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Chapter 5. Large Quantity Generator Requirements of California Health And Safety Code >> Division 104. >> Part 14. >> Chapter 5.
(a) Each large quantity generator, except as specified in
subdivisions (b) and (c), shall register with the enforcement 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.
(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.
A large quantity generator required to register with the
enforcement agency shall file with the enforcement agency a medical
waste management plan, on forms prescribed by the enforcement agency,
if provided. The plans shall contain, but are 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, 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 offsite medical waste treatment facility to which the medical waste is being hauled, if applicable.
(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 using, at a minimum, one of the methods of decontamination specified in subdivision (a) or (b) of Section 118295, thereby rendering the property to an acceptable sanitary condition following the completion of treatment services at the site.
(k) A statement certifying that the information provided is complete and accurate.
(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, 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 offsite medical waste treatment facility to which the medical waste is being hauled, if applicable.
(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 using, at a minimum, one of the methods of decontamination specified in subdivision (a) or (b) of Section 118295, thereby rendering the property to an acceptable sanitary condition following the completion of treatment services at the site.
(k) A statement certifying that the information provided is complete and accurate.
Large quantity generators shall be subject to at least
annual inspection by the enforcement agency.
(a) Large quantity generators that treat medical waste
onsite using steam sterilization, incineration, microwave technology,
or other department approved treatment technology to treat medical
waste shall train the operators of the equipment in its use, proper
protective equipment to wear, if necessary, and how to clean up
spills to ensure that the equipment is being operated in a safe and
effective manner.
(b) Annual training for the operators shall be provided after the initial training has been completed.
(c) The training shall be documented and the documentation shall be retained at the facility for a minimum of two years. Training shall comply with applicable federal Occupational Safety and Health Administration regulations, including those found in Section 1910 of Title 29 of the Code of Federal Regulations.
(b) Annual training for the operators shall be provided after the initial training has been completed.
(c) The training shall be documented and the documentation shall be retained at the facility for a minimum of two years. Training shall comply with applicable federal Occupational Safety and Health Administration regulations, including those found in Section 1910 of Title 29 of the Code of Federal Regulations.
(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 update their medical waste management plan, established pursuant to Section 117960, when any of the information in the plan changes and shall have the plan on file for review during an inspection or upon request. The updated plan shall be submitted within 30 days of the change.
(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 update their medical waste management plan, established pursuant to Section 117960, when any of the information in the plan changes and shall have the plan on file for review during an inspection or upon request. The updated plan shall be submitted within 30 days of the change.
In addition to the fees collected pursuant to Section
117995, the department, in the implementation of this part, shall
recover its actual costs for services related to large quantity
medical waste generator followup inspections and enforcement
activities necessary to ensure compliance with this part. In no event
shall the department charge more than the actual costs incurred by
the department.
(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 the tracking document 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) Tracking documents or electronically archived tracking 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.
(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) Tracking documents or electronically archived tracking 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.
(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 up to 35.2 pounds 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.
(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.
Containment and storage of medical waste shall be in
accordance with Chapter 9 (commencing with Section 118275).
Medical waste shall be treated using treatment technologies
approved in accordance with Chapter 8 (commencing with Section
118215).
The fee schedule specified in Section 117995 shall be for
the issuance of medical waste registrations and onsite medical waste
treatment facility permits when the department serves as the
enforcement agency for large quantity generators. This fee schedule
shall be adjusted annually in accordance with Section 100425, or as
provided in the regulations adopted by the department, not to exceed
the reasonable regulatory costs of the department. Local enforcement
agencies shall set fees that shall be sufficient to cover their costs
in implementing this part with regard to large quantity generators.
The registration and annual permit fee for large quantity
generators shall be set in following amounts:
(a) (1) A general acute care hospital, as defined in subdivision (a) of Section 1250, that has one or more beds, but not more than 99 beds, shall pay six hundred dollars ($600), a facility with 100 or more beds, but not more than 199 beds, shall pay eight hundred sixty dollars ($860), a facility with 200 or more beds, but not more than 250 beds shall pay one thousand one hundred dollars ($1,100), and a facility with 251 or more beds shall pay one thousand four hundred dollars ($1,400).
