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U.S. Department of Health and Human Services


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Public Meeting: FDA Food Safety Modernization Act - Focus on Inspections and Compliance Breakout Sessions - Discussion Topics and Questions

Enforcement Authorities
Facilitator: William Correll

  1. How do you suggest FDA employ the use of its revised administrative detention authority in a preventive controls environment?
  2. State regulators:

Can you provide examples where you have recently used your embargo/detention authorities?

Can you describe examples where States have used embargo in situations where the subject food was produced contrary to established food safety preventive control standards; for instance, contrary to those standards defined under the juice or seafood Hazard Analysis and Critical Control Points rule?

  1. How do you see FDA implementing food facility registration suspension, and under what circumstances should FDA use its suspension authority?

Under what circumstances should FDA use its mandatory food recall authority?

Under what circumstances do you envision FDA using food facility registration suspension in conjunction with ordering a mandatory food recall?

Frequency and Targeting of Facility Inspections
Facilitator: Michael Rogers

  1. What data sources are available that could assist with the designation of high risk/non-high risk facility inventories? What data sources could assist with targeting foreign firms for inspection?
  2. What criteria should FDA consider when defining its high risk and non high risk facility inventories? If the criteria you suggest require use of data that FDA does not currently collect or otherwise possess, how should FDA acquire that information?
  3. How should FDA evaluate or “weigh” the criteria to determine risk? What factor(s) should be considered the most important and should this vary depending on the circumstances?

Manner of Inspection in a Preventive Controls Environment
Facilitator: Kathy Gombas

  1. What inspection approaches could FDA use to satisfy the domestic and foreign inspection frequency mandates, including by working with State and local governments?
  2. What inspection tools (e.g., new technologies) could FDA use to meet the domestic and foreign inspection frequency mandates?
  3. How might FDA use firms’ written preventive control plans that will be required in the future under section 103 of FSMA, or information from those plans, to prioritize FDA’s work and develop inspectional strategies?
  4. How should FDA work with foreign governments with respect to inspections of those food facilities in their countries that offer food products for import to the United States?

Improving the Reporable Food Registry
Facilitator: Ted Elkin

  1. What information is necessary to enable a consumer to accurately identify whether the consumer is in possession of a reportable food?
  2. What methods could best be used by grocery stores to inform consumers of information to enable them to identify whether they possess a reportable food?
  3. Are there other approaches to getting key information in the hands of consumers in real time that FDA should also consider pursuing?
  4. Who should FDA consider to be a grocery store subject to the consumer notification requirement in section 417(h) of the FD&C Act?
  5. What methods are grocery stores currently using to provide notice of food recalls to consumers?