(1)Existing law regulates the distribution and use of livestock drugs, as defined, by the Secretary of Food and Agriculture. Existing law also requires a person to obtain a license from the secretary to manufacture, sell, distribute, or store commercial feed, including commercial feed containing drugs.

This bill would, beginning January 1, 2018, prohibit the administration of medically important antimicrobial drugs, as defined, to livestock unless ordered by a licensed veterinarian through a prescription or veterinary feed directive pursuant to a veterinarian-client-patient relationship, as specified, and would prohibit the administration of a medically important antimicrobial drug to livestock solely for purposes of promoting weight gain or improving feed efficiency. The bill would require the Department of Food and Agriculture, in consultation with the Veterinary Medical Board, the State Department of Public Health, universities, and cooperative extensions, to develop antimicrobial stewardship guidelines and best management practices on the proper use of medically important antimicrobial drugs and would require the department to gather information on medically important antimicrobial drug sales and usage, antimicrobial resistant bacteria, and livestock management practice data. The bill would require information provided pursuant to those provisions to be held confidential, as specified. The bill would authorize the department to request and receive copies of veterinary feed directives from certain persons to implement the bills provisions. The bill would make a first violation of the bills provisions subject to a civil penalty of up to $250 for each day a violation occurs, and would make second and subsequent violations subject to an administrative fine of $500 for each day a violation occurs, except as specified.

(2)Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.

This bill would make legislative findings to that effect.

(1)Existing law regulates the distribution and use of livestock drugs, as defined, by the Secretary of Food and Agriculture. Existing law also requires a person to obtain a license from the secretary to manufacture, sell, distribute, or store commercial feed, including commercial feed containing drugs.

This bill would, beginning January 1, 2018, prohibit the administration of medically important antimicrobial drugs, as defined, to livestock unless ordered by a licensed veterinarian through a prescription or veterinary feed directive pursuant to a veterinarian-client-patient relationship, as specified, and would prohibit the administration of a medically important antimicrobial drug to livestock solely for purposes of promoting weight gain or improving feed efficiency. The bill would require the Department of Food and Agriculture, in consultation with the Veterinary Medical Board, the State Department of Public Health, universities, and cooperative extensions, to develop antimicrobial stewardship guidelines and best management practices on the proper use of medically important antimicrobial drugs and would require the department to gather information on medically important antimicrobial drug sales and usage, antimicrobial resistant bacteria, and livestock management practice data. The bill would require information provided pursuant to those provisions to be held confidential, as specified. The bill would authorize the department to request and receive copies of veterinary feed directives from certain persons to implement the bills provisions. The bill would make a first violation of the bills provisions subject to a civil penalty of up to $250 for each day a violation occurs, and would make second and subsequent violations subject to an administrative fine of $500 for each day a violation occurs, except as specified.

(2)Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.

This bill would make legislative findings to that effect.

(1)Existing law regulates the distribution and use of livestock drugs, as defined, by the Secretary of Food and Agriculture. Existing law also requires a person to obtain a license from the secretary to manufacture, sell, distribute, or store commercial feed, including commercial feed containing drugs.

This bill would, beginning January 1, 2018, prohibit the administration of medically important antimicrobial drugs, as defined, to livestock unless ordered by a licensed veterinarian through a prescription or veterinary feed directive pursuant to a veterinarian-client-patient relationship, as specified, and would prohibit the administration of a medically important antimicrobial drug to livestock solely for purposes of promoting weight gain or improving feed efficiency. The bill would require the Department of Food and Agriculture, in consultation with the Veterinary Medical Board, the State Department of Public Health, universities, and cooperative extensions, to develop antimicrobial stewardship guidelines and best management practices on the proper use of medically important antimicrobial drugs and would require the department to gather information on medically important antimicrobial drug sales and usage, antimicrobial resistant bacteria, and livestock management practice data. The bill would require information provided pursuant to those provisions to be held confidential, as specified. The bill would authorize the department to request and receive copies of veterinary feed directives to implement the bills provisions. The bill would make a first violation of the bills provisions subject to a civil penalty of $250 for each day a violation occurs, and would make second and subsequent violations subject to an administrative fine of $500 for each day a violation occurs, except as specified.

(2)Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.

This bill would make legislative findings to that effect.

(1)Existing law regulates the distribution and use of livestock drugs, as defined, by the Secretary of Food and Agriculture. Existing law also requires a person to obtain a license from the secretary to manufacture, sell, distribute, or store commercial feed, including commercial feed containing drugs.

This bill would, beginning January 1, 2018, prohibit the administration of medically important antimicrobial drugs, as defined, to livestock unless ordered by a licensed veterinarian through a prescription or veterinary feed directive pursuant to a veterinarian-client-patient relationship, as specified, and would prohibit the administration of a medically important antimicrobial drug to livestock solely for purposes of promoting weight gain or improving feed efficiency. The bill would require the Department of Food and Agriculture, in consultation with the Veterinary Medical Board, the State Department of Public Health, universities, and cooperative extensions, to develop antimicrobial stewardship guidelines and training materials best management practices on the proper use of medically important antimicrobial drugs and, in coordination with specified national entities, and would require the department to gather information on medically important antimicrobial drug sales and usage, antimicrobial resistant bacteria, and livestock management practice data. The bill would require information provided pursuant to those provisions to be held confidential, as specified. The bill would authorize the department to request and receive copies of veterinary feed directives to implement the bills provisions. The bill would make a first violation of the bills provisions subject to a civil penalty of $250 for each day a violation occurs, and would make second and subsequent violations subject to an administrative fine of $500 for each day a violation occurs, except as specified.

(2)Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.

This bill would make legislative findings to that effect.

(1)Existing law regulates the distribution and use of livestock drugs, as defined, by the Secretary of Food and Agriculture. Existing law also requires a person to obtain a license from the secretary to manufacture, sell, distribute, or store commercial feed, including commercial feed containing drugs.

This bill would, beginning January 1, 2018, prohibit the administration of medically important antimicrobial drugs, as defined, to livestock unless ordered by a licensed veterinarian through a prescription or veterinary feed directive pursuant to a veterinarian-client-patient relationship, as specified, and would prohibit the administration of a medically important antimicrobial drug to livestock solely for purposes of promoting weight gain or improving feed efficiency. The bill would require the Department of Food and Agriculture, in consultation with the Veterinary Medical Board, the State Department of Public Health, universities, and cooperative extensions, to develop guidelines and training materials on the proper use of medically important antimicrobial drugs and, in coordination with specified national entities, would require the department to gather information on medically important antimicrobial drug sales and usage, antimicrobial resistant bacteria, and livestock management practice data. The bill would require information provided pursuant to those provisions to be held confidential, as specified. The bill would make a first violation of the bills provisions subject to a civil penalty of $250 for each day a violation occurs, and would make second and subsequent violations subject to an administrative fine of $500 for each day a violation occurs, except as specified.

(2)Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.

This bill would make legislative findings to that effect.

(1)Existing law regulates the distribution and use of livestock drugs, as defined, by the Secretary of Food and Agriculture. Existing law also requires a person to obtain a license from the secretary to manufacture, sell, distribute, or store commercial feed, including commercial feed containing drugs.

This bill would, beginning January 1, 2018, prohibit the administration of medically important antimicrobial drugs, as defined, to livestock unless ordered by a licensed veterinarian through a prescription or veterinary feed directive pursuant to a veterinarian-client-patient relationship, as specified, and would prohibit the administration of a medically important antimicrobial drug to livestock solely to cause an increased rate of for purposes of promoting weight gain or improved improving feed efficiency. The bill would require the Department of Food and Agriculture, in consultation with the Veterinary Medical Board and Board, the State Department of Public Health, universities, and cooperative extensions, to implement programs to promote antimicrobial stewardship in livestock, develop guidelines and training materials on the proper use of medically important antimicrobial drugs and, in coordination with specified national entities, would require the department to develop a monitoring program to gather information on sales, medically important antimicrobial drug sales and usage, resistance, and management practice data for medically important antimicrobial drugs. antimicrobial resistant bacteria, and livestock management practice data. The bill would require information provided pursuant to those provisions to be held confidential, as specified. The bill would make a first violation of the bills provisions subject to a civil penalty of $250 for each day a violation occurs, and would make second and subsequent violations subject to an administrative fine of $500 for each day a violation occurs. occurs, except as specified.

(2)Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.

This bill would make legislative findings to that effect.

(1)Existing law regulates the distribution and use of livestock drugs, as defined, by the Secretary of Food and Agriculture. Existing law also requires a person to obtain a license from the secretary to manufacture, sell, distribute, or store commercial feed, including commercial feed containing drugs.

This bill would, beginning January 1, 2018, prohibit the administration of medically important antimicrobial drugs, as defined, to livestock unless ordered by a licensed veterinarian through a prescription or veterinary feed directive pursuant to a veterinarian-client-patient relationship, as specified, and would prohibit the administration of a medically important antimicrobial drug to livestock solely to cause an increased rate of weight gain or improved feed efficiency. The bill would require the Department of Food and Agriculture, in consultation with the Veterinary Medical Board and the State Department of Public Health, to implement programs to promote antimicrobial stewardship in livestock, and, in coordination with specified national entities, would require the department to develop a monitoring program to gather information on sales, usage, resistance, and management practice data for medically important antimicrobial drugs. The bill would require information provided pursuant to those provisions to be held confidential, as specified. The bill would make a first violation of the bills provisions subject to a civil penalty of $250 for each day a violation occurs, and would make second and subsequent violations subject to an administrative fine of $500 for each day a violation occurs.

(2)Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.

This bill would make legislative findings to that effect.

(1)Existing law regulates the distribution and use of livestock drugs, as defined, by the Secretary of Food and Agriculture. Existing law also requires a person to obtain a license from the secretary to manufacture, sell, distribute, or store commercial feed, including commercial feed containing drugs.

This bill would, beginning January 1, 2018, prohibit the administration of medically important antimicrobial drugs, as defined, to livestock unless ordered by a licensed veterinarian through a prescription or veterinary feed directive pursuant to a veterinarian-client-patient relationship, as specified, and would prohibit the administration of a medically important antimicrobial drug to livestock solely to cause an increased rate of weight gain or improved feed efficiency. The bill would require the Department of Food and Agriculture, in consultation with the Veterinary Medical Board and the State Department of Public Health, to implement programs to promote antimicrobial stewardship in livestock, and, in coordination with specified national entities, would require the department to develop a monitoring program to gather information on sales, usage, resistance, and management practice data for medically important antimicrobial drugs. The bill would require information provided pursuant to those provisions to be held confidential, as specified. The bill would make a first violation of the bills provisions subject to a civil penalty of $250 for each day a violation occurs, and would make second and subsequent violations subject to an administrative fine of $500 for each day a violation occurs.

(2)The Veterinary Medicine Practice Act provides for the licensure and regulation of veterinarians and the practice of veterinary medicine by the Veterinary Medical Board, and requires an applicant for a renewal license to complete 36 hours of continuing education in the preceding 2 years.

This bill would require a veterinarian who receives a licence to practice veterinary medicine on or after January 1, 2018, to complete an approved course on the judicious use of medically important antimicrobial drugs every 4 years as part of the continuing education requirement.

(3)Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.

This bill would make legislative findings to that effect.

(4)Because a violation of the provisions of the Veterinary Medicine Practice Act would be a misdemeanor, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

(1)Existing law regulates the distribution and use of livestock drugs, as defined, by the Secretary of Food and Agriculture. Existing law also requires a person to obtain a license from the secretary to manufacture, sell, distribute, or store commercial feed, including commercial feed containing drugs.

This bill would, beginning January 1, 2017, 2018, prohibit the administration of medically important antimicrobial drugs, as defined, to livestock unless ordered by a veterinarian through a prescription or veterinary feed directive pursuant to a veterinarian-client-patient relationship, as specified, and would prohibit the administration of a medically important antimicrobial drug to livestock solely to cause an increased rate of weight gain or improved feed efficiency. The bill, subject to the availability of funding for this purpose, would require the Department of Food and Agriculture to develop a program or participate in an initiative to track the use of medically important antimicrobial drugs in livestock and to track antimicrobial-resistant bacteria and patterns of emerging resistance. The bill would also require the department to adopt regulations to promote the judicious use of medically important antimicrobial drugs in livestock, as specified. The bill would require the Department of Food and Agriculture, in consultation with the Veterinary Medical Board and the State Department of Public Health, to implement programs to promote antimicrobial stewardship in livestock, and, in coordination with specified national entities, would require the department to develop a monitoring program to gather information on sales, usage, resistance, and management practice data for medically important antimicrobial drugs. The bill would require information provided pursuant to those provisions to be held confidential, as specified. The bill would make a first violation of the bills provisions subject to a civil penalty of $250 for each day a violation occurs, and would make second and subsequent violations subject to an administrative fine of $500 for each day a violation occurs.

(4)Because a violation of the bills provisions provisions of the Veterinary Medicine Practice Act would be a misdemeanor, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law regulates the distribution and use of livestock drugs, as defined, by the Secretary of Food and Agriculture. Existing law also requires a person to obtain a license from the secretary to manufacture, sell, distribute, or store commercial feed, including commercial feed containing drugs.

This bill would, beginning January 1, 2017, prohibit the administration of medically important antimicrobial drugs, as defined, to livestock unless prescribed ordered by a veterinarian through a prescription or veterinary feed directive pursuant to a veterinarian-client-patient relationship, as specified. The bill would make it unlawful to administer a specified, and would prohibit the administration of a medically important antimicrobial drug to livestock solely to cause an increased rate of weight gain or improved feed efficiency. The bill bill, subject to the availability of funding for this purpose, would also require the Department of Food and Agriculture to develop a program or participate in an initiative to track the use of medically important antimicrobial drugs in livestock and to track antibiotic-resistant antimicrobial-resistant bacteria and patterns of emerging resistance, and would also require the department, until March 1, 2020, to submit an annual report summarizing that data to the Legislature. resistance. The bill would also require the department to adopt regulations to promote the judicious use of medically important antimicrobial drugs in livestock, as specified.

Because a violation of the bills provisions would be misdemeanor, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law regulates the distribution and use of livestock drugs, as defined, by the Secretary of Food and Agriculture. Existing law also requires a person to obtain a license from the secretary to manufacture, sell, distribute, or store commercial feed, including commercial feed containing drugs.

This bill would prohibit the administration of medically important antimicrobial drugs, as defined, to livestock unless prescribed by a veterinarian pursuant to a veterinarian-client-patient relationship, as specified. The bill would make it unlawful to administer a medically important antimicrobial drug to livestock solely to cause an increased rate of weight gain or improved feed efficiency. The bill would also require the Department of Food and Agriculture to develop a program to track the use of medically important antimicrobial drugs in livestock and to track antibiotic-resistant bacteria and patterns of emerging resistance, and would also require the department, until March 1, 2020, to submit an annual report summarizing that data to the Legislature. The bill would also require the department to adopt regulations to promote the judicious use of medically important antimicrobial drugs in livestock, as specified.

Because a violation of the bills provisions would be misdemeanor, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

(Without Reference to File)

SENATE THIRD READING

STR Bill Id:SB 27

Author:(Hill)

As Amended Ver:September 10, 2015

Majority vote

SENATE VOTE: 25-10

SUMMARY: Prohibits, beginning January 1, 2018, the use of medically important anti-microbial drugs (MIAMs) for the treatment of livestock animals, except pursuant to a prescription or feed directive from a licensed veterinarian and when, in the professional judgment of a licensed veterinarian, the MIAMs are necessary: 1) to treat a disease or infection; 2) to control the spread of disease or infection; or 3) in relation to surgery or a medical procedure. This bill allows for prophylaxis to prevent the elevated risk of disease transmission or infection and forbids the use of MIAMs for growth promotion and feed efficiency. Specifically, this bill:

1. In order to implement and monitor compliance with the MIAM rules, the bill requires the California Department of Food and Agriculture (CDFA) to:

   1. Coordinate with the federal Food and Drug Administration (FDA) to develop a program to track antimicrobial drug sales, use, resistance, and management practices; and,

   2. Develop antimicrobial stewardship guidelines on good management practices in consultation with the Veterinary Medical Board (VMB), the California Department of Public Health (DPH), universities, and cooperative extensions; and,

   3. Conduct outreach and training, and report to the Legislature by January 1, 2019, the results of outreach and monitoring activities.

FISCAL EFFECT: According to the Assembly Appropriations Committee, this bill has:

1. Estimated General (GF) and Special Fund (SF) costs of approximately $864,000 in 2015-16 and $4.8 million in 2016-17 to develop programs, stewardship guidelines, monitoring systems and procedures, and regulations, as well as begin training, inspections, and MIAMs use tracking. Annual GF and SF costs of approximately $4.3 million thereafter to continue training, inspections, and tracking. Some of these costs may be funded from federal and local sources, and potentially offset in part with civil fine revenue.

2. Potentially significant costs to VMB and DPH to help develop stewardship guidelines and training materials.

COMMENTS: Antimicrobial drugs have been widely used in human medicine since the 1940s. Antimicrobial drugs have significant health benefits in both human and animal medicine, and are important and valuable tools used to treat and prevent illness and infection. Incidences of antimicrobial resistance have been recorded over time and, if left unchecked, pose a threat to public health.

The Centers for Disease Control and Prevention (CDC) estimates that in the United States, more than two million people are sickened every year with antibiotic-resistant infections, with at least 23,000 infections resulting in death. CDC notes that the use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Up to 50% of all antibiotics prescribed for people are either not needed or not optimally effective as prescribed. Antibiotics are also used in food-producing animals for the purpose of promoting growth, which CDC recommends phasing out.

The FDA has issued several industry recommendations regarding the use of MIAMs in the feed and drinking water of food-producing animals. The recommendations contained in Guidance for Industry #152, #213, and #219 establish lists of antibiotics important to human health, promote judicious use of those drugs in food production, and encourage veterinary oversight to ensure compliance with industry best practices.

In March 2015, President Obama issued a national action plan on combating antibiotic-resistant bacteria. The five-year action plan articulated goals of slowing the emergence of resistant bacteria, strengthening surveillance efforts, advancing the development and use of rapid diagnostics to identify resistant bacteria, accelerate development of new antibiotics, treatments, and vaccines, and improve collaboration among stakeholders. For antimicrobial use in food animals, the plan seeks to implement FDA guidance.

According to the author, overuse and misuse of antibiotics in livestock animals, especially antibiotics important in human medicine, contributes to antibiotic resistance. To address the overuse and misuse, this bill is intended to ensure veterinary oversight; encourage judicious use of MIAMS and prohibit use for growth promotion and other nontherapeutic purposes; and, monitor MIAM sales, usage, management practices, and resistance.

According to supporters, many antimicrobials used in food production are currently available at feed stores and online, without any veterinary prescription or oversight and this bill will stop this practice along with making all use of MIAMs require a prescription. Furthermore, supporters argue the prophylactic use exception has been carefully crafted for judicious use of MIAMs, and the bill explicitly forbids MIAM use for growth promotion and feed efficiency.

While recent amendments removed much of the opposition, those still opposed argue this bill explicitly authorizes the routine use of antibiotics on animals that are not sick through the exception for prophylactic use to prevent disease transmission or infection. Opponents fear prophylactic use will allow back door use for nontherapeutic purposes, and is precisely the low-dose use that contributes most to resistant bacteria. Furthermore, opponents assert that surveillance of MIAM use in food animal production needs to be mandatory.

Analysis Prepared by: Victor Francovich / AGRI. / (916) 319-2084 FN: 0002319

 UNFINISHED BUSINESS  

Bill No: SB 27

Author: Hill (D)

Amended: 9/10/15

Vote: 21

SENATE AGRICULTURE COMMITTEE: 3-0, 4/21/15

AYES: Galgiani, Pan, Wolk

NO VOTE RECORDED: Cannella, Berryhill

SENATE APPROPRIATIONS COMMITTEE: 5-2, 5/28/15

AYES: Lara, Beall, Hill, Leyva, Mendoza

NOES: Bates, Nielsen

SENATE FLOOR: 25-10, 6/2/15

AYES: Beall, Berryhill, Block, Cannella, Galgiani, Hall, Hancock, Hernandez, Hertzberg, Hill, Hueso, Jackson, Lara, Leno, Leyva, Liu, McGuire, Mendoza, Mitchell, Monning, Pan, Pavley, Roth, Wieckowski, Wolk

NOES: Anderson, Bates, Fuller, Gaines, Moorlach, Morrell, Nguyen, Nielsen, Runner, Vidak

NO VOTE RECORDED: Allen, De León, Glazer, Huff, Stone

ASSEMBLY FLOOR: Not available

SUBJECT: Livestock: use of antimicrobial drugs

SOURCE: Author

DIGEST: This bill restricts the use of medically important antimicrobial drugs in livestock for specified purposes, requires a veterinarian’s prescription or feed directive for use, and eliminates the over-the-counter availability of these drugs; requires the California Department of Food and Agriculture (CDFA) to, in coordination with federal programs and agencies, develop a program to track antimicrobial drug use in livestock and the emergence of antimicrobial-resistant bacteria; and requires CDFA to develop antimicrobial stewardship guidelines and best management practices on the proper use of these drugs.

Assembly Amendments clarify when medically important antimicrobial drugs may be used for preventative purposes, provide further details regarding the CDFA antimicrobial monitoring program, and levy penalties for violators of this new chapter, among other amendments.

ANALYSIS:

Existing federal law:

1. Requires the Food and Drug Administration (FDA) to protect public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs. Within FDA, the Center for Veterinary Medicine regulates the manufacture and distribution of drugs that will be administered to animals and regulates medicated feed.

2. Establishes the Animal Drug Availability Act in 1996 to create a new regulatory category for certain animal drugs used in animal feed. Previously, drugs were only available through two means: over-the-counter (OTC) and by prescription. As new drugs (antimicrobials) were developed, FDA recognized the need for these drugs to be administered through feed. However, FDA wanted to establish greater control and safety measures than were currently available under OTC status since some of these drugs could contribute to drug toxicity and antimicrobial resistance or have other unintended outcomes. Therefore, the Veterinary Feed Directive (VFD) was created to allow more flexibility for new animal drugs to be administered through medicated feed but done so under the supervision of a licensed veterinarian (78 Federal Register 75517, December 12, 2013).

Existing state law:

1. Requires CDFA, through the Livestock Drug Program, to regulate the manufacture, sale, registration, and use of livestock drugs, except when the livestock drug is sold by prescription only, used exclusively by a veterinarian, or used only under a veterinarian’s direction. CDFA is required to register OTC livestock drugs and regulate their use for safety and efficacy (Food and Agricultural Code §14200 et seq.).

2. Requires the California State Board of Pharmacy to enforce laws and regulations regarding prescription drugs and drugs used exclusively by veterinarians (Business and Professions Code § 4000 et seq.).

This bill:

1. Provides definitions for “medically important antimicrobial drug,” “livestock,” and “veterinary feed directive.”

2. Prohibits, beginning January 1, 2018, the administration of a medically important antimicrobial drug to livestock unless ordered by a veterinarian, through a prescription or feed directive, that has established a veterinarian-client-patient relationship.

3. Allows, beginning January 1, 2018, the use of a medically important antimicrobial drug when, in the professional judgement of a licensed veterinarian, the drug is necessary for any of the following:

1. To treat a disease or infection.

2. To Control the spread of a disease or infection

3. In relation to surgery or a medical procedure.

2. Allows the use of a medically important antimicrobial drug when, in the professional judgement of a licensed veterinarian, it is needed for prophylaxis (prevention) to address an elevated risk in the contraction of a particular disease or infection.

3. Prohibits a person from administering a medically important antimicrobial drug to livestock in a repeated or regular pattern unless if consistent with #3, above.

4. Prohibits a person from administering a medically important antimicrobial drug to livestock solely for the purposes of promoting weight gain or improving feed efficiency.

5. Allows medically important antimicrobial drugs to be sold, with a prescription or veterinary feed directive, by retailers licensed to sell restricted drugs.

6. Requires CDFA, in consultation with the Veterinary Medical Board, the State Department of Public Health, universities, and cooperative extensions, to develop antimicrobial stewardship guidelines and best management practices on the proper use of these drugs for disease treatment, control, and prevention.

7. Requires CDFA to consult with livestock producers, veterinarians and other stakeholder on ensuring livestock timely access to treatment for producers in rural areas with limited access to veterinary care.

8. Defines “antimicrobial stewardship” as a commitment to:

1. Use medically important antimicrobial drugs only when necessary to treat, control, and, in some cases, prevent disease.

2. Select and administer the appropriate medically important antimicrobial drug, dose, duration and route of administration.

3. Use medically important antimicrobial drugs for the shortest duration necessary and administered to the fewest animals necessary.

9. States the intent of the Legislature that CDFA coordinate with specified federal agencies to implement the expanded antimicrobial resistance surveillance efforts in the National Action Plan for Combating Antibiotic-Resistant Bacteria.

10. Requires CDFA to gather information, as specified, on medically important antimicrobial drug sales and usage, as well as antimicrobial resistant bacteria and livestock management practice data. Monitoring efforts shall not be duplicative of federal monitoring programs, and to the extent feasible, CDFA shall coordinate with specified federal agencies to develop these efforts.

11. Requires CDFA to work with willing participants to gather this data, and participation shall be done in a manner that does not breach veterinary-client-patient confidentiality laws.

12. Requires CDFA to report to the Legislature by January 1, 2019, the results of outreach and monitoring efforts.

13. Requires CDFA to seek funds from federal, state, and other sources to implement the monitoring program.

14. Authorizes CDFA to obtain copies of veterinary feed directives.

15. Maintains confidentiality of data collected to prevent the identification of an individual farm or business.

16. Levies a $250 per day civil penalty on persons who violate this new chapter, or an administrative fine of $500 per day of violation for a second or subsequent violation. Violators are also required to attend an educational program on the judicious use of medically important antimicrobial drugs within 90 days of the violation. This provision excludes veterinarians, who are subject to disciplinary sanctions pursuant to the Veterinary Medicine Practice Act.

Background

Antimicrobial drugs were first developed in 1928 and became widely used in human medicine in the 1940s. These new drugs quickly proved to have significant health benefits in both human and animal medicine and to this day are extremely valuable tools used to treat and prevent illness and infection. However, incidences of antimicrobial resistance have been recorded over time and, if not addressed, pose a serious threat to public health.

Antimicrobial resistance may develop for several reasons. One of the most widely accepted contributors to antimicrobial resistance is the misuse of antimicrobial drugs. When bacteria are exposed to an antimicrobial drug, it provides the opportunity for “survival of the fittest” where only the strongest, most immune bacteria survive. These surviving, antimicrobial-resistant bacteria then multiply to form new colonies of resistant bacteria that may spread and infect other individuals. For this reason, it is important to use antimicrobial drugs judiciously in both human and animal medicine as one method to mitigate resistance.

The Centers for Disease Control and Prevention (CDC) recently issued a report titled Antibiotic Resistance Threats in the United States, 2013. The CDC estimates that in the United States more than two million people are sickened every year with antibiotic-resistant infections with at least 23,000 infections resulting in death. In its report, the CDC lists four core actions that fight the spread of antibiotic resistance: 1) preventing infections from occurring and preventing resistant bacteria from spreading, 2) tracking resistant bacteria, 3) improving the use of antibiotics, and 4) promoting the development of new antibiotics and new diagnostic tests for resistant bacteria.

The CDC notes that the use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Up to 50% of all antibiotics prescribed for people are either not needed or not optimally effective as prescribed. Antibiotics are also used in food-producing animals for the purpose of promoting growth, which the CDC recommends phasing out. FDA has developed guidances (described below) to promote judicious use of antimicrobials that would prohibit their use for improved feed efficiency or increased weight gain. According to the FDA’s annual report on antimicrobial sales for animal use, 97% of medically important antimicrobial drugs are sold OTC and not through a veterinarian’s prescription or feed directive. The FDA guidances will address this issue and others, as described in further detail below.

In December 2013, the FDA released the final draft of the Guidance for Industry #213 (GFI #213), which contains nonbinding recommendations regarding the use of medically important antimicrobial drugs in the feed and drinking water of food-producing animals. These recommendations include: 1) phasing out the use of medically important antimicrobial drugs in food-producing animals for production purposes (growth promotion and feed efficiency) and 2) veterinary oversight of these drugs when used in the feed or water of food-producing animals.

The FDA’s GFI #213 would change the status of antimicrobial drugs administered in feed from OTC to VFD. Due to this change, the FDA recognizes that current VFD regulations must be revised and streamlined to minimize the impact on veterinarians, the animal feed industry, and producers. These revisions are believed to be critically important and are scheduled to be completed before the three-year implementation timeline for GFI #213.

On September 18, 2014, President Obama issued Executive Order 13676: Combating Antibiotic-Resistant Bacteria, which states that this is an issue of national security and that “the Federal Government will work domestically and internationally to detect, prevent, and control illness and death related to antibiotic-resistant infections by implementing measures that reduce the emergence and spread of antibiotic-resistant bacteria and help ensure the continued availability of effective therapeutics for the treatment of bacterial infections.” Later that same month, the White House issued the National Strategy for Combating Antibiotic-Resistant Bacteria, and in March 2015, the White House issued the National Action Plan for Combating Antibiotic-Resistant Bacteria (Action Plan).

The Action Plan lays out a five-year plan with five distinct goals: 1) slow the emergence of resistant bacteria, 2) strengthen One-Health surveillance efforts, 3) advance the development and use of rapid diagnostic tests to identify resistant bacteria, 4) accelerate the development of new antibiotics, other treatments, and vaccines, and 5) improve international collaboration to achieve these goals. For antimicrobial use in food animals (livestock), the Action Plan seeks to implement FDA’s guidances for industry, described later in this analysis.

The United States Department of Agriculture (USDA) currently operates national laboratory systems that survey national animal health and monitor antimicrobial resistance: the National Animal Health Monitoring System (NAHMS) and the National Antimicrobial Resistance Monitoring System (NARMS). NAHMS was created in 1983 to collect and analyze data on animal health, management, and productivity and to conduct national studies on livestock populations. NAHMS is recognized as a statistical unit under the Confidential Information Protection and Statistical Efficiency Act (CIPSEA), which allows producers or livestock owners to voluntarily provide sensitive and confidential information such as on-farm management practices and animal health issues. USDA states that this is vital to encourage voluntary participation and to maintain high response rates.

