Toxic Chemicals
EPA's New Assessment Process Will Increase Challenges EPA Faces in Evaluating and Regulating Chemicals Gao ID: GAO-08-743T April 29, 2008The 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.
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 assessments--a 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 GAO's 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 delays--even 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 EPA's IRIS assessment process in a manner that limits the credibility of IRIS assessments and hinders EPA's 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 GAO's 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 GAO's draft report, EPA said it would consider the report's recommendations, which were aimed at streamlining the process and better ensuring that EPA has the ability to develop transparent, credible assessments. However, EPA's 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, EPA's new process expressly defines such comments as "deliberative" and excludes them from the public record. GAO continues to believe it is critical that input from all parties--particularly agencies that may be affected by the outcome of IRIS assessments--be publicly available. As recommended in GAO's 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 EPA's new process is not responsive to GAO's recommendations, the viability of this critical database has been further jeopardized.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-08-743T, Toxic Chemicals: EPA's New Assessment Process Will Increase Challenges EPA Faces in Evaluating and Regulating Chemicals
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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 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.
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 assessments”a 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 GAO‘s 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 delays”even 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 EPA‘s IRIS assessment process in a manner that
limits the credibility of IRIS assessments and hinders EPA‘s 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 GAO‘s 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 GAO‘s draft
report, EPA said it would consider the report‘s recommendations, which
were aimed at streamlining the process and better ensuring that EPA has
the ability to develop transparent, credible assessments. However,
EPA‘s 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, EPA‘s new process expressly defines
such comments as ’deliberative“ and excludes them from the public
record. GAO continues to believe it is critical that input from all
parties”particularly agencies that may be affected by the outcome of
IRIS assessments”be publicly available. As recommended in GAO‘s 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 EPA‘s new
process is not responsive to GAO‘s 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
stephensonj@gao.gov.
[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 stephensonj@gao.gov. 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:
This appendix contains a figure that is an illustration of a flowchart of EPA's IRIS Assessment Process, as follows:
1) Annual request for nomination of IRIS chemicals for assessment
(step where EPA has provided additional opportunity for input from potentially affected federal agencies for all chemicals);
2) Determine the annual agenda and publish it in the Federal Register
(step where EPA has provided additional opportunity for input from potentially affected federal agencies for all chemicals);
3) Scientific literature search;
4) Federal Register notice/data call-in (step where EPA has provided additional opportunity for input from potentially affected federal agencies for all chemicals);
5) Development of a draft qualitative assessment;
6) Federal agency and public review of draft qualitative assessment (step where EPA has provided additional opportunity for input from potentially affected federal agencies for all chemicals);
7) EPA and federal agency review of comments (step where EPA has provided additional opportunity for input from potentially affected federal agencies for all chemicals);
8) Is the chemical mission critical? If yes, proceed to step 9; if no proceed to step 12;
9) Interagency evaluation to close data gaps (additional step, under EPA‘s planned changes, to its assessment process and steps where EPA has provided additional opportunity for input from potentially affected federal agencies for mission-critical chemicals);
10) Is there interest in conducting research to close data gaps? If yes, proceed to step 11; if no proceed to step 12;
11) Federal agency development of new studies; (additional step, under EPA‘s planned changes, to its assessment process and steps where EPA has provided additional opportunity for input from potentially affected federal agencies for mission-critical chemicals);
12) Development of a complete draft IRIS assessment (qualitative and quantitative), including internal peer consultation;
13) Is the chemical mission critical? If yes, proceed to step 14a; if no, proceed to step 14b;
14a) EPA consults with federal agencies to determine level and scope of peer review (additional step, under EPA‘s planned changes, to its assessment process and steps where EPA has provided additional opportunity for input from potentially affected federal agencies for mission-critical chemicals);
14b) EPA determines the level and scope of the peer review;
15) Internal agency review by the 18-member IRIS Agency Review Committee;
16) Revised draft IRIS assessment (may require a return to step 15);
17) OMB/interagency review coordinated by OMB (step where potentially affected federal agencies already had an opportunity for input);
18) Revised draft IRIS assessment (may require a return to step 17);
19) Independent external peer review and public comment (step where potentially affected federal agencies already had an opportunity for input);
20) Revised draft IRIS assessment;
21a) Second internal agency review by the 18-member IRIS Agency Review Committee (may require a return to step 20);
21b) Second OMB/interagency review coordinated by OMB (may require a return to step 20); (step where potentially affected federal agencies already had an opportunity for input);
22) Completion of IRIS assessment, EPA management review and approval, and posting on IRIS.
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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