Advancing Actionable Alternatives to Vertebrate Animal Testing for Chemical Safety Assessment
U.S. Environmental Protection Agency
National Center for Environmental Research
Science to Achieve Results (STAR) Program
Funding Opportunity Number: EPA-G2018-STAR-C1
Catalog of Federal Domestic Assistance (CFDA) Number: 66.509
Solicitation Opening Date: August 8, 2018
Solicitation Closing Date: September 25, 2018: 11:59:59 pm Eastern Time
Synopsis of Program:
The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications proposing research that will promote the development and use of alternative test methods and strategies that address the “3Rs” of toxicity testing: 1) reduce, 2) refine, and/or 3) replace vertebrate animal testing. For the purposes of this RFA, alternative test methodsrefer to those that incorporate the “3Rs” principles. Pertinent research includes approaches such as analog/read-across techniques, mathematical models, and tiered testing approaches that integrate evidence from multiple sources to help accomplish these goals. In addition to the development of new alternative test methods and strategies, translational science approaches that use available data to develop and/or advance actionable approaches for risk assessment of chemicals are also critical. In this context, approaches that facilitate the use of existing animal data sources to reduce, refine, or replace the need for new vertebrate animal tests are as welcome as those that provide new data streams. The research activities to be funded under this announcement are intended to advance the science underpinning the use of non-vertebrate test methods, and to develop actionable alternative approaches to: 1) developmental toxicity tests in humans; 2) reproductive toxicity tests in humans; and/or 3) ecotoxicity tests.
This solicitation provides the opportunity for the submission of applications for projects that may involve human subjects research. Human subjects research supported by the EPA is governed by EPA Regulation 40 CFR Part 26 (Protection of Human Subjects). This includes the Common Rule at subpart A and prohibitions and additional protections for pregnant women and fetuses, nursing women, and children at subparts B, C, and D. Research meeting the regulatory definition of intentional exposure research found in subpart B is prohibited by that subpart in pregnant women, nursing women, and children. Research meeting the regulatory definition of observational research found in subparts C and D is subject to the additional protections found in those subparts for pregnant women and fetuses (subpart C) and children (subpart D). All applications must include a Human Subjects Research Statement (HSRS, as described in Section IV.C.5.c of this solicitation), and if the project involves human subjects research, it will be subject to an additional level of review prior to funding decisions being made as described in Sections V.D and V.E of this solicitation.
Guidance and training for investigators conducting EPA-funded research involving human subjects may be obtained here:
Basic Information about Human Subjects Research
Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA
The STAR Program’s goal is to stimulate and support scientific and engineering research that advances EPA’s mission to protect human health and the environment. It is a competitive, peer-reviewed, extramural research program that provides access to the nation’s best scientists and engineers in academic and other nonprofit research institutions. STAR funds research on the environmental and public health effects of air quality, environmental changes, water quality and quantity, hazardous waste, toxic substances, and pesticides.
Anticipated Type of Award: Grant or Cooperative Agreement
Estimated Number of Awards: Approximately five awards
Anticipated Funding Amount: Approximately $4,250,000 total for all awards
Potential Funding per Award: Up to a total of $850,000, including direct and indirect costs, with a maximum duration of 3 years. Cost-sharing is not required. Proposals with budgets exceeding the total award limits will not be considered.
Public and private nonprofit institutions/organizations, public and private institutions of higher education, and hospitals located in the U.S., state and local governments, Federally Recognized Indian Tribal Governments, and U.S. territories or possessions are eligible to apply. See full announcement for more details.
Full information and application materials may be found on the following website: