Attachment_1_-_FINAL_PWS_Post_OGC_Comments.pdf

PERFORMANCE WORK STATEMENT

EPA’S SUPPORT FOR PEER REVIEW AND RISK ASSESSMENT ACTIVITIES

I. INTRODUCTION

The Environmental Protection Agency (EPA), Office of Research and Development (ORD), recognizes the importance of collaboration with other agencies and the public as active participants in matters of scientific and technical peer reviews. Open meetings characterized by public participation provides a measure of popular support by ensuring that community environmental concerns are addressed. Peer Review activities promote learned assessment of EPA’s scientific and technical products, a consideration of paramount importance in establishing the legitimacy and integrity of the Agency. As an assurance of integrity, and scientific acceptance, external peer review of Agency products is an important component of the scientific process. It provides a focused, objective evaluation of a research proposal, publication, risk assessment, health advisory, guidance, or other document prior to its dissemination or use by the agency. The criticism, suggestions and new ideas provided by the peer reviewers stimulate creativity, whereby the product is strengthened and its direction more certain having weathered scientific discussion and scientific community acceptance.

II. OBJECTIVE

The contractor shall provide all facilities, equipment, supplies and services necessary to perform, in accordance with all applicable laws and regulations, external peer review of Agency products, both scientific and technical, and associated support services. Scientific and technical peer reviews shall be conducted by individuals holding scientific and/or technical expertise in disciplines relevant to the subject matter being reviewed. Peer reviews shall ensure that the most important literature has been reviewed and that the review has stated the scientific evidence correctly. Secondly, the contractor shall assess the correct use of scientific and technical evidence for the development of a new theory or providing further research concerning an existing theory. The contractor shall perform scientific and technical analysis, to include situations where the result may be unknown. In these instances, the objective of the review is to provide the most plausible scientific explanation for the occurrence.

On exceptional occasions, the contractor may be requested to perform an assessment of an occurrence or provide a rapid response assessment from field reports, or literature, where the objective requires not only the application of sound science but immediacy of action to produce an analytical report or to identify the most recent applicable literature under very short turn-around times, either or both, as to the development of the proposal or the provision of support. As requested, the contractor shall identify the most plausible scientific explanation or the existence of literature or reports, relevant to the matter at issue.

External scientific and technical peer reviews shall ensure proper usage and conceptual soundness of technology, science, and methodology, and establish the validity of results obtained through the use of the

Agency’s products. The contractor shall communicate these findings in scientifically and technically sound assessments and products suitable for use by EPA Program Offices and external customers.

The scope of permissible objectives under this contract is intended to be broad-based and sufficient to perform across scientific disciplines, encompassing a wide-range of environmentally applicable peer review support services, to specifically include administrative support and logistical assistance in support of scientific workshops and meetings where potential or previously reviewed issues are likely to be raised for peer review, or where the subject of concern involves issues that have already been through the peer review process. Logistical support, as provided above, shall include all necessary actions taken to facilitate, plan, arrange, staff, and conduct workshops and meetings to support the peer review process, to include developing documents and issue papers relevant to the proper conduct of peer reviews, and preparing instructional materials for reviewers sufficient for the communication of Agency guidelines and principles. The contractor shall perform literature searches to insure the consideration of the most recent scientific literature.

III. TECHNICAL SUPPORT REQUIREMENTS

All work under this Performance Work Statement (PWS) will be ordered through Task Orders (TOs) issued by the Contracting Officer (CO). Pursuant to these TOs, the contractor shall perform the following tasks in support of the above-described objective:

A. Peer Review Services

A.1. The Contractor shall perform scientific/technical peer review of documents and materials related to the following:

- Agency work products

- scientific and technical papers and reviews

– health effects assessments of chemical substances that include the derivation of references doses, reference concentrations, inhalation unit risks and oral slope factors developed in accordance with

EPA assessment guidelines

– health and/or ecological assessments, guidelines, and reviews that may be designated as Highly

