Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
1.0 Introduction
URD using horizontal drilling and hydraulic fracturing are unlocking vast U.S. reserves of oil and
natural gas found in shale and other tight-rock formations. Developing energy from shale is an
advanced process that uses the latest drilling technologies and equipment. The growth of this
unconventional oil and gas development over the past decade has resulted in economic growth
and a surge in domestic oil production in the U.S.
The increasing use of this technology has brought with it concerns about potential
environmental and health impacts to communities where URD operations are taking place. Air
emissions near gas drilling sites have been measured in a number of communities1-2. Adverse
effects on infants and children (e.g., low birth weight, birth defects, cancer, asthma) and adults
(e.g., endocrine disruption, physiological and psychological symptoms) have been alleged.
Despite this, few epidemiology studies have been published to date, and no population-based
studies have been done which considered groundwater as the potential route of exposure3.
Epidemiology studies which were published relied upon ecologic measures of exposure and
secondary outcome data, and were limited by a lack of individual-level risk factor information4-5
as well as questions about outcome validity. While these studies have contributed to the
literature in this important area, causality cannot be assessed due to their methodological
limitations. This RFP seeks proposals for analytical epidemiology studies designed to further
research in this area beyond the ecologic, hypothesis-generating studies published thus far.
2.0 Scope
There are 3 phases of the project covered by this RFP. Note that a study area should be selected
which can support the data requirements described in Phases 1 and 2 below, and ultimately, the
formal epidemiologic analysis described in Phase 3. Given the complexity of the issue, multidisciplinary research and collaboration with other institutions that may have more expertise in
certain disciplines is encouraged.
It is anticipated that an independent Scientific Advisory Board (SAB) will be formed to help API
oversee the conduct of proposals funded by this RFP. API would periodically convene the SAB to
review study progress and reports, and to seek independent advice on all scientific aspects of
the study. It is anticipated that the SAB would comment on final protocols and deliverables, and
help provide critical input on decisions regarding both scope and scientific methods. API would
convene the SAB at particular times during the conduct of the study, but it is also envisioned
that the investigators could request input from the SAB via API.
Phase 1: Assessment of Personal Exposure. This phase involves characterizing chemical
exposures in either air, or air and potable water in residents living near sites devoted to URD. It
would include personal exposure measurements of individuals who live varying distances from
these sites, and could potentially include biomarkers of exposure. It is of interest to incorporate
the effects of factors such as distance from a URD site, topography, prevailing winds, distance to
other emissions sources, and characterization of emissions from these sources. Researchers
should also consider potential differences in exposure during the course of URD operations (well
construction, hydraulic fracturing and well production). This phase could potentially be
conducted simultaneously with Phase 2.
Phase 2: Assessment of health outcome data sources. The second phase involves identifying
and evaluating sources of health outcome data that can be used in a formal epidemiologic
study. Of interest are (a) individual data from predominant HMOs or other health care plans,
(b) publicly-available health records, or (c) primary collection of health data. For each source,
this phase would assess the suitability (i.e., completeness, quality, accuracy, appropriateness),
availability of the data source, and cost to acquire the data for epidemiologic research. It should
also address availability and cost to acquire individual health risk factor data or data on coexposures pertinent to the health outcome, potentially through subject interview. A sample of
data from the source(s) evaluated will be expected as a deliverable for this study phase, and will
be assessed in APIs evaluation of whether to fund Phase 3.
Phase 3: Formal epidemiologic analysis. The last phase is a formal epidemiologic analysis
including study and control areas from which exposure data were collected in Phase 1, and
which are of sufficient population size, and have suitable health outcome data as demonstrated
in Phase 2. We note that although most epidemiology research in this subject area to-date has
focused on birth outcomes, this RFP is open as to health outcomes studied. RFP responders
should describe the outcome(s) to be investigated and the rationale for choosing the
outcome(s). The proposed epidemiological study should be designed to test the causal
relationship between community exposure to URD operations and the selected health
outcome(s), rather than generating hypotheses or describing associations.
