U.S. Environmental Protection Agency, Program Contract Service Center (3803R), 401 M Street, SW, Washington, DC 20460-0001

B -- TECHNICAL SUPPORT FOR CHEMISTRY REVIEW OT TOLERANCE PETITIONS SOL RFQ-DC-98-00192 DUE 092198 POC Valoree S. Lilley, lilley.valoree@epamail.epa.gov WEB: click here to download a copy of the RFQ, http://www.epa.gov/oamhpod1/oppts_grp/dc9800192/index.htm. E-MAIL: click here to contact the contract specialist, lilley.valoree@epamail.epa.gov. The U.S. EPA is seeking a contractor to provide technical support for the determination of the potential effects of pesticides indirectly applied to food under FAR Part 13 Simplified Acquisition Procedures. This is a small business set-aside. The SIC code for this requirement is 8732. The EPA is FACNET certified. You may e-mail the contract specialist at: lilley.valoree@epamail.epa.gov. Please include the following: Company name, address, phone number, and business class. NO PHONE CALLS WILL BE ACCEPTED. Two copies of the proposal must be submitted by the due date. U.S. MAIL ADDRESS IS -- USEPA, 401 M Street, SW, Mail Code 3803R, Washington, D.C. 20460, ATTN: Valoree S. Lilley. HAND CARRIED PROPOSALS should be submitted to the Ronald Reagan Building, 6th Floor, Room 61107, 1300 Pennsylvania Avenue, Washington, D.C. 20460. Proposals are due NLT 2:00 p.m., September 18, 1998. This procurement will provide EPA's Office of Pesticide Programs with technical support for the determination of the potential effects of pesticides indirectly applied to food (e.g. sanitizers used on food-contact surfaces and pesticides in food-contact articles), on human health and on the environment, through the review and evaluation of chemistry data contained in pesticide tolerance petitions. The contractor must be cleared for access to FIFRA CBI and must control FIFRA CBI according to the requirements specified for contractors in the EPA publication, "FIFRA Information Security Manual", dated July 1988. Access of the contractor to FIFRA CBI is intermittent and will not require allocation of office space. The contractor shall provide detailed information on the process used in reviewing data packages, including hard copies of all supporting technical materials/references, and any publicly-owned software (e.g. as may be acquired through federal agencies such as the U. S. Food and Drug Administration). Reports submitted by the contractor that contain technical recommendations to the Agency (which will be used by EPA personnel in developing policy), will explain and rank action alternatives, if any; describe the procedures used to arrive at technical recommendations, summarize the substance of deliberation; report any dissenting views; list the sources relied upon; and make clear the methods and considerations upon which the technical recommendations are based. The Contractor shall exercise independent judgment on scientific issues. However, the Contractor shall not draw conclusions regarding regulatory decisions, nor provide advice to EPA regarding the safety of pesticides in food. Determinations of the safety of a pesticide is reserved to EPA. SCOPE OF WORK The contractor shall supply the necessary labor, materials, equipment, services and facilities (except as otherwise specified) required for the performance of this requirement. The scientific quality of assessments and reports and their timely preparation in accordance with negotiated schedules are of paramount importance in the performance of this contract. Consequently, the contractor shall have the necessary technical and scientific knowledge and experience to work effectively from contract start-up and throughout the course of the contract. In addition, the contractor shall have a Quality Assurance (QA) / Quality Control (QC) program that maintains the quality of products. Performance of work under this contact shall be initiated by technical direction issued by the Project Officer. TASKS Task 1. Preparation of Chemistry DERs The contractor shall review and critically examine chemistry data submitted as part of petitions (hereinafter referred to as data packages) for pesticides indirectly added to food. Approximately ten (10) data packages will be reviewed by the contractor. The contractor shall prepare a Data Evaluation Report(DER) for each data package. DERs typically address the following: identity, characterization, specifications, manufacturing process including by-products or impurities of the pesticide; results of migration studies; and dietary exposure estimates. These reports will be used by EPA, in conjunction with other information in its safety assessment of pesticides in food. The Contractor, in carrying out this task shall rely on EPA's Pesticide Assessment Guidelines, and FDA's guidance in regulating indirect food additives (e.g. FDA's Recommendations for Chemistry Data for Indirect Food Additive Petitions, June, 1995.). DERs shall provide comments, discussions, or analyses, as appropriate, regarding the following: 1. The adequacy with which the pesticide is identified (CAS#, if appropriate, analytical data supporting identity). 