Influential Scientific Assessments (HISA) or Influential Scientific Information (ISI) that must be peer reviewed in accordance with the OMB Final Information Quality Bulletin on Peer Review

– research plans and proposals

– preparation of instructional materials to communicate guidelines and standards

– chemical-specific hazard or risk assessments for regulatory actions

– site specific, place based, or regional based health or ecological assessments

– documents that include toxicological reviews on hazard identification, dose-response information and risk characterization, human health and ecological risk assessments, cancer and non-cancer assessments provisionally developed for Superfund Risk Assessors, and various statistical methodologies

– scientific issue papers, methodologies, and procedures that advance the state-of-the-science of hazard, exposure, and risk assessment concerning health and the environment

A.2. When conducting peer reviews, the contractor shall follow EPA’s Science Policy Council Handbook on

Peer Review, (EPA/100/B-15/001, October 2015, 4th Edition), or the most recent rendition of that handbook.

The Handbook can be found electronically at the EPA website, https://www.epa.gov/sites/production/files/2015-

10/documents/epa_peer_review_handbook_4th_edition_october_2015.pdf

A.3. The number of reviewers required and their qualifications will be provided in the task orders and their qualifications may vary with the technical nature of the product. Individual peer reviewers shall have expertise, national or international, in mission related areas which include, without limitation: risk assessment methodology; toxicology; microbiology; infectious diseases; statistics; epidemiology; biomathematical modeling; pharmacokinetics; software modeling; exposure modeling and assessment development; risk characterization; developmental toxicology and mutagenicity; pulmonary toxicology; dose response assessment;

physiology; chemistry; biology; ecology--including terrestrial systems, aquatic systems, combined aquatic and terrestrial systems, landscapes, particular species of flora and fauna, and industrial ecology; economics--including cost benefit analysis; and regulatory impact analysis.

http://www.epa.gov/sites/production/files/2015-http://www.epa.gov/sites/production/files/2015-http://www.epa.gov/sites/production/files/2015-

A.4.The contractor may be required, as identified in the task order, to provide the public opportunity to recommend peer review panel members. As the contractor assembles a proposed peer review panel, the contractor shall review and consider public recommendations. EPA will publish a Federal Register (FR) Notice to announce the availability of the document to the public, including a request for public comment and a link to

EDOCKET (EPA’s freely available electronic official public docket and comment system) for the submission of public comments. The FR notice will also include an invitation for the public to observe the panel meeting and orally comment.

A.5. The contractor shall direct panel reviewers to EDOCKET at http://www.epa.gov/edocket to access and view the comments submitted by the public after the close of the public comment period which may be 10 days prior to the panel meeting date. Panel reviewers shall be instructed to consider the public comments that address significant or technical issues relevant to the document under review. Panel reviewers shall not respond to the individual comments. The panel review experts shall use the public comments to help prepare for participation in the panel discussions. Comments received after the initial closing dates shall not be considered by the reviewers.

A.6. The contractor may be required, as specified in the task order, to provide the public opportunity to comment on the peer review panel composition. Subsequent to EPA’s acceptance of the comprised expertise of the proposed peer review panel members, the contractor shall make publicly available a description of the proposed peer review panel, the contractors’ statement as to why they judge the peer review panel to be without conflict of interest and either without significant bias or with any such bias appropriately disclosed and balanced. The contractor shall invite public comment on the makeup of the proposed peer review panel with respect to expertise, conflict of interest and bias. The contractor shall assemble and consider comments received, and make any further adjustments that the contractor believes are supportable and appropriate, to the peer review panel. Copies of any comments received shall be provided to the EPA Task Order Project Officer.

A.7. The contractor shall submit peer review written comments, with all supporting materials, such as additional references or suggested approaches, to the EPA PO and/or TOPO. Review packages submitted by the contractor to EPA shall include: written general comments and specific changes or revisions required to improve clarity and scientific changes or revisions required to improve clarity and scientific accuracy of documents or products; any new data that might contribute to the derivation of improved processes and procedures; and other scientific and technical materials that may be pertinent. The contractor shall also be available to clarify any peer review comments and recommendations.

