BILL ANALYSIS Ó SENATE COMMITTEE ON APPROPRIATIONS Senator Ricardo Lara, Chair 2015 - 2016 Regular Session SB 27 (Hill) - Livestock: use of antibiotics ----------------------------------------------------------------- | | | | | | ----------------------------------------------------------------- |--------------------------------+--------------------------------| | | | |Version: December 1, 2014 |Policy Vote: AGRI. 3 - 0 | | | | |--------------------------------+--------------------------------| | | | |Urgency: No |Mandate: Yes | | | | |--------------------------------+--------------------------------| | | | |Hearing Date: May 4, 2015 |Consultant: Robert Ingenito | | | | ----------------------------------------------------------------- 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 SB 27 (Hill) Page 1 of ? 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 SB 27 (Hill) Page 2 of ? 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." SB 27 (Hill) Page 3 of ? 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. SB 27 (Hill) Page 4 of ? 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 SB 27 (Hill) Page 5 of ? 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. -- END --