CONNECTICUT - ENVIRONMENTAL ISSUES

January 1, 2008

State laws and regulations that affect your medical practice

1. How is medical waste regulated in Connecticut?

(a) Definitions:

"Air pollution control residue" means unburned particles and air pollution control reactants which become entranced in the stack gases of an incinerator and which are removed and collected by air pollution control equipment.

"Biological" means a preparation made from a living organism or its products, including vaccines and cultures, intended for use in diagnosing, immunizing or treating humans or animals or in research pertaining thereto.

"Biomedical waste" means untreated solid waste, any disposable container thereof and any reusable container thereof which has not been decontaminated, generated during the administration of medical care or the performance of medical research involving humans or animals, including infectious waste, pathological waste and chemotherapy waste, but excluding (1) any solid waste which is a hazardous waste or a radioactive material; (2) untreated solid waste generated during the administration of medical care in a single or multiple family residence by a resident thereof; (3) discarded materials used for personal hygiene, such as diapers, facial tissues, and sanitary napkins, unless such materials are isolation waste; (4) syringes, hypodermic needles and other medical equipment used by farmers for the treatment of their livestock in the course of conducting farming, provided that such equipment is not excluded when used by a veterinarian or at the direction of a veterinarian; and (5) samples of biomedical waste collected and transported by Department personnel for enforcement purposes. As used in this definition of biomedical waste, the term "multiple family residence" does not include any facility specified in the definition of biomedical waste generator set forth in this section.

"Biomedical waste generator" or "generator" means any person who owns or operates a facility that produces biomedical waste in any quantity, including but not limited to the following: general hospitals, skilled nursing facilities or convalescent hospitals, intermediate care facilities, in-patient care facilities for the developmentally disabled, chronic dialysis clinics, free clinics, health maintenance organizations, surgical clinics, acute psychiatric hospitals, laboratories, medical buildings, physicians offices, veterinarians, dental offices and funeral homes.

"Biomedical waste incinerator residue" means bottom ash, air pollution control residue and other residuals of the combustion process of an incinerator utilized for the combustion of biomedical waste.

"Biomedical waste treatment facility" means a solid waste facility capable of storing, treating or disposing of any amount of biomedical waste, excluding any facility where the only biomedical waste stored, treated or disposed of is biomedical waste generated at the site where such facility is located.

"Biomedical waste transporter" or "transporter" means a person engage in the transportation of biomedical waste by air, rail, highway, or water.

"Blood product" means any substance derived from human blood, including but not limited to plasma, platelets, red or white blood cells, and interferon.

"Body fluid" means any substance which emanates or derives from the human body, including but not limited to blood, semen, vaginal Secretion cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid an pericardial fluid, but excluding feces, urine, nasal secretions, sputum, sweaters, vomitus, saliva, and breast milk, unless any such excluded substance contains visible blood or is isolation waste.

"Bottom ash" means unburned or unburnable solid residue from incineration processes that does not become airborne.

"Central collection point" means a location, whether located on or off the generator's site, where such generator consolidates biomedical waste accumulated from original generation points before transporting it for treatment storage, or disposal, provided that such central collection point is operate by such generator.

"C.F.R." means the Code of Federal Regulations.

"Chemotherapy waste" means waste which has come in contact with a antineoplastic agent during the preparation, handling or administration such an agent. A container which is or has been used to contain such an agent shall be deemed chemotherapy waste even if such container is empty.

"Container" means any receptacle in which material is placed. "Primary container" means the initial container in which biomedical waste is place when multiple containers for packaging of biomedical waste are require under subsection (b) of this section. "Secondary container" means a contains in which a primary container is placed.

"Decontaminate" means to substantially reduce or eliminate, by disinfection or other means, any biological hazard that is or may be associated with biomedical waste.

"Etiologic agent" means an organism defined to be an etiologic agent

"Incinerator" means any device, apparatus, equipment or structure defined in Sections 22a-174-1 and 22a-174-18 (c) (1) of the Regulations of Connecticut State Agencies.

"Infectious agent" means any organism, such as a virus or bacterium, the is capable of being communicated by invasion and multiplication in body tissue and capable of causing disease or adverse health impacts in humans.

"Infectious waste" means waste which is capable of causing an infectious disease, is one of the wastes listed below, or is waste identified as infectious by a licensed health care provider. Waste shall be deemed capable of causing an infectious disease if there is reason to believe that it has been contaminated by an organism that is known or suspected to be pathogenic to humans and if such organism may be present in sufficient quantities are with sufficient virulence to transmit disease. The following are listed as infectious waste:

(1) Any discarded culture or stock of infectious agents and associated biologicals, including human and animal cell cultures from clinical, hospital, picnic health, research and industrial laboratories; any waste from the production of biologicals; any discarded etiologic agent; any discarded live or attenuated vaccine or serum; and any discarded culture dish or device used to transfer, inoculate, or mix cell cultures.

(2) Any body fluid, waste human blood, or waste blood product, any container of any of the foregoing, and any disposable item that is saturated or dripping with a body fluid or that was saturated or dripping with a body fluid and has since caked with dried body fluid.

(3) Any discarded used sharp and any residual substance therein.

(4) Any discarded unused hypodermic needle, scalpel blade, suture needle or syringe.

(5) Any discarded animal carcass, animal body part or animal bedding, when such carcass, part or bedding is known to be contaminated with or to have been exposed to an infectious agent.

(6) Isolation waste.

(7) Any material collected during or resulting from the cleanup of a spill of infectious or chemotherapy waste.

(8) Any waste which is neither a hazardous waste nor a radioactive material subject to and which is mixed with infectious waste.

"Interment" means burial in a cemetery or burial place.

"Isolation waste" means discarded material contaminated with body fluids from (A) humans who are isolated to protect others from a highly communicable disease, and (B) animals which are isolated because they are known to be infected with an infectious agent capable of causing a highly communicable disease. A highly communicable disease is one listed in Biosafety Level 4 of the Centers for Disease Control/National Institutes of Health Guidelines entitled Biosafety in Microbiological and Biomedical Laboratories and dated May, 1988.

"Original generation point" means the location on a site where biomedical waste is generated.

"Pathological waste" means any human tissue, organ, or body part removed during surgery, autopsy or other medical procedure. Pathological waste does not include formaldehyde or other preservative agent, or a human corpse or part thereof.

"Publicly owned treatment works" or "POTW" means publicly owned treatment works or POTW.

"Sharp" means an item capable of causing a puncture or cut, including but not limited to a hypodermic needle, scalpel blade, and broken glassware, provided that (1) broken glassware shall not be deemed a sharp unless it is known to be contaminated with an infectious agent, and (2) a syringe, regardless whether a hypodermic needle is attached thereto, shall be deemed a sharp.

"Shipping paper" means a shipping order, bill of lading, manifest, or other shipping document

"Small quantity generator" means a biomedical waste generator that generates less than 50 pounds of biomedical waste in any calendar month or who transports, or delivers for transport, in any single shipment less than 50 pounds of biomedical waste.

"Spill" means any unplanned release, leaking, pumping, pouring, emptying, or depositing of biomedical waste or any planned release, leaking, pumping, pouring, emitting, or depositing of biomedical waste in violation of the requirements of this section.

"Storage" means the temporary holding of biomedical waste, other than temporary holding conducted in accordance with the conditions describe in subparagraphs (A), (B), (C), (D), (E) and (F) of subdivision (g)(15) of this section, at any location before treating or disposing of it or transporting for treatment, disposal, or further storage.

"Tracking form" means the tracking form described and required under subsection (h) of this section.

