The shocking truth about the new animal food rule: PART III

Human food vs. animal food: Glaring differences

The proposed rule for pet food and animal feed is similar to FDA’s Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, however, there are some major differences in the way the two rules address relevant hazards. Although FDA attempted to use the new human food Current Good Manufacturing Practices (CGMPs) as a starting point for the proposed animal food CGMPs, the FDA sharply deviated from any similarity when it decided to allow waste material into animal food.

What goes to the very heart of both of these proposed rules is that under the Federal Food, Drug & Cosmetic Act (FD&C Act) “food” is defined as “articles used for food or drink for man or other animals” (see 21 U.S.C. 321(f)). However, the FDA thinks that food, for humans and animals, should not be held under the same protection the law affords and is proposing that human and animal food are addressed through separate regulations.

According to the proposed rule:

“In some facilities, “waste” from human food production, such as by-products that may not be edible for humans, or lack nutritional value for humans, are used or sold for animal food. Many species of animals have different digestive systems and nutritional requirements than humans, thus allowing for this use.” (see Proposed rule § 507.1(d))

FDA is proposing separate regulations applicable to certain hazards that may be associated with animal food with more stringent regulations applicable to human food, rather than a single regulation that covers all food and hazards subject to preventive controls. This proposal is in complete ignorance of the federal FD&C Act which mandates that all food, whether for human or animal, must be safe.

However, the FDA disagrees:

“…human food waste that is used for animal food would be treated as “food” for the purposes of its animal food use and as waste for the purposes of its role in human food production.”

You decide: Is that acceptable? If not, then you need to tell them so.

Adulterated food? Okey-dokey

The FDA actually believes that pet food employees can tell if ingredients are contaminated just by looking at them:

“…visual inspection alone could identify physical hazards in incoming raw materials and ingredients and prevent contaminated ingredients from being added to animal food.”

But, I guess that becomes a moot point when you consider that there is no requirement that animal food be protected from contaminants that may “drip, drain, or be drawn into the food”.

Hell, there isn’t even a requirement for containers and carriers of raw materials be inspected.

But, by far the most putrid proposed rule is the allowance of adulterated animal food, raw materials, and ingredients, including rework susceptible to contamination with pests, undesirable microorganism, or extraneous materials in animal food if, as the FDA says, “a manufacturer wishes to use such materials in manufacturing such food.” The FDA says it’s okey-dokey, as long as it’s:

“reworked” or “reconditioned” into pet food and animal feed as long as they are “reconditioned using a method that has been proven to be effective.”

I don’t care how much they re-cook it — that’s gross.

Allergens? Ah, phooey

Two areas that receive major attention in human food are control of cross contact from allergens and protection of food packaging from both cross-contact and cross contamination. But when it comes to the animal food rule? Meh.

The Agency said major food allergens do not to apply to animal food. Yet it is well established that some animals, just like humans, suffer from allergies. It has been estimated that food allergies affect four to six percent of young animals and two to three percent of full-grown adult animals.

Also conspicuously absent from the proposed rule is the entire issue of drug allergies. Specifically, as it relates to drug residues found in meat, dairy and poultry which then contaminate food for animals. Just as there are humans with an allergic responses to specific drugs, animals too can suffer many of the same problems that humans do.

Food fraud? Meh. FDA holds off on dealing with it

Despite the melamine contamination case that helped to inspire the very law with which the proposed rule is based on, the Food Safety Modernization Act, the FDA does not intend to address “hazards that may be intentionally introduced, including by acts of terrorism” in either the human or animal rule. The agency explicitly indicated that this consideration is being left for another time; perhaps because they want to develop it in collaboration with the U.S. Department of Homeland Security, it’s hard to say.

However, FDA explicitly requested comments on another type of intentional adulterant: those introduced for economic motives. They are seeking comments on whether to include economically motivated adulterants as a potential hazard for which there is already a widely recognized risk (e.g. addition of melamine to enhance perceived quality and/or protein content).

To me, this is a no-brainer: The FDA should revise its approach to potential hazards that may be intentionally introduced for economic reasons for the simple reason that such hazards are considered reasonably likely to occur.

