committee to close meetings at which 
information exempt from disclosure under FOIA would be discussed, the 
President of the National Academy of Sciences assured the bill's 
sponsor, in a letter commenting on the House bill that would later be 
enacted into law, that the Academy would not rely on the deliberative 
process exemption as the basis for closing a meeting. 

"I wish to assure you that we subscribe fully to the goal of providing 
as much openness as possible in our work. In particular, we have no 
intention of using Section 552(b)(5), which deals with interagency 
memoranda, as a basis for closing meetings of Academy committees. In 
fact, it is the Academy's standard practice not to treat the type of 
material covered by Section 552(b)(5) as confidential input to any 
Academy deliberative process. This procedure insures that, inasmuch as 
possible, all the information that a committee uses to reach its 
conclusion is in the public record." 

10. We were asked by the Chairman, Senate Committee on Environment and 
Public Works, to examine the potential effects of planned changes to 
the IRIS assessment process on EPA's ability to ensure that IRIS 
provides current, credible risk information. This review therefore 
involved evaluating a draft of EPA's planned IRIS assessment changes. 
GAO audits and reviews include those providing prospective analyses of 
possible or planned agency actions. We may also assess the ability of 
alternative approaches to yield better program performance or eliminate 
factors that inhibit program effectiveness. As is typical in cases in 
which we evaluate draft proposals, we make our recommendations on the 
IRIS assessment process in the spirit of informing those revisions. 

[End of section] 

Appendix VI: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

John B. Stephenson, (202) 512-3841 or [email protected]: 

Staff Acknowledgments: 

In addition to the contact named above, Christine Fishkin (Assistant 
Director), Mark Braza, Nancy Crothers, Laura Gatz, Richard P. Johnson, 
Summer Lingard, Susan Swearingen, and Delia Zee made key contributions 
to this report. Also contributing to this report were Tim Bober, Phylis 
Cline, Michael Derr, and Cynthia Taylor. 

[End of section] 

Footnotes: 

[1] The National Academies comprises four organizations: the National 
Academy of Sciences, the National Academy of Engineering, the Institute 
of Medicine, and the National Research Council. 

[2] Transparency is relevant to both the IRIS assessment process (for 
example, the public availability of information about the assessment 
process, the input from external reviews on draft assessments, and 
EPA's responses to them) and the content of IRIS assessments (for 
example, the rationale for using specific data sets, assumptions, or 
models). In this report, the transparency issues we discuss primarily 
relate to the IRIS assessment process. 

[3] The cancer slope factor and unit risk typically are both upper 
bound estimates (the plausible statistical upper limits of the true 
value of a quantity). 

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

[5] This internal peer review continues to be conducted during the 
assessment drafting stage. 

[6] OMB did not include these five assessments towards EPA's fiscal 
year 2006 annual performance goals and thus does not acknowledge that 
EPA sent 16 draft assessments to it for OMB/interagency review that 
fiscal year. 

[7] EPA has, in some cases, divided an ongoing assessment into two 
assessments. For example, in fiscal year 2007, the arsenic assessment 
covering both cancer and noncancer risks, which was started in 2003, 
was divided into two separate assessments. Although the noncancer 
assessment was started in 2003, IRIS Track, which tracks the status of 
ongoing assessments, shows a 2007 start date for the IRIS noncancer 
assessment. 

[8] The two offices identified the same priority chemicals in eight 
cases. 

[9] The other nominations were for chemicals in IRIS with outdated 
assessments. 

[10] The preliminary findings of the Use of IRIS Project were presented 
during the EPA's Board of Scientific Counselors' Human Health Risk 
Assessment Subcommittee meeting on November 15, 2007. 

[11] EPA, Human Health Risk Assessment Multi-Year Plan (Washington, 
D.C., 2007). 

[12] In its 2005 multiyear plan EPA, specified that it would send the 
assessments for acrylamide, MTBE, naphthalene, tetrachloroethylene 
(perc), acrylonitrile, formaldehyde, methanol, methylene chloride, 
trichloroethylene, and dioxin for external review during fiscal years 
2006 and 2007. Only acrylamide and tetrachloroethylene (perc) have been 
sent to OMB for OMB/interagency review. 

