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Chapter 4. Small Quantity Generator Requirements of California Health And Safety Code >> Division 104. >> Part 14. >> Chapter 4.
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
in accordance with Chapter 8 (commencing with Section 118215).
The fee schedule specified in Section 117923 shall be for
the issuance of medical waste registrations and for conducting
inspections pursuant to this chapter when the department serves as
the enforcement agency for small 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 small
quantity generators required to be registered pursuant to Section
117925.
(a) The registration and inspection fee for small quantity
generators using onsite treatment, including an autoclave,
incinerator, or microwave technology, to treat medical waste is one
hundred dollars ($100), that shall be paid once every two years.
(b) The annual permit fee for a common storage facility permitted pursuant to Section 117928 is the amount specified in the following schedule:
(1) For storage facilities serving 10 or fewer generators, the permit fee is one hundred dollars ($100).
(2) For storage facilities serving 11 or more generators, but not more than 50 generators, the permit fee is two hundred fifty dollars ($250).
(3) For storage facilities serving more than 50 generators, the permit fee is five hundred dollars ($500).
(b) The annual permit fee for a common storage facility permitted pursuant to Section 117928 is the amount specified in the following schedule:
(1) For storage facilities serving 10 or fewer generators, the permit fee is one hundred dollars ($100).
(2) For storage facilities serving 11 or more generators, but not more than 50 generators, the permit fee is two hundred fifty dollars ($250).
(3) For storage facilities serving more than 50 generators, the permit fee is five hundred dollars ($500).
(a) When the department is the enforcement agency, the
department shall impose and cause the collection of an annual medical
waste generator fee in an amount not to exceed twenty-five dollars
($25) on small quantity generators of medical waste, except for those
small quantity generators that are required to register pursuant to
Section 117925 and those generators generating only pharmaceutical
waste as defined in paragraph (3) of subdivision (b) of Section
117690. Nothing in this part shall prevent the department from
contracting with entities other than the department for these fee
collection activities or from entering into agreements with medical
waste transporters for the collection of these fees, if the
department determines that such a fee collection arrangement would be
cost effective.
(b) If the department determines to enter into a contract with a medical waste transporter for the collection of the fees, the department shall do all of the following:
(1) Establish that not more than 7.5 percent of the fees collected may be recovered by the medical waste transporter as administrative costs for the collection of those fees.
(2) Establish that the administrative costs for the collection of the fees shall be the same for all medical waste transporters.
(3) Prohibit any medical waste transporter from waiving the generator fee without the written approval of the department and only if the medical waste generator has made a written request for the waiver.
(4) Require the medical waste transporter to report the fees collected pursuant to subdivision (a) to the department.
(5) Prohibit the medical waste transporter from assuming the role of the department as an enforcement agent for purposes of collecting the medical waste generator fees.
(6) Require medical waste transporters to include the following language in at least 12-point type on their invoices to medical waste generators: "Pursuant to Section 117924 of the California Health and Safety Code, the State Department of Public Health has contracted with us to collect your annual medical waste generator fee. The department may offset our costs of collection and administration in an amount that may not exceed 7.5 percent of the fee collected. We may not waive the fee without written approval of the department, and only if you have made a written request for the waiver."
(7) Ensure that generators subject to this section are required to pay the fee only once per year.
(b) If the department determines to enter into a contract with a medical waste transporter for the collection of the fees, the department shall do all of the following:
(1) Establish that not more than 7.5 percent of the fees collected may be recovered by the medical waste transporter as administrative costs for the collection of those fees.
(2) Establish that the administrative costs for the collection of the fees shall be the same for all medical waste transporters.
(3) Prohibit any medical waste transporter from waiving the generator fee without the written approval of the department and only if the medical waste generator has made a written request for the waiver.
(4) Require the medical waste transporter to report the fees collected pursuant to subdivision (a) to the department.
(5) Prohibit the medical waste transporter from assuming the role of the department as an enforcement agent for purposes of collecting the medical waste generator fees.
(6) Require medical waste transporters to include the following language in at least 12-point type on their invoices to medical waste generators: "Pursuant to Section 117924 of the California Health and Safety Code, the State Department of Public Health has contracted with us to collect your annual medical waste generator fee. The department may offset our costs of collection and administration in an amount that may not exceed 7.5 percent of the fee collected. We may not waive the fee without written approval of the department, and only if you have made a written request for the waiver."
(7) Ensure that generators subject to this section are required to pay the fee only once per year.
(a) Each small quantity generator using onsite steam
sterilization, incineration, or microwave technology to treat medical
waste shall register with the enforcement agency. Small 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).
(b) Small quantity generators using onsite treatment, as specified in subdivision (a), that operate 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) Small quantity generators using onsite treatment, as specified in subdivision (a), as specified in subdivision (b), 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.
(b) Small quantity generators using onsite treatment, as specified in subdivision (a), that operate 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) Small quantity generators using onsite treatment, as specified in subdivision (a), as specified in subdivision (b), 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.
