3734.021 Standards for generators and transporters of infectious wastes and owners and operators of treatment facilities.
Infectious wastes shall be segregated, packaged, treated, transported, and disposed of in accordance with rules adopted under this section.
The director of environmental protection, in accordance with Chapter 119. of the Revised Code, shall adopt, and may amend and rescind, rules necessary or appropriate to protect human health or safety or the environment:
(A) Establishing standards for generators of infectious wastes that include, without limitation, the following requirements and authorizations that:
(1) All generators of infectious wastes:
(a) Place all infectious wastes identified in division (R)(7) of section 3734.01 of the Revised Code, and all unused, discarded hypodermic needles, syringes, and scalpel blades, in rigid, tightly closed, puncture-resistant containers on the premises where they are generated before they are transported off that premises. Containers containing such wastes shall be labeled “sharps” and, if the wastes have not been treated to render them noninfectious, shall be conspicuously labeled with the international biohazard symbol.
(b) Either treat all specimen cultures and cultures of viable infectious agents on the premises where they are generated to render them noninfectious by methods, techniques, or practices prescribed by rules adopted under division (C)(1) of this section before they are transported off that premises for disposal or ensure that such wastes are treated to render them noninfectious at an infectious waste treatment facility off that premises that is owned or operated by the generator, an infectious waste treatment facility that holds a license issued under division (B) of section 3734.05 of the Revised Code, an infectious waste treatment facility that is located in another state that is in compliance with applicable state and federal laws, or a treatment facility that is authorized by rules adopted under division (C)(6) of this section, prior to disposal of the wastes.
(c) Except as otherwise provided in division (A)(1)(c) of this section, wastes generated by a generator who produces fewer than fifty pounds of infectious wastes during any one month that are subject to and packaged and labeled in accordance with rules adopted under division (A)(1)(a) of this section shall be transported and disposed of in the same manner as solid wastes. Such generators who treat specimen cultures and cultures of viable infectious agents on the premises where they are generated shall not be considered treatment facilities as “treatment” and “facility” are defined in section 3734.01 of the Revised Code.
(d) Wastes subject to and treated in accordance with rules adopted under division (A)(1)(b) of this section shall be transported and disposed of in the same manner as solid wastes.
(e) For the purposes of this section and rules adopted under it, 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 either of the following:
(i) Were not intentionally exposed to infectious agents during research, production of biologicals, or testing of pharmaceuticals;
(ii) Either were produced by a veterinarian holding a license issued under Chapter 4741. of the Revised Code or were treated or disposed of by a person holding a license issued under Chapter 953. of the Revised Code.
(f) For the purposes of this section and rules adopted under it, no 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, by a facility that holds a license or renewal of a license issued under Chapter 4717. of the Revised Code shall be considered when determining the quantity of infectious wastes produced by that generator.
(g) Wastes generated by a generator who produces fewer than fifty pounds of infectious wastes during any one month that are subject to and packaged in accordance with rules adopted under division (A)(1)(a) of this section may be transported to a treatment facility owned or operated by a hospital with which the generator has staff privileges, as “hospital” is defined in section 3727.01 of the Revised Code. Such a generator who so transports infectious wastes, other than untreated specimen cultures and cultures and stocks of viable infectious agents, that are generated on the generator’s premises is not a transporter for the purposes of this section or section 3734.022 of the Revised Code.
(h) Wastes generated in providing care to a patient by an emergency medical services organization, as defined in section 4765.01 of the Revised Code, may be taken to and left at a hospital, as defined in section 3727.01 of the Revised Code, for treatment at a treatment facility owned or operated by the hospital or, in conjunction with infectious wastes generated by the hospital, at another treatment facility regardless of whether the wastes were generated in providing care to the patient at the scene of an emergency or during the transportation of the patient to a hospital. An emergency medical services organization that transports infectious wastes that are so generated to a hospital for that purpose is not a transporter for the purposes of this section or section 3734.022 of the Revised Code.
(i) Wastes generated by an individual for purposes of the individual’s own care or treatment may be taken to and left at a hospital, as defined in section 3727.01 of the Revised Code, for treatment at a treatment facility owned or operated by the hospital or, in conjunction with infectious wastes generated by the hospital, at another treatment facility. An individual or member of an individual’s household who transports wastes so generated by the individual to a hospital for that purpose is not a transporter for the purposes of this section or section 3734.022 of the Revised Code.
(2) Each generator of fifty pounds or more of infectious wastes during any one month:
(a) Register with the environmental protection agency as a generator of infectious wastes and obtain a registration certificate. The fee for issuance of a generator registration certificate is three hundred dollars payable at the time of application. The registration certificate applies to all the premises owned or operated by the generator in this state where infectious wastes are generated and shall list the address of each such premises. If a generator owns or operates facilities for the treatment of infectious wastes it generates, the certificate shall list the address and method of treatment used at each such facility.
A generator registration certificate is valid for three years from the date of issuance and shall be renewed for a term of three years upon the generator’s submission of an application for renewal and payment of a three hundred dollar renewal fee.
The rules may establish a system of staggered renewal dates with approximately one-third of such certificates subject to renewal each year. The applicable renewal date shall be prescribed on each registration certificate. Registration fees shall be prorated according to the time remaining in the registration cycle to the nearest year.
The registration and renewal fees shall be credited to the infectious wastes management fund, hereby created in the state treasury.
(b) Segregate infectious wastes from other wastes at the point of generation. Nothing in this section and rules adopted under it prohibits a generator of infectious wastes from designating and managing wastes, in addition to those defined as infectious wastes under section 3734.01 of the Revised Code, 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 chapter and rules adopted under it applicable to the management of infectious wastes.
