FDA updates progress on judicious use of antimicrobials

The U.S. Food and Drug Administration has announced its second progress report on its strategy to promote the judicious use of antimicrobials in food-producing animals.
In December 2013, the agency took a significant step forward in addressing antimicrobial resistance by publishing Guidance #213, which calls on animal drug sponsors of approved medically important antimicrobials administered through medicated feed or water to remove from their product labels indications for use related to growth promotion, and bring the remaining therapeutic uses of these products under the oversight of a veterinarian by December 2016.
In March 2014, 283 applications were identified as being affected by Guidance #213. Since that time, 10 new generic and combination approvals were added to the list of affected applications; by law, the agency has no basis for refusing to approve these applications as long as they meet regulatory standards for approval. Some affected drug sponsors have already started implementing the recommended changes to their affected antimicrobial products: three applications have been converted from over-the-counter to prescription dispensing status; production indications have been withdrawn from one application; and 32 affected applications have been completely withdrawn.
Sponsors of all of the affected applications, including the additions, remain committed to participating in the strategy. One drug sponsor who was not previously affected by GFI #213, Pharmgate L.L.C., acquired all of the affected applications of Pennfield Oil Co. and ADM Alliance Nutrition Inc. Pharmgate has notified the agency in writing of its intent to engage in the judicious use strategy as outlined in GFI #213.
The FDA continues to work closely with affected drug sponsors to help ensure that the changes they agreed to make as described in GFI #213 are completed in an orderly manner by the end of December 2016. The FDA also intends to use a variety of metrics to assess the effect of these changes over time, including existing data on drug sales and resistance as well as additional on-farm data. The agency is working closely with the U.S. Department of Agriculture and the Centers for Disease Control to hold a joint public meeting in spring 2015 to discuss ways to collect and use on-farm use data. Details of the public meeting will be released closer to the meeting date.

German poultry, livestock farmers face more antibiotic scrutiny

Local authorities in Germany will soon be able to recommend change where antibiotic use on farms is found to be above average and, in extreme cases, suspend livestock owners from farming.
The change, aimed at gradually reducing the use of antibiotics in livestock farming, is part of the 16^th Act amending the German Drug Act, which came into force in July, and applies to chicken, turkey, pig and cattle farmers.
Under the new system, supervisory authorities will assess the frequency of antibiotic therapy on a farm and make comparisons with other farms. Following comparisons, a farmer can be required to take action deemed necessary.
As part of the system, poultry and other farmers must report every six months on what antibiotics they have administered to which animals in the period and in what quantities. After federal state authorities and the Federal Office of Consumer Protection and Food Safety have analyzed the data, a nationwide “farm-specific biannual therapeutic frequency” list will be drawn up, with first due for publication in March 2015.
If a farm’s individual index exceeds the federal average, the farmer and veterinarian will have to jointly identify the causes and take steps to curb antibiotic use. If a farm’s index is among the highest 25 percent, the farmer will, after consultation with veterinarians, have to draw up a written plan to cut antimicrobial use and submit that plan to the competent authorities.
Farmers can now be obliged to change husbandry methods, feeding practices, stocking densities and hygiene measures, and failure to comply could result in fines or a suspension from keeping animals.

Decreasing antimicrobial resistance trends shown in FDA report

The U.S. Food and Drug Administration (FDA) on August 11 released its National Antimicrobial Resistance Monitoring System (NARMS) 2011 Executive Report, showing mostly decreasing antimicrobial resistance trends. The annual NARMS Executive Report focuses on resistance to antibiotics that are considered important in human medicine as well as multidrug resistance (described as resistance to three or more classes of antibiotics), according to the FDA.
Under the NARMS program, samples are collected from human, food producing animals and retail meat sources, and tested for certain bacteria, specifically non-typhoidal Salmonella, Campylobacter, E. coli and Enterococcus, to determine whether such bacteria are resistant to various antibiotics used in human and veterinary medicine.
Among the key findings are:


• Eighty-fivepercent of non-typhoidal Salmonella collected from humans, whichincludes Heidelberg, Hadar, Typhimurim, and Enteritidis serotypes, had noresistance to any of the antibiotics tested.  (Non-typhoidal Salmonellarefers to one of the 2,300 serotypes of Salmonella except forTyphi, Paratyphi A, Paratyphi B (tartrate negative) and Paratyphi C.)
• Duringits 16-year history, NARMS has found Salmonella resistance tociprofloxacin to be very low (less than0.5 percent in humans, less than 3 percent in retail meat, and less than 1percent in animals at slaughter).  Ciprofloxacin, one of the most common antibiotics to treatSalmonella infections in humans, belongsto a group of drugs called fluoroquinolones whichwere ceased for use in poultry in 2005.
• Multi-drugresistance in Salmonella from humans and slaughtered chickens wasthe lowest since NARMS testing began.
• Resistanceto erythromycin, the antibiotic of choice to treat Campylobacter infections,in Campylobacter jejuni (C. jejuni) has remained at less than 4percent in isolates obtained from humans, retail chicken and slaughtered chicken since testing began.
"NCC (National Chicken Council) is pleased to see many positive trends in the data including a decrease in resistance in several foodborne pathogens and that first-line antibiotics remain effective in treating illnesses," said Ashley Peterson, Ph.D., NCC vice president of scientific and regulatory affairs.  "Though this data is from 2011, this report provides a strong case that the continued judicious use of antibiotics by poultry and livestock producers is aiding in the reduction of resistance in various foodborne pathogens.
"Chicken producers, veterinarians and our animal health partners are committed to continue to preserve the effectiveness of antibiotics for both humans and animals and minimize the potential for bacteria to develop resistance.
"NCC supports FDA's Guidance #213 that is phasing-out the growth-promoting uses of those antibiotics in livestock and poultry that are used in human medicine.  We believe that this transition will continue to preserve the effectiveness of those antibiotics used to treat human illnesses.  We also support FDA's proposed Veterinary Feed Directive (VFD) that will ensure all antibiotics that are administered to food producing animals will be done so under the prescription of a licensed veterinarian.  Both of these actions by FDA and full cooperation by chicken producers and animal health companies will help continue to drive the decrease in resistance in foodborne pathogens.
"One thing consumers should remember is that all pathogens potentially found on raw chicken, regardless of strain or resistance profile, will be fully destroyed by handling the product properly and cooking it to an internal temperature of 165F."

RUMA plan for UK Antimicrobial Resistance Strategy launched

The Responsible Use of Medicines in Agriculture Alliance (RUMA) fully supports the UK Government’s five-yearAntimicrobial Resistance (AMR) Strategy launched on September 10, 2013, and has produced an action plan for the animal agriculture sector.
RUMA Secretary General, John FitzGerald, said on April 23 the alliance had discussed the actions that will be required to implement the strategy and had developed the action plan that has been published on the RUMA website. The plan is based on the detailed actions in Annex B of the strategy and sets out the actions that RUMA and/or its individual member organizations will take. Inevitably, the plan is still at an early stage. RUMA members have agreed to review and record progress of the plan at RUMA’s quarterly meetings and to publish the plan and its subsequent revisions to provide an open report on how this work is developing.
During these reviews, new actions will be added to the plan including any identified by the high level steering group made up of Defra Antimicrobial Resistance Coordination Group (DARC), Antimicrobial Resistance and Health Care Associated Infections (ARHAI) and Advisory Committee on the Microbiological Safety of Food Working Group (ACMSF) members set out in the strategy as being responsible for agreeing the overall plan for its implementation.
In response to the action to improve public engagement, RUMA has published an information note on antibiotic resistance on its website.
The information note aims to:
• Explain antibiotic resistance and why it matters to human and animal health
• Set out why and how antibiotics are used in UK farms
• Identify the risks to public health from use of antibiotics in farming
• Explain the responsible use of antibiotics in farming
• Identify the changes in legislative controls (for antibiotic use in veterinary medicines and feed additives) that RUMA believes are appropriate and proportionate to manage the limited risk of antibiotic use in farm animals leading to clinical treatment problems in humans.
RUMA Secretary General  John FitzGerald said that the alliance had published the information note to help all interested parties from consumers to regulators to understand the complex topic of antibiotic resistance and the use of antibiotics in livestock.

