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1. FDA Regulation to Help Ensure Judicious Use of Antibiotics in Food-Producing Animals
Veterinary Feed Directive (VFD) final rule issued today
FDA Ctr. for Veterinary Medicine
June 2, 2015
The U.S. Food and Drug Administration announced today the Veterinary Feed Directive (VFD) final rule, an important piece of the agency's overall strategy to promote the judicious use of antimicrobials in food-producing animals. This strategy will bring the use of these drugs under veterinary supervision so that they are used only when necessary for assuring animal health. The VFD final rule outlines the process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed that require the supervision of a licensed veterinarian) and provides veterinarians in all states with a framework for authorizing the use of medically important antimicrobials in feed when needed for specific animal health purposes.
The VFD final rule continues to require veterinarians to issue all VFDs within the context of a veterinarian-client-patient relationship (VCPR) and specifies the key elements that define a VCPR. These key elements include that the veterinarian engage the client (i.e., animal producer or caretaker) to assume responsibility for making clinical judgments about patient (i.e., animal) health, have sufficient knowledge of the animal by conducting examinations and/or visits to the facility where the animal is managed, and provide for any necessary follow-up evaluation or care. The final rule will require veterinarians to follow state-defined VCPR requirements; in states where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians will need to issue VFDs in compliance with federally defined VCPR requirements. All veterinarians will need to adhere to a VCPR that includes the key elements in the final rule.
"The actions the FDA has taken to date represent important steps toward a fundamental change in how antimicrobials can be legally used in food-producing animals," said Michael R. Taylor, FDA deputy commissioner for foods. "The VFD final rule takes another important step by facilitating veterinary oversight in a way that allows for the flexibility needed to accommodate the diversity of circumstances that veterinarians encounter, while ensuring such oversight is conducted in accordance with nationally consistent principles."
In December 2013, the agency published a guidance document, which calls on animal drug manufacturers of approved medically important antimicrobials that are put into water or feed of food-producing animals to voluntarily stop labeling them as drugs that can be used to promote animal growth and change the labeling of their products for the remaining uses to require veterinary oversight of these drugs when they are used for therapeutic purposes. All of the affected makers of these drugs have committed in writing to participate in the strategy.
Full text: http://tinyurl.com/pmy37jh
See Also:
Veterinary Feed Directive [Final Rule]
Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)
Rules and Regulations
Pages 31707-31735
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13393]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 514 and 558
Docket No. FDA-2010-N-0155
RIN 0910-AG95
Veterinary Feed Directive
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA's current VFD regulation established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This amendment is intended to improve the efficiency of FDA's VFD program while protecting human and animal health.
DATES: This rule is effective October 1, 2015.
Full text:
http://www.gpo.gov/fdsys/pkg/FR-2015-06-03/html/2015-13393.htm
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Veterinary Feed Directive Regulation Questions and Answers; Draft Guidance for Industry; Availability
Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
Proposed Rules
Pages 31520-31521
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13394]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
Docket No. FDA-2010-N-0155
Veterinary Feed Directive Regulation Questions and Answers; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Draft revised guidance; availability.
Full text:
http://www.gpo.gov/fdsys/pkg/FR-2015-06-03/html/2015-13394.htm
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2. Obama Hosts Antibiotic-Resistance Summit To Curb Overuse: 5-Year Plan To Prevent 2 Million Infections A Year
By Susan Scutti
MedicalDaily.com
June 2, 2015
Convening today at the White House, the Forum on Antibiotic Stewardship brings together more than 150 representatives of companies, retailers, and human and animal health organizations committed to implementing changes over the next five years. The intention, as spelled out in President Obama's plan, is to reduce and conserve antibiotic use in order to slow the emergence of resistant bacteria and prevent the spread of resistant infections.
Every year two million people become ill and 23,000 people die when infected with antibiotic-resistant infections, estimates the Centers for Disease Control and Prevention (CDC). Such infections are caused by bacteria which have become immune to antibiotics due to overuse of these life-saving drugs in both animals and people. Prevention, the very first step in the war against antibiotic resistance, begins with hand hygiene.
