[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]
EPA'S IRIS PROGRAM: REVIEWING ITS
PROGRESS AND ROADBLOCKS AHEAD
=======================================================================
JOINT HEARING
BEFORE THE
SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
SUBCOMMITTEE ON ENVIRONMENT
COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTEENTH CONGRESS
FIRST SESSION
__________
MARCH 27, 2019
__________
Serial No. 116-9
__________
Printed for the use of the Committee on Science, Space, and Technology
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://science.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
37-709PDF WASHINGTON : 2019
--------------------------------------------------------------------------------------
COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
HON. EDDIE BERNICE JOHNSON, Texas, Chairwoman
ZOE LOFGREN, California FRANK D. LUCAS, Oklahoma,
DANIEL LIPINSKI, Illinois Ranking Member
SUZANNE BONAMICI, Oregon MO BROOKS, Alabama
AMI BERA, California, BILL POSEY, Florida
Vice Chair RANDY WEBER, Texas
CONOR LAMB, Pennsylvania BRIAN BABIN, Texas
LIZZIE FLETCHER, Texas ANDY BIGGS, Arizona
HALEY STEVENS, Michigan ROGER MARSHALL, Kansas
KENDRA HORN, Oklahoma NEAL DUNN, Florida
MIKIE SHERRILL, New Jersey RALPH NORMAN, South Carolina
BRAD SHERMAN, California MICHAEL CLOUD, Texas
STEVE COHEN, Tennessee TROY BALDERSON, Ohio
JERRY McNERNEY, California PETE OLSON, Texas
ED PERLMUTTER, Colorado ANTHONY GONZALEZ, Ohio
PAUL TONKO, New York MICHAEL WALTZ, Florida
BILL FOSTER, Illinois JIM BAIRD, Indiana
DON BEYER, Virginia VACANCY
CHARLIE CRIST, Florida VACANCY
SEAN CASTEN, Illinois
KATIE HILL, California
BEN McADAMS, Utah
JENNIFER WEXTON, Virginia
------
Subcommittee on Investigations and Oversight
HON. MIKIE SHERRILL, New Jersey, Chairwoman
SUZANNE BONAMICI, Oregon RALPH NORMAN, South Carolina,
STEVE COHEN, Tennessee Ranking Member
DON BEYER, Virginia ANDY BIGGS, Arizona
JENNIFER WEXTON, Virginia MICHAEL WALTZ, Florida
------
Subcommittee on Environment
HON. LIZZIE FLETCHER, Texas, Chairwoman
SUZANNE BONAMICI, Oregon ROGER MARSHALL, Kansas, Ranking
CONOR LAMB, Pennsylvania Member
PAUL TONKO, New York BRIAN BABIN, Texas
CHARLIE CRIST, Florida ANTHONY GONZALEZ, Ohio
SEAN CASTEN, Illinois JIM BAIRD, Indiana
BEN McADAMS, Utah VACANCY
DON BEYER, Virginia
C O N T E N T S
March 27, 2019
Page
Hearing Charter.................................................. 2
Opening Statements
Statement by Representative Mikie Sherrill, Chairwoman,
Subcommittee on Investigations and Oversight, Committee on
Science, Space, and Technology, U.S. House of Representatives.. 9
Written Statement............................................ 11
Statement by Representative Ralph Norman, Ranking Member,
Subcommittee on Investigations and Oversight, Committee on
Science, Space, and Technology, U.S. House of Representatives.. 13
Written Statement............................................ 15
Statement by Representative Lizzie Fletcher, Chairwoman,
Subcommittee on Environment, Committee on Science, Space, and
Technology, U.S. House of Representatives...................... 17
Written Statement............................................ 19
Statement by Representative Roger Marshall, Ranking Member,
Subcommittee on Environment, Committee on Science, Space, and
Technology, U.S. House of Representatives...................... 21
Written Statement............................................ 23
Statement by Representative Frank D. Lucas, Ranking Member,
Committee on Science, Space, and Technology, U.S. House of
Representatives................................................ 25
Written Statement............................................ 26
Written statement by Representative Eddie Bernice Johnson,
Chairwoman, Committee on Science, Space, and Technology, U.S.
House of Representatives....................................... 29
Witnesses:
Panel 1:
Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant
Administrator for Science and Senior Advisor, Office of
Research and Development, Environmental Protection Agency
Oral Statement............................................... 31
Written Statement............................................ 33
Mr. Alfredo Gomez, Director, Natural Resources and Environment,
Government Accountability Office
Oral Statement............................................... 41
Written Statement............................................ 43
Discussion....................................................... 58
Panel 2:
Dr. Bernard D. Goldstein, Professor Emeritus and Dean Emeritus at
University of Pittsburgh Graduate School of Public Health
Oral Statement............................................... 75
Written Statement............................................ 77
Dr. Ivan Rusyn, Professor, Department of Veterinary Integrative
Biosciences; Chair, Interdisciplinary Faculty of Toxicology;
and Director, Superfund Research Center, Texas A&M University
Oral Statement............................................... 84
Written Statement............................................ 86
Dr. Julie E. Goodman, Principal, Gradient
Oral Statement............................................... 97
Written Statement............................................ 99
Ms. Wilma Subra, President, Subra Company; and Technical Advisor,
Louisiana Environmental Action Network
Oral Statement............................................... 103
Written Statement............................................ 105
Discussion....................................................... 123
Appendix I: Answers to Post-Hearing Questions
Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant
Administrator for Science and Senior Advisor, Office of
Research and Development, Environmental Protection Agency...... 140
Mr. Alfredo Gomez, Director, Natural Resources and Environment,
Government Accountability Office............................... 147
Appendix II: Additional Material for the Record
Letter from the American Chemistry Council submitted by
Representative Ralph Norman, Ranking Member, Subcommittee on
Investigations and Oversight, Committee on Science, Space, and
Technology, U.S. House of Representatives...................... 150
Letter from the Colorado Department of Public Health &
Environment submitted by Representative Lizzie Fletcher,
Chairwoman, Subcommittee on Environment, Committee on Science,
Space, and Technology, U.S. House of Representatives........... 155
EPA Executive Summary submitted by Representative Bill Foster,
Committee on Science, Space, and Technology, U.S. House of
Representatives................................................ 157
EPA'S IRIS PROGRAM: REVIEWING ITS
PROGRESS AND ROADBLOCKS AHEAD
----------
WEDNESDAY, MARCH 27, 2019
House of Representatives,
Subcommittee on Investigations and Oversight,
joint with the Subcommittee on Environment,
Committee on Science, Space, and Technology,
Washington, D.C.
The Subcommittees met, pursuant to notice, at 10:01 a.m.,
in room 2318 of the Rayburn House Office Building, Hon. Mikie
Sherrill [Chairwoman of the Subcommittee on Investigations and
Oversight] presiding.
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Sherrill. This hearing will come to order.
Without objection, the Chair is authorized to declare
recess at any time.
Good morning, and welcome to the Investigations and
Oversight Subcommittee's first hearing of the 116th Congress.
I'm pleased to work alongside Ranking Member Norman of South
Carolina and look forward to a productive and collaborative
relationship.
This is also a joint Subcommittee hearing with the
Environment Subcommittee, and I'm very pleased to welcome my
fellow Chair Mrs. Fletcher, who's on her way, and her
counterpart in the minority, Representative Marshall of Kansas.
I expect this is just the beginning of the cooperative
partnership that our Subcommittees will enjoy during this
Congress, and I look forward to continuing to work closely with
you in the weeks and months ahead.
In this first hearing, we are focusing on a subject that
directly impacts the state of public health in this country.
The EPA's (Environmental Protection Agency's) Integrated Risk
Information System, or IRIS, is tasked with developing
impartial, science-based assessments on toxicity of chemicals.
It is considered the gold standard for chemical toxicity
assessments in the United States, and note that IRIS is not
itself a risk management program or a regulator. Instead, its
findings are used by other branches of the EPA and State and
local governments to inform guidelines and regulations about
what levels of human exposure to a given chemical are
acceptable.
IRIS has produced toxicity assessments for a multitude of
dangerous chemicals, including asbestos, mercury and ethylene
oxide, to name a few. Unfortunately, we have learned in recent
weeks that IRIS is being undercut by political leadership at
the EPA. America needs a strong, empowered IRIS to provide EPA,
States, tribes, municipalities, and communities everywhere with
the best-available science regarding chemical toxicity.
When IRIS is prevented from doing its work, the public is
less informed, and therefore less safe. The public needs IRIS
to be independent of outside influence, but the GAO report we
will discuss today outlines troubling facts about political
interference with IRIS. Political appointees at EPA have
blocked the release of IRIS assessments, imposed new
bureaucratic hurdles, and reduced the number of priority
chemicals for IRIS to evaluate with no explanation.
The formaldehyde assessment in particular has been ready to
be released for over a year. Then-EPA Administrator Scott
Pruitt said so himself in a January 2018 hearing before the
Senate. Press reports indicate that IRIS has determined a
connection exists between formaldehyde and leukemia. It is
unacceptable for political considerations to suppress IRIS'
findings. I fail to see any credible reason why findings of
fact on chemical risks should be withheld from the public. EPA
must release the IRIS formaldehyde assessment as soon as
possible.
EPA's management of the IRIS Program has prompted concern
as well. In October 2018, 28 out of roughly 30 IRIS employees
spent 25 to 50 percent of their time working on risk
evaluations for a different EPA office. This kind of staff
reassignment distracts IRIS from its core mission and deprives
IRIS of the resources it needs to address its own work in a
timely fashion.
I'm very pleased to welcome the distinguished witnesses
appearing here today. And in our two panels, we have government
officials, eminent scholars, and community advocates who see
the real-world impact of IRIS assessments. We appreciate your
willingness to appear before our Subcommittees today.
Protecting the public from toxic chemicals is a core
function of the EPA, and IRIS is vital to the EPA's ability to
accomplish its mission. I'm pleased to have the opportunity to
continue this Committee's work to ensure that IRIS is allowed
to do its job for the sake of public health.
[The prepared statement of Chairwoman Sherrill follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Sherrill. The Chair now recognizes Mr. Norman
for an opening statement.
Mr. Norman. Thank you so much, Chairwoman Fletcher and
Chairwoman Sherrill. Thank you all for convening this meeting.
I want to thank the witnesses for taking your time to come.
It's very important what you're doing.
We're here today to examine the EPA's Integrated Risk
Information System program, which is also called IRIS. This
hearing provides an opportunity to review the issues and
challenges that burden the IRIS Program, steps that IRIS has
taken toward addressing these issues, and challenges that
remain today. I'm hopeful that our expert panel of witnesses
will paint a detailed picture of how to improve the IRIS
Program and remedy issues that have burdened us for years.
As Ranking Member of the Investigations and Oversight
Committee, I approach this issue from an oversight perspective,
focused on how to improve IRIS. With a background in business
and real estate, I've learned how burdensome and costly,
onerous regulations have become.
My experience in the real estate business has also taught
me a thing or two about construction. For example, one of the
primary tenets of construction is that your foundation is
critical. If you build atop a faulty foundation, the entire
structure is at risk and likely ruined where it stands.
As I understand it, IRIS assessments are analogous to a
structural foundation. In preparing chemical assessments, IRIS
conducts the first two steps of the risk assessment process:
First, a hazard identification; second, a dose-response
assessment. EPA's program and regional offices then rely on
IRIS assessments and the foundation for conducting the last two
steps of the risk assessment process, including an exposure
assessment and a risk characterization.
As with a structural foundation, if an IRIS assessment is
based on flawed information, or is itself faulty, then it
jeopardizes all subsequent work that builds atop a faulty
foundation. As a result, faulty assessments can lead to bad
regulations and unnecessary public health scares. The IRIS
Program must continue to address transparency issues that have
plagued it over the past decade because Americans need
assurance that sound science forms the foundation for
government regulations.
The U.S. Government Accountability Office (GAO) added IRIS
to its list of government programs that are highly vulnerable
to risk of waste, fraud, abuse, and mismanagement in 2009. IRIS
was added to GAO's ``High-Risk List'' because actions were
needed to streamline and increase the transparency and the
dependency of IRIS assessments. Despite attempts at improvement
and efforts to remedy its challenges over the past decade, IRIS
remains on the High-Risk List today.
In addition to its High-Risk List, GAO recently published a
report that examined IRIS' efforts to improve its chemical
assessment process and implement outstanding recommendations.
While GAO commended IRIS for its efforts to address identified
challenges, it also appropriately recognized that there
remained much room for much improvement, especially with
respect to issues of timeliness and transparency.
I want to thank the GAO for its great work. However, I was
puzzled by certain findings regarding EPA leadership. In both
reports, GAO seemed to fault EPA's leadership for delaying
IRIS' progress. It also appeared that EPA leadership was
chastised for failing to publicly commit to making IRIS a top
priority, as was done by a previous Administrator, under a
prior Administration.
I would suggest that a brief pause may have been necessary
to adequately address the issues and challenges that IRIS faces
and develop a plan of action for future progress. For example,
think about repairing a rollercoaster. If you don't try to fix
a malfunctioning rollercoaster while it's rolling around full
of people. Instead, you suspend operations, you pull the cars
off the track for evaluation, which makes for a better ride and
safer in the end. Perhaps delays due to EPA leadership
deliberation and assessment of IRIS should be handled in a
similar fashion.
Despite its issues and challenges, the IRIS Program must
still serve a critical function. And everyone here today
recognizes the importance of ensuring Americans are protected
from the dangers and hazards that IRIS aims to combat. It is
for this reason that we must ensure IRIS' work is transparent,
scientifically sound, and carried out in a timely and an
efficient manner.
I look forward to a productive and insightful discussion
with our distinguished witnesses about the issues and
challenges that the IRIS Program faces and the efforts that
IRIS has made in remedying them, and what remains to be done to
ensure that IRIS lives up to its potential.
Thank you, Madam Chairwoman. I yield back.
[The prepared statement of Mr. Norman follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Sherrill. Thank you, Mr. Norman.
The Chair now recognizes the Chairwoman for the
Subcommittee on the Environment, Mrs. Fletcher, for an opening
statement.
Mrs. Fletcher. Thank you, Madam Chairwoman. Good morning. I
would like to join the Chairwoman and Ranking Member Norman in
welcoming all of our witnesses on both panels here today.
The EPA's IRIS Program conducts human health assessments
that look at the health effects of chemical exposures in the
environment. IRIS assessments are unique in providing
information on chemical exposures and environmental hazards
that may affect the general population, including children and
the elderly, and that can occur over a lifetime. IRIS
assessments follow a thorough process that includes internal
and external peer review, as well as opportunity for public
input.
While the IRIS Program suffered from timeliness and
transparency issues earlier this decade, the program has
incorporated many recommendations from the GAO and the National
Academies of Sciences that have improved its processes. The
IRIS Program was intentionally placed in EPA's Office of
Research and Development, a nonregulatory program office at the
Agency, to ensure that only credible science guided the
development of its impartial assessments, which are not
regulatory in nature.
There are many Federal, State, and local stakeholders,
however, that rely on IRIS assessments to help make regulatory
decisions that protect public health. Program and regional
offices within the EPA routinely rely on IRIS assessments to
guide their risk-management decisions. IRIS assessments are not
only considered to be--are not considered to be duplicative of
other Federal chemical assessments like those carried out under
the EPA's Toxic Substances Control Act, or TSCA.
This is why the recent series of announcements by the EPA
removing the chemical formaldehyde from its IRIS workflow and
adding it to its TSCA workflow is concerning. It appears to
reset the clock on a late-stage IRIS assessment. Non-Federal
stakeholders, including community groups and State, local, and
tribal agencies, rely on IRIS assessments not only because of
their rigor and thoroughness, but also because many of these
entities do not have the capacity to conduct such thorough
toxicity assessments on their own. The values derived in IRIS
assessments are routinely the top choice of State regulatory
bodies in their standard-setting work because they are the most
thoroughly developed and vetted values available.
Because of its rigorous process and the reliance of both
Federal and non-Federal stakeholders of IRIS assessments to use
them to direct risk-management decisions relating to public
health, the program plays a unique role that is complementary
to other review processes like TSCA.
Given this background, the findings of the GAO's March 4
report detailing political interference in the publication of
IRIS assessments raise serious concerns. The EPA is responsible
for protecting public health and the environment through the
application of sound science and should not be creating
internal roadblocks to performing this critical mission.
