Section 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.

Historical Notes

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

Statutory Authority

§ 10.1-1402 of the Code of Virginia.