AB 2039: Solid waste: home-generated sharps.
- Session Year: 2015-2016
- House: Assembly
- Latest Version Date: 2016-04-05
(1)The stated purpose of the California Integrated Waste Management Act of 1989, administered by the Department of Resources Recycling and Recovery, is to reduce, recycle, and reuse solid waste generated in the state to the maximum extent feasible in an efficient and cost-effective manner to conserve water, energy, and other natural resources. That act requires a pharmaceutical manufacturer selling or distributing medication that is intended to be self-injected at home to submit, on an annual basis, to the department a plan supporting the safe collection and proper disposal of specified waste devices, known as home-generated sharps.
This bill would require a producer of home-generated sharps or a stewardship organization designated by the producer to submit a home-generated sharps stewardship plan by July 1, 2018, to the Department of Resources Recycling and Recovery. The bill would require the plan to provide for the development and implementation of a recovery program to reduce the generation of, and manage the end of life of, home-generated sharps, and to include specified elements, including provisions to meet specified minimum collection rates for the home-generated sharps subject to the plan.
This bill would provide for the review and approval of the plan by the department. The bill would require the department upon the date a plan is approved, to post on its Internet Web site a list of producers covered by the approved plan.
This bill would require a producer or stewardship organization, by April 1, 2020, and every year thereafter, to prepare and submit to the department an annual report describing the activities carried out pursuant to its plan during the previous calendar year. The department would be required to review and either approve or disapprove the report and, if the annual report does not demonstrate the achievement of the required collection rate increase, would authorize the department to impose a civil penalty on the producer or stewardship organization or to require the program to take additional actions with regard to improving and increasing the number of home-generated sharps collection points, ensuring accessibility to those points, and providing additional education and outreach activities.
This bill would require a producer or stewardship organization submitting a plan to the department to pay the department an annual administrative fee in an amount that is sufficient to cover the departments full costs of administering and enforcing these provisions. The bill would require the department to deposit the fees in the Safe Sharps Disposal Account, which the bill would establish in the Integrated Waste Management Fund, for the departments expenditure upon appropriation by the Legislature, to administer and enforce the bills requirements.
This bill would authorize the department to impose an administrative civil penalty on a person who violates the bills requirements. The department would be required to deposit all penalties collected into the Safe Sharps Disposal Penalty Account, which the bill would create in the Integrated Waste Management Fund, available upon appropriation by the Legislature, to enforce the bills requirements.
The bill would require the department, by February 1, 2018, to appoint a stakeholder advisory committee to provide specific recommendations and strategic guidance to producers and stewardship organizations. The bill would also require the stakeholder advisory committee to annually report to the department on the progress of the producers and stewardship organizations implementation of the bills provisions.
(2)The Medical Waste Management Act, administered by the State Department of Public Health, prohibits a person from knowingly placing home-generated sharps waste in certain types of containers, requires that home-generated sharps waste be transported only in a sharps container, as defined in that act, or another container approved by the department or local enforcement agency, and requires that this waste be managed only at specified locations.
This bill would additionally allow home-generated sharps waste to be managed at a facility or collection point operated pursuant to an approved home-generated sharps stewardship plan.
(1)The stated purpose of the California Integrated Waste Management Act of 1989, administered by the Department of Resources Recycling and Recovery, is to reduce, recycle, and reuse solid waste generated in the state to the maximum extent feasible in an efficient and cost-effective manner to conserve water, energy, and other natural resources. That act requires a pharmaceutical manufacturer selling or distributing medication that is intended to be self-injected at home to submit, on an annual basis, to the department a plan supporting the safe collection and proper disposal of specified waste devices, known as home-generated sharps.
This bill would require a producer of home-generated sharps or a stewardship organization designated by the producer to submit a home-generated sharps stewardship plan by July 1, 2018, to the Department of Resources Recycling and Recovery. The bill would require the plan to provide for the development and implementation of a recovery program to reduce the generation of, and manage the end of life of, home-generated sharps, and to include specified elements, including provisions to meet specified minimum collection rates for the home-generated sharps subject to the plan.
This bill would provide for the review and approval of the plan by the department. The bill would require the department upon the date a plan is approved, to post on its Internet Web site a list of producers covered by the approved plan.
This bill would require a producer or stewardship organization, by April 1, 2020, and every year thereafter, to prepare and submit to the department an annual report describing the activities carried out pursuant to its plan during the previous calendar year. The department would be required to review the report and, if the annual report does not demonstrate the achievement of the required collection rate increase, would authorize the department to impose a civil penalty on the producer or stewardship organization or to require the program to take additional actions with regard to improving and increasing the number of home-generated sharps collection points, ensuring accessibility to those points, and providing additional education and outreach activities.
This bill would require a producer or stewardship organization submitting a plan to the department to pay the department an annual administrative fee in an amount that is sufficient to cover the departments full costs of administering and enforcing these provisions. The bill would require the department to deposit the fees in the Safe Sharps Disposal Account, which the bill would establish in the Integrated Waste Management Fund, for the departments expenditure upon appropriation by the Legislature, to administer and enforce the bills requirements.
This bill would authorize the department to impose an administrative civil penalty on a person who violates the bills requirements. The department would be required to deposit all penalties collected into the Safe Sharps Disposal Penalty Account, which the bill would create in the Integrated Waste Management Fund, available upon appropriation by the Legislature, to enforce the bills requirements.
The bill would require the department, by February 1, 2018, to appoint a stakeholder advisory committee to provide specific recommendations and strategic guidance to producers and stewardship organizations. The bill would also require the stakeholder advisory committee to annually report to the department on the progress of the producers and stewardship organizations implementation of the bills provisions.
(2)The Medical Waste Management Act, administered by the State Department of Public Health, prohibits a person from knowingly placing home-generated sharps waste in certain types of containers, requires that home-generated sharps waste be transported only in a sharps container, as defined in that act, or another container approved by the department or local enforcement agency, and requires that this waste be managed only at specified locations.
This bill would additionally allow home-generated sharps waste to be managed at a facility or collection point operated pursuant to an approved home-generated sharps stewardship plan.
The California Integrated Waste Management Act of 1989, which is administered by the Department of Resources Recycling and Recovery, requires each city and county, and each regional agency formed pursuant to the act, to develop a source reduction and recycling element of an integrated waste management plan to divert 50% of all solid waste, through source reduction, recycling, and composting activities. Existing law makes a legislative declaration that it is the policy goal of the state that not less than 75% of solid waste generated be source reduced, recycled, or composted by 2020, but prohibits the department from establishing or enforcing a diversion rate on a city or county that is greater than the 50% diversion rate.
This bill would provide that it is the intent of the Legislature to reduce waste in the state.
The California Integrated Waste Management Act of 1989, which is administered by the Department of Resources Recycling and Recovery, requires each city and county, and each regional agency formed pursuant to the act, to develop a source reduction and recycling element of an integrated waste management plan to divert 50% of all solid waste, through source reduction, recycling, and composting activities. Existing law makes a legislative declaration that it is the policy goal of the state that not less than 75% of solid waste generated be source reduced, recycled, or composted by 2020, but prohibits the department from establishing or enforcing a diversion rate on a city or county that is greater than the 50% diversion rate.
