On-Farm Food Safety Section

Keep up with the latest news on this dynamic topic that impacts growers on multiple levels. Developing a farm food safety plan is a good idea for all growers, and may be required as part of food safety audits if you sell to certain buyers.

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Getting a Grip on the FDA Antibiotic Rule

(Editor’s note: This article is taken from the June 1st, New Jersey Farmer Animal Science Update column.  It is co-authored by Michael L Westendorf PhD, Rutgers University; Jon E Higgins VMD  Acorn Farmvets LLC; and Dan Wunderlich, New Jersey Department of Agriculture).

You may have heard and are seeking more information about upcoming changes in the availability of Over-the-Counter (OTC) antibiotics for use in livestock.  The United States Food and Drug Administration (FDA) recently enacted the Guidance for Industry Rule – 263 (GFI-263) referred to here as the FDA Antibiotic Rule.  This rule regulates the relationship between veterinarians and livestock producers, and the usage of drugs that are medically important for humans.

The FDA Antibiotic Rule describes the use of antibiotics and provides veterinarians and livestock producers with guidelines for prescribing their sub-therapeutic use in feed or water and therapeutic usages for maintaining animal health well-being.  This Rule requires all veterinarians to prescribe such uses: provided there is a Veterinarian-Client-Patient-Relationship (VCPR) in place.

What is a VCPR? According to the American Veterinary Medical Association (AVMA) a VCPR “is the basis for interaction among veterinarians, their clients, and their patients, and is critical to the health of animals.”  This agreement means that veterinarians assume responsibility for clinical judgements related to animal health, it guarantees that the veterinarian has the knowledge to make such judgements, and that they are available for evaluation, examination, visitation, emergency coverage, and continuing care and treatment.  The veterinarian provides oversight of treatment, compliance, outcome, and the maintenance of patient records.  The client agrees to follow the veterinarian’s instructions.

What does this mean?  In the future, veterinarians will not be able to prescribe drugs for use by livestock producers unless there is a valid VCPR in place.  A VCPR is more than a phone call asking for veterinary advice, it is more than a tele-health consult on a farm that the veterinarian does not have a prior, professional relationship.  The veterinarian will be familiar with the farm, its management, its livestock, and existing animal health conditions. So, a valid VCPR is key, but this change does not mean that every time you have a sick animal that a veterinarian must visit your farm, examine, and treat that animal. But it does require the farmer will regularly seek out veterinary advice and service to maintain animal health.  When a proper VCPR is in place, a veterinarian can prescribe animal drugs for usage on livestock farms.  Over the Counter (OTC) antibiotics will not be available without a VCPR and a veterinary prescription.  Prescriptions can only be filled by veterinarians or animal health companies and other farm service companies or vendors (your local feedstore may not be approved).

It is also important to understand this overall change goes back to the instituting of the Veterinary Feed Directive (VFD) requirement, which was approved by the FDA in 2017.  The VFD is focused on maintenance of human and animal health.  The VFD ensures that drugs medically important for humans can no longer be used sub-therapeutically in animal feed or water for purposes of growth, performance, feed efficiency, etc. This class of drugs can only be used therapeutically in animal feed or water, that’s when animal health or sickness requires it.  In such cases the VFD rule requires veterinarians to authorize the use of animal drugs in feed or water only when a VCPR is in place and only when and if animal health requires it.  The VFD may allow some off-label use of drugs only when other options are not available and animal health requires it.

What does this mean?  There is concern about the development of microbial resistance to many antibiotics.  Many believe this is the result of overprescribing drugs, for both humans and animals, and concern that “superbugs” will result from sub-therapeutic levels in the feed and possibly infect humans; these bugs may not be affected by antibiotics (human or animal).  The VFD rule was enacted to strengthen and give more oversight to individual licensed veterinarians for the purpose of using antibiotics in the feed to treat actual disease conditions.

Beginning with the enactment of the FDA Antibiotic Rule (GFI-263) all antibiotics that are OTC will transition to prescription only from a licensed veterinarian and only when a VCPR is in place. Some of the drugs that will be restricted are penicillin, tylosin, tetracyclines, and sulfamethazine (calf boluses), and mastitis and dry-treat tubes (this is just a representative list, for more information go to https://www.fda.gov/animal-veterinary/antimicrobial-resistance/list-approved-new-animal-drug-applications-affected-gfi-263 or search for GFI-263 – FDA prohibited animal drug list).

Can these drugs still be used?  Of course, but they must be used as directed/recommended from your herd/flock veterinarian with a valid VCPR (when animals are sick, and health and well-being is at risk). (Veterinary-Client-Patient-Relationship) as described above.

There are drugs that are not prohibited, because they are used as animal drugs only, and not in human medicine.  These can still be used to enhance growth and feed efficiency.  Some approved drugs are listed below:

  • Ionophores (monensin (rumensin), lasalocid (Bovatec, etc.)

Other drugs that are not antimicrobials, for example:

  • Anthelmintics/Dewormers: Fenbendazole/Safeguard, Ivermectin, Prohibit/Levamisol
  • Coccidiostats: Amprolium (Corid), Decoquinate, Diclazuril

Drugs covered by the FDA Antibiotic Rule (GFI-263) are those that are used in both animal and human medicine.  They can no longer be used without veterinary oversight.  Only a veterinarian can legally authorize animal drugs for prescription, and then only after appropriate knowledge of the animals/farm  in question, with exam if needed, and when a proper relationship with the client (VCPR must be in place).

The FDA Antibiotics Rule should be seen as positive for the animal and food production industries and may have important effects on human health.  Additionally, it will allow more targeted antibiotic treatment, so animals that need treatment get it and those that don’t need antimicrobial therapy are not treated unnecessarily. American farmers are innovative, and levels of management are always improving.  This rule will allow producers to improve management and disease prevention and reduce reliance on antibiotics.

