This project developed and updated four independent models for the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN). The models investigated the impacts of FDA regulations on small entities, in compliance with the Regulatory Flexibility Act. Small business entities have fewer resources to devote to regulatory compliance and may be unduly burdened by regulatory-related costs.
The four models corresponded to four FDA-regulated industries:
- Candy manufacturing industry
- Cosmetics industry
- Ready-to-eat food manufacturing industry
- Dietary supplements manufacturing industry
Data for the models came largely from the U.S. Census Bureau’s Economic Census—Manufacturing Industry Series and Manufacturing Subject Series, Statistics of U.S. Businesses: Dynamic Data, and the Annual Survey of Manufacturers. These principal sources were augmented by data from Harris Interactive, the Federal Reserve Board, the Internal Revenue Service, the Federation of Tax Administrators website, the Candy Buyers’ Directory, and CCH’s 2006 State Tax Handbook.
Developed in Excel, the models used approximately 12 spreadsheets per model to house the data. Insight identified, acquired, and cleaned the data; constructed data tables in a format that could be used by the CFSAN models; and evaluated the results. All data were subjected to a thorough quality assurance process that involved an independent review of every data element. The models were invoked repeatedly using varying data assumptions to test their stability and the generated results. Insight wrote a guide to updating and using the models with details on (1) the data sources used in the CFSAN models, (2) the data elements used from each data source, (3) the process used for acquiring and preparing data for the models, and (4) the impacts of the updated models.
Electronic models; final report, Updating CFSAN Small Business Models for Four FDA-Regulated Industries (March 2008)