CTEC Comments on Draft Phase I Health Study Work Plan for Butte
The following letter was submitted by CTEC as part of the public commenting process for the “Draft Public Health Study Remedial Design Work Plan for the Butte Priority Soils Operable Unit (BPSOU)” prepared by the Butte-Silver Bow Health Department with EPA and consultants. The draft work plan and CTEC letter can be downloaded below.
Citizens can offer public comment on the draft health study work plan until December 30, 2012. Refer to Cialis alternative for details on how to submit comments.
Comments on the Draft Public Health Study Remedial Design Work Plan
for the Butte Priority Soils Operable Unit
CTEC appreciates the opportunity to comment on the Draft Public Health Study Remedial Design Work Plan for the Butte Priority Soils Operable Unit (Draft Plan). We believe that a scientifically rigorous health study can do much to develop an objective and commonly recognized understanding as to whether the Superfund Program is providing for a safe and healthful environment. Given Draft Plan’s overall importance to the Superfund project, we are, as you know, quite disappointed that you decided to take a more limited approach to public participation thus far. Moving forward, we wish to establish a more deliberative and collaborative working relationship. Accordingly, we submit these comments recognizing there are some things we may not yet understand and in a sincere effort to be constructive.
Overall, CTEC supports the near-term focus on evaluating biomonitoring data, and we are encouraged to see that the blood lead and other relevant data are being incorporated into a useable database. This is relatively easy to do and is perhaps most directly applicable to established EPA procedures for assessing exposure and risk. However, we find that the draft health plan does not fully live up to the mandated expectations. Our comments are therefore organized into two categories. General Comments focus on our overall assessment of the draft plan, and it identifies those broader elements we find lacking. The Specific Comments focus on aspects of the proposed biomonitoring plan that may benefit from more detailed consideration.
- No longer-term studies or conceptual strategy proposed: Section 4.1 of the Final Multi-Pathway Residential Metals Abatement Program Plan (RMAP) states, “Butte-Silver Bow will perform public health studies every five years for a period of 30 years” , p. 7. No studies beyond a report next year evaluating existing biomonitoring data are proposed. Only vague reference is given on page 1 of the Draft Plan to focusing “initial study resources” on evaluation of currently available information.
- Inadequate assessment of epidemiology information: Section 4.1 of the RMAP (p. 7) provides several different requirements for the health studies, including, “compiling and interpreting the morbidity and mortality statistics as an epidemiology study, and compiling and interpreting influencing factors (environmental or cultural) for mortality rates”. Only three paragraphs of the Draft Plan are focused on meeting these objectives (see page 2) with reference to brief summary of prior work done by ATSDR (provided in Appendix A). However, there is no critical examination of the thoroughness of ATSDR’s work. We note for example that one of the more common types of cancers caused by arsenic, squamous cell carcinoma, is not reportable and not assessed. What might be done to overcome this limitation? Also, non-cancer endpoints are not addressed. Lastly, the three paragraphs of Draft Plan text conclude with a reference to epidemiological studies that might be of interest to future public health studies, but no details are given as to if, when or how this interest might be addressed.
- Narrowly defined and poorly articulated study question: The study question is not clearly presented until page 16 of the Draft Plan (though shades of it are mentioned on pages 3 and 13). This presentation of the proposed study objective comes too late in the document and is too poorly constructed relative to typical scientific norms to effectively guide the document. Structurally, it seems inappropriate to have the study question dependent upon available data. Technically, the focus on exposure rather than health and the focus on lead, arsenic and mercury, seem too narrow. The types of questions that Terri Hocking related in his guest opinion to the Montana Standard are more meaningful to CTEC and more consistent with the proper structure of research questions (though we do not intend these to be CTEC’s proposed list of study questions):
- “Do we have higher cancer rates than other communities, and are they caused by environmental contaminants?
- Why are the contaminants of concern as defined by EPA limited to lead, arsenic, and mercury?
- Are there cumulative effects of environmental contamination of one or more chemicals of concern?
Is our drinking water safe?”
The drinking water concern is particularly relevant to those residents using well water.
Some of these types of questions are addressed, in part, in the Draft Plan, but is difficult to discern because of the structure of the document. Some of the needed information is provided in Section 2.1 while other information related to the same point is provided in Section 2.3. Regardless, we do not ask that the document must be re-written (other than as needed to address our specific comments below). We reiterate our shared understanding of the central importance of evaluating the biomonitoring data. However, the narrowly defined study question in combination with the structure of the document seems to distract from a compelling and coherent assessment of the above listed questions which are more central to the concerns of CTEC and the broader Butte community. Overall, the work reflects the efforts of applied environmental scientists and policy makers rather than public health research scientists.
