Rules for Antimicrobial Drug Use in Food Animals

IMG_2278On October 1, 2015, United States Food and Drug Administration (FDA) rules changed for the use of certain antimicrobial drugs (antibiotics) commonly used in livestock production.

Craig Lewis, DVM, MPH, DACVPM, Veterinary Medical Officer, Office of the Center Director Center for Veterinary Medicine at the FDA said, “Any antimicrobial use can lead to resistance.” He urged producers to take steps now to mitigate risks of increasing the number of antibiotic-resistant bacteria in our food supply to protect human and animal health.

With a focus on public health and food security, the FDA issued a Guidance for Industry # 209 “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals” which aims to limit medically important antibiotic drugs to theraputic purposes necessary for animal health. The guide also calls for veterinary oversight or consultation for antibiotic therapeutic use in food-producing animals.

In the FDA’s Guidance for Industry # 213, manufacturers of antimicrobial drugs delivered in livestock feed or water are requested to adjust their product labels by December 2016, voluntarily. Manufacturers are asked to remove uses to “increase rate of weight gain” or “improve feed efficiency.” These production uses will no longer be legal after the labels are changed. New antibiotic labels should only list therapeutic uses.

Off-label uses of drugs in or on animal feed or in water are already illegal.

Affected antibiotics currently used in medicated feeds include Aminoglycosides, Diaminopyrimidines, Hygromycin B, Linocosamides, Macrolides, Penicillins, Streptogramins, Sulfas and Tetracyclines. Drugs currently used in water that will be affected include Aminoglycosides, Linocosamides, Macrolides, Penicillins, Sulfas and Tetracyclines.

Drugs already requiring a prescription or VFD for judicious use include Avilamycin, Florfenicol, Tilmicosin or Rx-Tylosin. Ionophores, Bacitracin or Bambermycins and non-antibiotic drugs will not be affected.

A Veterinary Feed Directive (VFD) drug or combination of drugs is intended for use in or on animal feed under veterinary supervision. VFD drug or drug combination use is limited to that approved by the FDA’s Center for Veterinary Medicine’s (CVM) and subject to a valid VFD. Drug combinations are also subject to FDA CVM approval.

Veterinarians are legally responsible for ensuring their VFDs are complete and accurate. To be legal, the veterinarian must be licensed to practice and be operating within a valid Veterinarian Client Patient Relationship (VCPR). The VFD must state the:

  • Client/owner name, business or home address and phone number
  • Veterinarian’s name, address and phone number
  • Species and production class and approximate number of animals to be treated
  • The animals’ location
  • Date of the VFD issuance
  • Indication(s) being treated
  • Medication(s) name and dosage/treatment or feeding rate and withdrawal times
  • Expiration date of the VFD (maximum of 6 months)
  • Precautionary statements or special instructions as required
  • Affirmation of intent for combination – if the veterinarian is allowing combination of medications
  • Statement “The use of feed containing this VFD drug in a manner other than as directed (extra label use) is not permitted”
  • Veterinarian’s electronic or written signature

Veterinarians must keep their original VFDs for at least 2 years. Veterinarians can learn more about their responsibilities at www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455416.htm.

Nathan Hubbard of Agfinity, Inc. urged veterinarians and feed mills/distributors to educate their clients on how the new VFD rules may affect their operation and their customers’ responsibilities. Educate customers via group meetings, brochures and your website. Do not wait until January 2017.

Veterinarians, producers and feed mills/distributors must carefully review and verify VFDs for completeness and accuracy.  By law, a feed mill/distributor cannot fill an incomplete or inaccurate VFD. Feed mills/distributors must keep their copy of the VFDs for at least 2 years. VFD medicated feed must be properly labeled with all the required VFD information. Feed mills/distributors selling or shipping VFD medicated products to other distributors must first obtain an acknowledgment letter from the recipient distributor.  .

In case of a state or FDA inspection, Hubbard recommends veterinarians’, feed mills/distributors’ and producers’ VFD records be organized and easily accessible. Some states require record archiving beyond the Federal minimum of 2 years. Producers can learn about their legal obligations at www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455413.htm. The FDA and CVM are currently working with State and local officials, veterinarians, industry leaders and experts, feed mills/distributors and the public to help ensure a smooth and seamless transition under the new Rule.

Some treatment courses may require two VFDs to complete treatment. For treatment duration and permitted refills, see www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/MedicatedFeed/BlueBirdLabels/default.htm

Not all medicated feeds will require a VFD, even after Guidance # 213 is fully implemented (target of January 2017). There are a number of non-antibiotic medicated feeds. There are also feed with antibiotics, which not deemed “medically important” in humans.