A.8. For reports that include peer review panel recommendations, the contractor shall: (1) explain and rank the policy or action alternatives; (2) describe the procedures used to arrive at the recommendations; (3) summarize the substance of the peer review panel deliberations; (4) summarize any peer review panel dissenting views; (5) list the sources relied upon; and (6) provide any other information necessary to make clear the methods and considerations upon which the recommendations are based.

A.9. The Contractor shall submit the peer review documents to the Task Order Project Officer (TOPO) in final form. All final peer reviews submitted shall include copies of the literature cited or make reference to the citations in the document for the PO to verify and approve.

A.10. Contractor(s) will be provided an account in HERO (Health and Environmental Research Online) for purposes of this contract, with access to scientific literature. Copyright law of the U.S. (Title 17 U.S. Code) governs the making of reproductions of copyrighted material. Section 107 of the copyright act instructs that, http://www.epa.gov/edocket

“the fair use of a copyrighted work for purposes such as … research, is not an infringement of copyright.” The

Contractor is liable for any infringement. To set up the HERO account, the contractor shall send an email to hero@epa.gov – and include the following information: names, addresses, phone numbers, emails of all contractors needing HERO accounts, project name, start date and end date. The contractors will receive their

HERO account information, with user documentation, within 3 business days.

B. CONFLICT OF INTEREST

B.1. The contractor shall insure that all peer reviews are conducted in a manner so as to avoid all actual or potential conflicts of interest, including the submission of conflict of interest certifications consistent with contract requirements (See: Exhibit 1 - Conflict of Interest Evaluation for Task Orders for sample content.

Actual questions/COI content may vary by individual Task Order). The contractor shall follow NCEA’s peer review guidance about screening and documenting COI and the appearance of a lack of impartiality (See

Exhibit 1), and EPA’s Conflict of Interest Review Process for Contractor-Managed Peer Reviews of EPA

HISA and ISI documents (https://www.epa.gov/sites/production/files/2015-01/documents/epa-process-for-contractor_0.pdf), as applicable. The contractor shall provide EPA a letter for each panel peer review attesting to the absence of any conflict of interest (COI) or providing disclosure with regard to any appearance of a lack of impartiality, together with the contractor’s plan of action in mitigation of any perceived conflict of interest

(See: Exhibit 2).

B.2. Each peer review shall include a report providing the following information in support of the selection of external peer reviewers:

B.3. Identifying the task order number, and the information as applicable to the selection of external reviewers, the contractor shall provide the TOPO with the affiliation, qualifications, and a short academic and professional biography for each of the specified or necessary number of candidate reviewers. The contractor shall ensure that the candidate reviewers meet the technical qualification criteria and determine if any conflict of interest or appearance of a lack of impartiality exists. During the reviewer screening process, the Contractor shall conduct a simple Internet search for public comments made by each potential panel member as another source to identify if any COI or an appearance of a lack of impartiality exists.

B.4. The contractor shall certify in writing that the selected reviewers are free from any conflict of interest or any appearance of conflict, as would create reasonable question as to the ability of the selected reviewer to impartiality exercise independent and unbiased professional judgment in the performance of the work to be performed. The statement as to absence of conflict shall be made/confirmed as, dependent upon the work provided under the task order, but not less often than:

1. within 1 week of the initial conference call as specified by individual Task Order Performance

Work Statements (PWS) (via letter to EPA, see template for the selection of peer reviewers letter);

2. two weeks before the meeting (notice of recertification); and

3. the day of the meeting (notice of recertification).

B.5. The contractor shall instruct peer reviewers to report any changes that would impact their COI or impartiality status anytime during the performance of work and the contractor shall immediately notify the CO, the PO, and TOPO of any change in report status.

