EPA, ADP Placement Section (3803F), 401 M St. SW, Washington, DC 20460-0001

70 -- SOFTWARE DIETARY SOL software dietary DUE 081297 POC Ben Fulton, 202-260-6213 The EPA is issuing this sources sought synopsis to identify any vendors offering software that will perform dietary and aggregate exposure assessments for exposure to pesticides. The software must meet the Agency's minimum requirements outlined below, which reflect criteria established to satisfy the requirements set forth in the Food Quality Protection Act of 1996 (FQPA). These requirements also address material weaknesses in the current exposure software which were identified in two GAO audits (1989 and 1991). 1) Analytical Capabilities -- The purpose of the proposed licensure is to obtain software with the capabilities of performing dietary risk assessments and combining the outputs of these assessments with the results of nondietary assessments as required under FQPA. The software must be capable of performing chronic, cancer and acute dietary assessments. Acute assessments must be both deterministic and probabilistic in nature. Analyses must be available allowing evaluation of exposure to a variety of subpopulations selected using the following demographic parameters: age, sex, race/ethnicity, region, and season surveyed. The demographic subgroups in the Dietary Risk Evaluation System (DRES) must be represented.The system must contain algorithms to conduct probability-based aggregate exposure assessments in formats that do not require additional programming by EPA/OPP staff. Default formulae for calculating the Average Daily Dose for various nondietary routes of exposure (oral, inhalation, and dermal) combined in scenarios such as those in the draft Residential Exposure SOPs must be provided. The software must allow the user to modify these formulae. The software must include algorithms for estimating the probability of exposure for various use scenarios and various application frequency scenarios (biweekly, monthly, seasonally, etc.) and any combination of these factors. Multiple statistical options must to be included to allow better fit of existing data and to conduct sensitivity analyses. Documentation must be provided to demonstrate that the algorithms have been independently validated. The algorithms must allow EPA to conduct aggregate exposure for the respondents in each of the USDA CSFII populations, on an individual-by-individual basis and to subsequently generate estimates of probabilities of exposure across the population by season and over the year on a daily basis. The algorithms must allow distributions to be included for each component of the exposure assessment and to include default factors in the absence of data. The algorithms must allow EPA to select different distributions required to describe data distributions through modelling as well as the capability of using point estimates or empirical approaches through resampling of actual data where a distribution can not be defined. The software must permit definition of these distributions using parameters appropriate for the type of distribution selected. 2) Required Data and Files -- The system must contain appropriate data to support the assessment, and the capacity to construct files containing potential exposure parameters. Food consumption data must be provided to support development of exposure assessments. These must include USDA's Continuing Survey of Food Intakes by Individuals (CSFII) (1989-1991, 1994-1995 and options for 1996, when available). Food consumption data must be provided "as eaten" as well as translated into the ingredients upon which OPP establishes tolerances. The food consumption data must be provided in a form that will allow EPA to modify the translation factors to conduct sensitivity analyses to evaluate the impact of major changes in the US food supply. The demographic and socioeconomic data from the surveys for each respondent must be provided in conjunction with the food consumption data. Demographic data must include age, sex, race/ethnicity, region and season surveyed. Socioeconomic data must include income, employment status, family size, education housing statistics, vegetarian or nonvegetarian status and any other relevant statistics from the survey. The option must be available to obtain additional survey data translated to ingredients and "as eaten" as it becomes available. The system must include default estimates of various biological parameters that are need to estimate exposure. The sources of the default values must be clearly documented. The USEPA August, 1996 Draft of the EPA Exposure Factors Handbook shall be used as a source of default values when they are available from that source. The system must provide the capability to construct and use files containing residue data to support assessments based upon tolerances and anticipated residues. In addition, the system must allow for the introduction of modifying factors such as percent crop treated and processing factors, and their inclusion in risk calculations. The system must contain current EPA-established tolerances and CODEX MRLs with the capacity to add new values as they are established for pesticide-commodity combinations. 3) QA/QC -- Demonstrated independent validation of the translation of data from consumption surveys and CODEX must be provided. The functioning of each algorithm must be validated, including examples where the same analysis has been conducted using an independent analysis system. A test system must be provided to permit periodic testing of software to verify that it is functioning correctly. 