Friday
March 24, 1989
Part II
Environmental
Protection Agency
40 CFR Parts 22 and 259
Standards for the Tracking and
Management of Medical Waste; Interim
Final Rule and Request for Comments
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12328 Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 22 and 259
[FHL-3512-5J
Standards for the Tracking and
Management of Medical Waste
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Interim final rule and request
for Comments.
SUMMARY: On November 1,1988, the
Medical Waste Tracking Act of 1988
(MWTA) was signed into law. Among
other things, this Act requires the U.S.
Environmental Protection Agency (EPA)
to establish a two-year demonstration
program for tracking medical waste
generated in States subject to the
program, even if the wastes are
ultimately taken out of the State for
treatment or disposal. The regulations'
establishing this program must include a
list of medical wastes to be tracked and
minimum standards for segregation from
other wastes, packaging, and labeling
before transport to treatment and/or
disposal facilities. Facilities that
incinerate medical waste on-site are
also subject to certain reporting
requirements. The MVVTA designates
Connecticut, New Jersey, New York, and
those States bordering the Great Lakes
as being subject to the demonstration
tracking program. Under certain
conditions, however, these designated
States may opt out of the program. In
addition, any other State may petition
the Agency to participate in the
program.
These regulations apply to medical
waste generators in States that
participate in the program. In addition,
they apply to other handlers
(transporters, transfer facilities, and
treatment or disposal facilities) who
manage regulate^ medical wastes that
originated in a State that participates in
the demonstration tracking program.
The Act also requires EPA to submit a
final report and two interim reports to
Congress discussing the program's
overall success and the information
obtained from the program to date. The
results of the demonstration program
will assist Congress in determining.
whether or not the provisions of the
medical waste tracking program should
be extended nationwide.
Today's interim final rule specifies the
procedures and criteria under which
States may petition in or opt out of the
demonstration program. It also lists the
wastes identified by EPA as medical
wastes for the purposes of the Medical
Waste Tracking Act and sets forth the
regulations and standards for
implementing the demonstration
tracking program under the Act. In
addition, today's rule requests public
comment on the regulations presented
here.
DATES: The regulation is effective June
22,1989.
Compliance— The effective date for
the demonstration program is June 22,
1989 through June 22,1991. Transporters
must notify EPA prior to collecting or-
transporting regulated medical waste
generated in a Covered State during the
demonstration program. Notification
should be received by the Agency prior
to the effective date of today's
regulations. Notice for States petitioning
in and opting out of the demonstration
program must be submitted by April 24,
1989.
Comments—Members of the public
may submit comments on today's rule
until May 23,1989. Comments must be
submitted in triplicate to the Resource
Conservation and Recovery Act (RCRA)
Docket at the address below.
ADDRESSES: The docket for this
rulemaking (Docket No. F-89-MTPF-
FFFFF) is located at the U.S.
Environmental Protection Agency, 401M
Street SW., Washington, DC 20460.
Public comments should be sent to this
address and should include the above-
referenced docket number. The docket is
open from 9:30 a.m. to 3:30 p.m., Monday
through Friday, except for Federal
holidays. You may make an
appointment to review docket materials
by calling (202) 475-9327. You may copy
a maximum of 100 pages of material from
any one regulatory docket at no cost.
Additional copies cost $0.15 per page.
States' notices to petition in or opt out
of the program should be sent to the
Administrator of EPA, 401M Street SW.,
Washington, DC 20460, with a copy to
the 'Chief, Waste Characterization
Branch (OS-332), at the same address.
FOR FURTHER INFORMATION CONTACT:
The toll-free RCRA/Superfund Hotline
at (800) 424-9346 or (202) 382-3000 in
Washington, DC, or Michael Petruska,
Office of Solid Waste, U.S.
Environmental Protection Agency, 401M
Street SW., Room S-242 Washington,
DC 20460.
SUPPLEMENTARY INFORMATION:
I. Authority
n. Background
A. The Medical Waste Tracking Act of 1988
B. Subtitle! of RCRA
C. Previous Agency Action Concerning
Infectious Waste
D. Consultation and Public Comment
1. Consultation with States and Other
Parties
2. Consultation with International Joint
Commission
III. Future Agency Action
A. Actions Under Other Agency Programs
B. Reports to Congress
C. Regulatory Assessment
D. Educational Activities
E. Program Evaluation
IV. Overview of the Demonstration Program
Tracking System
A. Uniform Tracking Form
B. How the Tracking System Operates
1. Generator Responsibilities
2. Transporter and Transfer Facility
Responsibilities
3. Treatment and Disposal Facility
Responsibilities
V. Analysis of the Rule—Part 259 Standard
for the Tracking and Management of
Medical Waste
A. Subpart A— General
1. Waste Generated in a Covered State
2. Effective Dates and Duration of the
Program
B. Subpart B—Definitions
1. Storage
2. Treatment
3. Generator
C. Subpart C—Covered States
1. Connecticut, New Jersey, and New York
2. Great Lakes States
3. Other States
D. Subpart D—Regulated Medical Waste
1. Definition of Solid Waste
2. Definition of Medical Waste
3. Definition of Regulated Medical Waste
4. Determination to Exclude Certain Waste
Types
5. Unregulated Medical Wastes
6. Mixtures
7. Exclusions and Exemptions
8. Relationship to Previous EPA Definition
E. Subpart E—Pre-transport Requirements
1. Segregation Requirements
2. Packaging Requirements
3. Storage Requirements
4. Decontamination Standards for Reusable
Containers
5. Labeling Requirements
B. Marking (Identification) Requirements
F. Subpart F—Generator Requirements
1. Applicability and General Requirements
2. Requirement to Use Transporters who
Have Notified EPA
3. Acquisition and Use of the Tracking,
Form
4. Use of Logs by Generators of Less Than
50 Pounds Per Month
5. Exports of Regulated Medical Waste
6. Recordkeeping
7. Exception Reporting
8. Additional Reporting
G. Subpart G—On-site Incinerator
Requirements
1. Recordkeeping
2. Reporting
H. Subpart H—Transporter Requirements
1. Transporter Notification
2. Vehicle Requirements
3. Transporter Tracking Form Requirements
4. Acceptance of Medical Waste
6. Consolidation or Remanifesting of
Regulated Medical Waste
6. Transporter Recordkeeping and
Reporting Requirements
7. Delivery of Regulated Medical Waste
Outside the United States
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Federal Register / Vol. 54. No. 56 / Friday. March 24. 1989 /Rules and Regulations 12327
I. Subpart I—Treatment, Destruction, and
Disposal Facilities
1. Applicability
2. Types of Treatment, Destruction, and
Disposal Facilities
3. Use of the Tracking Form
4. Tracking Form Discrepancies
5. Recordkeeping Requirements
6. Treatment. Destruction, and Disposal of
Medical Waste
J. Subpart J—Rail Shipments of Regulated
Medical Waste
VI. Relationship to Other EPA Programs
A. Other Subtitles of RCRA
1. Subtitle C—Hazardous Waste
Management
2. Subtitle D—State or Regional Solid
Waste Plans
3. Subtitle G—Miscellaneous Provisions
B. CERCLA
C. Clean Air Act
D. Water Pollution Control
1. Clean Water Act
2. Marine Plastic Pollution Research and
Control Act of 1987
3. Marine Protection, Research and
Sanctuaries Act of 1972
4. United States Public Vessel Medical
Waste Anti-Dumping Act of 1988
5. Shore Protection Act of 1988
E. EPA Research Activities
F. EPA's Office of International Activities
VII. Relationship to other Federal Regulatory
Programs
A. Nuclear Regulatory Commission (NRC)
1. Labeling
2. Manifesting
3, Packaging
4. Limitation of Generator's Disposal
Options
' B. United States Department of Agriculture
(USDA)
1. Animals with Conmunicable Diseases
2. Veterinary Biological Products
C. Department of Labor (DDL)—
Occupational Safety and Health
Administration (OSHA)
D. Department of Health and Human
Services (DHHS)
1. Food and Drug Administration (FDA)
2. Public Health Service (PHS)
3. Health Care Financing Administration
(HCFA)
E. Department of Transportation (DOT)
1. Hazardous Materials Shipments
2. MARPOL 73/78
VIII. Federal Facilities
IX. Joint Federal and State Implementation
A. Regulatory Authority
B. Enforcement Authority
X. Regulatory Impacts
A. Executive Order 12291—Regulatory
Impact
1. Cost Methodology
2. Direct Compliance Costs
3. Characterizing the Regulated Community
4. Medical Waste Generation Rates
5. Existing Management Practices
ift. Tracking: System Requirements
7. Generators of Less Than SO Pounds
8. Incinerator Reporting
9. Packaging-
10. Existing and Proposed Medical Waste
' Regulations '•• ?
11. Results. '•'...
12. Sensitivity-Analysis
13. Benefits
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
I. Authority
These regulations are issued under the
authority of sections 2002,11001,11002,
11003,11004,11005.11010, and 11011 of
the Solid Waste Disposal Act of 1970, as
amended by the Medical Waste
Tracking Act of 1988. 42 U.S.C. 6992 et
seq.
II. Background
A. The Medical Waste Tracking Act of
1988
The Medical Waste Tracking Act
(MWTA) of 1988 was signed into law on
November 1,1988. This Act amends the
Solid Waste Disposal Act, commonly
referred to as the Resource
Conservation and Recovery Act
(RCRA), to require the Administrator of
the Environmental Protection Agency
(EPA) to promulgate regulations that
establish a demonstration tracking
system for medical waste.
The. MWTA was enacted as a
response to public concern over the
degradation of shoreline areas,
particularly in Connecticut, New Jersey,
and New York, from washups of sewage
and other waste. The medical debris
raising the most concern were wastes,
such as needles, syringes, blood bags,
bandages, and vials. See 134 Cong. Rec.
S10737 (August 3.1988). There were
also reports of other incidents of
careless management of medical waste;
for instance, by disposal into open
dumpsters, creating additional concern
for public safety. 134 Cong. Rec. H 9536
(October 4,1988).
The result of the beach washups was
the closure of beaches, economic losses
in affected shore communities, and
public concern over the health hazards
associated with medical wastes and the
general degradation of the shore
environment 134 Cong. Rec. S19745
(August 4,1988) and 134 Cong. Rec.
H 9538 (October 4,1988). Improper
management of medical waste raised
concerns over the health risks posed by
the infectious character of the waste, the
physical hazard posed by the wastes,
particularly needles and other sharps,
and the aesthetic degradation of the
vulnerable shoreline environment 134
Cong. Rec. S10738 (August 3,1988).
Congress found the appearance of
medical waste on the beaches .to be
repugnant, intolerable, arid
unacceptable. 134 Cong. Rec. S10739-S
10745 (August 4,1988).
The..MWTA was enacted against this
background of health and environmental
concerns. The Act was intended to be:a
first step in addressing these problems.
134 Cong. Rec. S15327 (October 7,1988).
The Act establishes a "cradle to grave"
system'to track medical waste
generated in the regions most affected
by medical waste mismanagement
problems to its final destination. The
Act thus is intended to address the
medical waste mismanagement problem
in several ways. First, the tracking
system is designed to be implemented
quickly so that, to the extent the
program controls sources contributing to
washups, washups of medical waste in
the summer of 1989 will be avoided. Id.
Second, the bill was designed to prevent
careless m'anagement of the waste by
establishing tracking and storage
requirements and subjecting violators to
administrative, civil, and criminal
penalties. 134 Cong. Rec. S15328
(October 7,1988). Third, the Act was
intended to provide, through the
tracking system, assurance that the
medical waste generated in the affected
States in fact reaches its intended
destination, and a mechanism for
tracing incidents of improper disposal to
responsible parties. 134 Cong. Rec.
H 9537 (October 4,1988) and 134 Cong.
Rec. S10745 (August 3,1988). As noted
by the sponsor of the bill, the tracking
system is intended to work as a "burglar
alarm," alerting EPA and State officials
whenever waste has not reached its
intended destination and leaving a
paper trail that will lead to the violators.
134 Cong. Rec. H 9536 (October 4,1988).
Finally, the legislation is intended to
provide information to Congress on the
effectiveness of the program and
whether and how a broader program
should be developed. 134 Cong. Rec.
S10743 (August 3,1988).
EPA has developed a regulatory
program that should accomplish a
number of objectives set forth hi the
Act. Under today's regulations,
increased quantities of medical waste
will be packaged securely. This will
reduce the chances of waste handlers
and the public being exposed to medical
waste. Although currently available
data suggest that medical waste does
not generally pose a significant potential
for disease transmission, proper
packaging will reduce physical hazards
(i.e., needle sticks, etc.), and it will help
ensure that any health risks are
minimized.
Second, due to the presence of labels.
marking tags, and a uniform tracking
form, medical waste will be more easily
identified. This should serve as a
deterrent to careless or otherwise
improper waste management, and it will
help identify parties who do not manage
their waste properly. Better
identification of medical waste is also
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12328 Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations
likely to lead to the waste being
managed separately from, and with
greater care than, general refuse.
The principal Intent of the Act was to
prevent beach closings caused by the
washup of medical waste. However, the
available evidence suggests that the
tracking program established today may
have only a limited effect on reducing
beach washups.
According to* the report of the New
York Department of Environmental
Conservation (NYDEC), Investigation:
Sources of the Beach Washups of 1988,
November, 1988 (on file for public
review in the docket), the debris that
washed up on New Jersey and New
York beaches consisted of "floatables,"
solid wastes such as household trash
and garbage, wood and miscellaneous
debris, NYDEC estimated that between
1% and 10% of these floatables consisted
of insulin-type syringes, blood vials, and
other "medical-related waste". The
other "medical related waste" category
encompasses several waste types not
included within today's listing of
regulated medical waste and hence not
subject to regulation.
NYDEC's investigations of the 1988
washups and comparison with earlier
beach washups have led to the following
conclusions:
• With few exceptions, floatable
debris cannot be traced to any specific
source;
• Most of these wastes are likely to
come from:
—The improper transport and handling
of solid waste destined for disposal at
the Fresh Kills landfill:
—Inadequate handling procedures,
supervision, and maintenance at the
marine transfer stations;
—Combined sewer overflows;
—Raw sewage discharges caused by
occasional breakdowns at one or
more of New York City's sewage
treatment plants:
—Storm water outlets;
• Other activities that were judged
less likely to contribute include:
—Litter deposited by beach users;
—Recreational boating;
—Commercial shipping;
• Floatables that become stranded on
sandbars are sometimes refloated by the
tides and washed ashore;
• Weather conditions contributed to
the volume and persistence of washups;
and
• Illegal disposal appears to account
for some of the wastes (i.e., the blood
vials).
The amount of medical waste washup
was extremely small compared with
both the total amount of garbage that
washed ashore and the volume of such
waste generated and disposed by New
York City's hospitals. Moreover, had
these wastes emanated from a hospital,
a larger variety of waste types would
have been present. Specifically, more
noninsulin type syringes, bloody
bandages and dressings, bed sheets, and
surgical gowns and gloves would have
appeared.
According to the NYDEC report, the
extent and public health significance of
medical waste washups were
exaggerated by inaccurate news reports.
For example, household trash was
misidentified as medical waste, and
what were erroneously reported to be
discarded laboratory animals turned out
to be common sewer rats that had
drowned at sea.
Evidence indicates that some of the
regulated medical waste is being placed
into the solid waste stream of New York
City. Hospitals are sometimes lax in
sorting their wastes; doctors,
laboratories, nursing homes, and clinics
sometimes mix medical-related waste
with trash; and intentional dumping of
regulated medical waste is done to
avoid the expense of disposal.
Outpatients such as diabetics and other
intravenous users also dispose of their
waste in municipal trash.
In summary, today's regulations may
not significantly reduce the amount of
medical waste deposited on beaches.
Sources of medical waste not addressed
by the regulations (e.g., household
medical care and intravenous drug use)
are known to contribute significantly to
beach waste wash-ups. However, the
regulations should ensure that medical
wastes from institutions and commercial
sources are being managed properly.
Furthermore, one of the intentions of the
MWTA is to provide information to
Congress about the sources and possible
solutions to the medical waste problem.
During the two-year demonstration
program, EPA will collect information
on the scope of the medical waste
problem, the usefulness of the tracking
system in solving that problem, and the
availability of other effective solutions.
EPA will be assessing the effects of
the program over the next two years.
Generally we will look at factors such
as: . . '
(l) The extent of compliance with the
requirements.
(2) The quantity and type of debris
found on beaches in 1989 and 1990, and
compare the results with those from last
summer.
EPA will try to assess what sources
are contributing to medical waste found
on beaches, and therefore, to what
extent the demonstration program, even
when fully implemented, can reduce
washups.
Finally, EPA will examine the
comments received on today's rule.
Many parts of the rule, such as the
scope of the wastes that are covered
and the packaging requirements, are
based on EPA's best technical
judgement. Comments may provide
additional information and expert
recommendations. Additional
information may also be available from
other sources, such as the study the
Agency for Toxic Substances and
Disease Registry (ATSDR) will be
conducting under RCRA section 11009.
This is discussed below.
B. Subtitle J of RCRA
The Medical Waste Tracking Act
adds Subtitle J, discussed below, to
RCRA.
Section 11001 describes the scope of
the demonstration program, which,,
includes Connecticut, New Jersey, New
York, and the States contiguous to the
Great Lakes, which are Illinois, Indiana,
Michigan, Minnesota, Ohio,
Pennsylvania, and Wisconsin. Other
States may petition the EPA
Administrator for inclusion in the
program. The States which have
petitioned in, to date, include American
Samoa. States in the program are
referred to as "Covered States."
The States bordering the Great Lakes
may opt out of the demonstration
program by notifying EPA by April 24,
1989. In addition, Connecticut, New
Jersey, and New York may remove
themselves from participation if the
Governor of the State notifies the
Administrator by April 24,1989, and
EPA determines that the State has
implemented a medical waste tracking
program no less stringent than that
promulgated by EPA under Subtitle J.
Section 11001(d) provides that the
program will expire two (2) years after
the effective date of the regulations.
Finally, States that wish to petition in
must do so by April 24,1989, in order to
be considered for inclusion in the
demonstration program.
Section 11002 of the Act designates
the following general types or classes of
. medical wastes that must be tracked
under the demonstration program: (1)
Cultures and stocks of infectious agents
and associated biologicals; (2)
pathological waste; (3) human blood and
blood products; (4] used sharps (e.g.,
syringes, needles and surgical blades);
(5) contaminated animal carcasses; (6)
surgery or autopsy waste; (7) laboratory
wastes; (8) dialysis wastes; (9)
discarded medical equipment; and (10)
isolation wastes. Section 11002 requires
EPA to promulgate regulations within
six (6) months following enactment bt
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Federal Register / Vol. 54. No. 56 /Friday, March 24, 1989 / Rules and Regulations 12329
MWTA (May 1,1989) that list all of the
wastes that are subject to tracking. EPA
cannot exclude any wastes in the first
five waste types (1-5), but is authorized
to exclude wastes in the second five
waste types (6-10) if the Administrator
determines that such wastes do not pose
a substantial present or potential hazard
to human health or the environment
when improperly managed. Further, EPA
may regulate other waste associated
with medical care that the Agency
determines poses a substantial threat to
human health or the environment. As
required by this section, EPA has
developed the list in today's rule, and
refers to the wastes covered by the rule
as "regulated medical wastes."
Section 11003 discusses the
requirements of the tracking program,
for which EPA must promulgate
regulations by May 1,1989. Section
11003(a) specifies that the program must
provide a system for tracking regulated
medical wastes listed by EPA
regulations under section 11002 (i.e.,
regulated medical %vaste), from a
generator in a Covered State to the
receiving, off-site incineration or
disposal facility. (Under today's rule,
medical waste that is incinerated, or
otherwise treated and destroyed, must
be tracked only to the point of such
treatment and destruction, provided
certain conditions are met.) The tracking
program must use a uniform form for
tracking and include a system for
providing generators with assurance
that the disposal or treatment facility
has received the waste. In addition, the
tracking program must provide that: (1)
Wastes are segregated at the point of
generation, where practicable; (2)
wastes are placed in containers that will
protect waste handlers and the public
from exposure; and (3) appropriate
labels are placed on containers of the
waste. Section 11003(d) allows EPA to
establish various regulations for
different types of medical waste and for
different types of generators.
Under section 11003(b), EPA may
exempt from the tracking program
generators of less than 50 pounds of
medical waste in a calendar month.
Section 11003(c) requires that EPA
establish recordkeeping and reporting
requirements for generators that
incinerate medical wastes on-site and
that would, on this basis, be exempt
from tracking waste. Reporting must
include, at a minimum, the volume and
types of medical wastes incinerated
during the six (6) months after the
effective date of the tracking
regulations.
Section 11004 requires that any person
vho ge erates, stores, treats, transports.
disposes, or otherwise handles medical
waste must furnish, upon the request of
any duly designated EPA official or
representative, any information relating
to such medical waste. The authority
provided under this section is not
limited to demonstration States or
facilities covered by Subtitle J regulation
nor is it limited to the types of medical
waste regulated for purposes of the
tracking program. The provisions of
Section 11004 govern any "medical
waste" as defined in section 1004(40) of
RCRA. The Act provides EPA this
authority for access to information
needed to support the development of
any regulation or report required under
Subtitle J, or to assist in the enforcement
of any provision of this Subtitle.
Section 11005 contains enforcement
provisions for the MWTA. Section
11005(a) specifies that, upon determining
that a violation of Subtitle J has
occurred, EPA may assess a civil
penalty for any past or current violation
and/or order of compliance, or
commence a civil action in U.S. District
Court. Penalties of up to $25,000 per day
for each violation of a requirement or
prohibition under the Act or for failure
to comply after issuance of a
compliance order may be assessed. An
alleged violator may request a public
hearing within 30 days after EPA's
issuance of an order under this section.
Under section 11005(b), criminal
penalties of up to $50,000 per day of
violation or two (2) years of
imprisonment may be assessed for those
who knowingly omit material
information or give false information in
documents required under this Subtitle,
or for those who knowingly handle
listed medical wastes and destroy, alter,
oir conceal required documents. Persons
who knowingly violate the requirements
or the regulations under Subtitle } can be
fined up to $50,000 per day of violation
or imprisoned for up to five (5) years.
Repeat offenders under this Subtitle are
subject to double the maximum
penalties.
Section 11005(c) specifies that any
knowing violator who, at the time of the
violations knowingly places another
person in imminent danger of death or
serious bodily injury by his or her
violation, may be fined up to $250,000 or
subject to imprisonment for 15 years, or
both. Organizations may be fined up to
$1,000,000 for knowingly endangering
another person.
Section 11005(e) states that civil
penalties assessed under this Act shall
be in accordance with the
Administrator's RCRA uvil penalty
policy.
Section11006 pertains to Federal
activities and requires all Federal
agencies in a demonstration State to
comply with the provisions of this Act
and with all Federal, State, interstate,
and local medical waste requirements,
both substantive and procedural, and
including administrative orders and
criminal, civil, and administrative
penalties. Certain exemptions may be
granted by the President if they are in
the paramount interest of the United
States. The President must report to
Congress each January all exemptions
granted during the previous year.
Section 11007 concerns Subtitle J's
relationship to State law. Subtitle J does
not preempt State or local law, or
otherwise affect State law, except that
any State form for tracking medical
waste from persons subject to regulation
under Subtitle J must be identical to the
one required by EPA in today's
regulation. However, the State may
require submission of additional
information.
Section 11008 requires EPA to submit
to Congress two interim reports and a
final report on medical waste and the
demonstration tracking program. The
final report is due within three (3)
months following expiration of the
demonstration program, and must
include the following information:
• An analysis of medical waste
generators in the U.S., the types and
amounts of medical waste generated,
and the methods currently used to
manage medical waste;
• Evaluation of the threat posed by
medical waste or its incineration to
human health and the environment;
• Estimates of the costs associated
with the improper management of
medical waste;
0 Estimates of the costs associated
with the tracking and management
requirements under the demonstration
program;
• An evaluation of the success of the
demonstration program, resulting
changes in medical waste incineration
and storage practices, and alternative
tracking procedures;
• An examination of available and
potentially available methods for
managing and treating medical waste,
including factors influencing the
effectiveness of treatment methods;
• An analysis of the existing State
and local controls on the management of
medical waste and the appropriateness
of using any existing State requirements
or RCRA Subtitle C (hazardous waste)
controls nationwide for medical waste;
• An evaluation of the
appropriateness of the Act's provision
for penalties for insuring compliance,
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12330 Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations
including a review of the penalty levels
imposed;
• An evaluation of the effect of
excluding households and small
quantity generators from medical waste
regulation and potential guidelines for
these parties; and
• An examination of available and
potentially available methods for the
reuse or reduction in volume of medical
waste generated.
The two interim reports submitted to
Congress must detail any information
available in these areas at the time of
submission. These interim reports are
due on August 1,1989, and June 22,1990,
respectively. Because of the
Congressional and public interest in the
medical waste problem, the final Report
to Congress will contain a
comprehensive evaluation of the
demonstration program. In the first
interim report EPA will describe in
detail the evaluation methodology to be
used. The second interim report will
provide preliminary results of this
program evaluation.
Section 11009 requires the Agency for
Toxic Substances and Disease Registry
(ATSDR) to report to Congress, by
November 1,1990, the potential for
infection or injury to workers and the
public from handling medical waste,
estimates concerning the number and
seriousness of cases of infection or
injury resulting from handling sharps or
from other medical waste management
activities, and estimates concerning the
number of cases of diseases traceable to
medical wastes (particularly the Human
Immunodeficiency Virus (HIV) and
Hepalitis-B). EPA is coordinating its
activities with ATSDR in the health
assessment area.
Section 11010 identifies general
provisions for the Subtitle including a
requirement that EPA consult with the
affected States (i.e., the 10 States named
in the Act) on the regulations and with
the International Joint Commission with
respect to medical waste originating in
Canada. In addition, this section
exempts EPA from otherwise applicable
requirements for public comment tinder
the Administrative Procedure Act (APA)
and for paperwork burden analysis
under the Paperwork Reduction Act
(PRA) concerning the listing and
tracking regulations.
Section 11011 establishes the effective
date for regulations under Subtitle J. The
regulations must become effective 90
days after promulgation, unless EPA
finds that 90 days is unnecessary for
compliance.
Section III of the MWTA amended
RCRA, adding a new definition of
"medical waste" to Section 1004 of
RCRA related to the new program
established by the MWTA.
C. Previous Agency Action Concerning
Infectious Waste
On December 18,1978, the Agency
proposed comprehensive regulations '
under the Solid Waste Disposal Act, as
amended by RCRA, for hazardous waste
management. In this proposal, EPA
proposed to classify certain infectious
wastes as hazardous waste (43 FR
58946). (Wastes listed or designated by
EPA as "hazardous" under Section 3001
of RCRA are subject to stringent
"cradle-to-grave" regulations under
Subtitle C of RCRA, which include,
among other provisions, tracking of such
wastes via a national uniform manifest,
restrictions on land disposal, and
permits for all treatment, storage, and
.disposal facilities.) The wastes proposed
.for listing in 1978 included infectious
materials generated by certain
departments in health care facilities and
veterinary hospitals, laboratories
handling infectious agents, and sewage
treatment facilities. These wastes would
have been exempt if they were sterilized
or incinerated in accordance with
specified methods.
EPA proposed to list these wastes as
hazardous because the Agency believed
at the time that if they were improperly
managed, they could pose a substantial
hazard to human health and the
environment. Thus, such wastes would
meet the RCRA Section 1004 definition
of "hazardous waste." A number of
comments received in response to the
proposed regulation claimed, however,
that there was no evidence that
infectious wastes pose serious hazards
to human health or the environment. As
a result of these comments and EPA's
reconsideration of the hazards posed by
these wastes, EPA did not list infectious
waste as a hazardous waste in the final
rule (45 FR 33087; May 19,1980). EPA
explained that it was not listing
infectious waste at this time because
it* * * fjje Agency has not been able to
complete the work necessary to identify
the treatment methods it would allow to
be used to exempt these wastes from
regulation". Id. Instead, the Agency
initiated several data collection
activities to assess the problems posed
by infectious waste management and
disposal. EPA used the resulting
information to develop a guidance
document which was distributed to the
public in draft form hi 1982 outlining a
practical approach for infectious waste
management (47 FR 43162, September
30,1982). The Agency then solicited
comments on the draft guidance
document, specifically seeking advice
from professionals in the health care
industry. The text was revised based on
these comments and published in 1986
as a final guidance document, entitled
EPA Guide for Infectious Waste
Management.
In addition to publishiag the guidance
document, the Agency has taken an
active role hi training health care
professionals in the responsible
management of infectious medical
waste. Agency staff have participated as
faculty or professional experts at
symposia sponsored by the American
Hospital Association and the American
Society for Hospital Engineering.
However, in 1987, several isolated
incidents of improper management and
disposal of infectious wastes led to
increased public concern about the
potential threat of these wastes to
human health and the environment. In
response, the Agency convened a panel
of experts in November 1987 to discuss
the definition, proper management of,
and risks posed by infectious wastes.
On June 2,1988, the Agency published
a notice in the Federal Register (53 FR
20140), announcing the availability of
various documents and requesting
public comments on five issues affecting
infectious waste management: the
definition of infectious waste; the nature
of infectious waste (risks and problems;
the extent of mismanagement;
pretreatment and packaging, and
disposal requirements); the role of EPA
in infectious waste management;
tracking of infectious waste; and
exemptions from medical waste
management controls. Although the
passage of MWTA superceded many
aspects of the June 2 notice, EPA
considered relevant comments received
on the June 2 notice in developing
today's rule.
D. Consultation and Public Comment
Because publication of a proposal for
today's rule was not possible given
Congressional requirement that this
program be expeditiously implemented,
the Agency has made special efforts to
coordinate the development and
implementation of today's rule with
interested parties. The Act specifically
requires EPA to consult with the
affected States, and allows for
consultation with other interested
parties at EPA's discretion, in
promulgating today's rule. Also, EPA
was directed to consult with the
International Joint Commission (IJC) to
determine how to monitor the disposal
of medical waste emanating from
Canada.
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12331
1. Consultation with States and Other
Parties
EPA began the consultation process
by contacting virtually every State to
obtain information op medical waste
regulatory programs. EPA then
concentrated on the ten States named in
the Act, and developed a detailed
summary of these States' medical waste
regulations, both existing and proposed.
(See the report entitled, "State Medical
Waste Regulatory Summary Report for
Medical Waste Tracking Act States"
available in the docket.) EPA considered
these regulations in developing the
program promulgated today.
EPA sponsored two meetings with the
affected States to obtain input on the
interim final rule. EPA sponsored a
meeting in New York City on December
14,1988, with the States of Connecticut
New Jersey, and New York to solicit
their input in drafting the regulation.
Then, on December 19 and 20, EPA, in
conjunction with the National
Governors' Association (NGA),
sponsored a two-day workshop in which
representatives from the 10 affected
States, plus the States of Alabama,
Delaware, Florida, Massachusetts,
North Carolina, and South Carolina, and
from the Great Lakes Commission
discussed regulatory and
implementation issues associated with
today's Part 259 regulations. (See EPA/
State Meeting to Consider Medical
Waste Tracking Regulation Issues,
available in the docket)
The Agency also sponsored a meeting
on medical waste on November 14-16,
1988, in Annapolis, Maryland. Over 50
individuals representing trade and
professional associations, government
agencies, severalStates, and other
organizations attended the meeting.
Comments and suggestions were
solicited from the participants
concerning three major topic areas
relevant to the Medical Waste Tracking
Act of 1988: medical waste definitions;
segregation, packaging, labeling, and
tracking requirements; and information
needs to develop the Reports to
Congress. The Agency compiled the
comments and suggestions from the
meeting. (See "Proceedings of the
Meeting on Medical Waste" available in
the docket for this rule.) All of these
meetings provided information upon
•vhich this rule is based.
In addition to these activities, the
Agency met individually,with
appropriate staff of several Federal
agencies including the Department of
Defense (DOD), the Veterans
Administration (VA), the National
Institutes of Health (NOi), the Centers
for Disease Control (CDC), and the
Department of Transportation (DOT) to
obtain information on medical waste
management practices.
2. Consultation with International Joint
Commission '
In compliance with the requirements
of the Medical Waste Tracking Act, EPA
has initiated discussions with the
International Joint Commission
regarding the development of the
Agency's medical waste tracking
program. EPA also is working with the
Canadian Government on the tracking
of these wastes.
IIL Future Agency Action
A. Actions Under Other Agency
Programs
EPA's efforts on this rule represent
only one phase of a multiphase program
to investigate and address the medical
waste problem. Other aspects of this
program are described in Section VL
Another continuing effort with
particular bearing on this rule is a study
of medical waste generation, treatment
transportation, and disposal in the
States of New Jersey and New York,
which have been particularly affected
by medical waste mismanagement
Through a combination of site visits and
surveys, EPA is developing a baseline of
information that will be used later in
evaluating the effectiveness of the
demonstration program.
B, Reports to Congress
In response to section 11008 of RCRA
Subtitle J, and as discussed in section
II.B. of this Preamble, EPA will develop
three reports—two interim and one
final—describing the extent of the
medical waste management problem.
These reports will provide Congress
with an account of medical waste
generation, management, potential for
causing adverse health or environmental
effects, costs, and the results of the
demonstration program. This
information is intended to aid Congress
in determining the most appropriate
course of future action in this area. The
interim reports are to be based on the
best information available to the
Agency at the time of submission. The
final report will provide a thorough
evaluation of the identified subjects.
C. Regulatory Assessment
Following the evaluation of the
demonstration program and the
completion of research for the reports to
Congress, the Agency also will reassess
the need for regulation of medical waste
on a national scale and identify
alternatives to national regulations.
Currently, EPA is considering
developing guidance for State legislative
and regulatory programs for medical
waste as an alternative to national
regulations. These programs could be
adopted in whole or in part by
individual States, depending on the
needs and resources of the States. These
issues will be addressed in the context
of the EPA reports to Congress.
JD. Educational Activities
EPA has undertaken efforts that will
enable the Agency and affected States
to communicate the new requirements
promulgated today to the regulated
communities within those States. EPA
plans to sustain its educational efforts hi
these States throughout the duration of
the demonstration program. As part of
this endeavor, the Agency continues to
recommend its 1986 EPA Guide for
Infectious Waste Management both to
health care facilities outside the scope
of the demonstration program, and as a
supplement to today's regulations for
health care facilities in the Covered
States.
Informational materials may be
obtained by contacting the implementing
State agency, or by calling the EPA
RCRA Hotline at (800) 424-8348 or (202)
382-3000. The EPA Guide for Infectious
Waste Management is available for
purchase only from the National
Technical Information Service
(telephone (703) 487-4650) as publication
PB-88-199130.
E. Program Evaluation
Congress directed EPA to establish
this system as a demonstration project
to determine whether such an approach
would be an effective means of reducing
beach closings due to medical waste
wash-ups. A critical element of the
program consists of the evaluation
necessary to determine if the approach
mandated by the MWTA achieves the
policy goals identified by Congress. In
consultation with ATSDR, EPA will
establish a baseline of existing disposal
practices; the incidences and causes of
past beach closings; and the incidences
of recreational and occupational injuries
caused by medical waste. Using this
baseline, EPA will evaluate the program
under the following criteria:
• The effect on treatment and
disposal practices, including the volume
of elicit disposal;
• The effect on the number of beach
closings;
• Changes in aggregate health and
environmental effects;
• Changes in risks faced by health
care providers, patients, and .medical
waste handlers;
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12332 Federal Register / Vol. 54, No. 56 / Friday. March 24. 1989 / Rules and Regulations
• The effect on the cost of medical
waste disposal; and
• Covered States effectiveness in
utilizing tracking system data to
discover improper medical waste
disposal.
EPA requests comments on these
criteria.
IV. Overview of the Demonstration
Program Tracking System
As indicated above, the principal
Congressional concern with medical
waste was the lack of any tracking
mechanism. Thus the MVVTA requires
EPA to institute a tracking program that
would provide assurance that medical
wastes reach their proper destinations
for disposal.
EPA, for the purpose of these
regulations, is using the term destination
facility to signify the facility to which
the medical waste is transported for
proper disposal. Section 259.10(b] of
today's rule defines a destination
facility as a disposal facility including
facilities that both treat and destroy
medical waste (e.g., off-site incinerators)
which complete the medical waste
tracking form by signing the form and
sending a copy to the party that initiated
it, thus closing the chain-of-custody
requirements.
The framework Congress established
does not provide for regulation of
household-generated medical waste, but
otherwise grants EPA authority to
regulate medical waste generated in the
Covered States, even when this waste is
transported into non-Covered States.
Therefore, the regulations apply to
generators in Covered States, and to
transporters and owners and operators
of transfer, treatment, and disposal
facilities who accept or handle regulated
medical waste generated in one of the
Covered States.
The tracking system promulgated in
today's rule will provide assurances that
regulated medical waste is properly
handled and managed from its point of
generation until it reaches the disposal
facility. The tracking system requires
each person hi the chain-of-custody of
medical waste management to take
responsibility for assuring that the
waste reaches the proper treatment or
disposal facility. A tracking form must
accompany the waste from generation to
disposal or to treatment and destruction,
thus leaving a paper trail which may
identify sources of mismanagement.
Exception and discrepancy reporting
requirements are specified so that
appropriate State and Federal officials
are notified if regulated ^medical wastes
do not reach their designated
destination.
Generators, transporters, treaters, and
disposers are also required to keep
certain records that will aid in
determining whether mismanagement of
regulated medical waste has occurred.
Additionally, today's rule establishes
segregation and packaging standards to
limit the possibility of exposure of waste
handlers and the general public to
regulated medical waste. This rule also
requires that transporters submit
periodic reports that EPA will use to
identify the generators of regulated
medical waste, types and amounts of
medical waste generated, current
methods of medical waste management,
and to obtain information on the number
and identity of generators of less than 50
pounds per month of regulated medical
waste. The Agency has determined that
requiring transporters to submit such
reports is the most effective means of
obtaining this information during a short
demonstration program because of their
central position within the medical
waste management system, the fewer
numbers of transporters relative to
generators under this rule, and because
transporters are more likely to already
maintain such types of information.
The Agency has accelerated this
rulemaking to ensure that the rule,
consistent with Congressional intent, is
in place by this summer's beach season.
The rule is issued in interim final form
without prior notice and comment, as
specifically authorized by Congress,
because there is insufficient time
available to propose the regulation,
accept comments, and promulgate it so
that it becomes effective prior to the
summer of 1989. In addition, EPA did not
shorten the 90 day period between
promulgation and the effective date of
the program (as provided in section
11011) because EPA believes that the
regulated community will generally need
the full 90-day period in order to come
into compliance with today's rule. For
the same reasons, the Agency is
extending the applicability of the
consolidated rules of practice to
administrative hearings for violations of
the Act and regulations.
The remainder of this section
generally outlines the responsibilities of
each person (i.e., the generator,
transporter, and treatment or disposal
facility) in the management of regulated
medical waste. As discussed in Section I
of the Preamble, the general structure
for the system is explained in section
11003 of the Medical Waste Tracking
Act of 1988. The Act establishes three
performance standards for the tracking
system. The program must:
(1) Provide for tracking of the
transportation of the waste from the
generator to the disposal facility with
the exception of wastes that are
incinerated (which heed not be tracked
after incineration);
(2) Include a system for assuring the
generator of the waste that the waste is
received by the disposal facility; and
(3) Use a uniform form for tracking in
each of the Covered States.
Given this mandate, EPA looked to
two primary sources for developing a
Federal medical waste tracking
program. First, the Agency examined the
existing Uniform Hazardous Waste
Manifest (UHWM) system under RCRA
Subtitle C. In the UHWM system, a
"manifest" functions as a shipping
document that accompanies the waste
from its point of generation to its
ultimate destination. The manifest
provides a record for waste handlers
(generators, transporters, and treatment
and disposal facilities), documenting
when the waste changes hands and if K
has ultimately been delivered to. a
disposal facility.
Second, the legislative history
indicates Congressional intent that EPA
consider New Jersey and New York
tracking regulations as a model for the
Federal program. Therefore, EPA also
reviewed the emergency medical waste
tracking programs currently being
implemented in New Jersey and New
York. Both States have instituted
medical waste tracking programs similar
to the UHWM.
Based on its analysis of these
systems, the Agency concluded that a
system utilizing a tracking form would
provide the most feasible means for
monitoring the movement of medical.
waste from its point of generation to
ultimate treatment and destruction or
disposal and that, given the relatively
short time frame available, the system
should be based in large part on the
UHWM. Additionally, a tracking form
system would be largely self-
implementing; under this system, the
generator would bear the responsibility
for reporting any waste he ships off-site
that does not actually arrive at the
destination treatment and destruction
facility or the disposal facility. The
paper trail established through the use
of a multiple-copy tracking form would
confirm the physical delivery of the
waste to transporters and designated
disposers, thereby providing checks on
the activities of all parties involved.
Furthermore, reporting requirements
associated with manifesting, such as
exception and discrepancy reports, have
been incorporated into the tracking
system to alert the Agency to any
anomalies that develop. Finally, the
Agency incorporated many of the
elements of the New Jersey and New
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Federal Register / Vol. 54. No. 56 / Friday, March 24, 1989 / Rules and Regulations
12333
York'programs into the Federal medical
waste tracking program. In particular,
the Agency felt that the emergency
manifest format used by New Jersey and
New York could be adapted readily to
achieve the objectives/of the Federal
program; therefore, the New Jersey and
New York form have, been a basis for
the tracking form promulgated today.
In summary, the Agency determined
that the medical waste tracking system
outlined in today's regulation should
establish a system separate and distinct
from the hazardous waste program, yet
should incorporate several essential
elements pf the UHVVM system as well
as significant .portions of the New Jersey
and New York State programs. This
combination best meets the objectives
of the Medical Waste Tracking Act. The
essential elements of the system are
discussed next.
A. Uniform Tracking Form
Section 11003 of the Medical Waste
Tracking Act requires the Agency to
develop a uniform form for tracking to
be used in each of the Covered States.
The'use of such a form will facilitate
inspection and enforcement activities
and the adoption of standard operating
procedures for waste handlers. Section
11007 stipulates that States or localities
that require a tracking form for waste
subject to the Federal program must use
a form identical to EPA's. States,
however, may require additional
information to be provided on a
separate attachment. Although the
Agency initially considered adopting the
Uniform Hazardous Waste Manifest
tracking form as the standard form, the
Agency has determined that a unique
tracking form would be more useful for
the medical waste tracking program.
Several factors contributed to this
decision:
(1) The legislative history indicates
that the Agency, to the extent possible,
should avoid disrupting either New
Jersey's of New York's emergency
medical waste tracking programs. These
programs do not Utilize the UHWM
tracking form. While the Agency
recognizes that the form promulgated in
today's rule also varies slightly from the
State forms, EPA engaged in extensive
consultations with the two States and,
ultimately, the States and EPA agreed
that the form issued today is appropriate
for the Federal program;
(2) The health care industry generally
believes that the information
requirements (e.g., DOT shipping
description) of the existing hazardous
waste manifest are not appropriate;
(3) Most generators of regulated
medical waste subject to the medical
waste tracking form r squirements do not
have an EPA Hazardous Waste
identification (ID] number, which is
required for the UHWM, and it would be
very difficult to establish an ID system
for the estimated 150,000 medical waste
generators subject to this rule;
(4) Because of the special information
needs for medical waste tracking, the
Agency would need to develop a new
set of instructions for completing the
UHWM when it is utilized for tracking
regulated medical waste. A new set of
instructions for completing this manifest
for regulated medical waste is likely to
create confusion for those persons
transporting and disposing of RCRA
hazardous wastes. The potential for
confusion may also be exacerbated by
the short duration and limited scope
(i.e., waste generated in Covered States
only) of this program;
(5) In most States and under RCRA,
medical waste need not be disposed of
in RCRA Subtitle C facilities. However,
because transporters and disposal
facility owners and operators have been
trained that waste shipments
accompanied by a UHWM may be
disposed of only in a RCRA Subtitle C
facility, use of the UHWM may create
confusion over where medical waste
may be disposed or treated. As a result,
. disposal or treatment facilities might
reject medical waste accompanied by
the Subtitle C manifest At the same
time, because waste accompanied by
the UHWM would no longer be
restricted to Subtitle C facilities; some
hazardous waste may be diverted to
general solid waste facilities.
Ultimately, the medical waste tracking
system must provide the necessary
paper trail to meet the objectives of the
demonstration tracking program while,
at the same time, being easy to
implement by the regulated community.
The Agency requests comments as to
whether another tracking system or
tracking form is more appropriate man
the distinct Medical Waste Tracking
Form that has been developed for the
Federal demonstration program. For
example, the Agency requests comments
on whether advance notice of tracking
should be required of generators so that
a treatment or disposal facility would be
notified to expect delivery of regulated
medical waste in advance of the waste's
arrival.
B. How the Tracking System Operates
Under the medical waste tracking
system, the tracking form serves as a
shipping document and as a record that
will verify the movement and
disposition of regulated medical waste
following its generation. Each party (i.e.,
generator, transporter, and treatment
and disposal facility) who handles
regulated medical waste has
responsibilities to make certain that the
waste is properly managed. The
following paragraphs identify the
general responsibilities of each party.
1. Generator Responsibilities
a. Generators of 50pounds or more
per month. Today's rule requires
generators in the Covered States who
generate 50 pounds or more of regulated
medical wasle in a calendar month to
complete a tracking form for each
shipment of regulated medical waste
intended for off-site treatment or
disposal.
The tracking form must be prepared
by the generator when regulated
medical waste is transported or offered
for transport off-site (i.e., when the
generator turns waste over to a
transporter for delivery to an off-site
treatment and destruction or disposal
facility). The generator must obtain a
copy of the medical waste tracking form
(see the acquisition of manifest
discussion in the section-by-section
analysis that follows), complete the form
according to the instructions provided in
Appendix I to Part 259, and sign and
date the tracking form certification by
hand. The generator also must make
certain that the regulated medical waste
is properly segregated, packaged,
labeled, and marked. Before releasing
custody of the waste to the transporter,
he must obtain the signature of the
transporter and the date of acceptance
on all copies of the tracking form. The
generator must retain a copy of the
tracking form for his records and give
the remaining copies of the tracking
form to the initial transporter. The
generator also should receive a copy of
the form back from the disposal facility
within 35 days. The generator must file
an exception report with the Regional
Administrator and the State if he does
not receive the copy within 45 days from
the initial date of acceptance by the
transporter.
b. Generators of less than 50 pounds
per month. In many cases, very small
volumes of medical waste have been
responsible for extensive public
concern. Due to the potential adverse
effects that could be caused by
mismanagement, the Agency decided
not to exempt generators of small
amounts of regulated medical waste
from all aspects of the program.
However, as provided by the statute,
today's rule exempts generators of less
than 50 pounds of regulated medical
waste per calendar month from
preparing a tracking form, unless they
ship an individual shipment of SO
pounds or more. Such generators,
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12334 Federal Register / Vol. 54, No. 56 / Friday, March 24. 1989 / Rules and Regulations
however, still are required to maintain
loga recording each of their shipments of
less than 50 pounds. In addition, EPA
has determined that proper packaging of
regulated medical waste is necessary to
ensure proper containment of the waste
and to protect waste handlers and the
public from exposure to these materials.
Labeling and marking are directly
related to the tracking requirements
because the transporters are initiating
forms for these wastes, and other waste
handlers must be able to identify the
contents as regulated medical waste.
The Agency, therefore, has not
exempted these generators from the
requirements to properly package, label,
mark and transport their waste in
accordance with today's regulations.
2. Transporter and Transfer Facility
Responsibilities
a. General. Transporters, including
transporters who operate transfer
facilities, must be authorized through a
notification process to transport and/or
operate in a Covered State. (The
notification procedures are explained in
Subsection V.) After submitting
notification, the transporter may accept
regulated medical waste for transport.
Before accepting any shipment of
regulated medical waste, however, the
transporter must verify that all the
information required on the tracking
form is complete and that the regulated
medical waste ia properly packaged,
labeled, and marked. The transporter
then must sign and date the medical
waste tracking form certifying his
acceptance of the shipment from the
generator, and return a copy of the form
to the generator.
The transporter then must carry the
tracking document and the associated
medical waste to the destination facility
or to the next transporter of the waste. If
delivery to the next transporter or
destination facility is not possible, the
transporter must contact the generator
for further instructions, note such
instructions in the space provided on the
form for additional information, and
carry out those instructions consistent
with applicable law. Until the signature
of the destination facility or subsequent
transporter is obtained, the waste is
considered to be in the custody of the
transporter who last signed the tracking
form.
b. Consolidation or remanifesting of
regulated medical waste. Under today's
rule, certain transporters and owners or
operators of transfer facilities must
initiate tracking forms. A transporter
who receives one or more individual
shipments from generators of less than
50 pounds per month of regulated
medical waste that are not accompanied
by a tracking form must initiate the
form. The transporter is also required to
consolidate all such shipments onto a
single tracking form. As noted in the
section-by-section analysis, transporters
and owners or operators of transfer
facilities will be required to attach a
separate sheet of paper or log to the
tracking form that identifies each
generator and the amount of
corresponding waste that has been
consolidated onto the tracking form.
The Agency also is allowing
transporters and owners or operators of
transfer facilities to consolidate or
remanifest individual shipments of
regulated medical waste weighing less
than 220 pounds onto a single tracking
. form. The Agency believes that the
tracking program would become
unimplementable if treatment and
disposal facility operators were required
to sign and account for a tracking form
for each and every generator, including
generators of less than 50 pounds, of
regulated medical waste (e.g., a single
truck could contain as many as 500
individual shipments of regulated
medical waste, each weighing 100
pounds or less). However, to facilitate
recordkeeping by transporters, EPA
recommends that shipments between 50
and 220 pounds accompanied by a
tracking form not be consolidated with
shipments of less than 50 pounds from
/generators exempt from use of the
tracking form. To simplify recordkeeping
procedures, EPA believes that shipments
between 50 and 220 pounds should be
consolidated onto a single tracking form
while shipments of less than 50 pounds
from generators exempt from use of the
tracking form should be consolidated
onto a second, separate tracking form.
Today's rule also requires that
transporters (including owners or
operators of transfer facilities) maintain
copies of all tracking forms for a period
of three (3) years. Transporters must
submit periodic reports to the State and
to EPA summarizing waste quantity,
information (generation and
destination).
3. Treatment and Disposal Facility
Responsibilities
a. General. When regulated medical
waste is delivered to the destination
facility, the owner or operator of the
facility must sign and date the tracking
form to certify that the regulated
medical waste was received. The owner
or operator also must note discrepancies
such as differences in the quantity or
type of waste identified on the tracking
form and the quantity or type of waste
actually received at the facility. When
such discrepancies cannot be resolved ,
with the generator and transporters, the
owner or operator must notify
appropriate State and EPA officials.
After acceptance, the owner or
operator must send a copy of the signed
tracking form to the generator within 15
days of delivery. This represents the
final segment of the tracking loop. It
signifies to the generator that his waste
has been received by the destination
facility.
b. Treatment or destruction facilities
initiating tracking forms. An owner or
operator of a treatment facility must
initiate a tracking form when the waste
has been treated, but has not been
destroyed through such processes as
grinding or shredding. Similarly when
waste has been either shredded or
ground but not treated the facility must
initiate a tracking form. The waste thus
still requires transport to a final disposal
site. Specific instructions for dealing
with this situation are included next in
the detailed section-by-section analysis.
V. Analysis of the Rule—Part 259
Standard for the Tracking and
Management of Medical Waste
The previous section explained the
general operation of the demonstration
tracking program, as well as the basic
responsibilities of each individual
involved in the generation, transport,
and treatment and disposal of regulated
medical waste. The paragraphs that
follow provide a detailed section-by-
section analysis of the mle, discussing
the rationale behind the requirements,
and providing guidance for interpreting
various sections of the rule. Those
sections of the rule that are self-
explanatory are not addressed in the
Preamble.
A.SubpartA—General
Subpart A of today's rule provides
general information on the new Part 259.
This section of the Preamble deals with
three issues concerning the program's
scope and applicability: the limitation of
the program to medical waste generated
within the Covered States; effective
dates and duration of the program; and
notification to EPA by the State when
taking enforcement actions.
1. Waste Generated in a Covered State
(Section 259.10)
Section V.C. of this Preamble
discusses how States may petition in or
opt out of the demonstration program.
States that are in the program are
referred to as "Covered States" (see
RCRA section 11001). Other States are
referred to as "non-Covered States."
RCRA section 11003(a) requires EPA to
establish a demonstration tracking
program for listed medical wastes
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Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 /, Rules and Regulations
12335
generated in a Covered State. The
tracking program applies to such waste,
generated in a Covered State, from its
point of generation to its final
destination even if that destination is in
a non-Covered State; however, these
requirements do not apply to wastes
shipped from a non-Covered State to a
Covered State, as discussed below.
(Shipments into a foreign country are
discussed in Section V.H. of this
Preamble.)
The Medical Waste Tracking Act of
1988 (MWTA) provides authority to
establish a demonstration tracking
program based on the type of waste
being managed and the fact that the
waste has been generated in a Covered
State. In light of the common practice of
interstate transport and disposal of
medical waste, Congress provided this
authority in order to ensure that such
wastes can be tracked to their point of
disposal or point of treatment and
destruction (e.g., incineration),
regardless of whether that destination is
within a Covered State. No limitation on
this authority exists specifying that the
waste must be generated and disposed
of in a Covered State. In fact, Congress
amended the original Senate medical
waste tracking bill that did limit the
program to waste generated and
disposed of in a Covered State. Thus,
the statutory basis for the scope of the
demonstration program is tied to the
waste at issue and is based on such
waste meeting two conditions: (!) The
waste must be listed by EPA under
section 11002, and (2) such waste must
be generated in a; Covered State. Where
these two conditions are satisfied, all
persons or facilities handling such waste
are subject to the demonstration
program requirements. This includes
transporters or facilities located in non-
Covered States if they receive regulated
medical waste generated in Covered
States.
Accordingly, while the generator
requirements for the tracking program
are limited to persons located in
Covered States, requirements for
transporters and for owners or operators
of treatment or disposal facilities apply
to any person handling medical waste
from a generator in those Covered
States, even if the transportation,
treatment, or disposal does not occur in
a Covered State. Hence, owners and
operators of treatment or disposal
facilities operating in non-Covered
States will still be responsible under
today's rule for returning tracking forms
to generators in-Covered States, thus
maintaining the integrity of the tracking
program (see § 259.1(c)).
As discussed above, Congress clearly
intended the program to apply to the
management of medical wastes
generated in Covered States wherever
that activity occurs. It is also clear that
medical waste which meets one of the
EPA listing descriptions and was
generated outside a Covered State, but
transported into or through a Covered
State, is not regulated under the
demonstration program. Therefore, there
is a need to identify the geographic
origin of a particular shipment of
medical waste in order to determine
whether regulatory requirements apply.
This raises enforcement and
implementation problems with respect
to waste found in a Covered State, but
which is claimed to be generated in a
non-Covered State and thus is not
regulated. EPA has addressed this
problem in § 259.1(d), which states that
any regulated medical waste that is
transported or otherwise managed
within the boundaries of a Covered
State will be presumed to have been
generated in the Covered State and thus
subject to all applicable tracking
requirements. This presumption may be
rebutted by proving by a preponderance
of the evidence that the waste in
question was generated outside the
Covered State. The burden is on the
regulated party to rebut the
presumption.
EPA believes the presumption made in
§ 259.1(d) is necessary to allow effective
implementation of the demonstration
program. Precedent for such a
presumption is found under other RCRA
regulations (e.g., 40 CFR 261.2 for
recycled material]. The presumption is
based on the rationale that, since
medical waste is generated in all of the
Covered States, the physical presence of
medical waste in a Covered State is a
fairly reliable indication that the waste
was generated in that State. EPA
recognizes that there will be exceptions,
but believes that the burden of
demonstrating the origin of the waste
should be placed on the persons
managing the medical waste. Id.
Moreover, providing appropriate
documentation should not be difficult.
First, under current industry practices,
medical wastes shipped out of State are
accompanied by shipping papers.
Second, many States not participating in
the demonstration program are
nonetheless implementing then- own
medical waste programs, which often
include a requirement for manifesting or
tracking the medical waste. In either
case, easily accessible and sufficient
documentation will be available to
substantiate the claim of nonregulated
status. The person claiming
nonregulated status, however,;bear' he
burden of proof in any enforcement
action.
Comments are requested on this
presumption and on alternative ways hi
which the Agency could implement the
distinction between waste generated hi
a Covered State and waste generated in
a non-Covered State.
2. Effective Dates and Duration of the
Program (Section 259.2)
Congress specified that the
demonstration program would be hi
place for 24 months, beginning on the
effective date of the EPA regulations
(see RCRA Section llOOl(d)) and that
EPA's regulations would generally take
effect 90 days after promulgation. (See
RCRA section 11011.) The regulations
promulgated today will take effect and
become enforceable on June 22,1989.
This is the full 90-day period authorized
under RCRA Section 11011. Although
New Jersey and New York currently are
operating under programs quite similar
to the rules promulgated today, the
Agency believes the regulated
communities hi those States also will
need the full 90 days to implement the
medical tracking form and reach
compliance. Therefore, the
demonstration program will expire on
June 22,1991, for all waste generated hi
Covered States. Enforcement actions,
however, may be initiated after the
expiration date to address violations
occurring during the demonstration
program.
B. Subpart B—Definitions
Today's rule includes a list, of terms
that have been defined specifically to
address the management of medical
waste. These definitions are included hi
Subpart B of die rule (§ 259.10). Certain
definitions from 40 CFR 260.10.
applicable to hazardous waste
management, have been incorporated by
reference. Other terms used in the
hazardous waste regulations, and
defined in § 260.10, have been redefined
in § 259.10(a) for use in the medical
waste management regulations. Finally,
terms that are unique to the medical
waste management regulations are
defined in § 259.10(b).
For three defined terms, "facility,"
"transporter," and "landfill," the only
change from the definition to § 260.10 is
the substitution of the words "medical
waste" for the words "hazardous waste
in the Subtitle € definition. This is
necessary for the obvious reason that
today's rule addresses medical waste
arid not hazardous waste. Three other
terms listed in § 259.10(a); ("storage,"
"treatment," and "generator") also
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Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules a:nd Regulations
replace the words "hazardous waste"
with the words "medical waste;"
however, the definitions of these terms
in § 259.10 also include other changes
from the existing § 260.10 definitions.
These additional changes are indicated
and explained below.
1. Storage
The definition of storage in § 259.10(a)
differs slightly from the definition of
storage in § 260.10. Today's rule
specifies that storage is the temporary
holding of medical waste at a central
collection point, whereas the definition
in § 260.10 defines storage as the
temporary holding of waste prior to
treatment, disposal, or transport
elsewhere. This distinction is intended
to clarify that medical waste storage is
considered to be those instances where
waste is held at a generator's facility
where it is accumulated in the normal
course of business prior to packaging,
transport, treatment, or disposal (e.g.,
near a loading dock). It is also intended
to clarify that the temporary holding of
medical waste, for instance during brief
periods for collection (e.g., at a nurses
station in the pediatric ward), is not
intended to constitute storage or subject
the temporary accumulation area to
applicable storage requirements.
2. Treatment
Treatment also is defined in today's
rule in a different manner than it is
defined in 1260.10. Under today's rule,
treatment includes any method,
technique, or process designed t.
change the biological character or
composition of any medical waste so as
to reduce or eliminate its potential for
causing disease. This definition differs
from the Subtitle C definition in that
changes to the physical or chemical
character of medical waste which also
affect the infectious nature of tire waste
are not considered treatment; rather, the
focus of treatment is to reduce or
eliminate the infectious biological
character of the waste. Thus, the
definition In today's rule emphasizes
treatment of the biological hazard. (The
definition is the same as that in the 1986
EPA Guide for Infectious Waste
Management.)
Treatment as defined under today's
rule is intended to encompass those
processes, including thermal treatment
(such as incineration), steam
sterilization, and other treatment
techniques (e.g., chemical treatment),
that are generally effective in reducing
or eliminating the infectious risk posed
by these wastes. New technologies
capable of rendering medical waste
innocuous would also fall within this
definition. Finally, the reader should
note that the discussion above pertains
to waste treatment. As discussed in a
later section of the Preamble, the
definition of medical waste also uses the
term "treatment" but in that context the
term refers to patient treatment (e.g., the
provision of health care services). The.
regulatory definition of "treatment" also
incorporates this distinction.
3. Generator
Generator, as used in today's rule, is
intended to include any person, by site,
whose act or process produces a
regulated medical waste or whose act
first causes a medical waste to be
subject to this regulation. Two key
aspects of this definition warrant
emphasis. First, person, as defined
under § 259.10, includes any 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. This definition is intended to
include any form of business entity and
to incorporate the Act's revision of the
RCRA definition of "person" under
section 11006(b) (Federal Facilities).
Second, persons are evaluated by site to
determine who satisfies the definition of
a generator. Thus, each individual
generation site, such as a hospital
located on a contiguous piece of
property, is an individual generator;
however, a hospital which has four (4)
noncontiguous pieces of property on
which medical waste is generated, has
four (4) generation sites, one on each
piece of property, and each site is a
generator. In contrast, several "persons"
(for instance, independent, private
practitioners) located in the same
building are each separate generators,
because the definition of generator is a
"person, by site."
In addition to the terms defined in
§ 259.10(a) of Subpart B, several new
terms have been defined in § 259.10(b).
These terms are discussed below, as
they are used in the regulations.
C. Subpart C—Covered States
When amending RCRA to establish
the demonstration tracking progran for
medical waste, Congress directed that
the effort cover 10 specific States.
However, the legislation also contains
provisions for allowing these States to
withdraw from participation in the
program and for other States to join the
effort. Congress provided that the
Governors of the States be given 30 days
from the promulgation date of these
provisions to make decisions regarding
their participation. This discussion
elaborates on the process for petitioning
in and opting out of the demonstration
program. EPA has made special efforts,
including working with the National
Governors' Association, to provide
Covered States and States interested in
participating in the demonstration
program with information concerning
the program.
Once the 30-day opt-out/petition in
period has expired, EPA will not add
additional States or consider petitions to
delete States from the demonstration
program. Furthermore, persons who
generate or manage medical waste in
Covered States that do not opt out will
be subject to the program for its 24-
month duration as required by section
11001(d). The procedures for States to
opt out or petition into the program are
discussed below.
1. Connecticut, New Jersey, and New
York
Because improper medical waste
disposal incidents on the East Coast
have arisen most visibly, Congress
conditioned the opting out by three
specified States—Connecticut, New
Jersey, and New York—on a showing
that their respective State medical
waste tracking programs are no less
stringent than the Federal
demonstration program. Therefore, if
any of these three States request not to
participate, EPA will evaluate that
State's program elements to determine
whether or not they are at least as
stringent as the Federal program. In the
absence of specific Congressional
direction regarding the requirement that
these States' programs be "no less
stringent" than the Federal program,
EPA intends to use the existing RCRA
Subtitle C State authorization criteria as
guidance (see 40 CFR Part 271). Under
the Subtitle C process, the State's
program requirements are generally
compared to the Federal requirements
item-by-item. If EPA determines that the
State's program is no less stringent as
the program promulgated today, the
Agency will revise today's interim final
rule by amending Part 259 to remove
that State from the Covered States list. If
the State's program is not found to meet
the no less stringent standard, the State
will remain in the Federal program.
2. Great Lakes States
Congress also directed that seven
States contiguous to the Great Lakes
(Illinois, Indiana, Michigan, Minnesota,
Ohio, Pennsylvania, and Wisconsin) be
subject to the demonstration program,
unless the Governors of such States
notify EPA in writing within 30 days of
promulgation that they have chosen not
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Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations
12337
to participate. Congress did not
establish a "no less stringent" standard
for these States. EPA will identify those
States that elect to opt out in a later
Federal Register notice.
3. Other States
States not mentioned above may elect
to participate in the demonstration
program. The Governor of a State
electing to participate must petition EPA
by April 24,1989 to be included on the
list of Covered States. The definition of
"State" in RCRA section 1004(31)
includes the several States, the District
of Columbia, Puerto Rico, the Virgin
Islands, American Samoa, Guam, and
the Commonwealth of the Northern
Mariana Islands. EPA interprets the
term "Governor" to include the
Governor in any of the several States, or
the equivalent head of the executive
branch of the government for those
other governmental entities. The Act
specifies that EPA must determine
whether to include a petitioning State in
the program within 30 days of receipt of
the petition (RCRA section llOOl(c)).
American Samoa has already petitioned
to be included in the program, and EPA /
will make a determination regarding
American Samoa and any other petition-
in States after the 30 day period.
The Agency is planning to publish the
final list of Covered States in the
Federal Register shortly after the April
24,1989, opt-out/petition-in deadline.
D, SubpartD—Regulated Medical
Waste
Section 11002 of RCRA requires EPA
to develop and promulgate a list of
medical wastes to be tracked under the
demonstration progran. The statute
provides the basic components of the
list by identifying five waste types that
must be included: (1) Cultures and
stocks of infectious agents and
associated biologicals; (2) pathological
waste; (3) human blood and blood
products; (4) used sharps (e.g., syringes,
needles, and surgical blades); and (5)
contaminated animal carcasses. The
statute also identifies five additional
waste types that EPA is authorized to
exclude from the demonstration program
if the Agency determines that
mismanagement of such wastes would
not pose a substantial threat to human
health or the environment; (6) surgery or
autopsy waste; (7) laboratory wastes; (8)
dialysis wastes; (9) discarded medical
equipment; and (10) isolation wastes.
The Act also gives EPA authority to add
other medical wastes.to the list if the
Agency determines that such wastes
may pose a substantial threat to human
health or the environment.
The Act's designation of two different
"universes" of medical waste originates,
in part, from EPA's Guide for Infectious
Waste Management (1986). In that
document, the Agency identified two
universes of medical waste: "infectious"
medical waste and "miscellaneous
contaminated wastes." The first
universe, "infectious" medical wastes,
included those wastes listed in the Act
as waste types 1, 2, 3, 4, 5, and 10. The
Agency, at the time, believed that all of
these wastes should be specially
managed. The second universe included
those wastes listed in the Act as waste
types 6, 7, 8, and 9. EPA recognized that,
depending on the specific characteristics
of the "miscellaneous contaminated
wastes," they could be handled
appropriately as "infectious" medical
wastes or noninfectious medical wastes
based on the determination of a
responsible infection control
practitioner.
Clearly, one of the most controversial
aspects of EPA's guidance document has
been its inclusion of isolation wastes
(waste type 10 in the Act) in the first
universe of "infectious" medical wastes.
The health care community, medical
.professionals, and public health officials
have strongly criticized this aspect of
the guidance document stating that,
except under special circumstances,
isolation wastes are unlikely to pose a
significant hazard to human health or
the environment. Thus, EPA believes
that Congress, in formulating the
statutory list of medical wastes subject
to the demonstration program, relied on
the basic format of the original waste
listing as set forth hi the 1986 guidance
document (i.e., separating the universe
of medical waste into "infectious" and
"miscellaneous contaminated waste"
categories). However, EPA also believes
that Congress concurred with prevailing
scientific opinion concerning the relative
threat posed by isolation patient waste
(listed in the EPA guidance document as
an infectious waste category) and
designated this as a category that the
Administrator may exclude from the
demonstration program based on the
authority of section 11002(b).
In today's rule, medical wastes to be
tracked under the demonstration
program are referred to as "regulated
medical waste." Regulated medical
waste is a subset of medical waste
which, in turn, is a subset of "solid
waste" as defined in RCRA section 1004.
