Recent Enforcement Letter Indicates FDA Gets Serious About Bute Ban

Ronald Andio, DBA Patron Farms, LLC 7/9/12

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761


July 9, 2012

Via United Parcel Service

Mr. Ronald A. Andio, Owner
Ronald Andio, DBA Patron Farms, LLC
4445 South Turner Road
Canfield, Ohio 44406

Dear Mr. Andio:

On April 03, 05, and 30, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your livestock operation located at 4445 South Turner Road, Canfield, Ohio 44406. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about August 20, 2011, you sold a bay thoroughbred gelding horse, identified with back tag (b)(4) (USDA Tag (b)(4)) for slaughter as food. On or about August 23, 2011, (b)(4) slaughtered this animal. The Canadian Food Inspection Agency (CFIA) analysis of tissue samples collected from this animal identified the presence of phenylbutazone at 0.0025 parts per million (ppm) in the muscle tissue and 0.026 ppm in the kidney tissue and clenbuterol at 0.0039 ppm in the eye (target tissue). FDA has not established a tolerance for residues of phenylbutazone and clenbuterol in the edible tissues of horses. The presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to inquire about the medication status of animals purchased for slaughter. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4).

The violations listed above are not intended to an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated animals.  As such, you share responsibility for violating the Federal Food, Drug and Cosmetic Act.  To avoid future illegal residue violations you should take precautions such as:

1. Implementing a system to determine from the source of the animals whether the animals has been medicated and with what drug(s); and

2. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue.  If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

We also note that the slaughterhouse has on file an Equine Information Document (EID) certificate (or guarantee) dated August 23, 2011 from the producer stating that this animal that you sold had not been administered any drugs or vaccines or treated with any substances not permitted for use in food processing equine in the last 180 days prior to your purchase of this animal. During our inspection of your firm, you admitted that you filled out and signed the producer’s name to this form and did not inquire of the producer the medication status of this animal. You provided this EID to the dealer who purchased this animal from you. Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. 331(h). You should take appropriate actions to ensure that this violation does not recur.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence.  If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed.  Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Mr. Mark E. Parmon, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Mark E. Parmon at (513) 679-2700, Ext. 2162, (513) 679-2773 (fax), or email:

Sincerely yours,


Paul J. Teitell
District Director
Cincinnati District

cc: Dr. Tony Forshey, Acting Chief
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, OH 43068-3399

26 comments for “Recent Enforcement Letter Indicates FDA Gets Serious About Bute Ban

  1. Susan
    August 23, 2012 at 4:08 pm


    Thanks for your comment.

    You bring up a good point, about dealers buying horses with EIDs signed by the owner. This puts the drug liability – criminal and civil – onto the owner.

    Thing is, many of us know horse owners who’ve lied on EIDs, too. The problem is rampant.

    My concern is the US horse market gets saddled with an impossible task, and who’s going to pay for it.

    Horses are different from cattle, they have jobs. They need to move from barn to barn, across state lines, multiple owners. I agree 100% for food safety .. that means individual microchip tracing of horses, and personal responsibility.

    What do you think it would cost the American horse industry to clean up its drug problem in horses exported to slaughter?

    How much did the taxpayers spend on Mr. Andio’s violations?

    Seems like we have two choices.

    Either sellers like Mr Andio keep lying – a public health risk – or everybody gets sadddled with boondoggle paperwork, expense and liability.

    All it takes is one contaminated horse to kill a child.

    Seems a whole lot better to just end this now, like the American people have been asking Congress to do.

    Thanks again for your comments.

    • Joe
      August 23, 2012 at 8:28 pm


      First of all, taxpayers pay nothing for his fines. in the case of Mr. Andio EU will be contacting him thru our ag department. He will be paying a fine and hopefully he will get prosecuted for lying on a legal document. This man is a contract buyer for a plant in Canada. That plant will deduct from his pay plus the trucking what that the plant paid. I hear today that he will no longer be able to ship horses to Canada any longer. This is what lying has cost him and I hope a whole lot more. The problem we have is that the state livestock boards and FSIS does not help or even prosecute a dealer who sells cattle that are full of drugs. I know of a plant owner that does beef who lost over $ 200,000 per year on his total gross income, and he got no help from anyone with truckers and dealers who sold cattle that had been given drugs and lied on their EID paperwork. Again the taxpayer does not pay one cent.

