Expanding Health Analysis: Metabolic Endpoints
Pre-Proposal Solicitation Scope of Work for:
Expanded Health Analysis of Metabolic Health Outcomes
The primary objective of the proposed research is to support the California Air Resources Board’s efforts to expand assessment of air pollution-related adverse health outcomes, using quantitative or qualitative methods. Research has shown that numerous health endpoints are associated with exposure to a variety of criteria pollutants and toxic air contaminants. This proposed study will help identify and quantify, where possible, additional California-specific health outcomes associated with changes in air pollution levels related to CARB’s regulations, policies, and programs.
On April 23, 2020, the California Air Resources Board (CARB) adopted Board Resolution 20-131 that directed CARB staff to do the following: to develop new quantitative and qualitative approaches for health benefit assessment that include a broader range of health outcomes; to explore and develop new methods accounting for increased vulnerability and exposures in impacted communities; to update and expand methodologies to include ozone and secondary pollution; and to propose new approaches for evaluating additional pollutants. CARB has routinely quantified three health endpoints associated with particulate matter (PM) exposure: premature death from cardiopulmonary disease, hospitalizations for heart- and lung-related causes, and emergency room visits for asthma. The proposed research will focus specifically on adding more air pollutants and health impacts to those currently analyzed.
Scientific evidence supports the existence of additional PM-related health outcomes2 and health impacts from other criteria pollutants such as ozone3. Under this contract, the contractors will collect and/or evaluate scientific data to estimate adverse metabolic health effects that are linked to pollution emissions and exposures in California. Additionally, the contractors will be asked to evaluate these data for racial and ethnic subgroups and provide concentration-response (C-R) functions for subgroups in addition to average population health data and C-R functions. The subgroup information is an important component of the research project. This research will augment the air pollution research and associated health impacts that CARB currently analyzes for its regulations, strategies, and programs.
A priority area of interest for this contract is air pollutant exposure and its association with adverse metabolic effects such as type 2 diabetes4, 5,6, 7, 8. CARB is interested in a variety of endpoints, such as incidence and progression of the metabolic disease as well as mortality. In addition, CARB's secondary research interest includes other adverse metabolic effects or risk factors (for example high blood pressure) that contribute to metabolic dysfunction that demonstrate important associations with air pollution. Evidence from epidemiologic and experimental studies report positive associations between long-term PM2.5 exposure and metabolic effects. The U.S. EPA in their 2019 ISA concluded that the collective evidence is “suggestive of a causal relationship.” 2 For example, there are positive associations reported in epidemiological studies between long-term PM2.5 exposure and diabetes-related mortality. Further, based on experimental studies, there are reports of associations between long-term PM2.5 exposure and increased blood glucose, insulin resistance, and inflammation. CARB is seeking research to assess these effects for criteria pollutants and, to the extent possible, toxic air contaminants. The main objectives for this project will be to:
- Evaluate adverse metabolic effects such as type 2 diabetes and possibly other metabolic effects or risk factors to determine priority health endpoints associated with air pollution,
- Use an air pollution exposure modeling approach to identify statewide and, if possible, localized C-R functions between air pollutants and the priority health endpoints identified,
- Develop monetized values (cost of illness and wiliness to pay) for those health impacts and associated uncertainties.
This project will provide quantified assessment of public health impacts of additional health outcomes and air pollutants (criteria air pollutants and, where possible, toxic air contaminants), and potentially their associated economic values, as well as identification of potential qualitative health outcomes. This will in turn promote better understanding of the full scope of health and welfare protections from California’s air pollution regulations, programs, and policies. The results from this research will help CARB, the greater scientific community, the general public, and residents of impacted communities to better understand the public health impacts of air pollution. Due to the broad scope of this project, multidisciplinary teams and multi-university teams are encouraged to apply.
III. Scope of Work
The proposed study should address the following objectives.
