www.blytheco.comwww.blytheco.com
The Role of Technology in Food
Processing Compliance and
TraceabilitySeptember 25, 2014
Agenda
Panel IntrosQuestions for our Panel
The State of the Industry todayThe Top Requirements and CapabilitiesSolutions to Help
Why Sage ERP X3?Your QuestionsNext Steps
Introductions
Alicia AndersonStrategic Marketing, Blytheco19 years in ERP sales, service and marketingLeading ERP provider to food processors
Introductions
Dr. Roger Clemens
Past-President, Institute of Food TechnologistsChief Scientific Officer at HornAdjunct Professor of Pharmacology and Pharmaceutical Sciences within the USC School of Pharmacy.Frequently cited and interviewed by more than 500 domestic and international health journalists, and has appeared on numerous televised (KABC, Good Morning America, Good Morning London, CNN, CBS 48 Hours) interviews.
Introductions
Mark Pinard
Senior Solution EngineerSage X3 ExpertDesigns technology solutions for hundreds of Food and Beverage companies nationwide
What is the state of the industry in regards to compliance?
What are the risks we are seeing with food producers regarding safety?
What is the current “state of the industry”?
In the United States alone, federal regulation costs
businesses nearly $1 trillion dollars per year.
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The Evolution of Food Control
Deg
ree o
f S
pecifi
cit
y
Degree of Command & Control
Courtesy of Bill Layden
Information
Regulation
No Good Food/Bad Food; All Foods Fit
Better-for-you Foods
Restrictions on license to sell; zoning restrictions
Litigation, class action suits
Government audits on sales based on usage, nationalized food companies
Self-regulation based on nutrition standards
Nutrition standards used to tax, restrict marketing & advertising, restrict access, limit eligibility in food assistance
Warning labels, changes to GRAS status
Ban, ration
FOOD REGULATION MAZE CFSAN (Center for Food Safety and Applied Nutrition)
USDA (United States Department of Agriculture) FSIS
EPA (Environmental Protection Agency)
FWS (Fish & Wildlife Service; Dept of the Interior)
Alcohol and Tobacco Tax and Trade Bureau (TTB) (formerly ATF)
DEA (Drug Enforcement Agency)8
FOOD LAW AND NUTRITION GUIDANCE MILESTONES
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06
T. Roosevelt,Pure Food & Drug Act & Federal Meat Inspection Act
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Revision of 1906 Act
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FD&C Act
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06
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58
19
00
Food Additives Amendment; Delaney proviso, “zero tolerance”; GRAS published & petition process
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Color Additive Amendment
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70
EPA established
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“Proxmire Amendments”Toxic Substances Control Act
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80
Infant Formula Act;First Dietary Guidelines for Americans
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90
NLEA;OrganicsFood Production
Act
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DSHEA
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99
Pearson vs. Shalala (US Appeals Court)
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66
Negligible Risk;Fair Packaging and Labeling Act
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02
Public Health and Security Preparedness and Response Act (aka Bioterrorism Act)
Trans fats and food allergens labeling;SAFE Port Act;Dietary Supplement and Nonprescription Drug Consumer Protection Act
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07
CGMPs for Dietary Supplements;SAERs mandated (12.22.07); Final June 2010
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86
Safe Drinking Water and Toxic Enforcement Act; Proposition 65 (CA)
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Food and Nutrition BoardFirst RDAs established
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97
DRIs established;Food & Drug Modernization Act;
GRAS notification
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Cyclamate banned;GRAS Review;White House Conference on Food, Nutrition, and Health
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Cyclamate discovered
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Farm Bill – Sec 912
Non-binding HC Guidelines for DS
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FDA Food Safety Modernization Act
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Health Care; § 4205
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Gluten-free Labeling of Foods
BIOTERRORISM ACT (2002)• Congress’ response to 9/11/01 attacks
• Official title: Public Health Security and Bioterrorism Preparedness and Response Act of 2002
