When ingredient standards are violated, things go wrong, such as the 2007 pet food melamine incident or aflatoxin and vomitoxin poisonings due to contaminated grain products.
When ingredient standards are violated, ingredients are adulterated, used incorrectly or include something they shouldn’t.
Safety and Utility Standards
Any ingredient or additive used must have its nutritional or technical purpose established through a legally-recognized due process. An ingredient must be used within the limits of its established safety and utility.
The recognized due processes for establishing safety and utility for things added to feed include:
· Generally Recognized as Safe (GRAS) for an intended use that has legally defined parameters in regulation
· Subject of an Approved Food Additive Petition
· Informal Review Sanctioned (i.e. AAFCO-defined)
· Drug Approval
o But only one drug has been approved for use in pet food and it is no longer marketed.
Generally Recognized as Safe (GRAS)
A majority of scientific experts recognize these ingredients are safe for use in feeds for a specific purpose which sets or incurs specific limits for amounts, species and other characteristics consistent with good manufacturing and feeding practices.
· This status can be based on a safe history of common use in food or feed prior to 1958 (the year Congress passed a law defining food additives and GRAS substances).
· Some GRAS ingredients are listed in the U.S. Food and Drug Administration (FDA) regulations (many spices, for example), but others are obvious without being included in the regulations. For example, sugar and vinegar are GRAS, even though no one ever officially proved their safety.
· Sufficient scientific evidence can prove a substance’s safety and make it GRAS.
o This evidence must be in the public domain, which generally means it is published so that qualified experts can examine it.
Some examples of GRAS substances include:
· copper sulfate used for supplying copper to the animal’s diet
· tocopherols used as a preservative
· turmeric used as pet food flavoring or seasoning
Subject of an Approved Food Additive Petition
Manufacturers that want to use an ingredient that is not GRAS may be required to file a food additive petition. Ingredients in this classification of approval are required to demonstrate through well-controlled scientific studies that the ingredient is safe under the conditions that it is used.
Examples of approved food additives include:
· nutrients, such as sources of selenium and a synthetic source of vitamin K
· ingredients intended for technical purposes, such as some preservatives and stabilizers
Any use not provided for in the approved food additive petition is illegal.
Informal Review Sanctioned (AAFCO-Defined)
This category contains ingredients covered by AAFCO Feed Ingredient Definitions.
These numerous ingredients are of rather uncomplicated origin, such as animal and plant byproducts, processed grain and forage products, as well as many mined ingredient products.
Examples include wheat middlings, dried-egg product and brewers dried yeast.
The FDA can provide an informal scientific review to define these ingredients because of the relatively low risk they pose.
Example of Violative Ingredient
Copper sulfate, a GRAS substance, can be added to a pet food to supply copper to the diet. But this addition must be in compliance with the GRAS-stated purpose and nutritional and toxic limits depending on the species.
Copper is a nutritionally required micronutrient in the AAFCO Dog Food Nutrient Profiles; it must be present in a complete dog food formulated to meet the AAFCO profiles.
But if copper sulfate were used in a pet food to control a disease, that would be a violation of this GRAS ingredient standard because it is not approved for use as drug.
If more copper sulfate was added to a dog food than the AAFCO Dog Food Nutrient Profiles allow, that would be a violation of the GRAS approval because the rate is not consistent with good feeding practices.
If the copper sulfate were contaminated with selenium salts to the extent that toxic levels of selenium would result in the pet food) that would also violate ingredient standards because the copper sulfate is contaminated to the point of adulteration.
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Standards Requiring Freedom from Adulteration
All animal feeds and pet foods must be unadulterated. Adulteration is a prohibited act under state and federal law covering animal feed and pet food.
The Federal Food Drug and Cosmetic Act (FFDCA) describes unsafe substances and practices regarding adulteration. For additional information, refer to FFDCA:
· Section 402: Adulterated Food
· Section 406: Tolerances for poisonous or deleterious substances in food regulations
· Section 408: Tolerances and exemptions for pesticide chemical residues
· Section 409: Food Additives
· Section 512: New animal drugs
· Section 721: Listing and certification of color additives for foods, drugs, devices, and cosmetics
Feed and Ingredient Process Control Standards
Process controls are procedures designed to make sure an ingredient or feed product is acquired, handled, mixed, stored, used properly during manufacturing to assure the safety and effectiveness of the ingredient or feed.
If feed production methods are correct, the feed product should be correct. Traditionally such controls are called good manufacturing practices (GMPs) and will be required by the Food Safety Modernization Act.
In animal feed manufacturing, there are GMPs for animal drugs, animal feeds mixed with drugs (which means livestock feeds, because legal drugs aren’t normally delivered to pets through feed) and for canned pet food products. (Note that the GMPs for canned pet food products are the same GMPs that apply to canned human food products, “low-acid canned-food GMPs.” They prevent microbial growth and toxin production in canned products.)
Though GMPs are largely limited to canned pet food products, AAFCO and the FDA have been promoting the development of GMPs for all animal feed ingredients and all animal feeds, including pet foods.
New Animal-Feed GMP Regulations
States are beginning to adopt and enforce the relatively new AAFCO Model Good Manufacturing Practice Regulations for Feed and Feed Ingredients.
In its published proposed regulations to implement the Food Safety Modernization Act (FSMA), enacted in 2011, the FDA has indicated it will now require GMPs for all animal feeds and pet foods. The FDA is in the process of finalizing regulations to put this requirement into effect.
The AAFCO Model GMPs impose the following requirements, among others, on manufacturing of feed and feed ingredients:
· Employees who receive, store, manufacture, process, package, label, sample, transport or distribute feed or feed ingredients must be trained to do the job they are responsible for.
· The building and grounds where animal feed is made must be built so they can be cleaned and they must be kept clean.
· Chemicals, lubricants, pesticides, fertilizers and cleaning compounds unapproved for use in feed must be stored to minimize contamination and adulteration risks.
· Equipment must be suitable for its intended purpose, designed to facilitate cleaning and inspection and be maintained and operated in such a way that minimizes feed adulteration risk.
· Procedures for receiving ingredients must be established, including record keeping, and ingredient and inventory checks
· Documentation of manufacturing operations and procedures is required so that there are instructions for how to do these tasks.
· Records must be kept for product sampling and analysis, tracking of finished products and recalled product.
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The FDA has been working on Animal Feed Safety System (AFSS) for a while. This aligns with AAFCO’s interest in developing GMPs for animal feeds.
In addition to the FSMA, other federal legislation was passed after the 2007 melamine pet food incident that required FDA to develop, among other items, regulations including new ingredient standards.
More recently, federal legislation has been signed that requires the development of additional regulations to better address ingredient and feed safety. For the most up-to-date news on these and other efforts, visit the FDA website.