Adulterated Meat and Inadequate Horse Care Results in a Slap on The Wrist

For many, this letter from July 12, 2012 to  Ron Andio will be old news:


If you don't feel like clicking, here is the meat of the letter (sadly, pun intended):

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 www.fda.gov

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.

In summary, on 3 different days in April of 2012, the FDA conducted inspections of Andio's farm and found violations.  The inspection was apparently a result of the CFIA (Canadian Food Inspection Agency) testing a horse Andio sent to slaughter in Canada in April of 2011 (yes, 2011) and finding Bute in its system.  Bute is an illegal drug to administer to any animal entering the human food chain.

The FDA went on to say "their investigation 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."

And continued with:

"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."

According to this letter, Mr. Andio not only supplied toxic horse meat to Canada, but admitted to falsifying documents to state otherwise, forging the signature of the individual or firm he got the horse from, and supplying these falsified documents to the dealer who bought the horses from him and took them to slaughter.

We don't know exactly what the statement about inadequate conditions means.  It certainly doesn't bode well for the animals in his possession.

What is perhaps most appalling is that the FDA slaps him on the wrist and asks for a letter stating how compliance will be done in the future.  Other questions abound.  Why did it take a year for the letter to be sent to Andio?  Why is he still allowed to ship horses when the CFIA has a zero tolerance policy for Bute?

The CFIA only randomly tests meat products.  ( http://www.inspection.gc.ca/food/information-for-consumers/fact-sheets/specific-products-and-risks/meat-and-poultry-products/horse-meat/eng/1331217628360/1331225704619 )  There is no way of knowing how much toxic meat is entering the system, but based on what we know about the percentage of American horses who have received Bute, it's easy to guess that it's a very, very significant amount.

Consumers in both the European Union and elsewhere should be scared, very, very scared to consume anything that may contain American horse meat.  The article below cites a number of terrifying side effects:


"Published in Food and Chemical Toxicology, the research study states that the health hazards associated with bute in horse meat aren’t dose related.

According to the study, bute causes bone-marrow depression like aplastic anemia, agranulocytosis, thrombocytopenia, leucopenia, pancytopenia, and hemolytic anemia, which are fatal in the vast majority of cases. The elderly are more susceptible than younger adults. The risks for developing bone-marrow depression and other serious effects are heightened because humans metabolize bute into oxyphenbutazone, which also causes bone-marrow depression.

The study also demonstrates that children are at increased risk of developing aplastic anemia from minute levels of bute and oxyphenbutazone in horse meat, presumably because their bones are still growing. But even very low levels of bute can result in a hypersensitivity reaction in susceptible adults that’s mostly fatal. All of these effects are considered to be idiosyncratic, meaning it is unknown who will be afflicted.

The National Toxicology Program showed that bute is a carcinogen. In fact, bute can cause chromosomal alterations that lead to cancers like leukemia in humans.

In amounts lower than those that cause bone-marrow depression, bute can also result in a serum sickness–like illness resulting in “fever, fatigue, malaise, and inflammation of the kidney, swollen glands and an enlarged spleen. A person can end up on dialysis for the rest of their life,” the authors of the peer-reviewed research study wrote in a follow-up letter to the editor.

Because bute was taken off the market for human use more than a decade ago due to its side effects, no long-term studies have been or will be conducted. No safe levels were set by food-safety regulators. Therefore, the drug was banned for all animals intended for human consumption, and there is no withdrawal time."

Part of the takeaway message here is that horse dealers can easily pass horses with drug histories into the food chain, and that the "system" in place to protect consumers is lax at best.  The dealers don't care what they are shipping; they just want their cash.  And the government agencies appear to be largely asleep at the wheel.

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