250 R.I. Code R. 250-RICR-140-15-1.13

Current through October 15, 2024

Section 250-RICR-140-15-1.13 - Generator Requirements for Off-Site Transportation of Regulated Medical Waste

A. Applicability

1. A person who generates regulated medical waste and whose generating facility is located in Rhode Island shall determine if that waste is a regulated medical waste (as defined in §§ 1.2(C) and 1.5 of this Part).

2. Any generator that transports off-site or offers for transport off-site any regulated medical wastes shall comply with all requirements for such transport set forth in §§ 1.6 through 1.9, and 1.11 of this Part.

3. A generator of regulated medical wastes shall determine the quantity of regulated medical wastes generated in a calendar month, and the quantity transported or offered for transport off-site for treatment, destruction, or disposal.

4. Vessels at port in Rhode Island are subject to the requirements of this section for those regulated medical wastes that are transported ashore in Rhode Island. The owner or operator of the vessel and the person(s) removing or accepting waste from the vessel are considered co-generators of the waste.

5. A generator that treats and destroys or disposes of regulated medical waste on-site (e.g., incineration, burial or sewer disposal covered by §307(b) through (d), of the Clean Water Act) is not subject to tracking requirements for that waste. However, generators of regulated medical waste with on-site incinerators are subject to DEM on-site incinerator requirements.

6. Generators of regulated medical waste with on-site treatment and/or destruction system(s) are subject to the requirements of § 1.12 of this Part. In addition, generators who treat and destroy regulated medical waste are subject to §§ 1.6 through 1.10 of this Part. Generators who treat or dispose of regulated medical waste on-site may also be subject to additional Federal, State, or local laws and regulations.

7. Training/Notification Requirement: Generators shall notify in writing all employees involved with the off-site transportation of regulated medical wastes of the provisions in § 1.13 of this Part. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials.

B. General Requirements Generator shall send regulated medical waste only to a permitted facility. Except as provided below, he/she shall not offer regulated medical waste to a medical waste transporter that does not have a medical waste transporter permit number and a valid RI medical waste transporter permit as indicated by an official sticker on each transportation unit. Generators shall use transporters who have been issued a Rhode Island regulated medical waste transporter permit number by the Rhode Island Department of Environmental Management,

1. Generators of fifty (50) pounds or more of regulated medical waste per calendar month: Generators who generate, transport, or offer for transport off-site fifty (50) pounds or more of regulated medical waste in a calendar month are subject to the requirements of §§ 1.6 through 1.11 of this Part and all requirements of this Section for each shipment of regulated medical waste.

2. Small Quantity Generator(s): Small quantity generators are subject to the requirements of §§ 1.6 through 1.11 of this Part and are exempt from:

a. The requirement to use a transporter who has been issued a Rhode Island regulated medical waste transporter permit; and,

b. The requirement to use a tracking form; and,

c. The requirements of § 1.13(C) of this Part;

d. The exemption(s) contained in §§ 1.13(B)(2)(a) through (c) of this Part shall only be applicable if the following conditions are met:

(1) The regulated medical waste is transported from the original generation point to a satellite facility or central collection point owned by the generator.

(2) From the time the waste is received at the central collection point, the generator must store and ship the waste in accordance with all other generator requirements of these regulations, including requirements to use a medical waste tracking form.

(3) Small quantity generators and crime scene cleanup contractors that transport regulated medical waste between satellite facilities or to a central collection point shall apply to the Department for a Letter of Authorization. This authorization shall last for a period of three (3) years, after which time the generator must reapply.

(4) Notwithstanding the requirements of § 1.13(B)(2)(d) ((1)) of this Part, small quantity generators in the same building may share a common storage facility within the building (before the waste is transported off-site), without applying for a letter of authorization; provided that the appropriate logs are kept at both the original generation point and the central collection point, as described in § 1.13(E)(2) of this Part; and,

(5) Prior to utilization of a common storage facility pursuant to § 1.13(B) of this Part, all participating small quantity generators shall be signatories to a written agreement which describes, at a minimum, the person(s) responsible for preparing the medical waste tracking form, the person(s) responsible for arranging off-site transportation of regulated medical waste, and the person(s) assuming legal responsibility for any violation of these regulations. Notwithstanding the foregoing, any written agreement must be approved in advance by the Director if the average total regulated medical waste generated per month is in excess of two hundred (200) pounds; and,

(6) Other than small quantity generators may act as the manager/agent for agreements pursuant to §§ 1.13(B) through (C) of this Part provided that: they are located in the same building as the participants; all regulated medical waste received under the agreement is segregated from their own regulated waste; and all regulated medical waste received under the agreement is transported off-site under a separate medical waste tracking form; and,

(7) The regulated medical waste is transported by the generator, or an authorized employee, in a vehicle owned by the generator or authorized employee; and,

(8) The generator shall compile a shipment log and maintain records as required in § 1.13(E)(2) of this Part.