[13] Under the executive order, significant guidance is defined as, "a 
guidance document disseminated to regulated entities or the general 
public that may reasonably be anticipated to (1) lead to an annual 
effect of $100 million or more or adversely affect in a material way 
the economy, a sector of the economy, productivity, competition, jobs, 
the environment, public health or safety, or State, local, or tribal 
governments or communities; (2) create a serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
(3) materially alter the budgetary impacts of entitlements, grants, 
user fees or loan programs or the rights or obligations of recipients 
thereof; or (4) raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
this Executive order." 

[14] Examples cited by the former director include scientific data such 
as subtle biologic changes, biomarkers, and partial data on one or more 
mechanistic hypotheses. 

[15] Examples of PBPK model applications in risk assessments include 
interspecies extrapolation of the dose-response relationship, route- to-
route extrapolation, estimation of response from varying exposure 
conditions, estimation of human variability (within the whole 
population or subpopulations), and high-to-low dose extrapolation. 

[16] EPA plans to release draft reports in 2010 on methods for 
analyzing and characterizing uncertainty in hazard and dose response 
and in PBPK models. 

[17] According to an EPA official, the November 2007 review of the IRIS 
program by the Board of Scientific Counselors, an independent board of 
experts appointed by EPA to assess its program, concluded that the 
program "met expectations." A report covering this review, which 
included evaluating the scientific quality of IRIS assessments, is 
expected in early 2008. 

[18] Also referred to as RDX or hexahydro-1,3,5-trinitrotriazine. 

[19] The Board of Scientific Counselors is a federal advisory committee 
established by EPA to provide advice, information, and recommendations 
about the Office of Research and Development's research program. 

[20] OMB recently proposed a bulletin that would have provided risk 
assessment guidance to federal agencies. The proposed bulletin stated 
that "every quantitative risk assessment should provide a range of 
plausible risk estimates when there is scientific uncertainty or 
variability." OMB decided not to finalize the bulletin after a National 
Academies' committee severely criticized it, noting, among other 
shortcomings, that "the description of uncertainty and variability in 
the bulletin is oversimplified and does not recognize the complexities 
of different types of risk assessments or the need to tailor 
uncertainty analysis to a given agency's particular needs." In 
particular, the committee noted that "a central estimate and a risk 
range might be misleading in situations when sensitive populations are 
of primary concern." National Academies, Scientific Review of the 
Proposed Risk Assessment Bulletin from the Office of Management and 
Budget Committee to Review the OMB Risk Assessment Bulletin 
(Washington, D.C., 2007). 

[21] In January 2006, the Assistant Administrator for Research and 
Development was appointed as EPA's Science Advisor. 

[22] EPA officials said that in July 2007, approval authority to send 
draft assessments to OMB was again devolved to the Director, NCEA. 

[23] According to the fiscal year 2004, 2005, and 2006 standard 
operating procedures for IRIS assessments, before an assessment is 
posted on the Web site, chemical managers are required to (1) brief the 
IRIS Program Director and other NCEA management on any significant 
changes since external review and (2) prepare a fact sheet for review 
and approval by the Assistant Administrator, Office of Research and 
Development, before the IRIS Program Director submits the final 
assessment documents to the IRIS Web master for posting on the IRIS Web 
site. 

[24] A December 1998 notice stated that EPA planned to complete the 
chloroform assessment, as well as 23 other assessments, in fiscal year 
1999 or fiscal year 2000. In 2001, EPA completed assessments addressing 
oral exposure to chloroform (oral RfD and cancer assessments); however, 
the assessment addressing inhalation exposure (RfC) needed by the 
Office of Air and Radiation is currently being drafted. Since 2002, EPA 
has been reporting the chloroform (inhalation route) assessment as 
being under way or generally complete and planned for entry into IRIS 
within a year or 2. 

[25] National Academies, Scientific Review of the Proposed Risk 
Assessment Bulletin from the Office of Management and Budget Committee 
to Review the OMB Risk Assessment Bulletin (2007). 

[26] The European Union and California restrictions cover five 
phthalates, including dibutyl phthalate. 

