Findings and Intent. | |
Definitions. | |
Authority to Adopt Rules and Regulations. | |
Registration Requirements For Small Quantity Generators. | |
Requirements For Nonregistrant Small Quantity Generators. | |
Medical Waste Haulers. | |
Permit Requirements For Common Storage Facilities. | |
Registration Requirements For Large Quantity Generators. | |
Permit Requirements For On-Site Medical Waste Treatment Facilities. | |
Containment and Storage Requirements. | |
Treatment Requirements. | |
Enforcement. | |
Inspection and Investigation Fees. | |
Fees. | |
Severability. | |
(a) The California Medical Waste Management Act, California Health and Safety Code, Division 20, Chapter 6.1, authorizes the California State Department of Health Services and local public health departments to register, permit, inspect and collect fees from facilities that generate medical waste to determine whether those facilities store, treat and dispose of those wastes in a manner that complies with the medical waste requirements of state law.
(b) The Board of Supervisors finds that public health and the environment in the City and County of San Francisco will be significantly enhanced by authorizing the Director of Public Health to implement and enforce a medical waste management program as set forth in Section 25034.3 of the California Health and Safety Code.
(c) It is the intent of the Board of Supervisors that, when necessary for the protection of public health, and as authorized under Section 25018 of the Health and Safety Code, the medical waste management program of the City and County of San Francisco shall be more stringent than state law whenever required by this ordinance or by the Director.
(Added by Ord. 375-92, App. 12/23/92)
The following definitions are applicable to this Article 25.
(a) "Act" means the Medical Waste Management Act, Chapter 6.1, Division 20, California Health and Safety Code.
(b) "Biohazard bag" means a disposable red bag which is impervious to moisture and has a strength sufficient to preclude ripping, tearing, or bursting under normal conditions of usage and handling of the waste-filled bag. A biohazard bag shall be constructed of material of sufficient single thickness strength to pass the 165-gram dropped dart impact resistance test as prescribed by Standard D 1709-85 of the American Society for Testing and Materials and certified by the bag manufacturer.
(c) "Biohazardous waste" means any of the following:
(1) Laboratory waste, including, but not limited to, all of the following:
(A) Human or animal specimen cultures from medical and pathological laboratories,
(B) Cultures and stocks of infectious agents from research and industrial laboratories,
(C) Wastes from the production of bacteria, viruses, or the use of spores, discarded live and attenuated vaccines, and culture dishes and devices used to transfer, inoculate, and mix cultures;
(2) Waste containing any microbiologic specimens sent to a laboratory for analysis;
(3) Human surgery specimens or tissues removed at surgery or autopsy, which are suspected by the attending physician, surgeon or dentist of being contaminated with infectious agents known to be contagious to humans. Human surgery specimens or tissues which have been fixed with formaldehyde or other fixatives are not biohazardous waste;
(4) Animal parts, tissues, fluids, or carcasses suspected by the attending veterinarian of being contaminated with infectious agents known to be contagious to humans;
(5) Waste, which at the point of transport from the generator's site, at the point of disposal, or thereafter, contains recognizable fluid blood, fluid blood products, containers, or equipment containing blood that is fluid or blood from animals known to be infected with diseases which are highly communicable to humans;
(6) Waste containing discarded materials contaminated with excretion, exudate, or secretions from humans who are required to be isolated by the infection control staff, the attending physician or surgeon, the attending veterinarian, or the Director, to protect others from highly communicable diseases or isolated animals known to be infected with diseases which are highly communicable to humans.
(d) "Common storage facility" means any on-site designated accumulation area maintained in accordance with this Chapter, used by small quantity generators otherwise operating independently, for the storage of medical waste for collection by a hazardous waste hauler.
(e) "Common storage facility permit" means a permit issued by the Director regulating the operation of a common storage facility.
(f) "Container" means the bag or rigid container in which medical waste is placed prior to transporting for purposes of storage or treatment.