For more information please go to the FDA website https://www.fda.gov/animal-veterinary/antimicrobial-resistance/gfi-263-frequently-asked-questions-farmers-and-ranchers and search the Frequently Asked Questions; also please go to https://dairy.osu.edu/newsletter/buckeye-dairy-news/volume-25-issue-1/over-counter-antibiotics-will-require-veterinary  for an excellent overview. On livestock VCPR details, please read: https://www.aabp.org/resources/aabp_guidelines/VCPRGuideline_032020.pdf

Please contact your veterinarian for assistance or the New Jersey Department of Agriculture Division of Animal Health (http://www.nj.gov/agriculture/divisions/ah/).  See also your local Rutgers Cooperative Extension Service office for information (https://njaes.rutgers.edu/county/)

United States Department of Agriculture (USDA) Changes to Audit Costs

USDA has just announced that proposed audit fees for the Harmonized and GAP/GHP audits will increase to $155 per hour. The average Harmonized Audit runs anywhere from 12 to 15 hours, GAP/GHP audits average 5 to 10 hours. The current fee is $132 per hour. For anyone who needs an audit try to schedule before October 1, 2023 when the new rates take effect.  For further information or discuss the proposed increases contact:  Melissa Bailey, Associate Administrator, AMS, USDA, Room 2036–S, 1400 Independence Ave. SW, Washington, DC 20250; telephone (202) 205–9356, or email melissa.bailey@usda.gov.

Fruit and Vegetable Grower Feedback Needed on Produce Safety Costs, Needs, and Barriers

Time is running out to give feedback. We would like to ensure that there is good representation from all types of growers across the country so please share this announcement across your grower networks. Below is a table summarizing response numbers by state so you can see how your state is represented.

 

The Produce Safety Alliance (PSA) Team and personnel from the Northeast Center to Advance Food Safety (NECAFS) at the University of Vermont would like to understand the costs and the barriers of beginning or expanding food safety practices on farms and in packinghouses to make educational materials more relevant to fruit and vegetable growers and packers. To do this, we have developed a survey to collect food safety information from fruit and vegetable growers across the country.

What are the Goals of this Survey?

To understand:

·        what steps growers have taken toward adopting food safety practices on their farm,

·        the costs of adopting food safety practices (both one-time and reoccurring), and

·        where growers have questions about food safety.

Why Should You Participate?

The detailed information that is provided will allow future educational materials to be tailored to specific challenges that growers are facing.

Who Should Participate?

We are looking for feedback from people involved in fruit and vegetable production and packing, including those who have and who have not adopted food safety practices. This survey should be completed by someone who has knowledge about the operation’s produce safety practices (e.g., equipment, finances, supplies, training, market distribution, third-party audits).

Participation is voluntary and anonymous. It will take 10 – 30 minutes to complete the survey, depending on the farms’ food safety practices.

By completing this survey, you can choose to be entered into a raffle to win a $75 prepaid credit card. Ten participants will randomly be selected to win. The raffle will be held when the survey closes, approximately June 1st. If selected, you will be contacted to confirm your mailing address and acknowledge acceptance of the $75 prepaid credit card.

Direct link to the English-language survey: https://qualtrics.uvm.edu/jfe/form/SV_agW9o6VWOUCivCC

Direct link to the Spanish-language survey: https://qualtrics.uvm.edu/jfe/form/SV_agW9o6VWOUCivCC?Q_Language=ES

Application for Cost-Share Grant Funding for Installation of Deer Fencing on UNPRESERVED Farmland – Out NOW

“The NJDA Deer Fencing Program makes cost-sharing funding available for the installation of deer fencing on unpreserved farms. The program is conducted in accordance with N.J.S.A 4:40-6.1.”

Please click here for the full application, eligibility, and other important information

Timing is important if considering this program. NJDA began accepting applications on 5/15/23.

 

Your Input Needed on Preharvest Water use in Produce

Do you irrigate produce?Survey link
Have questions about Subpart E or agricultural water?

The On-Farm Food Safety Team is involved in a national survey to find out:

  • Does the produce industry understand the rule?
  • What areas of the rule are still unclear to the industry.
  • How preharvest water is used and treated on farms across the U.S.

This survey will help us get a better understanding of what you know and how extension educators can assist the industry. Please take a few minutes and fill out the survey by clicking on the image to the right.

Free webinar – Retraining and Upskilling Workers on Produce Safety Best Practices

Did you know that well trained employees have a higher job satisfaction and feel more valued by their employer? Employees satisfied with job training are more committed to their employers and more willing to accept organization goals and values. This is a key component in creating a food safety culture on your farm. Well trained, committed employees are less likely to look for another job, reducing employee turnover on the farm and the turnover costs associated with having to find new employees.

Growers leave training courses with a lot of information, the majority of which needs to be taught to your employees. You are sent home with food safety educational tools such as handouts, knowledge, and binders, but are not given guidance on how to use these resources to train your employees. This webinar will help.

Join us on Wednesday, April 12, 2023 to talk about tips to train employees at our free lunchtime webinar Retraining and Upskilling Workers on Produce Safety Best Practices from 12 – 1pm Eastern Time.

This webinar will feature Phil Tocco, Extension Educator at Michigan State University Extension.

At the end of the webinar participants will:

  • Understand how to verify training is working.
  • Discern what training is required for different employees.
  • Develop a process for training folks on your farm.

You can register for the webinar at this link: Webinar: Retraining and Upskilling Workers on Produce Safety Best Practices