The Economics Team at the FDA/CFSAN is located within the Office of Regulations, Policy, and Social Sciences. It is comprised of 12 economists and 1 administrative assistant with backgrounds in various applied microeconomic fields. The economists are responsible for performing regulatory impact analyses, consulting with program offices on policy implications, and developing original research. Their work must adhere to various executive orders and guidance related to regulatory analysis. They collect both long-term and short-term data from a variety of sources to complete their analyses under various timelines and project scopes. They provide input during the FDA rulemaking process and interact with regulatory reviewers at multiple agencies during oversight of their work. They currently have over 20 rules and guidance documents to develop related to the Food

1. FDA/CFSAN Economics:
How We Operate
QUADS
FOOD SAFETY REGULATORY ECONOMICS
WORKING GROUP
May 19th
, 2011

2. • The Economics Team
• How we do our work
– Economists’ responsibilities
– Analysis requirements
– Data collection
• Interaction with FDA, other agencies,
HHS, and OMB
• Food Safety Modernization Act (FSMA)

3. The CFSAN Economics Team
• Located in the Office of Regulations, Policy, and Social
Sciences, in the Division of Social Sciences
– Share the office with Regulatory Counsel and Social Science
• 12 economists + 1 administrative assistant
• Backgrounds are a wide a variety of Applied Micro fields
– Agricultural Economics, Environmental, Natural Resource,
Health, Development, Labor, IO, Game Theory, Public Finance,
Econometrics, Computational, Law and Economics,
Demography

4. Economists’ Responsibilities
• Perform Regulatory Impact Analyses
• Consult with program offices and
management as experts on the
implications of policy on public health and
industry
• Develop original research to inform policy

5. Analysis Requirements
• Executive Orders 12866 and 13563
• OMB Circular A-4 (guidance for EO
12866)
• Paperwork Reduction Act
• Regulatory Flexibility Act as amended by
the Small Business Regulatory
Enforcement and Fairness Act
• Unfunded Mandates Reform Act

6. Data Collection
• Depends on the project and the timeline
– Significance
– Scope
– Deadline
• Rarely do we use nationally representative
data for every piece of an analysis

7. Data Collection: Long Term
• Large contracts
– Good Manufacturing Practices (GMP) Survey
– Farm shutdown model
– Labeling cost model
– Food defense survey
– Food handling practices model
– Small business model
• In-house research
– Cost of illness model
– Illness attribution
– Burden of obesity
– Characterization of the produce industry

8. Data Collection: Short Term
• Every project, regardless of scope, significance, or long timeline, has some piece that
must be done in a hurry
• Short term contracts
– Expert elicitation
– Literature review
• Go-to data sets
– Dunn&Bradstreet Database (D&B)
– County Business Patterns (CBP) and Economic Census
– Operational and Administrative System for Import Support (OASIS)
– National Agricultural Statistics Service (NASS)
– Bureau of Labor Statistics (BLS)
– Nielsen
– Mintel
– Scanner Data
– Trade association data
• New data found specific to project
• When all else fails…
– Phone calls and Google

9. The Rulemaking Process

10. Interaction with Reviewers and
Regulatory Oversight
• CFAN Economists are a Center resource
– Interaction with regulatory review outside of Center is
often filtered
– Degree of direct interaction depends on many things
• FDA
• Other agencies
• HHS
• OMB

11. FSMA Et. Al.
• More than 20 rules guidances to be published by Summer, 2012, plus
numerous deliverable studies and reports
– Processed food
– Produce
– Food Defense
– Importer verification and 3rd
party certification
– Food transport
– Updates on Prior notice, registration, administrative detention
– …and more….
• Affordable Health Care Act
– Menu and vending machine labeling
• Others
– Nutrition label update
– Infant formula
– Gluten free

12. Data Sources
• NASS: http://www.nass.usda.gov/
• CBP: http://www.census.gov/econ/cbp/index.html
• BLS: http://www.bls.gov/
• OASIS:
http://www.fda.gov/ForIndustry/ImportProgram/AdmissibilityDetermi
nationsforShipmentsofForeign-originOASIS/ucm077691.htm