Antibiotic rules: Knowledge gap remains

From the October issue: With big changes to rules governing antibiotic use in animal agriculture pending at the end of this year, producer opinions range from cautious support to skeptical opposition, with some producers taking a wait-and-see approach.

The rules in question include the FDA's Guidance for Industry 213, which removes performance or production claims from the labels of medically important antibiotics, and the expanded veterinary feed directive (VFD) rule which ends over-the-counter (OTC) purchases of medically important feed-grade antibiotics, placing their purchase and use under the direct oversight of veterinarians.

Medically important antibiotics currently used in cattle feeds for therapeutic purposes that will require new labels under the VFD rule include chlortetracycline, chlortetracycline plus sulfamethazine, neomycin plus oxytetracycline, oxytetracycline, tylosin and virginiamycin.

A while back, we posted an online request for comments on the upcoming rules, asking two general questions regarding the challenges and opportunities likely to result as the rules take effect.

Our informal survey cannot, of course, provide a statistically significant analysis of producer attitudes, and is intended just as a snapshot of opinions from our readers. Also, those who responded clearly have some awareness of the rule changes and have formed opinions. Previous industry studies have indicated a significant percentage of producers remain largely unaware of the rules or their implications.

Following are some representative responses to our questions.

What do you see as the greatest challenge(s) in complying with the upcoming antibiotic rules?


Increased cost to constantly consult with a vet. Lack of flexibility. Paperwork. Limits my ability to be a good stockman.


More bureaucracy and time consuming documentation at the farm level In order to achieve compliance of another gov't regulation without a measurable benefit at the farm level.


Lack of available large animal vets in our area.


Lack of vets availability at night and on the weekend.


Increase cost for vet visit and for the antibiotics.


Animals will suffer due to lack of antibiotic availability.


How will the antibiotic be distributed to the farmer by the bottle or by the shot?


The paper work, more stress on vets, less tools to keep animals healthy, more cost feed additives and vaccines have already gone up considerably


Livestock not getting timely treatment.
Denmark has demonstrated an increase in human resistance problems since the ban that started 26 years ago.


Getting a drug in time to avoid a financial disaster from death loss.


I think the biggest challenge will be for producers to update their facilities so they can raise animals without antibiotics, and what it will do is eliminate the lower tier producers, who at the end of the day doesn't make money and only dumps meat, milk, eggs, and other products on the market that nobody makes any profit on and only gives the livestock raising sector a bad image.


Everything about the new rules is stupid. I use antibiotics only when I have to. I never abuse them.


Learning to navigate the rules in order to be able to treat my animals in a timely manner when illness appears.


Very small, part-time, 4-H and FFA producers are going to have a very hard time keeping their animals healthy.

This will cause a lot of needless animal suffering.

And cause some of the above producers to discontinue. I also see it as adding cost.

The prescriptions will not be free.

I think VFD stands for "veterinary financial security directive".


I think the new rules will create barriers to obtaining medications to treat animal illnesses. I believe it will increase the amount of work for veterinarians and thus increase costs for producers.

It is very hard to make a profit in today's market so this will increase costs and reduce profit what little there is.


People starving to death, not enough food to eat.

What do you see as the opportunities for producers (and veterinarians) as the rules take full effect beginning Jan. 1, 2017?


Positives it should finally put to bed the consumer perception that we are out here pumping our animals full of antibiotics 24/7.


Should drive more research for antibiotic alternatives for animal treatment of infections.


May help stop the abuse of antibiotics in animals.


Accountability of those that will not follow labels, some general or regular additives I have used will discontinue that is probably good.


Will give more vets a job, and ability to charge for phone consultation.


Preventing the unnecessary use of any drug. They should also do the same in the human population.


The opportunity/challenge for vets will be to educate producers on vaccines, and not just promote vaccines from just one pharmaceutical company.




It should help many smaller operators decide to leave the industry, making room for more mega-livestock farms. It should also add to the income flow for many vet services. Other than this nothing positive in my mind.


Make producers accountable and give us data to use in our marketing. But ultimately we will find the same amount of antibiotic residues, and make no progress in the fight towards antibiotic resistance.


Management of antibiotics and taking measures to prevent antibiotic resistance is a good thing but with all control measures there are increased costs.


Maybe cure obesity.

Overall, our responses suggest an ongoing need for veterinarians to help educate client on the new rules and their impacts, and to demonstrate the financial benefits of veterinary involvement in an operation's herd health and overall management.

The FDA's Center for Veterinary Medicine offers an array of information on the rule changes on its VFD website, including the final VFD rule, fact sheets and Q&A pages.


FDA to focus on duration of use

For its next step in toward ensuring antibiotic stewardship, FDA recently announced it will focus on medically important feed antibiotics for which the labels do not define duration of use. In its Federal Register notice describing this initiative, FDA notes that while GFI 213 sets an expectation that new indications of medically important antimicrobial drugs used in or on feed and water will have defined durations of use, it does not address what to do with respect to some currently approved therapeutics that lack defined durations of use. Along with labeling that is silent on duration of use, some examples on currently approved labeling are "Feed continuously" and "Feed continuously as the sole ration."

Antimicrobials with approved therapeutic (Treatment/Control/Prevention) indications with undefined durations of use in cattle





Bacterial enteritis

Chlortetracycline. Oxytetracycline.

Liver Abscesses

Chlortetracycline. Tylosin. Oxytetracycline. Neomycin With Oxytetracycline. Virginiamycin.



Source: FDA


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