[27] IRIS assessments cover individual chemicals, not cumulative 
exposure to multiple related chemicals. This is an emerging risk 
assessment issue that will require developing new assessment 
methodologies. The congressional letter expressed concerns that the 
draft IRIS assessment would not adequately protect public health but 
did not request that it be entirely redone. Among other things, the 
Natural Resources Defense Council letter suggested that EPA revisit its 
decisions regarding the uncertainty factors used. 

[28] Presentations at the Society for Risk Analysis meting reflect the 
views of the authors and "do not necessarily reflect the views of any 
other organization or agency." 

[29] Using its 1996 Proposed Guidelines for Carcinogen Risk Assessment, 
EPA concluded in the 1998 IRIS assessment of naphthalene that its human 
carcinogenic potential could not be determined at that time, but noted 
that there was suggestive evidence of potential human carcinogenicity. 
(EPA also noted that under its 1986 cancer guidelines, EPA classified 
naphthalene as a possible human carcinogen.) Subsequently, in 2002, the 
International Agency for Research on Cancer (IARC), part of the World 
Health Organization, concluded that naphthalene is possibly 
carcinogenic to humans; in 2004, the Department of Human Health and 
Services' National Toxicology Program concluded that naphthalene can 
reasonably be anticipated to be a human carcinogen. EPA's current 
assessment will be subject to the agency's 2005 cancer guidelines. 

[30] 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. 

[31] 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. 

[32] The National Priorities List is EPA's list of seriously 
contaminated sites. 

[33] The cancer portion of the formaldehyde assessment was originally 
issued in 1989 and updated in 1991; the noncancer assessment was added 
in 1990. 

[34] NCI published the results of its study in two publications. The 
first study, published in November 2003, focused on the association 
between formaldehyde exposure and leukemia. M. Hauptmann, J. H. Lubin, 
P. A. Stewart, R. B. Hayes, A. Blair, "Mortality from 
Lymphohematopoietic Malignancies among Workers in Formaldehyde 
Industries," Journal of the National Cancer Institute (2003). The 
second study, published in June 2004, evaluated the association between 
formaldehyde exposure and other cancers--including nasopharyngeal 
cancer. M. Hauptmann, J. H. Lubin, P. A. Stewart, R. B. Hayes, A. 
Blair, "Mortality from Solid Cancers among Workers in Formaldehyde 
Industries," American Journal of Epidemiology (2004). The results of 
the NIOSH study were described in one publication, dated March 2004, 
which assessed mortality from all causes and all cancers. L. E. 
Pinkerton, M. J. Hein, L. T. Stayner, "Mortality among a Cohort of 
Garment Workers Exposed to Formaldehyde: an Update," Occupational and 
Environmental Medicine (2004). 

[35] Natural Resources Defense Council v. E.P.A., 489 F.3d 1364, 1372- 
73 (D.C. Cir, 2007). The court did not specifically address EPA's 
reliance on the CIIT study, holding instead that the Clean Air Act 
prohibited establishment of the exemptions at issue. 

[36] Physiologically based pharmacokinetic models are a class of 
dosimetry models 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. 

[37] GAO, Human Health Risk Assessment: EPA Has Taken Steps to 
Strengthen Its Process, but Improvements Needed in Planning, Data 
Development, and Training, GAO-06-595 (Washington, D.C.: May 31, 2006). 

[38] Developing this process, publishing a notice about it in the 
Federal Register, and holding a public meeting to obtain public input 
on the proposed process has been an item OMB has included in its PART 
review of EPA's human health risk assessment program. 

[39] Under the proposal, EPA could also identify chemicals "of major 
importance" which would be treated as mission-critical chemicals. 

[40] Under EPA's draft proposed IRIS assessment process, EPA would 
develop, for all chemicals, an additional draft IRIS assessment--one 
that includes only qualitative information--that must undergo internal 
review. Only draft qualitative assessments for chemicals that are 
identified as mission critical would be released for the error 
correction step. 

[41] According to DOD, the Materials of Emerging Regulatory Interest 
Team is a virtual interagency team composed of individuals throughout 
DOD with a common interest in emerging contaminants. 

[42] Other possible types of DOD risk management investments include 
material and process substitutions and personal protective equipment. 

