BILL NUMBER: AB 2039AMENDED BILL TEXT AMENDED IN ASSEMBLY APRIL 5, 2016 AMENDED IN ASSEMBLY MARCH 17, 2016 INTRODUCED BY Assembly Member Ting FEBRUARY 16, 2016 An act to amend Section 118286 of the Health and Safety Code, and to repeal and add Article 3.3 (commencing with Section 47115) of Chapter 1 of Part 7 of Division 30 of the Public Resources Code, relating to solid waste. LEGISLATIVE COUNSEL'S DIGEST AB 2039, as amended, Ting. Solid waste: home-generated sharps. (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 department's 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 department's expenditure upon appropriation by the Legislature, to administer and enforce the bill's requirements. This bill would authorize the department to impose an administrative civil penalty on a person who violates the bill's 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 bill' s 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 bill' s 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. Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. (a) The Legislature finds and declares all of the following: (1) The United States Environmental Protection Agencyestimates 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 sh arps 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 generator's 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: Article 3.3. Safe Home-Generated Sharps Recovery Program 47115. 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 person's 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 producersthe 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 committee's 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 thenumberamount, 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 thenumberamount, 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 thenumberamount, 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 stewardshipprogramplan with existing localmedical wastehousehold hazardous waste and other collection programs, to the extent this requirement is reasonably feasible and mutually agreeable. (6) Programs to reduce the number ofpostconsumerhome-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 program's 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 reportsubmitted toapproved by the department pursuant to this section available to the public on the department's 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 department's 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.