AMERICAN CHEMISTRY COUNCIL LONG-RANGE RESEARCH INITIATIVE TARGETED REQUEST FOR PROPOSALS RfP Title Developing Exposure Indices for Rapid Prioritization of Chemicals in Consumer Products RfP Number MTH-10-01 Proposal Due Date June 21, 2010 Optional Informational Conference Call: Tuesday, May 25, 2010 (15:00 UTC/GMT; 11:00 AM US Eastern; 8:00 AM US Western; see SPECIAL REQUIREMENTS section below for more details) INTRODUCTION The American Chemistry Council s (ACC) Long-Range Research Initiative (LRI) was created in 1999 to support science essential for understanding the impact of chemicals on human health and the environment (see www.americanchemistry.com/lri for more information). The new LRI Research Strategy specifically addresses the growing gap between advancements in the new technologies and the science to interpret and understand the emerging data. Key questions include what research is needed to bridge this knowledge gap; how to harness the data to better inform decisions about public health; and how best to communicate research outcomes as they evolve. The LRI supports research in various ways, one of the most important of which is through a competitive research project program of which this Request for Proposals (RfP) is a part. DESCRIPTION OF RfP Background Globally there is a need to characterize potential risk to human health and the environment that arises from the manufacture and use of tens of thousands of chemicals. Currently, a significant research effort is underway to apply new technologies to screen and prioritize chemicals for toxicity. For example, the US EPA is completing the Phase I pilot for a chemical prioritization research program, called ToxCast TM. Here EPA is developing methods for using computational chemistry, high-throughput screening, and toxicogenomic technologies to predict potential toxicity and prioritize limited testing resources. There is a clear need for a parallel effort to ensure that the required exposure science, data and tools are ready to address immediate needs for rapid characterization of exposure potential for prioritization and chemical risk management. In 2009, EPA's Office of Research and Development launched its ExpoCast program. Through ExpoCast, ORD aims to develop novel approaches and metrics to screen and evaluate chemicals based on biologically relevant human exposures. Combining information from 1
ToxCast with information from ExpoCast will help determine priority chemicals for evaluation based on potential to harm human health. Investigators in the US EPA National Center for Computational Toxicology have proposed a Toxicological Prioritization Index (ToxPI) designed to integrate multiple domains of knowledge to inform chemical prioritization: (http://epa.gov/ncct/practice_community/cpcp_17dec09_toxcast-edcprioritization_reif_v4.pdf). The ToxPI framework is amenable to incorporation of new data from any number of sources and provides the opportunity to enrich prioritization of potential hazard with exposure information. The framework also provides graphical insight into the multiple domains considered in chemical profiling and prioritization and can be continually updated with new chemicals and future data. As such, the ToxPI platform provides important context for application and further development of exposure prioritization models as well as for incorporation of exposure model results into chemical prioritization schemes. Research Objectives/Project Scope Here we are interested in potential application of existing screening models (and additional model development where necessary) to derive exposure classification indices (i.e., componentsslices) that could be used to incorporate exposure information into ToxPI. Where possible, multiple metrics should be considered to cover important aspects of exposure space and product lifecycle. Important consideration may include: Physical -Chemical properties Product characteristics (manufacture, formulation, use, lifecycle) Emission characteristics (indoor/outdoor, media of release, amount available for release/contact) Pathways (media, routes) Scale (far-field, near-field) Target characteristics (individual, population, lifestage, lifestyle, susceptibility) Dosimetry (ADME) Derived indices should be clearly documented so that these could be picked up and used in other prioritization schemes. Model assumptions and data sources for analyses provided as part of this research activity will also need to be transparently presented. Application of an index should be demonstrated on a range of compounds and on a large number of compounds (on the order of 100-1000). Benchmark chemicals should be proposed for inclusion in analyses of developed indices as internal controls. Where preliminary analyses indicate the need for additional information/data and/or model development, these needs should be identified. REFERENCES Sheldon, LS, and EA Cohen Hubal. (2009) Exposure as Part of a Systems Approach for Assessing Risk. Environ Health Perspect 117(8)1181-1184. Cohen Hubal EA, et. al. (2010) Advancing Exposure Characterization for Chemical Evaluation and Risk Assessment, in press (contact Tina_Bahadori@AmericanChemistry.com, if interested). 2
SPECIAL REQUIREMENTS To facilitate response to the specific focus of this RfP and its accelerated timelines, the American Chemistry Council will hold a conference call on Tuesday, May 25 th, 15:00 UTC/GMT (11:00 AM US Eastern; 8:00 AM US Western) to answer any questions. If you are interested and available to participate, please email Dr. Bahadori at Tina_Bahadori@AmericanChemistry.com to request access to this call. You may send your request to Dr. Bahadori up to two hours before the call is scheduled to begin. A goal of the LRI is to share broadly the results of funded projects. Thus, it is expected that results be submitted for publication in peer-reviewed scientific journals and presented at scientific meetings, conferences, and/or symposia. The ACC s policy is to support the public release of research findings from LRI-sponsored projects. All proposals should include costs for preparing manuscripts for submission to peer-reviewed scientific journals and supplying the ACC with three reprints of each journal article and an electronic version of the published article. Brief (250-word) annual progress reports are required. The final report can be an assembly of peer-reviewed publications, printed abstracts, and any other related material not submitted for publication (e.g., additional data or analyses too detailed for publication). Any other reporting requirements will be negotiated as part of the development of the research contract. All proposals should include reasonable