[43] The National Academies recently addressed this issue as follows: 
"The committee believes that risk assessors and risk managers should 
talk with each other; that is, a 'conceptual distinction' does not mean 
establishing a wall between risk assessors and risk managers. Indeed 
they should have constant interaction. However, the dialogue should not 
bias or otherwise color the risk assessment conducted, and the 
activities should remain distinct; that is, risk assessors should not 
be performing risk management activities." National Academies, 
Scientific Review of the Proposed Risk Assessment Bulletin from the 
Office of Management and Budget Committee to Review the OMB Risk 
Assessment Bulletin (2007). 

[44] The National Academies recently emphasized that "stakeholders from 
all points on the spectrum of interested parties--other state and 
federal agencies, advocacy groups from industry, and affected 
communities--can be expected to offer perspectives on the risk 
assessment policies under discussion." National Academies, Scientific 
Review of the Proposed Risk Assessment Bulletin. 

[45] "Other information" includes 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. 

[46] These five assessments address short-term health risks. According 
to EPA, while OMB had previously agreed that these assessments would be 
included in EPA's 2006 annual performance goals that OMB uses to 
evaluate EPA's performance, in November 2007, OMB told EPA that it 
would not count EPA's short-term assessments toward meeting its goals, 
thereby lowering EPA's performance rating by OMB. 

[47] In January 2008, GAO provided OMB staff with the opportunity to 
provide comments on the draft report titled "Statement of Facts for 
GAO's Review of EPA's Integrated Risk Information System." As you were 
aware, from our discussion on January 18, 2008, OMB staff had a number 
of concerns about the draft statement of facts, which were discussed in 
the January 22, 2008 comments that were sent to you. It appears that 
many of those comments have not been incorporated into the current 
draft report and our concerns remain. But rather than reiterating them 
all here, 1 will highlight our overarching comments on the draft 
report. 

[48] Draft report, pp. 22-27. 

[49] OMB has a broad interest in the quality, objectivity, utility and 
integrity of information disseminated by Federal Agencies. See OMB's 
Guidelines for Ensuring and Maximizing the Quality, Objectivity, 
Utility, and Integrity of Information Disseminated by Federal Agencies 
(2002), 67 Fed. Reg. 8452 (Feb. 22, 2002), available at [hyperlink, 
http://www.whitehouse.gov/omb/fedreg/reproducible2.pdf]; OMB's Final 
Information Quality Bulletin for Peer Review (2002), 70 Fed. Reg. 2664 
(Jan. 14, 2005), available at [hyperlink, 
http://www.whitehouse.goviomb/fedreg/2005/011405_peer.pdf]; and the 
OMB/OSTP Updated Principles for Risk Analysis, available at [hyperlink, 
http://www.whitehouse.gov/omb/memoranda/fy2007/m07-24.pdf]. 

[50] OMB recognizes that there is also a second round of interagency 
review in the current IRIS process. This review seeks to ensure that 
comments from expert reviewers and the public have been transparently 
and objectively addressed. 

[51] Draft report, p. 21. 

[52] Draft report, p. 25. 

[53] In fact, when the draft report does provide a specific example, 
such as its discussion of naphthalene, it does so inaccurately. Draft 
report, pp. 36-38. OMB staff does not agree with the characterizations 
as presented in the draft report and suggests that readers would 
benefit from looking at the EPA documentation.: (i) the EPA charge for 
the peer consultation, which resulted from interagency dialogue, 
available at [hyperlink, 
http://oaspub.epa.gov/eims/eimscomm.getfile?p_download_id=46877]; and 
(ii) the peer consultation report, available at [hyperlink, 
http://oaspub.epa.gov/eims/eimscomm.getfile?p_download_id=442588]. 

[54] In fact, the draft report recognizes that it "did not evaluate the 
scientific content or quality of IRIS assessments." Draft report, p. 3. 

[55] Draft report, p. 26. 

[56] We do not consider the interagency process to constitute peer 
review; rather the document that EPA releases at a later step in the 
process will be subject to external peer review and public comment. EPA 
has a very transparent process by which draft IRIS assessments are 
released for public comment and external peer review before they are 
issued as final documents. The credibility of IRIS assessment is in 
part based on this rigorous and transparent external peer review and 
public comment process. 

