Subpart A - General
Sec.
259.1 Purpose, scope, and applicability
259.2 Effective dates and duration of the
demonstration program.
Subpart B - Definitions
259.10 Definitions
Subpart C - Covered States
259.20 States included in the demonstration program
Subpart D - Regulated Medical Waste
259.30 Definition of
regulated medical waste
259.31 Mixtures
Subpart E - Pre-Transport Requirements
259.39 Applicability
259.40 Segregation requirements
259.41 Packaging requirements
259.42 Storage of regulated medical waste prior to transport,
treatment, destruction, or
disposal
259.43 Descontamination standards for reusable containers
259.44 Labelling requirements
259.45 Marking (identification) requirements.
Subpart F - Generator Standards
259.50 Applicability and
general requirements.
259.51 Exemptions
259.52 Use of the tracking form
259.53 Generators exporting regulated medical waste
259.54 Recordkeeping
259.55 Exception reporting
259.56 Additional reporting
Subpart G - On - Site incinerators
259.70 Applicability
259.71 Transporter acceptance of regulated medical, waste
259.72 Transporter notification
259.73 Vehicle requirements
259.74 Tracking form requirements
259.75 Compliance with the tracking form
259.76 Consolidating or remanifesting waste to a new tracking
form
259.77 Recordkeeping
259.78 Reporting
259.79 Additional reporting
Subpart I - Treatment, Destruction, and Disposal Facilities
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
Authority 42 U.S.C. 6912, 6992 et. seq.
Source: 54 FR 12371, Mar. 24, 1989, unless otherwise noted.
(a) The purpose of this part is to establish a
demonstration program for tracking 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 destructions facilities) or destination
facilities (e.g., disposal facilities) who
transport, offer for transport, or other-wise 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 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
o the evidence, through shipping papers or other
documenation, 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,
in the Covered States of Connecticut, New Jersey, and New
York. The demonstration
program will be effective for the period of July 24, 1989,
to June 22, 1991, in the State of
Rhode Island and the Commonwealth of Puerto Rico.
(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.
259.10 Definitions
(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 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
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 be come 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 sub-division of a State, any interstake body, or any department, agency or
instrumentality of the United States.
Solid waste 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 regulated 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; dialysate;
amniotic, cerebro spinal, 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).
Container means any portable device in which a regulated medical waste is stored,
transported, disposed or other-wise handled. The term container as used in this part does
not include items in the Table or Regulated Medical Waste at 259.30 (a) of this part.
Covered States means those States that are participating in the demonstration medican
waste tracking program and includes: Connecticut New Jersey, New York, Rhode Island, and
Puerto Rico. Any other State is a Non-Covered 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 is no longer
generally recognizable as medical waste because the waste has been ruined, torn apart, or
mutilated (it does not mean compaction) through:
(1) Processes such as thermal treatment or melting, during which treatment and destruction
could occur; or
(2) Processes such as shredding, grinding, tearing, or breaking, during which only
destruction would take place.
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 inmunization 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 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.
Package means the packaging/containers and its contents.
Packaging means the assembly of one or more containers and any other components necessary
to assure minimum compliance with 259.41 of this part.
Regulated medical waste means those medical wasted that have been listed in 2159.30(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.
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 the purpose of this part, Covered States are the States of Connecticut, New
Jersey, New York, Rhrode Island, and Puerto Rico.
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 diagnosts, 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 Description
(1) Cultures and Stocks
Cultures
and stocks of infectious agents and
associated biologicals, including cultures from
medical and pathlogical 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.
(2) Pathological Wastes
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.
(3) Human Blood and Blood Products
(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 develop-
ment of pharmaceuticals. Intravenus bags are
also included in this category.
(4) Sharps
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 tubing, and cultures 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.
(5) Animal Waste
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.
(6) Isolation Wastes
Biological waste and discarded materials
contaminated with blood, excretion, exudates,
or
secretions from humans who are isolated to
protect others from certain highly
communica-
ble 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. Department of Health and Human Services, and all other applicable
shipping requirements are exempt from the requirements of this part.
(ii) Samples of regulated medical waste transported off-site by EPA - or State-designated
enforcement personel for enforcement purposes are exempt from the requirements of this
part during the enforcement proceeding.
259.31 Mixtures
(a) Except as provided in paragraph (b) of
this section, mixtures of solid waste and regulated medial waste listed in 259.30 (a) of
this subpart are a regulated medical waste.
(b) Mixtures of hazardous waste identified or listed in part 261 of this chapter and
regulated medical waste listed in 259.30 (a) of this subpart are subject to the
requirements in this part, unless the mixture is subject to the hazardous waste manifest
requirements in part 262 or part 266 of this chapter.
Note to paragraph (b): Mixtures of regulated medical waste with hazardus waste that is
exempt from the hazardous waste manifest requirements (.e.under 40 CFR.261.5 remain
subject to this Part.
259.39 Applicability
Generators must comply with the requirements of this subpart prior to shipping waste off-site, and generators must comply with 259.42 of this Sub-part for on-site storage. Transporters, intermediate handlers (e.g., treatment or destruction facilities), and destination facilities must comply with applicable requirements of this subpart, when specified in subparts H or 1 of this part.
259.40 Segregation requirements:
(a)(1) Generators must segregate regulated
medical waste intended for transport off-site to the extent practicable prior to placement
in containers according to paragraph (a)(2) of this section.
(2) Generators must segregate regulated medical waste into sharps (Classes 4 and 7 of
259.30(a) of this subpart including sharps containing residual fluid). fluids (quantities
greater than 20 cubic centimeters), and other regulated medical waste.
(b) If other waste is placed in the same container(s) and its entire contents according to
the requirements in 259.41, 259.44, and 259.45 of this part.
259.41 Packaging requirements
Generators must ensure that all packages of
regulated medical wastes meet the following requirements before transporting or offering
for transport such waste off-site. Generators may use one or more containers to meet these
requirements.