That is why I am glad we will be hearing from witnesses on
both of our distinguished panels today, hearing from the EPA
and GAO on the findings of this recent the GAO report and
gaining a better understanding of the need for and importance
of IRIS assessments, the improvements the program has made over
the years, and the critical role these assessments play in
protecting public health.
And with that I yield back.
[The prepared statement of Chairwoman Fletcher follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Sherrill. Thank you, Madam Chairwoman.
And the Chair now recognizes Mr. Marshall for an opening
statement.
Mr. Marshall. Thank you, Chairwoman Fletcher and Chairwoman
Sherrill, for holding this hearing, and thank you to the
witnesses for being here today.
The EPA's IRIS Program was established to identify and
characterize the health hazards of chemicals found in the
environment. The program conducts chemical hazard
identification and dose response assessments, which serve as a
source of toxicity information for EPA program and regional
offices as well as State and local agencies.
As a physician, I understand the importance of chemical
toxicity assessments and their role in protecting the
environment and advancing public health, particularly for
sensitive populations such as children, pregnant women, and the
elderly. Accordingly, it should be our top priority to ensure
the underlying science that goes into these assessments is of
the highest quality. Unfortunately, the IRIS Program has a poor
track record in this department, and despite some recent
progress by EPA leadership, many issues remain.
Two of the most troublesome problems for the IRIS Program
are its inability to produce final products in a timely manner
and an unexplained lack of scientific transparency in the
assessment process. Both the National Academy of Sciences (NAS)
and the Government Accountability Office (GAO) have recently
published reports that criticize the program and make
recommendations for improvement.
The National Academy of Sciences has published three
reports detailing similar problems while making suggestions for
reform and improvement of the program. The NAS reports in 2011
and 2014 found serious problems with IRIS and proposed sweeping
recommendations to overhaul the program. If those
recommendations had been fully implemented within the last 8
years, the program would be operating in a more functional
manner and able to produce chemical assessments in a way that
is timely, transparent to the public, and reflective of the
best current scientific methodologies. Instead, we continue to
live report to report, looking at incremental progress and an
overall lack of tangible results.
The 2018 NAS review commends IRIS for its progress to
implement systematic review of chemical assessments. And while
I agree that IRIS' progress is commendable, several other
critical products and recommendations remain unaddressed and
incomplete. Publication of a robust handbook that details
internal process, incorporation of mode-of-action information,
and utilization of a weight-of-evidence framework are a few
examples of simple objectives that have not been accomplished
despite recommendations to do that. I hardly find the 2018 NAS
review consequential in its praise of the program. In fact, I
think it is a clear indication that a lot of work remains.
Likewise, the GAO has issued ongoing criticism of the
program. In 2009, GAO added the IRIS Program to its High-Risk
List, which identifies Federal programs with heightened
vulnerabilities to fraud, waste, abuse, and mismanagement. Even
with clear deficiencies pointed out and the EPA seemingly
taking steps toward a few of the recommendations for
improvement, the program continues to appear on the High-Risk
List to this day.
Separate of the High-Risk List, GAO recently issued a
report that was largely critical of current EPA leadership and
its efforts to manage and update the IRIS Program. Democrats
and environmental groups continue to point to this report as
evidence that the Trump Administration is trying to stifle
science. On the contrary, I think these efforts are critical to
overhauling a flawed program so it's responsive to program and
regional office needs and best serve EPA's core mission. The
program has many issues that need to be addressed, and EPA
leadership is taking necessary steps to do just that.
One of the most troubling issues with IRIS is the
publication of misleading or questionable information that can
create confusion for Americans regarding the health risks
associated with a given chemical. The 2016 IRIS assessment for
ethylene oxide is a prime example. Naturally produced by the
human body and plants, ethylene oxide is produced commercially
to sterilize medical equipment. OSHA (Occupational Safety and
Health Administration) set a safety standard of 1 part per
million for workers exposed 8 hours a day, 5 days a week. This
seems to be a reasonable value given that high, long-term
exposure may increase cancer risks.
EPA's IRIS Program, however, set a lower risk value at 100
parts per quadrillion. And I think that's about a difference of
10 to the 9th. That value is 19,000 times lower than naturally
occurring levels of ethylene oxide in the human body.
Essentially, this assessment correlates to a normal human
metabolism, and breathing ambient air is enough to cause
cancer.
It is clear that much work remains before IRIS assessments
can be tabbed as the gold standard review that the program was
established to be. Meeting objective and transparent standards
for evaluating chemical risks will require substantial changes
and improvements to the program. I'm hopeful that one day soon
the IRIS Program will be able to produce high-quality,
scientifically sound chemical assessments that are widely
accepted by the scientific community, and I look forward to
working with my colleagues to ensure this happens.
Thank you, and I yield back.
[The prepared statement of Mr. Marshall follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Sherrill. Thank you, Mr. Marshall.
We are pleased to have the Full Committee Ranking Member,
Mr. Lucas, with us today, so the Chair now recognizes the
Ranking Member for an opening statement.
Mr. Lucas. Thank you, Madam Chair, and thank you to all the
witnesses for being here today to discuss EPA's IRIS Program.
Over the last 10 years, numerous reports have been issued
criticizing the IRIS Program for its lack of transparency,
improper scientific processes, and ineffectiveness in
addressing the needs of EPA regional and program offices. The
flaws are well-documented. Current EPA leadership is taking
positive steps to address these issues, and I laud their
progress. However, we have yet to see a completed assessment of
the IRIS Program that fully incorporates all of the
recommendations made in the last decade.
Unfortunately, that means there are numerous IRIS
assessments in the database that are questionable, unreliable,
and in some instances just plain incorrect. Take IRIS'
assessment of ethylene oxide, which is used to sterilize
medical equipment. In fact, some medical equipment can't be
sterilized by any other chemical. In 2016, IRIS set an absurd
risk value that is 19,000 times lower than the levels of this
chemical that naturally occur in the human body. Assessments
like this can have disastrous effects on the economy and human
health if relied upon by government agencies in crafting
regulation.
Accordingly, today's hearing raises an important theme: How
we characterize the chemicals in the environment.
Unfortunately, there are too many government agencies, both
national and international, that mischaracterize risk
associated with chemicals. These agencies, just like the IRIS
Program, have a history of identifying extremely conservative,
even paranoid levels of exposure that can be classified as
carcinogenic.
Another program with a poor track record of assessing risk
is the International Agency for Research on Cancer, IARC.
Unlike IRIS, IARC's problems go beyond bad science. IARC is
plagued by a severe lack of transparency and accountability, as
well as significant conflicts of interest. But other parallels
with IRIS exist. IARC assessments have led to the
classification of things like red meat and coffee as being
carcinogenic. States like California adopt these assessments at
face value and slap a warning on every product imaginable. The
public promptly ignores these warnings because they know coffee
will not give them cancer. In the end, we are left with useless
and ineffective regulations that only serve to waste taxpayer
money.
Although the IRIS Program does not have regulatory
authority, it is important to note the consequences of when
government agencies miscategorize risk. As I said, I'm pleased
the current Administration is taking a thoughtful and
meaningful look at how we characterize I should say, chemical
risk. I'm hopeful these efforts will bear fruit. In the
meantime, we will remain vigilant in ensuring that programs
like IRIS are useful, transparent, and effective in meeting
EPA's core mission of protecting human health and the
environment.
I yield back, Madam Chairwoman. Thank you.
[The prepared statement of Mr. Lucas follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Sherrill. Thank you, Mr. Ranking Member.
If there are Members who wish to submit additional opening
statements, your statements will be added to the record at this
point.
[The prepared statement of Chairwoman Johnson follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Sherrill. At this time I would like to introduce
the witnesses for our first panel: Dr. Jennifer Orme-Zavaleta,
the Principal Deputy Assistant Administrator for Science with
the Office of Research and Development and the Science Advisor
for the Environmental Protection Agency, the EPA; and Mr.
Alfredo Gomez, Director of the Natural Resources and
Environment team with the Government Accountability Office, the
GAO. Mr. Gomez is also the principal author of the March 2019
GAO report on the Integrated Risk Information System, IRIS,
which is the basis of our hearing today.
As our witnesses should know, you will each have 5 minutes
for your spoken testimony. Your written testimony will be
included in the record for the hearing. When you all have
completed your spoken testimony, we will begin with the
questions, and each Member will have 5 minutes to question the
panel. We will start with Dr. Orme-Zavaleta.
TESTIMONY OF DR. JENNIFER ORME-ZAVALETA,
PRINCIPAL DEPUTY ASSISTANT ADMINISTRATOR FOR
SCIENCE AND SCIENCE ADVISOR, OFFICE OF
RESEARCH AND DEVELOPMENT, EPA
Dr. Orme-Zavaleta. Thank you, and good morning, Chairwomen
Fletcher and Sherrill, Ranking Members Marshall and Norman, and
other distinguished Members of the two Subcommittees. My name
is Jennifer Orme-Zavaleta, and I'm the Principal Deputy
Assistant Administrator for Science in EPA's Office of Research
and Development (ORD). I also act as the Agency's Science
Advisor. My responsibility as the career lead for ORD is to
ensure that we provide solid and robust science to inform
Agency decisions.
I have worked for EPA since 1981 in the areas of human
health and ecological risk, research, policy development,
strategic planning, and program implementation. Of these nearly
38 years, I've spent 26 in ORD, which is the parent office of
the Integrated Risk Information System, commonly called IRIS. I
appreciate the opportunity to talk with you today about IRIS. I
was at EPA when IRIS was created, and I've seen it grow into
the rigorous scientific program it is today.
ORD's highly trained IRIS staff helped the program's
regions, States, and others assess the risk of potential
exposures to chemicals and nonchemical contaminants. IRIS
assessments are a key part of this, providing the first two
steps of the risk-assessment process: Hazard identification and
dose-response assessment. This information informs risk
assessments that are conducted by EPA programs, regions,
States, and others, though some EPA programs conduct their own
hazard and dose-response assessments.
IRIS assessments provide a scientific foundation for
decisionmaking under an array of environmental laws. The IRIS
assessment process ensures transparency, scientific rigor, and
provides opportunities for public, stakeholder intra- and
interagency engagement. This process also includes robust
independent scientific peer review.
In 2011 and 2014, the National Academy of Sciences issued
reports outlining recommendations to improve the IRIS Program
by adopting systematic review, and this is known for
transparency and scientific rigor. In 2017, IRIS began to
implement systematic review across its assessments, and since
then, IRIS has made assessment plans and protocols available to
the public earlier in the assessment development process,
providing more time to consider scientific complexities.
In a report published in April 2018, the National Academies
concluded that IRIS has made substantial progress. GAO has also
provided input to improve the IRIS Program, which has included
suggestions to increase timeliness, transparency, and process
challenges. In a recent audit report, GAO found that IRIS has
made improvements and has demonstrated the impacts of actions
that we've taken. IRIS has made these improvements by
incorporating project and program management by moving away
from a one-size-fits-all assessment to a mixed portfolio of
chemical evaluation products. In addition, IRIS has optimized
systematic review software tools, which are increasing the
efficiency and promoting greater transparency by making
information more accessible to the public.
With these changes, a large segment of the assessment
portfolio can now be completed in 1 to 3 years instead of 3 to
10. The GAO report noted this, indicating that the preparation
of several recent draft assessments has taken months, not
years. To ensure that these new and improved processes are
successful, IRIS has extensively trained its staff and is
extending this training across the Agency and to the
stakeholder community as well.
Another major challenge--change in how IRIS operates is in
how EPA programs request and prioritize IRIS assessments.
Because IRIS assessments play such a critical role, the EPA
Administrator requested a formal process signed off at the
Assistant Administrator level, through which programs identify
what IRIS assessments are a priority, when they are needed, and
why they are needed. This process was completed in December and
identified 11 priority chemicals. This formal process is a
great improvement, as it brings further stability and
responsiveness to the IRIS Program while also reinforcing
accountability between the requesting program office and the
IRIS Program. We will continue to conduct this process
annually, though programs may nominate a new assessment at any
time.
Now that the prioritization process is complete, the public
and stakeholders can expect to see IRIS assessments move
forward. Last week, IRIS released a systematic review protocol
for hexavalent chromium, and we plan to release other
assessment materials soon. The formal prioritization process,
along with the improvements in IRIS, has made--has helped us to
address the NAS and GAO recommendations, and this will continue
to make IRIS more efficient and a more effective program.
We recognize that we still have work to do, but I am
confident that as we move forward and address these open--we
will address these open recommendations and concerns identified
by the GAO.
So thank you for the opportunity to appear before you
today, and I look forward to answering your questions.
[The prepared statement of Dr. Orme-Zavaleta follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Sherrill. Thank you, Dr. Orme-Zavaleta.
And now, I would like to recognize Mr. Gomez for his
testimony.
TESTIMONY OF ALFREDO GOMEZ,
DIRECTOR, NATURAL RESOURCES AND ENVIRONMENT,
GOVERNMENT ACCOUNTABILITY OFFICE
Mr. Gomez. Chairman--Chairwomen Sherrill and Fletcher,
Ranking Members Norman and Marshall, and Members of the
Subcommittees, good morning. I'm pleased to be here today to
discuss our work on EPA's efforts to address toxic chemicals.
As has been noted, EPA is responsible for reviewing
chemicals in commerce and for those entering the marketplace.
EPA's ability to effectively implement its mission of
protecting public health and the environment depends on its
credible and timely assessments of the risks posed by these
chemicals. The Agency's Integrated Risk Information System
program, which is under the Office of Research and Development,
identifies and characterizes the health hazards of chemicals
and produces human health toxicity assessments. EPA program and
regional offices rely in part on these assessments to make risk
management decisions.
My statement today summarizes our March 2019 report on
EPA's efforts to produce IRIS assessments. I will discuss the
extent to which the IRIS Program has made progress in
addressing identified challenges and in producing chemical
assessments. And as has already been noted by the Committee, we
also recently issued our High Risk update, which includes
transforming EPA's process for assessing and controlling toxic
chemicals.
Just as a matter of background, I wanted to mention that
the IRIS Program uses a seven-step process to produce
assessments, so there's a lot of review that's built into the
process. First, EPA has to determine the scope and the
questions that the assessment will cover, and these are
released for review and public comment. The draft assessment is
then developed using systematic review. After the full draft is
developed, it goes through agency review, interagency review,
and external peer review and public comment. After staff make
revisions to address the comments, the draft then goes through
another round of internal and interagency review. Then the
program finalizes and posts the assessments to the IRIS
website.
So historically, developing IRIS assessments has been a
lengthy process and typically takes several years to complete.
The IRIS Program has made progress addressing timeliness and
transparency challenges in the assessment process. So, for
example, the IRIS Program is now employing project management
principles and specialized software to better plan assessments
and utilize staff. In addition, the program has begun
assessments that are more limited in scope and targeted to
specific program and regional office needs.
The IRIS Program has implemented systematic review, which
provides a structured and transparent process for identifying
relevant studies, reviewing their methodological strengths and
weaknesses, and integrating these studies as part of weight-of-
evidence analysis.
In early 2018, EPA made progress on assessments that were
in development. However, EPA leadership deliberations delay the
release of some assessments by 6 months. So in June 2018, the
Administrator's office told IRIS officials that they could not
release any IRIS documentation without a formal request from
EPA program office leadership. In August 2018, the Office of
Research and Development asked program offices through a survey
to reconfirm which of the 20 ongoing chemical assessments they
needed. Several program offices responded confirming their
needs for these assessments.
Then in late October 2018, prior to releasing the results
of the initial survey, these offices were asked to limit their
chemical requests further to the top three or four assessments.
EPA leadership did not provide them a reason for the limit or
guidance on prioritizing assessments.
Then finally in December 2018, as has been noted, EPA
publicly issued its IRIS Work Plan, which provided an updated
list of 13 assessments. Eleven of the 13 chemicals on the IRIS
Work Plan were requested by two EPA program offices. The two
remaining assessments were already at external peer review. EPA
gave no indication of when additional assessments could be
requested or what the IRIS Program's workflow would be in the
future.
While the program's work was delayed, EPA directed 28 of
approximately IRIS staff to support implementation of TSCA with
25 to 50 percent of their time according to officials. It is
unclear if this is a temporary workforce shift or if TSCA will
require this level of support moving forward.
