Rule 3745-27-30 | Standards for generators of infectious wastes.
(A) Each generator of less than fifty pounds of infectious waste in any one month (small generator) shall:
(1) Identify and separate infectious from non-infectious waste at the point of generation for the purposes of determining whether the generator must comply with paragraph (B) of this rule;
(2) Place sharp infectious wastes in a "sharps" container.
(3)
(a) Either treat all specimen cultures and cultures of viable infectious agents on the premises where they are generated to render them noninfectious by any of the methods, techniques, or practices prescribed by paragraph (B) of rule 3745-27-32 of the Administrative Code before they are transported off that premises for disposal; or
(b) Ensure that such wastes are treated to render them noninfectious at a treatment facility off that premises that is owned or operated by the generator, a treatment facility that holds a license issued under division (B) of section 3734.05 of the Revised Code, a treatment facility that is authorized by rule 3745-27-32 of the Administrative Code, prior to disposal of the wastes, or a facility in another state operating in compliance with state and federal regulations.
(4) Not be considered a treatment facility as "treatment" and "facility" are defined in section 3734.01 of the Revised Code when the generator treats specimen cultures and cultures of viable infectious agents on the premises where they are generated. Such treated cultures may be transported and disposed of in the same manner as solid wastes and need not comply with the disposal paper as described in rule 3745-27-33 of the Administrative Code;
(5) Quantify the waste generation rate and keep records recorded in pounds. This generation rate and record shall pertain to the aggregate quantity of waste generated on the premise owned or operated by the generator on a calendar month basis. Upon request of the board of health or its authorized representative, or the director or his authorized representative, the generator shall provide information regarding the infectious waste generation rate, the generator shall quantify and record the monthly generation rate. A monthly generation rate log shall display the month and the weight of all the infectious waste generated on the premises during that calendar month.
(6) Determine by monthly records, required by paragraph (A)(5) of this rule, if fifty pounds or more of infectious waste is generated. If fifty pounds or more of infectious waste is generated in any one month the generator shall register with the Ohio environmental protection agency as a generator of infectious waste on the forms prescribed by the director and as outlined in paragraph (A) of rule 3745-27-36 of the Administrative Code. Generator registration certificates shall apply to premises and shall not include emergency vehicles or public safety vehicles; and
(7) Comply with paragraph (C) of this rule.
A generator who complies with paragraph (A)(2) of this rule and who generates less than fifty pounds of infectious wastes each month and does not hold a certificate of registration as a generator of infectious wastes may dispose of infectious wastes in the same manner as solid wastes.
(B) Each generator of infectious wastes holding a certificate of registration under paragraph (A) of rule 3745-27-36 of the Administrative Code, and any other person who generates fifty pounds or more of infectious wastes in any one month (large generator), shall:
(1) Segregate infectious wastes from other wastes at the point of generation. At a minimum, infectious wastes shall be placed in separate containers, from other wastes until rendered non-infectious;
(2) Place sharp infectious wastes in a "sharps" container;
(3) Not grind any sharp infectious wastes, not compact any such wastes until after the wastes have been treated in accordance with rule 3745-27-32 of the Administrative Code and not compact or grind any other type of infectious wastes until after the wastes have been treated in accordance with rule 3745-27-32 of the Administrative Code;
(4) Dispose of the infectious wastes at a solid waste disposal facility holding a license issued under division (A) of section 3734.05 of the Revised Code, after being treated to render them non infectious by either:
(a) Treating the infectious waste that is generated at a facility owned or operated by the generator by any of the methods, techniques, or practices prescribed by paragraph (A) of rule 3745-27-32 of the Administrative Code to render them non-infectious; or
(b) Designating the wastes for treatment off that premises at an infectious waste treatment facility holding a license issued under division (B) of section 3734.05 of the Revised Code, or to a facility that holds a license issued under section 4717.17, and a permit issued under Chapter 3704. of the Revised Code to the extent that the treatment of those wastes is consistent with that permit and its terms and conditions prior to disposal of the wastes, or a facility in another state operating in compliance with state and federal regulations.
(5) Provide information on the major components of the infectious wastes, any method of treatment of the wastes to render them non-infectious, and the generator's system for distinguishing between waste containers that contain treated and untreated wastes to persons with whom the generator has entered into an arrangement to treat or dispose of the wastes upon receiving a written request from those persons;
(6) Ensure that all treated infectious wastes that are transported off the premises where they are generated are accompanied by a disposal paper that meets the requirements of rule 3745-27-33 of the Administrative Code.
