Administrative Code

Virginia Administrative Code
10/6/2022

Part X. Permit Application and Issuance Procedures

Article 8
Radioactive Materials

9VAC20-120-680. Scope.

This part of the chapter describes procedures for obtaining a permit for the transfer, treatment or storage of regulated medical waste, unless specifically excluded by these regulations or under a permit by rule as defined in 9VAC20-120-160, 9VAC20-120-170, and 9VAC20-120-180. Owners and operators of regulated medical waste management units shall have permits during the active life (including the closure periods) of the unit. An applicant may be considered to have a permit or a permit may be terminated for one or more units at a facility without simultaneously affecting all of the units at the facility.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 10.1, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-690. Applicability; exemptions from permit requirements; off-site permits by rule; experimental facility permits; variances.

A. Except for on-site permit by rule facilities described in Part IV (9VAC20-120-160 et seq.) of this chapter, no person shall construct, operate or modify a regulated medical waste management facility in this Commonwealth without a permit issued by the director in accordance with this part. Notwithstanding the above, the management of materials excluded under Part III (9VAC20-120-80 et seq.) of this chapter or conditionally exempt under Part III shall not require a permit.

B. Each regulated medical waste management facility permit shall be limited to one site and shall be nontransferable between sites.

C. A new permit is required when there is:

1. Any new regulated medical waste management facility; or

2. Any change in design or process of a regulated medical waste management facility that will, in the opinion of the director, result in a substantially different type of facility.

D. The owner or operator of the following facilities shall be deemed to have a regulated medical waste management facility permit notwithstanding any other provisions of Part X (9VAC20-120-680 et seq.) of this chapter, if all the conditions listed are met:

1. The owner or operator of a storage facility or transfer station:

a. Notifies the director of his intent to operate such a facility and provides to the department documentation required under 9VAC20-120-710 B;

b. Provides the director with a certification that the facility meets the standards of Part V (9VAC20-120-330 et seq.) of this chapter;

c. Furnishes to the director a certificate signed by a registered professional engineer that the facility has been designed and constructed in accordance with the standards of Part V;

d. Submits to the director an operational plan describing how the standards of Part V will be met and provides the operational information required in 9VAC20-120-730;

e. Submits to the director a closure plan describing how the standards of 9VAC20-120-290 will be met;

f. Submits to the director the proof of financial responsibility if required by the Financial Assurance Regulations for Solid Waste Facilities (9VAC20-70); and

g. Submits to the director the results of the public participation effort conducted in accordance with the requirements contained in 9VAC20-120-690 D 4.

2. The owner or operator of an incineration or other treatment facility:

a. Notifies the director of his intent to operate such a facility and provides to the department documentation required under 9VAC20-120-710 B;

b. Provides the director with a certification that the facility meets the standards of Part VII (9VAC20-120-520 et seq.), VIII (9VAC20-120-580 et seq.), or IX (9VAC20-120-630 et seq.) of this chapter;

c. Furnishes to the director a certificate signed by a registered professional engineer that the facility has been designed and constructed in accordance with the standards of Part VII, VIII, or IX of this chapter;

d. Submits to the director an operational plan describing how the standards of Part VII, VIII, or IX will be met, and provides the operational information required in 9VAC20-120-730;

e. Submits to the director a closure plan describing how the standards of 9VAC20-120-290 will be met;

f. Submits to the director the proof of financial responsibility if required by the Financial Assurance Regulations for Solid Waste Facilities (9VAC20-70); and

g. Furnishes to the director a copy of the facility permit issued for air pollution control of any regulated point source discharges at the facility.

3. Use of materials in a manner constituting disposal. (Reserved)

4. Public participation.

a. Before the initiation of any construction at the facility under 9VAC20-120-690 D 1 or 9VAC20-120-690 D 2, the owner or operator shall publish a notice in a major local newspaper of general circulation informing the public that he intends to construct and operate a facility eligible for an off-site permit by rule. The notice shall include:

(1) A brief description of the proposed facility;

(2) A statement that the purpose of the public participation is to acquaint the public with the technical aspects of the facility and how the standards and the requirements of this chapter will be met;

(3) Announcement of a 30-day comment period, in accordance with 9VAC20-120-690 D 4 d, and the name and address of the owner's or operator's representative where comments shall be sent;

