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AB-403 Solid waste: home-generated sharps.(2013-2014)

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AB403:v96#DOCUMENT

Amended  IN  Assembly  April 18, 2013
Amended  IN  Assembly  April 08, 2013
Amended  IN  Assembly  March 19, 2013

CALIFORNIA LEGISLATURE— 2013–2014 REGULAR SESSION

Assembly Bill No. 403


Introduced by Assembly Members Stone and Eggman

February 15, 2013


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 403, as amended, Stone. Solid waste: home-generated sharps.
(1) Existing law 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 of Resources Recycling and Recovery a plan supporting the safe collection and proper disposal of specified waste devices.
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 April 1, 2015, 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 end of life of, home-generated sharps, and to include specified elements, including provisions to meet unspecified specified minimum collection rates for the home-generated sharps subject to the plan.

The

This bill would provide for the review and approval of the plan by the department and would require the department, on January 1, 2016, or upon the date the first plan is approved, whichever is earlier, to post on its Internet Web site a list of producers for which the department has approved a plan. The bill would require a wholesaler, health care facility, retailer, or other distributor that distributes or sells home-generated sharps to monitor the department’s Internet Web site to determine if the sale of a producer’s home-generated sharps is in compliance with the bill. The bill would, as of 120 days after that posting, prohibit a producer or retailer from selling or offering for sale in this state home-generated sharps to a person in this state unless the producer of those home-generated sharps is in compliance with the bill’s requirements.

The

This bill would require a producer or stewardship organization, by April 1, 2017, and every subsequent year thereafter, to prepare and submit to the department an annual report describing the activities carried out pursuant to the plan during the previous calendar year. The department would be required to review the report and would direct the department, if the annual report does not demonstrate the achievement of an unspecified collection rate increase, 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. The bill would authorize the department to exempt a producer or stewardship organization from the annual report requirements if the department determines that the collection rate for the home-generated sharps subject to a plan meets a 95% collection rate.

The

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, and the department would be authorized to expend the moneys in that account, upon appropriation by the Legislature, to administer and enforce the bill’s requirements.

The

This bill would require the department to enforce these provisions and would authorize the department to impose an administrative civil penalty on a person who violates the bill’s requirements or on a producer or stewardship organization that does not achieve the unspecified minimum collection rate. 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, and the department would be authorized to expend the moneys in that account, upon appropriation by the Legislature, to enforce the bill’s requirements.
(2) The existing 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 the act, or other 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   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 The Legislature finds and declares all of the following:
(a) 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.
(b) 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 at collecting the majority of sharps disposed of each year in California. As a result, thousands of pounds of illegally disposed of sharps enter the municipal waste stream each year, putting many people at risk of injury or infection.
(c) Sharps in the trash pose serious health risks to 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 follow-up care, including multiple lab tests and medications.
(d) 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.
(e) 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 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 department pursuant to subdivision (b) of Section 118245.
(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.

The Legislature finds and declares that the purpose of the safe home-generated sharps recovery program established by this article is to require the producers of injection devices to develop and implement a program to collect, transport, and process home-generated sharps, thereby reducing the costs, public health risks, and environmental impacts of the illegal and unsafe disposal of home-generated sharps in this state.

47116.47115.
 For purposes of this article, the following terms have the following meanings:
(a) “Baseline” is a percentage that is determined by dividing the estimated weight of home-generated sharps collected in the calendar year by the estimated weight of home-generated sharps sold in the previous calendar year.

(a)

(b) “Consumer” means a person that purchases or owns home-generated sharps.

(b)

(c) “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)

(d) “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.
(e) “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.
(f) “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 sells, offers for sale, or distributes home-generated sharps in the state under the person’s own name or brand, 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.

(d)

(g) “Program” means the program implementing an approved home-generated sharps stewardship plan.

(e)

(h) “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.

