Thomas Vogel – Director, Food Safety DFA of California Jeremiah Szabo – Director of Operations, DFA of California  

The Red Seal – Your Road to FSMA and Quality Compliance  

• Auditor, Trainer, Consultant – DFA of California

• Driving force behind our food safety operations in the areas of Good Manufacturing Practice (GMP), Good Agricultural Practice (GAP) and supplier assurance programs, including HACCP, SQF and BRC  

• BSC in Chemistry and an accomplished food safety trainer for numerous food safety manager certification courses

• In addition, he is a GMP/HACCP instructor, a Lead Auditor trainer, and is also certified to audit on the Global Food Safety Initiative for SQF and BRC. He is certified in numerous product categories

• 35 years of experience in the food industry, while working for national and international companies in quality assurance, product development and auditing.  

Our Presenters Today – Thomas Vogel

Our Presenters Today – Jeremiah Szabo

• Operations Director for commodity inspection and laboratory programs, Auditor, Trainer, Consultant – DFA of California

• 10 years of food industry experience working in Quality Control, Quality Assurance, Laboratory management, and food safety.

• BSC in Biological sciences, certified HACCP auditor, certified to audit to Global Food Safety Initiative (GFSI) audits for BRC and SQF audits, GMP/HACCP/Internal Auditor trainer,

   

Purpose Of This Session

•  Overview of Food Safety Modernization Act

•  Provide an update on the implementation of FSMA

•  How the Red Seal can assist with FSMA compliance

•  How the Red Seal can give a market advantage

•  Q&A

Food Safety Modernization Act (FSMA)

Congress passed FSMA on December 20th 2010 President Obama signed it into law on January 4th, 2011 Congress sets the laws, FDA develops the regulations to fit with the laws and then enforces the laws.

Initial timetable had a 3 year implementation plan with parts being implemented immediately and other parts gradually but FDA has not been able to meet this timeframe and it is now likely to be a 5-7 year plan.

Food Safety Modernization Act (FSMA)

Federal Judge from the US District Court in Northern California has ruled that FDA has to meet the following timetable.

Regulations all had to be published by November 30th, 2013.

All comment periods have to be closed out by March 31st, 2014.

Final regulations need to be put into effect by June 30th, 2015.

Followed by a 3 year implementation plan for Industry.

 Food Safety Modernization Act 2010

Title 1 Designed to improve capacity to prevent food safety problems Title 2 Designed to improve capacity to detect and respond to food safety problems Title 3 Designed to improve the safety of imported food Title 4 Includes miscellaneous provisions

 Food Safety Modernization Act 2010  Exempted Businesses  •  FSMA does not apply to facilities regulated by

USDA (meat, poultry and eggs) •  Also exempted are the following industries from

any changes: •  Juice manufacturers  •  Seafood processors  •  Alcohol-related facilities  •  Low acid canning (except to expand their Hazard

Analysis)  •  Small Businesses < $500,000 sales and 50% of their

sales within 275 miles of their facility (Tester amendment)  

•    FDA is considering modified requirements for warehouses and having Preventive Controls only if they are storing refrigerated products.

•  Section 101 FDA access to your records  •  Section 102 Registration and possible suspension by

FDA  •  Section 103 Preventive Controls (HACCP)  •  Section 104 FDA hazard information  •  Section 105 Produce food safety guidelines  •  Section 106 Regulations to prevent intentional

adulteration  •  Section 107 Fee assessments by FDA  •  Section 108 National agriculture and food defense

strategy

Title 1 Sections Designed to prevent food safety problems

•  Section 109 Annual reporting by Secretary of Homeland Security  •  Section 110 Building domestic capacity  •  Section 111 Sanitary transportation regulations  •  Section 112 Allergen education  •  Section 113 New dietary ingredients  

Title 1 Sections Continued

We are for the purpose of this update confining our updates to the following Sections of FSMA:

Section 103 Preventive Controls Rule proposal.

