food safety pest management & fumigation services

Food Safety Pest Management& Fumigation Services

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FPA is an organization ofRegional companies formally organized to provide

National capabilities of:

Fumigation

Pest Management / Food Safety

Alternatives to Fumigation

Coverage in North America

FSMA Webinar 2014Food Safety Modernization Act (FSMA)By: John B. Mueller 4

The Food Safety Modernization Act –

FSMA The most sweeping reform of our food safety laws in more than 70 years, was signed into law on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination of the food supply to preventing it. The law applies to human food as well as to food for animals, including pets.

FDA.gov

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1906 –

Pure Food and Drug Act

1938 –

Food, Drug, and Cosmetic Act

Food Safety Modernization Act -

FSMA

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Source: David Fairfield -

NGFA

FSMA Court-Established DeadlinesSubject

Deadlines

Publishing Proposed

Rule

Close of Comment

Period

Publishing Final Rule

Produce Rule Published Jan. 16, 2013 Nov. 22, 2013 Oct. 31, 2015

CGMPs and Preventive Controls -

Human FoodPublished

Jan. 16, 2013 Nov. 22, 2013 Aug. 30, 2015

Foreign Supplier Verification Programs Published

July 29, 2013 Jan. 27, 2014 Oct. 31, 2015Accreditation of

Third-Party AuditorsCGMPs and Preventive Controls -

Animal FeedPublished

Oct. 29, 2013 March 31, 2014 Aug. 30, 2015

Food Defense/ Intentional Adulteration

PublishedDec. 24, 2013 March 31, 2014 May 31, 2016

Sanitary Transportation of Food/Feed

Published Feb. 5, 2014 May 31, 2014 March 31,

2016

Food Safety Modernization Act -

FSMA

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Food Safety Modernization Act -

FSMA

What can we learn from the Food Industry?Sanitation / Quality Manager

GMP

HACCP

Third Party Audits –

3PA

FDA

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FSMA

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FSMA Components:

FSMA

Food Rule

Feed Rule

Secretary of HHS

Proposed §

507.3 defines "animal food" as food  for animals other than man, and includes pet food, 

feed, and raw materials and ingredients.

FDA

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What are the Feed Rule, Exemption, Pro’s & Con’s for RAC’s

being

Held?

Grain Not Cleaned

No FDA Baseline for Feed

Largest Feed Ingredient

Grain Industry Samples for Hazards

Controls for Safety and Quality

No Historical Issues

Con’s Pro’s

Food Safety Modernization Act -

FSMA

FSMA

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FSMA

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FSMA

1) Do Nothing

Now.

2) Conform

Current

Processes

& Programs.

3) Fully Comply.

What are your CHOICES

today?

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FSMA

Why CONFORM or COMPLY?

1) Not Exempt = Law.

2) Exempt but Buyer Requires.

3) Exempt Status Could Change.

Designate a “Qualified”

Person.

Study Applicable Rule.

Understand Terminology

Integrate Your Processes & Procedures

Identify Gaps

CONFORM or COMPLY! What is next?

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FSMA

FSMA

The Law –

38,931 – Pest -

0

– Mold -

0

– Cleaning -

0

– Sanitation -

3

– Protection -

23

– Homeland Security -

53

– Safety -

155

Feed Rule –

113,730

– Pest -

58

– Mold -

11

– Cleaning -

121

– Sanitation -

72

– Protection -

33

– Homeland Security -

1

– Safety –

481

– FD&C -

390

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United States Grain Standards

Act

Egg Products

Inspection Act

Poultry Products

Inspection Act

Secretary of

Agriculture

Federal Meat

Inspection Act

Packers and

Stockyards Act

United States

Warehouse Act

Agricultural Adjustment

Act

Agricultural Marketing

ActAg Marketing Agreement

Act

USDA

FDA

Public Health

Service ActFD&C

Secretary of HHS

Import Statutes

Managing Ports of

Entry

Entry Inspection Activities

Securing the Borders of the US

Agricultural Import

ATTTB

Secretary Homeland Security

Homeland Security Act

USDTSecretary

of Treasury

DHS

FSMA

Codex

United States Grain Standards

Act

InternationalPrograms

Export Issues

FGIS

Bio-Terrorism

Act

FSMA

Terms for Grain– “Raw Agricultural Commodities –

RAC’s”

– “Raw Materials for Animal Feed”

– “Raw Ingredients”

Terms for Grain Facility– “Holding”

– “Held”

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FSMA

Focus – Current Good Manufacturing Practices -

cGMP

– Hazard Analysis

– Risk Base Preventative Controls

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FSMA

Trained Person (cGMP)– Competent supervisory personnel.

– Background of education or competent experience for clean and safe animal food.

– ID plant sanitation failures.

– ID food contamination.

– Trainer

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FSMA

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Plant and Ground – (cGMP)

FSMA

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Sanitation Design –

(cGMP)

FSMA

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Sanitation Design – (cGMP)

FSMA

Sanitary Operation –

(cGMP)– Cleaning

• SOP’s

• Training

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FSMA

Sanitary Operation –

(cGMP)– Daily

– As Needed

– Weekly

– Monthly

– Quarterly

– Yearly

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Master

Sanitation

FSMA

Sanitary Operation –

(cGMP)

– Chemical Handling• List what you use.

• Make an approved chemical list.

• Gather all SDS (EPA).

• Consider how these are stored.

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FSMA

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FSMA

Sanitary Operation –

(cGMP)

– Pest Management• In house v Hired.

• Documentation

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FSMA

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Hazard Analysis and Rick Based Preventative Controls– .

