The Medical Waste Management Act, among other things, authorizes a local agency to approve, as part of a medical waste management program, a location as a point of consolidation for the collection of home-generated sharps waste, which, after collection, is transported and treated as medical waste. The act requires sharps containers at a home-generated sharps consolidation point that are ready for disposal to not be held more than 7 days, except as provided.

This bill would extend the time period that sharps containers at a home-generated sharps consolidation point may be held from 7 to 14 days.

ASSEMBLY THIRD READING

ATR Bill Id:AB 444

Author:(Ting and Gray)

As Amended Ver:April 18, 2017

Majority vote

SUMMARY: Authorizes the California Environmental Protection Agency (Cal/EPA) to develop a statewide program for the collection, transportation, and disposal of home-generated medical waste, including sharps waste and pharmaceutical waste.

EXISTING LAW:

1) Pursuant to the Medical Waste Management Act (MWMA) regulates the collection, storage, transportation, and management of medical waste, including sharps. (Health and Safety Code (HSC) Section 117600, et seq.)

FISCAL EFFECT: According to the Assembly Appropriations Committee, enactment of this bill could result in a one-time cost to Cal/EPA of $400,000 over a two-year period to develop a statewide program, including completing a stakeholder and regulatory process (special funds).

COMMENTS: Need for the bill: According to the author, "This bill provides authority to the California Environmental Protection Agency (Cal/EPA) to develop a take-back program for home-generated pharmaceutical and sharps waste, subject to Budget appropriation. Current law does not provide for a comprehensive statewide take-back program for home-generated medical waste, and California homes contain increasing numbers of medical waste, both pharmaceutical and sharps, which are not always being disposed of properly."

Medical sharps: An estimated one million Californians inject medications at locations other than traditional health care facilities, which generate approximately 936 million sharps each year, and the numbers of patients using injectable medications will continue to grow because it is an effective delivery method for various medications. The most common home use of sharps is to manage diabetes. Other reasons to inject at home include hepatitis, multiple sclerosis, infertility, migraines, allergies, hemophilia, and medications for pets. According to statistics from the California Department of Resources Recycling and Recovery (CalRecycle), 43% of all self-injectors throw needles in the trash.

Sharps collection: Home-generated sharps waste is required to be put into an approved sharps container before being transported out to an approved drop-off location or via mail-back program. CalRecycle maintains the Facility Information Toolbox (FacIT) Website, which currently lists more than 600 facilities where residents can take their home-generated sharps such as hospitals, pharmacies, or household hazardous waste facilities.

Sharps collection requirements under the Medical Waste Management Act (MWMA): The Department of Public Health (DPH) has the authority to approve locations as points of consolidation for the collection of home-generated sharps waste, which, after collection, is transported and treated as medical waste. An approved consolidation location is known as a "home-generated sharps consolidation point." A home-generated sharps consolidation point must comply with all of the following requirements: (1) All sharps waste shall be placed in sharps containers; and (2) sharps containers ready for disposal shall not be held for more than seven days without the written approval of the enforcement agency.

Joint Legislative Audit Committee (JLAC) audit of pharmaceutical and sharps waste: In 2016, Assemblymembers Ting and Gray submitted an audit request that was approved that requested that the State Auditor provide independently developed and verified information related to the DPH, CalRecycle, and a selection of counties' waste disposal standards for home-generated sharps and pharmaceutical waste. The audit was released on May 9, 2017.

There have been several legislative attempts over the past several years dealing with home-generated medical waste. Additionally, there have been several local ordinances adopted throughout the state that regulate home-generated medical waste within their jurisdiction. The recent audit provides all stakeholders with a common set of information regarding the current management of home-generated medical waste. This bill seeks to establish a statewide program for the collection, transportation, and disposal of home-generated medical waste in California.