NARMS was established in 1996 by the FDA in conjunction with the CDC and USDA to monitor trends in antimicrobial resistance from human, retail meat, and food animal samples. The goals and objectives of NARMS’ monitoring program are to monitor trends in antimicrobial resistance among foodborne bacteria, conduct research to better understand the emergence and spread of resistant bacteria, and to assist the FDA in decision making for the approval of antimicrobial drugs for animals.

The California Animal Health and Food Safety (CAHFS) Laboratory System, created as a partnership between CDFA and the UC Davis School of Veterinary Medicine, is the state entity responsible for providing rapid diagnostic testing for animal health diseases, and those diseases that affect humans. Most recently, CAHFS has been involved in detecting avian influenza in both commercial and backyard poultry but also conducts testing on any animal brought to the lab with other concerns such as poisoning, salmonella or other bacterial infections, rabies, and other serious health issues for both livestock and pets. CAHFS is part of the National Animal Health Laboratory Network, which has been included as a component of national surveillance efforts in President Obama’s Action Plan for combating antimicrobial resistance.

Comments

Governor’s Veto. Governor Brown vetoed a previous version of this bill in 2014 (SB 835, Hill). In his veto message, Governor Brown stated that “more needs to be done to understand and reduce our reliance on antibiotics. To that end, I am directing the Department of Food and Agriculture to work with the Legislature to find new and effective ways to reduce the unnecessary antibiotics used for livestock and poultry.”

Veterinarian-client-patient relationship. The California Code of Regulations (16 CCR § 2032.1) requires a veterinarian to establish a veterinarian-client-patient relationship before administering, prescribing, dispensing, or furnishing a drug or medicine. This relationship is established when the veterinarian has sufficient knowledge of the animal through an examination or by medically appropriate and timely visits to the premises where the animal is housed. Additionally, a veterinarian shall not prescribe a drug for longer than one-year duration.

Preventative and routine use. There is argument as to whether antimicrobial drugs are being used judiciously when administered to animals for the purpose of disease prevention. The concern relates to the use of antimicrobial drugs when a disease is not clinically present and which could provide the opportunity for the continual, prolonged, or routine use of antimicrobial drugs in food animals.

However, the California Veterinary Medical Association is concerned that if antimicrobial use is restricted then veterinarians would be prevented from “making the best medical decisions for the health and welfare of their patients. There are many instances where it is important to administer antibiotics prophylactically, such as to prevent the active spread of ‘silent killer’ diseases such as Chlamydophila abortus in sheep, particularly when there is no test available to determine which sheep are the carriers of the disease. Veterinarians must have the flexibility to provide scientific and medically appropriate treatment for animals under their care.”

Monitoring program. The federal government is currently proposing an expanded nationwide antimicrobial use and resistance surveillance program as outlined in the USDA Antimicrobial Resistance Plan published in June 2014 and in President Obama’s Action Plan. This bill seeks to coordinate with this program.

Over-the-counter accessibility. This bill eliminates the OTC availability of all medically important antimicrobial drugs administered to livestock. There are concerns from the livestock industry that this will limit their ability to obtain the medication necessary to properly care for their livestock, however this bill recognizes this challenge and several agricultural organizations, such as the California Cattlemen’s Association, remain neutral on this bill.

Antimicrobial stewardship. Several livestock industries have developed best management practices/quality assurance/herd improvement programs that address animal welfare and food safety issues. The Beef Quality Assurance program includes guidelines on the judicious use of antimicrobial drugs. Additionally, the American Veterinary Medical Association provides guidelines for the judicious use of antimicrobial drugs in livestock. Should this bill become law, CDFA may draw from these or similar existing programs to develop a statewide guidance program.

Opposition. Several organizations have removed their opposition from this bill, such as the Natural Resources Defense Council, Environmental Working Group, and CALPIRG (please see the Assembly Agriculture Committee analysis dated 9/9/2015 for a more complete list). However, not all of those in opposition have provided an updated position since the most recent amendments have been adopted. Therefore, those listed as “opposed” may in fact have also changed their position to neutral, however this cannot be verified as of 9/11/2015.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Assembly Appropriations Committee, this bill will cost approximately $864,000 in FY 2015-16 and $4.8 million in FY 2016-17 from General and Special Funds to develop programs, stewardship guidelines, monitoring systems and procedures, and regulations, as well as begin training, inspections, and use tracking. Annual General and Special Fund costs are estimated to be approximately $4.3 million per year thereafter to continue training, inspections, and tracking. Some of these costs may be funded from federal and local sources, and potentially offset in part with civil fine revenue. In addition, there are potentially significant costs to the Veterinary Medical Board and the State Department of Public Health to help develop stewardship guidelines and training materials.

SUPPORT: (Verified 9/11/15)

Adventist Health

California Academy of Preventive Medicine

California Children’s Hospital Association

California Naturopathic Doctors Association

California Optometric Association

California Society of Health-System Pharmacists

California Veterinary Medical Association

Humane Society Veterinary Medical Association

Infectious Disease Association of California

Loma Linda University Health

OPPOSITION: (Verified 9/11/15)

Alliance for the Prudent Use of Antibiotics

Animal Welfare Approved

Center for Agriculture and Food Systems, Vermont Law School

Center on Race, Poverty and the Environment

Compassion Over Killing

Diestel Family Turkey Ranch

Friends of the Earth

Hunger Action LA

Institute for Agriculture and Trade Policy

Organic Consumers Association

Physicians for Social Responsibility, Los Angeles

Southern California Public Health Association

Urban Environmental Policy Institute

Women Organizing Resources, Knowledge and Services

ARGUMENTS IN SUPPORT: According to the author, “The overuse and misuse of antibiotics, especially antibiotics important in human medicine, contributes to antibiotic resistance as a growing public health threat. Inappropriate antibiotic use and overuse in humans drives the development of antibiotic resistance, but there is also a concern about antibiotic use in livestock and poultry. Based on the best information available from the federal Food and Drug Administration (FDA), it’s estimated that at least 70 percent of all medically important antibiotics are sold for use in livestock and poultry. […] The data available on antibiotic use in livestock and poultry is in itself a problem; in large part, many consider the data to be insufficient since the only data collected is sales data. More, and better data, needs to be collected to properly address this issue. While there may be data gaps about antibiotic use in livestock and poultry, we do know that under current law the majority of medically important antibiotics may be sold for use in livestock and poultry without veterinary oversight. […] Antibiotic stewardship programs are a commitment to always use antibiotics only when they are necessary, to choose the right antibiotics and to administer them in the right way in every case. Antibiotic stewardship programs have been effective in reducing inappropriate antibiotic use in humans, as well in reducing antibiotic resistance. […] However, there is no similar requirement that veterinarians and livestock and poultry producers follow antibiotic stewardship guidelines.”

ARGUMENTS IN OPPOSITION: Those opposed to this bill have the same concern: namely, that this bill does not go far enough to restrict the use of antimicrobial drugs for preventative or routine uses in livestock. These organizations state that, “Antibiotic-resistant infections can result in longer illnesses, more hospitalizations, the use of antibiotics with greater side-effects, and even death when treatments fail. Resistant infections are estimated to cost the U.S. up to $61 billion annually in additional health care costs and lost productivity. Growing resistance also puts complicated medical procedures such as heart surgery, organ transplants, and chemotherapy in jeopardy” due to reliance on effective antibiotics. Furthermore, about 70% of all medically important antibiotics sold in the U.S. are used in livestock production, where much of the use is to accelerate animal growth and for disease prevention. By continuing to allow antibiotics to be used for disease prevention, these drugs could still be administered in low doses to entire herds when there is no disease present and where other interventions could obviate the need for their use. (Please see the comments section titled “Opposition” on page 9 for further clarification on the status of these organizations’ opposed position).

Prepared by: Anne Megaro / AGRI. / (916) 651-1508

9/11/15 21:00:10

**** END ****

PROPOSED TO BE AMENDED

Date of Hearing: September 9, 2015

ASSEMBLY COMMITTEE ON AGRICULTURE

Henry Perea, Chair

SBPCA Bill Id:SB 27

Author:(Hill) – As Amended Ver:September 4, 2015

SENATE VOTE: 25-10

SUBJECT: Livestock: use of antimicrobial drugs.

SUMMARY: This bill prohibits, beginning January 1, 2018, the use of medically important anti-microbial drugs (MIAMs) for the treatment of livestock animals, except pursuant to a prescription or feed directive from a licensed veterinarian and when, in the professional judgment of a licensed veterinarian, the MIAMs are necessary: 1) to treat a disease or infection; 2) to control the spread of disease or infection; or 3) in relation to surgery or a medical procedure. This bill allows for prophylaxis to prevent the elevated risk of disease transmission or infection and forbids the use of MIAMs for growth promotion and feed efficiency. Specifically, this bill:

1. In order to implement and monitor compliance with the MIAM rules, the bill requires the California Department of Food and Agriculture (CDFA) to:

   1. Coordinate with the federal Food and Drug Administration (FDA) to develop a program to track antimicrobial drug sales, use, resistance, and management practices; and,

   2. Develop antimicrobial stewardship guidelines on good management practices in consultation with the Veterinary Medical Board (VMB), the California Department of Public Health (DPH), universities, and cooperative extensions; and,

   3. Conduct outreach and training, and report to the Legislature by January 1, 2019, the results of outreach and monitoring activities.

EXISTING LAW:

Federal law:

1. Requires FDA to protect public health by ensuring the safety, effectiveness, quality, and security of human and veterinary drugs. Within FDA, the Center for Veterinary Medicine regulates the manufacture and distribution of drugs that will be administered to animals and regulates medicated feed.
   
   
   

2. Established the Animal Drug Availability Act in 1996 to create a new regulatory category for certain animal drugs used in animal feed. Previously, drugs were only available through two means: over-the-counter (OTC) and by prescription. As new drugs (antimicrobials) were developed, FDA recognized the need for these drugs to be administered through feed.

3. Created the Veterinary Feed Directive (VFD) to allow more flexibility for new animal drugs to be administered through medicated feed, under the supervision of a licensed veterinarian.

State law:

1. Requires CDFA, through the Livestock Drug Program, to regulate the manufacture, sale, registration, and use of livestock drugs, except when the livestock drug is sold by prescription only, used exclusively by a veterinarian, or used only under a veterinarian’s direction. CDFA is required to register OTC livestock drugs and regulate their use for safety and efficacy.
   
   

2. Requires the California State Board of Pharmacy to enforce laws and regulations regarding prescription drugs and drugs used exclusively by veterinarians.

FISCAL EFFECT: According to the Assembly Appropriations Committee, this bill has:

1. Estimated General (GF) and Special Fund (SF) costs of approximately $864,000 in 2015-16 and $4.8 million in 2016-17 to develop programs, stewardship guidelines, monitoring systems and procedures, and regulations, as well as begin training, inspections, and MIAMs use tracking. Annual GF and SF costs of approximately $4.3 million thereafter to continue training, inspections, and tracking. Some of these costs may be funded from federal and local sources, and potentially offset in part with civil fine revenue.

2. Potentially significant costs to VMB and DPH to help develop stewardship guidelines and training materials.

COMMENTS: Antimicrobial drugs have been widely used in human medicine since the 1940s. Antimicrobial drugs have significant health benefits in both human and animal medicine, and are important and valuable tools used to treat and prevent illness and infection. Incidences of antimicrobial resistance have been recorded over time and, if left unchecked, pose a threat to public health.

The Centers for Disease Control (CDC) estimates that in the United States, more than two million people are sickened every year with antibiotic-resistant infections, with at least 23,000 infections resulting in death. CDC notes that the use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Up to 50% of all antibiotics prescribed for people are either not needed or not optimally effective as prescribed. Antibiotics are also used in food-producing animals for the purpose of promoting growth, which CDC recommends phasing out.

The FDA has issued several industry recommendations regarding the use of MIAMs in the feed and drinking water of food-producing animals. The recommendations contained in Guidance for Industry #152, #213, and #219 establish lists of antibiotics important to human health, promote judicious use of those drugs in food production, and encourage veterinary oversight to ensure compliance with industry best practices.

In March 2015, President Obama issued a national action plan on combating antibiotic-resistant bacteria. The five year action plan articulated goals of slowing the emergence of resistant bacteria, strengthening surveillance efforts, advancing the development and use of rapid diagnostics to identify resistant bacteria, accelerate development of new antibiotics, treatments, and vaccines, and improve collaboration among stakeholders. For antimicrobial use in food animals, the plan seeks to implement FDA guidance.

According to the author, overuse and misuse of antibiotics in livestock animals, especially antibiotics important in human medicine, contributes to antibiotic resistance. To address the overuse and misuse, this bill is intended to ensure veterinary oversight; encourage judicious use of MIAMS and prohibit use for growth promotion and other nontherapeutic purposes; and, monitor MIAM sales, usage, management practices, and resistance.

According to supporters, many antimicrobials used in food production are currently available at feed stores and online, without any veterinary prescription or oversight and this bill will stop this practice along with making all use of MIAMs require a prescription. Furthermore, supporters argue the prophylactic use exception has been carefully crafted for judicious use of MIAMs, and the bill explicitly forbids MIAM use for growth promotion and feed efficiency.

Opponents argue this explicitly authorizes the routine use of antibiotics on animals that are not sick through the exception for prophylactic use to prevent disease transmission or infection. Opponents fear prophylactic use will allow back door use for nontherapeutic purposes, and is precisely the low-dose use that contributes most to resistant bacteria. Furthermore, opponents assert that the expanded surveillance of MIAM relies on voluntary cooperation from participants to gather samples and is insufficient to provide statistically significant or accurate data on actual MIAM use and resistance.

The proposed amendments do the following:

1. Strike a section dealing with preventive use of MIAMs and instead allow for preventive use of MIAMs when it is determined by a veterinarian that MIAMs are needed to address an elevated risk of a disease or infection.
   
   
   

2. Clarify that CDFA has the authority to request and receive records related to VFDs, as specified.
   
   
   

3. Make technical and clarifying changes.

REGISTERED SUPPORT / OPPOSITION:

Support

Adventist Health

California Academy of Preventive Medicine

California Children’s Hospital Association

California Naturopathic Doctors Association

California Optometric Association

California Society of Health-System Pharmacists

California State Parent Teacher Association

California Veterinary Medical Association

Humane Society Veterinary Medical Association

Infectious Disease Association of California

Loma Linda University Health

Opposition

Alliance for the Prudent Use of Antibiotics

Animal Welfare Approved

California League of Conservation Voters

California Public Health Association –North

CALPIRG

Center for a Livable Future, Johns Hopkins Bloomberg School of Public Health

Center for Food Safety

Compassion Over Killing

Consumers Union

Dignity Health

Environmental Working Group

Food & Water Watch

Food Chain Workers Alliance

Green America

Health Care Without Harm

Institute for Agriculture and Trade Policy

Natural Resources Defense Council

Organic Consumers Association

Physicians for Social Responsibility, San Francisco Bay Area Chapter

Prevention Institute

Roots of Change

San Francisco Baykeeper

Slow Food California

Women Organizing Resources, Knowledge and Services (WORKS)

Analysis Prepared by: Victor Francovich / AGRI. / (916) 319-2084

SENATE THIRD READING

STR Bill Id:SB 27

Author:(Hill)

As Amended Ver:September 4, 2015

Majority vote

SENATE VOTE: 25-10

SUMMARY: Prohibits, beginning January 1, 2018, the use of medically important anti-microbial drugs (MIAMs) for the treatment of livestock animals, except pursuant to a prescription or feed directive from a licensed veterinarian and when, in the professional judgment of a licensed veterinarian, the MIAMs are necessary: 1) to treat a disease or infection; 2) to control the spread of disease or infection; 3) in relation to surgery or a medical procedure; or 4) as prophylaxis to prevent the elevated risk of disease transmission or infection. This bill forbids the use of MIAMs for growth promotion and feed efficiency.

