It all began with a question from AAFCO: What does “Feed Grade” mean? It is going to be a topic of discussion at the upcoming 2015 AAFCO Meeting in Denver this August.

Your challenge is to guess what “Feed Grade” is. Because if the working definition the Centers for Veterinary Medicine (CVM) proposed is any indication of what we can expect from the brightest minds in government, then we need all the help we can get. Here’s their suggestion:

“CVM – The substance is of an appropriate grade and suitable purity and is prepared and handled as an animal food ingredient.”

Oh boy.

The purpose of this game is to navigate the complex laws governing pet food. Your challenge is to understand the differences between federal law, and federal compliance policies within three, entirely separate, governing bodies: FDA, USDA, and AAFCO.

The FDA regulates ingredients used in pet foods by setting maximum and minimum limits on specific nutrients and by banning the use of antibiotics and medications. The USDA is responsible for meat quality and decides which animals can be used in pet foods. Lastly, we have AAFCO, who has posed this question to us: How do you define what is “Feed Grade”?

The foundation on which all food law rests on

Before we start, it helps to know the legal foundation for which all food is based on (and that includes food for animals): The Federal Food, Drug, and Cosmetic Act (FFDCA) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

Under the FFDCA 201(f), food is defined as articles used for food or drink for man or other animals. Therefore, pet food manufacturing is subject to the FFDCA.

A creative interpretation of the food law

Yet, the Center for Veterinary Medicine (CVM) states, “animal feeds provide a practical outlet for plant and animal byproducts not suitable for human consumption,” a statement seemingly contradictory to the regulations of the FFDCA, which apply equally to human and animal foods.

The FDA/CVM believes as long as pet food made from diseased animals is OK just as long as the crap is cooked out of it – literally:

“…Processed pet food, including pet food consisting of material from diseased animals or animals which have died otherwise than by slaughter, goes through a kill step, such as heat processing, which is designed to kill harmful bacteria…

…Before processing, these commodities may be considered in violation of 402(a)(5), however, when properly processed in accordance with these regulations, CVM considers canned pet foods, otherwise not in violation of the statute or regulations, to be safe and suitable for consumption by pets regardless of the origin of animal tissues used…

….however, the Center for Veterinary Medicine (CVM) is aware of no instances of disease or other hazard occurring from canned packing house offal or the tissues of animals that may have died otherwise than by slaughter.”

Even though the FFDCA says one thing, the FDA has these nifty loopholes, called ‘Compliance Policies,’ that essentially let some pretty awful stuff into pet food.

Example #1: FDA Compliance Policy (675.400 Rendered Animal Feed Ingredients) the agency states:

“No regulatory action will be considered for animal feed ingredients resulting from the ordinary rendering process of industry, including those using animals which have died otherwise than by slaughter, provided they are not otherwise in violation of the law.”

Example #2: FDA Compliance Policy (690.300 Canned Pet Food) says:

“Pet food consisting of material from diseased animals or animals which have died otherwise than by slaughter, which is in violation of 402(a)(5) will not ordinarily be actionable, if it is not otherwise in violation of the law. It will be considered fit for animal consumption.”

Example #3: FDA’s Compliance Policy (675.100 Diversion of Contaminated Food for Animal Use) which states:

“FDA does not object to the diversion to animal feed of human food adulterated with rodent, roach, or bird excreta.”

Example #4: FDA Compliance Policy (675.200 Diversion of Adulterated Food to Acceptable Animal Feed Use) states:

“The Center will consider the requests for diversion of food considered adulterated for human use in all situations where the diverted food will be acceptable for its intended animal food use. Such situations may include:
a. Pesticide contamination in excess of the permitted tolerance or action level.
b. Pesticide contamination where the pesticide involved is unapproved for use on a food or feed commodity.
c. Contamination by industrial chemicals.
d. Contamination by natural toxicants.
e. Contamination by filth.
f. Microbiological contamination.
g. Over tolerance or unpermitted drug residues.”

The answer to what “Feed Grade” is, already exists

The answer to AAFCO’s question “What is Feed Grade?” has already been answered. The answer lies deeply embedded into federal law within the United States Department of Agriculture, Food Safety and Inspection Service, Code of Federal Regulations.

What is the meaning of “Feed Grade?”

It’s “inedible.”

By definition, any food deemed not fit for human-consumption is defined as “inedible:”

“Inedible” is defined by regulation as adulterated, uninspected, or not intended for use as human food…Most “inedible product” generated by retail processing is normally edible product that has been chosen by the establishment to be downgraded to inedible product, mainly because there is no further use for it as an edible product.

