Report
Pork Checkoff
May/June 2015 • VOL. 11 NO. 3
Newsletter
Antibiotic Changes:
18 months and Counting
B
y the end of 2016, the U.S. Food and Drug Administration will implement a new policy aimed at on-farm use
of antibiotics in food-animal production. The agency’s
goal is to work with the production sector to eliminate the
use of medically important (to human illness) antibiotics for
growth promotion and to bring therapeutic use – to treat,
control or prevent specific disease – under veterinary oversight. Pork producers should be taking steps now to prepare
for the changes.
“Antibiotics aren’t going away, but on-farm use
will change. Producers should sit down with their
veterinarians to discuss how to apply veterinary
feed directives and other herd-health strategies.”
– Jennifer Koeman, DVM, Pork Checkoff
“That sounds like a long way off, but producers need
to start getting ready,” said Jennifer Koeman, DVM, Pork
Checkoff’s director of producer and public health. “Antibiotics aren’t going away, but on-farm use will change. Producers should sit down with their veterinarians to discuss
how to apply veterinary feed directives (VFDs) and other
herd-health strategies.”
At the centerpiece of FDA’s policy are 283 products that
will be added to the VFD list, said Bill Flynn, DVM, deputy
director for science policy at FDA’s Center for Veterinary
Medicine. Over-the-counter sales of these products will be
eliminated, and their use will require veterinary oversight
and diagnosis for a specific animal health condition. Producers will need a VFD to gain access to the affected feed-based
antibiotics and a prescription for water-based products.
“The action focuses on antibiotics approved prior to 2003
and the need to bring them up to today’s standard,” Flynn
said. “It’s a very substantial change to the landscape of products that will be handled under the VFD framework. We’re
talking about individual products, combinations, generics –
products that have been around for 40 years.”
FDA is relying on stakeholder collaboration (drug
companies, veterinarians, producers and the feed milling
sector) to move the action forward. All 26 companies that
market drugs to the pork industry have provided a written
commitment to make product and label changes, removing
production claims and requiring veterinary oversight by the
December 2016 deadline.
The National Pork Board, the National Pork Producers
Council (NPPC) and American Association of Swine Veterinarians (AASV) are working to help producers and veterinarians implement FDA’s directive.
Record Keeping Is Critical
Producers, veterinarians and
feed processors will need to be
especially diligent in keeping
records associated with VFDs and
©2015 National Pork Board, Des Moines, IA USA. This message funded by America’s Pork Checkoff Program.
continued on page 2
FDA Moves Forward
on Antibiotic Guidance
The U.S. Food and Drug Administration (FDA) is taking a
new approach on the judicious use of medically important
(to treat human illness) antibiotics in food-animal production. It involves voluntary cooperation by all sectors.
Here’s a snapshot of FDA’s time line to implement these
changes.
Guidance 209: In 2010, FDA outlined its intent and recommendations regarding growth promotion uses of medically important antibiotics in food-animal production. This action applies to both feed-grade
and water-based antibiotics. FDA also specified that veterinarian
oversight will increase for the remaining therapeutic applications (prevention, treatment and control) of medically important antibiotics.
Guidance 213: On Dec. 11, 2013, FDA initiated a three-year
transition process to complete its food-animal antibiotic strategy. This
action requests animal-health companies to outline intentions to voluntarily remove any production/growth-promotion uses from product
labels of medically important antibiotics. The guidance also eliminates
over-the-counter status of these medications and increases veterinary oversight for on-farm therapeutic use by requiring a veterinarian
feed directive (VFD) for feed applications and a prescription for water
treatments. December 2016 is the deadline for this guidance to be
completed and implementation to begin.
Proposed VFD Rule: On March 12, 2013, FDA concluded the
comment period on its proposed VFD rule. According to the agency,
the final rule outlining specific details of the VFD process for feedgrade antibiotics and the regulatory foundation is expected to be
released sometime this spring (2015).
Compounds Not Included: Antibiotics of interest to pork producers that will not be affected by FDA’s new policy include bacitracin,
tiamulin, carbadox, bambermycin and narasin. For a list of affected
products, go to http://www.pork.org/antibiotics.
continued from page 1
prescription antibiotic use once the new policy rule goes into
effect. Fortunately, records associated with Pork Quality
Assurance® Plus (PQA Plus®) certification already have this
covered.
“But producers don’t always keep all of the data today that
will be required in the future, so improving on that will be a
priority,” said Liz Wagstrom, DVM, chief veterinarian with
NPPC. “There also will be interest in measuring how FDA’s
policy is impacting antibiotic usage on the farm. That will be
an ongoing discussion – what to measure, whom to collect
data from and how to analyze and report it.”
Meanwhile, Flynn added that FDA plans to release progress reports on its Judicious Use Strategy every six months
(likely in June and December).