- Minimal opportunities for future public involvement: Section 2.4.2 of the Draft Plan provides minimal opportunities for public involvement. While this minimal approach is perhaps adequate for the evaluation of biomonitoring data, with modest expansion as indicated in our Specific Comments, it is not sufficient to address the longer-term study needs as reflected by the kinds of questions mentioned in comment 3 above.
General Comment Summary and Proposed Actions: The core issue underlying our General Comments is the desire to constructively identify what kinds of epidemiological studies might be done in the future that would improve our understanding of the health protectiveness of the remedy. CTEC is concerned that thus far there has been inadequate involvement by qualified epidemiological researchers. A highly polarized, dueling science kind of debate has been going on this past year, often through the media, that has undermined public understanding of and trust in the science. While we support moving forward with the biomonitoring assessment, CTEC proposes a separate track to assess possible options for future 5-year health studies. We believe this process needs to start by more thoughtfully considering the kinds of questions the studies need to ask, better understanding the limitations of what existing epidemiology can do to answer the study questions, what kinds of new epidemiology data is maybe needed, and what other kinds of studies such as ongoing biomonitoring should be conducted into the future. Moreover, we strongly believe that a well designed, deliberative process of engagement between the agencies and affected, interested community members will do much to achieve a well-informed, common understanding of the healthful nature of the Butte community and any additional remediation needs for the Superfund Program moving forward.
p. 6, 1st paragraph, Section 2.1.2, Overview of the RMAP: The current plan for collection of arsenic and mercury biomonitoring data has not resulted in the collection of adequate data to evaluate the effectiveness of Superfund remediation. There should be a commitment to reconsider the current approach as part of a broader commitment to consider additional studies in future years, beyond the currently proposed blood-lead data evaluation.
p. 14-15, Section 2.2, Study Objectives and Approach: Three different metrics are proposed to assess the “efficacy of the RMAP”: summary statistics by year, time matched comparisons with other population(s), and comparisons across neighborhoods. However, the reasons for these metrics are not stated. Moreover, it’s unclear how the “efficacy of the RMAP” is to be assessed. Some restatement of the quantitative metrics for “mitigating harmful exposure” need to identified, such as those listed on page 7 of the RMAP with due consideration to recent reconsideration of what constitutes safe blood lead levels. It can then be shown how the three proposed metrics relate to this broader goal. While the first metric makes some sense for reasons that extend beyond the explanation provided in the text, the need for the next two metrics are not clear. The bottom line is that blood lead levels need to remain below acceptable levels, on a community wide basis, consistent with the expressed professional judgments of the CDC and EPA. We appreciate that lead exposures can remain elevated for the reasons stated at the close of this section on page 15; however, the section should end with criteria that would define unacceptable levels and the kinds of actions that would be considered to remedy such a finding. [Note: we recognize that some of this requested information may be covered in other sections, such as Section 2.3.2, page 17, but the repetitive structure of the document makes it hard to put it all together in a way that is clear, concise and not open to contradiction.]
p. 16, 2nd paragraph (not including bullets), Section 2.3.1, State the Problem: Verb tenses throughout this paragraph seem amiss with past and future work in confusing ways. Moreover, the text’s flow seems to be from past to future to present actions. Key here is the need to clarify what the agencies really propose to do regarding support and input to the study development. Is this referring only to this work plan and the proposed 2013 report, or is it to the future 5-year health studies. We suggest it should include the latter, and in either case, what kind of support is needed?
p. 17, 1st paragraph, Section 2.3.2, Step 2: Identify the Goal of the Study: Public participation should be integrated into this description for how any RMAP deficiencies are identified and responded to. In particular, CTEC seeks an active role in encouraging participation in the voluntary cleanup program. Also, the roles and responsibilities of various agencies in supporting/approving of response actions should be stated.
p. 17, 1st and 2nd bullets, Section 2.3.3, Step 3: Identify the Information Inputs: Please explain why “representative distributions” are needed as it relates to the planned assessment criteria. A community level response seems inconsistent with the individual level response identified on page 7 of the RMAP. Also, it seems you need representative data within neighborhoods rather than “within the Butte community” to meet the first line of evidence listed as bullet 1 at the bottom of the page. Please clarify what those neighborhoods are and why a neighborhood approach is important. Also, what about arsenic and mercury biomonitoring data needs? Also, enough is known to state at this point in the Draft Plan at some level of professional judgment if the available data meets your input needs, and if not, what needs to be done.