True inedible product is that product that has been contaminated or adulterated and therefore is not acceptable as an edible product or as ingredient of an edible product or used to produce and edible product.

An example of true inedible is the fat and meat scraps removed from drains at the end of the processing operations cleaning activities.”

What kind of “inedible” animal by-product does the USDA allow as “suitable for use in animal food?”

“…hide or skin, hair, horns, teeth, fats, bone, ligaments and cartilage, feet, glands, blood, and lungs. Some inedible offal, along with normally edible offal that has been deemed unsuitable for human consumption, bones from meat processing, and cattle that are unsuitable for human consumption (nonambulatory and other condemned cattle), is rendered for use in the industrial, cosmetic, and feed manufacturing industries.”

Alternatively, the USDA defines products “fit for human consumption” to be officially “edible.” These foodstuffs have been processed, inspected, and passed manufacturing regulations (i.e. process control regulations) that are designed to assure safety for consumption by humans.

How does the USDA separate “inedible” from “edible” material?

“The regulations require that each condemned carcass, part, or visceral organ be marked with the “U.S. Inspected and Condemned” brand (312.6(a) (5), 381.101). If the condemned product cannot be branded because of its size or texture, it must be placed in a container identified with the words “U.S. Condemned.” Condemned product is to be disposed of by tanking.” (aka rendering)

How does AAFCO define ingredients “suitable for use in animal food?”

“…meat, meat by products, poultry, poultry by products, poultry meal that are the “clean flesh derived from slaughtered mammals.”

hmmmm.

If “Feed Grade” is “inedible,” what, pray tell, is “Human Grade”?

We circle right back around to the “edible” v. “inedible” terms again. Because “Feed Grade” by definition is “inedible,” then, obviously, “Human Grade” is “edible.”

Because AAFCO has no legal definition covering quality standards or grades of ingredients in general, marketing terms such as human-grade will continue to proliferate and will be used to attempt to identify sources of quality animal tissue ingredients that come from a USDA-inspected facilities and have passed USDA inspection for human consumption. Until there are measurable attributes (standards) that describe the value and utility of the product, companies will continue to use these types of terms.

What does the FDA have to say about “Human Grade” claims?

“Because the terms “human grade” and “human quality” have no legal definition – simply means that AAFCO has no requirements regarding them. Claims that the product is “human grade” must be true according criteria spelled out in regulations. If a manufacturer is able to substantiate and verify the claim, it neither untruthful nor misleading and a company has a constitutional right to make truthful statements about the human grade quality of its products on the labels. In order to avoid problems with regulators, a pet food manufacturer should obtain a statement of No Objection from the Federal FDA.”

However, the FDA isn’t going to do that anymore. Recently, the FDA decided not to issue any more “Statements of No Objection” or “Letters of No Objection” to pet food companies who make pet food in USDA registered human food production facilities with, obviously, human edible ingredients anymore.

“For a human grade claim, like any label claim, a manufacturer or distributor should have information to substantiate that the claim is truthful and not misleading. We believe claims that a product is made with human grade ingredients represent the product as a whole to be fit for human consumption.

CVM believes that ingredients that are fit for human consumption become unfit for human consumption when combined with other ingredients that are unfit for human consumption, or when the ingredients or resulting products are not stored, handled, processed, or transported in ways that are consistent and compliant with regulations for good manufacturing practices (GMPs) for human foods as specified in 21 CFR 110.

It is possible that an animal food could be produced in a facility licensed to produce human foods under GMPs for human foods, entirely from ingredients fit for human consumption, and be stored, handled, processed and transported by means suitable for maintaining the product as being fit for human consumption.

If these conditions are met, the manufacturer can represent the product to be fit for human consumption or “human grade” even if it is intended to be fed to an animal.

 If the product as a whole is not fit for human consumption, then claiming it to be “human grade” or made with “human grade ingredients” may be false and misleading and misbrands the product under the Federal Food, Drug, and Cosmetic Act.

In order to substantiate that a human grade claim is truthful and not misleading, a manufacturer or distributor should have information from each of the individual ingredient suppliers that verifies the individual ingredients supplied to the manufacturer are fit for human consumption.

The manufacturer or distributor should also maintain evidence that the finished product is manufactured under current GMPs for human food in a facility licensed to produce human food. Such evidence may include, but not be limited to, facility licenses or permits for operation of edible food manufacturing facilities or results of most recent inspections issued by local or state public health authorities.

