Amended IN Assembly April 21, 2025 Amended IN Assembly March 12, 2025 CALIFORNIA LEGISLATURE 20252026 REGULAR SESSION Assembly Bill No. 754Introduced by Assembly Member ConnollyFebruary 18, 2025 An act to amend Sections 42030, 42031, 42031.4, 42031.6, 42032, 42032.2, 42033, 42033.2, 42033.4, 42033.6, 42034, 42034.2, 42034.4, 42035, 42035.2, 42035.4, 42035.6, 42035.8, 42036, 42036.2, and 42036.4 of, and to amend the heading of Chapter 2 (commencing with Section 42030) of Part 3 of Division 30 of, and to amend the headings of Article 2 (commencing with Section 42031) of, and Article 3 (commencing with Section 42032) of, Chapter 2 of Part 3 of Division 30 of, the Public Resources Code, relating to solid waste. repeal and amend Section 13263.3 of the Water Code, relating to water quality.LEGISLATIVE COUNSEL'S DIGESTAB 754, as amended, Connolly. Solid waste: pharmaceutical and sharps waste: producer responsibility program. Water quality: pollution prevention plans.The Porter-Cologne Water Quality Control Act establishes a statewide program for the control of the quality of all the waters of the state. The act authorizes the State Water Resources Control Board, a California regional water quality control board, or a publicly owned treatment works to require a discharger, as defined, to complete a pollution prevention plan if the discharger meets certain criteria.This bill would repeal certain inoperative provisions of law relating to these pollution prevention plans and would make conforming and nonsubstantive changes in the law relating to the plans.Existing law establishes a stewardship program, under which a manufacturer or distributor of covered drugs or specified sharps, or other entity defined to be covered, is required to establish and operate, either on its own or as part of a group of covered entities through membership in a stewardship organization, a stewardship program for covered drugs or for specified sharps, as applicable. Existing law requires the Department of Resources Recycling and Recovery to adopt regulations for the administration of the program. Existing law defines the terms stewardship organization, stewardship plan, and stewardship program for purposes of the program. For purposes of the program, existing law establishes the Pharmaceutical and Sharps Stewardship Fund and the Pharmaceutical and Sharps Stewardship Penalty Account within the fund.This bill would delete the terms stewardship organization, stewardship plan, and stewardship program and would replace them with the terms producer responsibility organization, producer responsibility plan and producer responsibility program, respectively. The bill would, for purposes of the program, define producer responsibility organization to have the same meaning as stewardship organization, producer responsibility plan to have the same meaning as stewardship plan, and producer responsibility program to have the same meaning as stewardship program. The bill would rename the Pharmaceutical and Sharps Stewardship Fund as the Pharmaceutical and Sharps Producer Responsibility Fund and would rename the Pharmaceutical and Sharps Stewardship Penalty Account as the Pharmaceutical and Sharps Producer Responsibility Penalty Account.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YESNO Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 13263.3 of the Water Code, as added by Section 3 of Chapter 92 of the Statutes of 1999, is repealed.13263.3.(a)The Legislature finds and declares that pollution prevention should be the first step in a hierarchy for reducing pollution and managing wastes, and to achieve environmental stewardship for society. The Legislature also finds and declares that pollution prevention is necessary to achieve the federal goal of zero discharge of pollutants into navigable waters.(b)(1)For the purposes of this section, pollution prevention means any action that causes a net reduction in the use or generation of a hazardous substance or other pollutant that is discharged into water and includes any of the following:(A)Input change, which means a change in raw materials or feedstocks used in a production process or operation so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(B)Operational improvement, which means improved site management so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(C)Production process change, which means a change in a process, method, or technique that is used to produce a product or a desired result, including the return of materials or their components for reuse within the existing processes or operations, so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(D)Product reformulation, which means changes in design, composition, or specifications of end products, including product substitution, so as to reduce, avoid, or eliminate the generation of problem pollutants discharged in wastewater.(2)For the purposes of this section, pollution prevention does not include actions that merely shift a pollutant in wastewater from one environmental medium to another environmental medium, unless clear environmental benefits of such an approach are demonstrated.(c)(1)For the purposes of this section, discharger means any entity required to obtain a national pollutant discharge elimination system (NPDES) permit pursuant to the Clean Water Act (33 U.S.C. Sec. 1251 et seq.), or any entity subject to the pretreatment program as defined in Part 403 (commencing with Section 403.1) of subchapter N of Chapter 1 of Part 403 of Title 40 of the Code of Federal Regulations.(2)For the purposes of this section, industrial discharger means any discharger other than a publicly owned treatment works (POTW).(d)(1)The state board, a regional board, or a POTW may require a discharger subject to its jurisdiction to complete a pollution prevention plan if any of the following apply:(A)A discharger is determined to be a chronic violator and the board or the POTW determines that pollution prevention could achieve compliance.(B)The discharger contributes, or has the potential to contribute, to the formation of a toxic hot spot as defined in Section 13391.5.(C)The discharger discharges a pollutant for which the permitted level is lower than the practical quantification limit and the state board, a regional board, or the POTW determines that additional reductions of the pollutant are necessary.(D)The board determines pollution prevention is necessary to achieve a water quality objective.(2)The state board, a regional board, or a POTW may require an industrial discharger subject to its jurisdiction to complete a pollution prevention plan that includes all of the following:(A)An analysis of the pollutants that the facility discharges into water or introduces into POTWs, a description of the sources of the pollutants, and a comprehensive review of the processes used by the discharger that result in the generation and discharge of the pollutants.(B)An analysis of the potential for pollution prevention to reduce the generation of the pollutants, including the application of innovative and alternative technologies and any adverse environmental impacts resulting from the use of those methods.(C)A detailed description of the tasks and time schedules required to investigate and implement various elements of pollution prevention techniques.(D)A statement of the dischargers pollution prevention goals and strategies, including priorities for short-term and long-term action.(E)A description of the dischargers intended pollution prevention activities for the immediate future.(F)A description of the dischargers existing pollution prevention methods.(G)A statement that the dischargers existing and planned pollution prevention strategies do not constitute cross-media pollution transfers, and information that supports that statement.(H)Toxic chemical release data for those dischargers subject to Section 313 of the Emergency Planning and Community Right to Know Act of 1986 (42 U.S.C. Sec. 11023).(I)Proof of compliance with the Hazardous Waste Source Reduction and Management Review Act of 1989 (Article 11.9 (commencing with Section 25244.12) of Chapter 6.5 of Division 20 of the Health and Safety Code) if the discharger is also subject to that act.(J)An analysis of the relative costs and benefits of the possible pollution prevention activities.(3)A regional board may require a POTW to complete a pollution prevention plan that includes all of the following:(A)An estimate of all of the sources of a pollutant contributing, or potentially contributing, to the loadings of a pollutants in the treatment plant influent.(B)An analysis of the methods that could be used to prevent the discharge of the pollutants into the POTW, including application of local limits to industrial or commercial dischargers regarding pollution prevention techniques, public education and outreach, or other innovative and alternative approaches to reduce discharges of the pollutant to the POTW. The analysis also shall identify sources, or potential sources, not within the ability or authority of the POTW to control, such as pollutants in the potable water supply, airborne pollutants, pharmaceuticals, or pesticides, and estimate the magnitude of those sources, to the extent feasible.(C)An estimate of load reductions that may be attained through the methods identified in subparagraph (B).(D)A plan for monitoring the results of the pollution prevention program.(E)A description of the tasks, cost, and time required to investigate and implement various elements in the pollution prevention plan.(F)A statement of the POTWs pollution prevention goals and strategies, including priorities for short-term and long-term action, and a description of the POTWs intended pollution prevention activities for the immediate future.(G)A description of the POTWs existing pollution prevention programs.(H)An analysis, to the extent feasible, of any adverse environmental impacts, including cross-media impacts or substitute chemicals, that may result from the implementation of the pollution prevention program.(I)An analysis, to the extent feasible, of the costs and benefits that may be incurred to implement the pollution prevention program.(e)The state board or the regional board may establish a schedule of actions identified in the pollution prevention plans for the discharger.(f)The state board or regional board shall solicit comments from the public on a pollution prevention plan prepared pursuant to this section and address the public comments when determining what schedule of actions, if any, to establish for the discharger pursuant to this section.(g)The state board and regional boards shall make the pollution prevention plans available for public review, except to the extent that information is classified as confidential because it is a trade secret. Trade secret information shall be set forth in an appendix that is not available to the public.(h)Any costs incurred by the state board or a regional board resulting from actions required by this section shall be paid for from revenue generated by the fees imposed by Section 13260.(i)The state board or regional board may assess civil penalties pursuant to Section 13385 against a discharger for failure to complete a pollution prevention plan ordered by the state board or a regional board, or for failure to comply with a schedule of actions ordered by the state board or a regional board pursuant to this section.(j)A POTW may assess civil penalties and civil administrative penalties pursuant to Sections 54740, 54740.5, and 54740.6 of the Government Code against an industrial discharger for failure to complete a pollution prevention plan when ordered by the POTW, for submitting a plan that does not comply with the act, or for failure to comply with a schedule of actions ordered by the POTW pursuant to this section, unless the regional board has assessed penalties for the same action.(k)A discharger may change its pollution prevention plan, including withdrawing from a pollution prevention measure approved by the state board, a regional board, or a POTW, if the discharger determines that the measure will have a negative impact on product quality, the safe operation of the facility, or the environmental aspects of the facilities operation, and the discharger demonstrates to the board or the POTW an alternative measure that achieves that same pollution prevention objective.(l)The state board shall adopt a format to be used by dischargers for completing the plan required by this section. The format shall address all of the factors the discharger is required to include in the plan. The board may include any other factors determined by the board to be necessary to carry out this section. The adoption of the format pursuant to this section is not subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.SEC. 2. Section 13263.3 of the Water Code, as amended by Section 1 of Chapter 807 of the Statutes of 2000, is amended to read:13263.3. (a) The Legislature finds and declares that pollution prevention should be the first step in a hierarchy for reducing pollution and managing wastes, and to achieve environmental stewardship for society. The Legislature also finds and declares that pollution prevention is necessary to support the federal goal of zero discharge of pollutants into navigable waters.(b) (1) For the purposes of this section, pollution prevention means any action that causes a net reduction in the use or generation of a hazardous substance or other pollutant that is discharged into water and includes any of the following:(A) Input change, which means a change in raw materials or feedstocks used in a production process or operation so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(B) Operational improvement, which means improved site management so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(C) Production process change, which means a change in a process, method, or technique that is used to produce a product or a desired result, including the return of materials or their components for reuse within the existing processes or operations, so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(D) Product reformulation, which means changes in design, composition, or specifications of end products, including product substitution, so as to reduce, avoid, or eliminate the generation of problem pollutants discharged in wastewater.(2) For the purposes of this section, pollution prevention does not include actions that merely shift a pollutant in wastewater from one environmental medium to another environmental medium, unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or POTW. publicly owned treatment works (POTW).(c) For the purposes of this section, discharger means any entity required to obtain a national pollutant discharge elimination system (NPDES) permit pursuant to the federal Clean Water Act (33 U.S.C. Sec. 1251 et seq.), or any entity subject to the pretreatment program as defined in Part 403 (commencing with Section 403.1) of Subchapter N of Chapter 1 of Part 403 I of Title 40 of the Code of Federal Regulations.(d) (1) The state board, a regional board, or a POTW may require a discharger subject to its jurisdiction to complete and implement a pollution prevention plan if any of the following apply:(A) A discharger is determined by the state board to be a chronic violator, and the state board, a regional board, or the POTW determines that pollution prevention could assist in achieving compliance.(B) The discharger significantly contributes, or has the potential to significantly contribute, to the creation of a toxic hot spot as defined in Section 13391.5.(C) The state board, a regional board, or a POTW determines pollution prevention is necessary to achieve a water quality objective.(D) The discharger is subject to a cease and desist order issued pursuant to Section 13301 or a time schedule order issued pursuant to Section 13300 or 13308.(2) A pollution prevention plan required of a discharger other than a POTW pursuant to paragraph (1) shall include all of the following:(A) An analysis of one or more of the pollutants, as directed by the state board, a regional board, or a POTW, that the facility discharges into water or introduces into POTWs, a description of the sources of the pollutants, and a comprehensive review of the processes used by the discharger that result in the generation and discharge of the pollutants.(B) An analysis of the potential for pollution prevention to reduce the generation of the pollutants, including the application of innovative and alternative technologies and any adverse environmental impacts resulting from the use of those methods.(C) A detailed description of the tasks and time schedules required to investigate and implement various elements of pollution prevention techniques.(D) A statement of the dischargers pollution prevention goals and strategies, including priorities for short-term and long-term action.(E) A description of the dischargers existing pollution prevention methods.(F) A statement that the dischargers existing and planned pollution prevention strategies do not constitute cross media pollution transfers unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or the POTW, and information that supports that statement.(G) Proof of compliance with the Pollution Prevention and Hazardous Waste Source Reduction and Management Review Act of 1989 (Article 11.9 (commencing with Section 25244.12) of Chapter 6.5 of Division 20 of the Health and Safety Code) if the discharger is also subject to that act.(H) An analysis, to the extent feasible, of the relative costs and benefits of the possible pollution prevention activities.(I) A specification of, and rationale for, the technically feasible and economically practicable pollution prevention measures selected by the discharger for implementation.(3) The state board or a regional board may require a POTW to complete and implement a pollution prevention plan that includes all of the following:(A) An estimate of all of the sources of a pollutant contributing, or potentially contributing, to the loading of that pollutant in the treatment plant influent.(B) An analysis of the methods that could be used to prevent the discharge of the pollutants into the POTW, including application of local limits to industrial or commercial dischargers regarding pollution prevention techniques, public education and outreach, or other innovative and alternative approaches to reduce discharges of the pollutant to the POTW. The analysis also shall identify sources, or potential sources, not within the ability or authority of the POTW to control, such as pollutants in the potable water supply, airborne pollutants, pharmaceuticals, or pesticides, and estimate the magnitude of those sources, to the extent feasible.(C) An estimate of load reductions that may be attained through the methods identified in subparagraph (B).(D) A plan for monitoring the results of the pollution prevention program.(E) A description of the tasks, cost, and time required to investigate and implement various elements in the pollution prevention plan.(F) A statement of the POTWs pollution prevention goals and strategies, including priorities for short-term and long-term action, and a description of the POTWs intended pollution prevention activities for the immediate future.(G) A description of the POTWs existing pollution prevention programs.(H) An analysis, to the extent feasible, of any adverse environmental impacts, including cross media impacts or substitute chemicals, that may result from the implementation of the pollution prevention program.(I) An analysis, to the extent feasible, of the costs and benefits that may be incurred to implement the pollution prevention program.(e) The state board, a regional board, or a POTW may require a discharger subject to this section to comply with the pollution prevention plan developed by the discharger after providing an opportunity for comment at a public proceeding with regard to that plan.(f) The state board, regional boards, and POTWs shall make the pollution prevention plans available for public review, except to the extent that information is classified as confidential because it is a trade secret. Trade secret information shall be set forth in an appendix that is not available to the public.(g) The state board or regional board may assess civil liability pursuant to paragraph (1) of subdivision (c) of Section 13385 against a discharger for failure to complete a pollution prevention plan required by the state board or a regional board, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the POTW has assessed penalties for the same action.(h) A POTW may assess civil penalties and civil administrative penalties pursuant to Sections 54740, 54740.5, and 54740.6 of the Government Code against a discharger for failure to complete a pollution prevention plan when required by the POTW, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the state board or a regional board has assessed penalties for the same action.(i) A discharger may change its pollution prevention plan, including withdrawing from a pollution prevention measure required by the state board, a regional board, or a POTW, if the discharger determines that the measure will have a negative impact on product quality, the safe operation of the facility, or the environmental aspects of the facilitys operation, or the discharger determines that the measure is economically impracticable or technologically infeasible. Where practicable and feasible, the discharger shall replace the withdrawn measure with a measure that will likely achieve similar pollution prevention objectives. A measure may be withdrawn pursuant to this subdivision only with the approval of the executive officer of the state board or the regional board, or the POTW.(j) The state board shall adopt a sample format to be used by dischargers for completing the plan required by this section. The sample format shall address all of the factors the discharger is required to include in the plan. The state board may include any other factors determined by the state board to be necessary to carry out this section. The adoption of the sample format pursuant to this section is not subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(k) The state board, a regional board, or a POTW may shall not include a pollution prevention plan in any waste discharge requirements or other permit issued by that agency.(l)This section prevails over Section 13263.3, as added to the Water Code by Assembly Bill 1104 of the 19992000 Regular Session.SECTION 1.The heading of Chapter 2 (commencing with Section 42030) of Part 3 of Division 30 of the Public Resources Code is amended to read:2.Pharmaceutical and Sharps Waste Producer Responsibility ProgramSEC. 2.Section 42030 of the Public Resources Code is amended to read:42030.For purposes of this chapter, the following terms have the following meanings:(a)Authorized collection site means a location where an authorized collector operates a secure collection receptacle for collecting covered products.(b)Authorized collector means a person or entity that has entered into an agreement with a program operator to collect covered drugs, including, but not limited to, any of the following:(1)A person or entity that is registered with the United States Drug Enforcement Administration and that qualifies under federal law to modify that registration to collect controlled substances for the purpose of destruction.(2)A law enforcement agency.(3)A retail pharmacy that offers drug take-back services in compliance with Article 9.1 (commencing with Section 1776) of Title 16 of the California Code of Regulations.(c)Controlled substance means a substance listed under Sections 11053 to 11058, inclusive, of the Health and Safety Code or Section 812 or 813 of Title 21 of the United States Code, or any successor section.(d)Cosmetic means an article, or a component of an article, intended to be rubbed, poured, sprinkled, sprayed, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Cosmetic includes articles with or without expiration dates.(e)(1)Covered drug means a drug, including a brand name or generic drug, sold, offered for sale, or dispensed in the State of California in any form, including, but not limited to, any of the following:(A)Prescription and nonprescription drugs approved by the United States Food and Drug Administration pursuant to Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355) or Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).(B)A drug marketed pursuant to an over-the-counter drug monograph.(C)A drug in a medical device, or a combination product containing a drug and a medical device.(2)Covered drug does not include any of the following:(A)Vitamins or supplements.(B)Herbal-based remedies and homeopathic drugs, products, or remedies.(C)Cosmetics, soap, with or without germicidal agents, laundry detergent, bleach, household cleaning products, shampoos, sunscreens, toothpaste, lip balm, antiperspirants, or any other personal care product that is regulated as both a cosmetic and a nonprescription drug under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).(D)A drug for which a pharmaceutical product stewardship or producer responsibility program or drug takeback program is provided in the state as part of a United States Food and Drug Administration managed risk evaluation and mitigation strategy under 21 U.S.C. Sec. 355-1.(E)Biological drug products, as defined by 42 U.S.C. Sec. 262(i)(1), including those products currently approved in the state under a new drug application that will be deemed to be licensed under Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262) pursuant to Section 7002(e) of the federal Biologics Price Competition and Innovation Act of 2009 (Public Law 111-148).(F)A medical device, or a component part or accessory of a medical device, if it does not contain a covered drug.(G)Drugs that are used for animal medicines, including, but not limited to, parasiticide products for animals.(H)Dialysate drugs or other saline solutions required to perform kidney dialysis.(f)(1)(A)Covered entity means the manufacturer of covered products that are sold in or into the state.(B)If no entity that meets the definition in subparagraph (A) is in the state, covered entity means the distributor of covered products that are sold in or into the state that is licensed as a wholesaler, as defined in Section 4043 of the Business and Professions Code, but does not include a warehouse of a retail pharmacy chain that is licensed as a wholesaler if it engages only in intracompany transfers between any division, affiliate, subsidiary, parent, or other entity under complete common ownership and control.(C)If no entity that meets the definition in subparagraph (A) or (B) is in the state, covered entity means a repackager, as defined in Section 4044 of the Business and Professions Code, of covered products that are sold in or into the state.(D)If no entity that meets the definition in subparagraph (A), (B), or (C) is in the state, covered entity means the owner or licensee of a trademark or brand under which covered products are sold in or into the state, regardless of whether the trademark is registered.(E)If no entity that meets the definition in subparagraph (A), (B), (C), or (D) is in the state, covered entity means the importer of the covered products that are sold in or into the state.(2)The department shall adopt regulations on the process for determining what entity is a covered entity following the priority order set forth in paragraph (1).(g)Covered product means a covered drug or home-generated sharps waste.(h)Department means the Department of Resources Recycling and Recovery, and any successor agency.(i)Distributor means a wholesaler, as that term is defined in Section 4043 of the Business and Professions Code.(j)Drug means any of the following:(1)An article recognized in the official United States Pharmacopoeia, the official National Formulary, the official Homeopathic Pharmacopoeia of the United States, or any supplement of the formulary or those pharmacopoeias.(2)A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals.(3)A substance, other than food, intended to affect the structure or any function of the body of humans or other animals.(4)A substance intended for use as a component of any substance specified in this subdivision.(k)Generic drug means a drug that is chemically identical or bioequivalent to a brand name drug in dosage form, safety, strengths, route of administration, quality, performance, characteristics, and intended use, though inactive ingredients may vary.(l)(1)Home-generated sharps waste has the same meaning as defined in Section 117671 of the Health and Safety Code.(2)Home-generated sharps waste does not include either of the following:(A)Components manufactured for use with external ambulatory insulin pump therapy systems or continuous glucose monitoring systems, including, but not limited to, insulin infusion sets, glucose sensors that are sterile goods indicated for single subcutaneous use, sterile drug delivery channels indicated for single subcutaneous use, and injection ports.(B)A biological product, as defined in Section 262(i)(1) of Title 42 of the United States Code, including a combination product, as defined in Section 3.2(e) of Title 21 of the Code of Federal Regulations.(m)Mail-back program means a method of collecting covered products from ultimate users by using prepaid, preaddressed mailing envelopes as described in Section 1776.2 of Title 16 of the California Code of Regulations.(n)Nonprescription drug means any drug that may be lawfully sold without a prescription.(o)Pharmacy has the same meaning as defined in Section 4037 of the Business and Professions Code.(p)Prescription drug means a drug, including, but not limited to, a controlled substance, that is required under federal or state law to be dispensed with a prescription, or is restricted to use by practitioners only.(q)Producer responsibility organization means an organization exempt from taxation under Section 501(c)(3) of the federal Internal Revenue Code of 1986 (21 U.S.C. Sec. 501(c)(3)) that is established by a group of covered entities in accordance with this chapter to develop, implement, and administer a producer responsibility program established pursuant to this chapter.(r)Producer responsibility plan means the plan for collecting and properly managing covered products that is developed by a covered entity or producer responsibility organization pursuant to this chapter.(s)Producer responsibility program means a program for the collection, transportation, and disposal of covered products.(t)Program operator means a covered entity, or producer responsibility organization on behalf of a group of covered entities, that is responsible for operating a producer responsibility program in accordance with this chapter.(u)Proprietary information means information that is all of the following:(1)Submitted pursuant to this chapter.(2)A trade secret, or commercial or financial information, that is privileged or confidential, and is identified as such by the entity providing the information to the department.(3)Not required to be disclosed under any other law or any regulation affecting a covered product or covered entity.(v)Retail pharmacy means an independent pharmacy, a supermarket pharmacy, a chain pharmacy, or a mass merchandiser pharmacy possessing a license from the state board to operate a pharmacy.(w)Retail pharmacy chain means a retail pharmacy with five or more stores in the state.(x)Sharps means hypodermic needles, pen needles, intravenous needles, lancets, and other devices that are used to penetrate the skin for the delivery of medications.(y)State board means the California State Board of Pharmacy.(z)Ultimate user means a state resident or other nonbusiness entity and includes a person who has lawfully obtained, and who possesses, a covered product, including a controlled substance, for the persons own use or for the use of a member of the persons household. Ultimate user does not include a needle exchange program established under Section 121349 of the Health and Safety Code, or a medical waste generator, as defined in Section 117705 of the Health and Safety Code.SEC. 3.The heading of Article 2 (commencing with Section 42031) of Chapter 2 of Part 3 of Division 30 of the Public Resources Code is amended to read:2.Covered Entities and Producer Responsibility OrganizationsSEC. 4.Section 42031 of the Public Resources Code is amended to read:42031.(a)(1)No later than 90 days after the effective date of this section, a covered entity shall provide a list of covered products, and a list and description of any drugs or sharps that are not covered products, that it sells or offers for sale in the state to the state board.(2)A covered entity, or a producer responsibility organization on behalf of a group of covered entities, shall update the lists described in paragraph (1) and provide the updated lists to the state board on or before January 15 of each year or upon request of the department.(b)No later than 90 days after the effective date of this section, a retail pharmacy that sells a covered product under its own label shall provide written notification to the state board identifying the covered entity from which the retail pharmacy obtains a covered product that the retail pharmacy sells under its store label.(c)The state board shall verify the information received pursuant to subdivisions (a) and (b) and make it available to the department upon request.(d)The state board may issue a letter of inquiry to any entity listed in subparagraphs (A) to (E), inclusive, of paragraph (1) of subdivision (f) of Section 42030 requesting a list of all drugs and sharps it distributes in California, regardless of whether the drugs or sharps are covered under this chapter, the name of the manufacturer of those products, and any additional information necessary to carry out this chapter. An entity that is issued a letter of inquiry pursuant to this subdivision shall respond in writing no later than 60 days after receipt of the letter. Responses to those inquiries may be shared with the department, but are otherwise deemed proprietary and exempt from disclosure. If the entity does not believe it is a covered entity for purposes of this chapter, it shall submit all of the following to the state board in response to the letter of inquiry:(1)The basis for the claim that it is not a covered entity.(2)A list of any drugs and sharps it sells, distributes, repackages, or otherwise offers for sale within the state.(3)If applicable, the name and contact information of the person or entity from which it obtains a drug or sharp identified pursuant to paragraph (2).(e)The state board shall obtain and verify and, within 30 days of receipt or upon request by the department, submit to the department a list of drugs and sharps sold or offered for sale in the state excluded from the definition of covered drugs pursuant to paragraph (2) of subdivision (e) of Section 42030 or excluded from the definition of home-generated sharps waste in subdivision (l) of Section 42030.(f)Notwithstanding Section 42036.4, information submitted by the state board to the department under this chapter may include proprietary information.(g)The state board shall notify the department if any covered entity or producer responsibility organization is in violation of this section for purposes of enforcement by the department.SEC. 5.Section 42031.4 of the Public Resources Code is amended to read:42031.4.(a)Except as specified in subdivision (d) of Section 42035, a covered entity is not in compliance with this chapter and is subject to penalties pursuant to Article 6 (commencing with Section 42035) if, commencing one year from the adoption of regulations pursuant to Section 42031.2, a covered product sold or offered for sale by the covered entity is not subject to an approved producer responsibility plan, which is submitted by the covered entity or by a producer responsibility organization that includes the covered entity, that has been approved by the department pursuant to Section 42032.(b)In order to comply with the requirements of this chapter, a covered entity may establish and implement a producer responsibility program independently, or as part of a group of covered entities through membership in a producer responsibility organization exempt from taxation under Section 501(c)(3) of the federal Internal Revenue Code of 1986 (21 U.S.C. Sec. 501(c)(3)).SEC. 6.Section 42031.6 of the Public Resources Code is amended to read:42031.6.(a)A program operator shall conduct a comprehensive education and outreach program intended to promote participation in the producer responsibility program. At a minimum, the education and outreach program shall do all of the following:(1)Promote its producer responsibility program to ultimate users by providing signage for hospitals, pharmacies, and other locations, as necessary.(2)Provide educational and outreach materials for persons authorized to prescribe drugs, pharmacies, pharmacists, ultimate users, and others, as necessary.(3)Establish an internet website that publicizes the location of authorized collectors and provides other information intended to promote the use of the producer responsibility program.(4)Prepare and provide additional outreach materials not specified in this section, as needed to promote the collection and proper management of covered drugs and home-generated sharps waste.(5)Encourage ultimate users to separate products that are not covered products from covered products, when appropriate, before submitting the covered products to an authorized collection site or mail-back program.(b)A program operator shall not, as part of the education and outreach program, promote the disposal of a covered product in a manner inconsistent with the services offered to ultimate users by the producer responsibility program.SEC. 7.The heading of Article 3 (commencing with Section 42032) of Chapter 2 of Part 3 of Division 30 of the Public Resources Code is amended to read:3.Producer Responsibility PlansSEC. 8.Section 42032 of the Public Resources Code is amended to read:42032.(a)(1)Within six months of the adoption date of regulations by the department pursuant to Section 42031.2, a program operator shall submit to the department for approval a complete producer responsibility plan that meets the requirements of Section 42032.2 for the establishment and implementation of a producer responsibility program, in a format determined by the department.(2)The department shall approve a proposed producer responsibility program if the program operator submits a completed plan that meets the requirements of this section.(b)(1)Before submitting a producer responsibility plan to the department pursuant to this section, a program operator shall submit its proposed producer responsibility plan to the state board for review, and to any other applicable state agencies with areas of authority relative to the producer responsibility plan. The duration of time that the state board takes to review a producer responsibility plan pursuant to this paragraph shall not count toward the time limit specified in paragraph (1) of subdivision (a).