So, Chairwomen Sherrill and Fletcher, Ranking Members
Norman and Marshall, and Members of the Subcommittees, this
concludes my statement. I'd be pleased to answer questions.
[The prepared statement of Mr. Gomez follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Sherrill. Thank you, Mr. Gomez.
At this point we will begin our first round of questions.
The Chair recognizes herself for 5 minutes.
First of all, Mr. Gomez, I want to commend you and your
colleagues at the GAO on your thorough and meticulous work in
the report that was published on March 4. The Subcommittee
appreciates your efforts to help us better understand the
status of the IRIS Program.
Can you summarize the GAO's findings regarding the recent
EPA's leadership decisions that hindered IRIS' ability to
complete its toxicity assessments?
Mr. Gomez. Maybe I can just provide another summary of
the--as our audit documented, the steps. As I mentioned
earlier, it started in August with ORD sending out a survey to
all of the program offices to reconfirm whether the 20 ongoing
assessments were still needed. And so offices then responded to
that. In fact, there were three offices, program offices, that
responded that they needed the majority of those assessments.
In fact, it was the Office of Land and Emergency Management
which requested that all 20 of those chemical assessments were
needed. The Office of Water requested 15 of those, and the
Office of Children's Health Protection requested 18. Also, the
Office of Policy did confirm all of them.
And as I also noted, then in October the--sorry, there was
then--there was then a request in mid-October, a second time,
for offices to reprioritize and to further reduce the number of
assessments to three or four.
Chairwoman Sherrill. And so you had mentioned also in
releasing the reports that I believe it was August--it was in
2018. A new policy came out that you had to ask leadership to
release the reports or get authorization----
Mr. Gomez. Yes, so essentially before an IRIS assessment
could be issued, it had to be requested by an Assistant
Administrator or even if you needed an assessment, that it
needed to be at that level.
Chairwoman Sherrill. OK. And before that, how did it work?
Mr. Gomez. The IRIS officials, the offices would just work
with the program offices at EPA and ask them what----
Chairwoman Sherrill. Determine----
Mr. Gomez [continuing]. They needed.
Chairwoman Sherrill. And then we've been talking a bit
about the 2011 National Academies' review of IRIS' draft
formaldehyde assessment, and it identified areas for IRIS to
improve. Much has changed since then, so can you also--and you
spoke a little bit about timeliness and transparency, but can
you also provide an overview of the progress that IRIS has made
since 2011 in improving its assessment process?
Mr. Gomez. Sure. So that's also something that we discussed
in our High Risk update report where we lay out the areas in
which--and I think it's been mentioned by a number of the
Members of the Committee already that there are a number of
areas in the IRIS Program where there have been improvements in
terms of them using systematic review, in terms of them trying
to improve the timeliness process, and so there have been a
variety of areas that we covered in terms of building the
capacity of the program, making sure that they have an action
plan in place. And so those are the areas that we highlight,
and we gave the program a rating of partially met in all of
those areas because we do see a lot of progress. And, as has
been noted, this is a program that historically has taken a
long time to do chemical assessments, and so we see that
there's a lot of improvement that's been taking place.
Chairwoman Sherrill. And yet now some of the timeliness
problems are because leadership is holding up the ability to
release the assessments?
Mr. Gomez. So, as we noted in our report, in that 6-month
period, there was a delay while these deliberations were taking
place, and so that's what we were calling attention to.
Chairwoman Sherrill. And finally, can you detail the IRIS
staff reassignments in support of the Toxic Substances Control
Act that occurred in October 2018?
Mr. Gomez. Sure. So as we noted in the report and as I
noted in my statement, there--EPA directed 28 of their 30 IRIS
staff to support implementation of TSCA, and they were
providing anywhere from 25 to 50 percent of their time.
Chairwoman Sherrill. Thank you very much.
I will now recognize Mr. Norman for 5 minutes.
Mr. Norman. Thank you, Chairwoman Sherrill.
In the 2014 report, the National Academy of Sciences
specifically recommended that EPA finalize and release a
handbook that outlines the IRIS assessment evaluation process.
This recommendation was reiterated in 2018. The NAS evaluation
of IRIS which stated that the EPA would complete the handbook
in 2018.
Mr. Gomez, in preparing the recent reports, was the GAO
provided a copy of the IRIS handbook?
Mr. Gomez. Yes, we have it. It's a draft copy because it
has not been finalized yet. And that is something that we are
also tracking, and so we've been looking to see when EPA is
going to release that.
Mr. Norman. OK. Dr. Orme-Zavaleta, have you reviewed the
IRIS handbook?
Dr. Orme-Zavaleta. And please feel free to call me
Jennifer.
Mr. Norman. I'll call you doctor.
Dr. Orme-Zavaleta. I know my name's a mouthful. So we have
a draft IRIS handbook that has gone through Agency review; it
was initiated last summer. We received comments all the way
through to December. We had our 5-week hiatus with the
shutdown. We are still in the process of addressing some of the
comments that came in and will continue to work toward
completing that document.
Mr. Norman. When will it be ready for publication in your
opinion?
Dr. Orme-Zavaleta. So we're--conversations with some of the
commenters are still ongoing. Some of the questions are not as
easily identified, and in my opinion was going to extend into a
broader conversation across the Agency, so we'll have to see
how we can complete the document. And for those issues that
need further work, what will be the process for addressing
those.
Mr. Norman. Can you identify this morning what the hold up
is exactly, and I guess when it will be completed with where
you are, where you see it?
Dr. Orme-Zavaleta. So some of the conversation is around
how we evaluate hazard and how we identify or categorize areas
of hazard, and these are conversations that involve more than
one office, and so this is something that I'm looking to engage
other parts of the Agency through our risk assessment forum to
address whether that holds up this document or not. I think
that's something that we still have to determine. So my hope is
that we complete this soon, but this is a process that we are
continuing. I've raised with the Administrator, and hopefully,
we'll have a path forward on how to address.
Mr. Norman. Well, I mean, in my world--I mean, I'm a real
estate developer. I look on a handbook as a blueprint to go by
on projects. If you don't have a handbook, you really can't
move forward. And the excuses I've heard--am I right? It hasn't
been completed in 8 years?
Dr. Orme-Zavaleta. What hasn't been completed in 8 years?
Mr. Norman. The handbook.
Dr. Orme-Zavaleta. So I don't know when the handbook was
initiated. I came into this role over this past year. But
elements of the handbook are being captured in some of our
systematic review protocols, and those documents are moving
forward. So the document we just released last week on
hexavalent chromium incorporates elements of that handbook. So
we are utilizing that blueprint, and we're able to move forward
on our assessments. The particular handbook is an internal
guide for us, and just completion of that is something that
we're still working through comments.
Mr. Norman. But it's very important to have the handbook--
--
Dr. Orme-Zavaleta. Absolutely.
Mr. Norman [continuing]. As a guide so you can adequately
move forward.
Dr. Orme-Zavaleta. And we are utilizing that internally and
running it through our assessment so that we keep those
assessments moving.
Mr. Norman. Thank you. Mr. Gomez, the GAO has reviewed the
IRIS Program over many years and multiple Administrations. In
the GAO's review of the IRIS Program, has it found that the
IRIS Program has regularly produced timely assessments for you
all?
Mr. Gomez. No, sir. One of the findings is that it takes a
long time, many years, to produce assessments, and so, as has
been noted and discussed, we and the National Academies have
made recommendations to improve the timeliness of those
assessments.
Mr. Norman. Well, with that, then, do you think the IRIS
Program should remain high on the GAO's High-Risk List?
Mr. Gomez. So we--we have it on a High-Risk List because we
do see that it needs improvement to produce those assessments
that are needed by other EPA program offices and folks outside
of EPA, so until we see demonstrated progress in the program,
it's going to remain on the list, yes.
Mr. Norman. Well, I would stress the importance of getting
it in. In my world we're on penalties if we don't make
something in a timely response. I can't just say to our
tenants, you know, we're trying. It gives you an ending and a
beginning date. Eight years to me is out of the question. Thank
you all so much.
Chairwoman Sherrill. Thank you. I now recognize Chairwoman
Fletcher for 5 minutes.
Mrs. Fletcher. Thank you, Madam Chairwoman. Thank you to
the witnesses this morning. Your testimony has been helpful.
My first question is directed at Dr. Orme-Zavaleta.
According to the EPA, the role of the Office of Science
Advisor, or OSA, is to provide leadership on science and
technology issues and policy to facilitate the integration of
the highest quality science into the Agency's policies and
decisions. As the current acting EPA Science Advisor can you
discuss the OSA's role in EPA's strengthening transparency in
regulatory science proposed rule? Was the OSA consulted during
the drafting of this proposed rule before it was submitted to
the Federal Register?
Dr. Orme-Zavaleta. So the answer to that is no. The
science--the STPC (Science and Technology Policy Council) was
given a briefing once the proposal was out and has been aware
of the next steps. The Agency received a number of comments.
We're still going through and synthesizing those comments, and
then we'll determine our next steps forward.
Mrs. Fletcher. OK. And on a related note, the EPA
ostensibly bases its environmental and public health protection
regulations on robust science. How often do you engage with
regulatory program offices within the Agency and provide
scientific input on new regulatory actions? For example, how
often are you consulted on the Agency's deregulatory actions?
Dr. Orme-Zavaleta. So the--in the regulatory process, the
Agency establishes an ADP (Action Development Process)
workgroup, which is a--I don't remember the specific acronym,
but it engages representatives across the Agency and is
overseen by the lead office with the particular regulatory
action. So our office and our staff are engaged when they have
these workgroups formed and working through the different
regulatory efforts.
Mrs. Fletcher. How often do you meet with Administrator
Wheeler to provide scientific input into decisionmaking at the
highest levels of the EPA?
Dr. Orme-Zavaleta. So I have a regular monthly meeting with
the Administrator. I also see him weekly for--he meets with
our--the senior leadership across the Agency. And then if there
are specific rulemaking activities or issues to be addressed
and there will be a meeting convened for briefing and either I
or my staff will be involved in those discussions.
Mrs. Fletcher. And how often did you or your predecessor
meet with Administrator Pruitt for the same purpose?
Dr. Orme-Zavaleta. So less. Each Administrator has their
own style and approach, and with Administrator Pruitt he
participated in senior staff meetings periodically, but I did
not have an opportunity to meet with him as a representative of
ORD.
Mrs. Fletcher. Thank you, Dr. Orme-Zavaleta.
One other question relating to the GAO report is the GAO
found that by October 2018 that more than 90 percent of IRIS
staff were spending up to half their time supporting risk
evaluation under TSCA, is that correct? And so----
Mr. Gomez. That is correct, yes.
Mrs. Fletcher. OK. So, Dr. Orme-Zavaleta, since Congress
has clearly expressed its intent that the IRIS Program remain
within ORD, how could EPA justify diverting staff hired for the
sake of implementing IRIS to other program offices within the
Agency?
Dr. Orme-Zavaleta. So just to be clear, the staff remained
in ORD, and within the Agency, ORD is a partner with a number
of our program offices working through different scientific
issues, whether it's helping with implementation of TSCA or
working with the Office of Water on some of their science
issues or OLEM (Office of Land and Emergency Management) or
others. So we take a one-EPA approach in leveraging the
expertise and experience across the Agency for the different
types of scientific disciplines. Some offices may not have as
many types of scientists that ORD has, and so we work with them
collaboratively in trying to sort through these different
issues.
Mrs. Fletcher. OK. And I want to follow up on one other
question that one of my colleagues asked about the publication
of the IRIS handbook. I know that we've already discussed it a
little bit, but can you give us any insight into what has
caused the delays in its publication?
Dr. Orme-Zavaleta. So, again, we submitted the handbook for
Agency review toward the end of last summer. We had comments
come in through the course of the fall, some as late as
December, and then with the shutdown that set us behind, so we
are doing catch up and we are working through some of the
issues that have been raised.
Mrs. Fletcher. OK. Thank you. I yield back the remainder of
my time.
Chairwoman Sherrill. Thank you. The Chair now recognizes
Representative Biggs.
Mr. Biggs. Thank you, Madam Chair, and thank you,
panelists, for being here today.
I think it's no secret to anybody who's watched my
performance on this Committee that I've been a longtime critic
of the IRIS Program. In the last Congress, while serving as the
Chairman of the Environment Subcommittee, I sponsored
legislation to effectively eliminate IRIS in its current form
and return chemical assessments to the appropriate program
offices of EPA. That bill, the Improving Science in Chemical
Assessments Act, was voted out of the full SST Committee last
July. I've reintroduced this bill the current Congress, but I
doubt for some reason that it'll be reported out of this
Committee again anytime soon. And I'm disappointed with that of
course, that the chemical assessments process at EPA has not
received a complete structural overhaul despite years' and
years' worth of criticism and observations by the NAS and GAO.
That said, apparently, there have been few glimmers of hope
at EPA over the last couple of years, and I'm happy about that,
but clearly, there are at least some high-level officials at
the Agency who generally believe that: One, chemical
assessments should rely on good, transparent, publicly
available science, and that's true. And two, chemical
assessments should be carefully tailored to serve program and
regional office needs, and I'm happy about that.
And I want to hear more from your perspective, Mr. Gomez.
The most recent GAO report on the IRIS Program reiterates yet
again that EPA should develop an action plan that, among other
reforms, places primary responsibility for chemical assessments
in the relevant program offices. Is that a fair
characterization?
Mr. Gomez. No, sir.
Mr. Biggs. Please state how would you characterize it?
Mr. Gomez. So, the way IRIS came about, it was because
there were many different program offices doing their own
chemical assessments, sometimes different values were
generated, and so this was an effort to centralize and to come
up with Agency consensus on these assessments. And I'm sure
that Jennifer can also talk about that history and evolution of
the IRIS Program. So that is our understanding of it.
And our reports on the High-Risk List on IRIS are looking
to improve the IRIS Program to make it more timely, to make it
more transparent, as you said, so that it is using the best
available studies that are out there, and it's going through
the proper levels of review both internal and external peer
review.
Mr. Biggs. Well, can you explain why the EPA leadership has
been criticized for beginning to do what GAO has been
requesting?
Mr. Gomez. So and--again, in our current report we focus
on--we do talk about the progress that EPA is making, which
we've been chatting about, but we also talk about other
challenges that the program is facing. And so we were drawing
attention to the delays in issuing the assessments. As we've
said, these assessments take a long time, sometimes years to
do, so that's what we've been focusing on. And there is a lot
of progress, and we do note that in the ratings that we do for
the IRIS Program, but yet there's still challenges ahead.
Mr. Biggs. Well, one of the interesting pieces of testimony
that I'm taking from this today, is this notion of the
handbook, the handbook that may have been ordered 8 years ago,
recommended 8 years ago, certainly recommended 4 years ago, and
yet I think it just takes a lot of moxie to come in here today
and say, well, the reason we don't have this done is because we
had a 35-day government shutdown this year. That's incredible
moxie and doesn't get at the heart of this, but I think it does
get at the heart of what the ultimate problem with IRIS is, and
that is a bogged-down bureaucratic system that needs to be
streamlined and fixed. And I hope that you take that into
consideration. It's meant as positive feedback. I hope that
it's criticism that requires and produces some real self-
evaluation because I'm still disappointed at the IRIS Program,
and I'm disappointed at the almost glacial pace that we see in
change in that program.
I yield back.
Chairwoman Sherrill. Thank you. I'd now like to recognize
Representative Bonamici for 5 minutes.
Ms. Bonamici. Thank you very much. Thanks to the Chairs and
Ranking Members and to our witnesses.
The Environmental Protection Agency should rely on the best
available independent science to inform Federal policy, and the
EPA mandate is to protect public health and the environment,
and that can only be achieved if the EPA is acting on the basis
of science that's independently verifiable and free from
political influence, bias from ideology and conflicts of
interest, and that certainly includes credible assessments of
the risks posed by chemicals.
And I've been on this Committee for about 7 years now and
of course have sat in many hearings, as have many of my
colleagues, about IRIS over the years. There's no question that
there is a need for improvement, but what I am hearing today
and what I am seeing in the recent GAO report I do not consider
improvement.