"Transfer" means to move, or the movement of, biomedical waste from one location on the site where such waste was generated to another location on such site.

"Transport" means to move biomedical waste by air, rail, highway, or water from the site at which such waste was generated to any other site.

"Transportation" means the act of transporting or the state of being transported.

"Transport vehicle" or "vehicle" means any conveyance used for the transportation of biomedical waste. Each cargo-carrying compartment of a vehicle, such as a truck trailer or railroad freight car, is a separate vehicle.

"Treat" means to decontaminate biomedical waste and to physically alter it so as to render it unrecognizable as biomedical waste.

"Treatment" means the act of treating or the state of being treated.

"Universal biohazard symbol" means the symbol shown in 29 C.F.R. Section 1910.145 (f) (8) (ii).

"Violent mechanical stress" means tensile or compressive forces acting, upon packaging material so as to cause such material to tear, rip, burst, or otherwise fail.

(b) Requirements for Generators of Biomedical Waste:

(1) A biomedical waste generator shall identify the solid waste he generates which is biomedical waste.

(2) A biomedical waste generator shall segregate biomedical waste from other solid waste to the extent practicable prior to placing biomedical waste in primary containers. Biomedical waste shall be segregated into the following categories:

(A) Sharps and any residual substances therein

(B) Body fluids in a quantity greater than 20 cubic centimeters

( C ) Other biomedical waste

(3) A biomedical waste generator shall prepare a written biomedical waste management plan for each facility at which he generates biomedical waste such plan shall set forth policies and procedures for segregating biomedical waste as required by subdivision (2) of this subsection and for assuring than the following requirements are satisfied:

(A) Biomedical waste mixed with hazardous waste shall be managed as hazardous waste in accordance with law.

(B) Biomedical waste mixed with radioactive material shall be managed as radioactive material in accordance with law.

( C ) Any solid waste which is neither hazardous nor is a radioactive material and which is mixed with biomedical waste shall be managed as biomedical waste in accordance with law.

(D) Any category of biomedical waste set forth in subdivision (2) of this subsection shall not be mixed with, or placed in a primary container with, any other such category of biomedical waste.

(4) Before transporting or offering for transport biomedical waste, a generator shall package the waste according to the following requirements:

(A) Biomedical waste shall be placed in containers that are:

(i) Rigid;

(ii) Leak-resistant;

(iii) Impervious to moisture;

(iv) Sufficiently strong to prevent tearing or bursting under normal conditions of use and handling; and

(v) Sealed to prevent leakage.

(B) Sharps and any residual substances therein shall be placed in containers that are puncture-resistant and meet the requirements of subparagraph (A) of this subdivision.

( C ) Body fluids in quantities greater than 20 cubic centimeters shall be placed in containers that are break-resistant and tightly lidded or stoppered and meet the requirements of subparagraph (A) of this subdivision.

(D) A generator may use as many containers as necessary to satisfy the requirements of subparagraphs (A), (B) and (C) of this subdivision.

(E) An individual item of biomedical waste that is too large to be placed in a standard-sized container shall be deemed an "oversized item" and shall be handled in a manner that minimizes contact with transport workers and the public. A water-resistant identification tag identifying in indelible writing the generator's name, address, and phone number shall be enclosed with or affixed to an oversized item. A generator shall indicate any special handling instructions for an oversized item in Box 14 of the tracking form.

(F) A container for biomedical waste shall not be reused to contain biomedical waste or for any other purpose unless (i) the surfaces of such container were protected from contamination by infectious agents through the use of a liner, bag or other device which was removed with the waste, or (ii) such container has been thoroughly washed to remove any visible indication of contamination and then disinfected by one of the procedures specified in subdivision (e)(6) of this section.

(5) Persons packaging biomedical waste shall wear such personal protective equipment as is required by law.

(6) Biomedical waste that is intended to be stored, treated, or disposed of at the site where it is generated shall be segregated and packaged in primary containers in accordance with the requirements of this subsection.

(7) Before transporting or offering for transport biomedical waste, a generator shall affix to, or cause to be imprinted on, the outside of each container a water-resistant label displaying in indelible writing the universal biohazard symbol or the words "medical waste" or "infectious waste." Such a label need not be affixed to or imprinted on a container of biomedical waste which has been decontaminated but not treated, but such a container shall be marked in accordance with subdivision (8) of this subsection.

(8) Before transporting or offering for transport biomedical waste, a generator shall mark containers as follows:

(A) A water resistant identification tag of at least three inches by five inches shall be affixed to the outside of both the primary and secondary containers and shall indicate in indelible writing the generator's name and address. In addition, the tag affixed to the secondary container shall indicate in indelible writing the name, address, business location and permit number of the transporter who accepted the waste from the generator and the date on which such transporter accepted the waste.

(B) When biomedical waste is transported by more than one transporter, each transporter other than the transporter who accepted the waste from the generator shall affix a water-resistant identification tag on the outside of the secondary container. Such tag shall be at least three inches by five inches and shall be affixed in such manner as not to obscure previously affixed identification tags. Such tag shall indicate in indelible writing the name address, business location, and permit number of the transporter affixing the tag and the date such transporter accepted the waste.

(9) No person shall hire or use a transporter for the transportation of biomedical waste unless such transporter has been issued a permit by the Commissioner under subsection (g) of this section.

( c ) Requirements for Storage of Biomedical Waste:

(1) Biomedical waste shall be stored such that other materials may not become mixed with such waste, and shall be stored in areas which are accessible only to those persons who are authorized by the generator, transporter, or solid waste facility operator, as applicable, to handle biomedical waste. Any outdoor storage area, such as a dumpster, shed or trailer, shall be locked.

(2) Biomedical waste shall be stored in a manner and location that maintains the integrity of its packaging and provides protection from water precipitation and wind.

(3) All areas used for the storage of biomedical waste shall be constructed of finished materials that are impermeable and capable of being easily maintained in a sanitary condition.

(4) Biomedical waste shall be stored only in a nonputrescent state; to maintain a nonputrescent state, biomedical waste may be refrigerated during storage.

(5) A sign displaying the universal biohazard symbol shall be posted wherever biomedical waste is stored.

(6) Biomedical waste shall not be compacted or subjected to violent mechanical stress during storage.

(7) Biomedical waste shall be stored in a manner that provides protection from animals and does not provide a breeding place or food source for insects or rodents.

(d) Requirements For Transfer of Biomedical Waste:

(1) Biomedical waste shall be handled during transfer in a manner that does not impair the integrity of its packaging.

(2) Trash chutes shall not be used to transfer biomedical waste.

(3) Biomedical waste shall not be compacted or subjected to violent mechanical stress during transfer.

(e) Requirements for Transportation of Biomedical Waste:

(1) A biomedical waste transporter shall not transport or accept for transport biomedical waste that is not packaged, labeled and marked in accordance with subdivisions (4), (7), and (8) of subsection (b) of this section.

(2) A biomedical waste transporter shall not transport or accept for transport biomedical waste which is not accompanied by a tracking form which complies with subsection (h) of this section.

(3) A biomedical waste transporter shall ensure that any vehicle used to transport biomedical waste meets the following requirements:

(A) Biomedical waste shall be transported in a fully enclosed, leak-resistant cargo compartment.

(B) Biomedical waste shall not be subjected to compaction or violent mechanical stress during loading and unloading.

( C ) Each cargo compartment shall be constructed of impermeable materials and kept free of visible contamination.

(D) No cargo compartment shall be used to transport any food or drink intended for human or animal consumption.

(E) Each cargo compartment shall be locked when left unattended.

(4) Biomedical waste shall be transported only in a nonputrescent state; to maintain a nonputrescent state, biomedical waste may be refrigerated during transport.

