Toxic Chemicals: EPA's New Assessment Process Will Increase	 
Challenges EPA Faces in Evaluating and Regulating Chemicals	 
(29-APR-08, GAO-08-743T).					 
                                                                 
The Environmental Protection Agency's (EPA) mission includes	 
evaluating and regulating toxic chemicals. EPA's Integrated Risk 
Information System (IRIS) program is a chemical evaluation	 
program that is a critical component of EPA's capacity to support
scientifically sound environmental regulations and policies. The 
IRIS database contains EPA's scientific position on the potential
human health effects of exposure to more than 540 chemicals. This
testimony highlights GAO's work on toxic substances, focusing on 
(1) its March 2008 report, Chemical Assessments: Low Productivity
and New Interagency Review Process Limit the Usefulness and	 
Credibility of EPA's Integrated Risk Information System and (2)  
key changes to the IRIS assessment process EPA included in its	 
revised IRIS assessment process released on April 10, 2008. It	 
also highlights the findings of two GAO reports on EPA's	 
regulation of toxic chemicals. For the IRIS report, GAO analyzed 
EPA data and interviewed officials at relevant agencies,	 
including the Office of Management and Budget (OMB). For this	 
testimony, GAO supplemented the IRIS report with a review of	 
EPA's revised IRIS assessment process announced earlier this	 
month. Given the importance of the IRIS program to EPA's ability 
to protect public health and the environment, Congress should	 
consider requiring EPA to suspend its new process and develop one
that is responsive to GAO's recommendations.			 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-08-743T					        
    ACCNO:   A81909						        
  TITLE:     Toxic Chemicals: EPA's New Assessment Process Will       
Increase Challenges EPA Faces in Evaluating and Regulating	 
Chemicals							 
     DATE:   04/29/2008 
  SUBJECT:   Chemical agents					 
	     Chemical exposure					 
	     Chemical regulation				 
	     Chemical research					 
	     Chemicals						 
	     Data integrity					 
	     Databases						 
	     Environmental monitoring				 
	     Health hazards					 
	     Information disclosure				 
	     Information infrastructure 			 
	     Information management				 
	     Interagency relations				 
	     Policy evaluation					 
	     Program evaluation 				 
	     Public health					 
	     Quality assurance					 
	     Regulatory agencies				 
	     Reporting requirements				 
	     Risk assessment					 
	     Risk management					 
	     Schedule slippages 				 
	     Toxic substances					 
	     Assessments					 
	     Timeliness 					 
	     Transparency					 
	     EPA Integrated Risk Information System		 

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GAO-08-743T

   

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Testimony: 

Before the Committee on Environment and Public Works, U.S. Senate: 

United States Government Accountability Office: 

GAO: 

For Release on Delivery: 

Expected at 10:00 a.m. EDT Tuesday, April 29, 2008: 

Toxic Chemicals: 

EPA's New Assessment Process Will Increase Challenges EPA Faces in 
Evaluating and Regulating Chemicals: 

Statement of John B. Stephenson, Director: 

Natural Resources and Environment: 

GAO-08-743T: 

GAO Highlights: 

Highlights of GAO-08-743T, a testimony before the Committee on 
Environment and Public Works, U.S. Senate. 

Why GAO Did This Study: 

The Environmental Protection Agencyï¿½s (EPA) mission includes evaluating 
and regulating toxic chemicals. EPAï¿½s Integrated Risk Information 
System (IRIS) program is a chemical evaluation program that is a 
critical component of EPAï¿½s capacity to support scientifically sound 
environmental regulations and policies. The IRIS database contains 
EPAï¿½s scientific position on the potential human health effects of 
exposure to more than 540 chemicals. 

This testimony highlights GAOï¿½s work on toxic substances, focusing on 
(1) its March 2008 report, Chemical Assessments: Low Productivity and 
New Interagency Review Process Limit the Usefulness and Credibility of 
EPAï¿½s Integrated Risk Information System and (2) key changes to the 
IRIS assessment process EPA included in its revised IRIS assessment 
process released on April 10, 2008. It also highlights the findings of 
two GAO reports on EPAï¿½s regulation of toxic chemicals. For the IRIS 
report, GAO analyzed EPA data and interviewed officials at relevant 
agencies, including the Office of Management and Budget (OMB). For this 
testimony, GAO supplemented the IRIS report with a review of EPAï¿½s 
revised IRIS assessment process announced earlier this month. Given the 
importance of the IRIS program to EPAï¿½s ability to protect public 
health and the environment, Congress should consider requiring EPA to 
suspend its new process and develop one that is responsive to GAOï¿½s 
recommendations. 

