BILL ANALYSIS Ó AB 333 Page 1 ( Without Reference to File ) CONCURRENCE IN SENATE AMENDMENTS AB 333 (Wieckowski) As Amended August 22, 2014 Majority vote ---------------------------------------------------------------------- |ASSEMBLY: |67-6 |(May 23, 2013) |SENATE: |33-0 |(August 27, 2014) | ---------------------------------------------------------------------- ------------------------------------------------------------------------ |COMMITTEE VOTE: |6-0 |(August 29, 2014) |RECOMMENDATION: |concur | |(E.S. & T.M.) | | | | | ------------------------------------------------------------------------ Original Committee Reference: E.S. & T.M. SUMMARY : Makes numerous changes to the Medical Waste Management Act (MWMA) including, among other things, codifying federal requirements, modifying definitions, creating procedures for the generation of medical waste from a temporary event, and modifying contracts with medical waste transporters for the collection of fees. The Senate amendments : 1)Recognize that the MWMA governs medical waste management at the facility where the waste is generated, transfer stations and treatment facilities, and governs tracking medical waste beyond federal transportation documentation requirements. 2)Recognize that the United States Department of Transportation (US DOT) imposes standards for transporting medical waste on public roads and highways while in transit, and the United States Postal Service (USPS) imposes standards for the transportation of medical waste through the mail. 3)Require the California Department of Public Health (CDPH) to submit to the Legislature, by January 1, 2016, a report describing the interaction of federal and state law for the transport of regulated medical waste, and require CDPH to convene a stakeholder group, including small and large quantity generators, haulers, transfer station and treatment facility AB 333 Page 2 operators, local enforcement agencies (LEA), and retailers in its effort to develop the report. 4)Authorize CDPH to update standards related to the transportation of medical waste through a guidance document provided to MWMA stakeholders and posted on CDPH's Web site, and exempt CDPH from the Administrative Procedures Act if those standards are consistent with the US DOT requirements. 5)Authorize CDPH to temporarily waive the state transportation requirements in the event that a person, including CDPH, seeks a preemption determination under federal law, and determine that the federal requirements are the law of this state for transporting medical waste during the temporary waiver and/or if preemption is found. 6)Reference US DOT and USPS regulations in various provisions related to the transport of medical waste. 7) Revise and consolidate definitions for "biohazardous waste," "pharmaceutical waste," "sharps waste," "trace chemotherapeutic waste," and "trauma scene waste," under a single revised definition for "medical waste." 8) Revise additional various definitions used throughout the MWMA, including: a) The definition of "biohazard bag" and specify color coding requirements for the purpose of segregating waste; b) The definition of "highly communicable diseases" to update categorization to reference the appropriate Centers for Disease Control and Prevention risk group; c) The definition of "medical waste treatment facility" to specify over which land the facility has control; d) The definition of "pharmaceutical" to reference the Department of Toxic Substances Control's authority over hazardous waste; e) The definition of "sharps container" to specify that trace chemotherapeutic wastes are not required to be lined with a plastic liner; and, AB 333 Page 3 f) The definition of "transfer station" to clarify defined locations are permitted by CDPH. 9)Clarify the reference to existing law for treating medical waste as permitted by an LEA. 10)Require small quantity generators (SQG) to include additional information in the medical waste management plan ("plan"), including: a) Steps taken to categorize generated pharmaceutical waste and how those wastes are disposed; and, b) A closure plan for the termination of the treatment facility. 11)Require registered medical waste generators to additionally provide to LEA shipping documents of all untreated medical waste shipped offsite. 12)Delete requirements for medical waste generators to apply for a limited quantity hauling exemption, and authorize SQGs and large quantity generators (LQG) to transport limited quantities of medical waste up to 35.2 pounds to the central location of accumulation as long as specific conditions are met, including that the transport is in accordance with the requirements of the US DOT Material of Trade Exception, and the person transporting medical waste provides a log to the receiving facility with specified information. 13)Reference the applicable transportation requirements for transporting medical waste from adjacent properties. 14)Require LQGs to include additional information in the plan, including: a) Steps taken to categorize generated pharmaceutical waste and how those wastes are disposed; and, b) A closure plan for the termination of the treatment facility. 15)Require medical waste generators to update their plan within 30 days from when any relevant information in the plan changes, and require the plan be maintained on file for review. AB 333 Page 4 16)Clarify further that "medical waste" does not include waste generated in biotechnology that does not contain a highly communicable disease. 17)Authorize registered LQGs to generate medical waste at temporary events, and require LQGs to notify LEA within 72 hours of an event, unless the sponsor of the temporary event previously notified the LEA of the event. 18)Authorize SQGs to generate medical waste at temporary events, and require SQGs to notify LEA within 72 hours of event, unless the sponsor of the temporary event previously notified the LEA of the event. 19)Increase the percentage of administrative fee medical waste transporters may retain from 5% to 7.5% to cover administrative costs. 20)Limit administrative fees paid by medical waste generators to be paid no more than once per year. 21)Require operators of onsite sterilization equipment used at SQGs to receive annual training that complies with federal Occupational Safety and Health Administration (OSHA) standards and records of training to be maintained for two years. 22)Require LQGs to annually train operators of onsite sterilization equipment consistent with federal OSHA standards, and records of training to be maintained for two years. 23)Require medical waste transported out of state to be consigned to a permitted medical waste treatment facility out of state and refer to state law for treating medical waste crossing an international border. 24)Authorize solid waste facility operators to arrange for proper treatment and disposal of erroneously disposed medical waste at a solid waste facility. 25)Require a person applying for a permit for an offsite medical waste treatment facility to additionally include information regarding a plan for closure describing decontamination methods. 26)Clarify that heat sensitive tape or another acceptable method AB 333 Page 5 only need to be placed on liner bags when biohazard bags or sharps containers are contained in a larger lined bag for autoclave treatment. 27)Require human anatomical parts, excluding teeth, to be disposed of by interment, incineration, or appropriate alternative treatment technologies. 28)Specify that the containerization and storage requirements currently in the MWMA only apply at the point of generation and when the waste is collected in the room. 29)Specify additional labeling and containerization requirements. 30)Revise the usage of biohazardous bags in certain health care settings, establish weight limits for medical waste placed in biohazardous bags at three pounds or one gallon, and change the biohazardous waste storage requirements at transfer stations. 31)Delete outdated implementation and sunset dates. 32)Delete confusing statutory cross-references. AS PASSED BY THE ASSEMBLY , this bill made technical and conforming changes to the MWMA. Specifically, this bill: 1) Deleted the existing definition of "biohazard bag," and instead replaced it with the definition in the Code of Federal Regulations. 2) Amended the definition of "medical waste management plan" to specify that the document that is completed by generators of medical waste describes how the medical waste generated at their facility shall be segregated, handled, stored, packaged, treated, or shipped for treatment, as applicable. Specified that the medical waste management plan is to be completed on forms prepared by the enforcement agency, only if those forms are provided by the enforcement agency. 3) Required a solid waste transporter who discovers that he or she has (unknowingly) hauled untreated medical waste to a landfill or materials recovery facility to contact the originating generator of the medical waste to respond to the landfill or recovery facility to provide ultimate proper disposal of the medical waste. AB 333 Page 6 4) Clarified that the statutory requirements for treatment of carcasses of animals that die of infectious diseases includes those that are euthanized because they are suspected of having been exposed to infectious disease. FISCAL EFFECT : According to the Senate Appropriations Committee: 1)Initial costs of $156,000 annually from the Medical Waste Management Fund for fiscal year (FY) 2015-16 and FY 2016-17 to assist with compliance with the changes to the MWMA. 2)Minor revenue losses to the Medical Waste Management Fund by allowing medical waste transporters to keep an additional 2.5% of the small generator annual fee for administrative costs. COMMENTS : What is medical waste?: Medical waste is waste materials generated at health care facilities, such as hospitals, clinics, physician's offices, dental practices, blood banks, and veterinary hospitals/clinics, as well as medical research facilities and laboratories. Medical waste can contain pathogens, blood, low levels of radioactivity, discarded needles, syringes, scalpels, expired drugs and vaccines, which can pose a hidden risk of infection, radioactivity