FEFAC to focus on ‘greening’ livestock farming at meeting

As the EU moves from the Common Agriculture Policy into the implementation period of the reform package, close scrutiny is required as the agreements are put into practice. At the 57^th FEFAC Annual General Meeting, there will be focus on the contribution animal nutrition can make to the "greening" of livestock farming in order to meet the policy goals for sustainable development while improving competitiveness.
The key driver for future growth in the compound feed industry will be the anticipated increase in global demand for European dairy products. FEFAC, the European Feed Manufacturers' Federation, has invited European Dairy Association (EDA) President Michel Nalet to share the EDA's perspective on EU dairy market outlooks in the background of the CAP reform dynamics, with particular attention for the lifting of milk quotas in 2015.
Martin Scholten, chairman of the Animal Task Force, a science-based organization that brings together industry and academic experts as regards innovations in the livestock industry, has been invited to highlight the key research and development challenges in EU livestock farming and animal nutrition. Submitting common precompetitive research projects in support of initiatives for sustainable agriculture will help to demonstrate the new opportunities for the value chain part of the livestock sector.
FEFAC also invited European Commission Food and Veterinary Office Director Michael Scannell as a keynote speaker to discuss the main implications of the future interaction between the official controls of competent authorities and the private sector's own check systems. A key focus area will be the role animal nutrition can play to reduce the need for antibiotics, as has been outlined in the EU action plan on antimicrobial resistance.

EU antimicrobial resistance study finds significant resistance in Salmonella, Campylobacter

Bacteria most frequently responsible for food-borne infections, such as Salmonella andCampylobacter, show significant resistance to common antimicrobials. Combined resistance, or co-resistance, to critically important antimicrobials remains low, and while this means treatment options for serious infections with these zoonotic bacteria are available in most cases, the fact that antimicrobial resistance was commonly detected is cause for concern.
The findings were published in the European Food Standards Authority-European Centre for Disease Prevention and Control European Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2012.  The report includes data submitted by 26 of the EU member states.

Salmonella
The joint report shows that clinical resistance in humans to commonly used antimicrobials in Salmonella spp isolates was frequently detected at EU level, with almost half of the isolates being resistant to at least one antimicrobial, and 28.9 percent of isolates being multidrug resistant.
Levels of clinical resistance and co-resistance in Salmonella spp isolates to critically important antimicrobials, however, were low.
Resistance in animals to commonly used antimicrobials in Salmonella spp isolates was frequently detected in the animal species monitored, especially in broilers, pigs and turkeys. Resistance to ciprofloxacin (a critically important antimicrobial), was frequently observed in broilers and turkeys. Co-resistance to the critically important antimicrobials, ciprofloxacin and cefatoxime, was either not detected or reported at very low levels in reporting member states.

Campylobacter
In Campylobacter spp isolates from human cases, clinical resistance to common antimicrobials was frequently detected. Very high proportions of isolates (47.4 percent EU average) were resistant to the critically important antimicrobial ciprofloxacin with increasing trends observed in several member states.
Microbiological resistance to commonly used antimicrobials in Campylobacter spp isolates was frequently detected in broilers. Co-resistance to critically important antimicrobials, ciprofloxacin and erythromycin, in C jejuni in broilers was either not detected or reported in low levels.

Escherichia coli
Microbiological resistance to commonly used antimicrobials in E. coli isolates was frequently reported in broilers and pigs. Co-resistance to critically important antimicrobials in these animal species was mostly not detected or recorded at very low levels among the reporting member states.

