W. Va. Code R. § 64-56-11

Current through Register Vol. XLI, No. 50, December 13, 2024

Section 64-56-11 - Commercial Infectious Medical Waste Management Facilities

11.1. This section of this rule applies only to commercial infectious medical waste management facilities.

11.2. A commercial infectious medical waste management facility may not utilize incineration technology in any form, including the manufacture or burning of refuse-derived fuel in any form.

11.3. A commercial infectious medical waste management facility shall have effective controls for the management of infectious medical waste to ensure the protection of public health, safety, welfare and the environment.

11.4. The Secretary shall conduct an investigation of the infectious medical waste stream in the region affected by the proposed facility and determine that programs have been established to minimize and reduce the infectious medical waste stream the facility will serve prior to issuing a permit. The Secretary may issue a permit only if he or she makes a specific finding that as to the medical waste stream the proposed facility will be consistent with the legislative findings and purpose stated in W. Va. Code § 20-51-2.

11.5. No person may establish, construct, operate, maintain, or allow the use of property for a commercial infectious medical waste management facility within:

11.5.a. The one-hundred (100) year flood plain;

11.5.b. Five hundred (500) feet of a dwelling, measured from the edge of the boundary of the facility, unless written permission is received from the owner of the dwelling;

11.5.c. An area where the Secretary has determined, after consultation with relevant state and federal agencies, that the facility will be in violation of applicable state or federal laws or regulations concerning:

11.5.c.1. Wetlands;

11.5.c.2. Any endangered or threatened species of animal or plant;

11.5.c.3. Surface water;

11.5.c.4. Groundwater quality; or

11.5.c.5. The emission of any air contaminant.

11.6. A proposed infectious medical waste management facility shall provide evidence of financial capability suitable to the scope of the facility to the Secretary.

11.6.a. Prior to the issuance of a permit to operate a commercial infectious medical waste treatment facility, the intended operator shall obtain a performance bond payable to the Secretary in an amount established by the Secretary equal to the projected cost of operating the facility for sixty (60) days at full capacity.

11.6.a.1. The performance bond shall be paid to the Secretary upon:

11.6.a.1.a. Closure of the facility, including voluntary closure and closure as a result of permit revocation or suspension, unless thirty (30) days before closure the operator has notified the Secretary of closure and before closure has provided the Secretary with certified mail receipts of its mailing of notices of closure to all its customers thirty (30) days before closure: Provided, That a performance bond payment made under this subparagraph shall be returned by the Secretary upon verification that the operator provided the notices as required; or

11.6.a.1.b. Improper closure of the facility requiring corrective expenditures by the Secretary.

11.6.a.2. A bond payment may be used by the Secretary to correct an improper closure and to continue operation of a facility until its customers can be properly notified of the pending closure.

11.7. No person may own, construct, modify or operate a commercial infectious medical waste facility, nor may any person store, transport, treat or dispose of any infectious medical waste without first obtaining a permit from the Secretary.

11.8. The owner of an infectious medical waste facility is responsible for insuring that the facility has a permit.

11.9. Pre-siting Notices.

11.9.a. In order to obtain approval to locate a commercial infectious medical waste facility an applicant shall, in accordance with W. Va. Code § 20-5K-3, Procedure for Public Participation, file a pre-siting notice with the Secretary, the department of environmental protection and the county commission or commissions and the local solid waste authority or authorities of the county or counties in which the facility is to be located. Such notice shall be available for public review, and shall include:

11.9.a.1. A description of the location at which the proposed facility may be sited;

11.9.a.2. Information concerning the anticipated size of the proposed facility;

11.9.a.3. An estimate of the volume, type, and origin of the infectious medical waste to be handled at the proposed facility;

11.9.a.4. A United States Geological Survey (USGS) topographic map showing the location and anticipated boundaries of each site being considered for the proposed facility;

11.9.a.5. A description of the technology that is to be used in the treatment of infectious medical waste;

11.9.a.6. The name, address, telephone numbers and e-mail-address of the owner or applicant of the proposed facility;

11.9.a.7. The name, address, telephone numbers and e-mail address of the operator of the proposed facility, if different from the owner or applicant; and

11.9.a.8. Other information that the Secretary may require.