What GAO Found: 

The IRIS database is at serious risk of becoming obsolete because EPA 
has not been able to routinely complete timely, credible assessments or 
decrease its backlog of 70 ongoing assessmentsï¿½a total of 4 were 
completed in fiscal years 2006 and 2007. In addition, recent assessment 
process changes, as well as other changes EPA was considering at the 
time of GAOï¿½s review, further reduce the timeliness and credibility of 
IRIS assessments. 

* Although EPA has taken steps to improve the IRIS program since 2000 
and has developed a number of draft assessments for external review, 
its efforts to finalize assessments have been thwarted by a combination 
of factors, including two new OMB-required reviews of IRIS assessments 
by OMB and other federal agencies; 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 and 
methods. 

* The OMB/interagency reviews of draft assessments involve 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. For example, the OMB/interagency reviews lack 
transparency, and OMB required EPA to terminate five assessments EPA 
had initiated to help it implement the Clean Air Act. 

* The changes to the IRIS assessment process that EPA was considering, 
but had not yet issued at the time of GAOï¿½s review, would have added to 
the already unacceptable level of delays in completing IRIS assessments 
and further limited the credibility of the assessments. 

On April 10, 2008, EPA issued a revised IRIS assessment process, 
effective immediately. In its February 2008 comments on GAOï¿½s draft 
report, EPA said it would consider the reportï¿½s recommendations, which 
were aimed at streamlining the process and better ensuring that EPA has 
the ability to develop transparent, credible assessments. However, 
EPAï¿½s new process is largely the same as the draft GAO evaluated, and 
some key changes also are likely to further exacerbate the productivity 
and credibility concerns GAO identified. For example, while the draft 
process would have made comments on IRIS assessments from other federal 
agencies part of the public record, EPAï¿½s new process expressly defines 
such comments as ï¿½deliberativeï¿½ and excludes them from the public 
record. GAO continues to believe it is critical that input from all 
partiesï¿½particularly agencies that may be affected by the outcome of 
IRIS assessmentsï¿½be publicly available. As recommended in GAOï¿½s March 
2008 report, to effectively maintain IRIS, EPA must, among other 
things, streamline its lengthy assessment process and adopt 
transparency practices that provide assurance that IRIS assessments are 
appropriately based on the best available science and that they are not 
inappropriately biased by policy considerations. Since EPAï¿½s new 
process is not responsive to GAOï¿½s recommendations, the viability of 
this critical database has been further jeopardized. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-743T]. For more 
information, contact John B. Stephenson at (202) 512-3841 or 
[email protected]. 

[End of section] 

Madam Chairman and Members of the Committee: 

I am pleased to be here today to discuss issues associated with the 
Environmental Protection Agency's (EPA) evaluation and regulation of 
toxic chemicals. Over the past few years, GAO has issued a number of 
reports on this topic. Today I will focus primarily on our most recent 
report in this area that examined EPA's Integrated Risk Information 
System (IRIS)--one of the most significant tools that EPA has developed 
to effectively support its mission of protecting people and the 
environment from harmful chemical exposures. IRIS contains EPA's 
scientific position on the potential human health effects that may 
result from exposure to more than 540 chemicals in the environment and 
is a critical component of EPA's capacity to support scientifically 
sound environmental decisions, policies, and regulations. It is also 
relied upon by state and local environmental programs and some 
international regulatory bodies for managing their environmental 
protection programs. 

The toxicity assessments in the IRIS database fulfill the first two 
critical steps of the risk assessment process--providing hazard 
identification and quantitative dose-response assessments. 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 development of health risk 
assessments is thus directly dependent on the development of toxicity 
assessments such as those developed in the IRIS program. With risk 
assessment information, decision makers can make informed risk 
management decisions on how to protect public health, reflecting other 
important data and considerations, such as the costs and benefits of 
mitigating identified risks, the technological feasibility of managing 
risks, and the concerns of various stakeholders. Examples of risk 
management decisions include deciding how much of a chemical a company 
may discharge into a river, determining the extent to which a hazardous 
waste site must be cleaned up, and setting 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 risk management decisions and serve as a 
basis for regulatory consideration. However, EPA's productivity in 
finalizing IRIS assessments is poor, and EPA has a significant backlog 
of incomplete IRIS assessments and a growing number of outdated 
assessments. Importantly, EPA has not been able to complete assessments 
of key chemicals of concern to public health, including dioxin, 
formaldehyde, trichloroethylene (TCE), naphthalene, and 
tetrachloroethylene (perc) (see app. I). 