3.0 Deliverables
The Researcher will submit the deliverables listed below. Results from Phases 1 and 2 will be
reported to both an API subcommittee that will monitor the study and the SAB, and will provide
an opportunity for the Researcher to demonstrate that the exposure data collected and health
data source identified are sufficient for a formal epidemiologic study. API will obtain input from
the SAB in assessing the deliverables, reviewing the results and determining whether to fund
Phase 3. The assessment will examine whether the findings are generalizable across the
intended population, whether the population is of sufficient size to be useful, and the likely
scientific quality of a formal study. (RFP responders should refer to Appendix I for a list of
criteria API will use to assess study quality.) In the case of peer-reviewed publications, the SAB
and API will be given the opportunity to comment on the draft manuscript(s), but the
Researcher will be under no obligation to respond to comments on such drafts. API expects that
the Researcher will submit the manuscript(s) for publication shortly after receiving comments
from the SAB and API.
Specific deliverables are:
3.1
3.2
3.3
3.4
3.5
Assessment of suitability of exposure and outcome data for formal epidemiology study,
justification for further funding, and a draft protocol for the study, if a study is
recommended
3.6
3.7
Quarterly conference calls to provide progress updates, starting from three full months
after the award letter is sent
A statement explaining your interest in this project and how in your judgment the
special experience and skills of the members of your team make it exceptionally wellqualified to perform this work.
4.2
Copies of three to five studies previously authored by members of your team that
demonstrate experience in the area of environmental epidemiology and/or exposure
assessment adequate to successfully complete the work called for in this RFP.
4.3
The CVs of the principal investigator(s) and all of the senior technical staff to be assigned
to the project.
4.4
A detailed Scope of Work specifically describing the tasks that are proposed to be
executed in the preparation of the deliverables.
4.5
A detailed budget identifying the staff costs (per hour and projected number of hours)
for all technical staff to be assigned to the project, equipment and material costs, and
any indirect costs. This detailed budget will also provide by study phase, estimates of
the costs for each step identified in the Scope of Work.
4.6
A detailed timeline for completion of the study, including date the work will begin.
5.2
The Scope of Work proposed and the extent to which it will meet objectives of this RFP
5.3
5.4
The total cost of the bid, including the percentage of any indirect cost
5.5
The likelihood of a large well-documented epidemiologic study that can assess potential
health effects from URD.
If you are interested in this opportunity please email Dr. Patrick Beatty (contact information
listed below) of your intent to submit a proposal. The proposal should be no longer than 10
pages exclusive of supporting information (such as your statement of qualifications, curriculum
vitae or other materials you believe to be relevant to this engagement). APIs generic advice on
preparing a proposal to aid your efforts (Appendices A-II through A-IV) is attached. Please
contact Dr. Beatty should there be any questions.
API reserves the right to accept or reject any proposal without the assignment of reason
for doing so.
There is no provision for reimbursement by API of costs incurred by the bidder in
responding to this solicitation.
The bidder should acknowledge that if awarded the contract, she/he will:
o Function as an independent contractor in the conduct of this study, and assume
full responsibility for all actions, damages, injuries, etc.
o At all times comply with all laws, rules and regulations of applicable
jurisdictions.
In no case should any confidential or proprietary information be included in the
proposal.
6.0 References:
1. McKenzie LM, Witter RZ, Newman LS, et al (2012) Human health risk assessment of air
emissions from development of unconventional natural gas resources. Science of the
Total Environment. doi:10.1016/j.scitotenv.2012.02.018.
2. Bunch AG, Perry CS, Abraham L, et al (2013). Evaluation of impact of shale gas
operations in the Barnett Shale region on volatile organic compounds in air and
potential human health risks. Science of the Total Environment.
doi.org/10.1016/j.scitotenv.2013.08.080.
3. Adgate JL, Goldstein BD, McKenzie LM (2014) Potential public health hazards, exposures
and health effects from unconventional natural gas development. Environmental
Science and Technology. http://pubs.acs.org/doi/abs/10.1021/es404621d. Accessed:
May 22, 2014.
4. Fryzek J, Pastula S, Jiang X, et al (2013) Childhood cancer incidence in Pennsylvania
counties in relation to living in counties with hydraulic fracturing sites. Journal of
Occupational and Environmental Medicine. 55(7):796-801.
