fda food safety
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FSMA OPPORTUNITY OR PROBLEM ?
2 | Kennedy and Coe Dec.10th, 2014
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
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TOPICS COVERED TODAY
Food Safety Modernization Act
What does it mean to my facility ?
What are some other areas of concern
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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
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STRONG GLOBAL PLATFORM
Corn Soybeans Wheat Grain & Ingredients Facilities Fertilizer Facilities Columbia Grain Inc. (CGI)
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SECOND LARGEST GRAIN OPERATION Grain Majors Storage Capacity
ADM Gavilon/CGI Cargill CHS Bunge
Source: 2014 Grain & Milling Annual ranking by storage capacity
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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
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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
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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).
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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)
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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
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
Was produced, packaged or held under insanitary conditions; or
Contains concealed, inferior ingredients or filler material, among others (economic adulteration).
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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.
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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
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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.
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CRITICAL CONTROL POINT
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CRITICAL CONTROL POINT
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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
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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
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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
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
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HAZARD ANALYSIS AND CRITICAL CONTROL POINTS
Each facility would be required to prepare and implement a written food safety plan which includes the following:
Risk-Based Preventive controls
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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
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WHAT IS WRONG WITH THIS PICTURE ?
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WHAT IS WRONG HERE
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AND HERE ?
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