Impact of FSMA on the Regulation of Domestic and Imported Animal Food by Daniel G. McChesney, Ph.D. at Wild Bird Feeding Industry 2011 Annual Meeting Naples, Florida November 12, 2011

Agenda Preventive Controls Registration Inspection, Compliance and Response Import Controls Fees

Main Themes of Legislation Prevention Inspections, Compliance, and Response Import Safety Enhanced Partnerships

Preventive Controls Food safety at human food facilities Food safety at animal food facilities Prevention of intentional contamination at human and animal food facilities, dairy farms, and produce farms and packing facilities Food safety at produce farms and unregistered packing facilities Food safety during transportation of human and pet food and feed

General Principles Science-based – Controls that are minimally necessary to protect public health Flexibility – where specific preventive controls are mandated, alternatives are accepted if validated Risk-based – burden tracks risk Small business sensitivity – Tiered effectiveness dates based on size – Some provisions not needed for smallest firms in some cases exemptions from preventive controls

What Will the Preventive Control Rule Look Like cGMPs similar to 21 CFR 225; 21 CFR 110 Preventive controls Recordkeeping Exemptions

Current Good Manufacturing Practices Elements Personnel. Plant and grounds. Sanitary operations. Sanitary facilities and controls. Equipment and utensils. Processes and controls. Warehousing and distribution.

Preventive Control Elements Requirements for a food safety plan Plan must be written Hazard analysis. Preventive controls for hazards that are reasonably likely to occur. Recall plan for animal food in which there is a hazard that is reasonably likely to occur. Monitoring. Corrective action. Verification. Supplier approval and verification program. Modified requirements for a facility solely engaged in the storage of packaged animal food that is not exposed to the environment. Records required for preventive controls.

Areas to be Addressed by Preventive Controls Process Controls Supplier Controls Sanitation Controls, that impact animal food safety Submission of food safety plans – Plans? – Profiles?

Exemptions New preventive controls provisions (food safety system) do not apply to facilities: – In compliance with Seafood HACCP or Juice HACCP In compliance with LACF regulations (microbiological hazards) – In compliance with Dietary Supplement GMPs – Exempt through “Tester Amendment” (size, distance and nature of customers) – Exemption on size – Specific activities – Low risk on farm manufacturing (determined by FDA)

Timeline for Preventive Control Rules Statutory Due Date: Final rule published: 7/3/12 Current timeline: – Proposed rule published: FDA target early January 2012 – Final rule published: Summer 2012 Public meetings – 3-4 public meeting anticipated on proposed rule

Registration Re-register every two years starting in 2012 – Additional categories being request for animal food – Requesting AAFCO Ingredient categories with some consolidation Abbreviated process to support biennial registration being considered Requiring electronic submission being considered Requirements for revoking registration being developed

Inspection, Compliance, and Response Mandated inspection frequency – Considering new ways to inspect New tools – Mandatory recall – Expanded records access – Expanded administrative detention – Suspension of registration – Enhanced product tracing – Third party laboratory testing

Import Safety: Most Groundbreaking shift Foreign Supplier Verification Program Requires food from abroad to be as safe as domestic Importers now responsible for ensuring that their foreign suppliers have adequate preventive controls in place FDA can rely on third parties to certify that foreign food facilities meet U.S. requirements Can require mandatory certification for high-risk foods Voluntary qualified importer program--expedited review Can deny entry if FDA access for inspection is denied

FEES FSMA provides for FDA to collect a variety of fees – Support and establish FSVP including 3 rd party certification – Re-inspection fees for domestic and imported products – Export certificate for food/feed

Interactive and robust FSMA webpage 24,000+ viewers/month More than 8,000 subscribers It’s already the second most popular Foods Program page link to FSMA is located in the box called Public Health Focus