(5) A biomedical waste transporter shall ensure that his name, permit number and the words "medical waste" are displayed on the two sides and back of each cargo compartment in letters that are at least three inches tall and in a color contrasting with the color of such compartment.

(6) Vehicle surfaces that have had contact with spilled or leaked biomedical waste shall be decontaminated by (A) cleaning with a solution of industrial strength detergent for the purpose of removing visible soil, and (B) one of the following procedures:

(i) Exposure to water of at least 180 ° F for at least 30 seconds.

(ii) Exposure to a chemical sanitizer by rinsing with or immersion in one of the following for at least 3 minutes: hypochlorite solution (500 ppm available chlorine), phenolic solution (500 ppm active agent), iodoform solution (100 ppm available iodine), or quaternary ammonium solution (400 ppm active agent).

(7) Any person loading or unloading biomedical waste onto or off of a vehicle shall wear such personal protective equipment as is required by law.

(8) Each vehicle shall carry a spill clean-up kit which includes at least the following:

(A) Enough absorbent material to absorb at least ten gallons of liquid.

(B) One gallon of hospital-grade disinfectant in a sprayer capable of dispersing its charge both in a mist and in a stream at a distance of ten feet.

( C ) Fifty red plastic bags, seals, and labels. Such bags shall (i) meet the specifications of subparagraph (11) (4) (A) of this section, and (ii) be large enough to enclose any standard-sized container used for biomedical waste.

(D) Enough clean impermeable overalls, gloves, boots, caps, and surgical masks for use by at least two persons. Overalls, boots and caps should be fitted to the persons intended to wear them and shall be made of Tyvek (Registered Trademark) or material that provides equivalent protection. Top boot coverings shall be at least 75 mil thick, boot soles shall be at least 3/4 inch thick, and boot heels shall be at least 1- 1/4 inches thick. Gloves shall be of heavy neoprene or material that provides equivalent protection, and shall be of be at least 25 mils thick. Duct tape for sealing clothing at the wrists and ankles shall be included in each clean-up kit.

(E) A fire extinguisher, boundary marking tape, a high-intensity flashlight, and an American National Red Cross standard 24-unit first aid kit or its equivalent.

(9) In the event of a biomedical waste spill, personnel wearing clean-up apparel and using equipment described in subparagraph (8) (D) of this subsection shall immediately:

(A) Secure the area where the spill took place;

(B) Apply a sufficient amount of absorbent material in and around the spill area such that all liquid spillage is contained and absorbed;

( C ) Place damaged containers and spilled biomedical waste into bags specified in subparagraph (8) (C) of this subsection;

(D) Decontaminate the area affected by the spill and take other clean-up measures as appropriate under the circumstances;

(E) Clean and decontaminate used reusable components of the clean-up kit;

(F) Clean and decontaminate reusable components of apparel and related equipment before disrobing;

(G) Remove apparel and related equipment and place disposable items thereof in bags specified in subparagraph (8) (C) of this subsection; and

(H) Replace used non-reusable components of the clean-up kit.

(f) Requirements for Treatment and Disposal of Biomedical Waste:

(1) A solid waste facility shall not accept biomedical waste which is not packaged, labeled, and marked in accordance with subdivisions (4), (7), and (8) of subsection (b) of this section.

(2) A solid waste facility shall not accept biomedical waste which is not accompanied by a tracking form which complies with subsection (h) of this section.

(3) Biomedical waste shall be disposed of as follows:

(A) Chemotherapy waste shall be disposed of only by incineration.

(B) Pathological waste shall be disposed of only by incineration or interment.

( C ) Infectious waste shall be disposed of only by (i) incineration; (ii) discharge to a sanitary sewer, provided that such waste is in liquid or semi-solid form, that secondary treatment is available at the publicly owned treatment works or privately owned treatment works to which such waste is discharged, that local law does not prohibit such discharge, that all permits and other authorizations required by law have been obtained for such discharge, and that aerosol formation is minimized during such discharge to such sewer or (iii) any other method which provides protection of the public health and the environment at least equivalent to that provided by the disposal methods specified in this subparagraph and which is first described in writing to the Commissioner and approved in writing by the Commissioner.

(4) No person shall:

(A) Deliver biomedical waste or cause biomedical waste to be delivered to any incinerator, whether located inside or outside of Connecticut, unless such incinerator complies with all applicable law; or

(B) Operate an incinerator at which biomedical waste is burned unless such incinerator complies with all applicable law.

(5) Biomedical waste incinerator residue shall be managed as a special waste.

(6) A steam sterilizer used to decontaminate biomedical waste shall be operated in accordance with the following requirements:

(A) In a gravity flow sterilizer, biomedical waste shall be subjected to a temperature of not less than 250 ° F (121 ° C) at 15 pounds per square inch of gauge pressure for no less than 60 minutes.

(B) In a vacuum type sterilizer, biomedical waste shall be subjected to a temperature of not less than 270 ° F (132 ° C) at 27 pounds per square inch gauge pressure for no less than 45 minutes.

( C ) Notwithstanding subparagraphs (A) and (B) of this subdivision, a different combination of operational time, temperature and pressure may be utilized for steam sterilization of biomedical waste if such combination is first described in writing to the Commissioner and approved in writing by the Commissioner. The Commissioner will not grant approval unless such combination is proven on the basis of thorough tests, including tests of its capacity to kill Bacillus stearothermophilus, to completely and reliably kill all microorganisms in waste at design capacity.

(D) Biomedical waste shall be steam sterilized in its primary container. The primary container shall be placed in the sterilization chamber so that sufficient space is provided between the chamber walls and the container to allow the steam to penetrate the container. The primary container shall then be unsealed to allow the steam to penetrate the contents of the container.

(E) Unless a steam sterilizer is equipped to continuously monitor and record temperatures during the entire length of each sterilization cycle, the operator of such sterilizer shall affix to the primary container temperature-sensitive tape which will indicate when the desired temperature is reached. Biomedical waste shall not be considered decontaminated unless the temperature-sensitive tape indicates that a temperature of at least 250 ° F (121 ° C) was reached during the sterilization process. A steam sterilizer which is used for the first time after the effective date of this section shall automatically and continuously monitor and record temperatures throughout the entire length of each steam sterilization cycle.

(F) At least once during every forty hours of operation, tests shall be conducted to evaluate the effectiveness of the sterilization process, including tests of the capacity of such process to kill Bacillus stearothermophilus. A log shall be maintained recording the dates and results of such tests.

(G) At least once during every forty hours of operation, a sterilization unit shall be evaluated to determine whether it is operating properly with respect to temperature and pressure. A log shall be maintained recording the dates and results of such evaluations and the dates of calibration.

(H) For each sterilization unit a log shall be maintained recording, for each use, the date, time, operator, type and approximate amount of biomedical waste treated, the sterilization pressure reading and the post-sterilization reading on the temperature-sensitive tape.

(7) Unless it is physically altered so as to render it unrecognizable as biomedical waste, decontaminated biomedical waste shall be subject to the requirements of this section.

(8) If biomedical waste is treated or disposed of at the site where it was generated, the generator shall develop written procedures for each treatment or disposal method in use at such site and for ensuring compliance with such procedures. Such procedures shall be incorporated into the biomedical waste management plan required by subdivision (b)(3) of this section and shall (A) assure the effectiveness of any treatment method in use and reflect acceptable standards of practice; (B) provide for and conduct an ongoing program of staff training on the implementation of such procedures and the requirements of this section; and (C) provide for a quality assurance/quality control program to assure compliance with the biomedical management plan prepared pursuant to subsection (b) of this section.

