BILL ANALYSIS Ó ------------------------------------------------------------ |SENATE RULES COMMITTEE | AB 1442| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ THIRD READING Bill No: AB 1442 Author: Wieckowski (D), et al. Amended: 8/21/12 in Senate Vote: 21 SENATE ENVIRONMENTAL QUALITY COMMITTEE : 7-0, 7/2/12 AYES: Simitian, Strickland, Blakeslee, Hancock, Kehoe, Lowenthal, Pavley SENATE APPROPRIATIONS COMMITTEE : 7-0, 8/16/12 AYES: Kehoe, Walters, Alquist, Dutton, Lieu, Price, Steinberg ASSEMBLY FLOOR : 78-0, 5/30/12 - See last page for vote SUBJECT : Pharmaceutical waste SOURCE : Author DIGEST : This bill defines pharmaceutical waste for purposes of the Medical Waste Management Act, and exempts a pharmaceutical waste generator or parent organization that employs health care professionals who generate pharmaceutical waste from specified medical waste hauling requirements if the generator, health care professional, or parent organization retains specified documentation and meets specified requirements and if the facility receiving the medical waste retains specified documentation and meets specified requirements. This bill also authorizes pharmaceutical waste to be transported by the generator or CONTINUED AB 1442 Page 2 health care professional who generated the pharmaceutical waste, a staff member of the generator or health care professional, or common carrier, as defined, pursuant to these provisions. ANALYSIS : The existing Medical Waste Management Act, administered by the State Department of Public Health, regulates the management and handling of medical waste, as defined. Existing law requires that all medical waste be hauled by either a registered hazardous waste hauler or by a person with an approved limited-quantity exemption granted pursuant to specified provisions of law. Violation of these provisions of law is a crime. This bill: 1.Defines "common carrier" as either of the following: A. A person or company that has a United States Department of Transportation number issued by the Federal Motor Carrier Safety Administration and is registered with the Federal Motor Carrier Safety Administration as a for-hire property carrier. B. A person or company that has a motor carrier of property permit issued by the Department of Motor Vehicles pursuant to the Motor Carriers of Property Permit Act and, if applicable, a carrier identification number issued by the Department of the California Highway Patrol. 1.Defines "pharmaceutical waste" as any pharmaceutical that for any reason may no longer be sold or dispensed for use as a drug. Pharmaceutical does not include any pharmaceutical that meets either of the following criteria: A. The pharmaceutical is being sent out of the State of California to a reverse distributor, as defined, that is licensed as a wholesaler of dangerous drugs by the California State Board of Pharmacy. B. The pharmaceutical is being sent by a reverse distributor, as defined, offsite for treatment and AB 1442 Page 3 disposal in accordance with applicable laws, or to a reverse distributor that is licensed as a wholesaler of dangerous drugs by the California State Board of Pharmacy as is permitted transfer stations if the reverse distributor is located within the State of California. 1.Specifies that medical generators keep the name of the common carrier used by the generator to transport pharmaceutical waste offsite for treatment and disposal, on file, or file that information with the enforcement agency, along with other required information relating to the maintenance, treatment and transport of medical waste. 2.Exempts a pharmaceutical waste generator or parent organization that employs health care professionals who generate pharmaceutical waste from the hazardous waste hauling requirement if the generator, health care professional, or parent organization meets certain specified requirements, including: A. Maintaining on file, or filing with the enforcement agency, specified documents relating to the maintenance, treatment and transport of medical waste. B. The requirement that the generator or health care professional who generated the pharmaceutical waste transports the pharmaceutical waste himself or herself, or directs a member of his or her staff to transport the pharmaceutical waste to a parent organization or another health care facility for the purpose of consolidation before treatment and disposal, or contracts with a common carrier to transport the pharmaceutical waste to a permitted medical waste treatment facility or transfer station. C. Maintaining and providing a tracking document, as specified, to the intended destination facility, requiring the destination facility to notify the generator of any discrepancies between the items received and the tracking document, and requiring the generator to notify the enforcement agency of any AB 1442 Page 4 discrepancies, unless the health care professional who generates pharmaceutical waste returns the pharmaceutical waste to the parent organization, and under that case, is authorized to substitute a single-page form or multiple entry log for the tracking document if the form or log contains specified information. 