(f)

(i) “Stewardship organization” means a nonprofit organization created by one or more producers that also includes at least four additional members, who shall be representatives from each of the following entities, but not more than one representative per entity, to the extent that the other entities do not have a representative:
(1) A local government.
(2) A distributor.
(3) A solid waste hauler.
(4) A consumer health organization that will implement the home-generated sharps stewardship plan.

(g)“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.

(h)“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 sells, offers for sale, or distributes home-generated sharps in the state under the person’s own name or brand, 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.

(i)

(j) “Stakeholder” means a person that is subject to, or will 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.

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, 2010, and annually thereafter, 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)A producer or retailer shall not sell or offer for sale in this state home-generated sharps to a person in this state unless the producer of those home-generated sharps is in compliance with this article.

(b)The sales prohibition specified in subdivision (a) shall apply no earlier than 120 days after the date that the department posts on its Internet Web site a list of producers for which the department has approved a plan pursuant to paragraph (1) of subdivision (a) of Section 47121.

(c)The sales prohibition specified in subdivision (a) shall apply until the producer of the home-generated sharps is listed as compliant on the department’s Internet Web site or demonstrates compliance pursuant to subdivision (b) of Section 47122.

47118.47117.
 (a) On or before April 1, 2015, a producer or a stewardship organization designated by the 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, 2016.
(b) The producer, group of producers, or stewardship organization shall consult with stakeholders during the development of the home-generated sharps stewardship plan, including soliciting stakeholder comments and responding to stakeholder 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 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 collection rate for the home-generated sharps subject to the plan, which shall be determined using, as a baseline, the number of home-generated sharps collected by all producers subject to the plan, by weight, during the 2014 calendar year, as compared to the average number of home-generated sharps that are sold in the state during the 2013 calendar year by producers that are 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, 2016, the minimum collection rate shall be _____ 25 percent of the average above the baseline number of home-generated sharps that are sold in the state during the previous three calendar years by the producers who are subject to the plan. the 2014 calendar year, as established by the department pursuant to paragraph (2).
(B) On and after January 1, 2017, the minimum collection rate shall be _____ 20 percent of the average number of home-generated sharps that are sold in the state during the previous three calendar years year by the producers who are subject to the plan.
(C) On and after January 1, 2018, and annually thereafter, the collection rate shall be determined pursuant to Section 47120. 47119.
(4) (A) A demonstration of sufficient funding for the home-generated sharps stewardship program proposed by the plan, including a funding mechanism for securing and dispersing funds to cover administrative, operational, and capital costs.
(B) The plan shall require the producer, and not consumers, to be responsible for implementing the home-generated sharps stewardship program.
(C) The plan shall require that any surplus funds provided to implement the home-generated sharps stewardship program be used only to implement the program.
(5) Coordinate the home-generated sharps stewardship program with existing local medical waste collection programs, to the extent this requirement is reasonably feasible and mutually agreeable by those programs.
(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 that would promote the collection of home-generated sharps. This information may include, but is 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.
(B) Written materials and templates of materials for reproduction by retailers to be provided to the consumer at the time of purchase or delivery, or both. These written materials shall include information on the prohibition of 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 5,000 people in the state.

47119.47118.
 A retailer may voluntarily participate as a home-generated sharps collection point pursuant to the home-generated sharps stewardship program.

47120.47119.
 On or before January 1, 2018, the department shall consult with producers, stewardship organizations, local government, solid waste haulers, the health community, and all other stakeholders regarding the program performance. The department shall set a fair and reasonable minimum collection rate for the 2018 calendar year and for each subsequent calendar year to achieve the goal of safely managing all home-generated sharps in this state.

47121.47120.
 (a) The department shall review a home-generated sharps stewardship plan submitted pursuant to Section 47118 47117 within 90 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 47118. 47117. If the department does not approve the plan, the department shall allow the producer or stewardship organization to resubmit the plan within 90 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 a 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 a summary form of financial, production, or sales data if the department does not disclose financial, production, or sales data of a producer or stewardship organization.
(c) On or before_____ , July 1, 2015, or three months after a plan is approved pursuant to subdivision (a), whichever is later, but no later than January 1, 2016, the producer or stewardship organization shall implement the home-generated sharps stewardship program described in the approved plan.

