U.S. FOOD AND DRUG ADMINISTRATION REGULATIONS (FDA) Dr. DONALD A. PRATER, DVM Deputy Director (Foods), US FDA Europe Office

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U.S. FOOD AND DRUG ADMINISTRATION REGULATIONS
(FDA)Dr. DONALD A. PRATER, DVMDeputy Director
(Foods), US FDA Europe Office

• Presented at How to do business in the USA
• May 24, 2011, Thessaloniki, Greece
• Organized by the American-Hellenic Chamber of
  Commerce

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FDAs Mission

• Protect public health by assuring the safety and
  efficacy of
• human drugs
• biological products
• medical devices and products that emit radiation
• animal feed and veterinary drugs
• food and cosmetics
• Advance public health by facilitating innovations
  that make medicines and foods more effective,
  safer and more affordable
• Provide the public with accurate, science-based
  information on medicines and foods

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Challenges of Globalization

• Globalization has fundamentally changed the
  environment for regulating food and medical
  products and has created unique regulatory
  challenges for FDA
• More foreign facilities supplying the U.S.
• Increasing volume of FDA-regulated imported
  products
• 2 Trillion worth of products enters the U.S.
  from more than
• 150 countries, with 130,000 importers of record,
  and from
• more than 300,000 foreign facilities

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Number of Foreign Sites Making FDA-Regulated
Drugs Has More Than Doubled Since 2001
Official FDA Data ORA/DIOP
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Note Number of foreign facilities inspections
are scaled in fiscal year. Number of
foreign facilities are scaled in calendar year.
Numbers approximate due to data limitations.
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FDA Foreign Offices
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U.S. Food Safety System

• Department of Health and Human Services (HHS)
• Food and Drug Administration (FDA)
• Centers for Disease Control and Prevention (CDC)
• Department of Agriculture (USDA)
• Food Safety and Inspection Service (FSIS)
• Animal and Plant Health Inspection Service
  (APHIS)
• Foreign Agricultural Service (FAS)
• Environmental Protection Agency (EPA)
• Department of Commerce (NOAA NMFS)
• Bureau of Customs and Border Protection (CBP)
• Alcohol and Tobacco Tax and Trade Bureau (TTB)
• State and local health and agricultural agencies

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Bioterrorism Act Regulations

• Took effect December 12, 2003
• FDA and Border Patrol/Customs collaboration
• Facility Registration (foreign 226,373 total
  382,866)
• Domestic and foreign facilities engaged in
  manufacturing, processing, packing and holding of
  food
• Greece has 1,166 registered facilities
• The EU has 54,181 registered facilities
• Prior Notification of imported foods
• 2 hours by land
• 4 hours by air or by rail
• 8 hours by sea

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Major FDA Center for Food Safety and Applied
Nutrition (CFSAN) Programs

• - Food facility registration and prior notice for
  imports
• Minimization of health risks due to chemical and
  biological contamination
• Safety of dietary supplements, infant formulas
  and medical foods
• Pre-market safety of substances added to food,
  including colors
• Safety of food and ingredients developed through
  biotechnology

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Major CFSAN Programs

• Food and allergen labeling, health claims
• Seafood and juice HACCP regulatory programs
• Low Acid Canned Food/Acidified Food (LACF)
  process registration
• Post-market surveillance and compliance
• International food standard and safety
  harmonization (Codex, WTO)
• Technical cooperation and assistance

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Reportable Food Registry

• Portal opened September 2009
• All registered food facilities (domestic and
  foreign) required to report in 24 hours
• When there is reasonable probability that food
  or feed will produce serious adverse health
  consequences to humans or animals (equivalent to
  Type 1 Recall)
• Served by HHS Safety Reporting Portal

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Food Defense Approach

• Detect and identify harmful organisms and toxins
  in food (Awareness)
• Train industry and state officials on CARVER
  vulnerability assessments (Prevention)
• Criticality
• Accessibility
• Recuperability
• Vulnerability
• Effect
• Reconcilability
• Develop effective strategies to protect the food
  supply from terrorist threats (Protection)
• ALERT, FIRST

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How to Export Food to the U.S.

