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Good Science

June 2017


June 28, 2017   government and food policy

 

EPA budget proposal cuts research capabilities

Groundbreaking research to develop 21st-Century, nonanimal chemical assessment methods is at risk. Amazing examples include advanced robots that can screen thousands of chemicals at once, 3-D human livers that can test how humans metabolize pesticides, and a virtual embryo that predicts how chemicals will affect unborn children.

Sen. Tom Udall (D-N.M.), a sponsor of the 2016 Lautenberg Chemical Safety Act for the 21st Century, denounced plans to cut funding to the Office of Research and Development, calling the proposed budget “offensive.”

"I’m glad to hear you [EPA Administrator Scott Pruitt] say you support robust implementation of TSCA," Udall said. "Yet this proposal cuts programs that are vital to TSCA, such as the Office of Research and Development—cut in half—and core agency functions like enforcement. We can’t just build a wall around the TSCA office and expect it will perform."

When the Lautenberg Act passed Congress and was signed into law last year, stakeholders—including nonprofit organizations, labor advocates, and the chemical industry—celebrated. The new law gave the EPA important new powers—and responsibilities—to assess and manage chemical risks. The EPA must assess the tens of thousands of chemicals in the environment, starting with the most dangerous. It must affirm that new chemicals entering the market will be safe for their intended use. And it must consider the risks of chemicals on sensitive populations such as young children, and the risks of mixtures of chemicals.

Recognizing that our current test methods, mostly based on animals, are not up to this task, the authors of the Lautenberg Act required that the EPA and the chemical industry reduce and replace animal tests, and prioritize the development of new test methods and strategies that do not use animals. As required by the law, the EPA is currently drafting a strategic plan to develop nonanimal test methods that will help it assess chemical risks, for publication by June 2018.

The EPA must also prioritize from the thousands of chemicals in the environment to determine which are the most dangerous, for further study and regulation. With its Endocrine Disruptor Screening Program for the 21st Century, the EPA demonstrated how new tools can be used successfully. It has screened more than 1,800 chemicals using a set of in vitro rapid tests in combination with computer prediction algorithms, focusing government and private resources on high priority chemicals and saving tens of thousands of animals.

As it develops these groundbreaking tools, the EPA is leading the world in making data about how chemicals cause toxicity publicly available for researchers, industry, and the general public to use. In the past 10 years, the National Center for Computational Toxicology had made data on hundreds of thousands of chemicals publicly available. This means that as the EPA conducts its own research, it spurs more research at our nation’s universities, speeding progress to replace outdated animal tests with more human-relevant methods.

The EPA needs the research being conducted by the Chemical Safety for Sustainability research program and the National Center for Computational Toxicology in order to meet the responsibilities Congress gave it when it passed the Lautenberg Act. We urge EPA Administrator Scott Pruitt to maintain funding for these vital programs in its FY2018 budget to ensure continued protection of public health, the environment, and animals.

 

June 20, 2017   animal testing

 

Physicians Committee Scientist Leads New ‘Canadian Centre for Alternatives to Animal Methods'

From the back of a napkin to reality: The Physicians Committee’s Charu Chandrasekera is set to lead the first Canadian center for the research and validation of alternative methods.

Millions of animals are used each year for studies of fundamental biology and disease, drug development, and toxicity testing. Despite decades of extensive research—often in animals—we still do not fully understand human biology and disease mechanisms. Fully 96 percent of drugs tested to be safe and effective in animals fail in human clinical trials. Therefore, there is an urgent need to transition from animal testing to humane and human-relevant methods to advance human medicine.

Many countries across the globe have already established nonanimal alternatives research and testing centers, and finally Canada joins them. Last week the University of Windsor in Windsor, Ontario, Canada, announced that it has established the first Canadian center dedicated exclusively to human-centered biomedical research and testing, the Canadian Centre for Alternatives to Animal Methods (CCAAM) and its subsidiary, the Canadian Centre for the Validation of Alternative Methods (CCVAM).

The University of Windsor is a comprehensive academic institution located on the Canadian border, across the river from Detroit, Mich. Since 1857, the University has been a progressive and inclusive community that comes together to study, to learn, to teach, and to serve. It places high priority on creativity and collaboration, and respect for ethical social values. CCAAM will contribute to that legacy.

The vision of CCAAM is the replacement of animals in Canadian biomedical research, education, and regulatory testing through 21st century science, innovation, and ethics. CCAAM/CCVAM will develop, validate, adopt, and promote alternatives in Canada through extensive research, academic, and regulatory initiatives in partnership with national and international academic, industry, government, and public sectors, including Health Canada and Environment Canada.

CCAAM plans to establish a state-of-the-art research infrastructure to enable fully humanized research and testing using only human biomaterials and human-based methods. Through in-house, external, and multicenter collaborative efforts, CCAAM will develop research initiatives to study fundamental human biology in health and disease.

CCAAM will develop unique first-in-its-class undergraduate and graduate academic programs in animal replacement science to educate the next generation of scientists, ethicists, and policymakers.

Through these various initiatives at CCAAM/CCVAM, Canada will officially join the global alternatives community and contribute to this field in a uniquely Canadian way.

The Physicians Committee plans to collaborate with CCAAM closely on many fronts to replace the use of animals in research, education, and toxicity testing. The Physicians Committee’s vice president of research policy, Kristie Sullivan, M.P.H., and director of research advocacy, Ryan Merkley, will serve on CCAAM’s advisory council.

June 16, 2017   animal testing

 

Integrated Chemical Environment

We are exposed to hundreds of chemicals every day. Thus, assessing chemical safety is a huge public health and environmental issue. Regulators have historically assessed chemical safety with animal tests. Given the ethical and scientific issues with using animals, however, there has been a large push to replace animals with nonanimal tests. In order to organize data from methods that have already been developed and to speed the development of more methods the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) has launched the Integrated Chemical Environment (ICE).

ICE is an open source web-based resource that integrates in vivo and in vitro data, high throughput screening data from the Tox21 consortium, and physicochemical property data from 10,000 chemicals. Making these data available to test method developers, companies, and other governments will speed the development of new methods and approaches to predict or test the safety of chemicals without animals. Furthermore, integrating data that compares the results of new methods with old methods or human responses, much of which have been generated over many years of validation studies, will also help speed the validation of new methods and combinations of methods.

Perhaps the most exciting feature of ICE is the incorporation of in vivo to in vitro extrapolation (IVIVE) information.  As the name implies, this feature would provide tools to assess safe doses of chemicals or drugs in a whole organism based on the doses that caused harm in an in vitro assay. NICETAM also has plans to link the IVIVE feature to biological pathways, which would be a valuable tool to predict the toxicity of chemical substances.

Just in time for the summer, ICE is undergoing its first version update in July (v1.1). One useful tool to be added in July is a workflow for the prediction of skin sensitization without animal testing. Skin sensitization refers to the potential of a chemical to cause an allergic skin reaction that can be quite painful to people, and to animals who are used in tests to assess it. The tool uses results of chemical prediction tools based on a chemical’s structure and other features.

Although this tool is fairly new, its utility is promising with respect to integrating data to answer hypotheses about chemical toxicity and to adding value to increasing test methods that do not use animals. What we can already assess with certainty is that the efforts of NICETAM, and the development of ICE, are great strides towards replacing the use of animals in chemical safety testing and developing reliable and scientifically valid methods to achieve that goal.

ICE can be found at https://ice.ntp.niehs.nih.gov.

Bell SM, Phillips J, Sedykh A, et al. An integrated chemical environment to support 21st-century toxicology. Environ Health Perspect. 2017;125(5):054501. doi: 10.1289/EHP1759.