Mr. Chair, I yield myself such time as I may consume. Mr. Chair, this bill does not permit me to mince words. This bill is an insidious attack on EPA's ability to use the best science to protect…
Mr. Chair, I yield myself such time as I may consume.
Mr. Chair, this bill does not permit me to mince words. This bill is an insidious attack on EPA's ability to use the best science to protect public health, and its consideration on the House floor today is the culmination of one of the most anti-science and anti-health campaigns I have witnessed in my 22 years as a Member of Congress.
The genesis of this legislation is the Republicans' longstanding obsession with two seminal scientific studies conducted by Harvard University and the American Cancer Society.
These studies link air pollution with increased illnesses and death; moreover, those results were confirmed by multiple independent researchers and organizations including the National Research Council and the Health Effects Institute.
The Republican majority has harassed EPA for more than 2 years in an attempt to get access to the raw data used in those studies, presumably in an attempt to cast doubt on the conclusion that air pollution is bad for the health of Americans and to prevent EPA from trying to keep the air we breath clean.
The EPA told my Republican colleagues that since the studies involved the personal health information of
hundreds of thousands of volunteers, the raw data was stringently protected from public disclosure; therefore, even if they were the legal custodian of this data, they could not lawfully hand over such sensitive information.
Instead, in compliance with the law, EPA provided the Science Committee with all of the ``de-identified'' data within its possession, which ran to hundreds of pages of data rolled in like a grocery cart. This was not enough for my colleagues, and so they have decided to pursue this pernicious piece of legislation.
Rather than explain the problems with this legislation myself, I will simply quote from a letter we received from the American Lung Association and the American Thoracic Society, two leading and trusted public health organizations. They state:
The legislation will compel the U.S. Environmental
Protection Agency to either ignore the best science by
prohibiting the Agency from considering peer-reviewed
research that is based on confidential patient information or
force EPA to publicly release confidential patient
information, which would violate Federal law.
This is an untenable outcome that would completely
undermine the ability of the EPA to perform its
responsibilities under the Clean Air Act and myriad other
Federal laws. The legislation will not improve EPA's actions;
rather, it will stifle public health protections.
My colleagues on the other side of the aisle will wrongly claim that this legislation is consistent with the requirements of major scientific journals, the White House's policy to promote public access to federally-funded research, and recommendations from independent groups like the Administrative Conference of the United States. This is simply not true.
All of those entities recognize the balance between making data public and protecting confidentiality and personal privacy. They do not paint scientists or the EPA into a corner and tell them that the only way their research can be used or considered is if all of that data is available in a form--let me quote from the bill--``that is sufficient for independent analysis and substantial reproduction.''
That phrase is critical to understanding the implications of H.R. 4012. According to a letter from the American Cancer Society to EPA, they ``are not aware of any way to create a de-identified version of the Cancer Prevention Study II data set sufficient to protect confidentiality of the participants while at the same time allowing a true replica of the studies.''
Because legitimate researchers like the American Cancer Society must publish their peer-reviewed results in a de-identified form, if this bill becomes law, the EPA will not be able to rely on those important studies to protect public health and the environment.
I would like to quote Dr. Ellen Silbergeld from Johns Hopkins University, a witness at a hearing the Science Committee held on this bill. She states:
If the EPA is unable to access the peer-reviewed literature
because raw data are not available as proposed in the
``Secret Science'' bill, then we move to the dysfunctional
situation where the EPA will be unable to sustain its
decisions because these will be based on inadequate or
incomplete science.
This is not a position that I can support. Let me be clear: this bill is an attempt to constrain the EPA under the guise of promoting transparency.
A diverse set of voices from the scientific, public health, legal, and environmental communities agree with me and have criticized this legislation. I have received letters from more than 50 organizations expressing their concern with H.R. 4012, including the American Lung Association, the American Thoracic Society, the American Association for the Advancement of Science, the Union of Concerned Scientists, the Association of Public and Land-grant Universities, the Association of American Universities, the Natural Resources Defense Council, and the Environmental Defense Fund.
Whatever views my fellow Members may have about specific EPA rules and regulations, I would hope that they will see this bill for what it is, a malicious assault on EPA's ability to protect public health. Limiting or prohibiting what science EPA uses as part of its rulemaking would be a consequence of this bill. The American people deserve better.
I strongly urge my colleagues to oppose this legislation, and I reserve the balance of my time.
Mr. Chairman, I yield 4 minutes to the gentleman from California (Mr. Waxman), the ranking member of the Energy and Commerce Committee.
I yield an additional minute to the gentleman.
Mr. Chairman, I yield 2 minutes to the gentlewoman from California (Ms. Lofgren), the second most senior member of the full committee on the Democratic side.
Mr. Chairman, before I yield to my next speaker, I would like to enter in the Record a series of letters from outside groups opposed to this legislation, including the American Lung Association, the American Association for the Advancement of Science, League of Conservation Voters, and many others.
In addition, I would also like to place a Statement of Administration Policy threatening a veto of this bill into the Record.
American Lung Association,
American Thoracic Society,
November 17, 2014.
House of Representatives,
Washington, DC.