In the last several years, GAO issued a number of reports on EPA's 
toxics programs, highlighting program shortcomings and recommending 
management improvements. My testimony today addresses (1) the 
highlights of our March 2008 report, Chemical Assessments: Low 
Productivity and New Interagency Review Process Limit the Usefulness 
and Credibility of EPA's Integrated Risk Information System,[Footnote 
1] being released today, and (2) key changes to the IRIS assessment 
process that EPA included in its revised process released on April 10, 
2008. We are also providing information on two of our prior reports on 
EPA's regulation of toxic chemicals (see app. II).[Footnote 2] For our 
March 2008 report, we examined 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). We also 
examined the potential effects of 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 and the resources 
provided to the program for fiscal years 2000 through 2007, user needs, 
and EPA's assessment completion goals. We also interviewed EPA's 
National Center for Environmental Assessment officials who manage the 
IRIS assessment program; officials from other EPA program offices and 
federal science and health agencies involved in the IRIS assessment 
process; and officials from the Department of Defense, the Department 
of Energy (DOE), the National Aeronautics and Space Administration 
(NASA), and OMB. For this testimony, we supplemented our report with an 
analysis of the IRIS assessment process that EPA released on April 10, 
2008. We conducted this work from April 16 to April 29, 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. 

Background: 

IRIS was created in 1985 to help EPA develop consensus opinions within 
the agency about the health effects of chronic exposure to chemicals. 
Its importance has increased over time as EPA program offices and the 
states have increasingly relied on IRIS information in making 
environmental protection decisions. Currently, the IRIS database 
contains assessments of more than 540 chemicals. 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 are 
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. 

A typical IRIS assessment contains a qualitative hazard identification 
description and quantitative dose-response assessments. 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, 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 quantitative estimates of 
noncancer effects or qualitative cancer assessments of exposure to 
chemicals in the environment. While these latter assessments provide 
information on the effects of long-term exposures to chemicals, they 
provide only qualitative assessments of cancer risks (known human 
carcinogen, likely human carcinogen, etc.) and not quantitative 
estimates of cancer potency, which are required to conduct quantitative 
risk assessments. 

EPA's IRIS assessment process has undergone a number of formal and 
informal changes during the past several years. While the process used 
to develop IRIS chemical assessments 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 OMB/interagency 
reviews, managed by OMB, that provide 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. 

Findings and Recommendations from Our March 2008 Report on the 
Productivity and Credibility of EPA's Integrated Risk Information 
System: 

The IRIS database is at serious risk of becoming obsolete because the 
agency has not been able to routinely complete timely, credible 
assessments or decrease a backlog of 70 ongoing assessments. 
Specifically, 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 including 
the imposition of external requirements, the growing complexity and 
scope of risk assessments, and certain EPA management decisions. In 
addition, the changes to the IRIS assessment process that EPA was 
considering at the time of our review would have added to the already 
unacceptable level of delays in completing IRIS assessments and further 
limited the credibility of the assessments. 

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

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 (see fig. 1). 

Figure 1: Number of Completed IRIS Assessments, Draft Assessments to 
OMB, and IRIS Staff in Full-Time Equivalents, Fiscal Years 2000-2007: 

This figure is a combination line graph showing the number of completed 
IRIS assessments, draft assessments to OMB, and IRIS staff in full-time 
equivalents, fiscal years 2000 to 2007. 

Fiscal year: "2000"; 
Draft IRIS assessments to OMB for OMB/interagency review: [Empty]; 
IRIS assessments completed: 5.0; 
IRS staff level in full-time equivalent: 7.8. 

Fiscal year: "2001"; 
Draft IRIS assessments to OMB for OMB/interagency review: [Empty]; 
IRIS assessments completed: 7; 
IRS staff level in full-time equivalent: 7.8. 

Fiscal year: "2002"; 
Draft IRIS assessments to OMB for OMB/interagency review: [Empty]; 
IRIS assessments completed: 3; 
IRS staff level in full-time equivalent: 7.8. 

Fiscal year: "2003"; 
Draft IRIS assessments to OMB for OMB/interagency review: [Empty]; 
IRIS assessments completed: 11; 
IRS staff level in full-time equivalent: 12.8. 	

Fiscal year: "2004"; 
Draft IRIS assessments to OMB for OMB/interagency review: 1; 
IRS staff level in full-time equivalent: 27; 
IRIS assessments completed: 4. 

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

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

Fiscal year: "2007"; 
Draft IRIS assessments to OMB for OMB/interagency review: 2; 
IRIS assessments completed: 16; 
IRS staff level in full-time equivalent: 37. 