This relationship is illustrated in Figure
1. The term "regulated medical waste"
includes the list of medical wastes, as
determined by EPA, and certain
mixtures of these wastes with other
types of wastes. This section of the
Preamble discusses the criteria used to
define or designate medical waste as
"regulated medical waste," explains the
content and rationale behind the
regulatory listing of regulated medical
waste, and describes the conditions
under which waste classes may be
exempted from regulation,
BILLING CODE 6560-50-M
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12338
Federal Register / Vol. 54, No. 56 / Friday, March 24,1989 / Rules and Regulations
FIGURE 1
REGULATED MEDICAL WASTE COVERED BY PART 259
No
Is Iht wast*
a Solid Wast* According
lo RCRA Soclion 1004 f
Th* Wast* is Not a
Regulated Medical Wast*
Dots th* Solid Wast*
M«*t th* Medical Wast*
Definition In, Section
259.10 ?
Is th*
Medical Wast*
listed in Section
259.30(a)
th*
Mtdical Wast*
Exempt or Excluded from th*
Definition of Regulated
Medical Wast* Under
Section 259.30(b) ?
Th* Mtdical Wast* is a
Regulated Medical Wast*
Th* Wast* is Not a
Regulated Medical Wast*.
Is th*
Regulated Medical
Waste Generated
in a Covered
Stat* ?
Th* Wast* is Subject to
Part 259 Regulations.
Th* Regulated Medical
Wast* is not Subject to
Part 259 Regulations.
MJtta COOC CS40-5C-C
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Federal Register /Vol. 54, No. 56 / Friday. March 24, 1989 / Rules and Regulations 12339
1. Definition of Solid Waste
Solid waste, as defined in section 1004
of RCRA, includes discarded solid,
liquid, semisolid, or contained gaseous
material, among other materials.
Specifically excluded from the meaning
of the term "solid waste" is domestic
sewage, because Congress did not
intend for materials that are legally
discharged to sewers to be regulated
under RCRA. Such discharge is subject
to the Clean Water Act and also may be
subject to State and local controls.
Similarly, materials which health care
facilities discharge to sewers flowing to
a publicly owned treatment works
(POTW) are not "solid waste" and are
not subject to the demonstration
program. For purposes of the
demonstration program, the term
"domestic sewage" has the same
specific meaning as in the Subtitle C
(hazardous waste management) program
(i.e., untreated sanitary wastes and
other materials which flow through a
sewer system to a POTW). See 40 CFR
2. Definition'of Medical Waste
Medical waste is a subset of solid
waste. Section 1004(40) of RCRA, as
amended by the MWTA, defines
medical waste as follows:
Except as otherwise provided in this
paragraph, the term "medical waste" means
any solid waste which is generated in the
diagnosis, treatment, 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 Subtitle C or any household
waste as defined in regulations under Subtitle
C. ' *"" "
Following is EPA's interpretation of
this definition. ..,"•'...
a. General. EPA interprets "diagnosis,
treatment, or immunization" to include
waste generated during the provision of
medical services such as surgery,
dialysis, obstetrical procedures, routine
checkups, and health maintenance
activities. (Treatment in ?he statutory
definition refers to the pioaslon of
patient care; EPA also interprets
treatment to mean the preparation of
human and animal remains before
interment or cremation. Treatment when
used hi the context of medical waste
management means to reduce or
eliminate a medical waste's disease-
causing potential.) However, EPA does.
not interpret "medical waste" to include
waste generated as a result of activities
ancillary to patient care, such as general
refuse from administrative offices, or
cafeteria waste.
Solid waste generated during
"research pertaining to" the diagnosis,
treatment, or immunization of humans
or animals is "medical waste" if it
results from one of the following
practices: (1) Diagnosis research—waste
generated by facilities engaged in
pathology research, the development of
diagnostic procedures, and the,
evaluation of health effects of various
Pharmaceuticals and chemicals; and (2)
Treatment research—waste generated
during research pertaining to the
treatment of patients and in the
evaluation of the effectiveness of such
treatment; and (3) Immunization
research—waste generated during
research pertaining to the development
oil new or improved vaccines, evaluation
of the effectiveness of the vaccines, or in
the development and evaluation of
immunization techniques. Biotechnology
wastes are medical wastes only if the
end-product is a biological intended for
use in diagnosing, immunizing, or
treating humans or animals or in
research pertaining to these activities.
Solid waste that is generated as a result
of biotechnology activities producing
microorganisms for pesticide or
industrial applications (e.g., mineral
extraction, oil recovery, chemical
production, and chemical degradation)
if) not medical waste and is, therefore,
not subject to the requirements of the
demonstration program.
In summary, EPA interprets the
universe of medical waste generators to
include, but not be limited to, hospitals,
physicians' offices, dental offices,
veterinary practices, funeral homes,
research laboratories that perform
health-related analyses or services,
nursing homes, and hospices. However,
as discussed later in this section, only a
portion of the medical waste generated
by these facilities is "regulated medical
waste" and thus subject to the
demonstration program.
b. Exclusions. In developing this
definition, Congress determined that
both hazardous waste and household
waste (as defined under the Subtitle C
regulations, 40 CFR 261.4(b)(l)) should
not be regulated under the
demonstration program and, thus,
specifically excluded them from the
meaning of medical waste in the
statutory definition (section 1004(40) of
RCRA). The terms "hazardous waste"
and "household waste" have specific
meanings in the Subtitle C (hazardous
waste management) program (see 40
CFR Part 281). For purposes of the
demonstration program, they retain
those meanings.
Hazardous waste listed or identified
in 40 CFR Part 261 is not "medical
waste" but may be subject to Part 259
requirements when mixed with
regulated medical waste. EPA interprets
the term "hazardous waste identified or
listed under Subtitle C" to include any
hazardous/waste as generated.
Accordingly, mixtures of hazardous
waste and medical waste are not
excluded from the definition of "medical
waste" by virtue of the hazardous waste
mixture rule (40 CFR 261.3). Under
today's regulation, only mixtures of
hazardous waste and medical waste
that are subject to the Subtitle C
manifest requirements are excluded
from Part 259 requirements. Mixtures of
hazardous waste and medical waste are
discussed later in this Preamble section.
Household waste, as defined in the
Subtitle C regulations (40 CFR 261.4(b)),
is not medical waste, and is not subject
to the requirements of the demonstration
program. The Agency has stated that the
exclusion is limited to waste generated
by individuals on the premises of a
residence for individuals and composed
primarily of materials found in waste
generated by consumers in their homes.
49 FR 44978 (November 13,1984). Thus,
if the waste is domestic waste generated
at a residence, it is "household waste"
and thus excluded from this program.
As a result, the wastes generated by
health care providers in private homes
where they provide medical services to
individuals would be "household
waste." Because the household
wastestream is excluded, the waste
generated by the health care provider in
private homes would not be subject to
the tracking or management
requirements even when removed from
the home and transported to the
physician's place of business.
Although the Agency believes that
nursing homes are "residential" in some
ways, their primary purpose is the
provision of health care services.
Because such facilities are primarily for
the purpose of providing health care
and, like a hospital, the residential
aspects are a necessary incident of the
health care, and because such facilities
are expected to generate amounts and
types of medical waste significantly
different from waste generated by
consumers in their homes, such wastes
are not considered "household waste"
under § 261.4, and must be managed as
regulated medical waste. EPA will be
studying the effects of this household
waste exclusion as part of its Report to
Congress under section 11008, and will
consider regulatory and nonregulator'
options for dealing with any
mismanagement problems associated
with such waste.
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12340 , Federal Register / Vol. 54, No. 56 / Friday. March 24. 1989 / Rules and Regulations
3. Definition of Regulated Medical
Waste
Regulated medical waste is medical
waste that has not been specifically
excluded in the provisions and is either
(a) a listed medical waste, or (bj a
mixture of a listed medical waste and a
solid waste. EPA has listed seven (7]
classes of medical waste that must be
tracked under the demonstration
program and has described the items
included in each class. The regulated
items have been grouped by waste class
BO that generators can easily identify
those wastes that are subject to the
tracking requirements.
Today's rule requires these
substances to be tracked under the
demonstration program only if they are
waste materials and are being shipped
off-site for treatment or disposal. When
these substances are being transported
from site to, site for analysis or as a
commercial product (e.g., pathological
specimens or blood), they are not
subject to the requirements of the
demonstration program, as a result of
that shipment, because they are not
waste materials. However, if these
materials become waste and they meet
the definition of regulated medical
waste, they will be subject to these
regulations if generated in a Covered
State.
Of the seven (7) waste classes listed
below, the first six parallel six (0) of the
first 10 waste types identified in section
11002 of the statute. The seventh has
been added by EPA under the authority
of section 11002(a)(ll). The descriptions
for each of the first six (6) waste classes
presented in Subpart D of today's rule
are based on EPA's interpretation of the
statute and the authority provided in
section 11002(b) and section
11002(a)(ll). The remainder of this
section discusses each class of regulated
medical waste and explains EPA's
interpretations regarding the items
included in each class. EPA based these
descriptions, in part, on discussions held
during meetings with various
representatives of the health care and
solid waste' management communities
on November 14-16,1988, and with
State representatives on December 19
and 20,1988.
a. Class 1—Cultures and stocks. EPA
includes, within this class, those wastes
(cultures-and stocks o,f infectious agents)
meeting the statutory description of
section 11002(a)(l), described below:
Cultures and stocks of infectious agents
and associated blologicals, including: cultures
from medical and pathological laboratories;
culture* 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.
As guidance in determining what
"infectious agents" are, those agents
listed in Classes 2 through 4 of the
Centers for Disease Control's (CDC's)
Classification ofEtiologic Agents on the
Basis of Hazard (July, ,1974) would be
included. EPA believes that these
guidelines are suitable to indicate which
medical wastes warrant regulation.
Also, EPA has interpreted the term
"biological" to mean preparations made
from organisms, or from products of
their metabolism, intended for use in
diagnosing, immunizing, or treating
humans or animals, or in research
pertaining thereto. See the definition in
§ 259.10. EPA notes that under the
definition of "infectious agents" and
"biologicals," agents that cause disease
in non-human animals, but not in
humans, are not covered under this
class, however, agents that cause
disease in both humans and non-human
animals are covered. The main concern
with this class is potential hazard to
human health.
Examples of wastes that may fall in
this category include cultures of medical
specimens, stocks of infectious agents
used to produce vaccines, vaccines that
are off-specification, culture dishes, and
swabs used to inoculate cultures.
b. Class 2—Pathological wastes.
EPA's regulatory description of Class 2
is based on the language in the section
11002(a)(2) definition, and reads as
follows:
Human pathological wastes, including
tissues, organs, body parts, and body fluids
that are removed during surgery or autopsy,
or other medical procedures, and specimens
of body fluids and their containers.
• As described above, the pathological
waste class includes wastes of human
origin only. Thus, except for those
specific animal wastes included in
Classes 5 and 6, described below, and
except for certain items that meet the
conditions of waste Class 1, pathological
wastes from veterinary practices are
specifically excluded from regulation
under this part. As explained previously,
the 10 medical waste types listed in the
Act are virtually identical to the
infectious medical wastes identified in
the 1986 EPA Guide for Infectious Waste
Management. However, the guidance
was intended to include only human
pathological wastes, and thus all
examples of pathological waste in the
guidance are of human origin. Although
the statute and legislative history are
unclear as to whether Congress
intended to include all pathological
waste, under this class, EPA believes
Congress intended to include the same
wastes that were included in the EPA,
Guide for Infectious Waste
Management. Thus, EPA interprets the
Act to include pathological wastes of
human origin only. , ,
While EPA is aware that some
arguments can be made that animal
pathological wastes should be included
in Class 2 (e.g., it may be'difficult, in
some cases,, to distinguish between
human and animal pathological wastes),
animal wastes that are known to be
contaminated and thus potentially
harmful to human health are already
regulated under waste Class 5. Other
animal wastes are regulated under Class
6. For all of the above reasons, the
Agency has determined that waste Class
2, pathological waste, should include
wastes of human origin only. The
Agency requests specific comments oft ,
this decision. ...-.'-..••"
EPA has added the phrase, "other
medical procedures," to account for
pathological wastes generated from
procedures not normally considered ,
surgery (e.g., obstetrical procedures). '
Also being included under this waste
class are discarded body fluids and
discarded specimens of body fluids and
their containers. These are included at
the recommendation of health •
professionals who regard .the potential
for causing health effects posed by such
fluids to be the same as for other
pathological wastes. „:;
c. Class 3—Human blood and blood
products. The regulatory description of
Class 3 is based on section 11002(a)(3).
Class 3 includes: '"'
(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.
This waste class .covers, bulk waste ..••.
human blood and products derived from
blood, such as discarded units of blood.
and other licensed blood products. EPA
has also included in this class the
containers used to hold blood (e.g.,
blood bags and blood vials) because
these containers may be contaminated
by blood, and thus present the same
hazards as the blood itself. In addition,
the mismanagement of these containers
may result in the type of serious •
environmental degradation that closed
beaches in past summers. The
legislative history indicates that the
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Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 /Rules and Regulations
12341
MWTA was clearly intended to address
this type of degradation.
Intravenous bags are being included
in this category because they may
continue to resemble blood bags even
after'certain treatment processes.
Although intravenous bags may not
have come into contact with any
pathogenic microorganisms, the
aesthetic degradation of the
environment caused when they are
mismanaged warrants their inclusion in
the demonstration tracking program.
EPA is using the authority under RCRA
section 11002(a)(ll) to list these items,
and is including these items in this part
of the regulation for convenience.
Class 3 also includes items that are
saturated and/or dripping with human
blood or that were saturated and/or
dripping but have since dried. These
wastes are aesthetically objectionable
and, while they may present low
potential for causing adverse health
effects, in certain instances they pose a
potential health threat if mishandled in
the presence of other waste material
such as sharps. This concern should
only be present if the blood is in liquid
form. Items with large quantities of
dried blood are not likely to transmit
disease. The blood is generally not
present in a form (i.e., liquid) likely to
pose a significant hazard to the persons
handling the waste, but blood-caked
items may still cause environmental
(aesthetic) degradation, so these items
are included in Class 3 as described
above.
cL Class 4—Used Sharps. EPA's
regulatory description of Class 4. used
sharps, is based on section 11002 (a)(4),
and reads as follows:
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, test
tubes, 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.
Sharps, with the exception of certain
glassware, as explained below, are
universally recognized as requiring
stringent regulation under this program,
given the unique bio and physical
hazards as well as environmental
degradation problems associated with
used sharps (unused sharps are
addressed in a separate class). The
statutory waste type description has
been modified slightly to clarify that
sharps generated in care pf both humans
and animals are covered. It also
includes the word "treatment" to cover
sharps generated from the preparation
of human and annual remains for burial
or cremation. Syringes are included
under this class regardless of whether a
needle is attached because EPA believes
that this interpretation is consistent with
the intent of Congress under the Medical
Waste Tracking Act to minimize further
improper disposal of aesthetically
offensive medical wastes in the natural
environment. Blood vials and culture
dishes, which may also meet the
descriptions of Waste Classes 3 and 1,
respectively, were included in this class
because the packaging requirements for
sharps are more protective of waste
handlers. Needles with attached tubing
are included because of the physical and
biohazard that may be present .with the
needle.
EPA has included in Cla'ss 4 certain
wastes from RCRA section 11002(a)(7).
These wastes are slides and cover slips .
that were in contact with infectious
agents. In general, laboratory glassware
that was not in contact with infectious
agents does not pose the same kinds of
aesthetic concerns as other sharps and
is already adequately managed as
general refuse. Therefore, only slides
and cover slips that were in contact
with infectious agents are listed in Class
4.
Finally, because the physical and
aesthetic concerns are independent of
the nature of medical service provided,
EPA interprets Class 4 to cover sharps
used in veterinary services, as well as
human patient care.
e. Class 5—Animal waste. EPA's
description of Class 5 is based on
section 11002(a)(5], and reads as
follows:
Contaminated animal carcasses, body
ports, 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.
Two modifications were made to the
statutory language to clarify the wastes
included in this class. First, the phrase
"known to have been" was added to
emphasize that only wastes from
animals known to have been exposed to
infectious agents during research are
regulated medical waste. Without this
phrase, it would be difficult for
generators to identify accurately those
wastes that should be regulated, which
would make both compliance with and
enforcement of this regulation
problematic. This definition does not
include household pets, farm animals, or
wastes from farm animals unless they
were exposed to infectious agents
during research, production of
biologicals, or testing of
Pharmaceuticals.
The second clarification includes
veterinary hospitals as an example of a
research facility. This was suggested by
attendees at EPA's medical waste'
meetings, because such facilities may
generate contaminated animal waste.
Wastes generated by general veterinary
practices (e.g., small animals) are not
covered in Class 5. However, the reader
should note that sharps from veterinary
services are covered under Class 4.
As guidance in determining what
organisms are "infectious agents", the
reader may use those agents identified
in Classes 2, through 4 of the CDC's
Classification of Etiologic'Agents on the
Basis of Hazard (July, 1974, available in
the docket). Because EPA's definition of
"infectious agent" in 1259.10 is limited
to those organisms that cause disease or
adverse health impacts in humans, only
animal wastes potentially posing a
hazard to human health are covered in
Class 5.
f. Class 6—Isolation wastes. EPA's
regulatory description of this class is
identical to section 110Q2(a)(10) in all
but one respect, and reads as follows:
Biological waste and discarded materials
contaminated with blood, excretion,
exudates, or secretions from humans who are
isolated to protect others from highly
communicable diseases, or isolated animals
known to be infected with highly
communicable diseases.
Although the statute refers.to
"communicable diseases" generally, the
Agency believes that only certain highly
communicable diseases should be
included in the demonstration program.
Health care professionals recommend
that the scope of this class be limited to
only those specific diseases that are
sufficiently communicable to pose a
potential threat to public health (for
example, diseases caused by those
agents listed in Classification 4 by the
CDC in Classification ofEtiologic
Agents on the Basis of Hazard (1974)).
The Agency considered regulating all
wastes from isolation patients, but
concluded that many of the waste items
are already covered under other waste
classes, and that regulating all wastes
from isolation patients would needlessly
subject large amounts of waste to
handling and packaging according to the
requirements of the tracking program
even though the large majority of such
waste would be neither infectious nor
aesthetically objectionable. For
example, health care facilities have the
option of assessing which isolation
wastes, in addition to those required by
these regulations, should be managed as
regulated medical waste. EPA requests
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12342 Federal Register / Vol. 54, No. 56 / Friday. March 24, 1989 / Rules and Regulations
comments on its approach and
recommendations on any alternative
approaches.
g. Class 7—Unused sharps. Under the
authority provided by section
11002(a)(ll) of the MWTA, EPA has
elected to include the following unused,
discarded sharps as a class of regulated
medical waste: hypodermic needles,
suture needles, syringes, and scalpel
blades. The improper disposal of sharps
has, in some areas, presented sufficient
potential health hazard and
environmental degradation for local
officials to restrict public access to
beaches. When inappropriate
appearances of sharps occurs, as in the
example of beach wash-ups, it is neither
practical nor necessary to try to
distinguish used from unused sharps for'
several reasons. First, both used and
unused sharps present the same
physical hazard in terms of the potential
for puncture injuries. Second, time
usually does not allow for the testing of
improperly disposed sharps to
determine the presence of infectious
agents. Additionally, unused sharps
present the same possibility of aesthetic
degradation of the environment as do
used sharps. Given the legislative
history indicating serious Congressional
concern over environmental degradation
caused by sharps, the Agency believes
the combination of physical hazards and
aesthetic concerns are sufficient reasons
to list certain unused sharps as
regulated medical waste.
4. Determination To Exclude Certain
Waste Types
EPA has made a determination that
certain wastes listed in section 11002(a)
of RCRA do not pose a substantial
present or potential hazard to human
health or the environment when
improperly managed. EPA made this
determination after numerous
discussions with public health experts
and a thorough review of the available
Information, including contact with Dr.
William Rutala, a researcher who
conducts an annual literature review to
locate documented cases of disease
transmission. EPA has concluded that
items in waste types (l)-{5) have some
potential to cause harm, and has
structured today's rule so that the
wastes in sections 11002(a) (6)-(9) which
may pose a present or potential threat to
human health are regulated medical
wastes subject to Part 259 requirements.
The remaining wastes (those not
included within the waste classes listed
in the regulation) do not pose
substantial health or environmental
hazards. This determination is described
in more detail in the Background
Document for Part 259 Subpart D,
Listing of Medical Waste, available in
the docket for this rulemaking.
Under section 11002(b) of RCRA, the
Administrator is authorized to exempt
from the requirements of the
demonstration program any of the
wastes, by type or by item, listed in
sections 11002(a) (6)-{10) of the statute if
he determines that such wastes do not
pose a substantial present or potential
threat to human health or the
environment when improperly treated,
stored, transported, disposed of, or
otherwise managed. The sections
11002(a) (6)-(9) waste descriptions are
based on a waste's source and contain a
variety of items. Many of the individual
items in sections 11002(a) (6}-(9) are,
under certain conditions, already
included in the sections 11002 (a) (l)-(5)
waste types. For example, surgery
wastes such as scalpels and suture
needles are already included in section
11002(a)(4), and laboratory wastes such
as discarded tissue specimens are
already included in section 11002(a)(2).
EPA examined the remaining items in
sections 11002(a) (6]-(9) that are not
identified in section 11002(a) (1}~(5). and
has specifically listed in the regulation
certain items that may pose a
substantial health or environmental
hazard. As explained previously, used
slides and cover slips (from
laboratories] that were in contact with
infectious agents are examples of items
from sections 11002(a) (6)-{9) that were
included in the regulation. Thus, EPA
has determined it is not necessary to list
sections 11002(a) (6)-(9) specifically in
today's rule.
For the remaining wastes included in
sections 11002(a) (6) through (9), in
comparison to the wastes that Congress
mandated to be subject to the tracking
program due to their potentially harmful
physical properties (e.g., sharps) and/or
biological properties (e.g., blood or
cultures), the items to be excluded do
not exhibit either property sufficiently to
warrant inclusion in the demonstration
program. (In evaluating the potential for
wastes to present an infection hazard,
factors such as the presence of a
pathogen at its infecting dose, the
pathogen's portal of entry to the body,
and the host's resistance to infection
must be considered.) EPA also
conducted a thorough review of
available information and consulted
with representatives of the Centers for
Disease Control, the National Institutes
of Health, other health care
professionals, and State officials; based
on these consultations, EPA did not find
evidence that the handling of those
remaining wastes included in sections
11002(a) (6) through (9). not already
addressed in EPA regulated medical
waste Classes 1 through 7, present a
substantial hazard to human health or
the environment when mismanaged. On
this basis, the Agency believes that
wastes in sections 11002(a) (6) through
(9) that are not already included in the
EPA Classes 1 through 7 should not be
included in the demonstration program.
In certain instances, EPA recognizes
that a health care professional may
determine that some wastes in sections
11002(a) (6) through (9) should be
handled as infectious wastes based on
the professional's experience and
knowledge of the waste in light of the
specific conditions necessary to transmit
disease (presence of a pathogen of
sufficient virulence; dose; portal of
entry; and resistance of host). In these
instances, consistent with the Agency's
1986 guidance document, EPA
encourages the health care provider to
manage such wastes as regulated
medical waste. However, EPA believes
that the decision on how to manage such
wastes is appropriately made by the
generator on a case-by-case basis
according to its established infection
control procedures.
In summary, as described above, EPA
believes that the demonstration program
and its tracking requirements are
targeted to those wastes that have been
improperly managed and on those likely
to pose a substantial threat to human
health and the environment. If, as a
result of the demonstration program and
other studies required by the Act, the
Agency determines that additional
wastes are posing a substantial threat to
human health or the environment, EPA
may expand the list of regulated medical
waste to ensure strict management of
problem wastes.
5. Unregulated Medical Wastes
Certain wastes generated in a medical
setting or research laboratories that are
not covered in the listing of regulated
medical waste are not subject to the
Part 259 regulations, except for mixtures
described below. EPA nonetheless
recommends that any waste that an
individual practitioner or health care
professional believes may pose a risk of
disease transmission should be handled
as a regulated medical waste.
6. Mixtures .;
EPA is requiring mixtures of regulated
medical waste and other nonhazardous
solid waste, including non-regulated
medical waste, to be regulated under
today's requirements. This requirement
is established to prevent parties from
avoiding regulation through mixing.
Also, the physical and aesthetic
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Federal Register / Vol. 54, No. 56 / Friday, March 24. 1989 / Rules and Regulations 12343
properties that caused Congress*
concern over many of these wastes are
not removed by mixing and such
mixture would be inconsistent with the
Congressional mandate that medical
wastes be segregated to the extent
practicable. •'. . •
However, mixtures of regulated
medical waste with hazardous waste
that is subject to the hazardous waste
manifest requirements are subject to
regulation as hazardous waste, not
medical waste (See § 259.31). EPA has
determined that when regulated medical
waste is mixed with hazardous waste,
and the resulting mixture; is otherwise
subject to the hazardous waste
manifesting requirements, it is
unnecessary to require an additional
tracking form for the medical waste
component of the mixture.
7. Exclusions and Exemptions
Section 259.30(b) pf today's rule
identifies seven provisions under which
medical wastes are not subject to the
requirements of the demonstration
program. This section of the Preamble
explains five of those provisions. The
provisions for household and hazardous
waste exclusions are discussed
elsewhere in the Preamble.
k. Incinerator ash and treatment/
destruction residue. Regulated medical
waste that has been both treated, so as
to substantially reduce or eliminate its
potential for causing disease, and
destroyed, is no longer regulated
medical waste, but generators who both
treat and destroy regulated medical
waste on-site are subject to certain
recordkeeping requirements under this
Part while they conduct the treatment
arid destruction. In addition, section
HOOSfa) specifically excludes waste
which has been incinerated from the
tracking program. In today's regulation,
these two types of residues cease to be
regulated medical waste at the point
where the incineration has been
completed, or at the point where both
treatment and destruction processes
have been conducted.
Processes such as incineration involve
reducing or eliminating the biological
and physical hazard of the wastes, as
well as their visually offensive nature, to
the extent that they are no longer likely
to pose a substantial threat to human
health or the environment in the event of
mismanagement. Residues from wastes
that have been treated and destroyed
(e.g., waste that has been
decontaminated and ground up) and
incinerator ash are no longer Regulated
medical waste" and can be managed
under other applicable requirements for
such residues. The Agency believes that
it is sound policy tn encourage treatment
to reduce the biologic and physical
hazard of regulated medical wastes as
early in the waste management chain as
possible, thereby minimizing the
potential impacts resulting from
mismanagement of the waste. •
Under § 259.30(b)(l)(iv) the first
criterion, treatment, is satisfied if the
waste is processed by a means designed
to reduce levels of infectious agents. The
purpose of this provision is to ensure
that the concentration of
microorganisms capable of causing
disease in humans is reduced so as to
render such waste noninfectious or less
infectious and, thus, safer to handle,
transport, and dispose of. However,
waste need not be sterilized. The
treatment processes commonly
available are not 100% effective in
inactivating microorganisms. Complete
inactivation is unnecessary, since any
refuse is expected to support some level
of bacterial activity.
In the context of medical waste
management, "treatment" is defined as
any method, technique, or process
designed to change the biological
character or composition of medical
waste so as to eliminate or reduce its
potential for causing disease. EPA's 1986
guidance document, EPA Guide for
Infectious Waste Management (U.S.
" EPA, Office of Solid Waste and
Emergency Response, EPA/530-SW-86-
014, May 1986), describes many of the
techniques available for adequately
treating regulated medical waste. As tha
guidance document explains,
incineration and steam sterilization
(autoclaving) are the most common
treatment methods for medical wastes.
There are, however, several other less
commonly used treatment methods that
are acceptable for certain waste types,
such as chemical disinfection, thermal
inactivation, and irradiation. Not all of
these processes will meet the treat and
destroy criteria, but some combinations
(e.g., chemical disinfection followed by
grinding) may indeed meet both criteria.
EPA strongly encourages operators of
treatment devices to become familiar
with these guidelines. Further, the
Agency recognizes that methods and
technologies other than those discussed
in the guidance document may be
available for treating medical waste and
does not want to discourage emerging or
innovative technologies. Regardless of
the method chosen, the important point
is that the operator should understand
the factors affecting the effectiveness of
the treatment method used and establish
a program to ensure that the treatment
objectives ana met. Specifically, EPA
recommends:
i. Using standard operating
procedures for each process employed
for treating regulated medical waste;
ii. Monitoring all treatment processes
to ensure efficient and effective
treatment;
iii. Using biological indicators to
monitor treatment (other indicatorsjnay
be used, provided that their
effectiveness has been successfully
demonstrated); and
iv. Selecting treatment methods
appropriate for the waste types being
treated. • ' -
The lack of an objective treatment
standard for determining whether a
waste has been disinfected is
problematic. Data are not currently
available to establish objective
standards. A long-term goal of EPA's
medical waste program is to evaluate
the effectiveness of various treatment
alternatives and either to issue
additional guidance or promulgate
treatment standards. Additionally,
generators and treatment facility owners
and operators are advised to consult
with the waste management agency in
their State to determine if additional
requirements apply. States may require
operating plans or specify operating
conditions or monitoring methods.
The second criterion in
§ 259.30(b)(l)(iv), destruction of the
waste, is satisfied when the waste is
ruined, torn apart, or mutilated so that it
is no longer generally recognizable as
medical waste. EPA has determined that
when waste has been both treated
(substantially removing or reducing any
biological hazard) and destroyed,-all of
the Agency's concerns (i.e., biological
and physical hazards, and aesthetic
degradation) have been addressed, and
tracking of the waste is unnecessary.
Processes capable of destroying
medical wastes include incineration,
grinding, shredding, crushing, or melting.
EPA recognizes that a determination of
when a medical waste is "destroyed" is
somewhat subjective, but believes this
standard is workable in practice for
owners or operators of treatment and
destruction facilities, and for generators.
Moreover, Congress acknowledged the
validity of the "rendered
unrecognizable" standard, in section
11008(a)(6), with respect to medical
waste treatment and the protection of
human health and the environment.
One currently used method that meets
both conditions involves the
combination of chemical disinfection
and grinding. Another process that could
achieve the same results involves steam
sterilization followed by shredding. EPA
notes that for grinding processes,
"destruction" can generally be assessed
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12344 Federal Register / Vol. 54, No. 56 /'Friday, March 24, 1989 / Rules and Regulations
by use of a mesh size determination for
the ground particles. The processes
currently in use can generally achieve a
% inch mesh size (i.e., the resulting .
particles will pass through screening
having one-half inch wide openings).
This standard is only being used as a
guide, however, because no grinding
process that EPA is aware of can
achieve a % inch particle size for 100%
of the material.
It should be noted that the exclusion
applies to wastes at the point in the
waste management chain when the
waste has been both treated and
destroyed. If wastes are treated and
destroyed on-site by the generator, they
typically enter the general refuse waste
stream directly and are not subject to
the substantive requirements of the
demonstration tracking program.
Regulated medical waste that is shipped
off-site for treatment is subject to the
requirements of the demonstration
program up to the point it is treated and
destroyed. After it has been treated and
destroyed, it is no longer regulated
medical waste.
Finally, EPA has included a
requirement for persons claiming that
they have caused regulated medical
waste to meet the terms of the exclusion
to maintain records of the amounts of
waste treated and destroyed (and
therefore excluded from regulation). The
records could be simply a log onto
which entries are made on a regular
basis (i.e., daily, per batch, etc.).
Generators who use on-site incinerators
must keep these records under § 259.61,
discussed elsewhere-in the Preamble, in
which case no additional recordkeeping
is required. Generators using processes
other than incineration are not subject
to S 259.61, but, nonetheless, must keep
records to qualify for the exclusion
under i 259.54(c). ,
EPA believes such a recordkeeping
provision is necessary to ensure the
exclusion is not abused by persons who
do not track their waste and do not
really meet the terms of the exclusion.
EPA notes that when a broad remedial
scheme is established, such as Subtitle J,
the burden of proof should fall on
persons claiming any available
exclusions or exemptions from that
scheme.
b. Human remains. The regulation
provides that human remains (e.g.,
corpses and anatomical parts) that are
stored, transported, or otherwise
managed for purposes of interment or
cremation, are not subject to any
requirements of this part, because such
human remains are not "regulated
medical waste". Inclusion of this
provision in the regulation is for
purposes of clarification.
c. Etiologic agents. The Agency
recognizes that etiologic agents are
being transported interstate between
facilities according to regulations set by
the U.S. Department of Transportation
and the U.S. Department of Health and
Human Services. The Agency believes
that those existing regulations ensure
safe packaging, handling, and transport
of these materials and, thus, these
materials should be exempt from today's
rule. However, when' etiologic agents
that are regulated medical waste are
intended for discard and are not being
transported according to DOT and HHS
regulations, they are subject to all of the
requirements of today's rule.
A. Enforcement samples. Sample's, of
regulated medical waste obtained
during enforcement procedures by
authorized EPA personnel or States
using Federal authorities are exempt
from the requirements of this Part. These
samples, typically small in volume,
temporarily taken out of the waste
management system for evaluation, and
subject to the oversight of government
agencies involved in legal proceedings,
are unlikely to be mismanaged.
However, when such evaluations or
legal proceedings are concluded, the
sample will again be subject to all of the
requirements of today's rule.
8. Relationship to Previous EPA
Definition
In addition to providing guidance on
waste management practices, the EPA
Guide for Infectious Waste
Management provides a definition of
"infectious waste." The recommended
definition includes six waste types that
should be managed according to the
guidelines and four "optional" types that
could be managed as either infectious
waste or general refuse at the discretion
of the generator.
Today's rule does not define
infectious waste; rather, it defines those
medical wastes that are subject to the
requirements of the demonstration
program, regardless of infectiousness.
Actual or potential infectiousness of a
waste is only one criterion the Agency
used to determine which wastes must be
tracked under this program; physical
hazard and potential aesthetic
degradation of the environment are also
major considerations.
