RFPRiskAssessment11-10-2011.pdf

Request for Proposal

Services

USFS – Risk Management Services

Solicitation No.: AG-3187-S-12-0002

NAICS CODE: 541620

Due Date: December 12, 2011

Time: 10:00 AM (EST)

AG-3187-S-12-0002

WO Operations

Risk Assessment

TABLE OF CONTENTS

OVERVIEW…………………………………………………………………………………………………………………. 3

PART I—THE SCHEDULE…………………………………………………………………………………………………. 3

SECTION B--SUPPLIES OR SERVICES AND PRICES/COSTS……………………………………………………… 3

SECTION C--DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK………………………………………….6

SEED PROJECT STATEMENT OF WORK (SOW)…………………………………………………………………….20

SECTION D--PACKAGING AND MARKING

SECTION E--INSPECTION AND ACCEPTANCE

SECTION F--DELIVERIES OR PERFORMANCE

SECTION G--CONTRACT ADMINISTRATION DATA

SECTION H--SPECIAL CONTRACT REQUIREMENTS

PART II--CONTRACT CLAUSES…………………………………………………………………………………………22

SECTION I--CONTRACT CLAUSES

PART III--LIST OF DOCUMENTS, EXHIBITS, AND OTHER ATTACHMENTS…………………………………….29

SECTION J--LIST OF ATTACHMENTS

PART IV--REPRESENTATIONS AND INSTRUCTIONS……………………………………………………………… 30

SECTION K--REPRESENTATIONS, CERTIFICATIONS, AND

OTHER STATEMENTS OF OFFERORS OR RESPONDENTS

SECTION L--INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS OR RESPONDENTS……….. 38

SECTION M--EVALUATION FACTORS FOR AWARD………………………………………………………………. 45

Attachment A……………………………………………………………………………………………………………….. 49

OVERVIEW

This Request for Proposal (RFP) is issued by United States Department of Agriculture (USDA) Forest Service (FS)

– Washington Office (WO)-Operations, 1720 Peachtree St., NW, Suite 700, Atlanta, GA 30309, hereinafter referred to as FS, to obtain the services of one General "Prime" Contractor (GC), and also referred to as Offeror or

Contractor, who shall be singularly responsible to satisfy the terms of the resulting contract.

This requirement is for a national Indefinite Delivery Indefinite Quantity (IDIQ) contract for technical support for pesticide human health and ecological risk assessments, and environmental impact analysis and documentation as prescribed in the Scope of Work, herein. This will be a five (5) year contract, a base year with four (4) renewal option years. The contract ordering minimum is $30,000 and the overall maximum ordering limit for this contract is

$2,000,000.00 inclusive of all options. A single award is anticipated as a result of this solicitation.

PROPOSAL SUBMISSION INSTRUCTIONS –

See Section L – Instructions

The contract will be a Firm-Fixed-Priced.

This acquisition is in accordance with FAR 15 - Best Value Continuum. Award will be made to that offeror whose proposal is (1) technically acceptable and (2) technical/cost relationship is the most advantageous to the

Government. Evaluation factors other than price, when combined, are more important than price in the award decision. The critical factor in making any cost/technical trade-off is not the spread between the technical ratings, but rather, the significance of that difference. The significance of the spread of ratings will be determined on the basis of what the difference might mean in terms of the performance and what it would cost the Government to take advantage of it. Award may not necessarily be made for technical capabilities that would appear to exceed those needed for the successful performance of the work. The Government reserves the right to make cost/technical tradeoffs that are in the best interest of and advantageous to the Government. See Section L & M for further information.

SET ASIDE: Small Business Entities

Letter of Acknowledgment – Attachment A

Please complete the attached letter of acknowledgment (Attachment A), and forward to the Contracting

Officer at cncarey@fs.fed.us by December 2, 2011 to verify your intention to place a proposal and to be placed on the list to receive copies of questions and answers.

PART I—THE SCHEDULE

SECTION B--SUPPLIES OR SERVICES AND PRICES/COSTS

mailto:cncarey@fs.fed.us

SECTION C--DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

STATEMENT OF WORK (SOW)

TECHNICAL SUPPORT FOR PESTICIDE HUMAN HEALTH AND ECOLOGICAL RISK

ASSESSMENTS, AND ENVIRONMENTAL IMPACT ANALYSES AND DOCUMENTATION

INDEFINITE DELIVERY INDEFINITE QUANTITY (IDIQ) CONTRACT

I. INTRODUCTION

The United States Department of Agriculture (USDA) Forest Service (FS) is responsible for managing

National Forest System Land to provide a mix of goods and services to the public. Each Forest Land and

Resource Management Plan details specific resource management objectives and output goals. These plans provide for access to the national forests, livestock grazing, timber management, visual quality, water quality, and vegetation, wildlife and fish diversity. To produce these outputs some pest management and some vegetation management must be done. Different environmental conditions and different management goals and objectives determine the need for, and amount of, pest or vegetation management to be done.