3. Shipments Between Generator's Facilities: Generators are exempt from the requirement to use transporters that have a Rhode Island regulated medical waste transporter permit number when transporting regulated medical waste from the original generation point to a central collection point, or between satellite facilities, provided they meet all of the following conditions:

a. The regulated medical waste is transported by the generator, or the generator's authorized employee, in a vehicle owned by the generator or the employee; and,

b. The regulated medical waste is brought to a central collection point or treatment facility owned or operated by the generator.

(1) Small quantity generators who transport regulated medical waste between satellite facilities shall apply for a letter of authorization from: Rhode Island Department of Environmental Management, Office of Land Revitalization and Sustainable Materials Management, 235 Promenade Street, Providence, RI 02908.

(2) Other generators (i.e., those who generate and transport or offer for transport more than fifty (50) pounds of regulated medical waste in a calendar month) with multiple locations shall apply for a transporter permit and letter of authorization as per § 1.14 of this Part from: Rhode Island Department of Environmental Management, Office of Land Revitalization and Sustainable Materials Management, 235 Promenade Street, Providence, RI 02908;

c. The original generation point and the central collection point or treatment facility are located in the State of Rhode Island; and,

d. The generator compiles and maintains a shipment log at each generation point and each central collection point as required by § 1.13(E) of this Part.

4. Shipments of Sharps and Unused Sharps through the U.S. Postal Service: small quantity generators who transport regulated medical waste (sharps and unused sharps) by the U.S. Postal Service are exempt from the requirement to use a transporter that has a Rhode Island regulated medical waste transporter permit number provided that the following conditions are met:

a. The package is sent by first class or priority mail in accordance with § 1.10(Q) of this Part (Infectious Substances) of the United States Postal Service Domestic Mail Manual.

b. The generator compiles a shipment log and maintains the original shipping papers as required by § 1.13(E) of this Part;

c. Reports shall be submitted to the Director for the periods of January 1 to June 30 and July 1 to December 31 of each year. These reports shall be received by the Director within forty-five (45) days of the end of each reporting period.

5. Transportation of sharps from residences by health care professionals: Health care professionals and veterinarians who generate medical waste that would otherwise be classified as household medical waste, may transport the waste back to their offices without a medical waste tracking form, provided the waste is properly packaged in accordance with § 1.7 of this Part and that the waste is properly handled as regulated medical waste upon arrival at the central collection point.

C. Use of the Tracking Form

1. Except as otherwise exempted in § 1.13(B) of this Part, a generator that transports or offers for transport regulated medical waste for off-site treatment or disposal shall prepare a tracking form according to this section.

2. Generators may obtain samples of the Rhode Island Medical Waste Tracking Form from: Rhode Island Department of Environmental Management, Office of Land Revitalization and Sustainable Materials Management, 235 Promenade Street, Providence, RI 02908.

3. The generator shall prepare the number of tracking form copies that will provide the generator, each transporter(s), and each intermediate handler with one copy, and the owner or operator of the destination facility with two copies.

4. The generator shall also:

a. Sign the certification statement on the tracking form by hand;

b. Obtain the signature of the initial transporter and include the date of acceptance on the tracking form; and,

c. Retain one copy, in accordance with § 1.13(E) of this Part.

5. For rail shipments of regulated medical waste within the United States that originate at the site of generation, the generator shall send at least three (3) copies of the tracking form dated and signed in accordance with § 1.13(C) of this Part to:

a. The next non-rail transporter, if any; or,

b. The intermediate handler or destination facility if transported solely by rail; or,

c. The last rail transporter to handle the waste in the United States if exported by rail.

D. Generators Exporting Regulated Medical Waste Generators, including transporters and intermediate handlers that initiate tracking forms, which export regulated medical waste to a foreign country for treatment and destruction, or disposal, shall request the destination facility to provide written confirmation that the waste was received. If the generator does not receive written confirmation from the destination facility within forty-five (45) days from the date of acceptance of the waste by the first transporter, the generator shall submit an exception report as required under § 1.13(F) of this Part.

E. Recordkeeping

1. Except as provided in § 1.13(E)(2) of this Part, each generator shall:

a. Retain both the original generator receipt [yellow-copy, page 4] and the completed generator copy [white-copy, page 1] of each tracking form signed in accordance with § 1.13(C) of this Part, for at least three hundred and seventy-five (375) days from the date the waste was accepted by the initial transporter; and,

b. Retain for a period of three hundred and seventy-five (375) days a copy of all exception reports required to be submitted under § 1.13(F) of this Part.