Generators may continue to follow
EPA guidelines for waste management
within their facilities; however, when
regulated medical wastes are generated
in Covered States, such wastes are
subject to the requirements of the
demonstration tracking program
described in these provisions. Any
suggestions in the EPA Guide for
Infectious Waste Management that are
not completely consistent with the Part
259 requirements would be superseded
by today's regulations. Generators in
non-Covered States should continue to
rely on the EPA Guide, and must comply
with applicable State and local rules.
In summary, regulated medical waste
that has been treated and destroyed is
exempt from all but certain
recordkeeping requirements under
'today's rule. The reader should note that
waste that is treated, but not destroyed.
must be tracked but is subject to certain
reduced requirements. (This is discussed
later in the Preamble.) Also, generators
are required to classify their wastes as
"untreated" or "treated" on the tracking
form, and transporters must report
quantities of such wastes transported.
As explained later in the Preamble, EPA
will be collecting information to
determine changes in treatment
practices over the life of the
demonstration program.
The Agency welcomes comments on
the general definition of regulated
medical wastes, on the appropriateness
and content of the list of regulated
medical wastes, and on the exclusions
and exemptions provided. EPA also
requests comments or suggestions for a
more objective method of determining
what constitutes "treated and
destroyed."
E. Subpart E Pre-transport
Requirements
The Act requires EPA to include
specific requirements for segregation,
packaging, and labeling of medical
waste regulated in the demonstration
program. As a result, today's rule
includes pre-transport requirements for
medical waste, including requirements
for segregating regulated medical wastes
from other types of solid waste (e.g.,
general refuse, hazardous wastes),
separating medical wastes by category
(untreated and treated), packaging the
medical wastes, and labeling and
marking the packaged materials. The
requirements of Subpart E generally
apply to those regulated medical wastes
generated in a Covered State that are
transported, or offered for transport, off-
site. Wastes that are treated and/or
disposed of on-site at a generator's
facility are subject only to the general
storage requirements of § 259.42. Most of
these requirements are applicable to,
and must be complied with by, the
generator. Several of the requirements
may also apply to transporters and
treatment facilities (e.g., storage).
Generators must ensure that all
medical waste oubject to these
regulations meets all pre-transport
requirements prior to shipment or being
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offered for shipment off-site, either from
the generator's facility or from any"
intermediate site of treatment and/or
storage. Wastes treated on-site prior to
being transported off-site for disposal
must meet all pre-transport
requirements before being shipped off-
site. However, as discussed above,
medical wastes that are incinerated or
otherwise "treated and destroyed" on-
site are exempt from these regulations
under 1259.30(b}(2). Regulated medical
wastes retained on-site prior to
incineration or other treatment or
disposal processes must be stored in a
manner that will prevent unauthorized
access to the waste and will keep the
waste free of animals and pests. The
regulated medical wastes to be
incinerated on-site are not subject to
any other pre-transport requirements.
Incinerator ash is exempt from Part 259
requirements, but must be managed hi
accordance with applicable Federal,
State, or local requirements. Regulated
medical wastes that will be incinerated
off-site must meet all pre-transport.
requirements prior to transport.
EPA's intent, in establishing
segregation, packaging, labeling, and
marking requirements for regulated
medical wastes, is to ensure proper
containment of the waste and to protect
workers, handlers, and the general
public from exposure to these materials.
EPA intends for all packages containing
regulated medical wastes to be labeled
and marked and, therefore, easily
identified as medical waste. Generator
compliance with these rules will alert
workers and waste handlers to take
necessary precautions when handling or
transporting the waste to protect
themselves and the environment. As
discussed below, the generator's
signature on the tracking form is the
generator's certification that the waste
is packaged, labeled, and marked
properly.
1. Segregation Requirements (Section
259.4O)
a. General. This section requires
generators of medical waste to segregate
all categories of medical waste, to the
extent practicable, prior to transport off-
site. EPA believes it is generally
necessary to segregate sharps, including
sharps containing residual fluids, and
fluids in quantities greater than 20 cubic
centimeters (cc) from all other medical
waste, as well as to segregate these
wastes from each other. EPA believes
that sharps and fluids pose special
problems in waste handling and are best
managed if placed in" special containers.
If not segregated, these items can
contaminate other medical waste.
Segregating sharps arid fluids should
increase the integrity and safety of all
medical waste packaging and protect
those persons handling the waste. Used
needles, syringes, and other sharps,
including the residual fluids contained
therein, must meet more stringent
packaging requirements than all other •
waste. In addition, fluids in quantities
greater than 20 cubic centimeters (cc)
must meet certain packaging
requirements. Other regulated medical
waste must be segregated, to the extent
practicable, from other waste (e.g.,
hazardous, radioactive, or general
refuse), as well as from sharps and
fluids.
b. Mixing of regulated medical waste.
When regulated medical waste cannot
be segregated from other waste (i.e., it is
not practicable), the generator must
ensure that the waste is packaged and
marked according to the applicable
packaging requirements. For example, if
general refuse is placed in the same
container as fluids, then the packaging
must meet the requirements for fluids.
Further, if "untreated" regulated medical
waste is mixed and co-packaged with
"treated" regulated medical waste the ,
package must be labeled and identified
on the tracking form as "untreated
medical waste." The scheme outlined
above provides incentives for
segregation when it is advantageous for
the generator to do so, but still does not
preclude co-packaging when the
generator determines it to be necessary
or appropriate.
2. Packaging Requirements (Section
259.41)
Section 11003 of the MWTA requires
that the demonstration program include
requirements for packaging medical
waste that will protect waste handlers
and the public from exposure to the
dangers posed by medical waste. Under
today's rule, generators must make
certain that all medical waste is
packaged prior to being transported or
offered for transport off-site to ensure
the containment of the waste, the
protection of workers and waste
handlers from exposure to the waste,
and the protection of human health and
the environment.
Today's rule requires that all
regulated medical waste to be managed
off-site must be packaged in rigid, leak-
resistant packaging. Any number of
containers may be used to satisfy the
basic performance requirements; for
instance the combination of a plastic
bag and a rigid cardboard box generally
could satisfy the performance standards
of "leak-resistance" and "rigid."
Although the plastic bags and other
containers commonly used for waste
collection within the facility are
generally able to withstand the stresses
of handling and transport within the
facility, the Agency believes that
additional, rigid containerization is
required to ensure integrity of the
packaging during transit off-site. The
generator must ensure that the § 259.41
packaging requirements are met prior to
the waste's being transported off-site. In
a hospital setting, this means that
wastes could be placed in containers
(such as bins) meeting the requirements
in a central location, such as a loading
area. •
The Agency believes that these
packaging requirements are an effective
way to containerize waste that has been
accumulated according to the common
established collection and handling
practices utilized in the health care
setting. Comments submitted by an
association representing waste handlers
in response to the June 2,1988 Federal
Register notice (53 FR 20140) support the
requirement for rigid packaging for
waste that is transported off-site.
The Agency recognizes that, if the
generator decides to double package the
waste to meet the requirements,
increased handling and disposal costs
may result. To increase the options
available to the generator and
transporter, today's regulations provide
for the utilization of reusable containers,
such as bins and drums, provided a liner
is used or the container is
decontaminated prior to reuse.
The Agency has not established
special packaging standards for bulk
materials (e.g., animal bedding) that are
classified as regulated medical waste,
since it is uncertain that a need exists
for transport of such regulated medical
wastes in bulk. The Agency requests
comment on whether generators of
regulated medical waste foresee the
need to provide for bulk transport and
any special packaging requirements that
might be considered.
Today's rule also specifies special
packaging requirements for sharps and
fluids. EPA's basic objectives in
establishing these packaging
requirements are: (a) To ensure that aJ
wastes are properly contained, without
leakage or release into the environment;
and (b) to provide flexibility in how
parties may meet the standards.
The Agency has been requested to
establish specific performance
standards by some interested parties tor
specific types of containers (i.e., plastic
bags, sharps containers, and boxes)
when used for containment of regulated
medical waste during transport
However, the Agency believes that it is
inappropriate to specify specific
performance standards for such
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containers, since packaging materials
vary extensively in their physical and
mechanical properties. For instance, it is
quite possible that a 1-mil-thick film of
one polymer material will be more
puncture, impact, and abrasion resistant
than a 2-mil-thick film of a different
polymeric material. The physical
properties can be affected further by the
manufacturing process, such as
extrusion and injection molding. The
most appropriate manner of determining
the suitability of a particular container
with respect to its ability to resist
puncture, leaking, and/or breaking
under individual usage conditions is to
subject the container to those
conditions. Therefore, in today's rule,
the Agency has set general performance
standards for packaging of regulated
medical waste. EPA requests comment
on the appropriateness of these
standards. The standards, discussed
next, include general requirements for
all regulated medical waste, and
additional requirements for sharps and
fluids.
a. General packaging requirements. In
all cases, regulated medical waste
intended for transport offsite must be
placed in a single container or a
combination of containers that is rigid
and leak resistant. For example, a box,
pail, drum, or other container that can
be closed or secured to prevent leakage
during shipment could satisfy the "rigid"
performance standard, and in some
cases could satisfy the "leak-resistance"
requirement as well. In other cases, a
plastic bag used as an inner liner may
be necessary to satisfy the "leak-
resistance" requirement, or even more
protective packaging may be necessary.
The rule does not specify the containers'
composition or size, thus providing as
much flexibility in packaging as
possible. If untreated regulated medical
waste is packaged in plastic bag(s), the
bag(s) must be red in color or display
the universal biohazard symbol. The
bag(s) must-be sufficiently sturdy to
prevent tearing or breaking and must be
sealed securely to prevent leakage.
When treated regulated medical waste,
other than sharps and fluids, is
packaged in plastic bag(s), it must be
packaged similarly to untreated
regulated medical waste,"except the
bag(s) does not need to be labeled.
Labeling requirements are discussed in
section V.E.5. Reusable containers may
be used, as well as containers that can
be loaded on pallets and moved by
forklift or mechanical mean's, as long as
the handling procedures do not subject
the containers to.undue mechanical
stress or compaction.
b. Sharps and fluids packaging
requirements. EPA is requiring that all
sharps, including those that contain
residual fluids, be placed in packaging
that is rigid, leak-resistant, and
puncture-resistant. If the container(s)
cannot be sealed to prevent leakage, it
must be placed in a plastic bag or other
leak-resistant container that can be '
sealed to prevent leakage. The intent is
to ensure that sharps and associated
residual fluids (often blood) are securely
contained and the integrity of the
packaging is maintained from the time
the waste leaves the generator's site
until the time the waste is disposed of or
is treated and destroyed.
The rule specifies that fluids in
quantities greater than 20 cubic
centimeters shipped off-site for
treatment and/or disposal be packaged
in packaging that is rigid, leak-resistant,
and break-resistant to guard against
spillage. All vessels or containers must
be tightly sealed or stoppered to prevent
leakage or spillage during transport.
Fluids should not be placed in glass
containers, since these containers may
break during transport or handling.
Blood bags and other non-rigid
containers of fluids that contain more
than 20 cc of fluid are required to be
packaged as fluids (see § 259.41 (b)(2)),
since these items contain quantities of
fluid which could be released during
waste handling, contaminating other
waste and posing a hazard for waste
handlers.
Syringes and other containers such as
vials and blood bags that contain fluids
in quantities of greater than 20 cubic
centimeters (cc) may be emptied prior to
packaging. EPA has established a fluid
residual level of up. to 20 cc's that may
remain in syringes, tubing, vessels, and
containers and still allow the waste to
be packaged under the requirements of.
§ 259.41 (a) and (b)(l) only. This 20 cc
level has been established based on the
State of New Jersey's regulations, as a
conservative estimate of the residual
volume of fluid that will remain in a
container after it has been emptied. The
Agency is concerned that attempts to
remove all remaining fluids may expose
health care workers to additional risk,
and such small volumes of fluid should
not present any significant potential for
contaminating other wastes or waste
handlers.
c. Packaging requirements for
oversized medical waste. EPA has not
established specific packaging
requirements for "oversized" medical
waste as defined in § 259.10. Wastes
falling into this category include
regulated medical waste too large to be
adequately packaged in accordance
with the above standards (i.e., the waste
will not fit in standard-sized plastic bags
or containers). These wastes should be
managed to protect the waste handler
and public from exposure;
3. Storage Requirements (Section 259.42)
Although an optimal medical waste
management plan might involve the
same-day collection and treatment of
regulated medical waste, many
generating facilities are unable to
accommodate this management scheme.
This is particularly true for parties
generating relatively small quantities of
regulated medical waste. Thus,
regulated medical waste intended for
disposal off-site may require storage
prior to transport off-site.
The Agency, in referring to on-site
storage prior to transport, is referring
specifically to that area of the facility
where waste is stored or accumulated
prior to off-site transport or disposal (or
incineration or treatment/destruction
on-site). Typically, it is the area within a
generator's facility where waste is put
into secondary containers, packages are
marked and labeled, and where the
medical waste tracking form is 7
completed. As explained previously, the
Agency is not regulating intermediate
accumulation areas, such as the area of.
the facility where waste is first
generated (e.g., patient rooms, operating
rooms, laboratories and waste holding
areas (areas of the facility where waste
is accumulated and temporarily held))
until it is moved to the facility's final on-
site storage and packaging area.
The storage requirements in today's
rule are also applicable to regulated
medical waste during transport and
prior to treatment and disposal. These
requirements will reduce the potential
number of occurrences where, the public
could be exposed to the waste.
EPA has established limited
requirements to provide a minimum
Standard of safety and to ensure
containment of the medical waste under
the general authorities of sectipn
11003(a)(4)(A) and (B), which require
segregation and proper containment of
waste to protect the public from
exposure. EPA recognizes that
individual States or localities may
determine that additional requirements,
or more specific' requirements, are
necessary. EPA is considering
developing guidance (e.g., as part of a
Model State Program) to aid States in
the development of storage standards.
Under today's rule, regulated medical
waste must be stored in accordance
with the following requirements: (a)
Regulated medical waste must be stored
in a manner and location that maintains
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12347
the integrity of the packaging and
affords protection from water, rain, and
wind; (b) regulated medical waste must
be maintained in a nonputrescent state
to avoid becoming a nuisance to
workers and the public. Refrigeration
may be necessary depending on the type
of waste stored and the length of the
storage period; (c) regulated medical
waste, can be stored in outside storage
areas (e.g., dumpsters, sheds, tractor
trailers) only if the areas are locked to
prevent unauthorized access; (d)
regulated medical waste stored on-site
must be contained in a secure, locked
area, with access limited to authorized
waste handlers and employees in order
to prevent exposure to the public; and
(e) regulated medical waste must be
stored in a manner that affords
protection from.animals and does not
provide a breeding place or a food
source for insects and rodents.
EPA believes these are good
housekeeping practices which are
necessary to maintain proper sanitary
conditions and which will protect the
public from exposure. Comments are
requested on these requirements and on
the need for additional requirements.
4. Decontamination Standards for
Reusable Containers (Section 259.43)
EPA is promulgating in today's rule
general requirements for the
decontamination of packaging/shipping
containers to allow for their reuse
without compromising the safety of
waste handlers. Any rigid container
which is reused must be 'decontaminated
prior to reuse if the container is visibly
contaminated. If, for any reason, a
container cannot be decontaminated
and rendered free of visible
contamination, the container will be
considered regulated medical waste and
must be handled, treated, and disposed
of as such. Inner liners used in
conjunction with reusable containers
must be disposed of with the regulated
medical waste they contain. EPA's goal
is to ensure protection of all waste
handlers. Therefore, any non-rigid
package liners must remain intact and
be disposed of with the waste, and may
not be reused.
Section 259.43(b) requires containers
to be free of any visible signs of
contamination prior to reuse. Under
§ 259.43(c), any container that cannot be
rendered free of visible contamination
must be managed as regulated medical
waste. The Agency is not requiring
waste handlers to utilize any specific
method to decontaminate containers in
these regulations because there was
insufficient time to conduct technical
studies to determine the effectiveness of
various methods. EPA suggests tha<
reusable containers be thoroughly
washed and decontaminated each time
they are emptied, unless the surfaces of
the containers have been completely
protected from contamination by
disposable inner liners, bags or other
packaging devices removed with the
waste. Review of State standards
indicates that suggested methods of
decontamination include, but are not
limited to, agitation to remove visible
contaminants combined with one of the
following procedures: (a) Exposure to
hot water of at least 82 "C (180 °F) for a
minimum of 15 seconds; or (b) exposure
to chemical disinfection in accordance
with the EPA-approved label directions
for hypochlorite, iodoform, or
quaternary ammonium antimicrobial
products. The Agency requests comment
on the appropriateness of these
suggested decontamination methods and
other methods which may be in use.
5. Labeling Requirements (Section
259.44)
Section 11003 of the MWTA requires
EPA to establish appropriate
requirements for the labeling of
regulated medical waste containers or
packages. The purpose is to ensure that
regulated medical waste can be easily
identified as such during shipment and
disposal. Under today's rule, EPA is
requiring that each package containing
untreated regulated medical waste be
imprinted or affixed with a label
including the words "Infectious Waste,"
"Medical Waste," or a label displaying
the universal biohazard symbol. When a
red bag is used as a container, however,
the color red is recognized as an
indicator that the bag contains untreated
regulated medical waste and serves the
same function as the label. However, a
label is always required on the outer
surface of an untreated regulated
medical waste package, regardless of
the color of the package.
Regulated medical waste categorized
as "treated medical waste", discussed
above, does not require a label on the
package. Such waste poses a
substantially reduced risk of disease
transmission, and a label indicating
"infectiousness" would not be
appropriate.
8. Marking (Identification) Requirements
(Section 259.45)
Today's rule requires generators to
ensure that all packages of regulated
medical waste, including treated
medical wastes and oversized medical
wastes, that are shipped off-site be
marked clearly to identify both the
generator and transporter of the medical
waste. The purpose of this requirement
is to facilitate identification of the
generator and transporter of any
regulated medical waste that is found to
be mismanaged or disposed of
improperly. All containers must be
marked with the identity of the
generator. The marking(s) placed on the
outer surface of the package, once it has
been prepared for shipment, must also
include the identity of the transporter,
the date that the waste is removed from
the generator's site, and identification of
the package's contents as medical
waste. In conjunction with the date,
other markings may be used to indicate
or establish the unique shipment (e.g.,
the tracking form number, a bar-code
label, or some other assigned box
number). All such tags or markings must
be water resistant to ensure survival of
the information in the event the
package(s) or container(s) becomes wet.
The marking, affixed to or. placed on
the package must specify the name of
the generator and the generator's State
permit or identification number. If the
State does not issue permit or
identification numbers, then the
generator's address must be used.
Because EPA will not be issuing any
generator identification numbers under
this demonstration program, the
generator's permit or identification
number will be any such identification
number that is required by the State.
Generators can use pre-printed
markings or have the marking printed
directly on the package. The
identification tags must be of sufficient
dimensions to contain all of the
information required and should be
printed with lettering sufficiently large
to be read easily.
Markings placed on the outermost
surface of the package must contain, in
addition to the generator identification
information, similar information for all
transporters (i.e., transporter's name,
address, and/or State permit or
identification number). Generators
should obtain this information from
transporters; transporters may provide
generators with pre-printed tags, or may
mark the packages for the generator
prior to acceptance. The marking also
must include the date the package was
shipped in order to facilitate tracking of
individual shipments.
When regulated medical waste is
handled by more than one transporter,
each subsequent transporter must affix
an additional, separate identification tag
to the outermost surface of the package
with the transporter's name, address
and/or State permit or identification
number, and the date of transfer (see
' § 259.70[e)). All such tags should be
placed on the secondary package so a'
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12348 Federal Register / Vol. 54, No. 56 / Friday. March 24, 1989 / Rules and Regulations
not to obscure previously placed tags or
markings.
F, Subpart F—Generator Requirements
The generator's role in tracking
medical waste is vital since he is
responsible for packaging, labeling, and
marking the waste and for initiating the
tracking process. The following
paragraphs describe major sections of
the generator regulations in Subpart F of
Part 259.
1. Applicability and General
Requirements (Section 259.50)
a. General. The rule requires all health
care providers or other affected facilities
located in the Covered States to
determine whether the wastes they
generate are regulated medical wastes.
The Agency will work with the States,
trade associations, and other Federal
agencies to inform generators in the
Covered States of their new
responsibilities under today's rule.
Generators who generate mixtures of
regulated medical waste and hazardous
waste may be subject to today's rule for
those mixtures if the waste is not
subject to the manifesting requirements
of Subtitle C. Mixtures of regulated
medical waste and radioactive wastes
are subject to today's rule (see Section
VII. A of the Preamble).
Under today's rule, vessels (including
foreign-flagged ships) must manage any
regulated medical waste according to
these regulations when at port in a
Covered State, and when such waste is
to be removed from the vessel for
transport and disposal. In situations
where a ship is docked at a shore base,
the shore base may perform the
generator functions, such as maintaining
records and initiating the tracking form,
if waste is to be sent off-site, provided
that the waste is stored at all times in
compliance with the on-site storage-
provisions hi § 259.42. In this situation,
the ship operator and shore base
operator are "co-generators" of the
waste, and either may assume generator
responsibilities. However, both parties
remain liable for compliance.
Wastes managed at the generator's
site through incineration, disposal to the
sewer, or burial, are not subject to the
segregation, packaging, labeling,
marking, or tracking requirements.
These wastes are subject, however, to
storage requirements (§ 259.42) prior to
on-site disposal. Additionally, all
medical wastes incinerated on-site are
subject to a Congressionally-mandated
recordkeeping and reporting
requirement, discussed below. As,
discussed above, persons who claim the
"treated and destroyed" exemption must
also maintain certain records.
b. Generator exemptions according to
quantity. Generators who will be
sending their medical waste off-site
must estimate quantities that will be
shipped off-site to determine if they may
be subject to reduced tracking
requirements, as discussed below.
Section 11003(b) allows EPA to
establish an exemption from the
tracking requirements for generators of
small quantities of regulated medical
waste based on the quantity generated
per calendar month. EPA has
determined that some form of exemption
from the full tracking requirements is
appropriate for generators of less than
50 pounds per calendar month, because
the paperwork burden resulting from
tracking each shipment individually
would overwhelm generators,
transporters, treaters and disposers,
making the whole tracking system
virtually impossible to administer and
thus ineffective. This would be
especially problematic in a program of
short duration that affects persons not
formerly subject to similar regulation
where Congress clearly envisioned
expeditious implementation.
Discussions with State officials and
health care organizations indicate that
under the definition of "regulated
medical waste" in today's rule, the
universe of generators in the less than 50
pounds per month category would be
extremely large (in excess of 100,000).
EPA considered an outright exemption
under which waste from this category of
generators could be disposed of in the
normal (e.g., general refuse) solid waste
stream. (This would be similar to the
"small quantity" hazardous waste
generator exemption under 40 CFR
261.5.) EPA rejected this option because
some problems have been caused by
relatively small quantities of medical
waste being improperly managed.
For the reasons discussed above,
under today's rule, generators of less
than 50 pounds per month of regulated
medical waste are responsible for:
proper packaging, labeling, and marking
of waste; use of transporters who have
notified EPA; and use of a log to record
when waste is transported off-site (see
§ 259.50(e)(2)). These generators are not
required to complete a tracking form for
each shipment, nor are they required to
comply with the associated exception
reporting requirements. These two
exemptions should result in a significant
reduction of the paperwork burden for
medical waste managers. EPA believes
this limited exemption achieves the
appropriate balance between the need
to ensure that even very small quantities
of medical waste are properly managed
and the need to develop a program that
can be quickly and easily implemented.
Comments are requested on the/,.
approach described above.
There are two further considerations
related to generators of less than 50
pounds per month. First, wastes ;
disposed on-site (e.g., land-filled ,or
sewer-disposed) are not counted
towards the 50 pound limit. Since these
wastes would not be subject to the
tracking requirements of today's rule, it
is not appropriate to change a •-'-
generator's regulatory status based on
the amount of material not sent offrsite.
(EPA notes that a similar concept is
used in the hazardous waste rules at 40
CFR 261.5.) Also, the reader should note
that a generator need not count the ••
weight of the packaging materials -
against the 50 pound per month limit,
Second, the tracking requirements of
today's rule apply in full to a generator
of less than 50 pounds per month, if he
accumulates his waste on-site and ships
a package or packages with a total
weight of 50 pounds or more at, any one
time or in.any calendar month. The
small generator exemption is thus ;
limited to persons who generate less -i
than .50 pounds per month and ship less
than 50 pounds at any time. The purpose
of the 50 pound shipment rule is to -
overcome the difficulties in ensuring
compliance with the generator's
determination that he generates less •
than 50 pounds per month. Thus, the i'
shipment rule establishes a clear
measure for generators and transporters
as to when a tracking form must
accompany individual shipments of >
waste. •
Under Subpart H of today's rule,
transporters who' pick up wastes from
generators producing less than 50 . .
pounds per month will be responsible
for initiating a tracking form for those
wastes. However, transporters are
allowed to initiate a single tracking form
to cover all of the waste present on each
truck that is generated by generators of
less than 50 pounds per month. A
separate tracking document for each
generator is not required. Therefore,
while the generator is relieved of some
of the paperwork burden, his waste still
will be responsibly tracked and
handled. This is somewhat different
from the approach under the hazardous
waste regulations. In the hazardous
waste regulations, EPA does not
regulate waste from generators of less
than 100 kilograms (220 pounds) per
month (except for acutely hazardous
waste; see 40 CFR 261.5). Since the • •
medical waste tracking regulations
.essentially regulate all listed medical
wastes, the Agency determined some
flexibility was necessary for managing
so many very small shipments, and
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. Federal Register / Vol. 54. No. 56 / Friday, March 24, 1989 / Rules and Regulations 12349
developed the approach described
above.
c. Shipments between generators'
facilities. EPA has established special
requirements for shipments of regulated
medical waste when the waste remains
under the generator's direct control (i.e.,
within an institution or company) (see
§ 259.51(b)). An institution or company
sometimes ships waste from the original
generation point (e.g., a location
elsewhere in the same city) to a central
collection point where waste is
consolidated for further shipment or
treatment, including incineration. In the
Uniform Hazardous Waste Manifest
system, when shipments of hazardous
waste move "off-site" (i.e., must traverse
along, as opposed to across a public
road), a manifest is required. For
regulated medical waste, EPA believes
that tracking of such internal waste
movements and use of transporters that
have notified EPA is unnecessary,
provided certain conditions are met
As an alternative to the full tracking
provisions in today's rule, EPA is
allowing a generator to transport his
own waste without a tracking form from
the point of original generation to a
central collection point within the same
State (see § 259.51(b)) provided he
complies with the packaging, labeling,
and marking provisions of Subpart E
and the additional reporting
requirements of § 259.56 of Subpart F.
Generators who elect to use this
exemption are required to keep
operating logs at each site of original
generation and central collection point,
containing information similar to that
required of generators of less than 50
pounds per month under § 259.50(e)(2).
When transporting the shipment, the
generator's representative (probably an
employee) signs the first log maintained
at the point of original generation; upon
delivery to the central collection point,
the representative signs the second log
maintained at the central collection
point. At that time, the waste is once
again subject to all of the requirements
of Part 259, including Subpart G if the
waste is incinerated. EPA believes that
since the waste is under the generator's
direct control during this transit, and
since the transport will typically be
short distances, the waste will be
properly managed without the need for
the tracking form.
This approach is different from that
required under the hazardous waste
regulations (i.e., each shipment of
hazardous waste sent off-site (traversing
public roads) must be manifested).
Available information indicates that
medical waste does not pose the same
kinds or degree of hazard posed by
hazardous waste, which is why EPA has
not listed medical waste as hazardous
waste. Further, EPA anticipates that
many medical waste generators, such as
research facilities, will want to transport
small amounts of medical waste to
central locations for further
management. Under the Subtitle C
program, generators of less than 100
kilograms (220 pounds) per month may
ship waste without a manifest. Under
today's rules, all generators of regulated
medical waste are regulated. Requiring
initiation of tracking forms from all of
these generators could overwhelm the
tracking system and make it difficult to
implement, especially given the
relatively short duration of the
demonstration program.
d. Transport by generators of less
than 50 pounds of regulated medical
waste per month. EPA also has
established special requirements for
generators of less than 50 pounds per
month. In certain circumstances
{§ 259.51(a)), these generators may be
exempt from the requirement to use
transporters who have notified EPA, and
from the requirement to use the tracking
form. This exemption allows a generator
to transport his own regulated medical
waste hi his personal vehicle to his
place of business, a health care facility,
or a treatment or disposal facility,
without the need to comply with the
transporter notification requirements,
provided the waste is properly
packaged, labeled, and marked. To
qualify for this exemption, the generator
must have a written agreement with the
facility to accept the waste. The purpose
of this provision is to ensure that
medical professionals (e.g., physicians
or veterinarians) providing medical
services away from their place of
business are allowed to transport the
waste back to either: (1) Their place of
business for proper transport to a
treatment or disposal facility; or (2)
directly to a health care, treatment, or
disposal facility. EPA has established
these conditions because the Agency
believes that health care professionals
are capable of safely transporting small
amounts of regulated medical waste
when compliance with the full set of
requirements would be unpractical.
While EPA's hazardous waste
regulations do not make special
provisions for this kind of transport,
under Section 261.5, EPA does not
regulate the transport of such small
amounts of hazardous waste (except
acutely hazardous waste).
Finally, the reader should note that
small individual generators may find it
economical to contract as part of a
group for waste management services.
For example, a number of practitioners
in a building, each with their own
practice, could contract with a hauling
and disposal company as a group. In this
case, medical waste could be picked up
from each practice within the building in
packaging that would not be adequate
for off-site transport (i.e., in plastic bags
only) but the transporter would then
combine the waste in packages that
meet all requirements (e.g., boxes, bins,
etc.) before actually removing the waste,
from the building. In this way, these
smaller generators could take advantage
of economies available when shipping
larger quantities. Generators may also
make similar arrangements with their
building maintenance companies. In
either case, each generator of course
remains responsible for complying with
the applicable generator requirements.
Also, as described in detail below,
today's rule would allow transporters to
"remanifest" (i.e., combine many small
shipments on one tracking form)
shipments from small generators,
leading to reduced paperwork. Also, the
building management company may act
under a contractual agreement and
perform the remanifesting or
consolidation function on behalf of the
transporter.
2. Requirement To Use Transporters
Who Have Notified EPA (Section
259.50(f))
Except as discussed below for mail
shipments, and above for the special
provisions in § 259.51 (a) and (b),
generators in a Covered State may offer
waste only to a transporter who has
notified EPA that he intends to operate
in that Covered State as a regulated
medical waste transporter. The
notification procedure for transporters is
discussed in Section V.H. of the
Preamble and in § 259.72. The generator
is responsible for determining whether a
transporter that he plans to use has
notified EPA. EPA will provide each
State with a list of transporters who
have notified EPA in their State.
Questions concerning the status of a
transporter hi any Covered State also
may be addressed to the Chief, Waste
Characterization Branch, U.S. EPA (OS-
332), 401 M St. SW., Washington, DC
20460. The Agency will maintain a
master list for each Covered State of all
transporters that have notified EPA and
have been assigned a medical waste
identification number.
As described below, when certain
regulated medical waste is shipped by
mail, as specified in § 259.51(c),
generators need not meet the
requirement to use a transporter who
has notified EPA if certain conditions
are met. In meetings with State
representatives, EPA was informed that
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12350 Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations
services are being offered whereby
discarded sharps are being sent by mail
to facilities for treatment and disposal.
Today's rule allows this practice to
continue provided the generator sends
the shipment by registered mail with a
return receipt requested and the
shipping package conforms with all U.S.
Postal Service requirements. The
exemption contained in today's
regulations allows this method of
transport for generators of less than 50
pounds of regulated medical waste per
month who ship sharps (waste Classes 4
and 7); these generators are not required
to complete tracking forms for their
shipments of less than 50 pounds. For
this reason the exemption is limited to
those generators who meet the
conditions of § 259.50{e)(2)[i). The return
mail receipt serves the dual purpose of
substituting for the transporter log and
tracking form. The Agency notes that
the Postal Service is currently
Devaluating its rules for shipping
biological materials through'the mail.
EPA will continue discussions with the
Postal Service on whether, and under
what conditions, such shipments will
continue to be allowed.
3. Acquisition and Use of the Tracking
Form (Section 259.52)
The core of the demonstration
program, as explained above, is the
requirement to track medical wastes
from the site of generation to the
treatment or disposal facility. Each
generator of 50 pounds per calendar
month or more, or any generator who
Initiates a shipment of 50 pounds or
more, is responsible for initiating a
tracking form according to the directions
given in § 259.52 and Appendix I.
(Requirements for generators of less
than 50 pounds per month are discussed
below.) Even if the waste is being sent
to a non-Covered State, the generator is
required to initiate a tracking form so
that he may receive a signed copy,
assuring him of the waste's receipt at
the destination facility. There must be a
sufficient number of copies (at least four
(4)) so that the generator, each
transporter, and the disposal facility or
treatment and destruction facility will
each have a copy for its records;
furthermore, there must be an additional
copy to be returned to the generator.
States may require additional copies if
they so choose under State regulations.
a. Acquisition of the medical waste
tracking form. Today's rule provides for
a hierarchy of tracking form use similar
to that in the UHWM system. As with
the Subtitle C hazardous waste
manifest. States may choose to print the
Federally-required Medical Waste
Tracking Form. The State form must be
identical to the one published today as
Part 259, Appendix I. If the State in
which regulated medical waste is to be
disposed (consignment State) is a
Covered State supplying and requiring
the use of a State-printed medical waste
tracking form, then the generator must
use the tracking form of the State of
disposal. (The same requirement'also
applies to those instances where the
transporter initiates a tracking form.) If
the State in which the regulated medical
waste is to be disposed is a Covered
State that does not supply or require the
use of its tracking form, or the State is
non-Covered, then the generator must
use the medical waste tracking form of
the Slate of generation if it supplies the
form. If neither the generator State nor
the consignment (disposal) State
supplies the medical waste tracking
form, then the generator may have the
Federal form (attached in the Appendix
I to Part 259) reproduced for its use.