The EPA's Integrated Risk Management System, or IRIS,
remains distinct from the regulatory programs of the EPA
intentionally. It's striking that the EPA would consider moving
away from the robust science and preventing IRIS from
disclosing its findings to the public. Continued efforts to
sideline science from the policymaking process at the EPA will
have chilling consequences for every person in this country who
benefits from clean air and water and particularly and
disproportionately young children, seniors, and the health-
impaired.
Mr. Gomez, in the March 4 GAO report entitled ``Chemical
Assessment Status of EPA's Efforts to Produce Assessments and
Implement the Toxic Substances Control Act,'' it outlines that
in June 2018 EPA leadership in the Office of Research and
Development instructed the IRIS Program to not release an
assessment without a formal request from the current leadership
of a program office. And then ORD instructed the IRIS Program
to not publicly release any assessment documentation for public
comment, agency, or peer review while the responses to a survey
of program and regional offices needs were being compiled. And
the list then of that--so it's 20 assessments was then reduced
to three or four chemicals. I'm obviously concerned.
David Dunlap, a former Koch Industries lobbyist, now serves
as a Deputy Assistant Administrator for Research and
Development. These findings of the increased role of ORD in the
IRIS assessment processes are very concerning.
So, Mr. Gomez, prior to June 2018, had political leadership
at ORD ever limited the release of IRIS assessments?
Mr. Gomez. That is not our understanding.
Ms. Bonamici. Did the GAO find any other changes to the
seven-step process that IRIS uses to complete toxicity
assessments?
Mr. Gomez. No, we are not aware of any changes at this
point.
Ms. Bonamici. Thank you. I want to point out there's just a
section in the GAO report, page 25, that talks about the calls
for advice from program office officials represented the first
time the IRIS Program heard about requests for a prioritized
list according to the IRIS Program officials since neither the
program and regional offices nor the IRIS Program had
information from the Administrator's office about what the
prioritization was meant to achieve. The IRIS Program was
unable to provide guidance about what chemicals may be
considered a priority or how they might be able to continue to
work on. And then the reduction with no apparent reason, those
things are documented in the GAO report, very concerning.
Dr. Orme-Zavaleta, it's my understanding that you oversaw
the August 2018 survey of program and regional office needs for
20 assessments. Did you and any other career staff at ORD and
IRIS have any role during the second round of survey in
October?
Dr. Orme-Zavaleta. So once we received some initial
responses from the programs in response to the August memo,
there was a conversation the Administrator had with his
leadership where there was conversation about further
prioritizing. There was concern that the number of responses
that came back, which was around 50 or so chemical requests,
was too large.
Ms. Bonamici. And what was the basis--did--was that
explained? What does too large mean?
Dr. Orme-Zavaleta. I wasn't involved in those discussions,
so I can't say.
Ms. Bonamici. Did you ever see the findings from the first
survey, and are they publicly available?
Dr. Orme-Zavaleta. So I did receive memos from the response
of the survey from each of the program offices that responded,
so yes, I have those, and I believe GAO received those from
some of them.
Ms. Bonamici. And the second survey from what I can tell
from the GAO report was fairly informal, maybe even verbally
sent. What factors determine the chemicals that were selected
as priorities from the second survey?
Dr. Orme-Zavaleta. So for the second survey there was a
template that was returned back to me that was signed off by
the Assistant Administrator for those offices. And, again, they
were asked to respond what were their needs, how are they to be
used, and when were they needed, and so that was the
information that was provided back to me, and that included 11
compounds.
Ms. Bonamici. My time is expired. I yield back. Thank you,
Madam Chair.
Chairwoman Sherrill. Thank you. And now the Chair yields 5
minutes to Dr. Marshall.
Mr. Marshall. Thank you so much, Chairwoman.
I think all my questions are directed to Dr. Orme-Zavaleta,
so thank you so much for being here. Does IRIS assessment
include any consideration of actual human exposure or making
any determination of actual human risk?
Dr. Orme-Zavaleta. So the--as noted earlier, the IRIS
Program involves the first two steps of the risk assessment
process, so it focuses on hazard and then dose response. That
provides that scientific foundation, which then moves to a
program office, and their program offices will apply other
statutory considerations for the programs they implement that
include exposure and risk characterization.
Mr. Marshall. I would suppose when you were doing your
studies--you have four or five studies going at a time on one
particular substance?
Dr. Orme-Zavaleta. So in looking at hazard and dose
response, we look at all available literature that is available
for that particular chemical, and that can include animal
information, human information. This is where our systematic
review process comes into play where it helps to organize and
synthesize that----
Mr. Marshall. What do you do when there's conflicting data,
which I see all the time as a physician. I'll see 20 studies on
a particular issue and there's usually lots of conflict between
the studies that I'll read.
Dr. Orme-Zavaleta. There's a lot of conversation, there's a
lot of judgment that's employed in going through these
evaluations, and that's why it's so critical that we have the
levels of review that we have. So as we look through all of the
information available in making determinations and judgments
about hazard and dose response that forms those toxicity----
Mr. Marshall. And do you share with others, here's the
studies we looked at and this is why we chose this one over
that one----
Dr. Orme-Zavaleta. Yes.
Mr. Marshall [continuing]. So that's a transparent process?
Dr. Orme-Zavaleta. Absolutely.
Mr. Marshall. OK. It looks like to me that sometimes IRIS
assessments set levels for a chemical below levels that are
found naturally in the environment, which little Kansas common
sense to me that doesn't make sense. Do you agree that
sometimes you set numbers down that are lower than naturally
occurring in the environment?
Dr. Orme-Zavaleta. So depending on the chemical and what
information is available--and so I don't know if you have a
specific compound in mind, but we'll look at all of the
available information, and that will feed into our dose-
response assessments that could give a risk level that
incorporates various levels of uncertainty as well.
Mr. Marshall. So if we're sitting in this room and we were
packed here together and whether it's ethylene oxide or
formaldehyde, whichever one it is, if you're setting levels
lower than what we measure--do you ever measure what's just
commonly occurring in the environment and--it just doesn't make
sense to me.
Dr. Orme-Zavaleta. So the measurement information is not
part of the hazard dose-response evaluation. That's what comes
in with the program offices in looking at exposure and
determining what the final risk assessment will be. Keep in
mind IRIS just provides the hazard and dose response and will
give us a level--a toxicity level for either a cancer or a
noncancer. Then that goes to a program office who will complete
the risk assessment process by factoring in exposure and risk
characterization information and then moves into that
regulatory context.
Mr. Marshall. So, you know, as a scientist, do you think it
would be OK to set a hazard level lower than what occurs
naturally in the environment at times?
Dr. Orme-Zavaleta. It's going to be data-driven, and it's
not going to be done in an ad-hoc way. These assessments go
through rigorous review within the Agency, between Federal
agencies.
Mr. Marshall. Right.
Dr. Orme-Zavaleta. It opens up for public comment. It goes
through a rigorous external peer review. And then, as Mr. Gomez
noted, once we come through and incorporate those comments, it
goes back through another round of review within the Agency and
between agencies.
Mr. Marshall. You know, as a physician, I have to take lots
of data but eventually have to take some common sense every
once in a while as well. When I see a study that just makes no
sense at all to me and they come to a conclusion that I do an
experiment on that particular medication or treatment plan with
my patients, so I do hope there's some common sense every once
in a while.
Are IRIS assessment cancer classifications representative
of actual human health risk?
Dr. Orme-Zavaleta. I'm sorry, can you clarify----
Mr. Marshall. Yes.
Dr. Orme-Zavaleta [continuing]. That again?
Mr. Marshall. Yes. Are IRIS assessment cancer
classifications representative of actual human health risk?
Dr. Orme-Zavaleta. So the Agency has cancer risk assessment
guidelines, and those were last developed in 2005, and that
lays out different levels of carcinogenicity classification
based on available information, so--that will include whatever
information we have from human data as well as animal data or
other supporting data, and those go into those cancer
classifications.
Mr. Marshall. OK. Thank you. And I yield back.
Chairwoman Sherrill. Thank you. And now the Chair
recognizes Representative Tonko.
Mr. Tonko. Thank you to the Chairs and Ranking Members for
an important hearing.
The process--or processes through which science is
conducted, reviewed, or communicated to the public and
incorporated into policymaking must be transparent. It must be
free from inappropriate political, ideological, and financial
and other undue influence. We have seen a disturbing trend at
EPA lately where science is being sidelined. I'm extremely
concerned by the actions that have suppressed information and
kept results hidden from the general public. I am also
disappointed by recent efforts to hurt the IRIS Program.
The IRIS Program has reviewed hundreds of chemicals and
supports programs across our entire Agency. This is an
important program that keeps us safe. We should not be gutting
it. We should be ensuring that it has the resources and staff
to thrive and continue to provide for toxicity information.
Instead, some here in Congress and in the Administration want
to give an even louder voice to industry interests that would
replace unbiased expertise. This would hurt public health and
is a dangerous endeavor. EPA's priority must be to protect
public health and our environment.
So, Dr. Orme-Zavaleta, according to GAO, the Office of
Children's Health Protection, or OCHP, submitted a lengthy set
of priority chemicals for the first round of the IRIS survey
but did not see any of its priorities reflected in the December
program outlook due to its lack of response during the second
round. OCHP is a critical EPA office that focuses on the unique
vulnerabilities facing children from environmental dangers. Our
children's health should always be a priority, top priority for
EPA.
So my question is, was OCHP asked to participate in the
second round of the IRIS survey along with the other program
offices?
Dr. Orme-Zavaleta. They did receive that information to
participate in the second round and in fact did submit their
priorities, but it came in after the list and December memo had
been finalized. You know, that said, as we noted in our
process, an office can identify or nominate a new assessment
need at any time, and we'll have another formal round of
requests coming later this summer.
Mr. Tonko. Can you explain the timing? And was it a
coincidence that OCHP submitted its list precisely when it was
too late to include them?
Dr. Orme-Zavaleta. So I was not involved in the further,
the second phase of that prioritization process. I'm not aware
of what particular timeframe was identified. Again, I was
informed of here was the list and then I released memos and----
Mr. Tonko. But there was no--no one shared a prior history
with you about----
Dr. Orme-Zavaleta. I was not involved in those
conversations.
Mr. Tonko. What chemicals did OCHP include on its second
round priority list of three to four chemicals? And was
formaldehyde one of those chemicals?
Dr. Orme-Zavaleta. I believe formaldehyde was one of those
chemicals, but we can get back with you. I don't recall the
full list.
Mr. Tonko. And does ORD consider the protection of
children's health a priority? And if so, why did it not make
more of an effort to include OCHP's request in the final list
of IRIS chemicals?
Dr. Orme-Zavaleta. So we consider--so we are a supplier of
science to the Agency's programs that use that information, and
so as far as children's health programs, yes, we do consider it
vitally important, and we help to sponsor some research at the
children's health centers, along with NIEHS. Again, with the
particular process I was not involved in that and did not
receive the final input until early December.
Mr. Tonko. Can you imagine how they could have made more of
an effort to include OCHP's request?
Dr. Orme-Zavaleta. I think that's something that we can
think about going forward.
Mr. Tonko. But nothing constructive that you would offer
this panel today?
Dr. Orme-Zavaleta. No, not at this point.
Mr. Tonko. Mr. Gomez, GAO's findings reveal a disturbing
level of political interference with IRIS. If political
appointees inside EPA are excluding the EPA career staff from
key decisions, it raises a host of concerns about whether those
appointees can be trusted to do the right thing for IRIS and
the public. Was GAO able to determine who inside EPA made the
decision to conduct a second round of the IRIS priority survey?
And who decided to limit that round to three to four chemicals
per program office?
Mr. Gomez. So that's something we do not have clear
information on, so as we reported it was our understanding that
something was done early to limit them, but we don't know. What
we do know, though, is that we do have responses from some of
the offices that did submit it in the second round saying these
are our three and four chemicals.
Mr. Tonko. OK. I am out of time, so I will yield back,
Madam Chair.
Chairwoman Sherrill. Thank you. The Chair now recognizes
Representative Bird--Baird, sorry.
Mr. Baird. Thank you, Madam Chair. I appreciate the
witnesses being here today.
My question really goes to Dr. Orme-Zavaleta, and that has
to do with the fact that Mr. Gomez mentioned a seven-step
process for chemical assessment development recognition, and so
in that process there's a draft of IRIS assessments, and
they're circulated internal to the EPA and to the region for
review. So how are those comments and concerns resolved? And
then once they've been submitted for review, then how do they
resolve those concerns and questions?
Dr. Orme-Zavaleta. So the IRIS Program has regular
communications with program and regional representatives. I
think they may meet even monthly. And as comments and questions
come in, there are conversations with the full group to sort
through and resolve those particular comments, and then that
moves onto the next phase.
Mr. Baird. So I guess you're saying as those come in, if
they're valid and reviewed, then they are incorporated in with
the process and----
Dr. Orme-Zavaleta. And there is a conversation between the
IRIS staff and the program representatives, as well as regional
representatives on addressing those comments.
Mr. Baird. A second part of that question, I understand the
interagency science review formally was coordinated by the OMB
(Office of Management and Budget), but how is that review
currently coordinated?
Dr. Orme-Zavaleta. The interagency science review process
was revised in 2009 to be entirely managed and coordinated by
EPA. OMB is a participant in the interagency science review
process, along with other agencies and White House offices.
Mr. Baird. OMB? OK. Mr. Gomez, I have a couple of questions
for you. It was noted that the IRIS officials have implemented
systematic review. Do we have any current documentation that
would suggest guidance on how this systematic review takes
place on this process?
Mr. Gomez. So--and this is also something that Dr. Orme-
Zavaleta can elaborate on. But systematic review is something
that's been in place in EPA for a while. They have started also
to use the software that allows them actually to do this
faster. So, yes, we are aware that this is something that the
IRIS Program is using. It is something that--that's good. In
fact, I think maybe on your second panel there's someone that
is even an expert on systematic review or knows a lot more
about it.
Mr. Baird. Thank you. One more question in that regard. To
your knowledge, what specific IRIS assessments completed since
2014 have demonstrated full of implementation of the EPA IRIS
system review process, any idea?
Mr. Gomez. So, I'm sorry, you're asking how many have been
released and went through the whole process?
Mr. Baird. And completed the whole process----
Mr. Gomez. Yes.
Mr. Baird [continuing]. Since 2014.
Mr. Gomez. Perhaps Dr. Orme-Zavaleta might know. I don't
think there's been many. I think there was one that was
released recently.
Dr. Orme-Zavaleta. While RDX was released recently (August,
2018) it does not represent full implementation of the IRIS
systematic review process. Because the assessment was already
in development when the 2011 NAS recommendations were released,
the final assessment reflects early implementation in the
programmatic adoption of the NRC recommendations.
Mr. Baird. Thank you, and I yield back my time.
Chairwoman Sherrill. Thank you, Mr. Baird. The Chair now
recognizes Representative McAdams.
Mr. McAdams. Thank you, Madam Chair.
I have a question for Dr. Orme-Zavaleta. Press reports and
Senate testimony from then-EPA Administrator Scott Pruitt
indicate that the IRIS formaldehyde assessment has been ready
for public release since 2017, since the end of 2017, and that
the assessment establishes a link between formaldehyde exposure
and leukemia. Formaldehyde did not appear on the December 2018
list of IRIS priority chemicals, and the GAO report indicated
that its future is unknown. So my question is what is the
status of the formaldehyde assessment, and when can we expect
it to be released for public comment?
Dr. Orme-Zavaleta. So we do have a draft formaldehyde
assessment, and with TSCA recently announcing that formaldehyde
is in their top 20, we're going to be having conversations with
our Office of Chemical Safety and Inclusion Prevention to
determine next steps in going forward. We feel that the
assessment that we have will be--will help with that TSCA
determination, and we need to determine next steps for
supporting the other Agency needs.
Mr. McAdams. So along those lines, why was the
formaldehyde--why was formaldehyde left off the list of--the
new list of IRIS priority chemicals, and who made that decision
to leave it off?
Dr. Orme-Zavaleta. So each program office made their
decisions on what were their priorities, how they were going to
use it, and when they needed it, and so I wasn't involved in
those conversations. Again, the programs help provide the
priorities, and then our responsibility is implementing those
priorities and providing the best science available.
Mr. McAdams. So who would've made the decision to not
include formaldehyde on that list?