(2)An agency that receives a producer responsibility plan shall review the producer responsibility plan for compliance with state and federal laws and regulations related to the agencys respective authority. The agency shall determine compliance or noncompliance with those laws and regulations, and provide to the program operator that determination and an explanation for any finding of noncompliance, within 90 days of receipt of the producer responsibility plan.(3)A program operator may submit an updated proposed producer responsibility plan to an agency that issued a determination of noncompliance to attempt to obtain a determination of compliance. A program operator shall submit any determination received from an agency when it submits its producer responsibility plan to the department.(4)If, 90 days after submitting a producer responsibility plan to an applicable agency, a program operator has not received a response from the applicable agency, the program operator may submit a certification to the department that the producer responsibility plan is consistent with all other applicable laws and regulations.(c)(1)The department shall determine if a producer responsibility plan is complete, including the determinations required pursuant to subdivision (b), and notify the submitting program operator within 30 days of receipt.(2)If the department finds that the producer responsibility plan is complete, the departments 90-day review period for consideration of approval of the producer responsibility plan set forth in subdivision (d) shall commence upon the original date of receipt.(3)If the department determines the producer responsibility plan is incomplete, the department shall identify for the program operator the required additional information, and the program operator shall resubmit the producer responsibility plan within 30 days.(4)If the department determines upon resubmission that the producer responsibility plan is complete, the departments 90-day review period for consideration of approval of the producer responsibility plan shall commence upon the date of receipt of the resubmitted producer responsibility plan.(d)(1)The department shall review a complete submitted producer responsibility plan and shall approve, disapprove, or conditionally approve the producer responsibility plan within 90 days of receipt of the complete producer responsibility plan.(2)The department may consult with, or submit a producer responsibility plan for review to, the state board or another state agency it determines is necessary to determine the completeness of the producer responsibility plan or for making a determination on the approval of the producer responsibility plan or an amendment to the producer responsibility plan. The duration of time that the department takes to review a producer responsibility plan pursuant to this paragraph shall not count toward the 90-day time limit specified in paragraph (1).(e)A program operator shall submit any significant changes to a producer responsibility plan in writing for approval by the department, and shall not implement the changes prior to that approval.(f)(1)If the department disapproves a submitted producer responsibility plan pursuant to subdivision (d), the department shall explain, in writing within 30 days, how the producer responsibility plan does not comply with this chapter, and the program operator shall resubmit a revised producer responsibility plan to the department.(2)If the department finds that the revised producer responsibility plan submitted by the program operator does not comply with the requirements of this chapter and disapproves the plan, the covered entity operating its own producer responsibility program, or the producer responsibility organization and the covered entities that are members of the producer responsibility organization, are not in compliance with this chapter until the program operator submits a producer responsibility plan that the department approves.(g)A program operator shall fully implement operation of an approved producer responsibility program no later than 270 days after approval by the department of the producer responsibility plan that establishes the producer responsibility program.(h)If a producer responsibility plan is revoked pursuant to subdivision (a) of Section 42035.4 or terminated by the program operator that submitted the producer responsibility plan, a covered entity no longer subject to that producer responsibility plan may, without being subject to penalties pursuant to Article 6 (commencing with Section 42035), sell or offer for sale covered products in the state for a period of up to one year after the producer responsibility plan terminated or was revoked if the covered entity continues to operate under the most recent approved producer responsibility plan to which the covered entity was subject.(i)The department shall make all producer responsibility plans submitted pursuant to this section available to the public, except proprietary information in the plans protected pursuant to Section 42036.4.SEC. 9.Section 42032.2 of the Public Resources Code is amended to read:42032.2.(a)(1)To be complete, a producer responsibility plan for covered drugs shall do all of the following:(A)Identify and provide contact information for the producer responsibility organization, if applicable, and each participating covered entity, and identify each covered drug sold or offered for sale by each participating covered entity.(B)Identify and provide contact information for the authorized collectors for the producer responsibility program, as well as the reasons for excluding any potential authorized collectors from participation in the program.(C)Include any determinations provided by a state agency pursuant to subdivision (b) of Section 42032. Any determination of noncompliance shall be accompanied by a superseding determination of compliance.(D)Demonstrate adequate funding for all administrative and operational costs of the producer responsibility program, to be borne by participating covered entities.(E)Provide for a handling, transport, and disposal system that complies with applicable state and federal laws, including, but not limited to, regulations adopted by the United States Drug Enforcement Administration.(F)Provide for a collection system that complies with the requirements of this chapter and meets all of the following requirements for authorized collection sites in each county in which the producer responsibility plan will be implemented:(i)Provides for a minimum of five authorized collection sites or one authorized collection site per 50,000 people, whichever is greater.(ii)Provides for a reasonable geographic spread of authorized collection sites and an explanation for the geographic spread.(iii)Provides for a mail-back program covering any counties where there is not an authorized retail pharmacy operating as an authorized collection site.(G)Require a program operator to do all of the following:(i)Permit an ultimate user who is a homeless, homebound, or disabled individual to request prepaid, preaddressed mailing envelopes, or an alternative form of a collection and disposal system, as described in paragraph (2) of subdivision (c), that would render the covered drug inert. A program operator shall accept that request through an internet website and toll-free telephone number that it shall maintain to comply with the requests.(ii)Provide alternative methods of collection from ultimate users for any covered drugs, other than controlled substances, that cannot be accepted or commingled with other covered drugs in secure collection receptacles or through a mail-back program, to the extent technically feasible and permissible under applicable state and federal law, including, but not limited to, United States Drug Enforcement Administration regulations.(iii)(I)Provide a service schedule that meets the needs of each authorized collection site to ensure that each secure collection receptacle is serviced as often as necessary to avoid reaching capacity and that collected covered drugs are transported to final disposal in a timely manner. Additionally, a receipt or collection manifest shall be left with the authorized collection site to support verification of the service. The authorized collection site shall maintain and make available to the department this documentation.(II)An authorized collector shall comply with applicable federal and state laws regarding collection and transportation standards, and the handling of covered drugs, including United States Drug Enforcement Administration regulations.(H)Provide the policies and procedures for the safe and secure collection, transporting, and disposing of the covered drug, describe how and where records will be maintained and how, at a minimum, instances of security problems that occur will be addressed, and explain the processes that will be taken to change the policies, procedures, and tracking mechanisms to alleviate the problems and to improve safety and security.(2)Paragraph (1) shall apply only with regard to covered drugs.(b)(1)At least 120 days before submitting a producer responsibility plan to the department, the operator of a producer responsibility program for covered drugs shall notify potential authorized collectors in the county or counties in which it operates of the opportunity to serve as an authorized collector for the proposed producer responsibility program. If a potential authorized collector expresses interest in participating in a producer responsibility program, the program operator shall commence good faith negotiations with the potential authorized collector within 30 days.(2)A retail pharmacy shall make a reasonable effort to serve as an authorized collector as part of a producer responsibility program in the county in which it is located. If the minimum threshold described in clause (i) of subparagraph (F) of paragraph (1) of subdivision (a) is not met in each county in which a retail pharmacy chain has store locations, the retail pharmacy chain shall have at least one location or 15 percent of its store locations, whichever is greater, in that county serve as authorized collectors in a producer responsibility program.(3)A program operator shall include as an authorized collector under its producer responsibility program any entity listed in subdivision (b) of Section 42030 that offers to participate in the producer responsibility program, in writing and without compensation, even if the minimum convenience standards set in clause (i) of subparagraph (F) of paragraph (1) of subdivision (a) have been achieved. The program operator shall include the offering entity as an authorized collector in the program within 90 days of receiving the written offer to participate. A program operator shall not be required to respond to offers pursuant to this paragraph until the program operators producer responsibility plan has been approved by the department.(c)After a producer responsibility plan for covered drugs has been approved, the program operator may supplement service, if approved by the department, for a county in which it operates that does not have the minimum number of authorized collection sites due to circumstances beyond the program operators control, by establishing one or both of the following:(1)A mail-back program. The mail-back program may include providing information on where and how to receive mail-back materials or providing the locations at which it distributes prepaid, preaddressed mailing envelopes. The program operator shall propose the locations of those envelope distribution locations as part of the producer responsibility plan. Prepaid mailing envelopes may be mailed to an ultimate user upon request.(2)An alternative form of collection and disposal of covered drugs that complies with applicable state and federal law, including, but not limited to, United States Drug Enforcement Administration regulations.(d)(1)To be complete, a producer responsibility plan for home-generated sharps waste shall do all of the following:(A)Identify and provide contact information for the producer responsibility organization, if applicable, and each participating covered entity, and identify each covered product sold or offered for sale by each participating covered entity.(B)Include any determinations provided by a state agency pursuant to subdivision (b) of Section 42032. Any determination of noncompliance shall be accompanied by a superseding determination of compliance.(C)Demonstrate adequate funding for all administrative and operational costs of the producer responsibility program, to be borne by participating covered entities.(D)Provide for a handling, transport, and disposal system, at no cost to the ultimate user, that complies with applicable state and federal laws.(E)Maintain an internet website and toll-free telephone number for purposes of providing information on the program, including disposal options, and to receive requests for sharps waste containers from ultimate users.(F)Provide that a producer responsibility program for home-generated sharps waste shall be a mail-back program for home-generated sharps waste that complies with this chapter and that meets all the following requirements:(i)The program provides or initiates distribution of a sharps waste container and mail-back materials at the point of sale, to the extent allowable by law. Containers and mail-back materials shall be provided at no cost to the ultimate user. The program operator shall select and distribute a container and mail-back materials sufficient to accommodate the volume of sharps purchased by an ultimate user over a selected time period.(I)For any sharps, the packaging, an insert or instructions, or separate information provided to the ultimate user shall include information on proper sharps waste disposal.(II)All sharps waste containers shall include on a label affixed to the container or packaging, or on a separate insert included in the container or packaging, the program operators internet website and toll-free telephone number.(III)All sharps waste containers shall include prepaid postage affixed to the container or to the mail-back packaging.(ii)Upon request, the program provides for reimbursement to local agencies for disposal costs related to home-generated sharps waste, unless the program operator provides for the removal of the home-generated sharps waste from the local household hazardous waste facility.(I)A local agency shall not knowingly request reimbursement for disposal expenses pursuant to this subparagraph for disposal costs resulting from a municipal needle exchange program or a medical waste generator.(II)Reimbursement costs shall be limited to the actual costs of transportation from the household hazardous waste facility and for the actual costs of disposal.(III)A request for reimbursement pursuant to this clause shall be submitted with a declaration under penalty of perjury that the local agency has not knowingly requested reimbursement for expenses prohibited by this section.(IV)A cost is eligible for reimbursement pursuant to this clause if the cost is incurred 270 days or more after the approval of a producer responsibility plan for home-generated sharps waste.(2)Paragraph (1) shall apply only with regard to home-generated sharps waste.(e)A producer responsibility plan shall include provisions to expand into jurisdictions not included in the producer responsibility plan pursuant to Section 42036.2, in the event a jurisdiction repeals its local stewardship or producer responsibility program ordinance.(f)A producer responsibility plan shall include educational and outreach provisions to meet the requirements of Section 42031.6.SEC. 10.Section 42033 of the Public Resources Code is amended to read:42033.With the submission of a producer responsibility plan, a program operator shall submit to the department an initial producer responsibility program budget for the first five calendar years of operation of its producer responsibility program that includes both of the following:(a)Total anticipated revenues and costs of implementing the producer responsibility program.(b)A total recommended funding level sufficient to cover the producer responsibility plans budgeted costs and to operate the producer responsibility program over a multiyear period.SEC. 11.Section 42033.2 of the Public Resources Code is amended to read:42033.2.(a)On or before March 31 of each year, a program operator shall prepare and submit to the department both of the following:(1)A written report describing the producer responsibility program activities during the previous reporting period of one year.(2)A written program budget for producer responsibility program implementation for the upcoming calendar year.(b)An annual report submitted pursuant to paragraph (1) of subdivision (a) shall include, at a minimum, all of the following for the prior year:(1)A list of covered entities participating in the producer responsibility organization.(2)The updated and reverified list provided pursuant to paragraph (2) of subdivision (a) of Section 42031 of covered products that each covered entity subject to the producer responsibility plan sells or offers for sale.(3)The amount, by weight, of covered products collected from ultimate users at each authorized collection site that is part of the producer responsibility program.(4)For a producer responsibility plan for covered drugs, the name and location of authorized collection sites at which covered drugs were collected.(5)For a producer responsibility plan for home-generated sharps waste, information on the mail-back program.(6)Whether policies and procedures for collecting, transporting, and disposing of covered products, as established in the producer responsibility plan, were followed during the reporting period and a description of each instance of noncompliance, if any occurred.(7)Whether any safety or security problems occurred during collection, transportation, or disposal of collected covered products during the reporting period and, if so, what changes have been or will be made to policies, procedures, or tracking mechanisms to alleviate the problem and to improve safety and security.(8)How the program operator complied with all elements in its producer responsibility plan.(9)Any other information the department reasonably requires.(c)An annual program budget submitted pursuant to paragraph (2) of subdivision (a) shall include, at a minimum, both of the following for the upcoming calendar year:(1)An independent financial audit of the producer responsibility program, as required by subdivision (b) of Section 42033.4, funded by the producer responsibility organization from the charge paid from its member covered entities pursuant to Section 42034 or by a covered entity if it operates its own producer responsibility program.(2)Anticipated costs and the recommended funding level necessary to implement the producer responsibility program, including, but not limited to, costs to cover the producer responsibility plans budgeted costs and to operate the producer responsibility program over a multiyear period in a prudent and responsible manner.(d)(1)The department shall determine if a submitted annual report and program budget are complete and notify the submitting producer responsibility organization or covered entity within 30 days.(2)If the department finds that an annual report and program budget are complete, the departments 90-day review period for consideration of approval of the annual report and program budget, set forth in subdivision (e), shall commence upon the original date of receipt.(3)If the department determines either an annual report or a program budget is incomplete, the department shall identify for the program operator within 30 days the required additional information, and the program operator shall submit a revised annual report or program budget, as applicable, within 30 days.(4)If the department determines upon resubmission that the annual report or program budget is complete, the departments 90-day review period for consideration of approval of the annual report or program budget shall commence upon the date of receipt of the resubmitted report or program budget.(e)(1)The department shall review the annual report and program budget required pursuant to this section and within 90 days of receipt shall approve, disapprove, or conditionally approve the annual report and program budget.(2)(A)If the department conditionally approves an annual report or program budget, the department shall identify the deficiencies in the annual report or program budget and the program operator shall comply with the conditions of the conditional approval within 60 days of the notice date, unless the Director of Resources Recycling and Recovery determines that additional time is needed.(B)If the department conditionally approves an annual report or program budget and the conditions are not met within 60 days of the notice date, unless additional time is granted pursuant to subparagraph (A), the department shall disapprove the annual report or program budget.(3)If the department disapproves an annual report or program budget, the department shall identify the deficiencies in the annual report or program budget and the program operator shall submit a revised annual report or program budget and provide any supplemental information requested within 60 days of the notice date.SEC. 12.Section 42033.4 of the Public Resources Code is amended to read:42033.4.(a)A program operator shall keep minutes, books, and records that clearly reflect the activities and transactions of the program operators producer responsibility program.(b)(1)The minutes, books, and records of a program operator shall be audited at the program operators expense by an independent certified public accountant retained by the program operator at least once each calendar year.(2)A program operator shall arrange for the independent certified public accountant audit to be delivered to the department, along with the annual report and program budget submitted pursuant to subdivision (a) of Section 42033.2.(3)The department may conduct its own audit of a program operator. The department shall review the independent certified public accountant audit for compliance with this chapter and consistency with the program operators producer responsibility plan, annual report, and program budget submitted pursuant to this chapter. The department shall notify the program operator of any conduct or practice that does not comply with this chapter or of any inconsistencies identified in the departments audit. The program operator may obtain copies of the departments audit, including proprietary information contained in the departments audit, upon request. The department shall not disclose any confidential proprietary information protected pursuant to Section 42036.4 that is included in the departments audit.SEC. 13.Section 42033.6 of the Public Resources Code is amended to read:42033.6.As part of the administration of this chapter, within 12 months of a program operators submission of three consecutive complete annual reports submitted pursuant to Section 42033.2, the department shall develop, and post on its internet website, a report analyzing whether the program operators producer responsibility program provides adequate access to safe disposal of home-generated sharps waste or covered drugs, as applicable, to the ultimate user.SEC. 14.Section 42034 of the Public Resources Code is amended to read:42034.In order to further the objective that covered entities establish and implement producer responsibility programs that comply with the requirements of this chapter, each covered entity, either individually or through a producer responsibility organization, shall pay all administrative and operational costs associated with establishing and implementing the producer responsibility program in which it participates, including the cost of collecting, transporting, and disposing of covered products.SEC. 15.Section 42034.2 of the Public Resources Code is amended to read:42034.2.(a)(1)On March 1 and September 1 of each year, a program operator shall pay to the department an administrative fee. The department shall set the fee at an amount that, when paid by every covered entity, is adequate to cover the departments and any other state agencys projected full costs of administering and enforcing this chapter, including any incurred costs that have not been reimbursed. Before March 1 and September 1 of each year, the department shall compare the total amount of fees collected for the operative billing cycle to the total actual and reasonable costs of administering and enforcing this chapter over the same period so that the total amount of fees collected is adequate and does not exceed the states full actual and reasonable regulatory costs to implement and enforce this chapter. These costs may include the actual and reasonable costs associated with regulatory activities pursuant to this chapter before submission of producer responsibility plans pursuant to Section 42032.(2)For a producer responsibility organization, the administrative fee paid pursuant to paragraph (1) shall be funded by the covered entities that make up the producer responsibility organization. This administrative fee shall be in addition to the charge paid pursuant to Section 42034. A producer responsibility organization may require its participating covered entities to pay the administrative fee and the charge paid pursuant to Section 42034 at the same time.(b)The department shall deposit administrative fees paid by a program operator pursuant to subdivision (a) into the Pharmaceutical and Sharps Producer Responsibility Fund. Upon appropriation by the Legislature, moneys in the fund may be expended by the department, the state board, and any other agency that assists in the regulatory activities of administering and enforcing this chapter. Upon appropriation by the Legislature, moneys in the fund may be used for those regulatory activities and to reimburse any outstanding loans made from other funds used to finance the startup costs of the departments activities pursuant to this chapter. Moneys in the fund shall not be expended for any purpose not enumerated in this chapter.(c)The Pharmaceutical and Sharps Stewardship Fund, established by Section 1 of Chapter 1004 of the Statutes of 2018 (Senate Bill No. 212), is hereby renamed and continued in existence as the Pharmaceutical and Sharps Producer Responsibility Fund.SEC. 16.Section 42034.4 of the Public Resources Code is amended to read:42034.4.(a)(1)A producer responsibility organization may conduct an audit of covered entities that are required to remit a charge or administrative fee to the producer responsibility organization pursuant to Sections 42034 and 42034.2 to verify that the administrative fees and charges paid are proper and accurate. In addition, a producer responsibility organization may conduct an audit of authorized collectors to verify the charges submitted are proper and accurate.(2)The purpose of the audits described in paragraph (1) is to ensure parties required by this chapter to pay or collect an administrative fee or charge are paying or collecting the proper amount to implement the program.(b)If a producer responsibility organization conducts an audit pursuant to subdivision (a), it shall do all of the following:(1)Conduct the audit in accordance with generally accepted auditing practices.(2)Limit the scope of the audit of covered entities to confirming whether a charge or administrative fee has been properly paid by the covered entities.(3)Hire an independent third-party auditor to conduct the audit.(4)Provide a copy of the audit to the department.SEC. 17.Section 42035 of the Public Resources Code is amended to read:42035.(a)(1)On or before June 30th of each year, the department shall post on its internet website a list of producer responsibility organizations, including entities with an approved producer responsibility plan, and covered entities, authorized collection sites, retail pharmacies, and retail pharmacy chains provided in the producer responsibility plans that are in compliance with this chapter.(2)The state board shall coordinate with the department to verify that the list posted pursuant to paragraph (1) is consistent with the information submitted to each agency pursuant to Section 42031.(b)A covered entity or producer responsibility organization that is not listed on the departments internet website pursuant to subdivision (a), but demonstrates compliance with this chapter before the department is required to post the following years list pursuant to subdivision (a), may request a certification letter from the department stating that the covered entity or producer responsibility organization is in compliance with this chapter. A covered entity or producer responsibility organization that receives a certification letter shall be deemed to be in compliance with this chapter.(c)A distributor or wholesaler of covered products, and a pharmacy or other retailer that sells or offers for sale a covered product, shall monitor the departments internet website to determine which covered entities and producer responsibility organizations are in compliance with this chapter. The distributor or wholesaler and the pharmacy or other retailer shall notify the department if it determines that a covered product that it sells or offers for sale is from a covered entity that is not listed on the departments internet website.(d)The sale, distribution, or offering for sale of any inventory that was in stock before the commencement of a producer responsibility program is exempt from this chapter and not required to be subject to a producer responsibility plan.(e)If the department determines a covered entity or producer responsibility organization is not in compliance with this chapter, the department shall remove the entity from the list maintained on the departments internet website pursuant to subdivision (a).SEC. 18.Section 42035.2 of the Public Resources Code is amended to read:42035.2.(a)(1)The department may impose an administrative penalty on any covered entity, program operator, producer responsibility organization, or authorized collector that sells, offers for sale, or provides a covered product in violation of this chapter.(2)The amount of the administrative penalty imposed pursuant to this subdivision shall not exceed ten thousand dollars ($10,000) per day unless the violation is intentional, knowing, or reckless, in which case the administrative penalty shall not exceed fifty thousand dollars ($50,000) per day.(b)The department shall not impose a penalty on a program operator pursuant to this section for failure to comply with this chapter if the program operator demonstrates it received false or misleading information that contributed to its failure to comply, including, for a producer responsibility organization, from a participating covered entity.(c)The department shall deposit all penalties collected pursuant to this section in the Pharmaceutical and Sharps Producer Responsibility Penalty Account, in the Pharmaceutical and Sharps Producer Responsibility Fund. Upon appropriation by the Legislature, moneys in the Pharmaceutical and Sharps Producer Responsibility Penalty Account may be expended by the department on activities including, but not limited to, the promotion of safe handling and disposal of covered products, grants for related purposes, and the administration and enforcement of this chapter.(d)The Pharmaceutical and Sharps Stewardship Penalty Account, established by Section 1 of Chapter 1004 of the Statutes of 2018 (Senate Bill No. 212), is hereby renamed and continued in existence as the Pharmaceutical and Sharps Producer Responsibility Penalty Account.SEC. 19.Section 42035.4 of the Public Resources Code is amended to read:42035.4.Upon a written finding that a covered entity, program operator, producer responsibility organization, or authorized collector has not met a material requirement of this chapter, in addition to any other penalties authorized under this chapter, the department may take one or both of the following actions to ensure compliance with the requirements of this chapter, after affording the covered entity, producer responsibility organization, or authorized collector a reasonable opportunity to respond to, or rebut, the finding:(a)Revoke the program operators producer responsibility plan approval or require the program operator to resubmit the producer responsibility plan.(b)Require additional reporting relating to compliance with the material requirement of this chapter that was not met.SEC. 20.Section 42035.6 of the Public Resources Code is amended to read:42035.6.(a)A covered entity, producer responsibility organization, program operator, retail pharmacy, or retail pharmacy chain shall do both of the following:(1)Upon request, provide the department with reasonable and timely access, as determined by the department, to its facilities and operations, as necessary to determine compliance with this chapter.(2)Upon request, provide the department with relevant records necessary to determine compliance with this chapter.(b)A covered entity, producer responsibility organization, program operator, retail pharmacy, or retail pharmacy chain shall maintain and keep accessible all records required to be kept or submitted pursuant to this chapter for a minimum of three years.(c)All reports and records provided to the department pursuant to this chapter shall be provided under penalty of perjury.(d)The department may take disciplinary action against a covered entity, producer responsibility organization, program operator, pharmacy, retail pharmacy, or retail pharmacy chain that fails to provide the department with the access to information required pursuant to this section, including one or both of the following:(1)Imposing an administrative penalty pursuant to Section 42035.2.(2)Posting a notice on the departments internet website, in association with the list that the department maintains pursuant to paragraph (1) of subdivision (a) of Section 42035, that the covered entity, producer responsibility organization, program operator, pharmacy, retail pharmacy, or retail pharmacy chain is no longer in compliance with this chapter.(e)The department shall not prohibit as a disciplinary action a covered entity, producer responsibility organization, program operator, pharmacy, retail pharmacy, or retail pharmacy chain from selling a covered product.SEC. 21.Section 42035.8 of the Public Resources Code is amended to read:42035.8.All handling, transport, and disposal undertaken as part of a producer responsibility program under this chapter shall comply with applicable state and federal laws, including, but not limited to, regulations adopted by the United States Drug Enforcement Administration.SEC. 22.Section 42036 of the Public Resources Code is amended to read:42036.(a)Except as provided in subdivision (c), an action specified in subdivision (b) that is taken by a producer responsibility organization or a covered entity pursuant to this chapter is not a violation of the Cartwright Act (Chapter 2 (commencing with Section 16700) of Part 2 of Division 7 of the Business and Professions Code), the Unfair Practices Act (Chapter 4 (commencing with Section 17000) of Part 2 of Division 7 of the Business and Professions Code), or the Unfair Competition Law (Chapter 5 (commencing with Section 17200) of Part 2 of Division 7 of the Business and Professions Code).(b)Subdivision (a) shall apply to all of the following actions taken by a producer responsibility organization or covered entity:(1)The creation, implementation, or management of a producer responsibility plan approved by the department pursuant to Article 3 (commencing with Section 42032) and the determination of the types or quantities of covered products collected or otherwise managed pursuant to a producer responsibility plan.(2)The determination of the cost and structure of an approved producer responsibility plan.(3)The establishment, administration, collection, or disbursement of the charge or administrative fee imposed pursuant to Section 42034 or 42034.2, respectively.(c)Subdivision (a) shall not apply to an agreement that does any of the following:(1)Fixes a price of or for covered products, except for an agreement related to costs, charges, or administrative fees associated with participation in a producer responsibility plan approved by the department and otherwise in accordance with this chapter.(2)Fixes the output of production of covered products.(3)Restricts the geographic area in which, or customers to whom, covered products are sold.SEC. 23.Section 42036.2 of the Public Resources Code is amended to read:42036.2.(a)This chapter does not apply to a drug or sharp within a jurisdiction that is subject to a local stewardship or producer responsibility program pursuant to an ordinance that took effect before April 18, 2018. If that ordinance is repealed in the jurisdiction or, if more than one ordinance is applicable, those ordinances are repealed in the jurisdiction, the drug or sharp shall be subject to this chapter in that jurisdiction within 270 days after the date on which the ordinance is, or ordinances are, repealed.(b)This chapter shall preempt a local stewardship or producer responsibility program for drugs or sharps enacted by an ordinance or ordinances with an effective date on or after April 18, 2018.(c)A local stewardship or producer responsibility program for covered products enacted by an ordinance that has an effective date before April 18, 2018, may continue in operation, but the program and its participants shall not receive or benefit from moneys from the Pharmaceutical and Sharps Producer Responsibility Fund or the Pharmaceutical and Sharps Producer Responsibility Penalty Account, including, but not limited to, for administrative or enforcement costs. Participants of a local stewardship or producer responsibility program for covered products enacted by an ordinance that has an effective date before April 18, 2018, shall be eligible to participate in a producer responsibility program under this chapter and thereby become eligible to receive funds from the Pharmaceutical and Sharps Producer Responsibility Fund or the Pharmaceutical and Sharps Producer Responsibility Penalty Account only if the local stewardship or producer responsibility program is dissolved.SEC. 24.Section 42036.4 of the Public Resources Code is amended to read:42036.4.Proprietary information submitted to the department under this chapter shall be protected by all parties as confidential and shall be exempt from public disclosure under the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code). The department and other parties may only disclose proprietary information in an aggregated form that does not directly or indirectly identify financial, production, or sales data of an individual covered entity or producer responsibility organization. Proprietary information may be disclosed to the party that submitted the proprietary information.