(c) For purposes of containment, place infectious wastes, other than those subject to rules adopted under division (A)(1)(a) of this section, in plastic bags that are impervious to moisture and are sufficiently strong to preclude ripping, tearing, or bursting under normal conditions of handling and ensure that the filled bags are securely tied to prevent leakage or expulsion of the wastes from them during storage, handling, or transport. The generator shall ensure that, prior to transportation off the premises where generated, infectious wastes that have not been treated to render them noninfectious, other than those subject to division (A)(1)(a) of this section, are contained in bags that either are red in color or conspicuously labeled with the international biohazard symbol.
(d) Either treat the infectious wastes that it generates at a facility owned or operated by the generator by methods, techniques, or practices prescribed by rules adopted under division (C)(1) of this section to render them noninfectious, or designate 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, at an infectious waste treatment facility that is located in another state that is in compliance with applicable state and federal laws, or at a treatment facility authorized by rules adopted under division (C)(6) of this section, prior to disposal of the wastes. After being treated to render them noninfectious, the wastes shall be disposed of at a solid waste disposal facility holding a license issued under division (A) of section 3734.05 of the Revised Code or at a disposal facility in another state that is in compliance with applicable state and federal laws.
(e) Not grind any infectious wastes identified in division (R)(7) of section 3734.01 of the Revised Code, not compact any such wastes until after the wastes have been treated in accordance with rules adopted under divisions (C)(1) and (3) of this section, and not compact or grind any other type of infectious wastes until after the wastes have been treated in accordance with rules adopted under division (C)(1) of this section;
(f) 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 the permit for the system issued under Chapter 6111. of the Revised Code;
(g) Employ only transporters who are registered under section 3734.022 of the Revised Code to transport off the premises where they were generated infectious wastes that have not been treated to render them noninfectious;
(h) Cause all infectious wastes that have not been treated to render them noninfectious, and those subject to rules adopted under division (A)(1)(a) of this section that have not also been treated in accordance with rules adopted under division (C)(3) of this section, to be transported in shipments consisting only of untreated infectious wastes;
(i) May transport or cause to be transported infectious wastes that have been treated to render them noninfectious, and those wastes subject to rules adopted under division (A)(1)(a) of this section that have also been treated in accordance with rules adopted under division (C)(3) of this section, in the same manner as solid wastes are transported;
(j) Provide information on the composition of its infectious wastes, the treatment of the wastes to render them noninfectious, and the generator’s system for distinguishing between waste packages that contain treated and untreated wastes to persons with whom the generator has entered into a contract or agreement to transport, treat, or dispose of the wastes upon receiving a written request from those persons;
(k) Ensure that all infectious wastes, whether treated or untreated, that are transported off the premises where they are generated are accompanied by a shipping paper that meets the requirements of rules adopted under division (D)(1) or (2) of this section, as appropriate.
(B) Establishing standards for transporters of infectious wastes that include, without limitation, the following requirements that the transporters:
(1) Transport only properly packaged and labeled wastes;
(2) Transport wastes that have not been treated to render them noninfectious only in a leak-resistant, fully covered vehicle compartment;
(3) Not compact infectious wastes that have not been treated to render them noninfectious and not compact any infectious wastes subject to rules adopted under division (A)(1)(a) of this section that have not also been treated in accordance with rules adopted under division (C)(3) of this section;
(4) Transport infectious wastes that have not been treated to render them noninfectious and infectious wastes subject to rules adopted under division (A)(1)(a) of this section, that have not also been treated in accordance with rules adopted under division (C)(3) of this section, in shipments consisting only of untreated infectious wastes;
(5) Transport infectious wastes that have been treated to render them noninfectious, and, in the case of wastes subject to rules adopted under division (A)(1)(a) of this section, have also been treated in accordance with rules adopted under division (C)(3) of this section, in the same manner as solid wastes;
(6) Promptly disinfect surfaces of transport vehicles that have had untreated infectious wastes leaked or spilled onto them, in accordance with methods prescribed by the director by rule;
(7) Transport infectious wastes that have not been treated to render them noninfectious only to an infectious waste treatment facility holding an operating license issued under division (B) of section 3734.05 of the Revised Code, to an infectious waste treatment facility that is located in another state that is in compliance with applicable state and federal laws, to a treatment facility authorized by rules adopted under division (C)(6) of this section, or to an infectious waste treatment facility owned or operated by the generator of the wastes. If the generator designates a treatment facility on the shipping paper accompanying the wastes, the transporter shall deliver the wastes to that treatment facility.
(8) Comply with the shipping paper system established by rules adopted under division (D) of this section.
(C) Establishing standards for owners and operators of infectious waste treatment facilities that include, without limitation, the following requirements and authorizations that:
(1) Treatment of all wastes received be performed in accordance with methods, techniques, and practices approved by the director;
(2) Govern the location, design, construction, and operation of infectious waste treatment facilities. The rules adopted under division (C)(2) of this section shall require that a new infectious waste incineration facility be located so that the incinerator unit and all areas where infectious wastes are handled on the premises where the facility is proposed to be located are at least three hundred feet inside the property line of the tract of land on which the facility is proposed to be located and are at least one thousand feet from any domicile, school, prison, or jail that is in existence on the date on which the application for the permit to establish the incinerator is submitted under division (B)(2)(b) of section 3734.05 of the Revised Code.