Dear Representative: We are writing to express our
opposition to H.R. 4012 the Secret Science Reform Act of
2014. The American Lung Association is the oldest voluntary
health organization in the United States. The Lung
Association mission is to save lives by improving lung health
and preventing lung disease. We achieve our mission through
research, advocacy and education. The American Thoracic
Society is a medical professional society dedicated to the
prevention, detection, treatment and cure of pulmonary
disease, critical care illness and sleep disordered breathing
through research, education and advocacy.
Science is the bedrock of sound regulatory decision making.
The best science underscores everything our organizations do
to improve health. We strongly believe in a transparent and
open regulatory process. A vital element of research is
patient confidentiality. Physicians and researchers have
earned by trust of their patients by steadfastly maintaining
patient confidentiality. Patient confidentiality is a clear
legal obligation and a sacred vow.
The legislation before the Congress will compel the U.S.
Environmental Protection Agency to either ignore the best
science by prohibiting the agency from considering peer-
reviewed research that is based on confidential patient
information or force EPA to publicly release confidential
patient information, which would violate federal law. This is
an untenable outcome that would completely undermine ability
the U.S. Environmental Protection Agency to perform its
responsibilities under the Clean Air Act and myriad other
federal laws. The legislation will not improve EPA's actions,
rather it will stifle public health protections.
We note that the kind of information disclosure envisioned
in this legislation exceeds that required by peer reviewed
journals. We believe much of the intent of this legislation
is already achieved through the current peer review process
required by all academic journals. The vast majority of peer
reviewed journals require manuscript authors to register any
trial using human subjects with clinicaltrials.gov. This
public registry collects key information on the study
population, research goals and methods that allow outside
reviewers and scientists to either challenge or attempt to
reproduce study results. Additionally, the peer review
process and publication of results invites the broader
scientific community to debate study findings. Trial registry
and manuscript publications are only part of the process by
which scientific endeavors operate in a transparent
environment.
Private organizations, public charities, research
universities, the National Institutes of Health, the Centers
for Disease Control and Prevention, the Centers for Medicare
and Medicaid Services, the Department of Veterans Affairs,
corporations and many other entities conduct medical
research. Many of these organizations compile large
longitudinal data sets that track patients of a period of
time. These data serve as the basis of many studies that
permit epidemiologists to track disease and risk factor
information for large patient populations.
The published peer-reviewed information from such data
often may inform regulatory decision making at the EPA and
other federal agencies and inform future research. Not only
do these data inform regulatory action, they help inform
efforts to educate the public about the magnitude of a
disease, risk factors and steps individuals can take to
improve their health. In order for EPA to set the most
appropriate standards it must be informed by the best
information.
Understanding the impact of air pollution on human health
and the magnitude of harm caused by pollution at specific
levels helps the agency meet its obligations under the Clean
Air Act. Absent these data, it is unclear upon what basis the
agency could make sound decisions.
We urge the House of Representatives to reject H.R. 4012.
Sincerely,
Harold Wimmer,
National President & CEO, American Lung Association.
Stephen C. Crane, PhD, MPH,
Executive Director, American Thoracic Society.
Mr. Chairman, I yield 2 minutes to the gentlewoman from Massachusetts (Ms. Clark).
Mr. Chairman, I yield 2 minutes to the gentleman from New Jersey (Mr. Holt), the one scientist we have with a Ph.D. in physics in our body who is retiring and, as of next year, will become the CEO of AAAS.
Mr. Chairman, I yield the gentleman 1 additional minute.
Mr. Chairman, I yield 3 minutes to the gentlewoman from Oregon (Ms. Bonamici), who is ranking member on the Environmental Subcommittee.
Mr. Chairman, I reserve the balance of my time.
Mr. Chairman, I yield back the balance of my time.
Mr. Chair, I submit the following letters.
American Statistical Association,
Alexandria, VA, September 5, 2014.
Hon. Kevin McCarthy,
Majority Leader, House of Representatives, Washington, DC.
Dear Majority Leader McCarthy, As president-elect of the
American Statistical Association, with 19,000 members, I
write regarding H.R. 4012, the ``Secret Science Reform Act.''
We generally applaud the idea that researchers and federal
agencies strive to make data available to others--under
strict pledges to maintain confidentiality of data provided
by individuals and establishments where necessary--and to
encourage reproducible research. Access to data and
reproducibility of research are crucially important for
science to advance.
While H.R. 4012's intent is to make data more widely
available, we have several concerns and urge the bill to be
revised significantly before further consideration. Our
concerns include those voiced by others (especially the
American Association for the Advancement of Science) that the
bill's statements do not account for the complexities common
to the scientific process on research that involves
biological materials or physical specimens not easily
accessible, combinations of public and private data,
longitudinal data collected over many years that are
difficult to reproduce, and data from one-time events that
cannot be replicated. The bill as written could have far-
reaching consequences that would ultimately hamper or
undermine the scientific process generally and EPA's work
specifically. We also agree with the point that it would be
prudent to see the EPA's data access policy--in accordance
with the America COMPETES Reauthorization Act of 2010--
expected by year's end before further action on H.R. 4012.