      Think about the fact that USDA/FSIS only inspects 1% of all of the seafood that comes to America and 51% of that is condemended. We are eating the other 99%.?
      How about the peanut butter with rodent droppings, how about the
      apple juice and sauce shipped to America with strichnine.?

      You make an interesting point that horses move from barn to barn and across America. This is the reason that horses have to remain livestock and never get clasified as a pet or companion animal. Horses carry transmittal diseases from other livestock, the horse will not get the disease but will carry like you say from barn to barn where ever they go. Just check with a vet and he will verify this. If you are currently moving your horse you are required to have a current coggins test and heath papers signed by your vet. How would microchipping help here? Very simple, if the owner sells his horse and signs an EID for slaughter and lies, they will get caught and fine them. Lets not start something that all owners have to pay for.

      Again we need stiff fines for the few bad buyers and owners that lie on EID forms for all livestock. Just because someone is pro horse slaughter does not mean they condone crooks and liars. Lets get rid of the bad apples, not the whole barrel.

      We do not need to microchip our horse just to make them safe to go to slaughter, why should the majority of horse owners need to pay for the 1% of all the horses in America that go to slaughter. If there were a reliable system for not to slaughter this horse maybe. If someone owns a horse that they do not want to slaughter, easy enough. Never sell the horse and keep till it dies. The EID system if enforced right will prosecute the owner that lied on the document. When that horse is slaughtered it will be caught.

      If our (American) horses were full of drugs like some say, Canada would not have anything to ship after inspections. Over 70% of all horses slaughtered for human consumption come from America. Remember, one bute tablet in a swimming pool and it shows up..

      • Joe
        August 24, 2012 at 5:14 am


        Here is a very recent notice of drug violations in beef and dairy cattle that were sent to slaughter. Again there is no cost to the taxpayer. If there are cheats that lie on the EID paperwork, they will get caught. This goes for all livestock including horses. I have been scolded in the past by anti horse slaughter for posting articles like this. They say I am going to hurt the beef industry. WHY are we trying to hide a fact about food safety just to stop horse slaughter? There will always be more people eating beef than horsemeat. My main point is to protect FOOD SAFETY in all foods, Again we need stiff fines for those who chose to cheat and lie.

        We currently have over 25% of the beef we eat in America comming from Mexico. Look at their inhumane handling of livestock, HOW about HYGENE?

        The USDA inspects less than 5 % of all meats imported into America and we are eating the other 95 % with no question. Just what is the big fuss over horse meat? There is no proof that people are getting sick or dying from eating horse meat..

        • admin
          August 24, 2012 at 6:31 am

          Just curious, Joe. Who is your employer?

          The Editor

      • August 25, 2012 at 8:00 pm

        Joe, where do the salary dollars come from when the state has to go to court for his violations? Don’t taxpayer dollars pay for the Judge’s and legal salaries, the court clerks, the bailiff, etc.? So yes, it does cost taxpayers on fines. The cost of horse slaughter far exceeds the cost of inspections. There is wastewater clean-up, legal, law enforcement, and millions that will be needed to fix the non-existent transport program. Add to all that the cost of a national passport system, the added cost to horse owners to have a vet administer all meds so they can be recorded and you’ve got quite a heavy burden on all taxpayers and horse owners. The inspectors budget was slashed by $9M so that means we will be taking inspectors away from our food sources at a time when we need more inspectors.

        Inspections are random and are a check and balance that laws are being followed. The cost to test every horse properly would be prohibitive. You do need an national passport system because that is the only way you can ensure food safety in horses and that is what the market for US horses is dictating. No passport, no slaughter. Other markets such as China are also looking at implementing EU regs. Russia has already prohibited US chicken and is looking at banning US pork. They certainly aren’t going to take horses that can’t be proven safe for consumption.

        The person sending the horse to slaughter could be the third owner and not have a clue what the first two owners gave the horse. He can say he never gave the horse a banned substance but what about the other two? The idea is to prove the horse is drug free before sending him/her to slaughter. The only way to do that is to have a complete medical history via a passport. With traditional livestock, they are raised as food animals and don’t have other careers before going to slaughter. They don’t have multiple owners.

        • Joe
          August 27, 2012 at 12:26 pm


          Court costs and fines are paid by the person breaking the law. What ever the violation may be.