(a) Generators must ensure that all regulated medical waste is placed in a container or
containers that are:
(1) Rigid
(2) Leak-resistantt;
(3) Impervious to moisture;
(4) Sufficiently strong to prevent tearing or bursting under normal conditions of use and
handling; and
(5) Sealed to prevent leakage during transport.
(b)(1) In addition to the requirements of paragraph (a) of this section, generators must
package sharps and sharps with residual fluids in packaging/containers that are puncture
resistant.
(2) In addition to the requirements of paragraph (a) of this section, generators must
package fluids (quantities greater than 20 cubic centimeters) in packaging/containers that
are break resistant and tightly lidded or stoppered.
(c) Generators need not place oversized regulated medical waste in containers. Generators
must note any special handling instructions for these items in Box 14 of the tracking form
required under subpart F and appendix I of this part.
259.42 Storage of regulated
medical waste prior to transport, treatment, destruction,
or disposal
Any person who stores regulated medical waste
prior to treatment or disposal on-site, must comply with the following storage
requirements:
(a) Store the regulated medical waste in a; manner and location that maintains the
integrity of the packaging and provides protection from water, rain and wind;
(b) Maintain the regulated medical waste in a nonputrescent state, using refrigeration
when necessary;
(c) Lock the outdoor storage areas containing regulated medical waste (e.g.,dumpsters,
sheds, tractor trailers, or other storage areas) to prevent un-authorized access;
(d) Limit access to on-site storage areas to authorized employees; and
(e) Store the regulated medical waste in a manner that affords protection from animals and
does not provide a breeding place or a food source for insects and rodents.
259.43 Decontamination standards for reusable containers.
Generators, transporters, intermediate
handlers, and destination facility owners and operators must comply with the following
requirements with respect to reusing containers:
(a) All non-rigid containers and innerliners must be managed as regulated medical waste
under this part and must not be reused.
(b) Any rigid container used for the storage and/or transport of regulated medical waste
and designated for reuse once emptied, must be decontaminated if the container shows signs
of visible contamination.
(c) If any container used for the storage and/or transport of regulated medical waste is
for any reason not capable of being rendered free of any visible signs of contamination in
accordance with paragraph (b) of this section, the container must be managed
(labeled, marked and treated and/or disposed of) as regulated medical waste under this
part.
259.44 Labeling requirements.
Generators must label each individual
container used to meet the packaging requirements under 259.41 of this Subpart before
transporting or offering for transport off-site:
(a) Untreated regulated medical waste. Each container of untreated regulated medical
wastes must have a water-resistant label affixed to or printed on the outside of the
container. The label must include the words "Medical Waste," or "Infectious
Waste." or display the universal biohazard symbol. When a red plastic bag(s) is used
as an inner container, it need not display a label.
(b)Treated regulated medical waste. Packages containing treated regulated medical wastes
are not required to be labeled under this section but are required to be labeled under
this section but are required to be marked according to 259.45 of this subpart.
259.45 Marking (identification) requirements
Generators (including intermediate handlers)
must mark each individual container of regulated medical waste according to the following
marking requirements before the waste is transported or offered for transport off-site:
(a) The outer-most surface of the outer container must be marked with a water-resistant
identification tag of sufficient dimension to contain the following information:
(1) Generator's or intermediate handler's name;
(2) Generator's or intermediate handler's State permit or identification number. If the
generator's or intermediate handler's State does not issue permit or identification
numbers, then the generator's or intermediate handler's address;
(3) Transporter name;
(4) Transporter State permit or identification number, or if not applicable, then the
transporter's address;
(5) Date of shipment; and
(6) Identification of contents as medical waste.
(b) In addition to paragraph (a) of this section, if the generator has used inner
containers, including sharps and fluid containers, each inner container must be marked
wiht indelible ink or imprinted with water-resistant tags. The marking must contain the
following information:
(1) Generator's or intermediate handler's name;
(2) Generator's or intermediate handler's State permit or identification number. If the
generator's or intermediate handler's State does not issue permit or identification
numbers then the generator's or intermediate handlers' address.
259.50 Applicability and general requirements.
(a) This subpart establishes standards for
generators of regulated medical waste.
(b) A person who generates a medical waste as defined in 259.10(b) of this part, and who
is located in a Covered State, must determine if that waste is a regulated medical waste.
(c) A generator who either treats and destroys or disposes of regulated medical waste
on-site (e.g., incineration, burial or sewer disposal covered by section 307(b)-(d), of
the Clean Water Act) is not subject to tracking requirements for that waste.
Note to the section: Generators of regulated
medical waste with on-site incinerators are subject to the on-site incinerator
requirements in Subpart G of this Part, In addition, generators who treat and destroy
regulated medical waste are subject to 259.54(c). Generators who treat or dispose of
medical waste on-site may be subject to additional Federal, State or local laws and
regulations.
(d) Vessels at port in a Covered State are subject to the requirements of this Part for
those regulated medical wastes that are transported ashore in the Covered State. The owner
or operator of the vessel and the person(s) removing or accepting waste from the vessel
are considered co-generators of the waste.
(e) A generator of regulated medical waste must determine the quantity of regulated
medical waste that he generates in a calendar month, and that is transported or offered
for transport off-site for treatment, destruction, or disposal.
(1) Generators of 50 pounds or more per month. Generators who generate and transport or
offer for transport off-site 50 pounds or more of regulated medical waste in a calendar
mont are subject to the requirements of subpart E and all of the applicable requirements
of this subpart for each shipment of regulated medical waste.
(2) Generators of less than 50 pounds per month.
(i) Generators who generate and transport or offer for transport off-site less than 50
pounds of regulated medical waste in a calendar month are subject only to the requirements
of subpart E of this part and 259.50, 259.53, 259.54 (b) and (c), and 259.56 of this part,
unless exempt under 259.51.
(ii) Generators who generate less than 50 pounds of regulated medical waste in a calendar
month but who transport or offer for transport off-site more than 50 pounds in any one
shipment or in any one calendar month are subject to subpart E of this part and 259.50,
259.52, 259.53, 259.4 (a) and (c), 259.55, and 259.56 of this part, unless exempt under
259.51(b).
(f) Generators of regulated medical waste must use transporters who have notified EPA
under 259.72 of this part to transporte their regulated medical waste, except as provided
in 259.1 of this subpart.
259.51 Exemptions.
(a) Generators of less than 50 pounds per
month. Generators who meet the conditions of 259.50(e)(i) of this subpart are exempt from
the requirement to use a transporter which has notified EPA, exempt from the requirement
to use the tracking form, and exempt from the requirements of subpart H of this part,
except from the exception reporting requirements of 259.55 of this part, provided that the
following conditions are met:
(ii) The generator is transporting the regulated medical waste from the original
generation point to the generator's place of business; and
(2) The regulated medical waste is transported by the generator (or an authorized
employee) in a vehicle owned by the generator or authorized employee; and
Note to the section: Owned vehicle means a vehicle which is owned by or registered to the
generator or employee or is inder lease by the generator or authorized employee for a
minimum of 30 days.
(3) The generator must compile a shipment log and maintain records as required by
259.54(b)(2).
(b) Shipments between generator's facilities. Generators are exempt from the requirement
to use a transporter who has notified EPA, exempt from the use of the tracking form, and
exempt from the requirements of subpart H of this part when transporting regulated
medical waste from the original generation point to a central collection point or a
treatment facility owned or operated by the generator; provided they meet all fo the
following conditions:
(1) The regulated medical waste is transported by the generator (or the generator's
authorized employee) in a vehicle owned by the generator or the employee;
(2) The original generation point and the central collection point or treatment facility
are located in the same Covered State; and
(3) The generator compiles and maintains a shipment log at each original generation point
and each central collection point and each central collection point as required by
259.54(a)(2) of this part.
(c)Shipments of regulated medical waste (Classes 4 and 7) through the U.S. Postal Service.
Generators who meet the conditions of 259.50(e)(2)(i) of this sub-part who transport
regulated medical waste (Classes 4 and 7 of 259.30(a) of this part) by the U.S. Postal
Service, are exempt from the requirement to use a transpoter who has notified EPA and from
the requirement to use the tracking form, provided they meet the following conditions:
(1) The package is sent registered mail, return receipt requested (indicating to whom,
signature, date, and address where delivered); and
(2) The generator compiles a shipment log and maintains the original receipt and the
returned registered mail receipt as required by 259.54(b)(3) of this part.
259.52 Use of the tracking form
(a) Except as provided in 259.50(e)(2)(i) and
259.51 of this Sub-part, a generator who transports or offers for transport regulated
medical waste for off-site treatment or disposal, must prepare a tracking form according
to this section and the instructions includes in Appendix I to this part.
(b) Generators must obtain the tracking form the following sources:
(1) For generators who transport or offer for transport off-site regulated medical waste
to an intermediate handler or a destination facility in a Covered State which prints the
tracking form and requires its use, the form from that State; and
Note to Paragraph (b)(1): For generators who transport or offer for transport regulated
medical waste to another Covered State which prints the tracking form and requires its
use, the transporter is required to provide the generator with the receiving State's form.
(2) For all other generators, the tracking form from the State in which the waste was
generated; or
(3) If the generator's State does not print the tracking form, the generator must use the
tracking form in Appendix I of this part.
(c) The generator must prepare at least the number of tracking form copies that will
provide the generator, each transporter(s), and each intermediate handler with one copy,
and the owner or operator of the destination facility with two copies.
Note to Paragraph (c): The destination facility keeps one copy for their records and
returns the second copy to the generator.
(d) The generator must also:
(1) Sign the certification statement on the tracking form by hand;
(2) Obtain the handwritten signature of the initial transporter and date of acceptance on
the tracking form; and
(3) Retain one copy, in accordance with 259.54(a)(1)(i) of this part.
(e) For rail shipments of regulated medical waste within the United States that originate
at the site of generation, the generator must send at least three (3) copies of the
tracking form dated and signed in accordance with this section to:
(1) The next non-rail transporter, if any; or
(2) The intermediate handler of destination facility if transported solely by rail; or;
(3) The last rail transporter to handle the waste in the United States if exported by
rail.
259.53 Generators exporting regulated medical waste.
Generators (including transporters and intermediate handlers that initiate tracking forms) who export regulated medical waste to a foreign country (e.g., Canada) for treatment, destruction, or disposal, must request that the destination facility provide written confirmation that the waste was received. If the generator has not received that confirmation from the destination facility within 45 days from the date of acceptance of the waste by the first transporter, the generator must submit an exception report as required under 259.55 of this Subpart.
259.54 Recordkeeping
(a) Except as provided in paragraph (b) of
this section, each generator must:
(1)(i) Keep a copy of each tracking form signed in accordance with 259.52 of this part and
a signed copy of each completed tracking form signed by the owner or operator of the
destination facility in accordance with 259.81(a)(4) of this part, for at least three (3)
years from the date the waste was accepted by the initial transporter; and
(ii) Retain a copy of all esception reports required to be submitted under 259.55(c) of
this subpart for at least three (3) years from when the exception report was submitted.
(2) Generators who meet the conditions of 259.51(b) of this subpart must meet the
following requirements:
(i) A shipment log must be maintained at the original generation point for a period of
three (3) years from the date the waste was shipped. The log must contain the following
information:
(A) Date of shipment;
(B) Quantity (by weight) of regulated medical waste transported, by waste category
(i.e., untreated and treated);
(C) Address or location of central collection point; and
(D) Signature of generator's employee who will transport the waste, indicating acceptance.
(ii) A shipment log must be maintained at each central collection point for a period of
three (3) years from the date that regulated medical waste was accepted from each original
generation point and must contain the following information:
(A) Date of receipt;
(B) Quantity (by weight) of regulated medical waste accepted, by waste cattegory (i.e.,
untreated and treated);
(C) Address or location of original generation point; and
(D) Signature of generator or generator's representative who operates the central
collection point, indicating acceptance of the waste.
