06- 096 C.M.R. ch. 900, § 17

Current through 2024-51, December 18, 2024

Section 096-900-17 - Licensing of Treatment Facilities

A. Applicability

No person may treat biomedical waste without first obtaining a biomedical waste treatment facility license from the Department.

NOTE: Both incineration and non-incineration treatment technologies are considered to be a method of treatment, not disposal. The Department will not issue a license for the disposal of untreated biomedical waste.

B. Application Requirements

(1) Application for a biomedical waste treatment facility license must be made on a form obtained from the Department. The license application will be processed in accordance with Chapter 2 of the Department's rules. An applicant or licensee shall immediately notify the Department in writing of any change in circumstance or situation which changes or will change any information stated on his or her application.

(2) Persons wishing to incinerate biomedical waste must apply to the Department for a biomedical waste treatment facility license pursuant to this rule and an air emission license pursuant to Chapter 115, Major and Minor Source Air Emission License Regulations. A solid waste incineration facility currently licensed under Chapter 403 of the Department's Solid Waste Management Rules must apply to the Department to amend its license to cover biomedical waste in accordance with this rule prior to accepting biomedical waste.

(3) Persons wishing to treat biomedical waste utilizing a non-incineration treatment technology including, but not limited to, steam sterilization or microwaving, must obtain approval of the non-incineration treatment technology pursuant to Section 19 and a biomedical waste treatment facility license pursuant to this rule.

(4) The Department will not accept an application for the disposal of untreated biomedical waste.

(5) Biomedical Waste Management and Operations Plan

(a) Each biomedical waste treatment facility must submit a written biomedical waste management and operations plan. Such plan will set forth policies and procedures consistent with these rules for managing biomedical waste.

(b) The plan must include, at a minimum, the following:

(i) a description of the biomedical waste handled by the facility including type and volume of biomedical waste;

(ii) a detailed narrative explaining how the facility will operate, including, but not limited to, design capacity, equipment specifications, on site storage, and flow diagram schematics for all parts of the facility;

(iii) total capacity and life expectancy of the facility, including calculations used to derive these data;

(iv) hours and days of operation of the facility and the number of conveyances delivering biomedical wastes that are expected daily and that can be accommodated daily;

(v) a general inspection schedule for the facility;

(vi) a description of security procedures and equipment;

(vii) training procedures for personnel who handle biomedical waste;

(viii) emergency spill containment and cleanup procedures and equipment; and

(ix) the name, address, and telephone number of the person(s) responsible for biomedical waste management at the facility.

(c) The plan must be available for inspection at the facility by a public safety officer or authorized representative of the Department.

(6) Treated Biomedical Waste Management Plan

(a) In instances where the facility incinerates biomedical waste, the applicant must submit a plan for the storage, testing, removal and disposal of the incinerator ash.

(b) In instances where the facility treats biomedical waste using a non-incineration treatment technology approved pursuant to Section 19, the applicant must submit a plan for the storage, testing, removal and disposal of the treated waste and other residues, if any. The plan must demonstrate that the activity protects public health and safety and the environment and must provide for the following:

(i) the treated waste must meet the performance standards in Section 19 of this rule;

(ii) the wastes and treatment residues must be managed in a manner protective of human health and the environment;

(iii) all biomedical waste treated via a non-incineration treatment technology must be accompanied when shipped for disposal by a "Certificate of Destruction" certifying compliance with treatment performance standards as stated in Section 19;

(iv) the treated biomedical waste as a special waste must be handled, stored and disposed of as a special waste; and

(v) the plan must require a contract with a disposal facility licensed by the Department to accept special waste. The plan must also name all back up disposal facilities.

(7) The applicant must submit evidence of the applicant's history of compliance with laws, regulations and standards relating to environmental protection and any other information, including safety histories and training programs, which the Department deems to be necessary.

NOTE: For example, the Department may require the applicant to provide a list of all environmental licenses or permits previously obtained by the applicant in this, or any other, State as well as information pertaining to the status of those licenses or permits or to any related enforcement actions.

