Human Toxicology Project Consortium Lobbying Statements
Humane Society Family Activities Related to Promoting 21st Century Science
Lobbying efforts continue to focus on shifting appropriations within existing programs to prioritize funding for non-animal approaches to toxicological assessment:
- Senate and House FY15 Labor HHS Appropriations Report Language:
High Throughput Screening, Toxicity Pathway Profiling, and Biological Interpretation of Findings National Institutes of Health – Office of the Director
The Committee supports NIH’s leadership role in modernizing the approach for evaluating the safety of pharmaceuticals and chemicals based on the incorporation of advanced molecular biological and computational methods that envisions a move away from animal tests. NIH has indicated that development of this science is critical to several of its priorities, from personalized medicine to tackling specific diseases such as cancer and diabetes and including critical initiatives such as BRAIN and the National Center for Advancing Translational Sciences. The Committee encourages NIH to continue to expand both its intramural and extramural support for the use of human biology-based experimental and computational approaches in health research to further define human biology, disease pathways, and toxicity and to develop tools for their integration into clinical strategies and safety determination paradigms. Extramural and intramural funding should be made available for the development and evaluation of the relevance and reliability of human biology-based and pathway approaches and prediction tools to assure readiness and utility for regulatory and clinical applications, including pilot studies of pathway-based risk assessments. The Committee requests an update on current activities, a plan for future activities, and the fiscal year 2015 funding level for this area of research in the fiscal year 2016 congressional budget justification.
- House FY15 Department of the Interior, Environment and Related Agencies Report Language
(p. 57) Research: Chemical Safety and Sustainability.—The Committee recommends $130,832,000. The Committee rejects the proposed $1,533,000 reduction for the IRIS program. EPA is directed to use the funds provided to accelerate the implementation of the Chapter 7 recommendations and contract with the National Academy of Sciences to review the draft formaldehyde assessment, when released, to ensure that the recommendations contained in the 2011 NAS report have been fully addressed. Further, the Committee rejects the proposed $1,198,000 reduction for the endocrine disruptor research. The Committee does not support proposed delays in this critical and innovative research and directs EPA to continue to evaluate real-world exposures to endocrine disrupting chemicals, nanomaterials and other chemicals of concern. The use of high throughput programs like ToxCast and Tox21 will enable the Agency to characterize the risk and effects resulting from exposures to chemicals of concern.
(p. 57 – 58) Endocrine Disruptor Research.—The Committee has longstanding interest in EPA’s effort to determine possible health and environmental effects of chemicals. As part of EPA’s overall efforts to modernize risk assessment protocols, the Committee encourages EPA to incorporate the various recommendations of the National Academy of Sciences reports as well as all other relevant scientific literature and recommendations. Further, the Committee commends EPA for developing new scientific methods, removing barriers, and fostering cooperation in implementing the toxicity testing agenda that the 2007 National Academy of Sciences (NAS) report on Toxicity Testing in the 21st Century puts forth. The Agency is directed to submit to the Committee a report that outlines (1) progress to date to research, develop, validate and translate innovative chemical testing methods that characterize toxicity pathways, (2) efforts to coordinate across federal agencies, and (3) future plans to continue to implement the toxicity testing vision and strategy in the NAS report.
On 10 October 2012, Humane Society International and MEP Mario Pirillo of the Group of the Progressive Alliance of Socialists and Democrats hosted a workshop on “Advancing Safety Science and Health Research with Innovative, Non-Animal Tools” that recommended dedicated funding for pathway-based approaches to evaluating toxicity and disease as well as the formation of a transatlantic research partnership between the European Union and the United States to bolster the technology revolution taking place in pharmaceutical and chemical safety testing using cutting-edge non-animal techniques. Horizon 2020 is the European Union’s new funding programme for research, which will run from 2014 through 2020.
Chemicals, including those used in consumer goods, industrial processes and medicinal products, are essential to modern life, yet we lack innovative, efficient and human-relevant testing tools to inform regulatory safety decisions. New approaches are needed to promote economic growth, protect against adverse health and environmental impacts of chemicals, replace animal use, and support greener chemistries and safer products. But hope is on the horizon: Europe’s new Framework Programme for research and innovation—Horizon 2020—has the potential to revolutionize not only our approach to safety testing, but the field of human health research as a whole.