The problem of antiobiotic resistance "affects every community and potentially every patient," stated Dr. Tom Frieden, head of CDC, in his remarks during the forum's introductory session. He added that attention to this problem is necessary, otherwise "we risk undermining our ability to care and to cure."
Intertwined Issues
Animal health is human health, noted Tom Vilsack, secretary of agriculture, in his forum address. Vilsack also stressed the need to develop new animal-only antibiotics in this "long and difficult battle" that cannot be waged alone. Other officials, including Amy Pope, the deputy Homeland Security advisor, noted the necessity of unified action and the creation of antibiotic alternatives.
Global animal health company Elanco, a division of Eli Lilly, immediately rose to this latter challenge. President Jeff Simmons said Elanco, which reported $2.15 billion in sales for fiscal year 2013, has redirected two-thirds of animal pharmaceuticals budget to discovering "non-antibiotic" alternatives, including vaccines, immune modulators, and enzymes.
Full text: http://tinyurl.com/on2wbgz
See Also:
FACT SHEET: Over 150 Animal and Health Stakeholders Join White House Effort to Combat Antibiotic Resistance
White House Press Release
June 2, 2015
As part of the continued effort to combat antibiotic resistance, today the Obama Administration is convening a "White House Forum on Antibiotic Stewardship" to bring together key human and animal health constituencies involved in antibiotic stewardship-the development, promotion, and implementation of activities to ensure the responsible use of antibiotics. As part of the event, more than 150 food companies, retailers, and human and animal health stakeholders will highlight commitments to implement changes over the next five years to slow the emergence of resistant bacteria and prevent the spread of resistant infections.
Full text: http://tinyurl.com/qahg72g
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3. New case of Equine Herpes Virus reported in Oregon
Oregon Dept. of Agriculture News Release
June 1, 2015
A new case of Equine Herpes Virus-1 (EHV-1) has been confirmed in Oregon over the weekend according to the Oregon Department of Agriculture. The 14-year old Quarter Horse gelding from Marion County is hospitalized at the Oregon State University College of Veterinary Medicine's Large Animal Hospital after being admitted for sudden onset of neurologic signs of the disease. The horse has tested positive for both the wild type and the more serious neuropathogenic form of EHV-1.
Despite other cases of EHV-1 in Oregon in recent weeks, this detection is being classified as a new case because of the length of time and lack of strong epidemiological links to previous EHV-1 instances. The affected horse has not travelled or attended any shows or events for at least four months. The stable has been quarantined and all horses involved remain under active observation by owners and their veterinarians for clinical signs of disease.
Six of the eight quarantines associated with the previous EHV-1 cases have been released and two are pending.
Full text:
http://odanews.wpengine.com/new-case-of-equine-herpes-virus-reported-in-oregon/
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4. USDA Confirms More Highly Pathogenic H5N2 Avian Influenza in Five Flocks in South Dakota, Minnesota, and Iowa
USDA Animal and Plant Health Inspection Service Bulletin
June 2, 2015
WASHINGTON - The United States Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) has confirmed the presence of highly pathogenic H5N2 avian influenza (HPAI) in five additional flocks in South Dakota, Minnesota, and Iowa. No human infections with the virus have been detected at this time. CDC considers the risk to the general public from these HPAI H5 infections in wild birds, backyard flocks and commercial poultry, to be low.
USDA's National Veterinary Services Laboratories confirmed HPAI H5N2 in the following counties and states:
Moody County, South Dakota (June 1, 2015)
52,000 turkeys
2nd detection in this county
Renville County, Minnesota (June 1, 2015)
47,800 turkeys
6th detection in this county
Brown County, Minnesota (June 1, 2015)
18,300 turkeys
3rd detection in this county
Sac County, Iowa (June 1, 2015)
Turkeys (number pending)
7th detection in this county
Wright County, Iowa (June 1, 2015)
434,800 chickens
5th detection in this county
Full text:
http://content.govdelivery.com/accounts/USDAAPHIS/bulletins/1076e39
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5. Indiana Trains Prisoners To Combat Avian Flu
By Gretchen Frazee
IndianaPublicMedia.org
June 1, 2015
Indiana is training up to 300 prisoners how to cull poultry flocks infected by viruses.
