Stewardship of Antimicrobial Drug Use in Food Animals: Farmers Perspectives and Implementation Consideration - Constance Cullman, President, Farm Foundation, NFP, from the 2016 NIAA Antibiotic Symposium - Working Together For Better Solutions, November 1 - 3, 2016, Herndon, Virginia, USA.
More presentations at http://www.swinecast.com/2016-niaa-symposium-antibiotic-use-working-together-for-better-solutions
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Farm Foundation, NFP, works as a catalyst for sound public policy by providing
objective information to foster a deeper understanding of issues shaping the future for
agriculture, food systems and rural regions.
Since its founding in 1933, Farm Foundation has been a non-advocacy
organization. The Foundationâs action comes in bringing industry leaders together to
together to examine evolving issues that will shape the future, and identify options to
options to address those issues.
3. Why did Farm Foundation get involved?
An issue that has no boundaries â by species or geography
Agriculture committed to good stewardship
Access needed to comprehensive information to meeting new
policies
Farm Foundationâs unique reputation as an objective convener
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4. Guidance for Industry #209
âJudicious Use of Medically-Important Antimicrobial Drugs in Food-Producing Animalsâ
Animalsâ
Label changes required by Jan. 1, 2017
Guidance for Industry 213
âNew Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed
or Drinking Water of Foodâ
Takes full effect Jan. 1, 2017
Revised Veterinary Feed Directive Rule
Effective October 2015
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5. Farm Foundation Educational Workshops:
Public-Private Partnership: Farm Foundation, FDA, USDA
12 regional workshops â 530 attendees, as well as 300+ webcast veiwers
Target audiences:
⢠Livestock producers
⢠Veterinarians
⢠Feed Suppliers
⢠Support agencies and organizations, i.e. state and federal agencies, colleges
colleges of veterinary medicine, state departments of agriculture,
Cooperative Extension
Online survey â open to all interested parties, whether or not they attended
workshop
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6. Farm Foundation Approach and Methodology
Each workshop featured:
⢠Participation by senior FDA and USDA APHIS staff members
members
⢠Presentations by regional producers, veterinarians and feed
feed suppliers
⢠Significant time for discussion between participants, FDA and
and APHIS
FDA and APHIS left meetings with questions raised by workshop
workshop attendees. Workshop attendees left with
comprehensive overview of how policies will impact
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Anticipated Impacts on Livestock Industry
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8
12
17
19
20
25
30
0 5 10 15 20 25 30 35
Government Overstep
Inproved Food Supply/ Public Health
Increased Paperwork
Reduced Access to Antibiotics
Decreased Animal Health
Veterinarian Shortage
Increased Costs
Better Livestock Management
Improved Public Perception
Impacts on Industry
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Impact on Day-to-Day Business Activities
Increased
documentation/
paperwork - 20%
Higher cost - 9%
Decreased access
9%
Confusion/ need
for education
19%
Decreased animal
health- 9%
Other -5%
Lack of vets/
changing
relationship - 15%
No impact - 5%
Improved public
perception/
stewardship - 9%
10. Incentives, Disincentives for Research & Development of
New Antimicrobial Drugs and Alternatives to Antibiotics for
Food Animals
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Workshop organized by USDAâs Economic Research Service and Farm Foundation, NFP
More than 130 researchers, animal pharmaceutical manufacturers, health professionals
and government representatives participated.
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Next Steps:
⢠Need for more education and outreach
o Partnership with Animal Health Institute - focus on small
producers, who may not regularly use services of a
veterinarian
o These producers may raise small numbers of livestock, or keep
food-animals as pets
o NCBA/LMA reaching out to sale barns
o Information card, web site and radio interview series
13. Next steps
1) More education and outreach
2) Continuing dialogue between industry & state and federal regulators
⢠Important to support a continuing process of stewardship
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Continuing dialogue between industry & state and federal
regulators: Agreeing on Metrics
⢠After January 1 when implementation begins
⢠Looking to develop nationwide industry-agreed
upon metrics for measuring antibiotic use
⢠In partnership with key stakeholders -
researchers, foundations, retailors, etc.
15. Next steps
1) More education and outreach
2) Continuing dialogue between industry and state and federal
regulators
3) Access to veterinary services & the supply of food-animal
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In the depths of the Great Depression, our founders saw the need for a nonpartisan organization focused on the future of the nationâs agriculture and food systems.
Many of the issues have changed since our founding in 1933, but we remain committed to being an objective convener of public and private leaders seeking to understand the evolving issues shaping our future, and the options to address those issues.
In addition to its 83-year history of objectivity, the Foundation is unique in tackling issues that have no geography, crop or species boundaries, but which have the potential to significantly direct the future.
Stewardship of antimicrobial drug use is just such an issue.
In the depths of the Great Depression, our founders saw the need for a nonpartisan organization focused on the future of the nationâs agriculture and food systems.
Many of the issues have changed since our founding in 1933, but we remain committed to being an objective convener of public and private leaders seeking to understand the evolving issues shaping our future, and the options to address those issues.
