GROCERY MANUFACTURERS ASSOCIATION. Science Forum. Connecting Sound Science and Responsible Solutions

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1 GROCERY MANUFACTURERS ASSOCIATION Science Forum Connecting Sound Science and Responsible Solutions

2 FSMA Implementation Michael M. Landa Director, Center for Food Safety and Applied Nutrition Food and Drug Administration April 4, 2012

3 FY 2012 Budget

4 FY 12 Budget FDA received an increase of $39M for FSMA implementation -- $ 14M for CFSAN -- $ 25M for ORA CFSAN s resources are focused primarily on preventive controls for food processing and produce safety

5 Highlights of First Year Progress Outreach Three public meetings and more being planned Farm tours in 14 States More than 350 presentations, listening sessions More than 70 meetings globally Web site at 5

6 Implementation Highlights (cont.) Interim Final Rules Criteria for Administrative Detention Prior Notice of Imported Food Establishment, maintenance, and availability of records Guidance To dietary supplement industry on new dietary ingredients (draft guidance) To seafood industry on food safety hazards Reports to Congress Food Facilities, Imports and Foreign Offices Food Emergency Response Network FDA Foreign Offices 6

7 Implementation Highlights (cont.) Pilot projects on tracing Established the Produce Safety Alliance and the Food Safety Preventive Controls Alliance Met the FSMA mandate for foreign food safety inspections, and we are well on our way to meeting the 5-year inspection frequency mandate for high-risk domestic food facilities 7

8 Key Rules in the Pipeline Preventive controls for human food facilities Preventive controls for animal feed facilities Produce safety standards Foreign supplier verification program Accredited third-party certification program 8

9 Preventive Controls Human and animal feed addressed in separate but companion rules Are the most central, foundational rules in FSMA Examples of compliance with prevention standards include: sanitation, environmental controls & monitoring, food allergen controls, and current good manufacturing practices (cgmps) 9

10 Produce Safety FDA is required to set science- and riskbased standards for the safe production and harvesting of fruits and vegetables Addresses visible food safety concerns Examples of such standards include: water quality, employee hygiene, soil amendments, and animal intrusion in growing fields Special care needed to address diversity of produce sector 10

11 Foreign Supplier Verification Rule Creates new import oversight paradigm based on importer accountability Linked closely to preventive controls and produce safety requirements Together, these closely interconnected requirements establish the central core of the regulatory framework envisioned by FSMA Greater assurance of safety Addresses consumer concerns about imports Creates level playing field 11

12 Third-Party Certification Key to efficient assurance of import safety, implementation of FSVP, and implementation of supplier controls in preventive controls rules Builds on existing private sector audit system Pre-requisite for expedited entry under Voluntary Qualified Importer Program 12

13 FDA s Implementation Strategy Engage stakeholders pre-proposal Industry, consumers, international partners Public and individual meetings Dockets for written comment Prioritize major rules to establish core FSMA framework For certain final rules we will also prepare guidance to help industry comply with the requirements 13

14 Nutrition (the N in CFSAN)

15 Top Priority Nutrition Initiatives Menu and Vending Machine Labeling publish final rules Nutrition Facts Label (NFL) and Serving Sizes publish a proposed rule to update the NFL and serving sizes Infant Formula publish final rule on quality factors and cgmps Gluten-free Labeling publish final rule establishing a definition of gluten-free Sodium and Trans Fat considering strategies for reduction -- Sodium: Public meeting (11/10/11) -- Trans: We have been determining extent of reductions achieved thus far

16 Highlights of Recent Accomplishments

17 Highlights of Recent Accomplishments FSMA Draft Guidance for Industry on New Dietary Ingredient Notifications (7/11/11) Reopened comment period on gluten-free food labeling and made available a safety assessment of exposure to gluten for people with celiac disease (8/3/11) Public docket on sodium reduction strategies (9/15/11) Official establishment of the Coordinated Outbreak Response and Evaluation (CORE) Network (9/14/11) FDA clearance of Infant formula final rule (9/14/11) Foods and Veterinary Medicine Strategic Plan for CFSAN Strategic Plan for Science and Research

18 Looking Ahead Major Initiatives

19 Looking Ahead FSMA Implementation: Proposed rules on preventive controls for food and feed Proposed rule on produce safety Proposed rule to specify foreign supplier verification activities Proposed rule that will allow FDA to accredit expert organizations to certify third party auditors

20 Looking Ahead cont d Final rule on infant formula cgmps and quality control procedures Final rules on menu and vending machine labeling Final rule to define gluten-free labeling Proposed rule to update the Nutrition Facts Label and Serving Sizes