Section 105 Produce Guidelines. Section 106 Intentional Adulteration of Foods. Section 301 Voluntary Importer Program. Section 306 Risk Assessment on Imported Foods.  Section 307 Third Party Accredited Audits.

Sections Update

Section 103

cGMP and Hazard Analysis and Risk-Based Preventive Controls for Human food.

•  Requires registered facilities unless exempt, to:

•  Have a written food safety plan •  Perform a Hazard analysis •  Implement risk based preventive control

measures •  Conduct Monitoring •  Perform Corrective Actions •  Verify the effectiveness of these preventive

controls •  Maintain records (FDA to provide list of

what records will be required).

cGMP and Hazard Analysis and Risk-Based Preventive Controls for Human food. •  Requires all FDA registered facilities to

comply with the exception of Dietary Supplement manufacturers

•  Seafood companies. •  Juice manufacturers. •  Alcohol manufacturers. •  Low acid canning. •  Proposing to possibly exempt •  grinding, milling, or crushing of grains. •  In-farm packing of intact fruit and

vegetables. •  Facilities storing unexposed products.

Section 103

•  "Preventive Controls" vs. HACCP •  CCPs vs. CPs. •  Knowing your risks •  Managing your Risks •  Training

PREVENTIVE CONTROLS

PREVENTIVE CONTROLS vs. HACCP

FDA makes a point in this proposed rule that although Preventive Controls should be determined using Principle 1 (Hazard Analysis) as in developing a HACCP program the Preventive Controls should not be limited to just CCPs.

Need to include •  Pre-requisite programs •  Recall program •  Sanitation programs •  Environmental Pathogens and controls •  Allergens and controls •  Equipment Calibration •  Food Defense Program see Section 106.

 FDA's support information for requiring companies to develop and implement Preventive Controls programs vs. HACCP plans states that companies with HACCP plans have not put the due diligence into implementing and monitoring their CPs.

Thoughts are here that industry has deferred to a CP instead of a CCP so as to avoid having to monitor, record and react to possible variances required of a CCP in a HACCP Plan and this has thus continued to cause contaminated products to be distributed and hence cause subsequent Recalls.

Industry has also deferred to their Suppliers control of certain possible hazards to the extent that they trust their Suppliers but never verify their Suppliers can and do achieve this level of control of an "likely to occur" hazard.

PREVENTIVE CONTROLS vs. HACCP

Section 103 cGMP and Hazard Analysis and Risk-based Preventive Controls for Human food.

This proposed rule requires also:

• That low acid canning facilities expand  their hazard analysis to include chemical  and physical hazards

• Requires that each hazard analysis to  include the possibility of deliberate or "terroristic" contamination of your products. (However preventive controls for this are to be covered under your Food Defense plan (See Section 106) not this plan).

• Requires all companies to reanalyze their potential hazards every three years

Section 103  cGMP and Hazard Analysis and Risk-based Preventive Controls for Human food.        FSMA asks companies to assess chemical, radiological hazards, natural toxins, pesticides, drug residues in their hazard analysis, ( arsenic in chicken, aflatoxins in figs, or acrylamide in corn chips).        (FDA recently lowered the allowable arsenic level in apple juice to match that allowed in drinking water).

cGMP Working Group presented to the FDA 7 areas of opportunity for updating the cGMPs. • Training

• Documented Allergen controls • Documented environmental pathogen

control program • Documented SSOPs • Maintenance of food safety records • Possibly removing the exemption given

to companies who just handle raw agricultural products

• Getting public comment for time and

temperature as related to the safe storage of hot and cold foods

Red Seal Certification

Program

Certification Program Requirements

•  Red  Seal  Cer*ficate    Available  to  DFA  of  California  and  Specialty    Crop  Trade  Council  members  only!  

 •  DFA  Red  Seal  Member  companies  must  meet…  

 Facility  Requirements    Quality  Requirements  

 

No other Product Certification in the industry gives the customer….

