© EAGLE Food Registrations Inc CONFIDENTIAL 1 Food Safety ASQ Milwaukee Section November 18, 2013 Nancy Berger EAGLE Food Registrations, Inc November 2013

2 © EAGLE Food Registrations Inc CONFIDENTIAL Agenda  FSMA – what it means to the consumer  GFSI – what it is & how it is making the food chain safer  Food Safety – heading in the future

3 © EAGLE Food Registrations Inc CONFIDENTIAL Challenges  Food Safety Crisis – global  Government FDA/USDA budget cuts/not enough manpower  Too many individual audits with different expectations  Recalls and Media  Consumer health # 1 priority

4 © EAGLE Food Registrations Inc CONFIDENTIAL FSMA FDA Food Safety Modernization Act (FSMA)  Signed into law January 4, 2011  Most sweeping change in 70 years  Applies to human and animal food products  Special areas of the law for imports and produce  Helps the food chain build consumer confidence

5 © EAGLE Food Registrations Inc CONFIDENTIAL FSMA  7 Foundation Standards (such as food safety defense) still under development, deadline 6/30/2015 for feedback to finalize  5 Areas of FSMA Law Prevention GMPs/HACCP Inspection & Compliance Regulatory Response Import Safety Enhanced Partnerships

6 © EAGLE Food Registrations Inc CONFIDENTIAL FSMA  Prevention goal of the entire FMSA revisions: Preventative rather than reactive approach Stop it before it happens Reduce the likelihood of bad product out in the industry HACCP Program defined and implemented −Some exclusions apply (seafood; juice; small business less than $500,000 annual revenue) −Hazard Analysis Critical Control Points - Evaluate hazards; identify and implement preventive controls; monitor performance; maintain records −Sounds like a FMEA doesn’t it! Prevent Food Hazards!

7 © EAGLE Food Registrations Inc CONFIDENTIAL FSMA  Inspection and compliance -greater access to reports and plant  Catching up to USDA  USDA has been strong in this for a long time – USDA plants have inspection in each day; each shift

8 © EAGLE Food Registrations Inc CONFIDENTIAL FSMA  Regulatory Response – stronger recall processes if reasonable probability of causing serious adverse health consequences or death to humans or animals Registration of all food manufacturing facilities −Any manufacturer, processor, packer or warehouse/distribution −Not farms, restaurants, retail food establishment Detainment of product or suspension if reasonable probability of causing serious adverse health consequences or death to humans or animals

9 © EAGLE Food Registrations Inc CONFIDENTIAL FSMA  Import Safety is a big focus of FSMA Foreign supply verification program - 3 rd Party Audits Importer will have to have the audit certificate on file Set criteria for who can do the audits – approved government agencies/staff and approved auditing companies −Not enough FDA inspectors to do audits −Auditors will also have to be accredited −Starting with imports, but you know it will move to US manufacturers in near future ! Safety BIG Focus

10 © EAGLE Food Registrations Inc CONFIDENTIAL FSMA  Enhanced Partnership FDA staff will not be able to do it alone −Budget restraints Look to other agencies and organizations involvement −State health agencies −Local health agencies −Third Party Certification Bodies or Groups −BRINGS US TO GFSI AUDITS

11 © EAGLE Food Registrations Inc CONFIDENTIAL What is GFSI?  GFSI launched in 2000, following a directive from the CEOs in the food business  Now managed by The Consumer Goods Forum  Benchmarking process of schemes against guidance documents (by sectors)  Encourages stakeholders to share knowledge and strategy for food safety – develop best practices for common global framework

12 © EAGLE Food Registrations Inc CONFIDENTIAL Benefits of an FSMS  Preventive system  Provides systematic approach to managing food safety  Provides standards and guidelines for food safety  Provides verification and validation of system  Improves compliance to regulatory standards  Provides confidence to consumers  Demonstrates due diligence by processor  Auditable

13 © EAGLE Food Registrations Inc CONFIDENTIAL Oversight vs. Non-oversight  Non-oversight, Third-Party Audits Audits which are the product of a specific company −Examples = AIB, Silliker, Cook & Thurber These audits are created and controlled by the company who developed the audit criteria Type of audit used at Peanut Butter Corporation of America  Oversight Third-Party Audits All GFSI schemes

14 © EAGLE Food Registrations Inc CONFIDENTIAL Certification Process  Which program is best for their company? What are the reasons for seeking certification? −Required by customer Global business Mature vs. New FSMS  Standards are similar in a lot of ways, but unique Let’s share some of them

15 © EAGLE Food Registrations Inc CONFIDENTIAL Certification Process Training on the Standard Implementation - Internal or consultant - What fits your company’s needs On-site Pre-Assessment GAP analysis – internal or external

16 © EAGLE Food Registrations Inc CONFIDENTIAL Certification Process (continued)  Supplier Implements The System Create Documentation Identify gaps & correct the gaps Implement System & Train Verify - you do what you say you are doing Validate - Is it working? System Operational* *System must be operational for minimum of two months so records are created and it can be verified and validated

