The Role of Technology in Food Processing Compliance and Traceability

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

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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.

Transcript of The Role of Technology in Food Processing Compliance and Traceability

Page 1: The Role of Technology in Food Processing Compliance and Traceability

www.blytheco.comwww.blytheco.com

The Role of Technology in Food

Processing Compliance and

TraceabilitySeptember 25, 2014

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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

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Introductions

Alicia AndersonStrategic Marketing, Blytheco19 years in ERP sales, service and marketingLeading ERP provider to food processors

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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.

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Introductions

Mark Pinard

Senior Solution EngineerSage X3 ExpertDesigns technology solutions for hundreds of Food and Beverage companies nationwide

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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

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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

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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

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00

Food Additives Amendment; Delaney proviso, “zero tolerance”; GRAS published & petition process

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60

Color Additive Amendment

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70

EPA established

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“Proxmire Amendments”Toxic Substances Control Act

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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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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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08

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09

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

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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

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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

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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

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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.

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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

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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

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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

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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

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What are the most important technology capabilities you would

recommend for businesses today?

What tools are available to help meet these

requirements?

Available Solutions

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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

1

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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

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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

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