B.5.1 The Contractor shall provide a COI certification letter that includes a list of (insert

#) prospective reviewers within 1 week of the initial conference call described above. The letter shall mailto:hero@epa.gov mailto:hero@epa.gov https://www.epa.gov/sites/production/files/2015-01/documents/epa-process-for-contractor_0.pdf https://www.epa.gov/sites/production/files/2015-01/documents/epa-process-for-contractor_0.pdf certify that either no COI or appearance of a lack of impartiality exists or such has been resolved for each prospective reviewer (see template mentioned above). For each prospective reviewer, the submission shall include:

(1) The reviewer’s short academic and professional biography, and a brief paragraph to support their selection (technical expertise).

(2) Reviewer’s indication of availability and willingness to provide the review in the specified time frame.

(3) Certification of no conflict of interest or appearance of a lack of impartiality

B.5.2. Within 3 working days of receiving the TOPO’s comments on the draft list of reviewers, the

Contractor shall select and enlist the services of reviewers.

B.5.3 Two weeks before the peer review panel meeting, the contractor shall send each of the reviewers a copy of his/her completed COI questionnaire with a request to certify that the responses have not changed or to report any COI or impartiality changes which may impact his/her ability to participate.

Each reviewer shall sign and return a COI recertification to the contractor. After the re-certifications are received, the contractor shall notify EPA in writing and report any changes in a reviewer's conflict of interest or lack of impartiality status.

B.5.4 The day of the peer review panel meeting, the contractor shall provide written re-certification at the panel meeting to ensure that the panelists’ responses to the COI questionnaires have not changed impacting their conflict of interest status or lack of impartiality status.

C. Workshop and Meeting Support Requirements

The Contractor shall perform the following activities relative to peer review meeting/meetings that are not explicitly peer review or scientific workshop/workshop support as provided in the approved TO:

C.1. Pre-Workshop/Meeting Support:

(a) Identify attendees. Organize and provide support in arranging workshops, meetings, and presentations by individuals to address issues and concerns raised by the peer review and/or as requested;

(b) Arrange for workshops and meetings to be held at EPA office locations or other geographical sites specified in the TO;

(c) Arrange for facilities necessary to support equipment, agenda development and other logistical support including: tape recording, audiovisual, computer, photo-copying, and operation of audiovisual equipment, microphones, and lighted pointers (all photocopying shall adhere to the

Printing, EPAAR 152.208-70) (OCT 2000) DEVIATION);

(d) Select hotel and arrange for rooms for workshop participants as necessary;

(e) Develop registration process and materials needed for pre-workshop/ meeting and onsite activities, e.g., registration and distribution of workshop/ meeting materials, agendas, literature, information pamphlets, etc. to participants;

(f) Inspect meeting and workshop site with site personnel checking all facilities, furniture, equipment, and signs to ensure facilities are appropriate and sufficient to handle meeting/workshop and attendees’ requirements; and

(g) Provide identification badges for workshop and meeting attendees.

(h) The Contractor shall clearly identify itself as an EPA contractor. When in attendance at meetings, such identification shall include wearing identification that is different than the badges used by seminar attendees or Agency personnel attending or speaking at the meeting. Contractor personnel shall identify themselves as such when placing calls in conjunction with activities of the PWS.

C.2. Post-Workshop/Meeting Support

(a) The Contractor shall obtain all post-meeting/workshop comments, collect and compile all comments and suggested document revisions, transcribe meeting proceedings where required, and obtain all new hard copy references with distribution of copies as specified in the TO.

(b) Distribute draft proceedings summaries to the peer reviewers and/or participants for comment.

Distribute revised proceedings summaries to the PO/TOPO for review to ensure completeness and clarity before development of final document.

D. Document and Issue Paper Preparation

The contractor shall develop documents and issue papers in the areas specified in the TO. The proposed scientific and technical authors shall be recognized nationally or internationally in their field and have both a general knowledge, as well as the specific knowledge, expertise or experience as specified in the TO. The selected author/ consultant must have experience that includes authoring several journal articles or other technical documents that specifically relate to the topic. During the development of the documents, guidelines, or issue papers, the contractor may be required to meet and discuss the document. Subjects of documents, guidelines, or issue papers vary widely and will be defined specifically by the TO.