(4) Announcement of the date, time, and place for a public meeting held in accordance with 9VAC20-120-690 D 4 c; and

(5) Location where copies of the documentation to be submitted to the department in support of the off-site permit by rule notification and any supporting documents can be viewed and copied.

b. The owner or operator shall place a copy of the documentation and support documents in a location accessible to the public in the vicinity of the proposed facility.

c. The owner or operator shall hold a public meeting not earlier than 15 days after the publication of the notice required in 9VAC20-120-690 D 4 a and no later than seven days before the close of the 30-day comment period. The meeting shall be held to the extent practicable in the vicinity of the proposed facility.

d. The public shall be provided 30 days to comment on the technical and the regulatory aspects of the proposal. The comment period will begin on the date the owner or operator publishes the notice in the local newspaper.

5. Upon receiving the certifications and other required documents and after conducting a completeness review, the director will acknowledge their receipt and inform the owner or operator of the status of the submittal. If the applicant's submission is administratively incomplete, the letter will state that the facility will not be considered to have an off-site permit by rule until the missing certifications or other required documentation is submitted. At the time of the initial receipt or at a later date, the director may require changes in the documents designed to assure compliance with the standards of Parts V, VI, VII, VIII and IX of this chapter, if applicable. Should such changes not be accomplished by the facility owner or operator, the facility will not be deemed to have a regulated medical waste management facility permit.

6. An off-site permit by rule may not be transferred by the permittee to a new owner or operator. However, when the property transfer takes place without proper closure, the new owner shall notify the department of the sale and fulfill all the requirements contained in 9VAC20-120-690 D 1 through 9VAC20-120-690 D 3 with the exception of those dealing with the financial assurance. Upon presentation of the financial assurance proof required by 9VAC20-70-10 et seq. by the new owner, the department will release the old owner from his closure and financial responsibilities and acknowledge existence of the new off-site permit by rule in the name of the new owner.

7. The owner or operator of a facility operating under an off-site permit by rule may modify its design and operation by furnishing the department a new certificate prepared by the professional engineer and a new operational plan. Whenever modifications in the design or operation of the facility affect the provisions of the approved closure plan, the owner or operator shall also submit an amended closure plan. Should there be an increase in the closure costs, the owner or operator shall submit a new proof of financial responsibility as required by the Financial Assurance Regulations for Solid Waste Facilities (9VAC20-70).

8. In the event that a facility operating under an off-site permit by rule violates any applicable siting, design and construction, or closure provisions of Part V, VII, VIII, or IX of this chapter, the owner or operator of the facility will be considered to be operating an unpermitted facility and shall be required to close under 9VAC20-120-290, 9VAC20-120-710 and 9VAC20-120-750.

9. The director shall terminate off-site permit by rule and shall require closure of the facility whenever he finds that:

a. As a result of changes in key personnel, the requirements necessary for an off-site permit by rule are no longer satisfied;

b. The applicant has knowingly or willfully misrepresented or failed to disclose a material fact in his disclosure statement, or any other report or certification required under this chapter, or has knowingly or willfully failed to notify the director of any material change to the information in the disclosure statement;

c. Any key personnel has been convicted of any of the crimes listed in § 10.1-1409 of the Code of Virginia, punishable as felonies under the laws of the Commonwealth or the equivalent of them under the laws of any other jurisdiction; or has been adjudged by an administrative agency or a court of competent jurisdiction to have violated the environmental protection laws of the United States, the Commonwealth or any other state and the director determines that such conviction or adjudication is sufficiently probative of the permittee's inability or unwillingness to operate the facility in a lawful manner; or

d. The operation of the facility is inconsistent with the facility's operations manual and the operational requirements of the regulations.

E. The director may issue an experimental facility permit for any regulated medical waste treatment facility that proposes to utilize an innovative and experimental regulated medical waste treatment technology or process for which permit standards for such experimental activity have not been promulgated under Part VII, VIII or IX of this chapter. Any such permit shall include such terms and conditions as will assure protection of human health and the environment. Such permits shall:

1. Provide for the construction of such facilities based on the standards shown in Part V, VII, VIII, or IX, as necessary;

2. Provide for operation of the facility for no longer than one calendar year unless renewed as provided elsewhere in this chapter;

3. Provide for the receipt and treatment by the facility of only those types and quantities of regulated medical waste that the director deems necessary for purposes of determining the efficiency and performance capabilities of the technology or process and the effects of such technology or process on human health and the environment; and

4. Include such requirements as the director deems necessary to protect human health and the environment (including, but not limited to, requirements regarding monitoring, operation, closure and remedial action), and such requirements as the director deems necessary regarding testing and providing of information to the director with respect to the operation of the facility.

