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


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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 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

• 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).


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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)


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).


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

– 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 FDA’s electronic system


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.


CRITICAL CONTROL POINT


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: – Disease control; persons with illness or open wounds can’t have direct contact

with food or food surfaces

– Outer garments should not be contaminating

– Remove unsecured jewelry

– Hygiene (hand washing)

– Don’t eat, chew gum, drink beverages, or use tobacco near food

– Don’t store personal belongings or clothing near food

– Train employees in food protection principles


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


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


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


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 ?


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

http://ethanolproducer.com/articles/9273/the-new-sheriff-fdaundefineds-increased-focus


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FSMA – COMING SOON TO A PRODUCTION FACILITY NEAR YOU

• 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

http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

Contact info: [email protected]

402-889-4633

mailto:[email protected]

FDA food safety

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safety of human food

food safety system

grain storage system

word food

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