In essence, the manufacturer or distributor should be able to unequivocally demonstrate that if a human food label were placed on the product that it would be acceptable to human food authorities to sell the product for human consumption.

A state may request information to substantiate any claim on a pet food label during the registration process, including a human grade claim. Whether or not information to substantiate a claim is requested by a regulatory official before a product is marketed, firms are required to have information to substantiate all label claims.”

What does AAFCO have to say about “Human Grade” claims?

“…This term has no definition in any animal feed regulations. Instead, it is a marketing creation that aims to convince consumers those products so-emblazoned are somehow better than others…”

“…Claims that a product contains or is made from ingredients that are, “human grade,” “human quality,” “people foods,” “ingredients you would eat,” “food(s) that you would feed your family,” or similar claims, are false and misleading unless the entire product, itself, meets the USDA and FDA standards for foods to be edible by humans.

In order to substantiate that a human grade claim is truthful and not misleading, a manufacturer or distributor should have information from each of the individual ingredient suppliers that verifies the individual ingredients supplied to the manufacturer are fit for human consumption. 

The manufacturer or distributor should also maintain evidence that the finished product is manufactured under current GMPs for human food in a facility licensed to produce human food.  Such evidence may include, but not be limited to, facility licenses or permits for operation of edible food manufacturing facilities or results of most recent inspections issued by local or state public health authorities. 

In essence, the manufacturer or distributor should be able to unequivocally demonstrate that if a human food label were placed on the product that it would be acceptable to human food authorities to sell the product for human consumption.

A human edible ingredient becomes inedible for humans when that edible ingredient is mixed with other ingredients that are inedible for humans, or an edible ingredient is processed, held, stored or shipped in a manner that causes the ingredient to become inedible.  For example, if you have human edible chicken breast and transport it to a pet food facility, the chicken breast is no longer human edible.  The same applies if this human edible chicken breast is mixed with Chicken Meal (a non-human edible ingredient), both ingredients are now classified as inedible. 

Thus, such claims misbrand a product unless the product itself is, in fact, human edible, being manufactured, packaged, shipped and held under such conditions that conform to, and pass the standards set for, human edible products (21 CFR 110), and the manufacturer, shipper, distributor/wholesaler, and retailer have applicable current federal, state, and local permits, certificates, or licenses required for producing, shipping, handling, and selling products edible for people.”

The USDA, on the other hand, does not even recognize the “Human Grade” claim at all. Wisely, the USDA defines food as either “edible” or “inedible.”

Is raw pet food supposed to be “edible”?

According to the FDA, the answer is yes. Which begs another question, is raw pet food “human food” or “pet food” – or both? The FDA says it should be edible – for humans, that is:

“All meat- and poultry-derived ingredients should be United States Department of Agriculture (USDA)/Food Safety and Inspection Service (FSIS)-inspected and passed for human consumption…”

“…Safety: It is unlawful to introduce into interstate commerce any food, including food for pets and for other animals, which is adulterated (Section 301(a) of the FFDCA). Among the circumstances in which a food will be deemed adulterated are when: …(c) it is, in whole or in part, the product of a diseased animal or of an animal that has died otherwise than by slaughter (Section 402(a) of the FFDCA).”

“CVM is aware of the sale of dead, dying, disabled, or diseased (4-D) animals to salvagers for use as animal food. Meat from these carcasses is boned and the meat is packaged or frozen without heat processing. The raw, frozen meat is shipped for use by several industries, including pet food manufacturers, zoos, greyhound kennels, and mink ranches. This meat may present a potential health hazard to the animals that consume it and to the people who handle it.

POLICY: Uncooked meat derived from 4-D animals is adulterated under Section 402(a)(5) of the Act, and its shipment in interstate commerce for animal food use is subject to appropriate regulatory action.”

What about pet food that is made in a USDA federally inspected plant that produces human food?

Q. Can inedible product for use in pet food be manufactured in the edible product department using the same equipment as used for edible product (e.g., oven)?

A. Yes, but with restrictions.  Importantly, the following criteria must be met:

“The inedible product must be as specifically provided for in either 9 CFR 314.11 for certain condemned materials, 9 CFR 318.12(a) for other non-human food, or 9 CFR 381.152(a) as approved by the Administrator in specific cases.”

“The establishment must ensure that the equipment, facilities, and utensils are maintained in a sanitary condition in accordance with 9 CFR 416 to prevent the adulteration of edible product (produced for human consumption).”