For the purpose of expediting review and issuance of permits under this subsection, the director may, consistent with the protection of human health and the environment, modify or waive permit application and permit issuance requirements in Parts V, VII, VIII or IX, except that there may be no modification or waiver of regulations regarding local certification, disclosure statement requirements, financial responsibility or of procedures regarding public participation.

No experimental permit may be renewed more than three times. Each such renewal shall be for a period of not more than one calendar year.

F. The director may grant a variance in accordance with the procedures in Part XI (9VAC20-120-840 et seq.) of this chapter from any regulation contained in this part to a permittee, provided the requirements of Part X are met.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 10.2, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-700. Permit conditions.

The director may include conditions in any permit that he finds necessary to protect public health or the environment or to ensure compliance with this chapter.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 10.3, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-710. Notice of intent.

A. Any person who proposes to establish a new regulated medical waste management facility, or modify an existing regulated medical waste management facility, shall submit a permit application to the department, using the procedures set forth in 9VAC20-120-690 and other pertinent sections of this part.

B. To initiate the permit application process, any person who proposes to establish a new regulated medical waste management facility ("regulated medical waste management"), or modify an existing regulated medical waste management facility, or to amend an existing permit shall file a notice of intent with the director stating the desired permit or permit amendment, the precise location of the proposed facility, and the intended use of the facility. The notice shall be in letter form and be accompanied by the information described in 9VAC20-120-720.

No application shall be deemed complete unless it is accompanied by a disclosure statement for all key personnel as provided by DEQ Forms DISC-01 and DISC-02.

No application for a permit for a regulated medical waste management facility shall be considered complete unless the notice of intent is accompanied by a certification (DEQ Form Certificate-01) from the governing body of the county, city, or town in which the facility is to be located stating that the location and operation of the facility are consistent with all applicable ordinances. No certification shall be required for the application for an amendment or modification of an existing permit. For the convenience of the regulated community, a Request for Local Government Certification, DEQ Form CERT-01, is provided.

If the location and operation of the facility is stated by the local governing body to be consistent with all its ordinances, without qualifications, conditions, or reservations, the applicant will be notified that he may submit his application for a permit.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 10.4, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-720. Submission requirements.

A. The information provided in this section shall be included in the submission of a notice of intent as required in 9VAC20-120-710 unless otherwise specified in this section.

B. A letter will be provided stating the type of facility for which the permit application is made and the certification required in subsection F of this section and all pertinent information and attachments required by this section.

C. A key map delineating the general location of the proposed facility shall be prepared and attached as part of the application. The key map shall be plotted on a seven and one-half minute United States Geological Survey topographical quadrangle. The quadrangle shall be the most recent revision available, shall include the name of the quadrangle and shall delineate a minimum of one mile from the perimeter of the proposed facility boundaries. One or more maps may be utilized where necessary to insure clarity of the information submitted.

D. A near-vicinity map shall be prepared and attached as part of the application. The vicinity map shall have a minimum scale of one inch equals 200 feet (1 inch = 200'). The vicinity map shall delineate an area of 500 feet from the perimeter of the property line of the proposed facility. The vicinity maps may be an enlargement of a United States Geological Survey topographical quadrangle or a recent aerial photograph. The vicinity map shall depict the following:

1. All homes, buildings or structures including the layout of the buildings that will comprise the proposed facility;

2. The boundaries of the proposed facility;

3. The limits of the actual waste management areas within the boundaries of the proposed facility, if applicable;

4. Lots and blocks taken from the tax map for the site of the proposed facility and all contiguous properties;

5. The base flood plain, where it passes through the map area; or, otherwise, a note indicating the expected flood occurrence period for the area;

6. Existing land uses and zoning classification;

7. All water supply wells, springs or intakes, both public and private;

8. All utility lines, pipelines or land based facilities (including mines and wells); and

9. All parks, recreation areas, dams, historic areas, wetlands areas, monument areas, cemeteries, wildlife refuges, unique natural areas or similar features.