E. Literature Search Requirements

The Contractor shall provide pertinent articles in science and economic peer-reviewed journals, reports, proceedings of scientific, technical and economic conferences, monographs, books, or other documents such as those prepared by select committees or bodies. Examples include the National Academy of Sciences, the

National Science Foundation, the American Association for the Advancement of Science, the EPA Science

Advisory Board, the Society of Occupational and Environmental Health, the Society for Environmental

Toxicology and Chemistry, the Ecological Society of America, ASTDR Profiles, Society of Toxicologist, Society of Risk Analysis, ASTM, American Academy of Pediatrics, and other relevant professional and academic sources germane to specific peer reviews. The Contractor shall conduct extensive searches of all relevant databases and perform exhaustive literature searches pursuant to specific TO’s. The Contractor shall conduct computerized and manual literature searches, retrieve pertinent articles, and provide abstracts and summaries as in the manner indicated below:

Using databases specified in the TO, search the periodical literature for the specified period;

Using HERO, a U.S. EPA National Center for Environmental Assessment application database system containing bibliographic references used in assessment development process. HERO currently includes over 300,000 bibliographic references; 95% are articles from peer-reviewed scientific research journals.

For the period specified in the TO, searching for domestic and international non-periodical literature such as books, technical reports, monographs, and conference and symposium proceedings;

Searching for all secondary sources as specified in the TO;

Searching the proceedings from conferences, meetings and seminars, relevant documents (available from the Library of Congress, Congressional Reporting Service, the Government Printing Office), and academic sources (e.g., published and unpublished dissertations and theses);

Preparing an abstract of 150-300 words for each relevant article found. The abstract shall include purpose, summarize major findings, and provide principal conclusions and recommendations;

Using Internet capabilities to search and acquire information pursuant to an individual TO; and

Providing copies of all literature cited.

During examination of the identified literature, the Contractor shall place primary emphasis upon the adequacy of study design, quality control, and interpretation of study results, and determine the article’s relevance to a peer review.

F. Risk Assessment Guidelines Training

The EPA’s Risk Assessment Forum conducts training for EPA staff on the use of the guidelines in conducting risk assessments. The guidelines training program is designed to facilitate the transfer of risk assessment information and methods to EPA risk assessors and interested outside parties such as state officials and outside contractors. The Contractor shall develop a new generation of user workbooks, facilitator handbooks and other training materials for the Risk Assessment Guidelines training courses, as specified in approved TOs.

IV. DELIVERABLES AND SERVICES

The Contractor shall deliver complete comments as specified in the TO's to assure that they facilitate rapid assimilation and possible quick action by EPA. Deliverables will be used to improve the quality of planned and current research projects and to assess the scientific and technical accuracy of completed and current work before dissemination outside EPA. Deliverables are due as specified in the TO.

The Contractor shall:

Provide high quality peer reviews and workshops in the research areas specified by individual TOs;

Maintain the capability to provide such peer reviews and workshops as needed, document qualifications of personnel, and ensure performance of the work in accordance with EPA guidance;

Disseminate existing EPA supplied and specified documents as referenced in accordance with the TO;

Arrive at firm conclusions or recommendations, with supporting documentation and/or analyses;

Coordinate peer review findings with EPA and other selected individuals through tele-conferences, work-shops, and meetings involving the PO and the TOPO, to clarify specific scientific points made by a peer review panel, and to document views and scientific judgments made by peer reviewers as specified in the TO;

Provide full and accurate accounting of all work ordered as required;

Document peer review procedures used to ensure that all specifications as set forth in the TO are met;

Maintain a record of ongoing and completed peer reviews, and devise a system for documenting all peer reviews conducted; electronic copy of progress report on each task order shall be sent to the CO, PO, and the designated TOPO.

Provide follow-up information to peer reviewers, the CO and the PO;

Certify that no real or apparent conflicts of interest exists; in accordance with contract requirements.

Develop documents, issue papers and conduct literature reviews in the areas specified in the TO.

Provide pre-meeting and post-meeting workshop support including the planning, arranging, administering and conducting of required workshops and/or meetings.

