226, radium-228, and gross alpha particle radioactivity:

(a) Combined radium-226 and radium228-5 pCi/l;

(b) Gross alpha particle activity (including radium-226 but excluding radon and uranium)-15 pCi/l.

APPENDIX II

A. Processes to Significantly Reduce
Pathogens

Aerobic digestion: The process is conducted by agitating sludge with air or oxygen to maintain aerobic conditions at residence times ranging from 60 days at 15° C to 40 days at 20° C, with a volatile solids reduction of at least 38 percent.

Air Drying: Liquid sludge is allowed to drain and/or dry on under-drained sand beds, or paved or unpaved basins in which the sludge is at a depth of nine inches. A minimum of three months is needed, two months of which temperatures average on a daily basis above 0° C.

Anaerobic digestion: The process is conducted in the absence of air at residence times ranging from 60 days at 20° C to 15 days at 35° to 55° C, with a volatile solids reduction of at least 38 percent.

Composting: Using the within-vessel, static aerated pile or windrow composting methods, the solid waste is maintained at minimum operating conditions of 40° C for 5 days. For four hours during this period the temperature exceeds 55° C.

Lime Stabilization: Sufficient lime is added to produce a pH of 12 after 2 hours of contact.

Other methods: Other methods or operating conditions may be acceptable if pathogens and vector attraction of the waste (volatile solids) are reduced to an extent equivalent to the reduction achieved by any of the above methods.

B. Processes to Further Reduce Pathogens Composting: Using the within-vessel composting method, the solid waste is maintained at operating conditions of 55° C or greater for three days. Using the static aerated pile composting method, the solid waste is maintained at operating conditions of 55° C or greater for three days. Using the windrow composting method, the solid waste attains a temperature of 55° C or greater for at least 15 days during the composting period. Also, during the high temperature period, there will be a minimum of five turnings of the windrow.

Heat drying: Dewatered sludge cake is dried by direct or indirect contact with hot gases, and moisture content is reduced to 10 percent or lower. Sludge particles reach temperatures well in excess of 80° C, or the

wet bulb temperature of the gas stream in contact with the sludge at the point where it leaves the dryer is in excess of 80° C.

Heat treatment: Liquid sludge is heated to temperatures of 180° C for 30 minutes.

Thermophilic Aerobic Digestion: Liquid sludge is agitated with air or oxygen to maintain aerobic conditions at residence times of 10 days at 55-60° C, with a volatile solids reduction of at least 38 percent.

Other methods: Other methods or operating conditions may be acceptable if pathogens and vector attraction of the waste (volatile solids) are reduced to an extent equivalent to the reduction achieved by any of the above methods.

Any of the processes listed below, if added to the processes described in Section A above, further reduce pathogens. Because the processes listed below, on their own, do not reduce the attraction of disease vectors, they are only add-on in nature.

Beta ray irradiation: Sludge is irradiated with beta rays from an accelerator at dosages of at least 1.0 megarad at room temperature (ca. 20° C).

Gamma ray irradiation: Sludge is irradiated with gamma rays from certain isotopes, such as 60Cobalt and 137Cesium, at dosages of at least 1.0 megarad at room temperature (ca. 20° C).

Pasteurization: Sludge is maintained for at least 30 minutes at a minimum temperature of 70° C.

Other methods: Other methods or operating conditions may be acceptable if pathogens are reduced to an extent equivalent to the reduction achieved by any of the above add-on methods.

Facilities

AUTHORITY: 42 U.S.C. 6912, 6992 et seq.

SOURCE: 54 FR 12371, Mar. 24, 1989, unless otherwise noted.

Subpart A-General

§ 259.1 Purpose, scope, and applicability.

(a) The purpose of this part is to establish a demonstration program for tracking medical waste shipments pursuant to the Medical Waste Tracking Act of 1988.

(b) The regulations in this part apply to regulated medical waste as defined in Subpart D of this part that is generated in a Covered State as defined in Subpart C of this part.

(c) Generators, transporters, and owners or operators of intermediate handling facilities (e.g., treatment or destruction facilities) or destination facilities (e.g., disposal facilities) who transport, offer for transport, or otherwise manage regulated medical waste generated in a Covered State must comply with this part even if such transport or management occurs in a non-Covered State.

(d) Regulatory presumptions. The transportation and management of regulated medical waste, as defined in Subpart D of this part, in a Covered State is subject to regulations under this part, unless a person claiming a non-regulated status can demonstrate by a preponderance of the evidence,

259.80 Applicability.

259.81 Use of the tracking form.

259.82 Tracking form discrepancies.

259.83 Recordkeeping.

259.84 Additional reporting.

Subpart J-Rail Shipments of Regulated Medical Waste

259.90 Applicability.

259.91 Rail shipment tracking form requirements.

APPENDIX I TO PART 259 MEDICAL WASTE

TRACKING FORM AND INSTRUCTIONS APPENDIX II TO PART 259 ON-SITE INCINERATOR REPORT FORM AND INSTRUCTIONS APPENDIX III TO PART 259 TRANSPORTER REPORT AND INSTRUCTIONS

APPENDIX IV TO PART 259 RECOMMENDED MEDICAL WASTE TRANSPORTER NOTIFICATION FORM And InstructIONS

umentation, that the regulated medical waste was generated in a non-Covered State.