(b) Generators who meet the conditions of 259.50(e)(2)(i) of this subpart, who do not
transport or offer for transport off-site more than 50 pounds of regulated medical waste
in a single shipment, and who do not voluntarily comply with the use of the following
recordkeeping requirements:
(1) Generators who use a transporter who has notified EPA must maintain a log for a period
of three (3) years from the date of shipment that contains the following information for
each shipment or pickup:
(i) Transporter's name and address;
(ii) Transporter's State permit or identification number, if one is required by the State;
(iii) Quantity of regulated medical waste transported, by waste category (i.e., untreated
and treated);
(iv) Date of shipment; and
(v) The signature of the transporter's representative accepting the regulated medical
waste for transport.
(2) Generators who transport regulated medical waste to a health care facility or to a
treatment, destruction, or disposal facility as specified in 259.51(a) of this subpart
must compile and maintain a log for a period of three (3) years from the date of the las
shipment entered into the log. The log must contain the following information:
(i) Name and address of the intermediate handler, destination facility, or health care
facility to which the generator has transported that shipment of regulated medical waste;
(ii) Quantity (by weight) of regulated medical waste transported, by waste category (i.e.,
untreated and treated);
(iii) Date of shipment; and
(iv) Signture of the generator or his authorized representative who transported the waste.
(3) Generators who transport regulated medical waste by the U.S.Postal Service receipt and
the return mail receipt and maintain a shipment. Th log must contain the following
information:
(i) Quantity (by weight) of regulated medical waste transported, by waste category (i.e.,
untreated and treated);
(ii) Date of shipment; and
(iii) Name and address of each intermediate handler or destination facility to which the
generator has transported the regulated medical waste by the U.S.Postal Service.
(c) Each generator who treats and destroys regulated medical waste on-site by a method or
process ogher than incineration, must maintain the following records:
(1) The approximate quantity by weight, of regulated medical waste that is subject to the
treatment and destruction processes;
(3) For regulated medical waste accepted from generators meeting the exemption conditions
in 259.52 (a) or (c), information identifying the generator, the date the waste was
accepted, the weight of waste accepted, and the date the waste was treated and destroyed;
and
(4) Records must be maintained by the generator for a period of at least three (3) years
from the date the waste was treated and destroyed.
259.55 Exception Reporting.
(a) A generator who meets the conditions of
259.50 (e)(1) or (e)(2)(ii) of this subpart, or who utilizes a Medical Waste Tracking
form, must contact the owner or operator of the destination facility, transporter(s), and
intermediate handler(s), as appropriate, to determine the status of any tracked waste if
he does not receive a copy of the completed tracking form with the hand-written signature
of the owner or operator of the destination facility within 35 days of the date the waste
was acepted by the initial transporter.
(b) A generator must submit an Exception Report, as described below, to the State and the
EPA Regional Administrator for the Region in which the generator is located if he has not
received a completed copy of the tracking form signed by the owner or operator of the
destination facility within 45 days of the date the waste was accepted by the initial
transporter. The Exception Report must be postmarked on or before the 46th day and must
include:
(1) A legible copy of the original tracking form for which the generator does not have
confirmation of delivery; and
(2) A cover letter signed by the generator or his authorized representative explaining the
efforts taken to locate the regulated medical waste and the results of those efforts.
(c) A copy of the exception report must be kept by the generator for a period of at least
three (3) years from the due date of the report.
259.56 Additional Reporting.
The Administrator may require generators to furnish additional information concerning the quantities and management methods of medical waste as he deems necessary under RCRA section 11004
Subpart G - On-Site Incinerators
259.60 Applicability
(a) The regulations in this subpart apply to
generators of regulated medical waste who incinerate regulated medical waste on-site.
(b) Generators of regulated medical waste who incinerate such waste on-site.and who accept
regulated medical waste accompanied by a tracking form are also subject to the
requirements of subpart I of this part.
259.61 Recordkeeping.
(a) Generators must keep an operating log at
their incineration facility that includes the following information:
(1)(i) The date each incineration cycle was begun;
(ii) The length of the incineration cycle;
(iii) The total weight of medical waste incinerated, per incineration cycle; and
(iv) An estimate of the weight of regulated medical waste incinerated, per incineration
cycle.
(2) Generators with on-site incinerators that accept regulated medical waste from
generator(s) subect to 259.51(a) of this part must maintain the following information for
each shipment of regulated medical waste accepted:
(i) The date the waste was accepted;
(ii) The name and State permit or identification number of the generator who originated
the shipment. If the State does not issue permit or identification numbers, then the
generator's address;
(iii) The total weight of the regulated medical waste accepted from the originating
generator; and
(iv) The signature of the individual accepting the waste.
(b)(1) Generators must compile the operating log required by paragraph (a)(1) of this
section duing the following period: June 22, 1989, to June 22, 1991.
(2) Generators must retain the operating log until at least June 22, 1992.
(c) Generators with on-site incinerators that accept regulated medical waste from
generators subject to the tracking form requirements must keep copies of all tracking
forms for a period of three years from the date they accepted the waste.
(d) Generators must retain a copy of the on-site incinerator report form required under
259.62 of this subpart for three (3) years from the date of submission
259.62 Reporting.
(a) General. The owner or operator of an
on-site incinerator must prepare and submit two copies of the on-site incinerator report
on the form provided in appendix II of this part to: Chief, Waste Characterization Branch,
Office of Solid Waste (OS-332), U.S. Environmental Protecion Agency, 401 M Street, SW.,
Washington, DC 20460.
The reports must summarize information collected in the operating log during the first and
third six-month period after the effective date of the demonstration program, and must
contain the following information in the format provided in appendix II of this part:
(1) Facility name, mailing address, and location;
(2) Facility type (e.g., hospital, laboratory;
(3) Contact person;
(4) Waste feed information;
(5) The total number of incinerators at the facility that incinerate regulated medical
waste and information concerning each incinerator.
(b) Each report must contain the following certification, signed by the facility owner or
his authorized representative: I certify that I have personally examined and am familiar
with the information submitted in this and all attached documents, and that based on my
inquiry of those individuals immediately responsible for obtaining the information, I
believe that the submitted information is true, accurate, and complete.
