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Samantha Moran California Department of Food and Agriculture California Grain and Feed Association American Registry of Professional Animal Scientists California Department of Food and Agriculture

Update from CDFA on Model FSMA Plan Developed for the CA

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Samantha MoranCalifornia Department of Food and Agriculture

California Grain and Feed AssociationAmerican Registry of Professional Animal Scientists

California Department of Food and Agriculture

Internship

Cal Poly Animal Nutrition Center

My Role

Prerequisite Program

Food Safety Modernization Act (FSMA)

I participated in an internship sponsored by the California Grain and Feed Association and the American Registry of Professional Animal Scientists in coordination with the California Department of Food and Agriculture.

GOALDevelop outreach and educational material for the California feed industry that will assist in the compliance of FSMA regulations, within a 200 hour timeframe.

This facility was built in 2007

Small scale but capable of performing almost every manufacturing process found in industry. (With the exception of extruding and steam flaking/rolling.)

The Animal Nutrition Center provides most of the feed that is used for the animals on campus; including, cattle, horses, swine, poultry, etc

Produces medicated and non-medicated feed.

Responsibilities included: ◦ Served as the Student HACCP Coordinator HACCP Certified Facility

◦ Sampling, monitoring, inspecting, and essentially anything in relation to feed/food safety.

Having extensive knowledge in the feed manufacturing process, allowed me to have a good understanding for the need of a feed safety program which includes Standard Operating Procedures that are realistic, simple and easily adaptable.

I am now employed with the California Department of Food and Agriculture’s Feed Inspection Program (FIP).

My role at FIP: ◦ Safe Animal Feed Education program ◦ Developing outreach and educational materials◦ Inspection and compliance work in Northern CA◦ Product sampling

The material developed for the Food Safety Modernization Act are currently under review with the Feed Inspection Program management.

The Prerequisite program guidance will include material aimed to help industry become compliant with new current Good Manufacturing Practices.

A prerequisite program is the first step to developing a feed/food safety program.

A standard operating procedure (SOP) serves as an instruction guide to perform a certain task. The idea is that anyone, regardless of training level, can read a standard operating procedure and then perform the task correctly.

A Standard Operating Procedure (SOP) is meant to be a step-by-step instruction outline for a certain task. Standard operating procedures should be in place for all preventive control measures and any task that poses a potential risk to animal or human safety. Standard operating procedure must be followed, completely.

Title

Objective:

Person Responsible:

Procedure:

Monitoring:

Frequency:

Verification:

Validation:

Corrective Action:

Related Documents:

(While this outline does not have to be followed exactly it is a good way to ensure that all criteria is met in the development of the standard operating procedure.)

Sample Standard Operating Procedure

GOAL

Focuses on employees maintaining good personal hygiene and preventing the spread of microorganisms from illness or infection to feed or food-contact surfaces.

GOAL

Maintaining a clean facility and surrounding grounds. Limiting the availability of places that could harbor hazards such as pests or microorganism growth.

GOAL

Eliminate any hazards that could be spread through a lack of sanitation of the plant and all equipment.

GOAL

Maintaining a facility that prevents adulteration of feed. Implementing controls to record cleaning steps performed.

GOAL

Equipment and utensils are all stored in a sanitary fashion and in an area that will eliminate the possibility of contamination while not in use.

GOAL

To perform processing steps and employ controls to ensure the safety of the animal food produced.

GOAL

Everything from raw material to finished feed is stored and distributed in a manner that will minimize the likelihood of contamination.

The intent of the Food Safety Modernization Act is to create safe and clean animal food using manufacturing practices that minimize the likelihood of biological, chemical, physical, and radiological hazards that could affect animals and/or humans.

Hazard Analysis

Preventive Control

MonitoringVerification

Corrective Actions

Recall Plan

INGREDIENT/ PROCESSING STEP

POTENTIAL HAZARD INTRODUCED

IS THIS A SIGNIFICANT HAZARD? SEVERITY: LIKELIHOOD

ANIMAL HUMANJUSTIFICATION FOR SIGNIFICANCE

ANIMAL HUMAN

WHAT CONTROL MEASURED DO YOU HAVE IN PLACE TO PREVENT

Biological Severity Likelihood Severity Likelihood

Chemical

Physical

Radiological

Product:

INGREDIENT/ PROCESSING STEP

POTENTIAL HAZARD INTRODUCED

IS THIS A SIGNIFICANT HAZARD? SEVERITY: LIKELIHOOD

ANIMAL HUMANJUSTIFICATION FOR SIGNIFICANCE

ANIMAL HUMAN

WHAT CONTROL MEASURED DO YOU HAVE IN PLACE TO PREVENT

1A Receiving, Bulk Ingredients

BiologicalBSE

Contaminants from rodent or bird excrement

SeverityHigh

Low

LikelihoodLow

Low

SeverityModerate

Low

LikelihoodLow

Low

BSE contaminated feed that could lead to an outbreak of disease.

