Small Business CFSAN Models

Project Overview

The purpose of this project was to develop and update 4 independent models for the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN). The models were designed to investigate the impacts of FDA regulations on small entities, in compliance with the Regulatory Flexibility Act (RFA). These small business entities have fewer resources to devote to regulatory compliance and may be burdened unduly by regulatory-related costs.

The 4 models corresponded to 4 FDA-regulated industries:

  1. The candy manufacturing industry
  2. The cosmetics industry
  3. The ready-to-eat food manufacturing industry
  4. The dietary supplements manufacturing industry

Data for the models was derived 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 (ASM). These 3 principal sources were augmented by data from Harris Interactive; the Federal Reserve Board; the Internal Revenue Service; the Federation of Tax Administrators Web site; the “Candy Buyers’ Directory;” and CCH’s “2006 State Tax Handbook.” The models were developed in Excel using approximately 12 spreadsheets per model to house the data. Insight identified, acquired, and edited/cleaned the data; constructed data tables in a format that could be utilized by the CFSAN models; and evaluated results. All data were subjected to a thorough quality assurance process that involved an independent review of every data element. In addition, the models were invoked repeatedly using varying data assumptions to test both their stability and the generated results. Additionally, Insight wrote a guide to updating and using the models detailing 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 results/impacts of the updated models.

Core Activities

Literature Reviews and Environmental Scans; Secondary Data Analysis and Simulations; Database Development; Report Development and Presentation


  • Electronic models
  • A final report entitled “Updating CFSAN Small Business Models for Four FDA-Regulated Industries” (March 2008)