(c)(1) Dates. The first report is due February 6, 1990, and must contain information from
the first six months of the demonstration program.
(2) The second report is due February 6, 1991, and must contain information from the
thirteenth through the eighteenth month of the demostration program.
259.70 Applicability
(a) These requirements apply to transporters
including generators who transport their own waste, and owners and operators of transfer
facilities engaged in transporting regulated medical waste generated in a Covered State.
(b) These regulations do not apply to on-site transportation of regulated medical waste,
nor to shipments exempted unde 259.51 (a), (b), or (c) of this part.
(c) A transporter of regulated medical waste must meet all the requirements for generators
under subpart F of this part when he consolidates two or more shipments of regulated
medical waste onto a single tracking form or when he initiates a tracking form for medical
waste received from generators who met the conditions of 259.50 (e)(2)(i).
(d) Transporters must also comply with subpart E of this part if they:
(1) Store regulated medical waste in the course of transport; or
(2) Remove regulated medical waste from a reusable container; or
(3) Modify packaging of regulated medical waste.
259.71 Transporter acceptance of regulated medical waste.
(a) Transporters must not accept for
transport any regulated medical waste generated in a Covered State unless the outer
surface of the container is labeled and marked in accordance with subpart E of this part.
(b) Transporters must not accept a shipment of regulated medical waste from a generator
unless accompanied by a properly completed tracking form as required under supart F of
this part, unless the generator is exempt from the use of the tracking form under either
259.50(e)(2)(i) or 259.51 of this part.
(c) Marking (identification). When regulated medical waste is handled by more than one
transporter, each subsequent transporter must attach a water resistant identification tag
below the generator's marking on the outer surface of the packaing, that does not obscure
the generator's markings. The transporter taking possession of the shipment must ensure
that the tag contains the following information:
(1) Name of transporter taking possession (receiving) of the regulated medical waste;
(2) Transporter State permit or identification number. If the State does not issue permit
or identification numbers, then the transporter's address; and
(3) Date of receipt.
259.72 Transporter notification.
(a)(1) Transporters (including owners or
operators of transfer facilities) are prohibited from transporting regulated medical waste
generated in a Covered State unless they have notified EPA and the Covered State in
writing as provided in this Section.
(2) Transporters who accept regulated medical waste that was generated in a Covered State,
or who transport regulated medical waste that was generated in a Covered State, must
submit a separate notification form for each Covered State in which the regulated medical
waste was generated.
(3)(i) The original and one copy of the transporter notification must be sent to: Chief,
Waste Characterization Branch (OS-332), EPA Office of Solid Waste, 401 M Street, SW.,
Washington, DC20460.
(ii) An additional copy must be sent to the Director of the waste management agency in the
Covered State for which the transporter in notifying.
(b) Each transporter notification must contain the following information:
(1) Tranporter's name, mailing address, and EPA hazardous waste identification number (if
any);
(2) Name, address and telephone number for each transportation or transfer facility (by
site) that the transporter will operate from for each Covered State for which the
transporter is notifying;
(3) Identifications (State permit or license numbers) required to handle medical or
infections waste; and
(4) The following statement signed by a corporate official or the owner or operator: I
certify, under penalty of criminal or civil prosecution for making or submisson of false
statements, representations or omissions, that I have read, understand, and will comply
with the regulations at 40 CFR part 259, issued under authority of Subtitle J of the
Resource Conservation and Recovery Act.
Note to Paragraph (b): The Agency has published a suggested form for transporter
notification in appendix IV of this part which may be utilized by transporters notifying
EPA.
(c) EPA will issue transporters, who notify under this section, a unique EPA Medical Waste
Identification Number. This identification number will apply to all transporter sites
identified in paragraph (b)(2) of this section, that relate to each Covered State.
Transporters may accept regulated medical waste after notifying under this section. Upon
receipt of an EPA Medical Waste Identification Number, the transporter must make certain
that the number has been entered in Box 5 of the Medical Waste Tracking Form (appendix I
of this part) that accompanies each shipment they handle.
Note to the Section: States may impose or may presently have in place additional
licensign, permitting or other requirements that apply to transporters of regulated
medical waste.
259.73 Vehicle requirements.
(a) Transporters must use vehicles to
transport regulated medical waste that meet the following requirements:
(1) The vehicle must have a fully enclosed, leak-resistant cargo-carrying body;
(2) The transporter must ensure that the waste does not become putrescent and is not
subject to mechanical stress or compaction during loading and unloading or during transit;
(3) The transporter must maintain the cargo-carrying body in good sanitary condition; and
(4) The cargo carrying body must be secured if left unattended.
(b) The transporter must use vehicles to transport regulated medical waste that have the
following identification on the two sides and back of the cargo carrying body in letters a
minimum of 3 inches in height:
(1) The name of the transporter;
(2) The transporter's State permit or license number, if any; and
(3) A sign or the flowing words imprinted:
(i) MEDICAL WASTE; OR
(ii) INFECTIOUS WASTE.
(c) A transporter must not transport regulated medical waste in the same container with
other solid waste unless the transporter manages both as regulated medical waste in
compliance with this subpart.
259.74 Tracking form requirements.
(a) General. A transporter may not accept a
shipment of regulated medical waste in excess of 50 pounds from a generator in a Covered
State or from a generator in a Covered State or from a generator in a Covered State who
generates more than 50 pounds per month, unless it is accompanied by a tracking form
completed in accordance with appendix I of this part and signed by the generator in
accordance with the provisions of 259.52 of this part. In the case where a transporter
intends to deliver regulated medical waste generated in a Covered State to another Covered
State, the latter of which supplies its own tracking form and requires its use, the
transporter must provide the generator with the form of the Covered State to which the
waste is to be sent.
(b) Acceptance. Before accepting for transport or transporting any regulated medical waste
that is accompanied by a tracking form, the transporter must:
(1) Certify that the tracking form accurately reflects the number and total weight of the
packages being transported by signing and dating the tracking form acknowledging
acceptance of the regulated medical waste from the generator; and
(2) Return a signed copy of the tracking form to the generator before leaving the
generator's site.