- Identify and conduct a thorough literature search on proposed health endpoints;
- Identify priority health endpoints (e.g., type 2 diabetes) associated with air pollutants for developing C-R functions;
- Identify and use existing California-relevant health and exposure databases. This would include, for example, study cohorts, monitoring networks, and emission inventories. Other air quality modeling or statistical modeling approachescould be used. The strengths and potential shortcomings of the proposed data sources and modeling approaches are required;
- Identify California-relevant pollutants (criteria pollutants and, where possible, toxic air contaminants) and affected populations and develop air pollution data with fine spatial resolution to link with health data;
- Ensure that the study population is representative of California’s diversity (e.g., age, racial/ethnic background, socioeconomic status (SES), pre-existing health conditions, etc.);
- Stratify results by race, gender, and ethnicity to determine differential exposure and health impacts, and examination of how socioeconomic factors affect vulnerability, preferably including differentiation between socioeconomic impacts on vulnerability and environmental factors that increase vulnerability. If investigators cannot stratify these factors, investigators will work with CARB staff to determine best strategies to incorporate information from diverse populations;
- Identify exposure window(s) with high risk, the duration of the exposure (e.g., short- or long-term, or short high peaks repeated over time), and whether there is a threshold or linear relationship between the exposure and health impacts;
- Characterize the relationship between the selected pollutants and health endpoints, along with associated uncertainty factors;
- Implement a design that leads to a better understanding of the effects of additive exposures;
- Characterize the annual economic cost associated with the health endpoints in question if possible; and
- Propose statewide and, if possible, localized C-R functions for the selected endpoints and pollutants to be used in health analysis tools or suggest how the characterized relationship could be used in CARB’s analysis of health impacts associated with CARB’s regulations, policies, and programs.
- Determine interim milestones (completion and delivery date(s) for each task):
- Submit quarterly progress reports, a draft final report and final report to CARB,
- Participate in progress update meetings and a seminar at the conclusion of the project;
- Provide raw data, modeled data, and all data analyses results generated through the course of the project in electronic format;
- Prepare peer-reviewed journal articles as appropriate and provide a preview of the manuscript to CARB for their comments prior to submission. If researchers submit the manuscript to a journal, submitting it to open-access journals is required; and
- CARB requires new research contracts to incorporate equity components in the deliverables (see under IV. Deliverables).
Proposals shall detail the methods, data sources, and anticipated health endpoints the proposer intends to use for this analysis. The results of this study could be used to expand the number of health outcomes that CARB is able to assess in relation to changes in air pollutants brought about by CARB’s regulations, policies, and programs, thus providing a more complete picture of total effects on California’s diverse population.
The project proposal must include but not limited to the following deliverables:
At Beginning of Contract
- All researchers must undergo cultural competency training (examples include implicit bias training, racial equity training, etc.). Trainings should be completed or scheduled within 30 days of contract execution
- Work with CARB staff at the beginning of the project to create a 1-page plain-language outreach deliverable for public describing the project’s goals, process, and planned deliverables (available in multiple languages, template will be provided)
During Active Contract Period
- Quarterly Progress Reports and conference calls; The progress reports will include plain-language summaries that can be posted publicly. A progress report template will be provide
- Consultation calls with CARB and key stakeholders
Prior to Contract Close
- All data, analyses and analytical tools generated through the course of this project
- Data on health outcomes related to criteria pollutants and, where possible, air toxics pollutants
- Produce plain-language fact sheets, including suggestions for preventative actions (if such information is available) and these will be translated into Spanish
- Draft final report
- Include a plain language summary in draft final report
- Include an equity implications section in draft final report
- Work with CARB to create plain-language outreach deliverables for public summarizing results and impact of project (available in multiple languages);
- Final Report and virtual or in-person seminar
- Peer reviewed publications should be publicly available (please budget for this expense; submission-ready publications shall be reviewed by CARB staff).
Additional deliverables to be determined in consultation with CARB staff.
It is anticipated this project will be completed in 24 months from the start date. Cost shall not exceed $475,000.
1. CARB Resolution 20-13, https://ww3.arb.ca.gov/board/res/2020/res20-13.pdf
2. U.S. EPA 2019, Integrated Science Assessment (ISA) for Particulate Matter (Final Report, 2019). U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-19/188, 2019.
3. U.S. EPA 2020, Integrated Science Assessment for Ozone and Related Photochemical Oxidants. U.S. Environmental Protection Agency, Washington, DC, EPA-600/R-20-012, 2020.
4. Puett et al., Long-Term Exposure to Ambient Air Pollution and Type 2 Diabetes in Adults. Current Epidemiology Reports 2019; 6: 67–79.