[See PDF for image] 

Source: GAO analysis of EPA data. 

[End of figure] 

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 lead to the need to essentially 
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--48 had been in process for more 
than 5 years, and 12 of those for more than 9 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 (for 
example, developing a cancer potency estimate for assessments with only 
noncancer estimates). 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-directed OMB/interagency 
review process--also limits the credibility of the assessments because 
it lacks transparency. 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. In addition, the OMB/interagency reviews have hindered EPA's 
ability to independently manage its IRIS assessments. For example, 
without communicating its rationale for doing so, OMB directed EPA to 
terminate five IRIS assessments that for the first time addressed 
acute, rather than chronic exposure--even though EPA initiated this 
type of assessment to help it implement the Clean Air Act. 

The Expansion of Agencies' Roles in IRIS Assessments That EPA Was 
Considering at the Time of Our Review Would Have Caused Further Delays 
and Limited the Assessments' Credibility: 

For our March 2008 report, we reviewed the additional assessment 
process changes EPA was planning and concluded that they would likely 
exacerbate delays in completing IRIS assessments and further affect 
their credibility. Specifically, despite the OMB/interagency review 
process that OMB required EPA to incorporate into the IRIS assessment 
process in 2005, certain federal agencies continued to believe they 
should have greater and more formal roles in EPA's development of IRIS 
assessments. Consequently, EPA had been working for several years to 
establish a formal IRIS assessment process that would further expand 
the role of federal agencies in the process--including agencies such as 
DOD, which could be affected by the outcome of IRIS assessments. For 
example, 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. In addition, the agencies could be 
required to, for example, redesign systems and processes to eliminate 
hazardous materials; develop material substitutes; and improve personal 
protective clothing, equipment, and procedures. Under the changes that 
EPA was planning at the time of our review, these potentially affected 
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 changes would have provided federal agencies, 
including those facing potential regulatory liability, with several 
opportunities during the IRIS assessment process to subject particular 
chemicals of interest to additional process steps. These additional 
process steps, which would have lengthened assessment times 
considerably, include: 

* giving federal agencies and the public 45 days to identify additional 
information on a chemical for EPA's consideration in its assessment or 
to correct any errors on an additional assessment draft that would 
provide qualitative information;[Footnote 3] 

* giving potentially affected federal agencies 30 days to review the 
public comments EPA received and initiate a meeting with EPA if they 
want to discuss a particular set of comments; 

* allowing potentially affected federal agencies to have assessments 
suspended for up to 18 months to fill a data gap or eliminate an 
uncertainty factor that EPA plans to use in its assessment; and: 

* allowing other federal agencies to weigh in on (1) the level of 
independent peer review that would be sought (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); 
(2) the areas of scientific expertise needed on the panel; and (3) the 
scope of the peer reviews and the specific issues they would address. 

EPA estimated that assessments that undergo these additional process 
steps would take up to 6 years to complete. 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 their 
quality,[Footnote 4] 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's proposed changes would have 
allowed for including federal agencies' comments in the public record, 
the implementation of this proposal was delayed for a year, 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, which relies on, among other things, transparency. 

Recommendations Made in Our March 2008 Report: 

To address the productivity and credibility issues we identified, we 
recommended that the EPA Administrator 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 our 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. One of our recommendations--that EPA provide at 
least 2 years' notice of IRIS assessments that are planned--would, 
among other things, provide an efficient alternative to suspending 
assessments while waiting for new research because interested parties 
would have the opportunity to conduct research before assessments are 
started. 

In addition, we recommended that the EPA Administrator take steps to 
better ensure that EPA has the ability to develop transparent, credible 
IRIS 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 (1) determine the 
types of assessments it needs to support EPA programs and (2) 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. In its February 21, 2008, letter providing comments 
on our draft report, EPA said it would consider each of our 
recommendations in light of the new IRIS process the agency was 
developing. 

Key Changes to the IRIS Assessment Process That EPA Implemented in 
April 2008: 

On April 10, 2008, EPA issued a revised IRIS assessment process, 
effective immediately (see app. III for a flow chart of the process). 
Overall, EPA's revised process is not responsive to the recommendations 
made in our March 2008 report. While the revised process is largely the 
same as the draft proposed process we evaluated in our March 2008 
report, there are several key differences that are likely to further 
exacerbate the productivity and credibility issues we identified in our 
report. These changes are as follows. 