Producers must only feed VFD medicated feeds with a valid VFD and follow VFD instructions exactly. Do not transfer medicated feed to other animals, animal types or feed past the VFD expiration date. Be sure to follow withdrawal periods before processing. Do not mix medicated feed with other feed unless authorized in the VFD. Keep VFD records at least 2 years and have records available for possible inspection.

Producers do not have to take delivery of all medicated feed at once. Keep records to allocate multiple medicated feed shipments to a single VFD. If the number of animals drops and medicated feed is left over after the VFD period, the producer should discuss with their veterinarian whether they are allowed to continue feeding (under a new VFD) or wait for new symptoms to warrant medicated feed.

www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/MedicatedFeed/default.htm.

Veterinarians must specifically prohibit substitution with a generic drug on their VFD or feed mills/distributors may substitute a generic version of the VFD specified drug. Most OTC drugs transitioning to VFDs have generic counterparts.

Veterinarians do not have to personally administer every drug to every animal. Veterinarians must maintain a good Veterinarian Client Patient Relationship (VCPR) with producers and their livestock. Veterinarians writing VFDs must have sufficient knowledge of patients via:

  • Patient exam or familiarity with the production site and management team though past visits
  • Engage with clients and assume responsibility for decision-making on patient health
  • Provide follow-up evaluation or care as needed

Many states have formal requirements for VCPR. The federal definition will guide states without their own definition. VCPR guidelines may be inconsistent across state lines. This could challenge producers working in multiple states or selling across state lines.

View the FDA Guidance for Industry # 120 “Guidance for Industry Veterinary Feed Directive Regulation” at www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm464633.htm

Kevin Ochsner of the Adayana Agribusiness Group summarized the initial findings from the Farm Foundation’s survey on the impact of these new FDA rules. There are nearly an equal number of respondents who believe these changes will have a positive impact on the livestock industry as those who believe the new policy will negatively influence the livestock industry.  Some respondents said antibiotic use has been a crutch and believe this change will encourage more emphasis on stockmanship, stewardship and preventative medicine.  Other respondents predicted increased animal disease and death and ultimately, higher food prices for consumers. Two thirds of the 30 responding producers said the new rules would drive significant changes in their livestock management.

The biggest impact most respondants anticipate is the increased paperwork involved with VFDs. All stakeholders see a need for more producer, distributor and veterinarian education.

Some producers complained about additional paperwork with VFDs. They asked who would be responsible for producer, distributor and veterinarian education.

A workshop called “Stewardship of Medically-Important Antimicrobial Drug Use in Food Animals: Understanding the FDA Guidances and Veterinary Feed Directive” was held in Denver, Colorado on September 28, 2015. View the recorded workshop at http://livestream.com/BarnMedia/events/4339142. Learn more about the Farm Foundation’s workshop series at http://farmfoundation.org/webcontent/Stewardship-of-medically-important-antimicrobial-drug-use-in-food-animals-1901.aspx.

A similar story ran in Country Folks.

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Boost sales at fall farmers markets

Christine Bourque of Blue Heron Farm. Even in the early part of the season it is important to create a visual sense of abundance in the display. Photo by Mary Peabody

Christine Bourque of Blue Heron Farm. Even in the early part of the season it is important to create a visual sense of abundance in the display. Photo by Mary Peabody, UVM Extension

As days grow shorter and nights grow cooler (maybe), many growers see their largest harvests of the year. Be sure to sell that bountiful harvest at its freshest. UVM Extension’s Mary Peabody, Director of the Women’s Agricultural Network and UVM Extension Specialist in Community Resources and Economic Development offers growers these useful tools to liven up their market booths, draw in customers and boost sales.

