FDA food safety

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

TOPICS COVERED TODAY
•
Gavilon backgrounder
•
Food Safety Modernization Act
•
What does it mean to my facility ?
•
What are some other areas of concern

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 world’s most essential commodities

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

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

•
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

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
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Foreign Supplier Verification Program for importers
•
Currently receiving comments from industry, must be finalized Aug. 30th, 2015

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
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)

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:
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Contains substances that render it harmful to human or animal health (poisonous/deleterious substances);
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Was produced, packaged or held under insanitary conditions; or
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Contains concealed, inferior ingredients or filler material, among others (economic adulteration).

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.”

FSMA – SOME KEY REQUIREMENTS
•
Current Good Manufacturing Practices (CGMPs) and Preventive Controls
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Written analysis of food/feed safety hazards
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Use of preventive controls to eliminate or reduce the risk of identified hazards
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CGMPs requirements for food/feed facilities
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Facility Registration is required with FDA every two years on even numbered years
–
2014 is a re-registration year
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Registration is free through FDA’s electronic system

FSMA OVERVIEW
•
FSMA requires each registered facility do the following:
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(1)Evaluate known or reasonably foreseeable food safety hazards;
•
(2)Develop a written analysis of those hazards;
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(3)Identify and implement preventive controls as to those hazards;
•
(4)Monitor the effectiveness of the preventive controls;
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(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.

CRITICAL CONTROL POINT

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:
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Disease control; persons with illness or open wounds can’t have direct contact with food or food surfaces
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Outer garments should not be contaminating
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Remove unsecured jewelry
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Hygiene (hand washing)
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Don’t eat, chew gum, drink beverages, or use tobacco near food
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Don’t store personal belongings or clothing near food
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Train employees in food protection principles

CGMPS PART 2
Plant and Grounds: (good housekeeping)
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Removal of litter and waste
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Keep grass mowed
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Maintain roads, parking lots
–
Drainage around property
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Buildings clean and in good repair, proper equipment storage
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Pest control program; provide screening against pests
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Good lighting (no broken glass in food)
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Plant toilets; sanitary, good repair, effective hand washing

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.
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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

HAZARD ANALYSIS AND CRITICAL CONTROL POINTS
Each facility would be required to prepare and implement a written food safety plan which includes the following:
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Hazard analysis
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Risk-Based Preventive controls
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Recall Plan
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Monitoring
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Corrective actions
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Verification
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Recordkeeping

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
WHAT IS WRONG WITH THIS PICTURE ?

WHAT IS WRONG HERE

AND HERE ?

OTHER AREAS OF CONCERN
Our industry from time to time will look at new ways to reduce costs / improve efficiencies and thus will use new enzymes, yeasts, cleaning chemicals and emulsifiers that may or may not be GRAS or acceptable for feed / food.
•Antibiotic and sulfur levels measured
•Wet pad -- allowing adulterants ?
•Dry building – allowing adulterants ?
•Emulsifiers ?? GRAS (generally recognized as safe) ?
•Yeasts / Enzymes introducing a new GMO

FORWARD THOUGHTS
•
The new reality in the feed and biofuels world is that FDA is here to stay. We believe the actions outlined here are just the beginning of greater FDA involvement in the industry. Ethanol companies are well-advised to get ahead of the curve by understanding FDA’s involvement in the industry and putting in place the necessary FDA compliance systems and other policies to ensure compliance.
•
Opinion: The New Sheriff: FDA’s Increased Focus Faegre Baker Daniels
•We are likely only at the cusp of FDA’s oversight of feed co-products from the ethanol industry. Randy Ives -- 2011

28
FSMA – COMING SOON TO A PRODUCTION FACILITY NEAR YOU
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Only one thing to remember
FEED IS FOOD
•
42% steak, hamburger, roast (beef cattle)
•
30% milk, yogurt, cheese (dairy cattle)
•
18% ham, pork loin, bacon (swine)
•
10% eggs, chicken breast (poultry)
By 2016 - 2017 full compliance of FSMA regulations is required
For some production facilities this will require a change in mindset and will add costs
to all production facilities
FDA’s FSMA website: http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

Contact info:
randy.ives@gavilon.com
402-889-4633

FDA food safety

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