• Food protection (4 provisions)– Administrative Detention– Registration of Food Facilities– Establishment and Maintenance of Records– Prior Notice of Imported Food Shipments
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REGISTRATION OF FOOD FACILITIES• Facilities must be registered with the
FDA– Facility is any factory, warehouse, or
establishment, including importers– Exempts farms, restaurants, retail food
establishments, nonprofit food establishments (food prepared/served directly to consumer), and fishing vessels
– Registration deadline: December 12, 200311
THREATS TO FOOD SECURITY• Contamination of water supply
• Tampering of food supply
• Biological warfare against livestock and crops
• Contamination of imported foodstuffs
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SAFE PORT ACT (2006)“SECURITY AND ACCOUNTABILITY FOR EVERY PORT ACT OF 2006”
• Harnesses the power of “inspection” technology• Increases American
inspectors to dozens of foreign ports (Container Security Initiative)
• Improves efforts between the public and private sectors to improve cargo security (Customs Trade Partnership Against Terrorism)
• Provides additional authority for the Domestic Nuclear Detection Officehttp://www.whitehouse.gov/news/releases/2006/10/20061013-2.html
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THE PROBLEM: CHALLENGES OF A FOOD SITUATION
• Food supply system is extremely complex
• Global challenge acknowledged
• Food as a desirable terrorist vehicle
• Intentional vs. accidental contamination
• New paradigm for threats to food safety and defense management
FOOD GMP (VARIOUS IMPLEMENTATION DATES)
• FDA established CGMP working group 2002 to update 21CFR110 (CGMP in Manufacturing, Packing, or Holding Human Food)– General Provisions– Buildings and Facilities– Equipment– Production and Process Controls– Defect Action Levels
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FOOD DEFECT ACTION LEVELS (DALS)(MAY 1995; REVISED MARCH 1997; REVISED MAY 1998)
21CFR§110.110
In order to qualify as U.S. No. 1 Grade, the commodities listed below cannot exceed the following limits of contamination:
Blueberries – 2 maggots / 100 berries Coffee – 10% of beans infested Corn, canned – 2 insect larvae / 100 g Curry powder – 100 insect fragments / 100 g Ketchup – 30 fruit fly eggs / 100 g Peanut butter – 50 insect fragments / 100 g Pepper, ground – 475 insect fragments / 50 g Sesame seed – 5% of seeds infested Tree nuts – 5% insect-infested, rancid, moldy,
gummy, and shriveled or empty shells Wheat – 1% of grain infested
Pose no inherent hazard to health
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http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/sanitationtransportation/ucm203420.htm Accessed August 15, 2014http://www.fda.gov/food/guidanceregulation/ucm056174.htmAccessed August 15, 2014 (website updated July 10, 2014)
A grain elevator owned by the Frontier Cooperative loads rail cars with corn
by N
ati
Harn
ik, A
P
What are the top requirements we are seeing in industry today?
What are some specific challenges we are seeing in companies?
What are the technology requirements that companies need?
Industry Requirements and Challenges
There have been 26 multi-state outbreaks of food-borne
illness since Obama signed the FSMA into law, according to a
Pew analysis.
FOOD SAFETY MODERNIZATION ACT (FSMA, 2011)
• Applications– Specifically affects “food”: Beverages, dietary
supplements, produce, alcoholic beverages, seafood, dry goods, finished products and their ingredients
• Funding– Poorly funded; no funds for implementation (per Michael
Taylor, February 2014 – testimony before the House Energy and Commerce Committee)
• Enacted January 4, 2011
• Email Updates: https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_206
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KEY ASPECTS OF PROPOSED RULES• Confirm industry’s primary role on food
safety
• Risk-based and flexibility
• Address small business issues
• Extensive government, stakeholder input
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PRIMARY ELEMENTS OF FSMA• Hazard Analysis & Risk Preventive Controls
• Standards for Produce Safety
• Facility Inspections
• Mandatory Recall Authority
• Facility Registrations
• Record Inspection & Maintenance
• Import/Foreign Industry Provisions
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PRIMARY FRAMEWORK RULES (5)1. Preventive Controls for Human Food – Published Jan 2013
(FDA-2011-N-0920)
2. Produce Safety Standards – Published Jan 2013 (FDA-2011-N-0921)
3. Foreign Supplier Verification Program – Published Jul 2013 (FDA-2011-N-0143)
4. Accredited Third Party Certification – Published Jul 2013 (FDA-2011-N-0146)
5. Preventive Controls for Animal Food – Published Oct 2013 (FDA-2011-N-0922)
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FSMA TRACEABILITY• Pilot Projects for Improving Product Tracing