(3) Establish methods, techniques, and practices for treatment of wastes subject to rules adopted under division (A)(1)(a) of this section that may be used to substantially reduce or eliminate the potential of those wastes to cause lacerations or puncture wounds during handling, transportation, and disposal;
(4) Establish quality control and testing procedures to ensure compliance with the rules adopted under divisions (C)(2) and (3) of this section;
(5) Owners and operators of such facilities comply with the shipping paper system established by rules adopted under division (D) of this section;
(6) Infectious wastes may be treated at a facility that holds a license or renewal of a license to operate a crematory facility issued under Chapter 4717., 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. The rules adopted under divisions (C)(2) and (4) of this section do not apply to a facility holding such a license and permit.
In adopting the rules required by divisions (C)(1) to (4) of this section, the director shall consider and, to the maximum feasible extent, utilize existing standards and guidelines established by professional and governmental organizations having expertise in the fields of infection control and infectious wastes management.
(D) Establishing a system of shipping papers to accompany shipments of infectious wastes that are transported off the premises where they are generated, including the following requirements:
(1) Shipping papers that accompany shipments of wastes that have not been treated to render them noninfectious shall include the following elements:
(a) The name of the generator and address of the premises where the wastes were generated;
(b) A brief, general description of the nature of the wastes being shipped;
(c) A method by which the person causing the transportation of a shipment of wastes may designate the treatment or disposal facility, as appropriate, to which the transporter shall deliver the wastes;
(d) The requirement that when a shipment of wastes is transported off the premises where generated to a treatment facility owned or operated by the generator, the shipment need not be accompanied by a shipping paper and that, after treatment, the generator shall prepare a shipping paper that meets the requirements of rules adopted under division (D)(2) of this section to accompany the further shipment of the treated wastes to a solid waste disposal facility. When a shipment of untreated wastes is transported to a treatment facility not owned or operated by the generator of the waste, the owner or operator of the treatment facility shall prepare a separate shipping paper that meets the requirements of rules adopted under division (D)(2) of this section to accompany the shipment of the treated wastes from the owner’s or operator’s premises to a solid waste disposal facility.
(e) A certification by the person causing the wastes to be transported that the wastes are packaged and labeled in accordance with the rules adopted under this section and that the description of the wastes is accurate.
(2) Shipping papers that accompany shipments of wastes that have been treated to render them noninfectious shall include only the following elements:
(a) The name of the owner or operator of the facility where the wastes were treated and the address of the treatment facility;
(b) A certification by the owner or operator of the treatment facility where the wastes were treated that the wastes have been treated by methods, techniques, and practices prescribed by rules adopted under division (C)(1) of this section. If the treated wastes are to be compacted prior to transportation and contain any wastes subject to rules adopted under division (A)(1)(a) of this section, the shipping paper shall include an additional certification by the owner or operator of the treatment facility where the wastes were treated that they also have been treated in accordance with rules adopted under division (C)(3) of this section.
(E) This section and rules adopted under it do not apply to the treatment or disposal of wastes consisting of dead animals or parts thereof, or the blood of animals:
(1) By the owner of the animal after slaughter by the owner on the owner’s premises to obtain meat for consumption by the owner and the members of the owner’s household;
(2) In accordance with Chapter 941. of the Revised Code; or
(3) By persons who are subject to any of the following:
(a) Inspection under the “Federal Meat Inspection Act,” 81 Stat. 584 (1967), 21 U.S.C.A. 603, as amended;
(b) Chapter 918. of the Revised Code;
(c) Chapter 953. of the Revised Code.
(F) As used in this section, “generator” means a person who produces infectious wastes.
(G) Rules adopted under this section shall not concern or relate to personnel policies, salaries, wages, fringe benefits, or other conditions of employment of employees of persons owning or operating infectious waste treatment facilities.
(H) The director shall not issue any variance from the rules adopted under this section.
3734.021 Standards for generators and transporters of infectious wastes and owners and operators of treatment facilities.
Infectious wastes shall be segregated, packaged, treated, transported, and disposed of in accordance with rules adopted under this section.
The director of environmental protection, in accordance with Chapter 119. of the Revised Code, shall adopt, and may amend and rescind, rules necessary or appropriate to protect human health or safety or the environment:
(A) Establishing standards for generators of infectious wastes that include, without limitation, the following requirements and authorizations that:
(1) All generators of infectious wastes:
(a) Place all infectious wastes identified in division (R)(7) of section 3734.01 of the Revised Code, and all unused, discarded hypodermic needles, syringes, and scalpel blades, in rigid, tightly closed, puncture-resistant containers on the premises where they are generated before they are transported off that premises. Containers containing such wastes shall be labeled “sharps” and, if the wastes have not been treated to render them noninfectious, shall be conspicuously labeled with the international biohazard symbol.
(b) Either treat all specimen cultures and cultures of viable infectious agents on the premises where they are generated to render them noninfectious by methods, techniques, or practices prescribed by rules adopted under division (C)(1) of this section before they are transported off that premises for disposal or ensure that such wastes are treated to render them noninfectious at an infectious waste treatment facility off that premises that is owned or operated by the generator, an infectious waste treatment facility that holds a license issued under division (B) of section 3734.05 of the Revised Code, an infectious waste treatment facility that is located in another state that is in compliance with applicable state and federal laws, or a treatment facility that is authorized by rules adopted under division (C)(6) of this section, prior to disposal of the wastes.
(c) Except as otherwise provided in division (A)(1)(c) of this section, wastes generated by a generator who produces fewer than fifty pounds of infectious wastes during any one month that are subject to and packaged and labeled in accordance with rules adopted under division (A)(1)(a) of this section shall be transported and disposed of in the same manner as solid wastes. Such generators who treat specimen cultures and cultures of viable infectious agents on the premises where they are generated shall not be considered treatment facilities as “treatment” and “facility” are defined in section 3734.01 of the Revised Code.