* While the draft process we reviewed provided that comments on IRIS 
assessments from OMB and other federal agencies would be part of the 
public record, under the recently implemented process, comments from 
federal agencies are expressly defined as "deliberative" and will not 
be included in the public record. (Making these comments public would 
have been a change from the OMB/interagency review process that has 
been in place since 2004.) Given the importance and sensitivity of IRIS 
assessments, we believe it is critical that input from all parties, 
particularly agencies that may be affected by the outcome of IRIS 
assessments, be publicly available. Thus, under EPA's new process, 
input from some IRIS assessment reviewers--representatives of federal 
agencies, including those facing potential regulatory liability, and 
private stakeholders associated with these agencies--will continue to 
receive less public scrutiny than all other comments. 

* The newly implemented IRIS assessment process broadens EPA's 
characterization of IRIS assessments from "the Agency's scientific 
positions on human health effects that may result from exposure to 
environmental contaminants" to "the Agency's science and science policy 
positions" on such effects. As we highlighted in our report, 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. EPA's new, broader characterization of IRIS raises 
concerns about the agency's intent to ensure that scientific 
assessments are appropriately based on the best available science and 
that they are not inappropriately impacted by policy issues and 
considerations. 

* The new process includes several revisions to the time frames 
associated with various process steps. Most notably, while EPA has 
estimated that under the new process assessments may take up to 6 years 
to complete, the estimated time frames do not factor in the time needed 
for peer reviews conducted by the National Academies, which can take 2 
years to plan and complete.[Footnote 5] EPA typically uses reviews by 
the National Academies for highly controversial chemicals or complex 
assessments. Therefore, assessments reviewed by the National Academies 
are likely to take at least 8 years to complete. However, as discussed 
in our report, 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. As a result, we concluded that it was critical that EPA 
streamline its process to routinely support timely completion of 
assessments and avoid being caught in an endless cycle of delays. 
Further, EPA's lengthy assessment time frames must be considered in 
light of OMB's view that health assessment values in IRIS are out of 
date if they are more than 10 years old and if new scientific 
information exists that could change the health assessment values. 
EPA's new process institutionalizes time frames that could essentially 
require the agency to start assessment updates as soon as 2 years after 
assessments are finalized in order to keep the IRIS database current. 
Such time frames are not consistent with our recommendation that EPA 
clearly define and document a streamlined IRIS process that can be 
conducted within time frames that minimize the need for wasteful 
rework. Further, the agency would need a significant increase in 
resources to support such an assessment cycle. 

In addition, EPA had previously emphasized that, in suspending 
assessments to allow agencies to fill in data gaps, it would allow no 
more than 18 months to complete the studies and have them peer 
reviewed. However, under the new process, EPA states that it generally 
will allow no more than 18 months to complete the studies and have them 
peer reviewed. As we concluded in our report, we believe the ability to 
suspend assessments for up to 18 months would add to the already 
unacceptable level of delays in completing IRIS assessments. Further, 
we and several agency officials with whom we spoke believe that the 
time needed to plan, conduct, and complete research that would address 
significant data gaps, and have it peer reviewed, would likely exceed 
18 months. Therefore, the less rigid time frame EPA included in its new 
process could result in additional delays. 

* The new process expands the scope of one of the additional steps that 
initially was to apply only to chemicals of particular interest to 
federal agencies.[Footnote 6] Specifically, under the draft process we 
reviewed, EPA would have provided an additional review and comment 
opportunity for federal agencies and the public for what EPA officials 
said would be a small group of chemicals. However, under EPA's new 
process, this additional step has been added to the assessment process 
for all chemicals and, therefore, will add time to the already lengthy 
assessments of all chemicals. 

* Finally, EPA and OMB had planned for EPA to release a draft revised 
IRIS assessment process to the public, hold a public meeting to discuss 
EPA's: 

proposed changes, and seek and incorporate public input before 
finalizing the process. For example, in its letter commenting on our 
draft report, OMB emphasized that EPA had not completed the development 
of the IRIS assessment process, adding: "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." However, as stated above, EPA released its new assessment 
process without obtaining public input and made it effective 
immediately. 

Conclusions: 

The new IRIS assessment process that EPA implemented in April 2008 will 
not allow the agency to routinely and timely complete credible 
assessments. In fact, it will exacerbate the problems we identified in 
our March 2008 report and sought to address with our recommendations-- 
all of which were aimed at preserving the viability of this critical 
database, which is integral to EPA's mission of protecting the public 
and the environment from exposure to toxic chemicals. Specifically, 
under the new process, assessment time frames will be significantly 
lengthened, and the lack of transparency will further limit the 
credibility of the assessments because input from OMB and other 
agencies at all stages of the IRIS assessment process is now expressly 
defined as deliberative and therefore not subject to public disclosure. 
To effectively maintain IRIS, EPA must streamline its lengthy 
assessment process and adopt transparency practices that provide 
assurance that IRIS assessments are appropriately based on the best 
available science and that they are not inappropriately biased by 
policy issues and considerations. Federal agencies may appropriately 
participate in policy dialogues through the rule-making process and 
other interagency working groups, which are risk management activities 
that should occur after the risk assessment process that encompasses 
IRIS assessments. Finally, 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. 