(g) Requirements for Biomedical Waste Transporters:

(1) Other than an air carrier, no person shall transport or accept for transport biomedical waste unless such person has been issued a permit by the Commissioner under this subsection to transport biomedical waste.

(2) A small quantity generator may transport his own biomedical waste without a permit issued by the Commissioner under this subsection, provided that:

(A) Such generator complies with the requirements of subdivisions (1) through (5), (7) and (8) of subsection (b) of this section;

(B) The biomedical waste is transported to (i) a lawfully operating solid waste facility with which such generator has a written agreement to deliver his biomedical waste, or (ii) another place of business in Connecticut of such generator; and

( C ) The biomedical waste is transported (i) exclusively by such generator or by an employee whom he has authorized in writing to transport such waste; and (ii) in a vehicle owned by such generator or such employee.

(D) Such generator complies with the requirements of subdivision (i) (4) of this section.

(3) A small quantity generator who causes biomedical waste to be transported by the U.S. Postal Service is exempt from the requirements of this subsection and subsections (h) and (i) of this section, provided that:

(A) Such biomedical waste consists only of discarded used sharps and discarded unused hypodermic needles, scalpels, suture needs and syringes;

(B) Each package of such waste is sent registered mail, return receipt requested, indicating the name and address of the person to whom the waste was sent, the date when it was delivered, and the signature of the recipient; and

( C ) Complies with the requirements of subdivision (i) (5) of this section.

(4) An applicant for a permit under this subsection shall file his application with the Department on a form prescribed by the Commissioner. Such application shall include the following:

(A) The applicant's name, address, and business location.

(B) The manufacturer, model, year of manufacture, identification number and cargo-carrying capacity of each vehicle, used or to be used by the applicant, proof of ownership of such vehicle, and proof of current registration for such vehicle with a state motor vehicle department or agency.

( C ) The address of any transfer station or of any vehicle parking area used or to be used by the applicant pursuant to subdivision (15) of this subsection.

(D) The place or places where, and the manner in which, the applicant delivers or intends to deliver biomedical waste for treatment, storage, or disposal.

(E) Evidence of security from an insurer or surety authorized to do business in the State of Connecticut. Such security shall be in an amount of not less than $100,000 and shall provide liability coverage for bodily injury and property damage, including liability for environmental restoration resulting from negligence in the operation, maintenance, or use of any motor vehicle for transportation of biomedical waste. Security required under this paragraph:

(i) Shall remain in effect continuously while the permit is in effect;

(ii) Provide for written notification of the insurer's or surety's intent to cancel at least 35 days before cancellation; and

(iii) May be replaced by other security provided the liability of the retiring insurer or surety terminates on the effective date of the replacement security or at the end of the 35 day cancellation period required in subparagraph (E)(ii) of this subdivision, whichever is sooner.

(F) Evidence that biomedical waste transported by the applicant will be delivered to a lawfully permitted solid waste facility.

(G) Any other information reasonably required by the Commissioner to demonstrate that the applicant can be expected to safely transport biomedical waste and comply with all applicable provisions of this section during the term of the permit.

(5) A permit applicant shall make each vehicle and related equipment, and each vehicle parking area to be used by the applicant pursuant to subdivision (15) of this subsection, available for inspection by the Department in a safe and convenient location and at a reasonable time. The purpose of such inspection shall be to determine whether such vehicle complies with the requirements of subdivisions (3), (5), and (8) of subsection (e) of this section.

(6) The Commissioner shall decide whether to grant or deny a permit application based upon a review of the information and materials submitted by the applicant, the results of the vehicle inspection described in subdivision (4) of this subsection, and any other consideration authorized by law.

(7) The Commissioner shall notify an applicant in writing of the decision on the permit application. If an application is denied, the notice shall specify the reasons for denial. An application may be denied because the applicant has failed either to (A) comply with subdivision (4) or (5) of this subsection or (B) demonstrate that he can be expected to safely transport biomedical waste and comply with all applicable provisions of this section during the term of the permit. If the Commissioner grants an application the Department shall assign a permit number to the permittee.

(8) A biomedical waste transporter shall include his permit number on each tracking form.

(9) (A) A permit shall expire two years after the date of issuance. An application to renew a permit made no later than ninety days before the expiration date of such permit shall be deemed timely and sufficient.

(B) The Commissioner may revoke a permit issued under this subsection if the permittee (i) fails to comply with a statute, regulation or license administered, or order issued, by the Commissioner; (ii) fails to maintain in effect during the permit term the security specified in subparagraph (4) (E) of this subsection; or (iii) cannot be expected to safely transport biomedical waste or comply with all applicable provisions of this section during the term of the permit.

(10) A biomedical waste transporter shall notify the Department in writing of any change in majority ownership, name, address, or business location.

(11) A permit issued under this subsection is not transferable.

(12) Whenever any vehicle owned or operated by a biomedical waste transporter is involved in a spill of biomedical waste or whenever the vehicle is involved in an accident which renders the vehicle in non-compliance with this section, such transporter shall immediately notify both the Department and the director of health of the municipality in which the spill or accident occurred.

(13) Upon request of the Department, a biomedical waste transporter shall:

(A) Allow the Department to inspect tracking forms, shipment logs, reports, permits, licenses, billing records or other documents related to the transportation or other handling of biomedical waste.

(B) Allow the Department to inspect any vehicle or related equipment or any vehicle parking area used by the transporter pursuant to subdivision (15) of this subsection.

( C ) Decontaminate, utilizing procedures described in subdivision (6) of subsection (e), or allow the Department to decontaminate at the owner's expense, any vehicle that has been in contact with biomedical waste, or take or allow the Department to take any other measures necessary to make such vehicle safe for inspection.

(14) A generator who transports his own biomedical waste from its original generation point to a central collection point shall be exempt from the requirements of subsections (e), (g), and (h) of this section, provided that:

(A) The biomedical waste is transported by the generator or an employee authorized in writing in a vehicle owned by such generator or employee;

(B) The original generation point and the central collection point or solid waste facility are located in Connecticut; and

( C ) The generator compiles and retains a shipment log as required by subsection (i) (2) of this section.

(15) A biomedical waste transporter may store biomedical waste in the same vehicle he used to pick up and transport such waste from a generator only if:

(A) Such vehicle is parked at a location that

(i) Is under the direct control of the transporter, and

(ii) Has been approved for such use by the Commissioner in the transporter's biomedical waste transporter permit issued under this subsection;

(B) The location where such vehicle is parked is secured to prevent access thereto by any person other than the transporter and his employees;

( C ) Such vehicle is parked at such location for no longer than 48 consecutive hours, excluding weekends and State holidays;

(D) The biomedical waste is stored in accordance with the provisions of subsection (c) of this section;

(E) Such vehicle complies with the provisions of subdivision (e) (3) of this section; and

(F) No biomedical waste is loaded on to or off of such vehicle during storage.

(h) Requirements for Tracking Biomedical Waste:

(1) Except as provided in this subsection, a generator who transports or offers for transport biomedical waste shall use the tracking form in Appendix I of this section to track the movement of such waste from its site of generation to a solid waste facility or facilities for purposes of storage, treatment or disposal.

(2) Except as provided in subdivisions (g)(2), (3), and (14) of this subsection, before transporting or offering or delivering for transport biomedical waste, a generator shall prepare at least the number of tracking form copies that will provide himself and each transporter with one copy, and the operator of each solid waste facility where the waste is to be treated, stored or disposed with two copies.

