California Assembly Bill AB333 Amended / Bill

 BILL NUMBER: AB 333AMENDED BILL TEXT AMENDED IN SENATE JULY 11, 2013 AMENDED IN ASSEMBLY MAY 8, 2013 AMENDED IN ASSEMBLY MARCH 12, 2013 INTRODUCED BY Assembly Member Wieckowski FEBRUARY 13, 2013 An act to amend Sections 117695, 117710, 117765,  117903, 117918, 117935, 117943, 117945, 117950, 117960, 117970,   118025,  118027, and 118240 of, to add Sections 117946 and 117976 to,  and to repeal and add  Section  Sections  117630  , 117662, 117750, 117770, 117780, and 117975  of, the Health and Safety Code, relating to medical waste. LEGISLATIVE COUNSEL'S DIGEST AB 333, as amended, Wieckowski. Medical waste. (1) Existing law, the Medical Waste Management Act, regulates the disposal of medical waste, including requiring specified biohazard materials to be disposed of in biohazard bags and requiring specified treatment for medical waste. Transportation, storage, treatment, or disposal of medical waste in a manner not authorized by the act is a crime.  Existing law defines specified terms for purposes of the Medical Waste Management Act, including "biohazard bag," "medical waste management plan," "health care professional," "sharps container," "shipping document," and "treatment." Under existing law, health care professionals who generate medical waste are generally required to have medical waste transported by a registered hazardous waste transporter. Under existing law , a health care   professional is a person licensed under specified provisions, including dentists and physicians and surgeons.   Existing law defines a biohazard bag as a disposable red bag that has the strength to preclude ripping, tearing, or bursting under normal conditions of usage and handling and that is constructed of material of sufficient single thickness strength to pass the 165-gram dropped dart impact resistance test, as specified, and certified by the bag manufacturer.   This bill would change the definition of a biohazard bag to a film bag certified by the manufacturer as having passed specified tests for tear resistance and impact resistance. The bill would require a biohazard bag to be red unless other colors are used to further segregate the waste stream. If additional colors are used, the bill would require the color assignments to be designated in the facility' s medical waste management plan.   (2) Existing law defines a medical waste management plan as a document that is completed by generators of medical waste, as specified, on forms provided by the State Department of Public Health or a local agency.   This bill would define a medical waste management plan as a document that describes how the medical waste generated at a generator's facility shall be segregated, handled, stored, packaged, treated, or shipped for treatment, as applicable, and would only require the plan to be on department forms if those forms are provided by the department or local agency.   This bill would redefine the above-referenced terms for purposes of the Medical Waste Management Act and expand the scope of a health care professional to include any person who generates medical waste in a health care setting or in the course of providing health care services.   (2) Under the Medical Waste Management Act, medical waste generators, including large quantity generators and small quantity generators, are subject to various requirements relating to registration, record retention, and transportation of medical waste.   This bill would revise the registration procedures and the record requirements for large quantity and small quantity generators. The bill would exempt from regulation as a hazardous waste hauler a small quantity generator or large quantity generator that meets specified requirements, including retaining specified documentation and complying with certain federal requirements relating to a materials of trade exception.   The bill would make technical, conforming, and clarifying changes relating to these provisions.  (3) Existing law exempts from specified provisions of the Medical Waste Management Act a person who is authorized to collect solid waste and who unknowingly transports medical waste to a solid waste facility, incidental to the collection of solid waste. This bill would exempt those persons from the entire act, with regard to that waste, and would require the solid waste transporter to contact the originating generator of the medical waste to respond to the facility to provide ultimate proper disposal of the medical waste. (4) Existing law requires that animals that die of infectious diseases be treated as medical waste, as specified, if, in the opinion of the attending veterinarian or local health officer, the carcass presents a danger of infection to humans. This bill would require the carcasses of animals that have died of infectious diseases or that have been euthanized because of suspected exposure to infectious disease to be treated with a treatment technology approved by the department if, in the opinion of the attending veterinarian or local health officer, the carcass presents a danger of infection to humans. By expanding the definition of a crime, this bill would create a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 117630 of the Health and Safety Code is repealed. SEC. 2. Section 117630 is added to the Health and Safety Code, to read: 117630. "Biohazard bag" means a disposable film bag that is