(g) "Department" means the California Department of Health Services, Environmental Health Division.
(h) "Director" means the Director of Public Health or his designee, including any agents or registered environmental health specialists appointed by the Director.
(i) "Hazardous waste hauler" means a person registered as a hazardous waste hauler pursuant to Division 20, Chapter 6.5, Articles 6 (commencing with Section 25160) and 6.5 (commencing with Section 25167.1) of the California Health and Safety Code, and Chapter 30 (commencing with Section 66001) of Division 4 of Title 22 of the California Code of Regulations.
(j) "Highly communicable diseases" means diseases, such as those caused by organisms classified by the Federal Centers for Disease Control as Biosafety Level IV organisms, which, in the opinion of the Director, the infection control staff, the department, attending physician, surgeon, or attending veterinarian, merit special precautions to protect staff, patients, and other persons from infection. "Highly communicable diseases" does not include diseases such as the common cold, influenza, or other diseases not representing a significant danger to nonimmunocompromised persons.
(k) "Household waste" means any material, including garbage, trash, and sanitary wastes in septic tanks and medical waste, which is derived from households, farms or ranches.
(l) "Infectious agent" means a type of microorganism, bacteria, mold, parasite, or virus which normally causes, or significantly contributes to the cause of, increased morbidity or mortality of human beings.
(m) "Large quantity generator" means a medical waste generator that generates 200 or more pounds per month of medical waste.
(n) (1) "Medical waste" means waste which meets both of the following requirements:
(A) The waste is composed of waste which is generated or produced as a result of any of the following:
(i) Diagnosis, treatment, or immunization of human beings or animals,
(ii) Research pertaining to the activities specified in subparagraph (i),
(iii) The production or testing of biologicals;
(B) The waste is any of the following:
(i) Biohazardous waste,
(ii) Sharps waste.
(2) Medical waste may contain infectious agents.
(3) For purposes of this subsection, "biologicals" means medicinal preparations made from living organisms and their products, including, but not limited to, serums, vaccines, antigens and antitoxins.
(4) Medical waste which has been treated in accordance with Section 1511 and which is not otherwise hazardous, shall be considered solid waste as defined in Section 40191 of the California Public Resources Code, and not medical waste. Sharps waste rendered noninfectious pursuant to Paragraph (a)(4) of Section 1511 may be disposed of as solid waste if the waste is not otherwise hazardous.
(5) Medical waste does not include any of the following:
(A) Waste containing microbiological cultures used in food processing and biotechnology and any containers or devices used in the preparation and handling of these cultures, that is not considered to be an infectious agent pursuant to Subsection 1502(j);
(B) Urine, feces, saliva, sputum, nasal secretions, sweat, tears, and vomitus, unless they contain fluid blood, except as defined in Paragraph (c)(6) of Section 1502;
(C) Waste which is not biohazardous, such as paper towels, paper products, articles containing nonfluid blood, and other medical solid waste products commonly found in the facilities of medical waste generators;
(D) Hazardous waste, radioactive waste, or household waste;
(E) Waste generated from normal and legal veterinarian agricultural, and animal livestock management practices on a farm or ranch.
(o) "Medical waste generator" means any person, whose act or process produces medical waste and includes, but is not limited to, a provider of health care as defined in Subdivision (a) of Section 56.05 of the Civil Code. All of the following are examples of businesses which generate medical waste:
(1) Medical and dental offices, clinics, hospitals, surgery centers, laboratories, research laboratories, other health facilities required to be licensed pursuant to Division 2 (commencing with Section 1200), and unlicensed facilities;
(2) Veterinary offices, clinics, and hospitals;
(3) Pet shops.
(q) "Medical waste permit" means a permit issued by the Director to a medical waste treatment facility.
(r) "Medical waste registration" means a registration issued by the Director to a medical waste generator.