(c) In transit. The transporter must ensure that the tracking form accompanies the
regulated medical waste while in transit.
(d) Delivery of regulated medical waste in the United States. A transporter, upon delivery
of the regulated medical waste to another transporter (including a transfer facility) or
to an intermediate handler or destination facility located in the United States, must:
(1) Obtain the date of delivery and the handwritten signature of the transporter,
intermediate handling facility or destination facility on the tracking form;
(2) Retain one copy of the tracking form in accordance with 259.77 of this part; and
(3) Give the remaining copies of the tracking form to the accepting transporter,
intermediate handler, or destination facility.
(e) Delivery of regulated medical waste outside the United States. Any transporter who
transports regulated medical waste across an international border, or who delivers
regulated medical waste to a transporter or treatment, destruction, or destination
facility located in a foreing country (e.g., Canada) must:
(1) Obtain the signature of the accepting foreign transporter or destination facility; or
(2) Verify that the waste has been delivered to the next (foreign) transporter, or
treatment, destruction or destination facility by writing a statement to that effect in
Box 14, certifying that the entire shipment (as specified in Boxes 11, 12 and 13 of the
tracking form) has been delivered to the next (foreign) party, including the accepting
party's name, company name, and mailing address, and signing directly below that
certification statement;
(3) Retain one copy of the signed tracking form for his records; and
(4) Return all remaining copies of the tracking form by mail to the generator.
(f) Rail shipment. For shipments involving rail transportation, the requirements of 259.91
of this part apply to rail transporters in lieu of the requirements of paragraphs (b),
(c), and (d) of this section.
(g) Special requirements for waste from generators of less than 50 pounds/month. A
transporter accepting a shipment of less than 50 pounds of regulated medical waste from a
generator who generates less than 50 pounds of regulated medical waste from a generator
who generates less than 50 pounds per month need not comply with the requirements of
paragraphs (a) through (f) of this section provided that:
(1) The transporter compiles a log, containing the following information for each shipment
of regulated medical waste:
(i) The generator's name and State permit or identification number, or, if the generator's
State does not issue permit or identification numbers, then the generator's address.
(ii) The quantity of waste accepted (number of packages and total weight by waste category
(i.e., "untread" and "treated"); and
(iii) The date the waste is accepted;
(2) The transporter carries this log in the vehicle while transporting such regulated
medical waste to a second transporter;
(3) The transporter dates and signs the generator's log required under 259.54(b) of this
part; and
(4) The transporter compllies with 259.76(a) of this subpart.
259.75 Compliance with the tracking form.
(a) Except as provided in paragraph
(b) of this section, the transporter must deliver the entire quantity of regulated medical
waste that he has accepted from a generator or another transporter to:
(1) The intermediate handler or destination facility listed on the tracking form; or
(2) The next transporter.
(b) If the regulated medical waste cannot be delivered in accordance with paragraph (a) of
this section, the transporter must contact the generator for further directions, revise
the tracking form according to the generator's instructions, and deliver the entire
quantity of regulated medical waste from that generator according to the generator's
instructions.
259.76 Consolidating or remainfesting waste to a new tracking form.
(a) Transporters must complete a tracking
form for all regulated medical waste received from generators who meet the conditions of
259.50(e)(2)(i) of this part (in shipments of less than 50 pounds that are not accompanied
by a tracking form).
(b) A transporter may choose to consolidate or remanifest to a single tracking form all
shipments of regulated medical waste less than 220 pounds.
Note to Paragraph (b); EPA strongly recommends that, to minimize bookkeeping errors,
transporters consolidate or remainfest those shipments from generators who are required to
originate the tracking form separately from those shipments by generators who are not
required to originate the tracking form.
(c) When the transporter receives the signed tracking form that he initiated from the
destination facility, and the regulated medical waste was accompanied by a tracking form
originated by a generator, the transporter must:
(1) Attach a copy of the tracking form signed by the destination facility to the
generator's original tracking form;
(2) Retain a copy of each tracking form in accordance with 259.77 of this subpart; and
(3) Return a copy of each tracking form to the generator withing 15 days of receipt of the
tracking form from the destination facility.
(4) For each tracking form initiated, either by accepting waste from generators who meet
the condition of 259.50(e)(2)(i) of this part or by consolidating tracking forms onto a
new one, the transporter must maintain a consolidation log indicating all shipments
consolidated or remanifested on that form. The log must accompany the tracking form and
include the following information:
(i) Name of each generator;
(ii) Generator's State permit or identification number. If the generator's State does not
issue permit or identification numbers, then the generator's address;
(iii) Date the regulated medical waste was originally shipped by the generator;
(iv) Quantity of regulated medical waste (number of containers and/or weight in pounds) by
waste category (i.e., "'untreated" or "'treated") shipped by each
generator; and
(v) The names, State permit or identification numbers of all previous transporters or, if
not applicable, the transporters'addresses.
259.77 Recordkeeping
(a) A transporter of regulated medical waste
must keep a copy of the tracking form signed by the generator, himself, the previous
transporter (if applicable), and the next party, which may be one of the following:
another transporter; or the owner or operator of an intermediate handling facility; or
destination facility. The transporter must retain a copy of this form for a period of
three (3) years from the date the waste was accepted by the next party.
(b) For regulated medical waste that is not accompanied by a generator-initiated tracking
form, the transporter must retain a copy of all transporter initiated tracking forms and
consolidation logs for a period of three (3) years from the date the waste was accepted by
the transporter.
(c) For any regulated medical waste that was received by the transporter accompanied by a
tracking form, the transporter must:
(1) Retain a copy of the generator initiated tracking form signed by the intermediate
handler or destination facility and all associated consolidation logs for three (3) years
from the date the waste was accepted by the intermediate handler or destination facility.
(d) Transporters must retain a copy of each transporter report required by 259.78 of this
subpart for three (3) years after the date of submission.