Finally, EPA has established
provisions today that require a
transporter who will be hauling waste to
a Covered State which prints the
tracking form to obtain the form and
supply it to the generator. (See the note
after § 259.52(b)(3), and see
§ 259.74(a)(2).) EPA does not require this
of hazardous waste transporters, but
given the large number of small medical
waste generators (most of whom have
had little or no experience in obtaining
manifests), and the need to implement
the medical waste tracking program
quickly, EPA believes it is necessary to
place this responsibility on the
transporter.
b. Use of the medical waste tracking
form. When initiating the tracking form,
the generator, or his authorized
representative, must fill in the required
information and sign the certification on
the tracking form. (A transporter may
help the generator fill in the information,
but the generator is still responsible for
complying with Subparts E and F and
ensuring that the information entered on
the tracking form is correct.) The
certification states that the shipment
contents are properly classified,
packaged, labeled, and marked in
compliance with all applicable State and
Federal regulations, and that the
generator is aware that civil and
criminal penalties exist if he withholds
or misrepresents information on the
form. (See Appendix I for the
instructions for completing the Medical
Waste Tracking Form.)
The Generator Certification box of the
Medical Waste Tracking Form
promulgated today is similar to the
UHWM generator certification except
that it requires that the signatory be
formally authorized to sign for the
facility. As under any tracking program,
it is particularly important that the
person signing the medical waste
tracking form have the training and
knowledge necessary to determine that
the waste is actually properly packaged.
labeled and marked. As a result, the
person signing the form should be
properly designated by the person in
charge of the generator's operation (e.g.,
in a doctor's office, the doctor) in order
to ensure that the tracking of medical
waste, which is the cornerstone of the
demonstration program, is properly
carried out.
Although a formal authorization
would generally be provided for any
tracking form where the signatory must
sign on behalf of the facility, the form
promulgated today explicitly requires a
written authorization. EPA believes that
this requirement is warranted for
today's form for several reasons. First,
the regulations promulgated today will
apply to a large and diverse regulated
community which previously has not
been regulated by EPA. As a result, it is
necessary to describe with greater
specificity the steps generators will need
to take in order to assure that their
wastes are properly managed and
tracked. A requirement that
authorization be written will also
expedite awareness by facility officials
of their responsibilities under this new
program. Because of the relatively short
amount of time prior to the effective
date of this program and the desire to
have the program operational by this
summer, there can be no delay in
informing and educating persons
responsible-for medical waste
management to the program
requirements. Moreover, the need for
greater specificity is also heightened by
the short duration of the program
because there will be little time to revise
and cure any shortcomings in the
requirements promulgated today,
including the generator certification. For
these reasons, EPA is promulgating a
more detailed generator certification
statement in today's form than that
required under the UHWM.
The generator must identify his
medical waste as either "treated" or
"untreated," and must specify the
quantity of each (both number of
packages and total weight or volume) in
Box ll(a) and (b) of the tracking form.
EPA also has provided a space (Box
life)) for State regulated medical waste.
This may be used when a State
regulates medical wastes not covered
under the Federal program (e.g., wastes
from RCRA Sections 11002 (a) 6 through
9 that EPA chose not to list). The
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Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations
12351
quantity of State regulated wastes
should not be recorded in Boxes ll(a) or
ll(b) but should be recorded separately
in Box ll(c). Finally, the generator must
obtain the signature of the initial
transporter and retain a copy of the
signed tracking form for his records.
If rail shipments are initiated from the
site of generation, the generator is
responsible for sending at least one
copy of the signed tracking form to each
of the following: (1) the first non-rail
transporter, if one is used; (2) the
destination facility, if the waste is
transported solely by rail; and (3) the
last rail transporter, if the wastes are to
be exported.
These requirements are consistent
with the Subtitle C Uniforn Hazardous
Waste Manifest system for transport by
rail. The Agency did not wish to impose
a system of document handling that may
be disruptive to existing practices. The
rationale for establishing such a system
was developed in 45 FR12739, February
28,1980.
Finally, if the generator's medical
waste is subject to the Nuclear
Regulatory Commission (NRG)
regulations as well as EPA tracking
requirements, the information required
by the NRG can be placed on the
tracking form in the appropriate boxes
(e.g., generator's name and address).
Information required by NRG but not
required by EPA (e.g., radionuclide
identity) may be placed in Box 14
(Special Handling Instructions and
Additional Information). If the space in
Box 14 is not adequate, the generator
may attach sheets presenting the NRC-
required information. Box 14 also may
be used for instructions for handling
oversized regulated medical waste.
4. Use of Logs by Generators of Less
Than 50 Pounds Per Month (Section
259.54(b))
Generators who generate less than 50
pounds of regulated medical waste per
calendar month and do not ship in that
calendar month any package(s) greater
than 50 pounds must ma In lain a log that
contains information on every shipment
of medical waste, if tracking forms are
not used. The log, which must be
maintained on-site for three (3) years
from the date of the most recent entry,
must provide the following information
and must be signed by the transporter
when the waste is picked up: the
transporter's name and address; the
quantity and category of waste
transported; and the date of shipment.
If the waste is transported personally
by the generator, the log should be
completed to reflect this by having that
person (e.g., the generator) or his
authorized employee, who transports
the regulated medical waste, sign the log
as the transporter. The Agency is not
requiring the health care facility or
destination facility to sign the
generator's log since that would require
that the generator carry the log with him
each time he transported regulated
medical waste to a health care facility
or the destination facility. To ensure
that such wastes are delivered to the
health care facility, a treatment or
destruction facility, or the destination
facility, and that a record of the
transaction is available for inspection or
compliance monitoring, the Agency is
requiring that the health care or
destination facility to which the
generator transports the waste maintain
a log as required in § 259.83(b).
Some generators may not know the
volume of waste they generate until the
end of a month. Each generator,
however, is responsible for determining
his monthly generation and complying
with the appropriate requirements (see
§ 259.50(e), introductory text).
Generators who'believe they may
exceed the 50 pounds per calendar
month limit in a given month may find it
prudent to use the tracking form as a
precaution. Some transporters may, in
fact, require the tracking form from all
generators.
5. Exports of Regulated Medical Waste
(Section 259.53)
Generators (including transporters
who initiate tracking forms) exporting
regulated medical waste to a foreign
country for treatment and destruction or
disposal are required to request written
confirmation from the accepting facility
that the waste was received. In addition
to receiving the written confirmation,
the generator should also receive a copy
of the tracking form from the last
domestic (U.S.) transporter as required
under § 259.74(e). In order to obtain the
written confirmation, the Agency
suggests that generators, and
transporters who consolidate waste not
accompanied by a tracking form, who
are shipping regulated medical waste to
a foreign destination facility could
forward two copies of the tracking form
directly to the treatment and destruction
or disposal facility. The destination
generator should request that the owner
or operator of the facility, upon receipt
of the waste, sign and return a copy of
the tracking form, and in fact may want
to include such a clause in any contract
with the receiving facility.
The Agency also is requiring
transporters who deliver regulated
medical waste to a foreign carrier,
foreign transfer facility, or foreign
destination facility, to send a copy of the
tracking form to the generator with the
signature of the accepting transporter,
transfer facility, or destination facility. If
the accepting transporter or destination
facility is not willing to sign the tracking
form, the last domestic transporter
should indicate this in Box 14 of the.
tracking form (Special Handling
Instructions and Additional
Information).
Generators, including transporters
who have consolidated or remanifested
waste onto a new tracking form (see
§ 259.76), must file exception reports
within 45 days, as required under
§ 259.55, if they have not received
written confirmation of receipt of the
regulated medical waste by the
destination facility. This requirement
also applies in the case of foreign
shipments.
The requirement that the generator •
request written confirmation from the
destination facility, coupled with the
requirement that the last domestic
transporter send a signed copy of the
tracking form to the generator upon
delivery of the waste to a foreign
transporter, transfer facility, or
destination facility, provides reasonable
assurance that the waste has reached
the destination facility.
6. Recordkeeping (Section 259.54)
There are a number of recordkeeping
requirements for all generators of
medical waste, including generators of
less than 50 pounds per month.
Generators who are required to use the .
tracking form must keep a copy of each
tracking form for three (3) years from the
date of acceptance of the shipment by
the transporter. These generators also
must keep signed copies of each of the
corresponding tracking forms signed by
the destination facility for at least three
(3) years from the date of acceptance of
the shipment by the transporter. As with
all other recordkeeping requirements of
today's rule, the Agency has determined
that such records are necessary for
compliance monitoring and for providing
any generator-specific data needed to
assess the effectiveness of the program
and the need for national medical waste
regulations. Recordkeeping is of
particular importance in this program
because the size of the regulated
universe makes reporting by generators
infeasible. The Agency believes that
three years is the appropriate time
period for record maintenance under
this program for the following reasons: it
is the standard used in several of the
Covered States and other RCRA
programs; and it allows appropriate
enforcement actions for program
violations incurred during the
demonstration program.
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All records should be kept on-site so
that they are easily accessible for
inspection. If, however, recordkeeping
operations are normally conducted at
another corporate or business location,
the generator may keep records there, if
they will be readily accessible for
inspection purposes.
As described in the next section of
this Preamble (see Part 259, Subpart G),
generators who incinerate wastes on-
site must report the volume and type of
waste incinerated. (Information about
wastes accepted from off-site sources
should also be included in the reports,
where applicable.) Finally, generators
who claim the § 259.30{c)(2)(iv)
exemption for waste that has been
treated and destroyed must keep
records of the amounts treated in such a
manner in order to qualify for the
exemption.
7. Exception Reporting (Section 259.55)
For the tracking system to accomplish
its purpose, officials must be alerted
whenever the tracking "circle" is
broken. If the generator who initiated a
tracking form does not receive a signed
copy of the form from the destination
facility (and in the case of foreign
shipments, from the last domestic
transporter) within 35 days after the
waste was accepted by the initial
transporter, the generator must contact
both the transporter and the destination
facility to determine what happened to
the waste and the tracking form. If a
signed tracking form has not been
received within 45 days from the initial
date of transport, the generator must
submit an exception report to the
Regional Administrator and to his State
that includes: (a) A legible copy of the
tracking form for which the generator
did not receive a signed copy; and (b) a
letter signed by the generator, detailing
his efforts to locate the waste.
A copy of the exception report must
be kept hi the generator's records for
three (3) years.
8. Additional Reporting (Section 259.56)
Through broad authorities granted in
Section 11004 of the Act, EPA can
require generators to furnish additional
reports concerning medical waste
generated at their facilities. For
example, during an enforcement
proceeding, the Agency may require
additional information concerning the
disposition of certain quantities of
waste, including medical wastes not
sent off-site (e.g., wastes disposed of on-
site in sewers or landfills). Section
259.56 codifies the information gathering
authority provided hi section 11004 with
respect to generators of regulated
medical waste. Generators are required
to provide any information available
upon request EPA has codified similar
provisions for transporters (§ 259.79)
and for owners and operators of
destination facilities (§ 259.84).
Also, EPA requests comment
concerning the various sources of
information and strategies available to
gather the requisite information to
develop the Reports to Congress,
required under Section 11008. In
particular, EPA requests comments on
means to ascertain quantities-of
regulated medical wastes discharged to
sewers or landfilled on-site. Currently,
the regulations do not provide for
recordkeeping of these practices.
Additionally, it has been requested
that EPA require a one-time report from
generators describing the quantities of
medical waste in the section 11002(a}(6-
10) waste types that are not regulated
under the Part 259 requirements. EPA
has determined that methods other than
a generator report (e.g., a statistical
sampling of the various generator types)
could be used to obtain the same
information, with significantly less
burden on the generators. EPA requests
comment on the necessity of such a
generator report and on other means of
obtaining similar information.
G. Subpart G—On-Site Incinerator
Requirements >
Section 11003(c) of RCRA requires
EPA to promulgate recordkeeping and
reporting requirements for medical
waste generators in Covered States who
incinerate regulated medical waste on-
site and, thus, do not track such waste
under the requirements of the
demonstration program. The statute
further directs EPA to require these
generators to prepare and submit a
report summarizing the volumes and
types of medical waste incinerated on-
site during the first 6-month period
following the effective date of these
regulatory provisions.
The on-site incinerator reporting
requirements in today's regulation
satisfy this statutory requirement. EPA
has decided to use its broad authority
under RCRA Section 11004(a) to require
information on the incineration process
and the incinerators themselves, in
addition to the minimum information
required by .the Act. Also, EPA is
requiring the submittal of two reports.
The first report will cover the first six (6)
months of the demonstration program,
while the second will cover the
thirteenth through the eighteenth month
of the program. EPA believes the
minimum information required by the
statute will be more meaningful if it is
supplemented by information on the
incinerator operations, and if it is
obtained both at the beginning of the
demonstration program and after
generators and regulators have acquired
some experience with the specific
requirements of the demonstration
program. All of the information being
requested will be necessary to satisfy
the information requirements of RCRA
Section 11008, including the present or
potential threat to human health and the
environment posed by medical waste
incineration, and changes in
incineration practices attributable to the
demonstration program.
EPA chose not to require a breakdown
of incinerator waste feed by waste
classes as listed in today's rule for two
reasons. First, it is not feasible (and in
some cases it is impossible) for
generators to segregate their wastes
according to the seven waste classes.
Furthermore, in some cases, the
increased handling that would be
necessary to segregate wastes could
result in increased risks to health care
workers and other handlers of the
waste. Additionally, there is little
benefit in knowing the composition by
waste classes of the incinerator's waste
feed. To determine health and
environmental effects from incineration,
knowledge of the BTU content of the
wastes and the plastic and metal
content is more useful.
Finally, EPA is requesting the
information in terms of weight of
medical waste. Although the Act says
"volume," EPA presumes Congress
simply meant amount. Measurements of
actual volume are not reliable in this
instance. For example, compaction and
other volume reduction processes could
render a facility's volume estimate
meaningless for estimating quantities of
waste incinerated.
1. Recordkeeping (Section 259.61)
Today's rule requires medical waste
generators who incinerate medical
waste on site to compile an operating
log containing information on the
amounts of waste incinerated, the
frequency of incineration, and the length
of die incineration cycle.
EPA also is requiring generators with
oh-site incinerators to provide
information on amounts of waste
received from sources outside the
facility, in order to assure compliance
with the § 259.51(a) exemption and to
determine how much regulated medical
waste is brought from sources such as
private physicians or small group
practices. This information will provide
a more complete picture of the
quantities of regulated medical waste
being incinerated.
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12353
EPA is requiring information on the
number of days of operation during each
reporting period, the load frequency, and
load amount. Since the emissions vary
throughout an incineration cycle,
information on the number of start-ups
from a cold unit will be used to estimate
the health and environmental effects of
incineration.
The required information must be kept
in an operating log, and must be
recorded for each load or operating
cycle. The generator must retain the
operating log for three (3) years from the
effective date of today's rule.
2. Reporting (Section 259.62}
Today's rule requires generators of
regulated medical waste who incinerate
such waste on-site to prepare and .
submit two reports. These reports must
summarize the information contained in
the operating record. The legislation
stipulates the first reporting period: the
first six (6) months of the demonstration
program. EPA added a second reporting
period (months 13 to 18) in order to
determine whether there have been
changes in the management practices
associated with regulated medical waste
(e.g., changes in the volume of waste
incinerated) as a result of today's rule.
Reports must be submitted within 45
days of the last day of the reporting
period. The Agency believes that this
provides sufficient time to compile and
summarize the information contained in
the operating record and collect other
necessary information to be included in
the report.
EPA has developed a form for the
reports, which is found in Appendix II to
Part 259. Generators must use the form if
they incinerate regulated medical waste
on-site. EPA will make copies of the
necessary reporting forms available, and
generators also may use photocopies.
H. Subpart H—Transporter
Requirements
This section of the Preamble describes
specific requirements of today's rule as
they pertain to the off-site transport of
regulated medical wastes. It delineates
the responsibilities of transporters and
transfer facilities, and the Agency's
rationale for establishing these
responsibilities.
I. Transporter Notification (Section
259.72)
The central purpose of Subtitle J is to
track the movement of medical waste
from places of generation to the
destination facility. In order to ensure
that generators utilize transporters that
are aware of and understand the new
requirements of today's regulation, EPA
is requiring a notification from
transporters. This notification process
will help EPA and State officials
monitor implementation of the program
and ensure that transporters complete
their responsibilities under today's
demonstration program and deliver the
regulated medical waste to the
destination facility. Accordingly, today's
rule specifies that each transporter who
handles regulated medical waste
generated in a Covered State must
notify EPA of its intention to perform
this activity.
Transporters and transfer facilities
must submit a separate notification for
each Covered State in which the
transporter intends to accept regulated
medical waste directly from a generator.
If they do not accept regulated medical
waste directly from a generator, but
from another transporter, they also must
submit a notification for each Covered
State where the waste originated. This
notification may be by letter, or may be
prepared using the form in Appendix IV
of Part 259. The use of this form is not
required, but is strongly recommended
by EPA. Each notification must contain
the following information: transporter's
name, address (including all facilities
intended for handling regulated medical
waste which the transporter will operate
within the Covered State), telephone
number(s); State permit or identification
number(s), if applicable; and a
statement, signed by a corporate officer
or the owner/operator, that he has read,
understands, and-will abide by today's
regulations. An original and one copy of
that notification letter must be sent to
the Chief of the Waste Characterization
Branch, EPA Office of Solid Waste, (OS-
332), 401M Street, SW, Washington, DC
20460. EPA recommends that
transporters submit these notifications
via certified mail return receipt
requested. The return receipt can then
serve as evidence that they have indeed
submitted their notification.
A copy must also be sent to each
Covered State for which the transporter
is notifying. EPA will provide the
mailing address of the agency within
each State to whom the notification
should be sent in a Federal Register
notice to be published after the 30 day
State petition-in/opt-out period has
passed.
Transporters must provide separate
notifications for each Covered State in
which they will accept regulated
medical waste directly from a generator,
and for each Covered State whose
generators' regulated medical waste
they expect to transport. For example, if
Transporter A expects to pick up waste
in Covered Slates X and Y, he must
provide two notifications to EFA (one
for State X, one for Y), and he must also
send separate notifications to Covered
States X and Y. Also, if Transporter A
plans to accept regulated medical waste
generated in-State Z, a Covered State,
via an intermediate Transporter (e.g;,
transporter B), Transporter A must
nonetheless notify for Covered State Z
because he will be accepting Covered
State Z's waste. (Notification for
Covered State Z must be sent to EPA
and to Covered State Z.) This is required
even if Transporter A never enters
Covered State Z. (In this example,
Transporter B would also have to notify
for Covered State Z.)
EPA will maintain a master list of
transporters who have notified EPA for
their operations in Covered States. EPA
will also provide a list to officials in
each of the Covered States, to
supplement their own information on
transporters of waste that was
generated in their State. This list also
will facilitate any outreach, monitoring
and enforcement activities. States also
may use the information to develop
transporter licensing and permitting
programs, under State law, if they so
choose.
The Agency will, upon receipt of the
transporter's submittal of notification,
transmit an acknowledgment signed by
the Chief of the Waste Characterization
Branch to the transporter. This will
confirm that the transporter has
provided all required information in his
notification and will include an EPA
assigned Medical Waste Identification
Number.
2. Vehicle Requirements (Section 259.73)
a. Vehicle configuration and
condition. Proper handling of regulated
medical waste shipments will minimize
the potential for accidental discharge of
transported wastes and, thus, minimize
the opportunity for personal injury and/
or potential infection of waste handlers
or others who could come in contact
with it. Compaction and/or rough
treatment of packaged regulated
medical wastes may compromise the
integrity of the packaging and, therefore,
must be avoided. Based on these
concerns and the statutory requirement
that the regulations must provide for
proper containerization of medical
waste to protect waste handlers and the
public from exposure to the waste, the
Agency has required that all regulated
medical waste be transported in a leak-
resistant, fully enclosed, non-compactor,
cargo-carrying body thai is maintained
in good operational and sanitary
condition. Section V.E.4 of the Preamble
discusses decontamination practices
that have been described in various
guidance documents or state regulations
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32354 Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations
for reusable containers. The Agency is
also recommending that these practices
be used to decontaminate vehicles. EPA
solicits comments on the adequacy of
these practices in protecting consumer
products from contamination by residual
regulated medical wastes. In addition,
today's regulation allows the cargo
carrying body to be used to transport
properly packaged regulated medical
waste simultaneously with other
consumer products. EPA requests
comment on whether vehicles should be
dedicated to the transport of regulated
medical waste.
The requirement that the vehicle not
compact these wastes is based on
evidence that compaction frequently
will break the containers holding
medical waste, resulting in the
generation of loose waste, needles or
sharps protruding from containers, or
leaking blood and other fluids, all of
which are potential sources of exposure
to waste handlers or the public.
Compaction also can destroy labels or
container markings, thus making it
difficult to track the waste accurately or
to know whether a regulated medical
waste has been properly treated. For the
same reasons, medical waste must not
be subjected to violent mechanical
stress during loading and unloading.
b. Protective clothing. Although the
Agency is not requiring specific
protective clothing for persons
transporting and handling regulated
medical waste, EPA believes that in
order to avoid potential contamination
and/or injury while handling regulated
medical waste, persons involved in the
loading or unloading of packaged
regulated medical wastes onto or off the
transport vehicles should use
appropriate protective apparel as
required by the Occupational Safety and
Health Administration (OSHA). In the
event these protective garments become
contaminated and are discarded, they
should be disposed of properly (by
inclusion in the waste load, for
example).
c. Vehicle identification and markings
§2S9,73(b). The Agency believes that
public awareness of the medical waste
tracking system is essential and will
help in monitoring compliance with the
program. Public reporting of apparent
illegitimate handling and disposal
activities may help reduce the incidence
of these occurrences. To facilitate
identification of medical waste hauling
vehicles, both for monitoring and
reporting purposes, all vehicles involved
in the transport of regulated medical
waste must be marked appropriately
with the hauler's name and any
registration, license, or permit number
required by the State. The marking must
appear on both sides and the rear of the
cargo carrying body of the vehicle.
These markings must be at least three
(3) inches in height, and should be in a
color that contrasts with that of the
vehicle. The lettering sizes specified
above and in § 259.73 are based in part
on existing State regulations in New
York and New Jersey and should
facilitate easy identification of such
vehicles. Additionally, while carrying
regulated medical waste, both sides and
the back of the cargo carrying body
shall display the words "Medical
Waste" or "Infectious Waste." This may
be in the form of a removable sign or
markings. The Agency does not
recommend that the vehicle display the
universal biohazard symbol. Presently
this symbol is being utilized
internationally to identify vehicles
carrying etiologic agents and, as such,
provides a warning to emergency
personnel in the event of an accident.
The U.S. Department of Transportation
is also considering adopting this symbol
domestically as a label and placard for
etiologic agents. The Agency requests
comment on the appropriateness of
these requirements.
d. Accident response preparedness.
The Agency believes that proper
preparation for accidental releases
involving medical wastes can limit the
potential damage and/or contamination
associated with such incidents.
Although the Agency has insufficient
information to establish specific
standards for dealing with accidental
releases of regulated medical waste
during transport, EPA believes the
following guidance should be observed
to protect workers and the public.
Vehicles engaged in the transport of
medical waste should be equipped with
spill containment and cleanup materials,
have properly documented procedures
for responding to accidental releases,
and carry protective clothing (including
gloves and coveralls). Additionally, the
Agency believes all vehicles involved in
medical waste spills should be
decontaminated following any
accidental release. The Agency requests
further comment on the need for specific
requirements regarding accidental
releases, necessary spill containment
equipment for vehicles, protective
clothing for transport personnel, and
vehicle decontamination standards.
e. Storage restrictions and
requirements. (Section 259.73(a)(5)):
Regulated medical waste, as discussed
in Section V.E. of the Preamble, is to be
kept from reaching a putrescent state. In
addition, pathological wastes, body
fluids, anatomical parts, etc. must be
maintained in a nonputrescent state
during transport and storage or must be
refrigerated. Additionally, to prevent
unauthorized access to these wastes, all
vehicle cargo compartments containing
regulated medical waste must be
secured (locked) if at anytime the
vehicle is unattended. For example, the
vehicle should be secured if unattended
during a lunch break, during rest stops,
or when the driver or other responsible
persons will not be in visual sight of the
vehicle.
3. Transporter Tracking Form
Requirements (Section 259.74)
As explained in the introduction to
Section IV of the Preamble, the Agency
has determined that a tracking system,
designed along the lines of the UHWM
system, will be an effective method for
documenting the transport of regulated
medical waste from its point of
generation to its final destination.
Exception and discrepancy reports will
furl her aid in validating the system and
ensure that the proper management and
disposal of regulated medical waste
occurs. The tracking form documents the
movement of waste from the site of
generation to the site of disposal,
through each transaction phase in the
process. The tracking procedure for
transporters is specified in § 259.74. [As
explained previously, transporters who
intend to transport regulated medical
generated in a covered State to a
destination facility in a different
covered State that supplies and requires
the use of its medical waste tracking
form must provide the generator with
the tracking form of the destination
covered State.] Compliance with the
tracking form amounts to a chain-of-
custody procedure. The form must
accompany the shipment and each
person who signs the form is taking
responsibility ("custody") for the
shipment while it is in his possession.
4. Acceptance of Medical Waste
Before accepting any regulated
medical waste for transport, the
transporter must make certain through
visual inspection that the waste is
packaged, labeled, and marked in
accordance with all applicable
requirements (Subpart E of today's rule).
5. Consolidation or Remanifesting of
Regulated Medical Waste
Today's rule also specifies conditions
under which transporters must initiate
tracking forms. This need arises when
transporters receive shipments of less
than 50 pounds that are not
accompanied by a tracking form. Given
that today's rule requires that all
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Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations
12355
shipments of regulated medical waste .
generated in a Covered State be
accompanied by a tracking form when
delivered to a subsequent transporter,
intermediate handling or to a
destination facility, transporters will be
required to document such shipments
with tracking forms prior to transfer of
custody. Thei Agency believes that
transporters will have accumulated
more than 50 pounds of regulated
medical waste from numerous
generators of less than 50 pounds;
therefore, the tracking form is required.
The Agency is also allowing
transporters and owners or operators of
transfer facilities to consolidate and
remanifest individual shipments of
regulated medical waste that weigh less
than 220 pounds onto a single tracking
form. This provision will avoid the
significant burden that would otherwise
exist if transporters and treatment and
disposal facilities were required to sign
and account for individual tracking
forms for each and every shipment of
regulated medical waste. Specific
conditions and requirements for each
follow.
a. Generators of less than 50 pounds
per month. Shipments from generators of
less than 50 pounds per month may be
documented in one of two ways. First,
upon mutual agreement between the
generator and transporter, the parties
may simply use the tracking form as
required for generators of 50 pounds or
more per month. As an alternative,
however, the parties may take
advantage of the special provisions of
§§ 259.50(e)(2) and 259.74(g).
Under the second approach,
shipments of less than 50 pounds from
generators of less than 50 pounds per
month do not require a tracking form.
Rather, the transporter is required to
sign the generator's log and maintain his
own log recording each shipment of less
than 50 pounds. The transporter's log
must contain the following information
for each shipment: (1) Generator's name;
(2) generator's State permit or
identification number or address; (3)
quantity of waste by category
(untreated, treated); and (4) date of
shipment. (It is not the obligation of the
transporter to ensure that generators
who log shipments of less than 50
pounds of regulated medical waste
actually generate less than 50 pounds of
regulated medical waste per month; this
is the responsibility of the generator.
However, any individual shipments of
50 pounds or more must be accompanied
by a tracking form originated by the
generator.)
Before delivery to the disposal facility,
the transporter must initiate a tracking
form, completing the generator section,
to account for all consignments of less
than 50 pounds of regulated medical
waste in that load. Thus, in effect, the
transporter becomes a surrogate
generator for these materials. The
transporter also must attach to the
tracking form a list containing the
names of all generators and the number
of containers from each generator that
have been consolidated onto the
tracking form (e.g., this could be a copy
of the transporter's log sheet). This will
provide the transporter and the
treatment or disposal facility with
information necessary to handle any
discrepancies that may occur.
b. Shipments of less than 220 pounds.
All shipments of 50 pounds or more of
regulated medical waste or from a.
generator of 50 pounds or more per
month must be accompanied by a
tracking form which has been filled out
by the generator and signed by both
generator and transporter. This form
must be completed before the waste is
transported off-site. Transporters may
consolidate and remanifest shipments of
less than 220 pounds onto a single
tracking form for transport to a
destination facility or at the time those
materials are transferred to a second
transporter (see § 259.76 (b)-(d)). This
"remanifesting" also may include
shipments of less than 50 pounds that
are accompanied by tracking forms.
However, to facilitate recordkeeping by.
transporters, EPA strongly recommends
that shipments of less than 220 pounds
accompanied by a tracking form not be
consolidated or remanifested onto the
same tracking form as shipments of less
than 50 pounds that were not
accompanied by a tracking form.
Instead, transporters should consolidate
onto separate tracking forms: (1)
Shipments accompanied by tracking
forms; and (2) shipments of less than 50
pounds that are not accompanied by a
tracking form. Keeping the two types of
shipments separate will facilitate
recordkeeping for returning the tracking
forms to the original generators who
originated those tracking forms.
Remanifesting is done to condense
information from the tracking forms of
many small shipments onto a new
tracking form so that owners or
operators of destination facilities need
not sign an overwhelmingly large
number of individual tracking'forms.
EPA believes the approach described
here will reduce a potentially
overwhelming paperwork burden on
destination facilities while still meeting
the RCRA section 11003(a)(2) statutory
objective of "* * * providing the
generator of the waste with assurance
that the waste is received by the
destination facility." ' .
EPA has decided to allow
remanifesting of only relatively small,
quantities of regulated medical waste
because the remanifesting provision is
somewhat less stringent than requiring
each original tracking form to
accompany the shipment all the way to
its destination. This approach has not
been implemented by any of the
individual States, and has not
previously been allowed for hazardous
waste shipments. The remanifesting
provision increases the possibility of
clerical errors that could lead to
discrepancies in the quantities of
regulated medical waste being shipped
to their intended destinations. Thus,
prior to allowing such a provision for all
quantities of regulated medical waste,
EPA believes that the Agency must
monitor the effectiveness of this more
flexible procedure. Therefore, EPA is
restricting its use to shipments of less
than 220 pounds during the duration of
the demonstration program. EPA will
determine whether there is a significant
increase in the number of tracking
system violations for remanifested
regulated medical waste relative to that
which requires that individual tracking
forms accompany the waste. Comments
are requested on the 220 pound limit in
today's rule.
At the time the transporter initiates
the new tracking form, he also must
attach a copy of the transporter's log
indicating the following for each
consolidated load: (1) Generator's name;
(2) generator's identification number or
address; (3) quantity of waste by
category (untreated, treated); and (4)
date of shipment or original tracking
form number. Again, the purpose of
carrying and providing such information
to the destination facility is to. facilitate
the resolution of any discrepancies that
may occur. Here, as with consolidation
of logged material from generators of
less than 50 pounds per month, the
transporter becomes a surrogate
generator of the redocumented waste,
filling out the tracking form accordingly.
In these instances, the new tracking
form number must be indicated on the
original (the generator's) tracking
form(s), as specified in the instructions
for completing the tracking form (see
Appendix I to Part 259). The transporter
must not return a copy of the original
tracking form (the tracking form from
the original generator) to the generator
until he receives a signed, completed
copy of the new transporter-initiated
tracking form from the disposal facility.
A copy of that tracking form, signed by
the destination facility, must be
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12356 Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations
attached to the original form, and copies
of both forms returned to the generator.
The transporter also must enter on the
generator's original tracking form the
name of the destination facility if it is
different from the one already listed on
the form.
o. Shipments of more than 220 pounds.
Shipments greater than 220 pounds must
always be accompanied by the
generator-initiated tracking form which
must remain with that shipment until it
is accepted by the final destination
facility. Individual shipments over 220
pounds may not be consolidated onto
another tracking form by the
transporter. For each such shipment
over 220 pounds, the transporter shall
sign the form when accepting the waste,
leaving the designated copy with the
generator. The remaining copies of the
form must be maintained in the same
vehicle as the waste it covers at all
times (except as provided for in Subpart
J for rail carriers] until it is accepted by
the destination facility. The waste is
officially accepted by that facility when
the form is signed by a representative o'f
the destination facility and a signed
copy given to the transporter.
6. Transporter Recordkeeping and
Reporting Requirements
a. Recordkeeping. Today's rule also
specifies that all transporters who
transport regulated medical waste
originated in a Covered State must
maintain records of all transactions
involving these materials. Copies of all
tracking forms that the transporter has
signed must be kept for at least three (3)
years from the date of signature; this
includes all generator-initiated forms as
well as any mat the transporter has
initiated himself. Additionally, copies of
all logs pertaining to consolidation
activities (whether for shipments of less
than 50 pounds that are not
accompanied by tracking forms or for
those of up to 220 pounds that are
accompanied by forms) must be
maintained for a minimum of three (3)
years from the date of their initiation.
Finally, the transporter must keep copies
on file of all reports that he is required
to submit to EPA or any of the Covered
States during the demonstration
program; these will include all copies of
the transporter periodic reports as well
as any other reports, as required by
today's rule that relate to the medical
waste tracking program (e.g.. Exception
Reports, Discrepancy Reports).
b, Transporter periodic reports. The
transporter must prepare and submit
periodic reports to EPA and the
appropriate State agency responsible for
medical waste monitoring and
enforcement concerning the
management of regulated medical
waste, Transporters must prepare a
separate report for each Covered State
in which the transporter accepted
regulated medical waste directly from a
generator, and for each Covered State
that the transporter has accepted
regulated medical waste from another
transporter who accepted waste directly
from a generator. (The transporter who
accepted waste directly from the
generator may be the first of three or
more transporters that are involved in
the transport of such waste. Each
transporter involved in the transport of
the waste must report.) These reports,
which will provide EPA and the State
with information regarding
implementation of the program, must
contain the information required on the
form in Appendix HI to Part 259. Use of
this form is required. Reports must be
submitted for the first, second, third, and
fourth 180-day periods of the
demonstration program and must be
submitted 45 days after the last day of
the reporting period.
