§ 65623. Requirements Applicable to All Permits.

(a) The permittee shall comply with all requirements of this article and any specific conditions of the permit.

(b) No permittee shall continue an activity regulated by a medical waste facility permit after the expiration date of the permit. If the permittee fails to make a timely application for renewal, the medical waste permit shall expire on the expiration date.

(c) In an enforcement action, it shall not be a defense for a permittee to state or show that reducing or ceasing of the permitted activity would have been necessary in order to maintain compliance with the requirements of this article.

(d) The permittee shall take all reasonable steps to minimize or correct any adverse impact on the environment resulting from noncompliance with the conditions of the permit.

(e) The permittee shall at all times properly operate and maintain all facilities and systems of treatment and control (and related appurtenances) which are installed or used by the permittee to achieve compliance with the specific conditions of the permit and requirements of this article. Proper operation and maintenance shall include but not be limited to effective performance, adequate funding, adequate operator staffing and training, and adequate laboratory and process controls, including appropriate quality assurance procedures. Backup or auxiliary facilities or similar systems shall be operated only when necessary to achieve compliance with the requirements of this article.

(f) The permittee shall furnish to the enforcement agency any relevant information which the enforcement agency may request to determine whether cause exists for modifying, revoking and reissuing, or terminating the permit, or to determine compliance with the permit. The permittee shall also furnish to the enforcement agency upon request copies of records required to be kept by the permit. Such information shall be furnished within 30 days or as otherwise set by the enforcement agency if a longer duration is required.

(g) The permittee shall allow an authorized representative of the enforcement agency to:

(1) Enter, at reasonable times, the permittee's premises where a regulated facility or activity is located or conducted, or where records must be kept under the conditions of the permit;

(2) Have access to and copy, at reasonable times, any records that must be kept under the conditions of the permit;

(3) Inspect, at reasonable times, any facilities, equipment (including monitoring and control equipment), practices, or operations regulated or required under the permit; and

(4) Sample or monitor, at reasonable times, for the purposes of assuring permit compliance or as otherwise authorized by law, any substances or parameters at any location.

(h) The permittee shall establish and maintain a monitoring and sampling program.

(1) Samples and measurements taken for the purpose of monitoring shall be representative of the monitored activity.

(2) The permittee shall retain records of all monitoring information, including all calibration and maintenance records and all original strip chart recordings for continuous monitoring instrumentation, copies of all reports required by the permit, and records of all data used to complete the application for the permit, for a period of at least three years from the date of the sample, measurement, report, or application. This period may be extended by request of the enforcement agency at any time.

(3) Records of monitoring information shall include:

(A) The date, exact place, and time of sampling or measurements;

(B) The individual(s) who performed the sampling or measurements;

(C) The date(s) analyses were performed;

(D) The individual(s) who performed the analyses;

(E) The analytical techniques or methods used; and

(F) The results of such analyses.

(i) All applications, reports, or information submitted to the enforcement agency shall be signed and certified (see Section 65622).

(j) The permittee shall meet all reporting requirements as required below:

(1) The permittee shall give notice to the enforcement agency as soon as possible and at least 30 days in advance of any planned physical alterations or additions to the permitted facility.

(2) Reports of compliance or noncompliance with, or any progress reports on, interim and final conditions contained in any compliance schedule of the permittee's permit shall be submitted no later than 14 days following each scheduled date.

(3) The permittee shall report any noncompliance with the Medical Waste Management Act (Health and Safety Code, Sections 25015 et seq.) or this chapter which may endanger health, safety, or the environment. Any information shall be provided orally within 24 hours from the time the permittee becomes aware of the circumstances. A written report shall also be provided within five days of the time the permittee becomes aware of the circumstances. The written report shall contain a description of the noncompliance as specified above, and its cause; the period of noncompliance, including exact starting and ending dates and time frames, and, if the noncompliance has not been corrected, the anticipated time it is expected to continue; and steps taken or planned to reduce, eliminate, and prevent recurrence.

(4) The permittee shall report all instances of noncompliance with permit conditions not reported under subsections (1), (2), and (3) of this Section, at the time the monitoring reports are submitted. The reports shall contain the information listed in subsections (1) and (3) of this section.

(5) Where the permittee becomes aware that it failed to submit any relevant facts in a permit application, or submitted incorrect information in a permit application or in any report to the enforcement agency, it shall promptly submit the relevant facts or correct information.

(k) For a new medical waste facility, the permittee may not commence treatment or storage of medical waste; and for a facility being modified, the permittee may not treat or store medical waste in the modified portion of the facility until:

(1) The permittee has submitted to the enforcement agency, by certified mail or hand delivery, a letter signed by the permittee and a professional engineer, registered in California, stating that the facility has been constructed or modified in compliance with the permit; and

(2) The enforcement agency has inspected the modified or newly constructed facility and finds it is in compliance with the conditions of the permit;

(l) The following shall be included as information which shall be reported orally within 24 hours under subsection (j)(3) of this section:

(1) Information concerning release of any medical waste that may endanger the public health;

(2) Any information of a release or discharge of medical waste from or of a fire or explosion at a medical waste facility which could threaten the environment or human health outside the facility. The description of the occurrence and its cause shall include:

(A) Name, address, and telephone number of the owner or operator;

(B) Name, address, and telephone number of the facility;

(C) Date, time, and type of incident;

(D) Name and quantity of material(s) involved;

(E) The extent of injuries, if any;

(F) An assessment of actual or potential hazards to the environment and human health outside the facility, where this is applicable; and

(G) Estimated quantity and disposition of recovered material that resulted from the incident.

(m) The permittee shall attempt to reconcile any significant discrepancy in a tracking document. The permittee shall also report any medical waste received without a tracking document. In either case, the discrepancy with or without a tracking document shall be reported to the enforcement agency within 15 days.

HISTORY

1. New section filed 10-15-91 as an emergency; operative 10-15-91 (Register 92, No. 7). A Certificate of Compliance must be transmitted to OAL 2-12-92 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 1-23-92 as an emergency; operative 2-12-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 6-11-92 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 1-23-92 order including amendment of section and Note transmitted to OAL 6-2-92 and filed 7-14-92 (Register 92, No. 29).

4. Editorial correction of History 2 (Register 95, No. 47).

Note

Note: Authority cited: Sections 208 and 25017, Health and Safety Code. Reference: Sections 25040.5, 25050, 25062, 25063, 25064, 25070, 25071, 25072, 25072.5, 25074 and 25075, Health and Safety Code.