Code of Maine Rules › 06 - DEPARTMENT OF ENVIRONMENTAL PROTECTION › 096 - DEPARTMENT OF ENVIRONMENTAL PROTECTION - GENERAL › Chapter 900 - BIOMEDICAL WASTE MANAGEMENT RULES › Section 096-900-17 - Licensing of Treatment Facilities

Current through 2024-29, July 17, 2024
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.