All feed and ingredients coming from an outside source will be from a supplier that produces a safe and clean feed.

No significant risk Approved Supplier List Truck inspection upon arrival.

ChemicalPesticide residues

Naturally occurring toxins

High

Moderate

Low

Low

High

High

Low

Low

Contaminate feed leading to animal sickness

Climate not contusive for Mycotoxin growth

Pesticide residues can reside in meat and milk products and can lead to human illness

Toxins through milk can lead to toxicity, causing illness

Approved Supplier List Testing upon arrival

Limits placed on naturally occurring toxins such as Mycotoxins, as well as scheduled testing

PhysicalTrailer previously hauled trash, glass, or metal shards.

Moderate Low No significant risk

No significant risk

Physical non-food objects in feed could lead to animal injury

No significant risk Approved Supplier List Visual Inspection

Radiological No significant risk

Product: Corn,(Whole, Flaked, Crimped)

Hazard Analysis Example for Corn

Baled: Suncured Alfalfa Suncured Forage Hay (oat, wheat, barley)

Bulk: Alfalfa Pellet Almond Hulls Bakery Barley (Whole, Flaked) Canola Meal/Pellet Cargill PI Milk Plus Corn (Whole, Flaked Crimped) Corn Germ Meal Corn Gluten 60% Corn Gluten Feed Cottonseed, Whole Dairy ADE Vitamin Premix Dairy Grain Dairy Milk Cow Pellet Dried Distillers Grains w/Solubles Ground Grain Linseed Meal/Pellet Milo-Whole Oats (Whole, Ground, Crimped) Rice Bran Safflower Meal Soybean Hulls/Pellet Soybean Meal Soy Best Soy Plus Sunflower Meal Wheat Midds, Midds Pellet Wheat Starch

Bagged: Active Dry Yeast Amaferm Ammonium Chloride Apple Aid All Pro Biotics

Ammonium Sulfate Animate Ascirbic Acid 100 Availa 4 Availa Cu 100 Avizyme 1320 Beef Vitamin Premix Beet Pulp Pellets Bentonite Sod Bio-Chlor Bioplex Zinc 15 Biotin 1% Biotin 100 Mg/Lb Blood Meal (Pork or Beef) Buffer Pellet Broiler Vitamin Premix Calcium Carbonate Calcium Iodate Calcium Sulfate 885 Calf 2X Calf Pl R160 Carniking 10% Carophyll Red Carrots Dehydrated Cargill Pig Vitamin Premix Cargill Swine Trace Mineral Premix C2MZ Chelate Trace Mineral Choline Chloride 60% Chromium Tripicolinate Cobalt Carb 46% Cobalt Sulfate 7.5% Premix Copper Carbonate Copper Oxide-75 Copper Sulfate Cal Poly Close Up Premix Cal Poly Equine Mineral Premix Cal Poly Equine Vitamin Premix Cal Poly Layer Mineral Premix Cal Poly Layer Vitamin Premix Cal Poly Sow Add Premix

Cal Poly Swine Mineral Premix Cal Poly Swine Vitamin Premix CR Corn For Tx Sys Dairy Spice Flavor Diatomatious Earth Dicalcium Phosphate Diamond V XPC Diamond V Yeast XP DL- Methionine Dried Molasses DTI 3 MVP Premix Eddi 42 Gm/Lb Energy I Energy II Extruded Soybeans EZ-Keep Fat Sprayed Feather Meal Ferrous Sul 30 Fibrozyme Fish Meal Fish Meal Sealac Fish Premix Flavor Plus NM Foster Farms Mineral Premix Foster Farms Vitamin Premix Garlic Powder Gold Dye Gold Flavor Green Flavor Green Dye Herd Builder Flavor Herd Builder Starter Premix Pellet 36% Horse Pellet 776- Horse PMX5098 Iron Carbonate Iron Oxide- Brown Iron Oxide- Red Iron Oxide- Yellow Kerry Kreeme

Lactomil Lacto Sac Lactose Lamb Premix Pellet Layer Vitamin Premix Limestone L-Lysine HCL L-Threonine Magnesium Oxide Magnesium Sulfate Magnesium Sulfate 9.9% Manganous Oxide-60 Mega Lac R Mega Lac Plus w/ 6% Methionine MGK Chelate Trace Mineral MGK Cheated Micro Aid Milk Plus Premix Min Ad Mono-Dicalcium Phosphorous Mono Prop MTB 100 Nelson Vitamin/Trace Mineral Premix Niacin-99% Oyster Shell Oyster Shell Flour Papain Enzyme PCC Custom Calf Blend PCNS Dairy Fortifier Pell Tuff Pellunite Phosphorous Monoammonium Phosphorous Monosodium 25 Pig Nectar Premix Pellet 13 Premix Pellet 20 Premix Pellet Super 30 Potassium Carbonate Potassium Ch50 Potassium Iodide