This bill would provide that it is the intent of the Legislature to reduce waste in the state.
(a)The Legislature finds and declares all of the following:
(1)The United States Environmental Protection Agency estimates that about 9 million people in the United States currently use disposable needles (sharps) at home to deliver medications to treat a variety of diseases and conditions, including diabetes, cancer, multiple sclerosis, migraines, and allergies. United States households use more than 3 billion disposable needles and syringes each year. (EPA) has determined that improper management of discarded sharps can pose a health risk to the public, waste workers, janitors, and others. Specifically, the EPA cites a risk of transmission of diseases such as HIV, hepatitis, tetanus, and syphilis. In an October 2004 report entitled Community Options for Safe Needle Disposal, the EPA states that approximately 3 billion sharps are used in the home and that sharps users do not always understand the safest disposal methods. Additionally, a review of several studies, including one by the Department of Resources Recycling and Recovery, indicates that approximately 43 percent of all self-injectors throw sharps in the trash.
(2)Since 2008, it has been illegal in California for individuals to throw away home-generated sharps. While the state banned needles from trash disposal in 2008, there is still no consistent, statewide program that is sustainably funded or has high levels of effectiveness in California. As a result, thousands of pounds of illegally disposed sharps enter the municipal waste stream each year, putting many people at risk of injury or infection.
(3)Sharps in the trash pose serious health risks to law enforcement, firefighters, parks and recreation workers, hotel housekeepers, sanitation workers, water treatment facility operators, and the general public. In addition to the immediate risk of a needle stick injury, sharps put individuals at risk of acquiring blood-borne infectious diseases, such as hepatitis or HIV. Individuals who suffer a needle stick injury must receive immediate treatment and followup care, including multiple lab tests and medications.
(4)When sanitation workers encounter sharps, productivity suffers and costs increase. When workers sustain a needle stick injury, the costs of care are borne by the waste management company, the workers compensation insurer, and ultimately, taxpayers and ratepayers.
(5)The California Legislature has adopted a 50 percent diversion requirement for each local jurisdiction, and a policy goal of the state that 75 percent of solid waste be source reduced, recycled, or composted. Sanitation workers are increasingly hand-sorting solid waste in an effort to meet the diversion requirements. Despite repeated efforts to engineer protective gloves to prevent needle sticks, the absence of a consistent sharps disposal policy in this state is increasing the workplace danger for sanitation workers.
(6)In 2011, Assembly Bill 341 was enacted, declaring the 75 percent statewide policy goal and requiring the Department of Resources Recycling and Recovery to submit a report to the Legislature with regulatory and legislative recommendations for achieving the goal. The report, which was issued in August 2015, contains five priority strategies. One of the priority strategies identified by the report is extended producer responsibility, also known as product stewardship. Additionally, the report identifies hazardous materials, which include sharps, as a problem waste stream and recommends managing this problem product through extended producer responsibility.
(b)It is the intent of the Legislature, in enacting the Safe Home-Generated Sharps Recovery Program, as established by Article 3.3 (commencing with Section 47115) of Chapter 1 of Part 7 of Division 30 of the Public Resources Code, to ensure affordable and convenient sharps collection opportunities, which, in turn, will help prevent the improper management of those sharps.
SEC. 2.Section 118286 of the Health and Safety Code is amended to read:118286.(a)A person shall not knowingly place home-generated sharps waste in any of the following containers:
(1)Any container used for the collection of solid waste, recyclable materials, or greenwaste.
(2)Any container used for the commercial collection of solid waste or recyclable materials from business establishments.
(3)Any roll-off container used for the collection of solid waste, construction, and demolition debris, greenwaste, or other recyclable materials.
(b)Home-generated sharps waste shall be transported only in a sharps container, or other containers approved by the enforcement agency, and shall only be managed at any of the following:
(1)A household hazardous waste collection facility pursuant to Section 25218.13.
(2)A home-generated sharps consolidation point as defined in subdivision (b) of Section 117904.
(3)A medical waste generators facility pursuant to Section 118147.
(4)A facility through the use of a medical waste mail-back container approved by the United States Postal Service.
(5)A facility or other home-generated sharps collection point operated pursuant to a home-generated sharps stewardship plan approved pursuant to Article 3.3 (commencing with Section 47115) of Chapter 1 of Part 7 of Division 30 of the Public Resources Code.
SEC. 3.Article 3.3 (commencing with Section 47115) of Chapter 1 of Part 7 of Division 30 of the Public Resources Code is repealed.SEC. 4.Article 3.3 (commencing with Section 47115) is added to Chapter 1 of Part 7 of Division 30 of the Public Resources Code, to read:3.3.Safe Home-Generated Sharps Recovery Program47115.For purposes of this article, the following terms have the following meanings:
(a)Consumer means a person who purchases or owns home-generated sharps.
(b)Distributor means a person that sells sharps or provides sharps for free to the general public for home use, which may include, but is not limited to, a retailer, a veterinarian, or a health clinic, health dispensary, or health facility licensed under Division 2 (commencing with Section 1200) of the Health and Safety Code.
(c)Home-generated sharps means hypodermic needles, syringes with needles attached, pen needles, intravenous needles, lancets, or any other similar device intended to self-inject medication at home.
(d)Home-generated sharps stewardship plan or plan means a plan submitted by an individual producer or by a stewardship organization on behalf of one or more producers.
(e)Producer means, with regard to home-generated sharps that are sold, offered for sale, or distributed in the state, one of the following:
(1)The person who manufactures home-generated sharps and who sells, offers for sale, or distributes those home-generated sharps in the state under that persons own name or brand.
(2)If there is no person who is a producer of the home-generated sharps for purposes of paragraph (1), the producer of the home-generated sharps is the owner or licensee of a trademark or brand under which the home-generated sharps are sold or distributed in the state, whether or not the trademark is registered.
(3)If there is no person who is a producer of the sharps for purposes of paragraphs (1) and (2), the producer of those sharps is the person who imports the home-generated sharps into the state for sale or distribution.
(f)Program means the program implementing an approved home-generated sharps stewardship plan.
(g)Retailer means a person that sells home-generated sharps in the state to a consumer. A sale includes, but is not limited to, a transaction conducted through sales outlets, catalogs, or the Internet or any other similar electronic means.
(h)Stewardship organization means a nonprofit organization created by one or more producers the governing board of which includes three additional members, appointed by the director, one representing from each of the following entities: to act as an agent on behalf of the producers to design, submit, and administer a product stewardship plan pursuant to this article.
(1)A local government.
(2)A retailer.
(3)A solid waste hauler.
(i)Stakeholder means a person who will be subject to, or participate in, the program that will be implemented by a proposed home-generated sharps stewardship plan, including, but not limited to, consumers, retailers, distributors, and health care providers and facilities.
47115.2.On or before January 1, 2018, the department shall adopt regulations implementing this article.