(8) The applicant must submit information regarding liability insurance coverage as follows:

(a) The applicant must submit with his application, and annually thereafter, proof of liability insurance against bodily injury or property damage. The level of coverage must be at least one million dollars per occurrence and two million dollars annual aggregate or such other financial guarantees which the Department determines are equivalent. The Department may require a higher minimum level of insurance coverage for a particular facility if it finds that, because of the design, operation or location of the facility, higher coverage is necessary to protect the public health, safety and welfare or the environment.

(b) All liability insurance coverage amounts must be exclusive of legal defense costs.

(c) A financial test may not be used in lieu of liability insurance nor may an owner or operator self-insure.

(9) The applicant must demonstrate in his application sufficient financial capacity to construct, operate, maintain and close all aspects of the facility. Such demonstration shall be made on an annual basis.

(10) All engineering designs, reports, plans and other technical engineering documents must be signed and certified by a registered professional engineer.

(11) All geological work must be signed and certified by a State of Maine Certified Geologist, except that soils work may be signed and certified by a State of Maine Certified Soil Scientist.

(12) All property survey work must be signed and certified by a State of Maine Registered Land surveyor.

(13) All drawings, site plans and maps must be on sheets no smaller than 81/12" x 11" and no larger than 30" x 40" and will be folded to a size of 81/12" x 11" or smaller.

(14) Public Informational Meeting. The applicant must hold a public informational meeting. The purpose of the meeting is to provide information to the public and interested persons regarding the purpose of the project. The public informational meeting will be held in the municipal or political jurisdiction where the project is to be located. The public notice of the application provided in accordance with Chapter 2 must identify the date, time and place of the public informational meeting.

(15) Access to the Site. By filing an application for a license, the applicant agrees to provide authorized representatives of the Department with access to the facility site in order that the site may be evaluated for suitability as a biomedical waste treatment facility. Insofar as practical, access will be sought during normal business hours.

(16) Application Fee

(a) At the time of filing, the applicant must remit an application fee made payable to the Maine Hazardous Waste Fund. The application fee is determined as follows:

(i) for a facility which treats biomedical waste generated on-site or which treats no more than 15% on an annual average of biomedical waste generated off-site $3,500

(ii) for all other facilities $5,000

(b) Application fees are required for an initial application, a renewal application, and any application for a license amendment seeking approval for a substantial modification to a facility or license.

(c) A refund of 50% of the fee will be made to an applicant who withdraws the application within 30 calendar days of its submission.

(17) Annual Fee. The licensee must remit an annual fee of $1,000 upon the issuance of his license and on each anniversary date thereafter.

C.Decisions

The Department shall issue a biomedical waste treatment facility license whenever it finds that:

(1) the applicant has satisfied all application requirements,

(2) the proposed facility meets all siting and testing standards,

(3) the proposed facility meets all standards of the Site Location of Development Law, and

(4) the applicant has the financial and technical ability to construct, operate, maintain and close the facility in accordance with the operating, manifest and recordkeeping requirements of this section, all terms and conditions of the license, and all other requirements of this rule.

D. Terms

(1) A license or renewal of a license granted under this rule is valid for 5 calendar years beginning with the date of issuance, but may be for a shorter time period if the Department deems it necessary in order to assure compliance with this rule.

(2) A license under this rule is issued on the basis of information supplied in the application and is valid only so long as that information remains accurate.

(3) A license under this rule is issued only to and for the persons, location and activities specified in the license unless a license transfer is approved in accordance with Department rules.

(4) The biomedical waste treatment facility license or certified copy thereof obtained from the Department, must be available for inspection upon demand by any public safety officer or any authorized representative of the Department.

(5) A biomedical waste treatment facility may be inspected at any time for compliance with its license and this rule. Inspection may be made by a public safety officer or any authorized representative of the Department.

(6) The license may be modified, suspended or revoked by the Board pursuant to 38 M.R.S.A. Section341-D(3).

E.Standard Conditions

All treatment facility licenses issued under this rule are subject to the following standard conditions:

(1) The licensee must not operate, construct or maintain a biomedical waste treatment facility other than as described in the application approved by the Department.

