Lobbying/Funding

Related HTPC Supported Activities

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Humane Society Family Activities Related to Promoting 21st Century Science

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United States

Lobbying efforts in 2012 focused on shifting appropriations within existing programs to prioritize funding for non-animal approaches to toxicological assessment:

Chemical Risk Assessments- The Committee supports NIH’s leadership role in the creation of a new paradigm for chemical risk assessment based on the incorporation of advanced molecular biological and computational methods in lieu of animal toxicity 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. 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 evaluation strategies. Extramural and intramural funding should be made available for the evaluation of the relevance and reliability of human biology-based and Tox21-related methods and prediction tools to assure readiness and utility for regulatory purposes, 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 2014 funding level for this area of research in the fiscal year 2015 congressional budget justification.

(p. 107) Tox21 Program.—The Committee supports NIH’s leadership role in the Tox21 program, a collaborative effort with the EPA and the FDA to adopt advanced  molecular biological and computational methods in lieu of animal toxicity tests for conducting chemical risk assessments. The Committee encourages NIH to continue to expand its extramural support for the use of human biology-based experimental and computational approaches in health research to further define toxicity and disease pathways and develop tools for their integration into evaluation strategies. Extramural and intramural funding should be made available for the evaluation of the
relevance and reliability of Tox21 methods and prediction tools to assure readiness and utility for regulatory purposes, including pilot studies of pathway-based risk assessments. The Committee asks NIH to provide a report on fiscal year 2012 and 2013 funding for these activities in the fiscal year 2014 congressional budget justification.

(p. 48) Endocrine Disruptor Research.—The Committee has longstanding interest in EPA’s effort in determining possible health and environmental effects of chemicals. To improve analysis of chemicals, EPA needs to improve its scientific understanding of chemical properties in order to better inform the Agency’s Contaminant Candidate List as required by the Safe Drinking Water Act; Air Toxics Strategy as required under the Clean Air Act; and all required activities under the Toxic Substances Control Act. EPA is directed to provide a report to the Committee that details its current and future efforts to develop approaches to understand the toxicity of chemicals in terms of molecular ‘‘groups’’ or ‘‘families’’ based on the chemical’s intrinsic properties. In addition, 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 report, ‘‘Science and Decisions,’’ and develop a report on the latest scientific literature on low-dose toxicity and non-monotonic dose response curves.

(p. 49) ToxCast.— The Committee supports EPA’s leadership role in the creation of a new paradigm for chemical risk assessment based on the incorporation of advanced molecular biological and computational methods in lieu of animal toxicity tests. The Committee encourages EPA to continue to expand its support for the use of human biology-based experimental and computational approaches in health research to further define toxicity and disease pathways and develop tools for their integration into evaluation strategies. Funding should be made available for the evaluation of the relevance and reliability of Tox21 methods and prediction tools to assure readiness and utility for regulatory purposes, including pilot studies of pathway-based risk assessments. The Committee directs that EPA provide a report on associated funding in fiscal year 2013 for the aforementioned activities and a progress report of Tox21 activities in the fiscal year 2014 Congressional justification, featuring a five-year plan for projected budgets for the development of Tox21 methods, and including prediction models and activities specifically focused on establishing scientific confidence in them for regulatory applications.

European Union

Horizon 2020

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.