BILL ANALYSIS Ó AB 1442 Page 1 Date of Hearing: March 20, 2012 ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS Bob Wieckowski, Chair AB 1442 (Wieckowski) - As Amended: February 6, 2012 SUBJECT : Pharmaceutical waste. SUMMARY : Authorizes the transportation of pharmaceutical waste, as defined, by a common carrier. Specifically, 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. 2)Defines "pharmaceutical waste" as any pharmaceutical that for any reason may no longer be sold or dispensed for use as a drug. 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. 3)Authorizes a medical waste generator or parent organization that employs health care professionals who generate pharmaceutical waste to apply to the enforcement agency for a pharmaceutical waste hauling exemption if the generator, health care professional, or parent organization meets all of the following requirements: a) The generator or parent organization has on file one of the following: i) If the generator or parent organization is a small quantity generator required to register with the enforcement agency, the required medical waste management AB 1442 Page 2 plan, as defined in statute. ii) If the generator or parent organization is a small quantity generator not required to register, the information document, as defined in statute. iii) If the generator or parent organization is a large quantity generator, a medical waste management plan, as defined in statute. b) 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) The generator maintains a tracking document, as defined in statute. d) The health care professional who generates and returns the pharmaceutical waste to the parent organization is authorized to substitute a single-page form or multiple entry log for the tracking document if the form or log contains specified information. 4)Clarifies that this bill does not prohibit the use of a single document to verify the return of more than one container to a parent organization or another health care facility for the purpose of consolidation before treatment and disposal over a period of time, if the form or log is maintained in the files of the parent organization or another health care facility that receives the waste once the form or log is completed. 5)Makes other conforming changes. EXISTING LAW : 1)Requires, under the federal Controlled Substances Act, strict protocols for the collection of controlled substances to prevent their illegal diversion and abuse. AB 1442 Page 3 2)Regulates, under the federal Resource Conservation and Recovery Act (RCRA) of 1976, the management of solid and hazardous wastes. 3)Authorizes, under the California Hazardous Substances Act, the Department of Toxic Substances Control (DTSC) to regulate hazardous materials and wastes to ensure that the state is delegated authority in accordance with RCRA. 4)Establishes the Sherman Food, Drug, and Cosmetic Law, administered by the Department of Public Health (DPH), to regulate drugs and medical devices. 5)Provides for, under the Business and Professions Code, the licensure and regulation of pharmacies, pharmacists, and wholesalers of dangerous drugs or devices by the Board of Pharmacy (BOP) within the Department of Consumer Affairs. 6)Defines "dangerous drug" or "dangerous device" as any prescription drug or device unsafe for self-use in humans or animals, as specified (Business and Professions Code (BPC) §4022). 7)Defines "reverse distributor" as every person who acts as an agent for pharmacies, drug wholesalers, manufacturers, and other entities by receiving, inventorying, and managing the disposition of outdated or nonsalable dangerous drugs (BPC §4040.5). 8)Establishes the Medical Waste Management Act (MWMA) in Health and Safety Code (HSC) Sections 117600 - 118360. Under the MWMA,: a) Requires the DPH to adopt regulations that will establish and ensure statewide standards for uniformity in the implementation and administration of the MWMA and that will promote waste minimization and source reduction (HSC §117610). b) Includes in the definition of "medical waste" biohazardous waste (HSC §117690). Includes in the definition of "biohazardous waste" waste that is hazardous only because it is comprised of pharmaceuticals (HSC §117635). AB 1442 Page 4 c) Defines "pharmaceutical" as a prescription or over-the-counter human or veterinary drug including, but not limited to, a drug as defined the Sherman Food, Drug and Cosmetic Laws 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 (HSC §117747). d) Establishes a system to register and oversee small and large quantity medical waste generators. Requires generators to maintain on file or file with the enforcement agency specified documents relating to the maintenance, treatment and transport of medical waste (HSC §117915 et seq.). e) Prohibits a person from hauling medical waste unless the person is either a registered hazardous waste hauler or has an approved limited-quantity exemption (HSC §117900). f) Establishes a system to register and oversee medical waste haulers (HSC §118000 et seq.). i) Requires all medical waste transported to an offsite medical waste treatment facility to be transported by a registered hazardous waste transporter (HSC §118000). ii) Authorizes a medical waste generator or parent organization that employs health care professionals who generate medical waste to apply to the enforcement agency for a limited-quantity hauling exemption, if the generator or health care professional meets specified requirements (HSC §118030). g) Establishes a system to permit and oversee medical waste treatment facilities (HSC §118130 et seq.). FISCAL EFFECT : Unknown. COMMENTS : Need for the bill : According to the author, "Under existing law, pharmaceutical drugs can be sent to health care facilities through standard 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 AB 1442 Page 5 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. It is my understanding that administrative agencies cannot make this change without legislation." Pharmaceutical waste in California : According to CalRecycle, waste pharmaceuticals are expired (outdated), damaged, contaminated, or otherwise unwanted medicines which are to be discarded. They usually consist of prescription or over-the-counter human or veterinary drugs that are no longer needed or useable for their originally