impervious to moisture. The film bags that are used for transport shall be marked and certified by the manufacturer as having passed the tests prescribed for tear resistance in the American Society for Testing Materials (ASTM) D1922, "Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method" and for impact resistance in ASTM D 1709, "Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method," as those documents are published on January 1, 2014. The film bag shall meet an impact resistance of 165 grams and a tearing resistance of 480 grams in both parallel and perpendicular planes with respect to the length of the bag. The color of the bag shall be red, except when other colors are used to further segregate the waste stream, including for trace chemotherapy wastes, laboratory wastes, and other subsets of the waste stream. If additional colors are used other than the standard red bag, the color assignments shall be designated in the facility's medical waste management plan.  SEC. 3.   Section 117662 of the   Health and Safety Code   is repealed.   117662. "Health care professional" means any person licensed or certified pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code; any person licensed pursuant to the Osteopathic Initiative Act, as set forth in Chapter 8 (commencing with Section 3600) of Division 2 of the Business and Professions Code, or pursuant to the Chiropractic Initiative Act, as set forth in Chapter 2 (commencing with Section 1000) of Division 2 of the Business and Professions Code; and any person certified pursuant to Division 2.5 (commencing with Section 1797).   SEC. 4.   Section 117662 is added to the Health and Safety Code, to read: 117662. "Health care professional" means any person who generates medical waste in a health care setting or in the course of providing a health care service.   SEC. 3.   SEC. 5.  Section 117695 of the Health and Safety Code is amended to read: 117695. Medical waste that has been treated in accordance with the provisions of the Medical Waste Management Act, Chapter 8 (commencing with Section 118215), and that is not otherwise hazardous, shall thereafter be considered solid waste as defined in Section 40191 of the Public Resources Code and not medical waste.  SEC. 4.   SEC. 6.  Section 117710 of the Health and Safety Code is amended to read: 117710. "Medical waste management plan" means a document that is completed by generators of medical waste that describes how the medical waste generated at their facility shall be segregated, handled, stored, packaged, treated, or shipped for treatment, as applicable, pursuant to Section 117935 for small quantity generators and Section 117960 for large quantity generators, on forms prepared by the enforcement agency, if those forms are provided by the enforcement agency.  SEC. 7.   Section 117750 of the   Health and Safety Code   is repealed.   117750. "Sharps container" means a rigid puncture-resistant container that, when sealed, is leak resistant and cannot be reopened without great difficulty.   SEC. 8.   Section 117750 is added to the Health and Safety Code, to read: 117750. (a) "Sharps container" means a rigid puncture-resistant container used in patient care or research activities meeting the standards of, and receiving approval from, the federal Food and Drug Administration as a medical device used for the collection of discarded medical needles, other sharps, or, except as specified in subdivision (b), other waste. (b) For purposes of subdivision (a), "other waste" does not include any waste that is regulated pursuant to either of the following: (1) The federal Resource Conservation and Recovery Act of 1976, as amended (42 U.S.C. Sec. 6901 et seq.). (2) The Radiation Control Law (Chapter 8 (commencing with Section 114960) of Part 9).   SEC. 5.   SEC. 9.  Section 117765 of the Health and Safety Code is amended to read: 117765. "Storage" means the holding of medical wastes, in compliance with the Medical Waste Management Act, including Chapter 9 (commencing with Section 118275), at a designated accumulation area, offsite point of consolidation, transfer station, other registered facility, or in a vehicle detached from its means of locomotion.  SEC. 10.   Section 117770 of the   Health and Safety Code   is repealed.   117770. "Tracking document" means the medical waste tracking document specified in Section 118040.   SEC. 11.   Section 117770 is added to the Health and Safety Code, to read: 117770. "Shipping document" means the medical waste shipping document required by the federal Department of Transportation pursuant to Section 172.200 et seq. of Title 49 of the Code of Federal Regulations.   SEC. 12   .   Section 117780 of the   Health and Safety Code   is repealed.   117780. "Treatment" means any method, technique, or process designed to change the biological character or composition of any medical waste so as to eliminate its potential for causing disease, as specified in Chapter 8 (commencing with Section 118215).   SEC. 13.   Section 117780 is added to the Health and Safety Code, to read: 117780. "Treatment" includes any of the following: (a) Treatment for biohazardous waste is any method, technique, or process designed to change the biological character or composition of any biohazardous medical waste so as to eliminate its potential for causing disease. (b) Treatment for pharmaceutical waste is any method, technique, or process designed to destroy the character or composition of any pharmaceutical medical waste so as to eliminate its potential for creating public or environmental health harm. (c) Treatment for sharps waste is any method, technique, or process designed to change the biological character or composition of any biohazardous material found on the sharp so as to eliminate its potential for causing disease.   