BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | AB 333| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- THIRD READING Bill No: AB 333 Author: Wieckowski (D) Amended: 8/20/14 in Senate Vote: 21 SENATE ENVIRONMENTAL QUALITY COMMITTEE : 7-0, 6/18/14 AYES: Hill, Gaines, Fuller, Hancock, Jackson, Leno, Pavley SENATE APPROPRIATIONS COMMITTEE : 5-0, 8/14/14 AYES: De León, Hill, Lara, Padilla, Steinberg NO VOTE RECORDED: Walters, Gaines ASSEMBLY FLOOR : 67-6, 5/23/13 - See last page for vote SUBJECT : Medical waste SOURCE : Stericycle Inc. DIGEST : This bill makes numerous changes to the Medical Waste Management Act (MWMA) including, among other things, codifying existing federal preemptions and requirements, modifying definitions, creating procedures for the generation of medical waste from a temporary event, modifying contracts with medical waste transporters for the collection of fees, and preempting local programs regarding infectious waste. ANALYSIS : Existing federal law: CONTINUED AB 333 Page 2 1.Authorizes the United States Department of Transportation (DOT) to enforce rules on the transportation of medical waste on public roads and highways. 2.Authorizes the United States Postal Service (USPS) to regulate medical waste and sharps waste containers that are transported through the mail. Existing state law: 1.Requires, under the MWMA, the Department of Public Health (DPH) to regulate the management and handling of medical waste. The program authorizes off-site medical waste treatment facilities, oversees transfer stations, approves alternative treatment technologies, and acts as the local enforcement agency in 26 jurisdictions (including Los Angeles County) where local agencies have elected not to conduct their own enforcement. This bill: 1.Codifies the federal preemptions and requirements under DOT and USPS for the transportation and tracking of medical waste. 2.Expands the definition of "treatment" to specify the purpose of treatment for each subset of medical waste and authorizes the color coding of biohazard bags as follows: yellow bags are used to further segregate trace chemotherapy waste and white bags are used to further segregate pathology waste. 3.Increases the fees for medical waste to 7.5% and removes the provision allowing providers of mail-back systems to collect fees. 4.Specifies that when medical waste is transported out of state, if there is no permitted medical waste treatment facility in the receiving state or if the waste crosses an international border, then the waste must be treated as specified in the MWMA prior to leaving the state. 5.Requires a medical waste generator to maintain for a minimum of three years individual treatment operating records, and if applicable, shipping documents for all untreated medical waste shipped offsite for treatment, and shall report or submit to CONTINUED AB 333 Page 3 the enforcement agency, upon request, all of the following: A. Treatment operating records. Operating records shall be maintained in written or electronic form. B. An emergency action plan complying with regulations adopted by the DOT. C. Shipping documents or electronically archived shipping documents maintained by the facility and medical waste hauler of all untreated medical waste shipped offsite for treatment. 1.Makes various changes to the provisions relating to medical waste haulers, including removing provisions that conflict with the DOT regulation of those entities, authorizing a registered trauma scene waste practitioner, as specified, to haul medical waste, and making changes to the information medical waste haulers are required to provide to the DOT. 2.Makes various changes to the provisions relating to medical waste treatment facilities, including specifying the decontamination methods for a closure plan, lowering the time period for which records are maintained from three to two years, and authorizing the use of electronic information for operating records and shipping documents. 3.Revises the registration procedures and the record requirements for large quantity and small quantity generators and requires large and small quantity generators that operate treatment equipment to receive annual training to operate the equipment. 4.Authorizes a registered large quantity or small quantity medical waste generator to generate medical waste at a temporary event, including vaccination clinics, and requires the large quantity or small quantity generator to notify the enforcement agency of its participation at such an event at least 72 hours before the event, unless the sponsor of the temporary event previously notified the local enforcement agency of the event. 5.Exempts from regulation as a hazardous waste hauler a small quantity generator or large quantity generator that meets specified requirements, including retaining specified CONTINUED AB 333 Page 4 documentation and complying with certain federal requirements relating to materials of trade exception. 6.Exempts persons, who unknowingly transports medical waste to a solid waste facility from the MWMA, and requires the solid waste transporter to contact the originating generator of the medical waste to respond to the facility to provide ultimate proper disposal of the medical waste. 7.Requires the carcasses of animals that have died of infectious diseases or that have been euthanized because of suspected exposure to infectious disease to be treated with a treatment technology approved by the DOT if, in the opinion of the attending veterinarian or local health officer, the carcass presents a danger of infection to humans. 8.Requires the DOT to charge an application fee for a permit for a transfer station equal to $100 for each hour which the DOT spends on processing the application, but not more than $10,000, or as provided in the regulations adopted by the DOT, not to exceed the reasonable regulatory costs of the DOT. In addition, the annual permit fee for a transfer station is $2,000, or as provided in the regulations adopted by the DOT, not to exceed the reasonable regulatory costs of the DOT. 9.Consolidates all of the subcategories of medical waste into one definition. The definition of "medical waste" also includes animal specimens infected with pathogens known to be infectious to humans. Finally, the definition limits "sharps waste" to devices contaminated with bio-hazardous waste. Background Genesis of the MWMA . In the fall of 1989, there were several incidents of medical waste washing up on San Diego County beaches, as well as several reports of medical waste being disposed of in dumpsters and trash bins. In response to these incidents, both the Legislature and the executive branch considered new approaches to handling medical waste. At the time, California