Amended IN Assembly April 21, 2025 Amended IN Assembly March 12, 2025 CALIFORNIA LEGISLATURE 20252026 REGULAR SESSION Assembly Bill No. 754Introduced by Assembly Member ConnollyFebruary 18, 2025 An act to amend Sections 42030, 42031, 42031.4, 42031.6, 42032, 42032.2, 42033, 42033.2, 42033.4, 42033.6, 42034, 42034.2, 42034.4, 42035, 42035.2, 42035.4, 42035.6, 42035.8, 42036, 42036.2, and 42036.4 of, and to amend the heading of Chapter 2 (commencing with Section 42030) of Part 3 of Division 30 of, and to amend the headings of Article 2 (commencing with Section 42031) of, and Article 3 (commencing with Section 42032) of, Chapter 2 of Part 3 of Division 30 of, the Public Resources Code, relating to solid waste. repeal and amend Section 13263.3 of the Water Code, relating to water quality.LEGISLATIVE COUNSEL'S DIGESTAB 754, as amended, Connolly. Solid waste: pharmaceutical and sharps waste: producer responsibility program. Water quality: pollution prevention plans.The Porter-Cologne Water Quality Control Act establishes a statewide program for the control of the quality of all the waters of the state. The act authorizes the State Water Resources Control Board, a California regional water quality control board, or a publicly owned treatment works to require a discharger, as defined, to complete a pollution prevention plan if the discharger meets certain criteria.This bill would repeal certain inoperative provisions of law relating to these pollution prevention plans and would make conforming and nonsubstantive changes in the law relating to the plans.Existing law establishes a stewardship program, under which a manufacturer or distributor of covered drugs or specified sharps, or other entity defined to be covered, is required to establish and operate, either on its own or as part of a group of covered entities through membership in a stewardship organization, a stewardship program for covered drugs or for specified sharps, as applicable. Existing law requires the Department of Resources Recycling and Recovery to adopt regulations for the administration of the program. Existing law defines the terms stewardship organization, stewardship plan, and stewardship program for purposes of the program. For purposes of the program, existing law establishes the Pharmaceutical and Sharps Stewardship Fund and the Pharmaceutical and Sharps Stewardship Penalty Account within the fund.This bill would delete the terms stewardship organization, stewardship plan, and stewardship program and would replace them with the terms producer responsibility organization, producer responsibility plan and producer responsibility program, respectively. The bill would, for purposes of the program, define producer responsibility organization to have the same meaning as stewardship organization, producer responsibility plan to have the same meaning as stewardship plan, and producer responsibility program to have the same meaning as stewardship program. The bill would rename the Pharmaceutical and Sharps Stewardship Fund as the Pharmaceutical and Sharps Producer Responsibility Fund and would rename the Pharmaceutical and Sharps Stewardship Penalty Account as the Pharmaceutical and Sharps Producer Responsibility Penalty Account.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YESNO Local Program: NO
Amended IN Assembly April 21, 2025 Amended IN Assembly March 12, 2025
Amended IN Assembly April 21, 2025
Amended IN Assembly March 12, 2025
CALIFORNIA LEGISLATURE 20252026 REGULAR SESSION
Assembly Bill
No. 754
Introduced by Assembly Member ConnollyFebruary 18, 2025
Introduced by Assembly Member Connolly
February 18, 2025
An act to amend Sections 42030, 42031, 42031.4, 42031.6, 42032, 42032.2, 42033, 42033.2, 42033.4, 42033.6, 42034, 42034.2, 42034.4, 42035, 42035.2, 42035.4, 42035.6, 42035.8, 42036, 42036.2, and 42036.4 of, and to amend the heading of Chapter 2 (commencing with Section 42030) of Part 3 of Division 30 of, and to amend the headings of Article 2 (commencing with Section 42031) of, and Article 3 (commencing with Section 42032) of, Chapter 2 of Part 3 of Division 30 of, the Public Resources Code, relating to solid waste. repeal and amend Section 13263.3 of the Water Code, relating to water quality.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 754, as amended, Connolly. Solid waste: pharmaceutical and sharps waste: producer responsibility program. Water quality: pollution prevention plans.
The Porter-Cologne Water Quality Control Act establishes a statewide program for the control of the quality of all the waters of the state. The act authorizes the State Water Resources Control Board, a California regional water quality control board, or a publicly owned treatment works to require a discharger, as defined, to complete a pollution prevention plan if the discharger meets certain criteria.This bill would repeal certain inoperative provisions of law relating to these pollution prevention plans and would make conforming and nonsubstantive changes in the law relating to the plans.Existing law establishes a stewardship program, under which a manufacturer or distributor of covered drugs or specified sharps, or other entity defined to be covered, is required to establish and operate, either on its own or as part of a group of covered entities through membership in a stewardship organization, a stewardship program for covered drugs or for specified sharps, as applicable. Existing law requires the Department of Resources Recycling and Recovery to adopt regulations for the administration of the program. Existing law defines the terms stewardship organization, stewardship plan, and stewardship program for purposes of the program. For purposes of the program, existing law establishes the Pharmaceutical and Sharps Stewardship Fund and the Pharmaceutical and Sharps Stewardship Penalty Account within the fund.This bill would delete the terms stewardship organization, stewardship plan, and stewardship program and would replace them with the terms producer responsibility organization, producer responsibility plan and producer responsibility program, respectively. The bill would, for purposes of the program, define producer responsibility organization to have the same meaning as stewardship organization, producer responsibility plan to have the same meaning as stewardship plan, and producer responsibility program to have the same meaning as stewardship program. The bill would rename the Pharmaceutical and Sharps Stewardship Fund as the Pharmaceutical and Sharps Producer Responsibility Fund and would rename the Pharmaceutical and Sharps Stewardship Penalty Account as the Pharmaceutical and Sharps Producer Responsibility Penalty Account.
The Porter-Cologne Water Quality Control Act establishes a statewide program for the control of the quality of all the waters of the state. The act authorizes the State Water Resources Control Board, a California regional water quality control board, or a publicly owned treatment works to require a discharger, as defined, to complete a pollution prevention plan if the discharger meets certain criteria.
This bill would repeal certain inoperative provisions of law relating to these pollution prevention plans and would make conforming and nonsubstantive changes in the law relating to the plans.
Existing law establishes a stewardship program, under which a manufacturer or distributor of covered drugs or specified sharps, or other entity defined to be covered, is required to establish and operate, either on its own or as part of a group of covered entities through membership in a stewardship organization, a stewardship program for covered drugs or for specified sharps, as applicable. Existing law requires the Department of Resources Recycling and Recovery to adopt regulations for the administration of the program. Existing law defines the terms stewardship organization, stewardship plan, and stewardship program for purposes of the program. For purposes of the program, existing law establishes the Pharmaceutical and Sharps Stewardship Fund and the Pharmaceutical and Sharps Stewardship Penalty Account within the fund.
This bill would delete the terms stewardship organization, stewardship plan, and stewardship program and would replace them with the terms producer responsibility organization, producer responsibility plan and producer responsibility program, respectively. The bill would, for purposes of the program, define producer responsibility organization to have the same meaning as stewardship organization, producer responsibility plan to have the same meaning as stewardship plan, and producer responsibility program to have the same meaning as stewardship program. The bill would rename the Pharmaceutical and Sharps Stewardship Fund as the Pharmaceutical and Sharps Producer Responsibility Fund and would rename the Pharmaceutical and Sharps Stewardship Penalty Account as the Pharmaceutical and Sharps Producer Responsibility Penalty Account.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Section 13263.3 of the Water Code, as added by Section 3 of Chapter 92 of the Statutes of 1999, is repealed.13263.3.(a)The Legislature finds and declares that pollution prevention should be the first step in a hierarchy for reducing pollution and managing wastes, and to achieve environmental stewardship for society. The Legislature also finds and declares that pollution prevention is necessary to achieve the federal goal of zero discharge of pollutants into navigable waters.(b)(1)For the purposes of this section, pollution prevention means any action that causes a net reduction in the use or generation of a hazardous substance or other pollutant that is discharged into water and includes any of the following:(A)Input change, which means a change in raw materials or feedstocks used in a production process or operation so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(B)Operational improvement, which means improved site management so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(C)Production process change, which means a change in a process, method, or technique that is used to produce a product or a desired result, including the return of materials or their components for reuse within the existing processes or operations, so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(D)Product reformulation, which means changes in design, composition, or specifications of end products, including product substitution, so as to reduce, avoid, or eliminate the generation of problem pollutants discharged in wastewater.(2)For the purposes of this section, pollution prevention does not include actions that merely shift a pollutant in wastewater from one environmental medium to another environmental medium, unless clear environmental benefits of such an approach are demonstrated.(c)(1)For the purposes of this section, discharger means any entity required to obtain a national pollutant discharge elimination system (NPDES) permit pursuant to the Clean Water Act (33 U.S.C. Sec. 1251 et seq.), or any entity subject to the pretreatment program as defined in Part 403 (commencing with Section 403.1) of subchapter N of Chapter 1 of Part 403 of Title 40 of the Code of Federal Regulations.(2)For the purposes of this section, industrial discharger means any discharger other than a publicly owned treatment works (POTW).(d)(1)The state board, a regional board, or a POTW may require a discharger subject to its jurisdiction to complete a pollution prevention plan if any of the following apply:(A)A discharger is determined to be a chronic violator and the board or the POTW determines that pollution prevention could achieve compliance.(B)The discharger contributes, or has the potential to contribute, to the formation of a toxic hot spot as defined in Section 13391.5.(C)The discharger discharges a pollutant for which the permitted level is lower than the practical quantification limit and the state board, a regional board, or the POTW determines that additional reductions of the pollutant are necessary.(D)The board determines pollution prevention is necessary to achieve a water quality objective.(2)The state board, a regional board, or a POTW may require an industrial discharger subject to its jurisdiction to complete a pollution prevention plan that includes all of the following:(A)An analysis of the pollutants that the facility discharges into water or introduces into POTWs, a description of the sources of the pollutants, and a comprehensive review of the processes used by the discharger that result in the generation and discharge of the pollutants.(B)An analysis of the potential for pollution prevention to reduce the generation of the pollutants, including the application of innovative and alternative technologies and any adverse environmental impacts resulting from the use of those methods.(C)A detailed description of the tasks and time schedules required to investigate and implement various elements of pollution prevention techniques.(D)A statement of the dischargers pollution prevention goals and strategies, including priorities for short-term and long-term action.(E)A description of the dischargers intended pollution prevention activities for the immediate future.(F)A description of the dischargers existing pollution prevention methods.(G)A statement that the dischargers existing and planned pollution prevention strategies do not constitute cross-media pollution transfers, and information that supports that statement.(H)Toxic chemical release data for those dischargers subject to Section 313 of the Emergency Planning and Community Right to Know Act of 1986 (42 U.S.C. Sec. 11023).(I)Proof of compliance with the Hazardous Waste Source Reduction and Management Review Act of 1989 (Article 11.9 (commencing with Section 25244.12) of Chapter 6.5 of Division 20 of the Health and Safety Code) if the discharger is also subject to that act.(J)An analysis of the relative costs and benefits of the possible pollution prevention activities.(3)A regional board may require a POTW to complete a pollution prevention plan that includes all of the following:(A)An estimate of all of the sources of a pollutant contributing, or potentially contributing, to the loadings of a pollutants in the treatment plant influent.(B)An analysis of the methods that could be used to prevent the discharge of the pollutants into the POTW, including application of local limits to industrial or commercial dischargers regarding pollution prevention techniques, public education and outreach, or other innovative and alternative approaches to reduce discharges of the pollutant to the POTW. The analysis also shall identify sources, or potential sources, not within the ability or authority of the POTW to control, such as pollutants in the potable water supply, airborne pollutants, pharmaceuticals, or pesticides, and estimate the magnitude of those sources, to the extent feasible.(C)An estimate of load reductions that may be attained through the methods identified in subparagraph (B).(D)A plan for monitoring the results of the pollution prevention program.(E)A description of the tasks, cost, and time required to investigate and implement various elements in the pollution prevention plan.(F)A statement of the POTWs pollution prevention goals and strategies, including priorities for short-term and long-term action, and a description of the POTWs intended pollution prevention activities for the immediate future.(G)A description of the POTWs existing pollution prevention programs.(H)An analysis, to the extent feasible, of any adverse environmental impacts, including cross-media impacts or substitute chemicals, that may result from the implementation of the pollution prevention program.(I)An analysis, to the extent feasible, of the costs and benefits that may be incurred to implement the pollution prevention program.(e)The state board or the regional board may establish a schedule of actions identified in the pollution prevention plans for the discharger.(f)The state board or regional board shall solicit comments from the public on a pollution prevention plan prepared pursuant to this section and address the public comments when determining what schedule of actions, if any, to establish for the discharger pursuant to this section.(g)The state board and regional boards shall make the pollution prevention plans available for public review, except to the extent that information is classified as confidential because it is a trade secret. Trade secret information shall be set forth in an appendix that is not available to the public.(h)Any costs incurred by the state board or a regional board resulting from actions required by this section shall be paid for from revenue generated by the fees imposed by Section 13260.(i)The state board or regional board may assess civil penalties pursuant to Section 13385 against a discharger for failure to complete a pollution prevention plan ordered by the state board or a regional board, or for failure to comply with a schedule of actions ordered by the state board or a regional board pursuant to this section.(j)A POTW may assess civil penalties and civil administrative penalties pursuant to Sections 54740, 54740.5, and 54740.6 of the Government Code against an industrial discharger for failure to complete a pollution prevention plan when ordered by the POTW, for submitting a plan that does not comply with the act, or for failure to comply with a schedule of actions ordered by the POTW pursuant to this section, unless the regional board has assessed penalties for the same action.(k)A discharger may change its pollution prevention plan, including withdrawing from a pollution prevention measure approved by the state board, a regional board, or a POTW, if the discharger determines that the measure will have a negative impact on product quality, the safe operation of the facility, or the environmental aspects of the facilities operation, and the discharger demonstrates to the board or the POTW an alternative measure that achieves that same pollution prevention objective.(l)The state board shall adopt a format to be used by dischargers for completing the plan required by this section. The format shall address all of the factors the discharger is required to include in the plan. The board may include any other factors determined by the board to be necessary to carry out this section. The adoption of the format pursuant to this section is not subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.SEC. 2. Section 13263.3 of the Water Code, as amended by Section 1 of Chapter 807 of the Statutes of 2000, is amended to read:13263.3. (a) The Legislature finds and declares that pollution prevention should be the first step in a hierarchy for reducing pollution and managing wastes, and to achieve environmental stewardship for society. The Legislature also finds and declares that pollution prevention is necessary to support the federal goal of zero discharge of pollutants into navigable waters.(b) (1) For the purposes of this section, pollution prevention means any action that causes a net reduction in the use or generation of a hazardous substance or other pollutant that is discharged into water and includes any of the following:(A) Input change, which means a change in raw materials or feedstocks used in a production process or operation so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(B) Operational improvement, which means improved site management so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(C) Production process change, which means a change in a process, method, or technique that is used to produce a product or a desired result, including the return of materials or their components for reuse within the existing processes or operations, so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(D) Product reformulation, which means changes in design, composition, or specifications of end products, including product substitution, so as to reduce, avoid, or eliminate the generation of problem pollutants discharged in wastewater.(2) For the purposes of this section, pollution prevention does not include actions that merely shift a pollutant in wastewater from one environmental medium to another environmental medium, unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or POTW. publicly owned treatment works (POTW).(c) For the purposes of this section, discharger means any entity required to obtain a national pollutant discharge elimination system (NPDES) permit pursuant to the federal Clean Water Act (33 U.S.C. Sec. 1251 et seq.), or any entity subject to the pretreatment program as defined in Part 403 (commencing with Section 403.1) of Subchapter N of Chapter 1 of Part 403 I of Title 40 of the Code of Federal Regulations.(d) (1) The state board, a regional board, or a POTW may require a discharger subject to its jurisdiction to complete and implement a pollution prevention plan if any of the following apply:(A) A discharger is determined by the state board to be a chronic violator, and the state board, a regional board, or the POTW determines that pollution prevention could assist in achieving compliance.(B) The discharger significantly contributes, or has the potential to significantly contribute, to the creation of a toxic hot spot as defined in Section 13391.5.(C) The state board, a regional board, or a POTW determines pollution prevention is necessary to achieve a water quality objective.(D) The discharger is subject to a cease and desist order issued pursuant to Section 13301 or a time schedule order issued pursuant to Section 13300 or 13308.(2) A pollution prevention plan required of a discharger other than a POTW pursuant to paragraph (1) shall include all of the following:(A) An analysis of one or more of the pollutants, as directed by the state board, a regional board, or a POTW, that the facility discharges into water or introduces into POTWs, a description of the sources of the pollutants, and a comprehensive review of the processes used by the discharger that result in the generation and discharge of the pollutants.(B) An analysis of the potential for pollution prevention to reduce the generation of the pollutants, including the application of innovative and alternative technologies and any adverse environmental impacts resulting from the use of those methods.(C) A detailed description of the tasks and time schedules required to investigate and implement various elements of pollution prevention techniques.(D) A statement of the dischargers pollution prevention goals and strategies, including priorities for short-term and long-term action.(E) A description of the dischargers existing pollution prevention methods.(F) A statement that the dischargers existing and planned pollution prevention strategies do not constitute cross media pollution transfers unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or the POTW, and information that supports that statement.(G) Proof of compliance with the Pollution Prevention and Hazardous Waste Source Reduction and Management Review Act of 1989 (Article 11.9 (commencing with Section 25244.12) of Chapter 6.5 of Division 20 of the Health and Safety Code) if the discharger is also subject to that act.(H) An analysis, to the extent feasible, of the relative costs and benefits of the possible pollution prevention activities.(I) A specification of, and rationale for, the technically feasible and economically practicable pollution prevention measures selected by the discharger for implementation.(3) The state board or a regional board may require a POTW to complete and implement a pollution prevention plan that includes all of the following:(A) An estimate of all of the sources of a pollutant contributing, or potentially contributing, to the loading of that pollutant in the treatment plant influent.(B) An analysis of the methods that could be used to prevent the discharge of the pollutants into the POTW, including application of local limits to industrial or commercial dischargers regarding pollution prevention techniques, public education and outreach, or other innovative and alternative approaches to reduce discharges of the pollutant to the POTW. The analysis also shall identify sources, or potential sources, not within the ability or authority of the POTW to control, such as pollutants in the potable water supply, airborne pollutants, pharmaceuticals, or pesticides, and estimate the magnitude of those sources, to the extent feasible.(C) An estimate of load reductions that may be attained through the methods identified in subparagraph (B).(D) A plan for monitoring the results of the pollution prevention program.(E) A description of the tasks, cost, and time required to investigate and implement various elements in the pollution prevention plan.(F) A statement of the POTWs pollution prevention goals and strategies, including priorities for short-term and long-term action, and a description of the POTWs intended pollution prevention activities for the immediate future.(G) A description of the POTWs existing pollution prevention programs.(H) An analysis, to the extent feasible, of any adverse environmental impacts, including cross media impacts or substitute chemicals, that may result from the implementation of the pollution prevention program.(I) An analysis, to the extent feasible, of the costs and benefits that may be incurred to implement the pollution prevention program.(e) The state board, a regional board, or a POTW may require a discharger subject to this section to comply with the pollution prevention plan developed by the discharger after providing an opportunity for comment at a public proceeding with regard to that plan.(f) The state board, regional boards, and POTWs shall make the pollution prevention plans available for public review, except to the extent that information is classified as confidential because it is a trade secret. Trade secret information shall be set forth in an appendix that is not available to the public.(g) The state board or regional board may assess civil liability pursuant to paragraph (1) of subdivision (c) of Section 13385 against a discharger for failure to complete a pollution prevention plan required by the state board or a regional board, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the POTW has assessed penalties for the same action.(h) A POTW may assess civil penalties and civil administrative penalties pursuant to Sections 54740, 54740.5, and 54740.6 of the Government Code against a discharger for failure to complete a pollution prevention plan when required by the POTW, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the state board or a regional board has assessed penalties for the same action.(i) A discharger may change its pollution prevention plan, including withdrawing from a pollution prevention measure required by the state board, a regional board, or a POTW, if the discharger determines that the measure will have a negative impact on product quality, the safe operation of the facility, or the environmental aspects of the facilitys operation, or the discharger determines that the measure is economically impracticable or technologically infeasible. Where practicable and feasible, the discharger shall replace the withdrawn measure with a measure that will likely achieve similar pollution prevention objectives. A measure may be withdrawn pursuant to this subdivision only with the approval of the executive officer of the state board or the regional board, or the POTW.(j) The state board shall adopt a sample format to be used by dischargers for completing the plan required by this section. The sample format shall address all of the factors the discharger is required to include in the plan. The state board may include any other factors determined by the state board to be necessary to carry out this section. The adoption of the sample format pursuant to this section is not subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(k) The state board, a regional board, or a POTW may shall not include a pollution prevention plan in any waste discharge requirements or other permit issued by that agency.(l)This section prevails over Section 13263.3, as added to the Water Code by Assembly Bill 1104 of the 19992000 Regular Session.SECTION 1.The heading of Chapter 2 (commencing with Section 42030) of Part 3 of Division 30 of the Public Resources Code is amended to read:2.Pharmaceutical and Sharps Waste Producer Responsibility ProgramSEC. 2.Section 42030 of the Public Resources Code is amended to read:42030.For purposes of this chapter, the following terms have the following meanings:(a)Authorized collection site means a location where an authorized collector operates a secure collection receptacle for collecting covered products.(b)Authorized collector means a person or entity that has entered into an agreement with a program operator to collect covered drugs, including, but not limited to, any of the following:(1)A person or entity that is registered with the United States Drug Enforcement Administration and that qualifies under federal law to modify that registration to collect controlled substances for the purpose of destruction.(2)A law enforcement agency.(3)A retail pharmacy that offers drug take-back services in compliance with Article 9.1 (commencing with Section 1776) of Title 16 of the California Code of Regulations.(c)Controlled substance means a substance listed under Sections 11053 to 11058, inclusive, of the Health and Safety Code or Section 812 or 813 of Title 21 of the United States Code, or any successor section.(d)Cosmetic means an article, or a component of an article, intended to be rubbed, poured, sprinkled, sprayed, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Cosmetic includes articles with or without expiration dates.(e)(1)Covered drug means a drug, including a brand name or generic drug, sold, offered for sale, or dispensed in the State of California in any form, including, but not limited to, any of the following:(A)Prescription and nonprescription drugs approved by the United States Food and Drug Administration pursuant to Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355) or Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).(B)A drug marketed pursuant to an over-the-counter drug monograph.(C)A drug in a medical device, or a combination product containing a drug and a medical device.(2)Covered drug does not include any of the following:(A)Vitamins or supplements.(B)Herbal-based remedies and homeopathic drugs, products, or remedies.(C)Cosmetics, soap, with or without germicidal agents, laundry detergent, bleach, household cleaning products, shampoos, sunscreens, toothpaste, lip balm, antiperspirants, or any other personal care product that is regulated as both a cosmetic and a nonprescription drug under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).(D)A drug for which a pharmaceutical product stewardship or producer responsibility program or drug takeback program is provided in the state as part of a United States Food and Drug Administration managed risk evaluation and mitigation strategy under 21 U.S.C. Sec. 355-1.(E)Biological drug products, as defined by 42 U.S.C. Sec. 262(i)(1), including those products currently approved in the state under a new drug application that will be deemed to be licensed under Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262) pursuant to Section 7002(e) of the federal Biologics Price Competition and Innovation Act of 2009 (Public Law 111-148).(F)A medical device, or a component part or accessory of a medical device, if it does not contain a covered drug.(G)Drugs that are used for animal medicines, including, but not limited to, parasiticide products for animals.(H)Dialysate drugs or other saline solutions required to perform kidney dialysis.(f)(1)(A)Covered entity means the manufacturer of covered products that are sold in or into the state.(B)If no entity that meets the definition in subparagraph (A) is in the state, covered entity means the distributor of covered products that are sold in or into the state that is licensed as a wholesaler, as defined in Section 4043 of the Business and Professions Code, but does not include a warehouse of a retail pharmacy chain that is licensed as a wholesaler if it engages only in intracompany transfers between any division, affiliate, subsidiary, parent, or other entity under complete common ownership and control.(C)If no entity that meets the definition in subparagraph (A) or (B) is in the state, covered entity means a repackager, as defined in Section 4044 of the Business and Professions Code, of covered products that are sold in or into the state.(D)If no entity that meets the definition in subparagraph (A), (B), or (C) is in the state, covered entity means the owner or licensee of a trademark or brand under which covered products are sold in or into the state, regardless of whether the trademark is registered.(E)If no entity that meets the definition in subparagraph (A), (B), (C), or (D) is in the state, covered entity means the importer of the covered products that are sold in or into the state.(2)The department shall adopt regulations on the process for determining what entity is a covered entity following the priority order set forth in paragraph (1).(g)Covered product means a covered drug or home-generated sharps waste.(h)Department means the Department of Resources Recycling and Recovery, and any successor agency.(i)Distributor means a wholesaler, as that term is defined in Section 4043 of the Business and Professions Code.(j)Drug means any of the following:(1)An article recognized in the official United States Pharmacopoeia, the official National Formulary, the official Homeopathic Pharmacopoeia of the United States, or any supplement of the formulary or those pharmacopoeias.(2)A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals.(3)A substance, other than food, intended to affect the structure or any function of the body of humans or other animals.(4)A substance intended for use as a component of any substance specified in this subdivision.(k)Generic drug means a drug that is chemically identical or bioequivalent to a brand name drug in dosage form, safety, strengths, route of administration, quality, performance, characteristics, and intended use, though inactive ingredients may vary.(l)(1)Home-generated sharps waste has the same meaning as defined in Section 117671 of the Health and Safety Code.