Human biomonitoring is a method that measures environmental exposures to inform the linkage between disease risk and environmental hazards.1–6 The US National Health and Nutrition Examination Survey (NHANES) includes biomonitoring for many environmental exposures in the US population. However, NHANES methodology does not support addressing state or regional variation in exposure, nor state or regional exposure concerns.7
In 2003, the National Biomonitoring Program (NBP) within the Division of Laboratory Sciences at the Centers for Disease Control and Prevention (CDC) offered assistance to selected regional and state programs to conduct localized biomonitoring activities. The NBP assisted the formation of the Rocky Mountain Biomonitoring Consortium (RMBC), affiliating Arizona, Colorado, Montana, New Mexico, Utah, and Wyoming. The RMBC completed 9 demonstration projects and validated the process of implementing a regional public health laboratory-based biomonitoring consortium before ending in 2008. Of particular importance was the development of processes for coordinating, funding, and monitoring partner-state activities and processes for identifying and prioritizing regional environmental public health information needs that could be addressed through biomonitoring.8 During 2005, the RMBC participated in the Western Tracking Biomonitoring Collaborative (WTBC). The WTBC was intended to be a dialogue between biomonitoring and Environmental Public Health Tracking Network (EPHTN) programs in the western states and included Alaska, California, Hawaii, Idaho, Nevada, Oregon, and Washington in addition to the RMBC states. During 2005, the WTBC explored the synergy of EPHTN and biomonitoring and led to prioritization of regional exposure concerns.8
After the RMBC ended, New Mexico and Utah leveraged EPHTN special projects funds to continue small biomonitoring projects. New Mexico used biomonitoring to assess heavy metal (arsenic, cadmium, lead, manganese, mercury, molybdenum, selenium, and uranium) exposure from drinking water in community residents in counties along the Mexico border. New Mexico also conducted a biomonitoring surveillance project with military veterans returning from Afghanistan and Iraq to quantify exposure to uranium. The Utah EPHTN continued an RMBC demonstration project using newborn blood spots for cadmium, lead, and mercury surveillance. These projects were concluded in 2012. Colorado was able to maintain an ongoing biomonitoring project to assess exposures to multiple chemicals of concern experienced by children in the San Luis Valley. Concurrently, states received Public Health Emergency Preparedness (PHEP) grants. Laboratories used a portion of their state PHEP funds to expand analytical and staffing capacity.
Leveraging continued regional dialogue through EPHTN and PHEP collaborations, the 4 corners states formed the Four Corners States Biomonitoring Consortium (4CSBC) in 2014. These states share geophysical, cultural, economic, industrial, agricultural, and political environments. This led to identification of common environmental exposure concerns. The similarity of laboratory capabilities positively influenced creating the consortium, and the availability of EPHTN and PHEP programs made the 4CSBC feasible. However, funding was needed to support purchases of sampling and testing materials, participant recruitment and sampling activities, and travel for coordination meetings and conferences.
Before applying for funding, the 4CSBC:
- Ensured the legal framework and authority of the participant states to conduct biomonitoring, share laboratory capacity across state boundaries, and contract with each other.9
- Assembled state expert advisory panels to guide and oversee the project.
- Identified common exposure concerns and the potential for biomonitoring data to inform programs, policies, or other interventions. This activity started with lists of regional concerns developed through the RMBC and WTBC and was further informed by EPHTN interests, private well testing interests, inquiry from policy makers and the public, as well as laboratory and epidemiology feasibility assessments. A decision matrix was used by the consortium to focus on the 5 most relevant exposure concerns: heavy metal exposure from privately owned drinking water, phthalates, pyrethroids, 2,4-dichlorophenoxyacetic acid (2,4-D), and para-dichlorobenzene (2,5-DCP).
- Identified populations and likely exposure scenarios (eg, year-round or seasonal, ubiquitous or associated with land use practices, residential or occupational exposure).
- Established a timeline that synchronized laboratory requirements (acquisition, development, certification, and implementation of specimen testing, quality assurance, and reporting methodology) with epidemiologic requirements (recruitment, field collection, and reporting methodology).
- Established a plan for implementation of laboratory methods, including acquisition of standards, staff training, methods validation, and sampling materials and protocols.
- Drafted a study design that included participant recruitment and screening tools, informed consent, participant rights, lists of potential impacts, initial exposure assessment surveys, and data management procedures.
- Coordinated a process for establishing contractual relationships for each state that included developing a budget to support laboratory and epidemiology activities.
The consortium received funding through the NBP to increase laboratory and epidemiology capacity for biomonitoring, demonstrate the feasibility of consortium-associated biomonitoring activities, and develop a toolkit of epidemiology-focused products to complement the Association of Public Health Laboratories toolkit for laboratorians.
The Utah Department of Health was responsible for receiving funds from CDC and distributing subawards to the other state health agencies. Each state acquired institutional board review (IRB) approval through its state agency. Colorado obtained an additional IRB approval from the University of Colorado-Anschutz Medical Campus.
Developing Shared Laboratory Capacity
The 4CSBC selected 5 regional exposure concerns assessed by measuring in 27 urine metabolites. In some cases, the laboratorians found barriers in implementing methodology for some metabolites. Those included difficulty in obtaining analytical standards and applicable proficiency testing programs, as well as processes for controlling interferences. By collaborating with the NBP, solutions were found. For example, an overseas vendor was found for one of the analytical standards not available in the United States. Some of these barriers could have been avoided by aligning regional exposure concerns with national priorities such as those published in the Healthy People 2020 initiative.10 The NBP has standards, proficiency testing programs, and substantial expertise in the analytical methodology used to test for the exposure concerns that are national priorities.