Analysis Prepared by: Josh Tooker / E.S. & T.M. / (916) 319-3965 FN: 0000545

Date of Hearing: May 10, 2017

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez Fletcher, Chair

ABPCA Bill Id:AB 444

Author:(Ting) – As Amended Ver:April 18, 2017

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill authorizes the California Environmental Protection Agency (Cal EPA) to develop a statewide program for the collection, transportation, and disposal of home-generated medical waste, including sharps waste and pharmaceutical waste. Specifically, this bill:

1) Requires the program to comply with all federal and state laws related to the collection, transportation, and disposal of medical waste, and prohibits implementation without an appropriation through the Budget Act.

2) Defines "stakeholder" as a person who will be participating in the program that will be implemented by a proposed home-generated medical waste collection, transportation and disposal program, including, but not limited to, consumers, retailers, distributors, and health care providers and facilities.

3) Defines "home-generated sharps" as hypodermic needles, syringes with needles attached, pen needles, intravenous needles, lancets, or any other similar device intended to self-inject medication at home.

4) Defines "home-generated pharmaceutical waste" as a prescription or over-the-counter human or veterinary home-generated pharmaceutical, as defined in the Federal Food, Drug, and Cosmetic Act, that is a waste, as defined in state law (Health and Safety Code (HSC) § 25124), derived from a household, including, but not limited to, a multifamily residence or household.

FISCAL EFFECT:

1. Onetime Cal EPA costs of $400,000 over a two-year period to develop a statewide program, including completing a stakeholder and regulatory process (special funds).
2. Unknown, likely significant ongoing costs (special funds) to implement the program.

All requirements of the bill are subject to an appropriation in the Budget Act.

COMMENTS:

1. Purpose. According to author, current law does not provide for a comprehensive statewide take-back program for home-generated medical waste, and California homes contain increasing numbers of medical waste, both pharmaceutical and sharps, which are not always being disposed of properly. This bill provides authority to the California Environmental Protection Agency (CalEPA) to develop a take-back program for home-generated pharmaceutical and sharps waste, subject to a budget appropriation.
2. Background. An estimated one million Californians inject medications outside traditional health care facilities, which generate approximately 936 million sharps each year, and the numbers of patients using injectable medications will continue to grow because it is an effective delivery method for various medications. The most common home use of sharps is to manage diabetes. Other reasons to inject at home include hepatitis, multiple sclerosis, infertility, migraines, allergies, hemophilia, and medications for pets. According to statistics from CalRecycle, 43% of all self-injectors throw needles in the trash.

Home-generated sharps waste is required to be put into an approved sharps container before being transported out to an approved drop-off location or via mail-back program. CalRecycle maintains the Facility Information Toolbox (FacIT) Website, which currently lists more than 600 facilities where residents can take their home-generated sharps such as hospitals, pharmacies, or household hazardous waste (HHW) facilities.

While disposal of sharps is illegal, there is no statutory program in place to require the management of sharps by manufacturers, pharmaceutical companies, pharmacies, or others. Current law allows for a streamlined oversight structure for those that do wish to provide a voluntary disposal for sharps to their customers or the general public, but there is no mandate for them to do so. Some pharmacies and health care providers have developed programs as a way to assist their customers and have reported some success.

1. Local Government Programs. Currently, out of California's 58 counties, three counties (Tulare, San Luis Obispo, and Santa Cruz) and two cities (Galt and Santa Cruz) have ordinances that has some level of requirements on retail establishments that sell sharps to accept the used sharps for proper disposal. Other jurisdictions are considering a similar ordinances. According to CalRecycle, approximately 50 counties provide free disposal. At least eight counties and some cities provide free sharps containers and one county provides free mail-back containers to its residents as long as supplies last.
2. Joint Legislative Audit Committee (JLAC) Audit. In 2016, Assemblymembers Ting and Gray submitted an audit request that was approved asking the State Auditor to provide independently developed and verified information related to the Department of Public Health (DPH), CalRecycle, and a selection of counties' waste disposal standards for home-generated sharps and pharmaceutical waste. The release of this audit is expected in May of 2017.

Analysis Prepared by: Jennifer Galehouse / APPR. / (916) 319-2081

Date of Hearing: April 25, 2017

ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS

Bill Quirk, Chair

ABPCA Bill Id:AB 444 (

Author:Ting) – As Amended Ver:April 18, 2017

SUBJECT: Medical waste: home-generated medical waste

SUMMARY: Authorizes the California Environmental Protection Agency (Cal/EPA) to develop a statewide program for the collection, transportation, and disposal of home-generated medical waste, including sharps waste and pharmaceutical waste. Specifically, this bill:

1) Authorizes Cal/EPA to develop a statewide program, in consultation with stakeholders, for the collection, transportation, and disposal of home-generated medical waste, which may include home-generated sharps waste and home-generated pharmaceutical waste. Requires the program to comply with all federal and state laws related to the collection, transportation, and disposal of medical waste, and prohibits implementation without an appropriation through the Budget Act.

2) Defines "stakeholder" as a person who will be participating in the program that will be implemented by a proposed home-generated medical waste collection, transportation and disposal program, including, but not limited to, consumers, retailers, distributors, and health care providers and facilities.

3) Defines "home-generated sharps" as hypodermic needles, syringes with needles attached, pen needles, intravenous needles, lancets, or any other similar device intended to self-inject medication at home.

4) Defines "home-generated pharmaceutical waste" as a prescription or over-the-counter human or veterinary home-generated pharmaceutical, as defined in the Federal Food, Drug, and Cosmetic Act, that is a waste, as defined in state law (Health and Safety Code (HSC) § 25124), derived from a household, including, but not limited to, a multifamily residence or household.

EXISTING LAW:

1. Authorizes a city and a county household hazardous waste (HHW) element to include a program for the safe collection, treatment, and disposal of sharps waste generated by households. (Public Resources Code (PRC) § 41502)
2. Requires manufacturers of self-injectable medications to annually submit a plan describing how it provides for the safe collection and proper disposal of medical sharps. (PRC § 47115)
3. Requires each county to prepare a HHW element which identifies a program for the safe collection, recycling, treatment, and disposal of hazardous wastes, which are generated by households in the city and which should be separated from the solid waste stream. (PRC § 41510)
4. Defines "home-generated sharps waste" as hypodermic needles, pen needles, intravenous needles, lancets, and other devices that are used to penetrate the skin for the delivery of medications derived from a household, including a multifamily residence or household. (Health & Safety Code (HSC) § 117671)
5. Prohibits the disposal of home-generated sharps waste in the trash or recycling containers, and requires that all sharps waste be transported to a collection center in a sharps container approved by the local enforcement agency. (HSC § 118286)
6. Pursuant to the Medical Waste Management Act (MWMA) (HSC § 117600, et seq.):
   1. Defines "medical waste" as including waste generated from the consolidation of home-generated sharps. (HSC § 117690)
   2. Authorizes a registered medical waste generator to accept and consolidate home-generated sharps waste with the facility's medical waste stream under specified conditions. (HSC § 118147)
   3. Requires a person generating or treating sharps waste to ensure that the medical waste is treated to render it solid waste prior to disposal. (HSC § 118215)
   4. Requires sharps waste to be rendered noninfectious prior to disposal by a specified treatment method. (HSC § 118225)
   5. Specifies containerization, storage and labeling requirements for sharps waste. (HSC § 1118275, 118285, and 118286)
   6. Authorizes a local enforcement agency to approve a location as a point of consolidation for the collection of home-generated sharps waste, which, after collection, shall be transported and treated as medical waste. (HSC § 117904)

FISCAL EFFECT: Unknown.

COMMENTS:

Need for the bill: According to the author, "This bill provides authority to the California Environmental Protection Agency (CalEPA) to develop a take-back program for home-generated pharmaceutical and sharps waste, subject to Budget appropriation. Current law does not provide for a comprehensive statewide take-back program for home-generated medical waste, and California homes contain increasing numbers of medical waste, both pharmaceutical and sharps, which are not always being disposed of properly.

California has set a goal to recycle 75% of waste by 2020, which will require a great deal more of hand sorting of our waste stream. Inaction on sharps disposal may leave some workers over-exposed to health dangers, a risk compounded by the growing use of home-generated sharps."

Medical sharps: An estimated one million Californians inject medications outside traditional health care facilities, which generate approximately 936 million sharps each year, and the numbers of patients using injectable medications will continue to grow because it is an effective delivery method for various medications. The most common home use of sharps is to manage diabetes. Other reasons to inject at home include hepatitis, multiple sclerosis, infertility, migraines, allergies, hemophilia, and medications for pets.

Sharps waste: According to statistics from the California Department of Resources, Recycling and Recovery (CalRecycle), 43% of all self-injectors throw needles in the trash. According to CalRecycle's 2014 waste characterization study, 2014 Disposal-Facility-Based Characterization of Solid Waste in California, the composition of California’s overall disposed waste stream is dissected by material type. There is not a line-item for home-generated sharps, but under the category of HHW is the subcategory "Remainder/Composite Household Hazardous," which includes household hazardous material that, if improperly put in the solid waste stream, may present handling problems or other hazards, such as pesticides and caustic cleaners, sharps, medications, and supplements. The 2014 report estimates that remainder/composite household hazardous materials comprises more than 94,000 lbs (0.2%), of the total solid waste stream.

Sharps collection: Home-generated sharps waste is required to be put into an approved sharps container before being transported out to an approved drop-off location or via mail-back program. CalRecycle maintains the Facility Information Toolbox (FacIT) Website, which currently lists more than 600 facilities where residents can take their home-generated sharps such as hospitals, pharmacies, or HHW facilities.

While disposal of sharps is illegal, there is no statutory program in place to require the management of sharps by manufacturers, pharmaceutical companies, pharmacies, or others. Current law allows for a streamlined oversight structure for those that do wish to provide a voluntary disposal for sharps to their customers or the general public, but there is no mandate for them to do so. Some pharmacies and health care providers have developed programs as a way to assist their customers and have reported some success.

Currently, out of California's 58 counties, three counties (Tulare, San Luis Obispo, and Santa Cruz) and two cities (Galt and Santa Cruz) have an ordinance that has some level of requirements on retail establishments that sell sharps to accept the used sharps for proper disposal. Other jurisdictions are considering a similar ordinance. According to CalRecycle, approximately 50 counties provide free disposal. At least eight counties and some cities provide free sharps containers and one county provides free mail-back containers to its residents as long as supplies last.

Sharps collection requirements under the Medical Waste Management Act (MWMA): The Department of Public Health (DPH) has the authority to approve locations as points of consolidation for the collection of home-generated sharps waste, which, after collection, is transported and treated as medical waste. An approved consolidation location is known as a "home-generated sharps consolidation point." A home-generated sharps consolidation point must comply with all of the following requirements: (1) All sharps waste shall be placed in sharps containers; and (2) sharps containers ready for disposal shall not be held for more than seven days without the written approval of the enforcement agency.

Joint Legislative Audit Committee (JLAC) audit of pharmaceutical and sharps waste: In 2016, Assemblymembers Ting and Gray submitted an audit request that was approved that requested that the State Auditor provide independently developed and verified information related to the DPH, CalRecycle, and a selection of counties' waste disposal standards for home-generated sharps and pharmaceutical waste. The release of this audit is expected in May of 2017.