(2)Home-generated sharps waste does not include either of the following:(A)Components manufactured for use with external ambulatory insulin pump therapy systems or continuous glucose monitoring systems, including, but not limited to, insulin infusion sets, glucose sensors that are sterile goods indicated for single subcutaneous use, sterile drug delivery channels indicated for single subcutaneous use, and injection ports.(B)A biological product, as defined in Section 262(i)(1) of Title 42 of the United States Code, including a combination product, as defined in Section 3.2(e) of Title 21 of the Code of Federal Regulations.(m)Mail-back program means a method of collecting covered products from ultimate users by using prepaid, preaddressed mailing envelopes as described in Section 1776.2 of Title 16 of the California Code of Regulations.(n)Nonprescription drug means any drug that may be lawfully sold without a prescription.(o)Pharmacy has the same meaning as defined in Section 4037 of the Business and Professions Code.(p)Prescription drug means a drug, including, but not limited to, a controlled substance, that is required under federal or state law to be dispensed with a prescription, or is restricted to use by practitioners only.(q)Producer responsibility organization means an organization exempt from taxation under Section 501(c)(3) of the federal Internal Revenue Code of 1986 (21 U.S.C. Sec. 501(c)(3)) that is established by a group of covered entities in accordance with this chapter to develop, implement, and administer a producer responsibility program established pursuant to this chapter.(r)Producer responsibility plan means the plan for collecting and properly managing covered products that is developed by a covered entity or producer responsibility organization pursuant to this chapter.(s)Producer responsibility program means a program for the collection, transportation, and disposal of covered products.(t)Program operator means a covered entity, or producer responsibility organization on behalf of a group of covered entities, that is responsible for operating a producer responsibility program in accordance with this chapter.(u)Proprietary information means information that is all of the following:(1)Submitted pursuant to this chapter.(2)A trade secret, or commercial or financial information, that is privileged or confidential, and is identified as such by the entity providing the information to the department.(3)Not required to be disclosed under any other law or any regulation affecting a covered product or covered entity.(v)Retail pharmacy means an independent pharmacy, a supermarket pharmacy, a chain pharmacy, or a mass merchandiser pharmacy possessing a license from the state board to operate a pharmacy.(w)Retail pharmacy chain means a retail pharmacy with five or more stores in the state.(x)Sharps means hypodermic needles, pen needles, intravenous needles, lancets, and other devices that are used to penetrate the skin for the delivery of medications.(y)State board means the California State Board of Pharmacy.(z)Ultimate user means a state resident or other nonbusiness entity and includes a person who has lawfully obtained, and who possesses, a covered product, including a controlled substance, for the persons own use or for the use of a member of the persons household. Ultimate user does not include a needle exchange program established under Section 121349 of the Health and Safety Code, or a medical waste generator, as defined in Section 117705 of the Health and Safety Code.SEC. 3.The heading of Article 2 (commencing with Section 42031) of Chapter 2 of Part 3 of Division 30 of the Public Resources Code is amended to read:2.Covered Entities and Producer Responsibility OrganizationsSEC. 4.Section 42031 of the Public Resources Code is amended to read:42031.(a)(1)No later than 90 days after the effective date of this section, a covered entity shall provide a list of covered products, and a list and description of any drugs or sharps that are not covered products, that it sells or offers for sale in the state to the state board.(2)A covered entity, or a producer responsibility organization on behalf of a group of covered entities, shall update the lists described in paragraph (1) and provide the updated lists to the state board on or before January 15 of each year or upon request of the department.(b)No later than 90 days after the effective date of this section, a retail pharmacy that sells a covered product under its own label shall provide written notification to the state board identifying the covered entity from which the retail pharmacy obtains a covered product that the retail pharmacy sells under its store label.(c)The state board shall verify the information received pursuant to subdivisions (a) and (b) and make it available to the department upon request.(d)The state board may issue a letter of inquiry to any entity listed in subparagraphs (A) to (E), inclusive, of paragraph (1) of subdivision (f) of Section 42030 requesting a list of all drugs and sharps it distributes in California, regardless of whether the drugs or sharps are covered under this chapter, the name of the manufacturer of those products, and any additional information necessary to carry out this chapter. An entity that is issued a letter of inquiry pursuant to this subdivision shall respond in writing no later than 60 days after receipt of the letter. Responses to those inquiries may be shared with the department, but are otherwise deemed proprietary and exempt from disclosure. If the entity does not believe it is a covered entity for purposes of this chapter, it shall submit all of the following to the state board in response to the letter of inquiry:(1)The basis for the claim that it is not a covered entity.(2)A list of any drugs and sharps it sells, distributes, repackages, or otherwise offers for sale within the state.(3)If applicable, the name and contact information of the person or entity from which it obtains a drug or sharp identified pursuant to paragraph (2).(e)The state board shall obtain and verify and, within 30 days of receipt or upon request by the department, submit to the department a list of drugs and sharps sold or offered for sale in the state excluded from the definition of covered drugs pursuant to paragraph (2) of subdivision (e) of Section 42030 or excluded from the definition of home-generated sharps waste in subdivision (l) of Section 42030.(f)Notwithstanding Section 42036.4, information submitted by the state board to the department under this chapter may include proprietary information.(g)The state board shall notify the department if any covered entity or producer responsibility organization is in violation of this section for purposes of enforcement by the department.SEC. 5.Section 42031.4 of the Public Resources Code is amended to read:42031.4.(a)Except as specified in subdivision (d) of Section 42035, a covered entity is not in compliance with this chapter and is subject to penalties pursuant to Article 6 (commencing with Section 42035) if, commencing one year from the adoption of regulations pursuant to Section 42031.2, a covered product sold or offered for sale by the covered entity is not subject to an approved producer responsibility plan, which is submitted by the covered entity or by a producer responsibility organization that includes the covered entity, that has been approved by the department pursuant to Section 42032.(b)In order to comply with the requirements of this chapter, a covered entity may establish and implement a producer responsibility program independently, or as part of a group of covered entities through membership in a producer responsibility organization exempt from taxation under Section 501(c)(3) of the federal Internal Revenue Code of 1986 (21 U.S.C. Sec. 501(c)(3)).SEC. 6.Section 42031.6 of the Public Resources Code is amended to read:42031.6.(a)A program operator shall conduct a comprehensive education and outreach program intended to promote participation in the producer responsibility program. At a minimum, the education and outreach program shall do all of the following:(1)Promote its producer responsibility program to ultimate users by providing signage for hospitals, pharmacies, and other locations, as necessary.(2)Provide educational and outreach materials for persons authorized to prescribe drugs, pharmacies, pharmacists, ultimate users, and others, as necessary.(3)Establish an internet website that publicizes the location of authorized collectors and provides other information intended to promote the use of the producer responsibility program.(4)Prepare and provide additional outreach materials not specified in this section, as needed to promote the collection and proper management of covered drugs and home-generated sharps waste.(5)Encourage ultimate users to separate products that are not covered products from covered products, when appropriate, before submitting the covered products to an authorized collection site or mail-back program.(b)A program operator shall not, as part of the education and outreach program, promote the disposal of a covered product in a manner inconsistent with the services offered to ultimate users by the producer responsibility program.SEC. 7.The heading of Article 3 (commencing with Section 42032) of Chapter 2 of Part 3 of Division 30 of the Public Resources Code is amended to read:3.Producer Responsibility PlansSEC. 8.Section 42032 of the Public Resources Code is amended to read:42032.(a)(1)Within six months of the adoption date of regulations by the department pursuant to Section 42031.2, a program operator shall submit to the department for approval a complete producer responsibility plan that meets the requirements of Section 42032.2 for the establishment and implementation of a producer responsibility program, in a format determined by the department.(2)The department shall approve a proposed producer responsibility program if the program operator submits a completed plan that meets the requirements of this section.(b)(1)Before submitting a producer responsibility plan to the department pursuant to this section, a program operator shall submit its proposed producer responsibility plan to the state board for review, and to any other applicable state agencies with areas of authority relative to the producer responsibility plan. The duration of time that the state board takes to review a producer responsibility plan pursuant to this paragraph shall not count toward the time limit specified in paragraph (1) of subdivision (a).(2)An agency that receives a producer responsibility plan shall review the producer responsibility plan for compliance with state and federal laws and regulations related to the agencys respective authority. The agency shall determine compliance or noncompliance with those laws and regulations, and provide to the program operator that determination and an explanation for any finding of noncompliance, within 90 days of receipt of the producer responsibility plan.(3)A program operator may submit an updated proposed producer responsibility plan to an agency that issued a determination of noncompliance to attempt to obtain a determination of compliance. A program operator shall submit any determination received from an agency when it submits its producer responsibility plan to the department.(4)If, 90 days after submitting a producer responsibility plan to an applicable agency, a program operator has not received a response from the applicable agency, the program operator may submit a certification to the department that the producer responsibility plan is consistent with all other applicable laws and regulations.(c)(1)The department shall determine if a producer responsibility plan is complete, including the determinations required pursuant to subdivision (b), and notify the submitting program operator within 30 days of receipt.(2)If the department finds that the producer responsibility plan is complete, the departments 90-day review period for consideration of approval of the producer responsibility plan set forth in subdivision (d) shall commence upon the original date of receipt.(3)If the department determines the producer responsibility plan is incomplete, the department shall identify for the program operator the required additional information, and the program operator shall resubmit the producer responsibility plan within 30 days.(4)If the department determines upon resubmission that the producer responsibility plan is complete, the departments 90-day review period for consideration of approval of the producer responsibility plan shall commence upon the date of receipt of the resubmitted producer responsibility plan.(d)(1)The department shall review a complete submitted producer responsibility plan and shall approve, disapprove, or conditionally approve the producer responsibility plan within 90 days of receipt of the complete producer responsibility plan.(2)The department may consult with, or submit a producer responsibility plan for review to, the state board or another state agency it determines is necessary to determine the completeness of the producer responsibility plan or for making a determination on the approval of the producer responsibility plan or an amendment to the producer responsibility plan. The duration of time that the department takes to review a producer responsibility plan pursuant to this paragraph shall not count toward the 90-day time limit specified in paragraph (1).(e)A program operator shall submit any significant changes to a producer responsibility plan in writing for approval by the department, and shall not implement the changes prior to that approval.(f)(1)If the department disapproves a submitted producer responsibility plan pursuant to subdivision (d), the department shall explain, in writing within 30 days, how the producer responsibility plan does not comply with this chapter, and the program operator shall resubmit a revised producer responsibility plan to the department.(2)If the department finds that the revised producer responsibility plan submitted by the program operator does not comply with the requirements of this chapter and disapproves the plan, the covered entity operating its own producer responsibility program, or the producer responsibility organization and the covered entities that are members of the producer responsibility organization, are not in compliance with this chapter until the program operator submits a producer responsibility plan that the department approves.(g)A program operator shall fully implement operation of an approved producer responsibility program no later than 270 days after approval by the department of the producer responsibility plan that establishes the producer responsibility program.(h)If a producer responsibility plan is revoked pursuant to subdivision (a) of Section 42035.4 or terminated by the program operator that submitted the producer responsibility plan, a covered entity no longer subject to that producer responsibility plan may, without being subject to penalties pursuant to Article 6 (commencing with Section 42035), sell or offer for sale covered products in the state for a period of up to one year after the producer responsibility plan terminated or was revoked if the covered entity continues to operate under the most recent approved producer responsibility plan to which the covered entity was subject.(i)The department shall make all producer responsibility plans submitted pursuant to this section available to the public, except proprietary information in the plans protected pursuant to Section 42036.4.SEC. 9.Section 42032.2 of the Public Resources Code is amended to read:42032.2.(a)(1)To be complete, a producer responsibility plan for covered drugs shall do all of the following:(A)Identify and provide contact information for the producer responsibility organization, if applicable, and each participating covered entity, and identify each covered drug sold or offered for sale by each participating covered entity.(B)Identify and provide contact information for the authorized collectors for the producer responsibility program, as well as the reasons for excluding any potential authorized collectors from participation in the program.(C)Include any determinations provided by a state agency pursuant to subdivision (b) of Section 42032. Any determination of noncompliance shall be accompanied by a superseding determination of compliance.(D)Demonstrate adequate funding for all administrative and operational costs of the producer responsibility program, to be borne by participating covered entities.(E)Provide for a handling, transport, and disposal system that complies with applicable state and federal laws, including, but not limited to, regulations adopted by the United States Drug Enforcement Administration.(F)Provide for a collection system that complies with the requirements of this chapter and meets all of the following requirements for authorized collection sites in each county in which the producer responsibility plan will be implemented:(i)Provides for a minimum of five authorized collection sites or one authorized collection site per 50,000 people, whichever is greater.(ii)Provides for a reasonable geographic spread of authorized collection sites and an explanation for the geographic spread.(iii)Provides for a mail-back program covering any counties where there is not an authorized retail pharmacy operating as an authorized collection site.(G)Require a program operator to do all of the following:(i)Permit an ultimate user who is a homeless, homebound, or disabled individual to request prepaid, preaddressed mailing envelopes, or an alternative form of a collection and disposal system, as described in paragraph (2) of subdivision (c), that would render the covered drug inert. A program operator shall accept that request through an internet website and toll-free telephone number that it shall maintain to comply with the requests.(ii)Provide alternative methods of collection from ultimate users for any covered drugs, other than controlled substances, that cannot be accepted or commingled with other covered drugs in secure collection receptacles or through a mail-back program, to the extent technically feasible and permissible under applicable state and federal law, including, but not limited to, United States Drug Enforcement Administration regulations.(iii)(I)Provide a service schedule that meets the needs of each authorized collection site to ensure that each secure collection receptacle is serviced as often as necessary to avoid reaching capacity and that collected covered drugs are transported to final disposal in a timely manner. Additionally, a receipt or collection manifest shall be left with the authorized collection site to support verification of the service. The authorized collection site shall maintain and make available to the department this documentation.(II)An authorized collector shall comply with applicable federal and state laws regarding collection and transportation standards, and the handling of covered drugs, including United States Drug Enforcement Administration regulations.(H)Provide the policies and procedures for the safe and secure collection, transporting, and disposing of the covered drug, describe how and where records will be maintained and how, at a minimum, instances of security problems that occur will be addressed, and explain the processes that will be taken to change the policies, procedures, and tracking mechanisms to alleviate the problems and to improve safety and security.(2)Paragraph (1) shall apply only with regard to covered drugs.(b)(1)At least 120 days before submitting a producer responsibility plan to the department, the operator of a producer responsibility program for covered drugs shall notify potential authorized collectors in the county or counties in which it operates of the opportunity to serve as an authorized collector for the proposed producer responsibility program. If a potential authorized collector expresses interest in participating in a producer responsibility program, the program operator shall commence good faith negotiations with the potential authorized collector within 30 days.(2)A retail pharmacy shall make a reasonable effort to serve as an authorized collector as part of a producer responsibility program in the county in which it is located. If the minimum threshold described in clause (i) of subparagraph (F) of paragraph (1) of subdivision (a) is not met in each county in which a retail pharmacy chain has store locations, the retail pharmacy chain shall have at least one location or 15 percent of its store locations, whichever is greater, in that county serve as authorized collectors in a producer responsibility program.(3)A program operator shall include as an authorized collector under its producer responsibility program any entity listed in subdivision (b) of Section 42030 that offers to participate in the producer responsibility program, in writing and without compensation, even if the minimum convenience standards set in clause (i) of subparagraph (F) of paragraph (1) of subdivision (a) have been achieved. The program operator shall include the offering entity as an authorized collector in the program within 90 days of receiving the written offer to participate. A program operator shall not be required to respond to offers pursuant to this paragraph until the program operators producer responsibility plan has been approved by the department.(c)After a producer responsibility plan for covered drugs has been approved, the program operator may supplement service, if approved by the department, for a county in which it operates that does not have the minimum number of authorized collection sites due to circumstances beyond the program operators control, by establishing one or both of the following:(1)A mail-back program. The mail-back program may include providing information on where and how to receive mail-back materials or providing the locations at which it distributes prepaid, preaddressed mailing envelopes. The program operator shall propose the locations of those envelope distribution locations as part of the producer responsibility plan. Prepaid mailing envelopes may be mailed to an ultimate user upon request.(2)An alternative form of collection and disposal of covered drugs that complies with applicable state and federal law, including, but not limited to, United States Drug Enforcement Administration regulations.(d)(1)To be complete, a producer responsibility plan for home-generated sharps waste shall do all of the following:(A)Identify and provide contact information for the producer responsibility organization, if applicable, and each participating covered entity, and identify each covered product sold or offered for sale by each participating covered entity.(B)Include any determinations provided by a state agency pursuant to subdivision (b) of Section 42032. Any determination of noncompliance shall be accompanied by a superseding determination of compliance.(C)Demonstrate adequate funding for all administrative and operational costs of the producer responsibility program, to be borne by participating covered entities.(D)Provide for a handling, transport, and disposal system, at no cost to the ultimate user, that complies with applicable state and federal laws.(E)Maintain an internet website and toll-free telephone number for purposes of providing information on the program, including disposal options, and to receive requests for sharps waste containers from ultimate users.(F)Provide that a producer responsibility program for home-generated sharps waste shall be a mail-back program for home-generated sharps waste that complies with this chapter and that meets all the following requirements:(i)The program provides or initiates distribution of a sharps waste container and mail-back materials at the point of sale, to the extent allowable by law. Containers and mail-back materials shall be provided at no cost to the ultimate user. The program operator shall select and distribute a container and mail-back materials sufficient to accommodate the volume of sharps purchased by an ultimate user over a selected time period.(I)For any sharps, the packaging, an insert or instructions, or separate information provided to the ultimate user shall include information on proper sharps waste disposal.(II)All sharps waste containers shall include on a label affixed to the container or packaging, or on a separate insert included in the container or packaging, the program operators internet website and toll-free telephone number.(III)All sharps waste containers shall include prepaid postage affixed to the container or to the mail-back packaging.(ii)Upon request, the program provides for reimbursement to local agencies for disposal costs related to home-generated sharps waste, unless the program operator provides for the removal of the home-generated sharps waste from the local household hazardous waste facility.(I)A local agency shall not knowingly request reimbursement for disposal expenses pursuant to this subparagraph for disposal costs resulting from a municipal needle exchange program or a medical waste generator.(II)Reimbursement costs shall be limited to the actual costs of transportation from the household hazardous waste facility and for the actual costs of disposal.(III)A request for reimbursement pursuant to this clause shall be submitted with a declaration under penalty of perjury that the local agency has not knowingly requested reimbursement for expenses prohibited by this section.(IV)A cost is eligible for reimbursement pursuant to this clause if the cost is incurred 270 days or more after the approval of a producer responsibility plan for home-generated sharps waste.(2)Paragraph (1) shall apply only with regard to home-generated sharps waste.(e)A producer responsibility plan shall include provisions to expand into jurisdictions not included in the producer responsibility plan pursuant to Section 42036.2, in the event a jurisdiction repeals its local stewardship or producer responsibility program ordinance.(f)A producer responsibility plan shall include educational and outreach provisions to meet the requirements of Section 42031.6.SEC. 10.Section 42033 of the Public Resources Code is amended to read:42033.With the submission of a producer responsibility plan, a program operator shall submit to the department an initial producer responsibility program budget for the first five calendar years of operation of its producer responsibility program that includes both of the following:(a)Total anticipated revenues and costs of implementing the producer responsibility program.(b)A total recommended funding level sufficient to cover the producer responsibility plans budgeted costs and to operate the producer responsibility program over a multiyear period.SEC. 11.Section 42033.2 of the Public Resources Code is amended to read:42033.2.(a)On or before March 31 of each year, a program operator shall prepare and submit to the department both of the following:(1)A written report describing the producer responsibility program activities during the previous reporting period of one year.(2)A written program budget for producer responsibility program implementation for the upcoming calendar year.(b)An annual report submitted pursuant to paragraph (1) of subdivision (a) shall include, at a minimum, all of the following for the prior year:(1)A list of covered entities participating in the producer responsibility organization.(2)The updated and reverified list provided pursuant to paragraph (2) of subdivision (a) of Section 42031 of covered products that each covered entity subject to the producer responsibility plan sells or offers for sale.(3)The amount, by weight, of covered products collected from ultimate users at each authorized collection site that is part of the producer responsibility program.(4)For a producer responsibility plan for covered drugs, the name and location of authorized collection sites at which covered drugs were collected.(5)For a producer responsibility plan for home-generated sharps waste, information on the mail-back program.(6)Whether policies and procedures for collecting, transporting, and disposing of covered products, as established in the producer responsibility plan, were followed during the reporting period and a description of each instance of noncompliance, if any occurred.(7)Whether any safety or security problems occurred during collection, transportation, or disposal of collected covered products during the reporting period and, if so, what changes have been or will be made to policies, procedures, or tracking mechanisms to alleviate the problem and to improve safety and security.(8)How the program operator complied with all elements in its producer responsibility plan.(9)Any other information the department reasonably requires.(c)An annual program budget submitted pursuant to paragraph (2) of subdivision (a) shall include, at a minimum, both of the following for the upcoming calendar year:(1)An independent financial audit of the producer responsibility program, as required by subdivision (b) of Section 42033.4, funded by the producer responsibility organization from the charge paid from its member covered entities pursuant to Section 42034 or by a covered entity if it operates its own producer responsibility program.(2)Anticipated costs and the recommended funding level necessary to implement the producer responsibility program, including, but not limited to, costs to cover the producer responsibility plans budgeted costs and to operate the producer responsibility program over a multiyear period in a prudent and responsible manner.(d)(1)The department shall determine if a submitted annual report and program budget are complete and notify the submitting producer responsibility organization or covered entity within 30 days.(2)If the department finds that an annual report and program budget are complete, the departments 90-day review period for consideration of approval of the annual report and program budget, set forth in subdivision (e), shall commence upon the original date of receipt.(3)If the department determines either an annual report or a program budget is incomplete, the department shall identify for the program operator within 30 days the required additional information, and the program operator shall submit a revised annual report or program budget, as applicable, within 30 days.(4)If the department determines upon resubmission that the annual report or program budget is complete, the departments 90-day review period for consideration of approval of the annual report or program budget shall commence upon the date of receipt of the resubmitted report or program budget.(e)(1)The department shall review the annual report and program budget required pursuant to this section and within 90 days of receipt shall approve, disapprove, or conditionally approve the annual report and program budget.(2)(A)If the department conditionally approves an annual report or program budget, the department shall identify the deficiencies in the annual report or program budget and the program operator shall comply with the conditions of the conditional approval within 60 days of the notice date, unless the Director of Resources Recycling and Recovery determines that additional time is needed.(B)If the department conditionally approves an annual report or program budget and the conditions are not met within 60 days of the notice date, unless additional time is granted pursuant to subparagraph (A), the department shall disapprove the annual report or program budget.(3)If the department disapproves an annual report or program budget, the department shall identify the deficiencies in the annual report or program budget and the program operator shall submit a revised annual report or program budget and provide any supplemental information requested within 60 days of the notice date.SEC. 12.Section 42033.4 of the Public Resources Code is amended to read:42033.4.(a)A program operator shall keep minutes, books, and records that clearly reflect the activities and transactions of the program operators producer responsibility program.(b)(1)The minutes, books, and records of a program operator shall be audited at the program operators expense by an independent certified public accountant retained by the program operator at least once each calendar year.(2)A program operator shall arrange for the independent certified public accountant audit to be delivered to the department, along with the annual report and program budget submitted pursuant to subdivision (a) of Section 42033.2.(3)The department may conduct its own audit of a program operator. The department shall review the independent certified public accountant audit for compliance with this chapter and consistency with the program operators producer responsibility plan, annual report, and program budget submitted pursuant to this chapter. The department shall notify the program operator of any conduct or practice that does not comply with this chapter or of any inconsistencies identified in the departments audit. The program operator may obtain copies of the departments audit, including proprietary information contained in the departments audit, upon request. The department shall not disclose any confidential proprietary information protected pursuant to Section 42036.4 that is included in the departments audit.SEC. 13.Section 42033.6 of the Public Resources Code is amended to read:42033.6.As part of the administration of this chapter, within 12 months of a program operators submission of three consecutive complete annual reports submitted pursuant to Section 42033.2, the department shall develop, and post on its internet website, a report analyzing whether the program operators producer responsibility program provides adequate access to safe disposal of home-generated sharps waste or covered drugs, as applicable, to the ultimate user.SEC. 14.Section 42034 of the Public Resources Code is amended to read:42034.In order to further the objective that covered entities establish and implement producer responsibility programs that comply with the requirements of this chapter, each covered entity, either individually or through a producer responsibility organization, shall pay all administrative and operational costs associated with establishing and implementing the producer responsibility program in which it participates, including the cost of collecting, transporting, and disposing of covered products.SEC. 15.Section 42034.2 of the Public Resources Code is amended to read:42034.2.