The 4CSBC laboratories leveraged PHEP equipment and personnel for biomonitoring activities. This decision allowed the PHEP resources to be utilized beyond the PHEP-mandated proficiency testing activities and allowed the 4CSBC to apply more of the limited funding to sample collection and testing.
The laboratorians developed field guides for the epidemiologists, providing instruction on how specimens should be collected, aliquoted, preserved, transported, and submitted to the laboratory. This included developing 4CSBC unique submission forms and specimen accession processes to ensure that participant urine samples, exposure surveys, and drinking water samples (for the heavy metal component) could be linked.
Coordination of laboratory and epidemiology activities was accomplished through monthly conference calls, biannual face-to-face meetings, training webinars, and individual collaborative communication by phone or e-mail. In addition, a secure document repository was established for the purpose of archiving and sharing documents. Technical support related to analytical standards, proficiency testing, and method and instrument troubleshooting and optimization was easily accomplished through these communication channels.
An important lesson was the value of having chemists participate in fieldwork to assist with sample collection and management. Chemists were able to ensure that samples were proper aliquoted and preserved for speciation and shipping. Chemists were trained to support recruitment efforts and augment the field teams in exposure assessment procedures.
Developing Epidemiology Capacity
All 4 states utilized epidemiologists from existing programs with expertise in biomonitoring. New Mexico and Utah utilized EPHTN epidemiologists and health educators to assist with their state's 4CSBC activities. Experience from EPHTN activities provided valuable knowledge to assist in rapid development, testing, and implementation of recruiting, screening, enrollment, assessment, and health communication protocols. The EPHTN programs in those states were able to support private well water testing to augment the biomonitoring exposure assessment for heavy metals. Arizona and New Mexico have private well water programs that support well water testing. Colorado's 4CSBC activities took advantage of the experiences of an ongoing children's health project.
A variety of methods to recruit participants have been explored, including solicitation by public notice, utilizing a local cohort such as a university class, and door-to-door canvasing. The 4CSBC found that partnering with trusted local representatives, such as youth service organizations (eg, BSA, GSA, 4-H, FFA) or a local civic group (eg, a gardening club), was most effective. Another effective approach was working with agencies associated with exposure concerns (eg, mosquito abatement districts and pyrethroids).
Some participant recruitment approaches resulted in staff visiting participants in their homes. Field teams should have safety protocols. For example, team members should work in pairs with established means of communication with each other, especially for threatening situations. We found a set of code words worked well. Team members should be familiar with the communities where participant recruitment is occurring. This is best accomplished through coordinating with local officials.
Brief Progress Report
The 4CSBC has a “work in progress” toolkit of epidemiologic materials useful to agencies exploring a biomonitoring program. The toolkit can be found at www.4csbc.org. Currently, the toolkit provides examples of documents needed to initiate a biomonitoring project (ie, documents for the IRB), examples of participant recruitment materials, and examples of fact sheets on exposure concerns. The toolkit also contains stories illustrating lessons learned during the first years of the consortium that should be useful for new programs. Additional materials will be made available as they are approved for publication. The toolkit and all other documents on this Web site are available in the public domain.
To date, 757 participants and 443 private wells have been tested. Urinary samples have been collected for heavy metals, phthalates, and pyrethroids. Not all participants were screened for all classes of exposure concerns. The biomonitoring results are being returned to participants with an interpretation of the results in comparison with reference values, ways to reduce exposure, and fact sheets about chemicals. The epidemiology team is developing a multilevel risk model to evaluate data. In the future, model code and statistical analyses of risk will be made available on the 4CSBC Web site.
A large accidental release of mining waste in 2015 impacted waters in all 4 states, including the San Juan River. That release increased the levels of dissolved metals including aluminum, arsenic, cadmium, copper, iron, lead, manganese, mercury, and zinc in the water for several months.11 Water from the San Juan River flows through all 4CSBC states and is used for agriculture, recreation, and subsistence fishing. The release elevated public concern about water safety, resulting in increased interest in the biomonitoring program. In New Mexico and Utah, 4CSBC teams were able to leverage public interest to enroll participants in communities near the river. The 4CSBC staff collaborated with state EPHTN staff to develop information that could be provided to communities. During the sample collection events, teams provided education to the communities about principles of hydrogeology, water quality concerns, and potential for risk to health, thus empowering the communities to appropriately respond to this event.
Collaborating with tribal health services through state health department liaisons allowed the 4CSBC to include several First Nations populations. Associating with First Nations requires biomonitoring projects to be adaptable. For example, some tribes have specific cultural concerns regarding removal of human specimens from tribal lands because the specimens are spiritually viewed as an extension of the tribal participant's self. The 4CSBC extended the specimen management and destruction protocols to include procedures to return specimens and data to the tribal health authority.
The 4CSBC is feasible due to the ability to share laboratory and epidemiology resources. The design of the project allows states to have flexibility in the project application around a core set of uniform methods. Utilizing existing programs and resources enhanced the project. States considering starting biomonitoring projects should coordinate with laboratory and EPHTN personnel, local environmental health initiatives, and similar projects to best utilize resources. To date, the principal success of the project has been its ability to educate the public during the process of recruiting participants and field sampling. The future value of the 4CSBC will be its ability to inform public health practices at the regional and state levels.
Implications for Policy & Practice
- The 4CSBC is developing a toolkit that can provide a starting point for development of a regionalized biomonitoring program.
- The 4CSBC describes its best practices for implementing interagency and interstate collaboration within a regionalized biomonitoring program.
- The 4CSBC experience demonstrates the positive feasibility and practicality of future regionalized biomonitoring programs.
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