In order to implement and monitor compliance with the MIAM rules, this bill requires the Department of Food and Agriculture (CDFA) to:

1) Coordinate with the federal Food and Drug Administration (FDA) to develop a program to track antimicrobial drug sales, use, resistance, and management practices;

2) Develop antimicrobial stewardship guidelines on good management practices in consultation with the Veterinary Medical Board (VMB), the Department of Public Health (DPH), universities, and Cooperative Extensions; and,

3) Conduct outreach and training, and report to the Legislature by January 1, 2019, the results of outreach and monitoring activities.

FISCAL EFFECT: According to the Assembly Appropriations Committee, this bill has:

1. Estimated General Fund (GF) and Special Fund (SF) costs of approximately $864,000 in 2015-16 and $4.8 million in 2016-17 to develop programs, stewardship guidelines, monitoring systems and procedures, and regulations, as well as begin training, inspections, and MIAMs use tracking. Annual GF and SF costs of approximately $4.3 million thereafter to continue training, inspections, and tracking. Some of these costs may be funded from federal and local sources, and potentially offset in part with civil fine revenue.

2. Potentially significant costs to VMB and DPH to help develop stewardship guidelines and training materials.

COMMENTS: Antimicrobial drugs have been widely used in human medicine since the 1940s. Antimicrobial drugs have significant health benefits in both human and animal medicine, and are important and valuable tools used to treat and prevent illness and infection. Incidences of antimicrobial resistance have been recorded over time and, if left unchecked, pose a threat to public health.

The Centers for Disease Control (CDC) estimates that in the United States, more than two million people are sickened every year with antibiotic-resistant infections, with at least 23,000 infections resulting in death. CDC notes that the use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Up to 50% of all antibiotics prescribed for people are either not needed or not optimally effective as prescribed. Antibiotics are also used in food-producing animals for the purpose of promoting growth, which CDC recommends phasing out.

The FDA has issued several industry recommendations regarding the use of MIAMs in the feed and drinking water of food-producing animals. The recommendations contained in Guidance for Industry #152, #213, and #219 establish lists of antibiotics important to human health, promote judicious use of those drugs in food production, and encourage veterinary oversight to ensure compliance with industry best practices.

In March 2015, President Obama issued a national action plan on combating antibiotic-resistant bacteria. The five-year action plan articulated goals of slowing the emergence of resistant bacteria, strengthening surveillance efforts, advancing the development and use of rapid diagnostics to identify resistant bacteria, accelerate development of new antibiotics, treatments, and vaccines, and improve collaboration among stakeholders. For antimicrobial use in food animals, the plan seeks to implement FDA guidance.

According to the author, overuse and misuse of antibiotics in livestock animals, especially antibiotics important in human medicine, contributes to antibiotic resistance. To address the overuse and misuse, this bill is intended to ensure veterinary oversight; encourage judicious use of MIAMS and prohibit use for growth promotion and other nontherapeutic purposes; and, monitor MIAM sales, usage, management practices, and resistance.

According to supporters, many antimicrobials used in food production are currently available at feed stores and online, without any veterinary prescription or oversight and this bill will stop this practice along with making all use of MIAMs require a prescription. Furthermore, supporters argue the prophylactic use exception has been carefully crafted for judicious use of MIAMs, and the bill explicitly forbids MIAM use for growth promotion and feed efficiency.

Opponents argue this explicitly authorizes the routine use of antibiotics on animals that are not sick through the exception for prophylactic use to prevent disease transmission or infection. Opponents fear prophylactic use will allow back door use for nontherapeutic purposes, and is precisely the low-dose use that contributes most to resistant bacteria. Furthermore, opponents assert that the expanded surveillance of MIAM relies on voluntary cooperation from participants to gather samples and is insufficient to provide statistically significant or accurate data on actual MIAM use and resistance.

Analysis Prepared by: Victor Francovich / AGRI. / (916) 319-2084 FN: 0002145

SENATE THIRD READING

STR Bill Id:SB 27

Author:(Hill)

As Amended Ver:August 31, 2015

Majority vote

SENATE VOTE: 25-10

SUMMARY: Prohibits, beginning January 1, 2018, the use of medically important anti-microbial drugs (MIAMs) for the treatment of livestock animals, except pursuant to a prescription or feed directive from a licensed veterinarian and when, in the professional judgment of a licensed veterinarian, the MIAMs are necessary: 1) to treat a disease or infection; 2) to control the spread of disease or infection; 3) in relation to surgery or a medical procedure; or 4) as prophylaxis to prevent the transmission of disease or infection in specific situations. This bill forbids the use of MIAMs for growth promotion and feed efficiency.

In order to implement and monitor compliance with the MIAM rules, this bill requires the California Department of Food and Agriculture (CDFA) to:

1) Coordinate with the federal Food and Drug Administration (FDA) to develop a program to track antimicrobial drug sales, use, resistance, and management practices;

2) Develop antimicrobial stewardship guidelines on good management practices in consultation with the Veterinary Medical Board (VMB), the Department of Public Health (DPH), universities, and Cooperative Extensions; and,

3) Conduct outreach and training, and report to the Legislature by January 1, 2019, the results of outreach and monitoring activities.

FISCAL EFFECT: According to the Assembly Appropriations Committee:

1. Estimated General Fund (GF) and Special Fund (SF) costs of approximately $864,000 in 2015-16 and $4.8 million in 2016-17 to develop programs, stewardship guidelines, monitoring systems and procedures, and regulations, as well as begin training, inspections, and MIAMs use tracking. Annual GF and SF costs of approximately $4.3 million thereafter to continue training, inspections, and tracking. Some of these costs may be funded from federal and local sources, and potentially offset in part with civil fine revenue.

2. Potentially significant costs to VMB and DPH to help develop stewardship guidelines and training materials.

COMMENTS: Antimicrobial drugs have been widely used in human medicine since the 1940s. Antimicrobial drugs have significant health benefits in both human and animal medicine, and are important and valuable tools used to treat and prevent illness and infection. Incidences of antimicrobial resistance have been recorded over time and, if left unchecked, pose a threat to public health.

The Centers for Disease Control and Prevention (CDC) estimates that in the United States, more than two million people are sickened every year with antibiotic-resistant infections, with at least 23,000 infections resulting in death. CDC notes that the use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Up to 50% of all antibiotics prescribed for people are either not needed or not optimally effective as prescribed. Antibiotics are also used in food-producing animals for the purpose of promoting growth, which CDC recommends phasing out.

The FDA has issued several industry recommendations regarding the use of MIAMs in the feed and drinking water of food-producing animals. The recommendations contained in Guidance for Industry #152, #213, and #219 establish lists of antibiotics important to human health, promote judicious use of those drugs in food production, and encourage veterinary oversight to ensure compliance with industry best practices.

In March 2015, President Obama issued a national action plan on combating antibiotic-resistant bacteria. The five-year action plan articulated goals of slowing the emergence of resistant bacteria, strengthening surveillance efforts, advancing the development and use of rapid diagnostics to identify resistant bacteria, accelerate development of new antibiotics, treatments, and vaccines, and improve collaboration among stakeholders. For antimicrobial use in food animals, the plan seeks to implement FDA guidance.

According to the author, overuse and misuse of antibiotics in livestock animals, especially antibiotics important in human medicine, contributes to antibiotic resistance. To address the overuse and misuse, this bill is intended to ensure veterinary oversight; encourage judicious use of MIAMS and prohibit use for growth promotion and other nontherapeutic purposes; and, monitor MAIM sales, usage, management practices, and resistance.

According to the supporters many antimicrobials used in food production are currently available at feed stores and online, without any veterinary prescription or oversight and this bill will stop this practice along with making all use of MIAMs require a prescription. Furthermore, supporters argue the prophylactic use exception has been carefully crafted for judicious use of MIAMs, and the bill explicitly forbids MIAM use for growth promotion and feed efficiency.

Opponents argue this explicitly authorizes the routine use of antibiotics on animals that are not sick through the exception for prophylactic use to prevent disease transmission or infection. Opponents fear prophylactic use will allow back door use for nontherapeutic purposes, and is precisely the low-dose use that contributes most to resistant bacteria. Furthermore, opponents assert that the expanded surveillance of MIAM relies on voluntary cooperation from participants to gather samples and is insufficient to provide statistically significant or accurate data on actual MIAM use and resistance.

Analysis Prepared by: Victor Francovich / AGRI. / (916) 319-2084 FN: 0001679

Date of Hearing: August 19, 2015

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Jimmy Gomez, Chair

SBPCA Bill Id:SB 27

Author:(Hill) – As Amended Ver:August 17, 2015

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill prohibits, beginning January 1, 2018, the use of medically important anti-microbial drugs (MIAMs) for the treatment of livestock animals, except pursuant to a prescription or feed directive from a licensed veterinarian and when, in the professional judgment of a licensed veterinarian, the MIAMs are necessary: (a) to treat a disease or infection; (b) to control the spread of disease or infection; (c) in relation to surgery or a medical procedure; or (d) as prophylaxis to prevent the transmission of disease or infection in specific situations. The bill forbids the use of MIAMs for growth promotion and feed efficiency.

In order to implement and monitor compliance with the MIAM rules, the bill requires the Department of Food and Agriculture (DFA) to:

1) Coordinate with the federal Food and Drug Administration (FDA) to develop a program to track antimicrobial drug sales, use, resistance, and management practices;

2) Develop antimicrobial stewardship guidelines on good management practices in consultation with the Veterinary Medical Board (VMB), the Department of Public Health (DPH), universities, and Cooperative Extensions; and

3) Conduct outreach and training, and report to the Legislature by January 1, 2019 the results of outreach and monitoring activities.

FISCAL EFFECT:

1) Estimated General and Special Fund costs of approximately $864,000 in FY 2015-16 and $4.8 million in FY 2016-17 to develop programs, stewardship guidelines, monitoring systems and procedures, and regulations, as well as begin training, inspections, and MIAMs use tracking. Annual GF and SF costs of approximately $4.3 million thereafter to continue training, inspections, and tracking. Some of these costs may be funded from federal and local sources, and potentially offset in part with civil fine revenue.

2) Potentially significant costs to VMB and DPH to help develop stewardship guidelines and training materials.

COMMENTS:

1) Purpose. According to the author, overuse and misuse of antibiotics in livestock animals, especially antibiotics important in human medicine, contributes to antibiotic resistance. To address the overuse and misuse, this bill is intended to ensure veterinary oversight; encourage judicious use of MIAMS and prohibit use for growth promotion and other nontherapeutic purposes; and monitor MAIM sales, usage, management practices, and resistance. According to the California Veterinary Medical Association (CVMA), many antimicrobials used in food production are currently available at feed stores and online, without any veterinary prescription or oversight.

2) Antibiotic Resistant Bacteria. The Centers for Disease Control (CDC) estimates more than two million people are infected with antibiotic-resistant bacteria in the United States each year, with at least 23,000 of those infections resulting in death. The CDC claims the use of antibiotics is the single most important factor leading to antibiotic resistance around the world. According to the World Health Organization, antibiotics are used in greater quantities in healthy food-producing animals than in the treatment of disease in humans.

The FDA has issued several industry recommendations regarding the use of MIAMs in the feed and drinking water of food-producing animals. The recommendations contained in Guidance for Industry #152, #213, and #219 establish lists of antibiotics important to human health, promote judicious use of those drugs in food production, and encourage veterinary oversight to ensure compliance with industry best practices.

In March 2015, President Obama issued a national action plan on combating antibiotic-resistant bacteria. The five year action plan articulated goals of slowing the emergence of resistant bacteria, strengthening surveillance efforts, advancing the development and use of rapid diagnostics to identify resistant bacteria, accelerate development of new antibiotics, treatments, and vaccines, and improve collaboration among stakeholders. For antimicrobial use in food animals, the plan seeks to implement the FDA guidance.

3) FDA Guidance Insufficient. SB 835 (Hill), statutes of 2014, sought to codify the FDA guidance, but was vetoed by the Governor. In his veto message, the Governor indicated most animal producers were voluntarily complying with the FDA guidance, but that more needed to be done study the problem and reduce reliance on antibiotics.

4) The Prophylactic Problem. Opponents, led by Natural Resources Defense Council (NRDC), argue SB 27 explicitly authorizes the routine use of antibiotics on animals that are not sick through the exception for prophylactic use to prevent disease transmission or infection. NRDC argues prophylactic use will allow back door use for nontherapeutic purposes, and is precisely the low-dose use that contributes most to resistant bacteria.

In response, the CVMA argues the prophylactic use exception has been carefully crafted for judicious use of MIAMs, and the bill explicitly forbids MIAM use for growth promotion and feed efficiency. Furthermore, CVMA claims the bill requires veterinary input and prescriptions for use of MIAMs, and requires livestock owners to follow veterinary instructions. SB 361 (Hill), a companion bill to this legislation, further requires veterinarians to undertake continuing education pertaining to the judicious use of antimicrobials.

5) Voluntary Monitoring. SB 27 requires DFA to coordinate with the FDA on efforts to expand surveillance of MIAM use and resistant bacteria, relying on voluntary cooperation from participants to gather samples. Opponents assert such a system is insufficient to provide statistically significant or accurate data on actual MIAM use and resistance.

Analysis Prepared by: Joel Tashjian / APPR. / (916) 319-2081

Date of Hearing: July 1, 2015

ASSEMBLY COMMITTEE ON AGRICULTURE

Henry Perea, Chair

SBPCA Bill Id:SB 27

Author:(Hill) – As Amended Ver:June 25, 2015

SENATE VOTE: 25-10

SUBJECT: Livestock: use of antimicrobial drugs.

SUMMARY: This bill restricts the use of medically important antimicrobial (MIAM) drugs in livestock for specified purposes, requires a veterinarian’s prescription or feed directive for use, and eliminates the over-the-counter availability of these drugs; requires the California Department of Food and Agriculture (CDFA) to develop a program to track antimicrobial drug use in livestock and the emergence of antimicrobial-resistant bacteria; and, requires CDFA to adopt judicious use and antimicrobial stewardship guidelines. Specifically, this bill:

1. Provides definitions for both “medically important antimicrobial drug” and “livestock.”

2. Prohibits, beginning January 1, 2018, the administration of a MIAM drug unless ordered by a veterinarian, through a prescription or feed directive, that has established a veterinarian-client-patient relationship.

3. Prohibits, beginning January 1, 2018, the use of a MIAM drug except when, in the professional judgment of a licensed veterinarian, the drug is necessary for any of the following:

1. To treat a disease or infection;

2. To control the spread of a disease or infection;

3. In relation to surgery or a medical procedure; and,

4. To prevent the transmission of a particular disease or infection known or suspected to occur in a specific situation.

4. Prohibits a person from administering a MIAM drug to livestock for solely the purposes of promoting weight gain or improving feed efficiency.
   
   

5. Prohibits a person from administering a MIAM drug in a repeated or regular pattern unless if consistent with #3, above.
   
