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Annette Jones, DVM
State Veterinarian and Director
Animal Health and Food Safety Services
California Department of Food And Agriculture
Complying with California
Senate Bill 27
Livestock: Use of
Antimicrobial Drugs
SB 27 Livestock: Use of
Antimicrobial Drugs
I. Limits Use (January 1, 2018)
II. Stewardship Guidelines
III.Monitoring/Surveillance
Limits Use
 Effective January 1, 2018
 Applies to use in livestock, but not species
usually kept as pets (what does that mean?)
 Specific to medically important antimicrobials
as defined by FDA GFI 152 Appendix A,
including updates
 Can only be administered if ordered by a
veterinarian via prescription or veterinary
feed directive, under a valid veterinarian-
client-patient relationship
Limits Use
 Can only be used when in the judgement of a
licensed veterinarian is necessary to treat,
control and in some cases, prevent disease or
infection
 Prevention / Prophylaxis
 If related to surgery or medical procedure
 If “in the professional judgement of a licensed veterinarian,
it is needed for prophylaxis to address an elevated risk of
contraction of a particular disease or infection”
 If used to prevent disease beyond when related to surgery or
medical procedure, can not be used in a “regular pattern”
 Can never use solely for weight gain or feed
efficiency
Limits Use
 Medically important antibiotics labeled by
FDA for over the counter (OTC) sales can still
be obtained from retailers with prescription
or VFD
 Veterinary Food Animal Drug Retailer (B&P)
 Retail License for Restricted Drugs (FAC)
 May need regulations to add clarity
 Violations
 Licensed veterinarian: Practice Act disciplinary sanctions
 Others: Up to $250/day; second violation up to $500/day
Stewardship
 No delay in implementation
 Requires that CDFA work with others to develop
“antimicrobial stewardship guidelines and best
management practices for veterinarians and
livestock owners and employees”
 Must include scientifically validated best
practices such as vaccination, sanitation and
other management practices that may limit the
need for antibiotics
Stewardship
 Must include guidance on selection of most
appropriate antimicrobial drug, dose,
duration and route of administration
 Must include guidance on limiting the number
of animals treated and minimizing the
duration of treatment
Monitoring
 No delay in implementation
 Leveraging federal efforts, gather information
that may lead to a better understanding of the
links between use patterns and resistance
 Gather antimicrobial sales and use data,
conduct surveillance for resistance, and gather
management practice data (including health
outcomes)
 California’s major livestock segments
 Regions with significant livestock production
 Representative segments of the food production chain
Monitoring
 Willing participants and respecting veterinary-
client-patient confidentiality
 Authority to request and receive copies of VFD’s
 Information must be held confidential unless
aggregated
 Can be shared with VMB for enforcement of Practice Act or
Federal entities if confidentiality will also be protected
under federal law
 Report to the legislature January 1, 2019
What now?
 Department of Public Health
 Board of Pharmacy
 Veterinary Medical Board
 Producers and producer
organizations
 Feed mills and feed industry
organizations
 Retail stores distributing or
potentially distributing antibiotics
 Pharmaceutical companies and
business organizations
 Veterinarians and veterinarian
professional organizations
 Schools of Veterinary Medicine
 Consumer advocates
 CA Animal Health and Food Safety
Laboratory
 United States Department of
Agriculture (USDA)
 Food and Drug Administration
 Others TBD
 Extensive use of ad hoc advisory committees
comprised of stakeholders as well as technical
specialists and scientific advisors for specific topics
 Stakeholders include:
Phase I Funding
 8 Positions and $1.393 million General Fund
 Program Administration
 2.5 positions: implementation management, including efforts to attract supplemental funds
(federal grants, etc.), regulation development and supervision
 Regulated Use (2018):
 1 position for outreach (Feed mills)
 Monitoring (2016)
 2.5 positions for coordination with national efforts & development and initial implementation
of the CA monitoring strategy and gather and analyze appropriate VFD and Registered Retailer
sales data
 $50,000 to initiate strategy and capability for pathogen resistance monitoring at CAHFS
Laboratory System
 Stewardship (2016)
 2 positions to develop strategy and initiate development
 $50,000 in contract funding for species or production type specific expertise
Lessons
 Engage
 Drive the dialogue
 Veterinarian and physician professional groups and
academia important for credibility
 Communicate with commodity groups based on a history
of trust
VeterinariansConsumer
Advocates
Producers
trust
Thanks!