  • Wow! Factor – Eye-catching displays – attract customers and customers attract more customers – to see what attracted the first folks.
  • Abundance – Full baskets are more appealing, refill stock throughout the market and switch to smaller baskets when you get close to running out. Use shallow baskets or fill basket bottoms with a shallow box. Displaying a single layer of tender produce will reduce bruising or spoilage. Unless you are trying to sell baskets, focus your display on produce or value added products.
  • Reduce clutter – use simple boxes or baskets and a streamlined booth layout. Take weekly booth photos when you open up. Ask a trusted friend for suggestions.
  • Weatherproof Design – Set your display table beck from the edge of your tent to offer shoppers shade or shelter from sun or rain.
  • Customer-Friendly Space – Place cash register and scale at the side of your booth so that a queue to pay will not block your next group of shoppers. Leave space next to the register for people to put down their purse or write a check.
  • Speedy Checkout – Have a helper to bag purchase to speed check out and shorten queues.
  • 3-D Displays – Keep bestselling items between waist height and eye level. People do not like to bend over or may miss lower items. Simple, durable wooden racks can display multiple product sizes. Be sure upright displays are stable at windy outdoor markets.
  • Clear Labeling – Invest in waterproof name label for every item you plan to sell. Print the produce or product name in a simple, clear font; do not include a price. Use a wipe-off marker for to add prices. Label every basket or container. Signs should be readable from 3 – 5 feet away.
  • Educate – Offer recipes, samples or pairing suggestions. Many people are embarrassed to admit they do not know what some vegetables are or how to use them. Laminate signs with your farm story photos as well as basic product information.
  • Be Friendly – Shoppers go to farmers markets to build relationships with farmers. Stay off the phone and smile.
  • Stand Out – Wear your farm logo on an apron, t-shirt, jacket of hat so customers can identify you and your staff.
  • Great Employees – Train staff with your farm story and generous customer service skills.
  • Complementary Colors – Displays should focus on your products. Select solid muted colors for tablecloths, tent covers, banners and signs to complement your product offerings. Neutral earth tones complement food products. Skip the bright colors or wild prints.
  • Ready-to-Go – Have some bundled, priced packages ready for rushed shoppers. Offer recipe kits with produce and herbs: cut-up veggies for a stir-fry, chopped soup veggies or a salsa package. If you offer flowers, try having a few pre-made bouquets.
  • Packaging – Wrap up purchases so they arrive at customers’ homes in good condition.
  • Keep Things Working – Stock and always bring your spare parts kit with markers, tape, string, scissors, napkins/tissue and register tape.

Other important tips for farmer market vendors include:

  • Calibrate scales regularly
  • Keep a file of fun farm photos for your market displays, emails and social media
  • Keep a folder of great seasonal recipes to share with market customers. Take photos of your delicious creations to post with recipes.
  • Keep a notebook with frequently asked questions. Consider posting the FAQs on your website or a poster at your market booth.
  • Create produce care tips (storage temperatures, preparation tips or cooking times)
  • Check over market displays regularly. Repair any broken items; repaint any chipped areas. Wash or replace stained, damaged or worn banners, signs, tarps, baskets/boxes and storage bins. Wash market vehicles regularly.
  • Learn about local health codes concerning samples at farmers markets. If allowed, offer produce samples to boost sales.
  • Treat every customer graciously, no matter how tired you may be at the end of the day.
  • Review your booth layout to avoid overcrowding with huge harvest come in. customers need ample “personal space” and want to avoid tipping things over.
  • Special scents can draw in customers. Consider growing and offering herbs or selling fresh-baked goods. If you grow apples, consider a steaming crock-pot with mulled cider.
  • Accept credit cards or decide to accept personal checks. Many customers do not carry much cash.
  • Think back over the season so far, what display elements brought in the most sales, and which ones were disappointing. Consider display updates for the rest of the season.

There are many helpful resources available on-line for farmers value added producers:

Learn more about the Women’s Agricultural Network at uvm.edu/wagn. Subscribe to their enews or send a question to wagn@uvm.edu.  Contact Mary Peabody, Director of the Women’s Agricultural Network, as well as the UVM Extension Specialist in Community Resources and Economic Development, via email to mary.peabody@uvm.edu or call to (802) 223-2389 x13.

A similar story ran in the October 19, 2015 New England edition of Country Folks.

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Increase soil fertility by adding chickens in field rotations

About 100 Black Australorp chickens at Big Train Farm in Cranston, RI.

Black Australorp chickens at Big Train Farm in Cranston, RI.

Building soil fertility and organic matter is a standard practice in organic agriculture. Organic farmers count on healthy soils to increase crop yields and crop quality as well as their farm’s long-term sustainability. Farmers build soil fertility by feeding soil organisms, often by spreading composted animal manures. Efficient farmers encourage their livestock to spread and incorporate their own manure for speedy incorporation. Chickens can produce 1/4 pound of manure every day.

Crop planning accommodates appropriate “days to harvest” or waiting periods to allow fresh manure to break down. Farmers must wait 120 days for root crops or ready-to-eat crops like fennel and greens. A 90-day period is sufficient for crops without soil contact like broccoli or tomatoes.

Moving livestock regularly prevents destruction of soil structure and protects against overloading soils with potassium or nitrogen from too much manure in one place. Allowing chickens to scratch and peck at crop residues and weeds helps incorporate the manure, minimize Nitrogen loss through volatilization and prepare fields for future planting.