   

6. Allows MIAM to be sold at a feed store, as specified, with proof of a veterinarian order.
   
   

7. Allows CDFA to develop regulation, as specified.
   
   

8. Allows CDFA to implement programs to promote the judicious use of MIAM drugs in livestock. Programs may include, but are not limited to, antimicrobial stewardship guidelines, as specified.
   
   

9. Requires CDFA to work with specified stakeholders on ensuring that livestock has timely access to treatment in rural areas.
   
   

10. Defines “antimicrobial stewardship” as a commitment to:

1. Use MIAM drugs only when necessary to treat, control, and, in some cases, prevent disease;

2. Choose and administer the appropriate MIAM drug correctly each time; and,

3. Use MIAM drugs for the shortest duration necessary and administered to the fewest animals necessary.
   
   

1. Requires CDFA, in consultation with the Veterinary Medical Board (VMB), to sponsor projects or collaborate with specified entities to:
   
   

   1. Promote and develop training material to develop stewardship practices; and,
      
      

   2. Disseminate scientifically validated practical alternatives that may reduce antimicrobial use.
      
      

2. Requires CDFA to develop a monitoring program that gathers information on sales, usage, resistance, and management practice data. Requires CDFA to coordinate with federal monitoring systems and ensure that the monitoring program is compatible and not duplicative of the federal programs.
   
   

3. Allows CDFA to request information from livestock owners, veterinarian and distributors related to feed directives and prescriptions. Requires participation in information requests be done in a way that does not breach veterinary patient confidentiality law.
   
   

4. Requires CDFA to seek federal, state or other funds to implement the monitoring program.
   
   

5. Requires CDFA to consider how best to gather representative samples from:
   
   

   1. California’s major livestock segments;

   2. Regions with considerable livestock production; and,

   3. Representative segments of the food production chain.
      
      

6. Requires CDFA's monitoring program to work with willing participants and allows CDFA to consult with specified stake holders in implementing the monitoring program.
   
   

7. Requires that any released information gathered by the monitoring program is aggregated to prevent the identification of individual farms or businesses. Allows an exemption for the purpose of enforcing the Veterinary Medicine Practice Act.
   
   

8. Provides a $250.00 per day civil fine for a violation of this law. Provides for a $500 per day administrative fine for subsequent violations that take place with a year of a civil fine, in addition to attending an education program on the judicious use of antimicrobials, as specified.
   
   

   1. Allows the VMB to take action against a veterinarian in violation of this law.
      
      

9. Requires, starting January 1, 2018, veterinarians applying for licensure must complete an approved course on the judicious use of antimicrobials every four years, as a part of the continuing education requirement.

EXISTING LAW:

Federal law:

1. Requires the Food and Drug Administration (FDA) to protect public health by ensuring the safety, effectiveness, quality, and security of human and veterinary drugs. Within FDA, the Center for Veterinary Medicine regulates the manufacture and distribution of drugs that will be administered to animals and regulates medicated feed.

2. Establishes the Animal Drug Availability Act in 1996 to create a new regulatory category for certain animal drugs used in animal feed. Previously, drugs were only available through two means: over-the-counter (OTC) and by prescription. As new drugs (antimicrobials) were developed, FDA recognized the need for these drugs to be administered through feed.

3. Creates the Veterinary Feed Directive (VFD) to allow more flexibility for new animal drugs to be administered through medicated feed but done so under the supervision of a licensed veterinarian.

State law:

1. Requires CDFA, through the Livestock Drug Program, to regulate the manufacture, sale, registration, and use of livestock drugs, except when the livestock drug is sold by prescription only, used exclusively by a veterinarian, or used only under a veterinarian’s direction. CDFA is required to register OTC livestock drugs and regulate their use for safety and efficacy.

2. Requires the California State Board of Pharmacy to enforce laws and regulations regarding prescription drugs and drugs used exclusively by veterinarians.

FISCAL EFFECT: Unknown. This bill has been keyed fiscal by Legislative Counsel.

COMMENTS: Antimicrobial drugs have been widely used in human medicine since the 1940s. Antimicrobial drugs have significant health benefits in both human and animal medicine, and are important and valuable tools used to treat and prevent illness and infection. Incidences of antimicrobial resistance have been recorded over time and, if left unchecked, pose a threat to public health.

The Centers for Disease Control (CDC) estimates that in the United States, more than two million people are sickened every year with antibiotic-resistant infections, with at least 23,000 infections resulting in death. In a recent report, CDC lists four core actions that fight the spread of antibiotic resistance: 1) preventing infections from occurring and preventing resistant bacteria from spreading; 2) tracking resistant bacteria; 3) improving the use of antibiotics; and, 4) promoting the development of new antibiotic and new diagnostic tests for resistant bacteria.

CDC notes that the use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Up to 50% of all antibiotics prescribed for people are either not needed or not optimally effective as prescribed. Antibiotics are also used in food-producing animals for the purpose of promoting growth, which CDC recommends phasing out.

In the past decade, FDA has worked on creating Guidance for Industry (GFI) regarding the judicious use of MIAM drugs in food producing animals. In three GFIs, FDA has: 1) GFI #152, compiled a list of MIAM drugs categorized by their importance to human health; 2) GFI #219, developed principals that determine the appropriate or judicious use of such drugs, by limiting use to only when necessary to maintain animal health, and with veterinary oversight or consultation; and, 3) GFI #213 provided recommendations as to the implementation of the guidelines. The FDA concludes that using MIAM drugs for animal growth promotion or feed efficiency is not a judicious use, and that veterinary oversight or consultation is necessary when using these drugs.

In December 2013, FDA released the final draft of GFI #213. GFI #213 contains nonbinding recommendations to industry regarding the use of MIAM drugs in the feed and drinking water of food-producing animals. FDA intends to work with drug companies to help them voluntarily implement the recommendations, which include: 1) phasing out the use of MIAM drugs in food-producing animals for production purposes (growth promotion and feed efficiency); and, 2) include veterinary oversight of these drugs when used in the feed or water of food-producing animals.

In September of 2014, President Obama issued an Executive Order: Combating Antibiotic-Resistant Bacteria, and the National Strategy for Combating Antibiotic-Resistant Bacteria, and in March 2015, the White House issued the National Action Plan for Combating Antibiotic-Resistant Bacteria (Action Plan). The Action Plan lays out a five-year plan with five distinct goals: 1) slow the emergence of resistant bacteria; 2) strengthen One-Health surveillance efforts; 3) advance the development and use of rapid diagnostic tests to identify resistant bacteria; 4) accelerate the development of new antibiotics, other treatments, and vaccines; and, 5) improve international collaboration to achieve these goals. For antimicrobial use in food animals (livestock), the Action Plan seeks to implement FDA’s GFIs.

USDA currently operates national laboratory systems that survey national animal health and monitor antimicrobial resistance: the National Animal Health Monitoring System (NAHMS) and the National Antimicrobial Resistance Monitoring System (NARMS). NAHMS collects and analyzes data on animal health, management, and productivity and to conduct national studies on livestock populations. Under federal confidentially laws, data collected by NAHMS allows producers or livestock owners to voluntarily provide sensitive and confidential information such as on-farm management practices and animal health issues. USDA states that this is vital to encourage voluntary participation and to maintain high response rates.

NARMS was established by FDA in conjunction with CDC and USDA to monitor trends in antimicrobial resistance from human, retail meat, and food animal samples. The goals and objectives of NARMS’ monitoring program are to monitor trends in antimicrobial resistance among foodborne bacteria, conduct research to better understand the emergence and spread of resistant bacteria, and to assist FDA in decision making for the approval of antimicrobial drugs for animals.

The California Animal Health and Food Safety (CAHFS) Laboratory System is the state entity responsible for providing rapid diagnostic testing for animal health diseases, and those diseases that affect humans. CAHFS is part of the National Animal Health Laboratory Network, which has been included as a component of national surveillance efforts in President Obama’s Action Plan for combating antimicrobial resistance.

The author states the overuse and misuse of antibiotics, especially antibiotics important in human medicine, contributes to antibiotic resistance as a growing public health threat. Inappropriate antibiotic use and overuse in humans drives the development of antibiotic resistance, but there is also a concern about antibiotic use in livestock and poultry. To address the issues of antibiotic use in livestock and poultry, this bill will do the following: 1) Ensure veterinary oversight by requiring prescriptions for antibiotics administered to livestock; 2) Prohibit the use of MIAM for growth promotion; 3) Monitor MIAM sales, usage, resistance and management practice data; 4) Promote the judicious use of MIAMs; and, 5) require veterinarians to have continuing education on the judicious use of MIAMs. This bill is a significant step forward in overseeing the use of MIAMs.

The California Veterinary Medical Association (CVMA) has a support if amended position. CVMA has expressed strong support for this bill especially placing the use of MIAM under Veterinary oversight, via prescription and VFDs. CVMAs main concern in this bill is a potential "double jeopardy" for veterinarians due to the fines for violations in this legislation. Veterinarians would also be penalized under the VMB, which can include fines, probation and revocation of licenses. CVMA requested removing this "double jeopardy" for veterinarians and leaving disciplinary measures with in the VMB.

The Humane Society Veterinary Medical Association (HSVMA) has a support with amendments position. HSVMA states this bill has the potential to start California on the path to lessen antimicrobial resistance caused by the overuse of MIAMs in animal agriculture. HSVMA has suggested the following amendments:

1. Strengthening reporting requirements to CDFA on VFD and prescription use, and defining VFD or reference the definition in GFI's #209 and #213.
   
   

2. More specific language related to the continued sale of MIAMs at retail locations under this bill.
   
   

3. Changes to the antimicrobial stewardship program to add focus on lessening the use of MAIM, "allow" instead of "require" CDFA to consult with various groups and add a public health organization to the list of organizations to be consulted with for the program.
   
   

4. Tiering the fines for violations of this bill based on number of animals and the volume of MIAMs involved in the violation.

Opponents, many of which are opposed unless amended, state this bill does not go far enough to restrict the use of antimicrobial drugs for preventative or routine uses in livestock. Opponents point out antibiotic-resistant infections can result in longer illnesses, more hospitalizations, antibiotics with greater side-effects, and even death when treatments fail. Resistant infections are estimated to cost the U.S. up to $61 billion annually in additional health care costs and lost productivity. Furthermore, about 70% of all medically important antibiotics sold in the US are used in livestock, where much of the use is to accelerate animal growth and to offset risks created by the crowded and stressful conditions at many livestock and poultry facilities. Medical, veterinary, and scientific groups have called for an end to the misuse and overuse of antibiotics in livestock to help combat the rise of antibiotic resistance.

Opponents state the bill would stop the routine use of MIAMs in livestock that are used for growth promotion, but does not stop the use of the same MIAMs to prevent disease, which are made worse by crowded, stressful and unsanitary conditions. Many MAIMs have overlapping approved use of growth promotion and disease prevention; opponents state this bill would allow the continued use of growth promotion under the allowed disease prevention use. Opponents have mentioned the most effective way to lower MIAM use is to prohibit all antibiotic use in livestock production except for the treatment of sick animals.

The committee may which to consider the following technical amendments for conforming purposes:

1. On page six, line 21, before the word veterinarian insert the word licensed.

2. On page eight, line 16, strike the word animal, and replace with livestock.

REGISTERED SUPPORT / OPPOSITION:

 THIRD READING  

Bill No: SB 27

Author: Hill (D)

Amdended: 6/1/15

Vote: 21

SENATE AGRICULTURE COMMITTEE: 3-0, 4/21/15

AYES: Galgiani, Pan, Wolk

NO VOTE RECORDED: Cannella, Berryhill

SENATE APPROPRIATIONS COMMITTEE: 5-2, 5/28/15

AYES: Lara, Beall, Hill, Leyva, Mendoza

NOES: Bates, Nielsen

SUBJECT: Livestock: use of antimicrobials drugs

SOURCE: Author

DIGEST: This bill restricts the use of medically important antimicrobial drugs in livestock for specified purposes, requires a veterinarian’s prescription or feed directive for use, and eliminates the over-the-counter availability of these drugs; requires the California Department of Food and Agriculture (CDFA) to develop a program to track antimicrobial drug use in livestock and the emergence of antimicrobial-resistant bacteria should funds be made available; and requires CDFA to adopt judicious use regulations and antimicrobial stewardship guidelines.

ANALYSIS:

Existing federal law:

1. Requires the Food and Drug Administration (FDA) to protect public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs. Within FDA, the Center for Veterinary Medicine regulates the manufacture and distribution of drugs that will be administered to animals and regulates medicated feed.

2. Establishes the Animal Drug Availability Act in 1996 to create a new regulatory category for certain animal drugs used in animal feed. Previously, drugs were only available through two means: over-the-counter (OTC) and by prescription. As new drugs (antimicrobials) were developed, FDA recognized the need for these drugs to be administered through feed. However, FDA wanted to establish greater control and safety measures than were currently available under OTC status since some of these drugs could contribute to drug toxicity and antimicrobial resistance or have other unintended outcomes. Therefore, the Veterinary Feed Directive (VFD) was created to allow more flexibility for new animal drugs to be administered through medicated feed but done so under the supervision of a licensed veterinarian (78 Federal Register 75517, December 12, 2013).

Existing state law:

1. Requires CDFA, through the Livestock Drug Program, to regulate the manufacture, sale, registration, and use of livestock drugs, except when the livestock drug is sold by prescription only, used exclusively by a veterinarian, or used only under a veterinarian’s direction. CDFA is required to register OTC livestock drugs and regulate their use for safety and efficacy (Food and Agricultural Code §14200 et seq.).

2. Requires the California State Board of Pharmacy to enforce laws and regulations regarding prescription drugs and drugs used exclusively by veterinarians (Business and Professions Code § 4000 et seq.).

This bill:

1. Provides definitions for both “medically important antimicrobial drug” and “livestock.”

2. Prohibits, beginning January 1, 2017, the administration of a medically important antimicrobial drug unless ordered by a veterinarian, through a prescription or feed directive, that has established a veterinarian-client-patient relationship.

3. Prohibits, beginning January 1, 2017, the use of a medically important antimicrobial drug except when, in the professional judgement of a licensed veterinarian, the drug is necessary for any of the following:

1. To treat or control the spread of a disease or infection.

2. In relation to surgery or a medical procedure.

3. To prevent the transmission of a particular disease or infection known to occur in a specific situation.

4. Prohibits a person from administering a medically important antimicrobial drug in a repeated or regular pattern unless if consistent with #3, above.

5. Prohibits a person from administering a medically important antimicrobial drug to livestock for the purposes of promoting weight gain or improving feed efficiency.

6. Requires CDFA, should funds be made available, to develop a program or participate in an initiative to track the use of medically important antimicrobial drugs in livestock as well as antimicrobial-resistant bacteria and patterns of emerging resistance.

7. Requires CDFA to adopt regulations to promote the judicious use of medically important antimicrobial drugs in livestock. Regulations shall include antimicrobial stewardship guidelines that include rules on the proper use of medically important antimicrobial drugs for disease prevention.

8. Defines “antimicrobial stewardship” as a commitment to:

1. Use medically important antimicrobial drugs only when necessary to treat, control, and, in some cases, prevent disease.

2. Choose and administer the appropriate medically important antimicrobial drug correctly each time.

3. Use medically important antimicrobial drugs for the shortest duration necessary and administered to the fewest animals necessary.

Background

Antimicrobial drugs were first developed in 1928 and became widely used in human medicine in the 1940s. These new drugs quickly proved to have significant health benefits in both human and animal medicine and to this day are extremely valuable tools used to treat and prevent illness and infection. However, incidences of antimicrobial resistance have been recorded over time and, if not addressed, pose a serious threat to public health.

Antimicrobial resistance may develop for several reasons. One of the most widely accepted contributors to antimicrobial resistance is the misuse of antimicrobial drugs. When bacteria are exposed to an antimicrobial drug, it provides the opportunity for “survival of the fittest” where only the strongest, most immune bacteria survive. These surviving, antimicrobial-resistant bacteria then multiply to form new colonies of resistant bacteria that may spread and infect other individuals. For this reason, it is important to use antimicrobial drugs judiciously in both human and animal medicine as one method to mitigate resistance.

The Centers for Disease Control and Prevention (CDC) recently issued a report titled Antibiotic Resistance Threats in the United States, 2013. The CDC estimates that in the United States more than two million people are sickened every year with antibiotic-resistant infections with at least 23,000 infections resulting in death. In its report, the CDC lists four core actions that fight the spread of antibiotic resistance: 1) preventing infections from occurring and preventing resistant bacteria from spreading, 2) tracking resistant bacteria, 3) improving the use of antibiotics, and 4) promoting the development of new antibiotics and new diagnostic tests for resistant bacteria.

The CDC notes that the use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Up to 50% of all antibiotics prescribed for people are either not needed or not optimally effective as prescribed. Antibiotics are also used in food-producing animals for the purpose of promoting growth, which the CDC recommends phasing out. The US Food and Drug Administration (FDA) has developed guidances (described below) to promote judicious use of antimicrobials that would prohibit their use for improved feed efficiency or increased weight gain. According to the FDA’s annual report on antimicrobial sales for animal use, 97% of medically important antimicrobial drugs are sold OTC and not through a veterinarian’s prescription or feed directive. The FDA guidances will address this issue and others, as described in further detail below.

In December 2013, the FDA released the final draft of the Guidance for Industry #213 (GFI #213), which contains nonbinding recommendations regarding the use of medically important antimicrobial drugs in the feed and drinking water of food-producing animals. These recommendations include: 1) phasing out the use of medically important antimicrobial drugs in food-producing animals for production purposes (growth promotion and feed efficiency) and 2) veterinary oversight of these drugs when used in the feed or water of food-producing animals.

The FDA’s GFI #213 would change the status of antimicrobial drugs administered in feed from OTC to VFD. Due to this change, the FDA recognizes that current VFD regulations must be revised and streamlined to minimize the impact on veterinarians, the animal feed industry, and producers. These revisions are believed to be critically important and are scheduled to be completed before the three-year implementation timeline for GFI #213.

On September 18, 2014, President Obama issued Executive Order 13676: Combating Antibiotic-Resistant Bacteria, which states that this is an issue of national security and that “the Federal Government will work domestically and internationally to detect, prevent, and control illness and death related to antibiotic-resistant infections by implementing measures that reduce the emergence and spread of antibiotic-resistant bacteria and help ensure the continued availability of effective therapeutics for the treatment of bacterial infections.” Later that same month, the White House issued the National Strategy for Combating Antibiotic-Resistant Bacteria, and in March 2015, the White House issued the National Action Plan for Combating Antibiotic-Resistant Bacteria (Action Plan).

The Action Plan lays out a five-year plan with five distinct goals: 1) slow the emergence of resistant bacteria, 2) strengthen One-Health surveillance efforts, 3) advance the development and use of rapid diagnostic tests to identify resistant bacteria, 4) accelerate the development of new antibiotics, other treatments, and vaccines, and 5) improve international collaboration to achieve these goals. For antimicrobial use in food animals (livestock), the Action Plan seeks to implement FDA’s guidances for industry, described later in this analysis.

The United States Department of Agriculture (USDA) currently operates national laboratory systems that survey national animal health and monitor antimicrobial resistance: the National Animal Health Monitoring System (NAHMS) and the National Antimicrobial Resistance Monitoring System (NARMS). NAHMS was created in 1983 to collect and analyze data on animal health, management, and productivity and to conduct national studies on livestock populations. NAHMS is recognized as a statistical unit under the Confidential Information Protection and Statistical Efficiency Act (CIPSEA), which allows producers or livestock owners to voluntarily provide sensitive and confidential information such as on-farm management practices and animal health issues. USDA states that this is vital to encourage voluntary participation and to maintain high response rates.

NARMS was established in 1996 by the FDA in conjunction with the CDC and USDA to monitor trends in antimicrobial resistance from human, retail meat, and food animal samples. The goals and objectives of NARMS’ monitoring program are to monitor trends in antimicrobial resistance among foodborne bacteria, conduct research to better understand the emergence and spread of resistant bacteria, and to assist the FDA in decision making for the approval of antimicrobial drugs for animals.

The California Animal Health and Food Safety (CAHFS) Laboratory System, created as a partnership between CDFA and the UC Davis School of Veterinary Medicine, is the state entity responsible for providing rapid diagnostic testing for animal health diseases, and those diseases that affect humans. Most recently, CAHFS has been involved in detecting avian influenza in both commercial and backyard poultry but also conducts testing on any animal brought to the lab with other concerns such as poisoning, salmonella or other bacterial infections, rabies, and other serious health issues for both livestock and pets. CAHFS is part of the National Animal Health Laboratory Network, which has been included as a component of national surveillance efforts in President Obama’s Action Plan for combating antimicrobial resistance.

Comments

Governor’s Veto. Governor Brown vetoed a previous version of this bill in 2014 (SB 835, Hill). In his veto message, Governor Brown stated that “more needs to be done to understand and reduce our reliance on antibiotics. To that end, I am directing the Department of Food and Agriculture to work with the Legislature to find new and effective ways to reduce the unnecessary antibiotics used for livestock and poultry.”

Work-in-progress: The author and many of the stakeholder groups are aware that this bill is a working draft and does not represent the final language or all of the issues involved with limiting antimicrobial use in livestock. Several stakeholder groups have expressed interest in continuing to work with the author, and although many have chosen not to provide position letters at this point, the author has received a letter stating this intent from the California Veterinary Medical Association.

Veterinarian-client-patient relationship. The California Code of Regulations (16 CCR § 2032.1) requires a veterinarian to establish a veterinarian-client-patient relationship before administering, prescribing, dispensing, or furnishing a drug or medicine. This relationship is established when the veterinarian has sufficient knowledge of the animal through an examination or by medically appropriate and timely visits to the premises where the animal is housed. Additionally, a veterinarian shall not prescribe a drug for longer than one-year duration.

Preventative and routine use. There is argument as to whether antimicrobial drugs are being used judiciously when administered to animals for the purpose of disease prevention. The concern relates to the use of antimicrobial drugs when a disease is not clinically present and which could provide the opportunity for the continual, prolonged, or routine use of antimicrobial drugs in food animals.

However, the California Veterinary Medical Association is concerned that if antimicrobial use is restricted then veterinarians would be prevented from “making the best medical decisions for the health and welfare of their patients. There are many instances where it is important to administer antibiotics prophylactically, such as to prevent the active spread of ‘silent killer’ diseases such as Chlamydophila abortus in sheep, particularly when there is no test available to determine which sheep are the carriers of the disease. Veterinarians must have the flexibility to provide scientific and medically appropriate treatment for animals under their care.”

Tracking. The creation of an antimicrobial use and resistance tracking program has expressed support from the Natural Resources Defense Council, which believes that more data should be collected and available given the amount of antimicrobials used in feed and water. Conversely, a tracking program is an expressed concern of many of the agricultural stakeholders as well as the California Veterinary Medical Association given that the implementation of such a program is believed to be difficult and expensive, and that many details and responsibilities not specified in the current bill. For instance, it is unclear which entity would be required to report antimicrobial use: the producer, veterinarian, slaughterhouse, feed mill, or other entity. Another great concern of these groups is confidentiality of this information, as previously described with the NAHMS laboratory. Furthermore, the federal government is currently proposing an expanded nationwide antimicrobial use and resistance surveillance program, as outlined in the USDA Antimicrobial Resistance Plan published in June 2014 and in President Obama’s Action Plan.

Over-the-counter accessibility. This bill would eliminate the OTC availability of all medically important antimicrobial drugs administered to livestock. However, there are concerns from the livestock industry that this change will limit their ability to obtain necessary medication for their livestock. In some cases, the ranch is located in a remote area where a veterinarian is not readily available. Furthermore, if the antimicrobial is no longer available OTC at the local farm store and given that not all pharmacies carry livestock drugs, there is concern that the antimicrobial will not be available for purchase in a timely manner. However, the California Veterinary Medical Association believes that “there should be veterinary supervision of antimicrobial drugs in animals, since their improper use has serious implications.”

Antimicrobial stewardship. Several livestock industries have developed best management practices/quality assurance/herd improvement programs that address animal welfare and food safety issues. The Beef Quality Assurance program includes guidelines on the judicious use of antimicrobial drugs. Additionally, the American Veterinary Medical Association provides guidelines for the judicious use of antimicrobial drugs in livestock. Should this bill become law, CDFA may draw from these existing programs to develop a statewide guidance program; however, the issue of developing antimicrobial stewardship guidelines has not been thoroughly discussed within the context of this bill.

Continuing education. The California Veterinary Medical Association has proposed amendments that would make a course on the judicious use of antimicrobial drugs a required component of continuing education courses for veterinary license renewal. Currently, veterinarians must complete 36 hours of continuing education credits every two years as a requirement of license renewal. These classes allow veterinarians to stay current on new therapies, studies, treatments, illnesses, technologies, and other related issues; therefore if this amendment were adopted, veterinarians would be required to attend an approved course on the judicious use of antimicrobial drugs at least once every two years (Business and Professions Code § 4846.5).

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Senate Appropriations Committee, there are “unknown costs to CDFA to develop a program to track the use of antimicrobial drugs in livestock. Cost would be dependent on the scope of the program developed and the extent to which funding is made available (special fund).”

SUPPORT: (Verified 5/29/15)

None received

OPPOSITION: (Verified 5/29/15)

California League of Conservation Voters

California Public Health Association – North

CALPIRG

Center for Food Safety

Consumers Union

Dignity Health

Environmental Working Group

Food & Water Watch

Food Chain Workers Alliance

Health Care Without Harm

Humane Society Veterinary Medical Association

Natural Resources Defense Council

Physicians for Social Responsibility, San Francisco Bay Area Chapter

Prevention Institute

Roots of Change

ARGUMENTS IN SUPPORT: According to the author, “The overuse and misuse of antibiotics, especially antibiotics important in human medicine, contributes to antibiotic resistance as a growing public health threat. Inappropriate antibiotic use and overuse in humans drives the development of antibiotic resistance, but there is also a concern about antibiotic use in livestock and poultry. Based on the best information available from the federal Food and Drug Administration (FDA), it’s estimated that at least 70 percent of all medically important antibiotics are sold for use in livestock and poultry. […] The data available on antibiotic use in livestock and poultry is in itself a problem; in large part, many consider the data to be insufficient since the only data collected is sales data. More, and better data, needs to be collected to properly address this issue. While there may be data gaps about antibiotic use in livestock and poultry, we do know that under current law the majority of medically important antibiotics may be sold for use in livestock and poultry without veterinary oversight. […] Antibiotic stewardship programs are a commitment to always use antibiotics only when they are necessary, to choose the right antibiotics and to administer them in the right way in every case. Antibiotic stewardship programs have been effective in reducing inappropriate antibiotic use in humans, as well in reducing antibiotic resistance. […] However, there is no similar requirement that veterinarians and livestock and poultry producers follow antibiotic stewardship guidelines.”

ARGUMENTS IN OPPOSITION: All of the organizations listed on this analysis under “Opposition”, except for the Consumers Union, are in fact “Opposed unless amended.” These organizations have the same concern: namely, that this bill does not go far enough to restrict the use of antimicrobial drugs for preventative or routine uses in livestock. These organizations state that, “Antibiotic-resistant infections can result in longer illnesses, more hospitalizations, antibiotics with greater side-effects, and even death when treatments fail. Resistant infections are estimated to cost the U.S. up to $61 billion annually in additional health care costs and lost productivity. Growing resistance also puts complicated medical procedures such as heart surgery, organ transplants, and chemotherapy in jeopardy” due to reliance on effective antibiotics. Furthermore, about 70% of all medically important antibiotics sold in the US are used in livestock, where much of the use is to accelerate animal growth and to offset risks created by the crowded and stressful conditions at many livestock and poultry facilities. “Medical, veterinary, and scientific groups have called for an end to the misuse and overuse of antibiotics in livestock to help combat the rise of antibiotic resistance.”

The Consumers Union has similar concerns regarding the preventative use of antimicrobial drugs, as well as the concern that “the data reporting part of the bill does not require reporting of total quantity of antibiotics used.”

Prepared by: Anne Megaro / AGRI. / (916) 651-1508

6/1/15 19:33:04

**** END ****

SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

SB 27 (Hill) - Livestock: use of antibiotics

SUSPENSE FILE. AS AMENDED.

Bill Summary:

This bill would (1) restrict the use of antimicrobial drugs in livestock for specified purposes and require a veterinarian’s prescription, (2) require the California Department of Food and Agriculture (CDFA) to develop a program to track both antimicrobial use in livestock and the emergence of antibiotic-resistant bacteria, and (3) require CDFA to adopt judicious use regulations and antibiotic stewardship guidelines. Additionally, the bill would create a new crime, such that violations of its provisions would be a misdemeanor punishable by a fine and/or imprisonment in a county jail, as specified.

Fiscal Impact (as approved on May 28, 2015):

Unknown costs to CDFA to develop a program to track the use of antimicrobial drugs in livestock. Cost would be dependent on the scope of the program developed and the extent to which funding is made available (special fund).

Background:

Antimicrobial drugs were first developed in 1928 and became widely used in human medicine in the 1940s. These new drugs quickly proved to have significant health benefits in both human and animal medicine and to this day are extremely important and valuable tools used to treat and prevent illness and infection. However, incidences of antimicrobial resistance have been recorded over time and, if not addressed, pose a serious threat to public health.

Antimicrobial resistance may develop for several reasons, and one of the most widely accepted contributors to antimicrobial resistance is the misuse of antimicrobial drugs. When bacteria are exposed to an antimicrobial drug, it provides the opportunity for ‘survival of the fittest’ where only the strongest, most immune bacteria survive. These surviving antimicrobial-resistant bacteria then multiply to form new colonies of resistant bacteria that may spread and infect other individuals. For this reason, it is important to use antimicrobial drugs judiciously in both human and animal medicine as one method to mitigate resistance.

In 2013, the Centers for Disease Control and Prevention (CDC) issued a report titled Antibiotic Resistance Threats in the United States. CDC estimates that, nationwide, more than two million people are sickened every year with antibiotic-resistant infections, 23,000 of which result in death. In its report, CDC lists four core actions that fight the spread of antibiotic resistance: 1) preventing infections from occurring and preventing resistant bacteria from spreading, 2) tracking resistant bacteria, 3) improving the use of antibiotics, and 4) promoting the development of new antibiotics and new diagnostic tests for resistant bacteria.