It's one of several precautions the state is taking to prevent a new strain of the avian flu from taking hold in the state.
Indiana has been fortunate so far. Two strains of avian flu H5N2 and H5N8 have killed about 10 percent of the poultry industry's laying flock nationally and about 7 percent of the turkey flock.
Indiana has only had one case of the H2N8 virus affecting a backyard flock in May. The virus poses no risk to human health, but it is fatal to birds and spreads quickly, often wiping out entire chicken or turkey flocks.
In response, the Indiana State Board of Animal Health is partnering with the Department of Corrections to train low-level offenders at several locations across the state to euthanize and properly dispose of poultry that test positive for the virus.
"This is an unprecedented event," Denise Derrer, a spokeswoman for the Indiana State Board of Animal Health, says about the virus. "We are working with the industry, doing individual with their companies and individuals sites to make sure they are ready and can respond if we need to depopulate birds and have to do disposal and cleaning and disinfecting of the facility, which could be a very big job, especially for some of the larger operations we would have in the state."
Full text:
http://indianapublicmedia.org/news/indiana-trains-prisoners-combat-avian-flu-82875/
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6. Indiana lifts bird flu quarantine on poultry sites
By The Associated Press
WTHR.com
June 1, 2015
INDIANAPOLIS - The Indiana State Board of Animal Health has lifted its quarantine and other restrictions on poultry sites in a northeastern Indiana county following the detection of bird flu there last month.
The board said Monday the quarantine was lifted on poultry sites within three kilometers (1.86 miles) of the Whitley County mixed backyard flock where the virus was detected in early May. Other restrictions on all other poultry sites with 10 kilometers (6.2 miles) also were lifted Sunday.
It says all birds on 30 poultry sites within the 3-kilometer zone were tested twice for the virus and all tests came back negative.
Full text:
http://www.wthr.com/story/29212767/indiana-lifts-bird-flu-quarantine-on-poultry-sites
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7. Bird exhibits to be missing from Ohio fairs this year due to avian flu precautions
By Ann Domeck
Fox8.com
June 2, 2015
REYNOLDSBURG, Ohio - If you go looking for the chicken or turkey exhibit at one of the many fairs in Ohio this year, you won't find it, thanks to fears about avian flu.
The Ohio Department of Agriculture made the decision today [June 2] to cancel all live bird exhibitions in the state. And that ban includes county and independent fairs, the Ohio State Fair, and "all other gatherings of birds for show or for sale, including auctions and swap meets". There have been no reports of the avian flu in our state, and the ban is being put in place to keep it that way.
The Highly Pathogenic Avian Influenza (HPAI), also known as the avian flu, is extremely contagious and primarily affects domestic poultry. It's believed to be spread by wild, migrating birds. The virus was first identified in the United States in late 2014, and more than 44 million birds at more than 197 locations have been affected since then.
"This was a difficult decision because it means young people can't show their birds at fairs, but it's in the best interest of an industry that literally thousands of Ohio families and businesses depend on and which provides billions of dollars to our state's economy," said Ohio Department of Agriculture Director David T. Daniels.
Full text: http://tinyurl.com/osagodb
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8. Excess water creates problems for farmers and ranchers [AR]
Jesse Bocksnick, U of Arkansas System Division of Agriculture
Magnolia Reporter
May 29, 2015
This spring's wicked storms are giving Arkansas ranchers two kinds of headaches: declining hay quality and increased concern for livestock health due debris and bacteria stirred by floodwater.
County extension agents across the state said the saturated ground has made it impossible for hay growers to cut their meadows. According to the National Agricultural Statistics Service crop report released Monday, 50 percent of the state's pastures were rated fair, poor or very poor, with just 11 percent rated excellent. Sixty-five percent of non-alfalfa hay was fair, poor or very poor. The hay crop in Arkansas was valued at $360.9 million in 2013, according to NASS.
Andy Vangilder, Clay County extension staff chair for the University of Arkansas System Division of Agriculture, said fescue is getting a little too mature for the first cutting.
Full text: http://tinyurl.com/qb2hm88
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