(2) Relation of License to Application. A license issued under this rule is valid only as long as the information supplied in the application remains accurate. Approval of an application is dependent upon and limited to the proposals and plans contained in the application and supporting documents submitted and affirmed by the applicant. Any variation from the plans, proposals and supporting documents is subject to the review and approval of the Department prior to implementation.

(3) Duty to Comply. The licensee shall comply with all conditions of the license and these rules. Noncompliance with the license or rule constitutes a violation of law and is grounds for enforcement action, for license suspension or revocation, or for denial of any renewal application.

(4) Liability Insurance. A licensee must have liability insurance coverage in force at all times. The coverage will be appropriate for the licensed activity and for the risk involved. Under no circumstance may the amount of liability insurance in force be less than $1,000,000 per occurrence or $2,000,000 in aggregate.

(5) Local, State and Federal Permits. A licensee must hold all other local, state and federal permits, licenses and certifications required for the licensed activity and must comply with all applicable local, state and federal laws and rules.

(6) Record Keeping. A licensee must comply with all applicable state and federal requirements regarding the use of a manifest or log and the maintenance of other required records.

(7) Duty to Ensure Safe Operation. It is the duty of a licensee to ensure that the licensed activity is carried out safely and does not create a threat to public health or safety or the environment. A licensee must ensure that methods, equipment and personnel are adequate and capable to achieve this end.

(8) Inspection and Training Requirements. A licensee must comply with all state and federal inspection and training requirements as may from time to time be applied by law, rule or license condition to the licensed activity.

(9) Response to an Emergency. A licensee agrees to provide to the Department and to public safety agencies all information necessary for response to emergency situations involving the licensed activity and agrees to assist the Department in obtaining compliance with this rule.

(10) Discharge of Biomedical Waste. In the event of a discharge of biomedical waste in any amount, the licensee shall take immediate action to protect public health, safety and welfare and the environment, including the immediate implementation of the spill containment and cleanup procedures contained in the approved biomedical waste management and operations plan, and shall immediately report the discharge to the Maine Department of Environmental Protection.

(11) Duty to Mitigate. The licensee shall take all reasonable steps to minimize or correct any adverse impact on the environment resulting from noncompliance with the license.

(12) Duty to Reapply. If the licensee wishes to continue an activity regulated by the license after the expiration date of the license, the licensee must apply for and obtain a new license. Such application must be made at least one year prior to the expiration of the license.

(13) Duty to Provide Information. The licensee shall furnish to the Department, upon request, any information that the Department may require to determine compliance with the license and this rule. The licensee shall also furnish to the Department, upon request, copies of records required to be kept by the licensee and not otherwise required to be filed with the Department.

(14) Prior to Construction. All preconstruction terms and conditions must be met before construction begins.

(15) Construction/Operation within Two Years. If the construction or operation of the activity is not begun within 2 years, the approval will lapse and the applicant must reapply to the Department for a new approval. The applicant may not begin construction or operation of the facility until new approval is granted. Reapplications for approval must state the reasons why the facility was not begun within 2 years from the granting of the initial approval and the reasons why the applicant will be able to begin the activity within 2 years from the granting of a new approval, if granted. Reapplications for approval may include information submitted in the initial application by reference.

(16) Bid Specifications. A copy of this approval must be included in or attached to all contract bid specifications for the development.

(17) Contractor Copy. Work done by a contractor pursuant to this approval must not begin before the contractor has been given a copy of the license by the licensee.

F.Special Conditions

The Department may place special terms and conditions, , on any license issued under this rule. However, terms and conditions must address themselves to specifying particular means of satisfying minor or easily corrected problems, or both, relating to compliance with this rule and with all applicable statutes and must not substitute for or reduce the burden of proof on the applicant to affirmatively demonstrate to the Department that each of the applicable standards has been met.

G.Suspension or Revocation

(1) The Board may seek suspension or revocation of a license pursuant to 38 M.R.S.A. Section341-D(3).

(2) A licensee whose license has been revoked may not reapply for a license within one calendar year from the effective date of the revocation.

06- 096 C.M.R. ch. 900, § 17