(s) "Medical waste treatment facility" means all land and structures, and other adjacent land, including appurtenances or improvements thereon, used for treating medical waste or for associated handling and storage of medical waste. "Adjacent," for purposes of the preceding sentence, means real property within 400 yards from the property boundary of the existing medical waste treatment facility. Medical waste treatment facilities are those facilities treating waste pursuant to Paragraphs (a)(1) or (a)(3) of Section 1511. A medical waste treatment method approved pursuant to Paragraph (a)(4) of Section 1511 may be designated as a medical waste treatment facility by the Director if approved by the Department.
(t) "Mixed waste" means mixtures of medical and nonmedical waste. Mixed waste is medical waste, except for all of the following:
(1) Medical waste and hazardous waste is hazardous waste and is subject to regulation as specified in the statutes and regulations applicable to hazardous waste;
(2) Medical waste and radioactive waste is radioactive waste and is subject to regulation as specified in the statutes and regulations applicable to radioactive waste;
(3) Medical waste, hazardous waste, and radioactive waste is radioactive mixed waste and is subject to regulation as specified in the statutes and regulations applicable to hazardous waste and radioactive waste.
(u) "Off-site" means any location which is not on-site.
(v) "On-site," unless otherwise specified, means a medical waste treatment facility or a common storage facility on the same or adjacent property as the generator of the medical waste being treated or stored. "Adjacent," for purposes of the preceding sentence, means real property within 400 yards from the property boundary of the medical waste generator.
(w) "Person" means an individual, trust, firm, joint stock company, business concern, corporation, including but not limited to, a government corporation, partnership, and association. "Person" also includes any city, county, district, commission, the State or any division, agency, or political subdivision thereof, the Regents of the University of California, any interstate body, and the Federal Government or any Department or agency thereof to the extent permitted by law.
(x) "Sharps container" means a rigid puncture-resistant container which, when sealed, is leak resistant and cannot be reopened without great difficulty.
(y) "Sharps waste" means any device having acute rigid corners, edges, or protuberances capable of cutting or piercing, including, but not limited to, all of the following:
(1) Hypodermic needles, syringes, blades, and needles with attached tubing;
(2) Broken glass items, such as Pasteur pipettes and blood vials contaminated with other medical waste.
(z) "Small quantity generator" means a medical waste generator that generates less than 200 pounds per month of medical waste.
(aa) "Storage" means the holding of medical wastes at a designated accumulation area, as specified in Section 1510.
(bb) "Tracking document" means a medical waste tracking document prescribed by the Director or substantially similar thereto, which contains the following information regarding each load of medical waste being transported off-site:
(1) The name, address, and telephone number of the hazardous waste hauler, unless the medical waste is being transported pursuant to a Section 1506 hauling exemption;
(2) The type and quantity of medical waste transported;
(3) The name of the medical waste generator;
(4) The name, address, telephone number, and the signature of the authorized representative of the permitted treatment or transfer station receiving the medical waste.
(cc) "Transfer station" means any off-site location where medical waste is loaded, unloaded, or stored during the normal course of transportation of the medical waste. "Transfer station" does not include common storage facilities, large quantity generators used for consolidation of medical waste, or on-site treatment facilities. Transfer stations shall be permitted by the Department pursuant to the Act and this Article.
(dd) "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 Section 1511.
(Added by Ord. 375-92, App. 12/23/92)
(a) Program Implementation. The Director is authorized to implement and administer a medical waste management program as approved pursuant to the California Health and Safety Code. The Director may adopt and from time to time amend reasonable rules, regulations and guidelines consistent with and implementing the provisions of this Article. Prior to adoption of any rule or regulation under this Article, the Director shall provide a 30-day public comment period by providing published notice in an official newspaper of general circulation in the City and County of San Francisco of the intent to issue or amend the rule or regulation. Rules and regulations shall be approved by the Health Commission at a public hearing. In addition to the notices required by law, the Secretary of the Health Commission shall send written notice, at least 15 days prior to the hearing, to any interested party who sends a written request to the Health Commission for notice of hearings on medical waste regulation. Regulations promulgated by the Director and approved by the Health Commission shall be maintained in the office of the Clerk of the Board of Supervisors.
(b) Hearings on Permits and Administrative Orders. Whenever notice and a hearing are required for the Director's action on a permit, or for issuance of an administrative order, such notice shall be sent by certified mail to the permit applicant, permittee, property owner or facility operator. Notice of a hearing shall also be given by publication in a newspaper of general circulation in the City for at least two days and not less than 10 days prior to the date of such hearing. Any hearing under this Article may be continued by the person conducting the hearing for a reasonable time for the convenience of a party or a witness.
(1) The notice of hearing shall set forth the time and place of the hearing, the ground or grounds upon which the action is based, the pertinent code section or sections, and a brief statement of the factual matters in support thereof. The notice shall be given at least 15 days prior to the hearing date.
(Added by Ord. 375-92, App. 12/23/92)
(a) On-Site Treatment Registration. Each small quantity generator using on-site steam sterilization, incineration, or microwave technology to treat medical waste shall register with the Director.
(1) Small quantity generators using on-site treatment, as specified in Subsection (a), which operate as a business in the same building, or which are associated with a group practice in the same building, may register as one generator.
(2) Small quantity generators using on-site treatment, as specified in Subsection (a), operating as specified in Paragraph (a)(1) in different buildings on the same or adjacent property, or as approved by the Director, may register as one generator.
(3) "Adjacent," for purposes of paragraph (a)(2), means real property within 400 yards from the property boundary of the primary registration site.
(b) Registration Deadline. Small quantity generators subject to Subsection 1504(a) shall register with the Director and pay the required fee no later than 120 days after the effective date of this Article. In those cases where the generation of medical waste begins after the effective date of this Article, registration shall be completed pursuant to this Article prior to commencement of the generation of medical waste.
(c) Registration by Filing Management Plan. Any small quantity generator required to register with the Director pursuant to this Section shall file with the Director a medical waste management plan, on forms prescribed by the Director containing, but not limited to, all of the following:
(1) The name of the person responsible for operation of the small quantity generator, or with direct responsibility for management of medical waste;
(2) The business address of the person specified in Paragraph (1);
(3) The type of business;
(4) The types, and the estimated average monthly quantity, of medical waste generated;
(5) The type of treatment used on-site;
(6) The name and business address of the hazardous waste hauler used by the generator for backup treatment and disposal, for waste for which the on-site treatment method is not appropriate due to the hazardous or radioactive characteristics of the waste, or the name of the hazardous hauler used by the generator to have untreated medical waste removed for treatment and disposal;
(7) A statement indicating that the generator is hauling the medical waste generated in his or her business pursuant to Section 1506 and the name and any business address of the treatment and disposal facilities to which the waste is being hauled, if applicable;
(8) The name and business address of the 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;
(9) A statement certifying that the information provided is complete and accurate.
(d) Inspection and Additional Permitting Requirements. Small quantity generators required to register under Subsection 1504(a) are subject to biennial inspection of the on-site treatment facility by the Director and may be subject to the permitting requirements of Section 1509 for on-site medical waste treatment facilities as determined by the Director. The inspection and permitting requirements of this paragraph do not apply when on-site steam sterilization is not used for the treatment or disposal of medical waste.
(e) Duration of Registration; Renewal and Update of Information. Each small quantity generator registration issued by the Director under Subsection 1504(a) shall be valid for two years. Applications for renewal of the registration shall be filed with the Director on or before the expiration date. Small quantity generators shall submit an updated application form within 30 days of any change in the medical waste management plan information specified in Paragraphs (c)(1) to (c)(9) of this Section.
(f) Recordkeeping Requirements. Any medical waste generator required to register pursuant to this Section shall maintain individual treatment and tracking records, including tracking documents if applicable, for three years, or for the period specified in the Director's regulations, and shall report or submit to the Director, upon request, both of the following:
(1) Treatment operating records;
(2) An emergency action plan complying with regulations adopted by the State of California, pursuant to the Act.
(g) Containment and Storage Requirements. Containment and storage of medical waste shall be in accordance with Section 1510.
(h) Treatment Requirements. Treatment of medical waste shall be in accordance with Section 1511.
(i) Fees For Small Quantity Generator Registration. The registration and inspection fee for small quantity generators required to register under Subsection 1504(a) is $524.
(Added by Ord. 375-92, App. 12/23/92; amended by Ord. 176-04, File No. 040734, App. 7/22/2004; Ord. 148-08, File No. 080745, App. 7/30/2008)
(a) Recordkeeping by Nonregistrants. Small quantity generators who are not required to register pursuant to this Article shall maintain on file in their office all of the following:
(1) 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. The information document may be prepared using the medical waste management plan form prescribed by the Director pursuant to Subsection 1504(d);
(2) Records of any medical waste transported off-site for treatment and disposal, including the quantity of waste transported, the date transported, and the name of the hazardous waste hauler or individual hauling the waste pursuant to Subsection 1506(b). The small quantity generator shall maintain these records for not less than two years.
(b) Nonregistrant Fee and Notification. Every small quantity generator subject to Subsection 1505(a) shall mail a copy of the information document specified in Paragraph (a)(1) to the Director no later than 120 days after the effective date of this Article. In those cases where the generation of medical waste begins after the effective date of this Article, the information document shall be mailed to the Director within 30 days of commencement of the generation of medical waste.
(1) The information document shall be accompanied by a one-time fee of $154.
(2) A new information document and fee shall be submitted only if the generator moves to a new location more than 400 yards from the boundary of the location specified in the previous information document.
(Added by Ord. 375-92, App. 12/23/92; amended by Ord. 176-04, File No. 040734, App. 7/22/2004; Ord. 148-08, File No. 080745, App. 7/30/2008)
(a) Transportation of Waste. Except as otherwise exempted pursuant to Subsection 1506(b), all medical waste shall be transported off-site by a hazardous waste hauler in leak-resistant and fully enclosed rigid containers in vehicle compartments. Medical waste shall be transported off-site only to a permitted medical waste treatment facility, a permitted transfer station, or a permitted large quantity generator for the purpose of consolidation before treatment and disposal pursuant to this Article and the Act; provided that, no large quantity generator shall accept off-site medical waste for purposes of consolidation before treatment and disposal without written permission from the Director or as provided in a permit under this Article.
(1) No person shall transport medical waste in the same vehicle with other waste unless the medical waste is separately contained in rigid containers or kept separate by barriers from other waste, unless all of the waste is to be handled as medical waste under this Article.
(2) Any persons manually loading or unloading containers of medical waste shall be provided by their employer at the beginning of each shift with, and shall be required to wear, clean and protective gloves and coveralls, changeable lab coats, or other protective clothing.
(b) Application for Exemption. Small quantity generators may apply to the Director for an off-site limited-quantity hauling exemption, if the generator meets all of the following requirements:
(2) The generator transports the waste himself or herself, or directs a member of his or her staff to transport the waste, to a permitted medical waste treatment facility or a permitted transfer station before consolidation or treatment and disposal.
(3) The generator maintains a tracking document.
(A) Any person transporting medical waste off-site in a vehicle shall have a tracking document in his or her possession while transporting the waste.
(B) The original tracking document shall be provided to the facility receiving the medical waste.
(c) Issuance of Hauling Exemption; Fee. The Director may issue or modify small quantity generator hauling exemptions with such conditions as necessary to protect public health and welfare. Every applicant for an exemption shall pay a fee of $175 in addition to the small quantity generator registration fee under Section 1504 or the nonregistrant fee under Section 1505.
(Added by Ord. 375-92, App. 12/23/92; amended by Ord. 176-04, File No. 040734, App. 7/22/2004; Ord. 148-08, File No. 080745, App. 7/30/2008)
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