Annette Jones, DVM
State Veterinarian and Director
Animal Health and Food Safety Services
California Department of Food and Agriculture
Annette.jones@cdfa.ca.gov

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Dr. Annette Jones - Complying with California's Senate Bill 27 on Antibiotic Use in Livestock

  • 1. Annette Jones, DVM State Veterinarian and Director Animal Health and Food Safety Services California Department of Food And Agriculture Complying with California Senate Bill 27 Livestock: Use of Antimicrobial Drugs
  • 2. SB 27 Livestock: Use of Antimicrobial Drugs I. Limits Use (January 1, 2018) II. Stewardship Guidelines III.Monitoring/Surveillance
  • 3. Limits Use  Effective January 1, 2018  Applies to use in livestock, but not species usually kept as pets (what does that mean?)  Specific to medically important antimicrobials as defined by FDA GFI 152 Appendix A, including updates  Can only be administered if ordered by a veterinarian via prescription or veterinary feed directive, under a valid veterinarian- client-patient relationship
  • 4. Limits Use  Can only be used when in the judgement of a licensed veterinarian is necessary to treat, control and in some cases, prevent disease or infection  Prevention / Prophylaxis  If related to surgery or medical procedure  If “in the professional judgement of a licensed veterinarian, it is needed for prophylaxis to address an elevated risk of contraction of a particular disease or infection”  If used to prevent disease beyond when related to surgery or medical procedure, can not be used in a “regular pattern”  Can never use solely for weight gain or feed efficiency
  • 5. Limits Use  Medically important antibiotics labeled by FDA for over the counter (OTC) sales can still be obtained from retailers with prescription or VFD  Veterinary Food Animal Drug Retailer (B&P)  Retail License for Restricted Drugs (FAC)  May need regulations to add clarity  Violations  Licensed veterinarian: Practice Act disciplinary sanctions  Others: Up to $250/day; second violation up to $500/day
  • 6. Stewardship  No delay in implementation  Requires that CDFA work with others to develop “antimicrobial stewardship guidelines and best management practices for veterinarians and livestock owners and employees”  Must include scientifically validated best practices such as vaccination, sanitation and other management practices that may limit the need for antibiotics
  • 7. Stewardship  Must include guidance on selection of most appropriate antimicrobial drug, dose, duration and route of administration  Must include guidance on limiting the number of animals treated and minimizing the duration of treatment
  • 8. Monitoring  No delay in implementation  Leveraging federal efforts, gather information that may lead to a better understanding of the links between use patterns and resistance  Gather antimicrobial sales and use data, conduct surveillance for resistance, and gather management practice data (including health outcomes)  California’s major livestock segments  Regions with significant livestock production  Representative segments of the food production chain
  • 9. Monitoring  Willing participants and respecting veterinary- client-patient confidentiality  Authority to request and receive copies of VFD’s  Information must be held confidential unless aggregated  Can be shared with VMB for enforcement of Practice Act or Federal entities if confidentiality will also be protected under federal law  Report to the legislature January 1, 2019
  • 10. What now?  Department of Public Health  Board of Pharmacy  Veterinary Medical Board  Producers and producer organizations  Feed mills and feed industry organizations  Retail stores distributing or potentially distributing antibiotics  Pharmaceutical companies and business organizations  Veterinarians and veterinarian professional organizations  Schools of Veterinary Medicine  Consumer advocates  CA Animal Health and Food Safety Laboratory  United States Department of Agriculture (USDA)  Food and Drug Administration  Others TBD  Extensive use of ad hoc advisory committees comprised of stakeholders as well as technical specialists and scientific advisors for specific topics  Stakeholders include:
  • 11. Phase I Funding  8 Positions and $1.393 million General Fund  Program Administration  2.5 positions: implementation management, including efforts to attract supplemental funds (federal grants, etc.), regulation development and supervision  Regulated Use (2018):  1 position for outreach (Feed mills)  Monitoring (2016)  2.5 positions for coordination with national efforts & development and initial implementation of the CA monitoring strategy and gather and analyze appropriate VFD and Registered Retailer sales data  $50,000 to initiate strategy and capability for pathogen resistance monitoring at CAHFS Laboratory System  Stewardship (2016)  2 positions to develop strategy and initiate development  $50,000 in contract funding for species or production type specific expertise
  • 12. Lessons  Engage  Drive the dialogue  Veterinarian and physician professional groups and academia important for credibility  Communicate with commodity groups based on a history of trust
  • 14. Thanks! Annette Jones, DVM State Veterinarian and Director Animal Health and Food Safety Services California Department of Food and Agriculture Annette.jones@cdfa.ca.gov