1.Requires that medical waste treatment facilities maintain copies of tracking documents from common carriers. Background Some pharmaceutical wastes are classified as hazardous wastes. Others are medical waste, and still others are nonhazardous wastes. Which category a discarded pharmaceutical falls into depends on its chemical, physical, and toxicological properties and who generates the waste. The California Code of Regulations dictates that the generator of the waste is ultimately responsible for proper classification of waste streams and subsequently managing and disposing of the waste according to the appropriate rule governing each waste classification. The Department of Toxic Substances Control regulates pharmaceutical wastes that are considered hazardous under the federal Resource Conservation and Recovery Act. Some pharmaceutical waste that is not identified under the Act may be deemed hazardous under California standards, and subsequently classified as medical waste and therefore subject to the Medical Waste Management Act (MWMA). The Department of Public Health (DPH) oversees the MWMA and regulates medical waste. The MWMA specifies that medical waste, including pharmaceutical waste comprised of nonsalable and outdated prescription and over-the-counter drugs must be transported by a licensed hazardous waste hauler. If they meet certain requirements, medical waste generators can apply for a limited-quantity waste hauling exemption, and the generator of the medical waste may transfer the waste themselves to a medical waste treatment facility. These exemptions last one year, and do not allow the medical waste transporter to contract with a common carrier. AB 1442 Page 5 Current law is not clear regarding what constitutes "pharmaceutical waste," but according to DPH's Self-Assessment Manual for Proper Management of Medical Waste, pharmaceuticals that have "intrinsic value," or are creditable, are not considered waste and can be returned by a common carrier to a reverse distributer, which is licensed by the Board of Pharmacy to handle outdated or nonsalable prescription drugs and regulated by DPH to handle pharmaceuticals registered as medical waste. AB 1442 would define "pharmaceutical waste," as a subset of medical waste currently included in the DPH MWMA manual and allow pharmaceutical wastes to be transported by a common carrier as is authorized in most other states. Environmental concerns. A 2002 study by the US Geological Survey revealed widespread contamination in US waterways of prescription drugs, natural and synthetic hormones, detergent metabolites, plasticizers, insecticides, and fire retardants at low concentrations downstream from areas of intense urbanization and animal production. The results found that one or more of these chemicals were found in 80 percent of the streams sampled. Prescription drugs are of particular concern because of the low concentration necessary for activity in the body. According to the U.S. EPA, further research suggests that certain drugs may cause ecological harm and that more research is needed to determine the extent of harm and any role they may have in potential human health effects. California health facilities that generate large amounts of pharmaceutical waste must currently follow strict and costly handling and transporting protocols for medical waste. Allowing these facilities to transport pharmaceutical waste via common carrier may lessen the financial burden, and improve compliance with proper disposal procedures for pharmaceutical waste by health facilities, and potentially reduce pharmaceutical contamination in California wastewater. Comments According to the author, "Under existing law, pharmaceutical drugs can be sent to healthcare facilities AB 1442 Page 6 through common carriers, or standard shipping means. Unused drugs can sometimes be returned to the manufacturer for credit, via a common carrier. Expired and non-dispensable drugs must be shipped as "Medical Waste", requiring expensive hazardous waste shipping, instead of common carrier. This is unnecessarily expensive for pharmacies, hospitals, and other health care facilities, who are simply returning the exact same drug that was shipped to them by common carrier." FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: Yes According to the Senate Appropriations Committee, $280,000 from the Medical Waste Management Fund in 2013-14 and 2014-15 for two full time and one limited term Department of Public Health staff to coordinate with stakeholders statewide, oversee rulemaking process and develop regulations and $160,000 annually thereafter to review exemption requests and ensure compliance with documentation requirements. SUPPORT : (Verified 8/20/12) American Federation of State, County and Municipal Employees Bay Area Clean Water Agencies California Product Stewardship Council Californians Against Waste Central Contra Costa Solid Waste Authority City of Palo Alto City of San Jose City of Sunnyvale Clean Water Action East Bay Municipal Utility District EXP Pharmaceutical Services Corp. Fremont Chamber of Commerce Los Angeles County Solid Waste Management Committee IWM Task Force San Francisco Water Power Sewer Santa Clara Valley Water District Sierra Club California Solid Waste Association of North America AB 1442 Page 7 ASSEMBLY FLOOR : 78-0, 5/30/12 AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Beall, Bill Berryhill, Block, Blumenfield, Bonilla, Bradford, Brownley, Buchanan, Butler, Charles Calderon, Campos, Carter, Cedillo, Chesbro, Conway, Cook, Davis, Dickinson, Donnelly, Eng, Feuer, Fong, Fuentes, Furutani, Beth Gaines, Galgiani, Garrick, Gatto, Gordon, Gorell, Grove, Hagman, Halderman, Hall, Harkey, Hayashi, Roger Hernández, Hill, Huber, Hueso, Huffman, Jeffries, Jones, Knight, Lara, Logue, Bonnie Lowenthal, Ma, Mansoor, Mendoza, Miller, Mitchell, Monning, Morrell, Nestande, Nielsen, Norby, Olsen, Pan, Perea, V. Manuel Pérez, Portantino, Silva, Skinner, Smyth, Solorio, Swanson, Torres, Wagner, Wieckowski, Williams, Yamada, John A. Pérez NO VOTE RECORDED: Fletcher, Valadao DLW:n 8/21/12 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END ****