47115.4.(a)On or before February 1, 2018, the department shall appoint a stakeholder advisory committee to provide specific recommendations and strategic guidance to producers and stewardship organizations. The stakeholder advisory committee shall report annually to the department on the progress of the producers and stewardship organizations implementation of this article.
(b)Members of the advisory committee shall include members from the environmental community, solid waste haulers, local governments, retailers, and other key stakeholders.
(c)The stakeholder advisory committee shall be independent of the producers and stewardship organizations. The advisory committees expenses shall be paid by its members and not the producers or stewardship organizations.
(d)A producer or stewardship organization shall have no control over the stakeholder advisory committee or its activities.
47116.A pharmaceutical manufacturer that sells or distributes a medication in the state that is usually intended to be self-injected at home through the use of a home-generated sharp shall submit, on or before July 1 of each year, to the department, or its successor agency, a plan that describes how the manufacturer supports the safe collection and proper disposal of the home-generated sharps.
47117.(a)On or before July 1, 2018, a producer or a stewardship organization designated by a producer shall submit a home-generated sharps stewardship plan to the department. The home-generated sharps stewardship plan shall also be posted on the Internet Web site of the producer or stewardship organization. The plan shall provide for the implementation of the plan for each calendar year, commencing January 1, 2019.
(b)The producer or stewardship organization shall consult with the stakeholder advisory committee during the development of the home-generated sharps stewardship plan, including soliciting and responding to stakeholder advisory committee comments, and shall document those comments in the plan.
(c)The home-generated sharps stewardship plan shall provide for the development and implementation of a recovery program to reduce the generation of, and manage the end of life of, home-generated sharps in an environmentally sound and medically safe manner, including collecting, transporting, processing, and recycling or disposing. The plan shall include, at a minimum, all of the following elements:
(1)Contact information for all participating producers.
(2)Procedures for calculating the amount, by weight, of the home-generated sharps subject to the plan.
(3)Provisions to meet the minimum collection rate for the home-generated sharps subject to the plan, which shall be determined in the following manner:
(A)On and after January 1, 2020, the minimum collection rate shall be 20 percent of the number amount, by weight, of home-generated sharps that are sold in the state during the 2017 calendar year by producers.
(B)On and after January 1, 2021, the minimum collection rate shall be 40 percent of the number amount, by weight, of home-generated sharps that are sold in the state during the 2017 calendar year by the producers.
(C)On and after January 1, 2022, the minimum collection rate shall be 60 percent of the number amount, by weight, of home-generated sharps that are sold in the state during the 2017 calendar year by the producers.
(D)On and after January 1, 2023, and annually thereafter, the minimum collection rate shall be determined pursuant to Section 47120.
(4)A demonstration of sufficient funding for the home-generated sharps stewardship program proposed by the plan, including a funding mechanism for securing and disbursing funds to cover administrative, operational, and capital costs.
(5)Coordination of the home-generated sharps stewardship program plan with existing local medical waste household hazardous waste and other collection programs, to the extent this requirement is reasonably feasible and mutually agreeable.
(6)Programs to reduce the number of postconsumer home-generated sharps that are illegally disposed of, and to maximize the proper end-of-life management of home-generated sharps, including the collection of home-generated sharps, as practical, based on current medical waste program information.
(7)Education and outreach efforts for consumers, the medical community, and retailers to promote the collection of home-generated sharps. These efforts may include, but are not limited to, developing, and updating as necessary, educational and other outreach materials aimed at all retailers and distributors of home-generated sharps. These materials shall be made available to those parties and may include, but are not limited to, one or more of the following:
(A)Signage that is prominently displayed and easily visible to the consumer at the point of sale.
(B)Written materials and templates of materials for reproduction by retailers to be provided to the consumer at the point of sale or delivery, or both. These written materials shall include information on the prohibition on the improper disposal of home-generated sharps.
(C)Advertising or other promotional materials, or both, that include references to home-generated sharps collection opportunities and the prohibition on the improper disposal of home-generated sharps.
(8)Methods for demonstrating to the department that the program implemented pursuant to the plan achieves the maximum improvement possible in achieving the minimum collection rate.
(9)The establishment of at least one home-generated sharps collection point in every county in the state, but no less than one home-generated sharps collection point for every 25,000 people in each county.
(10)Procedures for complying with all applicable state and federal laws and regulations for the collection, consolidation, transportation, and recycling or disposal of home-generated sharps waste.
47118.(a)The department shall review a home-generated sharps stewardship plan submitted pursuant to Section 47117 within 60 days of receipt. The department shall approve the plan if the department determines the plan provides for the establishment of a home-generated sharps stewardship program that meets the requirements of Section 47117. If the department does not approve the plan, the producer or stewardship organization shall resubmit the plan within 60 days after receiving notice of disapproval from the department.
(b)(1)The approved plan shall be a public record, except that financial, production, or sales data reported to the department by the producer or by the stewardship organization is not a public record under the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code) and shall not be open to public inspection.
(2)Notwithstanding paragraph (1), the department may release financial, production, or sales data in summary form, if the department does not disclose financial, production, or sales data of individual producers.
(c)On or before January 1, 2019, or three months after a plan is approved pursuant to subdivision (a), whichever is later, but no later than April 1, 2019, the producer or stewardship organization shall implement the home-generated sharps stewardship program described in the approved plan.
47119.A retailer may voluntarily participate as a home-generated sharps collection point pursuant to the home-generated sharps stewardship program.
47120.On or before January 1, 2023, the department shall consult with producers, stewardship organizations, the stakeholder advisory committee, and all other stakeholders regarding the programs performance. The department shall set a fair and reasonable minimum collection rate for the 2023 calendar year and for each subsequent calendar year to achieve the goal of safely managing home-generated sharps in this state.
47121.Upon the date a plan is approved, the department shall post on its Internet Web site a list of producers covered by the approved plan. The department shall update this posting within 30 days of a change in compliance status of any producer.
47122.On or before April 1, 2020, and on or before April 1 of every year thereafter, each producer or stewardship organization implementing a plan shall prepare and submit to the department an annual report, as prescribed by the department, describing the activities carried out pursuant to the plan during the previous calendar year, commencing with the 2019 calendar year. The report shall include a list of the specific recommendations from the stakeholder advisory committee and an explanation for either accepting or rejecting those recommendations.
47123.(a)The department shall review and either approve or disapprove the annual report or reports submitted pursuant to Section 47122, including, but not limited to, reviewing the accuracy of the list of home-generated sharps collection points that are certified to be established pursuant to the applicable plan.
(b)If an annual report does not demonstrate that the applicable program has achieved the collection rate increase required pursuant to paragraph (3) of subdivision (c) of Section 47117, the department may require the program to take additional actions with regard to improving and increasing the number of home-generated sharps collection points, ensuring accessibility to those points, and providing additional education and outreach activities.
(c)If the department does not approve or disapprove a report within 45 days of receipt, the report shall be deemed approved by the department.
(d)The department shall make a report submitted to approved by the department pursuant to this section available to the public on the departments Internet Web site for one year.
47125.(a)A producer or stewardship organization submitting a plan to the department shall pay the department an annual administrative fee pursuant to subdivision (b).