and necessary travel and related expenses. Please include in the proposed travel plan at least one trip (for the cost proposal, assume it will be to Washington, DC) for the purpose of presenting research results to ACC, as well as to other scientific meetings. Foreign travel costs (defined as any travel outside the country of the Contractor's principal place of business) will require additional approvals. American Chemistry Council member companies have a time-sensitive legal requirement under the Toxic Substances Control Act (TSCA) to report to the U.S. Environmental Protection Agency (EPA) information which reasonably supports the conclusion that a substance or mixture presents a substantial risk of injury to health or the environment (unless the information is already in the public domain). If information you submit results in such TSCA reporting, you shall be informed. The Office of Management and Budget (OMB) has issued rules and guidelines regarding data and information used in regulations, which require that all data developed with federal funding and used in regulations be available to the public upon request. In addition, quality standards apply to information used for these purposes. The application of these guidelines to federally funded research is clear; however, the application to third party supported research (e.g., research sponsored by the American Chemistry Council) has not yet been decided. To help ensure that research pursuant to this Agreement is fully eligible for consideration by the EPA, the Council will require the Contractor to comply with the standards set forth in OMB Circular A- 110 (65 Federal Register 14406-14417 (March 16, 2000)). In addition, the Council may require the Contractor to abide by additional OMB or other regulatory information guidelines applicable 3
to research data. To the extent that this latter requirement imposes additional costs, the budget will be adjusted as mutually agreed to by the parties. ELIGIBILITY Proposals may be submitted by any domestic or foreign for-profit, not-for-profit, or non-profit organization, public or private entities, such as universities, colleges, laboratories, and contract research organizations; units of federal, state, and local governments with the necessary laboratory facilities; and research cooperatives. FUNDS AVAILABLE/PROJECT DURATION It is anticipated this solicitation will award multiple contracts. The total program cost (of all projects funded under this RfP for all years) has been budgeted in the range of $1 million. The project costs are expected to be commensurate with project scope. Proposals should include funds necessary to complete the full scope and deliverables described earlier, including direct and indirect costs (e.g., direct labor, fringe benefits, materials, subcontracts, purchased parts, shipping, indirect costs and rates, fees, status reports, publications, meeting presentations, travel expenses). Projects are expected to begin immediately upon execution of a contract. The duration of the project is expected to be commensurate with the goals of the project. Typical project durations may be one to three years, depending on scope. We will fund a mixed portfolio of shorter- and longer-term projects, if possible. PROPOSAL GUIDANCE Proposals must be received electronically by the ACC no later than close of business on Monday, June 21, 2010. Receipt of the electronic version is deemed to be in confidence. All proposals must be prepared using the RfP Proposal Submission Form. The Project Plan section must not be longer than 15 pages in length; this page limit does not include literature citations, attachments, and appendices. In addition, budgets, biographies/curricula vitae for the Principal Investigator and all other key personnel, and other submissions specified in the Proposal Form are not part of the 15-page limit. The electronic copy of the proposal should be sent to the following address: Tina Bahadori, D.Sc. Managing Director, Long-Range Research Initiative American Chemistry Council 1300 Wilson Blvd. Arlington, VA 22209 (703) 741-5214 Tina_Bahadori@americanchemistry.com The proposal must be signed by an individual who is authorized to sign on behalf of, and bind your organization to the proposed rates (including indirect costs). Incomplete or non-responsive proposals will be returned to applicants without further review. 4
Proposals that are complete and within the framework of the RfP will be peer-reviewed for scientific merit by independent scientists with expertise appropriate to the subject RfP. The following criteria will be used by peer reviewers to evaluate proposals: Scientific merit and feasibility relative to RfP; Expertise of investigator(s); and Quality Assurance (QA) and Good Laboratory Practices (GLP) processes, animal care/human subjects, and ethical considerations, as applicable. Peer reviewers will also assign each proposal an overall rating of Excellent, Very Good, Good, Satisfactory, or Unsatisfactory. Only proposals that receive an overall rating of Excellent or Very Good by the peer reviewers will be considered for funding as part of a relevance review, according to the following programmatic criteria: Relevance to the chemical industry, as described in the RfP; Proposed milestones/timelines; Appropriateness of the budget/cost-effectiveness; and Use of collaborators/leveraging. AWARD CRITERIA The criteria that will be used in making awards include receipt of a sufficient number of proposals of scientific merit and programmatic merit as described in criteria above; availability of funds; and LRI program balance. The ACC reserves the right to make no awards under this RfP. PROPOSAL REVIEW FEEDBACK PROCEDURES Each applicant will receive an electronic notification of receipt of their proposal. Each applicant will receive a copy of the peer-reviewers comments on the Peer-Review Evaluation Forms with the reviewer s identifying information deleted and the LRI s evaluation on the Proposal Selection Form. All applicants will receive a letter of notification regarding the award/non-award decision from the ACC on approximately 90 days after close of the RfP. TYPE OF AWARD The form of award under the LRI is a fixed-price contract between the ACC and the awardee. 5
INQUIRIES More details about the Long-Range Research Initiative can be found on www.americanchemistry.com/lri. Questions regarding this RfP should be directed in writing, preferably by e-mail, to the following address: Dr. Tina Bahadori Managing Director, Long-Range Research Initiative American Chemistry Council 1300 Wilson Blvd. Arlington, VA 22209 Phone: (703) 741-5214; Fax: (703) 741-6214 Tina_Bahadori@americanchemistry.com 6