E. A copy of the lease or deed (showing page and book location) or certification of ownership of the site. The department will not consider an application for a permit from any person who does not demonstrate legal control over the site for the period of the permit life.

F. A statement signed by the applicant indicating that he has sent written notice to all adjacent property owners or occupants that he intends to develop a regulated medical waste management facility on the site. A copy of the notice and the names and addresses of those to whom the notices were sent will also be provided.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 10.5, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-730. Operational information.

A. A narrative will be provided outlining the details of the design/operational capacities of the facility, emergency contingency information and daily operation of the facility as follows:

1. The narrative shall identify the project title; engineering consultants; site owner, licensee and operator; site life and capacity; municipalities, industries and collection and transportation agencies served; and waste types to be disposed. It shall also identify any exemptions desired by the applicant.

2. The narrative shall include the following information:

a. The rated capacity of the facility, in both tons per day and tons per hour;

b. The expected short-term and projected future long-term daily loadings;

c. The designation of normal loading, unloading and storage areas, including capacities in cubic yards and tons. Description of the time such areas can be practically used, based on expected short-term daily loadings;

d. The designation of emergency loading, unloading, storage or other actions to be taken when facility system down time exceeds 24 hours;

e. The designation of alternate treatment areas or plans for transfer of stored waste in the event facility system down time exceeds 72 hours.

3. The narrative will discuss the generation of process residues to include the following:

a. The expected daily quantity of waste residue generated;

b. The proposed ultimate disposal location for all facility-generated waste residues including, but not limited to, treated waste, ash residues and by-pass material, residues resulting from air pollution control devices, and the proposed alternate treatment or disposal locations for any unauthorized waste types, which may have been unknowingly accepted. The schedule for securing contracts for the treatment or disposal of these waste types at the designated locations shall be provided;

c. A descriptive statement of any materials use, reuse, or reclamation activities to be operated in conjunction with the facility, either on the incoming regulated medical waste or the outgoing residue.

4. A discussion of the proposed onsite and off-site transportation system intended to service vehicles hauling waste to the facility for processing, and vehicles removing reclaimed materials and or process residues from the facility. Onsite parking, access and exit points, and the mechanisms or features that will be employed to provide for an even flow of traffic into, out of, and within the site, shall be identified.

5. A detailed analysis shall be made of the financial responsibility for the time of site closing.

B. The operations manual shall provide the detailed procedures describing actions taken by facility personnel from the time of waste delivery, through waste storage, processing and final transportation and disposal. As a minimum, the operations manual shall include:

1. Daily operations including a discussion of the timetable for development; waste types accepted or excluded; typical waste handling techniques; hours of operation; traffic routing; drainage and erosion control; windy, wet and cold weather operations; fire protection equipment; manpower; methods for handling of any unusual waste types; methods for vector, dust and odor control; daily cleanup; salvaging; record keeping; parking for visitors and employees; monitoring; backup equipment with names and telephone numbers where equipment may be obtained; and other special design features. This information may be developed as a removable section to improve accessibility for the site operator.

2. The procedures that will be used to label individual waste containers, bulk containers or trailers with the date that the waste materials were received from off-site, and the procedures that will be used to demonstrate that the waste is treated within 15 days of receipt.

3. Site closing information consisting of a discussion of the anticipated sequence of events for site closing and discussion of those actions necessary to prepare the site for any anticipated post-closure use.

C. An emergency contingency plan that delineates procedures for responding to fire, explosions or any unplanned sudden or non-sudden releases of harmful constituents to the air, soil, or surface or ground water shall be submitted to the department as part of the Part B application. Before submission to the department it will be coordinated with the local police and fire departments, and the appropriate health care facility. The contingency plan shall contain:

1. A description of the actions facility personnel shall take in the event of various emergency situations;

2. A description of arrangements made with the local police and fire department that allow for immediate entry into the facility by their authorized representatives should the need arise, such as in the case of response personnel responding to an emergency situation; and

3. A list of names, addresses and phone numbers (office and home) of all persons qualified to act as an emergency coordinator for the facility. Where more than one person is listed, one shall be named as primary emergency coordinator and the other shall be listed in the order in which they will assume responsibility as alternates.

