Recently, you may have heard something about the Food and Drug Administration (FDA) making a new announcement regarding antibiotic use in livestock production.  Officially the agency that regulates the use of antibiotics said:  

“The U.S. Food and Drug Administration today is implementing a plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, such as to enhance growth or improve feed efficiency. The plan would also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs.” 

 

What Does This Policy Mean?

Is FDA throwing farmers under the bus?  Is this the end of antibiotic use on the farm?  Thankfully, not. FDA has been moving forward with this process (Guidance 209 and 213) since 2012.  In April 2012, FDA released these “draft documents” and asked the public to provide comments.

This release then opened multiple rounds of meetings, discussions and maybe some heated arguments.  All of the animal agriculture groups and pharmaceutical and production companies have been deliberating about antibiotic use in livestock production ever since this announcement was made. Actually, those groups have been deliberating since before April 2012.

For its part, the governing process is slow and deliberate. But it is one of the great fruits of a healthy democracy.

As you know, there are many political and foodie factions that have a strong misunderstanding about how to raise a pork chop, and they feel their practices should be adopted by all.  The rulemaking process attempts to keep a rational discussion going between groups in opposition and hopefully brings about a balanced solution in the end.

 

Essence of FDA’s Final Action

Lucky for you responsible pork producers, the FDA process is a great help to you. Essentially, it says “use your tools well, don’t waste your ammo, have good veterinary oversight, and keep good records.” All of these points look much like your PQA manual don’t they? The great thing about this action is each of you pork producers will be able to proudly say, “I am a conventional farmer who uses NO GROWTH-PROMOTING ANTIBIOTICS!” (or antibiotics which are medically important in human medicine).

Recall the reason this issue has arisen is the possible risk that farmers are encouraging the selection of bacteria resistant to antibiotics. The concern is those bacteria might infect humans and those humans would fail to recover when treated with an antibiotic similar to what you used in your pigs. So obviously if the antibiotic is one you use in pigs, but which doctors do not use in people, the risk should be minimal.  Thankfully, this is the approach FDA has taken.

 

Back to the Drawing Board

With this new policy in place, drug companies are going back to the drawing board and finding the medically important ways and bacteria to which their products apply.

For example, brand X may currently have an FDA- approved label claim, which says “for increased weight gain.” Now they need to go back and see if there are specific bacteria or diseases where the brand may apply.

Believe it or not, FDA does care about the animals’ health. Many who work in the federal agency are highly qualified veterinarians, many who were in practice.  They understand the importance of having effective antibiotics at the ready when infections arrive.

One of my favorite parts in the FDA Guidance 209 is:

“Principle: The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health.

 

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“In light of the risk that antimicrobial resistance poses to public health, FDA believes the use of medically important antimicrobial drugs in food-producing animals for production purposes (e.g., to promote growth or improve feed efficiency) represents an injudicious use of these important drugs. Production uses are not directed at any specifically identified disease, but rather are expressly indicated and used for the purpose of enhancing the production of animal-derived products.

In contrast, FDA considers uses that are associated with the treatment, control or prevention of specific diseases, including administration through feed and water, to be uses that are necessary for assuring the health of food-producing animals.”

This last sentence is something you will NOT find in the regulatory documents of many countries worldwide. Most “developing” countries are moving away from any antibiotic of any kind, unless the pigs are falling over dead.

But FDA has charted a strong path for keeping our animals healthy.  The latest Guidance 213 is showing the drug companies how to chart the course.

 

FDA Critics of Voluntary Policy

Now some of the so-called “consumer groups” criticize FDA for making the policy “voluntary,” even though it is actually not so.

Why do I say voluntary is not voluntary in this situation?  First is personal experience. In February 2008, I began a political appointment as deputy undersecretary for Food Safety in the U.S Department of Agriculture (USDA). We were in charge of all USDA meat inspections. It turned out that a processor of cull dairy cows in California (Hallmark-Westland) was harvesting downer cows, without USDA inspection – a big problem.

Therefore, we needed to implement a recall. Based on the employee interviews, we estimated that about two years of production (150 million pounds of beef) needed to be returned and destroyed.  At least 20 million pounds were in the school lunch program (whew).  So how does a government regulator approach this problem?

Of course, we can go to judges and get a warrant and lawyers to argue the situation, but fortunately, USDA usually just asks the company to recall, voluntarily. So, in one day, with two phone calls to company lawyers, we implemented the largest meat recall in U.S. history.

The second reason voluntary is effective is what I might call a pragmatic relationship. The drug companies are totally dependent upon FDA to get their products to the marketplace. There is no other way. So say for example they discover a great new product that makes pigs fly and guarantees profit. They must go through an incredibly difficult and expensive approval process, always.

They must sit down with some bespectacled FDA scientist to implement the approval process for their new drugs or drugs currently in use for growth promotion only. This scientist happens to ask, “So how is the relabeling approval process going for your growth-promoting product, brand X?” Cue uncomfortable, silence. So, obviously, it isn’t going to happen that a company would be uncooperative with FDA.

 

Veterinary Oversight

As far as veterinary oversight goes, FDA wants to increase it. As many of you know, currently many of the commonly used antibiotics are available over the counter. As an extra precautionary measure, FDA wants to make some medicines “veterinary directed” instead of over the counter.

So how will this affect you? The bottom line is the same as mentioned above – for you responsible pork producers who are using antibiotics the correct way, the increased oversight will just reinforce the good practices you are already using and at the same time give comfort to the concerned public about the healthy pork chops that they are buying.

Many of this concern about antibiotics has been started by the public, so this is a way to continue doing what you’re doing well and also put them at ease – a win-win situation. 

In summary, FDA has implemented a method which will help all producers to hold their heads high. You are doing your very best for the pigs and for the public.

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