In order to implement any pest or vegetation management program the USDA Forest Service must comply with the National Environmental Policy Act (NEPA) of 1969 as amended (40 CFR 1500-1508).

This law requires the completion of an environmental analysis for each action which may have significant impact on the human environment. In the event that data are incomplete or unavailable for the preparation of an analysis, the law specifically requires that an assessment be made to evaluate potential risks in the area of uncertainty (40 CFR 1502.22).

Pesticides, including herbicides, insecticides, fungicides, and many other materials, including semiochemicals, form a significant set of tools in the land manager's tool kit. Pesticidal agents are often the most effective tools available to combat a vegetation or pest problem. Unfortunately, significant data gaps exist for some pesticides and semiochemicals proposed for use. Under the law, and in response to the need to be good stewards, the significance of this missing information must be determined prior to evaluation of project alternatives which propose their use.

To provide the basis for evaluating the human, wildlife, other non-target organism and environmental risks in current or future pest or vegetation management programs, information is needed about: the inherent toxicological hazards of the pesticidal and semiochemical agents proposed for use; the exposure levels that project workers, the general public and specific at-risk groups, wildlife, non-target species and the environment might sustain; and the risks of adverse effects posed by the various hazard/exposure scenarios.

The Forest Service has, since the mid-1980s supported the development and deployment of Risk Assessments of chemicals proposed for use, which are compliant with the Council of Environmental Quality’s regulations for analyzing and providing an evaluation of reasonably foreseeable impacts of the potential use ―…based on theoretical approaches or research methods generally accepted by the scientific community.‖ (40CFR1502.22.b.3-4). To the present this program has been maintained via only two contractors, Labat-Anderson, Inc. (mid 1980s to early 1990’s) and Syracuse Environmental

Research Associates, Inc (SERA; mid 1990s to the present.) At present the body of this work includes risk assessments prepared for approximately 40 pesticides, several white papers, and two major computer tools, WorksheetMaker (a program which allows the generation of site specific RAs of the various chemicals for which general RAs have been developed) and GLEAMS Driver (a program which allows simplified [or full] access to the computing power of GLEAMS (a groundwater model which allows site-specific estimates of pesticide movement offsite after a treatment.) The contractor selected will (as tasked): generate original risk assessments or summary documents for pesticides not previously analyzed in the program, generate new useful tools to facilitate site specific risk analyses; maintain and improve existing tools; and, review and update existing risk assessments.

Under this contract, the Contractor shall provide a broad range of technical support to the FS. Examples of support needed include: the preparation of reviews of the science relating to specific pesticides and semiochemicals, the development of programmatic human health and ecological risk assessments, methods, and guidance, and the preparation of site-specific risk assessments. The Contractor shall also provide support for related activities and research to improve the science of risk assessment as necessary for FS activities, including developing methods and guidelines for assessing exposure to single pesticides, as well as complex exposures, e.g., exposures to multiple applications of pesticides, exposures to multiple pesticides or to mixtures of multiple pesticides, multiple-media (route) exposures of one or more pesticides,, and less-than-lifetime exposures to one or multiple pesticides. The Contractor shall also provide technical support and assistance on a variety of programmatic, site-specific, or up-to-the-minute risk assessment issues, and assistance in preparation of responses to Congressional, governmental (within and outside the Service), professional, and public inquiries relative to documents prepared under this contract, as required. This support and assistance may be in the form of, among other things, documents, letters, responses to comments, or expert testimony, generally relative to the prepared products. Some work assignments may require that the Contractor develop databases, software, or computer models to support the activities previously described. Specific areas of support are detailed below. All work required under this contract shall be defined in work assignments issued by the Contracting Officer (COR).

PART II. WORK REQUIREMENTS

A. GENERAL REQUIREMENTS

The contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). The contractor shall provide best-science Risk Assessments or summaries in other technical formats (as required) of the current knowledge relating to chemicals (both as technical grade materials and as formulated products) under consideration for use in Forest Service resource management programs; including, but not limited to, herbicides for silviculture work or control of non-native plants, insecticides for the control of invasive insect populations in the forest or seed orchard setting, fungicides for use in pest management in forest tree nurseries. In addition, as required, the contractor shall provide electronic tools which support application of the generalized risk assessments to project level site specific analyses being prepared by Forest Service units

The contract shall be an IDIQ (Indefinite Delivery Indefinite Quantity) contract with specific tasks being awarded by task order under that umbrella contract. Tasks shall be awarded as firm-fixed price awards.