Matter for Congressional Consideration: 

In light of the importance of the IRIS program to EPA's ability to 
protect the public health and the environment, the Congress should 
consider requiring EPA to suspend implementation of its new IRIS 
assessment process and develop a process that is responsive to our 
recommendations for a streamlined process that is transparent and 
otherwise responsive to our recommendations aimed at improving the 
timeliness and credibility of IRIS assessments. In addition, the 
Congress should consider requiring EPA to obtain and be responsive to 
input from the Congress and the public before finalizing a revised IRIS 
assessment process. 

Madam Chairman, this concludes my prepared statement. I would be happy 
to respond to any questions that you or other Members of the Committee 
may have at this time. 

GAO Contact and Staff Acknowledgments: 

For further information about this testimony, please contact John B. 
Stephenson on (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 statement. Contributors to this testimony 
include Christine Fishkin (Assistant Director), Laura Gatz, Richard P. 
Johnson, Nancy Crothers, David Bennett, and Crystal M. Huggins. 

[End of section] 

Appendix I: Examples of Key IRIS Assessments That Have Been Delayed: 

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 key factors 
we identified that have hindered EPA's productivity.[Footnote 7] 
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 8] 
"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 9] 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 
10] 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 11] 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 12] 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 
13] 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 
14] 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 15] 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 16] 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 had 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 in our March 2008 report on IRIS (GAO-08-440), 
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. 

[End of section] 

Appendix II: Summary of Two GAO Reports on EPA's Toxic Substances 
Control Act and Chemical Control Regulations in the EU: 

This appendix summarizes information presented in two prior GAO reports 
and related work on EPA's regulation of toxic chemicals. In 1976, 
Congress passed the Toxic Substances Control Act (TSCA) to authorize 
the Environmental Protection Agency (EPA) to obtain information on 
chemicals and regulate chemicals that pose an unreasonable risk to 
human health or the environment. In 2005, we reviewed EPA's efforts to 
assess the risks of new chemicals--those not yet in commerce--and the 
risks of existing chemicals--those already being used in 
commerce.[Footnote 17] In summary, EPA faces challenges in obtaining 
the information necessary to assess the human health and environmental 
risks of chemicals. 

Like the United States, the European Union has laws governing the 
production and use of chemicals. The European Union has recently 
revised its chemical control policy through legislation known as 
Registration, Evaluation and Authorization of Chemicals (REACH). In 
another report, we provided comparative information on TSCA and 
REACH.[Footnote 18] In summary, REACH generally requires that chemical 
companies develop and provide government regulators with information on 
chemicals' effects on human health and the environment, while TSCA 
generally does not. REACH is based on the principle that chemical 
companies have the responsibility to demonstrate that the chemicals 
they place in the market, distribute, or use do not adversely affect 
human health or the environment, while TSCA generally requires EPA to 
demonstrate that chemicals pose risks to human health or the 
environment prior to controlling risks related to their production, 
distribution, or use. The findings of these reports are summarized 
below. 

Key Findings in GAO's 2005 Report and Related Testimony: 

Overall, we found that EPA has limited information on the health and 
environmental risks of chemicals. EPA does not routinely assess the 
human health and environmental risks of existing chemicals and faces 
challenges in obtaining the information to do so. TSCA's authorities 
for collecting data on existing chemicals do not facilitate EPA's 
review process because they generally place the costly and time- 
consuming burden of obtaining data on EPA, rather than requiring 
chemical companies to develop and submit such data to EPA. 
Consequently, EPA has used its authorities to require testing for few 
of the over 60,000 chemicals already in commerce when EPA began 
reviewing chemicals under TSCA in 1979. Recognizing the need for 
additional information on existing chemicals, EPA has initiated 
voluntary programs. While these programs are a laudable effort to 
develop data on these chemicals, several problems remain, including 
that the chemical industry may not provide testing results in a timely 
manner for all chemicals in these programs and that even with 
additional test data, EPA would need to demonstrate that the chemicals 
pose unreasonable risks in order to control their production or use 
under TSCA. While TSCA does not define what risk is unreasonable, EPA 
has found it difficult to meet this standard. In order to withstand 
judicial scrutiny, a TSCA rule must be supported by substantial 
evidence in the rule-making record. In this regard, EPA officials say 
the act's legal standards are so high that they have generally 
discouraged EPA from using its authorities to ban or restrict the 
manufacture or use of chemicals. 