(3) When preparing the tracking form, a generator shall:

(A) Follow the instructions included in Appendix I of this section;

(B) On all copies of the tracking form, sign the certification statement by hand;

( C ) On all copies of the tracking form, have the transporter write his signature and the date he accepts the waste;

(D) Retain one copy of the signed and dated tracking form.

(4) Notwithstanding any other provision of this section, when a generator offers or delivers biomedical waste directly to a rail transporter for transport to a non-rail transporter or solid waste facility in Connecticut, such generator shall forward at least three copies of the tracking form, completed in accordance with subdivision (3) of this subsection, to:

(A) Such non-rail transporter, if any; or

(B) The operator of such solid waste facility.

(5) A generator who offers or delivers biomedical waste to a transporter, other than a rail transporter, for transport to a facility outside Connecticut for treatment, storage, or disposal shall request that the operator of such facility provide written confirmation to such generator that the waste was received. If the generator does not receive such confirmation within 45 days from the date he offered or delivered the waste for transport, he shall submit an exception report as required pursuant to subdivision (i) (11) of this section.

(6) (A) A transporter shall not accept biomedical waste unless it is accompanied by a tracking form completed in accordance with Appendix I of this section.

(B) Notwithstanding subparagraph (A) of this subdivision, a non-rail transporter may accept from a rail transporter biomedical waste that is not accompanied by a tracking form, provided that such non-rail transporter complies with subdivisions (8) and (13) of this subsection before delivering the waste to the next transporter or solid waste facility.

(7) Before accepting biomedical waste that is accompanied by a tracking form, a transporter shall:

(A) Verify that the tracking form accurately reflects the number of containers and the weight in pounds of all (i) untreated and (ii) decontaminated biomedical waste accepted;

(B) On all copies of the tracking form, provide his handwritten signature and the date he accepted the waste from the generator or prior transporter, as applicable; and

( C ) If the transporter is the first transporter of the waste, return a copy of the signed and dated tracking form to the generator before accepting the waste, or if the transporter is a subsequent transporter of the waste, return a copy of the signed and dated tracking form to the prior transporter before accepting the waste; and

(D) Retain one copy of the signed and dated tracking form.

(8) A transporter, other than a rail transporter, shall ensure that the tracking form accompanies the biomedical waste during transport.

(9) When a transporter, other than a rail transporter, delivers biomedical waste to another transporter or a solid waste facility in Connecticut, the delivering transporter shall:

(A) On all copies of the tracking form, obtain the date of delivery and the handwritten signature of the accepting transporter or the operator of the solid waste facility;

(B) Retain one copy of the signed and dated tracking form; and

( C ) Give the remaining copies of the signed and dated tracking form to the accepting transporter or the owner of the facility.

(10) When a transporter, other than a rail transporter, delivers biomedical waste to a transporter outside Connecticut or facility outside Connecticut, the delivering transporter shall:

(A) Verify that the waste has been delivered to the accepting transporter or operator of the facility;

(B) On all copies of the tracking form, have the accepting transporter or facility operator write his signature and the date he accepts the waste, or if the accepting transporter or facility operator will not provide his signature, the delivering transporter shall write his own signature and the date he delivers the waste;

( C ) Retain one copy of the signed and dated tracking form; and

(D) Return all remaining copies of the signed and dated tracking form by mail to the generator.

(11) A rail transporter shall ensure that a shipping paper accompanies each shipment of biomedical waste during transport and contains all the information required on the tracking form, other than that required by Boxes 7, 10, and 15. A rail transporter who accepts biomedical waste from a prior rail transporter and delivers such waste to a subsequent rail transporter is not required to sign the shipping paper relating to such shipment of waste.

(12) When a rail transporter delivers biomedical waste to a solid waste facility in Connecticut, such transporter shall:

(A) Have the operator of the solid waste facility write his signature and the date he accepts the waste on all copies of the tracking form which was forwarded by the generator or the first non-rail transporter to the solid waste facility, or, if the tracking form has not been received by the solid waste facility, on the shipping paper; and

(B) Retain a copy of the signed and dated tracking form or shipping paper, as applicable.

(13) When a non-rail transporter accepts biomedical waste from a rail transporter, such non-rail transporter shall:

(A) Write his signature and the date he accepts the waste on all copies of the tracking form which was forwarded by the generator or first non-rail transporter to the accepting non-rail transporter, or, if the tracking form has not been received by the accepting non-rail transporter, on the shipping paper;

(B) Leave a copy of the signed and dated shipping paper with the rail transporter, if applicable; and

( C ) Retain a copy of the signed and dated shipping paper or tracking form, as applicable.

(14) A transporter who accepts biomedical waste from a small quantity generator who does not voluntarily use the tracking form need not comply with the requirements of subdivision (6) of this subsection, provided that:

(A) Such transporter compiles a log containing the following information for each shipment of biomedical waste he accepts from a small quantity generator:

(i) The generator's name and address;

(ii) The number of containers and total weight of (1) untreated and (2) decontaminated waste accepted; and

(iii) The date the waste is accepted;

(B) Such transporter carries such log in his vehicle while transporting the waste to the next transporter or solid waste facility, as applicable;

( C ) Such transporter signs and dates the generator's log required under subdivision (i) (3) of this subsection; and

(D) Such transporter complies with subdivision (17) of this subsection.

(15) Except as provided in subdivision (14) of this subsection, a transporter shall deliver the entire quantity of biomedical waste that he accepts from a generator or prior transporter to:

(A) The solid waste facility identified on the tracking form, or

(B) The next transporter, if any.

(16) When biomedical waste cannot be delivered in accordance with subdivision (15) of this subsection, a biomedical waste transporter shall:

(A) Contact the generator for further directions;

(B) Revise the tracking form according to the generator's instructions; and

( C ) Deliver the entire quantity of biomedical waste according to the generator's instructions.

(17) A transporter shall initiate a tracking form, in accordance with the provisions of subdivisions (2) and (3) of this subsection, for all biomedical waste accepted from each small quantity generator who does not voluntarily use the tracking form.

(18) (A) A transporter may consolidate multiple shipments of biomedical waste on a single tracking form, provided that each such shipment weighs less than 220 pounds and such transporter initiates a new tracking form for such consolidated waste in accordance with the provisions of subdivisions (2) and (3) of this subsection.

(B) When a transporter receives from a solid waste facility a copy of a tracking form which he initiated pursuant to subparagraph (A) of this subdivision, and which the operator of such facility signed and dated in accordance with subdivision (20) of this subsection, such transporter shall:

(i) Attach a copy of the tracking form received from the solid waste facility to the copy of the tracking form originally prepared by the generator;

(ii) Retain a copy of the tracking form received from the solid waste facility; and

(iii) Return a copy of the tracking form received from the solid waste facility, together with a copy of the tracking form originally prepared by the generator, to the generator within 15 days of receiving the tracking form from the solid waste facility.

(19) For each tracking form initiated pursuant to subparagraph (18) (A) of this subsection, a transporter shall compile a consolidation log reflecting all shipments of biomedical waste consolidated on that form. The consolidation log shall accompany the tracking form during transportation of the waste and shall contain the following information for each shipment:

(A) Name and address of generator;

(B) Date on which the shipment was accepted by such transporter;

( C ) Number of containers and the weight in pounds of all (i) untreated and (ii) decontaminated biomedical waste in the shipment; and

(D) Name, address and state biomedical waste transporter permit number of each previous transporter, if any.

