In spring–summer 2006, we focused our attention on the PFOA findings to determine what additional studies and follow-up should be conducted. Efforts to identify potential sources of exposure were inconclusive. We presented our preliminary findings to our BCERC colleagues and shared with them our concern about how to proceed.
In summer 2006, the research team convened two “biomarker summits.” Attendees included members of the research team as well as experts in exposure assessment and toxicology. The objectives included presentation of the pilot study results and environmental samples collected at the schools; identification of the IRB of record for the pilot study; establishing priorities for verifying the pilot study results; and developing the components of a communication strategy. We discussed possible target audiences, what results might be reported, and how we might report those results.
In fall 2006, serum samples from 15 of the original community B pilot study girls and from 30 additional girls from the same community were sent to the CDC. We wanted to determine whether the elevated PFOA concentrations persisted and whether other study girls in community B were affected. Although the repeated PFOA concentrations decreased between 2005 and 2006 in community B, serum levels of 88% of the girls were above the NHANES 95th percentile.
We continued to review the scientific literature for PFOA studies as well as lay media sources for information about PFOA contamination. The “Community Exposure to C8 [PFOA] in the Little Hocking Water Service Area Study,” taking place 250 miles up the Ohio River from Cincinnati, was particularly compelling (Emmett et al. 2006
), as drinking water was determined to be the major source of exposure (compared with air), and the median PFOA blood concentration in children 6–10 years of age exceeded all other age groups except adults > 60 years of age. The U.S. Environmental Protection Agency regulators and researchers were contacted to learn about environmental sources and properties of PFOA as well as research addressing the biologic effects of exposure. Because of ongoing litigation and regulatory review, some of those contacted were nonresponsive. Online and print media were surveyed for information about known environmental sources, contamination patterns, and exposure avoidance recommendations. We also sought advice from the Silent Spring Institute (Newton, MA) and other researchers with practical experience reporting exposure biomarker results to study participants (Brody et al. 2007
; Galvez et al. 2007
As the decision to report the findings to the pilot study families evolved, the need for a communication plan became apparent. The plan needed to be responsive to all the target audiences, including study families, school administrators, health officials, and the media. The information needed to be factual, understandable, and consistent. It was important to use trusted individuals and institutions to communicate that plan (Galvez et al. 2007
). The plan also needed to be comprehensive, anticipating questions and reactions that might arise.
The communication plan consisted of:
- PowerPoint presentation(s) tailored to different audiences
- Information packet with fact sheets from government web sites
- Graphs depicting the range of results for a sample analyte for each chemical class
- Graphs depicting the range of PFOA results from the pilot study and other references
- A one-page summary of preliminary GUF study findings
- Glossary of terms
- Frequently Asked Questions (FAQs) with answers
- A dedicated phone line for questions from study families
- A press release.
The CCHMC IRB was notified of all components of the communication plan. Members of the research team developed the FAQs to ensure that we were prepared to address questions likely to arise and that our responses were consistent no matter the respondent, setting, or target audience.
In May 2007, three family meetings were held in the two pilot study communities and at CCHMC. In community B, study families received a written invitation, and the study principal investigator (PI) phoned each family to encourage attendance. The study PI, an adolescent medicine physician known to all of the study families, presented a study update and the biomarker results using PowerPoint slides carefully developed by the research team. A template was designed that depicted the study data points for an analyte for each chemical class. For example, brominated diphenyl ether–100 served as the sample analyte for the brominated flames retardants. The 50th and 95th percentiles based on NHANES data recently reported by the CDC (Calafat et al. 2007
) were included on each graph. Our consultations with Silent Spring Institute were especially helpful in the development of these graphics.
The PFOA findings were presented in a graphic that compared the results for communities A and B with data from the 1999–2000 NHANES national data set, a Parkersburg, West Virginia, cohort, and the San Francisco Bay area BCERC cohort. These additional data points were intended to provide context for the study families to interpret and compare the local data and their child’s results, as shown in . We used the West Virginia data because Parkersburg is < 250 miles up the Ohio River from Cincinnati.
Figure 1 Relative exposure communication tool illustrating the differences in serum concentration of PFOA in occupational and related community populations, two BCERC cohorts, and the U.S. population; presented to Cincinnati BCERC Pilot Study Families, May 2007. (more ...)
Each study family whose child participated in the pilot study received a report of the serum and urine biomarker results of their child. A sample analyte for each chemical class of biomarker was presented; the chemical classes included phenols, phthalates, cotinine, metals, phytoestrogens, brominated flame retardants, polychlorinated biphenyls, and persistent pesticides. Perfluorooctane sulfonate and PFOA were reported for the PFCs. The median for Greater Cincinnati (based on the 30 participants in communities A and B), national references (Calafat et al. 2007
; National Center for Environmental Health 2005
), and the child’s result were reported for each analyte.
The handout packet included a list of references, a glossary of > 70 terms, and copies of web site materials about the different biomarkers. These materials were downloaded from web sites maintained by federal agencies, state health agencies, and National Institutes of Health–sponsored research programs. The CCHMC IRB was notified of all materials provided to the study families.
At the meetings, time was allocated for questions and answers as well as one-on-one and small group discussions facilitated by the study PI and co-investigators. PFOA-related questions pertained to a) sources, pathways, and duration of exposure(s); b) possibility of follow-up studies that would include family members; c) likelihood of bioaccumulation; d) factors likely associated with higher concentrations, such as length of residence; e) recommendations for preventing future exposures; and f) implications for the puberty study. Given the dearth of specific information about exposure sources and pathways as well as health impacts, attendees asked why the information was being emphasized and should study families be concerned. Responses to these questions sought to allay concerns, emphasizing the absence of relevant data, the lack of standards, and the multiplicity of consumer products containing this compound.
In community B, the superintendent of the school district attended the meeting, having been alerted to the results by the study PI. The superintendent and several attendees commented that the findings might have implications beyond the study families and perhaps the county. The superintendent remarked that CCHMC is a trustworthy institution, inferring that there would be follow-up if health concerns came to light.
Three percent of the study families from community A and 41% of the study families from community B attended the meetings in their respective neighborhood school. Seventy-eight percent of the families attending the meetings completed a one-page evaluation of the program. Respondents generally felt the program met their expectations, that the information was presented in a manner they could understand, and that questions from the audience were answered satisfactorily. Respondents expressed interest in learning more about the study findings, both individual and aggregate results, especially from the psychosocial questionnaires as well as the exposure biomarkers, hormone analyses, and maturation assessments. As with the topics addressed in the question-and-answer period, respondents wanted more information about PFOA and ongoing updates. We mailed meeting-specific information packets to those study families who could not attend the meetings.
The UC Department of Public Relations and Communications had been alerted in advance about the family meetings. A press release was drafted should the need arise for a more public statement concerning the findings. Soon after the family meetings, members of the research team met with relevant water district personnel in Greater Cincinnati to notify them of the biomarker findings and to inquire about the availability of local water sample analyses for PFCs. Officials assisted us with information about their water intake sites along the Ohio River, purification technologies at each treatment facility, quality control standards, and the geographic distribution boundaries of each facility.