(d) Wastes subject to and treated in accordance with rules adopted under division (A)(1)(b) of this section shall be transported and disposed of in the same manner as solid wastes.
(e) For the purposes of this section and rules adopted under it, 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 either of the following:
(i) Were not intentionally exposed to infectious agents during research, production of biologicals, or testing of pharmaceuticals;
(ii) Either were produced by a veterinarian holding a license issued under Chapter 4741. of the Revised Code or were treated or disposed of by a person holding a license issued under Chapter 953. of the Revised Code.
(f) For the purposes of this section and rules adopted under it, no 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, by a facility that holds a license or renewal of a license issued under Chapter 4717. of the Revised Code shall be considered when determining the quantity of infectious wastes produced by that generator.
(g) Wastes generated by a generator who produces fewer than fifty pounds of infectious wastes during any one month that are subject to and packaged in accordance with rules adopted under division (A)(1)(a) of this section may be transported to a treatment facility owned or operated by a hospital with which the generator has staff privileges, as “hospital” is defined in section 3727.01 of the Revised Code. Such a generator who so transports infectious wastes, other than untreated specimen cultures and cultures and stocks of viable infectious agents, that are generated on the generator’s premises is not a transporter for the purposes of this section or section 3734.022 of the Revised Code.
(h) Wastes generated in providing care to a patient by an emergency medical services organization, as defined in section 4765.01 of the Revised Code, may be taken to and left at a hospital, as defined in section 3727.01 of the Revised Code, for treatment at a treatment facility owned or operated by the hospital or, in conjunction with infectious wastes generated by the hospital, at another treatment facility regardless of whether the wastes were generated in providing care to the patient at the scene of an emergency or during the transportation of the patient to a hospital. An emergency medical services organization that transports infectious wastes that are so generated to a hospital for that purpose is not a transporter for the purposes of this section or section 3734.022 of the Revised Code.
(i) Wastes generated by an individual for purposes of the individual’s own care or treatment may be taken to and left at a hospital, as defined in section 3727.01 of the Revised Code, for treatment at a treatment facility owned or operated by the hospital or, in conjunction with infectious wastes generated by the hospital, at another treatment facility. An individual or member of an individual’s household who transports wastes so generated by the individual to a hospital for that purpose is not a transporter for the purposes of this section or section 3734.022 of the Revised Code.
(2) Each generator of fifty pounds or more of infectious wastes during any one month:
(a) Register with the environmental protection agency as a generator of infectious wastes and obtain a registration certificate. The fee for issuance of a generator registration certificate is three hundred dollars payable at the time of application. The registration certificate applies to all the premises owned or operated by the generator in this state where infectious wastes are generated and shall list the address of each such premises. If a generator owns or operates facilities for the treatment of infectious wastes it generates, the certificate shall list the address and method of treatment used at each such facility.
A generator registration certificate is valid for three years from the date of issuance and shall be renewed for a term of three years upon the generator’s submission of an application for renewal and payment of a three hundred dollar renewal fee.
The rules may establish a system of staggered renewal dates with approximately one-third of such certificates subject to renewal each year. The applicable renewal date shall be prescribed on each registration certificate. Registration fees shall be prorated according to the time remaining in the registration cycle to the nearest year.
The registration and renewal fees shall be credited to the infectious wastes management fund, hereby created in the state treasury.
(b) Segregate infectious wastes from other wastes at the point of generation. Nothing in this section and rules adopted under it prohibits a generator of infectious wastes from designating and managing wastes, in addition to those defined as infectious wastes under section 3734.01 of the Revised Code, 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 chapter and rules adopted under it applicable to the management of infectious wastes.
(c) For purposes of containment, place infectious wastes, other than those subject to rules adopted under division (A)(1)(a) of this section, in plastic bags that are impervious to moisture and are sufficiently strong to preclude ripping, tearing, or bursting under normal conditions of handling and ensure that the filled bags are securely tied to prevent leakage or expulsion of the wastes from them during storage, handling, or transport. The generator shall ensure that, prior to transportation off the premises where generated, infectious wastes that have not been treated to render them noninfectious, other than those subject to division (A)(1)(a) of this section, are contained in bags that either are red in color or conspicuously labeled with the international biohazard symbol.
(d) Either treat the infectious wastes that it generates at a facility owned or operated by the generator by methods, techniques, or practices prescribed by rules adopted under division (C)(1) of this section to render them noninfectious, or designate 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, at an infectious waste treatment facility that is located in another state that is in compliance with applicable state and federal laws, or at a treatment facility authorized by rules adopted under division (C)(6) of this section, prior to disposal of the wastes. After being treated to render them noninfectious, the wastes shall be disposed of at a solid waste disposal facility holding a license issued under division (A) of section 3734.05 of the Revised Code or at a disposal facility in another state that is in compliance with applicable state and federal laws.