FSMA

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Sanitary Facilities and Controls –

(cGMP)– Secure water source.

– Sewage

– Toilets

– Radiological Contamination

FSMA

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Equipment & Utensils –

(cGMP)– Non-food Grade Lubricants

– Metal Fragments

– Brittle Plastic

– Wood

– Other Contaminants

Picture: CBG.com

FSMA

PROCEDURES

– Mandatory

– Unique

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Evaluate

SOP

Train

Validate

Evaluate

SOP

Train

Validate

Evaluate

SOP

Train

Validate

Evaluate

SOP

Train

Validate

PROCESS

– Standard

– Unique

DOCUMENTED

FSMA

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Warehousing and Distribution –

(cGMP)– Contamination

• “Glass”

• Fertilizer

FSMA

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Warehousing and Distribution

– Contamination

FSMA

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Hazard Analysis and Risk Based Preventative Control

– cGMPS were more standard practices

– Hazard Analysis and Rick Based Preventative Controls identify gaps and fill them with situational and changing needs.

Probe & Sample

Dry / Cool

Hold & Monitor

Release / Transport

FSMA

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Hazard Analysis and Risk Based Preventative ControlsPage 195 –

FDA uses the example, a facility holds shelled corn in bulk units for an extended time period until it is sold or mixed

into an animal food may identify the potential for growth of aflatoxin-

producting molds on the corn as a hazard reasonably likely to occur. As a process control to prevent such molds from growing on the corn during storage, the facility may elect to dry the corn to a specific moisture content (e.g., no more than 15 percent) prior to placing the corn in storage. The process control would be “drying”

and the associated parameter would be moisture level, with maximum value, or limit, being 15 percent.

The process control would be “drying”

and the associated parameter would be moisture level, with maximum value, or limit, being 15 percent.

FSMA

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Food Safety Plan– FSMA does not want to see a universal

corporate Food Safety Plan.• “Must be site specific”

• Each facilities food safety dynamic is like a finger print.

FSMA

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Hazard Analysis and Risk Based Preventative Controls

– The “FOOD SAFETY PLAN”• Scientifically Sound

– University Studies

– USDA Reports

• Technically Sound– Equipment Support

– Instrument Support

FSMA

– Biological

– Chemical

– Physical

– Radiological

– Natural Toxins

– Pesticides

– Drug residues

– Decomposition

– Parasites

– Allergens

– Unapproved food and color additives

– Natural Hazards

– Unintentionally Introduced

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Hazard Identification

FSMA

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Hazard Analysis and Risk Based Preventative Controls

– The “Catch All”

Proposed 507.33(d)(10) would require that the hazard evaluation consider the effect of any relevant factors that might potentially affect the safety of the finished animal food.

FSMA

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Hazard Analysis and Risk Based Preventative Controls

Probe & Sample

Dry / Cool

Hold & Monitor

Release / Transport

Hazards?

Prevention.

Monitor.

Verification / Validation

Hazards?

Prevention.

Monitor.

Verification / Validation

Hazards?

Prevention.

Monitor.

Verification / Validation

Hazards?

Prevention.

Monitor.

Verification / Validation

All Documented and Audit Ready.

DOCUMENTED

FSMA

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Hazard Analysis &

Risk Based Preventative Controls

– The Hazard Analysis as required.

– Preventive Controls as required.

– Recall Plan as required.

– Procedures, Frequency, and Monitoring.

– Corrective Action procedures.

– Verification procedures.

– Documented.

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FSMA

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Hazard Analysis and Risk Based Preventative Controls

– Food Safety Observations to comply with:

• Monitoring

the plan for performance.

• Supply required Corrective Actions.

• And supply Verification

of a well maintain food safety plan.

FSMA

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Hazard Analysis and Preventative Controls– Monitoring, Corrective Action, Verification:

• Mock Audit Program

– Incorporate FSO.

– Include all departments.

– Write work orders on the spot.

– Audit readiness…

FSMA

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Hazard Analysis and Risk Based Preventative Controls

– Monitor• Do you have a planned sequence of observations or

measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification.

– Sampling and Analysis

– Drying / Cooling Parameters

– Holding –

Maintaining Condition

FSMA

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Hazard Analysis and Risk Based Preventative Controls

– Annual Requirement or Supplier Audit - 3PA

Food Safety Modernization Act -

FSMA

What can we learn from the Food Industry?

Third Party Program Auditing –

3PA– What was: A three day audit = two days in the plant

looking and one day reviewing paperwork.

– What is: Two days on paperwork with one day in the plant.

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FSMA

What can we learn from the Food Industry?

Peer High Water Mark– Site specific interpretation.

– Industry specific interpretation.

– Peer interpretation.

– Auditor interpretation.

– Audit evolution…

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Federal Grain Inspection Service

Pest Management Provider

Organizations –

NGFA, GEAPS…

State Department of Agriculture

Ag Universities

Who are your Allies and Assets?

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FSMA

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Summary– Is doing nothing really an option?– FSMA will change our industry.– History is on our side –

lets show that the

future is as well.

FSMA

Not Exempt From Current Good

Manufacturing Practices -

cGMP

ExemptFrom Hazard Analysis

and Rick-Based Preventative Controls.

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John B. Mueller17338 Westfield Park RoadWestfield, Indiana 46074314 330-5336 (Cell)855 377-3444

john@foodprotectionservices.net

www.Food ProtectionServices.net

Member

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North American AssistanceFPS Operations:Bowling Green, KYChicago, ILIndianapolis, INJonesboro, ARKansas City, MOLongview, WAMemphis, TNSalina, KSSt. Louis, MOTacoma, WAToledo, OHWichita, KS