(20) When a solid waste facility accepts biomedical waste accompanied by a tracking form, the operator of such facility shall:

(A) Indicate in Box 23 of all copies of the tracking form any of the following:

(i) Any variation between the number of containers reportedly shipped by the generator and the number actually received by such solid waste facility;

(ii) Any variation between the number of containers of (i) untreated and (ii) decontaminated biomedical waste reportedly shipped by the generator and the number actually received by the solid waste facility;

(iii) Any containers that are broken, torn, or leaking; and

(iv) Lack of any required information or signatures on the tracking form;

(B) On all copies of the tracking form, write the delivery date of the waste and his handwritten signature, such signature constituting certification that the waste reflected on the tracking form was actually accepted by such solid waste facility;

( C ) Before the transporter leaves the facility, give him at least one copy of the signed and dated tracking form;

(D) Within 15 days of accepting the waste, send a copy of the signed and dated tracking form to the generator or transporter who initiated the tracking form; and

(E) Retain a copy of the signed and dated tracking form.

(21) (A) When a solid waste facility accepts biomedical waste from a rail transporter before receiving the tracking form forwarded by the generator or first non-rail transporter, the operator of the solid waste facility shall:

(i) Provide on the rail transporter's shipping paper the information described in subparagraphs (20)(A) and (B) of this subsection;

(ii) Before accepting the waste, give the rail transporter at least one copy of the signed and dated shipping paper;

(iii) Within 15 days of accepting the waste, send a copy of the signed and dated shipping papers to the generator or first non-rail transporter who initiated the shipping paper; and

(iv) Retain a copy of the signed and dated shipping paper.

(B) Upon receiving a tracking form forwarded by a generator or first non-rail transporter, the operator of a solid waste facility shall: (i) provide on the tracking form the information described in subparagraphs (20)(A) and (B) of this subsection, (ii) within 15 days of receiving such tracking form send a copy of the signed and dated tracking form to the generator or first non-rail transporter who initiated the tracking form, and (iii) retain a copy thereof.

(22) When the operator of a solid waste facility accepts biomedical waste and (i) discovers any condition described in subparagraph (20) (A) of this subsection or (ii) the waste is unaccompanied by a tracking form, such operator shall attempt to resolve the problem with the generator or transporter. If such operator is unable to resolve the problem, he shall submit a letter, within 15 days of accepting the waste, to the Department describing the nature of the problem and his attempts to resolve it. The letter shall be accompanied by a legible copy of the tracking form or shipping paper in question when the problem is of the type specified in subparagraph (20) (A) of this subsection. If the problem is of the type specified in subparagraph (20)(A)(iv) of this subsection, the operator shall specify in his letter the number of containers and the weight in pounds of all (A) untreated and (B) decontaminated biomedical waste accepted, and the name and address of each generator and transporter of the waste.

(i) Recordkeeping and Reporting Requirements for Generators, Transporters, and Solid Waste Facilities:

(1) Except as provided in subdivisions (3), (4) and (5) of this subsection a generator shall retain a copy of each tracking form signed in accordance with subparagraphs (11)(3)(B) and (C) of this section for at least three years from the date he offers or delivers biomedical waste to a transporter.

(2) A generator who seeks under subdivision (g)(14) of this section to be exempt from the requirements of subsections (e), (g), and (11) of this section shall comply with the following requirements.

(A) At the original generation point such generator shall compile a shipment log which includes an entry for each shipment of biomedical waste, and shall retain each such entry for at least three years from the date the waste is transported.

(B) Each entry in the shipment log required in subparagraph (A) of this subdivision shall consist of the following:

(i) The date the biomedical waste is transported from the original generation point;

(ii) The weight of (i) untreated and (ii) decontaminated biomedical waste transported;

(iii) The address or location of the central collection point or solid waste facility, as applicable; and

(iv) The signature of the individual who transports the waste.

( C ) At the central collection point such generator shall compile a shipment log which includes an entry for each shipment of biomedical waste, and shall retain each such entry for at least three years from the date the waste is received at the central collection point from the original generation point.

(D) Each entry in the shipment log required in subparagraph (C) of this subdivision shall consist of the following:

(i) The date the biomedical waste is received at the central collection point;

(ii) The weight of (1) untreated and (2) decontaminated biomedical waste received;

(iii) The address or location of original generation point; and

(iv) The signature of the individual who manages the central collection point.

(3) A small quantity generator who uses the services of a transporter to transport biomedical waste and who does not voluntarily prepare the tracking form is subject to the following recordkeeping requirements:

(A) Such small quantity generator shall compile a log which includes an entry for each shipment of biomedical waste, and shall maintain each such entry for three years from the date the waste is accepted by the transporter.

(B) Each entry in the log required in subparagraph (A) of this subdivision shall consist of:

(i) The transporter's name and address;

(ii) The transporter's state biomedical waste transporter permit number;

(iii) The weight of (1) untreated and (2) decontaminated biomedical waste transported;

(iv) The date the waste is delivered to the transporter; and

(v) The signature of the transporter or his employee, as applicable, who accepts the waste.

(4) A small quantity generator who transports biomedical waste pursuant to subdivision (g) (2) of this section shall comply with the following requirements:

(A) Such small quantity generator shall compile a log which includes an entry for each such shipment of biomedical waste, and shall retain each such entry for at least three years from the date the generator transports the waste off his site.

(B) Each entry in the log required in subparagraph (A) of this subdivision shall consist of the following:

(i) The name and address of the solid waste facility to which the biomedical waste is transported;

(ii) The weight of (1) untreated and (2) decontaminated biomedical waste transported;

(iii) The date the biomedical waste is transported; and

(iv) The signature of the individual who transports the waste.

(5) A small quantity generator who seeks under subdivision (g) (3) of this section to be exempt from the requirements of subsections (h) and (i) of this section shall:

(A) For each shipment, retain the original U.S. Postal Service receipt and the return mail receipt for at least three years from the date the waste is shipped;

(B) Compile a log which includes an entry for each shipment of biomedical waste and maintain each such entry for at least three years from the date the waste is mailed. Each entry in such log shall consist of:

(i) The weight of (1) untreated and (2) decontaminated biomedical waste mailed;

(ii) The date the biomedical waste is mailed; and

(iii) The name and address of the solid waste facility to which the biomedical waste is mailed.

(6) A generator who treats his own biomedical waste on his site shall compile an operating log which includes an entry for each treatment cycle. Each such entry shall be maintained for three years from the date the waste is treated and shall consist of:

(A) The date and time the treatment cycle begins and ends, and

(B) The weight in pounds of biomedical waste treated during each treatment cycle.

(7) A generator who accepts for treatment at his site biomedical waste generated by another generator or generators shall compile an operating log which includes an entry for each shipment of biomedical waste accepted. Each such entry shall be maintained for three years from the date the waste is accepted and shall consist of:

(A) The date the waste was accepted;

(B) The name and address of the generator who generated the waste;

( C ) The weight of (i) untreated and (ii) decontaminated biomedical waste accepted; and

(D) The signature of the individual accepting the waste.

(8) A generator who accepts for treatment at his site biomedical waste generated by another generator or generators subject to the requirements of subsection (11) of this section shall retain copies of the tracking form for three years from the date he accepts waste from such other generator or generators.

(9) A generator who treats his own biomedical waste on his site or who accepts for treatment at his site biomedical waste generated by another generator or generators shall prepare an annual report based on entries recorded in the operating log described in subdivision (6) of this subsection, and stating the total number of treatment cycles performed and the total weight of biomedical waste treated. The annual report shall be submitted to the Commissioner no later than February 15 of each year and shall cover the preceding calendar year. In addition to providing the said information, the generator shall include in the annual report the following information:

(A) His name and address and the address where he treats biomedical waste, if different;

(B) Type of generator he is (for example, general acute-care hospital or clinical laboratory);

( C ) Name and telephone number of contact person; and

(D) With respect to each other generator from whom the treating generator accepts biomedical waste:

(i) Type of generator (for example, acute-care hospital or clinical laboratory); and

(ii) Name and telephone number of a contact person.

