14 September2016

Request for Project (RfP): Improving exposure assessment methodologies for epidemiology studies on plant protection products (PPPs)

Background

Retrospective assessment of exposure to plant protection products (PPPs) has been identified as the pivotal weakness of many epidemiology studies focusing on PPPs and the health of occupational users and broader agricultural communities. In particular, a reliable reconstruction and valid quantitative assessment ofexposures which have occurred many years in the past, has not been possible. Reasons for this include the complexity of exposure, its large variation, its seasonality, the significant impact of the formulation type and use of protective equipment, the type of application equipment, the lack of environmental measurements on past exposure circumstances, and the influence of the weather during actual application. In addition, self-reported exposure information is subject to recallbias. These problems are well recognized within the regulatory and scientific community and ECPA has rated the improvement of exposure assessment as the highest priority for epidemiological research investigatingthe potential effects of long term PPP exposure on health.

Epidemiology studies have used a wide range of methods to assess exposure to PPPs. Examples include: questionnaire data, geospatial modeling, crop exposure matrixes, job exposure matrices and human biomonitoring. Limited efforts to validate these metrics have been undertaken. In particular, early efforts were made to determine the reliability of self-reported use of PPPs among farmers (Blair et al. 2002, Engel et al. 2001). Biomonitoring studies have been used to evaluate behavioural determinants of exposure(Acquavella et al. 2006, Arbuckle et al. 2002, Bradman et al. 2007). While reducing the subjective recall of self-reporting and providing valid assessment of current exposures, biomonitoring data have less predictive ability for retrospective assessment of past exposures.

Crop-exposure matrices (CEM) have been used to assess occupational exposures in several agricultural cohort studies, but one recent study has shown very poor agreement between exposure assessed using two CEM approaches and self-reported exposure information (Brouwer et al. 2016). The CEM represents an adaption of the Job Exposure Matrix for which crops, instead of job titles are used as the basic unit of resolution. Residential exposures have also been imputed from the California Pesticide Use Reportfor a number of epidemiology evaluations(Shelton et al. 2014, Ritz and Costello 2006). Ritz and Costello (2006) conducted a small pilot study to validate theirestimate of environmental exposure to organochlorines, but it predicted only 6% of the variance of DDE levels and the validity of exposure metrics for short lived pesticides is unclear.

RFP objectives

ECPA is seeking proposals for projects that will contribute to a better understanding of the accuracy and validity of surrogate measures of PPP exposure. The proposed study should address some commonly used approaches for assessment of occupational or residential exposure by comparison with actual measurement of exposure. These measures could exploit de novo or existing data. For example,a biomonitoring study could assess the validity of ecologic exposure classification based upon crop applications. In this case, the PPPs selected for study should not have an appreciable background level in the general population. Alternatively, farmers’ recall of PPP use versus objective data could be evaluated. With a number of jurisdictions requiring PPP applications to be registered, farmers’ near-term and long-term recall could be evaluated against an objective source. The essential element to the proposed projectwill be good quality exposure measurement as the reference to validate, or otherwise, the surrogate(s) of exposure.

Output

A final project report should be prepared andshould contain an executive summary (approx2-4 pages), the main detailed report, a bibliography and attachments with detailed study data (if not contained in the body of the main report).

It is expected that the findings will be developed into at least one peer-reviewed scientific publication and be presented at suitable scientific conference(s).

Cost and Timing

Start in January 2017, duration 3 years

Budget in the range of €500,000 to €1,000,000

Applicants will be expected to justify the budget in terms of expected impact and scientific credibility. Ability to leverage other projects or sources of funding will be beneficial. The successful applicant(s) will have demonstrated expertise in this area and will have a track record of quality publications. Applicants should provide a detailed study plan with clear explanation of how maximum value will be obtained (see Project Proposal Form, available in Attachment 2 below).

Partnering/Co-funding

Applicants should provide an indication of additional partners and funding opportunities that can be appropriately leveraged as part of their proposal. Partners can include, but are not limited to industry, government/regulatory organisations, or research institutions. Statements from potential partners should be included in the proposal package.

Possible regulatory and policy impact involvements/Dissemination

Applicants should provide clear information on the fit of their proposal with theproject objectives stated above and an indication on how and where the proposal could contribute to current regulatory and policy developments of PPPs. Applicants should also include details of any plans for disseminating the project results, including scientific publications and conference presentations.

References

Acquavella JF, Alexander BH, Mandel JS, Burns CJ, Gustin C. (2006)Exposure misclassification in studies of agricultural pesticides: insights frombiomonitoring. Epidemiology; 17: 69-74.