B. CONTRACTOR REQUIREMENTS

The contract requires a commitment of time and resources of an interdisciplinary nature demonstrating expertise in all phases of risk assessment and in risk characterization, particularly of pesticides and semiochemicals and their respective application programs. The contract requires the preparation of technically sound and legally defensible documents, including human health, wildlife, non-target species, and ecological risk assessments that public officials and the general public can read and comprehend. It also requires the preparation of other documents, including technical papers requiring analysis and assessment of special issues of risk, including effects on sensitive subgroups, associated with the use of pesticides and semiochemicals. An essential part of the contract shall be the research and development of innovative methods to characterize unusual exposures and risks to humans and the environment from FS pest and vegetation management programs.

The contractor shall prepare documents using the most current information available, including current

FS program information and pesticide or semiochemical data. This will require that the contractor search all pertinent databases, current literature, published and unpublished data, and results of current research, and also contact Federal, state, local, and private individuals involved in current and recent research, monitoring and regulatory activities associated with pest control or vegetation management efforts or the tools used in those efforts. For each task, the Contracting Officer's Representative (COR) may provide a suggested list of individuals (not to be considered inclusive) that the contractor should contact, as stipulated in the work assignment.

The contractor shall also contact individuals who are specifically knowledgeable regarding the current regulatory status of the pesticidal agent’s most recent toxicological information as needed. This includes chemical product managers of each agent and toxicologists at the US Environmental Protection Agency, and the manufacturer's technical representatives or product managers.

For each document prepared, a list of all sources of information, including databases searched (with the search strategy) and persons contacted shall be provided to the Forest Service when the document is completed.

The contractor shall establish a quality control and quality assurance process for the conduct of each document. A high standard of accuracy, clarity, completeness and editorial excellence shall be required for risk assessments, and all other submissions, both in draft form and final form. The

Contractor shall prepare a draft of each document for Forest Service internal review and concurrently shall procure three external technical peer reviews. Review shall be accomplished and changes incorporated before submission of the final document to the COR for evaluation and subsequent modification or final approval. The contractor shall provide continuous interaction with the COR on progress/status and direction of the documents.

Contractor shall procure necessary literature as needed. Copies of all literature/references cited by the contractor in carrying out any of the work assignments shall be provided to the Forest Service with the first draft. Copies of any additional literature references that are used in preparing the final products shall also be provided to the FS with the final product.

Work assignments under this contract shall fall within the areas identified below. All initial products shall be delivered in draft form for FS review. Required revisions may be provided by FS to the

Contractor for incorporation into the final delivered product. FS reviews of draft RAs shall occur concurrently with the three external technical reviews, and shall result in appropriate modification of the draft during preparation of final documents.

1. Pesticide and Semiochemical-Specific Risk Assessments and Related Products

The Contractor shall evaluate, review and update, and/or develop various scientific documents, computer programs, and reports which will be used by FS to assess the nature and degree of hazard/risk posed by pesticidal and semiochemical agents in a variety of formulations from their use in FS pest or vegetation management programs. Specific tasks will include:

a. Prepare rapid and brief technical reports or summaries on new pesticides or those proposed for use in FS management programs in the style, scope, and format required in the work assignment. (In terms of turnaround time, "rapid response basis" will be defined per work assignment and will be dependent upon specific technical issue and its related time sensitivity.)

b. Prepare, for written or oral presentation, responses to inquiries regarding the risk posed by pesticides proposed for use in FS programs in the style, scope, and format required in the work assignment.

Pesticide or semiochemical-specific documents and reports shall provide a scientifically and legally defensible evaluation of the toxic potential of the agents. They must accurately reflect state-of-the-art scientific knowledge and provide a delineation of the nature and extent of all identifiable effects on human health and ecological condition, including effects on wildlife and other non-target organisms and general ecological effects, resulting from exposure to the subject agent.

Pesticide and semiochemical-specific reports shall include accurate summaries of available data in the areas of acute toxicity, chronic and subchronic toxicity (including neurotoxicity, immunotoxicity and endocrine system effects), carcinogenicity, mutagenicity, teratogenicity, and other reproductive effects.

In addition, reports shall include discussions of special issues, such as special groups at risk (such as, children, pregnant women and their fetuses, elderly, immune compromised, multiple chemically sensitive individuals, nutritionally deficient). Detailed discussions of the pesticide's or semiochemical's physical and pharmacokinetic/pharmacodynamic properties shall also be included. A comprehensive search of all the pertinent literature and data bases shall be performed when appropriate. The data shall reflect the latest scientific knowledge obtained. The literature shall be critically evaluated, and accepted

EPA methods (where appropriate) shall be applied to the data to evaluate human health and ecological hazard. These methods include the use of less-than-lifetime exposures, the calculation and application of oral reference dose (RfD) and inhalation reference concentration (RfC), and the calculation of cancer potency (unit risk) factors, if not previously established by EPA. If these risk values have been established by EPA, but the Contractor determines that there are compelling circumstances requiring that selected values should be different, then discussions shall be included supporting the change.

A listing of pesticides and other Chemicals that have been evaluated in the ongoing program which this contract will support is to be found on the Forest Service’s Washington Office, Forest Health Protection website at http://www.fs.fed.us/foresthealth/pesticide/risk.shtml. Worksheets supporting these risk assessments (from which methods in current use can be readily determined) are found at http://www.fs.fed.us/foresthealth/pesticide/worksheets.shtml.

http://www.fs.fed.us/foresthealth/pesticide/risk.shtml

2. Human Health Risk Assessments and Related Products

The Contractor shall evaluate, review and update, and/or develop various scientific documents and reports that assess the nature and degree of human health risk posed by pesticidal and semiochemical agents in a variety of media from their use in FS pest or vegetation management programs, or the human health risk from non-implementation of the same programs. Specific tasks will include:

a. Review and revise existing, and prepare new human health risk assessments to analyze the potential risk from either implementing or not implementing FS pest or vegetation management programs in the style, scope, and format required in the work assignment.

b. Prepare rapid and brief technical reports or summaries of the human health risk posed by new pesticides or those proposed for use in FS management programs in the style, scope, and format required in the work assignment.

c. Prepare site-specific human health risk assessments. These assessments determine the nature and magnitude of human health risk occurring for a specific management program at a specific site.

Work assignments shall require the Contractor to prepare specific critical documents and discussions of risk assessments or components of the risk assessment paradigm (i.e., hazard identification, exposure assessment, dose-response assessment, risk characterization) for specific pesticides or semiochemicals.

These documents and discussions may be required to document and support theoretical and/or empirical approaches.

The risk assessment shall be technically sound and legally defensible under NEPA and current case law.

It shall incorporate state-of-the-art, currently accepted risk assessment methodology and risk characterization processes. This will require a significant degree of flexibility on the part of the preparer to remain current with methods which are changing in the evolving risk assessment environment. In addition, under some circumstances, it may be necessary to develop creative and innovative methods to characterize risks.

The risk assessment shall, at a minimum, contain: a) a description of the Forest Service pest control or vegetation management program being evaluated; b) a hazard characterization; c) a dose-response assessment; d) an exposure assessment; and, e) a characterization of human health risks. The format used shall be guided by the need to clearly identify and characterize the risks and to produce a document that will be easy for the general public and public officials to read and comprehend. The actual format required will be provided in the work assignment for the specific task.

3. Non-target and Ecological Risk Assessments and Related Products

The Contractor shall evaluate, review and update, and/or develop various scientific documents and reports that assess the nature and degree of non-target species and ecological risk posed by pesticidal and semiochemical agents in a variety of formulations from their use in FS pest or vegetation management programs, or the non-target and ecological risk form the non-implementation of the same programs. Specific tasks will include:

a. Review and revise existing, and prepare new non-target and ecological risk assessments to analyze the potential risk from either implementing or not implementing FS pest or vegetation management programs in the style, scope, and format required in the work assignment.

b. Prepare rapid and brief technical reports or summaries of the non-target and ecological risk posed by new pesticides or those proposed for use in FS management programs in the style, scope, and format required in the work assignment.

c. Prepare, for written or oral presentation, responses to inquiries regarding the non-target and ecological risk of pesticides proposed for use in FS programs in the style, scope, and format required in the work assignment.

d. Prepare site-specific non-target and ecological risk assessments. These assessments determine the nature and magnitude of non-target and environmental risk occurring for a specific management program at a specific site.

Work assignments shall require the Contractor to prepare specific critical documents and discussions of risk assessments or components of the risk assessment paradigm (i.e., hazard identification, exposure assessment, dose-response assessment, risk characterization) for specific pesticides or semiochemicals.

These documents and discussions may take the form of theoretical and/or empirical approaches.

The process necessary for the development of ecological risk assessments shall require considerable creative thought and the ability to apply those ideas to innovative methods.

1. Technical Support, Research and Related Products

The Contractor shall prepare various scientific documents and reports to address special issues or to meet special work assignments that might arise. The deliverables may be in the form of: written memos or letters, verbal or written discussions, technical papers or documents, software, database management, expert testimony, literature research projects, training programs or materials. Specific tasks may include:

a. Prepare various memos, letters, discussions, or technical papers addressing continuing special issues or issues of immediate concern to the FS in the style, scope, and format required in the work assignment.

b. Assist in preparation of various memos, letters, discussions, or technical papers in response to inquiries to the FS from Congress, other governmental agencies, the professional community, the public and others regarding documents prepared under this contract, in the style, scope, and format required in the work

c. Provide expert testimony on topics (that may be controversial) that are the subjects of documents prepared by the Contractor.