(e) Not grind any infectious wastes identified in division (R)(7) of section 3734.01 of the Revised Code, not compact any such wastes until after the wastes have been treated in accordance with rules adopted under divisions (C)(1) and (3) of this section, and not compact or grind any other type of infectious wastes until after the wastes have been treated in accordance with rules adopted under division (C)(1) of this section;
(f) 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 the permit for the system issued under Chapter 6111. of the Revised Code;
(g) Employ only transporters who are registered under section 3734.022 of the Revised Code to transport off the premises where they were generated infectious wastes that have not been treated to render them noninfectious;
(h) Cause all infectious wastes that have not been treated to render them noninfectious, and those subject to rules adopted under division (A)(1)(a) of this section that have not also been treated in accordance with rules adopted under division (C)(3) of this section, to be transported in shipments consisting only of untreated infectious wastes;
(i) May transport or cause to be transported infectious wastes that have been treated to render them noninfectious, and those wastes subject to rules adopted under division (A)(1)(a) of this section that have also been treated in accordance with rules adopted under division (C)(3) of this section, in the same manner as solid wastes are transported;
(j) Provide information on the composition of its infectious wastes, the treatment of the wastes to render them noninfectious, and the generator’s system for distinguishing between waste packages that contain treated and untreated wastes to persons with whom the generator has entered into a contract or agreement to transport, treat, or dispose of the wastes upon receiving a written request from those persons;
(k) Ensure that all infectious wastes, whether treated or untreated, that are transported off the premises where they are generated are accompanied by a shipping paper that meets the requirements of rules adopted under division (D)(1) or (2) of this section, as appropriate.
(B) Establishing standards for transporters of infectious wastes that include, without limitation, the following requirements that the transporters:
(1) Transport only properly packaged and labeled wastes;
(2) Transport wastes that have not been treated to render them noninfectious only in a leak-resistant, fully covered vehicle compartment;
(3) Not compact infectious wastes that have not been treated to render them noninfectious and not compact any infectious wastes subject to rules adopted under division (A)(1)(a) of this section that have not also been treated in accordance with rules adopted under division (C)(3) of this section;
(4) Transport infectious wastes that have not been treated to render them noninfectious and infectious wastes subject to rules adopted under division (A)(1)(a) of this section, that have not also been treated in accordance with rules adopted under division (C)(3) of this section, in shipments consisting only of untreated infectious wastes;
(5) Transport infectious wastes that have been treated to render them noninfectious, and, in the case of wastes subject to rules adopted under division (A)(1)(a) of this section, have also been treated in accordance with rules adopted under division (C)(3) of this section, in the same manner as solid wastes;
(6) Promptly disinfect surfaces of transport vehicles that have had untreated infectious wastes leaked or spilled onto them, in accordance with methods prescribed by the director by rule;
(7) Transport infectious wastes that have not been treated to render them noninfectious only to an infectious waste treatment facility holding an operating license issued under division (B) of section 3734.05 of the Revised Code, to an infectious waste treatment facility that is located in another state that is in compliance with applicable state and federal laws, to a treatment facility authorized by rules adopted under division (C)(6) of this section, or to an infectious waste treatment facility owned or operated by the generator of the wastes. If the generator designates a treatment facility on the shipping paper accompanying the wastes, the transporter shall deliver the wastes to that treatment facility.
(8) Comply with the shipping paper system established by rules adopted under division (D) of this section.
(C) Establishing standards for owners and operators of infectious waste treatment facilities that include, without limitation, the following requirements and authorizations that:
(1) Treatment of all wastes received be performed in accordance with methods, techniques, and practices approved by the director;
(2) Govern the location, design, construction, and operation of infectious waste treatment facilities. The rules adopted under division (C)(2) of this section shall require that a new infectious waste incineration facility be located so that the incinerator unit and all areas where infectious wastes are handled on the premises where the facility is proposed to be located are at least three hundred feet inside the property line of the tract of land on which the facility is proposed to be located and are at least one thousand feet from any domicile, school, prison, or jail that is in existence on the date on which the application for the permit to establish the incinerator is submitted under division (B)(2)(b) of section 3734.05 of the Revised Code.
(3) Establish methods, techniques, and practices for treatment of wastes subject to rules adopted under division (A)(1)(a) of this section that may be used to substantially reduce or eliminate the potential of those wastes to cause lacerations or puncture wounds during handling, transportation, and disposal;
(4) Establish quality control and testing procedures to ensure compliance with the rules adopted under divisions (C)(2) and (3) of this section;
(5) Owners and operators of such facilities comply with the shipping paper system established by rules adopted under division (D) of this section;
(6) Infectious wastes may be treated at a facility that holds a license or renewal of a license to operate a crematory facility issued under Chapter 4717., 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. The rules adopted under divisions (C)(2) and (4) of this section do not apply to a facility holding such a license and permit.
In adopting the rules required by divisions (C)(1) to (4) of this section, the director shall consider and, to the maximum feasible extent, utilize existing standards and guidelines established by professional and governmental organizations having expertise in the fields of infection control and infectious wastes management.
(D) Establishing a system of shipping papers to accompany shipments of infectious wastes that are transported off the premises where they are generated, including the following requirements:
(1) Shipping papers that accompany shipments of wastes that have not been treated to render them noninfectious shall include the following elements:
(a) The name of the generator and address of the premises where the wastes were generated;
(b) A brief, general description of the nature of the wastes being shipped;
(c) A method by which the person causing the transportation of a shipment of wastes may designate the treatment or disposal facility, as appropriate, to which the transporter shall deliver the wastes;
(d) The requirement that when a shipment of wastes is transported off the premises where generated to a treatment facility owned or operated by the generator, the shipment need not be accompanied by a shipping paper and that, after treatment, the generator shall prepare a shipping paper that meets the requirements of rules adopted under division (D)(2) of this section to accompany the further shipment of the treated wastes to a solid waste disposal facility. When a shipment of untreated wastes is transported to a treatment facility not owned or operated by the generator of the waste, the owner or operator of the treatment facility shall prepare a separate shipping paper that meets the requirements of rules adopted under division (D)(2) of this section to accompany the shipment of the treated wastes from the owner’s or operator’s premises to a solid waste disposal facility.
