BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | SB 423| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- THIRD READING Bill No: SB 423 Author: Bates (R) Amended: 8/31/15 Vote: 27 - Urgency SENATE ENVIRONMENTAL QUALITY COMMITTEE: 7-0, 7/15/15 AYES: Wieckowski, Gaines, Bates, Hill, Jackson, Leno, Pavley SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/27/15 AYES: Lara, Bates, Beall, Hill, Leyva, Mendoza, Nielsen SUBJECT: Retail nonprescription surplus products: determinations for reuse SOURCE: Author DIGEST: This bill establishes a process for the handling and management of retail nonprescription pharmaceutical surplus products. ANALYSIS: Existing federal law: 1)Authorizes, under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA), to oversee the safety of food, drugs, and cosmetics. 2)Regulates, under the Resource Conservation and Recovery Act (RCRA) of 1976, the management of solid and hazardous wastes. In the context of pharmaceuticals, RCRA imposes strict protocols for the collection of controlled substances. Existing state law: SB 423 Page 2 1)Provides that under the Medical Waste Management Act (MWMA), administered by the State Department of Public Health: a) Regulates the management, handling, and disposal of medical waste, as defined, including pharmaceutical waste. b) Defines "pharmaceutical waste" as any pharmaceutical that for any reason may no longer be sold or dispensed for use as a drug and excludes from this definition those pharmaceuticals that still have potential value to the generator because they are being returned to a reverse distributor for possible manufacturer credit. c) Defines "pharmaceutical" as a prescription or over-the-counter human or veterinary drug including, but not limited to, a drug as defined in the Sherman Food, Drug and Cosmetic Law or the Federal Food, Drug, and Cosmetic Act. "Pharmaceutical" does not include any pharmaceutical that is regulated pursuant to either RCRA or the Radiation Control Law; and certain items, such as household waste, are specifically excluded from the definition of medical waste. d) Specifies that waste comprised only of pharmaceuticals is hazardous, and is considered "medical waste," although it is not subject to hazardous waste laws, as specified. 2)Provides that under the Hazardous Waste Control Act (HWCA), administered by the Department of Toxic Substances Control (DTSC), regulates the management, handling and disposal of hazardous waste, as defined. This bill: 1)Establishes, until January 1, 2022, criteria to be followed for the handling and management of retail nonprescription pharmaceutical surplus products, as defined, if a reasonable determination for reuse has been made or when a reasonable determination for reuse cannot be made but the product has been recalled as required by law. 2)Authorizes DTSC to adopt regulations as deemed necessary to SB 423 Page 3 establish standards for the proper and safe handling of retail nonprescription pharmaceutical surplus products. 3)Specifies that a facility that elects to follow the procedures in this bill is not subject to regulation of specified products by the MWMA. 4)Declares the urgency of this statute. Background Risks of pharmaceuticals in the environment. A study conducted by the United States Geological Survey (USGS) from 1999-2000 sampled 139 streams across 30 states and found that 80% had measurable concentrations of both prescription and nonprescription drugs, steroids, and reproductive hormones. Since the USGS released its report in 2002, a number of studies have demonstrated the low-level presence of pharmaceutical agents throughout the environment and water supply. While the human effects of pharmaceutical agents in the environment are not fully understood, harm to aquatic organisms and ecosystems due to low levels of pharmaceutical agents are clearly established. As California further explores the re-utilization of water through water recycling, prevention of contamination becomes crucial to prevent public health exposure through water. Health risks associated with incineration. Incinerators are known to release numerous toxic chemicals into the atmosphere and to produce ashes and other solid waste residues that contaminate the air, water and soil as well as vegetation in the vicinity of the facility. Adverse health effects associated with incineration are of great concern as large population groups and workers may be exposed to derived toxic substances. Many of these chemicals are known to be persistent, bioaccumulative, carcinogenic or endocrine disruptors. Populations living near incinerators are potentially exposed to chemicals by way of inhalation of contaminated air, consumption of contaminated foods, water or dermal contact with contaminated SB 423 Page 4 soil. Additionally, there are occupational hazards for incinerator workers. Comments The confusion over "pharmaceutical waste." According to federal and California law, a pharmaceutical is anything that contains a "drug fact" label. A drug fact label is affixed to any product that makes a health claim. These products must meet specified FDA ingredient testing, disclosure, labeling and verification of health claim requirements. This includes prescription and over-the-counter drugs as well as some consumer products that make health claims, such as sunscreen, toothpastes, mouthwashes or lotions that contain sunscreen. Pharmaceuticals are medical waste and are required to be managed under MWMA, which is designed to ensure that medical waste does not enter the environment and does not present a risk to public health. However, toothpaste, mouthwashes, lotions and other over-the-counter products that do not contain drug facts are not medical waste. Depending on their characteristics and risks posed they must be handled pursuant to either hazardous or solid waste statutes, as defined and specified. Retail establishments argue that the various statutory and regulatory requirements of when a product becomes a waste and how it must be handled make it difficult for their employees to determine the appropriate handling. Additionally, MWMA requires that medical waste be incinerated. The retailers argue that because of the complexity of the current regulatory scheme, they are currently not separating products that may be able to be donated or liquidated from those that are deemed waste if there is any question that they may instead be required to be disposed of, in order to ensure that they don't violate the various statutory waste handling requirements. The retailers assert that the result is a far greater than necessary rate of disposal/incineration of items that could have been retained for their useful life. Striking a balance. MWMA, HWCA and other state and federal SB 423 Page 5 waste laws have specific requirements for handling, transportation and disposal to protect public health and the environment. When alternative management standards are adopted, the standards are narrowly crafted and contain specific conditions for tracking, handling, transportation and disposal to accommodate the unique nature of the wastestream. SB 423 recognizes the public policy benefit of diverting more waste and crafts an alternative management scheme that provides some flexibility within the statute for the point at which this category of items is determined to be a waste. While it is important in providing this flexibility, it is equally important that it be balanced with appropriate tracking and accountability to ensure safe handling and enforceability of the statute. FISCAL EFFECT: Appropriation: No Fiscal Com.:YesLocal: Yes According to the Senate Appropriations Committee this bill will have unknown costs to the Hazardous Waste Control Account for DTSC to "register" specified entities. SUPPORT: (Verified8/27/15) California Retailers Association CVS Health OPPOSITION: (Verified8/27/15) None received Prepared by:Rachel Machi Wagoner / E.Q. / (916) 651-4108 8/30/15 19:48:52 **** END **** SB 423 Page 6