          The EID needs to be filled out by anyone owning livestock, regardless of how many times it is sold. In the case of a horse, it asks what drugs have been given in the last 180 days, it also asks how long have you owned the horse. If the current owner only owned the horse (for example) 30 days that he can verify, that horse would have to be held another 150 days before entering the slaughter chain. Why do we have feedlots, it is to make sure that any horse that an EID does not show 180 days drug free.

          Here is an example of drugs used in cattle if they are not kept out of the food chain for the required period. Horses is 180 days before slaughtering. The EID only asks WHAT DRUGS have been given in the last 180 days..

          • Joe
            August 27, 2012 at 1:33 pm


            Dairy cattle as well as all cattle there are only 5 to 15 % tested. It is here in the article as well as a friend who owns a large slaughter plant tells me the same thing. Just why do you and others always try to make a big deal out of just horses. There are just as many drugs used on cattle as horses. There are people lying on EID paperwork for cattle as well as horses. There is no reason just to pick on horses other than to try to prove your anti slaughter agenda..

            I was curious to see if I could ascertain how many dairy cows sold to slaughter go untested?

            I found this link that suggests a major plant would only test 5-15% of dairy cows. The cows were selected for testing based on visible signs of sickness or treatment. Surely not all treated animals exhibit these signs, and inspectors certainly miss some cows that should be tested. FSIS should increase the percentage of cows being tested for drug residues and expand testing to cover cows when inspectors fail to observe signs of treatment.


          • admin
            August 27, 2012 at 7:50 pm

            Joe, we asked you before, who do you work for?

          • Joe
            August 28, 2012 at 6:28 am


            I am not payed by anyone. I do this just to get both sides of the story out. Some reporters and editors only write what their agenda is. We have problems in areas where some chose not to report. I am refering to horses, most only write or report their agenda. Anti slaughter, we have inhumane handling in all livestock. I do not condone it, the violaters need to be prosecuted same goes for owners or dealers who falsify and lie on EID paperwork that is required before slaughter. Thank you for your concern, if you want to pay for my comments I MAY consider..

          • admin
            August 28, 2012 at 6:36 am

            Again Joe, we asked what you do for a living. Also, we asked you not to use an acronym such as EID. Not all Horseback readers are a familiar with the slaughter process as you seem to be and don’t know what this is. The policy of avoiding acronyms is not targeted at you, but is being demanded of those who post here in the interest of fairness and clarity. As journalists we avoid first reference use of acronyms as well as jargon. We believe it’s only right to ask that of those who post on our site.

          • Joe
            August 28, 2012 at 8:51 am


            I am retired from farming and ranching family back ground..

            I have a question as to why you did not scold Vicki Tobin for talking about the EID ( Animal Livestock Indentfication of Ownership forms.) Vicki speaks as though every horse EID is forged. That is absolutualy false, most sales barns that use the EID paperwork announce when the animal enters if it has the owner signed paperwork. MOST dealers will not purchase that horse because these buyers are the ones who ship to a plant that slaughters horses going to the EU countries. There a lot of dealers who ship to Mexico that do not require this paperwork. Again the USDA/FSIS uses the same ownership paperwork (EID) for cattle that are going to slaughter. If someone forges the paperwork or ships an animal to slaughter that has drugs, they are put on the USDA list and any animal coming from a violater is inspected. These are not part of the random checking. The violaters livestock are, all 100% inspected.

            I think Vicki should have to prove that all EID’s are forged. If a horse is bought that does not have the paperwork, either the buyer is going to use that horse, maybe feed it to gain weight and more value or ship to a buyer that does not need the EID form.

          • admin
            August 28, 2012 at 8:57 am

            Vicki wasn’t asked beccause I just instituted the policy.

          • Susan
            August 28, 2012 at 9:54 am


            As a rancher, you seem to be familiar with the drug affidavit process.

            With or without the EID form, can you honestly state you have never sold a horse to slaughter that has received BUTE (Phenylbutazone, a commonly used med with no legal withdrawal period) or Clenbuterol (ditto) at any time in their lives?

            Let’s keep this simple: These are the main drugs causing recalls in Europe of US horse meat. If there are residues, that proves US horses are getting meds banned from the food supply, then being sold to the killer.

            That’s a problem, don’t you agree?

            Many Americans would even go so far to say it’s a serious character flaw.

            The whole point of this discussion is about horse killers lying about drugs, breaking food safety laws, and thinking they can get away with it. Not about obfuscation on regs.

            I’d be willing to bet we both know horsemen who signed off on a false EID drug affidavit to sell a horse to slaughter. It’s the old school “livestock” culture.

