TESTIMONY OF THE SOCIETY OF TOXICOLOGY
ORAL PRESENTATION TO
THE HOUSE APPROPRIATIONS SUBCOMMITTEE ON
LABOR, HEALTH AND HUMAN SERVICES,
EDUCATION AND RELATED AGENCIES
U.S. HOUSE OF REPRESENTATIVES
March 14, 2000
Presented by
Dr. Jay I. Goodman
President, The Society of Toxicology
Good Morning. My name is Jay
Goodman. I am a Professor of Pharmacology and Toxicology at Michigan
State University and President of the Society of Toxicology, 1999-2000.
I am pleased to have this opportunity to present my opinions concerning
research in toxicological sciences and the views of the Society
of Toxicology in support of Fiscal Year 2001 funding for the National
Institutes of Health (NIH), and specifically for the National Institute
of Environmental Health Sciences (NIEHS).
The Society of Toxicology is a professional
organization that brings together over 5,000 toxicologists in academia,
industry, and government. The Society of Toxicology is dedicated
to supporting research in toxicological sciences that leads to sound
scientific information that can be employed to reduce uncertainties
in assessing risks to human health and the environment. Enhancing
science-based risk assessment benefits everyone through improved
decision-making that protects the health of people and their environment
while at the same time providing for a more rational use of our
limited financial resources, i.e., a win-win situation.
Funding
Request
First, on behalf of the
Society of Toxicology, I want to thank you Mr. Chairman and thank
your colleagues on this Subcommittee for demonstrating tremendous
leadership in the area of biomedical research by providing a 15%
increase to the National Institutes of Health (NIH) in both Fiscal
Years 1999 and 2000. Your commitment to the campaign to double the
budget for NIH by Fiscal Year 2003 provides great hope to Americans
afflicted with disease and disabling conditions and ensures that
we will continue to unlock the mystery of disease, including diseases
that may be attributable to causal agents in the environment.
Mr. Chairman,
the Society of Toxicology strongly supports you in this goal and
urges that you continue the NIHx2 campaign in Fiscal Year 2001.
We urge the Committee to support the recommendation of the Ad Hoc
Group for Biomedical Research Funding calling for a $2.7 billion,
or 15%, increase for NIH in FY 2001. We also urge the Committee
to support the professional judgement budget recommended by the
NIEHS calling for a 19% increase in Fiscal Year 2001, given its
important role in increasing our understanding of how the environment
potentially affects our health. Whether it is exploring asthma incidence
in children, testing for the toxic potential of chemicals, or better
understanding the genetics underlying environmental risk factors,
NIEHS supported research is leading the way in bridging the gap
between public policy and environmental health science.
Research
Opportunities
Basic research focused on discerning
the mechanism or mode of action of a particular agent of interest
is of fundamental importance to society. It provides the basis on
which we make reasonable estimates as to whether or not harm might
occur to people or the environment under realistic conditions of
exposure. Furthermore, as we explore mechanisms by which chemical
and physical agents may produce toxicity we learn more about basic
biology; thus, toxicology is one of the basic biomedical sciences.
The quality of life in our
Country has improved markedly over the past century. For example,
life span was approximately 45 in 1900 and today it is 75+ years.
Indeed, much of the good life that many of us enjoy is attributable
directly to the proper use of chemicals, including medicines, to
benefit people. Research in toxicology, including the use of animals,
has and continues to play a key role by defining the conditions
of use under which we may employ chemicals for good causes that
benefit society. Yes, there have been some problems/mistakes made;
however, importantly, we are striving to improve and research focused
upon the key aspects of risk assessment (outlined below) will permit
us to continue to make progress.
The scientific
basis of risk assessment can be enhanced by the development of improved
test systems and improved means for interpretation of results. Key
aspects of any risk assessment include an emphasis on: (1) selection
of doses used for testing and extrapolation, e.g., there should
not be an emphasis on the use of excessive doses; (2) dose-response
relationships, including extrapolation from high to low doses, e.g.,
effects that occur at high doses do not necessarily occur at low
doses; (3) species-to-species extrapolation; and (4) exposure assessment,
e.g., we need to take into consideration the relationship between
doses used in testing as compared to the amounts that people might
actually encounter. It is important to define conditions under which
chemicals may be used, beneficially with a high degree
of safety, and to identify those situations when a chemical’s
use should either be restricted severely or it should be banned.
This entails hypothesis-driven research and it is consistent with
the notion that it is the dose which makes the poison. Members of
the Society of Toxicology believe strongly that our investment in
biomedical research must be increased and sustained over the long-term
if we are going to take advantage of the many exciting research
opportunities that exist in environmental health sciences. We support
the research agenda and priorities identified by NIEHS Director
Dr. Kenneth Olden. These can further the development of the science
that is necessary to provide a basis for sound decisions leading
to both improved protection of human health and the environment.