(a)(1)On March 1 and September 1 of each year, a program operator shall pay to the department an administrative fee. The department shall set the fee at an amount that, when paid by every covered entity, is adequate to cover the departments and any other state agencys projected full costs of administering and enforcing this chapter, including any incurred costs that have not been reimbursed. Before March 1 and September 1 of each year, the department shall compare the total amount of fees collected for the operative billing cycle to the total actual and reasonable costs of administering and enforcing this chapter over the same period so that the total amount of fees collected is adequate and does not exceed the states full actual and reasonable regulatory costs to implement and enforce this chapter. These costs may include the actual and reasonable costs associated with regulatory activities pursuant to this chapter before submission of producer responsibility plans pursuant to Section 42032.(2)For a producer responsibility organization, the administrative fee paid pursuant to paragraph (1) shall be funded by the covered entities that make up the producer responsibility organization. This administrative fee shall be in addition to the charge paid pursuant to Section 42034. A producer responsibility organization may require its participating covered entities to pay the administrative fee and the charge paid pursuant to Section 42034 at the same time.(b)The department shall deposit administrative fees paid by a program operator pursuant to subdivision (a) into the Pharmaceutical and Sharps Producer Responsibility Fund. Upon appropriation by the Legislature, moneys in the fund may be expended by the department, the state board, and any other agency that assists in the regulatory activities of administering and enforcing this chapter. Upon appropriation by the Legislature, moneys in the fund may be used for those regulatory activities and to reimburse any outstanding loans made from other funds used to finance the startup costs of the departments activities pursuant to this chapter. Moneys in the fund shall not be expended for any purpose not enumerated in this chapter.(c)The Pharmaceutical and Sharps Stewardship Fund, established by Section 1 of Chapter 1004 of the Statutes of 2018 (Senate Bill No. 212), is hereby renamed and continued in existence as the Pharmaceutical and Sharps Producer Responsibility Fund.SEC. 16.Section 42034.4 of the Public Resources Code is amended to read:42034.4.(a)(1)A producer responsibility organization may conduct an audit of covered entities that are required to remit a charge or administrative fee to the producer responsibility organization pursuant to Sections 42034 and 42034.2 to verify that the administrative fees and charges paid are proper and accurate. In addition, a producer responsibility organization may conduct an audit of authorized collectors to verify the charges submitted are proper and accurate.(2)The purpose of the audits described in paragraph (1) is to ensure parties required by this chapter to pay or collect an administrative fee or charge are paying or collecting the proper amount to implement the program.(b)If a producer responsibility organization conducts an audit pursuant to subdivision (a), it shall do all of the following:(1)Conduct the audit in accordance with generally accepted auditing practices.(2)Limit the scope of the audit of covered entities to confirming whether a charge or administrative fee has been properly paid by the covered entities.(3)Hire an independent third-party auditor to conduct the audit.(4)Provide a copy of the audit to the department.SEC. 17.Section 42035 of the Public Resources Code is amended to read:42035.(a)(1)On or before June 30th of each year, the department shall post on its internet website a list of producer responsibility organizations, including entities with an approved producer responsibility plan, and covered entities, authorized collection sites, retail pharmacies, and retail pharmacy chains provided in the producer responsibility plans that are in compliance with this chapter.(2)The state board shall coordinate with the department to verify that the list posted pursuant to paragraph (1) is consistent with the information submitted to each agency pursuant to Section 42031.(b)A covered entity or producer responsibility organization that is not listed on the departments internet website pursuant to subdivision (a), but demonstrates compliance with this chapter before the department is required to post the following years list pursuant to subdivision (a), may request a certification letter from the department stating that the covered entity or producer responsibility organization is in compliance with this chapter. A covered entity or producer responsibility organization that receives a certification letter shall be deemed to be in compliance with this chapter.(c)A distributor or wholesaler of covered products, and a pharmacy or other retailer that sells or offers for sale a covered product, shall monitor the departments internet website to determine which covered entities and producer responsibility organizations are in compliance with this chapter. The distributor or wholesaler and the pharmacy or other retailer shall notify the department if it determines that a covered product that it sells or offers for sale is from a covered entity that is not listed on the departments internet website.(d)The sale, distribution, or offering for sale of any inventory that was in stock before the commencement of a producer responsibility program is exempt from this chapter and not required to be subject to a producer responsibility plan.(e)If the department determines a covered entity or producer responsibility organization is not in compliance with this chapter, the department shall remove the entity from the list maintained on the departments internet website pursuant to subdivision (a).SEC. 18.Section 42035.2 of the Public Resources Code is amended to read:42035.2.(a)(1)The department may impose an administrative penalty on any covered entity, program operator, producer responsibility organization, or authorized collector that sells, offers for sale, or provides a covered product in violation of this chapter.(2)The amount of the administrative penalty imposed pursuant to this subdivision shall not exceed ten thousand dollars ($10,000) per day unless the violation is intentional, knowing, or reckless, in which case the administrative penalty shall not exceed fifty thousand dollars ($50,000) per day.(b)The department shall not impose a penalty on a program operator pursuant to this section for failure to comply with this chapter if the program operator demonstrates it received false or misleading information that contributed to its failure to comply, including, for a producer responsibility organization, from a participating covered entity.(c)The department shall deposit all penalties collected pursuant to this section in the Pharmaceutical and Sharps Producer Responsibility Penalty Account, in the Pharmaceutical and Sharps Producer Responsibility Fund. Upon appropriation by the Legislature, moneys in the Pharmaceutical and Sharps Producer Responsibility Penalty Account may be expended by the department on activities including, but not limited to, the promotion of safe handling and disposal of covered products, grants for related purposes, and the administration and enforcement of this chapter.(d)The Pharmaceutical and Sharps Stewardship Penalty Account, established by Section 1 of Chapter 1004 of the Statutes of 2018 (Senate Bill No. 212), is hereby renamed and continued in existence as the Pharmaceutical and Sharps Producer Responsibility Penalty Account.SEC. 19.Section 42035.4 of the Public Resources Code is amended to read:42035.4.Upon a written finding that a covered entity, program operator, producer responsibility organization, or authorized collector has not met a material requirement of this chapter, in addition to any other penalties authorized under this chapter, the department may take one or both of the following actions to ensure compliance with the requirements of this chapter, after affording the covered entity, producer responsibility organization, or authorized collector a reasonable opportunity to respond to, or rebut, the finding:(a)Revoke the program operators producer responsibility plan approval or require the program operator to resubmit the producer responsibility plan.(b)Require additional reporting relating to compliance with the material requirement of this chapter that was not met.SEC. 20.Section 42035.6 of the Public Resources Code is amended to read:42035.6.(a)A covered entity, producer responsibility organization, program operator, retail pharmacy, or retail pharmacy chain shall do both of the following:(1)Upon request, provide the department with reasonable and timely access, as determined by the department, to its facilities and operations, as necessary to determine compliance with this chapter.(2)Upon request, provide the department with relevant records necessary to determine compliance with this chapter.(b)A covered entity, producer responsibility organization, program operator, retail pharmacy, or retail pharmacy chain shall maintain and keep accessible all records required to be kept or submitted pursuant to this chapter for a minimum of three years.(c)All reports and records provided to the department pursuant to this chapter shall be provided under penalty of perjury.(d)The department may take disciplinary action against a covered entity, producer responsibility organization, program operator, pharmacy, retail pharmacy, or retail pharmacy chain that fails to provide the department with the access to information required pursuant to this section, including one or both of the following:(1)Imposing an administrative penalty pursuant to Section 42035.2.(2)Posting a notice on the departments internet website, in association with the list that the department maintains pursuant to paragraph (1) of subdivision (a) of Section 42035, that the covered entity, producer responsibility organization, program operator, pharmacy, retail pharmacy, or retail pharmacy chain is no longer in compliance with this chapter.(e)The department shall not prohibit as a disciplinary action a covered entity, producer responsibility organization, program operator, pharmacy, retail pharmacy, or retail pharmacy chain from selling a covered product.SEC. 21.Section 42035.8 of the Public Resources Code is amended to read:42035.8.All handling, transport, and disposal undertaken as part of a producer responsibility program under this chapter shall comply with applicable state and federal laws, including, but not limited to, regulations adopted by the United States Drug Enforcement Administration.SEC. 22.Section 42036 of the Public Resources Code is amended to read:42036.(a)Except as provided in subdivision (c), an action specified in subdivision (b) that is taken by a producer responsibility organization or a covered entity pursuant to this chapter is not a violation of the Cartwright Act (Chapter 2 (commencing with Section 16700) of Part 2 of Division 7 of the Business and Professions Code), the Unfair Practices Act (Chapter 4 (commencing with Section 17000) of Part 2 of Division 7 of the Business and Professions Code), or the Unfair Competition Law (Chapter 5 (commencing with Section 17200) of Part 2 of Division 7 of the Business and Professions Code).(b)Subdivision (a) shall apply to all of the following actions taken by a producer responsibility organization or covered entity:(1)The creation, implementation, or management of a producer responsibility plan approved by the department pursuant to Article 3 (commencing with Section 42032) and the determination of the types or quantities of covered products collected or otherwise managed pursuant to a producer responsibility plan.(2)The determination of the cost and structure of an approved producer responsibility plan.(3)The establishment, administration, collection, or disbursement of the charge or administrative fee imposed pursuant to Section 42034 or 42034.2, respectively.(c)Subdivision (a) shall not apply to an agreement that does any of the following:(1)Fixes a price of or for covered products, except for an agreement related to costs, charges, or administrative fees associated with participation in a producer responsibility plan approved by the department and otherwise in accordance with this chapter.(2)Fixes the output of production of covered products.(3)Restricts the geographic area in which, or customers to whom, covered products are sold.SEC. 23.Section 42036.2 of the Public Resources Code is amended to read:42036.2.(a)This chapter does not apply to a drug or sharp within a jurisdiction that is subject to a local stewardship or producer responsibility program pursuant to an ordinance that took effect before April 18, 2018. If that ordinance is repealed in the jurisdiction or, if more than one ordinance is applicable, those ordinances are repealed in the jurisdiction, the drug or sharp shall be subject to this chapter in that jurisdiction within 270 days after the date on which the ordinance is, or ordinances are, repealed.(b)This chapter shall preempt a local stewardship or producer responsibility program for drugs or sharps enacted by an ordinance or ordinances with an effective date on or after April 18, 2018.(c)A local stewardship or producer responsibility program for covered products enacted by an ordinance that has an effective date before April 18, 2018, may continue in operation, but the program and its participants shall not receive or benefit from moneys from the Pharmaceutical and Sharps Producer Responsibility Fund or the Pharmaceutical and Sharps Producer Responsibility Penalty Account, including, but not limited to, for administrative or enforcement costs. Participants of a local stewardship or producer responsibility program for covered products enacted by an ordinance that has an effective date before April 18, 2018, shall be eligible to participate in a producer responsibility program under this chapter and thereby become eligible to receive funds from the Pharmaceutical and Sharps Producer Responsibility Fund or the Pharmaceutical and Sharps Producer Responsibility Penalty Account only if the local stewardship or producer responsibility program is dissolved.SEC. 24.Section 42036.4 of the Public Resources Code is amended to read:42036.4.Proprietary information submitted to the department under this chapter shall be protected by all parties as confidential and shall be exempt from public disclosure under the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code). The department and other parties may only disclose proprietary information in an aggregated form that does not directly or indirectly identify financial, production, or sales data of an individual covered entity or producer responsibility organization. Proprietary information may be disclosed to the party that submitted the proprietary information.
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. Section 13263.3 of the Water Code, as added by Section 3 of Chapter 92 of the Statutes of 1999, is repealed.13263.3.(a)The Legislature finds and declares that pollution prevention should be the first step in a hierarchy for reducing pollution and managing wastes, and to achieve environmental stewardship for society. The Legislature also finds and declares that pollution prevention is necessary to achieve the federal goal of zero discharge of pollutants into navigable waters.(b)(1)For the purposes of this section, pollution prevention means any action that causes a net reduction in the use or generation of a hazardous substance or other pollutant that is discharged into water and includes any of the following:(A)Input change, which means a change in raw materials or feedstocks used in a production process or operation so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(B)Operational improvement, which means improved site management so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(C)Production process change, which means a change in a process, method, or technique that is used to produce a product or a desired result, including the return of materials or their components for reuse within the existing processes or operations, so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(D)Product reformulation, which means changes in design, composition, or specifications of end products, including product substitution, so as to reduce, avoid, or eliminate the generation of problem pollutants discharged in wastewater.(2)For the purposes of this section, pollution prevention does not include actions that merely shift a pollutant in wastewater from one environmental medium to another environmental medium, unless clear environmental benefits of such an approach are demonstrated.(c)(1)For the purposes of this section, discharger means any entity required to obtain a national pollutant discharge elimination system (NPDES) permit pursuant to the Clean Water Act (33 U.S.C. Sec. 1251 et seq.), or any entity subject to the pretreatment program as defined in Part 403 (commencing with Section 403.1) of subchapter N of Chapter 1 of Part 403 of Title 40 of the Code of Federal Regulations.(2)For the purposes of this section, industrial discharger means any discharger other than a publicly owned treatment works (POTW).(d)(1)The state board, a regional board, or a POTW may require a discharger subject to its jurisdiction to complete a pollution prevention plan if any of the following apply:(A)A discharger is determined to be a chronic violator and the board or the POTW determines that pollution prevention could achieve compliance.(B)The discharger contributes, or has the potential to contribute, to the formation of a toxic hot spot as defined in Section 13391.5.(C)The discharger discharges a pollutant for which the permitted level is lower than the practical quantification limit and the state board, a regional board, or the POTW determines that additional reductions of the pollutant are necessary.(D)The board determines pollution prevention is necessary to achieve a water quality objective.(2)The state board, a regional board, or a POTW may require an industrial discharger subject to its jurisdiction to complete a pollution prevention plan that includes all of the following:(A)An analysis of the pollutants that the facility discharges into water or introduces into POTWs, a description of the sources of the pollutants, and a comprehensive review of the processes used by the discharger that result in the generation and discharge of the pollutants.(B)An analysis of the potential for pollution prevention to reduce the generation of the pollutants, including the application of innovative and alternative technologies and any adverse environmental impacts resulting from the use of those methods.(C)A detailed description of the tasks and time schedules required to investigate and implement various elements of pollution prevention techniques.(D)A statement of the dischargers pollution prevention goals and strategies, including priorities for short-term and long-term action.(E)A description of the dischargers intended pollution prevention activities for the immediate future.(F)A description of the dischargers existing pollution prevention methods.(G)A statement that the dischargers existing and planned pollution prevention strategies do not constitute cross-media pollution transfers, and information that supports that statement.(H)Toxic chemical release data for those dischargers subject to Section 313 of the Emergency Planning and Community Right to Know Act of 1986 (42 U.S.C. Sec. 11023).(I)Proof of compliance with the Hazardous Waste Source Reduction and Management Review Act of 1989 (Article 11.9 (commencing with Section 25244.12) of Chapter 6.5 of Division 20 of the Health and Safety Code) if the discharger is also subject to that act.(J)An analysis of the relative costs and benefits of the possible pollution prevention activities.(3)A regional board may require a POTW to complete a pollution prevention plan that includes all of the following:(A)An estimate of all of the sources of a pollutant contributing, or potentially contributing, to the loadings of a pollutants in the treatment plant influent.(B)An analysis of the methods that could be used to prevent the discharge of the pollutants into the POTW, including application of local limits to industrial or commercial dischargers regarding pollution prevention techniques, public education and outreach, or other innovative and alternative approaches to reduce discharges of the pollutant to the POTW. The analysis also shall identify sources, or potential sources, not within the ability or authority of the POTW to control, such as pollutants in the potable water supply, airborne pollutants, pharmaceuticals, or pesticides, and estimate the magnitude of those sources, to the extent feasible.(C)An estimate of load reductions that may be attained through the methods identified in subparagraph (B).(D)A plan for monitoring the results of the pollution prevention program.(E)A description of the tasks, cost, and time required to investigate and implement various elements in the pollution prevention plan.(F)A statement of the POTWs pollution prevention goals and strategies, including priorities for short-term and long-term action, and a description of the POTWs intended pollution prevention activities for the immediate future.(G)A description of the POTWs existing pollution prevention programs.(H)An analysis, to the extent feasible, of any adverse environmental impacts, including cross-media impacts or substitute chemicals, that may result from the implementation of the pollution prevention program.(I)An analysis, to the extent feasible, of the costs and benefits that may be incurred to implement the pollution prevention program.(e)The state board or the regional board may establish a schedule of actions identified in the pollution prevention plans for the discharger.(f)The state board or regional board shall solicit comments from the public on a pollution prevention plan prepared pursuant to this section and address the public comments when determining what schedule of actions, if any, to establish for the discharger pursuant to this section.(g)The state board and regional boards shall make the pollution prevention plans available for public review, except to the extent that information is classified as confidential because it is a trade secret. Trade secret information shall be set forth in an appendix that is not available to the public.(h)Any costs incurred by the state board or a regional board resulting from actions required by this section shall be paid for from revenue generated by the fees imposed by Section 13260.(i)The state board or regional board may assess civil penalties pursuant to Section 13385 against a discharger for failure to complete a pollution prevention plan ordered by the state board or a regional board, or for failure to comply with a schedule of actions ordered by the state board or a regional board pursuant to this section.(j)A POTW may assess civil penalties and civil administrative penalties pursuant to Sections 54740, 54740.5, and 54740.6 of the Government Code against an industrial discharger for failure to complete a pollution prevention plan when ordered by the POTW, for submitting a plan that does not comply with the act, or for failure to comply with a schedule of actions ordered by the POTW pursuant to this section, unless the regional board has assessed penalties for the same action.(k)A discharger may change its pollution prevention plan, including withdrawing from a pollution prevention measure approved by the state board, a regional board, or a POTW, if the discharger determines that the measure will have a negative impact on product quality, the safe operation of the facility, or the environmental aspects of the facilities operation, and the discharger demonstrates to the board or the POTW an alternative measure that achieves that same pollution prevention objective.(l)The state board shall adopt a format to be used by dischargers for completing the plan required by this section. The format shall address all of the factors the discharger is required to include in the plan. The board may include any other factors determined by the board to be necessary to carry out this section. The adoption of the format pursuant to this section is not subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.
SECTION 1. Section 13263.3 of the Water Code, as added by Section 3 of Chapter 92 of the Statutes of 1999, is repealed.
### SECTION 1.
13263.3.(a)The Legislature finds and declares that pollution prevention should be the first step in a hierarchy for reducing pollution and managing wastes, and to achieve environmental stewardship for society. The Legislature also finds and declares that pollution prevention is necessary to achieve the federal goal of zero discharge of pollutants into navigable waters.(b)(1)For the purposes of this section, pollution prevention means any action that causes a net reduction in the use or generation of a hazardous substance or other pollutant that is discharged into water and includes any of the following:(A)Input change, which means a change in raw materials or feedstocks used in a production process or operation so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(B)Operational improvement, which means improved site management so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(C)Production process change, which means a change in a process, method, or technique that is used to produce a product or a desired result, including the return of materials or their components for reuse within the existing processes or operations, so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(D)Product reformulation, which means changes in design, composition, or specifications of end products, including product substitution, so as to reduce, avoid, or eliminate the generation of problem pollutants discharged in wastewater.(2)For the purposes of this section, pollution prevention does not include actions that merely shift a pollutant in wastewater from one environmental medium to another environmental medium, unless clear environmental benefits of such an approach are demonstrated.(c)(1)For the purposes of this section, discharger means any entity required to obtain a national pollutant discharge elimination system (NPDES) permit pursuant to the Clean Water Act (33 U.S.C. Sec. 1251 et seq.), or any entity subject to the pretreatment program as defined in Part 403 (commencing with Section 403.1) of subchapter N of Chapter 1 of Part 403 of Title 40 of the Code of Federal Regulations.(2)For the purposes of this section, industrial discharger means any discharger other than a publicly owned treatment works (POTW).(d)(1)The state board, a regional board, or a POTW may require a discharger subject to its jurisdiction to complete a pollution prevention plan if any of the following apply:(A)A discharger is determined to be a chronic violator and the board or the POTW determines that pollution prevention could achieve compliance.(B)The discharger contributes, or has the potential to contribute, to the formation of a toxic hot spot as defined in Section 13391.5.(C)The discharger discharges a pollutant for which the permitted level is lower than the practical quantification limit and the state board, a regional board, or the POTW determines that additional reductions of the pollutant are necessary.(D)The board determines pollution prevention is necessary to achieve a water quality objective.(2)The state board, a regional board, or a POTW may require an industrial discharger subject to its jurisdiction to complete a pollution prevention plan that includes all of the following:(A)An analysis of the pollutants that the facility discharges into water or introduces into POTWs, a description of the sources of the pollutants, and a comprehensive review of the processes used by the discharger that result in the generation and discharge of the pollutants.(B)An analysis of the potential for pollution prevention to reduce the generation of the pollutants, including the application of innovative and alternative technologies and any adverse environmental impacts resulting from the use of those methods.(C)A detailed description of the tasks and time schedules required to investigate and implement various elements of pollution prevention techniques.(D)A statement of the dischargers pollution prevention goals and strategies, including priorities for short-term and long-term action.(E)A description of the dischargers intended pollution prevention activities for the immediate future.(F)A description of the dischargers existing pollution prevention methods.(G)A statement that the dischargers existing and planned pollution prevention strategies do not constitute cross-media pollution transfers, and information that supports that statement.(H)Toxic chemical release data for those dischargers subject to Section 313 of the Emergency Planning and Community Right to Know Act of 1986 (42 U.S.C. Sec. 11023).(I)Proof of compliance with the Hazardous Waste Source Reduction and Management Review Act of 1989 (Article 11.9 (commencing with Section 25244.12) of Chapter 6.5 of Division 20 of the Health and Safety Code) if the discharger is also subject to that act.(J)An analysis of the relative costs and benefits of the possible pollution prevention activities.(3)A regional board may require a POTW to complete a pollution prevention plan that includes all of the following:(A)An estimate of all of the sources of a pollutant contributing, or potentially contributing, to the loadings of a pollutants in the treatment plant influent.(B)An analysis of the methods that could be used to prevent the discharge of the pollutants into the POTW, including application of local limits to industrial or commercial dischargers regarding pollution prevention techniques, public education and outreach, or other innovative and alternative approaches to reduce discharges of the pollutant to the POTW. The analysis also shall identify sources, or potential sources, not within the ability or authority of the POTW to control, such as pollutants in the potable water supply, airborne pollutants, pharmaceuticals, or pesticides, and estimate the magnitude of those sources, to the extent feasible.(C)An estimate of load reductions that may be attained through the methods identified in subparagraph (B).(D)A plan for monitoring the results of the pollution prevention program.(E)A description of the tasks, cost, and time required to investigate and implement various elements in the pollution prevention plan.(F)A statement of the POTWs pollution prevention goals and strategies, including priorities for short-term and long-term action, and a description of the POTWs intended pollution prevention activities for the immediate future.(G)A description of the POTWs existing pollution prevention programs.(H)An analysis, to the extent feasible, of any adverse environmental impacts, including cross-media impacts or substitute chemicals, that may result from the implementation of the pollution prevention program.(I)An analysis, to the extent feasible, of the costs and benefits that may be incurred to implement the pollution prevention program.(e)The state board or the regional board may establish a schedule of actions identified in the pollution prevention plans for the discharger.(f)The state board or regional board shall solicit comments from the public on a pollution prevention plan prepared pursuant to this section and address the public comments when determining what schedule of actions, if any, to establish for the discharger pursuant to this section.(g)The state board and regional boards shall make the pollution prevention plans available for public review, except to the extent that information is classified as confidential because it is a trade secret. Trade secret information shall be set forth in an appendix that is not available to the public.(h)Any costs incurred by the state board or a regional board resulting from actions required by this section shall be paid for from revenue generated by the fees imposed by Section 13260.(i)The state board or regional board may assess civil penalties pursuant to Section 13385 against a discharger for failure to complete a pollution prevention plan ordered by the state board or a regional board, or for failure to comply with a schedule of actions ordered by the state board or a regional board pursuant to this section.(j)A POTW may assess civil penalties and civil administrative penalties pursuant to Sections 54740, 54740.5, and 54740.6 of the Government Code against an industrial discharger for failure to complete a pollution prevention plan when ordered by the POTW, for submitting a plan that does not comply with the act, or for failure to comply with a schedule of actions ordered by the POTW pursuant to this section, unless the regional board has assessed penalties for the same action.(k)A discharger may change its pollution prevention plan, including withdrawing from a pollution prevention measure approved by the state board, a regional board, or a POTW, if the discharger determines that the measure will have a negative impact on product quality, the safe operation of the facility, or the environmental aspects of the facilities operation, and the discharger demonstrates to the board or the POTW an alternative measure that achieves that same pollution prevention objective.(l)The state board shall adopt a format to be used by dischargers for completing the plan required by this section. The format shall address all of the factors the discharger is required to include in the plan. The board may include any other factors determined by the board to be necessary to carry out this section. The adoption of the format pursuant to this section is not subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.
(a)The Legislature finds and declares that pollution prevention should be the first step in a hierarchy for reducing pollution and managing wastes, and to achieve environmental stewardship for society. The Legislature also finds and declares that pollution prevention is necessary to achieve the federal goal of zero discharge of pollutants into navigable waters.