Dr. Orme-Zavaleta. So that was through the program offices,
and the requests that I received were signed off at the
Assistant Administrator level.
Mr. McAdams. So--and just last week EPA announced that it
would designate formaldehyde a high-priority chemical under the
Toxic Substances Control Act. How can formaldehyde be
simultaneously a high-priority chemical under TSCA and not a
priority at all for IRIS?
Dr. Orme-Zavaleta. So I wouldn't say that it's not a
priority for IRIS. We have not discontinued that work, and that
information is going to be leveraged in helping to support TSCA
moving forward, but there's going to be more conversations to
follow on our next steps.
Mr. McAdams. Thank you. One question for Mr. Gomez. Can you
explain what you meant when you wrote in your testimony that
the absence of the formaldehyde assessment, quote, ``could
create confusion for stakeholders?''
Mr. Gomez. Right, so I think that there are stakeholders
that were expecting to see that assessment and may in fact have
use for it, and so now that it's not on the final list, I think
there are questions about what happened to it, as you were
asking, and where--when is it going to be released.
Mr. McAdams. All right. Thank you. I yield back.
Chairwoman Sherrill. Thank you, Mr. McAdams. Now, the Chair
recognizes Representative Babin.
Mr. Babin. Sure, thank you. Thank you, Madam Chair.
Mr. Gomez, in your review of the IRIS Program, you rely in
part on the 2018 NAS report to find that the IRIS Program has
made significant progress. This 2018 NAS review was simply, if
I understand it, a check-the-box exercise organized by career
program officials confirming that changes have been made to the
program. In other words, the NAS review did not examine any
IRIS products to ensure proper scientific rigor. It did not
identify any tangible outcomes as a result of the changes made
to the program. Did GAO identify any of these shortcomings
after using the 2018 NAS review as a primary source for praise
of the program?
Mr. Gomez. So perhaps what I can do is just explain the
approach that we take in looking at the progress that the IRIS
Program is making. So while we do look at other reports that
are out there like the NAS study that you mentioned, we're
looking at a couple of criteria, so we're looking at whether
there is leadership commitment, you know, does the program have
the capacity to do the work, do they have a plan in place to do
the work, are they monitoring how well they're doing, and are
they also demonstrating progress? So we look at all of those
elements to then come up with a rating, and for the IRIS
Program in particular, as we've been discussing, they have made
some progress, so we are giving them the rating of partially
met, so they're not fully met, and that is why it's still on
the High-Risk List for GAO, and we're continuing to look at it.
But we are concerned, as others, about the length of time
that it takes to issue these assessments, and so timeliness is
an area that has a lot of attention.
Mr. Babin. OK. Thank you. And then, Dr. Orme-Zavaleta, I
see the Administration has taken steps to prioritize chemicals
for assessment in the IRIS Program. Would you classify this as
a positive step for IRIS?
Dr. Orme-Zavaleta. I do. I think we have always gone out to
programs in helping to identify what their needs are, but this
new process raises it to the Assistant Administrator level, and
that's going to help provide greater stability to the program,
as well as greater accountability not only to the program
offices and reminding them that they made this request but also
in helping us in meeting those particular requests.
Mr. Babin. OK. Thank you, and I yield back, Madam Chair.
Chairwoman Sherrill. Thank you. The Chair now recognizes
Representative Beyer.
Mr. Beyer. Thank you, Madam Chair.
Mr. Gomez, one of the main concerns I have reading the GAO
report is that, you know, the IRIS, which we've talked about
for many years on this Committee, is just far too important to
allow chemical assessments to be decided by anything short of a
transparent, collaborative process that listens to the voices
of the career staff.
So in reading the GAO report, you talked about how the
ORD's second request is made verbally at a meeting, including
direction to the program offices to limit their request to no
more than three to four chemicals. Did ORD explain to you why
it was appropriate to do this directive verbally and with no
prior consultation and not through a documented process?
Mr. Gomez. No, sir, we don't have any additional
information as to any additional guidance that was provided as
to how they should further limit those assessments.
Mr. Beyer. OK. And then, Dr. Orme-Zavaleta, I know you've
read all this carefully. Does it make any sense to you that ORD
proceeded to a second round of the survey with no involvement
from IRIS leadership?
Dr. Orme-Zavaleta. So the conversation that took place was
a meeting that the Administrator has weekly with his senior
leadership, the Assistant Administrators, and so I was not
there, I was not involved in that particular conversation. I
don't know how the request was made. I don't know the
conversation that ensued.
Mr. Beyer. Mr.--thank you. Mr. Gomez, did GAO--you know, we
talked a lot about how the shrinking from 22 subject chemicals
down to 11, and this is part of the prioritization process. Was
there any evidence that IRIS was incapable of handling the
previous largest--larger workflow?
Mr. Gomez. As we understand it, the IRIS Program was able
to handle that workload given their current resources.
Mr. Beyer. And we certainly heard from--based on the
questions from any of the other people on the panel that there
were chemicals left out of that.
Dr. Orme-Zavaleta, and again, I know this wasn't in your
decisionmaking, but when did ORD decide to reduce the number of
priority chemicals by so much? And, you know, one of the
criticisms again that shows up in the GAO report was there
was--there's no information at the EPA Administrator's office
about what the prioritization was meant to achieve.
Dr. Orme-Zavaleta. So, again, I wasn't involved in that
conversation. I don't know that it was requested by the ORD
representative or by the Administrator.
Mr. Beyer. You know, the suspicious part of me wonders if
the prioritization wasn't simply used as a way to eliminate
chemicals that are controversial within industry and focus on
ones that are easy, low-hanging fruit, for example,
formaldehyde, which raises the prospect that this is not
science driving it but rather politics and money, so----
Dr. Orme-Zavaleta. So, again, I wasn't there, but if you'd
like further information, we can go back to staff and respond
back.
Mr. Beyer. OK. Great. Thank you very much. Mr.--Madam
Chair, I yield back.
Chairwoman Sherrill. Thank you. The Chair now recognizes
Dr. Foster.
Mr. Foster. Thank you. I appreciate it, and I appreciate
being allowed to serve on this--in this hearing, although I
don't actually serve on the Committee.
I'd like to bring up the issue of ethylene oxide.
Willowbrook, Illinois, in my district is home to a
sterilization facility that's used ethylene oxide for decades
to sterilize medical equipment. And this community has
unfortunately become an example of the important role that the
EPA plays in defending public health and what can happen when
these systems don't do as well as they should.
In the case of ethylene oxide, there was roughly a 15-year
gap between the publication of scientific papers that indicated
ethylene oxide was a far more powerful carcinogen than had
previously been assumed and the corrective actions and eventual
shutdown of that facility in my district that was venting
apparently unsafe amounts of ethylene oxide into nearby
neighborhoods.
And I request unanimous consent to insert into the record
the Executive Summary of the EPA's Evaluation of the Inhalation
Carcinogenicity of Ethylene Oxide into the record.
Chairwoman Sherrill. Without objection.
Mr. Foster. Thank you. And so Dr.--oh, boy--Orme-Zavaleta--
--
Dr. Orme-Zavaleta. Jennifer.
Mr. Foster. Jennifer, you know, what would the reasons have
been for a 15-year delay in the scientific findings and the
actual actions? You know, are these things limited by just a
shortage of manpower? You've got tens of thousands of chemicals
and you have to prioritize your effort and you just don't have
enough people on this, or is this a situation where there's a
lot of pressure from industry that's delaying--causing a 15-
year delay of this kind?
Dr. Orme-Zavaleta. Yes, so I'm not exactly clear on--you're
thinking of the timeframe. IRIS provided an assessment for
ethylene oxide in 2016.
Mr. Foster. Correct. And all the references in that were
scientific papers dating from the late 1990s, early 2000s.
Dr. Orme-Zavaleta. So, you know, I think that that's
something I can take back to staff and we can get further
information on how additional information can be incorporated,
but the assessment that was published in 2016 went through--
it's a very complex chemical, a lot of intricacies in trying to
evaluate those risks.
Mr. Foster. Simple chemical but with complex biological
effects.
Dr. Orme-Zavaleta. There you go. And so in going through
the reviews, it went through two rounds of review with our
Scientific Advisory Board, which is not always common, but a
very rigorous, thorough review, as well as reviewed through the
different Federal agencies and within EPA, so it's a very solid
assessment, and it's one that we continue to support, and
that's part of our responsibility----
Mr. Foster. I understand. It just would have been nice if
it would have been faster----
Dr. Orme-Zavaleta. Yes.
Mr. Foster [continuing]. Than 15 years. And I was just
wondering if this is a--I guess the point of my question is if
this is a manpower-limited thing, then I think there is an
argument to be made to just increase the manpower available so
this situation doesn't happen because you can mess up either
way. You know, there are people panicked selling their houses,
and if it turns out the best scientific indications are that is
unnecessary, then, you know, mistakes have been made in that
direction. And of course there's the danger of damage to human
health.
And so if you could actually have a look at that specific
case and see to what extent if you had--were not manpower
limited----
Dr. Orme-Zavaleta. Yes, we'll be glad to follow up.
Mr. Foster [continuing]. Whether--what that timescale could
have been compressed to be.
Dr. Orme-Zavaleta. Sure.
Mr. Foster. And also if you could come up with a best
estimate of the number of people, you know, who will--you know,
assuming that the report stays valid, a best estimate of the
number of people, additional cancer cases nationwide due to
that delay and particularly the avoidable part that might be
avoided with more investment in manpower.
And just more generally does the EPA or any third party
maintain estimates of the cumulative number of lives saved by
EPA actions?
Dr. Orme-Zavaleta. So I think that's something I'll also
have to follow up on. There are evaluations that are not
necessarily conducted within ORD but other parts of the agency
that looks at impact analyses, and so that's something we can
follow up on.
Mr. Foster. Yes. It would be a very good thing to do. Also,
the cumulative costs because your actions impose costs on
industry, and they save human lives, and seeing those two
numbers side-by-side, both cumulatively and for specific
actions, I think would clarify a lot of the thinking that--and
certainly we tend to talk past each other when we are only
looking at one side of it in this Committee in the past----
Dr. Orme-Zavaleta. OK.
Mr. Foster [continuing]. And that would allow you of course
to look at the number of lives saved per dollar of cost, which
is a very tough thing to talk about in politics, but really,
you know, that's I think one of the lenses that we have to look
at this through. And particularly in cases where the actions
are delayed because of manpower limitations that might allow us
to think about whether an investment here--to quantify whether
an investment in increased manpower would save a, you know,
roughly quantifiable number of human lives. So if you do get
back with those. And if it turns out that you don't have those
estimates, come up with a scope of a congressional request to
get those numbers reported. I think it would clarify our
thinking greatly.
And thank you. I see my time is up, and I yield back.
Chairwoman Sherrill. Well, thank you very much. Thank you
to Dr. Orme-Zavaleta and Mr. Gomez for your testimony today.
We'll now have a short break while we seat our next panel of
witnesses. Thank you, everyone.
[Recess.]
Chairwoman Sherrill. Welcome back. At this time I would
like to introduce our second panel of witnesses. Dr. Bernard D.
Goldstein is a Professor Emeritus and Dean Emeritus at the
University of Pittsburgh, Graduate School of Public Health; Dr.
Ivan Rusyn, a Professor with the Department of Veterinary
Integrative Biosciences at Texas A&M University, and the Chair
for the Interdisciplinary Faculty of Toxicology. He also serves
as the Director of the Texas A&M Superfund Research Center.
Dr. Julie E. Goodman is a principal at Gradient, an
environmental and risk sciences consulting firm with a focus on
workplace and environmental chemicals.
And our final witness, Ms. Wilma Subra. Ms. Subra is the
Founder and President of Subra Company, Inc., an environmental
consulting firm in New Iberia, Louisiana. She also serves as a
Technical Advisor to the Louisiana Environmental Action
Network.
Dr. Goldstein, you are recognized for 5 minutes.
TESTIMONY OF DR. BERNARD D. GOLDSTEIN,
PROFESSOR EMERITUS AND DEAN EMERITUS,
UNIVERSITY OF PITTSBURGH GRADUATE
SCHOOL OF PUBLIC HEALTH
Dr. Goldstein. Chairwoman Sherrill, Chairwoman Fletcher,
and distinguished committee Members, I appreciate the
opportunity to speak in front of this Committee again. To keep
the time, I will focus on the core principles of why IRIS was
developed and its relevance to today. It's not just my age that
permits me to look back this far. I was Assistant Administrator
for Research and Development appointed by President Reagan
working under Administrators Ruckelshaus and Lee Thomas as IRIS
was under development.
My conclusion regrettably is that rather than streamlining,
disemboweling is really what is happening here. We are
destroying the current long-term scientific basis for how EPA
functions. My background is detailed in my written testimony. I
want to emphasize that through the years, I've worked closely
with industry. In my current consultant work in toxic tort
cases I have about equally an expert defending an industry as I
am an expert for the plaintiff side suing the industry, and it
depends upon the facts of the case.
So why was IRIS developed? In 1983, soon after the NAS Red
Book was released, I became EPA's Assistant Administrator for
Research and Development. First, generally not known now, but
EPA was already doing risk assessments. The problem was that
the silo structure that characterized the EPA then and now made
risk assessments a shambles. Now, this will occur again if
assessments are removed from EPA's science offices to program
offices. Different default assumptions were a key issue.
Administrator Ruckelshaus recognized that for risk
assessment to be useful, it needed to be sufficiently
standardized and transparent so that, in his words, it would
not be like beating a spy to get whatever answer you wanted.
External transparent peer review is recognized as being
crucial.
And yet another reason for centralized ORD-led approaches,
which I haven't heard discussed, is the obvious budgetary
consequences because risk became--assumed a major role in
assigning agency priorities. The program offices might want to
increase the risk for air as opposed to water or water as
opposed to air if, in fact, they are the ones allowed to have a
say in what the basic approaches were.
Subsequently, other important roles for IRIS have been
recognized. The local purposes, which I'm glad to hear both
Chairwomen describe--I recently had a paper--a document from
the Allegheny County Health Department responding to a concern
of local community, gentrifying community about some old
industries there. It relied heavily on the IRIS process. It
relied heavily on IRIS numbers, which were duplicated in this
document.
There's also a need to be responsive to national concerns
that in a sense help us with world trade issues. We have
something that's recognized worldwide in IRIS. If we politicize
it, we will no longer be able to look back and expect other
countries to use it because it'll be seen as a politicized
effort rather than the science that it now is.
And we need a centralized science--we need a centralized
IRIS within ORD to decide whether and how to incorporate new
science. And there is much new science related to hazard,
related to dose response that has to be incorporated.
It should be clear, Administrator Wheeler's decision to cut
IRIS' budget, withhold its assessments from peer review, and
move the formaldehyde issue is quite a contradiction of these
founding principles.
So let me conclude by saying that I have the deepest
respect for Dr. Orme-Zavaleta--and I do call her Jennifer. I
think she's doing really extremely well under the
circumstances. But as the appointee of President Reagan
confirmed by the U.S. Senate, I would have resigned had
Administrator Ruckelshaus or Administrator Thomas tried to do
the things that are happening now.
I cannot recommend that the current AA of ORD resign; there
is none, nor in the third year of this Administration even are
rumors to whose name might be sent to the Senate. And it is
unlikely that any reputable scientist would accept such a
nomination.
I would welcome answering questions about my overall
written testimony, including transparency, about which I have
previously testified in front of this Committee and about
formaldehyde, which, as a hematologist and toxicologist, I've
long been involved with. Thank you.
[The prepared statement of Dr. Goldstein follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Sherrill. Thank you very much.
Dr. Ivan Rusyn, you are now recognized for 5 minutes.
TESTIMONY OF DR. IVAN RUSYN,
PROFESSOR, DEPARTMENT OF VETERINARY INTEGRATIVE
BIOSCIENCES; CHAIR, INTERDISCIPLINARY
FACULTY OF TOXICOLOGY; AND DIRECTOR,
SUPERFUND RESEARCH CENTER, TEXAS A&M UNIVERSITY
Dr. Rusyn. Thank you. Chairwoman Sherrill, Chairwoman
Fletcher, distinguished Members of the Subcommittees, I'm
honored to appear before you today for this hearing.