NIEHS research on the Environmental
Genome Project will help us to better understand why some people
might be more susceptible to environmental exposures leading to
disease development than others. This area of risk assessment is
one which we know the least about. In this context, it is important
to understand that exposure assessment, as noted above, is a key
aspect of risk assessment. In order to be credible, a risk assessment
must be based upon realistic data concerning exposure. The Society
of Toxicology commends NIEHS for its planned interagency collaboration
with the Centers For Disease Control and Prevention (CDC) and the
Environmental Protection Agency (EPA) to improve the technological
sophistication of exposure assessment and the use of exposure assessment
in developing disease prevention strategies.
The Society
of Toxicology supports the partnership between the NIEHS and the
Environmental Protection Agency to establish a national network
of Children’s Environmental Health and Disease Prevention Research
Programs to study children’s health issues that might
be linked to the environment, such as pediatric asthma and other
respiratory diseases. These illnesses have lifelong adverse health
implications for children and consume substantial health care dollars.
Furthermore, basic research is required in order to learn whether
or not there is a difference in the susceptibility of children as
compared to adults with regard to the toxic potential of particular
chemicals.
A strong investment in NIEHS
will continue the study of the potential adverse effects of chemicals
that might be able to disregulate endocrine activity. It is important
to ascertain whether or not these compounds, often referred to as
endocrine disrupters, actually contribute to human disease
at the levels they are found in the environment. The Society is
especially pleased that NIEHS is moving forward with a number of
studies to examine the possible linkage between exposure to alleged
endocrine disregulating chemicals and disorders affecting both male
and female reproductive health.
We applaud the NIEHS for spearheading the NIH research effort in
collaboration with the FDA and industry and academia, to develop
biomarkers for the efficacy and safety of new drugs. It is
imperative that promising therapeutics move from the laboratory
to the patient in a more timely manner with a high level of assurance
concerning their efficacy and safety. You can be sure that the Society
of Toxicology will continue to promote this important research collaboration.
Under Dr. Olden’s direction, NIEHS has taken a leadership role
with regard to encouraging partnerships involving government, academia
and industry to work on environmental health-related issues.
NIEHS continues to play an important role in the multi-agency effort
to identify the research needs on the safety and efficacy of herbal
medicines. Of the approximate 2,000 herbal products in use,
only a few have been adequately tested for efficacy and toxic potential.
As the use of these alternative therapies becomes more widespread,
there is the need for scientifically valid information about both
the benefits and risks of their use.
Superfund Hazardous Substances Basic Research Program
The Society of Toxicology also wants to express its strong support
for the Superfund Hazardous Substances Basic Research Program. This
program is administered by NIEHS although it is funded through a
pass through from the EPA to NIEHS. The Superfund Hazardous Substances
Basic Research Program is the only scientific research program focused
on health and cleanup issues for Superfund hazardous waste sites.
It represents an important collaboration between EPA and NIEHS,
and it should ensure that environmental cleanup decisions are based
on sound environmental health science.
The Superfund Hazardous Substances
Basic Research Program supports university and medical school research
to understand the public health consequences of local hazardous
waste sites, as well as to develop better methods for remediation.
It is important to note that this is the only university-based research
program that brings together biomedical and engineering scientists
to provide the science and technology base needed for making accurate
assessments of human health risks and developing cost-effective
cleanup technologies.
The primary purpose of Superfund Hazardous Substances Basic Research
Program is to provide the scientific basis needed to make accurate
assessments of the human health risks at hazardous waste sites.
In addition, research data is used to determine which contaminated
sites must be cleaned up first, to what extent clean up is needed,
and how best to clean up contaminated sites in the most cost-effective
manner. The Society of Toxicology is disappointed that the President’s
budget request reduces funding for this important program by $11.5
million. We hope Congress will consider restoring funding for this
program to its Fiscal Year 2000 level of $60 million. I understand
that this funding matter is not under the jurisdiction of this Subcommittee.
With that said, I urge the Members of the Subcommittee to engage
in the necessary discussions with the VA-HUD and Independent Agencies
Appropriations Subcommittee to ensure that these resources are continued.
Conclusion
Once again, thank you for continued leadership in the area of biomedical
research and for considering the funding priorities I have just
outlined on behalf of the Society of Toxicology. We look forward
to working with you to continue the campaign Congress initiated
two years ago to double the NIH budget by 2003, and to continue
the pursuit of the many promising research opportunities at hand
as a result of the nation’s investment in biomedical research.
Under Dr. Olden’s leadership, the NIEHS is taking a leadership
role with regard to enhancing the scientific basis that is necessary
in order to make better decisions concerning our environment.
Thank you.
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