(b)(1)For the purposes of this section, pollution prevention means any action that causes a net reduction in the use or generation of a hazardous substance or other pollutant that is discharged into water and includes any of the following:
(A)Input change, which means a change in raw materials or feedstocks used in a production process or operation so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.
(B)Operational improvement, which means improved site management so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.
(C)Production process change, which means a change in a process, method, or technique that is used to produce a product or a desired result, including the return of materials or their components for reuse within the existing processes or operations, so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.
(D)Product reformulation, which means changes in design, composition, or specifications of end products, including product substitution, so as to reduce, avoid, or eliminate the generation of problem pollutants discharged in wastewater.
(2)For the purposes of this section, pollution prevention does not include actions that merely shift a pollutant in wastewater from one environmental medium to another environmental medium, unless clear environmental benefits of such an approach are demonstrated.
(c)(1)For the purposes of this section, discharger means any entity required to obtain a national pollutant discharge elimination system (NPDES) permit pursuant to the Clean Water Act (33 U.S.C. Sec. 1251 et seq.), or any entity subject to the pretreatment program as defined in Part 403 (commencing with Section 403.1) of subchapter N of Chapter 1 of Part 403 of Title 40 of the Code of Federal Regulations.
(2)For the purposes of this section, industrial discharger means any discharger other than a publicly owned treatment works (POTW).
(d)(1)The state board, a regional board, or a POTW may require a discharger subject to its jurisdiction to complete a pollution prevention plan if any of the following apply:
(A)A discharger is determined to be a chronic violator and the board or the POTW determines that pollution prevention could achieve compliance.
(B)The discharger contributes, or has the potential to contribute, to the formation of a toxic hot spot as defined in Section 13391.5.
(C)The discharger discharges a pollutant for which the permitted level is lower than the practical quantification limit and the state board, a regional board, or the POTW determines that additional reductions of the pollutant are necessary.
(D)The board determines pollution prevention is necessary to achieve a water quality objective.
(2)The state board, a regional board, or a POTW may require an industrial discharger subject to its jurisdiction to complete a pollution prevention plan that includes all of the following:
(A)An analysis of the pollutants that the facility discharges into water or introduces into POTWs, a description of the sources of the pollutants, and a comprehensive review of the processes used by the discharger that result in the generation and discharge of the pollutants.
(B)An analysis of the potential for pollution prevention to reduce the generation of the pollutants, including the application of innovative and alternative technologies and any adverse environmental impacts resulting from the use of those methods.
(C)A detailed description of the tasks and time schedules required to investigate and implement various elements of pollution prevention techniques.
(D)A statement of the dischargers pollution prevention goals and strategies, including priorities for short-term and long-term action.
(E)A description of the dischargers intended pollution prevention activities for the immediate future.
(F)A description of the dischargers existing pollution prevention methods.
(G)A statement that the dischargers existing and planned pollution prevention strategies do not constitute cross-media pollution transfers, and information that supports that statement.
(H)Toxic chemical release data for those dischargers subject to Section 313 of the Emergency Planning and Community Right to Know Act of 1986 (42 U.S.C. Sec. 11023).
(I)Proof of compliance with the Hazardous Waste Source Reduction and Management Review Act of 1989 (Article 11.9 (commencing with Section 25244.12) of Chapter 6.5 of Division 20 of the Health and Safety Code) if the discharger is also subject to that act.
(J)An analysis of the relative costs and benefits of the possible pollution prevention activities.
(3)A regional board may require a POTW to complete a pollution prevention plan that includes all of the following:
(A)An estimate of all of the sources of a pollutant contributing, or potentially contributing, to the loadings of a pollutants in the treatment plant influent.
(B)An analysis of the methods that could be used to prevent the discharge of the pollutants into the POTW, including application of local limits to industrial or commercial dischargers regarding pollution prevention techniques, public education and outreach, or other innovative and alternative approaches to reduce discharges of the pollutant to the POTW. The analysis also shall identify sources, or potential sources, not within the ability or authority of the POTW to control, such as pollutants in the potable water supply, airborne pollutants, pharmaceuticals, or pesticides, and estimate the magnitude of those sources, to the extent feasible.
(C)An estimate of load reductions that may be attained through the methods identified in subparagraph (B).
(D)A plan for monitoring the results of the pollution prevention program.
(E)A description of the tasks, cost, and time required to investigate and implement various elements in the pollution prevention plan.
(F)A statement of the POTWs pollution prevention goals and strategies, including priorities for short-term and long-term action, and a description of the POTWs intended pollution prevention activities for the immediate future.
(G)A description of the POTWs existing pollution prevention programs.
(H)An analysis, to the extent feasible, of any adverse environmental impacts, including cross-media impacts or substitute chemicals, that may result from the implementation of the pollution prevention program.
(I)An analysis, to the extent feasible, of the costs and benefits that may be incurred to implement the pollution prevention program.
(e)The state board or the regional board may establish a schedule of actions identified in the pollution prevention plans for the discharger.
(f)The state board or regional board shall solicit comments from the public on a pollution prevention plan prepared pursuant to this section and address the public comments when determining what schedule of actions, if any, to establish for the discharger pursuant to this section.
(g)The state board and regional boards shall make the pollution prevention plans available for public review, except to the extent that information is classified as confidential because it is a trade secret. Trade secret information shall be set forth in an appendix that is not available to the public.
(h)Any costs incurred by the state board or a regional board resulting from actions required by this section shall be paid for from revenue generated by the fees imposed by Section 13260.
(i)The state board or regional board may assess civil penalties pursuant to Section 13385 against a discharger for failure to complete a pollution prevention plan ordered by the state board or a regional board, or for failure to comply with a schedule of actions ordered by the state board or a regional board pursuant to this section.
(j)A POTW may assess civil penalties and civil administrative penalties pursuant to Sections 54740, 54740.5, and 54740.6 of the Government Code against an industrial discharger for failure to complete a pollution prevention plan when ordered by the POTW, for submitting a plan that does not comply with the act, or for failure to comply with a schedule of actions ordered by the POTW pursuant to this section, unless the regional board has assessed penalties for the same action.
(k)A discharger may change its pollution prevention plan, including withdrawing from a pollution prevention measure approved by the state board, a regional board, or a POTW, if the discharger determines that the measure will have a negative impact on product quality, the safe operation of the facility, or the environmental aspects of the facilities operation, and the discharger demonstrates to the board or the POTW an alternative measure that achieves that same pollution prevention objective.
(l)The state board shall adopt a format to be used by dischargers for completing the plan required by this section. The format shall address all of the factors the discharger is required to include in the plan. The board may include any other factors determined by the board to be necessary to carry out this section. The adoption of the format pursuant to this section is not subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.
SEC. 2. Section 13263.3 of the Water Code, as amended by Section 1 of Chapter 807 of the Statutes of 2000, is amended to read:13263.3. (a) The Legislature finds and declares that pollution prevention should be the first step in a hierarchy for reducing pollution and managing wastes, and to achieve environmental stewardship for society. The Legislature also finds and declares that pollution prevention is necessary to support the federal goal of zero discharge of pollutants into navigable waters.(b) (1) For the purposes of this section, pollution prevention means any action that causes a net reduction in the use or generation of a hazardous substance or other pollutant that is discharged into water and includes any of the following:(A) Input change, which means a change in raw materials or feedstocks used in a production process or operation so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(B) Operational improvement, which means improved site management so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(C) Production process change, which means a change in a process, method, or technique that is used to produce a product or a desired result, including the return of materials or their components for reuse within the existing processes or operations, so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(D) Product reformulation, which means changes in design, composition, or specifications of end products, including product substitution, so as to reduce, avoid, or eliminate the generation of problem pollutants discharged in wastewater.(2) For the purposes of this section, pollution prevention does not include actions that merely shift a pollutant in wastewater from one environmental medium to another environmental medium, unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or POTW. publicly owned treatment works (POTW).(c) For the purposes of this section, discharger means any entity required to obtain a national pollutant discharge elimination system (NPDES) permit pursuant to the federal Clean Water Act (33 U.S.C. Sec. 1251 et seq.), or any entity subject to the pretreatment program as defined in Part 403 (commencing with Section 403.1) of Subchapter N of Chapter 1 of Part 403 I of Title 40 of the Code of Federal Regulations.(d) (1) The state board, a regional board, or a POTW may require a discharger subject to its jurisdiction to complete and implement a pollution prevention plan if any of the following apply:(A) A discharger is determined by the state board to be a chronic violator, and the state board, a regional board, or the POTW determines that pollution prevention could assist in achieving compliance.(B) The discharger significantly contributes, or has the potential to significantly contribute, to the creation of a toxic hot spot as defined in Section 13391.5.(C) The state board, a regional board, or a POTW determines pollution prevention is necessary to achieve a water quality objective.(D) The discharger is subject to a cease and desist order issued pursuant to Section 13301 or a time schedule order issued pursuant to Section 13300 or 13308.(2) A pollution prevention plan required of a discharger other than a POTW pursuant to paragraph (1) shall include all of the following:(A) An analysis of one or more of the pollutants, as directed by the state board, a regional board, or a POTW, that the facility discharges into water or introduces into POTWs, a description of the sources of the pollutants, and a comprehensive review of the processes used by the discharger that result in the generation and discharge of the pollutants.(B) An analysis of the potential for pollution prevention to reduce the generation of the pollutants, including the application of innovative and alternative technologies and any adverse environmental impacts resulting from the use of those methods.(C) A detailed description of the tasks and time schedules required to investigate and implement various elements of pollution prevention techniques.(D) A statement of the dischargers pollution prevention goals and strategies, including priorities for short-term and long-term action.(E) A description of the dischargers existing pollution prevention methods.(F) A statement that the dischargers existing and planned pollution prevention strategies do not constitute cross media pollution transfers unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or the POTW, and information that supports that statement.(G) Proof of compliance with the Pollution Prevention and Hazardous Waste Source Reduction and Management Review Act of 1989 (Article 11.9 (commencing with Section 25244.12) of Chapter 6.5 of Division 20 of the Health and Safety Code) if the discharger is also subject to that act.(H) An analysis, to the extent feasible, of the relative costs and benefits of the possible pollution prevention activities.(I) A specification of, and rationale for, the technically feasible and economically practicable pollution prevention measures selected by the discharger for implementation.(3) The state board or a regional board may require a POTW to complete and implement a pollution prevention plan that includes all of the following:(A) An estimate of all of the sources of a pollutant contributing, or potentially contributing, to the loading of that pollutant in the treatment plant influent.(B) An analysis of the methods that could be used to prevent the discharge of the pollutants into the POTW, including application of local limits to industrial or commercial dischargers regarding pollution prevention techniques, public education and outreach, or other innovative and alternative approaches to reduce discharges of the pollutant to the POTW. The analysis also shall identify sources, or potential sources, not within the ability or authority of the POTW to control, such as pollutants in the potable water supply, airborne pollutants, pharmaceuticals, or pesticides, and estimate the magnitude of those sources, to the extent feasible.(C) An estimate of load reductions that may be attained through the methods identified in subparagraph (B).(D) A plan for monitoring the results of the pollution prevention program.(E) A description of the tasks, cost, and time required to investigate and implement various elements in the pollution prevention plan.(F) A statement of the POTWs pollution prevention goals and strategies, including priorities for short-term and long-term action, and a description of the POTWs intended pollution prevention activities for the immediate future.(G) A description of the POTWs existing pollution prevention programs.(H) An analysis, to the extent feasible, of any adverse environmental impacts, including cross media impacts or substitute chemicals, that may result from the implementation of the pollution prevention program.(I) An analysis, to the extent feasible, of the costs and benefits that may be incurred to implement the pollution prevention program.(e) The state board, a regional board, or a POTW may require a discharger subject to this section to comply with the pollution prevention plan developed by the discharger after providing an opportunity for comment at a public proceeding with regard to that plan.(f) The state board, regional boards, and POTWs shall make the pollution prevention plans available for public review, except to the extent that information is classified as confidential because it is a trade secret. Trade secret information shall be set forth in an appendix that is not available to the public.(g) The state board or regional board may assess civil liability pursuant to paragraph (1) of subdivision (c) of Section 13385 against a discharger for failure to complete a pollution prevention plan required by the state board or a regional board, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the POTW has assessed penalties for the same action.(h) A POTW may assess civil penalties and civil administrative penalties pursuant to Sections 54740, 54740.5, and 54740.6 of the Government Code against a discharger for failure to complete a pollution prevention plan when required by the POTW, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the state board or a regional board has assessed penalties for the same action.(i) A discharger may change its pollution prevention plan, including withdrawing from a pollution prevention measure required by the state board, a regional board, or a POTW, if the discharger determines that the measure will have a negative impact on product quality, the safe operation of the facility, or the environmental aspects of the facilitys operation, or the discharger determines that the measure is economically impracticable or technologically infeasible. Where practicable and feasible, the discharger shall replace the withdrawn measure with a measure that will likely achieve similar pollution prevention objectives. A measure may be withdrawn pursuant to this subdivision only with the approval of the executive officer of the state board or the regional board, or the POTW.(j) The state board shall adopt a sample format to be used by dischargers for completing the plan required by this section. The sample format shall address all of the factors the discharger is required to include in the plan. The state board may include any other factors determined by the state board to be necessary to carry out this section. The adoption of the sample format pursuant to this section is not subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(k) The state board, a regional board, or a POTW may shall not include a pollution prevention plan in any waste discharge requirements or other permit issued by that agency.(l)This section prevails over Section 13263.3, as added to the Water Code by Assembly Bill 1104 of the 19992000 Regular Session.
SEC. 2. Section 13263.3 of the Water Code, as amended by Section 1 of Chapter 807 of the Statutes of 2000, is amended to read:
### SEC. 2.
13263.3. (a) The Legislature finds and declares that pollution prevention should be the first step in a hierarchy for reducing pollution and managing wastes, and to achieve environmental stewardship for society. The Legislature also finds and declares that pollution prevention is necessary to support the federal goal of zero discharge of pollutants into navigable waters.(b) (1) For the purposes of this section, pollution prevention means any action that causes a net reduction in the use or generation of a hazardous substance or other pollutant that is discharged into water and includes any of the following:(A) Input change, which means a change in raw materials or feedstocks used in a production process or operation so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(B) Operational improvement, which means improved site management so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(C) Production process change, which means a change in a process, method, or technique that is used to produce a product or a desired result, including the return of materials or their components for reuse within the existing processes or operations, so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(D) Product reformulation, which means changes in design, composition, or specifications of end products, including product substitution, so as to reduce, avoid, or eliminate the generation of problem pollutants discharged in wastewater.(2) For the purposes of this section, pollution prevention does not include actions that merely shift a pollutant in wastewater from one environmental medium to another environmental medium, unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or POTW. publicly owned treatment works (POTW).(c) For the purposes of this section, discharger means any entity required to obtain a national pollutant discharge elimination system (NPDES) permit pursuant to the federal Clean Water Act (33 U.S.C. Sec. 1251 et seq.), or any entity subject to the pretreatment program as defined in Part 403 (commencing with Section 403.1) of Subchapter N of Chapter 1 of Part 403 I of Title 40 of the Code of Federal Regulations.(d) (1) The state board, a regional board, or a POTW may require a discharger subject to its jurisdiction to complete and implement a pollution prevention plan if any of the following apply:(A) A discharger is determined by the state board to be a chronic violator, and the state board, a regional board, or the POTW determines that pollution prevention could assist in achieving compliance.(B) The discharger significantly contributes, or has the potential to significantly contribute, to the creation of a toxic hot spot as defined in Section 13391.5.(C) The state board, a regional board, or a POTW determines pollution prevention is necessary to achieve a water quality objective.(D) The discharger is subject to a cease and desist order issued pursuant to Section 13301 or a time schedule order issued pursuant to Section 13300 or 13308.(2) A pollution prevention plan required of a discharger other than a POTW pursuant to paragraph (1) shall include all of the following:(A) An analysis of one or more of the pollutants, as directed by the state board, a regional board, or a POTW, that the facility discharges into water or introduces into POTWs, a description of the sources of the pollutants, and a comprehensive review of the processes used by the discharger that result in the generation and discharge of the pollutants.(B) An analysis of the potential for pollution prevention to reduce the generation of the pollutants, including the application of innovative and alternative technologies and any adverse environmental impacts resulting from the use of those methods.(C) A detailed description of the tasks and time schedules required to investigate and implement various elements of pollution prevention techniques.(D) A statement of the dischargers pollution prevention goals and strategies, including priorities for short-term and long-term action.(E) A description of the dischargers existing pollution prevention methods.(F) A statement that the dischargers existing and planned pollution prevention strategies do not constitute cross media pollution transfers unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or the POTW, and information that supports that statement.(G) Proof of compliance with the Pollution Prevention and Hazardous Waste Source Reduction and Management Review Act of 1989 (Article 11.9 (commencing with Section 25244.12) of Chapter 6.5 of Division 20 of the Health and Safety Code) if the discharger is also subject to that act.(H) An analysis, to the extent feasible, of the relative costs and benefits of the possible pollution prevention activities.(I) A specification of, and rationale for, the technically feasible and economically practicable pollution prevention measures selected by the discharger for implementation.(3) The state board or a regional board may require a POTW to complete and implement a pollution prevention plan that includes all of the following:(A) An estimate of all of the sources of a pollutant contributing, or potentially contributing, to the loading of that pollutant in the treatment plant influent.(B) An analysis of the methods that could be used to prevent the discharge of the pollutants into the POTW, including application of local limits to industrial or commercial dischargers regarding pollution prevention techniques, public education and outreach, or other innovative and alternative approaches to reduce discharges of the pollutant to the POTW. The analysis also shall identify sources, or potential sources, not within the ability or authority of the POTW to control, such as pollutants in the potable water supply, airborne pollutants, pharmaceuticals, or pesticides, and estimate the magnitude of those sources, to the extent feasible.(C) An estimate of load reductions that may be attained through the methods identified in subparagraph (B).(D) A plan for monitoring the results of the pollution prevention program.(E) A description of the tasks, cost, and time required to investigate and implement various elements in the pollution prevention plan.(F) A statement of the POTWs pollution prevention goals and strategies, including priorities for short-term and long-term action, and a description of the POTWs intended pollution prevention activities for the immediate future.(G) A description of the POTWs existing pollution prevention programs.(H) An analysis, to the extent feasible, of any adverse environmental impacts, including cross media impacts or substitute chemicals, that may result from the implementation of the pollution prevention program.(I) An analysis, to the extent feasible, of the costs and benefits that may be incurred to implement the pollution prevention program.(e) The state board, a regional board, or a POTW may require a discharger subject to this section to comply with the pollution prevention plan developed by the discharger after providing an opportunity for comment at a public proceeding with regard to that plan.(f) The state board, regional boards, and POTWs shall make the pollution prevention plans available for public review, except to the extent that information is classified as confidential because it is a trade secret. Trade secret information shall be set forth in an appendix that is not available to the public.(g) The state board or regional board may assess civil liability pursuant to paragraph (1) of subdivision (c) of Section 13385 against a discharger for failure to complete a pollution prevention plan required by the state board or a regional board, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the POTW has assessed penalties for the same action.(h) A POTW may assess civil penalties and civil administrative penalties pursuant to Sections 54740, 54740.5, and 54740.6 of the Government Code against a discharger for failure to complete a pollution prevention plan when required by the POTW, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the state board or a regional board has assessed penalties for the same action.(i) A discharger may change its pollution prevention plan, including withdrawing from a pollution prevention measure required by the state board, a regional board, or a POTW, if the discharger determines that the measure will have a negative impact on product quality, the safe operation of the facility, or the environmental aspects of the facilitys operation, or the discharger determines that the measure is economically impracticable or technologically infeasible. Where practicable and feasible, the discharger shall replace the withdrawn measure with a measure that will likely achieve similar pollution prevention objectives. A measure may be withdrawn pursuant to this subdivision only with the approval of the executive officer of the state board or the regional board, or the POTW.(j) The state board shall adopt a sample format to be used by dischargers for completing the plan required by this section. The sample format shall address all of the factors the discharger is required to include in the plan. The state board may include any other factors determined by the state board to be necessary to carry out this section. The adoption of the sample format pursuant to this section is not subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(k) The state board, a regional board, or a POTW may shall not include a pollution prevention plan in any waste discharge requirements or other permit issued by that agency.(l)This section prevails over Section 13263.3, as added to the Water Code by Assembly Bill 1104 of the 19992000 Regular Session.
13263.3. (a) The Legislature finds and declares that pollution prevention should be the first step in a hierarchy for reducing pollution and managing wastes, and to achieve environmental stewardship for society. The Legislature also finds and declares that pollution prevention is necessary to support the federal goal of zero discharge of pollutants into navigable waters.(b) (1) For the purposes of this section, pollution prevention means any action that causes a net reduction in the use or generation of a hazardous substance or other pollutant that is discharged into water and includes any of the following:(A) Input change, which means a change in raw materials or feedstocks used in a production process or operation so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(B) Operational improvement, which means improved site management so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(C) Production process change, which means a change in a process, method, or technique that is used to produce a product or a desired result, including the return of materials or their components for reuse within the existing processes or operations, so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(D) Product reformulation, which means changes in design, composition, or specifications of end products, including product substitution, so as to reduce, avoid, or eliminate the generation of problem pollutants discharged in wastewater.(2) For the purposes of this section, pollution prevention does not include actions that merely shift a pollutant in wastewater from one environmental medium to another environmental medium, unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or POTW. publicly owned treatment works (POTW).(c) For the purposes of this section, discharger means any entity required to obtain a national pollutant discharge elimination system (NPDES) permit pursuant to the federal Clean Water Act (33 U.S.C. Sec. 1251 et seq.), or any entity subject to the pretreatment program as defined in Part 403 (commencing with Section 403.1) of Subchapter N of Chapter 1 of Part 403 I of Title 40 of the Code of Federal Regulations.(d) (1) The state board, a regional board, or a POTW may require a discharger subject to its jurisdiction to complete and implement a pollution prevention plan if any of the following apply:(A) A discharger is determined by the state board to be a chronic violator, and the state board, a regional board, or the POTW determines that pollution prevention could assist in achieving compliance.(B) The discharger significantly contributes, or has the potential to significantly contribute, to the creation of a toxic hot spot as defined in Section 13391.5.(C) The state board, a regional board, or a POTW determines pollution prevention is necessary to achieve a water quality objective.(D) The discharger is subject to a cease and desist order issued pursuant to Section 13301 or a time schedule order issued pursuant to Section 13300 or 13308.(2) A pollution prevention plan required of a discharger other than a POTW pursuant to paragraph (1) shall include all of the following:(A) An analysis of one or more of the pollutants, as directed by the state board, a regional board, or a POTW, that the facility discharges into water or introduces into POTWs, a description of the sources of the pollutants, and a comprehensive review of the processes used by the discharger that result in the generation and discharge of the pollutants.(B) An analysis of the potential for pollution prevention to reduce the generation of the pollutants, including the application of innovative and alternative technologies and any adverse environmental impacts resulting from the use of those methods.(C) A detailed description of the tasks and time schedules required to investigate and implement various elements of pollution prevention techniques.(D) A statement of the dischargers pollution prevention goals and strategies, including priorities for short-term and long-term action.(E) A description of the dischargers existing pollution prevention methods.(F) A statement that the dischargers existing and planned pollution prevention strategies do not constitute cross media pollution transfers unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or the POTW, and information that supports that statement.(G) Proof of compliance with the Pollution Prevention and Hazardous Waste Source Reduction and Management Review Act of 1989 (Article 11.9 (commencing with Section 25244.12) of Chapter 6.5 of Division 20 of the Health and Safety Code) if the discharger is also subject to that act.(H) An analysis, to the extent feasible, of the relative costs and benefits of the possible pollution prevention activities.(I) A specification of, and rationale for, the technically feasible and economically practicable pollution prevention measures selected by the discharger for implementation.(3) The state board or a regional board may require a POTW to complete and implement a pollution prevention plan that includes all of the following:(A) An estimate of all of the sources of a pollutant contributing, or potentially contributing, to the loading of that pollutant in the treatment plant influent.(B) An analysis of the methods that could be used to prevent the discharge of the pollutants into the POTW, including application of local limits to industrial or commercial dischargers regarding pollution prevention techniques, public education and outreach, or other innovative and alternative approaches to reduce discharges of the pollutant to the POTW. The analysis also shall identify sources, or potential sources, not within the ability or authority of the POTW to control, such as pollutants in the potable water supply, airborne pollutants, pharmaceuticals, or pesticides, and estimate the magnitude of those sources, to the extent feasible.(C) An estimate of load reductions that may be attained through the methods identified in subparagraph (B).(D) A plan for monitoring the results of the pollution prevention program.(E) A description of the tasks, cost, and time required to investigate and implement various elements in the pollution prevention plan.(F) A statement of the POTWs pollution prevention goals and strategies, including priorities for short-term and long-term action, and a description of the POTWs intended pollution prevention activities for the immediate future.(G) A description of the POTWs existing pollution prevention programs.(H) An analysis, to the extent feasible, of any adverse environmental impacts, including cross media impacts or substitute chemicals, that may result from the implementation of the pollution prevention program.(I) An analysis, to the extent feasible, of the costs and benefits that may be incurred to implement the pollution prevention program.(e) The state board, a regional board, or a POTW may require a discharger subject to this section to comply with the pollution prevention plan developed by the discharger after providing an opportunity for comment at a public proceeding with regard to that plan.(f) The state board, regional boards, and POTWs shall make the pollution prevention plans available for public review, except to the extent that information is classified as confidential because it is a trade secret. Trade secret information shall be set forth in an appendix that is not available to the public.(g) The state board or regional board may assess civil liability pursuant to paragraph (1) of subdivision (c) of Section 13385 against a discharger for failure to complete a pollution prevention plan required by the state board or a regional board, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the POTW has assessed penalties for the same action.(h) A POTW may assess civil penalties and civil administrative penalties pursuant to Sections 54740, 54740.5, and 54740.6 of the Government Code against a discharger for failure to complete a pollution prevention plan when required by the POTW, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the state board or a regional board has assessed penalties for the same action.(i) A discharger may change its pollution prevention plan, including withdrawing from a pollution prevention measure required by the state board, a regional board, or a POTW, if the discharger determines that the measure will have a negative impact on product quality, the safe operation of the facility, or the environmental aspects of the facilitys operation, or the discharger determines that the measure is economically impracticable or technologically infeasible. Where practicable and feasible, the discharger shall replace the withdrawn measure with a measure that will likely achieve similar pollution prevention objectives. A measure may be withdrawn pursuant to this subdivision only with the approval of the executive officer of the state board or the regional board, or the POTW.(j) The state board shall adopt a sample format to be used by dischargers for completing the plan required by this section. The sample format shall address all of the factors the discharger is required to include in the plan. The state board may include any other factors determined by the state board to be necessary to carry out this section. The adoption of the sample format pursuant to this section is not subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(k) The state board, a regional board, or a POTW may shall not include a pollution prevention plan in any waste discharge requirements or other permit issued by that agency.(l)This section prevails over Section 13263.3, as added to the Water Code by Assembly Bill 1104 of the 19992000 Regular Session.