Arbuckle TE, Burnett R, Cole D, Teschke K, Dosemeci M, Bancej C, Zhang J.(2002) Predictors of herbicide exposure in farm applicators. Int Arch OccupEnviron Health; 75: 406-14.

Blair A, Tarone R, Sandler D, Lynch CF, Rowland A, Wintersteen W, Steen WC, Samanic C, Dosemeci M, Alavanja MC.(2002) Reliability of Reporting on Life-StyleandAgriculturalFactorsbyaSampleofParticipantsintheAgriculturalHealthStudyfromIowa.Epidemiology;13: 94-99.

Bradman A, Whitaker D, Quiros L, Castorina R, Henn BC, Nishioka M, Morgan J, et al. (2007) Pesticides and their metabolites in the homes and urine of farmworker children living in the Salinas Valley, CA. J Exposure Sci Environ Epidemiol; 17:331-349.

Brouwer M, Schinasi L, Beane Freeman LE, Baldi I, Lebailly P, Ferro G,Nordby KC, Schuz J, Leon ME, Kromhout H. (2016) Assessment ofoccupational exposure to pesticides in a pooled analysis of agriculturalcohorts within the AGRICOH consortium. Occup Environ Med; 73:359-67

Engel LS, Seixas NS, Keifer MC, Longstreth WT, Jr., Checkoway H. (2001) Validity study of self-reported pesticide exposure among orchardists. J ExpoAnal Environ Epidemiol; 11: 359-68.

Ritz B, Costello S. (2006) Geographic model and biomarker-derivedmeasures of pesticide exposure and Parkinson's disease. Ann N Y Acad Sci;1076: 378-87.

Shelton JF, Geraghty EM, Tancredi DJ, Delwiche LD, Schmidt RJ, Ritz B, Hansen RL, Hertz-Picciotto I. (2014) Neurodevelopmental disorders and prenatal residential proximity to agricultural pesticides: the CHARGE study.Environ Health Perspect; 122(10):1103-9.

DEADLINE FOR SUBMISSIONS: Friday 4 November 2016

Project submissions should be emailed to ECPA, c/o Peter Day, by close of business, Friday 4 November 2016.

Applicants should use the relevant project proposal form, available in Attachment 2 below. Further guidance for applicants submitting proposals for this RfP is also available in Attachment 1 below.

Any queries regarding this request for proposal can be directed to ECPA, Peter Day, either by email, or by phone +32 2 663 7601.

Attachment 1: Guidance for Applicants - Request for Project (RfP): Improving exposure assessment methodologies for epidemiology studies on plant protection products (PPPs)

1. Background and objectives for RfP

Applicants should refer to the above Request for Proposal (RfP) description.

2. Applicant and eligibility

Applicants should use the Project Proposal Form (see Attachment 2 below) to submit a proposal for consideration for this RfP.

Proposals may be submitted by any European or non-European, for-profit or non-profit organisation, public or private entity, such as universities, research institutes, laboratories, and contract research organisations, units of national and local governments, with the necessary expertise and experience relevant for the RfP. Collaborations between experts and institutions are encouraged.

3. General guidance for proposals

Proposals should include a clear and detailed description of the approach to meet the objectives of this RfP, including parameters to be considered and the experimental methods to be applied.

Proposals should be received electronically by ECPA no later than close of business on the deadline, Friday 4 November2016. All applications will be treated in confidence. The Project Plan section must be no longer than 15 pages in length, not including cited literature, attachments, and appendices. All proposals must be prepared using the Project Proposal Form (Attachment 2). The proposal should be sent by email to the address mentioned in section 9.

4. Budget

Project costs are expected to be commensurate with project scope and should not exceed the budget indicated in the RfP. Proposals should include funds necessary to complete the full scope and deliverables including direct (staff, travel and living expenses, consumables) and indirect costs (overheads).

Reasonable and necessary travel and related expenses should be clearly specified. Applicants should include regular tripsto Brussels for the purpose of reporting onprojectprogress.

The budget section should also include costs for preparing manuscripts for submission to scientific peer-reviewedscientific journals.

5. Review criteria and selection committee

The scientific evaluation and selection of application(s)will be managed by ECPA. Applications that are complete and within the scope of the RfP will be assessed for their scientific merit and their relevance by a committee of expertsappointed by ECPA. The following criteria will be used to evaluate proposals:

  • Scientific merit and feasibility relative to the RfP;
  • Scientific relevance (relationship to other projects and relevant publications);
  • Experience and expertise of investigator(s) relevant to the RfP;
  • Broader relevance to the regulation of plant protection products (PPPs);
  • Proposed milestones/timelines;
  • Appropriateness of the budget/cost-effectiveness; and
  • Use of collaborators/ leveraging.