(e) A certification by the person causing the wastes to be transported that the wastes are packaged and labeled in accordance with the rules adopted under this section and that the description of the wastes is accurate.
(2) Shipping papers that accompany shipments of wastes that have been treated to render them noninfectious shall include only the following elements:
(a) The name of the owner or operator of the facility where the wastes were treated and the address of the treatment facility;
(b) A certification by the owner or operator of the treatment facility where the wastes were treated that the wastes have been treated by methods, techniques, and practices prescribed by rules adopted under division (C)(1) of this section. If the treated wastes are to be compacted prior to transportation and contain any wastes subject to rules adopted under division (A)(1)(a) of this section, the shipping paper shall include an additional certification by the owner or operator of the treatment facility where the wastes were treated that they also have been treated in accordance with rules adopted under division (C)(3) of this section.
(E) This section and rules adopted under it do not apply to the treatment or disposal of wastes consisting of dead animals or parts thereof, or the blood of animals:
(1) By the owner of the animal after slaughter by the owner on the owner’s premises to obtain meat for consumption by the owner and the members of the owner’s household;
(2) In accordance with Chapter 941. of the Revised Code; or
(3) By persons who are subject to any of the following:
(a) Inspection under the “Federal Meat Inspection Act,” 81 Stat. 584 (1967), 21 U.S.C.A. 603, as amended;
(b) Chapter 918. of the Revised Code;
(c) Chapter 953. of the Revised Code.
(F) As used in this section, “generator” means a person who produces infectious wastes.
(G) Rules adopted under this section shall not concern or relate to personnel policies, salaries, wages, fringe benefits, or other conditions of employment of employees of persons owning or operating infectious waste treatment facilities.
(H) The director shall not issue any variance from the rules adopted under this section.
3734.021 Standards for generators and transporters of infectious wastes and owners and operators of treatment facilities.
Infectious wastes shall be segregated, packaged, treated, transported, and disposed of in accordance with rules adopted under this section.
The director of environmental protection, in accordance with Chapter 119. of the Revised Code, shall adopt, and may amend and rescind, rules necessary or appropriate to protect human health or safety or the environment:
(A) Establishing standards for generators of infectious wastes that include, without limitation, the following requirements and authorizations that:
(1) All generators of infectious wastes:
(a) Place all infectious wastes identified in division (R)(7) of section 3734.01 of the Revised Code, and all unused, discarded hypodermic needles, syringes, and scalpel blades, in rigid, tightly closed, puncture-resistant containers on the premises where they are generated before they are transported off that premises. Containers containing such wastes shall be labeled “sharps” and, if the wastes have not been treated to render them noninfectious, shall be conspicuously labeled with the international biohazard symbol.
(b) Either treat all specimen cultures and cultures of viable infectious agents on the premises where they are generated to render them noninfectious by methods, techniques, or practices prescribed by rules adopted under division (C)(1) of this section before they are transported off that premises for disposal or ensure that such wastes are treated to render them noninfectious at an infectious waste treatment facility off that premises that is owned or operated by the generator, an infectious waste treatment facility that holds a license issued under division (B) of section 3734.05 of the Revised Code, an infectious waste treatment facility that is located in another state that is in compliance with applicable state and federal laws, or a treatment facility that is authorized by rules adopted under division (C)(6) of this section, prior to disposal of the wastes.
(c) Except as otherwise provided in division (A)(1)(c) of this section, wastes generated by a generator who produces fewer than fifty pounds of infectious wastes during any one month that are subject to and packaged and labeled in accordance with rules adopted under division (A)(1)(a) of this section shall be transported and disposed of in the same manner as solid wastes. Such generators who treat specimen cultures and cultures of viable infectious agents on the premises where they are generated shall not be considered treatment facilities as “treatment” and “facility” are defined in section 3734.01 of the Revised Code.
(d) Wastes subject to and treated in accordance with rules adopted under division (A)(1)(b) of this section shall be transported and disposed of in the same manner as solid wastes.
(e) For the purposes of this section and rules adopted under it, 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 either of the following:
(i) Were not intentionally exposed to infectious agents during research, production of biologicals, or testing of pharmaceuticals;
(ii) Either were produced by a veterinarian holding a license issued under Chapter 4741. of the Revised Code or were treated or disposed of by a person holding a license issued under Chapter 953. of the Revised Code.
(f) For the purposes of this section and rules adopted under it, no 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, by a facility that holds a license or renewal of a license issued under Chapter 4717. of the Revised Code shall be considered when determining the quantity of infectious wastes produced by that generator.
(g) Wastes generated by a generator who produces fewer than fifty pounds of infectious wastes during any one month that are subject to and packaged in accordance with rules adopted under division (A)(1)(a) of this section may be transported to a treatment facility owned or operated by a hospital with which the generator has staff privileges, as “hospital” is defined in section 3727.01 of the Revised Code. Such a generator who so transports infectious wastes, other than untreated specimen cultures and cultures and stocks of viable infectious agents, that are generated on the generator’s premises is not a transporter for the purposes of this section or section 3734.022 of the Revised Code.
(h) Wastes generated in providing care to a patient by an emergency medical services organization, as defined in section 4765.01 of the Revised Code, may be taken to and left at a hospital, as defined in section 3727.01 of the Revised Code, for treatment at a treatment facility owned or operated by the hospital or, in conjunction with infectious wastes generated by the hospital, at another treatment facility regardless of whether the wastes were generated in providing care to the patient at the scene of an emergency or during the transportation of the patient to a hospital. An emergency medical services organization that transports infectious wastes that are so generated to a hospital for that purpose is not a transporter for the purposes of this section or section 3734.022 of the Revised Code.
(i) Wastes generated by an individual for purposes of the individual’s own care or treatment may be taken to and left at a hospital, as defined in section 3727.01 of the Revised Code, for treatment at a treatment facility owned or operated by the hospital or, in conjunction with infectious wastes generated by the hospital, at another treatment facility. An individual or member of an individual’s household who transports wastes so generated by the individual to a hospital for that purpose is not a transporter for the purposes of this section or section 3734.022 of the Revised Code.
(2) Each generator of fifty pounds or more of infectious wastes during any one month:
(a) Register with the environmental protection agency as a generator of infectious wastes and obtain a registration certificate. The fee for issuance of a generator registration certificate is three hundred dollars payable at the time of application. The registration certificate applies to all the premises owned or operated by the generator in this state where infectious wastes are generated and shall list the address of each such premises. If a generator owns or operates facilities for the treatment of infectious wastes it generates, the certificate shall list the address and method of treatment used at each such facility.
A generator registration certificate is valid for three years from the date of issuance and shall be renewed for a term of three years upon the generator’s submission of an application for renewal and payment of a three hundred dollar renewal fee.
The rules may establish a system of staggered renewal dates with approximately one-third of such certificates subject to renewal each year. The applicable renewal date shall be prescribed on each registration certificate. Registration fees shall be prorated according to the time remaining in the registration cycle to the nearest year.
The registration and renewal fees shall be credited to the infectious wastes management fund, hereby created in the state treasury.
(b) Segregate infectious wastes from other wastes at the point of generation. Nothing in this section and rules adopted under it prohibits a generator of infectious wastes from designating and managing wastes, in addition to those defined as infectious wastes under section 3734.01 of the Revised Code, 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 chapter and rules adopted under it applicable to the management of infectious wastes.
(c) For purposes of containment, place infectious wastes, other than those subject to rules adopted under division (A)(1)(a) of this section, in plastic bags that are impervious to moisture and are sufficiently strong to preclude ripping, tearing, or bursting under normal conditions of handling and ensure that the filled bags are securely tied to prevent leakage or expulsion of the wastes from them during storage, handling, or transport. The generator shall ensure that, prior to transportation off the premises where generated, infectious wastes that have not been treated to render them noninfectious, other than those subject to division (A)(1)(a) of this section, are contained in bags that either are red in color or conspicuously labeled with the international biohazard symbol.
(d) Either treat the infectious wastes that it generates at a facility owned or operated by the generator by methods, techniques, or practices prescribed by rules adopted under division (C)(1) of this section to render them noninfectious, or designate 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, at an infectious waste treatment facility that is located in another state that is in compliance with applicable state and federal laws, or at a treatment facility authorized by rules adopted under division (C)(6) of this section, prior to disposal of the wastes. After being treated to render them noninfectious, the wastes shall be disposed of at a solid waste disposal facility holding a license issued under division (A) of section 3734.05 of the Revised Code or at a disposal facility in another state that is in compliance with applicable state and federal laws.
(e) Not grind any infectious wastes identified in division (R)(7) of section 3734.01 of the Revised Code, not compact any such wastes until after the wastes have been treated in accordance with rules adopted under divisions (C)(1) and (3) of this section, and not compact or grind any other type of infectious wastes until after the wastes have been treated in accordance with rules adopted under division (C)(1) of this section;
(f) 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 the permit for the system issued under Chapter 6111. of the Revised Code;
(g) Employ only transporters who are registered under section 3734.022 of the Revised Code to transport off the premises where they were generated infectious wastes that have not been treated to render them noninfectious;
(h) Cause all infectious wastes that have not been treated to render them noninfectious, and those subject to rules adopted under division (A)(1)(a) of this section that have not also been treated in accordance with rules adopted under division (C)(3) of this section, to be transported in shipments consisting only of untreated infectious wastes;
(i) May transport or cause to be transported infectious wastes that have been treated to render them noninfectious, and those wastes subject to rules adopted under division (A)(1)(a) of this section that have also been treated in accordance with rules adopted under division (C)(3) of this section, in the same manner as solid wastes are transported;
(j) Provide information on the composition of its infectious wastes, the treatment of the wastes to render them noninfectious, and the generator’s system for distinguishing between waste packages that contain treated and untreated wastes to persons with whom the generator has entered into a contract or agreement to transport, treat, or dispose of the wastes upon receiving a written request from those persons;
(k) Ensure that all infectious wastes, whether treated or untreated, that are transported off the premises where they are generated are accompanied by a shipping paper that meets the requirements of rules adopted under division (D)(1) or (2) of this section, as appropriate.
