Food Safety Modernization Act: Are You Ready? March 27, 2012 Gary Jay Kushner NPA Annual Meeting La Playa, Florida

2 Agenda Main Requirements of FSMA FDA Implementation So Far Provisions Already in Effect What’s Next Inspections and Records Access Preparation

3 Overview Law signed on January 4, 2011 FDA has conducted extensive outreach FDA has already completed some actions Some provisions already in effect Messaging from FDA mostly positive, but issues may surface in proposed rules Activity will accelerate during 2012 Food companies have started to prepare

4 Main Elements of FSMA 1. New Responsibilities on Food Companies 2. New Controls over Imported Food 3. New Powers for the FDA 4. New Fees on Food Companies and Importers

5 New Responsibilities for Food Companies Affecting daily operations –Food Safety Plans/Preventive Controls –Supply Chain Management –Records Maintenance and Access –Food Defense Plans Applies to all Registered Facilities –Including warehouses –Including foreign facilities

6 Not To Be Forgotten Bi-annual registration Safety standards for fruits and vegetables Traceability Records access under Bioterrorism Act Performance standards

7 New Controls Over Imported Food Supply chain verification procedures Foreign facilities subject to same requirements as domestic facilities FDA authority to require third party certification for food safety-related reason Accredited laboratory must be used for certain testing Expedited entry at border if safety and security guidelines met

8 New or Enhanced Enforcement Powers for FDA Increased inspection frequency – High Risk Domestic – every 3 years – Low Risk Domestic – every 5 years – Ramp up Foreign inspections (600 to 19,200 over 6 years) Suspension of registration Mandatory recall Expanded administrative detention authority

9 New Fees on Food Companies and Importers Reimbursement to FDA –Reinspections –Recall (very limited) Export certificates Fast lane for imports Fees already in effect for facility reinspections

10 Implementation Timetable Various effective dates for different provisions Basic timeline (set by statute) – 18 months – food safety plans – 24 months – foreign supplier verification – Longer for traceability – Bi-annual registration begins 2012 Detailed schedule for FDA regulations and guidance Longer implementation time for small and very small businesses Enforcement discretion

11 FDA Outreach Agency conducted 3 public meetings in spring 2011 –Import provisions –Preventive controls –Inspections and enforcement  Each meeting followed by open public docket Additional docket opened for guidance documents to support preventive controls rulemaking Meetings held with subject matter experts and trade associations

12 FDA Actions Published interim final rule for administrative detention –Trigger is: “reason to believe” an article of food is “adulterated or misbranded” –Tied to seizure and injunction actions Published interim final rule for prior notice of imports –Requires prior notice for an imported food to identify any country to which the article of food has been shipped, but refused entry

13 FDA Actions – Reinspection Fees FDA can assess reinspection fees against: 1.Domestic facilities to cover reinspection-related costs Reinspection: previous inspection was “Official Action Indicated” and the noncompliance was materially related to food safety 2.Domestic facilities to cover recall-related activities performed by FDA if the facility refuses to comply with a mandatory recall order FDA published notice of reinspection fee costs –Rates: $224/hour; $325/hour if foreign travel required (per person)

14 FDA Actions – Reinspection Fees 3.Importers to cover reinspection-related costs Imports: reconditioning of imported food; importers seeking admission of an article that has been detained; entities requesting removal from an import alert for detention without physical examination; and destruction of food that has been refused admission FDA has curtailed plans to implement the reinspection fees. Currently: –Reinspection fees will only be assessed if the initial inspection occurred after October 1, 2011 –Import reinspection fees are not being implemented yet –Mandatory recall fees are in effect

FDA Actions Selected IFT to conduct traceability pilots –Produce; packaged food –Stakeholder meetings on pilot scope –Completion and report expected late spring 2012 Updated website with improved search capability for recalls Issued anti-smuggling strategy Issued series of Q & A documents Met other statutory deadlines (reports to Congress, updating Seafood HACCP Guidance, issuing guidance on new dietary ingredient notifications) 15

16 Provisions Already in Effect Mandatory recall Suspension of registration Administrative detention (enhanced version) Prior notice of imports (enhanced version) Emergency access to records (enhanced version) Reinspection fees (but not for imports)

17 What’s Next Proposed rules expected soon FDA priorities are: –Preventive controls –Fresh produce –Foreign supplier verification –Third-party accreditation standards Comment periods likely to be short (60 days), with no extensions FDA will try to issue final rules by January 2013 (end of Obama’s first term) Enforcement dates to be specified in final rules

FDA Culture is Changing More aggressive and enforcement-minded For example, FDA is: –Conducting many more inspections (with the states) –Issuing many more Warning Letters for food GMPs –Increasing oversight of imports, especially ingredients, and conducting foreign on-site inspections –Testing more, both environment and product –Expanding working definition of “high risk” Nut-containing products Dairy/cheese 18

Inspections - What to Do Now FDA will not have routine access to food safety records until July 2012, at the earliest But, inspections have already changed: –FDA is energized and persistent and will note all possible violations as inspectional observations –FDA will demand access to records the agency lacks the legal authority to access –FDA will try to take photographs even without express legal authority –Inspections involve comprehensive environmental sampling (“swab-a-thon”) 19

Inspections – Changes to Come Historically, FDA has inspected food processing facilities for basic sanitation and to detect visible problems with the facility or the product produced Under FSMA, FDA also will focus on whether facilities are implementing effective food safety systems –This “systems-based” approach is aimed at preventing problems on a continuing basis, not just when the inspector is in the facility This change is consistent with a main theme of FSMA: Move from reaction to prevention 20

Inspections – Changes to Come As soon as July 2012, FDA will have increased access to a broad range of records, including food safety plans and implementation documents FDA will likely start with the hazard analysis in the Food Safety (HACCP) Plan and related controls –Are all the hazards addressed? –Are there adequate controls, especially CCPs? –Is there scientific validation for CCPs/kill steps? Complete documentation will be critical! 21

Inspections – Changes to Come FDA will carefully review production records, focusing on monitoring for CCPs and documentation of corrective actions –Plant personnel should work with inspectors to narrow the scope of their request –It’s okay to ask questions about what they are looking for to narrow the focus Having good records to document corrective actions is best way to show FDA company is acting responsibly Remember: If you didn’t document it, it didn’t happen! 22

Records Access Will be Central Feature of FSMA Inspections Records you will need to have ready: –Hazard Analysis –Food Safety Plan (with designated controls) –Scientific basis for preventive controls –Monitoring records –Corrective actions –Verification, including environmental and product testing –Consumer complaints related to food safety –Supply chain oversight (domestic and foreign) –Recall plan and records of any recalls conducted 23

24 Preparing Now Initial briefings of senior management Initial trainings: –Quality staff and plant managers –Co-manufacturers and suppliers Review/update: –HACCP plans –Supplier qualification procedures –Records maintenance procedures Work with NPA to file comments

25 Conclusion FDA has been very open so far FDA appears driven to complete required actions and implement the law in a timely manner –Election year –Budget Although there have been some delays, implementation/enforcement is just around the corner Inspections will change significantly, so preparation is key

26 Contact Information Gary Jay Kushner Hogan Lovells US LLP (202)

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