Further, EPA's reviews of new chemicals can provide only limited 
assurance that health and environmental risks are identified before the 
chemicals enter commerce because TSCA does not require chemical 
companies to test new chemicals before notifying EPA of their intent to 
manufacture a chemical. Furthermore, chemical companies generally do 
not voluntarily perform such testing. Because of a general lack of 
data, EPA has developed scientific models to predict the potential 
exposure and toxicity levels of new chemicals. However, the use of 
these models can present weaknesses in the assessment because the 
models are not always accurate in predicting physical chemical 
properties and the evaluation of general health effects is contingent 
on the availability of information on chemicals with similar molecular 
structures. Additionally, chemical company estimates of a chemical's 
production volume and anticipated uses provided in the premanufacture 
notices that EPA uses to assess exposure can change substantially after 
EPA completes its review and manufacturing begins. However, these 
estimates do not have to be amended by companies unless EPA promulgates 
a rule determining that a use of a chemical constitutes a significant 
new use, which EPA has done for only a small percentage of new 
chemicals. Despite limitations in the information available on new 
chemicals, EPA's reviews have resulted in some action being taken to 
reduce the risks of over 3,600 new chemicals submitted for review. 

EPA's ability to provide the public with information on chemical 
production and risk has also been hindered by strict confidential 
business information provisions of TSCA, which generally prohibits the 
disclosure of confidential business information. According to EPA 
officials, about 95 percent of the premanufacture notices for new 
chemicals contain some information that is claimed as confidential. 
While EPA has the authority to evaluate the appropriateness of 
confidentiality claims, these efforts are time and resource-intensive, 
and the agency does not have the resources to challenge a significant 
number of claims. State environmental agencies and others have 
expressed interest in obtaining information claimed as confidential 
business information for use in various activities, such as developing 
contingency plans to alert emergency response personnel to the presence 
of highly toxic substances at manufacturing facilities. Chemical 
companies recently have expressed interest in working with EPA to 
identify ways to enable other organizations to use the information 
given the adoption of appropriate safeguards. 

In our June 2005 report, we recommended that Congress consider 
providing EPA with additional authorities under TSCA to improve its 
ability to assess chemical risks, such as providing the EPA 
Administrator with the authority to require that chemical companies 
develop test data when production volumes reach certain levels. We also 
recommended that the EPA Administrator take several actions to improve 
EPA's management of its chemical program, including revising its 
regulations to require that companies reassert confidentiality claims 
under TSCA within a certain time period after the information is 
initially claimed as confidential. EPA did not disagree with the 
report's findings and is in the process of implementing several of our 
recommendations. 

Key Findings in GAO's 2007 Report and Related Correspondence: 

Overall, we found that REACH, the legislation through which the 
European Union has recently revised its chemical control policy, 
requires chemical companies to develop more information than TSCA on 
the effects of chemicals on human health and the environment. REACH 
generally requires that chemical companies develop and provide 
government regulators information on chemicals' effects on human health 
and the environment, while TSCA generally does not. For example, under 
REACH, chemical companies provide, and in some cases develop, 
information on chemicals' physical/chemical properties and health and 
environmental effects for both new and existing chemicals produced over 
specified volumes. REACH also provides regulators the general authority 
to require chemical companies to provide additional test data and other 
information when necessary to evaluate a chemical's risk to human 
health and the environment. In contrast, TSCA places the burden on EPA 
to demonstrate that data on health and environmental effects are needed 
before requiring chemical companies to develop the data. In this 
regard, while TSCA requires chemical companies to notify EPA before 
producing or importing a new chemical, it does not require chemical 
companies to develop and provide data on health and environmental 
effects unless EPA promulgates a rule requiring them to do so. In 
promulgating such a rule, EPA must demonstrate that data already 
available are insufficient and that either (1) the chemical may present 
an unreasonable risk or (2) the chemical is or will be produced in 
substantial quantities and that there is or may be substantial human or 
environmental exposure to the chemical. 