As a matter of disclosure pertaining to the topic of
today's hearing, I'm currently chairing a workshop committee of
the National Academies to support development of EPA's IRIS
toxicological review. However, I appear before you today
representing my own perspectives, not those of the Academies or
the Texas A&M University.
I would like to offer insights from my role as a researcher
in the field of toxicology and a person with understanding of
the process of developing human health assessment in general
and those of the IRIS Program in particular. I have more than a
decade of service as peer reviewer of various IRIS assessments,
including 2011 Review of the EPA's Draft IRIS Assessment of
Formaldehyde. I also served as a faculty fellow to the IRIS
Program for 2 years where I interacted with IRIS staff in a
variety of scientific methodological issues directly relevant
to implementation of the advice from the National Academies. My
laboratory is funded by the NIH (National Institutes of
Health), the EPA, the National Academies, California EPA, and
the European Petroleum Refineries Association.
With respect to the Committee's interest in the role that
IRIS plays in the field of chemical toxicity assessment, I note
that it is difficult to overstate the importance of the IRIS
Program to the protection of public health in the United States
and abroad. Both the National Academies and the EPA themselves
acknowledged the key role that IRIS-produced assessments play
in many risk management decisions and superfund site cleanup.
IRIS values are relevant for protecting the health and
well-being of everyone, not only those who may be exposed in
the workplace and not only by a narrow choice of the routes of
exposure. As such, IRIS values are held to the highest standard
in terms of the quality of their assessments, undergo
exhaustive intra-government and external reviews, and the
process generates very important and widely used toxicity
values and classifications.
With respect to the Committee's interest in the progress
IRIS has made addressing recommendations from the National
Academies, I note that a 2011 NRC (National Research Council)
report: Review of the EPA's Draft IRIS Assessment of
Formaldehyde offered a roadmap for the overall changes of the
process, as well as some specific guidance. And the report did
recognize that this process may take time and that EPA is fully
capable of implementing suggested improvements, hence no delay
in releasing other assessments was recommended.
Two subsequent committees of the National Academies weighed
in on the process and progress and have commended the IRIS
Program for the work that they're doing. I fully agree with the
conclusions of those reports.
Overall, it is my opinion that substantial improvements in
the IRIS process have been made in a relatively short period of
time, and it is clear that the IRIS Program welcomed the advice
it had been receiving from the National Academies and other
stakeholders. The IRIS Program fully embraced the concept of
systematic review. Systematic review is neither easy, nor it is
straightforward, and the IRIS Program is to be commended for
their leadership in this area.
Also, a number of strategic decisions were made by IRIS to
develop specific guidance documents and further standardize the
process. A number of software solutions have been implemented,
and investments in staff training and improvements to the
interactions with outside stakeholders were made.
It is disconcerting to me, however, that it appears that
the IRIS Program lacks the support from the leadership of the
EPA in terms of providing it with sufficient financial
resources and adequate staffing. It has been stated in the 2019
GAO report discussed this morning that a number of recent
events may have grave consequences to the ability of the IRIS
Program to continue implementation of the advice from the
National Academies to complete their draft assessments and to
set further priorities commensurate with the needs of other
offices at the EPA and of their other stakeholders. These
developments are troubling, and I encourage the Subcommittees
to look into the GAO report's facts and conclusions and to
determine whether EPA may need to support and strengthen the
IRIS Program, as suggested by the National Academies.
In conclusion, it is my opinion that the IRIS Program has
implemented the recommendations of the National Academies. The
IRIS Program should be supported with adequate financial
resources and staff. I also support strengthening the oversight
by Congress of the implementation of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act.
Thank you for the opportunity to appear in this hearing,
and I'd be happy to answer any questions the Members might
have.
[The prepared statement of Dr. Rusyn follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Sherrill. Thank you very much.
Dr. Goodman, you're now recognized for 5 minutes.
TESTIMONY OF DR. JULIE E. GOODMAN,
PRINCIPAL, GRADIENT
Dr. Goodman. Thank you very much for the opportunity to
speak today. I am Dr. Julie Goodman, an epidemiologist and
board-certified toxicologist at Gradient, an environmental
sciences consulting firm. We assist public and private
organizations in evaluating the risks of chemicals and other
substances to human health and the environment.
I have been developing and applying weight-of-evidence and
systematic review methodology for over 10 years in a variety of
settings, and I taught a graduate-level class on this topic at
Harvard University. Much of my work has been published in the
peer-reviewed literature. I'm presenting testimony today as an
independent scientist. While my travel costs have been paid by
my company, I'm here today on my own time and I am not being
compensated for the time I spent preparing this testimony.
As you heard earlier, in 2011, a National Academy of
Sciences or NAS committee provided recommendations for the IRIS
Program in the context of a review of formaldehyde. In
response, EPA released a draft handbook for IRIS assessments in
2013, and then in 2014 and 2018, NAS reviewed and evaluated the
IRIS assessment process more generally, including progress made
since 2011.
Both the 2011 and 2014 NAS reviews stated that the IRIS
Program lacked a clear conceptual framework and clear and
transparent methods. Further, NAS concluded that EPA did not
fully assess the weight of evidence or justify the selection of
studies for the derivation of toxicity values. The 2014 NAS
review also specifically called for the finalization of the
draft IRIS handbook.
Since that time, EPA has made substantial improvements to
the IRIS process, including the development and application of
systematic review methods for evidence identification,
evaluation, and integration, but not all of the identified
issues have been resolved.
To date, EPA has shown progress on a chemical-by-chemical
basis using the IRIS Assessment Plans for uranium and ammonia
and systematic review protocols for chloroform and chromium
assessments as examples of its new portfolio approach. EPA
announced it will move forward with a revised handbook, which
will be put through peer review and public comment processes
this year. This is undoubtedly needed and a critically
important step forward, and EPA is to be commended for these
actions.
I note that while it is true that a one-size-fits-all
protocol for all chemicals is not feasible, and details of the
individual chemical assessments will vary based on the specific
research questions identified and on the available data, all
IRIS assessments will benefit from a clearly written framework
that serves as a standard operating procedure, or SOP, for
agency systematic reviews. The SOP can be expanded to include
chemical-specific tailoring as needed to each phase of specific
chemical reviews. An iterative approach can be used to
incorporate new issues and knowledge into the SOP as it becomes
available.
To follow through on its intention to use systematic review
and weight-of-evidence methodology for hazard identification,
EPA needs to complete an individual assessment using the new
process. My experience with developing these types of
approaches has shown that it is important to apply a framework
in a chemical-specific setting to determine where its strengths
lie and where it falls short and should be revised.
IRIS assessments both identify hazards associated with
chemicals and characterize these hazards by generating toxicity
values. With regard to the latter, EPA is always limited to
studies with sufficient data for dose-response analysis, so the
handbook should describe what will be done if these studies are
not reflective of the science as a whole.
In addition to studies that identify toxic effects, part of
the hazard identification process is to consider studies that
inform the mechanism of toxicity. EPA should indicate how it
will consider this mechanistic evidence when deriving toxicity
values. For example, if mechanistic studies clearly show a
threshold effect, then it should be incorporated into the dose-
response analysis, and linear low-dose extrapolations should
not be applied.
Now, there's no doubt that conducting systematic reviews
takes more time and resources than nonsystematic reviews.
However, a completed handbook that can and should be revised to
reflect the best-available science will go a long way toward
expediting assessments and increasing transparency and
consistency across assessments. More importantly, with an
established standard procedure in place, EPA staff will have
better guidance to conduct IRIS assessments in a systematic and
unbiased manner. This will allow stakeholders and members of
the public to better understand the process and provide input
and ultimately will increase their confidence in EPA's
assessments.
In conclusion, to address the NAS recommendations for the
IRIS Program dating back to 2011, EPA needs to complete a
general guidance framework for IRIS assessments and a revised
handbook. EPA also needs to complete assessments that both
apply this guidance and demonstrate that dose-response analyses
and toxicity value derivations will be informed by the overall
weight of evidence and biological mechanisms. Thank you very
much.
[The prepared statement of Dr. Goodman follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Sherrill. Thank you. Ms. Subra, I now recognize
you for 5 minutes.
TESTIMONY OF WILMA SUBRA,
PRESIDENT, SUBRA COMPANY;
AND TECHNICAL ADVISOR,
LOUISIANA ENVIRONMENTAL ACTION NETWORK
Ms. Subra. Thank you, Madams Chairwomen and distinguished
Members of the Subcommittees for the opportunity to testify
here today. I have provided technical assistance to community
groups throughout the United States and in some foreign
countries dealing with environmental and human health issues
for more than 52 years.
From the beginning of the publication available through
IRIS assessment program, the information provided by IRIS has
been extremely valuable in identifying health hazards of
chemicals and evaluating exposure situations in the impacted
communities. The toxicological information provides a complete
evaluation of each chronic pathway of exposure and resulting
risk. This information is critical in providing community
members accurate and focused exposure and risk information per
chemical.
No matter what the situation, impacted community members
are never exposed to just a single chemical. Focused on only
one chemical or contaminant results in the underestimation of
exposure, risk, and associated health. Community members' risk
has to be included in all chemicals, all pathways of exposure,
and all concentrations in all media in order to adequately
identify the risk and develop pathways moving forward.
When we look at the impacts of formaldehyde, formaldehyde
is a precursor to many other chemical compounds produced by
industrial facilities. In Louisiana, we have 31 major
industrial facilities with more than 13 million pounds of
formaldehyde being released into the environment each year. In
Texas, we have 77 major industrial facilities releasing more
than 819,000 pounds of formaldehyde into the environment each
year. In the United States, we have 727 major industrial
facilities releasing 19 million pounds into the environment.
So an example of some of the communities that have been
impacted by formaldehyde, the work I've done, in Natchitoches,
Louisiana, there's a plywood mill. The citizens around the
facility were very ill. We did air samples to determine that
formaldehyde was the major toxic component. We went in and met
with the company that was making the plywood and determined
that they were using a formaldehyde-based glue or resin.
Working with the community and the industry, they changed the
kind of resin or glue that they were using, and therefore, the
health impacts of the community were much improved.
Then we have a Georgia-Pacific facility in Crossett,
Arkansas. It has a pulp mill, it has a paper mill, and it has a
chemical mill. The chemical mill actually makes the
formaldehyde for use at all three facilities. The citizens
complained of two things: Air emissions, odors of hydrogen
sulfide, and formaldehyde. Hydrogen sulfide is the most
disruptive to their health, but formaldehyde is the most toxic.
Based on all the work with the citizens, we convinced EPA
and they brought in the National Enforcement Investigation
Center, which identified that the emissions of formaldehyde
were being missed by the facility because they were using the
wrong kind of detector to do their leak detection and repair.
So, as a result of that, they issued them all sorts of
violations and then in December of last year there came the
penalty notice where they required them to pay $300,000 for
each agency, that State agency and the Federal agency. They
required them to do $1.2 million in restitution and $1 million
over 3 years for supplemental environmental projects. These
were all reduced emissions of the toxic chemicals, primarily
formaldehyde.
Then we have a self-help group that does housing for
disadvantaged people. They were looking at changing to a
contractor that build the houses and would put it on their
lots. As it turned out, they were using a resin that had
formaldehyde in it. We had conversations with them. They
declined to change the kind of resin they were using.
Therefore, the self-help group no longer even considered having
those houses because they didn't want their environmental
justice community members exposed.
And then finally, we had the hurricanes of 2005, Katrina
and Rita, a huge impact to Louisiana, Mississippi, Alabama, and
Texas. And, as a result, we found out by doing sampling with
Sierra Club that a large number of people were living in the
FEMA (Federal Emergency Management Agency) trailers that were
provided that had huge emissions of formaldehyde. We did 32
tests in one set. Thirty exceeded EPA's criteria for
formaldehyde, 44 tests and 40 exceeded. As a result of that,
120,000 families were estimated as living in FEMA trailers with
formaldehyde over the acceptable level. And in a FEMA trailer,
it's an enclosed environment. Emissions into the air, everyone
in the families are impacted. And so that was a situation where
you did good for the community members but resulted in health
impacts to those community members. And a large number of them
were children and pregnant females.
[The prepared statement of Ms. Subra follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Sherrill. Thank you. Thank you. Well, thank you
to all of our witnesses. At this point we'll begin our first
round of questions. The Chair recognizes herself for 5 minutes.
So, Dr. Goldstein, in your testimony you spoke about the
state of EPA chemical assessments prior to the establishment of
IRIS. Can you please elaborate on the impetus to establish the
IRIS Program and what needs it was filling that program offices
were unable to address?
Dr. Goldstein. Yes, the--IRIS to me was always a--sort of a
smooth just continuation of the description of what I gave
under Administrators Ruckelshaus and Thomas. How to name it was
lots of debate. I remember one of the original ideas was the
Coordinated Risk Assessment Program, but the acronym served to
be of no value.
The issue of how to move forward for EPA always came down
to the natural tension between the program offices and a
central administrative type of structure as the Office of
Research and Development. And through the years that has just
progressed. So it was just a building onto the issue of we need
a centralized approach, the Administrator has to understand
what the relative--what risk means to priorities and prioritize
among the various problems that the Administrator was facing in
responding to Congress. Congress needed to know which were the
riskier problems that EPA was dealing with. And it should come
from a central organizational structure with lots of external
reviews.
Chairwoman Sherrill. Thank you very much. And from our
previous panel we learned that EPA's Office of Children Health
Protection, or OCHP, believes formaldehyde is one of the top
three or four IRIS priority chemicals for its office. That
means formaldehyde is one of the major chemical dangers facing
children today. Unfortunately, OCHP did not submit its
priorities until it was too late in the process for them to be
included. But, Dr. Rusyn, can you describe some of the
documented health impacts of formaldehyde particularly for
children and why our children are especially vulnerable to
formaldehyde exposure?
Dr. Rusyn. Thank you. I speak on my recollection from the
information contained in the draft IRIS formaldehyde assessment
that the committee that I served on reviewed in 2010 and 2011.
I do not work on formaldehyde, so I'm not expert by any stretch
of imagination. But the draft assessment included evaluation of
the literature and derivation of toxicity values for inhalation
exposure, which was of greatest concern. And the concerns that
already were pointed out today especially from the
particleboard in FEMA trailers and others, are something that
is definitely bringing this type of a route of exposure to
concern and especially because children are also exposed and
are also considered a vulnerable population. This is something
that the agency needed to account for in how they derived
toxicity values from some of the studies in adults. So
respiratory irritation and exacerbation of asthma and other
types of respiratory illnesses were some of the health effects
that were pointed out in the draft assessment.
Chairwoman Sherrill. Thank you very much. And, Dr. Rusyn,
since your participation in the 2011 National Academies' review
of the draft formaldehyde assessment, what progress have you
observed in IRIS' ability to implement the recommendations made
and to increase its productivity and transparency?
Dr. Rusyn. So, as I mentioned in my oral and written
testimony, the process of IRIS evaluations is under a
microscope and has been from all sides, from GAO, from
Congress, from the National Academies, and from other
stakeholders. The progress has been primarily focused on the
process because the criticism that the 2011 report has provided
was largely on the process and the transparency of the
documents. So the systematic review process, the frequent
releases of information that are now part of the IRIS Program's
standard operating procedures increased transparency, increased
the stakeholder engagement, and actually move the field
forward. But it's important to note that risk assessment is not
something that is stagnant. There's a lot of new data. There's
a lot of methodological work, and I think IRIS is the leader in
this pushing the methodology forward.
Chairwoman Sherrill. And we have a few more seconds. How
are they the leader would you say?
Dr. Rusyn. The systematic review is something that is more
established in the medical community where systematic reviews
are undertaken to create centralized guidelines for certain
conditions and for their treatments, so to standardize across
different physicians and make sure that they're treating their
patients based on best science. How to apply this process to
environmental health was really unclear, so this is something
that has only begun about 5 or 6 years. So IRIS Program has
taken the leadership position in actually creating case studies
and guidelines for this, so they're really pushing the field
forward.
Chairwoman Sherrill. Thank you. Thank you, everyone. And
now the Chair will recognize Mr. Norman for 5 minutes.
Mr. Norman. Thank you, Chairwoman Sherrill.
Dr. Goodman, there's been a lot of talk about systematic
review and higher standards to improve the IRIS Program. Can
you explain the systematic review in layman's terms and
describe why its implementation is critical to improving IRIS?