(b)The department shall impose the annual fee in an amount that is sufficient to cover the departments full costs of administering and enforcing this article, including any program development costs or regulatory costs incurred by the department prior to the submittal of a plan. The department shall deposit the fees in the Safe Sharps Disposal Account, which is hereby established in the Integrated Waste Management Fund. The department may expend the moneys in the Safe Sharps Disposal Account, upon appropriation by the Legislature, to administer and enforce this article.
47126.(a)The department shall enforce this article and may impose an administrative civil penalty on a person who violates this article in an amount of up to one thousand dollars ($1,000) per violation per day.
(b)The department may impose an administrative civil penalty on a person who intentionally, knowingly, or negligently violates this article in an amount of up to ten thousand dollars ($10,000) per violation per day.
(c)(1)The department may either impose the civil penalty specified in subdivision (a) or (b) on a producer or stewardship organization for which the annual report submitted does not demonstrate that the minimum collection rate has been achieved pursuant to paragraph (3) of subdivision (c) of Section 47117, or require the producer or stewardship organization to take additional actions to comply with this article pursuant to subdivision (b) of Section 47123.
(2)In assessing a penalty pursuant to this subdivision on a producer or stewardship organization, the department shall consider any exigent circumstance that contributed to the producer or stewardship organization not meeting the required minimum collection rate.
(d)The department shall deposit all penalties collected pursuant to this section into the Safe Sharps Disposal Penalty Account, which is hereby created in the Integrated Waste Management Fund. Upon appropriation by the Legislature, moneys deposited into the Safe Sharps Disposal Penalty Account may be expended by the department to enforce this article.
47127.(a)Except as provided in subdivision (c), an action solely to increase the collection of home-generated sharps by a producer, stewardship organization, or retailer that affects the types or quantities being collected, or the cost and structure of any program implementing a stewardship plan, is not a violation of the statutes specified in subdivision (b).
(b)The following statutes are not violated by an action specified in subdivision (a):
(1)The Cartwright Act (Chapter 2 (commencing with Section 16700) of Part 2 of Division 7 of the Business and Professions Code).
(2)The Unfair Practices Act (Chapter 4 (commencing with Section 17000) of Part 2 of Division 7 of the Business and Professions Code).
(c)Subdivision (a) does not apply to an agreement establishing or affecting the price of home-generated sharps or the output or production of home-generated sharps or an agreement restricting the geographic area or customers to which home-generated sharps will be sold.
(a)The Legislature finds and declares all of the following:
(1)The United States Environmental Protection Agency estimates that about 9 million people in the United States currently use disposable needles (sharps) at home to deliver medications to treat a variety of diseases and conditions, including diabetes, cancer, multiple sclerosis, migraines, and allergies. United States households use more than 3 billion disposable needles and syringes each year.
(2)Since 2008, it has been illegal in California for individuals to throw away home-generated sharps. While the state banned needles from trash disposal in 2008, there is still no consistent, statewide program that is sustainably funded or has high levels of effectiveness in California. As a result, thousands of pounds of illegally disposed sharps enter the municipal waste stream each year, putting many people at risk of injury or infection.
(3)Sharps in the trash pose serious health risks to law enforcement, firefighters, parks and recreation workers, hotel housekeepers, sanitation workers, water treatment facility operators, and the general public. In addition to the immediate risk of a needle stick injury, sharps put individuals at risk of acquiring blood-borne infectious diseases, such as hepatitis or HIV. Individuals who suffer a needle stick injury must receive immediate treatment and followup care, including multiple lab tests and medications.
(4)When sanitation workers encounter sharps, productivity suffers and costs increase. When workers sustain a needle stick injury, the costs of care are borne by the waste management company, the workers compensation insurer, and ultimately, taxpayers and ratepayers.
(5)The California Legislature has adopted a 50 percent diversion requirement for each local jurisdiction, and a policy goal of the state that 75 percent of solid waste be source reduced, recycled, or composted. Sanitation workers are increasingly hand-sorting solid waste in an effort to meet the diversion requirements. Despite repeated efforts to engineer protective gloves to prevent needle sticks, the absence of a consistent sharps disposal policy in this state is increasing the workplace danger for sanitation workers.
(6)In 2011, Assembly Bill 341 was enacted, declaring the 75 percent statewide policy goal and requiring the Department of Resources Recycling and Recovery to submit a report to the Legislature with regulatory and legislative recommendations for achieving the goal. The report, which was issued in August 2015, contains five priority strategies. One of the priority strategies identified by the report is extended producer responsibility, also known as product stewardship. Additionally, the report identifies hazardous materials, which include sharps, as a problem waste stream and recommends managing this problem product through extended producer responsibility.
(b)It is the intent of the Legislature, in enacting the Safe Home-Generated Sharps Recovery Program, as established by Article 3.3 (commencing with Section 47115) of Chapter 1 of Part 7 of Division 30 of the Public Resources Code, to ensure affordable and convenient sharps collection opportunities, which, in turn, will help prevent the improper management of those sharps.
SEC. 2.Section 118286 of the Health and Safety Code is amended to read:118286.(a)A person shall not knowingly place home-generated sharps waste in any of the following containers:
(1)Any container used for the collection of solid waste, recyclable materials, or greenwaste.
(2)Any container used for the commercial collection of solid waste or recyclable materials from business establishments.
(3)Any roll-off container used for the collection of solid waste, construction, and demolition debris, greenwaste, or other recyclable materials.
(b)Home-generated sharps waste shall be transported only in a sharps container, or other containers approved by the enforcement agency, and shall only be managed at any of the following:
(1)A household hazardous waste collection facility pursuant to Section 25218.13.
(2)A home-generated sharps consolidation point as defined in subdivision (b) of Section 117904.
(3)A medical waste generators facility pursuant to Section 118147.
(4)A facility through the use of a medical waste mail-back container approved by the United States Postal Service.
(5)A facility or other home-generated sharps collection point operated pursuant to a home-generated sharps stewardship plan approved pursuant to Article 3.3 (commencing with Section 47115) of Chapter 1 of Part 7 of Division 30 of the Public Resources Code.
SEC. 3.Article 3.3 (commencing with Section 47115) of Chapter 1 of Part 7 of Division 30 of the Public Resources Code is repealed.SEC. 4.Article 3.3 (commencing with Section 47115) is added to Chapter 1 of Part 7 of Division 30 of the Public Resources Code, to read:3.3.Safe Home-Generated Sharps Recovery Program47115.For purposes of this article, the following terms have the following meanings:
(a)Consumer means a person who purchases or owns home-generated sharps.
(b)Distributor means a person that sells sharps or provides sharps for free to the general public for home use, which may include, but is not limited to, a retailer, a veterinarian, or a health clinic, health dispensary, or health facility licensed under Division 2 (commencing with Section 1200) of the Health and Safety Code.
(c)Home-generated sharps means hypodermic needles, syringes with needles attached, pen needles, intravenous needles, lancets, or any other similar device intended to self-inject medication at home.
(d)Home-generated sharps stewardship plan or plan means a plan submitted by an individual producer or by a stewardship organization on behalf of one or more producers.
