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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!
[email protected]/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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