Dr. Goodman. Yes, so the idea behind a systematic review is
that there is a clearly formulated question and, based on that
question, a protocol is developed for every aspect of the
review, including the literature search strategy, what studies
you're going to include and exclude, what information you're
going to take from that--those studies, importantly, how you
evaluate the quality of those studies, their strengths and
limitations, and then how you integrate evidence from all these
studies, especially when there's contradicting evidence, what
you're going to do.
And the reason why it's so critical is so that you truly
get a sense of the whole state of the science. When a review is
conducted that's not systematic, what ends up happening is
critical information is ignored and then your conclusions
aren't really based on a good solid scientific foundation.
Mr. Norman. Thank you. And, again, Dr. Goodman, over the
years, there's been a lot of uncertainty surrounding
formaldehyde, specific criticisms of the IRIS Program's
handling of the formaldehyde assessment. Last week, EPA
announced that it will review formaldehyde in the TSCA program,
which is an actual regulatory program that can set useful
guidelines for the formaldehyde use. I think this is a
tremendously positive step toward making meaningful
determinations as to the risk associated with formaldehyde, and
I applaud the Administration for taking this step. Can you--Dr.
Goodman, again, can you please explain the potential downside
of relying on an IRIS assessment of formaldehyde to dictate how
we regulate that substance at the Federal level?
Dr. Goodman. Well, I think, as it stands, the IRIS handbook
hasn't been completed yet, so there's no standard operating
procedure for conducting IRIS assessments. And so even though
the assessments are moving in the direction of using systematic
review, it hasn't--systematic review hasn't been fully
implemented in any review to date, including what's been done
on formaldehyde to date. So in that sense I think what's most
important is that formaldehyde is reviewed in a systematic
fashion.
And I think the other aspect, as was talked about with the
first panel, IRIS provides toxicity values and that--and these
toxicity values take into account the hazard information, but
they don't take the next step in saying what are uses, how are
people using it, and what are the risks for those particular
uses? And that is done under TSCA.
Mr. Norman. OK. I'd like to thank each one of the witnesses
for taking your time again. There's been a lot of controversy
over IRIS, and we just want results. And thank you for taking
the time. Chairwoman, I have no further questions.
Chairwoman Sherrill. Thank you, Mr. Norman. I now recognize
Ms. Bonamici for 5 minutes.
Ms. Bonamici. Thank you so much to the Chairs and Ranking
Members. Thank you to all of our witnesses for being here.
I said during the first panel I've been on this Committee
for more than 7 years, and I have sat through many hearings
about IRIS and know that there--without question, there was a
need to improve. But the direction that I'm seeing I do not
consider improvement.
Dr. Goldstein, in your testimony you discuss a development
of the IRIS Program. I read your--back in the Ruckelshaus days
and the importance of a centralized ORD-led approach to risk
assessments and the value of independence of IRIS from other
program offices. In a September 2017 letter, the EPA's Science
Advisory Board reaffirmed that no other Federal entity performs
IRIS functions and that IRIS helps ensure consistency in
chemical assessment within the agency. I disagree with my
colleagues who continue to call for the elimination of IRIS.
And, Dr. Goldstein, based on your years of experience at
the EPA, what are the consequences of diminishing the
independence of IRIS? And how would consolidating the functions
of IRIS into various program offices affect the quality of
assessments?
Dr. Goldstein. I think the quality of assessments would
rapidly decline. It would be under the leadership of someone
appointed as a political appointee to make sure that air is
taken care of, water is taken care of, individual groups that
have individual laws and they will respond by looking at ways
that the risk be most supportive of what they think their
policy approaches ought to be. We need an independent group
that says what the science is and then everyone can use it but
cannot play with it as much as would occur if you got rid of
IRIS.
Ms. Bonamici. Thank you. And, Dr. Goldstein, in your
testimony you state that Administrator Wheeler's abrupt
dismantling of extensive science-based independent review
processes is unforgivable, and the current actions of EPA's
leadership to be incredibly shortsighted at best. I'm very
concerned about the lack of transparency, what appears to be a
significant limitation on the number of chemicals that are
being considered.
I also appreciated the candid statement in your testimony
that you would have resigned as Assistant Administrator of ORD
if EPA leadership had tried to make the changes now being
insisted on by Administrator Wheeler. I don't think we can
brush this aside or ignore it. It's--I'm deeply concerned about
the efforts to undermine scientific integrity and dismiss
agency scientists and the EPA's work and the consequences that
may endanger the EPA's ability to fulfill its mission. And we
know that mission is protecting public health and the
environment. What are the long-term consequences of the
continued disrespect and dismissal of science at the EPA?
Dr. Goldstein. Well, EPA will soon cease to function
effectively. It will continue to have debate after debate after
debate. The formaldehyde to me is a poster child of what
happens when we let politics get in the way of making
scientific--looking at the scientific basis for the
decisionmaking. One can take the science and make a decision
based upon what the laws are, what the policy issues are, but
one should not discard the science and basically decide in
advance I know what the science ought to be and then try to
make policy on that. That policy will eventually fail.
Ms. Bonamici. And thank you. And I have a question about
the career staff. I know that there are still many career staff
at the agency. How can we defend the work of the career staff
when the EPA leadership is limiting the release of information
to the public? What are your suggestions there?
Dr. Goldstein. I think you've asked the most important
question. My suggestion is as much oversight as you can give
would be very, very welcome in this way. You know, hearings
like this are just so important. And the career staff
recognizes that.
Ms. Bonamici. Thank you. And I want to reiterate what I
mentioned in the hearing on the first panel that IRIS is an
important program, yes. Based on the information we'd heard in
the past and the recent GAO report, yes, there is room for
improvement, and we can work together to bring about that
improvement, but we absolutely must maintain the separation and
respect the work of the career folks who are there trying to
make sure that there is, science and transparency regarding
IRIS and overall with the EPA.
So thank you for your leadership, Chairwoman Fletcher and
Chairwoman Sherrill and Ranking Members, and I yield back.
Chairwoman Sherrill. Thank you very much.
Now, the Chair recognizes Dr. Babin for 5 minutes.
Mr. Babin. Thank you, Madam Chair. I appreciate it. And
thank you, all you expert witnesses for being here as well.
Dr. Goodman, do IRIS assessments integrate all lines of
evidence, including potential adverse health effects to humans?
Dr. Goodman. I think the goal of IRIS assessments is
certainly to do that, and they do attempt to consider
epidemiology, toxicology, mode of action, mechanistic evidence,
but in practice sometimes relevant evidence is missed or in
other times the evidence is all there but it's not evaluated in
a systematic manner, meaning that, you know, not all studies
are created equal. Some are more robust, they have more
strengths. Others have more limitations. Just as an example,
sometimes in epidemiology it's very difficult to estimate
exposure, and some studies do a better job than others at
coming up with good exposure measurements. So I think that can
sometimes be an issue with IRIS assessments.
Mr. Babin. OK. And then do IRIS assessments include any
consideration of actual human exposures or make any
determination of the actual human risk?
Dr. Goodman. I believe that IRIS--the goal of the IRIS
assessment is really to conduct a hazard assessment, and then
once that assessment is done, it can then be used to evaluate
risk----
Mr. Babin. Oh.
Dr. Goodman [continuing]. Based on human uses of chemicals
and exposures.
Mr. Babin. OK. Does the TSCA program consider human
exposure?
Dr. Goodman. Yes, it does.
Mr. Babin. OK. And also is it true that other chemical
assessment agencies like the World Health Organization
recognize a safe threshold for formaldehyde exposure when they
establish values for long-term exposure to formaldehyde?
Dr. Goodman. Yes, I believe the World Health Organization
has acknowledged that the key mechanism for formaldehyde in
causing cancer is through cytotoxicity and cell proliferation,
and that specific mechanism has a threshold. And what that
means is there's an exposure level below which the body can
actually handle exposures to formaldehyde, and this won't
happen.
Mr. Babin. OK. Well, then would you elaborate on--just a
little bit on the importance of setting these safe threshold
values?
Dr. Goodman. Well, I think the idea is--the goal of all of
these programs is to determine what safe levels are or what
levels below which we can be confident that there isn't an
increased risk for adverse effects on human health. And so we
need that based on the best available science, and if the
science suggests that a mechanism of cancer or any other health
effect has a threshold, has a level below which there is no
increased risk, that needs to be incorporated in an assessment.
Mr. Babin. I see. And, Ms. Subra, you had mentioned--are
you from Louisiana by the way? Are you from Louisiana? Did I
hear you say you had some studies in Natchitoches and----
Ms. Subra. Right.
Mr. Babin [continuing]. Other areas? OK. Did you hear my
last question? Would you like to elaborate on it as well?
Ms. Subra. Could you repeat your question?
Mr. Babin. Yes, OK. The importance of setting safe
threshold values for anything----
Ms. Subra. Right.
Mr. Babin [continuing]. But we're talking about
formaldehyde here, if you would elaborate on that as well
because I know that you've had a lot of experience with this.
Ms. Subra. Right. So based on the citizens' complaints we
did air sampling and found that formaldehyde was the chemical
present in the largest quantity in the ambient air around the
facility where these people live, and then being able to
coordinate that back to the resins that were used by the
facility, that was the source of those emissions. And then we
worked with the facility to get those resins replaced, and as a
result, the formaldehyde in the air was non-detect once they
changed the resin they were using. So the health impacts to the
community improved tremendously based on removing that source
of pollution.
Mr. Babin. OK. Thank you. And I yield back, Madam Chair.
Thank you very much.
Chairwoman Sherrill. Well, thank you. And now the Chair
recognizes Chairwoman Fletcher for 5 minutes.
Mrs. Fletcher. Thank you, Madam Chair.
The EPA program--program and regional offices routinely
utilize IRIS assessments to meet the agency's mission.
Similarly, as I mentioned earlier, State regulatory agencies
are also highly dependent on IRIS values. I have with me a
letter from the Colorado Department of Public Health and
Environment (CDPHE), and I would like to add it to the record.
So I'll ask that the letter be added to the record.
Chairwoman Sherrill. Without objection.
Mrs. Fletcher. And this letter from the CDPHE unequivocally
states that they utilize IRIS toxicity values daily to protect
Coloradans' health. Additionally, nongovernmental stakeholders
utilize IRIS assessments to better educate and protect impacted
communities.
Ms. Subra, and your testimony describe how you utilize IRIS
assessments in your work. How regularly do you reference the
IRIS assessment values? Yes.
Ms. Subra. Depending on what facility and community I'm
working with and what all the chemicals are that are being
released by that facility, if there are some that I want
additional information on, I'll quickly check the IRIS database
and see if it's available. So it may be once a week, it may be
once a month, it may be once every 2 months, depending on what
new issues I'm working on. But on issues I'm working on a
regular basis I check it to see if anything new has been added
to that website to enable the citizens to better understand
what's going on.
Mrs. Fletcher. And what is it specifically about the IRIS
assessments that makes them a valuable resource to you as
compared to other toxicity values?
Ms. Subra. So early in the--my career you'd have to have
access to TOXNET and things like that, and only medical schools
had access and they didn't share that access, whereas when you
look at IRIS, they have all the literature available, and you
can then, if you are interested in any particular one, get
access to it. So it pulls together all of the available
information and journal articles in one place. I don't have to
go to three, four, five, or six places. And they've done the
compiling for me so I can quickly have access to that, and it
saves time as I'm trying to work and educate and empower the
communities.
Mrs. Fletcher. And on a related note in connection with
your work, what impacts to your work do you anticipate if the
IRIS Program is stifled in its ability to be able to produce
timely and comprehensive assessments?
Ms. Subra. So I only respond to communities that request
assistance, and then I look to see what those chemicals are.
One of the things we found is when IRIS does the assessment and
does come out with it, then it takes a long time to get it
implemented and get the results of their assessment to reduce
the exposure going on in the communities by working with the
industrial facilities that are sources of that emission.
Mrs. Fletcher. And how will impacted communities be
affected by a delayed IRIS process?
Ms. Subra. They are affected because of primarily the air
emissions. In a lot of other cases it's water, groundwater, and
solid waste. But when they're affected by the air, then we need
a handle to be able to say this is what's going on in the
ambient air in the community around this facility or these
facilities, and then, because of the IRIS information, then we
can determine whether or not it's harmful to the community and
what impacts it has on their health and then work with both the
industry, the local, the State, and the national,
environmental, and health agencies to get those emissions in
the ambient air reduced and thus reduce their exposure.
Mrs. Fletcher. Thank you. And I just have a limited amount
of time left, so I'll put this question out to everyone on the
panel, all the witnesses. Do you believe or why do you believe
the value of IRIS assessments for external stakeholders has
improved and increased over time? If anybody wants to take that
question.
Dr. Goldstein. Lots of hard work and lots of oversight and
insistence that that information be available.
Dr. Rusyn. And I think as well the level of scrutiny that
this program has and the level of scrutiny that each draft
assessment undergoes really provides the best available science
for that particular protective value in the cancer hazard
classification.
Mrs. Fletcher. Thank you. And I see I've gone over my time,
so, Chairwoman Sherrill, I will yield back.
Chairwoman Sherrill. Thank you. The Chair now recognizes
Ranking Member Marshall.
Mr. Marshall. Thank you so much, Chairwoman. I'll start
with Dr. Goodman.
I'm trying to understand linear assessments. When, as a
physician, we give a patient medicine, we start off with the
lowest dose possible, and then usually you'll hit a certain
dose to finally get the response you're wanting. And I never
see a linear progression to the side effects. It looks like we
just steadily go up and then suddenly, there's a number that
causes side effects. And I would think, you know, trying to
apply toxicology might be the same in reverse. So do you
typically use some type of linear analysis or is there
typically drop-off points?
Dr. Goodman. So right now, cancer is evaluated differently
than noncancer effects, so for noncancer health effects, it's
exactly as you say. When assessments are done, it's assumed
that a minimum exposure is necessary to see any type of toxic
effects, and below that exposure, those effects won't occur.
Now, it's actually--it's based on a regulatory context, not
based on biology, this idea that if there's something that can
cause cancer, one molecule of that something can cause cancer.
And so they do this process called linear low-dose
extrapolation meaning obviously you can't do a scientific study
of one molecule, so you take the higher doses and basically
plot out on a curve what the association is between the dose of
the chemical or exposure of the chemical and cancer risk, and
then you extrapolate from that lowest dose down to zero,
essentially assuming that there's risk down to zero. But if--
biologically that's not necessarily the case, particularly for
certain carcinogens that have certain mechanisms. And in that
case you should do exactly as you said. You should find the
exposure level--the minimum exposure level where you can
increase cancer risks, and then below that there's no evidence
for an increased cancer risk.
Mr. Marshall. How do you take the IRIS assessment cancer
classifications and then apply them to actual human health
risk? How do companies do that? The IRIS assessment cancer
classifications and then I'm trying to relate that from taking
that data to human risk.
Dr. Goodman. Well, I think the idea--I mean, if you're
talking about cancer, so a cancer slope factor, a number is
calculated, that's an estimate of what--you know, what cancer
risk is associated with specific exposures. But, as I said,
there's this extrapolation down to low exposure levels because
that can't be studied and so, by design, it is overestimating
cancer risk.
Mr. Marshall. Do private companies feel like IRIS has been
transparent?
Dr. Goodman. I don't know that I can speak for private
companies, so I don't know that I should answer that. I think
in some cases I would say I've heard----
Mr. Marshall. Does industry feel like IRIS has been
transparent?
Dr. Goodman. Again, I don't know that I should speak for
the industry, but I think there are some cases where the
scientific judgments have not been clear in IRIS assessments.
Mr. Marshall. OK. If you were in charge of IRIS, what
solutions would make it better? What are your thoughts to
improve IRIS?
Dr. Goodman. First priority is complete that handbook
because then we have a standard operating procedure so that all
assessments are done in the same manner. Also make sure that
all protocols and then actually the executed assessments are
completely transparent so it's absolutely clear when decisions
were made and the basis for those decisions.
Mr. Marshall. Why has it taken so long to do it? Any idea?
I'm kind of new to the game here. What have they told you why
they haven't gotten it done before?
Dr. Goodman. I don't think I'm the right person to answer
that.
Mr. Marshall. OK. All right. Think here for a second. Mr.