intended purpose. According to DPH and DTSC, pharmaceutical waste is classified either as hazardous waste, medical waste, or nonhazardous (solid) waste. Which category a discarded pharmaceutical falls into depends on its chemical, physical, and toxicological properties. Proper classification is necessary for generators to be in compliance with the laws regulating each waste type. The California Code of Regulations dictates that the generator of the waste is ultimately responsible for proper classification of waste streams, and then, once it is classified, for managing and disposing the waste according to the rule governing the particular waste classification. According DTSC, a discarded pharmaceutical may be identified as a hazardous waste in California if it appears on a regulatory list of hazardous wastes or exhibits ignitability, corrosively, reactivity or toxicity. DTSC is authorized to regulate pharmaceutical wastes to the extent they are regulated as hazardous waste under RCRA. Hazardous waste must be managed and disposed of in accordance with 40 Code of Federal Regulations (CFR) 261 and Division 4.5, 22 California Code of Regulations (CCR). Some wastes that are not regulated under RCRA are nevertheless identified as hazardous waste in California. Besides the properties mentioned above, a number of additional factors can cause a waste to exhibit the characteristic of toxicity under California standards and thus be considered a hazardous waste in California, including containing a substance listed in California Code of Regulations Section 66261.2, being toxic when inhaled, or being fatal to certain types of fish in laboratory AB 1442 Page 6 tests. Pharmaceutical wastes that meet California's definition of hazardous waste but not RCRA's definition, as well as pharmaceutical wastes generated by people who are not regulated under RCRA, are subject to the MWMA. Non-RCRA, non-California hazardous waste is handled as solid waste and may be disposed of in compliance with the disposal requirements of the local treatment works and waste acceptance criteria of the waste disposal facility. Regulation of pharmaceutical waste under the MWMA : Pharmaceutical wastes that must be managed according to the MWMA are those that are classified as "California only hazardous waste" by Chapter 11, Title 22, California Code of Regulations. On January 1, 1997, the authority for regulating pharmaceutical waste that is not RCRA hazardous waste but is California hazardous waste was transferred from the DTSC to the Department of Health Services (now DPH) under the MWMA. If a pharmaceutical waste meets the criteria of a California hazardous waste, it must be segregated in an appropriate container, properly labeled, stored, manifested, transported and incinerated at a regulated medical waste incinerator or destroyed through another method approved by the DPH. The MWMA prohibits a person from hauling medical waste unless the person is either a registered hazardous waste hauler or has an approved limited-quantity exemption. Reverse distribution and transporting pharmaceutical waste: It is common practice for pharmacies and other health care facilities to return unused pharmaceuticals to the manufacturer for credit or disposal. Health care facilities have the option of hiring reverse distributors to manage their unused and/or expired medication that could be returned to the manufacturer or wholesaler for credit. The reverse distributor determines which medications may be returned to the manufacturer or wholesaler for credit and arranges for disposal of unused medications that are waste. Once the unused pharmaceutical is determined to be ineligible for credit, it becomes waste and must be managed as such. In California, reverse distributors are regulated by both the BOP and the DPH. The BOP regulates activities involving "dangerous drugs," as defined in BPC § 4022, which includes prescription medications. Reverse distributors that intend to AB 1442 Page 7 receive "outdated or nonsalable dangerous drugs," which could include potentially creditable drugs, must register with the BOP as "drug wholesalers" (BPC §4040.5, 4043 and 4160). However, once a pharmaceutical is designated as "medical waste" pursuant to the MWMA, it is regulated by the DPH (HSC §117690). For purposes of the MWMA, the term "pharmaceutical" isn't restricted to "dangerous drugs" as set forth in the BPC, but rather is intended to cover all pharmaceuticals, including both prescription and over-the-counter drugs (HSC §117747). The MWMA requires that medical waste pharmaceuticals be sent to reverse distributors via a licensed hazardous waste hauler (HSC §118000). However, according to DPH's Self-Assessment Manual for Proper Management of Medical Waste, pharmaceuticals that have "intrinsic value" (such as outdated or otherwise unsalable pharmaceuticals that are returned for credit) are not considered "waste" and, thus, may be shipped to a reverse distributor via a common carrier. Therefore, under current law, whether or not a pharmaceutical is creditable determines whether it must be transported via a registered waste hauler or is authorized to be transported via common carrier. As is authorized under current law for outdated or otherwise unsalable creditable pharmaceuticals, this bill authorizes the transportation of outdated or otherwise unsalable non-creditable pharmaceuticals, which are designated as medical waste, via a common carrier. Proposed amendment : This bill currently requires generators of pharmaceutical waste to maintain specified tracking documents. In order to ensure that waste pharmaceuticals reach their intended destination, the Committee may wish to consider requiring that a recipient of pharmaceutical waste also maintain a copy of the required tracking documents. AB 1442 Page 8 REGISTERED SUPPORT / OPPOSITION : Support EXP Pharmaceutical Services Corp. (sponsor) American Federation of State, County, and Municipal Employees (AFSME) Bay Area Clean Water Agencies (BACWA) California Product Stewardship Council Californians Against Waste City of Palo Alto Clean Water Action Fremont Chamber of Commerce Los Angeles County Integrated Waste Management Task Force Sierra Club California Solid Waste Association of North America Opposition None received. Analysis Prepared by : Shannon McKinney / E.S. & T.M. / (916) 319-3965