The report must be submitted to EPA,
addressed to: Chief, Waste
Characterization Branch, Office of Solid
Waste, US EPA (OS-332), 401M Street
SW., Washington, DC 20460.
Transporters must include their EPA
Medical Waste Identification Number
on the report. One copy of the report
also must be sent to the Director of the
State agency responsible for
implementing the medical waste
tracking regulations. EPA will publish a
list of State agency addresses after the
30 day petition-in/opt-out period.
The information required includes the
quantities of regulated medical waste
(broken down into the "untreated" and
"treated" categories) accepted from
each generator, by name and site, during
the reporting period. These reports will
provide EPA not only with a list of all
generators entering waste into the
tracking system, but also the quantity of
regulated medical waste entering the
system. EPA will use this information to
help prepare the Reports to Congress
required under Section 11008, and by the
States or EPA to target inspection and
compliance monitoring efforts.
Transporters also must report on the
disposition of regulated medical waste
(i.e., whether the waste has been
delivered to a treatment or disposal
facility, or to another transporter), again
broken down into the "untreated" or
"treated categories." This information,
which will include both the names and
addresses of-receiving facilities as well
as waste quantity information, also will
be used for the Reports to Congress and
to target EPA or State inspection and
enforcement efforts.
The reports are intended to provide a
picture of the regulated medical waste
transportation system for such wastes
generated in Covered States. The
distinction between "untreated" and
"treated" medical waste will allow EPA
to assess changes in treatment practices
over the life of the program. All of the
information can be taken from the
required tracking forms or logs;
transporters should not need to generate
new information.
The reports must be submitted
according to the schedule outlined
above. The first report will provide EPA
and the States with information on
generators and treatment and disposal
facilities so that the Agency can
immediately target public outreach'
efforts and make modifications to the
system to improve its efficiency. EPA
believes there is a strong likelihood that,
upon analysis of the first report, EPA
will have identified all generators,
treaters, and disposers of regulated
medical waste. After this initial period,
the reporting will meet enforcement
needs and provide information for the
Reports to Congress. These periodic
reports will enable EPA and the States
to assess trends during the life of the
program. .
EPA initially considered requiring that
all generators, transporters and
treatment and disposal facilities submit
detailed reports concerning their
handling of regulated medical waste.
However, the Agency was concerned
about the ability to assimilate the
information from the estimated 150,000
generators, transporters, and destination
facilities within the Covered States.
Since transportation is the essential link
between generators and off-site
treatment and disposal, EPA believes
that the most efficient means of
compiling information will be from the
transporters. EPA anticipates that the
total number of regulated medical waste
transporters will number less than a
thousand:
In summary, the Agency has
attempted to minimize reporting
requirements in today's rule. However,
EPA believes monitoring of waste
movement is essential, and the
transporter, as the central actor, is in the
best position to collect, compile, and
report this information. Accordingly,
EPA is using its Section 11004{a)
authority to require submission of these
reports. . • . :
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7. Delivery of Regulated Medical Waste
Outside the United States {Section
259.74(eJ)
The Agency is aware that regulated
medical waste generated in several of
the Covered States is being transported
to Canada for treatment and disposal. In
addition, EPA understands that similar
waste generated in Canada is being
transported for treatment and disposal
into some of the Covered States.
Although the Agency believes that the
documentation and tracking of all such
regulated medical waste from its point
of generation to its point of disposal
may be advisable, the Medical Waste
Tracking Act only provides the authority
for tracking regulated medical waste
generated in Covered States. Today's
regulations.do not apply to waste
generated in a Covered State that is
shipped internationally, once it leaves
U.S. borders. In these cases, it is the
responsibility of the last U.S. transporter
(i.e., the transporter who delivers the
waste to another transporter, a transfer
facility, or a destination facility in a
foreign country) to sign the tracking
form verifying that the waste has been
delivered to a foreign transporter or
destination facility, retain one copy of
the signed tracking form, and return all
remaining copies by mail to the
generator. As noted elsewhere in the
Preamble, the Agency is requiring that
the generator request written
verification from the destination facility
located in the foreign country that the
waste was received by the facility.
The Agency requests comments on the
need for other requirements to ensure
that regulated medical wastes are
properly managed when exported. For
example, EPA could require that the
generator have a contract with the
foreign treatment and destruction
facility and/or the foreign disposal
facility stipulating that the facility return
a signed copy of the tracking form to the
generator.
I. Subpart I—Treatment, Destruction,
and Disposal Facilities
Today's regulations establish a
demonstration tracking program that
includes requirements for intermediate
handlers of regulated medical waste and
for destination facilities to ensure that
regulated medical waste is tracked from
the point of generation to the point of
final disposal. The MWTA does not
authorize or require EPA to establish
regulations that address the actual
treatment, destruction, or disposal of
regulated medical waste. The
requirements of Part 259 cease when
regulated medical waste is disposed of
at a landfill or the waste has been
"treated and destroyed" by incineration
or other techniques. (See Preamble
Section V.D. for a discussion of the
criteria or conditions that must be
satisfied for medical waste to be
considered treated and destroyed.)
Facilities meeting these latter conditions
include incinerators and treatment
facilities that, in addition to
decontaminating, also destroy the
regulated medical waste. Treatment,
destruction, and disposal facilities may
be subject to local, State, or other
Federal requirements in addition to
today's rules.
1. Applicability (Section 259.80)
The provisions described in § 259.80
of today's rule apply to destination
facilities (treatment and destruction, and
disposal facilities (including
incinerators)) and to intermediate
handlers that receive regulated medical
waste generated in a Covered State that
is required to be accompanied by a
tracking form. As described above, the
demonstration tracking program
requires the tracking of regulated
medical waste from the point of
generation until such waste is delivered
to the final disposal facility (or to
incinerators or other facilities that both
treat and destroy such waste). The rules
do not require the tracking of regulated
medical waste after it has been properly
incinerated, treated and destroyed, or
disposed of. Thus, waste that has been
either treated or destroyed, but not both,
must continue to be tracked until the
waste reaches a destination facility. The
requirements applicable to intermediate
handlers and destination facilities,
therefore, serve to ensure that facilities
participating in the demonstration
program properly complete the tracking
document and maintain all necessary
records for implementation of the
program.
Interstate transport of regulated
medical waste is now occurring, and
many facilities receiving regulated
medical waste are not located in States
participating in the demonstration
program. Today's rule requires that all
intermediate handlers and destination
facilities that accept regulated medical
waste generated in a Covered State
comply with Subpart I, whether they are
located in a Covered State or a non-
Covered State. This requirement is
necessary to ensure that generators in
Covered States receive a copy of the
tracking form 'signed by the destination
facility to which the waste is delivered.
In addition, the provisions of Subpart
I are also applicable to on-site treatment
and destruction and disposal facilih'es
that accept regulated medical waste
required to be accompanied by a
tracking form from off-site sources. Such
facilities include on-site incinerators •
that burn regulated medical waste and
facilities that treat and destroy the
waste.
2. Types of Treatment, Destruction, arid
Disposal Facilities
For purposes of today's rule,
treatment, destruction, and disposal
facilities can be differentiated into, two
distinct types: (a) Destination
facilities—facilities that either dispose
of the regulated medical waste or that
meet the "treat and destroy" criteria so
that the regulated medical waste no
longer needs to be tracked; and (b)
Intermediate handlers—facilities where
regulated medical waste is treated but
not destroyed and facilities where
regulated medical waste is destroyed,
but not treated, thereby requiring that
the regulated medical waste must
continue to be tracked to its final
disposal site. Each type is discussed
below. The reader should note that in
addition to the Federal tracking
requirements of today's rule, many
States and localities hav.e their own
laws and regulations for treatment,
destruction, and disposal facilities
which are unaffected by today's rule.
a. Destination facilities. Included in
this type are incinerators, treatment
facilities that "treat and destroy" the
waste, and disposal facilities.
Incinerators are subject to the
demonstration program as medical
waste treatment facilities when they
accept regulated medical waste. The
MWTA specifies that regulated medical
waste must be tracked from its point of
generation through either disposal or
incineration. By designating incineration
as an alternative end point, Congress
intended that incinerators used to treat
and destroy regulated medical waste
must comply with the same basic
requirements for signing and returning
the tracking form as disposal facilities
(i.e., each is the final destination of the
waste).
Similarly regulated are those
treatment facilities that subject the
medical waste to a series of processes
that both "treat" (e.g., steam
autoclaving) and "destroy" (e.g.,
grinding or melting processes) the waste.
These processes are similar to
incinerators because they alleviate the
potential to cause adverse human health
effects, physical hazards, and aesthetic
degradation of the environment. EPA
has therefore exempted the residuals of
these processes under § 259.30(c)(2)(iv).
Regulated medical wastes that have
been subjected to processes that both
treat and destroy the waste, remove the
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waste from the tracking requirements of
today's rule.
The requirements applicable to the
above-mentioned destination facilities
are identical under today's rule, since
each type of facility serves as an end
point for the tracking forms
accompanying regulated medical waste.
These requirements generally include
signing and returning (mailing) tracking
forms, signing return receipts in the case
of wastes shipped by mail, discrepancy
reporting, and maintaining the necessary
records (e.g., keeping copies of the
tracking forms and discrepancy reports
for three (3) years).
b. Intermediate handlers. Included in
this type are facilities that treat
regulated medical waste (disinfect or
decontaminate) but do not destroy it or
facilities that destroy the regulated
medical waste but do not treat it. These
intermediate handlers are required to
initiate a new tracking form to
accompany each shipment of treated or
destroyed regulated medical waste from
the intermediate handler's facility to the
destination facility. They are, in effect.
new generators of the regulated medical
waste. Specific tracking form handling
requirements have been established for
intermediate handlers to ensure that the
original generator of the waste obtains a
copy of the tracking form with the
signature of the destination facility.
These requirements are explained
below, under Use of the Tracking Form
(see I 259.81(c)).
3. Use of the Tracking Form (§ 259.81)
a. General. All destination facilities
and intermediate handlers that receive
regulated medical waste generated in a
Covered State accompanied by a
tracking form must satisfy several
requirements related to the form and the
waste it covers. Upon receipt, the owner
or operator must determine that the
tracking form accurately reflects the
waste received at the facility both in
terms of the description of regulated
medical waste specified on the form
(i.e., whether it is labeled properly as.
"untreated" or "treated"), the number of
containers, and the total quantity of the
shipment. (The reader should note that
under State regulations, the owner or
operator also may have to account for
State-regulated medical waste listed in
Box ll(c) of the tracking form.) If the
owner or operator discovers any
discrepancies between the information
contained on the tracking form and the
waste contained in the shipment, he
must note the discrepancy on the
tracking form. When discrepancies are
discovered (see discussion below), he
must attempt to resolve these
discrepancies by recounting or
rechecking the tracking form(s), or, if the
shipment was consolidated or
remanifested, by checking the
transporter's log and/or the tracking
forms initiated by the generator. Once a
discrepancy has been identified, the
generator, transporter(s), and the owner
or operator should take steps to resolve
the discrepancy and/or locate the
missing waste. If the discrepancy cannot
be resolved, the owner or operator of
the intermediate handling facility or the
destination facility is required to file a
discrepancy report as described below
(see also § 259.82).
Discrepancies that must be noted on
the tracking form are differences of
either quantity or description of
regulated medical waste. For purposes
of today's rule, discrepancies exist (for
containerized waste) if there is'any
variation in piece count (box, pail, or
drum), or if containers are not labeled
properly as untreated waste. Label
discrepancies can be identified through
a visual inspection of the label on the
outer most surface of the package and .
the description of the waste on the
tracking form (Box 11). If the material is
untreated regulated medical waste, the
label must contain the words "Infectious
Waste," or "Medical Waste," or display
the universal biohazard symbol.
Packages containing treated regulated
medical waste are not required to have
a label. The Agency is not
recommending that owners and
operators open containers of waste to
make further inspections, as this may
increase occupational exposure to the
waste.
In addition to the discrepancies
described above, arrival of improperly
packaged regulated medical waste or
arrival of regulated medical waste
accompanied by unsigned or otherwise
incomplete tracking forms are also
discrepancies. The Agency believes it is
important that the integrity of the
packaging containing regulated medical
waste be maintained from the point of
generation to the point of treatment or
disposal so that workers are not
exposed to regulated medical waste.
The Agency also believes that it is the
responsibility of all regulated medical
waste handlers—generators,
transporters, treaters, and disposers—to
ensure proper packaging and
containment of the waste as it is
transported and tracked through the
management system.
The Agency believes that an unsigned
or incomplete tracking form is a
significant cause for concern. It is an
indication that shipping papers may
have been altered or that regulated
medical waste has been mishandled
inadvertently somewhere between the
point of generation and the point at
which the waste reaches an
intermediate handler or destination
facility. The owner or operator of a
treatment or destruction facility, or a
disposal facility is ideally placed to note
such discrepancies.
'EPA is also concerned that, when
, regulated medical waste arrives at an
' intermediate handler or a destination
facility unaccompanied by a tracking
form, it is impossible for the owner or
operator to fulfill his requirement to
determine that the tracking form
accurately reflects the waste listed on
the form. He will be unable to check the
piece count or to determine that the
waste is described appropriately as
treated or untreated regulated medical
waste. In these instances, if the owner
or operator knows the waste should be
accompanied by a tracking form and
accepts it, he must file a discrepancy
report as described later in this
Preamble. EPA notes that it may be
difficult for the owner or operator to
identify regulated medical waste, except
where the container bears a marking
identifying the generator and
transporter.
Finally, the owner or operator should
follow any special instructions hi Box 14
of the tracking form for oversized items,
handling them accordingly.
b. Destination facilities. Once the
information contained on the tracking
form has been verified or any apparent
discrepancies noted, the owner or
operator of the destination facility must
sign and date each copy of the tracking
form. This signature certifies 'that the
waste described by the tracking form
has been received at the destination
facility. The facility owner or operator
must immediately give the transporter a
signed copy. This copy is the
transporter's confirmation that he
delivered the waste as described on the
tracking form or as otherwise noted in
the discrepancy box.
The owner or operator of the
destination facility must then return a
signed copy of the tracking form within
15 days of acceptance of the waste either
to the generator at the address indicated
on the form or, in the case of
consolidated or remanifested shipments
or shipments remanifested by an
intermediate handler, to the party that
initiated the tracking form. (The
transporter is then responsible for
providing the original generator with a
signed copy of the tracking document, as
explained in Section V.H. of the
Preamble.) If a transporter consolidated
shipments or prepared the tracking form
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because the waste originated from
generators of less than 50 pounds per
month, the tracking form must be
returned to the transporter that
reassigned or consolidated the
shipment.
c. Intermediate handlers. Intermediate
handlers, facilities that either treat or
destroy the regulated medical waste but
do not do both are required to continue
to track the waste to a destination
facility. These facilities are, in effect,
new generators. Intermediate handlers
who only treat the regulated medical
waste must initiate a new tracking form
to indicate that the waste category
changed from untreated to treated, and
to indicate any changes hi the number of
containers and/or weight of the wastes
being shipped to the destination facility.
Intermediate handlers who only destroy
regulated medical waste must initiate a
new tracking form to indicate the
change in the number of containers and/
or weight of regulated medical waste
caused by the destruction process.
These facilities also must meet all of the
generator requirements under Subparts
E and F of today's rule. In addition,
intermediate handlers must maintain a
log that correlates the waste accepted
from each original generator to the
waste shipments that he has initiated.
The log must include the generator's
name, State permit or identification
number, or if none, the generator's
address, the date of shipment or the
generator's unique tracking form number
assigned to that shipment, and the new
tracking form number to which the
waste was assigned.
Intermediate handlers that initiate a
new tracking form must retain the
original generator's tracking form until
the new tracking form that he initiated is
signed by the destination facility and
returned. Once the intermediate handler
has received the signed copy of the
tracking form from the destination
facility, he must send a copy of the
signed form, together with the original
generator's tracking form, to the original
generator. This process provides the
original generator of the waste with
assurance that the waste was received
by the destination facility fas required
by section 11003(a)).
d. Certification of disposal.
Discussions with members of the health
care industry have indicated that many
generators would prefer that the
tracking form include a box for
certification of disposal in addition to
the certification of acceptance. Several
reasons were cited for this preference,
including concern for a generator's
liability in the event of mishandling by
the disposal facility and the fact that
payment for disposal is often contingent
upon a receipt of disposal certification.
However, the Agency believes that this
second certification is not necessary to
meet the statutory requirement that the
generator is assured that the disposal
facility has received the waste. If the
generator wants certification of
disposal, he can stipulate the
requirement through either a contract
with the destination facility or by
requesting such certification in the
Special Handling and Additional
Instruction box on the tracking form.
The Agency requests comments on the
need for inclusion of a separate or
distinct box for certifying disposal on
-the tracking form.
4. Tracking Form Discrepancies (Section
259.82)
Upon discovering a discrepancy, as
described above, between the tracking
form and the actual shipment, the owner
or operator of a facility first must
attempt to reconcile the discrepancy and
should do so as soon as possible after
discovering the problem. For example,
the facility should first try to reconcile
the discrepancy with the transporter by
recounting the number of containers, or
by contacting the transporter to see if
the missing packagefs) or tracking forms
were placed on a different transport
vehicle. The facility should make
telephone inquiries to the other parties
in the chain of custody, and keep a
written record of these inquiries and the
information obtained. If the discrepancy
cannot be reconciled within 15 days, the
owner or operator of the facility must
notify the Regional Administrator for the
Region in which the facility is located
and the Regional Administrator and
State where the generator of the
regulated medical waste is located. The
notification must be in the form of a
letter describing the discrepancy and
efforts to resolve it The letter also must
contain a legible copy of the tracking
form and/or shipping paper at issue, if
one exists.
In the case of acceptance of regulated
medical waste unaccompanied by a
tracking form where the owner or
operator knows that a tracking form is
required, the owner or operator must
describe the quantity of waste that he
received, the identity of the transporter
who delivered the waste, and the
identity of the generators of the waste.
As a courtesy the facility also should
mail a copy of the discrepancy report to
the relevant generators) and
transporters). •
5. Recordkeeping Requirements {Section
259.83)
The owner or operator of a
destination facility or an intermediate
handler that receives regulated medical
waste generated in a Covered State.and
accompanied by a tracking form must
maintain records concerning the
delivery of each shipment of regulated
medical waste. These records must be
maintained for a minimum of three (3)
years from the date of receipt of the
waste. Information that must be
maintained includes: (a) copies of all
tracking forms and/or shipping papers;
(b) copies of all discrepancy reports
submitted; and (c) for generators who
deliver waste directly to destination
facilities and intermediate handlers as
allowed under the provisions of
§ 259.51(a), a log which includes the
information required in § 259.83(b).
6. Treatment, Destruction, and Disposal
of Medical Waste
The MWTA does not require or
authorize EPA to establish standards for
the treatment, destruction, or disposal of
medical waste. Rather, the Act focuses
on tracking these wastes. Accordingly,
treatment, destruction, and disposal
standards for regulated medical wastes
are not included in today's rule.
However, facilities are required to meet
any specific local, State, or Federal
requirements for the treatment,
destruction, or disposal of regulated
medical waste. Disposal facilities also
must meet all applicable local. State,
and Federal solid waste management
requirements.
Under section 4004 of RCRA (Subtitle
D), all solid waste must be disposed of
in a manner that poses no reasonable
probability of causing adverse effects to
human health or the environment.
Because solid waste classification
encompasses nearly all waste, including
medical waste, this restriction
comprises the minimal standard that all
disposal facilities for regulated medical
waste must meet. Practices that do not
meet this standard are considered by
the Agency to constitute open dumping
and thus are prohibited under 4005 of
RCRA. The Agency has established
criteria, detailed in 40 CFR Part 257, that
specify general performance standards
for solid waste disposal practices and
facilities. Currently, these criteria
address facility location, impact on
surface and ground water and on air
quality, land application of solid waste,
and other concerns.
In addition, the Agency recently has
proposed regulations revising the
Subtitle D criteria for municipal waste
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landfills (53 FR 33314, August 30,1988).
These proposed revisions, if adopted,
•would establish specific requirements
applicable to all municipal solid waste
landfill facilities. These requirements
include setting design goals for
protecting groundwater, groundwater
monitoring and corrective action,
closure and post-closure care, and
financial responsibility.
The responsibility for implementing
the Subtitle D regulations traditionally
has fallen upon the States, which are
required to establish solid waste
programs that meet the Federal criteria.
Many States, however, have gone well
beyond the Federal criteria in regulating
solid waste management facilities.
Additionally, the number of States that
regulate medical waste is increasing; all
of the States mentioned in Subtitle J
either have such regulations in place or
have indicated they will soon regulate
medical waste. These regulations
typically are comprehensive, including
requirements for treatment of the waste
(often specifying sterilization or
incineration) prior to disposal, and for
permitting the solid waste disposal
facilities. Today's rule is intended to
complement these State programs in
providing for the effective management
of medical waste.
Finally, in the MWTA Congress has
expressed serious interest in the
treatment and disposal of medical
waste. The Act requires that the Agency
report to Congress on current disposal
methods and requirements, as well as
on available treatment and disposal
methods, and on the health impacts and
costs of current and alternative
methods. The requirements of this
Subpart are intended to provide some of
the information necessary to develop
such reports. The Agency requests that
commenters submit available
information on alternative treatment
and destruction technologies, as well as
on disposal technologies. EPA will use
any information provided to develop, a
model State medical waste progran.
/. Subpart f—Rail Shipments of
Regulated Medical Waste (Section
259.90)
Subpart J of today's rule establishes
the procedures for handling the tracking
form and recordkeeping requirements
that rail carriers of regulated medical
waste must follow. The requirements
are identical to those established under
Subtitle C of RCRA for rail carriers. The
Agency believes that the unique
operational characteristics of the rail
industry necessitate that rail carriers be
subject to somewhat different tracking
and recordkeeping requirements than
those that apply to other transporters of
regulated medical waste.
Under today's rule, as under the
hazardous waste regulations, rail
transporters may, under certain
conditions, move regulated medical
waste without actually carrying the
tracking form (i.e., jt can be sent ahead
by mail). Also, shipments may be
transferred between two rail
transporters without obtaining the
accepting transporter's (rail carrier's)
signature, if so directed on the manifest
or tracking form. EPA explained the
necessity and basis for these special
provisions on February 26,1980, for
hazardous waste transporters (45 FR
12739), and the Agency believes similar
provisions are appropriate for regulated
medical waste when it is transported by
rail.
VI. Relationship to Other EPA Programs
The regulations promulgated today for
the medical waste tracking program are
required by amendments to the
Resource Conservation and Recovery
Act (RCRA), one of several laws that
EPA administers. Below is a discussion
of other EPA programs that are related
to the medical waste tracking program
promulgated today.
A. Other Subtitles of RCRA
1. Subtitle C—Hazardous Waste
Management
The definition of "medical waste"
found in RCRA section 1004(40)
specifically excludes hazardous waste
identified or listed under Subtitle C of
that act. The implementing regulations
at 40 CFR Part 261 identify
characteristics of hazardous waste and
list specific hazardous wastes. A
generator of a solid waste (which can be
solid, semisolid, liquid, or contained
gaseous waste) must determine if the
waste is hazardous under the Part 261
regulations. If the waste is a listed or
characteristic hazardous waste as
generated, it is not subject to regulation
under the Part 259 regulations. In
making this determination, the generator
must use the Federal regulations
defining hazardous waste. If the waste
is not hazardous under Federal
regulations, the generator proceeds to
determine whether the waste is
regulated medical waste.
The hazardous waste programs in
some States cover a broader universe of
wastes than the Federal program. The
wastes that are regulated as hazardous
by certain States, but not by the Federal
program, may also be regulated medical
wastes, because the "hazardous waste"
exclusion in section 1004(40) refers to
Federally-regulated hazardous waste.
In the case of mixtures of medical
waste and hazardous waste identified or
listed in Part 261, if the mixture is
subject to the hazardous waste manifest
requirements, it is exempt from the
medical waste tracking requirements.
Duplicative manifesting is unnecessary
and inconsistent with Congressional
intent, given the exclusion of hazardous
waste from the definition of "medical
waste." However, hazardous waste that
is exempted from the RCRA Subtitle C
manifest requirements does not present
the problem of duplicative tracking
when it is mixed with regulated medical
waste. Therefore, if the mixture of
regulated medical waste and hazardous
waste is not required to be tracked
under the Subtitle C rules, it must be
managed and tracked as regulated
medical waste. For example, if a
hazardous waste is exempt from
regulation because it is generated by a
conditionally exempt small quantity
generator (40 CFR 261.5) but is mixed
with a regulated medical waste, then the
entire quantity of waste must be
handled as regulated medical waste.
Certain cytotoxic agents, including the
following, are covered under RCRA
Subtitle C hazardous waste regulations:
Cyclophosphamide (also known as
Cytoxin) (U058); Daunomycin (U059);
Melphalan (U150); Mitomycin C (U010);
Streptozotocin (U206); and Uracil
Mustard (U237). The Agency will
determine in further study and
evaluation whether additional
cytotoxins should be regulated under
Subtitle C. The Agency requests
comment from the regulated community
regarding the proper management of
cytotoxic and antineoplastic drugs.
Residues from the treatment of
medical wastes may become hazardous
wastes. For example, incineration
reduces the volume of a waste, and the
volume reduction may cause a
concentration of metal constituents.
Thus, it is possible that a medical waste
regulated under Part 259 could become a
hazardous waste if incinerated, and the
resulting ash would be required to be
managed as a hazardous waste under
Subtitle C (40 CFR Parts 260 through
272).
Also, the reader may note several
parallels between the Subtitle C
(hazardous waste) and Subtitle J
(medical waste) regulatory programs.
However, differences in statutory
language and Congressional intent have
resulted in a program for medical waste
that is different from the hazardous
waste program. Section IV of this
Preamble details the differences
between the hazardous waste manifest
and the medical waste tracking form.
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Some examples of the differences
identified in section V of this Preamble
are the use of forms, and the various
definitions for transportation and , •,
treatment.
Finally, under section 11010(c), EPA
retains authority to list medical wastes
under RCRA section 3001, if necessary.
Available data do not suggest that such
a listing is warranted. The Agency will
reconsider this decision after collection
of additional information over the next 2
years during the development of the
interim and final reports on medical
waste required for submission to
Congress.
2. Subtitle D—State or Regional Solid
Waste Plans
Subtitle D of RCRA contains
objectives for environmentally sound
nonhazardous solid waste resource
recovery and disposal methods. To
satisfy one of these objectives, EPA has
promulgated criteria for determining
which land disposal facilities are
sanitary landfills (40 CFR Part 257).
Thus, solid waste disposal at a facility
meeting the sanitary landfill criteria
poses no reasonable probability of
adverse effects on human health or the
environment.
Medical wastes regulated under Part
259 may be disposed in facilities that
meet the sanitary landfill criteria,
subject to State or local restrictions on
such disposal. EPA has not promulgated
requirements for any form of treatment
(such as autoclaving or incineration)
prior to land disposal; however, a State
or locality may enact such treatment
requirements.
Finally, medical wastes not listed
under Part 259, Subpart D, of today's
rule remain subject to the requirements
of Subtitle D.
3. Subtitle G—Miscellaneous Provisions
Since medical waste is a solid waste,
EPA retains authority under RCRA
section 7003 to respond to situations in
which past or present solid waste
handling, storage, treatment,
transportation, or disposal may present
imminent and substantial endangerment
to human health or the environment.
EPA may either issue an administrative
order or file suit in the United States
District Court to obtain any necessary
relief. The Agency must provide notice
to the affected State of any suit under
this section. This authority supplements
section 11005 medical waste
enforcement authority.
ft CERCLA
The Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980, as amended (CERCLA), also
known as Superfund, provides for
emergency and long-term cleanup of
hazardous substances, pollutants, or
contaminants. Section 104(14) of this act
defines "hazardous substances," and 40
CFR 302.4 specifically lists or references
all CERCLA hazardous substances.
"Pollutant or contaminant," as defined
in section 101(33) of CERCLA, includes
disease-causing agents. There is no
tabulation of substances that fits the
definition of "pollutant or contaminant."
The broad language in the definition
could include pathogens, bacteria, and
viruses.
Under CERCLA section 104, EPA may
clean up releases or threatened releases
of either hazardous substances or
pollutants/contaminant's that may
present an imminent and substantial
danger to the public health or welfare.
(This authority and CERCLA section
106, which authorizes injunctive relief
against responsible parties for releases
of hazardous substances, is similar to
the RCRA section 7003 authority
described above.) Medical waste could
contain hazardous substances, or it
could contain pollutants or
contaminants. Thus, certain releases of
medical waste may be subject to
Superfund authority.
The Part 259, Subpart D, listing of
-medical wastes promulgated today,
however, does not trigger the addition of
wastes to the 40 CFR 302.4 list of
hazardous substances (in contrast to
Subtitle C listings). Today's rule does
not alter CERCLA authority or the
CERCLA liabilities of any persons
handling medical waste. In addition, the
hazardous material regulations of the
U.S. Department of Transportation
(which are tied to CERCLA listings) are
not affected by today's rules.
C. Clean Air Act
Currently, the Clean Air Act
regulations include a New Source
Performance Standard for incinerators
of solid waste, of which 50 percent or
more is municipal waste, charging more
than 50 tons per day, if those
incinerators were constructed or
modified after August 17,1971. The
regulations, found at 40 CFR 60.50,
specify a particulate matter emission
limit. Many health care facility
incinerators have a lower charging rate
and would not be regulated under this
performance standard. However, they
may be subject to other State or local air
pollution control regulations, including
State Implementation Plans which are
Federally enforceable under section 110
of the Clean Air Act.
The regulations promulgated today for
the medical waste demonstration
program do not require a particular
treatment technology for medical waste.
Certain States, however, have taken
steps to limit land disposal of untreated
medical waste. The actions of these
States could result in increased use of
incineration or other treatment
techniques. In addition, Congress
directed that incineration residues do
not require tracking under the medical
waste demonstration program. This
exemption may encourage generators to
incinerate their medical waste.
EPA's Office of Air Quality Planning
and Standards has begun investigating
the risks associated with hospital waste
incineration and is developing a training
course for hospital waste incinerator
operators. The Agency may decide to
develop standards for these sources
under the Clean Air Act.
D. Water Pollution Control
\. Clean Water Act
This law establishes the requirement
that discharges of pollutants, except in
compliance with the Act, are unlawful.
and further establishes programs to
control the discharges of pollutants to
navigable waters. The pretreatment
program establishes standards for the
introduction of pollutants into publicly
owned treatment works (section 307).
Direct discharges of pollutants to
navigable waters require a permit
incorporating technology-based
limitations and any more stringent
limitations necessary to comply witr-
State water quality standards.
Recent amendments to the Clean
Water Act prohibit the discharge'of
medical waste to navigable waters
(United States Public Vessel Medical
Waste Anti-Dumping Act of 1988, Public
Law 100-688, Title III, Subtitle B, section
3202). The Agency will be addressing
these amendments in a rulemaking
amending its National Pollution
Discharge Elimination System (NPDES)
regulations.
2. Marine Plastic Pollution Research and
Control Act of 1987 (Pub: L. 100-220)
Title II of this Act requires several
activities to be conducted and is divided
into three subtitles.
Subtitle A requires the U.S. Coast
Guard to prepare regulations to
implement the 1978 Protocol Relating to
The International Convention for the
Prevention of Pollution from Ships
(MARPOL), relating to disposal of
wastes from vessels. These regulations
were proposed in 1988.
Subtitle B requires the Environmental
Protection Agency and the Commerce
Department's National Oceanic and
Atmospheric Administration to study
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the sources and effects of plastic
materials on the environment, including
the marine environment, and on waste
disposal. A public education program
which encourages citizen pollution
patrols is also required to be developed
under this Subtitle. The objective of the
citizen pollution patrols is to assist State
and local officials in monitoring and
cleaning up ocean and shoreline
pollution. These activities are underway.
Subtitle C includes the development
of a plan specific to the restoration of
water quality in the New York Bight.
All three subtitles include plastics-
related activities which will aid efforts
to reduce the pollution of the marine
environment with medical waste.
3. Marine Protection, Research and
Sanctuaries Act of 1972
This Act prohibits the transportation
of materials from the United States for
the purpose of ocean dumping unless
authorized by a permit Recent
amendments to this law prohibit the
issuance of a permit for the
transportation of medical wastes for the
purpose of dumping.
4. United States Public Vessel Medical
Waste Anti-Dumping Act of 1988
Vessels that are owned, chartered or
operated by the U.S. Government, and
that are not engaged in commercial
service, are prohibited, except hi limited
specific circumstances, from disposing
into ocean waters potentially infectious
medical waste generated on board the
vessel. EPA, the Department of Defense,
and affected agencies must publish
guidance to implement this law.
5. Shore Protection Act of 1988
This law requires vessels (other than
public vessels) to obtain permits for
transporting municipal or commercial
solid wastes in coastal waters. The law
specifies loading, securing, unloading,
and clean-up procedures for waste
sources, vessels, and receiving facilities.
It also requires EPA, in consultation
with the Department of Transportation,
to promulgate regulations implementing
these requirements.
E. EPA Research Activities
The Agency's research facilities are
conducting studies to assess current
medical waste incineration practices for
improving combustion and to assess
risks from incineration of medical
waste. In addition, EPA is collecting and
evaluating information to meet the
requirements under the MWTA for the
Reports to Congress.
F. EPA's Office of International
Activities
Subtitle J has no specific provisions
for imports and exports of medical
waste, except a requirement that EPA
consult with the International Joint
Commission (IJC) to determine how to
monitor disposal of medical waste
emanating from Canada. Furthermore,
the Act implicitly requires the Agency to
track medical Wastes generated in a
State subject to the demonstration
program and disposed of in a foreign
country. It is the Office of International
Activities' (OIA) responsibility to make
certain that the concerns regarding the
import and export of medical wastes are
addressed.