In addition to its 83-year history of objectivity, the Foundation is unique in tackling issues that have no geography, crop or species boundaries, but which have the potential to significantly direct the future.
Stewardship of antimicrobial drug use is just such an issue.
The 530 workshop attendees directly influence the animal health decision of more than 3,000 producers and 2.6 million animals.
One of the benefits of this public private partnership was enhancing the dialogue between industry and federal regulators. Workshop participants identified as one of the most valuable elements of the workshop the direct interaction with FDA and USDA officials. FDA and APHIS left the meetings with questions raised. They responded to each of the questions and you can find the responses posted on the Farm Foundation website. The dialogue continuesâŚ
Survey respondents listed improved public perception and better livestock management at the two top industry impacts of the new policies. Those were followed by increased costs and concerns about animal health, including access to antibiotics and veterinary services.
In terms of day-to-day business activities, increased paperwork topped the list of anticipated impacts. A close second was the need for education to avoid confusion on what the new policies require. In third-anticipated changes in the relationship of vets and producers, as well as concern over the lack of veterinary services in some locales. Access to veterinary services is a particularly concern to farmers and ranchers who operate independently from large, integrated supply chains. Producers of small ruminants and other âminor speciesââsuch as deer, elk bison or honey bees, foresee reduced access to antibiotics as having a potentially large impact to their operations.
Farm industry and professional organizations, as well as federal and state agencies, agricultural media and Cooperative Extension are doing significant work to make producers aware of the changes.
Concerns remain that some small operationsâthe sundowner-type producers or the backyard chicken operationsâmay not be fully up to speed on the policy changes and the implications.
Cooperative Extension, with its responsibility for public education, and feed suppliers, who interact directly with farmers and ranchers on a daily basis, are especially important in closing the awareness gap and providing educational materials.
This March 2016 workshop was organized by USDAâs Economic Research Service and Farm Foundation, NFP
Items discussed to incentivize new products to reduce medically-important antibiotic use in livestock agriculture:
Establish which animal diseases should be targeted for incentives
Model the interaction of veterinary and human drug development to establish whether and what types of human drug R&D incentives can be utilized for veterinary products.
Analyze different types of government drug development incentive programs in the context of animal pharma to establish which are the most efficient and feasible specifically for veterinary products.
Most large livestock operations regularly use the services of a veterinarianâor may have a vet on staff. These operations are mostly likely up to speed on the new VFD rules.
Farm Foundationâs report highlighted concerns that smaller producersâfolks with smaller herds and flocks. This may include people who keep a few chickens in the backyard for egg production, or who food-producing animals as petsâyes rabbits are food animals, even if they are pets. These small producers may not regularly use the services of a veterinarian, or be involved in species groups. These producers may not be aware of the changes that will take place on Jan. 1.
Two key points to reach these types of producers are sale barns and retail outlets. The National Cattlemenâs Beef Association and the Livestock Marketing Association have teamed to put informational posters in all sale barns alert folks the changes.
Farm Foundation and the Animal Health Institute are focusing their work on retail outlets.
We have developed this informational card to bring attention to the deadline. It can be used by retailer at point of sale or at the cash register. It can also be used by educatorsâExtension specialists, or organizationsâas a handout and meeting resourceâa tool producers can take with to remind them of the issue and how to prepare.
The card refers people to a new websiteâfarmfoundation.org/VFDrulesâwhich offers informational resource from a variety of sources.
We are working with cooperatives and retailers, such as Growmark, Land OâLakes and Rural King, to distribute the cards in their retail outlets and to promote the information resources in their newsletters and other communiques.
We are also making the cards available to Extension livestock specialists across the nation to use at their educational workshops this fall.
To complement this work, we are also doing a series of radio news reports, featuring different stakeholders with information on why the change is taking place and how producers need to prepare.
These interviews will include a veterinarian, a pharmaceutical manufacturer, an FDA official and a feed supplier. The first interview was with Joe Swedberg, who chairs our project advisory committee and is a retired executive of Hormel.
If you would like any more information about this effort, I would be happy to visit with you after our session today.
As noted previously, participants identified the direction interaction with FDA and USDA officials as one of the most elements of the workshops. That interaction generated unanswered questionsâthe resolution of which will strength outcomes.
Continuing this type of dialogue is critical not only to the successful implement of the these policies, but to help support a continuing process of stewardship.
DO NOT MENTION THE SPECIFIC DATE!!!
Near-term, state & federal officials need to work with colleges of veterinary medicine and professional veterinary organizations to quickly develop options to provide access to veterinary services to small producers in underserved areas. Long-term, part of the solution will be efforts by colleges of veterinary medicine to increase the number of veterinarians with economically-sustainable food-animal. There may also be opportunities for other stakeholdersâincluding feed suppliers, Cooperative Extension and state regulatory authoritiesâto explore new models of delivering veterinary services in underserved areas.
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Some of the most difficult challenges will be meeting needs of producers raising other species, including small ruminants, deer, elk, bison, fish and other so-called âminor species.â Few products are approved for use in these species, which risk becoming âorphan indicationsâ due to the limited market size. FDA and the pharmaceutical industry along with industry groups will need to seek solutions to these challenges.