What is a “USDA Certified Pet Food?”

If you think it can’t get any more confusing – it does. Along with AAFCO and the FDA, into the mix comes the USDA with it’s very own regulations concerning pet food labeling and identification and the approval of pet food ingredients. The USDA also offers a voluntary inspection of canned foods through its Food Safety and Inspection Service. Manufacturers utilizing the voluntary inspection service may attach a USDA “seal” to their product labels signifying that the product is a “USDA Certified Product for Dogs, Cats and Other Carnivora.”

These Voluntary Inspection Regulations specify the amount of meat ingredients which must be used in the product, along with minimum nutrient requirements and label specifications.

The USDA has a different set of rules than the FDA as far as pet food rules go. Take the definition of some of the ingredients, for example, the USDA defines what they allow in a “USDA Certified pet food:”

“…Meat means the U.S. inspected and passed and so identified clean, wholesome muscle tissue of cattle, sheep, swine, or goats which is skeletal or which is found in the tongue, in the diaphragm, in the heart, or in the esophagus with or without the accompanying and overlying fat and the portions of skin, sinews, nerves, and blood vessels which normally accompany the muscle tissue and which are not separated from it in the process of dressing. It does not include the muscle found in the lips, snout, or ears.”

“Animal food meat by-product means the part other than meat which has been derived from one or more cattle, sheep, swine or goats that have been U.S. Inspected and Passed and is fit for use as animal food.”

“Poultry means any domesticated bird slaughtered in accordance with the Poultry Products Inspection Act, Public Law 85-172, 85th Congress, S. 1747, dated August 28, 1957 (21 U.S.C. 451 et seq.).”

“Poultry product means any edible part of fresh poultry which have been slaughtered for human food and from which the blood, feathers, feet, head and viscera have been removed in accordance with rules and regulations promulgated by the Secretary of Agriculture.”

“Animal food poultry byproduct means any portion of carcasses of poultry slaughtered under inspection and passed in accordance with the Poultry Products Inspection Act which is fit for use in animal food…”

What are the USDA requirements for raw “USDA Certified Pet Food?”

“…(b) Composition of canned or fresh frozen certified supplemental animal foods. (1) Certified animal protein supplement shall comply with the following requirements:

(i) Certified animal protein supplement shall contain not less than 95 percent of meat or animal food meat byproduct or both, or of horse meat or animal food horse meat byproduct or both, or of mule meat or animal food mule meat byproduct or both, or of poultry products. Upon specific approval of the Administrator, combinations of the above-specified ingredients may be used;

(ii) Certified animal protein supplement shall have added thereto a sufficient amount of fresh ground bone or other acceptable agent to satisfy the requirements of the regulations promulgated under the Meat Inspection Act (34 Stat. 1260), as amended (21 U.S.C. 71 et seq.), and the Horse Meat Act (41 Stat. 241; 21 U.S.C. 96), in order to insure decharacterization [denatured] of the product for human food purposes;

(iii) Certified animal protein supplement may contain not more than 3 percent wheat flour or other processing aid acceptable to the Administrator, which shall be of good quality, shall be free from insect infestation, and shall be otherwise fit for use as animal food;

(iv) Certified animal protein supplement shall contain not less than 15 percent protein; and

(v) Certified animal protein supplement shall contain not less than 3 percent fat…”

In addition, there are several other important distinctions which distinguish USDA Certified pet food to a standard other than the FDA’s. For example:

§355.19   Inspector to be informed when plant operates.There shall be no preparation of certified products at an inspected plant except under the supervision of an inspector.

§355.21   Products entering inspected plants: All products of a kind certified under this part or materials to be used in the preparation of such products when brought into an inspected plant shall be identified and inspected at the time of receipt and be subject to further inspection in such manner and at such time as may be deemed necessary. If, upon inspection, any such article is found to be unsound or otherwise unfit, it shall be handled as provided in §355.28. (See Disposal of Condemned Material, below)

DISPOSAL OF CONDEMNED MATERIAL

§355.28   Unfit material to be condemned.

Subject to §355.41, any certified products, or ingredients intended for use therein, which are decomposed or adulterated or otherwise unsound or unfit for use shall be condemned and destroyed, except that if the adulteration is such as will not preclude their legitimate use for some purpose other than the preparation of the certified products, they may be released by authorized inspectors for such other purpose for disposition under the supervision of the proper local, State, or Federal official. The operator of the inspected plant shall make such arrangement as may be necessary with the proper officials for the disposition of the article.

COMPOSITION OF CERTIFIED PRODUCTS

§355.29   Composition of certified products for dogs, cats, and other carnivora.

(a) Composition of canned or semi-moist certified maintenance food. (1) Only ingredients which are normal to canned or semi-moist food for dogs, cats, and other carnivora, which are favorable to adequate nutrition, and which are classed by the Administrator as conforming with requirements contained in this part shall be used in the preparation of certified maintenance food.

(2) Not less than 30 percent of meat or animal food meat byproduct or both, or of horse meat or animal food horse meat byproduct or both, or of mule meat or animal food mule meat byproduct or both, or of poultry products, shall be used in the preparation of canned or semi-moist certified maintenance food. Upon specific approval of the Administrator, combinations of the above specified ingredients may be used. The uncooked weight of the meat or animal food meat byproduct or both, or of the horse meat or animal food horse meat byproduct or both, or of the mule meat or animal food mule meat byproduct or both, or of the poultry products, or of the combinations thereof, shall be used in the calculation, and the percentage shall be obtained by relating this weight to the total weight of the certified maintenance food.

(3) Certified maintenance food shall contain not less than 10 percent of protein.

(4) Certified maintenance food shall contain a level of minerals and vitamins generally recognized to be essential to the nutritional value of the food.

(5) Vegetables and grains and their derivatives, used as ingredients of certified maintenance food, shall be of good quality, shall be free from discoloration, mold, smut, and insect infestation, and shall be otherwise fit for use as animal food.

(6) Inedible material such as tankage, dried blood, bone meal, and the like shall not be used as ingredients of certified maintenance food.

(7) Semi-moist certified maintenance food shall have a soft granular consistency, shall be shelf stable, and shall be processed so that the moisture content thereof does not exceed 27 percent of the net weight of such food.”

What about false claims on pet food labels?

Should you worry? Theoretically, no. But in the real world: Yes, you should worry. A lot.

The problem is, even though there are plenty of good laws on the books, pet food labels are not a regulatory enforcement priority, so they are seldom acted upon no matter how untruthful they are.

The Federal Trade Commission (FTC): While the FTC has backed out of enforcing pet food labeling back in 1999 (they said it was up to the FDA to do that), the states have laws on the books protecting consumers from false advertising. FTC concluded that the Guides were no longer needed since Model Pet Food Regulations issued by the Association of American Feed Control Officials and regulations promulgated by the U.S. Food and Drug Administration provide specific guidance to industry members about claims regarding nutrition, ingredients, and product characteristics.

Fair Packaging and Labeling Act: The Fair Packaging and Labeling Act contains additional regulations designed to prevent unfair or deceptive packaging and labeling, and to help make it possible for consumers to make value comparisons between products. Federal regulations concerning the labeling of pet food are published in Title 21, part 501 of the Code of Federal Regulations.

Did you know that all 50 states have enacted laws regulating false advertising or deceptive marketing, which often include these statutes under the state’s deceptive or unfair trade practices act?

So, anyone, no matter where they live in the U.S., can file a complaint. A consumer complaint alleging that a company engaged in unfair or deceptive trade practices, such as false or misleading advertising, would be brought under the general consumer protection statutes.

You should know that, if consumers are fed up with phony food claims, they can, and should, bring it to the attention of their state’s attorney general.

Uniform Deceptive Trade Practices Act (UDTPA): Twenty states have adopted the Uniform Deceptive Trade Practices Act (UDTPA). Under this Act, it is a deceptive trade practice to “represent that goods or services have sponsorship, approval, characteristics, ingredients, uses, benefits, or quantities that they do not have.” Failure to state a “material fact” is considered an illegal practice in only fourteen states. Twenty-eight states include broad provisions against misrepresentation of goods or misleading practices.

What does “Feed Grade” mean to me?

Congratulations! You made it this far, that is an accomplishment in and of itself. So, even if you didn’t understand a word of what was written, don’t feel bad, you’re not alone. Now for the winning definition…

“Feed Grade” ingredients are….drumroll….INEDIBLE!

By law, the definition of feed grade material is anything not fit for human consumption (i.e. inedible).

Even though the feed ingredient review and approval has become a cumbersome and lengthy, fractionated process that lacks transparency and sometimes, good scientific sense, we will continue to try convince industry that they cannot have it both ways. If they want to define feed-grade consumers deserve to know exactly what that means.