Potassium/Magnesium/Sulfate Poultry Trace Mineral Premix Protein Pellet Quadra 4 Alltech ReaShure Choline Red Flavor Rout Mold Inhibitor ROP- Royal Optimum Powder Salt Sana Kreeme Santoquin 66.6% Selenium 0.06% Selnosource AF 2000 Sheep Trace Mineral Sodium Sesquicarb SoyChlor Stock Joy Flavor Storagemate Dry Thiamine Mono Trace Mineral Premix Turkey Vitamin Premix UNF-40 Urea Vitamin A 30M U/G Vitamin A 650M U/G Vitamin D3 30 M U/G Vitamin D3 500K IU Vitamin E 20 M U/Lb Vitamin E 25% Vitamin E 125 Vitamin E 227M U/Lb Vitamin/Mineral Pellet Wheat Starch Whey Powder Yea Sac Yeast-Dried Brewers Yucca Powder Zinc Oxide- 72 Zinc Sulfate Zin-Pro 100

Zinpro 4 Plex ‘C’

Liquid: Aliment EZ Flake EZ Glo 3-70 Fat Molasses Soy Oil Vegetable Oil Water

Medicated: Amprol 25% Amprol Ethorpbate Aureozol- 500 Bac MD-50 RX Bambermycin 4G BMD-60 Bull Test Mineral R 1450 Calf Con PI Lasal 1400g RX Calf Pellet 25 Rum 1400g RX Carbadox 10 Coban- 60 RX CTC- Aureo 50 RX Decoquinate 6% Fenbendazol 20% Lasalocid 68G RX Linco-50 3 Nitro 20 Poloxalene 53% Pyram Tart- 48 Rabon 2.1% Rumensin 90g (Monesin) RX Salinomycin 60 G Tylosien-40 RX

Ingredients and/or processing steps that have either a hazard that is likely to occur or that has a high severity will need to be assigned a preventive control.

Preventive controls will be implemented to minimize, eliminate, or monitor these hazards.

INGREDIENT/ PROCESSING STEP

IDENTIFIED HAZARD

PREVENTATIVE MEASURE IN PLACE

MONITORING VERIFICATION ACTIVITIES

RECORDSWHAT WHO FREQUENCY

PREVENTIVE CONTROL MEASURESFOOD SAFETY MODERNIZATION ACT- 2012

INGREDIENT/PROCESSING STEP

IDENTIFIED HAZARD

PREVENTATIVE MEASURE IN PLACE

MONITORING VERIFICATION ACTIVITIES

RECORDSWHAT WHO FREQUENCY

Ingredient:Section 3, pages: ALLSection 4, pages: 1,2,4,6-23,27-30

Processing:Section 10, pages: 1,2,4,10,11,16

Mycotoxins/Aflatoxins/Fumonisin

Yes Critical Control Point # 1

Plant Manager

Designated Employee

Twice Yearly Samples sent tooutside lab

Kept for 2years

Ingredient: Section 6, pages: 7

Processing:Section 10, pages: 8, 38

Water Quality Yes

Sampling Testing

City Water Quality Report

Plant Manager

Designated Employee

8 hours of Boiler use

Annually

In house testing

City Water Testing

Kept for 2years

Printed Annually

Processing:Section 10, pages:9,20,21, 22,40

Magnet Efficiency

Yes Magnet Efficiency Test

Plant Manager

Designated Employee

Twice Yearly In house testing Kept for 2years

PREVENTIVE CONTROL MEASURESFOOD SAFETY MODERNIZATION ACT- 2012

ALL Preventive controls must have a monitoring step.

Parameters should be set for each hazard, whether it is zero tolerance or has a range of acceptance. ◦ EX// 20 ppb for aflatoxin level would be a parameter

All monitoring must be recorded and reviewed regularly

All preventive controls will have a SOP that describes the monitoring that needs to take place.

In the event that a processing error occurs or a parameter is not met, a corrective action will need to be documented. This will outline the who, what, where, etc. of the issue and how it is going to be dealt with.

Corrective Actions are not bad. They are proof that your FSMA plan is working. They show your ability to catch your mistakes before they leave the facility, which would then result in a recall.

An effective plan will always have corrective actions.

Verification serves as proof that your monitoring steps are working!

EVERYTHING must be documented.

Documentation serves as proof that you ARE doing what you say you are doing and is outlined in your plan!

In the event of a recall, having a written plan is essential. Everything that needs to be done will be outlined in a familiar and easy to follow form, which will lead to a fast and efficient recall.

Something to keep in mind:The better your tracking system is

the less feed you will need to recall.

Samantha Moran, [email protected]