Supplier verification? Nah

Considering the increasing risk of economically adulterated goods, it is essential that FDA include requirements for supplier verification for all forms of animal food, which should include supplier approval and verification schemes and on-site audits.

Instead, the FDA has set it aside in a separate ruling. But the Agency still wants to hear from you on why supplier approval and verification is an appropriate means of implementing the statutory directives:

“Although the Agency has not included these provisions in the proposed rule, the Agency also requests comment on if a supplier approval and verification program as one of the procedures, practices, and processes that preventive controls should be included in a final rule.”

Why should you care about foreign supplier verification? One word: CHINA.

Shoulda woulda coulda

Unlike the current human food facility CGMPs, the proposed animal food CGMPs contain an uneasy number of recommended requirements in place of mandatory requirements procedures, thereby giving manufacturers the opportunity of deciding for themselves which of those “recommendations” they wish to follow and those of which they have no intention of following.

Meanwhile, in the FDA’s proposed human food CGMP regulation, the Agency would delete twenty-one appearances of the word “should” and change nine instances of “should” to “must”.

Just what is a “should” anyway? Legally speaking, the Agency defines it this way:

“Defines “should,” explaining that “should” is used to state recommended or advisory procedures or identify recommended equipment. “Should” denotes non-binding guidance.” (Excerpted from B. Proposed § 507.3—Definitions)

“Should” is an ambiguous legal term, essentially meaningless. Imagine a speed limit sign that reads “Recommended Speed Limit” adding, “But, only you feel like it, after all — there’s no law saying you have to!”

Instead, the FDA is requesting comment on whether to change the proposed rules to require rather than recommend that the proposed rules become mandatory. You think?

Big Pet Food push back

Already, Big Pet Food (the Pet Food Institute and American Feed Industry Association) have complained that the rules will be too prescriptive and not account for the variation in types of manufacturing and products manufactured in the industry.

Even Dan McChesney, PhD, director of the Office of Surveillance and Compliance for FDA’s Center for Veterinary Medicine, admitted during the 2013 Feed and Pet Food Joint Conference that the agency needs industry’s input on the proposed CGMPs. “We probably made them too stringent and need to back off some; we’re looking for feedback from you for justification to back off,” he said.

Consumers will have counter industry’s push to get the FDA to back off by giving FDA feedback on why the rules need strengthening, because without consumer input, nothing will change.

Nothing.

No one is going to make the argument better than someone who has lost a pet due to a foodborne illness or a jerky treat from China. This is your chance to let the U.S. government know how important safe pet food is to you.

There may never be an opportunity like this one again in our lifetime, so don’t miss it.

Poisoned Pets’ summary of the rules

There are numerous things wrong with the proposed rule for animal food, but only a few issues are critical. They are:

The FDA has proposed allowing waste material into animal food.
The FDA has proposed the allowance of adulterated raw materials, and ingredients in animal food as long as it is reworked or reconditioned.
The FDA does not intend to address “hazards that may be intentionally introduced, including by acts of terrorism.”
The FDA liberal use of voluntary recommendations instead of mandatory requirements.

How do you feel about all this? Submit your comments to the FDA

This is a very important opportunity to engage the US Government. It is an incredible opportunity to help shape the laws that will protect animals. The FDA needs to hear from you: why these issues matter to you, why you think they are important and why they need to be addressed.

I recommend that you write your comment ahead of time and save it on your computer — there is a time limit when using the Federal Register System, and you may get timed out if you write your comment from scratch.
If your comment is less than one page, you can copy and paste it into the comment box. If it is longer, you can instead write “see attached” and upload a separate document, such as a Word or PDF file, with your comments.
It is very important to personalize your comments! I hope this article has helped you decide which issues are important to you and why.
To submit a comment, first go to the proposed rule for animal food at the Federal Register for the document. Then click on “Submit a Formal Comment”. You will be taken to the Regulations.gov site where you will be prompted to create an ID and then upload your comments.

The proposed rule simplified

In order to get an overview of the 400+ page proposed rule, I created several handy guides and tables to help you understand some of the basics. This is just a preview of them, you will need to click on the links (below) to view the files at full size: