Buckeye Dairy News: VOLUME 23, ISSUE 5

Chris Zoller, Extension Educator, Agriculture and Natural Resources, Tuscarawas County and Gustavo M. Schuenemann, Professor and Dairy Extension Veterinarian, Department of Veterinary Preventive Medicine, Ohio State University Extension

At a recent Beef Quality Assurance (BQA) training session, we discussed livestock drug use, proper administration, the importance of following the label (and veterinary instructions), and the importance of keeping records of drugs administered.

Real-Life Example

A producer attending the session stood up and described to the group what happened when he had an animal test positive for a drug residue.  An official from the Food and Drug Administration (FDA) came to his farm multiple times until finding him at home.  He was required to write a letter explaining what steps he would take to prevent the issue from arising again.  The FDA determined the first letter wasn’t adequate in addressing their concerns.  He was provided with websites to consult and had to write another letter addressing the concerns.  The producer now keeps detailed medication records and strongly encouraged every livestock producer to do the same!

Food Producing Animals

In livestock production, a medication may be necessary to treat diseases and restore health. Feed additives containing medications must be used only according to the label instruction. However, if precautions are not taken, problems can arise when an animal tests positive for a drug residue violation in meat, milk, and eggs.  Remember, these are food producing animals and it is the responsibility of the owner to ensure that a safe product is available to consumers. Drug and chemical residues in meat, milk, and eggs are of public health concern.

The FDA regulates the use of livestock medications in the United States and establishes tolerance levels for residues in meat, milk, and eggs.  Following label recommendations and maintaining accurate and proper treatment records helps ensure that violations do not occur.

Figure 1. Maintaining accurate and proper treatment records is just as important as having adequate working facilities!

Key Points

The following key points are from the document Adequate Drug Treatment Records Help Ensure Food Safety, available at this FDA website: https://www.fda.gov/animal-veterinary/animal-health-literacy/adequate-drug-treatment-records-help-ensure-food-safety

Live animals sold for slaughter for human consumption are considered food.

Under the Federal Food, Drug & Cosmetic Act (FFD&C Act), the definition of “food” includes “articles used for food or drink for man or other animals.” FDA considers live animals intended for food as “food” under the FFD&C Act.

Food held under insanitary conditions is adulterated under the law.

The FFD&C Act states that a food is adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”

Giving drugs to animals without keeping adequate records can constitute “insanitary conditions.”

In cases involving illegal drug residues in dairy cows, district courts have agreed with the U.S. government that the failure of a dairy farm to keep adequate records of the administration of drugs constituted inadequate control measures. The courts found that these inadequate control measures created “insanitary conditions” and, therefore, adulterated the food under the FFD&C Act.

Drug residues in edible tissues above a level set by FDA (the “tolerance”) are illegal.

When a food-producing animal is treated with a drug, residues of the drug sometimes remain in or on edible tissues from that animal. Residues include small amounts of leftover drug, or parts of the drug that aren’t completely broken down by the animal’s body. Immediately after administering a medication to sick animals, the drug enters the blood stream and is typically metabolized by liver and then eliminated by the kidney via urine. Most sick animals experience some degree of dehydration and low intake (feed and water) due to pain, and this may extend the drug clearance from the animal. Keep your treated animals fully hydrated to avoid residues in milk or meat.

FDA, through its Center for Veterinary Medicine, makes sure the residues that may be present in or on edible tissues from treated animals pose little risk to people. As part of the approval process for any drug intended for use in food-producing animals, the agency sets the drug’s tolerance and withdrawal period.  The tolerance is the level of residues allowed to be in or on the edible tissues. Residues higher than this level are called “violative” because they violate (are above) the tolerance set by FDA.

The withdrawal period is the time from when the animal was last treated with the drug to when the animal can be slaughtered for food or selling milk. The withdrawal period allows for the drug (or parts of the drug known as metabolites) in the edible tissues of the treated animal to get to levels that are at or below the tolerance.

It is illegal for dairy farmers, livestock dealers, and other animal producers to sell an animal for food that has drug residues in its edible tissues that are above the set tolerance.

What enforcement action can FDA take if I have a violation?

The producer described above did not have to pay any fines for the violation he incurred.  However, having to research information, make phone calls, work with the veterinary of record, and write two letters consumed much of his time.  Let’s take a look at possible enforcement action FDA may take against violators:

Warning letters – Are sent to the individuals or firms, advising them of specific noted violations. These letters request a written response as to the steps which will be taken to correct the violation.

Injunction – An order by a court that requires an individual or corporation to do or refrain from doing a specific act.

Criminal prosecution – May be recommended in appropriate cases for violation of Section 301 of the Act. Misdemeanor convictions, which do not require proof of intent to violate the Act, can result in fines and/or imprisonment up to one year. Felony convictions, which apply in the case of a second violation or intent to defraud or mislead, can result in fines and/or imprisonment up to three years.

Criminal Fines for Food Drug and Cosmetic Act Violations

Misdemeanor fines under the Act may reach $500,000 under some circumstances. The Criminal Fine Enforcement Act of 1994 (Public Law 98-596) provides for fines for violations of Federal law. Although it is not part of the Act, the Criminal Fine Enforcement Act of 1994 applies to all fines levied under the Act, as well as other statutes that contain provisions enforced by FDA.

The following fines are applicable for each offense:

• Up to $100,000 for a misdemeanor by an individual that does not result in death.
• Up to $200,000 for a misdemeanor by a corporation that does not result in death.
• Up to $250,000 for a misdemeanor by an individual that results in death or a felony.
• Up to $500,000 for a misdemeanor by a corporation that results in death or a felony.

The maximum imprisonment for a misdemeanor under the Act remains a year for each offense.

What drug treatment information do I need to maintain?

When treating food animals with any medications, the following must be recorded:

• Name of the drug used;
• Identity of the animal treated;
• Date of each administration of the drug to the animal;
• The dose;
• Route of administration. How the drug was given (for example, by mouth or by injection into muscle);
• The lawful written order of a licensed veterinarian in the context of a veterinarian-client-patient relationship (if applicable);
• Name of the person who gave the drug;
• Length of the withdrawal period; and
• Date the withdrawal period ends (milk can return to the bulk tank or treated animal can safely be sent to slaughter on or after this date).

Veterinary Client Patient Relationship (VCPR)

A VCPR is just what it says – a working relationship with a veterinarian who is familiar with your animals, production practices, and works with you to develop plans to prevent, control and treat diseases. The veterinarian is referred to as your Veterinarian of Record (VoR), and both the VoR and the client should sign a form to document this relationship. If this is you, excellent!  If emergency situations are the only times you see a veterinarian, maybe it’s time to schedule a visit to establish and document the VCPR.

Summary

An ounce of prevention is worth a pound of cure! Drug and chemical residues entering the food chain (milk, meat, or eggs) are of public health concern. Review and adjust health protocols at least once per year with your veterinarian. It really is in your financial best interest to avoid residues entering the food chain to maintain your market channels. In the event you receive an FDA letter indicating a residue violation was found in milk or meat, please contact your veterinarian immediately to develop the response letter documenting the corrective actions.

Sources

Adequate Drug Records Help Ensure Food Safety, Food and Drug Administration, https://www.fda.gov/animal-veterinary/animal-health-literacy/adequate-drug-treatment-records-help-ensure-food-safety

Types of FDA Enforcement Actions, Food and Drug Administration, https://www.fda.gov/animal-veterinary/resources-you/types-fda-enforcement-actions

Veterinary Feed Directive, https://vet.osu.edu/sites/vet.osu.edu/files/documents/extension/Brochure_VFD.pdf

Veterinary-Client-Patient-Relationship (VCPR) Template, https://vet.osu.edu/extension/general-food-fiber-animal-resources

Dr. Gustavo Schuenemann, Professor and Extension Veterinarian, and Jeffrey Workman, Extension Program Coordinator, Department of Veterinary Preventive Medicine, The Ohio State University

COVID-19 has certainly dominated the headlines and many of our daily conversations since March, 2020. For those directly involved in production agriculture, our lives and routines may have been disrupted, but our daily business and responsibilities of farming and raising livestock never stopped. 

Times like these should remind everyone of the importance of having a robust food production system to ensure a nation’s food security. Below are the frequently asked questions we receive when visiting farms.

To answer these questions, we should look at the unbiased science. The challenge with looking at the science regarding COVID-19 is that portions of the science do not yet exist, or are not yet confirmed through replication and hard evidence. Time must pass in order to generate data. 

Science is evolving as researchers around the world continue to study and learn more to create unbiased new knowledge that informs all of us. Answering one research question may lead to several new research questions, or the correct answer backed by science is no longer relevant moving forward as the virus has changed. 

The “gold standard” that we typically use in the U.S. for sharing information and making decisions regarding public health are the recommendations coming from the Centers for Disease Control and Prevention (CDC). The CDC develops and changes their recommendations based on the available scientific data at any given time.

There are coronaviruses on my farm — is this the same as COVID-19? 

No, there are animal coronavirus infections that are caused by different strains of coronavirus, such as calf diarrhea, winter dysentery in cows, and bovine respiratory disease complex (shipping fever). To prevent losses, producers vaccinate their animals to protect against diseases caused by coronavirus.

When and how will the COVID-19 pandemic end? 

We can’t yet say exactly when the pandemic will end, but we do know that the pandemic will essentially be over when the individuals who make up the population achieve some level of immunity which ultimately stops the spread.

How do you get immunity? 

Immunity may be natural, or infection-induced, in which a person is infected with the virus and recovers. Immunity can also be vaccine-induced in which a vaccine helps the body to produce antibodies. Individuals who make up the population must achieve immunity to stop the spread and ultimately end the pandemic. 

What is herd immunity?

Herd (or group) immunity occurs when a large portion of the population (or herd) has some level of immunity to a virus. This means if someone who didn’t have enough immunity becomes exposed and infected, the likelihood of them passing it on to someone else is much less because the majority of their contacts in their surroundings already have immunity. 

When a virus infects an individual, the individual either recovers or succumbs, and the virus can only survive by spreading to another host individual. We see in other viruses, such as the measles and mumps, in which the US population already has herd immunity, there are occasional small, isolated outbreaks, but the virus is unable to develop into a pandemic. 

Is immunity a sure thing? 

Typically, immunity from most viruses is never 100%. For example, we achieve immunity from the chickenpox virus through natural infection or vaccination, but there are still a few cases of reinfection identified worldwide. Influenza (flu) viruses have the ability to mutate, adapt, change, and jump across species. 

As the flu virus changes, a person who has been vaccinated over several years, and also has some infection-induced immunity, may still become infected. However, they have some immunity that lessons the severity of their infection and results in a faster recovery. 

Why should I get vaccinated?

The safest way to achieve some degree of immunity against COVID-19 is through vaccination. The current COVID-19 vaccines have been shown to be as high as 94% effective at preventing COVID-19 hospitalizations. The Delta variant is the newest strain of concern because it appears to be more contagious and severe than earlier strains of COVID-19. All indications thus far are that individuals who are fully vaccinated have protection from the Delta variant. It is important to keep in mind, if we learn that immunity wanes over time, or that the virus has significantly changed so that the current vaccine-induced immunity (or infection-induced immunity) is no longer effective, there could be recommendations for booster shots or other vaccine formulations at some point in the future. Individuals should choose whichever vaccine is available and they have the opportunity to receive. Current efficacy percentages reported are developed from subsets of people, and the true efficacy numbers will become much more valid and reliable as datasets become much larger and time passes. 

Keep in mind that the efficacy of the annual influenza vaccines is typically only 40 to 60%. All three COVID-19 vaccines have been found to be safe and effective. Everyone is biologically different and side effects vary. The reward (immunity or some degree of immunity from COVID-19) outweighs the risk (potential vaccine side effects). 

To conclude, the safest way to achieve immunity or some degree of immunity is by becoming fully vaccinated (individuals need both doses of a two-dose series). If an individual doesn’t achieve immunity that fully prevents infection, they may achieve a degree of immunity that decreases the severity of symptoms and duration. 

We all do personal risk assessments and consider the risk-benefit ratio each and every day without even thinking about it. There is risk in getting up in the morning and going to work. There is risk in driving a vehicle, operating machinery, flying on an airplane, and so on. Essentially everything we do in life has some degree of risk, but when individuals determine the benefit or reward outweighs the risk, they must carry on and move forward. Talk to your doctor or health care provider to discuss the best option for you and your family.