[57] Draft report page 6. 

[58] See [hyperlink, http://www.iom.edu/CMS/6008.aspx] and [hyperlink, 
http://www.nationalacademies.org/studvcommittenrocess.pdf]. In 1997, 
Congress ensured that NAS deliberations have heightened confidentiality 
protections, when Congress passed stand-alone legislation that added a 
new section (Section 15) to the Federal Advisory Committee Act (5 
U.S.C. App.) which specifically, and solely, addresses NAS and the 
National Academy of Public Administration. See the Federal Advisory 
Committee Act Amendments of 1997, Public Law 105-153, 111 Stat. 2689. 
The legislative history explains that Congress granted this protection 
"to preserve the quality of the research provided to the Federal 
Government through the National Academy of Sciences and the National 
Academy of Public Administration." Statement of Rep. Horn, Cong. Rec. 
1110579 (daily ed. November 9, 1997). Representative Horn explained 
that "[t]he administration, the House and the Senate, both the majority 
and minority, all agree the academy should not be subject to the full 
process of the Federal Advisory Committee Act." Id. As Rep. Horn also 
noted, id., Congress passed this legislation in response to the court 
decision earlier that year in Animal Legal Defense Fund, Inc. v. 
Shalala, 104 F3d 1209 (D.C. Cir.), cert. denied, 522 U.S. 949 (1997), 
in which the court held that NAS panels were subject to the full range 
of FACA disclosure requirements. In its decision, the court stated that 
NAS, in arguing for why it should not be subject to these requirements, 
referred to "the deleterious effects of FACA's requirements on its 
deliberative processes: As the NAS sees it, open meetings and records 
would compromise its internal review procedures and inhibit candid 
exchange among its members." Id. at 428. 

[59] Draft report, pp. 45-52. 

[60] By way of comparison, we note that, in providing to us the draft 
report for our comment, your cover page stated that the draft "is 
restricted to official use only"; is "subject to revision"; and "must 
be safeguarded to prevent improper disclosure." 

[61] NLRB v. Sears, Roebuck & Co., 421 U.S. 132, 149 ("it is reasonable 
to construe Exemption 5 to exempt those documents, and only those 
documents, normally privileged in the civil discovery context"); EPA v. 
Mink, 410 U.S. 73, 86 (1973) (The Freedom of Information Act (FOIA) 
contemplates that the public is entitled to all memoranda or letters 
that a private party could discover in litigation with the agency). 

[62] See Chrysler Corp. V. Brown, 441 U.S. 281, 293 (holding that 
exemptions from FOIA's general requirement to disclose agency documents 
do not prohibit agencies from disclosing information covered by the 
exemptions). In fact, OMB has voluntarily released information it 
considered to be protected from disclosure under FOIA, presumably 
because it saw some benefit in doing so. NRDC v. U.S. Department of 
Defense, 442 F.Supp.2d 857, 863 (C.D. Cal. 2006). It is unclear from 
the case which FOIA exemptions OMB believed were applicable. 

[63] E.g., Mead Data Central, Inc. v. U.S. Dept. of Air Force, 566 F.2d 
242, 260 (D.C. Cir. 1977) ("The focus of the FOIA is information, not 
documents, and an agency cannot justify withholding an entire document 
simply by showing that it contains some exempt material."). 

[64] E.g., Bristol-Myers v. FTC, 424 F.2d 935, 939 (FOIA "does not 
authorize an agency to throw a protective blanket over all information 
by casting it in the form of an internal memorandum. Purely factual 
reports and scientific studies cannot be cloaked in secrecy by an 
exemption designed to protect only those internal working papers in 
which opinions are expressed and policies formulated and recommended"); 
Southwest Center v. Biological Diversity v. USDA, 170 F.Supp.2d 931, 
943 (D. Ariz. 2000) ("FOIA exemption five does not protect research 
data"); Verrazzano Trading Corp. v. United States, 349 F.Supp. 1401, 
1406 (Cust. Ct. 1972) ("the exemption was not intended to protect 
factual or scientific reports and investigations"). 

[End of section] 

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