(C) All generators of infectious wastes shall comply with the following provisions:
(1) A generator of infectious wastes, who also generates wastes consisting of any instrument designed to pierce or lacerate used in the body adornment of human beings, that have come in contact with blood or other body fluids, including, but not limited to needles, syringes with an attached needle, or any other type of instrument designed for the purpose to pierce or lacerate, shall manage such instruments in the same manner as sharp infectious wastes;
(2) Nothing in this rule prohibits a generator of infectious wastes from designating and managing wastes, in addition to infectious wastes, as infectious wastes when, in the judgment of the generator, those other wastes should be managed as infectious wastes because they are, or are likely to be, contaminated with infectious agents. After designating any such other wastes as infectious, the generator shall manage those wastes in compliance with the requirements of this rule;
(3) Generators of infectious wastes may discharge untreated liquid or semiliquid infectious wastes consisting of blood, blood products, body fluids, and excreta into a disposal system, as defined in section 6111.01 of the Revised Code, unless the discharge of those wastes into a disposal system is inconsistent with the terms and conditions of any permit for the system issued under Chapter 6111. of the Revised Code;
(4) A generator holding a license issued under section 4717.17 of the Revised Code shall not consider the weight of blood, blood products, other body fluids, or embalming fluids that are discharged on the site of their generation into a disposal system, as defined in section 6111.01 of the Revised Code, when determining the quantity of infectious wastes produced by that generator or the monthly generation rate;
(5) A generator of infectious wastes may transport or cause to be transported infectious wastes that have been treated to render them noninfectious in accordance with paragraph (B) of rule 3745-27-32 of the Administrative Code in the same manner as noninfectious wastes are transported;
(6) No wastes consisting of dead animals or parts thereof shall be considered when determining the quantity of infectious wastes produced by any generator if the dead animals or parts meet all of the following:
(a) Were not intentionally exposed to infectious agents during research, production of biologicals, or testing of pharmaceutical;
(b) Were produced by a veterinarian holding a license issued under Chapter 4741. of the Revised Code; or
(c) Were treated or disposed of by a person holding a license issued under Chapter 953. of the Revised Code.
(7) Any infectious waste or infectious waste mixture that meets the definition of hazardous waste as specified in rule 3745-51-03 of the Administrative Code shall be managed as a hazardous waste in accordance with Chapters 3745-50 to 3745-69 of the Administrative Code. No generator of infectious waste shall transport, or cause to be transported, wastes deemed hazardous in accordance with rule 3745-51-03 of the Administrative Code to an infectious waste treatment facility licensed in accordance with section 3734.05 of the Revised Code;
(8) A generator of infectious waste who produces infectious waste that is also radioactive waste shall:
(a) Manage the waste in accordance with applicable Ohio department of health and U.S. nuclear regulatory commission regulations; and
(b) Use a monitoring instrument, calibrated at least annually, to verify that infectious waste that is also radioactive is no longer required to be managed in accordance with Ohio department of health and U.S. nuclear regulatory commission regulations; and
(c) Not transport, or cause to be transported, any infectious waste that is also radioactive to an infectious waste treatment facility licensed under section 3734.05 of the Revised Code unless the monitoring instrument indicates that the levels of radioactivity do not exceed Ohio department of health and U.S. nuclear regulatory commission regulations for managing as a non-regulated material or waste.
[Comment: The purpose of this paragraph is to clarify the interaction between this rule and the statutory requirements of the Ohio department of health, Chapter 3748. of the Revised Code and rules promulgated thereunder, and the U.S. nuclear regulatory commission when materials are both infectious waste and radioactive waste.]
(d) Infectious waste that is also radioactive but no longer required to be managed in accordance with Ohio department of health or U.S. nuclear regulatory commission regulations shall be handled in accordance with rule 3745-27-35 of the Administrative Code.
[Comment: The intent of this regulation is to have the generator of the wastes verify that the contents have decayed to a sufficient level that the wastes are no longer regulated as radioactive wastes or materials.]
(9) A generator, that is a hospital as defined in section 3727.01 of the Revised Code, may accept for treatment or storage prior to treatment the following wastes:
(a) Sharp infectious wastes and all unused discarded hypodermic needles, syringes, and scalpel blades that are in containers securely closed to prevent leaks or punctures that are generated by a generator of less than fifty pounds in any one month and who has staff privileges at the hospital;
(b) Infectious wastes generated by an individual for purposes of their own care or treatment; and
(c) Infectious wastes generated in providing care to a patient by an emergency medical services organization as defined in section 4765.01 of the Revised Code.
(10) An emergency medical services organization, as defined in section 4765.01 of the Revised Code, shall not be required to quantify the infectious waste that is accepted by a generator that is a hospital as defined in section 3727.01 of the Revised Code;
(11) A generator shall handle all infectious wastes in accordance with rule 3745-27-35 of the Administrative Code.
Supplemental Information