ü Facility  Food  Safety  Cer6fica6on  ü Customer  specific  Product  Quality  Cer6fica6on  

ü Customer  specific  Product  Laboratory  Cer6fica6on  

Red Seal Certified Commodities

Tree  Nuts……   Dried  Fruit……  

Food  Safety  Cer*fica*on  

Red  Seal  Member  facili;es  must….    Demonstrate  that  their  products  are  handled,  produced,  packaged  and  stored  at  a  facility  opera;ng  according  to…    ü  Codex  Alimentarius  (HACCP)  and  the  Na6onal  Advisory  

Commi9ee  on  Microbiological  Criteria  of  Foods  (NACMCF)  guidelines  

ü  Cer;fied  to  a  Global  Food  Safety  Ini;a;ve  (GFSI)  standard    

 Verified  by  an  authorized  DFA  food  safety  auditor  

Food  Safety  Cer*fica*on  

DFA  Red  Seal  Members  

Food  Safety  Cer*fica*on  

Product Quality Certification

 

Customer  Sa*sfac*on  is  #1!    

Quality  provisions  for  Red  Seal  Cer;fied  products:    

ü  Lot  averaging  not  allowed!    ü  Posi;ve  lot  iden;fica;on  

ü  Inspec;on  within  30  days  of  

shipment  

ü  No  arbitra;on  on  quality    

 

 

 

 

ü  No  Rejected  segments  

ü  Grading  to  meet  customer  

specifica;ons      

ü  Crop  year  cer;fied  

ü  Cer*fy  “Contract  

Requirements”  (i.e.  Laboratory  

tes*ng)  

Comparison between FSMA and The Red Seal requirements

•  WriKen    Food    Safety    Plan  ü  Both    FDA  and  DFA  require  that  the  facility  has  a  wriKen  food  safety  

plan.  ü  Both    FDA  and  DFA  require  that  staff  be  trained  and  an  experienced  

individual  is  responsible  for    developing  the  program  

•  Prerequisite  programs:    ü  DFA  emphasizes    the  importance  of    prerequisite  programs.  While  

FDA  does  not  specifically  address  PRP’s,  in  this  way  DFA  is  stronger.    

•  Allergen  Management  ü  Stronger  than  what  FSMA  requires  

•  Food  Defense    ü  FDA  did  not  include  anything  with  regard  to  Food  Defense  but  DFA  

requires  it.  

 

•  Valida*on    ü  Both  FDA  and  DFA  require  valida*on  of  the  HACCP  plan.  

•  Correc*ve  Ac*on  ü  DFA  is  stronger  than  FSMA  

•  Traceability  ü  Both  FDA  and  DFA  require  a  traceability  program  

•  Recall  Program  ü  Both  FDA  and  DFA  require  a  recall  program.  

•  Internal  Audits  ü  FDA  does  not  require  internal  audits,  DFA  is  stronger.    

•  Supplier  Verifica*on  ü  Stronger  DFA  emphasis  than  FDA  

 

Comparison between FSMA and The Red Seal requirements

Product Quality Certification

ü  Safer  Products  ü  Consistent  Uniformity  ü  Superior  Quality        

Ship  Red  Seal  Cer*fied!      

redseal@agfoodsafety.org  agfoodsafety.org/quality-­‐inspec*on/red-­‐seal-­‐cer*ficate  

Auditing, Certification, Training & Improvement Solutions

•  BRC Food Safety  •  SQF •  HACCP •  Training •  In House •  Public Courses •  Consultation

Food Safety Services

• Training Public and onsite training (SQF, BRC, HACCP, Advanced HACCP, Internal Auditor, Food Defense, GMP)

• Consulting On-site GAP analysis

HACCP program facilitation

Program review & development

Allergen program review and validation  Product specification building

• Audits Non-Accredited: GMP, Warehouse, HACCP Verification Accredited: GFSI benchmarked certification audits (DFA Global Certifications, LLC)

THANK YOU FOR ATTENDING

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Q&A