SEC. 14.   Section 117903 of the   Health and Safety Code   is amended to read:  117903. No person shall treat medical waste unless the person is permitted by the enforcement agency as required by this part or unless the treatment is performed by a medical waste generator and is a treatment method approved pursuant to  subdivision (d) of Section 118215   Chapter 8 (commencing with Section 118215)  .  SEC. 15.   Section 117918 of the   Health and Safety Code   is amended to read:  117918.  Treatment of medical   Medical    waste shall be  treated using treatment technologies approved by the department  in accordance with Chapter 8 (commencing with Section 118215).  SEC. 16.   Section 117935 of the   Health and Safety Code   is amended to read:  117935. Any small quantity generator required to register with the enforcement agency pursuant to Section 117930 shall file with the enforcement agency a medical waste management plan,  on forms prescribed by the enforcement agency  containing, but not limited to, all of the following  that apply  : (a) The name of the person. (b) The business address of the person. (c) The type of business. (d) The types, and the estimated average monthly quantity, of medical waste generated. (e) The type of treatment used onsite. (f) The name and business address of the registered hazardous waste hauler used by the generator for backup treatment and disposal, for waste when the onsite treatment method is not appropriate due to the hazardous or radioactive characteristics of the  waste, the   waste.   (g)     The  name of the registered hazardous waste hauler used by the generator to have untreated medical waste removed for treatment and  disposal, and, if applicable, the   disposal.   (h)     The  name of the common carrier used by the generator to transport pharmaceutical waste offsite for treatment and disposal pursuant to Section 118032.  (g) A statement indicating that the generator is hauling the medical waste generated in his or her business pursuant to Section 118030 and the name and any business address of the treatment and disposal facilities to which the waste is being hauled, if applicable.   (h) The name and business address of the registered hazardous waste hauler service provided by the building management to which the building tenants may subscribe or are required by the building management to subscribe and the name and business address of the treatment and disposal facilities used, if applicable.   (i) The steps taken to categorize the pharmaceutical wastes generated at the facility to ensure that the wastes are properly disposed of as follows:   (1) Pharmaceutical wastes classified by the federal Drug Enforcement Agency (DEA) as "controlled substances" are disposed of in compliance with DEA requirements.   (2) The name and business address of the hazardous waste hauler used by the generator to have wastes that are not regulated pursuant to the federal Resource Conservation and Recovery Act of 1976 and nonradioactive pharmaceutical wastes regulated as medical waste safely removed for treatment in compliance with subdivision (b) of Section 118222 as waste requiring specific methods.   (j) A closure plan for the termination of treatment at the facility.   (i)   (k)  A statement certifying that the information provided is complete and accurate.  SEC. 17.   Section 117943 of the   Health and Safety Code   is amended to read:  117943. A medical waste generator required to register pursuant to this chapter shall maintain  for a minimum of two years  individual  treatment, and tracking records, if applicable, for three years, or for the period specified in the regulations,   treatment operating records, and if applicable, shipping documents for all untreated medical waste shipped offsite for treatment,  and shall report or submit to the enforcement agency, upon request,  both   all  of the following: (a) Treatment operating records.  Operating records shall be maintained in written or electronic form.  (b) An emergency action plan complying with regulations adopted by the department.  (c) Shipping documents or electronically archived shipping documents maintained by the facility or medical waste hauler of all untreated medical waste shipped offsite for treatment.   (d) Documentation shall be made available to the enforcement agency onsite as soon as feasible, but no more than two business days following the request.   SEC. 18.   Section 117945 of the   Health and Safety Code   is amended to read:  117945. Small quantity generators who are not required to register pursuant to this chapter shall maintain on file in their office all of following: (a) An information document stating how the generator contains, stores, treats, and disposes of any medical waste generated through any act or process of the generator. (b) Records  required by the federal Department of Transportation  of any medical waste  transported   shipped  offsite for treatment and  disposal, including the quantity of waste transported, the date transported, the name of the registered hazardous waste hauler or individual hauling the waste pursuant to Section 118030, and, if applicable, the name of the common carrier transporting pharmaceutical waste pursuant to Section 118032. The small quantity generator shall maintain these records for not less than two years   disposal  .  