(2) In addition to the fees specified in paragraph (1), a general acute care hospital which is providing onsite treatment of medical waste shall pay an annual medical waste treatment facility inspection and permit fee of three hundred dollars ($300), if the facility has one or more beds but not more than 99 beds, five hundred dollars ($500), if the facility has 100 or more beds but not more than 250 beds, and one thousand dollars ($1,000), if the facility has 251 or more beds.
(b) A specialty clinic, providing surgical, dialysis, or rehabilitation services, as defined in subdivision (b) of Section 1204, shall pay three hundred fifty dollars ($350).
(c) A skilled nursing facility, as defined in subdivision (c) of Section 1250, that has one or more beds, but not more than 99 beds shall pay two hundred seventy-five dollars ($275), a facility with 100 or more beds, but not more than 199 beds shall pay three hundred fifty dollars ($350), and a facility with 200 or more beds shall pay four hundred dollars ($400).
(d) An acute psychiatric hospital, as defined in subdivision (b) of Section 1250, shall pay two hundred dollars ($200).
(e) An intermediate care facility, as defined in subdivision (d) of Section 1250, shall pay three hundred dollars ($300).
(f) A primary care clinic, as defined in Section 1200.1, shall pay three hundred fifty dollars ($350).
(g) A licensed clinical laboratory, as defined in paragraph (3) of subdivision (a) of Section 1206 of the Business and Professions Code, shall pay two hundred dollars ($200).
(h) A health care service plan facility, as defined in subdivision (f) of Section 1345, shall pay three hundred fifty dollars ($350).
(i) A veterinary clinic or veterinary hospital shall pay two hundred dollars ($200).
(j) A large quantity generator medical office shall pay two hundred dollars ($200).
(k) In addition to the fees specified in subdivisions (b) to (j), inclusive, a large quantity generator of medical waste which is providing onsite treatment of medical waste shall pay an annual medical waste treatment facility inspection and permit fee of three hundred dollars ($300).
(l) The department may collect annual fees and issue permits on a biennial basis.
(a) (1) A general acute care hospital, as defined in subdivision (a) of Section 1250, that has one or more beds, but not more than 99 beds, shall pay six hundred dollars ($600), a facility with 100 or more beds, but not more than 199 beds, shall pay eight hundred sixty dollars ($860), a facility with 200 or more beds, but not more than 250 beds shall pay one thousand one hundred dollars ($1,100), and a facility with 251 or more beds shall pay one thousand four hundred dollars ($1,400).
(2) In addition to the fees specified in paragraph (1), a general acute care hospital which is providing onsite treatment of medical waste shall pay an annual medical waste treatment facility inspection and permit fee of three hundred dollars ($300), if the facility has one or more beds but not more than 99 beds, five hundred dollars ($500), if the facility has 100 or more beds but not more than 250 beds, and one thousand dollars ($1,000), if the facility has 251 or more beds.
(b) A specialty clinic, providing surgical, dialysis, or rehabilitation services, as defined in subdivision (b) of Section 1204, shall pay three hundred fifty dollars ($350).
(c) A skilled nursing facility, as defined in subdivision (c) of Section 1250, that has one or more beds, but not more than 99 beds shall pay two hundred seventy-five dollars ($275), a facility with 100 or more beds, but not more than 199 beds shall pay three hundred fifty dollars ($350), and a facility with 200 or more beds shall pay four hundred dollars ($400).
(d) An acute psychiatric hospital, as defined in subdivision (b) of Section 1250, shall pay two hundred dollars ($200).
(e) An intermediate care facility, as defined in subdivision (d) of Section 1250, shall pay three hundred dollars ($300).
(f) A primary care clinic, as defined in Section 1200.1, shall pay three hundred fifty dollars ($350).
(g) A licensed clinical laboratory, as defined in paragraph (3) of subdivision (a) of Section 1206 of the Business and Professions Code, shall pay two hundred dollars ($200).
(h) A health care service plan facility, as defined in subdivision (f) of Section 1345, shall pay three hundred fifty dollars ($350).
(i) A veterinary clinic or veterinary hospital shall pay two hundred dollars ($200).
(j) A large quantity generator medical office shall pay two hundred dollars ($200).
(k) In addition to the fees specified in subdivisions (b) to (j), inclusive, a large quantity generator of medical waste which is providing onsite treatment of medical waste shall pay an annual medical waste treatment facility inspection and permit fee of three hundred dollars ($300).
(l) The department may collect annual fees and issue permits on a biennial basis.