2. Specifications proposed for the pesticide. If none are proposed, consider whether they are needed to establish chemical identity or ensure purity. 3. Manufacturing methods and materials, including solvents, reagents, etc.; impurities and/or byproducts present or likely to be present (identities and levels). 4. Review methods for determining the quantity of pesticide residue on food-contact surfaces under intended conditions of use. 5. Appropriateness of the test methods used in migration studies, particularly with respect to food-simulating solvents, the proposed food categories and use conditions. Comment on whether migration data reflect the most severe temperature/time conditions to which food-contact articles containing the pesticide will be exposed. The Contractor, when appropriate, shall determine the adequacy of migration studies in data packages by comparing these studies with migration studies in published literature that have been carried out using real foods or food simulants. The Contractor shall also on occasion, review proposed migration experiment protocols, noting deficiencies and providing technical recommendations. 7. Appropriateness of any model(s) and assumption(s) used in calculations of migration levels (where no studies have been performed) and on the accuracy of the calculations. 8. Review methods for calculating exposure from measured levels or in food-simulating solvents; comment on whether the information provided is sufficient to permit an estimation of the daily intake of the pesticide and provide an estimate of dietary exposure from the proposed use(s). 9. Assess the impact of deficiencies on the validity of the conclusions drawn from chemical information submitted. Task 2. Prepare Report on Migration Technology The Contractor shall prepare a report summarizing current Migration Technology/methods that are used or may be used to estimate the movement of pesticides into foods from treated articles. The report's treatment of Migration Technology shall include, but go beyond and be in greater detail than FDA's "Recommendations for Chemistry Data For Indirect Food Additive Petitions-1995." The report shall critically review (i.e. discuss advantages and limitations), and provide specific references, points-of-contact (including addresses and telephone numbers) for current analytical methods as well as products (e.g. migration cells) used in migration experiments. The report shall also identify research trends and needs in thearea of Migration Technology. Evaluation Factors Conflict of Interest Evaluation A Conflict of Interest (COI) plan must be included in the Offeror's proposal. The COI Plan will be evaluated on an "acceptable" or "not acceptable" basis. The COI Plan will be considered acceptable if it outlines procedures acceptable to the Government, that avoid or mitigate conflicts of interest (COI), whether real or apparent, throughout the period of performance of this contract. The government reserves the right not to evaluate proposals that do not include an acceptable COI Plan. The government also reserves the right to further negotiate the COI plan. The accepted COI Plan shall be incorporated into the contract. II. Technical Approach demonstrate a thorough understanding of each task in the statement of work(SOW) by preparing 1) a step-by-step plan, not to exceed one-page, on how chemistry reviews for tolerance petitions for pesticides indirectly applied to foods would be conducted and 2) a step-by step plan, not to exceed one-page, on gathering information for a Migraton Technology Report III. Past Performance Demonstrated relevant experience in completing tasks and delivering high quality products on a timely basis and on budget -- for projects involving a fixed budget. These tasks must be of similar complexity to those in the SOW . IV. Qualified Personnel Designated Project Manager with demonstrated education and professional qualifications to manage the tasks in the SOW, as evidenced by resumes and references. Proposed technical review staff must have demonstrated experience in the review and evaluation of chemistry data and exposure calculations for tolerance petitions and be knowledgeable on the analytical methods behind migration technology applicable to indirect food additives. They must also demonstrate the ability to write reports, evaluate scientific data and articulate scientifically defensible conclusions. Posted 09/02/98 (W-SN244801). (0245)

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