John Kenny of Big Train Farm in Cranston, RI uses his 100 Black Australorp as part of a four-step field management process. [Learn more here.]

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Food System Solutions in New England

Christoph Hinske and the Institute for Strategic Clarity will map New England’s regional food system.

Christoph Hinske of the Institute for Strategic Clarity will map New England’s Food System

According to many American food system workers and consumers, our food system is broken.

Organic farmer Diana Kushner of Arcadian Fields Farm in Hope Valley, RI explains it this way: “1) Local … food does not cost too much, industrial food with all of its hidden environmental and social costs (think slave labor and the plight of migrant workers) is too cheap. (2) Subsidies to corn and soy make [processed] food cheap.”

Field laborers, food processors and restaurant workers do not often receive living wages. New American Farmers (formerly known as migrant workers), typically earn so little they cannot afford to live where they work or purchase the food they produce. Food processors may work in dangerous production facilities with minimal safety training. Restaurant workers rarely havepaid sick leave. They risk being fired to stay home from work to care for a sick child or other family member. Many of the poorest workers fear reprisals, losing their jobs or becoming blacklisted if they complain. Worker advocacy groups offer these workers a voice.

[Read more here.]

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Sustainable production leads to success at Little River Farm

Bob Payne and Camille Abdel-Nabi in the bentwood greenhouse they built at Little River Farm.

Bob Payne and Camille Abdel-Nabi in the bentwood greenhouse they built at Little River Farm.

How many young farmers met their financial goals during their first year in business?

Bob Payne and Camille Abdel-Nabi started their 3-acre farm with solid training and experience in organic growing, high energy and a good business plan. Bob has an agricultural degree from University of Natural Resources and Life Sciences or Universität für Bodenkultur Wien (BOKU) in Vienna, Austria. He worked as a farmhand at Greenview Farm in Wakefield, RI. Camille met Bob while an apprentice at Greenview Farm. The couple praised the hands-on organic production, marketing and sales training from Greenview Farm’s owners, Craig and Emily Totten. Bob and Camille pass along these lessons to their farm apprentice at Little River Farm.

Founded in 2013, Little River Farm is a 3-acre vegetable farm. Farm owners use organic and sustainable practices to grow a broad variety of greens, herbs and vegetables. Bob and Camille’s favorites are arugula, mesclun greens, root vegetables, heirloom tomatoes and peppers. Little River Farm sells through a 40-member CSA, two farmers markets and a spring Market Garden Festival. The farm also sells wholesale to food cooperatives and restaurants.

Learn about this farm’s intensive planting, season extension tools and custom-built, bentwood greenhouse here.

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Terroir matters at Oxbow Brewing Company

Oxbow Brewing Co.

Oxbow Brewing Company

The Oxbow Brewing Company motto is “loud beer from a quiet place.” Local yeasts and bacteria influence many of their beers. Local fruit and honey will influence future beers. Co-owner Tim Adams, Director of Brewing Operations at Oxbow Brewing Company, said their brewery brews uses well water at their farm in Newcastle, Maine.

Company marketing targets craft beers aficionados and as well as newbies, inviting them to enjoy Oxbow’s funky saison beers. Sales continue to grow across the Northeast, Baltimore and Philadelphia and selected cities in northern Europe. Increasing production demanded more and larger equipment, overflowing the brewers’ rural barn in just two years. In 2014, Adams and Co-founder, Geoff Masland added a second production site – a 10,000 square foot warehouse in Portland’s east end industrial park, about an hour from their brewing barn. The Portland site handles the brewery’s barrel aging, blending and bottling. The barn now hosts additional large steel tanks increasing their production capacity for draught beers.

The Portland site also houses a Tasting Room. Picnic tables and twinkling Christmas lights welcome visitors. Servers offer table service delivering beer and water. Learn more here.

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Building a Great Farm Team

Dave Hambleton of Sisters Hill Farm

Dave Hambleton of Sisters Hill Farm (photo provided by Sisters Hill Farm)

Good hiring decisions help farm owners/managers and farm workers build an efficient, productive and happy team. Where does a farmer find good employees? How should farmers select the right apprentices, farm workers or farm managers to build a successful farm team?

David Hambleton has been the farm manager of Sisters Hill Farm in Stanfordville, NY for 16 years. He shared his experience with hiring, training and managing over 30 Apprentices in a workshop at the 2015 Northeast Organic Farming Association of New York (NOFA-NY) Winter Conference.

Interviews are just a small part of the hiring process. Farmers must begin a search by posting openings where their ideal candidates will see the listings. See the sites Hambleton posts his openings and read about his screening and interviewing process [here.]

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