Section 096-900-12 - Standards for GeneratorsA. PackagingBiomedical waste must be properly packaged to assure effective containment throughout the handling, storage, transport, and treatment processes.
(1) Biomedical wastes, other than sharps and bulk liquids, must be packaged in bags which are impervious to moisture and have a strength sufficient to resist ripping, tearing or bursting under normal conditions of usage and handling.(2) All bags containing biomedical waste must be red in color and imprinted with the international biohazard symbol and the words "biomedical waste" or "infectious waste." Waste in red bags will be considered biomedical waste and must be managed as biomedical waste.(3) Bags must be sealed by forming a secure closure which results in a leak-resistant seal.(4) Discarded sharps must be segregated from other biomedical waste at the point of generation. Discarded sharps will be placed directly into leak-resistant, rigid, puncture-resistant containers without clipping or breaking. When full or in preparation to be sent for treatment, these containers will be taped closed or tightly lidded to preclude loss or leakage of contents. After proper packaging, sharps containers may be placed in biomedical waste bags referred to in Section 12(A)(1) of these rules. NOTE: An example of an acceptable container for storing discarded sharps at home is an empty rigid plastic bottle.
(5) Discarded bulk blood and other liquids which is to be transported off-site will be packaged in tightly stoppered, unbreakable flasks or bottles or other appropriate containers.(6) All biomedical waste bagged in accordance with Section 12(A)(3), sharps containerized in accordance with Section 12(A)(4), and bulk liquids containerized in accordance with Section l2(A)(5) which are to be transported off-site must also be packaged for storage or handling by placement in disposable corrugated fiberboard boxes or equivalent rigid containers such as reusable pails, cartons, drums, or portable bins. The box or container must be leak-resistant or lined with a bag which is impervious to moisture and has a 200-pound burst strength as measured by the industry's Mullen test.(7) Reusable containers used for the handling of biomedical waste must be thoroughly washed and disinfected each time they are emptied unless the surfaces of the containers have been effectively protected from contamination by disposable liners, bags or other devices which are removed and disposed of with the waste. A red bag may not be enclosed in a bag of another color.(8) Reusable containers used for the handling of biomedical waste must not be used for containment of waste to be disposed of as non-biomedical waste or for any other purpose except after being disinfected.B. LabelingBiomedical waste to be transported off-site must be labeled immediately after packaging in accordance with Section 12(A)(6). The label must be securely attached to the outer layer of packaging and be clearly legible. Indelible ink will be used to complete the information on the label, and the label will be at least three inches by five inches in size. The following information must be included on the label:
(1) The name, address, business telephone number, and registration number of the generator;(2) "Biomedical Waste" or "Infectious Waste" in large print;(3) "Refrigeration Required" in large print if pathological waste, cultures, or animal carcasses or body parts are included in the contents;(4) The name, address, business telephone number, and registration number of the person or persons to whose control the biomedical waste is to be transferred;(5) The international biohazard symbol; and(6) The date upon which the biomedical waste was packaged in accordance with Section12(A)(6).C.Handling(1) Packages of biomedical waste must be handled in a manner that does not impair the integrity of the packaging.(2) Trash chutes will not be used to transfer biomedical waste between locations where it is contained.(3) Compactors must not be used in the handling of biomedical waste. Biomedical waste in bags or other containers must not be subjected to compaction by any compacting device and must not be placed for storage or transport in a portable or mobile trash compactor.D. Storage(1) Biomedical waste must be segregated from other wastes.(2) All on-site storage of containers of biomedical waste must be in a designated area away from general traffic flow patterns and, where possible, in a room reserved for this purpose. The manner of storage must prevent access to or contact with such waste by unauthorized persons.(3) Biomedical waste must be stored in a manner that preserves the integrity of the container and is not conducive to rapid microbial growth and/or putrefaction. Pathological waste, cultures, and discarded animal carcasses and body parts stored for more than 24 hours after packaging in accordance with Section 12(A)(3) must be refrigerated at a temperature of 45[DEGREE] F or below in a refrigerator or refrigerated space used only for biomedical waste.(4) All areas used for the storage of biomedical waste must be capable of being readily maintained in a sanitary condition.(5) All biomedical waste containers must be stored in a manner that allows access for inspection.(6) Biohazard signs must be posted wherever biomedical waste is stored or contained, including on storage rooms doors, refrigerators, bins and other containers.E.Manifests and Record Keeping Requirements(1) Except as provided for in Section 4, the generator of biomedical waste that is to be transported off-site for treatment or disposal shall initiate a biomedical waste 4-part manifest available from the Department. Copy 4 of the biomedical waste manifest is to be retained by the generator; Copy 3, by the transporter; Copy 2, by the transfer or treatment facility; and Copy 1 is to be returned to the generator.(2) If the generator does not receive the completed manifest from the treatment facility within 35 days after the date the waste was accepted by the transporter, the generator shall report this fact to the Department.(3) Retention of Records. Manifests must be retained by the generator 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 Commissioner. These records must be made available for inspection by the Department upon request.(4) The Department may approve electronic manifesting systems upon demonstration to the Department that the system meets EPA electronic manifest standards and provides an equal degree of regulatory oversight as the existing system. A paper copy must be provided to a generator upon request.06- 096 C.M.R. ch. 900, § 12