CDC notes that the use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Up to 50 percent of all antibiotics prescribed for people are either not needed or not optimally effective as prescribed. Antibiotics are also used in food-producing animals for the purpose of promoting growth, which the CDC recommends phasing out. The US Food and Drug Administration (FDA) has developed guidances to promote judicious use of antimicrobials that would prohibit their use for improved feed efficiency or increased weight gain. According to the FDA’s annual report on antimicrobial sales for animal use, 97 percent of medically important antimicrobial drugs are sold over-the-counter and not through a veterinarian’s prescription or feed directive.

September 18, 2014, President Obama issued Executive Order 13676: Combating Antibiotic-Resistant Bacteria, which states that this is an issue of national security and that “the Federal Government will work domestically and internationally to detect, prevent, and control illness and death related to antibiotic-resistant infections by implementing measures that reduce the emergence and spread of antibiotic-resistant bacteria and help ensure the continued availability of effective therapeutics for the treatment of bacterial infections.” Later that same month, the White House issued the National Strategy for Combating Antibiotic-Resistant Bacteria, and in March 2015, the White House issued the National Action Plan for Combating Antibiotic-Resistant Bacteria (Action Plan). The Action Plan lays out a five-year plan with five distinct goals: 1) slow the emergence of resistant bacteria, 2) strengthen One-Health surveillance efforts, 3) advance the development and use of rapid diagnostic tests to identify resistant bacteria, 4) accelerate the development of new antibiotics, other treatments, and vaccines, and 5) improve international collaboration to achieve these goals. For antimicrobial use in food animals (livestock), the Action Plan seeks to implement FDA’s guidances for industry.

Proposed Law:

This bill would, among other things, do the following:

• Provide definitions for both “medically important antimicrobial drug” and “livestock.”

• Prohibit the administration of a medically important antimicrobial drug unless prescribed by a veterinarian that has established a veterinarian-client-patient relationship.

• Prohibit the use of a medically important antimicrobial drug for the sole purpose of increasing weight gain or improving feed efficiency.

• Require CDFA to develop a program to track the use of medically important antimicrobial drugs in livestock as well as antibiotic-resistant bacteria and patterns of emerging resistance, and report specified information.

• Require CDFA, until March 1, 2020, to submit an annual report to the Legislature that summarizes the data from the tracking program.

• Require CDFA to adopt regulations to promote the judicious use of medically important antimicrobial drugs in livestock. Regulations shall include antibiotic stewardship guidelines that include rules on the proper use of medically important antimicrobial drugs for disease prevention.

• Define “antibiotic stewardship” as a commitment to: a) use medically important antimicrobial drugs only when necessary to treat and, in some cases, prevent disease and b) to choose and administer the appropriate medically important antimicrobial drug correctly each time.

• Create a new crime by making a violation of this chapter a misdemeanor punishable by up to six months in county jail and/or a fine not exceeding $1,000.

Related Legislation:

• SB 770 (Mendoza) of 2015. This bill would require the California Department of Food and Agriculture to continue to be the primary regulatory agency responsible for regulating medicated feed. This bill is currently on Third Reading on the Senate Floor.

• AB 49 (Mullin) of 2015. This bill would make findings and declarations regarding antibiotic use in food-producing animals and would state the intent of the legislature to enact legislation that would address the overuse of antibiotics in livestock production. This bill has not yet been assigned to a committee.

• SB 835 (Hill) of 2014. This bill would have codified the Food and Drug Administration’s Guidance for Industry #213, dated December 2013, by requiring CDFA to refuse to register a livestock drug administered in the feed or drinking water of food animals if such drug is a medically important antimicrobial drug. The bill was vetoed by the Governor.

• AB 1437 (Mullin) of 2014. This bill would have prohibited the sale of poultry or livestock in California if a medically important antimicrobial drug had been administered to the animal for nontherapeutic use such as growth promotion, feed efficiency, weight gain, or disease prevention. This bill would have required producers to maintain records and slaughter facilities to report specified information in regards to the use of medically important antimicrobial drugs. Hearing canceled at the request of the author; died in the Assembly Committee on Agriculture.

Staff Comments:

As noted above, the Governor vetoed a previous version of this bill in 2014 (SB 835, Hill). In his veto message, Governor Brown stated that “more needs to be done to understand and reduce our reliance on antibiotics. To that end, I am directing CDFA to work with the Legislature to find new and effective ways to reduce the unnecessary antibiotics used for livestock and poultry.” As was discussed when the bill had its hearing before the Senate Agriculture Committee, the current version of the bill is generally considered to be a working draft, and is currently awaiting input from the Administration.

Author Amendments (as adopted on May 28, 2015): Amendments would (1) eliminate the reporting requirement, (2) to make data tracking contingent on future funding, and (3) delete the bill’s establishment of a new crime.

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SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

SB 27 (Hill) - Livestock: use of antibiotics

This bill meets the criteria for referral to the Suspense File.

Bill Summary:

This bill would (1) restrict the use of antimicrobial drugs in livestock for specified purposes and require a veterinarian’s prescription, (2) require the California Department of Food and Agriculture (CDFA) to develop a program to track both antimicrobial use in livestock and the emergence of antibiotic-resistant bacteria, and (3) require CDFA to adopt judicious use regulations and antibiotic stewardship guidelines. Additionally, the bill would create a new crime, such that violations of its provisions would be a misdemeanor punishable by a fine and/or imprisonment in a county jail, as specified.

Fiscal Impact:

The precise fiscal impact of the bill’s provisions to CDFA is unclear at this time. However, because of the bill’s requirements that CDFA (1) track specified data, (2) adopt regulations, and (3) provide a specified report to the Legislature, this bill would likely result in annual new costs to CDFA in the hundreds of thousands of dollars minimally (special fund).

Background:

Antimicrobial drugs were first developed in 1928 and became widely used in human medicine in the 1940s. These new drugs quickly proved to have significant health benefits in both human and animal medicine and to this day are extremely important and valuable tools used to treat and prevent illness and infection. However, incidences of antimicrobial resistance have been recorded over time and, if not addressed, pose a serious threat to public health.

Antimicrobial resistance may develop for several reasons, and one of the most widely accepted contributors to antimicrobial resistance is the misuse of antimicrobial drugs. When bacteria are exposed to an antimicrobial drug, it provides the opportunity for ‘survival of the fittest’ where only the strongest, most immune bacteria survive. These surviving antimicrobial-resistant bacteria then multiply to form new colonies of resistant bacteria that may spread and infect other individuals. For this reason, it is important to use antimicrobial drugs judiciously in both human and animal medicine as one method to mitigate resistance.

In 2013, the Centers for Disease Control and Prevention (CDC) issued a report titled Antibiotic Resistance Threats in the United States. CDC estimates that, nationwide, more than two million people are sickened every year with antibiotic-resistant infections, 23,000 of which result in death. In its report, CDC lists four core actions that fight the spread of antibiotic resistance: 1) preventing infections from occurring and preventing resistant bacteria from spreading, 2) tracking resistant bacteria, 3) improving the use of antibiotics, and 4) promoting the development of new antibiotics and new diagnostic tests for resistant bacteria.

CDC notes that the use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Up to 50 percent of all antibiotics prescribed for people are either not needed or not optimally effective as prescribed. Antibiotics are also used in food-producing animals for the purpose of promoting growth, which the CDC recommends phasing out. The US Food and Drug Administration (FDA) has developed guidances to promote judicious use of antimicrobials that would prohibit their use for improved feed efficiency or increased weight gain. According to the FDA’s annual report on antimicrobial sales for animal use, 97 percent of medically important antimicrobial drugs are sold over-the-counter and not through a veterinarian’s prescription or feed directive.

September 18, 2014, President Obama issued Executive Order 13676: Combating Antibiotic-Resistant Bacteria, which states that this is an issue of national security and that “the Federal Government will work domestically and internationally to detect, prevent, and control illness and death related to antibiotic-resistant infections by implementing measures that reduce the emergence and spread of antibiotic-resistant bacteria and help ensure the continued availability of effective therapeutics for the treatment of bacterial infections.” Later that same month, the White House issued the National Strategy for Combating Antibiotic-Resistant Bacteria, and in March 2015, the White House issued the National Action Plan for Combating Antibiotic-Resistant Bacteria (Action Plan). The Action Plan lays out a five-year plan with five distinct goals: 1) slow the emergence of resistant bacteria, 2) strengthen One-Health surveillance efforts, 3) advance the development and use of rapid diagnostic tests to identify resistant bacteria, 4) accelerate the development of new antibiotics, other treatments, and vaccines, and 5) improve international collaboration to achieve these goals. For antimicrobial use in food animals (livestock), the Action Plan seeks to implement FDA’s guidances for industry.

Proposed Law:

This bill would, among other things, do the following:

• Provide definitions for both “medically important antimicrobial drug” and “livestock.”

• Prohibit the administration of a medically important antimicrobial drug unless prescribed by a veterinarian that has established a veterinarian-client-patient relationship.

• Prohibit the use of a medically important antimicrobial drug for the sole purpose of increasing weight gain or improving feed efficiency.

• Require CDFA to develop a program to track the use of medically important antimicrobial drugs in livestock as well as antibiotic-resistant bacteria and patterns of emerging resistance, and report specified information.

• Require CDFA, until March 1, 2020, to submit an annual report to the Legislature that summarizes the data from the tracking program.

• Require CDFA to adopt regulations to promote the judicious use of medically important antimicrobial drugs in livestock. Regulations shall include antibiotic stewardship guidelines that include rules on the proper use of medically important antimicrobial drugs for disease prevention.

• Define “antibiotic stewardship” as a commitment to: a) use medically important antimicrobial drugs only when necessary to treat and, in some cases, prevent disease and b) to choose and administer the appropriate medically important antimicrobial drug correctly each time.

• Create a new crime by making a violation of this chapter a misdemeanor punishable by up to six months in county jail and/or a fine not exceeding $1,000.

Related Legislation:

• SB 770 (Mendoza) of 2015. This bill would require the California Department of Food and Agriculture to continue to be the primary regulatory agency responsible for regulating medicated feed. This bill is currently on Third Reading on the Senate Floor.

• AB 49 (Mullin) of 2015. This bill would make findings and declarations regarding antibiotic use in food-producing animals and would state the intent of the legislature to enact legislation that would address the overuse of antibiotics in livestock production. This bill has not yet been assigned to a committee.

• SB 835 (Hill) of 2014. This bill would have codified the Food and Drug Administration’s Guidance for Industry #213, dated December 2013, by requiring CDFA to refuse to register a livestock drug administered in the feed or drinking water of food animals if such drug is a medically important antimicrobial drug. The bill was vetoed by the Governor.

• AB 1437 (Mullin) of 2014. This bill would have prohibited the sale of poultry or livestock in California if a medically important antimicrobial drug had been administered to the animal for nontherapeutic use such as growth promotion, feed efficiency, weight gain, or disease prevention. This bill would have required producers to maintain records and slaughter facilities to report specified information in regards to the use of medically important antimicrobial drugs. Hearing canceled at the request of the author; died in the Assembly Committee on Agriculture.

Staff Comments:

As noted above, the Governor vetoed a previous version of this bill in 2014 (SB 835, Hill). In his veto message, Governor Brown stated that “more needs to be done to understand and reduce our reliance on antibiotics. To that end, I am directing CDFA to work with the Legislature to find new and effective ways to reduce the unnecessary antibiotics used for livestock and poultry.” As was discussed when the bill had its hearing before the Senate Agriculture Committee, the current version of the bill is generally considered to be a working draft, and is currently awaiting input from the Administration.

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SENATE COMMITTEE ON AGRICULTURE

Senator Cathleen Galgiani, Chair

2015 - 2016 Regular

Bill No: SB 27 Hearing Date: 4/21/15

Subject: Livestock: use of antibiotics

SUMMARY

:

This bill would restrict the use of medically important antimicrobial drugs in livestock for specified purposes and require a veterinarian’s prescription; require the California Department of Food and Agriculture (CDFA) to develop a program to track antimicrobial use in livestock and the emergence of antibiotic-resistant bacteria; and require CDFA to adopt judicious use regulations and antibiotic stewardship guidelines. This bill would also create a new crime. Violations of the provisions would be a misdemeanor punishable by a $1,000 fine and/or six months imprisonment in a county jail.

BACKGROUND AND EXISTING LAW

:

Antimicrobial drugs were first developed in 1928 and became widely used in human medicine in the 1940s. These new drugs quickly proved to have significant health benefits in both human and animal medicine and to this day are extremely valuable tools used to treat and prevent illness and infection. However, incidences of antimicrobial resistance have been recorded over time and, if not addressed, pose a serious threat to public health.

Antimicrobial resistance may develop for several reasons. One of the most widely accepted contributors to antimicrobial resistance is the misuse of antimicrobial drugs. When bacteria are exposed to an antimicrobial drug, it provides the opportunity for “survival of the fittest” where only the strongest, most immune bacteria survive. These surviving, antimicrobial-resistant bacteria then multiply to form new colonies of resistant bacteria that may spread and infect other individuals. For this reason, it is important to use antimicrobial drugs judiciously in both human and animal medicine as one method to mitigate resistance.

The Centers for Disease Control and Prevention (CDC) recently issued a report titled Antibiotic Resistance Threats in the United States, 2013. The CDC estimates that in the United States more than two million people are sickened every year with antibiotic-resistant infections with at least 23,000 infections resulting in death. In its report, the CDC lists four core actions that fight the spread of antibiotic resistance: 1) preventing infections from occurring and preventing resistant bacteria from spreading, 2) tracking resistant bacteria, 3) improving the use of antibiotics, and 4) promoting the development of new antibiotics and new diagnostic tests for resistant bacteria.

The CDC notes that the use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Up to 50% of all antibiotics prescribed for people are either not needed or not optimally effective as prescribed. Antibiotics are also used in food-producing animals for the purpose of promoting growth, which the CDC recommends phasing out. The US Food and Drug Administration (FDA) has developed guidances to promote judicious use of antimicrobials that would prohibit their use for improved feed efficiency or increased weight gain. According to the FDA’s annual report on antimicrobial sales for animal use, 97% of medically important antimicrobial drugs are sold over-the-counter and not through a veterinarian’s prescription or feed directive. The FDA guidances will address this issue and others, as described in further detail below.

September 18, 2014, President Obama issued Executive Order 13676: Combating Antibiotic-Resistant Bacteria, which states that this is an issue of national security and that “the Federal Government will work domestically and internationally to detect, prevent, and control illness and death related to antibiotic-resistant infections by implementing measures that reduce the emergence and spread of antibiotic-resistant bacteria and help ensure the continued availability of effective therapeutics for the treatment of bacterial infections.” Later that same month, the White House issued the National Strategy for Combating Antibiotic-Resistant Bacteria, and in March 2015, the White House issued the National Action Plan for Combating Antibiotic-Resistant Bacteria (Action Plan).

The Action Plan lays out a five-year plan with five distinct goals: 1) slow the emergence of resistant bacteria, 2) strengthen One-Health surveillance efforts, 3) advance the development and use of rapid diagnostic tests to identify resistant bacteria, 4) accelerate the development of new antibiotics, other treatments, and vaccines, and 5) improve international collaboration to achieve these goals. For antimicrobial use in food animals (livestock), the Action Plan seeks to implement FDA’s guidances for industry, described later in this analysis.