13263.3. (a) The Legislature finds and declares that pollution prevention should be the first step in a hierarchy for reducing pollution and managing wastes, and to achieve environmental stewardship for society. The Legislature also finds and declares that pollution prevention is necessary to support the federal goal of zero discharge of pollutants into navigable waters.(b) (1) For the purposes of this section, pollution prevention means any action that causes a net reduction in the use or generation of a hazardous substance or other pollutant that is discharged into water and includes any of the following:(A) Input change, which means a change in raw materials or feedstocks used in a production process or operation so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(B) Operational improvement, which means improved site management so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(C) Production process change, which means a change in a process, method, or technique that is used to produce a product or a desired result, including the return of materials or their components for reuse within the existing processes or operations, so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.(D) Product reformulation, which means changes in design, composition, or specifications of end products, including product substitution, so as to reduce, avoid, or eliminate the generation of problem pollutants discharged in wastewater.(2) For the purposes of this section, pollution prevention does not include actions that merely shift a pollutant in wastewater from one environmental medium to another environmental medium, unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or POTW. publicly owned treatment works (POTW).(c) For the purposes of this section, discharger means any entity required to obtain a national pollutant discharge elimination system (NPDES) permit pursuant to the federal Clean Water Act (33 U.S.C. Sec. 1251 et seq.), or any entity subject to the pretreatment program as defined in Part 403 (commencing with Section 403.1) of Subchapter N of Chapter 1 of Part 403 I of Title 40 of the Code of Federal Regulations.(d) (1) The state board, a regional board, or a POTW may require a discharger subject to its jurisdiction to complete and implement a pollution prevention plan if any of the following apply:(A) A discharger is determined by the state board to be a chronic violator, and the state board, a regional board, or the POTW determines that pollution prevention could assist in achieving compliance.(B) The discharger significantly contributes, or has the potential to significantly contribute, to the creation of a toxic hot spot as defined in Section 13391.5.(C) The state board, a regional board, or a POTW determines pollution prevention is necessary to achieve a water quality objective.(D) The discharger is subject to a cease and desist order issued pursuant to Section 13301 or a time schedule order issued pursuant to Section 13300 or 13308.(2) A pollution prevention plan required of a discharger other than a POTW pursuant to paragraph (1) shall include all of the following:(A) An analysis of one or more of the pollutants, as directed by the state board, a regional board, or a POTW, that the facility discharges into water or introduces into POTWs, a description of the sources of the pollutants, and a comprehensive review of the processes used by the discharger that result in the generation and discharge of the pollutants.(B) An analysis of the potential for pollution prevention to reduce the generation of the pollutants, including the application of innovative and alternative technologies and any adverse environmental impacts resulting from the use of those methods.(C) A detailed description of the tasks and time schedules required to investigate and implement various elements of pollution prevention techniques.(D) A statement of the dischargers pollution prevention goals and strategies, including priorities for short-term and long-term action.(E) A description of the dischargers existing pollution prevention methods.(F) A statement that the dischargers existing and planned pollution prevention strategies do not constitute cross media pollution transfers unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or the POTW, and information that supports that statement.(G) Proof of compliance with the Pollution Prevention and Hazardous Waste Source Reduction and Management Review Act of 1989 (Article 11.9 (commencing with Section 25244.12) of Chapter 6.5 of Division 20 of the Health and Safety Code) if the discharger is also subject to that act.(H) An analysis, to the extent feasible, of the relative costs and benefits of the possible pollution prevention activities.(I) A specification of, and rationale for, the technically feasible and economically practicable pollution prevention measures selected by the discharger for implementation.(3) The state board or a regional board may require a POTW to complete and implement a pollution prevention plan that includes all of the following:(A) An estimate of all of the sources of a pollutant contributing, or potentially contributing, to the loading of that pollutant in the treatment plant influent.(B) An analysis of the methods that could be used to prevent the discharge of the pollutants into the POTW, including application of local limits to industrial or commercial dischargers regarding pollution prevention techniques, public education and outreach, or other innovative and alternative approaches to reduce discharges of the pollutant to the POTW. The analysis also shall identify sources, or potential sources, not within the ability or authority of the POTW to control, such as pollutants in the potable water supply, airborne pollutants, pharmaceuticals, or pesticides, and estimate the magnitude of those sources, to the extent feasible.(C) An estimate of load reductions that may be attained through the methods identified in subparagraph (B).(D) A plan for monitoring the results of the pollution prevention program.(E) A description of the tasks, cost, and time required to investigate and implement various elements in the pollution prevention plan.(F) A statement of the POTWs pollution prevention goals and strategies, including priorities for short-term and long-term action, and a description of the POTWs intended pollution prevention activities for the immediate future.(G) A description of the POTWs existing pollution prevention programs.(H) An analysis, to the extent feasible, of any adverse environmental impacts, including cross media impacts or substitute chemicals, that may result from the implementation of the pollution prevention program.(I) An analysis, to the extent feasible, of the costs and benefits that may be incurred to implement the pollution prevention program.(e) The state board, a regional board, or a POTW may require a discharger subject to this section to comply with the pollution prevention plan developed by the discharger after providing an opportunity for comment at a public proceeding with regard to that plan.(f) The state board, regional boards, and POTWs shall make the pollution prevention plans available for public review, except to the extent that information is classified as confidential because it is a trade secret. Trade secret information shall be set forth in an appendix that is not available to the public.(g) The state board or regional board may assess civil liability pursuant to paragraph (1) of subdivision (c) of Section 13385 against a discharger for failure to complete a pollution prevention plan required by the state board or a regional board, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the POTW has assessed penalties for the same action.(h) A POTW may assess civil penalties and civil administrative penalties pursuant to Sections 54740, 54740.5, and 54740.6 of the Government Code against a discharger for failure to complete a pollution prevention plan when required by the POTW, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the state board or a regional board has assessed penalties for the same action.(i) A discharger may change its pollution prevention plan, including withdrawing from a pollution prevention measure required by the state board, a regional board, or a POTW, if the discharger determines that the measure will have a negative impact on product quality, the safe operation of the facility, or the environmental aspects of the facilitys operation, or the discharger determines that the measure is economically impracticable or technologically infeasible. Where practicable and feasible, the discharger shall replace the withdrawn measure with a measure that will likely achieve similar pollution prevention objectives. A measure may be withdrawn pursuant to this subdivision only with the approval of the executive officer of the state board or the regional board, or the POTW.(j) The state board shall adopt a sample format to be used by dischargers for completing the plan required by this section. The sample format shall address all of the factors the discharger is required to include in the plan. The state board may include any other factors determined by the state board to be necessary to carry out this section. The adoption of the sample format pursuant to this section is not subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(k) The state board, a regional board, or a POTW may shall not include a pollution prevention plan in any waste discharge requirements or other permit issued by that agency.(l)This section prevails over Section 13263.3, as added to the Water Code by Assembly Bill 1104 of the 19992000 Regular Session.
13263.3. (a) The Legislature finds and declares that pollution prevention should be the first step in a hierarchy for reducing pollution and managing wastes, and to achieve environmental stewardship for society. The Legislature also finds and declares that pollution prevention is necessary to support the federal goal of zero discharge of pollutants into navigable waters.
###### 13263.3.
(b) (1) For the purposes of this section, pollution prevention means any action that causes a net reduction in the use or generation of a hazardous substance or other pollutant that is discharged into water and includes any of the following:
(A) Input change, which means a change in raw materials or feedstocks used in a production process or operation so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.
(B) Operational improvement, which means improved site management so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.
(C) Production process change, which means a change in a process, method, or technique that is used to produce a product or a desired result, including the return of materials or their components for reuse within the existing processes or operations, so as to reduce, avoid, or eliminate the generation of pollutants discharged in wastewater.
(D) Product reformulation, which means changes in design, composition, or specifications of end products, including product substitution, so as to reduce, avoid, or eliminate the generation of problem pollutants discharged in wastewater.
(2) For the purposes of this section, pollution prevention does not include actions that merely shift a pollutant in wastewater from one environmental medium to another environmental medium, unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or POTW. publicly owned treatment works (POTW).
(c) For the purposes of this section, discharger means any entity required to obtain a national pollutant discharge elimination system (NPDES) permit pursuant to the federal Clean Water Act (33 U.S.C. Sec. 1251 et seq.), or any entity subject to the pretreatment program as defined in Part 403 (commencing with Section 403.1) of Subchapter N of Chapter 1 of Part 403 I of Title 40 of the Code of Federal Regulations.
(d) (1) The state board, a regional board, or a POTW may require a discharger subject to its jurisdiction to complete and implement a pollution prevention plan if any of the following apply:
(A) A discharger is determined by the state board to be a chronic violator, and the state board, a regional board, or the POTW determines that pollution prevention could assist in achieving compliance.
(B) The discharger significantly contributes, or has the potential to significantly contribute, to the creation of a toxic hot spot as defined in Section 13391.5.
(C) The state board, a regional board, or a POTW determines pollution prevention is necessary to achieve a water quality objective.
(D) The discharger is subject to a cease and desist order issued pursuant to Section 13301 or a time schedule order issued pursuant to Section 13300 or 13308.
(2) A pollution prevention plan required of a discharger other than a POTW pursuant to paragraph (1) shall include all of the following:
(A) An analysis of one or more of the pollutants, as directed by the state board, a regional board, or a POTW, that the facility discharges into water or introduces into POTWs, a description of the sources of the pollutants, and a comprehensive review of the processes used by the discharger that result in the generation and discharge of the pollutants.
(B) An analysis of the potential for pollution prevention to reduce the generation of the pollutants, including the application of innovative and alternative technologies and any adverse environmental impacts resulting from the use of those methods.
(C) A detailed description of the tasks and time schedules required to investigate and implement various elements of pollution prevention techniques.
(D) A statement of the dischargers pollution prevention goals and strategies, including priorities for short-term and long-term action.
(E) A description of the dischargers existing pollution prevention methods.
(F) A statement that the dischargers existing and planned pollution prevention strategies do not constitute cross media pollution transfers unless clear environmental benefits of such an approach are identified to the satisfaction of the state board, the regional board, or the POTW, and information that supports that statement.
(G) Proof of compliance with the Pollution Prevention and Hazardous Waste Source Reduction and Management Review Act of 1989 (Article 11.9 (commencing with Section 25244.12) of Chapter 6.5 of Division 20 of the Health and Safety Code) if the discharger is also subject to that act.
(H) An analysis, to the extent feasible, of the relative costs and benefits of the possible pollution prevention activities.
(I) A specification of, and rationale for, the technically feasible and economically practicable pollution prevention measures selected by the discharger for implementation.
(3) The state board or a regional board may require a POTW to complete and implement a pollution prevention plan that includes all of the following:
(A) An estimate of all of the sources of a pollutant contributing, or potentially contributing, to the loading of that pollutant in the treatment plant influent.
(B) An analysis of the methods that could be used to prevent the discharge of the pollutants into the POTW, including application of local limits to industrial or commercial dischargers regarding pollution prevention techniques, public education and outreach, or other innovative and alternative approaches to reduce discharges of the pollutant to the POTW. The analysis also shall identify sources, or potential sources, not within the ability or authority of the POTW to control, such as pollutants in the potable water supply, airborne pollutants, pharmaceuticals, or pesticides, and estimate the magnitude of those sources, to the extent feasible.
(C) An estimate of load reductions that may be attained through the methods identified in subparagraph (B).
(D) A plan for monitoring the results of the pollution prevention program.
(E) A description of the tasks, cost, and time required to investigate and implement various elements in the pollution prevention plan.
(F) A statement of the POTWs pollution prevention goals and strategies, including priorities for short-term and long-term action, and a description of the POTWs intended pollution prevention activities for the immediate future.
(G) A description of the POTWs existing pollution prevention programs.
(H) An analysis, to the extent feasible, of any adverse environmental impacts, including cross media impacts or substitute chemicals, that may result from the implementation of the pollution prevention program.
(I) An analysis, to the extent feasible, of the costs and benefits that may be incurred to implement the pollution prevention program.
(e) The state board, a regional board, or a POTW may require a discharger subject to this section to comply with the pollution prevention plan developed by the discharger after providing an opportunity for comment at a public proceeding with regard to that plan.
(f) The state board, regional boards, and POTWs shall make the pollution prevention plans available for public review, except to the extent that information is classified as confidential because it is a trade secret. Trade secret information shall be set forth in an appendix that is not available to the public.
(g) The state board or regional board may assess civil liability pursuant to paragraph (1) of subdivision (c) of Section 13385 against a discharger for failure to complete a pollution prevention plan required by the state board or a regional board, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the POTW has assessed penalties for the same action.
(h) A POTW may assess civil penalties and civil administrative penalties pursuant to Sections 54740, 54740.5, and 54740.6 of the Government Code against a discharger for failure to complete a pollution prevention plan when required by the POTW, for submitting a plan that does not comply with the act, or for not implementing a plan, unless the state board or a regional board has assessed penalties for the same action.
(i) A discharger may change its pollution prevention plan, including withdrawing from a pollution prevention measure required by the state board, a regional board, or a POTW, if the discharger determines that the measure will have a negative impact on product quality, the safe operation of the facility, or the environmental aspects of the facilitys operation, or the discharger determines that the measure is economically impracticable or technologically infeasible. Where practicable and feasible, the discharger shall replace the withdrawn measure with a measure that will likely achieve similar pollution prevention objectives. A measure may be withdrawn pursuant to this subdivision only with the approval of the executive officer of the state board or the regional board, or the POTW.
(j) The state board shall adopt a sample format to be used by dischargers for completing the plan required by this section. The sample format shall address all of the factors the discharger is required to include in the plan. The state board may include any other factors determined by the state board to be necessary to carry out this section. The adoption of the sample format pursuant to this section is not subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.
(k) The state board, a regional board, or a POTW may shall not include a pollution prevention plan in any waste discharge requirements or other permit issued by that agency.
(l)This section prevails over Section 13263.3, as added to the Water Code by Assembly Bill 1104 of the 19992000 Regular Session.
For purposes of this chapter, the following terms have the following meanings:
(a)Authorized collection site means a location where an authorized collector operates a secure collection receptacle for collecting covered products.
(b)Authorized collector means a person or entity that has entered into an agreement with a program operator to collect covered drugs, including, but not limited to, any of the following:
(1)A person or entity that is registered with the United States Drug Enforcement Administration and that qualifies under federal law to modify that registration to collect controlled substances for the purpose of destruction.
(2)A law enforcement agency.
(3)A retail pharmacy that offers drug take-back services in compliance with Article 9.1 (commencing with Section 1776) of Title 16 of the California Code of Regulations.
(c)Controlled substance means a substance listed under Sections 11053 to 11058, inclusive, of the Health and Safety Code or Section 812 or 813 of Title 21 of the United States Code, or any successor section.
(d)Cosmetic means an article, or a component of an article, intended to be rubbed, poured, sprinkled, sprayed, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Cosmetic includes articles with or without expiration dates.
(e)(1)Covered drug means a drug, including a brand name or generic drug, sold, offered for sale, or dispensed in the State of California in any form, including, but not limited to, any of the following:
(A)Prescription and nonprescription drugs approved by the United States Food and Drug Administration pursuant to Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355) or Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).
(B)A drug marketed pursuant to an over-the-counter drug monograph.
(C)A drug in a medical device, or a combination product containing a drug and a medical device.
(2)Covered drug does not include any of the following:
(A)Vitamins or supplements.
(B)Herbal-based remedies and homeopathic drugs, products, or remedies.
(C)Cosmetics, soap, with or without germicidal agents, laundry detergent, bleach, household cleaning products, shampoos, sunscreens, toothpaste, lip balm, antiperspirants, or any other personal care product that is regulated as both a cosmetic and a nonprescription drug under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
(D)A drug for which a pharmaceutical product stewardship or producer responsibility program or drug takeback program is provided in the state as part of a United States Food and Drug Administration managed risk evaluation and mitigation strategy under 21 U.S.C. Sec. 355-1.
(E)Biological drug products, as defined by 42 U.S.C. Sec. 262(i)(1), including those products currently approved in the state under a new drug application that will be deemed to be licensed under Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262) pursuant to Section 7002(e) of the federal Biologics Price Competition and Innovation Act of 2009 (Public Law 111-148).
(F)A medical device, or a component part or accessory of a medical device, if it does not contain a covered drug.
(G)Drugs that are used for animal medicines, including, but not limited to, parasiticide products for animals.
(H)Dialysate drugs or other saline solutions required to perform kidney dialysis.
(f)(1)(A)Covered entity means the manufacturer of covered products that are sold in or into the state.
(B)If no entity that meets the definition in subparagraph (A) is in the state, covered entity means the distributor of covered products that are sold in or into the state that is licensed as a wholesaler, as defined in Section 4043 of the Business and Professions Code, but does not include a warehouse of a retail pharmacy chain that is licensed as a wholesaler if it engages only in intracompany transfers between any division, affiliate, subsidiary, parent, or other entity under complete common ownership and control.
(C)If no entity that meets the definition in subparagraph (A) or (B) is in the state, covered entity means a repackager, as defined in Section 4044 of the Business and Professions Code, of covered products that are sold in or into the state.
(D)If no entity that meets the definition in subparagraph (A), (B), or (C) is in the state, covered entity means the owner or licensee of a trademark or brand under which covered products are sold in or into the state, regardless of whether the trademark is registered.
(E)If no entity that meets the definition in subparagraph (A), (B), (C), or (D) is in the state, covered entity means the importer of the covered products that are sold in or into the state.
(2)The department shall adopt regulations on the process for determining what entity is a covered entity following the priority order set forth in paragraph (1).
(g)Covered product means a covered drug or home-generated sharps waste.
(h)Department means the Department of Resources Recycling and Recovery, and any successor agency.
(i)Distributor means a wholesaler, as that term is defined in Section 4043 of the Business and Professions Code.
(j)Drug means any of the following:
(1)An article recognized in the official United States Pharmacopoeia, the official National Formulary, the official Homeopathic Pharmacopoeia of the United States, or any supplement of the formulary or those pharmacopoeias.
(2)A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals.
(3)A substance, other than food, intended to affect the structure or any function of the body of humans or other animals.
(4)A substance intended for use as a component of any substance specified in this subdivision.
(k)Generic drug means a drug that is chemically identical or bioequivalent to a brand name drug in dosage form, safety, strengths, route of administration, quality, performance, characteristics, and intended use, though inactive ingredients may vary.
(l)(1)Home-generated sharps waste has the same meaning as defined in Section 117671 of the Health and Safety Code.
(2)Home-generated sharps waste does not include either of the following:
(A)Components manufactured for use with external ambulatory insulin pump therapy systems or continuous glucose monitoring systems, including, but not limited to, insulin infusion sets, glucose sensors that are sterile goods indicated for single subcutaneous use, sterile drug delivery channels indicated for single subcutaneous use, and injection ports.
(B)A biological product, as defined in Section 262(i)(1) of Title 42 of the United States Code, including a combination product, as defined in Section 3.2(e) of Title 21 of the Code of Federal Regulations.
(m)Mail-back program means a method of collecting covered products from ultimate users by using prepaid, preaddressed mailing envelopes as described in Section 1776.2 of Title 16 of the California Code of Regulations.
(n)Nonprescription drug means any drug that may be lawfully sold without a prescription.
(o)Pharmacy has the same meaning as defined in Section 4037 of the Business and Professions Code.
(p)Prescription drug means a drug, including, but not limited to, a controlled substance, that is required under federal or state law to be dispensed with a prescription, or is restricted to use by practitioners only.
(q)Producer responsibility organization means an organization exempt from taxation under Section 501(c)(3) of the federal Internal Revenue Code of 1986 (21 U.S.C. Sec. 501(c)(3)) that is established by a group of covered entities in accordance with this chapter to develop, implement, and administer a producer responsibility program established pursuant to this chapter.
(r)Producer responsibility plan means the plan for collecting and properly managing covered products that is developed by a covered entity or producer responsibility organization pursuant to this chapter.
(s)Producer responsibility program means a program for the collection, transportation, and disposal of covered products.
(t)Program operator means a covered entity, or producer responsibility organization on behalf of a group of covered entities, that is responsible for operating a producer responsibility program in accordance with this chapter.
(u)Proprietary information means information that is all of the following:
(1)Submitted pursuant to this chapter.
(2)A trade secret, or commercial or financial information, that is privileged or confidential, and is identified as such by the entity providing the information to the department.
(3)Not required to be disclosed under any other law or any regulation affecting a covered product or covered entity.
(v)Retail pharmacy means an independent pharmacy, a supermarket pharmacy, a chain pharmacy, or a mass merchandiser pharmacy possessing a license from the state board to operate a pharmacy.
(w)Retail pharmacy chain means a retail pharmacy with five or more stores in the state.
(x)Sharps means hypodermic needles, pen needles, intravenous needles, lancets, and other devices that are used to penetrate the skin for the delivery of medications.
(y)State board means the California State Board of Pharmacy.
(z)Ultimate user means a state resident or other nonbusiness entity and includes a person who has lawfully obtained, and who possesses, a covered product, including a controlled substance, for the persons own use or for the use of a member of the persons household. Ultimate user does not include a needle exchange program established under Section 121349 of the Health and Safety Code, or a medical waste generator, as defined in Section 117705 of the Health and Safety Code.
(a)(1)No later than 90 days after the effective date of this section, a covered entity shall provide a list of covered products, and a list and description of any drugs or sharps that are not covered products, that it sells or offers for sale in the state to the state board.
(2)A covered entity, or a producer responsibility organization on behalf of a group of covered entities, shall update the lists described in paragraph (1) and provide the updated lists to the state board on or before January 15 of each year or upon request of the department.
(b)No later than 90 days after the effective date of this section, a retail pharmacy that sells a covered product under its own label shall provide written notification to the state board identifying the covered entity from which the retail pharmacy obtains a covered product that the retail pharmacy sells under its store label.
(c)The state board shall verify the information received pursuant to subdivisions (a) and (b) and make it available to the department upon request.
(d)The state board may issue a letter of inquiry to any entity listed in subparagraphs (A) to (E), inclusive, of paragraph (1) of subdivision (f) of Section 42030 requesting a list of all drugs and sharps it distributes in California, regardless of whether the drugs or sharps are covered under this chapter, the name of the manufacturer of those products, and any additional information necessary to carry out this chapter. An entity that is issued a letter of inquiry pursuant to this subdivision shall respond in writing no later than 60 days after receipt of the letter. Responses to those inquiries may be shared with the department, but are otherwise deemed proprietary and exempt from disclosure. If the entity does not believe it is a covered entity for purposes of this chapter, it shall submit all of the following to the state board in response to the letter of inquiry:
(1)The basis for the claim that it is not a covered entity.
(2)A list of any drugs and sharps it sells, distributes, repackages, or otherwise offers for sale within the state.
(3)If applicable, the name and contact information of the person or entity from which it obtains a drug or sharp identified pursuant to paragraph (2).
(e)The state board shall obtain and verify and, within 30 days of receipt or upon request by the department, submit to the department a list of drugs and sharps sold or offered for sale in the state excluded from the definition of covered drugs pursuant to paragraph (2) of subdivision (e) of Section 42030 or excluded from the definition of home-generated sharps waste in subdivision (l) of Section 42030.
(f)Notwithstanding Section 42036.4, information submitted by the state board to the department under this chapter may include proprietary information.
(g)The state board shall notify the department if any covered entity or producer responsibility organization is in violation of this section for purposes of enforcement by the department.
(a)Except as specified in subdivision (d) of Section 42035, a covered entity is not in compliance with this chapter and is subject to penalties pursuant to Article 6 (commencing with Section 42035) if, commencing one year from the adoption of regulations pursuant to Section 42031.2, a covered product sold or offered for sale by the covered entity is not subject to an approved producer responsibility plan, which is submitted by the covered entity or by a producer responsibility organization that includes the covered entity, that has been approved by the department pursuant to Section 42032.
(b)In order to comply with the requirements of this chapter, a covered entity may establish and implement a producer responsibility program independently, or as part of a group of covered entities through membership in a producer responsibility organization exempt from taxation under Section 501(c)(3) of the federal Internal Revenue Code of 1986 (21 U.S.C. Sec. 501(c)(3)).
(a)A program operator shall conduct a comprehensive education and outreach program intended to promote participation in the producer responsibility program. At a minimum, the education and outreach program shall do all of the following:
(1)Promote its producer responsibility program to ultimate users by providing signage for hospitals, pharmacies, and other locations, as necessary.
(2)Provide educational and outreach materials for persons authorized to prescribe drugs, pharmacies, pharmacists, ultimate users, and others, as necessary.
(3)Establish an internet website that publicizes the location of authorized collectors and provides other information intended to promote the use of the producer responsibility program.
(4)Prepare and provide additional outreach materials not specified in this section, as needed to promote the collection and proper management of covered drugs and home-generated sharps waste.
(5)Encourage ultimate users to separate products that are not covered products from covered products, when appropriate, before submitting the covered products to an authorized collection site or mail-back program.
(b)A program operator shall not, as part of the education and outreach program, promote the disposal of a covered product in a manner inconsistent with the services offered to ultimate users by the producer responsibility program.
(a)(1)Within six months of the adoption date of regulations by the department pursuant to Section 42031.2, a program operator shall submit to the department for approval a complete producer responsibility plan that meets the requirements of Section 42032.2 for the establishment and implementation of a producer responsibility program, in a format determined by the department.
(2)The department shall approve a proposed producer responsibility program if the program operator submits a completed plan that meets the requirements of this section.
(b)(1)Before submitting a producer responsibility plan to the department pursuant to this section, a program operator shall submit its proposed producer responsibility plan to the state board for review, and to any other applicable state agencies with areas of authority relative to the producer responsibility plan. The duration of time that the state board takes to review a producer responsibility plan pursuant to this paragraph shall not count toward the time limit specified in paragraph (1) of subdivision (a).
(2)An agency that receives a producer responsibility plan shall review the producer responsibility plan for compliance with state and federal laws and regulations related to the agencys respective authority. The agency shall determine compliance or noncompliance with those laws and regulations, and provide to the program operator that determination and an explanation for any finding of noncompliance, within 90 days of receipt of the producer responsibility plan.
(3)A program operator may submit an updated proposed producer responsibility plan to an agency that issued a determination of noncompliance to attempt to obtain a determination of compliance. A program operator shall submit any determination received from an agency when it submits its producer responsibility plan to the department.