11.10. Permit Application Requirements. An application for a permit shall be submitted to the Secretary on forms prescribed by the Secretary, and unless otherwise specified in this rule, shall include the following:

11.10.a. The name, mailing address, and location of the facility for which the application is submitted;

11.10.b. The name, address, telephone number and e-mail address of the owner of the facility, and if the owner is an individual or a partnership;

11.10.c. The name, address, telephone number and e-mail address of the manager of the facility, if different from the owner; and if the manager is an individual or partnership different from the owner;

11.10.d. A proposed infectious medical waste management plan as required by Section 5 of this rule. The infectious medical waste management plan shall be incorporated into the permit as part of the permit conditions;

11.10.e. A description of the legal documents upon which the applicant bases his or her legal right to enter and conduct operations on the facility permit area and whether that right is the subject of pending court litigation;

11.10.f. All application documents related to engineering and design plans and specifications as compiled, signed, and sealed by a professional engineer who is registered to practice in West Virginia;

11.10.g. Appropriate legible exhibits, including maps, figures, photographs, and tables, of appropriate scale to show all required details necessary to clarify information or conclusions;

11.10.h. Documentation of arrangements for permitted facilities to receive all treated waste and wastewater;

11.10.i. A treatment technology plan in accordance with the provisions of Section 10.3 through 10.5 of this rule;

11.10.j. Financial assurance in the form of a collateral bond, an escrow account or a letter of credit equal to the proposed cost of the project;

11.10.k. A proposed design and a general discussion of the proposed operating procedures;

11.10.l. A notarized signature of the owner or principal officer verifying that the information contained in the application is true and correct to the best of that individual's knowledge and belief;

11.10.m. A review of land use zoning in the area with particular attention given to areas where zoning variances will be required, where agricultural impact statements may be required, or where flood plain, river corridors, or wetlands are designated;

11.10.n. A description of the present land use within two (2) miles of the permit area. The description shall include, but not be limited to:

11.10.n.1. Impacts upon transportation facilities;

11.10.n.2. Impacts upon public and private water supplies;

11.10.n.3. Impact upon land use patterns;

11.10.n.4. Impacts upon agricultural, commercial and residential real estate values;

11.10.n.5. Impacts upon wildlife;

11.10.n.6. Impacts upon endangered or threatened species of animals or plants;

11.10.n.7. Impacts upon aesthetics;

11.10.n.8. Impacts upon socioeconomic conditions;

11.10.n.9. Impacts to water resources;

11.10.n.10 Impacts on sewage collection and treatment systems;

11.10.n.11. Impacts on local emergency response crews and firefighters;

11.10.n.12. Impacts upon known recreational, historical, archaeological, or environmentally unique areas; and

11.10.n.13. Other impacts as determined by the Secretary;

11.10.o. A large-scale map with a minimum scale of one (1) inch equal to two hundred (200) feet and a maximum contour interval often (10) feet, or a 7.5 minute topographic map, showing the location of all of the following that occur either within the site boundaries or within two thousand five hundred (2,500) feet of the site:

11.10.o.1. Water supply wells;

11.10.o.2. Springs;

11.10.o.3. Wetlands (e.g., swamps, bogs, marshes);

11.10.o.4. Streams and drainages;

11.10.o.5. Public water supplies;

11.10.o.6. Other bodies of water;

11.10.o.7. Underground or surface mines;

11.10.o.8. Water quality monitoring points;

11.10.o.9. Occupied dwellings;

11.10.o.10 Roads;

11.10.o.11. Public buildings;

11.10.o.12 Sinkholes;

11.10.o.13. Property boundaries, including site property;

11.10.o.14. Current owners of record both surface and subsurface;

11.10.o.15. Easements or rights-of-way; and

11.10.o.16. One hundred (100) year flood plain boundary;

11.10.p. A description of present and proposed transportation routes and access roads, including any weight restrictions;

11.10.q. A description of buildings, treatment units, roads, and other structures to be constructed in conjunction with the facility, including the size of the construction and the number of miles of road to be constructed;

11.10.r. A description of emissions and discharges, such as dust, odors, gases, leachate, surface water runoff and collected groundwater associated with facility preparation, construction, operation and during and after closure of the facility;

11.10.s. A copy of any building permits required; and

11.10.t. A non-refundable application fee according to the schedule shown in Table 64-56A at the end of this rule.

11.11. Modifications.

11.11.a. When a permit is modified, only the conditions subject to modification are reopened. All other conditions of the permit remain in effect for the duration of the permit.

11.11.b. The Secretary may require additional information and, in the case of a major modification, may require submission of a new permit application.

11.11.c. Minor Modifications.

11.11.c.1 Modifications, except for major modifications as listed in this section, in the infectious medical waste plan may be made without notifying the Secretary and shall be included in the next application for permit renewal.

11.11.c.2 Permits may be modified by the Secretary at any time except for major modifications as listed in this section. Minor modifications do not require the completion of the public notice procedures.

11.11.d. Major Modifications.

A permittee shall submit an application for approval of a major modification before implementing the change. All major modifications shall be approved prior to implementation and require the opportunity for a public hearing as required by this rule unless an emergency is declared by the Secretary. For the purpose of this section a major modification means:

11.11.d.1. The capacity of the commercial infectious medical waste facility will be increased over the permitted capacity by more than ten percent (10%);

11.11.d.2. The performance or operation of the surface water control system will be significantly affected;

11.11.d.3. A decrease in the quality or quantity of data from any environmental monitoring system will occur;

11.11.d.4. The amount or type of financial assurance will change;

11.11.d.5. The facility boundary will be significantly changed;

11.11.d.6. Authorization is being sought to construct an additional structure used to increase the capacity of the facility;

11.11.d.7. Different permitted facilities are being considered to receive treated waste or wastewater;

11.11.d.8. Installing a new unit for the treatment of infectious medical waste or replacing existing treatment units not to include repair of improvements to existing units;

11.11.d.9. Changing the location of treatment;

11.11.d.10. Any other action that the Secretary determines may present substantial endangerment to public health, safety or the environment; or

11.11.d.11. Other similar modifications as determined by the Secretary.

11.11.e. Major modifications to an initial application for a new commercial infectious medical waste facility require the applicant to undergo a new pre-siting process as described in Sections 11.9. through 11.12 of this rule.

11.11.f. Permit renewals that contain major modifications shall be treated as major modifications.

11.12. Permit Suspension or Revocation.

11.12.a. Suspension. A commercial infectious medical waste facility permit may be suspended by order of the Secretary for any of the following reasons:

11.12.a.1. Violation of or failure to adhere to, W. Va. Code § 20-51-1et seq., this rule, the terms and conditions of the permit, or any order of the Secretary issued thereunder;

11.12.a.2. Interference with a representative of the Secretary in the performance of his or her duties; or

11.12.a.3. Discovery of failure in the application or during the permit issuance process to fully disclose all significant facts or the permittee's misrepresentation of any significant fact at any time.

11.12.b. Revocation. A commercial infectious medical waste facility permit may be revoked by order of the Secretary for any of the following reasons:

11.12.b.1. An attempt by an applicant or permittee to obtain or renew a permit by means of fraud, deceit or material misrepresentation;

11.12.b.2. Any deficiency at the facility constituting an imminent pollution, health, or safety hazard;

11.12.b.3. Persistent violation of W. Va. Code § 20-51-1et seq., this rule, permit terms and conditions, or orders issued by the Secretary under that Code Article or this rule;

11.12.b.4. Discovery of failure in the application, or during the permit issuance process, to fully disclose all significant facts or the permittee's misrepresentation of any significant fact at any time;

11.12.b.5. Failure to maintain proper bonding; if for any reason a permittee fails to maintain proper bonding, the Secretary shall issue a cease and desist order and revoke the permit and the permittee shall become fully liable for the amount of the bond; or

11.12.b.6. Any cause which would require disqualification pursuant to this rule from receiving a permit upon original application.