259.78 Reporting
(a)(1) A transporter who accepts regulated
medical waste generated in a Covered State must submit reports describing the source and
disposition of the waste. The reports must be submitted using the form in appendix III of
this part.
(2) Transporters who accept regulated medical waste directly from a generator in a Covered
State, or who transport regulated medical waste that was generated in a Covered State,
must submit a separate report for each Covered State's waste they have transported.
(b) Each report must be submitted as follows:
(1) One copy must be submitted as follows:
(1) One copy must be submitted to: Chiel, Waste Characterization Branch (OS-332), Office
of Solid Waste, U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC
204460; and
(2) A second copy must be submitted to the Director of the waste management agency in the
Covered State for which the transporter has compiled the report.
(c)(1) Each report must contain the following information in the format provided by
appendix III of this part:
(i) The transporter's name, address and EPA medical waste identification number;
(ii) The name and telephone number of a contact person;
(iii) Total number of generators from whom the transporter accepted regulated medical
waste;
(iv) The name, address, and type of each generator from whom the transporter accepted
regulated medical waste;
(v) The amount by weight and waste category (untreated or treated) of regulated medical
waste accepted from each generator;
(vi) The total, by weight and waste category, of regulated medical waste from all
generators in the Covered State that the transporter delivered to an intermediate handler
or to a destination facility; and
(vii) The total, by weight and waste category, of regulated medical waste from all
generators in the Covered State that the transporter delivered to a second transporter or
to a transfer facility.
(viii) The certification signed by the owner or operator, or his authorized
representative.
(2) Transporters who transport or deliver regulated medical waste to an intermediate
handler or to a destination facility must also provide the following information:
(i) The name and address of each intermediate handler and destination facility to which
waste from that Covered State was delivered;
(ii) The amount, by waste category, that was delivered;
(iii) The total number of intermediate handlers and destination facilities to which waste
was delivered.
(d) The transporter must submit reports covering the following periods:
(1) A report covering the 180 day period from June 23, 1989, to December 19, 1989.
(2) A report covering the 180 day period from December 20, 1989, to June 17, 1990.
(3) A report covering the 180 day period from June 18, 1990, to December 14, 1990.
(4) A report covering the 180 day period from December 15, 1990, to June 12, 1991.
(e) Transporters must submit the reports required in paragraph (d) of this section on or
before the date 45 days after the end of the reporting period.
(f) Each transporter who initiates a tracking form must meet the requirements of 259.55 of
this part, exception reporting, except that the 35 and 45 day periods begin on the day the
transporter accepted the waste from the generator.
259.79 Additional reporting.
The Administrator may requiere transporters to furnish additional information concerning the quantities and management methods of regulated medical waste as he deems necessary under RCRA section 11004.
259.80 Applicability
(a) These regulations apply to owners and
operators of facilities that receive regulated medical waste generated in a Covered State,
including facilities located in non-Covered States that receive regulated medical waste
generated in a Covered State. Facilities that are subject to this subpart include:
(1) Destination facilities (i.e., treatment and destruction facilities, a facility that
causes the regulated medical waste to meet the conditions of 259.30(b)(1)(iii) or (iv)of
this part).
(b)(1) Except as provided by paragraph (b)(2) of this section, this subpart does not apply
to generators who incinerate regulated medical waste on-site.
(2) This subpart applies to generators who receive regulated medical waste required to be
accompanied by a tracking form.
259.81 Use of the tracking form.
(a) Destination Facility. When a destination
facility receives regulated medical waste accompanied by a tracking form, the owner or
operator must:
(1) Sign and date each copy of the tracking form to certify that the regulated medical
waste listed on the tracking form was received;
(2) Note any discrepancies as defined in 259.82(a) of this subpart on the tracking form;
(3) Immediately give the transporter at least one copy of the signed tracking form;
(4) Send a copy of the tracking form to the generator (or to the transporter or
intermediate handler that initiated the tracking form) within 15 days of the delivery;
(5) Retain a copy of each tracking form in accordance with 259.83 of this subpart.
(b) Intermediate Handlers. When an intermediate handler receives regulated medical waste
accompanied by a tracking form, the owner or operator must meet the following
requirements:
(1) The owner or operator must meet all the requirements for generators under both
subparts E and F of this part including signing the tracking form accepting the waste as
specified in Box 20, noting any discrepancies on the tracking form number in Box 21 when
initiating a new tracking form for each shipment of regulated medical waste that has
either been treated or destroyed.
(2) The owner or operator must maintain a log matching the original generator's tracking
forms to the tracking form that he initiates. This log must include:
(i) Name(s) of generator(s)
(ii) Generator's State permit or identification number. If the State does not issue permit
or identification numbers, then the generator's address;
(iii) The date the regulated medical waste was originally shipped by the generator or the
generator's unique tracking form number; and
(iv) The new tracking form number to which the waste is assigned;
(3) Within 15 days of receipt of the tracking form that he initiated and that was signed
by the destination facility, the intermediate handler must:
(i) Attach a copy of the tracking form signed by the destination facility to the original
tracking form to the generator who initiated the tracking form; and
(ii) Send a copy of each tracking form to the generator who initiated the tracking form;
and
(iii) Retain a copy of each tracking form in accordance with the requirements of 259.83 of
this subpart.
(c) Rail shipments. If a destination facility or intermediate handler receives from a rail
transporter regulated medical waste that is accompanied by shipping papers containing the
information required on the medical waste tracking form, with the exception of the
generator's certification and chain of custody signatures, the owner or operator or his
agent, must
(1) Sign and date each copy of the tracking form or the shipping papers (if the tracking
form has not been received);
(2) Note any discrepancies as defined in 259.82(a) of this subpart on each copy of the
tracking form or shipping papers (if the tracking form has not been received);
(3) Immediately give the rail transporter at least one copy of the tracking form or
shipping papers (if the tracking form has not been received);
(4)(i) If the facility is a destination facility, send a copy of the signed and dated
tracking form to the generator within 15 days after the delivery. If the owner or operator
has not received the tracking form within 15 days of delivery, he must send a copy of the
signed and dated shipping papers to the party initiating the tracking form;
(ii) If the facility is an intermediate handler, retain a copy of the tracking form (or
the shipping papers if the tracking form has not been received), until he receives a copy
of the tracking form signed by the owner or operator of the destination facility. He then
must:
(A) Attach a copy of the tracking form signed by the destination facility to the original
tracking form (or the shipping papers if the tracking form has not been received)
initiated by another party;
(B) Send a copy of each tracking form (or each set of shipping papers) to the party who
initiated the tracking form; and
(C) Retain a copy of each tracking form in accordance with the requirements of 259.83 of
this subpart.