d. Perform various analyses to support pesticide- and semiochemical-specific assessments such as the statistical analysis of laboratory, field testing, or monitoring data; comparison of field data to exposure modeling data; mathematical modeling to determine dose-response relationships; investigation and documentation of the relationship of exposure time to dermal absorption rate for specific pesticides as assigned; and the estimation of risk of adverse ecological effects or human health effects for given doses, durations, and species in support of documents being prepared for this contract.

e. Prepare site-specific exposure assessments. These assessments determine the nature and magnitude of human and/or environmental exposure occurring for a specific pesticide or group of pesticides at a specific site.

f. Research and develop innovative methods to characterize exposures or risks to program workers or the public from FS programs that, because of special circumstances, do not readily fit into the typical risk assessment paradigm.

g. Develop data bases, software, or computer models, and manage the on-going compilation of data, as required by FS needs, and as provided in the work assignment.

h. Provide training in basic risk assessment methods to FS personnel in a scope and format provided in the work assignment. This training 'may be at various locations, and may include the production and supply of training materials.

In the preparation of any of the scientific documents required by a work assignment, there shall be critical discussion of each topic, not just a synopsis of the literature, along with a concise summary of the topic.

As appropriate, statistical analysis and a discussion of the strengths and weaknesses of the particular subject shall be presented.

C. Scientific Review and Response to Comments

Documents prepared by the Contractor will be subject to intra- or inter-agency review, expert peer review, and/or public review. The Contractor shall provide appropriate scientific and technical support required to update or modify documents based on the results of these reviews. The Contractor shall provide the COR with recommendations for document revisions, clearly outlining the rationale for such recommendations. The Contractor shall be prepared to respond to comments and queries from within or outside the agency, including the public, the scientific community, or Congress, regarding the scientific integrity of any document prepared. The Contractor shall also be prepared to provide expert testimony and serve as an expert witness in courts, should that become necessary.

D. Science Writing and Risk Communication

The Contractor shall provide appropriate scientific and technical support to enable FS to successfully communicate risk assessment information to individuals and organizations within and outside of the risk assessment field. The Contractor shall prepare the information in a variety of formats to meet the specific needs of a range of audiences which may include scientists, decision-makers, those unfamiliar with risk assessment, as well as experts in the field.

Work products may include leaflets and brochures addressing a variety of topics, including pesticide and semiochemical background information, rationale for programs, process descriptions, health and ecological effects, and methods or results of human health and ecological risk assessments and related special issues.

III . PRODUCT QUALITY

A. General Requirements

The Contractor is responsible for quality control and quality assurance of all tasks and shall adhere to the procedures set forth in the QA Program Plan which has been incorporated into this contract. As required by the WORK ASSIGNMENTS clause in Section B of the contract Schedule, the Contractor· shall provide a statement with each work plan describing the procedures which shall be used to arrive at recommendations, and listing the sources and methods proposed for consideration.

Risk assessment (including hazard identification, dose-response, and exposure assessment and characterization) is a technical analysis of many different kinds of scientific information, all of which are used to characterize the expected risk to human health or the environment. Such risk assessment analyses may result in scientific assessments that are less certain than ideal and therefore must be caveated as to their inherent strengths and limitations. All risk assessment products provided by the

Contractor shall include information that will fully characterize the projected risks to human health and the environment and shall specifically adhere to the following:

1. Risk assessments shall be accompanied by descriptive information carefully selected to ensure an objective and balanced characterization of risk in risk assessment reports and documents.

2. Risk assessment information shall be clearly presented, separate from any non-scientific risk management considerations.

3. Key scientific information and controversies on data and methods (i.e., use of animal or human data for extrapolating from high to low doses, use of pharmacokinetics data) shall be highlighted. A statement of confidence in the assessment shall identify all major uncertainties along with comment on their influence on the assessment.

4. When describing exposure scenarios, information shall be presented on the range of exposures and on the use of multiple risk-descriptors, e.g., measures of central tendency, high end of individual risk, population risk, and important subgroups.

All written products shall be of high quality and written in a clear concise style, with a logical organization and presentation of ideas and rationales. In most cases standard formats shall be used as specified in the work assignment and provided by FS. The Contractor is responsible for scientific and technical editing of all products. Written products shall be free of grammatical, spelling, and typographical errors, and shall accurately summarize the information with correct and complete reference citations. Scientific information shall be presented in a consistent style that makes it easy for the reader to follow, and utmost care shall be taken to ensure consistent and accurate information content and appropriate data interpretation throughout the document. Products not adhering to these standards or guidelines will not be accepted.

C. Computer Products

Some work assignments may require· that the Contractor develop data bases, software, or computer models. In general, the choice of software shall be based on a balanced consideration of technical requirements, user interface issues, life cycle analysis, advances in computer science, and compatibility with existing systems. Specifically, all computer application development tasks must conform to current

FS guidance and standards as promulgated by the Office of Information Resources Management.