exposure, and needle-stick injuries. Medical Waste Management Act: The MWMA was created in response to 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. AB 109 (Hayden), Chapter 1613, Statutes of 1990, and AB 1641 (Mojonnier), Chapter 1614, Statutes of 1990, were ultimately combined to form the MWMA to, according to the original Legislative intent, "comprise a single, integrated, and complementary approach to the storage, treatment, transportation, and disposal of medical waste." The MWMA allows any local ordinance regulating infectious waste that was in existence before 1990 and regulated both large and small quantity generators to continue. AB 333 Page 7 Enforcement, by the numbers: The MWMA allows local governments to elect to be the enforcement agency of the MWMA and to assess appropriate fees for their enforcement activities. Currently, CDPH is the enforcement authority for 25 counties, and as part of those duties issues permits to generators in those counties. CDPH also issues permits to transfer stations. Under CDPH's jurisdiction, there are: 1)118 transfer stations in California. 2)Roughly 6,500 SQGs registered with CDPH (defined as generating less than 200 pounds per month of medical waste). These can be doctor's offices, veterinary offices, dental offices, laboratories, research labs, and pharmacies. 3)Approximately 800 LQGs registered with CDPH. These are typically hospitals, skilled nursing facilities, psychiatric facilities, veterinary hospitals, or any of the examples above. Data is not maintained for the number of small and large quantity generators in the counties that serve as their own enforcement agencies and issue permits for the generators in their counties. Purpose for reform: According to the author, "[t]he Medical Waste Management Act was signed in to law in 1990 by Governor George Deukmejian. The MWMA made California one of the leading states in the nation in governing this waste stream. Many changes during the intervening 23 years in medical waste treatment, transportation oversight, and new requirements by landfill and waste water treatment operators regarding acceptance of portions of this waste stream necessitate an update of the Act. "Since enactment of the Medical Waste Management Act (MWMA), the federal Department of Transportation (DOT) has increased its regulatory oversight of transportation of medical waste which preempts state law. Similarly, the United States Postal Service (USPS) requirements for the mail back of medical waste also preempt state law. When the Act was initially implemented it was common practice to dispose of pharmaceutical wastes into landfills or through sewer systems. Heightened regulation of receiving waters of waste water treatment plants and the potential of runoff from landfills has resulted in these facilities tightening requirements AB 333 Page 8 for acceptance of pharmaceutical wastes for disposal. "The current Medical Waste Management Act (Sections 117600-118360 Health & Safety Code) was implemented in 1991 and federal agencies (Department of Transportation and US Postal Service) now regulate transportation of medical waste and pre-empt the state requirements. This creates conflict for California healthcare facilities and places them at risk of non-compliance with federal statutes. Administrative solutions cannot fix the problem as there is a conflict in the statutes governing medical waste treatment and transportation." Clarifying the role of federal requirements: Since this bill was amended to recognize the US DOT and USPS's requirements for transporting medical waste, confusion between stakeholders and CDPH has lingered over where federal law preempts state law, and where state law is permitted to be enforced over federal law. Supporters contend that clarification in the MWMA over which laws govern the transportation of medical waste - federal or state - will remove confusion from the industry over compliance requirements, and reduce risk for non-compliance with federal requirements. As reflected in the current version of this bill, negotiations have achieved consensus between stakeholders and CDPH on addressing the blurred lines between state and federal laws. This bill requires CDPH, in coordination with MWMA stakeholders, to develop a report regarding the implementation and interaction of federal and state law for the transport of regulated medical waste, and to provide that report to the legislature by January 1, 2016. While differences of opinion may remain on state versus federal authority for transporting regulated medical waste, this bill gives MWMA stakeholders clearer guidance on which rules to follow and which documentation forms to submit and maintain, and gives CDPH time to identify precise state jurisdiction and federal preemption where ambiguities from a regulator's perspective may remain. Substantial amendments in the Senate: While the subject matter of this bill is the same as was passed by the Assembly, the bill was substantially amended in the Senate to update and revise the MWMA. Analysis prepared by : Paige Brokaw / E.S. & T.M. / (916) AB 333 Page 9 319-3965 FN: 0005552