The United States Department of Agriculture (USDA) currently operates national laboratory systems that survey national animal health and monitor antimicrobial resistance: the National Animal Health Monitoring System (NAHMS) and the National Antimicrobial Resistance Monitoring System (NARMS). NAHMS was created in 1983 to collect and analyze data on animal health, management, and productivity and to conduct national studies on livestock populations. NAHMS is recognized as a statistical unit under the Confidential Information Protection and Statistical Efficiency Act (CIPSEA), which allows producers or livestock owners to voluntarily provide sensitive and confidential information such as on-farm management practices and animal health issues. USDA states that this is vital to encourage voluntary participation and to maintain high response rates.

NARMS was established in 1996 by the FDA in conjunction with the CDC and USDA to monitor trends in antimicrobial resistance from human, retail meat, and food animal samples. The goals and objectives of NARMS’ monitoring program are to monitor trends in antimicrobial resistance among foodborne bacteria, conduct research to better understand the emergence and spread of resistant bacteria, and to assist the FDA in decision making for the approval of antimicrobial drugs for animals.

The California Animal Health and Food Safety (CAHFS) Laboratory System, created as a partnership between CDFA and the UC Davis School of Veterinary Medicine, is the state entity responsible for providing rapid diagnostic testing for animal health diseases, and those diseases that affect humans. Most recently, CAHFS has been involved in detecting avian influenza in both commercial and backyard poultry but also conducts testing on any animal brought to the lab with other concerns such as poisoning (melamine), salmonella or other bacterial infections, rabies, and other serious health issues for both livestock and pets. CAHFS is part of the National Animal Health Laboratory Network, which has been included as a component of national surveillance efforts in President Obama’s Action Plan for combating antimicrobial resistance.

Existing federal law:

The Food and Drug Administration is responsible for protecting public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs. Within FDA, the Center for Veterinary Medicine regulates the manufacture and distribution of drugs that will be administered to animals and regulates medicated feed.

The Animal Drug Availability Act enacted in 1996 created a new regulatory category for certain animal drugs used in animal feed. Previously, drugs were only available through two means: over-the-counter (OTC) and by prescription. As new drugs (antimicrobials) were developed, FDA recognized the need for these drugs to be administered through feed. However, FDA wanted to establish greater control and safety measures than were currently available under OTC status since some of these drugs could contribute to drug toxicity and antimicrobial resistance or have other unintended outcomes. Therefore, the Veterinary Feed Directive (VFD) was created to allow more flexibility for new animal drugs to be administered through medicated feed but done so under the supervision of a licensed veterinarian (78 Federal Register 75517, December 12, 2013).

As concerns over antimicrobial resistance grew, the FDA created guidelines for industry regarding the judicious use of medically important antimicrobial drugs. In December 2013, the FDA released the final draft of the Guidance for Industry #213 (GFI #213), which contains nonbinding recommendations regarding the use of medically important antimicrobial drugs in the feed and drinking water of food-producing animals. These recommendations include: 1) phasing out the use of medically important antimicrobial drugs in food-producing animals for production purposes (growth promotion and feed efficiency) and 2) veterinary oversight of these drugs when used in the feed or water of food-producing animals.

The FDA’s GFI #213 would change the status of antimicrobial drugs administered in feed from OTC to VFD. Due to this change, the FDA recognizes that current VFD regulations must be revised and streamlined to minimize the impact on veterinarians, the animal feed industry, and producers. These revisions are believed to be critically important and are scheduled to be completed before the three-year implementation timeline for GFI #213.

Existing state law:

CDFA, through the Livestock Drug Program, is also responsible for regulating the manufacture, sale, registration, and use of livestock drugs, except when the livestock drug is sold by prescription only, used exclusively by a veterinarian, or used only under a veterinarian’s direction. CDFA is required to register over-the-counter livestock drugs and regulate their use for safety and efficacy (Food and Agricultural Code §14200 et seq.).

The California State Board of Pharmacy is responsible for licensing, regulating and enforcing laws and regulations regarding prescription drugs and drugs used exclusively by veterinarians (Business and Professions Code § 4000 et seq.).

PROPOSED LAW

:

This bill:

1. Provides definitions for both “medically important antimicrobial drug” and “livestock.”

2. Prohibits the administration of a medically important antimicrobial drug unless prescribed by a veterinarian that has established a veterinarian-client-patient relationship.

3. Prohibits the use of a medically important antimicrobial drug for the sole purpose of increasing weight gain or improving feed efficiency.

4. Requires CDFA to develop a program to track the use of medically important antimicrobial drugs in livestock as well as antibiotic-resistant bacteria and patterns of emerging resistance.

5. Requires the new tracking program to report the following:

   1. Type of drug used.

   2. Number of livestock on which the drug was used.

   3. Livestock species.

   4. Duration of administration of the drug.

   5. Purpose for which the drug was administered.

6. Requires CDFA, until March 1, 2020, to submit an annual report to the legislature that summarizes the data from the tracking program.

7. Requires CDFA to adopt regulations to promote the judicious use of medically important antimicrobial drugs in livestock. Regulations shall include antibiotic stewardship guidelines that include rules on the proper use of medically important antimicrobial drugs for disease prevention.

8. Defines “antibiotic stewardship” as a commitment to: a) use medically important antimicrobial drugs only when necessary to treat and, in some cases, prevent disease and b) to choose and administer the appropriate medically important antimicrobial drug correctly each time.

9. Creates a new crime by making a violation of this chapter a misdemeanor punishable by up to six months in county jail and/or a fine not exceeding $1,000.

ARGUMENTS IN SUPPORT:

According to the author, “The overuse and misuse of antibiotics, especially antibiotics important in human medicine, contributes to antibiotic resistance as a growing public health threat. Inappropriate antibiotic use and overuse in humans drives the development of antibiotic resistance, but there is also a concern about antibiotic use in livestock and poultry. Based on the best information available from the federal Food and Drug Administration (FDA), it’s estimated that at least 70 percent of all medically important antibiotics are sold for use in livestock and poultry. […] The data available on antibiotic use in livestock and poultry is in itself a problem; in large part, many consider the data to be insufficient since the only data collected is sales data. More, and better data, needs to be collected to properly address this issue. While there may be data gaps about antibiotic use in livestock and poultry, we do know that under current law the majority of medically important antibiotics may be sold for use in livestock and poultry without veterinary oversight. […] Antibiotic stewardship programs are a commitment to always use antibiotics only when they are necessary, to choose the right antibiotics and to administer them in the right way in every case. Antibiotic stewardship programs have been effective in reducing inappropriate antibiotic use in humans, as well in reducing antibiotic resistance. […] However, there is no similar requirement that veterinarians and livestock and poultry producers follow antibiotic stewardship guidelines.”

ARGUMENTS IN OPPOSITION:

All of the organizations listed on this analysis with the position of “oppose unless amended” have the same concern: namely, that this bill does not go far enough to restrict the use of antimicrobial drugs for preventative or routine uses in livestock. These organizations state that, “Antibiotic-resistant infections can result in longer illnesses, more hospitalizations, antibiotics with greater side-effects, and even death when treatments fail. Resistant infections are estimated to cost the U.S. up to $61 billion annually in additional health care costs and lost productivity. Growing resistance also puts complicated medical procedures such as heart surgery, organ transplants, and chemotherapy in jeopardy” due to reliance on effective antibiotics. Furthermore, about 70% of all medically important antibiotics sold in the US are used in livestock, where much of the use is to accelerate animal growth and to offset risks created by the crowded and stressful conditions at many livestock and poultry facilities. “Medical, veterinary, and scientific groups have called for an end to the misuse and overuse of antibiotics in livestock to help combat the rise of antibiotic resistance.”

The Consumers Union has similar concerns regarding the preventative use of antimicrobial drugs, as well as the concern that “the data reporting part of the bill does not require reporting of total quantity of antibiotics used.”

COMMENTS

:

Governor’s Veto: Governor Brown vetoed a previous version of this bill in 2014 (SB 835, Hill). In his veto message, Governor Brown stated that “more needs to be done to understand and reduce our reliance on antibiotics. To that end, I am directing the Department of Food and Agriculture to work with the Legislature to find new and effective ways to reduce the unnecessary antibiotics used for livestock and poultry.”

Work-in-progress: The author and many of the stakeholder groups are aware that this bill is a working draft and does not represent the final language or all of the issues involved with limiting antimicrobial use in livestock. It is the committee’s understanding that, although conversations and negotiations have been taking place since January, this bill is awaiting direction from the governor’s office before amendments will be adopted. These stakeholder groups have expressed interest in continuing to work with the author, and although many have chosen not to provide position letters, the committee has received a letter stating this intent from the California Veterinary Medical Association.

Definitions:

Antimicrobial vs. antibiotic: These terms tend to be used interchangeably, however, they are not synonyms. Antibiotics are drugs that are designed to attack bacteria; whereas, antimicrobials (which include antibiotics) encompass a larger class of drugs that affect not just bacteria but other disease-causing microorganisms such as fungi, protozoa, viruses, and parasites. The scope of this bill and that of federal actions are aimed toward reducing antimicrobial resistance, not just antibiotic resistance. These inconsistences are most noticeable between the documents published by FDA (antimicrobial) and the President’s office (antibiotics).

Veterinarian-client-patient relationship: The California Code of Regulations (16 CCR § 2032.1) requires a veterinarian to establish a veterinarian-client-patient relationship before administering, prescribing, dispensing, or furnishing a drug or medicine. This relationship is established when the veterinarian has sufficient knowledge of the animal through an examination or by medically appropriate and timely visits to the premises where the animal is housed. Additionally, a veterinarian shall not prescribe a drug for longer than one-year duration.

Outstanding issues: The following is a brief summary of the many outstanding issues that have yet to be resolved regarding antimicrobial use in livestock. This list may not be comprehensive; however, it does represent the major issues of concern.

Preventative and routine use: There is argument as to whether antimicrobial drugs are being used judiciously when administered to animals for the purpose of disease prevention. The concern relates to the use of antimicrobial drugs when a disease is not clinically present and which could provide the opportunity for the continual, prolonged, or routine use of antimicrobial drugs in food animals. According to those opposed to this bill unless amended, SB 27 maintains a loophole that will allow the routine use of antibiotics in animals that aren’t sick and where the use is not medically necessary. For instance, this bill would not prevent the routine use of antibiotics in animals where the disease risk is elevated due to poor animal husbandry practices. The Natural Resources Defense Council has been working on amendments that would go farther than this bill and President Obama’s national Action Plan to prevent the use of antibiotics for routine or preventative purposes.

Conversely, the California Veterinary Medical Association is concerned that if antimicrobial use is restricted then veterinarians would be prevented from “making the best medical decisions for the health and welfare of their patients. There are many instances where it is important to administer antibiotics prophylactically, such as to prevent the active spread of ‘silent killer’ diseases such as Chlamydophila abortus in sheep, particularly when there is no test available to determine which sheep are the carriers of the disease. Veterinarians must have the flexibility to provide scientific and medically appropriate treatment for animals under their care.”

Tracking: The creation of an antimicrobial use and resistance tracking program has expressed support from the Natural Resources Defense Council, which believes that more data should be collected and available given the amount of antimicrobials used in feed and water. Conversely, a tracking program is an expressed concern of many of the agricultural stakeholders as well as the California Veterinary Medical Association given that the implementation of such a program is believed to be difficult and expensive, and that many details and responsibilities not specified in the current bill. For instance, it is unclear which entity would be required to report antimicrobial use: the producer, veterinarian, slaughterhouse, feed mill, or other entity. Another great concern of these groups is confidentiality of this information, as previously described with the NAHMS laboratory. Furthermore, the federal government is currently proposing an expanded nationwide antimicrobial use and resistance surveillance program, as outlined in the United States Department of Agriculture (USDA) Antimicrobial Resistance Plan published in June 2014 and in President Obama’s Action Plan.

Over-the-counter accessibility: This bill would require that all medically important antimicrobial drugs administered to livestock be available through a veterinarian’s prescription only. (It is the author’s intent that this ‘prescription’ includes VFD as well, which will be clarified in the next version of this bill). However, there are concerns from the cattle industry that this change will limit their ability to obtain necessary medication for their livestock. In some cases, the ranch is located in a remote area where a veterinarian is not readily available. Furthermore, if the antimicrobial is no longer available OTC at the local farm store and given that not all pharmacies carry livestock drugs, there is concern that the antimicrobial will not be available for purchase in a timely manner. However, the California Veterinary Medical Association believes that “there should be veterinary supervision of antimicrobial drugs in animals, since their improper use has serious implications.”

Continuing education: The California Veterinary Medical Association has proposed amendments that would make a course on the judicious use of antimicrobial drugs a required component of continuing education courses for veterinary license renewal. Currently, veterinarians must complete 36 hours of continuing education credits every two years as a requirement of license renewal. These classes allow veterinarians to stay current on new therapies, studies, treatments, illnesses, technologies, and other related issues; therefore if this amendment were adopted, veterinarians would be required to attend an approved course on the judicious use of antimicrobial drugs at least once every two years (Business and Professions Code § 4846.5).

Misdemeanor charges: Existing provisions within the Veterinary Medicine Practice Act authorize the Veterinary Medical Board to revoke or suspend a veterinarian’s license and to assess a fine up to $5,000 for unprofessional conduct including, but not limited to, fraud, negligence, incompetence, animal cruelty, or conviction of a crime in regards to dangerous drugs or controlled substances (Business and Professions Code § 4875 et seq.). According to the California Veterinary Medical Association, the creation of a misdemeanor crime for failure to comply with this chapter would be unduly punitive given the existing authority of the Veterinary Medical Board as previously described.

However, this misdemeanor charge would apply to all Californians in violation of this chapter, not just veterinarians. According to the Business and Professions Code § 4831, any person who violates any provisions of the Veterinary Medicine Practice Act is guilty of a misdemeanor that is punishable by a fine of $500 to $2,000 and/or 30 days imprisonment in a county jail.

RELATED LEGISLATION

:

SB 770 (Mendoza) of 2015. This bill would require the California Department of Food and Agriculture to continue to be the primary regulatory agency responsible for regulating medicated feed. This bill is currently on Third Reading on the Senate Floor.

AB 49 (Mullin) of 2015. This bill would make findings and declarations regarding antibiotic use in food-producing animals and would state the intent of the legislature to enact legislation that would address the overuse of antibiotics in livestock production. This bill has not yet been assigned to a committee.

SB 835 (Hill) of 2014. This bill would have codified the Food and Drug Administration’s Guidance for Industry #213, dated December 2013, by requiring the secretary of the California Department of Food and Agriculture to refuse to register a livestock drug administered in the feed or drinking water of food animals if such drug is a medically important antimicrobial drug. Vetoed.

AB 1437 (Mullin) of 2014. This bill would have prohibited the sale of poultry or livestock in California if a medically important antimicrobial drug had been administered to the animal for nontherapeutic use such as growth promotion, feed efficiency, weight gain, or disease prevention. This bill would have required producers to maintain records and slaughter facilities to report specified information in regards to the use of medically important antimicrobial drugs. Hearing canceled at the request of the author; died in the Assembly Committee on Agriculture.

SUPPORT

:

None received

OPPOSE UNLESS AMENDED:

CALPIRG

California League of Conservation Voters

California Public Health Association – North

Center for Food Safety

Dignity Health

Environmental Working Group

Food & Water Watch

Food Chain Workers Alliance

Health Care Without Harm

Humane Society Veterinary Medical Association

Natural Resources Defense Council

Physicians for Social Responsibility, San Francisco Bay Area Chapter

Prevention Institute

Roots of Change

OPPOSITION

:

Consumers Union

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