The small quantity generator sh   all maintain, or have available electronically at the facility or from the medical waste hauler or common carrier, these records, for not less than two years.   (c) Documentation shall be made available to the enforcement agency onsite as soon as feasible, but no more than two days following the request.   SEC. 19.   Section 117946 is added to the   Health and Safety Code   , to read:   117946. (a) A small quantity medical waste generator or parent organization that employs health care professionals who generate medical waste may transport medical waste generated in limited quantities to the central location of accumulation, provided that all of the following are met: (1) The principal business of the generator is not to transport or treat regulated medical waste. (2) The generator shall adhere to the conditions and requirements set forth in the materials of trade exception, as specified in Section 173.6 of Title 49 of the Code of Federal Regulations. (3) A person transporting medical waste pursuant to this section shall provide a form or log to the receiving facility, and the receiving facility shall maintain the form or log for a period of two years, containing all of the following information: (A) The name of the person transporting the medical waste. (B) The number of containers of medical waste transported. (C) The date the medical waste was transported. (b) A generator transporting medical waste pursuant to this section shall not be regulated as a hazardous waste hauler pursuant to Section 117660.   SEC. 20.   Section 117950 of the   Health and Safety Code   is amended to read:  117950. (a) Each large quantity generator, except as specified in subdivisions (b) and (c), shall register with the enforcement  agency. Large quantity generators owning or operating a medical waste treatment facility shall also apply for a permit for that treatment facility pursuant to Chapter 7 (commencing with Section 118130)   agency prior to commencement of the generation of medical waste  . (b) Large quantity generators operating as a business in the same building, or that are associated with a group practice in the same building, may register as one generator. (c) Large quantity generators as specified in subdivision (a), operating in different buildings on the same or adjacent property, or as approved by the enforcement agency, may register as one generator. (d) "Adjacent," for purposes of subdivision (c), means real property within 400 yards from the property boundary of the primary registration site.  All federal transportation requirements specified in Section 173.6 of Part 49 of the Code of Federal Regulations shall apply for purposes of transporting medical waste from adjacent properties.   SEC. 21.   Section 117960 of the   Health and Safety Code   is amended to read:  117960. Any large quantity generator required to register with the enforcement agency  pursuant to Section 117950  shall file with the enforcement agency a medical waste management  plan, on forms prescribed by the enforcement agency   plan  containing, but not limited to, all of the following: (a) The name of the person. (b) The business address of the person. (c) The type of business. (d) The types, and the estimated average monthly quantity, of medical waste generated. (e) The type of treatment used onsite, if applicable. For generators with onsite medical waste treatment facilities,  including incinerators or steam sterilizers or other treatment facilities as determined by the enforcement agency,  the treatment capacity of the onsite treatment facility. (f) The name and business address of the registered hazardous waste hauler used by the generator to have untreated medical waste removed for treatment, if applicable, and, if applicable, the name and business address of the common carrier transporting pharmaceutical waste pursuant to Section 118032.  (g) The name and business address of the registered hazardous waste hauler service provided by the building management to which the building tenants may subscribe or are required by the building management to subscribe, if applicable.   (h)   (g)  The name and business address of the offsite medical waste treatment facility to which the medical waste is being hauled, if applicable.  (i)   (h)  An emergency action plan complying with regulations adopted by the department.  (i) If applicable, the steps taken to categorize the pharmaceutical wastes generated at the facility to ensure that the wastes are properly disposed of as follows:   (1) Pharmaceutical wastes classified by the federal Drug Enforcement Agency (DEA) as "controlled substances" are disposed of in compliance with DEA requirements.   (2) The name and business address of the hazardous waste hauler used by the generator to have wastes that are not regulated pursuant to the federal Resource Conservation and Recovery Act of 1976 and nonradioactive pharmaceutical wastes regulated as medical wastes safely removed for treatment in compliance with subdivision (b) of Section 118222, as waste requiring specific methods.   (j) A closure plan for the termination of treatment at the facility.   (j)   (k)  A statement certifying that the information provided is complete and accurate.  SEC. 22.   Section 117970 of the   Health and Safety Code  is amended to read:  117970. (a) Each enforcement agency shall follow procedures consistent with this chapter in registering medical waste generators. (b) Each medical waste registration issued by the enforcement agency  for large quantity generators  shall be valid for one year. (c) An application for renewal of the registration shall be filed with the enforcement agency not less than 90 days prior to the expiration date. Failure to meet this requirement shall result in an assessment of a late fee. (d) Generators shall  submit within 30 days an updated application form when any of the information specified in subdivisions (a) to (j), inclusive, of Section 117960 changes   update their medical waste management plan within 30 days when any of the information in their medical waste management plan changes and shall have the plan on file for review during an inspection or upon request  .  SEC. 23.   Section 117975 of the   Health and Safety Code   is repealed.   117975. A medical waste generator required to register pursuant to this chapter shall maintain individual treatment, and tracking records, if medical waste is removed from the generator's site for treatment, for three years or for the period specified in the regulations.   SEC. 24.   Section 117975 is added to the Health and Safety Code, to read: 117975. (a) A large quantity medical waste generator required to register pursuant to this chapter shall maintain for a minimum of two years individual treatment records and shipping documents for all untreated medical waste shipped offsite for treatment. The generator shall report or submit to the enforcement agency, upon request, all of the following: (1) Treatment operating records. Operating records shall be maintained in written or electronic form. (2) An emergency action plan in accordance with regulations adopted by the department. (3) Shipping documents or electronically archived shipping documents maintained by the facility or medical waste hauler of all untreated medical wastes shipped offsite for treatment. (b) Documentation shall be made available to the enforcement agency onsite as soon as feasible, but no more than two business days following the request.   SEC. 25.   Section 117976 is added to the   Health and Safety Code   , to read:   117976. (a) A large quantity medical waste generator or parent organization that employs health care professionals who generate medical waste may transport medical waste generated in limited quantities to the central location of accumulation, provided that all of the following are met: (1) The principal business of the generator is not to transport or treat regulated medical waste. (2) The generator shall adhere to the conditions and requirements set forth in the materials of trade exception, as specified in Section 173.6 of Title 49 of the Code of Federal Regulations. (3) A person transporting medical waste pursuant to this section shall provide a form or log to the receiving facility, and the receiving facility shall maintain the form or log for a period of two years, containing all of the following information: (A) The name of the person transporting the medical waste. (B) The number of containers of medical waste transported. (C) The date the medical waste was transported. (b) A generator transporting medical waste pursuant to this section shall not be regulated as a hazardous waste hauler pursuant to Section 117660.   SEC. 26.   Section 118025 of the   Health and Safety Code   is amended to read:  118025. All medical waste shall be hauled by  either  a registered hazardous waste hauler or by a person with an  approved limited-quantity exemption granted pursuant to Section 118030   exception granted pursuant to Section 117946 for small quantity generators or pursuant to Section 117976 for large quantity generators  .  SEC. 6.   SEC. 27.  Section 118027 of the Health and Safety Code is amended to read: 118027. A person who is authorized to collect solid waste, as defined in Section 40191 of the Public Resources Code, who unknowingly transports medical waste to a solid waste facility, as defined in Section 40194 of the Public Resources Code, incidental to the collection of solid waste  ,  is exempt from the provisions of the Medical Waste Management Act with regard to that waste. If a solid waste transporter discovers that he or she has hauled untreated medical waste to a landfill or materials recovery facility, he or she shall contact the originating generator of the medical waste to respond to the landfill or recovery facility to provide ultimate proper disposal of the medical waste.  SEC. 7.   SEC. 28.  Section 118240 of the Health and Safety Code is amended to read: 118240. Notwithstanding Section 9141 of the Food and Agricultural Code, animals that die from infectious diseases or that are euthanized because they are suspected of having been exposed to infectious disease shall be treated with a treatment technology approved by the department for that use if, in the opinion of the attending veterinarian or local health officer, the carcass presents a danger of infection to humans.  SEC. 8.   SEC. 29.  No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.