Veterinar y Oversight, Research Priorities Are Key
The reality of FDA’s proposed changes is that producers
will have to have more interaction with veterinarians. However, that’s a net positive on many levels.
“Maintaining a close working relationship with a veterinarian who is knowledgeable about pork production can benefit
producers in many ways,” said Harry Snelson, DVM, communications director for AASV. “Judicious use of antibiotics is
just one part of an overall herd-health management plan. Veterinarians can help design herd-health and production plans
that strive to decrease disease, enhance performance and
produce safe, wholesome pork for the global market.”
Aside from increasing veterinary interaction, the quest for
responsible antibiotic use involves honing research priorities. Earlier this spring, the White House released a fiveyear, $1.2 billion action plan to address antibiotic resistance,
including human and animal applications, and to guide
public health and healthcare professionals. The plan cited
additional research and the development of new antibiotics,
therapies and vaccines among its goals.
The pork industry welcomes this approach to the antibiotics issue. “Our industry pledges to go beyond simply
complying with federal guidance,” said Chris Hodges, National Pork Board chief executive officer. “U.S. pig farmers
are committed to continuous improvements to produce safe,
PQA® Plus Provides
Foundation for Antibiotic Use
“U.S. pig farmers are committed to continuous
improvements to produce safe, wholesome
pork in a socially responsible way. Antibiotics are
just one piece of a much broader plan that our
farmers use to keep their animals healthy.”
– Chris Hodges, National Pork Board CEO
wholesome pork in a socially responsible way. Antibiotics are
just one piece of a much broader plan that our farmers use to
keep their animals healthy.”
For decades, the pork industry has been a leader in directing and funding antibiotic research, from the causes and
transmission of antibiotic resistance to identifying alternative
products or practices to help minimize antibiotic use. The
Pork Checkoff also shares related information and research
with U.S. retailers and foodservice companies.
“Collaboration across our industry, from the farms to the
dinner table is critical,” Hodges said. “Sharing information
underscores the safeguards already in place for antibiotic
use in pork production and illustrates our focus on improving pork’s safety, quality and nutritional value, a priority on
which producers, retailers and consumers can all agree.”
To get the best handle on the basics of antibiotic use and
compliance, producers should turn to what they already
know and rely on – the Pork Checkoff’s Pork Quality Assurance® Plus (PQA Plus®) program. Together with consultation
with their herd veterinarians, producers should be able to
navigate the changes coming from the U.S. Food and Drug
Administration’s (FDA) new antibiotic use guidelines and the
expansion of the veterinary feed directive (VFD) rule.
Today, more than 60,000 producers have completed the
PQA Plus on-farm education and certification program. All
major packers require producers to participate in the program before they will purchase their market hogs.
The program’s Good Production Practices continue to
provide the basic platform for pork producers and their employees to ensure responsible antibiotic use on the farm day
in and day out.
“PQA Plus outlines the principles of responsible antibiotic
use,” said Jennifer Koeman, DVM, director of producer and
public health for the Pork Checkoff. “Producers have a long
history of using antibiotics responsibly. With the PQA Plus
principles already in place, we are well in line with the new
FDA strategy.”
Antibiotic Principles of PQA Plus
Principle I: Take appropriate steps to decrease the
need for the application of antibiotics.
Principle 2: Assess the advantages and
disadvantages of all uses of antibiotics.
Principle 3: Use antibiotics only when they will
provide measurable benefits.
Principle 4: Fully implement management
practices described for responsible use of animal
health products into daily operations.
Principle 5: Have a working veterinarian/client/
patient relationship and follow the responsible
antibiotic use guidelines.
Q&A
Expanding the Herd-Health
Partnership with Your Vet
Veterinarians have always
played an important role in
managing herd health, but
with the Food and Drug
Administration’s (FDA) new
antibiotic policy, that partnership will become even more
critical. All producers, whether
Harry Snelson, DVM
they have one pig or 100,000,
will need veterinary oversight
to obtain certain feed-grade and water antibiotics to
prevent, treat or control a diagnosed swine illness.
“FDA’s intent is to increase veterinary oversight
and involvement in determining when and how
antibiotics will be used on the farm,” said Harry
Snelson, DVM, director of communications for
the American Association of Swine Veterinarians
(AASV). “Veterinarians will need to work with
their clients to address the impact of increased
restrictions on antibiotic use.”
Snelson offers additional perspectives on the
future producer/veterinarian partnership.
Q: With the FDA’s new antibiotic-use policy,
how will antimicrobial applications change
on the farm?
