Pork Industry Antibiotics Update Jennifer Koeman, DVM, MSc, MPH, DACVPM Director, Producer and Public Health

Changes in Antibiotic Regulation – What Will It Mean On the Farm?

Antibiotic Regulation US Food and Drug Administration regulates animal and human antibiotics State pharmacy boards have authority over veterinary prescribing

Antibiotic Label Claims Disease Treatment Disease Control Disease Prevention – Treatment, Control and Prevention are considered therapeutic – FDA has said they are necessary for animal health and welfare Growth Promotion or Improvement of Nutritional Efficiency

Antibiotic Classes Medically important (as defined by FDA) – Same, or in same classes, as antibiotics used to treat humans – Most antibiotics approved for use in animal feed are medically important with possible exceptions: Swine: bacitracin, mecadox, narasin, bambermycin, and tiamulin

Regulatory Action

Regulatory Activity Removal of growth promotion/nutritional efficiency use Increased veterinary oversight

Guidance for Industry #209 Guidance is how the regulatory agency will conduct their business – Does not have the force of law, but provides the agency’s position on regulatory matters – Voluntary is relative

Guidance for Industry #209 “Production uses” (growth promotion and nutritional efficiency) of antibiotics in classes used in human medicine are injudicious – Does not call them unsafe Requires other uses of these same classes of antibiotics be under “veterinary oversight”

FDA medically important All swine antibiotics will be affected under Guidance 209 except – Bacitracin – Carbadox – Bambermycin – Ionophores – Tiamulin These antibiotics will remain available for growth promotion and/or over-the-counter (OTC) in feed and water

Guidance for Industry #209 “Voluntarily” working with sponsors to discontinue claims or migrate production claims to disease prevention – Guidance #213 gives roadmap on implementation

Guidance for Industry #213 Animal Health sponsors have all agreed to voluntarily surrender their approvals for growth promotion, and move remaining therapeutic uses under VFD or prescription for affected products – Implementation to be completed by end of 2016

FDA Guidance 213/VFD Guidance #213 and VFD finalized Growth Promotion and Nutritional Efficiency labels will be removed by Dec – “Medically Important” Disease Prevention, Control and Treatment will be VFD in feed, Rx in water

What does this really mean? Most growth promotion uses will end by Dec 2016 Most feed grade antibiotics will no longer be available over-the-counter but will require a veterinary “order” Antibiotics in water will require a prescription

What does this really mean? Significant regulatory step that will result in changes on how antibiotics are used on the farm Once those labels are changed, it will be illegal to utilize these antibiotics to promote growth Producers will need a VFD or prescription to use these products in feed and water

How will this affect pork producers? Producers are going to lose some antibiotics or uses of antibiotics Increased costs and increased time Producers will need a close relationship with their veterinarian – access to rural veterinarians?

National Strategy

White House interest spawns new initiatives

Executive Order 13676: Combating Antibiotic- Resistant Bacteria—issued by President Barack Obama on September 18, 2014

National Strategy “Directs Federal agencies to accelerate response to this growing threat to the nation’s health and security.”

PCAST Surveillance – Want White House coordination Stewardship – Development of alternatives for animal use – Supportive of FDA process, for now Continued Development of Antibiotics – Calling for public private partnerships

National Action Plan “roadmap to guide the Nation in rising to this challenge” “guide activities by the U.S. Government…is also designed to guide action by public health, healthcare, and veterinary partners in a common effort to address urgent and serious drug- resistant threats that affect people in the U.S. and around the world.”

National Security Priority Defense, Agriculture, Health and Human Services to lead interagency task force – State, Justice, Homeland Security, USAID, Veterans Affairs, Environmental Protection, National Security Council CARB Advisory Panel – Stakeholders and experts to advise the agencies on the implementation of the CARB action plan

National Security Priority White House Forum on Antibiotic Stewardship – Key human and animal health constituencies to improve antibiotic use (antibiotic stewardship) nationwide

Marketplace

McDonald’s Global Vision Four criteria – Overall similar to FDA Guidance 209 – Restricted to prevention and treatment uses with veterinary oversight Six judicious use principals – Align with PQA Plus

McDonald’s Global Vision Verification criteria to effect meaningful change Reducing the use of medically-important antimicrobials in food animals

What does this mean? All swine antibiotics affected except: WHO/MCD Carbadox Bambermycin Ionophores FDA Bacitracin* Carbadox Bambermycin Ionophores Tiamulin* *On WHO list

McDonald’s U.S. Poultry Policy McDonald’s will only source chicken raised without antibiotics important to human medicine

What does this mean? All swine antibiotics prohibited for any use except: WHO/MCD Carbadox Bambermycin Ionophores FDA Bacitracin Carbadox Bambermycin Ionophores Tiamulin*

What does this mean? Dual use or human drugs prohibited Would leave swine industry with no treatment for pneumonia (mycoplasma or bacterial), Strep suis, H. parasuis, E.coli scours, and illeitis Only treatments allowed would be for swine dysentery and Salmonella choleraesuis

Not All Species Are the Same Ionophores are a unique class of antimicrobials that are not used in human medicine are not believed to select for cross-resistance to human antibiotics Ionophores are used in poultry to control coccidiosis (primary disease that leads to other secondary diseases)

Not All Species Are the Same The pork industry does not have an analogous product that cures the variety of illnesses that ionophores do in poultry Products used in the swine industry are either – Related to antibiotic classifications that are used in human medicine or – Have the potential for developing cross- resistance

Helping Producers Prepare

Antibiotics resource page Checkoff newsletter and magazine

Checkoff Newsletter May/June 2015

Checkoff Magazine Summer 2015

Industry Efforts National Pork Board Antibiotics Position Statement and Policy National Pork Board Three-Point Antibiotic Stewardship Plan Allocate up to $1.4 million in funding of scientific research and antibiotic risk assessment studies, producer education and consumer awareness programs

Checkoff Stewardship Plan

Priority Research Areas for Analysis and assessment of preventive uses of antibiotics at therapeutic doses in pork production to optimize swine health and public health. For example, this may include 2.Analysis and assessment of specific animal population antibiotic treatment versus individual animal treatment in pork production to optimize swine health and public health.

Priority Research Areas for 2016 cont. 3.Evaluation of on-farm challenges to antibiotic record keeping and identification ofstrategies to improve antibiotic record keeping practice for continuous improvement of responsible antibiotic use on the farm. 4.Characterization and assessment of the environmental fate of antibiotics, antibiotic metabolites, antibiotic resistant bacteria and antibiotic resistant genes on swine farms.

Priority Research Areas for 2016 cont. 5.Exploration of strategies to protect herd health and minimize the need for antibiotics.

This message funded by America’s Pork Producers Questions?