SB 27 Page 1 Date of Hearing: August 19, 2015 ASSEMBLY COMMITTEE ON APPROPRIATIONS Jimmy Gomez, Chair SB 27 (Hill) – As Amended August 17, 2015 Policy Committee: Agriculture Urgency: No State Mandated Local Program: No Vote: 7-1 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 SB 27 Page 2 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 antibioticresistant 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