(E) A statement, signed and dated by the treating generator, which reads: "I have personally examined and am familiar with the information submitted in this document and all attachments and certify under penalty of law that based on reasonable investigation, including my inquiry of those persons immediately responsible for obtaining the information, the submitted information is true, accurate and complete."

(10) A generator who does not, within 35 days of the date he delivers biomedical waste for transport, receive a copy of a signed tracking form from the solid waste facility to which such waste is to be delivered shall contact such facility and each known transporter of the waste to determine the status of the waste.

(11) A generator who does not, within 45 days of the date he delivers biomedical waste for transport, receive a copy of a signed tracking form from the solid waste facility to which such waste is to be delivered shall submit an exception report to the Commissioner. Such exception report shall be postmarked on or before the 46th day after the date the generator delivered the waste for transport and shall include:

(A) A legible copy of the tracking form as signed and dated by the generator and by the transporter accepting the waste; and

(B) A letter signed by the generator explaining the efforts he has taken to locate the waste and the results of such efforts.

(12) A generator shall retain a copy of an exception report submitted pursuant to subdivision (11) of this subsection for at least three years from its postmark date.

(13) A transporter shall, for each shipment of biomedical waste he transports, retain a copy of each tracking form signed by the generator, himself, any previous transporter, if applicable, and the person to whom he delivers the waste for at least three years from the date he delivers the waste.

(14) A transporter who accepts biomedical waste that is not accompanied by a generator-initiated tracking form shall, with respect to such waste, retain a copy of the tracking form and related consolidation log initiated by such transporter for at least three years from the date he accepts the waste.

(15) A transporter who accepts biomedical waste that is accompanied by a generator-initiated tracking form and who subsequently consolidates the waste to a single tracking form pursuant to subdivision (h) (18) of this section shall:

(A) Retain a copy of the generator-initiated tracking form for at least three years from the date he accepts the waste; and

(B) Retain a copy of the tracking form which he initiated and which is signed by the operator of the solid waste facility or subsequent transporter, as applicable, that accepts the waste for at least three years from the date such operator accepts the waste.

(16) A transporter who accepts biomedical waste that is generated in Connecticut or transported to Connecticut for storage, treatment or disposal shall, by each February 15, submit to the Commissioner a report identifying for the previous calendar year: each generator from whom the transporter accepted such waste and each solid waste facility to which the transporter delivered biomedical waste. Such report shall also include the following:

(A) The transporter's name, address and Connecticut biomedical waste transporter permit number;

(B) The name and telephone number of a contact person for the transporter;

( C ) The name, address and type of each generator, by state, from whom the transporter accepted biomedical waste;

(D) The total number of generators, by state, from whom the transporter accepted biomedical waste;

(E) The weight in pounds of (i) untreated and (ii) decontaminated biomedical waste the transporter accepted from each generator, by state;

(F) The name and address of each solid waste facility, by state, to which the transporter delivered biomedical waste generated in Connecticut;

(G) The name and address of each solid waste facility in Connecticut to which the transporter delivered biomedical waste generated outside of Connecticut;

(H) The total weight in pounds of (i) untreated and (ii) decontaminated biomedical waste from all generators, by state, which the transporter delivered to a solid waste facility in Connecticut for treatment or disposal;

(I) The total weight in pounds of (i) untreated and (ii) decontaminated biomedical waste from all generators, by state, which the transporter delivered in Connecticut to another transporter;

(J) The total weight in pounds of (i) untreated and (ii) decontaminated biomedical waste from all generators, by state, which the transporter delivered to a solid waste facility in Connecticut for transfer or storage;

(K) The total weight in pounds of (i) untreated and (ii) decontaminated biomedical waste from all generators in Connecticut which the transporter delivered to a transporter outside of Connecticut or a solid waste facility outside of Connecticut;

(L) The total number of solid waste facilities, by state, to which the transporter delivered biomedical waste; and

(M) A statement, signed and dated by the transporter, which is identical to that set forth in subparagraph (9)(E) of this subsection.

(17) A transporter who initiates a tracking form pursuant to subdivision (h)(17) or (11) (18) of this section is subject to the requirements of subdivisions (10), (11), and (12) of this subsection, except that the 35- and 45-day periods referred to in such subdivisions begin on the day such transporter accepts the biomedical waste in question.

(18) The operator of a solid waste facility that accepts biomedical waste shall retain (A) records compiled pursuant to subdivision (19) of this section and (B) copies of tracking forms and letters retained pursuant to subdivisions (11) (20), (21), and (22) of this section for at least three years from the date such operator accepts the waste.

(19) The operator of a solid waste facility that accepts biomedical waste shall compile written records containing (A) the name and address of each small quantity generator who delivers biomedical waste to such facility pursuant to subdivision (g) (2) of this section, (B) the date each waste shipment pursuant to such subdivision was delivered, (C) the weight in pounds of each such shipment and (D) the signature of the solid waste facility employee who accepted each such shipment.

(20) The operator of a solid waste facility that accepts biomedical waste in accordance with subparagraph (11)(21)(A) of this section shall retain his copy of the signed and dated shipping paper for three years from the date he accepts the waste.

(21) Appendix:

This appendix describes each section (box) of the biomedical waste tracking form and provides mandatory instructions for completing each of these sections. The generator shall complete Boxes 1-15, the transporter shall complete Boxes 16-21, and the operator of the solid waste facility shall complete Boxes 22-23. The transporter may assist the generator in completing any of the boxes, but the generator is responsible for ensuring the accuracy of information entered on the form and must sign Box 15 after Boxes 1-14 are completed.

Box 1: Generator's Name and Mailing Address. Enter the name and mailing address of the generator. The mailing address shall be the address to which the solid waste facility will return the signed copy of the tracking form, and should be for the location where the generator's tracking forms will be handled for purposes of recordkeeping and exception reporting (e.g., the company's billing office, corporate headquarters, or the actual site of generation).

While the address entered here need not identify the particular site of generation, the generator shall maintain his records so that individual waste shipments (identified by a unique tracking form number assigned by the generator, discussed next) can be associated with the actual sites of generation.

Box 2: Tracking Form Number. This is the unique number that the generator shall assign to each shipment of biomedical waste. It will ensure that each individual shipment can be identified and independently tracked from the site of generation. (The number may be the date of shipment or some other notation that the generator wishes to utilize.)

Box 3: Generator Telephone Number. Enter the telephone number of a contact person for the generator who can provide additional information about the shipment in the event of an emergency or in the event that the transporter or solid waste facility requires it for other reasons (e.g., to inform the generator that an alternative waste disposal facility must be used).

Box 4: State Generator Permit or ID Number. This box is not applicable under current state law and should be left blank.

Box 5: Transporter's Name, Mailing Address and U.S. Environmental Protection Agency ("EPA") Medical Waste Identification Number. Indicate in this space the name and address of the transporter who will be the first transporter of the biomedical waste which is the subject of the tracking form. The address shall be the business mailing address of the transporter. The transporter shall fill in his EPA Medical Waste Identification Number for the State in which the waste was generated. If a number has not yet been assigned, the transporter shall leave this box blank. The EPA Medical Waste Identification Number is assigned by EPA when the transporter notifies EPA.

Box 6: Transporter Telephone Number. Enter the telephone number of the transporter that the generator or solid waste facility operator may call to obtain information regarding a biomedical waste shipment.