§ 259.2 Effective dates and duration of the demonstration program.

(a) Except for records and reports required to be maintained or submitted under this part, the demonstration program will be effective for the period June 22, 1989, to June 22, 1991.

(b) The length of time parties must keep records required under this part is automatically extended in the case where EPA or a State initiates an enforcement action, for which those records are relevant, until the conclusion of the enforcement action.

(a) For the purposes of this part, all of the terms defined in 40 CFR 260.10 are hereby incorporated by reference, except for the following terms, which have been redefined as appropriate to address the management of medical waste specifically:

"Facility" means all contiguous land and structures, other appurtenances, and improvements on the land, used for treating, destroying, storing, or disposing of regulated medical waste. A facility may consist of several treatment, destruction, storage, or disposal operational units.

"Generator" means any person, by site, whose act or process produces regulated medical waste as defined in Subpart D of this part, or whose act first causes a regulated medical waste to become subject to regulation. In the case where more than one person (e.g., doctors with separate medical practices) are located in the same building, each individual business entity is a separate generator for the purposes of this part.

"Landfill" means a disposal facility or part of a facility where regulated medical waste is placed in or on the land and which is not a land treatment facility, a surface impoundment, or an injection well.

"Person" means an individual, trust, firm, joint stock company, corporation (including a government corporation), partnership, association, State, municipality, commission, political subdivision of a State, any interstate body, or any department, agency or instrumentality of the United States.

"Solid waste" means a solid waste defined in Section 1004 (27) of RCRA. "Storage" means the temporary holding of regulated medical wastes at a designated accumulation area before treatment, disposal, or transport to another location.

"Transfer facility" means any transportation-related facility including loading docks, parking areas, storage areas and other similar areas where shipments of regulated medical waste are held (come to rest or are managed) during the course of transportation. For example, a location at which regu

lated medical waste is transferred directly between two vehicles is considered a transfer facility. A transfer facility is a "transporter".

"Transportation" means the shipment or conveyance of regulated medical waste by air, rail, highway, or water.

"Transporter" means a person engaged in the off-site transportation of regulated medical waste by air, rail, highway, or water.

"Treatment" when used in the context of medical waste management means any method, technique, or process designed to change the biological character or composition of any regulated medical waste so as to reduce or eliminate its potential for causing disease. When used in the context of § 259.30(a) of this part, treatment means either the provision of medical services or the preparation of human or animal remains for interment or cremation.

(b) In addition, when used in this part, the following terms have the meanings given below:

"Biologicals"

means preparations made from living organisms and their products, including vaccines, cultures, etc., intended for use in diagnosing, immunizing or treating humans or animals or in research pertaining thereto.

"Blood products" means any product derived from human blood, including but not limited to blood plasma, platelets, red or white blood corpuscles, and other derived licensed products, such as interferon, etc.

"Body fluids" means liquid emanating or derived from humans and limited to blood; cerebrospinal, synovial, pleural, peritoneal and pericardial fluids; and semen and vaginal secretions.

"Central collection point" means a location where a generator consolidates regulated medical waste brought together from original generation points prior to its transport off-site or its treatment on-site (e.g., incineration).

“Covered States" means those States that are participating in the Demonstration Medical Waste Tracking Program and includes: Connecticut; Louisiana; New Jersey; New York; Rhode Island; Puerto Rico; and the District

of Columbia. Any other State is a NonCovered State.

"Decontamination" means the process of reducing or eliminating the presence of harmful substances, such as infectious agents, so as to reduce the likelihood of disease transmission from those substances.

"Destination facility" means the disposal facility, the incineration facility, or the facility that both treats and destroys regulated medical waste, to which a consignment of such is intended to be shipped, specified in Box 8 of the Medical Waste Tracking Form.

"Destroyed regulated medical waste" means regulated medical waste that has been ruined, torn apart, or mutilated through processes such as thermal treatment, melting, shredding, grinding, tearing or breaking, so that it is no longer generally recognizable as medical waste. It does not mean compaction.

"Destruction facility" means a facility that destroys regulated medical waste by ruining or mutilating it, or tearing it apart.

"Infectious agent" means any organism (such as a virus or a bacteria) that is capable of being communicated by invasion and multiplication in body tissues and capable of causing disease or adverse health impacts in humans.

"Intermediate handler" is a facility that either treats regulated medical waste or destroys regulated medical waste but does not do both. The term, as used in this Part, does not include transporters.

"Laboratory" means any research, analytical, or clinical facility that performs health care related analysis or service. This includes medical, pathological, pharmaceutical, and other research, commercial, or industrial laboratories.

"Medical waste" means any solid waste which is generated in the diagnosis, treatment (e.g., provision of medical services), or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals. The term does not include any hazardous waste identified or listed under Part 261 of this chapter or any household waste as defined in § 261.4(b)(I) of this chapter.