A: After 2016, pork producers will no longer be able to
purchase medically important feed-grade antibiotics
without a veterinary feed directive (VFD) written by a
licensed veterinarian. Related water-based antibiotics will require a prescription. Also, these products
will only be able to be used to prevent, control or
treat disease. Swine veterinarians and producers are
familiar with the VFD process given that the two current VFD products are both labeled for use in swine.
Q: What will be the swine veterinarian’s role?
A: Beyond overseeing VFD applications, veterinarians
will continue to work closely with their clients to ensure the ongoing judicious use of antibiotics. This will
include such tactics as designing herd-health strategies to minimize the use of antibiotics, as well as
performing diagnostics when necessary to prevent,
control and treat disease.
Q: How are veterinarians and the AASV preparing
for implementation of FDA’s new policy?
A: The AASV, the National Pork Board and National Pork
Producers Council have worked closely with the FDA to
understand how these changes will impact access to
antibiotics, as well as to make VFDs less cumbersome,
more efficient and user-friendly. We haven’t seen the
final VFD rule, but we don’t expect dramatic differences
from the process that we’re used to today. There will,
however, be changes to the number of products requiring
a VFD and perhaps the frequency with which VFDs will
need to be written. Because of this expectation, AASV
has conducted a number of outreach efforts to keep our
membership informed about the changes in antibiotic
access. We will conduct additional educational efforts
once the VFD rule is finalized.
Q: What should producers and veterinarians expect in terms of record keeping?
A: Like they say, “The job isn’t done until the paperwork is
finished.” Although the task of maintaining accurate and
complete records can be cumbersome, it’s a key aspect
of on-farm antibiotic use. The VFD has specific requirements about which records must be kept and by whom
(farmers, veterinarians and the medicated feed manufacturer) and for how long. The FDA may inspect the records
upon demand, so it’s important that all parties comply
with the guidelines. But beyond that, good record keeping is inherent in any antibiotic stewardship program and
forms the cornerstone of the Pork Quality Assurance®
Plus (PQA Plus®) program.
Q: What can producers do today to be prepared for
the upcoming changes?
A: It’s important that pork producers develop a relationship
with a veterinarian. Beyond prescribing drugs and issuing VFDs, the veterinarian can work with the producer
to develop strategies to minimize disease risk through
facility design, pig flows, vaccination protocols, herdhealth monitoring, disease surveillance and appropriate
diagnostics. Pork producers should work closely with
their veterinarian to understand the potential impact that
increased restrictions on medically important antibiotics might have on the herd. The veterinarian can provide
guidance on judicious antibiotic use and help ensure
compliance with the new guidelines and regulations.
It’s Not Too Early to Begin to Prepare
Preparation is key to success for most tasks, and that
holds true for a smooth implementation of new antibiotic-use
guidelines on the farm. Paul Ruen, a swine veterinarian at the
Fairmont Veterinary Clinic, Fairmont, Minnesota, and his
colleagues are working now to get their clients prepared.
“We have addressed antibiotic use and upcoming changes
in our client education seminars and small group manager
training sessions,” Ruen said. “We follow through with oneon-one education during farm visits and as the need to treat
animals arises.”
The clinic’s regular herd-health/management reports sent
to clients include additional antibiotic use guidance.
“Our swine care principles have always incorporated
timely use of diagnostics to direct the best medical care for
food safety, animal health and well-being,” he added. “Documenting that connection is a positive outcome for animal
agriculture.”
As a producer, Brad Greenway of Mitchell, South Dakota,
has already started to refine and implement production practices to further reduce the need for antibiotics. Biosecurity
measures lead the list, together with a revitalized vaccination
program for his pigs.
“We’re using more vaccines today, which keeps pigs
healthy and reduces the need for antibiotics,” Greenway said.
“We’re using more vaccines today, which in turn
should help keep pigs healthy and reduce the
need for antibiotics.”
– Brad Greenway, a South Dakota pork producer
Greenway mills his own feed and has added a probiotic
to enhance gut health for his pigs. Monitoring the animals’
environment and keeping pigs comfortable also is on his
daily list.
“All of those things added together make a difference in
herd health,” he said.
Ruen said making changes has always been a part of the
equation with raising pigs.
“Farming is a competitive business, and I see producers
who are making decisions every day to improve their operations,” Ruen said. “Change brings with it both challenges and
opportunities. Those with the right attitude, team members
and information will continue to improve and enjoy success.”
FOUR Steps to Take Today
According to Paul Ruen, a swine
veterinarian at the Fairmont Veterinary Clinic in Minnesota and former
AASV president, “Most producers
already work closely with their veterinarian to achieve proper decisions and use of antibiotics when
needed to ensure healthy pigs and
safe food, but there will be some individuals – producers and veterinarians both – that will need to get on
board as changes come into play.”
Here are Ruen’s recommended steps to initiate today:
• Secure a good working relationship with your herd veterinarian
and build familiarity with your production system.