• Register facility with FDA
• Register process for canning/aseptic packaging of
  Low Acid/Acidified Canned Foods (LACF)
• Give Prior Notice
• Use good practices in food production
• Agricultural
• Aquacultural
• Manufacturing
• HACCP
• Assure that the product is safe, wholesome,
  sanitary, properly packaged and labeled

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FDA Food Safety Modernization Act
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Main Themes of the Legislation
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Import Safety Most groundbreaking shift

• Current reliance on port-of-entry inspection
  cannot handle increase in imported food.
• Importers now responsible for ensuring that their
  foreign suppliers have adequate preventive
  controls in place
• Requires food from abroad to be as safe as
  domestic

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Import Safety Mandates

• Sec. 301. Foreign supplier verification program
• Requires importers to verify their suppliers use
  risk-based preventive controls that provide same
  level of protection as U.S. requirements.
• Sec. 302. Voluntary qualified importer program
• Allows for expedited review and entry facility
  certification required
• Sec. 303. Certification for high-risk food
  imports
• FDA has discretionary authority to require
  assurances of compliance for high-risk foods

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Import Safety Mandates

• Sec. 304. Prior notice of imported food shipments
• Requires information on prior refusals to be
  added to prior notice submission
• Sec. 305. Capacity building
• FDA mandate to work with foreign governments to
  build food safety capacity
• Sec. 306. Inspection of foreign food facilities
• Can deny entry if FDA access for inspection is
  denied
• Sec. 201. Targeting of inspection resources
• Increased inspection of foreign as well as
  domestic facilities

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Import Safety Mandates

• Sec. 307. Accreditation of third-party auditors
• FDA can rely on accredited third parties to
  certify that foreign food facilities meet U.S.
  requirements
• Sec. 308. Foreign Offices of the Food and Drug
  Administration.
• Establish offices in foreign countries to provide
  assistance on food safety measures for food
  exported to the U.S.
• Sec. 309. Smuggled Food
• In coordination with DHS, better identify and
  prevent entry of smuggled food

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Role of Third-Party Certification Programs

• Tool for importers to obtain needed assurances to
  meet their obligations for the foreign supplier
  verification program (sec. 301)
• A way for importers to participate in the
  voluntary qualified importer program to expedite
  movement of food through the import process (sec.
  302)
• Can be required by FDA to accompany high-risk
  foods (sec. 303)

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Import Projects Completed(as of May 2011)

• Sec. 304. Prior notice of imported food shipments
• Requires information on prior refusals to be
  added to prior notice submission
• Effective July 3, 2011

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Enhanced Partnerships Vital to Success

• International capacity building
• FDA has mandate to work with foreign governments
  to build their food safety capacity
• Allows FDA to rely more heavily on foreign
  government oversight
• Capacity building helps to prevent problems
  before products reach the U.S. port of entry.

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Implementation FDA is prepared

• Experience in preventive controls
• Implementation process in place
• Much work already underway
• Projects completed can be found on
  www.fda.gov/fsma

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But, many challenges

• Enormous workload
• - 50 new rules, guidance documents, reports in 3
  years
• Tight deadlines
• Changes wont appear overnight
• - Building new system will be a long-range
  process
• Resources

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Implementation Approach

• Coalition needed
• Transparency a priority
• Focus on public health protection
• Engage with stakeholders to help determine
  reasonable and practical ways to do so

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Priorities

• Prevention
• Mandatory preventive controls for facilities (FR
  18 months)
• Produce safety standards (FR 2 years)
• Intentional contamination (FR 18 months)
• Inspection, Compliance, and Response
• Administrative detention (IFR 120 days)
• Recall (Upon enactment)
• Suspension of registration (180 days)
• Imports
• Foreign supplier verification program (Guidance
  and FR 1 year)
• Accredited third-party certification program (FR
  2 years)
• Mandatory certification for high risk foods (Upon
  enactment)

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For more information

• www.fda.gov/fsma
• (Subscription feature available)

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Contact Information

• Donald A. Prater, DVM
• Deputy Director (Foods)
• FDA Europe Office
• Based at the European Food Safety Authority
• Parma, Italy
• Telephone [phone]
• Email donald.prater_at_fda.hhs.gov