EPA is currently consulting with the
Canadian government through the OIA
to identify and discuss issues related to
the transboundary movement of
regulated medical wastes between the
United States and Canada. The Agency
intends to use this information from
Canada in assessing the need for a
program which controls the export and
import of regulated medical wastes. This
information will be summarized in the
Reports to Congress. EPA, through the
Department of State, is providing a copy
of this interim final rule to the IJC to
meet the requirements of the MWTA.
VU. Relationship to Other Federal
Regulatory Programs
This section discusses the relationship
between the rule EPA is promulgating
today for medical waste tracking and
the regulatory programs of other Federal
agencies that in one way or another,
may apply to'the same wastes. In
general, the fact that another set of
Federal regulations applies to wastes
does not mean that the Resource
Conservation and Recovery Act (RCRA)
does not apply. In some cases, RCRA
regulations apply independently of, and
in addition to, other Federal rules.
However, the RCRA definition of solid
waste, given in section 1004(27),
excludes certain materials regulated
under other laws from RCRA coverage.
Further, section 11002(b) of RCRA
allows EPA to exclude medical waste
that does not pose a substantial hazard
to human health or the environment if
improperly managed. In exercising this
authority, EPA considered whether
existing Federal regulatory programs
may provide adequate protection for
some wastes, making RCRA Subtitle J
regulation unnecessary.
A. Nuclear Regulatory Commission
(NRC)
Certain waste streams may contain
materials that are source, special
nuclear, or by-product material, as
defined in the Atomic Energy Act, and
also may contain materials that meet the
definition of medical waste in section
1004(40) of RCRA. These wastes are
subject to regulation under both laws; if
one law's requirements are more
stringent, those requirements supersede
and supplement the less stringent ones.
As explained previously, generators
may treat and destroy their regulated
medical wastes, if they so choose, thus
making their mixed radioactive and
medical waste subject only to Nuclear
Regulatory Commission requirements.
Otherwise, such wastes are subject to
both sets of rules.
EPA has reviewed the NRC
regulations and finds that, while there
are similarities between EPA and NRC
requirements, there are also several
significant differences, particularly with
respect to labeling, manifesting, and
packaging. Because today's rule does
not exempt radioactive medical waste,
EPA is requiring generators of mixed
radioactive and medical waste to meet
both EPA and NRC labeling,
manifesting, and packaging
requirements. For a complete
description of the applicable NRC
regulations, refer to 10 CFR Part 20 and
10 CFR Part 61. Some important areas
where NRC regulations are clearly
distinct and more stringent than EPA
regulations are discussed below.
1. Labeling
The low-level radioactive waste
category (that which is suitable for near-
surface landfill) is broken down by the
NRC into three classes—^A, B, and C—
according to its level of radioactivity. As
specified in 10 CFR 20.311(d), it is the
responsibility of the generator to
• classify the waste properly. Radioactive
medical waste is most often Class A (the
least radioactive) waste. In any case, as
specified in 10 CFR 61.55 and § 61.57, it
must be labeled appropriately, in
addition to the labeling requirements of
Part 259, Subpart E, promulgated today.
2. Manifesting
The NRC requires a shipping manifest
for all radioactive waste destined for a
licensed land disposal facility. An EPA
medical waste tracking form is sufficient
for this requirement, provided that
certain additional information as
described below is recorded in Box 14
(Special Handling Instructions and
Additional Information) of the medical
waste tracking form. The tracking form
must indicate, as completely as
practicable, a physical description of the
waste, the volume of the waste, the
radionuclide identity and quantity, the
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total radioactivity, and the principal
chemical form. Generators may attach a
separate sheet with this information to
the Medical Waste Tracking Form.
NRC requires that the solidification
agent for liquid wastes must be
specified, Waste containing more than
0.1 percent chela ting agents by weight
must be identified and the percentage
weight of the chelating agent estimated.
Again, all of this information can be
included in Box 14 or on a separate
sheet. These and other NRC tracking
requirements are specified in 10 CFR
20.311.
NRC's exception reporting
requirement described in 10 CFR
20.311(h) is particularly noteworthy and
is more stringent than the EPA medical
waste exception reporting requirement.
Any shipment for which
acknowledgment of receipt by the
disposal facility is not received by the
generator within 20 days must be
investigated by the generator, traced,
and reported. In today's rule, EPA sets
forth a requirement that the exception
reporting process begins after 35 days.
Therefore, NRC's 20-day investigation
requirement is more stringent and takes
precedence, but if the exception is not
resolved within 45 days, then EPA'8
exception reporting requirements also
would have to be met, in addition to
NRC's reporting requirements.
3. Packaging
NRC requires that all classes of
radioactive waste be handled and
packaged according to specific
requirements. These requirements are
intended to provide stability to the
waste, to facilitate handling at the ,
disposal site, and to ensure the health
and safety of personnel at the disposal
site. EPA's and NRC's objectives in
providing requirements for.proper waste
packaging are consistent with each
Other. However, to protect personnel
handling and disposing of the waste,
NRC requires waste which contains
hazardous, biological, pathogenic, or
infectious material to be treated to
reduce, to the maximum extent
practicable, the potential hazard from
the nonradiological materials. This
requirement is more stringent than
EPA's and is in addition to the
requirements promulgated today.
Other important handling and
packaging requirements that are more
stringent than EPA's and must be
followed for radioactive medical waste
include the following: waste must not be
packaged for disposal in cardboard or
fiberboard boxes; liquid waste must be
solidified or packaged in sufficient
absorbent material to absorb twice the
volume of the liquid; solid waste
containing liquid shall contain as little
freestanding and noncorrosive liquid as
is reasonably achievable, but in no case
shall the liquid exceed one (1) percent of
the volume; waste must have structural
stability, which can be provided by the
waste form itself, by processing the
waste to a stable form, or by placing the
waste in a disposal container or
structure that provides stability after
disposal. These and other waste
handling and packaging requirements
are specified in 10 CFR 61.56.
4. Limitation of Generator's Disposal
Options
Today's medical waste tracking »
regulations do not restrict the treatment
or disposal options the generator may
choose, although generators may be
limited by State regulations. However,
the NRC regulations, in some cases,
limit the generator's disposal options.
These requirements are more stringent
and are in addition to the requirements
promulgated today.
B. United States Department of
Agriculture (USDA)
1. Animals With Communicable
Diseases
Certain animal wastes are regulated
by, USDA under 9 CFR Parts 50 through
56. According to the rules, contaminated
materials must be cleaned and
disinfected, or in some cases destroyed.
A USDA or State veterinary official
determines which materials must be
disinfected. Carcasses of animals killed
because of exposure to certain diseases
are sometimes sent for incineration or
burial. The USDA regulations require
Federal or State employees to supervise
the incineration or burial and to prepare
reports identifying the animal and its
disposition. However, USDA regulations
do not require tracking of the carcasses.
The area of overlap between the USDA
rules and today's rule is minimal
because the waste regulated by EPA
under Class 5 are contaminated animal
carcasses, body parts, and bedding of
animals exposed to infectious agents
during research, production of
biological, or testing of Pharmaceuticals.
Although no exemption was included in
today's rule, EPA requests comment on
whether animal carcasses that are both
regulated medical waste under
§259.30(a) and regulated by USDA
should be exempted from part 259
requirements.
2. Veterinary Biological Products
Products such as vaccines and
serums, intended for use in the
diagnosis, treatment, or prevention of
animal diseases, are regulated by
USDA. A warning label, required on
substances containing viable or
dangerous organisms (9 CFR Part 112),
instructs the user to burn the container
and all unused contents. USDA also
regulates imports of some veterinary
biological products which are classified
as wastes if they are imported without
appropriate permits and are then sent
for destruction. Today's medical waste
tracking regulations supplement these
existing USDA waste management
requirements.
C. Department of Labor (DDL)—
Occupational Safety and Health
Administration (OSHA)
OSHA regulations, specifically 29 CFR
Part 1910, Subparts I and J, include a
variety of general requirements for
worker protection. Personal protective
equipment, such as eye protection and
respirators, is required when necessary.
For all places of employment, waste
removal must be conducted to keep the
work environment sanitary. Special tags
and signs are required to identify
equipment, rooms, materials, and
experimental animals that contain, or
are contaminated with, biological
hazards.
OSHA is developing regulations to
protect health care workers from the
transmission of blood-borne infectious
diseases (52 FR 45438, November 27,
1987). A draft of the proposed regulation
was released to the public and is
available from the OSHA Docket Office
{(202) 532-7894; Docket H-370).
Additionally, the Departments of Labor
and Health and Human Services (HHS)
have initiated efforts to educate health
care workers concerning blood-borne
disease (see 52 FR 41888, October 30.
1987).
To the extent that workers are
protected by OSHA's regulations, some
regulations for hazard identification and
protective clothing already exist. The
packaging requirements for sharps and
fluids in today's rule also should serve
to protect waste handlers. Finally,
OSHA is considering the use of the
universal biohazard symbol in certain
workplace situations. This is compatible
with today's EPA rule, which specifies
that symbol as one means of identifying
packages of medical waste.
D. Department of Health and Human
Services
1. Food and Drug Administration (FDA)
The FDA regulates the production of
biological substances for preventing,
treating, or curing human diseases or
injuries. Facilities developing biological
products are licensed by the FDA. and
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they must meet standards for
cleanliness and timely, sanitary trash
disposal.
Laboratories conducting studies to
support research or product marketing
applications also are required to meet
certain standards. If they do not meet
these criteria, the validity of the studies
may be questioned and the studies may
be disqualified. Thus, both the
production facilities and laboratories
must comply with animal waste and
general refuse storage and disposal
Standards. (See 21CFR 58.43 and
i§ 211.50, 211.56, and 606.40).
For wastes shipped off-site that fall
into one of today's regulated medical
waste categories, today's regulations
impose packaging, segregation, labeling,
and tracking form requirements, and
supplement the FDA rules.
2. Public Health Service (PHS)
Interstate shipments of etiologic
agents are regulated by the Public
Health Service. An "etiologic agent" is
defined in PHS regulations (42 CFR 72.1)
as a viable microorganism or its toxin
which causes, or may cause, human
disease. Shipments of certain etiologic
agents must meet packaging
requirements and must be labeled with
a symbol for biological hazards. A
sender also must receive notification
that the shipment has arrived at its
destination. If the notification is not
received, the sender must notify the
Centers for Disease Control (CDC).
Imports of etiological agents and
human disease vectors are prohibited
unless accompanied by a permit. Human
remains from persons who died of
certain communicable diseases also are
prohibited from importation unless they
have been cremated, or embalmed and
placed in a sealed casket, or are
accompanied by a permit.
EPA has determined that etiologic
agents need not be regulated under the
EPA medical waste tracking program if
they are subject to PHS and Department
of Transportation (DOT) rules for
interstate shipments of etiologic agents.
(See the discussion in section V.D. of
this Preamble and paragraph E of this
section.)
3. Health Care Financing Administration
(HCFA)
To participate in the Medicare
program, health care facilities are
required to comply with specific
conditions of participation or coverage
that specify various patient health and
safety requirements. Generally, with
respect to waste disposal, these
conditions require health care facilities
to meet any State or local licensing
requirements, to have procedures for
proper, routine storage and prompt
disposal of trash, and to have policies
and procedures concerning infection
control.
The specific conditions of
participation or coverage for the various
provider types may be found at 42 CFR
405 Subpart L, Home Health Agencies;
Subpart M, Independent Laboratories;
Subpart N, Portable X-ray Services;
Subpart Q, Clinics, Rehabilitation
Agencies, and Public Health Agencies
as Providers of Outpatient Physical
Therapy and/or Speech Pathology
Services, and Outpatient Physical
Therapy Services Furnished by Physical
Therapists in Independent Practice;
Subpart U, End Stage Renal Disease
Facilities; Subpart X, Rural Health Clinic
Services; 42 CFR Part 416, Ambulatory
Surgical Services; 42 CFR Part 418,
Hospice Care; 42 CFR Part 482, , •:
Hospitals; 42 CFR Part 483, Subpart B
(redesignated on February 2,1989, 54 FR
5316), Long Term Care Facilities; and 42
CFR Part 485, Specialized Providers.
E. Department of Transportation (DOT)
1. Hazardous Materials Shipments
DOT regulates the transportation of
hazardous materials in commerce (49
CFR Parts 171 to 179). The regulations
' address: (a) Interstate transportation of
hazardous materials by motor vehicle,
rail car, aircraft and vessel; and (b) ,
intrastate transportation of certain
hazardous materials (hazardous wastes,
hazardous substances, and flammable
cryogenic liquids in portable tanks and
cargo tanks) by motor vehicle.
One class of hazardous materials is
the "etiologic agents" hazard class. As
currently defined in 49 CFR 173.388, an
"etiologic agent" means a viable
microorganism, or its toxin, which
causes or may cause human disease,
and is limited to those agents listed in 42
CFR 72.3 of the regulations of the
Department of Health and Human
Services. The list in 42 CFR 72.3 includes
many bacterial, fungal, viral and
rickettsial agents.
EPA has determined that etiologic
agents that are wastes are not regulated
medical wastes if they are shipped in
accordance with DOTs regulations for
etiologic agents. EPA made this
deternination because DOTs
regulations for shipping etiologic agents,
in combination with the Public Health
Service regulations discussed
previously, are generally more stringent
than the regulations promulgated today.
DOT's regulations for etiologic agents
specify that no person may ship a
package containing over four liters gross
volume of an etiologic agent. The
packaging must meet requirements
specified in 49 CFR 173.24 and 173.387,
and must be labeled with the etiologic
agents/biomedical material label as
specified in 49 CFR 173.388. In the event
of fire, breakage, spillage, or suspected
contamination involving etiologic agents
during the course of transportation
(including loading, unloading and
temporary storage), the carrier must
notify DOT by telephone at (800) 424-
8802 or (202) 267-2675, or the Centers for
Disease Control at (404) 633-5513 (49
CFR 171.15). The telephone notice must
be followed by a written report (49 CFR
171.16).
DOT has proposed to broaden its
definition of "etiologic agent" and to
eliminate an exception for cultures of
etiologic agents of 50 miliiliters or less
total quantity in one outside package (53
FR 45525, November 10,1988). DOT also
plans to reconsider other aspects of its
regulations for the transportation of
etiologic agents.
EPA notes as a point of clarification
that the rules promulgated today do not
add any additional materials to the list
of etiologic agents that are subject to
DOT's Hazardous Materials
Regulations, nor do the rules cause any
additional materials to come under DOT
regulation. Today's medical waste
tracking rules are independent of the
DOT Hazardous Materials Regulations.
2. MARPOL 73/78
The Protocol of 1978, relating to the
International Convention for the
Prevention of Pollution from Shipst 1973
(MARPOL 73/78), is an international
treaty for preventing ship generated
ocean pollution by oil, noxious liquid
substances, harmful substances, sewage,
and garbage. The section of the treaty
that seeks to prevent garbage pollution
is found in Annex V, recently in force
and incorporated into U.S. law as the
Act to Prevent Pollution from Ships (33
U.S.C. 1901-1911). The U.S. Coast Guard
has initiated a rulemaking to address
garbage disposal (53 FR 43622, October
27,1988). The Coast Guard regulations
will apply to all ship-generated garbage.
including regulated medical waste.
Ships that are owned or operated by the
United States and that are in
•noncommercial service will be subject
to compliance with Annex V on a
delayed compliance schedule. EPA rules
supplement these Coast Guard rules by
regulating the medical waste brought
ashore in a Covered State.
VIII. Federal Facilities
Under section 11006 of the MWTA,
Federal facilities managing regulated
medical waste generated in a Covered
State are subject to all Federal, State,
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interstate, and local requirements
applicable to the management of such
Wastes and are thus subject to today's
rule. This inclusion of Federal facilities
in the demonstration tracking program is
intended to ensure that Federal facilities
generating or otherwise handling
regulated medical waste are subject to
the same level of regulation as non-
Federal institutions. The participation of
these facilities is important if the
demonstration program is to capture all
of the medical waste generated in the
Covered States. In addition, Congress
has indicated that Federal facilities
should set an example in the proper
management of medical waste (see 134
Cong. Rec. H 9539, Oct. 4,1988).
Under today's rule, Federal facilities
located in a Covered State must comply
with all Federal, State, interstate, and
local requirements applicable in that
State, including regulations of the
Federal demonstration program. If a
State elects not to participate in the
program and opts out, the medical waste
generated by the Federal facilities
located in the State will not be subject
to the demonstration program.
In addition to expressly subjecting
Federal facilities in demonstration
States to medical waste regulations, the
MWTA also waives all immunity for the
United States and its agents, employees,
or officers from suit, process, or sanction
of any State or Federal court with
respect to the enforcement of applicable
medical waste regulations. This waiver
ensures that Federal facilities are
subject to the same legal deterrents with
regard to violating medical waste
regulations as non-Federal facilities.
However, the MWTA does provide for
a potential limited exemption for
Federal facilities from medical waste
regulation. As noted in Section 11006 of
RCRA Subtitle J, summarized in Section
H.B. of this Preamble, the President may
exempt Federal facilities under the
Executive Branch from compliance with
medical waste management
requirements if he determines that such
an exemption is in the paramount
interest of the United States. Such an
exemption can only be for one (1) year.
Additional exemptions are allowed, but
only if the President 'makes a new
determination of need, and then only for
a one (1) year period. The President
must report to Congress each January on
the exemptions to Federal facilities
granted under this authority in the
previous year, and state the reasons for
granting such exemptions.
IX. Joint Federal and State
Implementation
Several implementation issues have
arisen because of interstate movement
of medical waste. These are discussed
below.
A. Regulatory Authority
Many States have begun regulating
medical wastes under their own laws.
Section 11007(b) of RCRA reserves for
States and localities the ability to adopt
and enforce their own laws. Any State
or local requirement may be enforced
only by that State or locality.
One specific limitation on the '
regulatory authority of States under
RCRA section 11007(c] is the use of a
uniform medical waste tracking form.
This form must be identical in content
and format to the Federal form when it
is required from a person subject to the
Subtitle } regulations. However, Slates
may require supplemental information
(e.g., additional reports or supplemental
sheets to the tracking form).
EPA's experience with the hazardous
waste manifest system has shown that
uniformity in tracking form requirements
is necessary to reduce conflicting and
overlapping State requirements. (See 47
FR 9336, March 4,1982, and 49 FR10490.
March 20,1984, for further information
on the need for uniformity in hazardous
waste tracking forms.)
When non-Covered States require a
tracking form for regulated medical
waste generated in a Covered State, but
transported into or through their
jurisdictions, they also are bound by the
section Il007(c) requirement that the
tracking form be identical to the Federal
form in content and format. Therefore,
regulated medical waste generated in a
Covered State and shipped to a non-
Covered State may only be
accompanied by a tracking form
identical to the Federal form. If
regulated medical waste is generated,
transported, treated, or disposed only in
non-Covered States, then those States
may impose additional tracking
requirements on the waste and are not
limited by section 11007(c) of RCRA.
In some instances, medical waste will
be generated in a non-Covered State
and transported through or into a
Covered State. While the' waste is in the .
non-Covered State, that State can
impose its own tracking requirements.
Once the waste leaves the non-Covered
State and enters a Covered State, it will
be presumed to have been generated in
that Covered State. (See the discussion
in Section IV.A. of this Preamble.) This
presumption may be rebutted by a
preponderance of the evidence that the
waste was generated outside the
Covered State. Shipping papers or other
documentation accompanying the
shipment will thus be necessary to rebut
this presumption; the burden is on the
regulated party. In the absence of such
documentation, the transporter is
subject to, and must comply with, all
applicable management and tracking
requirements in today's rule.
B. Enforcement Authority
Section 11005 of the Medical Waste
Tracking Act gives the Administrator
authority to assess civil penalties, to
seek injunctive relief in United States
District Court for past or current
violations, and to seek criminal
penalties for knowing violations of the
Act. Section 11004 gives the
Administrator, or his representative,
authority to conduct inspections and
gather information on medical waste.
EPA will include a copy of its
enforcement strategy in the docket for
this rulemaking and will provide copies
of its strategy for implementing the
medical waste regulations to the
Regions and States prior to the effective
date of today's rule. Definition of the
EPA and State roles in enforcement,
information collection/management,
and outreach are the major issues thjit
will be addressed in the strategy.
As part of today's rule, EPA is
broadening the scope of the applicability
of the consolidated rules of practice
governing the administrative assessment
of civil penalties and the revocation and
suspension of permits, 40 CFR part 22;
The consolidated rules will govern
enforcement actions taken pursuant to
section 11005 of RCRA. The
consolidated rules of practice are
applicable only to enforcement actions
initiated by the Administrator.
EPA is issuing the rule on an interim
final basis pursuant to 5 U.S.C. 553(b)
(A) and (B), which allows the issuance
of rules without prior notice and
comment where the rules concern
agency practice or procedure or where
the Agency finds for good cause that
prior notice and comment is
unnecessary. Both of these, criteria are
met by these rules. Use of the
Consolidated Rules on an interim basis
will allow EPA to begin prompt
implementation of the administrative
penalty authority provided in the
Medical Waste Tracking Act. The
Consolidated Rules, codified at 40 CFR
Part 22, provide uniform procedures and
were promulgated after notice and •: •
opportunity for comment. For these
reasons, EPA believes that notice and
comment on this rule is "unnecessary"
under section 553 of the APA.
RCRA section 11005(a) also provides
that civil penalties assessed by the
United States for violations of Subtitle J
shall be assessed in accordance with the
Administrator's "RCRA Civil Penalty
Policy,""as such policy may be amended
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from time to time. EPA issued its
presently applicable "RCRA Civil
Penalty Policy" on May 18,1984, as an
internal Agency Guidance. A copy of the
policy is included in the docket for this
rulemaklng.
X. Regulatory Impacts
A. Executive Order 12291—Regulatory
Impact
Executive Order 12291 requires that
federal regulatory agencies determine
whether a new regulation will be
classified as a "major rule." EPA must
conduct a Regulatory Impact Analysis
for all major rules the Agency
promulgates.
The Administrator has determined
that today's final rule is not a major rule,
because it has total estimated impact
costs of less than $100 million per year.
This conclusion is based on a cost
analysis of today's rule. Therefore, EPA
has not conducted a full Regulatory
Impact Analysis. EPA has analyzed the
costs and potential benefits of today's
rule, but has not assessed the impact of
the costs on affected businesses. This
section provides the methodology and
results of the Agency's cost analysis and
the results of the benefit analysis.
The cost analysis involved developing
cost estimates for management practices
required by today's rule for the 10 states
targeted for involvement in the
demonstration program. Cost estimates
will change if any of the Covered States
opt out of the demonstration program, or
if any other states opt in. State
administrative costs as well as potential
indirect costs associated with changes
in waste management practices have not
been analyzed; their combined effects
on the costs of the rule are unclear.
1. Cost Methodology
In estimating the costs imposed on the
regulated community by today's interim
final rule, the Agency focused on
estimating only the direct costs incurred
through compliance with the rule (i.e.,
those costs incurred directly by
complying with the explicit
requirements of the rule] for the ten
Covered States. The approach EPA
developed involved the following steps:
(1) Characterizing the regulated
community in terms of the numbers and
types of generators, and the numbers of .
transporters affected; (2) estimating the
medical waste generation rates for each
of the generator categories and their rate
of waste shipments transported off site;
(3) accounting for both current state
regulations and existing waste
management practices governing
medical wastes that, for the purposes of
this analysis, are similar to the
requirements of today's rule; and (4)
estimating direct compliance costs for
packaging, tracking, generator
recordkeeping for generators of less
than 50 pounds of regulated medical
waste per month, transporter
recordkeeping and reporting, and
incinerator recordkeeping and reporting.
In this cost analysis, EPA did not
address any of the potential indirect
cost effects of the tracking system. For
example, medical waste disposal
capacity in the demonstration States
may be reduced if landfill facilities
become more reluctant to accept
medical wastes due to the associated
increased labor load and heightened
public awareness the rule will create
(i.e., the combination of packaging,
labeling, and tracking requirements may
cause increasing numbers of landfill
owner/operators to refuse handling
medical wastes). As a result, medical
waste disposal costs could increase. On
the other hand, increased use of
alternate treatment technologies would
decrease the amount of waste regulated
under today's rule and thus decrease
compliance costs. For example, both on-
site incineration and treatment and
destruction exempt waste from today's
rule. The combined effects of indirect
changes in waste management practices
on the costs of the rule are unclear. The
Agency solicits comment on these other
indirect costs, particularly in terms of
cost and price data and how the
tracking requirements will affect
disposal practices. The comments
received on the rule and the reporting
requirements should provide the Agency
information to assess the effects of th
tracking rule on existing disposal
practices. This assessment will be
included in the subsequent Report to
Congress.
2. Direct Compliance Costs
To estimate direct compliance costs,
EPA first divided each of the major
requirements of the rule into its
component tasks and estimated the
labor hours and material costs
associated with completion of each task.
The requirements of the rule fall into
five categories: packaging, tracking,
incineration recordkeeping and
reporting, generator recordkeeping (for
generators of less than 50 pounds per
month), and transporter reporting and
recordkeeping. Costs for the first four
categories are estimated for generators;
only costs for tracking are estimated for
transporters and disposers.
3. Characterizing the Regulated
Community
In order to estimate the direct
compliance costs imposed on the
regulated community by today's interim
final rule, EPA first divided the
regulated community into three groups:
medical waste generators, transporters
including transfer facilities, and
treatment and disposal facilities. EPA
subdivided the major generators of
medical wastes potentially subject to
regulation into 11 categories (ten .
categories of specific generator types
and one "other generators" category)
that are listed in Table 1. EPA obtained
most of the data on the numbers hi each
generator category in each of the ten
demonstration States from the
Department of Health and Human
Services and professional associations
(e.g., the American Medical Association,
the American Dental Association, etc.).
Other medical waste generator groups,
besides those included hi this analysis,
may likely exist; EPA requests comment
and input on these additional generator
categories.
TABLE 1.—GENERATOR CATEGORIES AND CHARACTERISTICS
Generator
Hospital*
Physician' Offices . _«.. . ... ... ...». - - '.
DtoUate .,..._.........,........„..,..,...,.,........... .'
ClWca -...-. -
Number '
1,889
54,070
51,592
5,232
5,610
1,279
9,560
14,449
419
Waste
generated per
week per gen.
(Ibs.)
2,000
32
8
10
32
250
10
16
200
Shipments per
year per gen.
156
26
12
12
26
52
12
12
. 52
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Federal Register / Vol. 54. No. 56 / Friday. March 24. 1989 / Rules and Regulations 12367
TABLE 1.—GENERATOR CATEGORIES AND CHARACTERISTICS—Continued
Generator
Infirmaries....
Hospices
Other
Total
Number *
1 000
111
759
145 970
Waste
generated per
week per gen.
(lbs.)a -
16
32
32
Shipments per
year per gen.
26
12
26
1 Data on the numbers of generators for the ten Covered states were obtained from the United States Department of Health and Human Services and from
various professional associations (e.g., American Medical Association, American Dental Association, etc.).
The Agency did not have precise data
on three of the generator categories:
infirmaries, blood banks, and "other
generators". The Agency used the total
number of universities in each of the ten
States as an estimate of the total
number of "infirmaries". The Agency
used the per capita number of
freestanding blood banks in New Jersey
to extrapolate an estimate of their
numbers in the remaining nine states. To
calculate the "other generators"
category, the Agency used the per capita
number of health maintenance
organizations (HMOs) and home health
agencies in New Jersey to estimate their
numbers in the remaining nine States.
The Agency has significant detailed
information relative to the State of New
Jersey's health care industry and thus
has used this available data to estimate,
through extrapolation, that information
for other less well-characterized states.
This analysis assumes that the per
capita facility numbers of New Jersey
are generally representative of the other
nine States. The Agency is continuing to
collect more detailed information to
further refine these estimates.
The Agency had limited information
concerning the number of transporters
and treatment and disposal facilities
that handle medical waste. For the
purposes of this analysis, the number of
treaters and disposers has no impac.t on
costs, since their costs are a function of
the number of shipments, not the
number of disposers. Data on the
number of transporters will affect cost
estimates, because the total transporter
reporting requirement costs are
dependent on the number of
transporters that must submit such
reports. Information on transporter
numbers is complicated by the fact that
medical waste transporters often
operate in multiple states and some
states have no licensing requirements
for transporters. In the absence of
detailed information, EPA estimates the
total number of transporters in the ten
states to be 1,000, based on experience
with current solid and hazardous waste
transportation and disposal practices.
4. Medical Waste Generation Rates
Based on EPA analyses and
interviews of medical waste generators
and transporters, EPA estimated the
average quantity of medical waste
generated by an average facility within
each of the generator categories. The
Agency recognizes that the size of the
facility and the waste generation rates
vary significantly within generator
categories, particularly for hospitals. In
estimating waste generation rates for •
hospitals and physician offices, EPA
used data available on per bed and per
patient waste generation rates, coupled
with data on numbers of beds and
numbers of patient visits, to determine
waste generation estimates for these
two generator categories. In determining
the amount of medical waste generated
by medical laboratories, the second
largest per facility generator of medical
waste by EPA estimates, EPA relied on
a New York Department of Health
(NYDH) study of 156 clinical
laboratories which found that, on
average, these facilities generate 51.7
pounds per day of "infectious" waste.
EPA assumed the universe of waste for
the NYDH study was equivalent to that
regulated under today's rule. EPA used
the NYDH survey result to estimate that
medical laboratories generate 250
pounds per week (50 pounds/day x 5
days/week) of medical wastes.
EPA also estimated the total number
of shipments for each generator category
based on available waste generation
rates and from interviews with both
generators and transporters. Based on
this information, EPA estimated that
hospitals ship out waste 3 times per
week, blood banks and medical
laboratories once a week, and the
remaining generator categories either
once every other week or once a month.
Table 1 provides a summary of the
Agency's assumptions made in
calculating waste generation and waste
shipment rates. The Agency requests .
additional data on waste generation and
shipment rates for all 11 generator
categories.
5. Existing Management Practices
There are a number of current waste
management practices that have been
adopted voluntarily by medical waste
generators that are substantively similar
to the requirements set forth in today's
interim final rule. In this cost analysis,
EPA accounted for these baseline
practices by reducing or eliminating
either .the incremental materials cost or
the required task time associated with
each component of the rule. For
example, because the Agency assumes
that sharps and fluids are already being
segregated, EPA applied no additional
compliance costs (for either materials or
labor time) for this requirement of the
rule.
6. Tracking System Requirements
EPA estimated the labor time required
to process the tracking requirements of
today's rule. A similar analysis of labor
time had been performed for the
Hazardous Waste Manifest's
Information Collection Request
document. EPA recognizes that some
generators, transporters, and disposers
already use manifests, shipping papers
or other tracking mechanisms to
document the movement of medical
waste; however, this cost analysis does
not attempt to adjust for these instances.
To the extent that medical wastes are
currently manifested in accordance with
today's rule, compliance costs utilized in
this analysis will tend to be overstated.
Each shipment of regulated medical
waste requires use of a tracking form;
therefore, the total number of shipments
per generator per year determines the
number of tracking forms that get
processed. To estimate the costs of
tracking, several different labor
components are included to reflect the
steps necessary to process waste
through the tracking system. EPA
estimates that completing and handling
the tracking form takes 15 minutes for
the generator and 5 minutes each for the
transporter and disposer; recordkceping
takes 5 minutes for the generator;
exception/discrepancy reporting takes 2
hours for the generator and one-half
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12368 Federal Register / Vol. 54, No. 56 / Friday. March 24, 1989 / Rules and Regulations
hour for the disposer; and transporter
reports require 80 hours of labor time.
To the estimated labor time, EPA
applied a fully loaded (benefits and
overhead] salary rate of $47,000 to
derive total labor costs. In addition to
these components of tracking, EPA
included estimates of the cost savings
derived from the consolidation or
remanifeating of multiple small
shipments as allowed under today's
rule. EPA realizes that consolidation or
remanifesting of medical wastes is not
Commonly practiced and, therefore,
estimated that only 10 percent of the
medical waste shipments will be
remanifested.
7, Generators of Less Than 50 Pounds
Today's interim final rule exempts
generators of less than 50 pounds per
month of medical waste from the
tracking requirements. However, these
generators are required to maintain log
books for their waste shipments. For the
generators of less than 50 pounds of
medical waste per month, EPA
estimated the incremental time required,
per shipment, to complete the log book
to be 5 minutes, which is one quarter of
the per shipment time that EPA
estimated it would take for all other
medical waste generators to complete
the tracking form and recordkeeping
requirements. Within each generator
category, EPA estimated the percentage
of generators that would qualify for this
exemption, and assigned either 0
percent, 10 percent, or 50 percent of
each generator category to the
subcategory of generators of less than 50
pounds. The Agency based its estimates
of the proportion of generators of less
than 50 pounds on the limited data
available, assuming that 50 percent of
the dentists, nursing homes, funeral
homes, and hospices would qualify for
the exemption. The Agency assumed
that no hospitals, medical laboratories,
or blood banks would qualify for the
exemption. All other generator
categories were assumed to have 10
percent of their facilities qualify as
generators of less than 50 pounds per
month. EPA believes these estimates are
conservative, particularly for
veterinarians, nursing homes, hospices,
and funeral homes whose generated
"medical waste" will consist principally
of sharps.
8. Incinerator Reporting
Waste incinerated on-site is not
subject to the labeling, packaging, and
tracking requirements of today's rule,
but is subject to recordkeeping and
periodic reporting requirements. EPA
estimated that these requirements entail
approximately 57 labor hours per facility
per year. These reporting requirements
impose much lower costs than if the
incinerated waste is shipped off-site as
medical waste.
For the purposes of this analysis, EPA
assumed that only hospitals use on-site
incineration, although a small portion of
the other generator categories also
utilize on-site incineration. An American
Hospital Association survey (1983)
estimates that 67 percent of United
States hospitals use on-site incineration.