Antimicrobial use, resistance symposium white paper released

The science behind the emergence, amplification, persistence and transfer of antibiotic resistance is highly complex and open to interpretation - and sometimes misinterpretation - from a wide variety of perspectives and misuse. If one thinks they understand antimicrobial resistance, it might not have been properly explained.
The extremely complex relationship between animal health, human health and environmental health is driven by two premises. The first is that antimicrobial resistance is a naturally occurring phenomenon that is present with or without the use of antimicrobials. The second is that anytime an antibiotic enters the ecosystem, it has the potential to contribute to the development of antibiotic resistance.
These two points were among the many shared during the "Bridging the Gap between Animal Health and Human Health" symposium sponsored by the National Institute for Animal Agriculture and conducted November 12-14, 2013, in Kansas City, Mo. These points and additional information synthesized from the symposium comprise a 27-page "Bridging the Gap between Animal Health and Human Health" symposium white paper recently released by NIAA.
"This white paper highlights information delivered during the symposium by 20 different speakers-including antibiotic use and resistance experts representing animal health, human health and public health as well as a consumer advocate organization, grocery retailers, staff members and selected media representing agriculture and consumer advocates," states Dr. Nevil Speer, Ph.D., Western Kentucky University, and co-chair of the "Bridging the Gap between Animal Health and Human Health" symposium.
"Open and candid presentations and discussions emphasized that those in human health and in animal health are committed to continuous improvement and are working to find common ground so a collective path forward can be formulated. Having a tug-of-war of human versus agricultural use of antibiotics doesn't advance a solution. This paper underscores the importance of taking a 360-degree view and addressing antibiotic resistance from an all-inclusive, science-based perspective."
The Antimicrobial Use and Resistance White Paper is available on the NIAA's website. Many of the symposium's PowerPoint presentations, including the audio, are also available in full.

Meat producers need to influence public opinion on antimicrobials

There is a concerted effort by a broad range of interest to curb the use of antimicrobials in meat production in the United States. Audrey Adamson, Vice President, Domestic Public Policy with the National Pork Producers Council, is on the front line of that battle legislatively, and in interactions with the mainstream media. She thinks animal agribusiness is holding its own with the legislative battles, but may be losing ground in the public opinion battle.
In an interview during the World Pork Expo in Des Moines, June 5-7, 2013, Adamson referred to recent good news on the legislative front. The night before, the U.S. House of Representatives had passed the Animal Drug and Animal Generic Drug User Fee Reauthorization Act, which provides a more predictable and timely review of new livestock and poultry medications by supporting FDA costs with manufacturers' fees through 2018. This will help expedite new therapies and drug development for livestock and poultry.
"The opponents to antimicrobials tried to put all sorts of restrictions in that bill, but we were able to keep it clean," said Adamson. She said  the 309-to-12 vote to pass ADUFA shows legislators are confident that the Food and Drug Administration  is doing what it needs to in antimicrobial regulation with Guidance 209 and 213.
She said the NPPC is participating with the FDA in the Voluntary Feed Directive. "We want to make sure the program works down on the farm and the veterinarians will be able to treat pig herds," Adamson said.
While celebrating the industry's legislative victories, Adamson is concerned about rising public opinion against antimicrobial use in meat production.
Referring the recent outcry over antimicrobials that started with the article in Consumer Reports  Adamson questions the motives behind that organization. "At the end of the article, it clearly stated that the research for the article was funded by the Pew Charitable Trusts," she said. "That isn't unbiased journalism."
Adamson has read article after article on the impact of antimicrobials used in meat production, and the meat industry was not represented. "The articles were  talking points from the various groups trying to stop antimicrobial use, without any input from the regulated community," said Adamson. "So, I thought we should reach out to reporters and tell the story of modern hog production."
Since then, she has met with reporters from the Wall Street Journal, the New York Times, the Chicago Tribune and other major media outlets to present the pork industry's side of the antimicrobial debate, and to start a running dialogue.
"The effort has paid off," said Adamson. "Now their reporters are calling us with questions."

