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  • FSMA OPPORTUNITY OR PROBLEM ?

  • 2 | Kennedy and Coe Dec.10th, 2014

    OBSERVATION #1

    The human brain is a wonderful organ. It starts to work as

    soon as you are born and doesn't stop until you get up to

    deliver a speech. -- George Jessel, American actor quote

  • 3 | Kennedy and Coe Dec.10th, 2014

    TOPICS COVERED TODAY

    Gavilon backgrounder

    Food Safety Modernization Act

    What does it mean to my facility ?

    What are some other areas of concern

  • 4 | Kennedy and Coe Dec.10th, 2014

    4

    WHO IS GAVILON

    Gavilon is a leading commodity management firm, connecting producers and consumers of feed, food and fuel in the U.S. and abroad We build trusting, mutually beneficial relationships with our suppliers, and provide quality information and service at a competitive price for our customers We provide origination, storage and handling, transportation and logistics, marketing and distribution and risk management services Headquartered in Omaha, Nebraska, we employ over 2,000 people worldwide

    Managing the worlds most essential commodities

  • 5 | Kennedy and Coe Dec.10th, 2014

    STRONG GLOBAL PLATFORM

    Corn Soybeans Wheat Grain & Ingredients Facilities Fertilizer Facilities Columbia Grain Inc. (CGI)

  • 6 | Kennedy and Coe Dec.10th, 2014

    SECOND LARGEST GRAIN OPERATION Grain Majors Storage Capacity

    469

    402 348

    301

    225

    ADM Gavilon/CGI Cargill CHS Bunge

    (million bushels)

    Source: 2014 Grain & Milling Annual ranking by storage capacity

  • 7 | Kennedy and Coe Dec.10th, 2014

    185 grain facilities with nearly 402 million bushels of licensed storage capacity the second largest U.S. grain storage system

    44 transload and storage ingredient facilities utilized in North America

    35 million short tons of grain and 7.4 million short tons of ingredients distributed in 2013

    50 exclusive marketing agreements with production facilities

    GRAIN & INGREDIENTS A Leading North American Operation

    Corn

    Soybeans

    Wheat

    Grain Facilities

    Ingredients Facilities

  • 8 | Kennedy and Coe Dec.10th, 2014

    BACKGROUND OF FSMA

    Signed into law January 4, 2011.

    Embraces preventing food safety system and recognizes the need for a global

    approach to food and feed safety.

    FDA proposed three additional rules that are foundational to the this preventive

    approach. Preventive controls for human food and animals

    Standards for produce safety

    Foreign Supplier Verification Program for importers

    Currently receiving comments from industry, must be finalized Aug. 30th, 2015

  • 9 | Kennedy and Coe Dec.10th, 2014

    FROM THE ORIGINAL FSMA RULES

    Would protect against the contamination of animal food note that they have used the word food , where you and I would

    normally say feed, all throughout the document. Is interesting to say the least, but really denotes their intent.

    Should be manufactured and distributed to ensure the safety of the food for animal consumption, as well as the safety of human food derived from these animals (e.g., meat, milk, and eggs).

  • 10 | Kennedy and Coe Dec.10th, 2014

    10

    FEED (DISTILLERS) IS FOOD

    One third of the corn used to make ethanol becomes distillers grains, most of which is fed to animals used to provide food.

    42% steak, hamburger, roast (beef cattle)

    30% milk, yogurt, cheese (dairy cattle)

    18% ham, pork loin, bacon (swine)

    10% eggs, chicken breast (poultry)

  • 11 | Kennedy and Coe Dec.10th, 2014

    FSMA DEFINITIONS

    What is food? The FDCA defines food as (1) articles used for food or drink for man or other

    animals, (2) chewing gum, and (3) articles used for components of any such article. Thus nearly

    every reference to food in the FDCA and in FSMA also refers to animal feed, including ingredients

    of animal feed. The term food includes distillers grains (DGs) and other co-products fed to

    animals.

    What is adulteration? Adulteration is a term FDA uses to describe the rendering of food or feed

    products as unfit for consumption. A product can be adulterated because it:

    Contains substances that render it harmful to human or animal health (poisonous/deleterious

    substances);

    Was produced, packaged or held under insanitary conditions; or

    Contains concealed, inferior ingredients or filler material, among others (economic adulteration).

  • 12 | Kennedy and Coe Dec.10th, 2014

    FROM ORIGINAL FSMA DOCUMENT

    In June of 2008, following an inspection, FDA initiated a mass seizure of animal food at a pet food distribution center after finding the animal food products were vulnerable to contamination, such as microbial contamination, as a result of infestation of the facility by rodents, birds and other pests.