IV. LITERATURE SEARCH REQUIREMENTS

During the preparation of documents, reports, and other projects, the Contractor may, in addition to using scientific expertise available on the Contractor's staff or expert consultants engaged by the

Contractor, utilize pertinent articles in scientific journals, reports, proceedings of scientific conferences, monographs, books, or other documents such as those prepared by select committees or bodies (such as those convened by the National Academy of Sciences or the World Health Organization). To determine the extent and availability of information germane to specific tasks, the Contractor shall conduct extensive and exhaustive searches (consistent with project level of effort) of all relevant data bases.

Subject- or chemical-specific independent literature searches shall be conducted by the Contractor.

When such a search is required by a work assignment, the Contractor shall conduct computerized and manual literature searches, retrieve/procure pertinent articles, and provide abstracts and summaries as indicated below.

Search the periodical literature for the period prescribed by the work assignment, using data bases specified in the work assignment.

Search for the specified period domestic and international non-periodical literature such as books, technical reports, monographs, and conference and symposium proceedings.

Search for the specified period all secondary sources designated in the work

Search sources such as National Cancer Institute, National Institute for Environmental

Health Sciences, and the National Center for Toxicological Research, Inc. for unpublished or interim research reports relevant to the subject of the work assignment.

For some work assignments the Contractor may be directed to prepare an abstract of 150-

300 words for each relevant citation found. The abstract shall include the purpose, a summary of developments, and a recounting of the principal conclusions and recommendations from the citation.

During examination of the literature, the Contractor shall place primary emphasis upon the adequacy of experimental design, quality control, and interpretation of results of each study, and determine the article's relevance to the assessment of actual or projected exposure to and risk posed by the material under study.

Work assignment deliverables shall include a printout of the literature search annotated to indicate what was considered, retrieved or not retrieved, and the reasons why.

When examining studies, the appropriateness of a study for determining risk values (e.g., RfDs/RfCs and cancer potency) shall be considered and documented.

Primary literature sources shall be used except in rare, extenuating circumstances.

V. FINAL REPORT FOR EACH WORK ASSIGNMENT

The specific final report requirements will be included in each work assignment and, unless stated otherwise in the task order, the format cited below will be used.

The Contractor shall revise all final drafts, both scientifically and technically, by incorporating FS-directed changes, as well as correcting any technical errors identified in the external technical reviews or uncovered in the Contractor's technical editing of the report.

The Contractor shall then deliver a clean, typewritten, reproducible master copy of the revised report/document to the COR. In addition duplicate ASCII text format diskettes containing the final, clean version of the report/document (one .docx and one .pdf form of the file are desirable) along with the supporting worksheets (.XLS format at the present time), and the literature files as described below.

Final format for the diskette’s contents will be required to be consistent with FS software current at the time of task award, and the format required will be stipulated at the time of issuance of, and be documented in, the work assignment.

At the time of peer review, copies or reprints of all identified literature (including both articles referenced and relevant articles considered but not referenced) shall be delivered to the COR along with an electronic copy of the draft of the report. An electronic copy of each referenced article, with accurate bibliographic data, must be delivered with the draft, and the final documents. A listing of all literature data bases surveyed (with years searched) along with copies of the search shall be provided to the COR in electronic form at the time of submission of the first draft of any report/document/project.

VI . REPORTING REQUIREMENTS FOR CONTRACTOR RECOMMENDATIONS

Any Contractor-prepared reports that include recommendations to FS shall:

(a) explain and rank the policy or action alternatives,

(b) describe the procedures used to arrive at the recommendations,

(c) summarize the substance of the deliberations,

(d) summarize any dissenting views,

(e) list the sources relied on,

(f) provide any other information necessary to make clear the methods and considerations upon which the recommendations are based.

C. GOVERNMENT RESPONSIBILITIES

During the preparation of documents the government will furnish no real property to the Contractor.

The Forest Service will provide data relating to pest and vegetation management programs as is appropriate to the work assignments. It shall be sufficient to insure that accurate details of the FS’s programs are incorporated in the analyses being produced.

Should face to face meetings between the contractor and the Forest Service be beneficial or necessary, the COR will make necessary arrangements for the meeting, either travelling to the Contractor’s location or arranging for an appropriate location for the meeting.

D. DELIVERY OR DELIVERABLES

All written deliverables shall be phrased in language which can be understood by a knowledgeable layperson. Toxicological, statistical and other technical terminology shall not be used without providing a glossary of terms.

The Contractor shall prepare a draft of each document for Forest Service internal review and concurrently shall procure three external technical peer reviews. Review shall be accomplished and changes incorporated before submission of the final document to the COR for evaluation and subsequent modification or final approval. The contractor shall provide continuous interaction with the COR on progress/status and direction of the documents.