p. 17, possible new bullet, Section 2.3.3, Step 3: Identify the Information Inputs: Please address the potential for exposure via groundwater as another route of exposure.
p. 18, 2rd paragraph (not including bullets), Section 2.3.4 Step 4: Define the Boundaries of the Study: The area is restricted to BPSOU’s RMAP, but most of the data has been collected from the Butte-Silver Bow County; how are they to be compared? It seems the study boundary needs to match the areas for which there are data? Also, as we consider alternative studies beyond evaluation of available blood-lead data, the study boundary may need to be modified. Perhaps the study boundary needs to be stated in more general terms, the greater Butte community, with individual studies focusing on sub-parts consistent with the available data?
p. 18, 3rd paragraph (not including bullets), Section 2.3.4 Step 4: Define the Boundaries of the Study: Please clarify what is meant by “the target populations of interest are young children…and pregnant mothers.” Does this apply to all metals? Are others therefore excluded? CTEC believes that protections should be extended to all persons.
p. 19, 1st paragraph, Section 2.3.5. Step 5: Develop a Decision Rule: Why should statistical measures of significance be decided later? What factors might lead to higher or lower limits? At a minimum, the role of oversight agencies and the public in this important decision-making process should be detailed at this point in the document.
p. 19, Section 2.3.6 Step 6: Specify Tolerable Limits on Decision Errors: There are no limits specified in this section. Rather, what is given are more in line with Decision Rules. Also, it’s not clear why statistical differences across neighborhoods or comparative temporal trends across communities are needed. The central point seems rather to get blood lead levels down to acceptable levels for all people who chose to participate in the voluntary cleanup program.
p. 19, paragraph 4, Section 2.3.6 Step 6: Specify Tolerable Limits on Decision Errors: The three data needs seem to belong in a prior section. Again, more planning thought and assessment should go into this plan regarding the ability of existing data to meet the proposed decision rule needs. Otherwise, we risk a major change to the plan outside of the existing agency review and public participation process.
p. 20, Section 2.3.7, Optimize the Design for Obtaining Data: Reiterating the last comment, this plan should not be approved until these optimization tasks are complete. Details for how the quality assurance review of RMAP data is to be done should be provided. Reference communities (if really needed) should also be selected prior to approval of the plan. The public should have the chance to review and comment on these procedures.
p. 21, last paragraph, Section 2.4.2 Task 2 – Community Outreach: Given CTEC’s strong interest in this Draft Plan, the nature of our questions, and the redundant structure of the Draft Plan that makes it hard to follow (see the next comment for example), we request that the proposed open house also include a presentation and group discussion on the proposed approach. We think that will be the best way to resolve many of our comments.
p. 22, paragraph 7, Section 2.4.4 Task 4 – Data Compilation: More detail is needed on how confidential information is to be handled throughout this study. Appendix D only describes the transcription process, not the storage, analysis and reporting of data put into electronic files. Bits and pieces of good information are provided in pages 7 to 9, 21, 23 and Appendix D in ways that are hard to integrated and understand. Page 6 mentions “participant and neighborhood coding”, yet page 8 mentions names and addresses, among other fields of information in the data file. Questions on details remain, such as: how is coding done, how many people have access to confidential information, how is access controlled, how is biomonitoring data connected with yard and house data, and how is quality control in transcription being done? A discussion on these points may be more helpful than a written response.
p. 23, paragraph 5, Section 2.4.5 Task 5 – Quality Assurance Review: CTEC requests that public review be added to any and all parts of this Draft Plan that involve decision-making and agency approval.
p. 23, Section 2.4.5 Task 6 – Data Analysis and Reporting: Detail, perhaps alluded to elsewhere, is needed regarding agency and public participation review procedures associated with a draft and final report. Also, some reconnecting of the “recommendations for future improvements” to the five-year reassessment process may be appropriate.
Note: These comments do not consider Appendix C, Non-Superfund Public Health Study Work Plan Design; Phase One Summit Valley Air Quality Butte Montana. This was deemed outside the permissible scope of the TAG.
CTEC Board of Directors
Prepared by Steve Ackerlund, November 30, 2012 with review and input from CTEC.