W. Va. Code R. § 64-56-4

Current through Register Vol. XLI, No. 45, November 8, 2024

Section 64-56-4 - Permit Application and Approval Procedures for Non-Commercial Infectious Medical Waste Management Facilities

4.1. This section applies only to non-commercial infectious medical waste facilities. No person may own, construct, modify or operate an infectious medical waste management facility, nor shall any person store, transport, treat or dispose of any infectious medical waste without first obtaining a permit from the Secretary, unless exempted by Sections 2.1., 2.2. or 4.17. of this rule.

4.2. No person shall begin physical construction of a new non-commercial infectious medical waste management facility without having received a permit.

4.3. The owner of a non-commercial infectious medical waste management facility shall be responsible for insuring that the facility has a permit.

4.4. The owner of an infectious medical waste facility shall provide public notice of intent to apply for a permit.

4.4.a. Public notice shall be given by any method reasonably calculated to give actual notice of the action in question to the persons potentially affected by it, including press releases or any other forum or medium to elicit public participation.

4.5. The applicant for a permit for a non-commercial infectious medical waste facility shall maintain a public participation file. This file shall contain a summary of all comments and responses received during the pre-application public notification phase by the facility. This file shall be submitted to the Secretary by the applicant with the application.

4.6. An application for a permit shall be submitted to the Secretary on forms prescribed by the Secretary and shall include the following:

4.6.a. The name, mailing address, and location of the facility, using latitude and longitude to the nearest second, for which the application is submitted;

4.6.b. The name, mailing and email addresses and telephone numbers of the owner of the facility;

4.6.c. The name, mailing and email addresses and telephone numbers of the manager of the facility, if different from the owner;

4.6.d. A copy of the proposed infectious medical waste management plan as required by Section 5 of this rule;

4.6.e. A copy of the public participation file; and

4.6.f. Information needed to demonstrate that the facility will be operated in compliance with this rule.

4.7. For new non-commercial infectious medical waste management facilities, the application shall be accompanied by a copy of a topographic map or equivalent showing the facility and the area one thousand (1,000) feet around the facility site with the following information included:

4.7.a. The map scale and date;

4.7.b. Land uses (e.g. any established zoning for residential, commercial, agricultural, recreational, industrial or other designated uses);

4.7.c. The orientation of the map (north arrow);

4.7.d. The legal boundaries of the facility with the latitude and longitude to the nearest second for the site;

4.7.e. Access control (fences, gates); and

4.7.f. Buildings to be used for treatment, storage, and disposal operations and other structures (e.g. recreation areas, run-off control systems, access and internal roads, storm, sanitary, and process sewerage systems, loading and unloading areas, fire control facilities).

4.8. The Secretary shall not begin the evaluation of a permit before receiving a complete application, as determined by the Secretary. Within thirty (30) days of the Secretary's receipt of a permit application, the completeness of the application shall be judged independently of the status of any other permit application or permit for the same facility or activity.

4.9. The Secretary shall not issue a permit before receiving a complete application.

4.10. The Secretary shall have the authority to request supplemental information needed to demonstrate that the facility will be operated in compliance with this rule.

4.11. When the Secretary determines an application for a new non-commercial infectious medical waste facility or a major change to an existing facility to be complete, he or she shall instruct the applicant or permittee to give public notice.

4.11.a. Public comment shall be conducted in accordance with the following guidelines:

4.11.a.1. Public notice shall be given by publishing the public notice as a Class II legal advertisement in a qualified newspaper, as defined in W. Va. Code § 59-3-1, serving the county where the facility will be located. That legal advertisement shall also be placed in newspapers of adjacent counties when a proposed facility is within two (2) miles of a county line. The cost of the publication will be the responsibility of the applicant who shall send a certification of publication to the Secretary within twenty (20) days after publication; and any other method reasonably calculated to give actual notice of the action in question to the persons potentially affected by it, including press releases or any other forum or medium to elicit public participation.

4.11.a.2. All public notices issued shall contain the following information:

4.11.a.2.A. The name and mailing and email addresses of the office processing the permit action for which notice is being given;

4.11.a.2.B. The name and mailing and email addresses of the permittee or permit applicant, and if different, of the facility or activity regulated by the permit;

4.11.a.2.C. A description of the activities covered in the application, including the type of technology that will be used to treat infectious medical waste, the types, amounts, and origins of infectious medical waste to be handled, site improvements, and infectious medical waste handling methods;

4.11.a.2.D. The name, mailing and email addresses, and telephone numbers of a person from whom interested persons may obtain further information;

4.11.a.2.E. A general description of the location of the proposed permit area including streams;

4.11.a.2.F. A clear and accurate location map. A map of a scale and detail found in the West Virginia official state highway map is the minimum standard for acceptance. The map size shall be at a minimum two (2) inches by two (2) inches. Longitude and latitude lines and a north arrow shall be indicated on the map, and such lines will cross at or near the center of the proposed permit area;

4.11.a.2.G. A reference to the date of previous public notices relating to the permit;

4.11.a.2.H. That any interested person may submit a written comment on the application, and that such comments shall include a concise statement of the nature of the issues raised;

4.11.a.2.I. That any interested person may submit a written request for a public hearing, and that such request shall include a concise statement of the nature of the issues raised; and

4.11.a.2.J. That the Secretary shall conduct a public hearing within forty-five (45) days in the county where the proposed facility is to be located whenever he or she receives a request.