Box 7: State Transporter Permit or ID Number. Enter the biomedical waste transporter permit number issued to transporter pursuant to subsection (g) of this section.

Box 8: Solid Waste Facility Name and Address. Enter the name and site address of the solid waste facility to which the biomedical waste is to be delivered. The site address is necessary to inform the transporter where the waste must be delivered. (If the generator does not have this information, the transporter may complete this section, but only before the generator signs the form. Transfer stations and other temporary storage facilities used by transporters for storage of waste during transport shall not be listed here as the solid waste facility.)

Box 9: Solid Waste Facility Telephone Number. Enter the solid waste facility's telephone number which a generator or transporter may call to obtain information regarding a biomedical waste shipment.

Box 10: State Solid Waste Facility Permit or ID Number. Enter the solid waste facility permit number assigned by Department of Environmental Protection. If the solid waste facility is located outside Connecticut, enter the facility permit or other identification number assigned by the State in which the facility is located.

Box 11: U.S. Environmental Protection Agency Waste Description. In Box 11 (A), indicate untreated biomedical waste. In Box 11 (B), indicate decontaminated biomedical waste. In Box 11 (C), indicate chemotherapy waste. The generator shall determine and indicate the type(s) of his waste before completing Boxes 12 and 13.

Box 12: Total Number of Containers. Enter the total number of containers (e.g., bags, boxes, pails, drums, etc.) for each applicable waste type in the corresponding space.

Box 13: Total Weight or Volume. Enter the total weight of the waste, by applicable waste type, in the corresponding space. If the waste is oversized and is not packaged in a standard container, a volumetric measure may be used; however, the unit of measure shall be noted in that space as well.

Box 14: Special Handling Instructions and Additional Information. Generators may use this space to indicate special transportation, treatment, storage, or disposal information or bill of lading information, including alternative treatment and/or disposal facility information, if necessary. Generators may also include in this box a written request for the solid waste facility to certify disposal of the waste through signature and dating within this box. (Note: The signature in the solid waste facility Certification Box (Box 22) is only to be used to acknowledge receipt of the waste at the time of deliver to the facility.)

For out-of-State shipments, generators shall enter in this space the point of departure (city and State) for those wastes destined for facilities outside of Connecticut. This space may also be used if there is need to identify a third transporter.

This space should also be used to provide special instructions or additional information regarding oversized biomedical waste that cannot be easily packaged in plastic bags or standard containers. In these instances, enter a description of the waste, including whether the waste is untreated or decontaminated, the number of pieces, and the approximate total weight.

Box 15: Generator's Certification. This statement, when signed by the generator, certifies that (i) all information required to be provided by that generator is accurate (including any information provided by the transporter in Boxes 1-14), (ii) all wastes indicated on the tracking form are properly prepared for transport, and (iii) all applicable State and Federal requirements have been met. The generator his name into this statement and read it, sign it by hand, and date it. The individual signing the statement must be authorized in writing to make the required declarations by the generator.

Box 16: Transporter 1 Certification of Receipt. The first transporter shall acknowledge acceptance of a biomedical waste shipment from the generator by signing the form in this box and recording the date of acceptance. Before doing so, a transporter shall indicate in Box 23 of the tracking form any circumstances of the type described in subparagraph (h)(20)(A) of this section. In those instances when a transporter initiates a tracking form, he shall complete Boxes 1-15 and if he is also the first transporter as identified in Box 5 (Transporter's Name and Mailing Address), he shall acknowledge receipt as transporter 1.

Box 17: Transporter 2 Name, Address, and U.S. Environmental Protection Agency Medical Waste Identification Number. In the event the waste shipment is to be transported by a second transporter, such second transporter shall enter in this box his name and business mailing address and his U.S. Environmental Protection Agency Medical Waste Identification Number if it is available.

Box 18: Transporter 2 Telephone Number. Enter the second transporter's telephone number to be used when checking or investigating the status of a shipment.

Box 19: Transporter 2 State Transporter Permit or ID Number. In this box, a second transporter shall enter his biomedical waste transporter permit number assigned under subsection (g) of this section, or, if such second transporter is an out-of-state transporter, he shall enter any permit or other identification number assigned to him by such other state.

Box 20: Transporter 2 or Intermediate Handler Certification of Receipt. A second transporter shall acknowledge acceptance of the waste shipment by entering his name and the date of acceptance and signing the form. Before doing so, he shall indicate in Box 23 of the tracking form any circumstances of the type described in subparagraph (h)(20)(A) of this section.

Box 21: New Tracking Form Number. If a biomedical waste transporter consolidates multiple biomedical shipments on a new tracking form, a new tracking form number shall be recorded in this box on the original generator's form.

Box 22: Solid Waste Facility. The operator of a solid waste facility shall acknowledge acceptance of biomedical waste by printing or typing his name and date of acceptance and signing in this box. Before doing so, he shall complete Box 23, as applicable, or, if there is nothing to record in Box 23, he shall place a check next to the statement "received in accordance with items 11, 12 and thirteen."

If biomedical waste is delivered to a solid waste facility other than that indicated in Box 8, the operator of the solid waste facility that accepted the waste shall complete Box 22 in the manner described in the foregoing paragraph and shall type or print his address, telephone number, and assigned permit number.

Box 23: Discrepancy Box. In Box 23 the operator of the solid waste facility shall indicate any circumstances of the type described in subparagraph (11)(20) (A) of this section. (Note: In some instances, due to the consolidation provisions of subdivisions (11)(18) and (19) of this section, transporters may also need to complete this box.)

CT ADC § 22a-209-15

2. How are physicians regulated by the Occupational Safety and Health Act (OSHA)?

Physicians in the clinical practice of medicine are subject to the OSHA regulations which protect employees who come into contact with blood and other potentially infectious agents.

3. What are the major requirements of the regulations?

The major requirements are:

A. Universal precautions, free vaccinations and post-exposure treatment.

The regulations require that all health care employers, including physicians, ensure that their employees follow universal precautions and have access to free hepatitis B vaccinations. "Universal precautions" is an approach to infection control where all human blood and certain bodily fluids are treated as if known to be infectious for HIV, and other bloodborne pathogens.

Post-exposure evaluation and treatment must also be provided, free-of-charge. This includes counseling, prophylaxis and AZT should it be recommended by a licensed health professional treating the employee.

B. Written Exposure Control Plan

The regulations require employers to develop a written exposure control plan which must identify the job classifications, procedures and tasks of employees who are exposed to blood and must specify the means used to protect such employees from infection. The plan must also set a schedule for implementing the methods for compliance and a procedure for the evaluation of circumstances surrounding exposure incidents.

Additionally, all exposure control plans must provide for the use of the following: 1) engineering controls, such as puncture-resistant containers for used needles; 2) work practice controls, such as rules that ensure employees are performing procedures in the safest way; 3) housekeeping controls, such as decontamination procedures, procedures for discarding contaminated needles and handling regulated wastes; and 4) use of protective equipment, such as gloves, gowns and masks that must be provided to employees free-of-charge.

The plan must be available to all employees. It must also be reviewed and updated at least annually and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new employee positions with occupational exposure. (See Appendix for Model Exposure Plan)

C. Employee Education

Employers must ensure that all employees with occupational exposure participate in a training program which must be provided at no cost to the employee and during work hours. Annual training must also be provided within one year of previous training.

D. Record-keeping

Employers must establish and maintain accurate records for each employee with occupational exposure. Records must include employee's name and social security number, copy of all results of examinations, medical testing and follow-up procedures. All medical records must be kept confidential.

4. Are there any penalties for non-compliance?

Yes. Non-compliance is subject to fines of up to $70,000 for a willful violation.

Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.