(e)Producer means, with regard to home-generated sharps that are sold, offered for sale, or distributed in the state, one of the following:
(1)The person who manufactures home-generated sharps and who sells, offers for sale, or distributes those home-generated sharps in the state under that persons own name or brand.
(2)If there is no person who is a producer of the home-generated sharps for purposes of paragraph (1), the producer of the home-generated sharps is the owner or licensee of a trademark or brand under which the home-generated sharps are sold or distributed in the state, whether or not the trademark is registered.
(3)If there is no person who is a producer of the sharps for purposes of paragraphs (1) and (2), the producer of those sharps is the person who imports the home-generated sharps into the state for sale or distribution.
(f)Program means the program implementing an approved home-generated sharps stewardship plan.
(g)Retailer means a person that sells home-generated sharps in the state to a consumer. A sale includes, but is not limited to, a transaction conducted through sales outlets, catalogs, or the Internet or any other similar electronic means.
(h)Stewardship organization means a nonprofit organization created by one or more producers the governing board of which includes three additional members, appointed by the director, one representing from each of the following entities:
(1)A local government.
(2)A retailer.
(3)A solid waste hauler.
(i)Stakeholder means a person who will be subject to, or participate in, the program that will be implemented by a proposed home-generated sharps stewardship plan, including, but not limited to, consumers, retailers, distributors, and health care providers and facilities.
47115.2.On or before January 1, 2018, the department shall adopt regulations implementing this article.
47115.4.(a)On or before February 1, 2018, the department shall appoint a stakeholder advisory committee to provide specific recommendations and strategic guidance to producers and stewardship organizations. The stakeholder advisory committee shall report annually to the department on the progress of the producers and stewardship organizations implementation of this article.
(b)Members of the advisory committee shall include members from the environmental community, solid waste haulers, local governments, retailers, and other key stakeholders.
(c)The stakeholder advisory committee shall be independent of the producers and stewardship organizations. The advisory committees expenses shall be paid by its members and not the producers or stewardship organizations.
(d)A producer or stewardship organization shall have no control over the stakeholder advisory committee or its activities.
47116.A pharmaceutical manufacturer that sells or distributes a medication in the state that is usually intended to be self-injected at home through the use of a home-generated sharp shall submit, on or before July 1 of each year, to the department, or its successor agency, a plan that describes how the manufacturer supports the safe collection and proper disposal of the home-generated sharps.
47117.(a)On or before July 1, 2018, a producer or a stewardship organization designated by a producer shall submit a home-generated sharps stewardship plan to the department. The home-generated sharps stewardship plan shall also be posted on the Internet Web site of the producer or stewardship organization. The plan shall provide for the implementation of the plan for each calendar year, commencing January 1, 2019.
(b)The producer or stewardship organization shall consult with the stakeholder advisory committee during the development of the home-generated sharps stewardship plan, including soliciting and responding to stakeholder advisory committee comments, and shall document those comments in the plan.
(c)The home-generated sharps stewardship plan shall provide for the development and implementation of a recovery program to reduce the generation of, and manage the end of life of, home-generated sharps in an environmentally sound and medically safe manner, including collecting, transporting, processing, and recycling or disposing. The plan shall include, at a minimum, all of the following elements:
(1)Contact information for all participating producers.
(2)Procedures for calculating the amount, by weight, of the home-generated sharps subject to the plan.
(3)Provisions to meet the minimum collection rate for the home-generated sharps subject to the plan, which shall be determined in the following manner:
(A)On and after January 1, 2020, the minimum collection rate shall be 20 percent of the number of home-generated sharps that are sold in the state during the 2017 calendar year by producers.
(B)On and after January 1, 2021, the minimum collection rate shall be 40 percent of the number of home-generated sharps that are sold in the state during the 2017 calendar year by the producers.
(C)On and after January 1, 2022, the minimum collection rate shall be 60 percent of the number of home-generated sharps that are sold in the state during the 2017 calendar year by the producers.
(D)On and after January 1, 2023, and annually thereafter, the minimum collection rate shall be determined pursuant to Section 47120.
(4)A demonstration of sufficient funding for the home-generated sharps stewardship program proposed by the plan, including a funding mechanism for securing and disbursing funds to cover administrative, operational, and capital costs.
(5)Coordination of the home-generated sharps stewardship program with existing local medical waste collection programs, to the extent this requirement is reasonably feasible and mutually agreeable.
(6)Programs to reduce the number of postconsumer sharps that are illegally disposed of, and to maximize the proper end-of-life management of home-generated sharps, including the collection of home-generated sharps, as practical, based on current medical waste program information.
(7)Education and outreach efforts for consumers, the medical community, and retailers to promote the collection of home-generated sharps. These efforts may include, but are not limited to, developing, and updating as necessary, educational and other outreach materials aimed at all retailers and distributors of home-generated sharps. These materials shall be made available to those parties and may include, but are not limited to, one or more of the following:
(A)Signage that is prominently displayed and easily visible to the consumer at the point of sale.
(B)Written materials and templates of materials for reproduction by retailers to be provided to the consumer at the point of sale or delivery, or both. These written materials shall include information on the prohibition on the improper disposal of home-generated sharps.
(C)Advertising or other promotional materials, or both, that include references to home-generated sharps collection opportunities and the prohibition on the improper disposal of home-generated sharps.
(8)Methods for demonstrating to the department that the program implemented pursuant to the plan achieves the maximum improvement possible in achieving the minimum collection rate.
(9)The establishment of at least one home-generated sharps collection point in every county in the state, but no less than one home-generated sharps collection point for every 25,000 people in each county.
47118.(a)The department shall review a home-generated sharps stewardship plan submitted pursuant to Section 47117 within 60 days of receipt. The department shall approve the plan if the department determines the plan provides for the establishment of a home-generated sharps stewardship program that meets the requirements of Section 47117. If the department does not approve the plan, the producer or stewardship organization shall resubmit the plan within 60 days after receiving notice of disapproval from the department.
(b)(1)The approved plan shall be a public record, except that financial, production, or sales data reported to the department by the producer or by the stewardship organization is not a public record under the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code) and shall not be open to public inspection.
(2)Notwithstanding paragraph (1), the department may release financial, production, or sales data in summary form, if the department does not disclose financial, production, or sales data of individual producers.
(c)On or before January 1, 2019, or three months after a plan is approved pursuant to subdivision (a), whichever is later, but no later than April 1, 2019, the producer or stewardship organization shall implement the home-generated sharps stewardship program described in the approved plan.
47119.A retailer may voluntarily participate as a home-generated sharps collection point pursuant to the home-generated sharps stewardship program.
47120.On or before January 1, 2023, the department shall consult with producers, stewardship organizations, the stakeholder advisory committee, and all other stakeholders regarding the programs performance. The department shall set a fair and reasonable minimum collection rate for the 2023 calendar year and for each subsequent calendar year to achieve the goal of safely managing home-generated sharps in this state.
47121.Upon the date a plan is approved, the department shall post on its Internet Web site a list of producers covered by the approved plan. The department shall update this posting within 30 days of a change in compliance status of any producer.