REACH is based on the principle that chemical companies have the 
responsibility to demonstrate that the chemicals they place in the 
market, distribute, or use do not adversely affect human health or the 
environment, while TSCA generally requires EPA to demonstrate that 
chemicals pose risks to human health or the environment prior to 
controlling risks related to their production, distribution, or use. 
Under REACH, chemical companies must obtain authorization to continue 
to use a chemical of very high concern, such as a chemical for which 
there is scientific evidence of probable serious health or 
environmental effects. Generally, to obtain such authorization, each 
chemical company needs to demonstrate that it can adequately control 
risks posed by the chemical, such as by requiring that workers wear 
safety equipment when working with the chemical or otherwise ensuring 
that the chemical is produced under safe conditions. If the chemical 
company cannot provide evidence of adequate control, authorization 
would be granted only if the socioeconomic advantages of a specific use 
of the chemical are greater than its potential risks, and if there are 
no suitable alternatives or technologies. 

Under TSCA, EPA has differing authorities to control the risks posed by 
new and existing chemicals. For new chemicals, EPA can restrict a 
chemical's production or use if the agency determines that insufficient 
information exists to permit a reasoned evaluation of the health and 
environmental effects of the chemical and that, in the absence of such 
information, the chemical may present an unreasonable risk to human 
health or the environment; the chemical is or will be produced in 
substantial quantities and either enters or may reasonably be 
anticipated to enter the environment in substantial quantities; or 
there is or may be significant or substantial human exposure to the 
substance. For existing chemicals, EPA may regulate those chemicals for 
which it finds a reasonable basis exists to conclude that they present 
or will present an unreasonable risk to human health or the 
environment. In this regard, EPA can promulgate a rule that bans or 
restricts the chemical's production, processing, distribution in 
commerce, use, or disposal, or that requires warning labels be placed 
on the chemical. However, TSCA requires EPA to choose the least 
burdensome requirement on the chemical industry that will adequately 
protect against the risk. 

TSCA and REACH both have provisions to protect information claimed by 
chemical companies as confidential or sensitive business information; 
however, REACH requires greater public disclosure of certain 
information, including information about (1) basic chemical properties 
such as melting and boiling points and (2) analytical methods that make 
it possible to detect a dangerous substance when discharged into the 
environment and to determine the effects of direct exposure to humans. 
In addition, REACH places greater restrictions on the kinds of 
information companies may claim as confidential or sensitive. For 
example, REACH generally does not allow confidentiality claims to apply 
to the chemical's trade name, and it does not allow such claims to 
apply to guidance on the chemical's safe use. 

[End of section] 

Appendix III: EPA's IRIS Assessment Process as of April 10, 2008: 

Figure: 

This figure is a flowchart showing EPA's IRIS assessment process as of 
April 10, 2008. 

[See PDF for image] 

Source: GAO analysis of EPA information. 

[End of figure] 

[End of section] 

Footnotes: 

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

[2] GAO, Chemical Regulation: Options Exist to Improve EPA's Ability to 
Assess Health Risks and Manage Its Chemical Review Program, GAO-05-458 
(Washington, D.C.: June 13, 2005); and GAO, Chemical Regulation: 
Approaches in the United States, Canada, and the European Union, GAO-06-
217R (Washington, D.C.: Nov. 4, 2005). 

[3] This represents an additional review of a new draft product and 
comment period that had not existed previously. 

[4] 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. 
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). 

[5] It is not clear whether the time frames exclude reviews conducted 
by EPA's Science Advisory Board, which can also add considerably more 
time than the most basic level of peer review used by the IRIS program-
-panels organized by an EPA contractor. 

[6] The new IRIS assessment process refers to such chemicals as 
"mission critical." 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 its operations. Impacts on the use of 
mission-critical chemicals include cessation or degradation of the 
conduct of the mission and/or unacceptable resource constraints. 

[7] The factors we identified 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. 

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

[9] 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. 

[10] 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. 

[11] 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. 

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

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

[14] 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). 

[15] 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. 

[16] 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. 

[17] GAO, Chemical Regulation: Actions Are Needed to Improve the 
Effectiveness of EPA's Chemical Review Program, GAO-06-1032T 
(Washington, D.C.: Aug. 2, 2006); and GAO, Chemical Regulation: Options 
Exist to Improve EPA's Ability to Assess Health Risks and Manage Its 
Chemical Review Program, GAO-05-458 (Washington, D.C.: June 13, 2005). 

[18] GAO, Chemical Regulation: Comparison of U.S. and Recently Enacted 
European Union Approaches to Protect against the Risks of Toxic 
Chemicals, GAO-07-825 (Washington, D.C.: Aug. 17, 2007); and GAO, 
Chemical Regulation: Approaches in the United States, Canada, and the 
European Union, GAO-06-217R (Washington, D.C.: Nov. 4, 2005). 

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