5. McKenzie LM, Guo R, Witter RZ, et al (2014) Birth outcomes and maternal residential
proximity to natural gas development in rural Colorado. Environmental Health
Perspectives. 122(4):412-417.
Appendix A-I
Criteria to assess study quality:
Accepted study design (e.g. cohort, case-control)
Properly selected exposed and unexposed groups (or cases and controls), with matching
or stratification of potential confounders (e.g. age, socio-economic status, smoking)
Clinical documentation of health outcomes or another form of verification of health
outcomes beyond self-reporting
Plausible exposure pathway scenario from source to receptor, verification of the
plausibility of the pathway, proper exposure metrics to reflect the pathway
Adequate control of potential selection bias, not self-selection
Adequate control of potentially confounding variables
Adequate statistical analysis, incorporating effects of confounding, interaction,
temporality, co-exposures, possible bias, model selection, etc.
Adequate population sizes with proper documentation of precision (preferably
confidence intervals)
Adequate control of exposure classification bias, quantification of bias or sensitivity
analyses
Proper interpretation of results with strengths and weaknesses properly reflected,
attention to internal consistency, coherence, multiple hypotheses testing, and
alternative explanation of effects (e.g. co-exposures, socio economic changes)
Appendix A-II
The following guidelines are for use by contractors in submitting proposals. The intent is to
make sure the scope of work, contract terms, and API requirements are clear to the contractor.
COST ESTIMATE, PAYMENT SCHEDULE, AND PROGRESS REPORTS
The prospective contractor should submit cost estimates, payment, and progress report
schedules suitable for analysis. Cost estimates accepted by API in the contract proposal stage
may be incorporated into the contract and become the basis for reimbursement during the
contract period.
Estimated contract costs shall include, in the order listed, the following cost breakdown:
Direct Labor
Fringe Benefits
Overhead (other direct costs not included in other line items)
Expendable Materials and Supplies
Travel
Capital Equipment (cost in excess of $500)
Other Costs (e.g., computer time rental, Photo copying, etc. - identify)
Subcontracts (including leases and rentals)
General and Administrative Expenses
Fee (if applicable)
Labor cost should be classified into appropriate categories (e.g. Project Director, Senior Staff
Engineer, Staff Engineer, Field Test Scientists, Research Assistant, Technical Assistant, Clerical,
etc.). The method of computing and applying hourly labor rates and overhead should be
described in sufficient detail to provide a basis for evaluating their reasonableness. Non-labor
cost estimates should include, but are not limited to, descriptions of materials and supplies,
information on proposed travel, a description of required capital equipment, the availability of
equipment already owned by the contractor, and the details of anticipated subcontracts.
Progress reports are required so that the department director or a designated representative
will have sufficient information to assess work in progress and the reasonableness of billings.
Appendix A-III
AMERICAN PETROLEUM INSTITUTE
PROPOSAL GUIDE FOR PROSPECTIVE CONTRACTORS
COST PROPOSAL
Direct Labor
Labor Category
Level of Effort
Hourly Rate
Total
Fringe Benefits
Overhead*
Direct Materials
Travel
Computer Costs
Other Direct Costs
(postage, phone,
etc.)
General &
Administrative*
Subcontract Costs
Fee
TOTAL COSTS
PROPOSED
Appendix A-IV
AMERICAN PETROLEUM INSTITUTE
PROPOSAL GUIDE FOR PROSPECTIVE CONTRACTORS
RESEARCH AND SPECIAL PROJECTS
PROPOSAL GUIDE
I.
SUBJECT
1. Designated Study or Project Title
II.
III.
MANPOWER REQUIREMENTS
1. Show man-weeks of effort to be applied to each task, and total level of effort
proposed.
IV.
PROGRAM DURATION
1. Give schedule of each task, and total time needed to complete project.
V.
COST
1. The proposal should present a fixed or not to exceed price for performance of the
entire study. The price should be broken down as described herein.
VI.
PROJECT ADMINISTRATION
1. Organization Chart
2. Biographic sketch of key personnel
VII.
CORPORATE QUALIFICATIONS
1. Corporate organization structure
10