            Gaming the drug rules is as rampant in the horse slaughter trade as it is on the tracks; it’s disingenuous to pretend otherwise.

            So let’s not change the subject. It’s not the job of the private citizens like Vicki to prove that people are breaking food safety laws.

            The FDA letter (above) makes it CLEAR dealers are responsible for taking measures to keep drugs out of the food supply. The dealer shares responsibility for law violations.

            And yes, the US taxpayer is paying for that enforcement (and subsidizing the profits generated by horse slaughter) as long as US horses are shipping to slaughter.

          • Joe
            August 28, 2012 at 9:41 am


            I do not believe this question about WHO I WORK For or WHAT DO YOU DO FOR A LIVING first of all is no ones business and further more has nothing to do with my participation in the comments or information I am bringing to this site.

            If it is others business I would like to ask you HOW MUCH Money do you get directly or indirectly from HSUS??

          • admin
            August 28, 2012 at 12:20 pm

            The question was valid, Joe, because since your very firt post you have sounded like a PR flack for the meat industry. As such, I thought it was a matter of honesty on your part to divulge whether you are a paid spokesman. I’m delighted to learn you are not. Regarding your question about HSUS. Horseback Magazine is a sole proprietorship that receives 100 percent of its revenue from our advertisers. We would refuse funding from HSUS or any other entity with a political stake in a story we are covering. In short, we are fiery independent and pride ourselves in our ability to piss off all sides of an issue.

            The Editor

          • August 27, 2012 at 9:59 pm

            Joe, you don’t honestly think the miniscule “court costs” the defendants sometimes pay is anywhere near the cost of running the courthouse, do you?

            The 180 days was an interim measure to allow the US to come into full compliance within 3 years (a passport system). The US has done NOTHING to come into compliance except make a mockery out of the meager regulations. The kill buyers complete the EIDs. There are no EIDs from former owners and no drug information on the EIDs. It is very evident the EIDs are worthless when the TBs keep going to slaughter. Every one of them has had bute and many are going straight from the track to the plant. There is no 180 day quarantine, no valid heath info, nothing. They can’t follow the meager regulations in place now but they keep touting humane and regulated plants. Now that is hysterical.

            The one attempt at a system (NAIS) was a miserable failure. Horse owners want no part of it. Perhaps that’s because the majority of horse owners are against horse slaughter. It’s going to become very expensive for horse owners if slaughter isn’t banned. They will have to call the vet to administer all meds so they can be recorded on the passport. You have a plant in NM that was shut down by the USDA in February for inhumane treatment of slaughter animals moaning because the USDA won’t give him a cert to inspect horses. Then you have the plant in Rockville that shut down and was sold because of a recall of 14,000 pounds of beef for eColi contamination. The closed plant is currently mired in legal issues that will take months if not years to sort out in court – liens, lawsuits, shell companies – a tangled mess. Is this what you want to bring back to US soil? It will make what happened in the former plants pale in comparison. And then there are the pesky little passports that will make just about every horse in America ineligible for slaughter. That will be one profitable plant, won’t it?

            So here we are how many years later and they’ve done nothing. Nothing but ignore regulations. Business as usual. The same crap as when the plants were open. They do as they please and it’s about time someone stepped up. Too bad it had to be the EU and not our own government. And to top it off, the blatant disregard of food safety in horses has everyone questioning the safety of our own food supply. More and more recalls, plants being shut down and the slaughter supporters want to take inspectors away from our own food sources to slaughter non-food animals. Just priceless.

            Or was that the plan all along so they can keep hiding what’s happening in livestock slaughter plants…… And the arrogance to try to ban undercover investigations. Yes, let’s protect the abusers and make the people exposing the abusers, criminals. Only in America!

          • admin
            August 28, 2012 at 5:59 am

            Again, please avoid using acronyms that might not be familiar to all readers. Spell out the name of the document or organization on first reference.

  2. Susan
    August 22, 2012 at 10:56 am


    The reason people say giving a horse BUTE makes it illegal to sell to slaughter is because that’s what the law and regulations state – US, Canada, EU.

    FDA bans selling a horse to slaughter if it has ever been given BUTE, or Clenbuterol. BUTE is a known human carcinogen.

    A few people have been arguing that there are no residues of BUTE. How can that be true? Horses they sell to slaughter (after promising in writing on the EID there was no BUTE) are testing positive for BUTE after being killed.

