Section 250-RICR-140-15-1.16 - Registration for Generators of Regulated Medical WasteA. General Requirements 1. As of January 1, 2012, no person whose primary business activity of purpose is the diagnosis (including testing and laboratory analysis), treatment, or immunization of human beings or animals, in research pertaining thereto, or in the preparation of human remains for burial or cremation, or in the production or testing of biologicals, or in the development of pharmaceuticals shall engage in the generation of regulated medical waste unless that person shall have registered with the Director in accordance with the requirements contained in § 1.16(A)(2) of this Part and have been issued a regulated medical waste generator registration number. For the purpose of these regulations, a person is considered to be a single generator, even if it utilizes more than one (1) site in the course of its operation.2. Contents of Application: A generator shall submit an application for a regulated medical waste generator registration number in a manner prescribed by the Director. The Department may require this form to be filled out on paper or in an online format. Such application shall include, as a minimum, the following: a. Name under which the application is being made;b. Business location(s) used to generate regulated medical waste, and mailing address if different from generation location(s);c. The type of generator facility at each business location;d. Applicant's business phone number;e. The name and phone number of the primary contact person for the facility;f. The approximate amount of regulated medical waste that will be generated per year at each location;g. If regulated medical waste is to be treated and/or destroyed on-site, provide a description of the treatment/destruction methods;h. If regulated medical waste is to be transported off-site for treatment and/or destruction, provide the approximate quantity of treated and untreated waste, as well as the name(s) and RI regulated medical waste transporter permit number(s) of the transporter(s);i. The signature of the applicant or a person duly authorized to act on behalf of the applicant; and,j. Any other information reasonably required by the Director to demonstrate that the applicant can safely generate and manage regulated medical waste in accordance with all applicable provisions of these regulations.3. Notification of Changes: A registered generator of regulated medical waste shall notify the Director, in writing, of any change(s) in the information required by the permit application. Such notification shall be provided in advance whenever possible. However, in no case shall the notification be postmarked later than five (5) business after the effective date of the change(s). Notwithstanding the foregoing, the Director shall be notified, in writing, of any additional location(s) to be included on the registration before any regulated medical waste is generated at that location.4. Expiration of Regulated Medical Waste Generator Registrations: Upon approval by the Director, a regulated medical waste generator registration shall expire on December 31 of the year of issuance, unless sooner suspended or revoked.5. Renewal of Regulated Medical Waste Generator Registrations a. Requests for renewal of a regulated medical waste generator registration shall be submitted not later than thirty (30) days prior to the expiration date of the current registration, and shall contain all the information required by § 1.16(A)(2) of this Part without reference to any previously submitted material.b. In any case in which a holder of a regulated medical waste generator registration has filed an application in proper form for renewal not less than thirty (30) days prior to the expiration date of his/her existing registration, the existing registration number shall not expire until final action on the application has been taken by the Director.B. Registration of More Than One Generator at the Same Site 1. Any person who generates regulated medical waste at a location operated by a legal entity of which such person has no legal relationship must register as a generator of regulated medical waste as required by R.I. Gen. Laws § 23-19.12-12, in the manner provided by § 1.16(A) of this Part. Such person shall be independently responsible for violations of the law and regulations that are committed by that person.2. If two or more individual generators register in accordance with § 1.16(A) of this Part as a single legal entity, they shall submit to the Director verification that they are a legal entity, which is responsible for the actions of its agents regarding the generation and management of regulated medical waste.3. Two or more individual generators at the same location who share examination rooms, jointly combine all regulated medical waste, and are each small quantity generators, but are not a single legal entity, shall each be required to obtain separate registrations pursuant to § 1.16(A) of this Part. Each person shall be independently responsible for violations of the law and regulations that are committed. For the purpose of determining registration categories, each such individual generator shall assume, unless proven otherwise, an equal proportion of all regulated medical waste generated at that location.C. Annual Registration Fee 1. The Director has established the following annual registration fees for generators of regulated medical waste: Generator Category | Waste Generated Per Generator Per Year | Annual Fee for Registration |
1 | Less than 25 lbs. | $30/generator |
2 | 25 lbs. to 100 lbs. | $40/generator |
3 | 101 lbs. to 500 lbs. | $60/generator |
4 | 501 lbs. to 2,000 lbs. | $160/generator |
5 | More than 2,000 lbs. | $200/generator |
2. Prorating of Fees. Any person submitting an application for a new regulated medical waste generator registration between July 1 and December 31 shall pay one-half of the appropriate fee specified in § 1.16(C)(1) of this Part. The fee for a new regulated medical waste generator registration submitted between January 1 and June 30 shall not be prorated.3. Adjustments to Fees. A facility that generates more regulated medical waste than permitted under their current generator category during the issuance period shall, upon renewal, be responsible for payment of the renewal registration fee for the higher generator category. No permit fee adjustments shall be made during the issuance period for facilities that generate less regulated medical waste than permitted under their current generator category.250 R.I. Code R. 250-RICR-140-15-1.16
Amended effective 4/22/2020