UK alliance cautions against agriculture antibiotics bans

The Responsible Use of Medicines in Agriculture Alliance has said it is disappointed in a recent early day motion laid in the UK House of Commons which calls for a reduction in the use of antibiotics by veterinary surgeons and farmers and for the routine prophylactic use of antibiotics on UK farms to be phased out.
The motion says that the overuse of antibiotics in intensive farming "adds to the serious public health threat from antibiotic resistance and the rise of superbugs, and the motions sponsors "welcome the government's efforts to reduce over-prescribing by doctors" and would like to see specific controls introduced on the use in livestock of antibiotics that are critically important in human medicine.
“RUMA is disappointed by this EDM, which repeats and relies on some of the myths on the use of antibiotics in agriculture and the impact this has on antibiotic resistance in humans,” said John FitzGerald, alliance secretary general. According to the organization, antibiotic resistance is an important health issue and the alliance supports the initiatives on responsible use in both human and animal medicine. Antibiotics are important for maintaining the health of both humans and animals, and it is important that all parties work together to ensure that antibiotics remain an effective tool in the treatment of humans and animals so that when they need to be used they can be.
"There is, however, scientific consensus that use of antimicrobials in human medicine, rather than antibiotic use in the veterinary sector, is the driving force for antibiotic resistant human infections," said the alliance. In addition, the organization said it believes that “prevention is better than cure,” and cautions against actions to ban preventive treatment. "There are many disease scenarios in livestock animals where prophylactic use of antibiotics is an essential part of responsible veterinary care for the protection of animal health and welfare," said the alliance. "It must be emphasized that any such preventive and control treatment of animals is always under the control of the prescribing veterinary surgeon who will use diagnostic, clinical and epidemiological information to inform their prescribing decisions."

British Veterinary Association supports advertising ban on antimicrobials

The British Veterinary Association has said it supports the decision to prohibit the advertising of antimicrobials directly to animal keepers from 2013 in a bid to reduce antimicrobial resistance.
The Veterinary Medicines Directorate, which regulates veterinary medicines in the UK, announced that the Veterinary Medicines Regulations will be revised in 2013 to take account of the change which the association has been calling for. The change has come as a result of the European Commission’s view that the UK did not correctly transpose the European Directive 2001/82/EC which prohibits the advertising of certain veterinary medicinal products to the ‘general public’.
When the directorate consulted on proposals to restrict the advertising of antimicrobials to farmers in 2010, the association supported the measure as a sensible approach to the responsible use of antimicrobials. In a letter to stakeholders, the VMD said that a number of interested parties from veterinary medicine hold the view that the advertising of antibiotics to keepers of animals leads to undue pressure to prescribe newer antibiotics, which can often be important in human medicine and are associated with the development of multiple resistances.
“The BVA has consistently argued for the restriction of advertising of antimicrobials to animal keepers and we believe this is the right decision," said Peter Jones, president of the association. “New antimicrobials are heavily advertised by pharmaceutical companies and there can be undue pressure put on veterinary surgeons by clients who want to try new products that promise good results, but which may not be appropriate from the point of view of responsible use.
“Antimicrobial resistance is a very serious issue for both animal and human health and we are pleased that the European Commission and the VMD have taken the view that the Regulations need to be revised. Ultimately, it is the veterinary surgeon who will make the decision on which veterinary products to use, and vets will continue to work with their farm clients to ensure antimicrobials are used prudently and responsibly.”

Denmark measures 3.2% drop in pig antibiotics use from 2009 numbers

Denmark’s VSP Knowledge Centre for Pig Production reports that total antimicrobial use on Danish pigs in 2010 dropped by 3.2% from the previous year.
There was a significant difference between the first and second half of 2010, with the usage of antibiotics falling by 14.2% in the period from July to December compared with January to June. VSP director Nicolaj Nørgaard said that the sharp downward trend was a great achievement for the country's veterinarians and pig producers. It had also shown that the country’s Yellow Card system of warning individual farms and their advisers about instances of excessive use was working as intended.
To ensure a continued decline in the application of antibiotics, VSP has launched a new four-year project aimed at generating new knowledge about treatments and ways to ensure better health in pigs without compromising animal welfare.

