The number of food and beverage recalls has nearly tripled since 1999, according to a Deloitte Consulting report. Cost-effective, future-oriented systems to help mid-sized companies support their teams by streamlining production, getting more from less, and tracking food safety and quality are becoming increasingly important in this risk-intensive environment. Join us for this unique online seminar featuring a panel of experts discussing how automation help food manufacturers manage the risks and compliance burden they face.

1. www.blytheco.comwww.blytheco.com
The Role of Technology in
Food Processing
Compliance and
Traceability
September 25, 2014

2. Agenda
Panel Intros
Questions for our Panel
The State of the Industry today
The Top Requirements and Capabilities
Solutions to Help
Why Sage ERP X3?
Your Questions
Next Steps

3. Introductions
Alicia Anderson
Strategic Marketing,
Blytheco
19 years in ERP sales,
service and marketing
Leading ERP provider to
food processors

4. Introductions
Dr. Roger Clemens
Past-President, Institute of Food
Technologists
Chief Scientific Officer at Horn
Adjunct 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.

5. Introductions
Mark Pinard
Senior Solution Engineer
Sage X3 Expert
Designs technology solutions for
hundreds of Food and Beverage
companies nationwide

6. 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.

7. 7
The Evolution of
Food Control
Degreeof
Specificity
Degree of Command &Courtesy of Bill Layden
Informatio
n
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

8. 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)
8

9. FOOD LAW AND NUTRITION
GUIDANCE MILESTONES
1906
T. Roosevelt,
Pure Food & Drug Act &
Federal Meat Inspection Act
1933Revision of 1906 Act
1938
FD&C Act
2006
1958
1900
Food Additives
Amendment;
Delaney proviso,
“zero tolerance”;
GRAS published &
petition process
1960
Color Additive
Amendment
1970
EPA
established
1976
“Proxmire
Amendments”
Toxic Substances
Control Act
1980
Infant Formula
Act;
First Dietary
Guidelines for
Americans
1990
NLEA;
Organics
Food
Production
Act
1994
DSHEA
1999
Pearson vs.
Shalala
(US Appeals
Court)
1966
Negligible Risk;
Fair Packaging
and Labeling
Act
2002
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
2007
CGMPs for Dietary
Supplements;
SAERs mandated (12.22.07);
1986
Safe Drinking Water and
Toxic Enforcement Act;
Proposition 65 (CA)
1941
Food and
Nutrition Board
First RDAs
established
1997
DRIs established;
Food & Drug
Modernization Act;
GRAS notification
1969
Cyclamate banned;
GRAS Review;
White House
Conference on Food,
Nutrition, and Health
1937
Cyclamate
discovered
2008
2009
Farm Bill
– Sec 912
Non-
binding
HC
Guideline
s for DS
2011
FDA
Food
Safety
Modern
ization
2010
Health
Care;
§
4205
9
2013
Gluten-
free
Labelin
g of
Foods

10. 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
10

11. 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, 2003
11

12. THREATS TO FOOD
SECURITY
• Contamination of water supply
• Tampering of food supply
• Biological warfare against livestock and crops
• Contamination of imported foodstuffs
12

13. 13
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

14. 14
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

15. 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
15

16. 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
16
http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/sanitationtransportation/ucm203420.htm
Accessed August 15, 2014
http://www.fda.gov/food/guidanceregulation/ucm056174.htm
Accessed August 15, 2014 (website updated July 10, 2014)
A grain elevator owned by the Frontier
Cooperative loads rail cars with corn
byNatiHarnik,AP

17. 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.

18. 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=US
FDA_206
18

19. 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
19

20. 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
20

21. 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)
21

22. 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
22
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm270851.htm
Updated September 15, 2014

23. FOOD PRODUCTION CHAIN
CONTAMINATION
http://www.cdc.gov/foodsafety/outbreaks/investigating-outbreaks/production-chain.html
Accessed September 18, 2014
23
• Contamination in
Production
• Contamination in
Processing
• Contamination in
Distribution
• Contamination in
Preparation

24. 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
 Recalls
24

25. 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
tracing technologies, practicality of implementation)
– Product tracing system (e.g., effectively and rapidly track and
track and trace food in the US or offered for import into the
the US.
– Additional recordkeeping for high risk foods (e.g., focus is to
focus is to mitigate adverse events among humans and
animals)
25
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm270851.htm
Updated September 15, 2014

26. What are the most
important technology
capabilities you would
recommend for businesses
today?
What tools are available to
help meet these
requirements?
Available Solutions

27. 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)
27

28. Top ERP capabilities identified by
food manufacturers
28
COMPLIANCE
& REPORTING
2
PRODUCTION
PLANNING
& INVENTORY
FORECASTING
3
SAFETY
& TRACEABILITY
1

29. Extensive Traceability
PRODUCER
SUPPLIER
PROCESSOR
WHOLESALER
SUBCONTRACTOR
RETAILER
PRODUCTION
INVENTORY
PURCHASING
SALES
SHIPPING
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
29

30. 30
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 Management
Ensure quality from start to finish

31. Formula and Recipe Management
31
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 the
production process, maintaining raw
material potency and other key
product attributes.
Achieve greater product and process consistency

32. Regulatory Compliance & Reporting
32
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

33. 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