Transcript Slide 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
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
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
Title 2
Title 3
Title 4
Designed to improve capacity to
prevent food safety problems
Designed to improve capacity to detect
and respond to food safety problems
Designed to improve the safety of
imported food
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.
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
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
Sections Update
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
Section 106
Section 301
Section 306
Section 307
Produce Guidelines.
Intentional Adulteration of Foods.
Voluntary Importer Program.
Risk Assessment on Imported Foods.
Third Party Accredited Audits.
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).
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.
PREVENTIVE CONTROLS
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"Preventive Controls" vs. HACCP
CCPs vs. CPs.
Knowing your risks
Managing your Risks
Training
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.
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.
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 Certificate
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….
Facility Food Safety Certification
Customer specific Product Quality
Certification
Customer 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!
 No Rejected segments
 Positive lot identification
 Grading to meet customer
 Inspection within 30 days of
shipment
 No arbitration on quality
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.
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
Product Quality
Certification
 Safer Products
 Consistent Uniformity
 Superior Quality
Ship Red Seal Certified!
[email protected]
agfoodsafety.org/quality-inspection/red-seal-certificate
Auditing, Certification, Training
& Improvement Solutions
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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