Our nation should be striving for transparency in
government and, as noted above, data accessibility, but these
goals also must be balanced with the necessity to protect
individuals' and businesses' privacy. The bill's language of
``publicly available'' except when ``prohibited by law''
acknowledges this balance, but that language is vague and may
be insufficient to protect individuals and businesses. In
particular, some data sets may not fall under ``prohibited by
law,'' yet the data are still collected under a pledge to
protect the identifiability and confidentiality of the
reported values. For example, the government, as well as
private and nonprofit sectors, routinely collects data--
including private business information and private health
information--under strict pledges to protect confidentiality.
In some studies, this is backed up with penalties for
violating those pledges. Such data should not be publicly
available to every person who might ask for them. Rather,
data subjects' confidentiality should be protected, for
example by policies and procedures that provide data access
to trusted users (i.e., approved users committed to
appropriate protections of the confidentiality of study
participants) while discouraging breaches of confidentiality
and/or by data redaction techniques developed in the
statistical and computer science communities. Under the
current wording, a choice may have to be made between
maintaining data confidentiality and issuing needed
regulations.
To emphasize the challenges and importance of
confidentiality protection, we note that simple but necessary
de-identification methods--like stripping names and other
personally identifiable information (PII)--often do not
suffice to protect confidentiality. Statisticians and
computer scientists have repeatedly shown it can be possible
to link individuals to publicly available sources, even with
PII removed. Thus, allowing unrestricted public access
without appropriate controls could result in unintended
disclosures. These could cause significant harm to the
advancement of science and the federal government--especially
the federal statistical system--as people may be less willing
to provide their data if highly publicized breaches occur.
In short, any requirements for making data available should
carefully consider the complexities, challenges, and
potential ramifications. We hope you will address these
concerns, which would require major modifications to the
bill. We would be happy to be of any assistance.
Sincerely,
David Morganstein,
President-Elect,
American Statistical Association.
Mr. Chairman, I rise in opposition to the amendment.
Mr. Chairman, I appreciate Mr. Gosar's amendment. At least it clarifies the underlying intent of this bill in that this information relied on by the EPA should be thrown up on the Web site.
The peer-reviewed science relied on by the EPA often involves personal health information and other confidential data that is legally protected from disclosure. No legitimate researcher would violate the law and leak confidential information--for example, to make a trade secret or information protected by HIPAA accessible to anyone who has an Internet connection.
This amendment only makes the underlying problems with the bill that much more obvious, and I urge my colleagues to oppose this amendment.
Mr. Chairman, I yield the remainder of my time to the gentleman from Illinois (Mr. Foster).
I yield back the balance of my time.
Mr. Speaker, I have a motion to recommit at the desk.
I am in its present form.
Mr. Speaker, let me begin by saying that this is the final amendment to the bill, which will not kill the bill or send it back to the committee. If adopted, the bill will immediately proceed to final passage as amended.
I have already spoken at some length about the problems with the underlying bill. The bill would prevent the Environmental Protection Agency from using the best science in its mission to protect public health.
However, this motion to recommit highlights a specific and very troubling aspect of this bill. As written, the bill would prevent EPA from proposing, finalizing, or disseminating risk, exposure, or hazard assessments or guidance based on nonpublic information.
I and my Democratic colleagues are concerned about how this language would impede the EPA's ability to respond to emergencies and disasters.
I will give you an example. In my hometown of Dallas, we had a well- publicized case of a man named Thomas Duncan tragically dying after being infected with the Ebola virus. This gentleman was originally sent home from the Texas Health Presbyterian Hospital when his symptoms were not initially identified as Ebola.
After Ebola was identified, great efforts were made to disinfect areas the gentleman had contact with while he was infected with Ebola.
I have a picture displayed here.
Here in my hand is EPA's list of disinfectants for use against Ebola virus. The EPA disseminates this critically important information on its Web site.
However, under this bill, the EPA could be prevented from disseminating this type of information because EPA-registered disinfectants are frequently supported by legally protected information or confidential business information.
In my hometown, not my district, two nurses who work at the Texas Health Presbyterian Hospital contracted Ebola. As a former nurse who worked in Dallas, I think it would be appalling to put our frontline health care workers, as well as the general public, at risk of the deadly Ebola virus or any other infectious disease all so we can take a political shot at EPA.
As another example of how this bill could affect emergency response, EPA could be prevented from providing guidance during toxic chemical spills like the one that occurred earlier this year in West Virginia. If that guidance to local emergency responders were based on confidential business information, which is oftentimes the case when dealing with registered chemicals, then the EPA would be prohibited from disseminating vital information to the local authorities. What is remarkable is that the Natural Resources Defense Council warned the committee of this exact issue in a letter back in February, but the majority chose to ignore those warnings. That is plain irresponsible.
My amendment would fix this problem by exempting any response to an emergency that could harm the health and safety of a community. The amendment won't fix all of the problems with this bill, but it will prevent one of the more morally objectionable outcomes of this legislation.
I urge adoption of this amendment, and I yield back the balance of my time.
Mr. Speaker, I demand a recorded vote.