    Rodent pellets, rodent urine stains, and bird droppings were found throughout the facility, including on bags and pouches of pet food. Rodents had chewed holes in some of the bags of dry dog and cat food and bird seed. The facility was not taking measures to control pest infestation. These type of issues are called contaminants.

  • 13 | Kennedy and Coe Dec.10th, 2014

    FSMA SOME KEY REQUIREMENTS

    Current Good Manufacturing Practices (CGMPs) and Preventive Controls

    Written analysis of food/feed safety hazards Use of preventive controls to eliminate or reduce the risk of identified hazards CGMPs requirements for food/feed facilities

    Facility Registration is required with FDA every two years on even

    numbered years 2014 is a re-registration year Registration is free through FDAs electronic system

  • 14 | Kennedy and Coe Dec.10th, 2014

    FSMA OVERVIEW

    FSMA requires each registered facility do the following:

    (1)Evaluate known or reasonably foreseeable food safety hazards;

    (2)Develop a written analysis of those hazards;

    (3)Identify and implement preventive controls as to those hazards;

    (4)Monitor the effectiveness of the preventive controls;

    (5)Take corrective actions as necessary if the preventive controls are not working;

    (6)Verify the system is working; and

    (7)Maintain records of all of these actions for two years.

  • 15 | Kennedy and Coe Dec.10th, 2014

    CRITICAL CONTROL POINT

  • 16 | Kennedy and Coe Dec.10th, 2014

    CRITICAL CONTROL POINT

  • 17 | Kennedy and Coe Dec.10th, 2014

    CURRENT GOOD MANUFACTURING PRACTICES (CGMPS) The proposed CGMPs would establish procedures in areas such as

    buildings and facilities, design and layout, cleaning and maintenance, pest control, and personnel hygiene. Examples for an ethanol plant;

    Personnel: Disease control; persons with illness or open wounds cant have direct contact

    with food or food surfaces

    Outer garments should not be contaminating

    Remove unsecured jewelry

    Hygiene (hand washing)

    Dont eat, chew gum, drink beverages, or use tobacco near food

    Dont store personal belongings or clothing near food

    Train employees in food protection principles

  • 18 | Kennedy and Coe Dec.10th, 2014

    CGMPS PART 2

    Plant and Grounds: (good housekeeping) Removal of litter and waste

    Keep grass mowed

    Maintain roads, parking lots

    Drainage around property

    Buildings clean and in good repair, proper equipment storage

    Pest control program; provide screening against pests

    Good lighting (no broken glass in food)

    Plant toilets; sanitary, good repair, effective hand washing

  • 19 | Kennedy and Coe Dec.10th, 2014

    OBSERVATION #2

    Probably the biggest area of concern is defining Significant Hazards which will drive all the compliance requirements.

    Most areas such as mycotoxins and sulfur issues will be handled by well

    written CGMPs.

    Pet food industry will have more opportunities versus an ethanol plant

    or a non medicated feed mill.

    Storage of toxic materials an open issue. Cannot co-mingle with food.

    Defining and controlling the critical control point is important

    Having a HACCP mindset will help

  • 20 | Kennedy and Coe Dec.10th, 2014

    HAZARD ANALYSIS AND CRITICAL CONTROL POINTS

    Each facility would be required to prepare and implement a written food safety plan which includes the following:

    Hazard analysis

    Risk-Based Preventive controls

    Recall Plan

    Monitoring

    Corrective actions

    Verification

    Recordkeeping

  • 21 | Kennedy and Coe Dec.10th, 2014

    CGMPS AND PREVENTIVE CONTROLS FOR ANIMALS

    FDA proposed rule breaks down into two areas: Current Good Manufacturing Practices (CGMPs)

    Preventive Controls for food for animals focuses on preventing problems in order to improve safety of these products.

    Applies to domestic and imported animal food including: Pet Food Animal Feed Ingredient Processing & Raw Materials

  • 22 | Kennedy and Coe Dec.10th, 2014

    22

    WHAT IS WRONG WITH THIS PICTURE ?

  • 23 | Kennedy and Coe Dec.10th, 2014

    WHAT IS WRONG HERE

  • 24 | Kennedy and Coe Dec.10th, 2014

    AND HERE ?

  • 25 | Kennedy and Coe Dec.10th, 2014

  • 26 | Kennedy and C

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