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Chapter 7. Medical Waste Treatment Facility Permits of California Health And Safety Code >> Division 104. >> Part 14. >> Chapter 7.

All offsite medical waste treatment facilities and transfer stations shall be permitted and inspected by the department. All onsite medical waste treatment facilities shall be permitted and inspected by the enforcement agency.
Each person operating an offsite medical waste treatment facility shall obtain a permit pursuant to this chapter from the department prior to commencement of the treatment facility's operation.
A health care facility accepting medical waste for treatment from the physicians and surgeons who are on the staff of the facility and who are small quantity generators shall be classified as an onsite treatment facility and shall be permitted and inspected by the enforcement agency.
A health care facility accepting medical waste for treatment from small quantity generators that are adjacent to the facility shall be classified as an onsite treatment facility and shall be permitted and inspected by the enforcement agency.
Notwithstanding any other provision of this chapter, a registered medical waste generator, which is a facility specified in subdivisions (a) and (b) of Section 117705, may accept home-generated sharps waste, to be consolidated with the facility's medical waste stream, subject to all of the following conditions:
  (a) The generator of the sharps waste, a member of the generator's family, or a person authorized by the enforcement agency transports the sharps waste to the medical waste generator's facility.
  (b) The sharps waste is accepted at a central location at the medical waste generator's facility.
  (c) A reference to, and a description of, the actions taken pursuant to this section are included in the facility's medical waste management plan adopted pursuant to Section 117960.
Each enforcement agency shall follow procedures that are consistent with the Medical Waste Management Act and the regulations adopted pursuant to this chapter, when issuing medical waste permits.
A person required to obtain an offsite medical waste treatment facility permit pursuant to this part shall file with the enforcement agency an application containing, but not limited to, all of the following:
  (a) The name of the applicant.
  (b) The business address of the applicant.
  (c) The type of treatment provided, the treatment capacity of the facility, a characterization of the waste treated at this facility and the estimated average monthly quantity of waste treated at the facility.
  (d) A disclosure statement, as provided in Section 25112.5, except for onsite medical waste treatment facilities.
  (e) A plan for closure of the facility using, at 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 ending of treatment services at the site.
  (f) Any other information required by the enforcement agency for the administration or enforcement of this part or the regulations adopted pursuant to this part.
(a) Prior to issuing or renewing a permit for an offsite medical waste treatment facility, the department shall review the compliance history of the applicant, under any local, state, or federal law or regulation governing the control of medical waste or pollution.
  (b) The department shall, pursuant to this section, deny a permit, or specify additional permit conditions, to ensure compliance with applicable regulations, if the department determines that in the three-year period preceding the date of application the applicant has violated laws or regulations identified in subdivision (a) at a facility owned or operated by the applicant, and the violations demonstrate a recurring pattern of noncompliance or pose, or have posed, a significant risk to public health and safety or to the environment.
  (c) In making the determination of whether to deny a permit or to specify additional permit conditions, the department shall take both of the following into consideration:
  (1) Whether a permit denial or permit condition is appropriate or necessary given the severity of the violation.
  (2) Whether the violation has been corrected in a timely fashion.
On and after April 1, 1991, all persons operating a medical waste treatment facility shall maintain individual records for a period of three years and shall report or submit to the enforcement agency upon request, all of the following information:
  (a) The type of treatment facility and its capacity.
  (b) All treatment facility operating records.
  (c) Copies of the tracking documents for all medical waste it receives for treatment from offsite generators, hazardous waste haulers, or, pursuant to Section 118032, common carriers.
(a) A medical waste permit issued by the enforcement agency to a medical waste treatment facility shall be valid for five years.
  (b) An application for renewal of the permit shall be filed with the enforcement agency not less than 90 days prior to the expiration date. If a permittee fails to make a timely application for renewal, the medical waste permit shall expire on the expiration date.
(a) A medical waste permit may be renewed if the enforcement agency finds the permittee has been in substantial compliance with this part and the regulations adopted pursuant to this part during the preceding permitted period or that the permittee corrected previous violations in a timely manner.
  (b) Upon approval of the enforcement agency, a permit may be transferred from one subsidiary to another subsidiary of the same corporation, from a parent corporation to one of its subsidiaries, or from a subsidiary to a parent corporation.
A person required to obtain a medical waste permit shall, at all times, possess a valid permit for each facility in operation. A medical waste permit shall terminate prior to its expiration date if suspended or revoked pursuant to Section 118350 or, notwithstanding Section 118355, if either of the following occurs:
  (a) The permittee sells or otherwise transfers the facility, except as specified in subdivision (b) of Section 118175.
  (b) The permittee surrenders the permit to the enforcement agency because the permittee ceases operation.
The enforcement agency shall issue a medical waste permit upon evaluation, inspection, or records review of the applicant if the applicant is in substantial compliance with this part and the regulations adopted pursuant to this part and the applicant has corrected any previous violations. A decision to issue or not to issue the permit shall be made by the enforcement agency within 180 days of the time that the application is deemed complete, unless waived by the applicant.
When issuing, renewing, or revising any treatment facility permit, the enforcement agency may prohibit or condition the handling or treatment of medical waste to protect the public health and safety.
An enforcement agency shall inform an applicant for a medical waste permit, in writing, upon the denial of any application for the permit. Within 20 days after the enforcement agency mails the notice, the applicant may present a written petition for a hearing to the enforcement agency. Upon receipt by the enforcement agency of the petition in proper form, the petition shall be set for hearing. If the department is the enforcement agency, the proceedings shall commence with the filing of a statement of issues and shall be conducted in accordance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code, and the department has all the powers granted to a department in that chapter. If the department is not the enforcement agency, the hearings shall be held in accordance with the ordinance adopting the medical waste management program.
The enforcement agency shall evaluate, inspect, and review the records of medical waste treatment facilities for compliance with this part.
The fee schedule specified in Section 118210 shall cover the issuance of medical waste treatment facility permits and an inspection program, when the department serves as the enforcement agency. This fee schedule shall be adjusted annually in accordance with Section 100425. The department may adjust by regulation the fees specified in Section 118210 to reflect the actual costs of implementing this chapter. Local enforcement agencies shall set fees that shall be sufficient to cover their costs in implementing this part with regard to large quantity generators.
(a) The department shall charge an annual permit fee for an offsite medical waste treatment facility equal to either one hundred twenty-seven ten thousandths of a cent ($0.0127) for each pound of medical waste treated or twelve thousand dollars ($12,000), whichever is greater. The department may collect annual fees and issue permits on a biennial basis.
  (b) The department shall charge an initial application fee for each type of treatment technology at an offsite medical waste treatment facility equal to one hundred dollars ($100) for each hour the department spends processing the application, but not more than fifty thousand dollars ($50,000), or as provided in the regulations adopted by the department.