4) Outputs -- Software must provide reports for the following types of dietary risk assessments: chronic, noncancer; chronic, cancer; acute. Chronic, noncancer assessments must report results as mean exposure values and percent of RfD or other relevant toxicology endpoint. Chronic, cancer assessments must report results as mean exposure values and excess cancer risk calculated using a Q1*. Acute assessments must provide distributions of exposure and risk (expressed as Margin of Exposure) with extrapolations to the 99.9th percentile of exposure for each subpopulation of interest. Calculations must be reported as consumers only andas total population. The percent of the total population reflected in the assessment must be noted. Each report must include summaries of dietary analyses described above including the chemical name, type of assessment performed, notation of the consumption database used, the subpopulation evaluated, any adjustment factors used, notation of the name of residue data files used in the assessment, and a comment field which can be used to make notations relevant to evaluation of the subsequent report. Software must provide formatted reports and data summaries for all assessments which can be stored to external electronic media and hard copy. In addition, a complete print out of input parameters, data and assumptions must be obtainable. The software must provide the capability to aggregate dietary and nondietary exposures for the purposed of produces a total risk assessment as described in the FQPA. In as much as the EPA has no experience in conducting or reviewing these assessments, an exact format is not available. However, reports must include the chemical name, type of assessment, type of distributions used, descriptors of the distributions, the exposure scenario under evaluation (including assumptions and defaults in the assessment), the population under consideration, distributions of exposure (with the capability of determining percentiles of exposure) and an estimate of the central tendency for the exposure distribution. Comment fields must be available to describe assumptions used in the assessment. A complete print out of input parameters, data and default assumptions must be obtainable. 5) Documentation -- A User Manual must be provided that describe the functioning of the software. Manuals must include the following information: content of databases provided as part of the software; validation of provided data; a discussion of algorithms used in the system calculations and their validation; clear concise directions on preparation of data files, how to perform analyses, how to generate and export reports, how to edit existing data files, performance of sensitivity analyses; the concepts underlying the functioning of the system. 6) Training and Technical Support -- Training in the use of the software for new users must be provided including navigation of the software, file building, how to perform analyses and generate reports, and how to modify existing reports for performing "what if" or sensitivity analyses. Telephonic technical support must be provided to address problems encountered in software use. Online help and guidance as to use of data, such as selection of models for developing distributions is required. 7) Access to upgrades -- Software upgrades during the period of the license must be available. 8) Strategy for Public Access -- Inability to provide capabilities for performance of dietary risk analyses to the public was cited as a material weakness in DRES in the 1989 and 1991 GAO audits. Description of a strategy for making the use of the software available to the public must be provided. This strategy must be implementable within six months of contract award. 9) Computer Interface and Environment -- The software must function in EPA's LAN environment which is: 1) client/server so that common data files can be shared on a LAN system; 2) currently operates in Windows 3.1 but is moving to Windows 95 environment; has desktop access through a 100 MHz 486 PC with 32 mB memory. In addition, pursuant to EPA's IRM policy, the software must be Year 2000 compliant. Ability to function in this environment must be demonstrated. 10) Statistical and Editing Capabilities -- The software interface must permit an EPA analyst without detailed statistical knowledge and no programming experience to select data, algorithms and associated parameters for performing analyses. Editing of existing data files must be easily accomplished to permit file updates and performance of sensitivity analyses. The intent of this sources sought synopsis is to locate any sources possessing software that performs the aforementioned requirements, therefore, no RFP is available. Any vendor wishing to respond to this synopsis must do so in writing. Your written response may contain any documentation you deem necessary (e.g., validation of databases and algorithms, samples of reports, software documentation, and/or user manuals) to demonstrate that your software product meets each of the requirements. Following EPA's review of the documentation, at EPA's option, one or all potential sources' software may be required to undergo a demonstration to validate the requirements. Responses must be received on or before August 12, 1997. Responses shall be submitted to: Environmental Protection Agency, Bid/Proposal Room (3803F), Attention: Ben Fulton, 401 M Street, S.W., Washington, D.C. 20460. Vendors' written response must reference Dietary and Aggregate Exposure Software. (0196)

Loren Data Corp. http://www.ld.com (SYN# 0409 19970717\70-0017.SOL)