5. Weaver et al., Associations between air pollution indicators and prevalent and incident diabetes in an African American cohort, the Jackson Heart Study. Environ Epidemiol. 2021 Apr 22;5(3):e140.
6. McAlexander et al., Evaluation of associations between estimates of particulate matter exposure and new onset type 2 diabetes in the REGARDS cohort. J Expo Sci Environ Epidemiol. 2021 Oct 16 doi: 10.1038/s41370-021-00391-9.
7. Yu et al., Ozone Exposure, Outdoor Physical Activity, and Incident Type 2 Diabetes in the SALSA Cohort of Older Mexican Americans. Environ Health Perspect. 2021 Sep;129(9):97004.
8. Bowe et al., Diabetes Minimally Mediated the Association Between PM2.5 Air Pollution and Kidney Outcomes. Sci Rep 2020 Mar 12;10(1):4586.6.
- Responsiveness to the Goals and Objectives Outlined in the Proposal Solicitation(15 points) Proposers should demonstrate a clear understanding of the policy objectives and research needs that CARB seeks to address with this project and should convey their knowledge of the subject. The proposal should spell out, in adequate detail, exactly what the Proposer proposes to do to satisfy the requirements of the Solicitation. The draft proposal must propose work that would satisfy the objective(s) stated in the Research Solicitation: The objective of this research is to estimate adverse metabolic health effects such as type 2 diabetes that are associated with air pollution emissions and exposures in California. CARB is also interested in a variety of endpoints, such as incidence and progression of the disease as well as mortality. In addition, CARB's secondary research interest includes other metabolic effects or risk factors (for example high blood pressure) that contribute to metabolic dysfunction that demonstrate important associations with air pollution.
- POLICY RELEVANCE/BENEFITS TO THE STATE(10 points) – Does the proposal describe how the project will provide data, information, and/or products to help CARB accomplish its mission? Results of this project (e.g., concentration-response functions) should support CARB to better determine benefits of air pollution regulations and policies in California.
- PREVIOUS WORK (15 points) – Do the researchers have relevant experience in this area? Is the team composed of a multidisciplinary team of experts? Do they discuss how they will build upon previous relevant work that was funded by CARB, other state agencies, and federal agencies such as US EPA, NSF, or NIH? Does the team bring in new talent that has not worked with CARB previously? Researchers new to CARB are encouraged to apply. Multidisciplinary teams and/or researchers from smaller universities are also encouraged to apply. 5 points will be reserved for project teams that meet at least one of the following criteria:
- The project team is multi-disciplinary
- The project team members come from various universities or include non-academic institutions or community-based organizations
- The project team includes one or more members, contributing significantly to the project (i.e. a principle investigator, co-principle investigator or co-investigator, contributing 25% or more of their time to the project) who have not worked with CARB in the past 5 years.
- TECHNICAL MERIT (25 points) - Describe the submission's technical strengths and/or weaknesses. Proposers should demonstrate the logic and feasibility of the methodology and technical approach to the project, spell out the sequence and relationships of major tasks, and explain methods for performing the actual work. Please factor in how well the draft proposal describes these areas:
- Identification and use of existing California-relevant health, exposure, and economic databases (Large study cohorts in California would be preferable.);
- State-of-the-art techniques for air quality modeling or statistical modeling for identifying concentration-response functions between air pollutants and metabolic health effects;
- Rigorous and scientifically defensible study designs and methods;
- Specific data analyses for racial and ethnic subgroups as data allows;
- The review team will be selecting only one draft proposal for development into a full proposal. If this draft proposal has potential, what areas or topics should be prioritized or better explained in the full proposal.
- LEVEL AND QUALITY OF EFFORT TO BE PROVIDED(15 points) – Does the proposal allocate time and resources in such a way that the objectives of the study will be met? Is supervision and oversight adequate for ensuring that the project will remain on schedule? Is the distribution of workload appropriate for activities such as research, evaluation and analysis, data reduction, computer simulation, report preparation, meetings, and travel? If pre-existing datasets are used are these available in a timely manner and at the spatial resolution needed?
- COST EFFECTIVENESS (20 points) - Does the cost seem appropriate for the proposed work? Does the proposed work seem feasible within the requested budget? Projects that provide co-funding or propose multiple heath endpoints should be evaluated more favorably.