BILL ANALYSIS Ó SB 27 Page 1 (Without Reference to File) SENATE THIRD READING SB 27 (Hill) As Amended September 10, 2015 Majority vote SENATE VOTE: 25-10 ------------------------------------------------------------------ |Committee |Votes|Ayes |Noes | | | | | | | | | | | | | | | | |----------------+-----+----------------------+--------------------| |Agriculture |7-1 |Perea, Gallagher, |Grove | | | |Cooper, Dodd, Eggman, | | | | |Irwin, Salas | | | | | | | |----------------+-----+----------------------+--------------------| |Appropriations |15-0 |Gomez, Bloom, Bonta, | | | | |Calderon, Chang, | | | | |Nazarian, Eggman, | | | | |Gallagher, Eduardo | | | | |Garcia, Holden, | | | | |Jones, Rendon, | | SB 27 Page 2 | | |Wagner, Weber, Wood | | | | | | | |----------------+-----+----------------------+--------------------| |Agriculture |7-0 |Perea, Gallagher, | | | | |Dodd, Irwin, | | | | |Jones-Sawyer, Mathis, | | | | |Quirk | | | | | | | | | | | | ------------------------------------------------------------------ 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: a) Coordinate with the federal Food and Drug Administration (FDA) to develop a program to track antimicrobial drug sales, use, resistance, and management practices; and, b) 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; SB 27 Page 3 and, c) 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 SB 27 Page 4 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 SB 27 Page 5 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