• Sit down with your veterinarian to evaluate all animal-health
management protocols and herd vaccination programs. Review
all swine medications currently being used within the operation.
• Discuss which products are affected by veterinary feed directives
and prescriptions and how the process will work on the farm.
• Walk through the record-keeping requirements and strategies.
Management Strategies to Enhance Judicious Use
W
hen it comes to raising healthy, productive
pigs and ultimately producing safe, nutritious
pork, management holds the key. There
certainly is a long list of factors that fall under the management umbrella, but they also present opportunity. A
tweak here or there can go a long way to enhance the
judicious use of antibiotics.
“Antibiotics are an important tool to ensure animal
health and well-being, and that won’t change with the
FDA’s antibiotic guidance,” said Lisa Becton, DVM,
swine health information and research director for
the Pork Checkoff. “There will be tighter restrictions
for use of medically important antibiotics on the farm,
but they will still be available to prevent, treat and
control diagnosed health issues with the guidance of a
licensed veterinarian.”
Becton offers these strategies to boost herd health and minimize the need for antibiotics on the farm:
Biosecurity – Prevent diseases by controlling traffic of pigs, people, vehicles and other
items that can carry diseases into a herd, such as boots, coveralls and supplies. • Apply all-in/all-out pig flow, preferably by site, but at least by room. See that workers honor
this flow in their daily movements.
• Thoroughly clean, disinfect and heat/dry facilities or rooms between pig groups. This includes
feeders, waterers and all other equipment.
• Never commingle pigs of different ages and sources among sites. Also limit commingling
within a site as much as possible.
Vaccinations – Successful vaccination depends on applying the right dosage at the right
time for the right health concern.
• Use diagnostics to confirm health issues.
• A vaccination program customized to your herd can help control and prevent disease.
• Never shortchange the process; always follow label instructions for the vaccine.
• Store and handle vaccines correctly to ensure viability.
Nutrition and the housing environment present other avenues that can influence pig health and potential
antibiotic use. Chris Hostetler, the Pork Checkoff’s director of animal science, offers these options to consider.
Feed additives – So far, no antimicrobial alternative has proven as universally effective as
antibiotics alone. Evaluate each alternative for the pathogen and application in question.
• Acidifiers, probiotics, essential oils may be options.
• Active proteins may help in young animals.
• Zinc and copper, which have antimicrobial properties, may be considered for swine.
Housing – Provide the proper environment for the animals’ age, weight and stocking density.
• Wean pigs at 21 to 28 days of age, sending heavier, more robust pigs on to the growing phase.
Older pigs require less medication or specialized diets, which also reduces production costs.
• Eliminate drafts and manage barn temperatures to meet pigs’ changing needs.
• Adjust ventilation to manage gases and humidity levels and to provide fresh air.
Inside: Pork industry prepares for changes in antibiotic use.
National Pork Board • P.O. Box 9114 • Des Moines, IA 50306
Adapt and Move Forward
“Pork producers
have a long history
of using antibiotics
properly. Still,
there’s always room
for improvement.”
Brad Greenway, Mitchell,
South Dakota
The Food and Drug Administration’s (FDA) new policy for on-farm use of medically
important antibiotics is scheduled to begin in December 2016. There is still much to
understand and work through, but you shouldn’t wait to start preparing.
“Pork producers need to realize that growth promotion and subtherapeutic use of
medically important antibiotics will go away,” said Brad Greenway, a Mitchell, South
Dakota pork producer and National Pork Board member. “It won’t affect all antibiotics, but there will be changes in both feed and water medication for farms of all sizes.”
Greenway says producers will adapt and be well positioned to move forward, but
not without solid preparation. That means staying informed and learning how FDA’s
changes will affect production at the farm level so that strategies for success can be
put in place. He points to pork.org as a good place to get more information.
Once in place, the new rule will mean that producers will have to work with their
veterinarians even more closely on things such as getting access to certain antibiotics
when needed to treat animals. He advises producers to strengthen their relationship
with their veterinarian now if needed and for those who don’t have a regular relationship with a veterinarian, start that process now.
Greenway also advises producers to document the antibiotics currently being using
and look for ways to strengthen herd-health records. Producers who have completed
a Pork Quality Assurance® Plus site assessment should be well-versed in the level of
detailed records that will be required, he said.
“The pork industry has always been proactive,” said Greenway. “Pork producers
have a long history of using antibiotics properly. Still, there’s always room for improvement, and all producers need to strive to keep getting better – something they’re very
familiar with doing.”
This special-topic newsletter is sent periodically to you by the Pork Checkoff.
Editor: Jan Jorgensen [email protected] • Contributing Editors: Marlys Miller, Mike King • Art Director: Beth Wonderlin