17 © EAGLE Food Registrations Inc CONFIDENTIAL Certification Process (continued)  Certification Steps Different by Standards −FSSC: Stage 1 and Stage 2 » Readiness visit (1) Certification Audit (2) −SQF: Document Review & Certification Audit  Close out Findings  Certification Granted Some GFSI audits are scored / some mirror ISO 9001 and are not scored Surveillance and or recertification audits −Requirements by standard

18 © EAGLE Food Registrations Inc CONFIDENTIAL GFSI Schemes The Three Major FSMS in the U.S. are:  Safe Quality Food (SQF)  British Retail Consortium (BRC)  FSSC 22000

19 © EAGLE Food Registrations Inc CONFIDENTIAL SQF – Overview SQF = Safe Quality Food  Developed in Australia in 1994  Food Marketing Institute purchased in 2003  One code with defined modules for industry specific operations  3 Levels of Certification (Benefit) Level 1 = Food Safety Fundamentals (GMPs, PRPs) Level 2 = Food Safety Plan (HACCP) Level 3 = Food Quality Plan (HACCP driven)

20 © EAGLE Food Registrations Inc CONFIDENTIAL SQF – Basic Facts & Benefits  All documentation is free on their website (Benefit)  Auditor approval controlled by scheme (Benefit)  Nine basic elements and HACCP based  Includes some elements found in 9001 and  Document Control, Management Review, Internal Audit, Corrective and Preventive Action  Standard by modules by food sector categories (Benefit)  Offers additional tools such as guidance documents for specific industries to strengthen program (Benefit)

21 © EAGLE Food Registrations Inc CONFIDENTIAL SQF – Basic Facts & Benefits  Provides discipline for document control  SQF Practitioner responsible for program (Benefit)  Includes 12 Step HACCP Plan  Food Safety Fundamentals Details for building and equipment design and construction Specific PRPs with defined criteria  Special attention to identity of preserved foods (i.e.; Kosher, Organic)  Requires verification and validation of system  Includes quality – based on HACCP method (Benefit)

22 © EAGLE Food Registrations Inc CONFIDENTIAL BRC - Overview  Developed in 1998  Published by the British Retail Consortium  Developed in response to retailer demand  Developed by BRC with contributions from retail, manufacturing, industry associations, and certifying bodies  Edition 6 released 2011, effective 1/2012

23 © EAGLE Food Registrations Inc CONFIDENTIAL BRC – Basic Facts & Benefits  Different schemes/standard by food sector categories  Eight fundamental requirements  HACCP based  Includes quality (Benefit)  Includes some elements found in ISO programs Document Control, Management Review, Internal Audits, etc.

24 © EAGLE Food Registrations Inc CONFIDENTIAL BRC – Basic Facts & Benefits  Provides discipline for document control  Includes 12 step HACCP plan  Very prescriptive PRPs  Special attention to foreign material control such as sharps control (Benefit)  Requires verification and validation of system  Auditor qualifications (Benefit)  Strong in Europe/Canada and for exporting there (Benefit)

25 © EAGLE Food Registrations Inc CONFIDENTIAL FSSC Overview  Newest of the three major GFSI standard  Combination of ISO 22000, PAS 220 (ISO :2009) and a few more requirements in Part 1 of FSSC  ISO was published in September 2005  Developed by joint effort of ISO & the food industry  Truly a global standard - 14 different countries represented

26 © EAGLE Food Registrations Inc CONFIDENTIAL FSSC – Basic Facts & Benefits  100% Food Safety driven (Benefit) Does not include a quality component  HACCP based – very specific requirements  Includes pre-requisite programs PAS 220 (ISO :2009)  Most aligned elements to 9001 (Benefit) Document control, resource management, management review, internal audit  Not scored – aligns with 9001 progress (Benefit)

27 © EAGLE Food Registrations Inc CONFIDENTIAL FSSC Basic Facts & Benefits  Provides discipline for document control  Foundation for continual improvement  Creation of a Food Safety Team  Includes all steps in the development and implementation of a HACCP plan  Control of non-conforming product critical (Benefit)  Validation & verification of system  Traceability

28 © EAGLE Food Registrations Inc CONFIDENTIAL  Last revision changes to FSSC22000 Category M – food grade packaging - added to scope of standard with the use of PAS 223 −Previously it did not offer an approved GFSI standard to the packaging industry Audit time requirements – minimum on site Surveillance audit are FULL SYSTEM audits FSSC – Basic Facts & Benefits

29 © EAGLE Food Registrations Inc CONFIDENTIAL Future of Food Safety  SQF, FSSC and BRC are benchmarking to FSMA Show gaps SQF completed GAP analysis and only a few FMS requirements fell short but they have many requirements that are more stringent Copy of this comparison is on the SQF website –

30 © EAGLE Food Registrations Inc CONFIDENTIAL Future of Food Safety  Complete roll-out of FSMS More accountability Proactive not Reactive Culture  GFSI keeping up with the changes in industry Unannounced audit Adding HACCP Hazards when identified More involvement with certified client recalls from auditing requirements Making a safer food chain!!!!

31 © EAGLE Food Registrations Inc CONFIDENTIAL Contact Information Questions For more information please call , visit or www.eagleregistrations.com