D. The applicant shall prepare and submit a detailed plan for closing any regulated medical waste management unit. Such a plan shall be prepared to reflect the actions required at any point in the life of the facility and at the time of closing the facility. The plan should reflect all steps necessary to isolate the facility from the environment or to remove all regulated medical waste and residue in the facility for proper treatment and to decontaminate the facility. The closure plan should reflect all actions necessary for facility abandonment or uses other than for regulated medical waste management.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 10.6, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-740. Effect of the permit.

A. Each facility permitted to accept regulated medical waste requires periodic inspection and review of records and reports. Such requirements shall be set forth in the final permit issued by the department. The permit applicant, by accepting the permit, agrees to the specified periodic inspections.

B. Compliance with a valid permit and this chapter during its term constitutes compliance for purposes of enforcement, with the Virginia Waste Management Act. However, a permit may be modified, considered invalid, or terminated for cause as set forth in 9VAC20-120-690 D 7, D 8, and D 9.

C. A permit does not convey any property rights of any sort, or any exclusive privilege.

D. A permit does not authorize any injury to persons or property or invasion of other private rights, or any infringement of federal, Commonwealth or local law or regulations.

E. A permit may be transferred in accordance with the procedures in 9VAC20-120-690 D 6.

F. The permit may, consistent with 9VAC20-120-700, specify a schedule of compliance leading to compliance with this chapter.

1. Any schedules of compliance under this subsection or subsection G of this section shall require compliance as soon as possible.

2. Except as otherwise provided, if a permit establishes a schedule of compliance that exceeds one year from the date of permit issuance, the schedule shall set forth interim requirements and the dates for their achievement.

a. The time between interim dates shall not exceed one year;

b. If the time necessary for completion of any interim requirement is more than one year and is not readily divisible into stages of completion, the permit shall specify interim dates for the submission of reports of progress toward completion of the interim requirements and indicate a projected completion date.

3. The permit shall be written to require that no later than 14 calendar days following each interim date and the final date of compliance, a permittee shall notify the director, in writing, of his compliance or noncompliance with the interim or final requirements.

G. A permit applicant or permittee may cease conducting regulated activities (by receiving a terminal volume of regulated medical waste, and, in case of treatment or storage facilities, closing pursuant to applicable requirements, or, in case of disposal facilities, closing and conducting post-closure care pursuant to applicable requirements) rather than continue to operate and meet permit requirements as follows:

1. If the permittee decides to cease conducting regulated activities at a specified time for a permit that has already been issued:

a. The permit may be modified to contain a new or additional schedule leading to timely cessation of activities; or

b. The permittee shall cease conducting permitted activities before noncompliance with any interim or final compliance schedule requirement already specified in the permit.

2. If the decision to cease conducting regulated activities is made before the issuance of a permit whose terms will include the termination date, the permit shall contain a schedule leading to termination that will ensure timely compliance with applicable requirements.

3. If the permittee is undecided whether to cease conducting regulated activities, the director may issue or amend a permit to continue two schedules as follows:

a. Both schedules shall contain an identical interim deadline requiring a final decision on whether to cease conducting regulated activities no later than a date that ensures sufficient time to comply with applicable requirements in a timely manner if the decision is to continue conducting regulated activities;

b. One schedule shall lead to timely compliance with applicable requirements;

c. The second schedule shall lead to cessation of regulated activities by a date that will ensure timely compliance with applicable requirements.

d. Each permit containing two schedules shall include a requirement that, after the permittee has made a final decision, he shall follow the schedule leading to compliance if the decision is to continue conducting regulated activities, and follow the schedule leading to termination if the decision is to cease conducting regulated activities.

4. The applicant's decisions to cease conducting regulated activities shall be evidenced by a firm public commitment satisfactory to the director, such as a resolution of the board of directors of a corporation.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 10.7, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-750. Closure care.

A. An owner, operator or permittee intending to close a regulated medical waste management facility shall notify the department of the intention to do so as least 180 calendar days prior to the anticipated date of closing.

B. Closure shall occur in accord with an approved closure plan, which shall be submitted with the permit application documents and approved when the director acknowledges that the facility is considered to have a permit. The holder of the permit shall submit a proposed modified closure plan to the department for review and approval as such modifications become necessary during the life of the facility.