11.12.c. Effect of Permit Suspension or Revocation.

11.12.c.1. Suspension. All infectious medical waste processing, treatment, storing or transfer activities and the receipt of any infectious medical waste at the facility shall cease immediately upon receipt of an order of suspension. Activities at the facility may recommence only after expiration of the order of suspension or upon revocation of that order by the issuing authority.

11.12.c.2. Revocation. All infectious medical waste processing, treatment, storing or transfer activities and the receipt of any infectious medical waste at the facility shall cease immediately upon receipt of an order of revocation. The facility owner shall submit either an application for a permit to close the facility or an application for a new commercial infectious medical waste facility permit within the time specified in the order of revocation.

11.12.c.3. Environmental Monitoring and Control. Environmental monitoring and control activities specified in an order of suspension or revocation shall continue at the commercial infectious medical waste facility for the duration of such order or until the authority that issued that order approves the cessation of such activities.

11.13. Transfer of Facility.

Permits issued by the Secretary are not transferable or assignable and shall automatically become invalid upon a change of ownership or upon suspension or revocation. An existing commercial facility that changes ownership may, however, continue to operate under the previous owners 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:

11.13.a. Advises the Secretary of such change of ownership including any management changes; and

11.13.b. Agrees 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.

11.14. Application Review. Within thirty (30) days of receipt of a permit application, compliance schedule, closure plan, or major modification application, the Secretary shall determine whether such application, schedule, or plan is complete and shall notify the applicant of his or her determination in writing. If the Secretary determines that such application, schedule, plan or modification is not complete, the notification shall advise the applicant of the deficiencies that require remedy.

11.14.a. The Secretary may not begin the evaluation of a permit before receiving a complete application, including any supplemental information requested.

11.14.b. The Secretary may not issue a permit before receiving a complete application.

11.14.c. The Secretary shall request formal comments from the county commission of the county in which the facility is proposed to be located and from any municipal government within two (2) miles of the proposed location, with any negative response to such application from any commission or municipal government to be considered by the Secretary and specific findings made as to the concerns raised by such responses.

11.15. Public Participation.

11.15.a. When the Secretary determines an application for a new facility to be complete, he or she shall conduct a public hearing in the county where the proposed facility is to be located.

11.15.b. When the Secretary determines an application for a major modification to be complete, he or she shall instruct the applicant or permittee to give public notice. The Secretary shall conduct a public hearing in the county where the proposed facility is to be located whenever he or she receives a request.

11.15.c. Public hearings shall be conducted in accordance with the following guidelines:

11.15.c.1. Public notice of a public hearing shall be given at least thirty (30) days before the hearing. Public comment will be accepted during those thirty (30) days.

11.15.c.2. Public notice shall be given by the applicant 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. The Secretary shall also require that legal advertisement 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.

11.15.d. All public notices issued shall contain the following information:

11.15.d.1. The name and address of the office processing the permit action for which notice is being given;

11.15.d.2. The name, address and email address of the permittee or permit applicant, and if different, of the facility or activity regulated by the permit;

11.15.d.3. A description of the activities covered in the application, including the type of commercial infectious medical waste facility, the types, amounts, and origins of infectious medical wastes to be handled, site improvements, and infectious medical waste handling methods;

11.15.d.4. The name, address, telephone numbers and email address of a person from whom interested persons may obtain further information, including copies of the application;

11.15.d.5. A brief description of the comment procedures and the date, time and place of the hearing, and other procedures by which the public may participate in the final permit decision;

11.15.d.6. A general description of the location of proposed permit area including streams;

11.15.d.7. 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;

11.15.d.8. A reference to the date of previous public notices relating to the permit;

11.15.d.9. For major modifications, the public notice shall state:

11.15.d.9.A. That any interested person may submit written comment on the application, and that such comments shall include a concise statement of the nature of the issues raised;

11.15.d.9.B. That any interested person may request a public hearing, and that such request shall include a concise statement of the nature of the issues raised; and

11.15.d.9.C. That the Secretary shall conduct a public hearing in the county where the proposed facility is to be located whenever he or she receives a request.