NOTE TO THIS DEFINITION: Mixtures of hazardous waste and medical waste are subject to this part except as provided in § 259.31.

"Original generation point" means the location where regulated medical waste is generated. Waste may be taken from original generation points to a central collection point prior to off-site transport or on-site treatment.

"Oversized regulated medical waste" means medical waste that is too large to be placed in a plastic bag or standard container.

"Regulated medical waste" means those medical wastes that have been listed in § 259.30(a) of this part and that must be managed in accordance with the requirements of this part.

"Tracking form" means the Federal Medical Waste Tracking Form that must accompany all applicable shipments of regulated medical wastes generated within one of the Covered States.

"Treated regulated medical waste" means regulated medical waste that has been treated to substantially reduce or eliminates its potential for causing disease, but has not yet been destroyed.

"Universal biohazard symbol" means the symbol design that conforms to the design shown in 29 CFR 1910.145(f)(8)(ii).

"Untreated regulated medical waste" means regulated medical waste that has not been treated to substantially reduce or eliminate its potential for causing disease.

"Waste category" means either untreated regulated medical waste or treated regulated medical waste.

[54 FR 12371, Mar. 24, 1989, as amended at 54 FR 24311, June 6, 1989]

Subpart C-Covered States

§ 259.20 States included in the demonstration program.

(a) The regulations of this part apply to Regulated Medical Waste that is generated in any Covered State.

(b) For purposes of this part, Covered States are the States of Connecticut, Louisiana, New Jersey, New York,

Rhode Island, Puerto Rico, and the District of Columbia.

[54 FR 24311, June 6, 1989]

Subpart D-Regulated Medical Waste

§ 259.30 Definition of regulated medical waste.

(a) A regulated medical waste is any solid waste, defined in § 259.10(a) of this part, generated in the diagnosis, treatment, (e.g., provision of medical services), or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals, that is not excluded or exempted under paragraph (b) of this section, and that is listed in the following table:

NOTE TO PARAGRAPH (A): The term "solid waste" includes solid, semisolid, or liquid materials, but does not include domestic sewage materials identified in § 261.4(a)(1) of this subchapter.

TABLE-REGULATED MEDICAL WASTE

Waste class

(1) Cultures and Stocks.

(2) Pathological Wastes.

(3) Human Blood and Blood Products.

Description

Cultures and stocks of infectious agents and associated biologicals, including: cultures from medical and pathological laboratories; cultures and stocks of infectious agents from research and industrial laboratories; wastes from the production of biologicals; discarded live and attenuated vaccines; and culture dishes and devices used to transfer, inoculate, and mix cultures. Human pathological wastes, including tissues, organs, and body parts and body fluids that are removed during surgery or autopsy, or other medical procedures, and specimens of body fluids and their containers.

(1) Liquid waste human blood; (2) products of blood; (3) items saturated and/or dripping with human blood; or (4) items that were saturated and/or dripping with human blood that are now caked with dried human blood; including serum, plasma, and other blood components, and their containers, which were used or intended for use in either patient care, testing and laboratory analysis or the development of pharmaceuticals. Intravenous bags are also included in this category.

TABLE-REGULATED MEDICAL WASTE

Continued

Waste class

(4) Sharps..

(5) Animal Waste.

(6) Isolation Wastes

Description

Sharps that have been used in animal or human patient care or treatment or in medical, research, or industrial laboratories, including hypodermic needles, syringes (with or without the attached needle), pasteur pipettes, scalpel blades, blood vials, needles with attached tubing, and culture dishes (regardless of presence of infectious agents). Also included are other types of broken or unbroken glassware that were in contact with infectious agents, such as used slides and cover slips. Contaminated animal carcasses, body parts, and bedding of animals that were known to have been exposed to infectious agents during research (including research in veterinary hospitals), production of biologicals, or testing of pharmaceuticals. Biological waste and discarded materials contaminated with blood, excretion, exudates, or secretions from humans who are isolated to protect others from certain highly communicable diseases, or isolated animals known to be infected with highly communicable diseases.

(7) Unused Sharps.... The following unused, discarded sharps: hypodermic needles, suture needles, syringes, and scalpel blades.

(b)(1) Exclusions. (i) Hazardous waste identified or listed under the regulations in Part 261 of this chapter is not regulated medical waste.

NOTE TO PARAGRAPH (b)(1)(i): Mixtures of regulated medical waste and hazardous waste are subject to Part 259, except as provided in § 259.31(b) of this subpart.

(ii) Household waste, as defined in § 261.4(b)(1) of this Chapter, is not regulated medical waste.

(iii) Ash from incineration of regulated medical waste is not regulated medical waste once the incineration process has been completed.

(iv) Residues from treatment and destruction processes are no longer regulated medical waste once the waste has been both treated and destroyed.

(v) Human corpses, remains, and anatomical parts that are intended for interment or cremation are not regulated medical waste.

(2) Exemptions. (i) Etiologic agents being transported interstate pursuant to the requirements of the U.S. De