Goldstein, what do you think--I mean, certainly, there's been a
handbook that they'd used for decades I would assume. They have
to have one. You could not supervise a lab without a handbook.
What's taken so long to get this to Congress and to all of us?
Dr. Goldstein. Sir, may I first answer the question you
asked before? I'm a physician, and you used the issue of
toxicity.
Mr. Marshall. I guess I'd really--I got 38 seconds left, so
I'd rather you answer this question.
Dr. Goldstein. OK. I'll be--may I send that to you?
Mr. Marshall. Sure.
Dr. Goldstein. The answer to this question is simple, I
just don't know. I'm not active at EPA right now. I do know
that doing something like a handbook, unless Congress requires
me to do it, in which case it becomes highest priority, is
really not that easy on a moving subject like this. And as new
science is brought in, as you heard about systems approaches,
boy, by the time you get this finished----
Mr. Marshall. I would say the first 20 steps are the same,
though. The first 20 steps should be the same no matter which
substance we're looking at, and I just can't believe it's been
8 or 10 years.
Thank you, and I yield back.
Chairwoman Sherrill. Thank you.
The Chair now recognizes Mr. Tonko for 5 minutes.
Mr. Tonko. Thank you, Chairwoman Sherrill. And welcome to
the panel. I firmly believe that we must ensure that
inappropriate political interference in the scientific process
does not get in the way of protecting our national security and
public health. And, Dr. Goldstein, I know that you had an
earlier exchange with my colleague, Representative Bonamici,
and I wanted to delve a little further. But before I do that,
why don't you express what you wanted to express if you could
do that in a matter of seconds.
Dr. Goldstein. OK. It's a very good question asked by Dr.
Marshall. It had to do with toxicity. You see the toxicity very
quickly, though, so if you're going to change the dose of a
drug and see toxicity, that's an immediate response. Cancer is
20, 30 years later. You won't see it as a physician. So it's
not really pertinent to the way they do risk assessment,
although it's a very good question.
Mr. Tonko. OK. Thank you. And now back to political
influence. In your testimony you touch upon how the current
political manipulations in the IRIS Program reflect the general
dysfunction at the EPA over the past 2 years, particularly with
the CASAC (Clean Air Scientific Advisory Committee) particulate
matter review. You go so far as to state that, and I quote,
``There is no question that today we are at the lowest point
ever since the formation of the EPA,'' close quote. This is
alarming to hear from someone who has been a close observer of
the agency for decades, particularly since you came to work at
the EPA following the infamously dysfunctional and frequently
hostile tenure of former Administrator Anne Gorsuch. How does
this Administration follow the pattern of behavior exhibited by
that Gorsuch EPA, and what makes this the lowest point in the
agency's history?
Dr. Goldstein. That's an easy question to answer. You
mentioned the Clean Air Scientific Advisory Committee. Before
becoming Assistant Administrator, I chaired that under Anne
Gorsuch. Anne Gorsuch did not interfere with the actions of the
Clean Air Scientific Advisory Committee. Administrator Wheeler
is.
Mr. Tonko. Well, what do you believe is the goal of these
attempts to undermine science at the EPA wherever possible?
Dr. Goldstein. Policymakers like to get the science they
want rather than the science that exists. I mean, it's built
into the tension of how we develop our regulations and how we
protect the public.
Mr. Tonko. So sheer manipulation. Dr. Goldstein, in your
testimony you mentioned that when you found evidence that
benzene is leukemogenic using funding from the American
Petroleum Institute, your funding was cutoff. While you say you
maintain respect for the scientific aptitude of industry, I
must say this is troubling to hear. When you were working for
industry, was there an understanding that your funding was
dependent upon a particular outcome?
Dr. Goldstein. They never said that they cut it off because
of the outcome. They were short of money that year was the
reason they gave. I think we all understood what the answer
really was. But, no, the issue of working with industry I think
it's really important. I think good scientists in academia
should work with industry, but it must be done in a way that's
very careful and must be understood exactly what industry
wants.
On the formaldehyde issue, I was asked to consult with
industry right after the IARC (International Agency for
Research on Cancer) meeting in 2010 said that it was a known
leukemogen, and I told them they had to repeat the key study.
They have yet to repeat it. Instead, they fund consultants to
nitpick the study.
Mr. Tonko. OK. Thank you. And given your experience, what
is your impression of the insistence by the American Chemistry
Council that the studies it funds exonerating formaldehyde are
sufficient to upend or at least call into serious question the
current weight of evidence regarding formaldehyde
carcinogenicity--whatever--carcinogens----
Dr. Goldstein. Cancer causation, sir.
Mr. Tonko. Yes.
Dr. Goldstein. These studies just indicate why this
transparency idea is simply a ruse to be able to get raw data,
not to be able to repeat the study but to be able to nitpick
the study. Consultants get paid for nitpicking studies,
changing blemishes into scars so that we will think there's a
real problem. One of the studies is one that I responded to in
print showing that their own data if anything proved the--
proved is too strong, but certainly strengthened the initial
study, not discredited it.
Mr. Tonko. Thank you very much. I just want to make a
statement that scientific integrity is about, in my opinion,
ensuring a process and atmosphere in which the science leads us
to the results. Public science informs national policy on
everything from pesticides to power grids. Our Nation's cities
and States need credible information to prepare for climate
change, and our families deserve to know if unsafe chemicals
are being sprayed on their food, dumped into their water
supplies, or added into the products they buy.
The efforts to silence science, distort, and bury or delay
the release of valuable science at EPA--and they serve as a
reminder of the urgency of passing the Scientific Integrity
Act, which I've introduced, to codify the requirement that all
agencies have strong scientific integrity policies that ensure
that science leads the way no matter the Administration.
Anything short of that is simply unacceptable.
And with that, Madam Chair, I will yield back.
Chairwoman Sherrill. Thank you so much.
I'd now like to recognize Mr. Cohen for 5 minutes.
Mr. Cohen. Thank you, Madam Chair, and Merritt's mother.
Dr. Goldstein, I am obviously not a toxicologist, not
obviously but I'm not. But Mr. Marshall asked some questions
earlier about ethylene oxide. He expressed concern that IRIS
risk values for inhalation of ethylene oxide are 19,000 times
lower than what the human body naturally produces. Do I have to
go further? I see your kind of--you're ready to respond. Isn't
it true that the human body produces and expels a lot of
substances that it would be dangerous to consume or inhale? And
is the presence of a chemical in some concentration--in the
digestive system, for example--going to mean the same level of
risk as if that chemical is found in your lungs? So can you
tell us about comparing these different levels and various--
also the chemicals if they're in the soil versus the air versus
the water we drink, et cetera, et cetera?
Dr. Goldstein. Thank you for the question. The--what's
fascinating to me is that industry has welcomed some recent
research, which I think is pretty good research, that shows
that about one-third of the--in my estimation, about one-third
of all cancer is due to bad luck. Well, what--yes, I mean, it's
going to happen whether we were exposed to anything or changed
our environment. That's not true for all cancers, certainly
lung cancer, others. But if you start with that as something
that industry believes, well, that means it's something
internal to our body. Well, if our body makes formaldehyde and
ethylene oxide, those are likely causes of this if you live
long enough you're going to get mutations to yourself that will
cause cancer, which is what bad luck really is about.
If you believe that, then clearly ethylene oxide can cause
cancer and basically would be responsible for some bad luck.
And if you think of it from the point of view of numbers, about
25 percent of us will get cancer. If one-third is due to bad
luck, that's about 8 percent of us. If we're talking about
Congress telling us we have to regulate it, say, 1 in 100,000
risk, well, 1 in 100,000, 8 percent of that is, what, 8,000 in
100,000 is due to this bad luck. If you're telling us to
regulate 1 in 1,000, a little bit more of ethylene oxide from
the outside, a little bit more formaldehyde from the outside
could easily produce that 1 in 8,000 that I just talked about,
and that's the level that IRIS is supposed to be informing
people about.
So it--to me it doesn't--I just don't understand why
ethylene oxide being an internal causation should make any
difference to the IRIS approach.
Mr. Cohen. Now you've got me totally confused.
Dr. Goldstein. Sorry.
Mr. Cohen. I took an aspirin religiously, taking it from
right to left of course, for years, and then I read recently
that for people that are--have the ability to remember Bill
Mazeroski that this was a bad thing to do, that it was going to
be hazardous to my health. Now you're telling me that cancer is
caused by water. So is it--what----
Dr. Goldstein. I didn't say that.
Mr. Cohen. Well, I'm just thinking, is it kidney stones or
is it cancer? Do I have to make a choice?
Dr. Goldstein. No, please don't make that choice. But there
is--I mean, none of us lives forever, and, as I said, there is
reasonably good evidence that mutations occur spontaneously in
the body for causes we don't understand but could well be
ethylene oxide or formaldehyde or other carcinogens we make
within our body, and that these represent--as I say, it's only
one-third of cancer, so two-thirds are out there ready to be
prevented. But if it's one-third, that's still, in relationship
to the 1 in 100,000 risk, which isn't IRIS' choice. That's, if
you will, your choice. That's the level of protection that the
country wants. It's a very big number.
Mr. Cohen. Let me ask you this. You worked at the EPA when
President Reagan was in office, is that correct?
Dr. Goldstein. Correct.
Mr. Cohen. And Reagan was kind of known as a conservative
and a guy that was pro-business. How would you compare
Ruckelshaus and other EPA Administrators to Scott Pruitt?
Dr. Goldstein. There's no comparison. I mean, it's--you're
talking about a completely different approach. The respect for
getting the science right from Bill Ruckelshaus, Lee Thomas,
the two Administrators I worked under, was very strong. And, as
I say, Anne Gorsuch did not interfere with the Clean Air
Scientific Advisory Committee. I chaired it.
Mr. Cohen. And then the Reagan Administration didn't try to
interfere with EPA from giving information to the public to
protect them as this Administration is?
Dr. Goldstein. That's not--that wasn't my level of
approach, so I can't really comment on that, but I do--on the
other things, I certainly do feel there's a difference.
Mr. Cohen. Thank you. And I yield back.
Chairwoman Sherrill. Thank you very much.
I now yield 5 minutes to Ms. Wexton.
Ms. Wexton. Thank you, Madam Chair, and thank you to the
witnesses for coming to testify before us this morning.
Dr. Goodman, what kinds of organizations fund Gradient's
research? Is it nonprofit organizations, trade organizations,
corporations? What kind of groups fund your research?
Dr. Goodman. We--it really runs the gamut from private to
public and government and nonprofit and for-profit and trade
groups.
Ms. Wexton. OK. And some of the groups that you've done
work for include the National Marine Manufacturers Association?
Do remember doing some work for them?
Dr. Goodman. I believe so, yes.
Ms. Wexton. The Styrene Information and Resource Center?
Dr. Goodman. Yes.
Ms. Wexton. The Formaldehyde Council?
Dr. Goodman. It--I don't remember, but it's possible.
Ms. Wexton. OK. BPA Global Group?
Dr. Goodman. Yes.
Ms. Wexton. The American Petroleum Institute?
Dr. Goodman. Yes.
Ms. Wexton. ExxonMobil?
Dr. Goodman. Yes.
Ms. Wexton. The American Chemistry Council?
Dr. Goodman. Yes.
Ms. Wexton. OK. So are you--have you heard of this--the
analysis by the Center for Public Integrity of 149 Gradient-
produced scientific articles and letters that found that 98
percent of the time the research that was conducted by
scientists at your company concludes that the chemical in
question is harmless at levels to which people are typically
exposed? Are you aware of that study?
Dr. Goodman. I'm familiar with that article. I haven't
looked at that statistic in a while, but if I remember
correctly, it was quite misleading, and I'm happy to go back
and look at it and provide you with something more----
Ms. Wexton. So you don't agree that it was 98 percent?
Dr. Goodman. No, I do not.
Ms. Wexton. OK. So can you then give me an example of a
time during your research at Gradient that you came to conclude
that the exposure for--the exposure threshold for a particular
chemical should actually be lower than an existing standard
would suggest?
Dr. Goodman. I don't know--I can't think of--not everything
I do has to do with standards and whether the standard should
be lower or higher, but I'm certainly--you know, the first
thing that comes to mind was when I was doing an evaluation of
a chemical in a toy and basically coming to the conclusion that
there was a possible toxic effect for children playing with the
toy, so that's just the one off the top of my head.
Ms. Wexton. So was that a specific level that you came to
conclude was--should be lower than what it was at the time?
Dr. Goodman. Well, basically that the chemical shouldn't be
in the toy at all because there was a not at risk.
Ms. Wexton. OK. And in your research at Gradient, can you
give me an example of a time that you came to a conclusion that
a chemical you were hired to study is carcinogenic at typical
exposure levels?
Dr. Goodman. Again, I don't know--I--the types of things we
do range from hazard assessment to risk assessment, so it's not
always about, you know, common uses and what people are
typically exposed to, but I'm actually--you know, this isn't
cancer, but I--I'm thinking now I actually have in the
published literature and actually some of this work was funded
by the American Petroleum Institute, as you mentioned, and some
by actually the Texas Commission on Environmental Quality,
which is a government agency, where we looked at air pollutants
and risks of asthma and some other respiratory effects, and we
did find that there was an increased risk for certain effects.
So--and again, I'm happy to give you a list of that if you----
Ms. Wexton. And was that research that you specifically
participated in at Gradient or just peer-reviewed articles and
scholarly journals that you have read?
Dr. Goodman. It was research we--I'm not exactly sure what
the question is. It was some--we've done some original research
where we actually look at air pollution data and health
outcomes, and then we done systematic reviews like we're
talking about here today where we looked at all the published
studies and said what it came to together. And all of that work
has been published in the peer-reviewed literature.
Ms. Wexton. And have you ever worked on a study for
Gradient where the client proposed their own conclusion, that
is, what they were hoping that the data would show?
Dr. Goodman. I--not that I can think of, but in the end, it
doesn't matter. I mean, that's--we get hired to do independent
scientific analyses and conduct them with rigor and
transparency and adhere to the highest scientific principles.
Ms. Wexton. And, Dr. Goldstein, in your testimony you
indicated that you have some extensive knowledge or experience
working with industry. And based on your knowledge of industry-
supported science, how frequently are results found that
contradict the business interests of the company or trade group
that's funding the research?
Chairwoman Sherrill. And if you could answer quickly. The
gentlewoman's time----
Dr. Goldstein. I will say not that unusually internally. I
mean, that's the role of internal scientists and industry is to
keep them out of trouble by having them not do the wrong thing,
so that's not uncommon. How much gets public is----
Ms. Wexton. Is another story, right. Thank you very much. I
yield back.
Chairwoman Sherrill. Thank you. And now, I believe the
Ranking Member, Mr. Norman, has a question he would like to
add, so I yield 1 minute to him.
Mr. Norman. Thank you, Chairwoman Sherrill.
Just to kind of follow up with this conversation we've been
having, I mean, Dr. Goodman, you're independent, and I think
Dr. Goldstein was mentioning as independent contractors if you
will you may cherry-pick different things to have a desired
outcome. Of all the companies you've had, have you had anybody
put pressure on you to come up with an outcome that may or may
not be what they wanted?
Dr. Goodman. The answer to that is no. Again, I get hired
to do independent analyses. But I think this whole idea of
systematic review and transparency, that's kind of the whole
point. That is the work I do. I use a protocol, we do it
systematically, and everything is transparent, so the idea is
anyone can see the methods we use, the judgments that were
made.
Mr. Norman. And I'm in the private arena, and we hire a lot
of consultants. For liability reasons alone, it would not make
sense for us to put any pressure on any business. We want to be
protected--as I think Dr. Goldstein mentioned, we want to be
protected, and the easiest way to have--invite a lawsuit is to
try to have a desired outcome, which is not the end result. The
media portrays that, but it's--in real life, in the real world
that's not how it works.
Thank you so much. I yield back.
Chairwoman Sherrill. Thank you to the Ranking Member.
Before we bring this hearing to a close, I want to thank
our witnesses for testifying before the Committee today. The
record will remain open for 2 weeks for additional statements
from the Members and for any additional questions the Committee
may ask of the witnesses.
The witnesses are excused, and the hearing is now
adjourned. Thank you.
[Whereupon, at 12:55 p.m., the Subcommittees were
adjourned.]
Appendix I
----------
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Appendix II
----------
Additional Material for the Record
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
[all]