06- 096 C.M.R. ch. 900, § 16

Current through 2024-44, October 30, 2024

Section 096-900-16 - Standards for Transfer Facilities

A.Facility Location Criteria

(1) Environmental Performance Standards. All biomedical waste transfer facilities must be located, designed, constructed, altered, operated, maintained, and closed in a manner that will ensure protection of public health and welfare and the environment. Protection of health and welfare and the environment includes, but is not limited to:

(a) prevention of adverse effects on ground water quality;

(b) prevention of adverse effects on surface water quality;

(c) prevention of adverse effects on air quality; and

(d) prevention of adverse effects due to migration of waste constituents in the subsurface environment.

(2) Siting Criteria. All new biomedical waste transfer facilities as well as substantial modifications to existing facilities are prohibited in the following areas:

(a) Areas in which a risk to any underground source of potable water for people may be created. Location within 300 feet is presumed to pose a risk such that a license cannot be issued unless demonstrated otherwise to the Department's satisfaction;

(b) Within 100 feet of any 100-year flood plain or within 100 feet of the level of any actual documented flood of a greater magnitude;

(c) On land defined as a wetland under statutes or regulations administered by the following Departments: Environmental Protection, Conservation (Land Use Regulation Commission - LURC), Inland Fisheries & Wildlife, Marine Resources or the State Planning Office;

(d) Areas in which a threat to the fisheries, wildlife or other natural resources of a sanctuary, refuge, preserve, state or federal park, designated wilderness area, critical area or fish hatchery may be created; and

(e) Within the boundaries of a state or federal park or designated wilderness area.

B.Design Standards

(1) Biomedical waste must be stored in conveyances or buildings that are leak-proof and equipped with locks.

(2) If the transfer facility is not located at a medical facility, it must be enclosed by a chain link fence, at least six feet in height, and access will be controlled by a locking gate or an alternate Department approved security system that offers equivalent protection.

(3) The fence, conveyances or buildings must be posted with warning signs which indicate a potential biological hazard.

(4) All biomedical waste conveyances and buildings used primarily for the storage of biomedical waste must be located at least 50 feet from the facility property boundaries.

(5) The operating area of the facility must be an impervious surface, such as asphalt or concrete, which must be kept entire.

(6) The facility must have provisions for the packaging of biomedical waste in the event that repackaging is required because the integrity of the original container has been compromised. Such re-packaging must be carried out in an enclosed space which is designed to contain any spillage of waste and prevent exposure to wind and precipitation.

C.Operating Standards

(1) The packaging, labeling, handling, and storage requirements specified in Sections 12(A), 12(B), 12(C), and 12(D) of this rule apply to biomedical waste transfer facilities.

(2) An operator of a biomedical waste transfer facility may not accept any biomedical waste that is not packaged and labeled in accordance with this rule and accompanied by a properly completed manifest except as provided for in Section 4 of this rule.

(3) Biomedical waste may not be re-packaged unless the integrity of the original packaging has been compromised such that it can no longer contain the wastes.

(4) Biomedical waste which was generated off-site may not be held at a transfer facility for more than one week (168 hours), except that:

(a) Pathological waste that is to be transferred off the site of the transfer facility for treatment may be stored up to 30 days provided it is frozen at a temperature of zero degrees Fahrenheit or below, and

(b) Trace chemotherapy waste and anti-neoplastic drugs as described in Section 7(B) of this rule that are to be treated at another facility may also be stored for up to 30 days.

NOTE: The purpose of the above provision is to enable the efficient consolidation and movement of biomedical waste to the limited number of licensed treatment facilities for these portions of the waste stream requiring specialized treatment without risk to human health or the environment.

(5) Pathological wastes, cultures, and discarded animal carcasses and body parts must be stored in refrigerated conveyances or storage buildings in a frozen state.

(6) Biomedical waste may not be compacted or subjected to violent mechanical stress during transfer, storage or any time prior to final treatment.

(7) All areas used for the storage of biomedical waste must be maintained in a sanitary condition and must be designed to control or contain any spillage of such wastes.

(8) The on-site population of disease vectors must be controlled to protect public health.

(9) The facility access gate and all biomedical waste conveyances and storage buildings must be closed except when loading or unloading wastes and must be locked whenever an operator is not in attendance at the facility.

(10) The biomedical waste transfer 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.

D. Closure

A licensee who no longer accepts waste at a site shall remove all biomedical waste and biomedical waste residues to a facility licensed to handle the waste. Remaining conveyances, equipment, buildings and soil containing or contaminated with biomedical waste or biomedical waste residues must be disinfected or disposed of at a facility licensed to handle the waste. The licensee shall provide 60 days written notice to the Department prior to closure and shall submit to the Department, within 10 days of completion of closure, certification that closure was completed in accordance with this rule.

E.Manifests and Record Keeping

(1) A transfer facility may not accept more than 50 pounds of biomedical waste from a biomedical waste generator or any quantity of biomedical waste from a transporter unless it is accompanied by a properly completed manifest.

(2) A transfer facility operator shall, in the presence of the generator or the transporter, complete the appropriate transfer facility portion of the manifest, including handwritten acceptance signature and date of acceptance, and immediately give a signed copy of the manifest to the generator or transporter, noting any discrepancies in manifest information.

(3) The operator of a biomedical waste transfer facility that has accepted biomedical waste from a generator without a manifest because the quantity is less than 50 pounds shall maintain a log of all such wastes which includes, at a minimum, the following:

(a) The name, address and identification number of the transfer facility;

(b) The type and volume of waste received;

(c) The date of receipt of such waste;

(d) The name, location and identification number of the generator; and

(e) The signature of the person receiving the waste.

(4) The transfer facility shall initiate a biomedical waste 4-part manifest available from the Department. In instances where the transfer facility initiates the manifest, Copy 4 of the biomedical waste manifest is to be retained by the transfer facility; Copy 3, by the transporter; Copy 2, by the transfer or treatment facility; and Copy 1 is to be returned to the transfer facility. If the transfer facility does not receive the completed manifest from the treatment facility within 35 days after the date the waste was accepted by the transporter, the transfer facility must report this fact to the Department.

(5) Retention of Records. Manifests and logs must be retained by the licensed biomedical waste transfer facility for a period of not less than 3 years. The period of retention of records is extended automatically during the course of any unresolved enforcement action regarding the regulated activity or as requested by the Department. These records must be available for inspection by the Department, upon request.

06- 096 C.M.R. ch. 900, § 16