ECPA will inform all applicants of the outcome of the selection and whether their applications are successful or not.

6. Monitoring

After the selection is completed and the successful application(s)identified, ECPA will monitor the scientific qualityand progress of the project. The Principal Investigator for the application will be expected to regularly report progress during thecourse of the project, in a format and frequency to be agreed with ECPA. At the end of the project, a detailed report on the project and its findingsshould be provided by the Principal Investigator.

The results of the project should be submitted for publication in a peer-reviewed scientific journal. Preliminary or final results should also be presented atrelevant scientific meetings, conferences, and/orsymposia.

7. Contracting

Once the selection of the successful applicant(s) is made, a contract will be established between the applicant’srespective organisation(s) and ECPA. Projects are expected to begin immediately upon execution of the contract.

The project proposal submitted by the applicant will be included in the contract. Any substantial deviations in the projectmustnotified to, and approved by, ECPA.

8. Enquiries

More details about ECPA, our industry and our member companies can be found on

Any questions regarding the RfP should be directed by email to ECPA, Peter Day, by phone +32 2 663 7601.

9. Submitting applications, deadline for applications

Project applications should be submitted by email to ECPA, c/o Peter Day, by close of business, Friday 4 November 2016.

10. Application documents

  • Project Proposal Form (Attachment2)
  • Request for Proposal (RfP), described above.

Attachment 2: Project Proposal Form - Request for Project (RfP), Improving exposure assessment methodologies for epidemiology studies on plant protection products (PPPs)

Please note the following:

- Please limit your proposal to 15 pages.

- The completed form should be submitted as a Microsoft Word document by email.

- Additional documents such as curriculum vitae of the Principal Investigator (highlighting evidence of the expertise, and contributions to the areas of science and technology relevant to this proposal) and any additional references should be sent as annexes.

- completed form should be submitted to ECPA by the deadline: close of business, Friday 4 November 2016

PROJECT PROPOSAL FOR SUBMISSION TO ECPA REQUEST FOR PROPOSAL
Name of organisation (administering projects if approved)
Contact person details / Family Name
Title (Dr, Prof etc.) / First Name
Address
Telephone No. / Fax No.
E-mail
Title of the research proposal/RfP title
Add Collaborators as necessary (names and institutions) / Collaborator 1
Job title
Affiliation
Address
Email
Telephone No.
Fax No.
Collaborator 2
Job title
Affiliation
Address
Email
Telephone No.
Fax No.
Objectives of Proposed Project
Describe the objectives of the project and the advances that it represents in relation to the current state of the science, including a description of the mechanistic basis for the proposed research.
Work Content
Give a detailed scientific and technical description of the proposed project identifying the different options available to meet the objectives
Responsibility of Partners
Breakdown overall project into work packages with an indication of partners involved in each work package, their roles and responsibilities. The interrelationship between the partners and work packages should also be indicated
Project Management Structure
Give a description of the management structure (e.g. use of PERT or GANTT diagrams)
Specific milestones, decision points and timing
A clearly defined milestone plan, that identifies all critical decision points during the course of the research programme.
Details of similar ongoing or previous research (e.g., list of publications)
Partnering/Co-funding
An indication of additional partners and funding opportunities that can be appropriately leveraged as part of this proposal.
Fit with ECPA overall objectives/Possible regulatory and policy impact involvements/ Dissemination
Information on the fit of this proposal with ECPA’s overall objectives and an indication on how and where this research project could play a role in the regulatory and policy areas. Dissemination plans should also be laid down.

Please provide total budget as well as separate budgets for all participating organisations.

Indicative level of funding (€)
Summary of Support Requested (€) / Year 1 / Year 2 / Year 3 / Comments
Staff
Travel & Living Expenses
Consumables
Sub-Total
Indirect Costs
Total

Add Affiliations budget as necessary

Indicative level of funding (€)
Summary of Support Requested (€) / Year 1 / Year 2 / Year 3 / Comments
Staff
Travel & Living Expenses
Consumables
Sub-Total
Indirect Costs
Total

Please return completed forms and any supporting documentation to:

ECPA

c/o Peter Day

Ave E. Van Nieuwenhuyse 4

B-1160 Brussels

Belgium

By email,, before close of business Friday 4 November 2016

1