11.15.e. 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 all public libraries in the county;

11.15.f. Copies of the application shall be available from the Secretary.

11.15.g. An official transcript of the hearing shall be available to the public from the Secretary.

11.15.h. Any person may submit oral or written statements and data concerning the proposed facility. Reasonable limits may be set on the time allowed for oral statements, and the written statements shall be submitted no later than ten (10) days after the close of public hearings.

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

11.15.j.1. Reopen or extend the public comment period to give interested persons an opportunity to comment on the information or argument submitted; or

11.15.j.2. Require an additional public hearing.

11.15.k. The applicant for a permit for a commercial infectious medical waste management facility shall maintain a public participation file. This file shall contain all the written comments received during the public comment period, copies of minutes of all meetings held by the applicant and a copy of the applicants written response to all written comment letters received during the written response period. This file shall be submitted to the Secretary by the applicant at the end of the comment period.

11.15.l. Based on comments received at the public hearing or upon written recommendations received, the Secretary may within thirty (30) days after the close of the public comment period, require the person who submitted the application to furnish additional information regarding ,the impact the siting of the proposed facility may have upon wetlands, endangered or threatened species of plants and animals, surface waters, underground waters, air quality, and other matters as determined by the comments received.

11.16. Permit Decision and Effective Date of Permit.

11.16.a. Within thirty (30) days of the close of the public comment period on an application for a new facility, or major modification of an existing permit, the Secretary shall respond in writing to the comments received.

11.16.b. After comments have been responded to, the Secretary shall issue a final permit decision. The Secretary shall provide written notification of his or her decision to the applicant and to each person who has submitted written comments or requested notice of the final permit decision. For the purposes of this section, a "final permit decision" means the final decision of the Secretary to grant, deny, revoke and reissue, or terminate a permit.

11.16.c. In the case of an application for a new facility, the Secretary shall grant or deny the application as filed and as made available to the public pursuant to the provisions of this section. The Secretary shall provide the reasons therefor in his or her written notification to the applicant. This notification shall also include reference to the procedures for appealing the final permit decision.

11.16.d. The Secretary may refuse to grant a permit for any of the following reasons:

11.16.d.1. If an applicant or permittee has attempted to obtain or renew a permit by means of fraud, deceit or material misrepresentation;

11.16.d.2. Discovery of failure in the application or during the permit issuance process to fully disclose all significant facts or the permittee's misrepresentation of any significant fact at any time; or

11.16.d.3. The Secretary determines, based on comments and recommendations received, that the facility is incompatible with existing or proposed land use patterns, including, but not limited to: transportation facilities; public water supplies; water resources; agricultural, commercial and residential real estate values; aesthetics; socioeconomic conditions generally; or if it endangers public health, safety or well-being.

11.16.e. A final permit decision shall become effective not less than thirty (30) days after the date of notice of the decision, unless an earlier date is requested by the applicant and agreed upon by the Secretary.

11.17. A retailer of sharps to be used by individuals in their own medical treatment may establish a small commercial infectious medical waste management facility to be used solely for the treatment of sharps sold by and returned to the retailer for treatment. Such small commercial infectious medical waste management facility shall apply for and obtain a permit according to the provisions of Section 4 of this rule. In addition to the requirements of Section 4, the application shall include a letter describing the location and estimated volume of sharps to be treated and a certified letter from an approved solid waste disposal facility agreeing to accept the treated waste. Such small commercial infectious medical waste management facility shall comply with Sections 6 and 10 of this rule, and may be exempted by the Secretary from the requirements of Sections 11.9 through 11.17 of this rule.

W. Va. Code R. § 64-56-11