along the Food Supply System Final Report (March 4, 2013)
• Draft Methodological Approach to Identifying High-Risk Foods (February 2014)– Designate high-risk foods for which additional
recordkeeping requirements are appropriate and necessary in order to rapidly and effectively track and trace such foods during a foodborne illness outbreak or other events
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http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm270851.htmUpdated September 15, 2014
FOOD PRODUCTION CHAIN CONTAMINATION
http://www.cdc.gov/foodsafety/outbreaks/investigating-outbreaks/production-chain.htmlAccessed September 18, 2014
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• Contamination in Production
• Contamination in Processing
• Contamination in Distribution
• Contamination in Preparation
WHY PRODUCT TRACING? Center for Disease Control and Prevention (CDC) estimates
48 million cases of foodborne illness
128,000 hospitalized
3,000 deaths
Foodborne illness source attribution 70% of investigations unresolved at the state level (CSPI)
42% of outbreaks from unknown foods (CDC)
7 pathogens cause 90% of illnesses, hospitalizations, and deaths due to known pathogens (CDC)
Challenges and opportunities in product tracing Epidemiological investigations
Traceback investigations
Recalls24
FSMA TRACEABILITY• SEC 204. Enhancing tracking and tracing of
food and recordkeeping (examples)– Conduct pilot projects directed to raw agricultural
commodities– Collect additional data (e.g., costs and benefits of tracing
technologies, practicality of implementation)– Product tracing system (e.g., effectively and rapidly track
and trace food in the US or offered for import into the US.– Additional recordkeeping for high risk foods (e.g., focus is
to mitigate adverse events among humans and animals)
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http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm270851.htmUpdated September 15, 2014
What are the most important technology capabilities you would
recommend for businesses today?
What tools are available to help meet these
requirements?
Available Solutions
TRACEABILITY CHARACTERIZATION Think “5 C’s
• Compatibility (facility, regulatory, audit)
• Compliance (harmonization)
• Costs (corporate and consumer)
• Chronology (timing of efforts and events)
• Complexity (multiple factors)
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Top ERP capabilities identified byfood manufacturers
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COMPLIANCE& REPORTING 2 PRODUCTION
PLANNING & INVENTORYFORECASTING3
SAFETY & TRACEABILITY
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Extensive Traceability
PRODUCER
SUPPLIER
PROCESSOR
WHOLESALER
SUBCONTRACTOR
RETAILER
PRODUCTION
INVENTORY
PURCHASING
SALESSHIPPING
RETURNS
CUSTOMER
Forward/backward traceability across the supply chain. By plant, batch or supplier, lots and sub-lots, for each ingredient and end-item with automated recall capabilities.
Equipped to manage any recall situation rapidly in minutes – not hours or days.
Improve visibility and the reduce risks of massive recalls
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Conduct inspections throughout packaging and production, then automatically quarantine suspicious or substandard items for further inspection or disposal.
QC testing and analysis covers raw materials, intermediates, and finished goods.
All test results are recorded and maintained together with production history.
Quality ManagementEnsure quality from start to finish
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Formula and Recipe Management
Supports single and multi-level Bill of Material (BOM) to manage recipes and routings during production.
Yield calculation and tracking (+/-) throughout production. Multiple units of measure conversion capabilities.
Manages by-products of theproduction process, maintaining raw material potency and other key product attributes.
Achieve greater product and process consistency
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Regulatory Compliance & Reporting
Manage exceptional events with automated workflow and alerts. Forward and reverse traceability with automated recall capabilities.
Security audit tracking, archives of historical transactions & electronic signature approvals.
Maintain records with Electronic Document Management (EDM).
360° view of business operations with a personal dashboard.
Event
Processing
User notification or alert
Rules
Exceed Compliance and Regulatory Mandates
Next Steps
Watch a video showing how a real-life recall plays out in Sage ERP X3, including:
Full traceability backward and forward to help pinpoint and handle problem ingredients.Workflows in the system that keep your team up to date on what’s happening.
Watch the video at http://info.blytheco.com/traceability-video