Report outlines US trade implications of antimicrobial restrictions in poultry, livestock

A new Congressional Research Service report takes a look at the potential trade implications for U.S. livestock and poultry exports from tightened restrictions or prohibitions in the use of antimicrobial drugs in animal feed for growth promotion.
The report focused on two specific scenarios: "tightened restrictions or prohibitions on key U.S. export markets, without corresponding changes in the United States on the use of antimicrobials in animal feed for growth promotion" and "tightened restrictions or prohibitions in key U.S. export markets, with corresponding prohibitions in the United States on the use of antimicrobials in animal feed for growth promotion." Possible outcomes under these scenarios, in terms of changes in U.S. livestock and poultry exports and changes in U.S. market share in global meat markets, were discussed, though the report determined that it is currently impossible to predict all future implications due to the large number of market variables and trade issues that would also need to be predicted.

Scientists discover antibiotic-resistant genes

Scientists at the U.S. Agricultural Research Service said they have detected over 700 genes that give microbes the ability to resist antibiotics and other antimicrobial compounds.
Concerned some of these organisms have acquired genetic resistance to the antibiotics used to kill them, researchers said finding genes that offer resistance is an important step for scientists looking for new ways to control the organisms.
Using DNA microarray technology, ARS and collaborators at the Sidney Kimmel Cancer Center said they have found what makes bacteria, including salmonella, E. coli and campylobacter, resistant. Findings were published in the journal Microbial Drug Resistance.

BVA encourages responsible antimicrobial use

The British Veterinary Association (BVA) is promoting the responsible use of antimicrobials in veterinary practice by launching an eight-point plan.
Veterinarians are encouraged to follow these guidelines:
1.Work with clients to avoid need for antimicrobials
2. Avoid inappropriate use
3. Choose the right drug for the right bug
4. Monitor antimicrobial sensitivity
5. Minimize prophylactic use
6. Minimize use perioperatively
7. Record and justify deviations from protocols
8. Report suspected failure
Antimicrobials are essential for the treatment and prevention of diseases in animals, says the association, but every use increases both the risk that resistance will develop and the potential for its transfer to man via food-borne pathogens. To protect animal and human health, and optimize food safety, antimicrobials should only be used responsibly and and when necessary.
The guideline is outlined in a poster that can be downloaded from the BVA's Web site. The new guidance supports the international “One World, One Health” message promoting awareness of the link between animal diseases and human health. The BVA is also working with the Federation of Veterinarians in Europe on using the poster in other European Union countries.

FDA official supports restricted antibiotic use

Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs, testified before the House Committee on Rules at a hearing for HR1549 on July 13. The bill entitled "Preservation of Antibiotics for Medical Act of 2009" introduced by Representative Louise Slaughter (D-NY) is considering restrictions on the use of antibiotics in food-producing animals.
Sharfstein expressed the view of FDA that non-judicious (presumably non-therapeutic) use of antibiotic drugs in food-producing animals should be restricted. Antimicrobials could, however, be used under veterinary supervision to prevent and control diseases in food-producing animals.
Interpreting the intent of HR1549 and the testimony presented, it is evident that antibiotics may be administered to prevent conditions such as clostridial enterotoxaemia and colibacillosis applying the FDA Prudent Use principles. Administration of antibiotics to promote growth or as a blanket preventive such as injection of day-old chicks would probably be disallowed if the bill is enacted.

FSIS to set zero salmonella tolerance for high-risk poultry products

USDA’s Food Safety and Inspection Service (FSIS) said it will issue a new notice establishing a zero tolerance for salmonella on raw, frozen, stuffed poultry products that have the appearance of being ready to eat.
Chicken cordon bleu, chicken kiev, and chicken stuffed with broccoli are included in this class of products. FSIS indicated that the notice would also provide instructions to inspection personnel on obtaining finished product samples on a regularly scheduled basis.
Although labels clearly warn consumers that the product must be cooked and should not be prepared in a microwave, many of the consumers who became ill from these products ignored the labels. FSIS said it has decided to take this action because of the number of foodborne illnesses over the past few years associated with this class of products and that labeling alone will not reduce the risk of these products to consumers.
FSIS said it believes there are steps that processors can take in the manufacture of these products, such as the use of antimicrobials, to achieve a non-detectible level of salmonella in the finished product.