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U.S. Department of Health and Human Services

International Programs

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Food Safety Modernization Act Embassy Briefing

Dr. Daniel McChesney
Director of Surveillance and Compliance
FDA Center for Veterinary Medicine
Talking Points at the
Food Safety Modernization Act Embassy Briefing
February 23, 2011

Preventive controls (18 months)

  • Comprehensive preventive controls for food and animal feed facilities
    • Written plan that details hazards associated with product and what is being done to control or eliminate the hazard. Implicit in this is documentation demonstrating how the decision to include or exclude a hazard was made.
    • Plans will be reviewed by FDA at the time of inspection;
    • FDA is reviewing whether to request these plans prior to inspection FDA is developing implementing regulations for preventive controls. We anticipate a proposed regulation by the end of this year and a final regulation in mid-2012
    • There will be separate regulations for human food and animal feed (includes pet food)
    • We envision the regulations being risk based and outcome oriented as apposed to directing specifically how hazard or process needs to be controlled.
    • Applies to all firms that must register under the bioterrorism act
    • Exemptions for food and feed produced and used on the farm as well as for limited direct to consumer sales of farm product.
    • Exemptions for small and very small businesses (definition not yet determined)
    • Firms and operations covered by the exemptions are required to demonstrate that they are complying with the ‘spirit of the regulation’. This can be done by demonstrating compliance with local / state food and feed safety requirements.
    • FDA developing guidance for industry on implementing the regulations. Because of the numerous segments of the food and feed industry we are considering establishing a docket in which industry and other interested parties can supply information on best practices for consideration by FDA. If FDA decides to establish a docket it will be announced in the FR.
  • Produce safety standards (2 yrs)
    • The regulation focuses only on the hazards associated with the production and harvesting of produce and requires FDA to establish minimum safety standards for raw agricultural products that if not met could result in the products posing a serious adverse health consequence or death.
    • Risk based, outcome oriented , and flexible in order to be applicable to all entities
      • Soil condition, animals in growing area, temperature control, hygiene, etc
    • Exemptions for direct marketing to consumers and varying times for implementation by small and very small businesses.
    • 3 public meeting for input on the regulation and guidance.
    • FDA is developing guidance for industry on implementing the regulation
    • Variances. There are provisions for a State or Foreign governments to request a variance from the standards in light of local growing conditions AND that procedures, processes, and practices in place provide the same level of public health protection. Reviewed in a timely manner, a decision is made and the petitioner is notified.

Import Safety

  • Foreign supplier verification program
    • Importer must verify that the food or feed imported by the importer complies with the preventive control or produce regulation or provides a same level of protection
      • Compliance can be demonstrated by inspections, lot certifications, preventive control plans, etc
      • Seafood and Juice HACCP and LACF are exempt
      • FDA to develop guidance and a regulation within a year
    • Voluntary Qualified Importer Program
      • Importer may request expedited review of designated foods: decision criteria include
        • Known safety risk associated with the food
        • Compliance history of foreign suppliers
        • Capability of the regulatory system of the exporting country to ensure compliance with US food standards
        • Compliance of importer with Foreign supplier verification program
    • Requirement for Import Certifications for Food
      • FDA may require certification that a food meets the requirements of the FFDCA
      • Certification from the government or qualified third party auditor
      • Decision criteria similar to voluntary qualified importer program but with opposite answer
      • Upon passage of FSMA mandatory certification for high risk foods and feeds
    • Accredited third-party certification
      • Within 2 years FDA shall establish a system for the recognition of accreditation bodies that accredit 3rd party auditors to certify imports meet the requirements for importation into the US
      • FDA can directly accredit 3rd party auditors after 2 years from the date of FSMA
      • Foreign governments; accreditation body or FDA will review and audit food safety systems and standards to ensure that the foreign government is capable of ensuring the safety of the food being imported into the US
      • Other third parties; accreditation body or FDA will review and audit the training and qualification of the audit agents and the standards they are using to determine whether a food or feed meets the entry requirements of the US.
      • Provisions address conflict of interest, limitations of inspections, etc
      • Fee provision to cover the cost to FDA to setting up the program
    • Other Provisions
      • Changes to prior notice (must list if shipment has been refused by another country
      • Building capacity of foreign governments
      • Inspection of foreign facilities
      • FDA foreign offices
      • Smuggled food