2. Generators that are exempt from using the medical waste tracking form, as specified in § 1.13(B) of this Part, shall meet the following requirements:

a. A shipment log shall be maintained at the original generation point for a period of three hundred and seventy-five (375) days from the date the waste was shipped. The log shall contain the following information:

(1) Date of shipment;

(2) Quantity and unit of measure of regulated medical waste transported, by waste category (i.e., untreated and treated);

(3) Address or location of central collection point;

(4) Signature of generator's employee who is transporting the waste, to signify delivery has been completed.

b. A shipment log shall be maintained at each central collection point for a period of three hundred and seventy-five (375) days from the date that regulated medical waste was accepted from each original generation point and shall contain the following information:

(1) Date of receipt;

(2) Quantity (and unit of measure) of regulated medical waste accepted, by waste category (i.e., untreated and treated);

(3) Address or location of original generation point; and,

(4) Signature of generator or generator's representative who operates the central collection point, to signify acceptance of the waste.

3. Generators that meet the conditions of § 1.13(B)(2) of this Part and do not voluntarily comply with the use of the medical waste tracking form are subject to the following recordkeeping requirements:

a. Generators that use a transporter that holds a valid Rhode Island regulated medical waste transporter permit shall maintain a log for a period of three hundred and seventy-five (375) days from the date of shipment that contains the following information for each shipment or pickup:

(1) Transporter's name and address;

(2) Transporter's regulated medical waste transporter permit number;

(3) Quantity and unit of measure of regulated medical waste transported, by waste category (i.e., untreated and treated);

(4) Date of shipment; and,

(5) The signature of the transporter's representative accepting the regulated medical waste for transport.

b. Generators who transport their own regulated medical waste to a treatment, destruction, or disposal facility as specified in § 1.13(B) (2)(d) of this Part shall compile and maintain a log for a period of three hundred and seventy-five (375) days from the date of the last shipment entered into the log. The log shall contain the following information:

(1) Name and address of the intermediate handler, destination facility, or health care facility to which the generator has transported the shipment of regulated medical waste;

(2) Quantity and unit of measure of regulated medical waste transported, by waste category (i.e., untreated and treated);

(3) Date of shipment; and,

(4) Signature of the generator or his authorized representative who transported the waste.

c. Generators that transport regulated medical waste by the U.S. Postal Service § 1.13(B)(4) of this Part shall retain the original shipping papers and a shipment log for a period of three hundred and seventy-five (375) days from the date of shipment. The log shall contain the following information:

(1) Quantity and unit of measure of regulated medical waste transported, by waste category (i.e., untreated and treated);

(2) Date of shipment; and,

(3) Name and address of each intermediate handler or destination facility to which the generator has transported the regulated medical waste by the U.S. Postal Service.

F. Exception/Discrepancy Reporting

1. A generator that meets the conditions of § 1.13(B)(1) of this Part or initiates a tracking form voluntarily shall contact the owner or operator of the destination facility, transporter(s), and intermediate handler(s), as appropriate, to determine the status of any tracked waste if he does not receive a copy of the completed tracking form with the signature of the owner or operator of the destination facility within thirty-five (35) days of the date the waste was accepted by the initial transporter.

2. A generator shall submit an exception report, as described below, to the Director if he has not received a completed copy of the tracking form signed by the owner or operator of the destination facility within forty-five (45) days of the date the waste was accepted by the initial transporter. The exception report shall be postmarked on or before the forty-sixth (46th) day and shall include:

a. A legible copy of the original tracking form for which the generator does not have confirmation of delivery; and,

b. A cover letter signed by the generator or his authorized representative explaining the efforts taken to locate the regulated medical waste and the results of those efforts.

c. The generator shall keep a copy of the exception report for a period of at least three hundred and seventy-five (375) days from the due date of the report.

3. A generator shall also submit a discrepancy report, as described below, to the Director if there are any discrepancies between the information contained on the original generator receipt [yellow-copy, page 4] and the signed/completed generator copy [white-copy, page 1] that are not documented in block 23 of the medical waste tracking form. This discrepancy report shall be postmarked no later than five (5) working days from the date that the signed/completed generator copy [white-copy, page 1] is received from the owner or operator of the destination facility and shall include:

a. A legible copy of both the original generator receipt and the signed/ completed generator copy received from the owner or operator of the destination facility; and,

b. A cover letter signed by the generator or his authorized representative identifying the discrepancies that were not documented in block 23 of the medical waste tracking form;

c. The generator shall keep a copy of this discrepancy report for a period of at least three hundred and seventy-five (375) days from the date of the report.

250 R.I. Code R. 250-RICR-140-15-1.13

Amended effective 4/22/2020