Copies of all deliverables shall be sent to the PO and TOPO in electronic copy (MS Word or Excel, Office 97, or higher, along with a portable document file (.pdf) copy. The deliverable will include, but not be limited to the task order title along with the task order number). This information shall be submitted in accordance with the format specified in the TO. In all matters, the Contractor shall perform in a manner that will ensure consistency of procedure and practice in support of the requirements of this Performance Work Statement

(PWS), and ensure consistent completion of all deliverables in accordance with the task order (TO).

V. ACCEPTANCE CRITERIA

A. General

Risk assessments for human health and ecological impacts follow the U.S. EPA Guidelines for Human Health and Ecological Risk Assessments. Risk assessments are important in environmental decision-making because of the high cost of eliminating environmental risks associated with their causes and the necessity of making regulatory decisions in the face of uncertainty. As a result, an assessment of the social-economic impacts as well as the regulatory impacts is an important part of a complete risk assessment.

Human health and ecological risk assessments are technical analyses of many different kinds of scientific information of varying form and quality, all of which are used to characterize the expected risk to human health and the environment. Such risk assessment analyses may result in scientific assessments that are less certain

Page 10 of than ideal and therefore, must be clearly identified as to their inherent strengths and weaknesses of their data quality and conclusions. All peer reviews provided by the Contractor shall look closely at this information in order to fully examine the conclusions reached by NCEA in characterizing projected risks to human health and the environment.

The Contractor shall ensure peer reviewers provide:

1. Numerical assessments accompanied by a written description that is objective and balances the characterization of impacts given the quality of the inputs, including the socio-economic impacts and regulatory impact, contained in reports and regulatory documents;

2. Assess key scientific information and controversies on data and methods. A statement of confidence in the assessment shall identify and describe all major uncertainties, particularly those involving the quality of data;

3. Assess whether key scientific information and controversies on data and methods, e.g., use of certain quantitative methodologies is highlighted. A statement of confidence in the assessment shall identify and describe all major uncertainties, particularly those involving the quality of data along with comment on their influence on the assessment; and

4. Assess whether in describing stressor effects scenarios, information is presented on the range of impacts and on the evidence, incidence and level of physical, chemical or biological stressors. A statement on findings and conclusions shall be provided.

B. Written Products

The Contractor shall ensure that peer reviews are written in a clear concise style, with a logical organization and presentation of ideas and rationales, such as:

1. Use standard formats as specified in a TO;

2. Perform scientific and technical editing of all products;

3. Written products shall be free of grammatical, spelling and typographical errors and accurately summarize the information with correct and complete reference citations; and

4. Present scientific, technical, and all other relevant information in a consistent style that makes it easy for the reader to follow and pay specific attention to insure consistent and accurate information content, and appropriate data interpretation throughout the document.

Products not adhering to these standards or guidelines or substantially lacking scientific quality will not be accepted. All correspondence, reports, data (including electronic materials) shall be delivered to the Task Order

Project Officer following the completion of each task order. The Contractor shall use current EPA methods and guidelines for performance of work, unless otherwise specified. The Contractor shall provide written reports and all completed TO documents in Microsoft Word, Office 97 or higher, electronic formats of use the EPA standard software, submitted electronically via pdf unless otherwise stated in the Task Order.

EXHIBIT 1 - CONFLICT OF INTEREST EVALUATION FOR TASK ORDERS

The contractor shall include a conflict of interest certification in all task orders in accordance with EPAAR

1552.209-71 and the Section B Clause "Ordering Procedures".

Prior to selecting expert panelists/peer reviewers, the contractor shall perform an evaluation to determine the existence of an actual or potential COI for each proposed panel member. The financial and professional information obtained by the Contractor as part of the evaluation to determine the existence of an actual or potential conflict of interest is considered private and non-disclosable to outside entities except as required by law and/or regulation.