statute only defined "infectious waste" as wastes that contain infectious organisms that cause human disease. This waste was treated as hazardous waste; however, this definition severely limited the types of wastes that could CONTINUED AB 333 Page 5 be regulated. In 1989 and 1990, bills were introduced by Assembly Member Hayden (AB 109) and Assembly Member Mojonnier (AB 1641). The goal of the bills was to respond to general concerns over the lax management of medical and infectious wastes and address specific issues identified in California and at the national level. Ultimately, the two bills were combined to form the MWMA and according to the original legislative intent, "comprise a single, integrated, and complementary approach to the storage, treatment, transportation, and disposal of medical waste" (Chapters 1613 and 1614, Statutes of 1990). The MWMA was placed under the Department of Health Services. During this same period, Congress enacted the Medical Waste Tracking Act (MWTA, 1988) to create a two year medical waste demonstration project. This project was designed to define medical waste and those wastes to be regulated, establish cradle-to-grave tracking procedures, and require regulations for standard practices regarding medical waste. However, the regulations developed under MWTA expired in 1999, leaving this matter under state jurisdiction. Timeline of additions to the MWMA since 1990 . The current bill is one of many attempts to further change or update the MWMA since its introduction. In 1995, SB 372 (Wright, Chapter 877) made various changes to the MWMA, including revisions to the definition of large quantity generator, medical waste exclusions, and storage. The bill also incorporated additional classes into the definition of medical waste and authorized the use of high temperatures to treat medical waste prior to disposal. Also in 1995, the MWMA was moved to the Department of Public Health (DPH) during Governor Wilson's reorganization of the Department of Health Services to DPH and the California Environmental Protection Agency (SB 1360, Committee on Health and Human Services, Chapter 415, Statutes of 1995). SB 1966 (Wright, Chapter 536, Statutes of 1996) moved the management and handling of waste pharmaceuticals under DPH and CONTINUED AB 333 Page 6 the MWMA and reestablished fee authorities for DPH for small quantity medical waste generators. In 1997, SB 1034 (Maddy, Chapter 732) added trauma scene waste management to the MWMA. This addition required the registration of commercial firms who clean up trauma scenes in order to ensure appropriate training and disposal of waste. SB 407 (Alpert, Chapter 139, Statutes of 1999) authorized the use of chemical disinfection as a treatment method for certain types of laboratory-generated medical waste if specified requirements were met. AB 2335 (Saldana, Chapter 166, Statutes of 2006) made various clarifying changes to the MWMA with the aim of reducing medical waste management costs and clarifying the complex regulatory framework. AB 1442 (Wieckowski, Chapter 689, Statutes of 2012) defined pharmaceutical waste, exempted the waste generator from certain hauling requirements, and allowed the waste to be transported by a common carrier in order to reduce costs for handling expired pharmaceutical wastes. Related Legislation AB 467 (Stone, Chapter 10, Statutes of 2014) created a licensure category for a surplus medication collection and distribution intermediary. AB 1893 (Stone and Eggman, 2014) would have made various changes to the handling of home-generated sharps. This bill failed on the Assembly Floor. SB 1014 (Jackson, of 2014) deals with changes to the disposal of home-generated pharmaceutical waste and defines home-generated pharmaceutical waste as not medical waste. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: Yes According to the Senate Appropriations Committee: Initial costs of $156,000 annually from the Medical Waste CONTINUED AB 333 Page 7 Management Fund (special) for FY 2015-16 and FY 2016-17 to assist with compliance with the changes to the MWMA. Minor revenue losses to the Medical Waste Management Fund (special) by allowing medical waste transporters to keep an additional 2.5% of the small generator annual fee for administrative costs. SUPPORT : (Verified 8/20/14) Stericycle Inc. (source) California Hospital Association Kaiser Permanente OPPOSITION : (Verified 8/20/14) California Department of Public Health Department of Finance ARGUMENTS IN SUPPORT : Kaiser Permanente writes, "The Medical Waste Management Act was created 23 years ago and is in need of modernizing to be more reflective of the changes in federal law that govern transport of these waste products. AB 333 deletes some out-of-date provisions to the MWMA; provides definitions for new processes and terminology; re-drafts the law to reorganize sections of the act to make it more user-friendly and easier to follow, and it better coordinates state transportation requirements with the federal transportation requirements, providing for more consistency in the requirements of each jurisdiction. "There has been extensive effort to develop a consensus bill within the stakeholder community, and I laud you and your staff for your leadership in this complicated policy area." ARGUMENTS IN OPPOSITION : The Department of Finance is opposed to this bill because it eliminates Public Health's authority to adjust application and permit fees for medical waste transfer stations and onsite treatment facilities through the regulations process. If current fees are not adequate to cover future program costs, the Medical Waste Management Program could be negatively impacted and Public Health would be forced to increase fees by amending statute, which may not allow Public Health to adjust fees in a timely manner. Furthermore, this CONTINUED AB 333 Page 8 bill imposes additional costs and workload on Public Health. ASSEMBLY FLOOR : 67-6, 5/23/13 AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Bloom, Blumenfield, Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian Calderon, Campos, Chau, Chesbro, Cooley, Dahle, Daly, Dickinson, Eggman, Fong, Fox, Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gordon, Gorell, Gray, Hall, Harkey, Roger Hernández, Jones-Sawyer, Levine, Linder, Logue, Lowenthal, Maienschein, Medina, Melendez, Mitchell, Morrell, Mullin, Muratsuchi, Nazarian, Nestande, Olsen, Pan, Patterson, Perea, V. Manuel Pérez, Quirk, Quirk-Silva, Rendon, Salas, Skinner, Stone, Ting, Wagner, Weber, Wieckowski, Williams, Yamada, John A. Pérez NOES: Bigelow, Chávez, Conway, Donnelly, Hagman, Wilk NO VOTE RECORDED: Grove, Holden, Jones, Mansoor, Waldron, Vacancy, Vacancy RM:e 8/20/14 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED