Chapter 2. Definitions of California Health And Safety Code >> Division 104. >> Part 14. >> Chapter 2.

Unless the context requires otherwise, the definitions in this article govern the construction of this part.

(a) "Biohazard bag" means a disposable film bag used to contain medical waste. Notwithstanding subdivision (b) of Section 117605, the film bags that are used to line the United States Department of Transportation (USDOT)-approved shipping containers for transport from the generator's facility onto roadways and into commerce to a treatment and disposal facility 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 D1709, "Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method," as those documents were 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.
  (b) The biohazard bag that is used to collect medical waste within a facility shall be manufacturer certified to meet the ASTM D1709 dart drop test, provided that when the bag is prepared for transport offsite, it is placed into a USDOT-approved container lined with a biohazard bag that is ASTM D1709 and ASTM D1922 certified.
  (c) The color of the bag shall be red, except when yellow bags are used to further segregate trace chemotherapy waste and white bags are used to further segregate pathology waste. The biohazard bag shall be marked with the international biohazard symbol and may be labeled by reference as authorized by the USDOT.

"Chemotherapeutic agent" means an agent that kills or prevents the reproduction of malignant cells. Chemotherapeutic agent excludes anti-inflammatory and antibiotic medications used to treat malignant cells in the practice of veterinary medicine.

"Common carrier" means either of the following:
  (a) A person or company that has a United States Department of Transportation number issued by the Federal Motor Carrier Safety Administration and is registered with the Federal Motor Carrier Safety Administration as a for-hire property carrier.
  (b) A person or company that has a motor carrier of property permit issued by the Department of Motor Vehicles pursuant to the Motor Carriers of Property Permit Act (Division 14.85 (commencing with Section 34600) of the Vehicle Code) and, if applicable, a carrier identification number issued by the Department of the California Highway Patrol pursuant to Section 34507.5 of the Vehicle Code.

"Common storage facility" means any designated accumulation area that is onsite and is used by small quantity generators otherwise operating independently for the storage of medical waste for collection by a registered hazardous waste hauler.

"Container" means the rigid container in which the medical waste is placed prior to transporting for purposes of storage or treatment.

"Empty" means a condition achieved when tubing, a container, or inner liner removed from a container that previously contained liquid or solid material, including, but not limited to, a chemotherapeutic agent, is considered empty. The tubing, container, or inner liner removed from the container shall be considered empty if it has been emptied so that the following conditions are met:
  (a) If the material that the tubing, container, or inner liner held is pourable, no material can be poured or drained from the tubing, container, or inner liner when held in any orientation, including, but not limited to, when tilted or inverted.
  (b) If the material that the container or inner liner held is not pourable, no material or waste remains in the container or inner liner that can feasibly be removed by scraping.

"Enforcement agency" means the department or the local agency administering this part.

"Enforcement officer" means the director, or agents or registered environmental health specialists appointed by the director, and all local health officers, directors of environmental health, and their duly authorized registered environmental health specialists and environmental health specialist trainees, or the designees of the director, local health officers, or the directors of environmental health.

"Fund" means the Medical Waste Management Fund created pursuant to Section 117885.

"Hazardous waste hauler" means a person registered as a hazardous waste hauler pursuant to Article 6 (commencing with Section 25160) and Article 6.5 (commencing with Section 25167.1) of Chapter 6.5 of Division 20 and Chapter 30 (commencing with Section 66001) of Division 4 of Title 22 of the California Code of Regulations.

"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).

"Highly communicable diseases" means diseases, such as those caused by organisms classified by the federal Centers for Disease Control and Prevention as risk group 3 organisms or higher.

"Household waste" means any material, including garbage, trash, and sanitary wastes in septic tanks and medical waste, that is derived from households, farms, or ranches. Household waste does not include trauma scene waste.

"Home-generated sharps waste" means hypodermic needles, pen needles, intravenous needles, lancets, and other devices that are used to penetrate the skin for the delivery of medications derived from a household, including a multifamily residence or household.

"Industrial hygienist" means a person who has met the educational requirements of an industrial hygiene certification organization, as defined in subdivision (c) of Section 20700 of the Business and Professions Code, and who has had at least one year in the comprehensive practice of industrial hygiene, as defined in subdivision (a) of Section 20700 of the Business and Professions Code.

"Infectious agent" means a type of microorganism, bacteria, mold, parasite, or virus, including, but not limited to, organisms managed as Biosafety Level II, III, or IV by the federal Centers for Disease Control and Prevention, that normally causes, or significantly contributes to the cause of, increased morbidity or mortality of human beings.

"Large quantity generator" means a medical waste generator, other than a trauma scene waste management practitioner, that generates 200 or more pounds of medical waste in any month of a 12-month period.

"Local agency" means the local health department, as defined in Section 101185, or the local comprehensive environmental agency established in accordance with Section 101275, of a county that has elected to adopt a local ordinance to administer and enforce this part, pursuant to Chapter 3 (commencing with Section 117800).

(a) "Medical waste" means any biohazardous, pathology, pharmaceutical, or trace chemotherapy waste not regulated by the federal Resource Conservation and Recovery Act of 1976 (Public Law 94-580), as amended; sharps and trace chemotherapy wastes generated in a health care setting in the diagnosis, treatment, immunization, or care of humans or animals; waste generated in autopsy or necropsy; waste generated during preparation of a body for final disposition such as cremation or interment; waste generated in research pertaining to the production or testing of microbiologicals; waste generated in research using human or animal pathogens; sharps and laboratory waste that poses a potential risk of infection to humans generated in the inoculation of animals in commercial farming operations; waste generated from the consolidation of home-generated sharps; and waste generated in the cleanup of trauma scenes. Biohazardous, pathology, pharmaceutical, sharps, and trace chemotherapy wastes that meet the conditions of this section are not subject to any of the hazardous waste requirements found in Chapter 6.5 (commencing with Section 25100) of Division 20.
  (b) For purposes of this part the following definitions apply:
  (1) "Biohazardous waste" includes all of the following:
  (A) (i) Regulated medical waste, clinical waste, or biomedical waste that is a waste or reusable material derived from the medical treatment of a human or from an animal that is suspected by the attending veterinarian of being infected with a pathogen that is also infectious to humans, which includes diagnosis and immunization; or from biomedical research, which includes the production and testing of biological products.
  (ii) Regulated medical waste or clinical waste or biomedical waste suspected of containing a highly communicable disease.
  (B) Laboratory waste such as human specimen cultures or animal specimen cultures that are infected with pathogens that are also infectious to humans; cultures and stocks of infectious agents from research; wastes from the production of bacteria, viruses, spores, discarded live and attenuated vaccines used in human health care or research, discarded animal vaccines, including Brucellosis and Contagious Ecthyma, as defined by the department; culture dishes, devices used to transfer, inoculate, and mix cultures; and wastes identified by Section 173.134 of Title 49 of the Code of Federal Regulations as Category B "once wasted" for laboratory wastes.
  (C) Waste that, at the point of transport from the generator's site or at the point of disposal contains recognizable fluid human blood, fluid human blood products, containers, or equipment containing human blood that is fluid, or blood from animals suspected by the attending veterinarian of being contaminated with infectious agents known to be contagious to humans.
  (D) Waste containing discarded materials contaminated with excretion, exudate, or secretions from humans or animals that are required to be isolated by the infection control staff, the attending physician and surgeon, the attending veterinarian, or the local health officer, to protect others from highly communicable diseases or diseases of animals that are communicable to humans.
  (2) Pathology waste includes both of the following:
  (A) Human body parts, with the exception of teeth, removed at surgery and surgery specimens or tissues removed at surgery or autopsy that are suspected by the health care professional of being contaminated with infectious agents known to be contagious to humans or having been fixed in formaldehyde or another fixative.
  (B) Animal parts, tissues, fluids, or carcasses suspected by the attending veterinarian of being contaminated with infectious agents known to be contagious to humans.
  (3) "Pharmaceutical waste" means a pharmaceutical, as defined in Section 117747, including trace chemotherapy waste, that is a waste, as defined in Section 25124. For purposes of this part, "pharmaceutical waste" does not include a pharmaceutical that meets either of the following criteria:
  (A) The pharmaceutical is being sent out of the state to a reverse distributor, as defined in Section 4040.5 of the Business and Professions Code, that is licensed as a wholesaler of dangerous drugs by the California State Board of Pharmacy pursuant to Section 4161 of the Business and Professions Code.
  (B) The pharmaceutical is being sent by a reverse distributor, as defined in Section 4040.5 of the Business and Professions Code, offsite for treatment and disposal in accordance with applicable laws, or to a reverse distributor that is licensed as a wholesaler of dangerous drugs by the California State Board of Pharmacy pursuant to Section 4160 of the Business and Professions Code and as a permitted transfer station if the reverse distributor is located within the state.
  (4) "Sharps waste" means a device that has acute rigid corners, edges, or protuberances capable of cutting or piercing, including, but not limited to, hypodermic needles, hypodermic needles with syringes, blades, needles with attached tubing, acupuncture needles, root canal files, broken glass items used in health care such as Pasteur pipettes and blood vials contaminated with biohazardous waste, and any item capable of cutting or piercing from trauma scene waste.
  (5) "Trace chemotherapeutic waste" means waste that is contaminated through contact with, or having previously contained, chemotherapeutic agents, including, but not limited to, gloves, disposable gowns, towels, and intravenous solution bags and attached tubing that are empty. A biohazardous waste that meets the conditions of this paragraph is not subject to the hazardous waste requirements of Chapter 6.5 (commencing with Section 25100) of Division 20.
  (6) "Trauma scene waste" means waste that is a regulated waste, as defined in Section 5193 of Title 8 of the California Code of Regulations, and that has been removed, is to be removed, or is in the process of being removed, from a trauma scene by a trauma scene waste management practitioner.

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.

Medical waste does not include any of the following:
  (a) Waste generated in food processing or biotechnology that does not contain an infectious agent, as defined in Section 117675, or an agent capable of causing an infection that is highly communicable, as defined in Section 117665.
  (b) Waste generated in biotechnology that does not contain human blood or blood products or animal blood or blood products suspected of being contaminated with infectious agents known to be communicable to humans or a highly communicable disease.
  (c) Urine, feces, saliva, sputum, nasal secretions, sweat, tears, or vomitus, unless it contains visible or recognizable fluid blood, as provided in subparagraph (C) of paragraph (1) of subdivision (b) of Section 117690.
  (d) 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.
  (e) Hazardous waste, radioactive waste, or household waste, including, but not limited to, home-generated sharps waste, as defined in Section 117671.
  (f) Waste generated from normal and legal veterinarian, agricultural, and animal livestock management practices on a farm or ranch unless otherwise specified in law.

"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 Section 56.05 of the Civil Code. All of the following are examples of businesses that generate medical waste:
  (a) Medical and dental offices, clinics, hospitals, surgery centers, laboratories, research laboratories, unlicensed health facilities, those facilities required to be licensed pursuant to Division 2 (commencing with Section 1200), chronic dialysis clinics, as regulated pursuant to Division 2 (commencing with Section 1200), and education and research facilities.
  (b) Veterinary offices, veterinary clinics, and veterinary hospitals.
  (c) Pet shops.
  (d) Trauma scene waste management practitioners.

"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.

"Medical waste permit" means a permit issued by the enforcement agency to a medical waste treatment facility.

"Medical waste registration" means a registration issued by the enforcement agency to a medical waste generator.