C. The department shall inspect all regulated medical waste management facilities that have been closed to determine if the closing is complete and adequate. It shall notify the owner of a closed facility, in writing, if the closure is satisfactory, and shall order necessary construction or such other steps as may be necessary to bring unsatisfactory sites into compliance with this chapter. Notification by the department that the closure is satisfactory does not relieve the operator of responsibility for corrective action to prevent or abate problems caused by the facility.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 10.8, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-760. Recording and reporting required of a permittee.

A. A permit may specify:

1. Required monitoring, including type, intervals and frequency, sufficient to yield data that are representative of the monitored activity;

2. Requirements concerning the proper use, maintenance, and installation of monitoring equipment or methods, including biological monitoring methods when appropriate; and

3. Applicable reporting requirements based upon the impact of the regulated activity and as specified in this chapter.

B. A permittee shall be subject to the following whenever monitoring is required by the permit:

1. 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 for at least three years from the sample or measurement date. The director may request that this period be extended.

2. Records of monitoring information shall include:

a. The date, exact place and time of sampling or measurements;

b. The individuals who performed the sampling or measurements;

c. The dates analyses were performed;

d. The individuals who performed the analyses;

e. The analytical techniques or methods used; and

f. The results of such analyses.

3. Monitoring results shall be maintained on file for inspection by the department.

C. A permittee shall be subject to the following reporting requirements:

1. Written notice of any planned physical alterations to the permitted facility, unless such items were included in the plans and specifications or operating plan approved by the department, shall be given to the director and approved before such alterations are to occur.

2. Reports of compliance or noncompliance with, or any progress reports on, interim and final requirements contained in any compliance schedule of the permit, shall be submitted no later than 14 calendar days following each schedule date.

3. The permittee shall report to the department any noncompliance or unusual condition that may endanger health or environment. Any information shall be provided orally within 24 hours from the time the permittee becomes aware of the circumstances. A written submission shall also be provided within five calendar days of the time the permittee becomes aware of the circumstances. The written submission shall contain a description of the noncompliance and its cause; the period of noncompliance, including exact dates and times, and, if the noncompliance has not been corrected, the anticipated time it is expected to continue. It shall also contain steps taken or planned to reduce, eliminate and prevent reoccurrence of the noncompliance.

D. Copies of all reports required by the permit, and records of all data used to complete the permit application must be retained by the permittee for at least three years from the date of the report or application. The director may request that this period be extended.

E. When the permittee becomes aware that he failed to submit any relevant facts or submitted incorrect information in a permit application or in any report to the director, he shall promptly submit such omitted facts or the correct information with an explanation.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 10.9, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-770. (Repealed.)

Historical Notes

Derived from VR672-40-01:1 §§ 10.10 to 10.13, eff. June 29, 1994; repealed, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-810. Amendment of permits.

A. Temporary authorizations.

1. Upon request of the permittee, the director may, without prior public notice and comment, grant the permittee a temporary authorization in accordance with the requirements of this section. Temporary authorizations shall have a term of not more than 180 calendar days.

2. a. The permittee may request a temporary authorization for:

(1) Any substantive amendment meeting the criteria in subdivision 3 b (1) of this subsection; and

(2) Any major amendment that meets the criteria in subdivision 3 b (1) or (2) of this subsection; or that meets the criteria in subdivisions 3 b (3) and (4) of this subsection and provides improved management or treatment of a regulated medical waste already listed in the facility permit.

b. The temporary authorization request shall include:

(1) A description of the activities to be conducted under the temporary authorization;

(2) An explanation of why the temporary authorization is necessary; and

(3) Sufficient information to ensure compliance with standards in Part V (9VAC20-120-330 et seq.) or VI (9VAC20-120-400 et seq.) of this chapter.

c. The permittee shall send a notice about the temporary authorization request to all persons on the facility mailing list. This notification shall be made within seven calendar days of submission of the authorization request.