(B) Establishing standards for transporters of infectious wastes that include, without limitation, the following requirements that the transporters:
(1) Transport only properly packaged and labeled wastes;
(2) Transport wastes that have not been treated to render them noninfectious only in a leak-resistant, fully covered vehicle compartment;
(3) Not compact infectious wastes that have not been treated to render them noninfectious and not compact any infectious wastes subject to rules adopted under division (A)(1)(a) of this section that have not also been treated in accordance with rules adopted under division (C)(3) of this section;
(4) Transport infectious wastes that have not been treated to render them noninfectious and infectious wastes subject to rules adopted under division (A)(1)(a) of this section, that have not also been treated in accordance with rules adopted under division (C)(3) of this section, in shipments consisting only of untreated infectious wastes;
(5) Transport infectious wastes that have been treated to render them noninfectious, and, in the case of wastes subject to rules adopted under division (A)(1)(a) of this section, have also been treated in accordance with rules adopted under division (C)(3) of this section, in the same manner as solid wastes;
(6) Promptly disinfect surfaces of transport vehicles that have had untreated infectious wastes leaked or spilled onto them, in accordance with methods prescribed by the director by rule;
(7) Transport infectious wastes that have not been treated to render them noninfectious only to an infectious waste treatment facility holding an operating license issued under division (B) of section 3734.05 of the Revised Code, to an infectious waste treatment facility that is located in another state that is in compliance with applicable state and federal laws, to a treatment facility authorized by rules adopted under division (C)(6) of this section, or to an infectious waste treatment facility owned or operated by the generator of the wastes. If the generator designates a treatment facility on the shipping paper accompanying the wastes, the transporter shall deliver the wastes to that treatment facility.
(8) Comply with the shipping paper system established by rules adopted under division (D) of this section.
(C) Establishing standards for owners and operators of infectious waste treatment facilities that include, without limitation, the following requirements and authorizations that:
(1) Treatment of all wastes received be performed in accordance with methods, techniques, and practices approved by the director;
(2) Govern the location, design, construction, and operation of infectious waste treatment facilities. The rules adopted under division (C)(2) of this section shall require that a new infectious waste incineration facility be located so that the incinerator unit and all areas where infectious wastes are handled on the premises where the facility is proposed to be located are at least three hundred feet inside the property line of the tract of land on which the facility is proposed to be located and are at least one thousand feet from any domicile, school, prison, or jail that is in existence on the date on which the application for the permit to establish the incinerator is submitted under division (B)(2)(b) of section 3734.05 of the Revised Code.
(3) Establish methods, techniques, and practices for treatment of wastes subject to rules adopted under division (A)(1)(a) of this section that may be used to substantially reduce or eliminate the potential of those wastes to cause lacerations or puncture wounds during handling, transportation, and disposal;
(4) Establish quality control and testing procedures to ensure compliance with the rules adopted under divisions (C)(2) and (3) of this section;
(5) Owners and operators of such facilities comply with the shipping paper system established by rules adopted under division (D) of this section;
(6) Infectious wastes may be treated at a facility that holds a license or renewal of a license to operate a crematory facility issued under Chapter 4717., 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. The rules adopted under divisions (C)(2) and (4) of this section do not apply to a facility holding such a license and permit.
In adopting the rules required by divisions (C)(1) to (4) of this section, the director shall consider and, to the maximum feasible extent, utilize existing standards and guidelines established by professional and governmental organizations having expertise in the fields of infection control and infectious wastes management.
(D) Establishing a system of shipping papers to accompany shipments of infectious wastes that are transported off the premises where they are generated, including the following requirements:
(1) Shipping papers that accompany shipments of wastes that have not been treated to render them noninfectious shall include the following elements:
(a) The name of the generator and address of the premises where the wastes were generated;
(b) A brief, general description of the nature of the wastes being shipped;
(c) A method by which the person causing the transportation of a shipment of wastes may designate the treatment or disposal facility, as appropriate, to which the transporter shall deliver the wastes;
(d) The requirement that when a shipment of wastes is transported off the premises where generated to a treatment facility owned or operated by the generator, the shipment need not be accompanied by a shipping paper and that, after treatment, the generator shall prepare a shipping paper that meets the requirements of rules adopted under division (D)(2) of this section to accompany the further shipment of the treated wastes to a solid waste disposal facility. When a shipment of untreated wastes is transported to a treatment facility not owned or operated by the generator of the waste, the owner or operator of the treatment facility shall prepare a separate shipping paper that meets the requirements of rules adopted under division (D)(2) of this section to accompany the shipment of the treated wastes from the owner’s or operator’s premises to a solid waste disposal facility.
(e) A certification by the person causing the wastes to be transported that the wastes are packaged and labeled in accordance with the rules adopted under this section and that the description of the wastes is accurate.
(2) Shipping papers that accompany shipments of wastes that have been treated to render them noninfectious shall include only the following elements:
(a) The name of the owner or operator of the facility where the wastes were treated and the address of the treatment facility;
(b) A certification by the owner or operator of the treatment facility where the wastes were treated that the wastes have been treated by methods, techniques, and practices prescribed by rules adopted under division (C)(1) of this section. If the treated wastes are to be compacted prior to transportation and contain any wastes subject to rules adopted under division (A)(1)(a) of this section, the shipping paper shall include an additional certification by the owner or operator of the treatment facility where the wastes were treated that they also have been treated in accordance with rules adopted under division (C)(3) of this section.
(E) This section and rules adopted under it do not apply to the treatment or disposal of wastes consisting of dead animals or parts thereof, or the blood of animals:
(1) By the owner of the animal after slaughter by the owner on the owner’s premises to obtain meat for consumption by the owner and the members of the owner’s household;
(2) In accordance with Chapter 941. of the Revised Code; or
(3) By persons who are subject to any of the following:
(a) Inspection under the “Federal Meat Inspection Act,” 81 Stat. 584 (1967), 21 U.S.C.A. 603, as amended;
(b) Chapter 918. of the Revised Code;
(c) Chapter 953. of the Revised Code.
(F) As used in this section, “generator” means a person who produces infectious wastes.
(G) Rules adopted under this section shall not concern or relate to personnel policies, salaries, wages, fringe benefits, or other conditions of employment of employees of persons owning or operating infectious waste treatment facilities.
(H) The director shall not issue any variance from the rules adopted under this section.