The contractor shall ensure that proposed peer reviewers will not have an actual or potential conflict of interest if they are selected to participate in a peer review. When determining if a proposed peer reviewer may have an actual or potential conflict of interest, the contractor should consider, among other things:

1) The sources and nature (obtained from a brief description of the work) of any compensated and non-compensated employment of the panel member and their spouse, including any government service for the preceding two years.

2) The sources of research support and project funding, including from any government source, for which the panel member served as the Principal Investigator, Significant Collaborator, Project Manager or Director during the preceding two years. For the panel member’s spouse, a general description of research and project activities in the preceding two years.

3) The compensated consulting activities of the panel member during the preceding two years, including the names of clients if compensation provided 15% or more of annual compensation. For the panel member’s spouse, a general description of consulting activities for the preceding two years.

4) The sources of compensated expert witness activities of the panel member and a brief description of the issue and testimony during the preceding two years. For the panel member’s spouse, a general description of expert testimony provided in the preceding two years.

5) The assets, including stocks, bonds, real estate, business, patents, trademarks, and royalties, for the panel member, their spouse and dependent children. Specifically, the financial holdings that collectively had a fair market value greater than $15,000 at any time during the preceding two year period (excluding, for example, a well -diversified mutual funds, money market funds, treasury bonds and personal residence).

6) Liabilities over $10,000 owed by the panel member, their spouse, and dependent children at any time in the preceding one year (excluding for example, mortgage on a personal residence, home equity loans, automobile and consumer loans).

7) A brief description of any public statements and/or positions of the panel member on, or closely related to, the matter under review.

8) A brief description of any previous involvement of the panel member with the development of the document

(or review materials) the individual has been asked to review (including previous peer reviews).

A brief description of any other information that might reasonably raise a question about an actual or potential personal conflict of interest or bias including any financial benefit that might be gained by the panel member (or anyone whose interests are imputed to the panel member) as a result of the outcome of the review.

EXHIBIT 2 – COI CERTIFICATION LETTER TO EPA

Date: Month Day, Year

To: EPA Contract Officer’s Representative (COR)

Contractor’s COI Certification Letter to EPA (Template)

From: Contractor Name

Contractor Company

Subject: Selection of Peer Review Panelists

For the External Peer Review of

Prior to potentially entering into any arrangement with a peer reviewer, [Contractor Company Name] has conducted a thorough evaluation to determine if the candidate reviewers pose a conflict of interest or an appearance of a lack of impartiality. Each candidate peer reviewer has provided answers to all questions of conflict of interest to date and all written information that [Contractor Company Name] collected shall be retained in [Contractor Company Name] ‘s files including an explanation of the suitability and rationale for including or excluding each final prospective panelist. In addition to the collection of written information, [Contractor Company Name] staff have conducted Internet searches for public comments made by each candidate reviewer.

With this letter, [Contractor Company Name] concludes and certifies that all prospective peer review panelists have adequately passed the COI evaluation process signifying that, in [Contractor Company Name]’s judgment, there is no significant evidence to trigger a COI finding for any of the prospective panel members listed below. [If a reviewer poses a conflict of interest but is considered possible to serve, the contractor shall report the COI and rationale to serve in this letter]. [Contractor Company Name] shall select and enlist the services of reviewers from the list of prospective panelists below.

Through [Contractor Company Name]’s continuing obligation to identify and report any actual or potential conflict of interest or an appearance of a lack of impartiality, [Contractor Company Name] ‘s files will document the results of each panelist’s recertification. If any actual or potential conflict of interest or appearance of a lack of impartiality is found, disclosure shall be made to the EPA.

Prospective Panel Members:

1. Name, Affiliation 6. Name, Affiliation

2. 7.

3. 8.

4. 9.

5. 10.

Date

(Contractor Official Signature)

(Print Contractor Name and Title)

This written certification has been prepared for EPA. By signing this letter EPA acknowledges that the contractor has certified that no conflict of interest exists or appearances of a lack of impartiality or all conflicts of interest have been reported. A copy of this letter will appear in the EPA Peer Review Record.

(EPA COR Signature)

(Print COR Name)

(EPA Peer Review Leader Signature)

(Print Peer Review Leader name)