(a) Any common storage facility for the collection of
medical waste produced by small quantity generators operating
independently, but sharing common storage facilities, shall have a
permit issued by the enforcement agency prior to the commencement of
storage of medical waste in the common storage facility.
(b) A permit for any common storage facility specified in subdivision (a) may be obtained by any one of the following:
(1) A provider of health care as defined in Section 56.05 of the Civil Code.
(2) The registered hazardous waste transporter.
(3) The property owner.
(4) The property management firm responsible for providing tenant services to the medical waste generators.
(b) A permit for any common storage facility specified in subdivision (a) may be obtained by any one of the following:
(1) A provider of health care as defined in Section 56.05 of the Civil Code.
(2) The registered hazardous waste transporter.
(3) The property owner.
(4) The property management firm responsible for providing tenant services to the medical waste generators.
Small quantity generators that treat waste onsite, pursuant
to subdivision (a) of Section 117925, shall register with the
enforcement agency prior to the commencement of treatment.
A 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, 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.
(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.
(g) The name of the registered hazardous waste hauler used by the generator to have untreated medical waste removed for treatment and disposal, if applicable.
(h) The name of the common carrier used by the generator to transport pharmaceutical waste offsite for treatment and disposal pursuant to Section 118032, if applicable.
(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 registered 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 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.
(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.
(g) The name of the registered hazardous waste hauler used by the generator to have untreated medical waste removed for treatment and disposal, if applicable.
(h) The name of the common carrier used by the generator to transport pharmaceutical waste offsite for treatment and disposal pursuant to Section 118032, if applicable.
(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 registered 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 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) Small quantity generators using onsite steam
sterilization, incineration, or microwave technology to treat medical
waste are subject to biennial inspection of that onsite treatment
facility by the enforcement agency and may be subject to the
permitting requirements for onsite medical waste treatment facilities
as determined by the enforcement agency.
(b) (1) The operators of the treatment equipment specified in subdivision (a) shall be required to receive training in the operation of the treatment equipment, proper protective equipment to wear, if any, how to clean up spills, and other information required to operate the treatment equipment in a safe and effective manner.
(2) Annual training for the operators shall be provided after the initial training has been completed.
(3) The training shall be documented for each treatment operator and retained on file at the generator 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) (1) The operators of the treatment equipment specified in subdivision (a) shall be required to receive training in the operation of the treatment equipment, proper protective equipment to wear, if any, how to clean up spills, and other information required to operate the treatment equipment in a safe and effective manner.
(2) Annual training for the operators shall be provided after the initial training has been completed.
(3) The training shall be documented for each treatment operator and retained on file at the generator 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 generator registration for small quantity generators issued by the enforcement agency shall be valid for two years.
(c) An application for renewal of the registration for small quantity generators shall be filed with the enforcement agency on or before the expiration date.
(d) Generators shall submit an updated application form when any of the information specified in their medical waste management plan, created pursuant to Section 117935, changes. The updated application form shall be submitted within 30 days of the change.
(b) Each medical waste generator registration for small quantity generators issued by the enforcement agency shall be valid for two years.
(c) An application for renewal of the registration for small quantity generators shall be filed with the enforcement agency on or before the expiration date.
(d) Generators shall submit an updated application form when any of the information specified in their medical waste management plan, created pursuant to Section 117935, changes. The updated application form shall be submitted within 30 days of the change.
(a) A medical waste generator required to register pursuant
to this chapter shall maintain for a minimum of three years
individual treatment operating records, and if applicable, the
tracking document for all untreated medical waste shipped offsite for
treatment, and 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 complying with regulations adopted by the department.
(3) Tracking documents or electronically archived tracking documents maintained by the facility and medical waste hauler of all untreated medical waste shipped offsite for treatment.
(b) Documentation shall be made available to the enforcement agency onsite.
(1) Treatment operating records. Operating records shall be maintained in written or electronic form.
(2) An emergency action plan complying with regulations adopted by the department.
(3) Tracking documents or electronically archived tracking documents maintained by the facility and medical waste hauler of all untreated medical waste shipped offsite for treatment.
(b) Documentation shall be made available to the enforcement agency onsite.
(a) Small quantity generators who are not required to
register pursuant to this chapter shall maintain on file in their
office all of 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.
(2) Records required by the United States Postal Service of any medical waste shipped offsite for treatment and disposal. The small quantity generator shall maintain, or have available electronically at the facility or from the medical waste hauler or common carrier, these records, for not less than three years.
(b) Documentation shall be made available to the enforcement agency onsite.
(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.
(2) Records required by the United States Postal Service of any medical waste shipped offsite for treatment and disposal. The small quantity generator shall maintain, or have available electronically at the facility or from the medical waste hauler or common carrier, these records, for not less than three years.
(b) Documentation shall be made available to the enforcement agency onsite.
(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 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.