The Forest Service will complete their review of the draft deliverable within 45 calendar days from date of receipt. The three contractor sponsored technical reviews required for all risk assessments should be completed concurrently with the Forest Service review. The Contractor shall preplan and set aside sufficient time from the closure of the review to allow incorporation of necessary changes (based on peer reviews) prior to delivery of the final copy prior to the task termination date.

1. Description of Tasks and Associated Deliverables: For each task awarded under this contract the deliverables shall be a draft document with supporting literature file, literature search description, and supporting analytic worksheets as described above. Final documents shall be delivered in both hard copy and electronic format (described above). Final electronic submission shall also include at least the following three supporting electronic files: literature files (used and reviewed but rejected literature, with explanatory notes detailing reasons for rejection where applicable); mathematical process worksheets; and, a file which includes all technical reviews with non-incorporated issues identified with the rationale for rejecting the reviewer’s comment.

Timely submission of deliverables is essential to successfully completing this requirement. Schedules for deliverables shall be developed to allow the Contractor maximum flexibility in scheduling the necessary document development. All deliverables shall be prepared and submitted according to format, content, and schedule described in the individual task’s SOW.

2. Reporting Requirements

The contractor is required to provide written progress reports monthly for the period when engaged in production of assigned tasks. This report shall be submitted electronically to the CO and the COR of record for each individual order under this IDIQ . The progress report shall cover all work completed during the specified period and shall present the work to be accomplished during the subsequent period.

This report shall also identify any problems that arose and a statement explaining how the problem was resolved. This report shall also identify any problems that have arisen but have not been completely resolved and provide an explanation.

Notice to offerors: All information and data related to this project that the contractor gathers or obtains shall be both protected from unauthorized release and considered the property of the government. The contracting officer will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this contract.

Press releases, marketing material, or any other printed or electronic documentation related to this project, must not be publicized without the written approval of the contracting officer.

E. TRAVEL

Travel required under this contract is minimal. Contractor will be expected to make available, as a minimum, the primary analyst assigned to this contract to travel to the first Forest Service (generally annual) Pesticide Coordinator’s Meeting following contract award both to introduce him/herself and to introduce the proposed product to the FS Regional Pesticide Coordinators who will be supporting the

COR in developing the FS program descriptions and internal Forest Service reviews. Sufficient time will be made available at that meeting for a presentation by the Contractor or primary analyst of the products proposed under the terms of the contract, with emphasis being placed on changes, if any, being proposed to the current methodology and format of the technical documentation to be developed. A minimum of one day should be allocated to the traveler so that both the formal presentation and also informal contacts/meetings may occur. If the Contractor finds it beneficial the traveler(s) would be welcome to attend the full meeting (excluding only any internal discussion of contractual matters) to get a broader perspective of the program within which the produced documents are to be employed.

This travel shall be reimbursed, post travel and on completion of appropriate documentation of the travel by the Forest Service consistent with Forest Service travel regulations. All required travel shall be included with task order proposal pricing and be in accordance with the federal travel regulations at the appropriate per diem rate as prescribed in FAR 31.205-46 Travel Costs.

F. CONTRACTOR EXPERIENCE REQUIREMENTS – KEY PERSONNEL

The contractor shall assign a person or team to produce scientifically and legally defensible documentation as described above. Each professional assigned to develop the technical analysis and the content of the final report shall have as a minimum education and experience as follows: a Ph.D. in a relevant scientific field and 5 years relevant experience; or, a Masters degree in a relevant scientific field and 8 years relevant experience; or, a Bachelors degree in a relevant scientific field and 10 years relevant experience. Support personnel shall have as a minimum 3 years experience and a demonstrated proficiency with the tools (software and hardware) necessary to accomplish the tasks assigned.

Production of documentation required under this contract requires expertise in the location of and interpretation of scientific literature, and the presentation of a detailed analysis of information in (at least) the following disciplines:

Toxicology:

general toxicology (human & wildlife) pharmacokinetics (human & wildlife) reproductive and developmental (human & wildlife) mutagenicity, teratology and oncology (human & wildlife) immunology, endocrinology (human & wildlife)

Pesticide chemistry:

formulated product chemistry and behavior of both the active ingredient and inert chemicals in the formulation [including production byproducts and contaminants] toxicology, breakdown processes and degradation products of concern [including potential for significant responses under the above toxicology headings] potential interactions between the chemical being considered and others found in or introduced into the environment, Pesticide environmental fate and behavior:

onsite residence timing off-site movement potential and characteristics potential for impact to non-target plants and animals potential for ecological degradation resulting from use

Modeling (as a minimum):

Human health risk assessment as a reflection of :

o Inherent chemical hazard o Exposure of receptor organism or environment o Dose-response

Ecological risk assessment:

o Wildlife risk as a function of the same three items as are to be modeled in human health risk assessment o Offsite movement of chemicals applied

Through soil

In air o Interaction of applied chemical(s) both onsite and with chemicals encountered if moved offsite

G. SECURITY REQUIREMENTS:

None required by the Forest Service. Potential exists for some requirements being imposed on the contractor by non-required (but potentially very useful) information providers, for example the security required for borrowed Confidential Business Data from the Environmental

Protection Agency.

