BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | SB 770| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- THIRD READING Bill No: SB 770 Author: Mendoza (D) Introduced:2/27/15 Vote: 21 SENATE AGRICULTURE COMMITTEE: 5-0, 4/7/15 AYES: Galgiani, Cannella, Berryhill, Pan, Wolk SUBJECT: Department of Food and Agriculture: medicated feed SOURCE: California Grain and Feed Association DIGEST: This bill requires the California Department of Food and Agriculture to continue to be the primary regulatory agency responsible for regulating medicated feed. ANALYSIS: Existing federal law authorizes 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, as well as medicated feed. Existing state law: 1)Requires the California Department of Food and Agriculture (CDFA), through the Feed Inspection Program, to regulate the manufacture of commercial feed through the establishment of good manufacturing practices, hazard analysis, and preventive control measures. This includes medicated feed premixes and medicated feeds, where regulations shall be based upon federal food and drug laws and regulations (Food and Agricultural Code SB 770 Page 2 § 14901 et seq.). 2)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 over-the-counter livestock drugs and regulate their use for safety and efficacy (Food and Agricultural Code §14200 et seq.). 3)Authorizes the California State Board of Pharmacy to license, regulate and enforce laws and regulations regarding prescription drugs and drugs used exclusively by veterinarians (Business and Professions Code § 4000 et seq.). This bill: 1)States findings and declarations regarding medicated feed, consolidating governance expertise, and coordination with the federal government on the implementation of feed safety laws such as the federal Food Safety Modernization Act. 2)Requires CDFA, notwithstanding any other law, to be the primary state agency responsible for regulating medicated feed, including medicated feed quality assurance and safety, and enforcing any handling and inspecting requirements imposed on medicated feed suppliers. 3)Requires CDFA, notwithstanding any other law, to be the primary state agency responsible for overseeing medicated feed ingredients and the sale of medicated feed that is subject to veterinarian oversight. Background Antimicrobial resistance: 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 SB 770 Page 3 these drugs when used in the feed or water of food-producing animals. Drug accessibility: Currently, antimicrobial drugs may be obtained one of three ways: over-the-counter (OTC), through a veterinarian's prescription, or through a veterinary feed directive (VFD) which does not require a prescription but does require veterinary oversight of a food-animal drug that is administered through feed or drinking water. 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. Comments Feed authority: CDFA currently serves as the regulatory and enforcement authority on livestock feed and has the expertise required to inspect, test, and verify that feed is safe and meets all quality assurance and handling and inspection requirements. However, there are concerns that future state or federal laws could change the status of certain drugs (i.e. antimicrobials) from OTC to VFD or prescription, which could transfer the jurisdiction of medicated feed to the California State Board of Pharmacy, which does not have experience regulating feed manufacturers. This issue was discussed but not fully addressed in SB 835 (Hill, 2014), which was vetoed, and it remains a concern for both the feed and livestock industries. FISCAL EFFECT: Appropriation: No Fiscal Com.:NoLocal: No SUPPORT: (Verified4/7/15) California Grain and Feed Association (source) Agricultural Council of California Animal Health Institute Association of California Egg Farmers California Cattlemen's Association SB 770 Page 4 California Farm Bureau Federation California Pork Producers Association California Poultry Federation Pacific Egg and Poultry Association OPPOSITION: (Verified4/7/15) None received ARGUMENTS IN SUPPORT: According to the author, "Federal and state legislation is currently being proposed that will transfer the responsibility of defining the usage of drugs or food additives added to commercial feed to the California State Board of Pharmacy (CBOP). Should this occur, this transfer will create a situation wherein feed manufacturers could be subject to inspections by two different agencies - CDFA and CBOP. SB 770 ensures that the California Department of Food and Agriculture (CDFA) will continue to oversee the manufacture and use of medicated feed in California, regardless of which agency regulates the medication being fed." [sic] According to the sponsor, "Because there is an existing Commercial feed program with licensed and trained inspectors, retaining the oversight of the inspection and regulation of the feed mills within CDFA will increase efficiency and cost effectiveness of the program and provide well trained staff. Feed mills are complex manufacturing facilities and in order to have effective regulations, we need inspectors that understand the feed manufacturing process." Prepared by:Anne Megaro / AGRI. / (916) 651-1508 4/8/15 15:13:12 **** END **** SB 770 Page 5