Specifically the audit will:

1. Include a review and evaluation of the laws, rules, and regulations significant to the audit objectives;
2. Determine, to the extent possible, the volume of home-generated sharps waste and pharmaceutical waste that was disposed of statewide using approved household disposal methods over the past three years;
3. Estimate, to the extent possible, the volume of home-generated sharps waste and pharmaceutical waste that may have been improperly disposed of statewide over the past three years;
4. Assess, to the extent possible, differences in home-generated sharps waste and pharmaceutical waste in areas with needle exchange programs versus areas without such programs;
5. Identify the methods that exist currently for free home-generated sharps and pharmaceutical waste disposal within California;
6. To the extent that information is available, determine the collection rate for voluntary take-back programs manufacturers funded in the past three years for home-generated sharps and pharmaceutical waste;
7. Determine which medical waste collection models generate the best waste collection results for both home-generated sharps and pharmaceutical waste. Consider county-based collection models, including needle exchange programs, as well as those adopted in Canada and other countries;
8. Identify any existing regulatory limitations on establishing home-generated sharps or pharmaceutical waste collection sites or on methods for collecting that waste. Assess the reasonableness of any barriers that exist;
9. Determine the statewide capacity for processing home-generated sharps and pharmaceutical waste in each of the last three years;
10. Determine the existing waste processing capacity in California that could accommodate growth in proper home-generated sharps and, if applicable, pharmaceutical waste disposal;
11. Determine where home-generated sharps and pharmaceutical waste is processed and the methods used to process the waste;
12. To the extent possible, compare processing rates for home-generated sharps waste and, if applicable, home-generated pharmaceutical waste, in a selection of jurisdictions the CDPH oversees to a comparable selection of jurisdictions with local oversight. Determine what differences exist among the jurisdictions that may affect California's processing rates;
13. Identify the recommendations CalRecycle and CDPH have made regarding home-generated sharps and pharmaceutical waste collection and disposal. Assess whether the recommendations reflect best practices; and,
14. Review and assess any other issues that are significant to the audit.

There have been several legislative attempts over the past several years dealing with home-generated medical waste. Additionally, there have been several local ordinances adopted throughout the state that also regulate home-generated medical waste within their jurisdiction. The recent audit, expected to be released in May of this year, will ideally provide all stakeholders with a common set up information regarding the current management of home-generated medical waste. AB 444 seeks to establish a statewide program for the collection, transportation and disposal of home-generated medical waste in California.

Related bills:

1. SB 212 (Jackson). Defines “home-generated pharmaceutical waste” as a prescription or over-the-counter human or veterinary home-generated pharmaceutical, as defined in Section 109925 of the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C.A. Sec. 321(g)(1)), that is a waste, as defined in Section 25124, derived from a household, including, but not limited to, a multifamily residence or household. This bill is pending action on the Senate Floor.
2. AB 2039 (Ting, 2016). Would have required the development and implementation of industry-generated plans to collect and recycle home-generated sharps. Held in the Assembly Environmental Safety and Toxic Materials Committee.
3. SB 1229 (Jackson, Chapter 238 Statutes of 2016). Provides qualified immunity from civil and criminal liability of participating entities that take reasonable care to ensure the health and safety of consumers and employees when maintaining secure drug take-back bins on their premises.
4. AB 1159 (Gordon, 2015). Proposed establishing a pilot product stewardship program for the management of medical sharps and household primary batteries. It was approved by the Assembly Environmental Safety & Toxic Materials Committee on April 28, 2015 by a 6-0 vote. AB 1159 was held in the Assembly Appropriations Committee.
5. AB 1893 (Stone/Eggman, 2014). Proposed requiring customers be given a free sharps disposal container with the sale of 50 or more medical sharps for self-injection. AB 1893 was pulled by the author from the Assembly Floor.
6. AB 403 (Stone/Eggman, 2013). Proposed requiring manufacturers that sell medical sharps to establish a product stewardship plan for home-generated medical waste. AB 403 was held in the Assembly Appropriations Committee.

REGISTERED SUPPORT / OPPOSITION:

Support

None on file.

Opposition

None on file.

Analysis Prepared by: Josh Tooker / E.S. & T.M. /