(4)If, 90 days after submitting a producer responsibility plan to an applicable agency, a program operator has not received a response from the applicable agency, the program operator may submit a certification to the department that the producer responsibility plan is consistent with all other applicable laws and regulations.
(c)(1)The department shall determine if a producer responsibility plan is complete, including the determinations required pursuant to subdivision (b), and notify the submitting program operator within 30 days of receipt.
(2)If the department finds that the producer responsibility plan is complete, the departments 90-day review period for consideration of approval of the producer responsibility plan set forth in subdivision (d) shall commence upon the original date of receipt.
(3)If the department determines the producer responsibility plan is incomplete, the department shall identify for the program operator the required additional information, and the program operator shall resubmit the producer responsibility plan within 30 days.
(4)If the department determines upon resubmission that the producer responsibility plan is complete, the departments 90-day review period for consideration of approval of the producer responsibility plan shall commence upon the date of receipt of the resubmitted producer responsibility plan.
(d)(1)The department shall review a complete submitted producer responsibility plan and shall approve, disapprove, or conditionally approve the producer responsibility plan within 90 days of receipt of the complete producer responsibility plan.
(2)The department may consult with, or submit a producer responsibility plan for review to, the state board or another state agency it determines is necessary to determine the completeness of the producer responsibility plan or for making a determination on the approval of the producer responsibility plan or an amendment to the producer responsibility plan. The duration of time that the department takes to review a producer responsibility plan pursuant to this paragraph shall not count toward the 90-day time limit specified in paragraph (1).
(e)A program operator shall submit any significant changes to a producer responsibility plan in writing for approval by the department, and shall not implement the changes prior to that approval.
(f)(1)If the department disapproves a submitted producer responsibility plan pursuant to subdivision (d), the department shall explain, in writing within 30 days, how the producer responsibility plan does not comply with this chapter, and the program operator shall resubmit a revised producer responsibility plan to the department.
(2)If the department finds that the revised producer responsibility plan submitted by the program operator does not comply with the requirements of this chapter and disapproves the plan, the covered entity operating its own producer responsibility program, or the producer responsibility organization and the covered entities that are members of the producer responsibility organization, are not in compliance with this chapter until the program operator submits a producer responsibility plan that the department approves.
(g)A program operator shall fully implement operation of an approved producer responsibility program no later than 270 days after approval by the department of the producer responsibility plan that establishes the producer responsibility program.
(h)If a producer responsibility plan is revoked pursuant to subdivision (a) of Section 42035.4 or terminated by the program operator that submitted the producer responsibility plan, a covered entity no longer subject to that producer responsibility plan may, without being subject to penalties pursuant to Article 6 (commencing with Section 42035), sell or offer for sale covered products in the state for a period of up to one year after the producer responsibility plan terminated or was revoked if the covered entity continues to operate under the most recent approved producer responsibility plan to which the covered entity was subject.
(i)The department shall make all producer responsibility plans submitted pursuant to this section available to the public, except proprietary information in the plans protected pursuant to Section 42036.4.
(a)(1)To be complete, a producer responsibility plan for covered drugs shall do all of the following:
(A)Identify and provide contact information for the producer responsibility organization, if applicable, and each participating covered entity, and identify each covered drug sold or offered for sale by each participating covered entity.
(B)Identify and provide contact information for the authorized collectors for the producer responsibility program, as well as the reasons for excluding any potential authorized collectors from participation in the program.
(C)Include any determinations provided by a state agency pursuant to subdivision (b) of Section 42032. Any determination of noncompliance shall be accompanied by a superseding determination of compliance.
(D)Demonstrate adequate funding for all administrative and operational costs of the producer responsibility program, to be borne by participating covered entities.
(E)Provide for a handling, transport, and disposal system that complies with applicable state and federal laws, including, but not limited to, regulations adopted by the United States Drug Enforcement Administration.
(F)Provide for a collection system that complies with the requirements of this chapter and meets all of the following requirements for authorized collection sites in each county in which the producer responsibility plan will be implemented:
(i)Provides for a minimum of five authorized collection sites or one authorized collection site per 50,000 people, whichever is greater.
(ii)Provides for a reasonable geographic spread of authorized collection sites and an explanation for the geographic spread.
(iii)Provides for a mail-back program covering any counties where there is not an authorized retail pharmacy operating as an authorized collection site.
(G)Require a program operator to do all of the following:
(i)Permit an ultimate user who is a homeless, homebound, or disabled individual to request prepaid, preaddressed mailing envelopes, or an alternative form of a collection and disposal system, as described in paragraph (2) of subdivision (c), that would render the covered drug inert. A program operator shall accept that request through an internet website and toll-free telephone number that it shall maintain to comply with the requests.
(ii)Provide alternative methods of collection from ultimate users for any covered drugs, other than controlled substances, that cannot be accepted or commingled with other covered drugs in secure collection receptacles or through a mail-back program, to the extent technically feasible and permissible under applicable state and federal law, including, but not limited to, United States Drug Enforcement Administration regulations.
(iii)(I)Provide a service schedule that meets the needs of each authorized collection site to ensure that each secure collection receptacle is serviced as often as necessary to avoid reaching capacity and that collected covered drugs are transported to final disposal in a timely manner. Additionally, a receipt or collection manifest shall be left with the authorized collection site to support verification of the service. The authorized collection site shall maintain and make available to the department this documentation.
(II)An authorized collector shall comply with applicable federal and state laws regarding collection and transportation standards, and the handling of covered drugs, including United States Drug Enforcement Administration regulations.
(H)Provide the policies and procedures for the safe and secure collection, transporting, and disposing of the covered drug, describe how and where records will be maintained and how, at a minimum, instances of security problems that occur will be addressed, and explain the processes that will be taken to change the policies, procedures, and tracking mechanisms to alleviate the problems and to improve safety and security.
(2)Paragraph (1) shall apply only with regard to covered drugs.
(b)(1)At least 120 days before submitting a producer responsibility plan to the department, the operator of a producer responsibility program for covered drugs shall notify potential authorized collectors in the county or counties in which it operates of the opportunity to serve as an authorized collector for the proposed producer responsibility program. If a potential authorized collector expresses interest in participating in a producer responsibility program, the program operator shall commence good faith negotiations with the potential authorized collector within 30 days.
(2)A retail pharmacy shall make a reasonable effort to serve as an authorized collector as part of a producer responsibility program in the county in which it is located. If the minimum threshold described in clause (i) of subparagraph (F) of paragraph (1) of subdivision (a) is not met in each county in which a retail pharmacy chain has store locations, the retail pharmacy chain shall have at least one location or 15 percent of its store locations, whichever is greater, in that county serve as authorized collectors in a producer responsibility program.
(3)A program operator shall include as an authorized collector under its producer responsibility program any entity listed in subdivision (b) of Section 42030 that offers to participate in the producer responsibility program, in writing and without compensation, even if the minimum convenience standards set in clause (i) of subparagraph (F) of paragraph (1) of subdivision (a) have been achieved. The program operator shall include the offering entity as an authorized collector in the program within 90 days of receiving the written offer to participate. A program operator shall not be required to respond to offers pursuant to this paragraph until the program operators producer responsibility plan has been approved by the department.
(c)After a producer responsibility plan for covered drugs has been approved, the program operator may supplement service, if approved by the department, for a county in which it operates that does not have the minimum number of authorized collection sites due to circumstances beyond the program operators control, by establishing one or both of the following:
(1)A mail-back program. The mail-back program may include providing information on where and how to receive mail-back materials or providing the locations at which it distributes prepaid, preaddressed mailing envelopes. The program operator shall propose the locations of those envelope distribution locations as part of the producer responsibility plan. Prepaid mailing envelopes may be mailed to an ultimate user upon request.
(2)An alternative form of collection and disposal of covered drugs that complies with applicable state and federal law, including, but not limited to, United States Drug Enforcement Administration regulations.
(d)(1)To be complete, a producer responsibility plan for home-generated sharps waste shall do all of the following:
(A)Identify and provide contact information for the producer responsibility organization, if applicable, and each participating covered entity, and identify each covered product sold or offered for sale by each participating covered entity.
(B)Include any determinations provided by a state agency pursuant to subdivision (b) of Section 42032. Any determination of noncompliance shall be accompanied by a superseding determination of compliance.
(C)Demonstrate adequate funding for all administrative and operational costs of the producer responsibility program, to be borne by participating covered entities.
(D)Provide for a handling, transport, and disposal system, at no cost to the ultimate user, that complies with applicable state and federal laws.
(E)Maintain an internet website and toll-free telephone number for purposes of providing information on the program, including disposal options, and to receive requests for sharps waste containers from ultimate users.
(F)Provide that a producer responsibility program for home-generated sharps waste shall be a mail-back program for home-generated sharps waste that complies with this chapter and that meets all the following requirements:
(i)The program provides or initiates distribution of a sharps waste container and mail-back materials at the point of sale, to the extent allowable by law. Containers and mail-back materials shall be provided at no cost to the ultimate user. The program operator shall select and distribute a container and mail-back materials sufficient to accommodate the volume of sharps purchased by an ultimate user over a selected time period.
(I)For any sharps, the packaging, an insert or instructions, or separate information provided to the ultimate user shall include information on proper sharps waste disposal.
(II)All sharps waste containers shall include on a label affixed to the container or packaging, or on a separate insert included in the container or packaging, the program operators internet website and toll-free telephone number.
(III)All sharps waste containers shall include prepaid postage affixed to the container or to the mail-back packaging.
(ii)Upon request, the program provides for reimbursement to local agencies for disposal costs related to home-generated sharps waste, unless the program operator provides for the removal of the home-generated sharps waste from the local household hazardous waste facility.
(I)A local agency shall not knowingly request reimbursement for disposal expenses pursuant to this subparagraph for disposal costs resulting from a municipal needle exchange program or a medical waste generator.
(II)Reimbursement costs shall be limited to the actual costs of transportation from the household hazardous waste facility and for the actual costs of disposal.
(III)A request for reimbursement pursuant to this clause shall be submitted with a declaration under penalty of perjury that the local agency has not knowingly requested reimbursement for expenses prohibited by this section.
(IV)A cost is eligible for reimbursement pursuant to this clause if the cost is incurred 270 days or more after the approval of a producer responsibility plan for home-generated sharps waste.
(2)Paragraph (1) shall apply only with regard to home-generated sharps waste.
(e)A producer responsibility plan shall include provisions to expand into jurisdictions not included in the producer responsibility plan pursuant to Section 42036.2, in the event a jurisdiction repeals its local stewardship or producer responsibility program ordinance.
(f)A producer responsibility plan shall include educational and outreach provisions to meet the requirements of Section 42031.6.
With the submission of a producer responsibility plan, a program operator shall submit to the department an initial producer responsibility program budget for the first five calendar years of operation of its producer responsibility program that includes both of the following:
(a)Total anticipated revenues and costs of implementing the producer responsibility program.
(b)A total recommended funding level sufficient to cover the producer responsibility plans budgeted costs and to operate the producer responsibility program over a multiyear period.
(a)On or before March 31 of each year, a program operator shall prepare and submit to the department both of the following:
(1)A written report describing the producer responsibility program activities during the previous reporting period of one year.
(2)A written program budget for producer responsibility program implementation for the upcoming calendar year.
(b)An annual report submitted pursuant to paragraph (1) of subdivision (a) shall include, at a minimum, all of the following for the prior year:
(1)A list of covered entities participating in the producer responsibility organization.
(2)The updated and reverified list provided pursuant to paragraph (2) of subdivision (a) of Section 42031 of covered products that each covered entity subject to the producer responsibility plan sells or offers for sale.
(3)The amount, by weight, of covered products collected from ultimate users at each authorized collection site that is part of the producer responsibility program.
(4)For a producer responsibility plan for covered drugs, the name and location of authorized collection sites at which covered drugs were collected.
(5)For a producer responsibility plan for home-generated sharps waste, information on the mail-back program.
(6)Whether policies and procedures for collecting, transporting, and disposing of covered products, as established in the producer responsibility plan, were followed during the reporting period and a description of each instance of noncompliance, if any occurred.
(7)Whether any safety or security problems occurred during collection, transportation, or disposal of collected covered products during the reporting period and, if so, what changes have been or will be made to policies, procedures, or tracking mechanisms to alleviate the problem and to improve safety and security.
(8)How the program operator complied with all elements in its producer responsibility plan.
(9)Any other information the department reasonably requires.
(c)An annual program budget submitted pursuant to paragraph (2) of subdivision (a) shall include, at a minimum, both of the following for the upcoming calendar year:
(1)An independent financial audit of the producer responsibility program, as required by subdivision (b) of Section 42033.4, funded by the producer responsibility organization from the charge paid from its member covered entities pursuant to Section 42034 or by a covered entity if it operates its own producer responsibility program.
(2)Anticipated costs and the recommended funding level necessary to implement the producer responsibility program, including, but not limited to, costs to cover the producer responsibility plans budgeted costs and to operate the producer responsibility program over a multiyear period in a prudent and responsible manner.
(d)(1)The department shall determine if a submitted annual report and program budget are complete and notify the submitting producer responsibility organization or covered entity within 30 days.
(2)If the department finds that an annual report and program budget are complete, the departments 90-day review period for consideration of approval of the annual report and program budget, set forth in subdivision (e), shall commence upon the original date of receipt.
(3)If the department determines either an annual report or a program budget is incomplete, the department shall identify for the program operator within 30 days the required additional information, and the program operator shall submit a revised annual report or program budget, as applicable, within 30 days.
(4)If the department determines upon resubmission that the annual report or program budget is complete, the departments 90-day review period for consideration of approval of the annual report or program budget shall commence upon the date of receipt of the resubmitted report or program budget.
(e)(1)The department shall review the annual report and program budget required pursuant to this section and within 90 days of receipt shall approve, disapprove, or conditionally approve the annual report and program budget.
(2)(A)If the department conditionally approves an annual report or program budget, the department shall identify the deficiencies in the annual report or program budget and the program operator shall comply with the conditions of the conditional approval within 60 days of the notice date, unless the Director of Resources Recycling and Recovery determines that additional time is needed.
(B)If the department conditionally approves an annual report or program budget and the conditions are not met within 60 days of the notice date, unless additional time is granted pursuant to subparagraph (A), the department shall disapprove the annual report or program budget.
(3)If the department disapproves an annual report or program budget, the department shall identify the deficiencies in the annual report or program budget and the program operator shall submit a revised annual report or program budget and provide any supplemental information requested within 60 days of the notice date.
(a)A program operator shall keep minutes, books, and records that clearly reflect the activities and transactions of the program operators producer responsibility program.
(b)(1)The minutes, books, and records of a program operator shall be audited at the program operators expense by an independent certified public accountant retained by the program operator at least once each calendar year.
(2)A program operator shall arrange for the independent certified public accountant audit to be delivered to the department, along with the annual report and program budget submitted pursuant to subdivision (a) of Section 42033.2.
(3)The department may conduct its own audit of a program operator. The department shall review the independent certified public accountant audit for compliance with this chapter and consistency with the program operators producer responsibility plan, annual report, and program budget submitted pursuant to this chapter. The department shall notify the program operator of any conduct or practice that does not comply with this chapter or of any inconsistencies identified in the departments audit. The program operator may obtain copies of the departments audit, including proprietary information contained in the departments audit, upon request. The department shall not disclose any confidential proprietary information protected pursuant to Section 42036.4 that is included in the departments audit.
As part of the administration of this chapter, within 12 months of a program operators submission of three consecutive complete annual reports submitted pursuant to Section 42033.2, the department shall develop, and post on its internet website, a report analyzing whether the program operators producer responsibility program provides adequate access to safe disposal of home-generated sharps waste or covered drugs, as applicable, to the ultimate user.
In order to further the objective that covered entities establish and implement producer responsibility programs that comply with the requirements of this chapter, each covered entity, either individually or through a producer responsibility organization, shall pay all administrative and operational costs associated with establishing and implementing the producer responsibility program in which it participates, including the cost of collecting, transporting, and disposing of covered products.
(a)(1)On March 1 and September 1 of each year, a program operator shall pay to the department an administrative fee. The department shall set the fee at an amount that, when paid by every covered entity, is adequate to cover the departments and any other state agencys projected full costs of administering and enforcing this chapter, including any incurred costs that have not been reimbursed. Before March 1 and September 1 of each year, the department shall compare the total amount of fees collected for the operative billing cycle to the total actual and reasonable costs of administering and enforcing this chapter over the same period so that the total amount of fees collected is adequate and does not exceed the states full actual and reasonable regulatory costs to implement and enforce this chapter. These costs may include the actual and reasonable costs associated with regulatory activities pursuant to this chapter before submission of producer responsibility plans pursuant to Section 42032.
(2)For a producer responsibility organization, the administrative fee paid pursuant to paragraph (1) shall be funded by the covered entities that make up the producer responsibility organization. This administrative fee shall be in addition to the charge paid pursuant to Section 42034. A producer responsibility organization may require its participating covered entities to pay the administrative fee and the charge paid pursuant to Section 42034 at the same time.
(b)The department shall deposit administrative fees paid by a program operator pursuant to subdivision (a) into the Pharmaceutical and Sharps Producer Responsibility Fund. Upon appropriation by the Legislature, moneys in the fund may be expended by the department, the state board, and any other agency that assists in the regulatory activities of administering and enforcing this chapter. Upon appropriation by the Legislature, moneys in the fund may be used for those regulatory activities and to reimburse any outstanding loans made from other funds used to finance the startup costs of the departments activities pursuant to this chapter. Moneys in the fund shall not be expended for any purpose not enumerated in this chapter.
(c)The Pharmaceutical and Sharps Stewardship Fund, established by Section 1 of Chapter 1004 of the Statutes of 2018 (Senate Bill No. 212), is hereby renamed and continued in existence as the Pharmaceutical and Sharps Producer Responsibility Fund.
(a)(1)A producer responsibility organization may conduct an audit of covered entities that are required to remit a charge or administrative fee to the producer responsibility organization pursuant to Sections 42034 and 42034.2 to verify that the administrative fees and charges paid are proper and accurate. In addition, a producer responsibility organization may conduct an audit of authorized collectors to verify the charges submitted are proper and accurate.
(2)The purpose of the audits described in paragraph (1) is to ensure parties required by this chapter to pay or collect an administrative fee or charge are paying or collecting the proper amount to implement the program.
(b)If a producer responsibility organization conducts an audit pursuant to subdivision (a), it shall do all of the following:
(1)Conduct the audit in accordance with generally accepted auditing practices.
(2)Limit the scope of the audit of covered entities to confirming whether a charge or administrative fee has been properly paid by the covered entities.
(3)Hire an independent third-party auditor to conduct the audit.
(4)Provide a copy of the audit to the department.
(a)(1)On or before June 30th of each year, the department shall post on its internet website a list of producer responsibility organizations, including entities with an approved producer responsibility plan, and covered entities, authorized collection sites, retail pharmacies, and retail pharmacy chains provided in the producer responsibility plans that are in compliance with this chapter.
(2)The state board shall coordinate with the department to verify that the list posted pursuant to paragraph (1) is consistent with the information submitted to each agency pursuant to Section 42031.
(b)A covered entity or producer responsibility organization that is not listed on the departments internet website pursuant to subdivision (a), but demonstrates compliance with this chapter before the department is required to post the following years list pursuant to subdivision (a), may request a certification letter from the department stating that the covered entity or producer responsibility organization is in compliance with this chapter. A covered entity or producer responsibility organization that receives a certification letter shall be deemed to be in compliance with this chapter.
(c)A distributor or wholesaler of covered products, and a pharmacy or other retailer that sells or offers for sale a covered product, shall monitor the departments internet website to determine which covered entities and producer responsibility organizations are in compliance with this chapter. The distributor or wholesaler and the pharmacy or other retailer shall notify the department if it determines that a covered product that it sells or offers for sale is from a covered entity that is not listed on the departments internet website.
(d)The sale, distribution, or offering for sale of any inventory that was in stock before the commencement of a producer responsibility program is exempt from this chapter and not required to be subject to a producer responsibility plan.
(e)If the department determines a covered entity or producer responsibility organization is not in compliance with this chapter, the department shall remove the entity from the list maintained on the departments internet website pursuant to subdivision (a).
(a)(1)The department may impose an administrative penalty on any covered entity, program operator, producer responsibility organization, or authorized collector that sells, offers for sale, or provides a covered product in violation of this chapter.
(2)The amount of the administrative penalty imposed pursuant to this subdivision shall not exceed ten thousand dollars ($10,000) per day unless the violation is intentional, knowing, or reckless, in which case the administrative penalty shall not exceed fifty thousand dollars ($50,000) per day.
(b)The department shall not impose a penalty on a program operator pursuant to this section for failure to comply with this chapter if the program operator demonstrates it received false or misleading information that contributed to its failure to comply, including, for a producer responsibility organization, from a participating covered entity.
(c)The department shall deposit all penalties collected pursuant to this section in the Pharmaceutical and Sharps Producer Responsibility Penalty Account, in the Pharmaceutical and Sharps Producer Responsibility Fund. Upon appropriation by the Legislature, moneys in the Pharmaceutical and Sharps Producer Responsibility Penalty Account may be expended by the department on activities including, but not limited to, the promotion of safe handling and disposal of covered products, grants for related purposes, and the administration and enforcement of this chapter.
(d)The Pharmaceutical and Sharps Stewardship Penalty Account, established by Section 1 of Chapter 1004 of the Statutes of 2018 (Senate Bill No. 212), is hereby renamed and continued in existence as the Pharmaceutical and Sharps Producer Responsibility Penalty Account.
Upon a written finding that a covered entity, program operator, producer responsibility organization, or authorized collector has not met a material requirement of this chapter, in addition to any other penalties authorized under this chapter, the department may take one or both of the following actions to ensure compliance with the requirements of this chapter, after affording the covered entity, producer responsibility organization, or authorized collector a reasonable opportunity to respond to, or rebut, the finding:
(a)Revoke the program operators producer responsibility plan approval or require the program operator to resubmit the producer responsibility plan.
(b)Require additional reporting relating to compliance with the material requirement of this chapter that was not met.
(a)A covered entity, producer responsibility organization, program operator, retail pharmacy, or retail pharmacy chain shall do both of the following:
(1)Upon request, provide the department with reasonable and timely access, as determined by the department, to its facilities and operations, as necessary to determine compliance with this chapter.
(2)Upon request, provide the department with relevant records necessary to determine compliance with this chapter.
(b)A covered entity, producer responsibility organization, program operator, retail pharmacy, or retail pharmacy chain shall maintain and keep accessible all records required to be kept or submitted pursuant to this chapter for a minimum of three years.
(c)All reports and records provided to the department pursuant to this chapter shall be provided under penalty of perjury.
(d)The department may take disciplinary action against a covered entity, producer responsibility organization, program operator, pharmacy, retail pharmacy, or retail pharmacy chain that fails to provide the department with the access to information required pursuant to this section, including one or both of the following:
(1)Imposing an administrative penalty pursuant to Section 42035.2.
(2)Posting a notice on the departments internet website, in association with the list that the department maintains pursuant to paragraph (1) of subdivision (a) of Section 42035, that the covered entity, producer responsibility organization, program operator, pharmacy, retail pharmacy, or retail pharmacy chain is no longer in compliance with this chapter.
(e)The department shall not prohibit as a disciplinary action a covered entity, producer responsibility organization, program operator, pharmacy, retail pharmacy, or retail pharmacy chain from selling a covered product.
All handling, transport, and disposal undertaken as part of a producer responsibility program under this chapter shall comply with applicable state and federal laws, including, but not limited to, regulations adopted by the United States Drug Enforcement Administration.
(a)Except as provided in subdivision (c), an action specified in subdivision (b) that is taken by a producer responsibility organization or a covered entity pursuant to this chapter is not a violation of the Cartwright Act (Chapter 2 (commencing with Section 16700) of Part 2 of Division 7 of the Business and Professions Code), the Unfair Practices Act (Chapter 4 (commencing with Section 17000) of Part 2 of Division 7 of the Business and Professions Code), or the Unfair Competition Law (Chapter 5 (commencing with Section 17200) of Part 2 of Division 7 of the Business and Professions Code).
(b)Subdivision (a) shall apply to all of the following actions taken by a producer responsibility organization or covered entity:
(1)The creation, implementation, or management of a producer responsibility plan approved by the department pursuant to Article 3 (commencing with Section 42032) and the determination of the types or quantities of covered products collected or otherwise managed pursuant to a producer responsibility plan.
(2)The determination of the cost and structure of an approved producer responsibility plan.
(3)The establishment, administration, collection, or disbursement of the charge or administrative fee imposed pursuant to Section 42034 or 42034.2, respectively.
(c)Subdivision (a) shall not apply to an agreement that does any of the following:
(1)Fixes a price of or for covered products, except for an agreement related to costs, charges, or administrative fees associated with participation in a producer responsibility plan approved by the department and otherwise in accordance with this chapter.
(2)Fixes the output of production of covered products.
(3)Restricts the geographic area in which, or customers to whom, covered products are sold.
(a)This chapter does not apply to a drug or sharp within a jurisdiction that is subject to a local stewardship or producer responsibility program pursuant to an ordinance that took effect before April 18, 2018. If that ordinance is repealed in the jurisdiction or, if more than one ordinance is applicable, those ordinances are repealed in the jurisdiction, the drug or sharp shall be subject to this chapter in that jurisdiction within 270 days after the date on which the ordinance is, or ordinances are, repealed.
(b)This chapter shall preempt a local stewardship or producer responsibility program for drugs or sharps enacted by an ordinance or ordinances with an effective date on or after April 18, 2018.
(c)A local stewardship or producer responsibility program for covered products enacted by an ordinance that has an effective date before April 18, 2018, may continue in operation, but the program and its participants shall not receive or benefit from moneys from the Pharmaceutical and Sharps Producer Responsibility Fund or the Pharmaceutical and Sharps Producer Responsibility Penalty Account, including, but not limited to, for administrative or enforcement costs. Participants of a local stewardship or producer responsibility program for covered products enacted by an ordinance that has an effective date before April 18, 2018, shall be eligible to participate in a producer responsibility program under this chapter and thereby become eligible to receive funds from the Pharmaceutical and Sharps Producer Responsibility Fund or the Pharmaceutical and Sharps Producer Responsibility Penalty Account only if the local stewardship or producer responsibility program is dissolved.
Proprietary information submitted to the department under this chapter shall be protected by all parties as confidential and shall be exempt from public disclosure under the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code). The department and other parties may only disclose proprietary information in an aggregated form that does not directly or indirectly identify financial, production, or sales data of an individual covered entity or producer responsibility organization. Proprietary information may be disclosed to the party that submitted the proprietary information.