06-096 C.M.R. ch. 900, § 15 - Licensing of Transfer Facilities

A. Applicability

(1) No person may accept biomedical waste generated off-site for the purpose of temporary storage prior to transport to another licensed biomedical waste transfer or treatment facility without first obtaining a biomedical waste transfer facility license from the Department.

(2) Exclusions. Generators of biomedical waste who accept less than a total of 100 pounds per month of biomedical waste from other generators for the purpose of temporary storage prior to transport to a licensed biomedical waste transfer or treatment facility are not transfer facilities for the purposes of this rule provided the waste accepted from off-site is stored with the receiving generator's biomedical waste and is managed in accordance with Sections 12(A), 12(B), 12(C), and 12(D) of this rule.

B. Application Requirements

(1) Application for a biomedical waste transfer facility license will 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.

(2) Persons wishing to establish a transfer facility shall apply to the Department at least 60 days prior to the date they wish to begin operations.

(3) 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.

(4) The applicant must submit:

(a) Evidence of the applicant's history of compliance with laws, regulations and standards relating to environmental protection.

NOTE: For example, the Department will 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.

(b) A certificate of liability insurance covering the licensed activity in an amount appropriate for the licensed activity and for the risk involved. In no event, however, may the limit of liability be less than $1,000,000.

(c) Any other information, including safety histories and training programs, which the Department deems to be necessary.

(5) The applicant must demonstrate in his application sufficient financial capacity to construct, operate, maintain and close all aspects of the facility.

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

(7) 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 must be folded to a size of 81/12" x 11" or smaller.

(8) Biomedical Waste Management and Operations Plan

(a) Each applicant for a biomedical waste transfer 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, a description of all biomedical waste storage areas and equipment specifications;

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

(iv) a general inspection schedule for the facility;

(v) a description of security procedures and equipment;

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

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

(viii) 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.

(9) Public Informational Meeting. The applicant must hold a public informational meeting on the project. 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 shall be held in the municipality 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.

(10) 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 transfer facility. Insofar as practical, access will be sought during normal business hours.

(11) Application Fee

(a) At the time of filing, the applicant must remit an application fee of $1,000 made payable to the Maine Hazardous Waste Fund.

(b) Application fees are required for an initial application, a renewal application, and an 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.

(12) Annual License Fee. The licensee must remit an annual fee of $500 upon the issuance of the license and on each anniversary date thereafter.

C. Decisions

The Department shall issue a biomedical waste transfer facility license whenever it finds that the applicant has satisfied all application requirements and has demonstrated the technical and financial ability to comply with the operating requirements and 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) A biomedical waste transfer 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.

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

E. Standard Conditions

All transfer facility licenses issued under this rule are subject to the following standard conditions.

(1) The licensee shall not operate, construct or maintain a biomedical waste transfer 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 shall have liability insurance coverage in force at all times. The coverage must 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.

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

(6) Record Keeping. A licensee shall comply with all applicable state and federal requirements regarding the use of a manifest 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 shall ensure that all methods, equipment and personnel are adequate and capable to achieve this end.

(8) Inspection and Training Requirements. A licensee shall 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 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 shall be made at least 6 months 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.

F. Special Conditions

The Department may place special conditions on any license issued under this rule. However, special conditions must address particular means of satisfying minor or easily corrected problems relating to compliance with this rule and with all applicable statutes and may 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

The Department 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.

Notes

06-096 C.M.R. ch. 900, § 15