4.11.a.3. The availability of the application shall include, but not be limited to, copies placed at the courthouse of the county in which the facility is to be located, the city or town hall of any municipal government within two (2) miles of the proposed location of the facility, and the primary public library in the county.

4.11.a.4. Copies of the application shall be available from the Secretary.

4.11.b. If any data, information or arguments submitted during the public comment period raise substantial new questions concerning the proposed major change or new facility, the Secretary shall:

4.11.b.1. Request additional information from the applicant; and

4.11.b.1.A. Reopen or extend the public comment period for thirty (30) days to give interested persons an opportunity to comment on the information or argument submitted; or

4.11.b.1.B. Require a public hearing.

4.11.c. In the event a public hearing is held:

4.11.c.1. Public notice of the hearing shall be given by the Secretary at least thirty (30) days before the hearing;

4.11.c.2. A transcript of the hearing shall be available to the public from the Secretary;

4.11.c.3. At the hearing, any person may make oral comments and submit written statements and data concerning the proposed major changes or new facility. Reasonable limits may be set on the time allowed for oral statements, and the written statements shall be submitted to the Secretary no later than ten (10) days after the close of the hearing; and

4.11.c.4. The Secretary shall act on the permit application within thirty (30) days after the date for the submission of written statements to the Secretary.

4.11.d. In the event a public comment period is held, the Secretary shall act on the permit application within thirty (30) days after the close of the comment period.

4.12. Permits shall be renewed annually prior to expiration. An application for permit renewal shall be submitted thirty (30) days prior to the expiration date of the previous permit. A late fee of 25% for all expired permits listed in this rule will be applied to the permit fee schedule. Payment must be received within 15 days of the expiration date to avoid the late fee assessment.

4.13. An application for an original or renewal permit shall be accompanied by a non-refundable permit fee according to the schedule shown in Table 64-56 A found at the end of this rule.

4.14. A permit shall be issued if the facility is, or in the case of a projected facility, is planned to be, in compliance with the applicable provisions of this rule and has submitted the permit fee.

4.15. The Secretary may refuse to grant or renew a permit if an applicant or permittee has attempted to obtain a permit by means of fraud, deceit or material misrepresentation or public comment reveals a situation which would endanger public health.

4.16. A permittee shall submit an application for approval of a major change in the permittee's infectious medical waste management plan before implementing the change. Minor changes in the infectious medical waste plan maybe made without notifying the Secretary and shall be included in the next application for permit renewal. All major changes shall be approved prior to implementation: Provided, That, no prior approval is necessary in the case of a hospital which may in an emergency make an immediate change in its plan necessary to protect the safety and care of patients, employees or the public. In such an event, the hospital shall notify the Secretary immediately followed by written notification within fifteen (15) days. An application for approval of any change in the plan which is beyond the control of the permittee shall be submitted within fifteen (15) days of its occurrence. A major change consists of any of the following:

4.16.a. Installing a new unit for the treatment of infectious medical waste or replacing existing units not including improvements, as determined by the Secretary, or repairs to existing units;

4.16.b. Changing the location of treatment; or

4.16.c. Permanently increasing the volume of infectious medical waste by at least twenty percent (20%), if the amount of the increase is fifty (50) pounds or more.

4.17. Small quantity generators who generate infectious medical waste in the provision of health care services in their own office are not required to obtain a permit. Small quantity generators shall keep their infectious medical waste management plan on file and shall make a copy available to the Secretary on request.

4.18. Permits issued by the Secretary for a non-commercial infectious waste facility are not transferable or assignable and shall automatically become invalid upon a change of ownership or upon suspension or revocation. An existing large quantity generator that changes ownership, however, may continue to operate under the previous owner's permit conditions until such time as the Secretary can process the new permit application required by this section, provided the new owner sends the Secretary a letter in which the new owner:

4.18.a. Advise the Secretary of any change of ownership including any management changes; and

4.18.b. Agree to be bound by the conditions and policies established in the infectious medical waste management plan for that facility by the previous owner until such time as a new management plan can be approved by the Secretary.

W. Va. Code R. § 64-56-4