47122.On or before April 1, 2020, and on or before April 1 of every year thereafter, each producer or stewardship organization implementing a plan shall prepare and submit to the department an annual report, as prescribed by the department, describing the activities carried out pursuant to the plan during the previous calendar year, commencing with the 2019 calendar year. The report shall include a list of the specific recommendations from the stakeholder advisory committee and an explanation for either accepting or rejecting those recommendations.
47123.(a)The department shall review the annual report or reports submitted pursuant to Section 47122, including, but not limited to, reviewing the accuracy of the list of home-generated sharps collection points that are certified to be established pursuant to the applicable plan.
(b)If an annual report does not demonstrate that the applicable program has achieved the collection rate increase required pursuant to paragraph (3) of subdivision (c) of Section 47117, the department may require the program to take additional actions with regard to improving and increasing the number of home-generated sharps collection points, ensuring accessibility to those points, and providing additional education and outreach activities.
(c)If the department does not disapprove a report within 45 days of receipt, the report shall be deemed approved by the department.
(d)The department shall make a report submitted to the department pursuant to this section available to the public on the departments Internet Web site for one year.
47125.(a)A producer or stewardship organization submitting a plan to the department shall pay the department an annual administrative fee pursuant to subdivision (b).
(b)The department shall impose the annual fee in an amount that is sufficient to cover the departments full costs of administering and enforcing this article, including any program development costs or regulatory costs incurred by the department prior to the submittal of a plan. The department shall deposit the fees in the Safe Sharps Disposal Account, which is hereby established in the Integrated Waste Management Fund. The department may expend the moneys in the Safe Sharps Disposal Account, upon appropriation by the Legislature, to administer and enforce this article.
47126.(a)The department shall enforce this article and may impose an administrative civil penalty on a person who violates this article in an amount of up to one thousand dollars ($1,000) per violation per day.
(b)The department may impose an administrative civil penalty on a person who intentionally, knowingly, or negligently violates this article in an amount of up to ten thousand dollars ($10,000) per violation per day.
(c)(1)The department may either impose the civil penalty specified in subdivision (a) or (b) on a producer or stewardship organization for which the annual report submitted does not demonstrate that the minimum collection rate has been achieved pursuant to paragraph (3) of subdivision (c) of Section 47117, or require the producer or stewardship organization to take additional actions to comply with this article pursuant to subdivision (b) of Section 47123.
(2)In assessing a penalty pursuant to this subdivision on a producer or stewardship organization, the department shall consider any exigent circumstance that contributed to the producer or stewardship organization not meeting the required minimum collection rate.
(d)The department shall deposit all penalties collected pursuant to this section into the Safe Sharps Disposal Penalty Account, which is hereby created in the Integrated Waste Management Fund. Upon appropriation by the Legislature, moneys deposited into the Safe Sharps Disposal Penalty Account may be expended by the department to enforce this article.
47127.(a)Except as provided in subdivision (c), an action solely to increase the collection of home-generated sharps by a producer, stewardship organization, or retailer that affects the types or quantities being collected, or the cost and structure of any program implementing a stewardship plan, is not a violation of the statutes specified in subdivision (b).
(b)The following statutes are not violated by an action specified in subdivision (a):
(1)The Cartwright Act (Chapter 2 (commencing with Section 16700) of Part 2 of Division 7 of the Business and Professions Code).
(2)The Unfair Practices Act (Chapter 4 (commencing with Section 17000) of Part 2 of Division 7 of the Business and Professions Code).
(c)Subdivision (a) does not apply to an agreement establishing or affecting the price of home-generated sharps or the output or production of home-generated sharps or an agreement restricting the geographic area or customers to which home-generated sharps will be sold.
SECTION 1.It is the intent of the Legislature to reduce waste in the state.
It is the intent of the Legislature to reduce waste in the state.
|
Date
|
Status
|
|---|---|
| Feb 16, 2016 | Read first time. To print. |
| Feb 17, 2016 | From printer. May be heard in committee March 18. |
| Mar 17, 2016 | From committee chair, with author's amendments: Amend, and re-refer to Com. on E.S. & T.M. Read second time and amended. |
| Mar 17, 2016 | Referred to Com. on E.S. & T.M. |
| Mar 28, 2016 | Re-referred to Com. on E.S. & T.M. |
| Apr 5, 2016 | From committee chair, with author's amendments: Amend, and re-refer to Com. on E.S. & T.M. Read second time and amended. |
| Apr 6, 2016 | Re-referred to Com. on E.S. & T.M. |
| Apr 12, 2016 | In committee: Set, first hearing. Hearing canceled at the request of author. |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
Date of Hearing: April 12, 2016
ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS
Luis Alejo, Chair
ABPCA Bill Id:AB 2039 (
Author:Ting) – As Amended Ver:April 5, 2016
SUBJECT: Solid waste: home-generated sharps
SUMMARY: Requires the development and implementation of industry-generated plans to collect and recycle home-generated sharps. Specifically, this bill:
- Declares that it is the intent of the Legislature, in enacting the Safe Home-Generated Sharps Recovery Program (Program), to ensure affordable and convenient sharps collection opportunities, which, in turn, will help prevent the improper management of those sharps.
- Repeals the provisions of Senate Bill (SB) 486 (Simitian, Chapter 591, Statutes of 2009), which requires a pharmaceutical manufacturer that sells or distributes a medication in California that is usually intended to be self-injected at home through the use of a hypodermic needle, pen needle, intravenous needle, or any other similar device, to submit a plan to the California Department of Resources Recycling and Recovery (CalRecycle) that describes the actions taken by the manufacturer to: 1) support or provide for the safe collection and proper disposal of the waste devices, and 2) educate consumers about safe sharps management and collection opportunities.
- Authorizes home-generated sharps waste to be managed by a facility or other home-generated sharps collection point operated pursuant to a home-generated sharps stewardship plan.
- Defines "home-generated sharps stewardship plan" as a plan submitted by an individual producer or by a stewardship organization on behalf of one or more producers.
- Defines "producer" as: 1) the person who manufactures home-generated sharps and who sells, offers for sale, or distributes those home-generated sharps in the state under that person’s own name or brand; 2) if there is no person who is a producer of the home-generated sharps, it is the owner or licensee of a trademark or brand under which the home-generated sharps are sold or distributed in the state, whether or not the trademark is registered; or, 3) if there is no person who is a producer of the sharps per 1) and 2) above, the producer of those sharps is the person who imports the home-generated sharps into the state for sale or distribution.
- Defines "stewardship organization" as either a nonprofit organization created by one or more producers to act as an agent on behalf of the producers to design, submit, and administer a product stewardship plan pursuant to this chapter; or a producer of a covered product.
- Requires CalRecycle, on or before January 1, 2018, to adopt regulations.
- Requires, on or before February 1, 2018, CalRecycle to appoint a stakeholder advisory committee, with representation from specific sectors, to provide recommendations and guidance to producers and stewardship organizations. Requires the stakeholder advisory committee to annually report to CalRecycle.
- Requires a pharmaceutical manufacturer that sells or distributes a medication that is intended to be self-injected at home to submit to CalRecycle a plan that describes how the manufacturer supports the safe collection and proper disposal of the home-generated sharps, on or before July 1 of each year.
- Requires, on or before July 1, 2018, a producer or a stewardship organization designated by a producer, to submit a home-generated sharps stewardship plan to CalRecycle.
- Requires the producer or stewardship organization to consult with the stakeholder advisory committee as it develops its stewardship plan. Requires the plan to provide for the development and implementation of a recovery program to reduce the generation of, and manage the end of life of, home-generated sharps in an environmentally sound and medically safe manner.
- Specifies that the stewardship plan must contain the following elements:
- Contact information for all participating producers;
- Procedures for calculating the amount, by weight, of the home-generated sharps subject to the plan;
- Provisions for meeting specified collection targets;
- A demonstration of sufficient funding to implement the plan;
- Coordination of the home-generated sharps stewardship plan with existing household hazardous waste (HHW) and other local collection programs;
- Programs to reduce the number of home-generated sharps that are illegally disposed of, and to maximize the proper end of life management of home-generated sharps;
- Education and outreach efforts;
- Methods for demonstrating that the program implemented achieves the maximum improvement possible on the improper disposal of home-generated sharps;
- The establishment of at least one home-generated sharps collection point in every county in the state, but no less than one home-generated sharps collection point for every 25,000 people in each county; and,
- Procedures for complying with all applicable state and federal laws and regulations for the collection, consolidation, transportation, and recycling or disposal of home-generated sharps waste.
- Requires CalRecycle to review a home-generated sharps stewardship plan within 60 days of receipt. Specifies timelines for approval and for requiring resubmission of a revised stewardship plan.
- Requires an approved plan to be public record, except for any financial, production, or sales data reported to CalRecycle by the producer or stewardship organization.
- Requires, on or before January 1, 2019, or three months after a plan is approved, whichever is later, but no later than April 1, 2019, the producer or stewardship organization to implement the home-generated sharps stewardship program described in the plan.
- Authorizes a retailer to voluntarily participate as a home-generated sharps collection point pursuant to the home-generated sharps program.
- Requires CalRecycle, on or before January 1, 2023, to consult with producers, stewardship organizations, the stakeholder advisory committee, and all other stakeholders regarding the Program's performance.
- Requires CalRecycle, once the plan is approved, to post on its Internet Website a list of producers covered under the plan.
- Requires, on or before April 1, 2020, and annually thereafter, each producer or stewardship organization implementing a plan to prepare and submit to CalRecycle an annual report with information describing the activities carried out pursuant to the plan and specific recommendations from the stakeholder advisory committee that were accepted or rejected by the stewardship organization.
- Requires CalRecycle to review and approve or disapprove the annual report and review the accuracy of the list of home-generated sharps collection points that are certified to be established pursuant to the plan.
- Authorizes CalRecycle, if the annual report does not demonstrate that the applicable program has achieved the collection rate increase as required pursuant to aforementioned collection targets, to require additional actions to improve collection rates.
- Requires a report deemed approved by CalRecycle if CalRecycle does not disapprove a report within 45 days of receipt. Requires all approved reports to be posted on CalRecycle's Website for one year.
- Requires a producer or stewardship organization submitting a plan to CalRecycle to pay an annual administrative fee, which shall be set at an appropriate amount to cover CalRecycle’s administrative costs.
- Establishes the Safe Sharps Disposal Account within the Integrated Waste Management Fund and requires the administrative fees to be deposited into that Account.
- Authorizes CalRecycle to enforce this article and impose a civil penalty of up to $1,000 per violation per day. Authorizes CalRecycle to impose a civil penalty on a person who knowingly and intentionally violates this article of up to $10,000 per violation per day.
- Establishes the Safe Sharps Disposal Penalty Account within the Integrated Waste Management Fund and requires all penalties to be deposited into that Account.
- States that any action by a producer, stewardship organization, or retailer is not a violation of the Cartwright Act (Business & Professions Code (B&P) § 16700, et seq.) or the Unfair Practices Act (B&P 1700, et seq.).
EXISTING LAW:
- Authorizes a city and a county HHW element to include a program for the safe collection, treatment, and disposal of sharps waste generated by households. (Public Resources Code (PRC) § 41502)
- 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)
- 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)
- 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 (H&S) § 117671)
- 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. (H&S § 118286)
- Pursuant to the Medical Waste Management Act (MWMA) (H&S § 117600, et seq.):
- Defines "medical waste" as including waste generated from the consolidation of home-generated sharps. (H&S § 117690)
- Authorizes a registered medical waste generator to accept and consolidate home-generated sharps waste with the facility's medical waste stream under specified conditions. (H&S § 118147)
- Requires a person generating or treating sharps waste to ensure that the medical waste is treated to render it solid waste prior to disposal. (H&S § 118215)
- Requires sharps waste to be rendered noninfectious prior to disposal by a specified treatment method. (H&S § 118225)
- Specifies containerization, storage and labeling requirements for sharps waste. (H&S § 1118275, 118285, and 118286)
- 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. (H&S § 117904)
FISCAL EFFECT: Unknown.
COMMENTS:
Need for the bill: According to the author, "AB 2039 requires sharps manufacturers to design, fund, and administer a take-back program to safely collect and dispose of home-generated sharps to keep them out of the trash … 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 leaves some workers over-exposed to health dangers, a risk compounded by the growing use of home-generated sharps. We must remove sharps from the waste stream on the front end so that important state recycling goals are not unintentionally at cross purposes with worker safety."
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 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 94,000lbs (0.2%), of the total solid waste stream.
Sharps risk: Improper sharps disposal can affect janitors, housekeepers, pest control workers, groundskeepers, waste management workers, and children or household pets among others. Roughly 25% to 45% of all facilities processing household trash (besides recycling) in California have workers hand-sorting recyclable material out of that trash. A single worker’s on-the-job needle stick can mean weeks of taking drugs to prevent the spread of infection, with side effects including nausea, depression, and extreme fatigue as well as months waiting for expensive periodic tests to reveal whether they contracted life-threatening HIV/AIDs or hepatitis B or C. According to CalRecycle, it costs between $154 to $2,411 for testing/treatment for a single needlestick, and around $4.6 million is spent in California every year due to needlesticks, primarily for testing for infection and work loss while testing.
In 2013, in connection with AB 1893 (Stone and Eggman) and a related Senate Labor Committee hearing, the Legislature requested that the Commission on Health and Safety and Workers' Compensation review whether provisions of current law offered sufficient protection against sharps injuries for workers outside healthcare occupations. As a result, the University of California, Berkeley (UC Berkeley) released a March 2015, study, Infection Risk from "Sharps" Injuries for Non-healthcare Workers, which found a contrary view. That study stated, "sharps injuries, outside the healthcare setting are uncommon. About 1-in-10,000 workers outside healthcare will experience a needlestick in a given year. For specific industries (education, food & hospitality, and waste management) and occupations (custodial services and protective services), this risk is substantially higher. However, even in these specific industries and occupations, the risk of a sharps injury is less than 1/1000 workers/year." The study concluded that, "no evidence that additional statutory and regulatory action covering home-health sharps waste or sharps injuries to non-healthcare workers is warranted."
The California Life Sciences Association asserts the results of the UC Berkeley study can be chalked up to existing opportunities for safe disposal, specifically stating that "because throwing sharps in the trash is already illegal, patients and healthcare providers have access to numerous sharps disposal options … Current options for disposal include manufacturers’ and others’ mail-back programs, disposal with the patient’s healthcare provider, disposal at designated household hazardous waste facilities and some pharmacies, needle destruction devices, and disposal via a rigid plastic container (e.g., bleach or detergent bottle) is permitted in ten counties. Furthermore, sharps manufacturers in California must already include safe disposal information in the packaging inserts accompanying the patient’s medicine, maintain a call center to answer disposal questions, and post safe disposal information on their websites. These requirements are in addition to the ongoing education and outreach to healthcare providers, and the patient’s primary source of information on home-health injectable medicines is generally his or her provider."
However, the UC Berkeley study specifically looked at the incidences of needlesticks, the cost to employers, and the cost (if any) and risk faced by workers. Even if the incidence of pricks, the pathogen transfer, and the cost to employers are all low, the intent of AB 2039 is to have a safe mechanism to prevent all injuries given the exponential growth of the consumption of injectable drugs at home.
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.
Under AB 2039, a home-generated sharps stewardship plan must establish at least one home-generated sharps collection point in every county in the state, but no less than one home-generated sharps collection point for every 25,000 people in each county, and the plan must include procedures for complying with all applicable state and federal laws and regulations for the collection, consolidation, transportation, and recycling or disposal of home-generated sharps waste.
Current requirements for sharps manufacturers: Pursuant to SB 486, a pharmaceutical manufacturer that sells or distributes a medication in California that is intended to be self-injected at home through the use of a hypodermic needle, pen needle, intravenous needle, or any other similar device, is required to submit a plan to CalRecycle that describes the actions taken by the manufacturer to support or provide for the safe collection and proper disposal of the waste devices, and educate consumers about safe sharps management and collection opportunities. To date, CalRecycle has received sharps collection and disposal plans from 29 pharmaceutical manufacturers or distributors.
According to the analysis of SB 486, "…with the prohibition of disposal of sharps in the waste stream and no convenient, cost effect [sic] method of management identified, it is time to take steps to find a solution of the problem. The first step to that is to identify what the companies that manufacture the medicines that are dispensed through a ‘sharp’ are doing to help their customers address the disposal ban issue… The author's office believes that this bill represents a first step toward developing an EPR [Extended Producer Responsibility] approach to the management of sharps, and provides a way to determine what the pharmaceutical industry is doing to assist with the effort to manage sharps."
In the opinion of the Monterey Regional Waste Management District, the voluntary provisions of SB 486 are not working. As of July 1, 2012, there were 31 plans submitted to CalRecycle, which were read and graded by a 9-person evaluation team, scoring each plan based on published consumer criteria. The Senate Bill 486 Evaluation Team Consumer Report Card found that, of those 31 manufacturer reports, 20, or nearly 65% of all submitted reports, were graded an F. In addition, 8 other manufacturers were graded “F/Incomplete” for not submitting plans by the legislatively mandated deadline of July 1 and being in violation of state law.
AB 2039 proposes to repeal the provisions enacted pursuant to SB 486, entirely, and replace them with new requirements for the collection and safe disposal of home-generated sharps.
Extended producer responsibility: CalRecycle defines extended producer responsibility (EPR) as a strategy to place a shared responsibility for end-of-life product management on the producers, and all entities involved in the product chain, instead of the general public; while encouraging product design changes that minimize a negative impact on human health and the environment at every stage of the product's lifecycle. This allows the costs of treatment and disposal to be incorporated into the total cost of a product. It places primary responsibility on the producer, or brand owner, who makes design and marketing decisions. It also creates a setting for markets to emerge that truly reflect the environmental impacts of a product, and to which producers and consumers respond.
By shifting costs and responsibilities of product disposal to producers and others who directly benefit, EPR provides an incentive to eliminate waste and pollution through product design changes.
There are a number of existing, statewide EPR programs for various products, including, but not limited to paint, used oil, and, most recently, mattresses.
AB 2039 proposes building on the models of the aforementioned programs to develop EPR for home-generated medical sharps.
Related bills:
- SB 1229 (Jackson) would provide that an entity registered with the federal Drug Enforcement Agency to receive a controlled substance for the purpose of destruction is not liable for civil damages, or subject to criminal prosecution, for maintaining a secure drug take-back bin on its premise. This bill will be heard in the Senate Judiciary Committee on April 12.
- 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.
- 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.
- 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
California Product Stewardship Council (Sponsor)
Atlas Disposal Industries
Bay Counties Waste Services
BMS Technologies
Burrtec Waste Industries
Butte County
Cal-Waste Recovery Systems
Californians Against Waste
California Alliance for Retired Americans
California Refuse Recycling Council
California State Association of Counties
California Teamsters Public Affairs Council Cal-Waste Recovery Systems
City and County of San Francisco
City of Sacramento
City of Lakewood
City of Sunnyvale
Consolidated Fabricators Corp.
County of Santa Clara
CR&R Environmental Services
Davis Waste Removal Co. Inc.
Desert Valley Disposal, Inc.
Drug Policy Alliance
East Bay Counties Waste Services
East Bay Sanitary Co.
E-Recycling of California
Garaventa Enterprises
Garden City Sanitation
GreenWaste Recovery
Inland Empire Disposal Association
Kern County
Kern Refuse, Inc.
League of California Cities
Los Angeles County Integrated Waste Management Committee/Task Force
Los Angeles County Waste Management Association
MarBorg Industries
Marin Sanitary Service
Monterey Regional Waste Management District
Napa Recycling & Waste Services
Northern Recycling Operations & Waste Services, LLC
Palm Springs Disposal Services
Recology
Rural County Representatives of California
San Diego County Board of Supervisors
San Francisco Public Utilities Commission
Silicon Valley Leadership Group
Solid Waste Association of North America
Solid Waste Association Orange County
South Lake Refuse & Recycling
Southern California Disposal & Recycling Stanislaus County
Strategic Materials
Turlock Scavenger Company
United Pharmacy
Upper Valley Disposal & Recycling
Western Placer Waste Management
Authority
Varner Bros
Opposition
Advanced Medical Technology Association
Amgen
AstraZeneca
BD
Biocom
Biotechnology Industry Organization
Biotechnology Innovation
Bristol-Myers Squibb
Cal Chamber
California Life Sciences Association
California Manufacturers and Technology Association
Industrial Environmental Association
Eli Lilly
Medtronic
Pharmaceutical Research and Manufacturers of America (PhRMA)
Silicon Valley Leadership Group
PhRMA
Analysis Prepared by: Paige Brokaw / E.S. & T.M. / (916) 319-3965
Bill Author
Bill Co-Author(s):