    It’s becoming increasingly clear some US horse owners and dealers think it’s OK to lie (in writing) about cancer causing drugs. Drugs, like BUTE, that can cause fatal liver failure and a fatal form of childhood anemia.

    They seem to believe it’s OK to lie about food safety laws – that the rest of us think are good ideas – to make money.

    Does this mean other things these people say (horses can be slaughtered humanely, horse meat is healthy protein, slaughter plants create jobs for Americans) might not be true, too?

    Not sure what your question was, hope that helps.

    • Joe
      August 23, 2012 at 9:09 am


      I agree that there is a few, not all dealers will lie. In most cases the owner signs the EID at the sales barn before the sale. The good dealers will not bid on a horse if it does not have a signed EID by owner which is announced on each animal as it goes into the ring. Anyone who lies on an EID whether it be for a horse or cattle. Beef and dairy cattle use an EID signed by the owner also before going to slaughter about drugs if they have been used within a certain time just like horses.

      We need to get rid of the bad apples not the whole barrel. I am 100% for food safety of every kind and humane transportation of all livestock. Thank you

  3. Lori
    August 22, 2012 at 9:22 am

    “FDA has not established a tolerance for residues of phenylbutazone and clenbuterol in the edible tissues of horses. The presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated…”

    Maybe they haven’t established a tolerance for those substances because they are known carcinogens, meaning ANY amount of those substances found in edible tissues “causes the food to be adulterated” … as stated in the very next sentence.

    • Joe
      August 22, 2012 at 11:17 am

      The EID that is required by the EU asks what drugs have been given in the last 180 days. The plants that are sending horsemeat to the EU are also checking for forbiden drugs. If all horses at some point in their life were given BUTE like a lot of people say on this site and it stayed with them for life, there would be a lot of horsemeat condemnded for the residue. With over 70% of all horses slaughtered in Canada coming from America we should be reports of TONS of meat condenended. The anti slaughter seem to be beating on a dead subject and will not admit it.

      • admin
        August 22, 2012 at 4:03 pm

        Sorry Joe, wrong again. Testing of meat in slaughterhouses is not done from samples where bute resides after the horse’s death. Bute is found in the kidney which until only recently, very recently, was never tested, and now only by the Canadians on the behest of the EU.

        • Joe
          August 23, 2012 at 8:44 am


          You are right, our current KIST testing that is done in red meat (horses included) tests the kidney, liver and tissue of the meat. IF THERE is any forbiden residue of any kind it will reject that carcus till further tests are done. And of course if BUTE were present it would tank that meat. Canadian tests are the same as our KIST tests we are told. Again USDA/FSIS testing will show any forbiden drugs.

  4. August 22, 2012 at 8:48 am

    Joe, banned means there are NO acceptable levels. Period. Extensive studies are done before any med is banned. When meds are banned, the risk is serious enough to prohibit its use in ALL food producing animals. Phenylbutazone and Clenbuterol are but two of the banned meds. They will never have withdrawal times because they are banned. Why are you having such a difficult time understanding this?

    It’s black and white. One dose and the animal (not just horses) can NEVER enter the food chain.

  5. Joe
    August 22, 2012 at 6:53 am


    This is very interesting, go to the 3rd paragraph and the 5th sentence. Quote( It states that FDA has not established a tolerance for residues of Phenylbutazone and Clenbuterol in the editable tissue of HORSES)

    Why do you and others say it condems all horses if at any time in their life BUTE has been given to a horse? Why has FDA not established a tolerance for HORSES? Horses have been slaughtered for years and continue to be slaughtered for human consumption. Horses are red meat that are covered in the FSIS hand book for red meat residues. This looks like some more of government not doing their job to assure food safety.

    • Denise
      August 22, 2012 at 8:04 am

      Until thresholds are established, equines are not qualified as a food source for humans.

      The EU has said that specific meds, like bute are not qualified for ANY withdrawal period. End of debate. No arguing. No spinning. No wiggle room.

      One dose….you are out as a food purveyor with equines. Period.

      Equines in the very long past were not exposed to these kinds of meds….now they are as an approved prophylaxis for scientific equine management…not as a food source.

      No, this looks like people that have always depended on slaughter of equines as disposal option and/or income. And to the contrary, it looks like the government (one part) is very much doing their job regarding food safety.

      As to withdrawal testing, put your questions to the Bayer’s, Fort Dodge’s, et al of the world.

Comments are closed.