1. The Red Seal – Your Road to FSMA and Quality Compliance
Thomas Vogel – Director, Food Safety DFA of California Jeremiah Szabo – Director of Operations, DFA of California

2. Our Presenters Today – Thomas Vogel
• 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
• 35 years of experience in the food industry, while working for national and international companies in quality assurance, product development and auditing.
• 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

3. 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,

4. 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

5. 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.

6. 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.

7. Title 1 Designed to improve capacity to prevent food safety problems
Food Safety Modernization Act 2010
Title 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

8. Also exempted are the following industries from any changes:
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.

9. Title 1 Sections Designed to prevent food safety problems
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

10. Title 1 Sections Continued
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

11. Sections Update Section 103 Preventive Controls Rule proposal.
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.

12. Section 103 Requires registered facilities unless exempt, to:
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).

13. Section 103
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.

14. PREVENTIVE CONTROLS
"Preventive Controls" vs. HACCP
CCPs vs. CPs.
Knowing your risks
Managing your Risks
Training

15. 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.

16. PREVENTIVE CONTROLS vs. HACCP
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.

17. 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

18. 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).

19. 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

20. Red Seal Certification Program

21. Certification Program Requirements
Red Seal Certificate
Available to DFA of California and Specialty Crop Trade Council members only!
DFA Red Seal Member companies must meet…
Facility Requirements
Quality Requirements

22. No other Product Certification in the industry gives the customer….
Facility Food Safety Certification
Customer specific Product Quality Certification
Customer specific Product Laboratory Certification

23. Red Seal Certified Commodities
Tree Nuts……
Dried Fruit……

24. 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

25. Food Safety Certification
DFA Red Seal Members

26. Food Safety Certification

27. Product Quality Certification
Customer Satisfaction is #1!
Quality provisions for Red Seal Certified products: 
No Rejected segments
Lot averaging not allowed!
Grading to meet customer specifications
Positive lot identification
Inspection within 30 days of shipment
Crop year certified
No arbitration on quality
Certify “Contract Requirements” (i.e. Laboratory testing)

28. 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.

29. Comparison between FSMA and The Red Seal requirements
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

30. agfoodsafety.org/quality-inspection/red-seal-certificate
Product Quality Certification
Safer Products
Consistent Uniformity
Superior Quality
Ship Red Seal Certified!
agfoodsafety.org/quality-inspection/red-seal-certificate

31. Auditing, Certification, Training & Improvement Solutions
BRC Food Safety
SQF
HACCP
Training
In House
Public Courses
Consultation

32. Food Safety Services • Training • Consulting • Audits
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)

33. THANK YOU FOR ATTENDINGv
Q&A