(a) "Medical waste treatment facility" means all land and structures, and other appurtenances or improvements on the land under the control of the treatment facility, used for treating medical waste offsite from a medical waste generator, including all associated handling and storage of medical waste as permitted by the department.
  (b) For purposes of this section, land is under the control of the treatment facility if it is owned, rented, or controlled by contractual agreement.

"Mixed waste" means mixtures of medical and nonmedical waste. Mixed waste is medical waste, except for all of the following:
  (a) Medical waste and hazardous waste is hazardous waste and is subject to regulation as specified in the statutes and regulations applicable to hazardous waste.
  (b) Medical waste and radioactive waste is radioactive waste and is subject to regulation as specified in the statutes and regulations applicable to radioactive waste.
  (c) 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.

"Offsite" means any location that is not onsite.

(a) "Onsite" means a medical waste treatment facility, or common storage facility on the same or adjacent property as the generator of the medical waste being treated.
  (b) "Adjacent," for purposes of subdivision (a), means real property within 400 yards from the property boundary of the existing medical waste treatment facility.

"Parent organization" means an organization that employs or contracts with health care professionals who provide health care services at a location other than at a health care facility specified in subdivision (a) of Section 117705.

"Person" means an individual, trust, firm, joint stock company, business concern, partnership, association, limited liability company, and corporation, including, but not limited to, a government corporation. "Person" also includes any city, county, district, commission, the state or any department, 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.

(a) "Pharmaceutical" means a prescription or over-the-counter human or veterinary drug, including, but not limited to, a drug as defined in Section 109925 of the Federal Food, Drug, and Cosmetic Act, as amended, (21 U.S.C.A. Sec. 321(g)(1)).
  (b) For purposes of this part, "pharmaceutical" does not include any pharmaceutical 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.A. Sec. 6901 et seq.). This waste stream shall be handled as a hazardous waste under the authority of Chapter 6.5 (commencing with Section 25100) of Division 20.
  (2) The Radiation Control Law (Chapter 8 (commencing with Section 114960) of Part 9).

(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 United States Food and Drug Administration as a medical device used for the collection of discarded medical needles or other sharps.
  (b) Sharps containers, including those used to containerize trace chemotherapeutic wastes, shall not be lined with a plastic bag or inner liner.

"Small quantity generator" means a medical waste generator, other than a trauma scene waste management practitioner, that generates less than 200 pounds per month of medical waste.

"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.

"Tracking document" means the medical waste tracking document specified in Section 118040.

"Shipping document" means the medical waste shipping document required by the United States Department of Transportation pursuant to Section 172.200 et seq. of Title 49 of the Code of Federal Regulations or the document required by the United States Postal Service pursuant to Domestic Mail Manual 601.10.17.5 (Mailability: Hazardous Materials: Sharps and Other Mailable Regulated Medical Waste).

(a) "Transfer station" means an offsite location permitted by the department where medical waste is loaded, unloaded, stored, or consolidated by a registered hazardous waste hauler during the normal course of transportation of the medical waste.
  (b) "Transfer station" does not include any onsite facility, including, but not limited to, common storage facilities, facilities of medical waste generators employed for the purpose of consolidation, or onsite treatment facilities.

(a) "Trauma scene" means a location soiled by, or contaminated with, human blood, human body fluids, or other residues from the scene of a serious human injury, illness, or death.
  (b) For purposes of this section, a location may include, but is not limited to, a physical structure that is not fixed geographically, such as mobile homes, trailers, or vehicles.

"Trauma scene waste management practitioner" means a person who undertakes as a commercial activity the removal of human blood, human body fluids, and other associated residues from the scene of a serious human injury, illness, or death, and who is registered with the department pursuant to Chapter 9.5 (commencing with Section 118321).

"Treatment" means any method, technique, or process designed to change or destroy the biological character or composition of any medical waste so as to eliminate its potential for causing disease or creating public or environmental harm, as specified in Chapter 8 (commencing with Section 118215).