(5) The destination facility and intermediate handlers must retain a copy of the tracking
form )or shipping papers if signed in lieu of the tracking form) for at least three (3)
years from the date of acceptance of the regulated medical waste.
Note to Paragraph (c): Destination facilities and intermediate handlers receiving
shipments by rail should expect to receive the tracking form from the generator, or the
preceding non-rail transporter who will have sent the tracking form to the facility by
some other means (e.g., by mail).
259.82 Tracking form discrepancies.
(a) Tracking form discrepancies are:
(1) For containers, any variation in piece count such as a discrepancy of one box, pail,
or drum in a truckload;
(2) For waste by categories (i.e., untreated or treated) discrepancies in number of
containers for each category of regulated medical waste as described on the label
imprinted or affixed to the outer surface of the package;
(3) Packaging that is broken, torn, or leaking; and
(4) Regulated medical waste that arrives at an intermediate handler or a destination
facility unaccompanied by a tracking form, where the owner or operator knows such form is
required, or for which the tracking form is incomplete or not signed.
(b) Upon discovering a discrepancy, the owner or operator must attempt to resolve (e.g.,
with telephone conversations) the discrepancy with the waste generator, the transporter
and/or the intermediate handler. If the discrepancy is not resolved, the owner or operator
must submit a letter, within 15 days of receiving the waste, to the EPA Regional
Administrator(s) for both the State of generation and the State in which the facility is
located as well as to the appropriate State agency for the Covered State in which the
generator is located. The letter must describe the nature of the discrepancy and the
attempts the owner or operator has undertaken to reconcile it. The owner or operator must
include with the letter a legible copy of the tracking form or shipping papers in
question. If the discrepancy is the type specified in paragraph (a)(4) of this section,
the report must specify the quantity of waste received, the transporter, and the
generator(s).
259.83 Recordkeeping.
(a) The owner or operator of a destination
facility or an intermediate handler receiving regulated medical waste generated in a
Covered State must maintain records for a minimum of three (3) years from the date the
waste was accepted. These records must contain the following information:
(1) Copies of all tracking forms required by the following paragraphs of this subpart:
259.81(a)(5), (b)(3)(iii); and (c)(4)(ii)(C); and the logs required by 259.81(b)(2) of
this subpart;
(2) The name and State permit or identification number of each generator who delivered
waste to the destination facility or intermediate handler under 259.51(a) of this part, if
the state does not issue permit or identification numbers then the generator's address;
and
(3) Copies of all discrepancy reports required by 259.82(b) of this supart.
(b) The owner or operator of a destinations facility or an intermediate handler that
accepts regulated medical waste from generator(s) subject to 259.51 (a) or (c) of this
part must maintain the following information for each shipment of regulated medical waste
accepted:
(1) The date the waste was accepted;
(2) The name and State permit or identification number of the generator who originated
shipment. If the State does not issue permit or identification numbers, then the
generator's address;
(3) The total weight of the regulated medical waste accepted from the originating
generator; and
(4) The signature of the individual accepting the waste.
259.84 Additional reporting.
The Administrator may require owners or operators of destination facilities and intermediate handlers to furnish additional information concening the quantitis and management methods of medical waste as he deems necessary under RCRA section 11004.
259.90 Applicability
(a) These requirements apply to persons
engaged in rail transportation of regulated medical waste generated in a Covered State.
(b) Rail transporters of regulated medical waste must also comply with subpart H of this
part, Transporter Requirements, except as otherwise provided in 259.74 (f) of this part.
259.91 Rail shipment tracking form requirements.
(a) The following requirements apply to all
shipments of regulated medical waste involving rail transport:
(1) When accepting regulated medical waste generated in a Covered State from a non-rail
transporter, the initial rail transporter must:
(i) Sign and date the tracking form acknowledging acceptance of the regulated medical
waste;
(ii) Return a signed copy of the tracking form to the non-rail transporter;
(iii) Forward at least three copies of the tracking form to:
(A) The next non-rail transporter, if any; or
(B) The intermediate handler or destination facility, if the shipment is delivered to that
facility by rail; or
(C) The last rail transporter designated to handle the waste in the United States; and
(iv) Retain one copy of the tracking form and rail shipping paper in accordance with
259.77 of this part.
(2) Rail transporters must ensure that a shipping paper containing all the information
required on the tracking form (excluding permitting or licensing numbers, generator
certification, and signatures) accompanies the shipment at all times. Intermediate rail
transporters are not required to sign either the tracking form(s) or shipping paper)s).
(3) When delivering regulated medical waste to an intermediate handler or destination
facility, a rail transporter must:
(i) Obtain the date of delivery and handwritten signature of the owner or operator of the
facility on the tracking form or the shipping papers (if the tracking form has not been
received by the facility); and
(ii) Retain a copy of the tracking form or signed shipping paper in accordance with 259.77
of this part.
(4) When delivering regulated medical waste to a non-rail transporter, a rail transporter
must:
(i) Obtain the date of delivery and the handwritten signature of the next non-rail
transporter onthe tracking form; and
(ii) Retain a copy of the tracking form in accordance with 259.77 of this part.
(5) Upon accepting regulated medical waste generated in a Covered State from a rail
transporter, a non-rail transporter must sign and date the tracking form (or the shipping
papers if the tracking form has not been received by the transporter) and provide a copy
to the rail
transporter.
Actualizado el 29/Set/98
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