3. The director shall approve or deny the temporary authorization as quickly as is practical. To issue a temporary authorization, the director shall find:

a. The authorized activities are in compliance with the standards of Part V (9VAC20-120-330 et seq.), VII (9VAC20-120-520 et seq.), VIII (9VAC20-120-580 et seq.) or IX (9VAC20-120-630 et seq.) of this chapter.

b. The temporary authorization is necessary to achieve one of the following objectives before action is likely to be taken on an amendment request:

(1) To facilitate timely implementation of closure or corrective action activities;

(2) To prevent disruption of ongoing waste management activities;

(3) To enable the permittee to respond to sudden changes in the types or quantities of the wastes managed under the facility permit; or

(4) To facilitate other changes to protect human health and the environment.

4. A temporary authorization may be reissued for one additional term of up to 180 calendar days provided that the permittee has requested a substantive or a major permit amendment for the activity covered in the temporary authorization, and (i) the reissued temporary authorization constitutes the director's decision on a substantive permit amendment in accordance with the Solid Waste Management Regulations (9VAC20-81) or (ii) the director determines that the reissued temporary authorization involving a major permit amendment request is warranted to allow the authorized activities to continue while the amendment procedures of the Solid Waste Management Regulations (9VAC20-81) are conducted.

B. Newly defined or identified wastes. The permittee is authorized to continue to manage wastes defined or identified as regulated medical waste under Part III (9VAC20-120-80 et seq.) of this chapter if he:

1. Was in existence as a regulated medical waste management facility with respect to the newly defined or identified regulated medical waste on the effective date of the final rule defining or identifying the waste; and

2. (i) Is in compliance with the standards of Part V, VII, VIII or IX, as applicable, with respect to the new waste, submits a minor modification request on or before the date on which the waste becomes subject to the new requirements or (ii) is not in compliance with the standards of Part V or VI, as applicable, with respect to the new waste, but submits a complete permit amendment request within 180 calendar days after the effective date of the definition or identifying the waste.

C. The suitability of the facility location will not be considered at the time of permit amendment unless new information or standards indicate that an endangerment to human health or the environment exists that was unknown at the time of permit issuance.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 10.14, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002; Volume 27, Issue 22, eff. August 3, 2011.

9VAC20-120-820. Duration of permits.

Any permit for the management of regulated medical waste shall expire after 10 years of operation. Permits shall not be extended beyond the 10 year permit by permit transfer or modifications. At any time more than 180 calendar days prior to the expiration of the permit and no more than 480 calendar days prior to the expiration of the permit, the holder of a valid permit may request that the director renew the permit and submit all information known to permit holder that is changed or new since the original permit application and that has not been previously submitted to the director. A permit may be renewed for a period of 10 years of operation. Processing of the request will be in accordance with the following:

1. If the holder of a valid permit for a regulated medical waste management facility files with the director a request to renew the permit at least 180 calendar days prior to the expiration of that permit, the director will cause an audit to be conducted of the facility's past operation, its current condition and the records held by the department concerning the facility. Within 60 calendar days of receipt of a proper request, the director will report to the applicant the findings of the audit and those items of correction or information required before renewal will be considered. The director shall review the environmental compliance history of the permittee, material changes in key personnel, and technical limitations, standards, or regulations on which the original permit was based. If the director finds repeated material or substantial violations of the permittee or material changes in the permittee's key personnel would make continued operation of the facility not in the best interest of human health or the environment, the director shall deny the request for renewal of the permit. If the director finds the facilities to be insufficient to comply with regulations in effect at the time of the proposed renewal, the director shall deny the request for renewal. The director shall request any information from the permittee that is necessary to conduct the audit, and that is reasonably available to the permittee and substantive to the proposed renewal.

2. If the applicant files for renewal less than 180 calendar days prior to the expiration of the original permit or files an improper application the director shall deny the application for renewal. If an application for renewal has been denied for a facility, any further applications and submittals shall be identical to those for a new facility.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 10.15, eff. June 29, 1994.

9VAC20-120-830. Existing facilities qualifications.

Owners and operators of existing and permitted infectious waste management facilities are not required to submit an application for a new permit at the time these amended regulations become effective. Existing permits will remain valid, except that conditions or waivers in existing permits that conflict with these amended regulations are void on the date six months from the effective date of these amended regulations. Operators of existing facilities are required to comply with these amended regulations within six months following their effective date and may comply at any time with any item contained in this chapter in lieu of a conflicting condition contained in an existing permit.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 10.16, eff. June 29, 1994.

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