Thomas Vogel – Director, Food Safety DFA of CaliforniaJeremiah 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 ofGood 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 alsocertified 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 2010President Obama signed it into law on January 4th, 2011Congress 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 2010Exempted 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 SectionsDesigned 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 thefollowing 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 andimplement Preventive Controls programs vs. HACCP plans statesthat companies with HACCP plans have not put the due diligenceinto implementing and monitoring their CPs.

Thoughts are here that industry has deferred to a CP instead of aCCP so as to avoid having to monitor, record and react to possiblevariances required of a CCP in a HACCP Plan and this has thuscontinued to cause contaminated products to be distributed andhence cause subsequent Recalls.

Industry has also deferred to their Suppliers control of certainpossible hazards to the extent that they trust their Suppliers butnever verify their Suppliers can and do achieve this level of control ofan "likely to occur" hazard.

PREVENTIVE CONTROLS vs. HACCP

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

This proposed rule requires also:

• That low acid canning facilities expandtheir hazard analysis to include chemicaland physical hazards

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

• Requires all companies to reanalyze theirpotential hazards every three years

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

FSMA asks companies to assesschemical, radiological hazards, naturaltoxins, pesticides, drug residues in theirhazard analysis, ( arsenic in chicken,aflatoxins in figs, or acrylamide in cornchips).

(FDA recently lowered the allowablearsenic level in apple juice to match thatallowed in drinking water).

cGMP Working Group presented to the FDA 7areas 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 givento companies who just handle rawagricultural products

• Getting public comment for time andtemperature as related to the safestorage of hot and cold foods

Red Seal Certification

Program

Certification Program Requirements

• Red Seal CertificateAvailable to DFA of California and Specialty

Crop Trade Council members only!

• DFA Red Seal Member companies must meet…

Facility RequirementsQuality Requirements

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

Facility Food Safety CertificationCustomer specific Product Quality

CertificationCustomer specific Product Laboratory

Certification

Red Seal Certified Commodities

Tree Nuts…… Dried Fruit……

Food Safety Certification

Red Seal Member facilities must….

Demonstrate that their products are handled, produced, packaged and stored at a facility operating according to…

Codex Alimentarius (HACCP) and the National Advisory Committee on Microbiological Criteria of Foods (NACMCF) guidelines

Certified to a Global Food Safety Initiative (GFSI) standard

Verified by an authorized DFA food safety auditor

Food Safety Certification

DFA Red Seal Members

Food Safety Certification

Product Quality Certification

Customer Satisfaction is #1!

Quality provisions for Red Seal Certified products:

Lot averaging not allowed!

Positive lot identification

Inspection within 30 days of

shipment

No arbitration on quality

No Rejected segments

Grading to meet customer

specifications

Crop year certified

Certify “Contract Requirements”

(i.e. Laboratory testing)

Comparison between FSMA and The Red Seal requirements

• Written Food Safety Plan Both FDA and DFA require that the facility has a written food safety

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

individual is responsible for developing the program

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

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

• Allergen Management Stronger than what FSMA requires

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

requires it.

• Validation Both FDA and DFA require validation of the HACCP plan.

• Corrective Action DFA is stronger than FSMA

• Traceability Both FDA and DFA require a traceability program

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

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

• Supplier Verification Stronger DFA emphasis than FDA

Comparison between FSMA and The Red Seal requirements

Product Quality Certification

Safer Products Consistent Uniformity Superior Quality

Ship Red Seal Certified!

redseal@agfoodsafety.orgagfoodsafety.org/quality-inspection/red-seal-certificate

Auditing, Certification, Training & Improvement Solutions

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

Food Safety Services

• TrainingPublic 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

• AuditsNon-Accredited: GMP, Warehouse, HACCP Verification

Accredited: GFSI benchmarked certification audits (DFA Global Certifications, LLC)

THANK YOU FOR ATTENDING

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Q&A