47122.47121.
 (a) (1) On January 1, 2016, or upon the date the first plan is approved, whichever is earlier, the department shall post on its Internet Web site a list of producers for which the department has approved a plan pursuant to subdivision (a) of Section 42121. 42120. The department shall update this posting no less than once every six months thereafter.
(2) On and after July 1, 2016, the department shall post a notice on its Internet Web site listing producers that are in compliance with this article and shall update this posting no less than once every six months.
(b) A producer that is not listed on the department’s Internet Web site pursuant to this section, but that demonstrates to the satisfaction of the department that it is in compliance with this chapter before the next notice is required to be posted pursuant to this section, may request a certification letter from the department stating that the producer is in compliance. The producer who receives that letter shall be deemed to be in compliance with this chapter.
(c) A wholesaler, health facility, as defined in Section 1250 of the Health and Safety Code, retailer, or other distributor that distributes or sells home-generated sharps shall monitor the department’s Internet Web site to determine if the sale of a producer’s home-generated sharps is in compliance with this chapter.

47123.47122.
 On or before April 1, 2017, and every subsequent year thereafter, each producer or sharps stewardship organization implementing a plan shall prepare and submit to the department an annual report describing the activities carried out pursuant to the plan during the previous calendar year, commencing with the 2016 calendar year. The annual report shall include, but is not limited to, all of the following elements:
(a) The number of home-generated sharps collected by the program in the previous calendar year and the collection rate achieved in the previous calendar year.
(b) A report of the total sales data for sharps sold to distributors in the state for the previous calendar year.
(c) A report on the feedback from a stakeholders’ meeting, that shall be hosted by the producers subject to the plan and made available by Webcast, prior to submittal of the annual report.
(d) Independently audited financial statements that detail the financing method selected to sustainably fund the implementation of the plan to achieve the minimum collection rates described in the plan, pursuant to paragraph (3) of subdivision (c) of Section 47118. 47117.
(e) Examples and descriptions of educational materials distributed to various stakeholders aimed at increasing collection.
(f) An evaluation of the effectiveness of the program specific to collection, public awareness, convenience, and reduced improper disposal associated with both legal and illegal drug use.
(g) Any programmatic changes the producer or the stewardship organization recommends based on new data provided in the report.
(h) The location, hours, and contact information for all home-generated sharps collection points established pursuant to the plan, including a certification that this information is accurate, that a home-generated sharps collection point has been established in every county in the state, and that the number of home-generated sharps collection points is equal to at least one for every 5,000 25,000 people in the state.

47124.47123.
 (a) The department shall review the annual report submitted pursuant to Section 47123, 47122, including reviewing the accuracy of the list of home-generated sharps collection points that are certified to be established pursuant to the plan, and the data used to determine the collection rate, including sales and collection data. The department shall also determine whether all of the elements specified in subdivisions (a) to (h), inclusive, of Section 47123 47122 are included in the report.
(b) If the annual report does not demonstrate that the program has achieved a collection rate increase of ___ percent, 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 all reports submitted to the department pursuant to this section available to the public on the department’s Internet Web site.

47125.47124.
 If the department determines that the collection rate for the home-generated sharps subject to a plan meets 95 percent, the department may exempt a producer or stewardship organization from any or all of the elements required to be included in the annual report specified in Section 47123. 47122.

47126.47125.
 (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 the 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.

47127.47126.
 (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 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 ____ percent minimum collection rate has been achieved. achieved pursuant to subdivision (b) of Section 47123. In lieu of imposing a civil penalty, the department may require a producer or stewardship organization to take additional actions to comply with this article.
(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.

47129.47127.
 (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) shall not apply to any an agreement establishing or affecting the price of home-generated sharps or the output or production of home-generated sharps, or any sharps or an agreement restricting the geographic area or customers to which home-generated sharps will be sold.