H. DATA RIGHTS

In accordance with Federal Acquisition Regulations (FAR) 27.405-1, ―Special Works.‖ FAR clause

52.227-17 Rights in Data—Special Works. ‖ is hereby incorporated by reference and made a part of this contract.

I. SECTION 508 – ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS

In December 2000, the Architectural and Transportation Barriers Compliance Board (Access Board), pursuant to Section 508(2)(A) of the Rehabilitation Act Amendments of 1998, established information technology accessibility standards for the federal government. Section 508(a)(1) requires that when federal departments or agencies develop, procure, maintain, or use Electronic and Information

Technology (EIT), they shall ensure that the EIT allows federal employees with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by other Federal employees. The Section 508 requirement also applies to members of the public seeking information or services from a federal department or agency. Section 508 text is available at http://www.opm.gov/HTML/508-textOfLaw.htm or http://www.section508.gov/index.cfm?FuseAction=Content&ID=14

J. PERIOD OF PERFORMANCE

This contract is proposed to be a five year contract: One base year with an additional four consecutive option years as exercised at the discretion of the Contracting Officer (CO).

http://www.opm.gov/HTML/508-textOfLaw.htm http://www.section508.gov/index.cfm?FuseAction=Content&ID=14

SEED PROJECT STATEMENT OF WORK (SOW)

This shall serve as the first task order for this award.

TASK ORDER STATEMENT OF WORK for Preparation of an Updated Human Health and Ecological Risk Assessment of Aminocyclopyrachlor

Purpose: The purpose of this work assignment is to provide technical support to the Forest Service by updating the human health and ecological risk assessment of the forestry uses of imazapyr herbicide

(CAS#858956-08-8).

Description of Work: The risk assessment shall involve de novo risk assessment. The documents shall incorporate relevant information necessary to clearly describe the potential risk to humans (workers and the public) and the environment with using aminocyclopyrachlor in Forest Service programs. Only

Forest Service use of aminocyclopyrachlor for vegetation control will be considered (at present primarily leafy spurge control). Based on a program analysis, all appropriate methods of application and ensuing exposure scenarios will be considered. Deliverables: Deliverables shall include a hard copy of the risk assessment of human health, wildlife health, and ecological risks posed by the use of aminocyclopyrachlor in the Forest Service’s national programs. Additional deliverables shall be an electronic copy of the risk assessment (on CD), an electronic file in appropriate format to be incorporated into the Forest Service web site as well as updated Forest Service risk assessment worksheets which comprise the quantitative basis of the document, and copies of all references cited in the risk assessment.

Schedule of Deliverables:

Provide the Proposed schedule of accomplishment to meet final delivery of risk assessment date below 10 days post award

Final risk assessment September 30, 2012

(including electronic copies, worksheets and references)

Proposed start date: February 15, 2012

-----End of SOW----

E. Price Proposal

Offerors shall also submit a price proposal as required in Section L of this solicitation

SECTION D--PACKAGING AND MARKING

{For this Solicitation, there are NO clauses in this Section}

SECTION E--INSPECTION AND ACCEPTANCE

FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): www.arnet.gov/far/

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSES

52.246-4 Inspection of Services--Fixed-Price (AUG 1996)

SECTION F--DELIVERIES OR PERFORMANCE

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): www.arnet.gov/far/

52.242-15 Stop Work Order (AUG 1989)

AGAR 452.211-74 Period of Performance (FEB 1988)

The base period of performance of this contract is from December 2011 through December2012 with four option years to be exercised as the discretion of the Contracting Officer (CO).

http://www.arnet.gov/far/

SECTION G--CONTRACT ADMINISTRATION DATA

AGAR 452.215-73 Post Award Conference (NOV 1996)

A post award conference with the successful offeror is required. It will be scheduled within 30 days after the date of contract award. The conference will be held at 1400 Independence Ave, SW, Washington, D.C. 20250-1147, or via teleconference (to be determined).

SECTION H--SPECIAL CONTRACT REQUIREMENTS

AGAR 452.237-74 Key Personnel (FEB 1988)

(a) The Contractor shall assign to this contract the following key personnel: Project Administrator

(b) During the first ninety (90) days of performance, the Contractor shall make no substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The

Contractor shall notify the Contracting Officer within 15 calendar days after the occurrence of any of these…