Based on this estimate, EPA assumed •
that 67 percent of the hospitals, as
characterized in this analysis, incinerate
their waste. EPA believes using this
estimate in its analysis is conservative,
since the 67 percent of hospitals that
have on-site incineration will tend to be
larger facilities that generate a greater
proportion of the total hospital waste
and, therefore, more than 67 percent of
total hospital waste is probably
incinerated. Furthermore, hospital
incineration use has likely increased
since 1983. Therefore, since incineration
of waste imposes lower costs to the
generator than shipping the waste off-
site, EPA's compliance cost estimate for
hospitals tends to overstate the total
cost to hospitals of tracking their waste.
9. Packaging
EPA recognizes that some form of
packaging of medical waste is currently
taking place, but the degree of labeling
and packaging of medical waste varies
widely. For the purposes of this
analysis, EPA assumed that "leak-
resistant" packaging requirements and
the labeling requirements are voluntarily
being met, but that the "rigid" packaging
requirement is not. For the purpose of
this analysis, EPA assumed that the
rigid container performance standard
would be met by a four cubic foot
cardboard box with a cost of $0.80 per
box. EPA recognizes that some medical
waste is currently being packaged in
rigid containers that would meet today's
requirements. To the extent that these
practices are currently being used,
compliance costs will tend to be
overstated. Similarly, to. the extent that
the performance standard can be met
with alternative containers (either more
or less expensive), compliance costs will
vary from those estimated. In addition
to the materials cost, EPA also has
calculated the labor time for the
generator to pack and seal each box of
waste to be five minutes. The total
number of boxes that are packed and
labeled for each generator category is
determined by dividing the weight of the
generator's waste (that is to be shipped
off-site) by the average weight capacity
(assumed at 20 pounds per box) of a four
(4) cubic foot cardboard box. For
instance, EPA estimates that the
average medical laboratory will
generate 13,000 pounds or 650 boxes of
medical waste per year (13,000/20=650).
10. Existing and Proposed Medical
Waste Regulations
In establishing baseline waste
management practices, EPA accounted
for existing State regulations. EPA
adjusted the cost estimates to reflect
State requirements that,'for the purposes
of this cost analysis, were determined to
be similar to today's rule. Where a
current State requirement is determined
to be similar to today's rule, EPA
assigned no incremental cost in that
State for that particular requirement. For
purposes of this analysis, EPA assumed
that none of the ten demonstration
States have current requirements that
are similar to all of the provisions in
today's rule and thus all States will have
facilities'that incur compliance costs.
Moreover, half of all affected States
(Connecticut, Indiana, Michigan, Ohio,
and Wisconsin) were assumed to have
no existing requirements similar to the
provisions that were analyzed in this
cost analysis. In addition, EPA has
estimated that Pennsylvania and
Minnesota have similar provisions only
for the packaging requirement; New
York and New Jersey have similar
provisions for all but the incinerator,
generator of less than 50 pounds per
month, and the transporter notification
requirements; and Illinois has been
estimated to have similar tracking
requirements solely for hospitals.
11. Results
During the two year demonstration
period, today's rule will impose average
annual compliance costs of
approximately $55.5 million, for a total
estimated 2 year program cost of $111
million (undiscounted). Thus the annual
costs of today's rule, according to EPA
estimates, are well below the "major"
rule threshold of $100 million. Estimated
compliance costs by component and
generator category are summarized in
Table 2.
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Federal Register / Vol. 54, No. 56 / Friday. March 24, 1989 /Rules and Regulations 12369
TABLE 2.—COST SUMMARY ANNUAL COSTS
[In thousands]
Regulated community
Hospitals
Physician* Offices
Dentists .„
Nursing Homes ..... „
Clinics™
Medical Laboratories.™ ;....
Funeral Homes
Veterinarians , „
Blood Banks..,..
Infirmaries ............ *
Hospices „ ;
Other „
Transporters
Disposal Facilities- , ,
Total ; „ „ „ „
Packaging rqts.
£A QfiA
5595
1 407
332
693
1 196
331
937
344
12
35
91
Q
0
15845
Tracking rqts.
«c-fQ
6 647
1 686
P17
839
410
oxe
995
132
4
i -jg Qgg
10 983
36 874
Reporting » rqts.
OfiA
582
97
0
qq
Total i-
10 CAft
3 675
finft
1 fi'hfi
AA9
4^fr
j*A
*9"
' »*fOp8
1 For generators of less than SO pounds per month.
2 This estimate includes $1.67 million for the incinerator-reouirement
3 Average annual cost over the 2 years of the demonstration program.
EPA estimates that physicians'
offices, due to their large number, and
hospitals, due to their high medical
waste generation,rate, together account
for over one-third of all costs. EPA
estimates that all generators combined
bear approximately half (55 percent) of
the total costs of today's rule, with the
remaining costs divided between
transporters and disposers.
EPA estimates that the overall
average compliance costs of today's rule
on a per generator facility basis range
from $3,757 per year for hospitals to $71
per year for dentists. EPA estimates that
the average incremental cost per pound
of generated medical waste for these
same two generator categories is $0.04
for hospitals and $0.17 for dentists. The
lower per pound cost for hospitals is due
to the fact that hospitals frequently
incinerate their waste; also, hospitals
dispose of more waste per shipment,
and therefore their per-pound tracking
costs are lower than dentists. EPA
estimates the average incremental cost
to generators in all the generator
categories is $0.08 per pound of medical
waste.
EPA estimates that the highest per
facility compliance cost is for hospitals
that do not incinerate their waste and
that do not currently meet the
requirements of today's rule. EPA
' estimated the highest cost for a
"typical" hospital (one that generates an
average of one ton of medical waste per
week) to be $15,638 per year. In contrast
a facility that generates more than 50
pounds of medical waste per month and
already meets the requirements of
today's rule will have no additional
compliance costs.
EPA estimates the packaging
requirements will impose costs of
approximately $16 million per year. The
amount of waste generated per year for
all generators in a category is the
driving force behind the costs for this
component; thus physicians' offices and
hospitals together account for two-thirds
of the total packaging costs. The
remaining nine generator categories
incur estimated aggregate annual
packaging costs that range from $12,000
for infirmaries to $1.4 million for
dentists.
EPA estimates that the costs of
compliance with the tracking
requirements ($36.8 million per year)
account for approximately two-thirds of
the total compliance costs. EPA
estimates that the generators will incur
approximately $12 million of these
tracking costs. Physician offices will
account for $6.6 million of this estimate,
dentists will account for $1.7 million,
and the remaining nine generator
categories account for less than $1
million each. The additional tracking
costs are distributed between
transporters and disposal facilities. EPA
estimates that transporters will incur
average annual tracking system costs of
approximately $14 million and disposers
approximately $11 million. The
transporters also must notify the Agency
of their intent to transport medical
waste; EPA estimates this onetime cost
will total approximately $8,000.
EPA estimates that incinerator
recordkeeping and reporting
requirements will total approximately
$1.7 million for the estimated 1,266
hospitals in the demonstration States
that currently use on-site incinerators.
Generators of less than 50 pounds per
month of medical waste, although
exempt from the tracking requirements,
are required to maintain a log of their
generated wastes. This requirement will
impose relatively small costs on these
generators ($1.1 million per year in
aggregate). For example, the estimated
5,400 physician offices that EPA
estimated are generators of less than 50
pounds of medical waste per month will
have recordkeeping costs of
approximately $264,000 (or $49 per
office) per year.
12. Sensitivity Analysis
These estimates may "understate
actual costs. For example, transport
vehicle and disposal costs are assumed
to be unchanged. For various reasons.
landfills are apparently less willing (ana]
in some cases unwilling) to accept
infectious waste, a phenomenon which
suggests that the rale will increase
disposal costs two additional ways,
First, landfills willing to accept
regulated medical waste will be able to
charge more for the service. Second, the
increased cost of land disposal will
stimulate the demand for incineration.
Limited information available to EPA
suggest that the current price for
medical waste incineration is about
$0.30 per pound. Based on Table 1, EPA
estimates about 230 million pounds of
medical waste (that is not currently
incinerated on site) are generated per
year in the 10 States expected to
participate. Assuming constant returns
to scale in incineration, every 1 percent
of this waste shift from land disposal to '
off-site incineration will increase total
costs by less than $1 million per year.
Thus, if just 10 percent of the medical
waste tallied in Table 2 is shifted to off-
site incineration, the annual cost of the
rule will be about 12 percent higher thaft
estimated. Savings from avoiding
landfill disposal fees, increased on-site
management, and alternative treatment
technologies, will offset this amount,
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12370
Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations
while limited incineration capacity
combined with increased demand will
tend to increase it.
In addition, EPA has not estimated the
effects of the transporter vehicle
components of today's rule that requires
all regulated medical waste be
transported hi a leak resistant, fully
enclosed, non-compactor, cargo-carrying
body that is maintained in good
operational and sanitary condition.
However, today's rule does not prohibit
the transport of regulated medical waste
simultaneously with other waste. The
Agency does not have data to rigorously
analyze how these transporter vehicle
requirements will affect current
practices and costs. However, limited
information supplied by transporters
and generators indicates that in many
instances medical wastes are already
transported in vehicles meeting the
requirements of today's rule. To the
extent that current practices do not
reflect these requirements, transporter
costs will be incurred. The Agency
solicits comments on existing transport
practices and the effects of today's rule
(including transport costs).
In short, the cost Figures provided here
ate meant to be rough estimates of the
actual costs of implementing the
management standards and tracking
requirements promulgated today. As
part of the program evaluation that will
be conducted pursuant to section 11008
and discussed earlier in this Preamble,
EPA will update these cost estimates as
new data is obtained. The Agency
encourages generators, transporters, and
disposers to submit cost information
that they consider relevant to assessing
the actual costs of the demonstration
program.
13. Benefits
EPA has identified several benefits of
today's rule that are discussed below.
Although the Agency has not quantified
all of these benefits, they may be
significant.
For instance, medical and solid waste
is often released into the environment
due to improper waste handling
practices. Today's rule, which includes
tracking requirements and transporter
vehicle requirements (i.e., leak-resistant,
fully enclosed, non-compacting vehicles)
will likely induce waste transporters to
haul medical waste separately from
general refuse, most likely in separate
trucks. These requirements will ensure
thai greater care is taken when
transporting medical wastes so that it is
not mishandled during transport and
released into the environment
EPA has not quantified benefits to
waste handlers and the general public
fron the packaging and labeling
requirements contained in today's rule.
Waste handlers will be able to
recognize contained medical waste so
they can manage it safely; furthermore,
medical waste will be more safely
packaged than general refuse so that
handlers will be less likely to be
exposed to its hazards. Likewise, if the
general public inadvertently comes into
contact with packaged medical waste,
they will be able to distinguish it from
other solid waste.
Today's rule will increase awareness
of the potential hazards and adverse
environmental and aesthetic
consequences of improper management
of medical waste. As a result of this
heightened awareness, EPA believes
that the proper handling of wastes in the
health care industry will extend beyond
the scope of today's rule.
In addition, EPA believes that the
tracking system may increase the
incentives for on-site treatment of
medical waste. Specifically, generators
may incinerate or treat and destroy their
wastes hi order to exempt these wastes
from today's requirements. As a result,
there will be less untreated medical
waste transported off-site, thereby
reducing the chance that it will be
aesthetically or biologically harmful.
Finally, there are inadequate data on
medical waste generation rates,
treatment practices, fate and transport
characteristics, and disposal practices
currently available. Implementing the
medical waste tracking system will
enable EPA to collect the detailed
information needed for the Reports to
Congress that the Agency is required to
complete (see Section 11008 of RCRA).
In fact, information gathering is one of
the principal purposes of the Act. By
collecting this information, the Agency
will be better able to identify the
problems associated with the
management of medical waste, quantify
the amounts and types of medical waste
generated, and thereby improve the
technical basis for evaluating the need
for further regulation.
In addition to the benefits discussed
qualitatively above, EPA has quantified
one additional potential social benefit of
today's interim final rule. For the
purposes of this particular benefits
analysis, EPA assumed the tracking
system to be effective in eliminating the
problem of medical wastes appearing on
the beaches of the demonstration States.
The data sources on which to base this
analysis are sparse, and the Agency has
estimated benefits based on limited
data. The Agency further recognizes that
the sources of beach wash-ups are not
certain. Moreover, a recent study
(NYDEC, 1988) suggests that combined
sewer overflows and transfer operations
at municipal solid waste landfills
located near water bodies contribute to
the problem. Also, household waste .
generators, a known source of medical
waste found on beaches, are not subject
to today's rule. Therefore, it is likely that
today's tracking rule may not directly or
significantly affect these potential
sources for wash-ups. However, since
reducing the wash-up of medical wastes
caused by sources, subject to today's
rule is one of the goals of the tracking
system, EPA has performed the benefits
analysis to illustrate the potential gains
from doing so.
For purposes of assessing this
potential benefit of the tracking system,
the Agency developed two approaches.
The two methodological approaches are
simplistic, but do provide some
quantitative estimation of the effects of
medical waste. The first approach is
based on benefits that accrue
specifically to beach users (e.g.,
sunbathers, swimmers, strollers). It uses
an estimate of the economic value of a
beach-day visit and the number of lost
beach-day visits a successful tracking
system would prevent. The second
approach is based on a broader range of
benefits that accrue not only to beach
users, but also to other groups such as
those who value the option to visit the
beach and those among the general
population who are not completely
indifferent to the fact that medical waste
is washing up on the nation's beaches.
In the first approach, analyzed benefits
are limited to Connecticut, New Jersey,
and New York; in the second approach,
benefits are accrued from all 10
demonstration States. Both
methodologies involve simple
extrapolations based on rough
approximations of the relevant
parameters. They are therefore
extremely sensitive to the assumptions
used and are, at best, accurate by .
perhaps an order of magnitude.
The first method estimates the value
of medical-waste related beach closing
in Connecticut, New York, and New
Jersey, at approximately $30 million.
This figure is obtained by extrapolation
based on very limited data concerning
New Jersey beach visitation. The second
approach uses a different method of
extrapolation to obtain an estimate of
$100 million for all 10 States expected to
participate in the demonstration
program.
In both cases, the management
standards and tracking program
established today are assumed to
eliminate all beach closings due to
medical waste. As indicated in the
background section of this Preamble,
however, the program is not expected to
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Federal Register / VoL 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations 12371
significantly reduce medical waste
wash-ups.
B. Regulatory Flexibility Act
In sections 11002 and 11003 of RCRA,
Congress set a six-month deadline for
EPA to promulgate regulations listing
the types of medical waste to be tracked
and establishing segregation, packaging,
labeling, and tracking requirements.
Section 11010 gives EPA specific
authority to promulgate today's
regulations without prior opportunity for
public comment. EPA has determined
that the time constraints established by
the statute make it impracticable to
propose the regulations and accept
public comments before promulgation of
the rule.
, Because the Agency is not required to
publish a proposal for public comment
in connection with today's'rule, this
rulemaking is not subject to the
Regulatory Flexibility Act (see 5 U.S.C.
603 and 604). Accordingly, no Regulatory
Flexibility Analysis has been prepared
for this rule, although future rulemakings
under RCRA Subtitle J may require such
an analysis. Also, section 11008(a)(3}(B)
requires EPA to report to the Congress
on the costs to businesses to comply
with the tracking program. To the extent
practical, EPA plans to assess, in
particular, costs to small businesses
affected by the rules in the reports
required by section 11008.
C. Paperwork Reduction Act
Section 11010 of RCRA states that the
Paperwork Reduction Act of 1980,44
U.S.C. 3501 et seq,, does not apply to
regulations required to be promulgated
within nine months of Subtitle J's
enactment. Thus, the recordkeeping and
reporting requirements contained in
today's rule are not subject to approval
by the Office of Management and
Budget. However, EPA has adhered to a
policy of minimizing the reporting
requirements in today's rule to the
extent possible consistent with statutory
requirements. For instance, where EPA
is requiring information to help develop
the section 11008 reports to Congress
(i.e., the transporter periodic reports and
the expanded incinerator report), EPA.is
requiring these reports from transporters
because that is the most efficient way to
obtain the information Congress
requires. EPA also has developed
special exemptions for generators of less
than 50 pounds per month under which
they need not initiate tracking forms for
each shipment; instead they must
maintain a log (see Part 259, Subpart F,
and Section V of today's Preamble).
last of Subjects
40 CFR Part 22
Administrative practice and
procedure, Penalties. •
40 CFR Part 259
Medical waste, Labeling, Packaging
and containers, Reporting and .
recordkeeping requirements, .Tracking,.
Incinerators. .
Dated: March 13,1989. .
William K. Reilly,
Administrator,
For the reasons set out in the
preamble, Title 40 of the Code of Federal
Regulations is amended as follows:
PART 22—CONSOLIDATED RULES OF
PRACTICE GOVERNING THE
ADMINISTRATIVE ASSESSMENT OF
CIVIL PENALTIES AND THE
REVOCATION OR SUSPENSION OF
PERMITS.
1. The authority citation for Part 22 is
revised to read as follows:
Authority: 15 U.S.C. sec. 2615; 42 U.S.C.
sees. 7545 and 7601; 7 U.S.C. sees. 138(1) and
(m); 33 U.S.C. sees. 1415 and 1418; 42 U.S.C.
sees. 6912,6928,6991(e), and 6992(d);
2. Section 22.01 is amended by
revising paragraph (a)(4) to read as
follows:
% 22.01, Scope of these rules.
(a)***
(4) The issuance of a compliance
order or the issuance of a corrective
action order, the suspension or
revocation of authority to operate
pursuant to section 3005(e) of the Solid
Waste Disposal Act, or the assessment
of any civil penalty under sections 3008,
9006 and 11005 of the Solid Waste
Disposal Act, as amended (42 U.S.C.
6928,6991(e) and 6992(d)), except as
provided in 40 CFR Parts 24 and 124.
* * * * *
3. A new Part 259 is added to read as .
follows:
PART 259—STANDARDS FOR THE
TRACKING AND MANAGEMENT OF
MEDICAL WASTE
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.
259.21 States electing not to participate.
259.22 States electing to participate.
Sec.
259.23 Notice of participating States.
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 Decontamination standards for
reusable containers.
259.44 Labeling requirements.
259.45 Marking (identification)
.requirements.
Subpart F—Generator Standards
259.50 Applicability and genera!
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
259.80 Applicability.
259.61 Recordkeeping.
259.62 .Reporting.
Subpart H—Transporter Requirements
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 reraanifesting 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 40 CFR Part 259 Medical
Waste Tracking Form and Instructions
Appendix II to 40 CFR Part 259 On-site
Incinerator Report Form and Instructions
Appendix III to 40 CFR Part 259' Transporter
Report and Instructions
Appendix IV to 40 CFR Part 259
Recommended Medical Waste
Transporter Notification Form and
Instructions
Authority: 42 U.S.C. 8912,6992 et seq.
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12372
Federal Register / Vol. 54, No. 58 / Friday, ^larch 24, 1989 / Rules and Regulations
Subpart A—Genera]
5 259.1 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, through
shipping papers or other documentation,
that the regulated medical waste was
generated in a non-Covered State.
5259.2 Effective dates and duration of tho
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.
Subpart B—Definitions
§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 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 hi 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 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; 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 hi the
demonstration medical waste tracking
program. It includes States identified
under Subtitle J of RCRA which have
not petitioned out of the program
pursuant to § -259.21 of this part and
States which have petitioned into the
program pursuant to § 259.22. 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 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.
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Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations 12373
"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 hi § 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
"'
"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.
Subpart C— Covered States
§259.20 States Included In th»
demonstration program.
(a) The regulations of this part apply
to all regulated medical waste that is
generated in any Covered State. This
Subpart further identifies the procedures
for States electing to participate or not
to participate in the demonstration
program. •
(b) For purposes of this part, Covered
States are the States of Connecticut,
Illinois, Indiana, Michigan, Minnesota,
New Jersey, New York, Ohio,
Pennsylvania, and Wisconsin. Any of
these States may elect not to participate
in the demonstration program using the
procedures in § 259.21 of this subpart.
States that the Administrator removes
from the demonstration program
pursuant to RCRA section 11001{b) are
non-Covered States.
(c) Any States not listed in paragraph
(b) of this section may petition to
participate in the demonstration
program pursuant to § 259.22 of this
subpart. States that the Administrator
has included hi the demonstration
program pursuant to a State petition are
Covered States.
§ 259.21 States electing not to participate.
(a)(l) If Connecticut, New Jersey or
New York elect not to participate in the
demonstration program, the Governor of
the State must notify the Administrator
no later than April 24,1989, of his
decision that the State elects not to
participate in the demonstration
program. The notification must include:
(i) A statement that the State has
implemented a medical waste tracking
program that is no less stringent than
the demonstration program of this part;
(ii) A copy of the State's regulations
implementing that program; and
{iii) A copy of the State statutes
authorizing that program, and a copy of
the State statutes and regulations
governing the State's administrative
procedures.
(2) The Administrator will consider
the information submitted under
paragraph (a)(l) of this section and shall
determine whether the State's program
is no less stringent than the Federal
program under this part. Upon a finding
by the' Administrator that the State's
program is no less stringent than Part
259, the Administrator shall remove the
State from the list of Covered States in
this subpart
(b) If Illinois, Indiana, Michigan,
Minnesota, Ohio, Pennsylvania, or
Wisconsin elect not to participate hi the
demonstration program, the Governor of
the State must provide written
notification to the Administrator no later
than April 24,1989.
§259.22 State* electing to participate.
Any State not listed in § 259.20(b) of
this subpart may elect to participate in
the demonstration program. The
'Governor of such State must submit a
petition to the Administrator no later
than April 24,1989, requesting inclusion
hi the demonstration program as a
Covered State.' Upon a determination to
accept such a petition, the Administrator
shall include the State on the list of
Covered States.
§ 259.23 Notice of participating States.
The Administrator shall publish a
notice hi the Federal Register listing
those States included in the
demonstration program after April 24,
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 hi the diagnosis,
treatment, (e.g., provision of medical
services), or immunization of human
beings or animals, hi research pertaining
thereto, or hi 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 § 26l.4(a)(l) 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 biologi-
cals, including: cultures from
medical and pathological lab-
oratories; cultures and stqcks
of infectious agents from re-
search and industrial laborato-
ries; wastes from the produc-
tion of biologicals; discarded
Kve and attenuated vaccines;
and culture dishes and de-
vices used to transfer, inocu-
late, and mix cultures.
Human pathological wastes, in-
cluding tissues, organs, and
body parts and body fluids
that are removed during sur-
gery or autopsy, or other medi-
cal procedures, and speci-
mens of body fluids and their
containers.
(1) Liquid waste human blood;
(2) products of blood; (3)
Hems saturated and/or drip-
ping with human blood; or (4)
items that were saturated and/
or dripping with human blood
that are now caked with dried
human Wood; including serum,
plasma, and other blood com-
ponents, and their containers,
which were used or intended
for use In either patient care,
testing and laboratory analysis
or the development of Phar-
maceuticals. Intravenous bags
are also Included In this cate-
gory.
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12374 Federal Register / Vol. 54, No. 56 / Friday. March 24. 1989 / Rules and Regulations
TABLE—REGULATED MEDICAL WASTE—
Continued
Waste class
(4) Sharps,,.
(S) Animal Waste..
(6) Isolation
Wastes.
(7) Unused
Sharps,
Description
Sharps that have been used in
animal or human patient cara
or treatment or in medical, re-
search, or. Industrial laborato-
ries. Including hypodermic nea-
dJes, syringes (with or without
the attached needle), paateur
pipettes, scalpel blades, blood
vials, needles with attached
tubing, and culture dishes (re-
gardless of presence of infec-
tious 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 infec-
tious agents during research
(Including research in veteri-
nary hospitals), production of
btoiogteals, or testing of Phar-
maceuticals.
Biological waste and discarded
materials contaminated with
blood, excretion, exudates, or
secretions from humans who
are isolated to protect others
from certain highly communi-
cabta diseases, or isolated ani-
mals known to be Infected
with highly communicable dis-
eases.
The following unused, discarded
sharps: hypodermic needles,
suture needles, syringes, and
scalpel blades.
(b)(l) 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)(l)(i): Mixtures of
regulated medical waste and hazardous
waste are subject to Part 259, except as
provided in S 2S9.31[b) of this subpart.
(ii) Household waste, as defined in
§ 261.4(b)(l) of this Chapter, is not
regulated medical waste.
(ill) 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 Transportation, 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 personnel
for enforcement purposes are exempt
from tie 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 medical 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(8) 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 286 of this chapter.
Note to paiagrah (b): Mixtures of regulated
medical waste with hazardous waste that is
exempt from the hazardous waste manifest
requirements (e.g., under 40 CFR 281.5)
remain subject to this Part.
Subpart E—Pre-Transport
Requirements
§259.39 Applicability.
Generators must comply with the
requirements of this subpart prior to
shipping waste off-site, and generators
must comply with § 25S.42 of this
Subpart 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 I of this part.
§ 259.40 Segregation requirements.
(a)(l) 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) as regulated medical
waste, then the generator must package,
label, and mark the 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
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-resistant;
(3) Impervious to moisture;
(4) Has a strength sufficient to prevent
tearing or bursting under normal
conditions of use and handling; and
(5) Sealed to prevent leakage during
transport.
(b)(l) In addition to the requirements
of paragraph (a) of this section,
generators must package sharps and
sharps with residual fluids in packaging
that is 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
that is 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 (e.g., landfill, interment,
treatment and destruction, or
incineration), or transport off-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
unauthorized 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.
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Federal Register / VoL 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations 12375
§ 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 packaging and inner
liners must be managed as regulated
medical waste under this part and must
not be reused..
(b) Any 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 package
of regulated medical waste according to
the following labeling requirements
before transporting or Offering for
transport off-site:
' (a) Untreated regulated medical
waste. Each package 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. Red plastic bag(s)
used as inner packaging 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 marked according to
§259.45 of this subpart.
S 259.45 Marking (Identification)
requirements.
.Generators (incluiling intermediate
handlers) must mark each package of.
regulated medical waste according to
the following marking requirements
before the waste is transported or
offered for transport off-site:
(a) The outermost surface of each
package prepared for shipment 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 with 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.
Subpart F—Generator Standards
§ 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
aire 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 month are
subject to the requirements of Subpart E
and all of the requirements of this
.Subpart lor 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 t6 the requirements of Subpart E
of this Part and §§ 259.50, 259.51 and
259.54(b) of this subpart.
(ii) Generators of regulated medical
waste who generate less than 50 pounds
in a calendar month but who transport
or offer for transport off-site more than
, 50 bounds in any one shipment, are also
subject to Subpart E of this part and all
of the requirements of this subpart for
each shipment of 50 pounds or more.
(f) Generators or regulated medical
wa'ste must use transporters who have
notified EPA under § 259.72 of this part
to transport their regulated medical
waste, except as provided in § 259.51 of
this subpart.
§259.51 Exemptions.
(a) Generators of less than 50 pounds
per month. Generators who meet the
conditions of § 259.50(e)(2) of this
subpart are exempt from the .
requirement to use a transporter who .
has notified EPA, exempt from the
requirement to use the tracking form,
and exempt from the requirements of
Subpart H of this part provided that the
following conditions are met:
(l)(i) The regulated medical waste is
transported to a health care facility, an
intermediate handler, or a destination:
. facility with which the generator .has a
written agreement to accept the
regulated medical waste; or-
(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 under lease
by the generator or authorized employee for a
minimum of 30 days.
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12376 Federal Register / Vol. 54, No. 56 / Friday, Marcn 24, 1989 / Rules and Regulations
(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, provided they meet all of 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 regulated medical waste is
brought to a central collection point or
treatment facility owned or operated by
the generator;
(3) The original generation point and
the central collection point or treatment
facility are located in the same Covered
State; and
(4) The generator compiles and
maintains a shipment log at each
original generation point and each
central collection point as required by
i 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
aubpart 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
transporter 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 UM of the tracking form.
(a) Except as provided in
§§ 259.50(e)(2)(i) and 259.51 of this
Subpart, 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
included in Appendix I to this part
(b) Generators mugt obtain the
tracking form from 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)(l): 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.
(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.
(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 or
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 and 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 Recorclkeephio,.
(a) Except as provided in paragraph
(b) of this section, each generator must:
(l)(i) Keep a copy of each tracking
form signed in accordance with § 259.52
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 exception
reports required to be submitted under
8 259.55(c) of this subpart.
(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
category (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
tracking form are subject to the
following recordkeepihg 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
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Federal Register / Vol. 54; No.-56 /Friday. March 24, 1989 / Rules and Regulations 12377
(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 last
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;
(iij Quantity (by weight) of regulated
medical waste transported, by waste
category (i.e., untreated and treated);
(iii) Date of shipment; and
(iv) Signature of the generator or his
authorized representative who
transported the waste.
(3) Generators who transport
regulated medical waste by the U.S.
Postal Service under § 259.51(c) of this
subpart must retain the original U.S.
Postal Service receipt and the return
mail receipt and maintain a shipment
log .for a period of three (3) years from
the date of shipment. The 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 other 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;
(2) Approximate percent, by weight, of
total waste treated and destroyed that is
regulated medical waste;
(3) For regulated medical waste .
accepted from generators meeting the
exemption conditions in § 259.51 (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)(l) or (e)(2)(ii)
of this subpart 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 handwritten
signature of the owner or operator of the
destination facility within 35 days of the
date the waste was accepted 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
00 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
arid who accept regulated medical
waste accompanied by a tracking form
are also subject to the requirements of
Subpart I of this part.
§ 259.61 Recordkeeplng.
••(a) Generators must keep an operating
log at their incineration facility that
includes the following information:
(l)(i) The date each incineration cycle
was begun; . ••.
(ii) The length of the incineration
cycle;
(iii) The total quantity of medical
waste incinerated, per incineration
cycle; and
(iv) An estimate of the quantity of
regulated medical waste incinerated, per
incineration cycle.
(2) Generators with on-site
incinerators that accept regulated
medical waste from generator(s) subject
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)(l) Generators must compile the
operating log required by paragraph
(a)(l) of this section duridg 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 Protection 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;
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12378 Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 /Rulesand
(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](l) 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 demonstration
program.
Subpart H—Transporter Requirements
§259.70 Applicability.
(a) These requirements apply to
transporters, including generators who
transport their own waste, and owners
and operators of transfer faculties
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 under § 259.51 (a), (b), or (c)
of this part.
(c) A transporter of regulated medical
waste must also comply with Subpart F
of this part when he consolidates two or
more shipments of regulated medical
waste onto a single tracking form.
(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 hi 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 Subpart 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 packaging, that does not
obscure the generator's or previous
transporter'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)(l) 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,
401M Street, SW., Washington, DC
20460.
(ii) An additional copy must be sent to
the Director of the waste management
agency in the Covered State for which
the transporter is notifying.
(b) Each transporter notification must
contain the following information:
(1) Transporter'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 infectious 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 submission 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 paragraph (b): The Agency has
published a suggested form for transporter'
notification in Appendix TV 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
for each Covered State for which they
have notified. 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 include it
on Box 5 of the Medical Waste Tracking
Form found in Appendix I of this part.
Note to the section: States may impose or
may presently have in place additional
licensing, 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 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 following words
imprinted:
(i) MEDICAL WASTE; or
(ii) REGULATED MEDICAL 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.
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Federal Register / Vol. 54. No. 56 / Friday. March 24. 1989 / Rules and Regulations , 12379
§ 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 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 Stale 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 tne
handwritten signature of the transporter,
or the owner or operator of the
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 foreign country (e.g.,
Canada) must:
(1) Sign the tracking form and verify
that the waste has been delivered to the
next (foreign) transporter, or treatment,
destruction, or destination facility;
(2) Retain one copy of the signed >
tracking form for his records; and
(3) 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/
monih. A transporter accepting a
shipment of 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., "untreated" 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 complies 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.
fb) 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 remanifestlng
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 remanifest
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; and
(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 within 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.
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12380 Federal Register / Vol. 54. No. 56 / Friday, March 24, 1989 / Rules and Regulations
§259.77 R«cordkeeplng.
(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 and
consolidated or remanifested by the
transporter to another tracking form, the
transporter must:
(1) Retain a copy of the generator-
initiated tracking form signed by the
transporter for three (3] years from the
date the waste was accepted by the
transporter; and
(2) Retain a copy of the transporter-
initiated tracking form signed by the
intermediate handler or destination
facility for three (3) years from the date
the waste was accepted by the
intermediate handler or destination
facility.
(d) 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)(l) 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 to:
Chief, Waste Characterization Branch
(OS-332), Office of Solid Waste, U.S.
Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460; and
(2) A second copy must be submitted .
to the Director of the waste management
agency in the State for which the
transporter has compiled the report.
(c)(l) Each report must contain the
following information in the format
provided by Appendix III of this part:
(i) The transporters 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
v/aste;
(v) The amount by weight and waste
category (untreated or treated) of
regulated medical waste acce'pted 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 require
transporters to furnish additional
information concerning the quantities
and management methods of regulated
. medical waste as he deems necessary •
under RCRA section 11004.
Subpart I—Treatment, Destruction,
and Disposal Facilities
§253.80 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)(l) (iii) or (iv) of this part
including incineration facilities, and
disposal facilities); and
(2) Intermediate handlers (i.e.,
facilities that either treat or destroy the
regulated medical waste, but do not
cause it to meet the conditions of
§ 259.30(b)(l) (iii) or (iv) of this part).
(b)(l) 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 does apply 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
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Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations 12381
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
xiiedical 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 signhig; the tracking form
accepting the waste as specified in Box
20 and entering the new 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;
(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 initiated by the
generator identified in § 259.81(b)(2)(i)
above;
(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 1.5 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 (of the shipping
papers if the tracking form has not been
received) initiated by another party;
P) 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
anives 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 of
operator must include with the letter a
legible copy of the tracking form or
shipping papers hi 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 Recordkeeplng.
(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
5 259.81(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 subpart.
(b) The owner or operator of a
destination facility or an intermediate
handler that accepts regulated medical.
waste from generator(s) subject to
§ 259.51(a) 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
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12382
Federal Register / VoL 54, No. 58 / Friday, March 24, 1989 / Rules and Regulations
(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
concerning the quantities and
management methods of medical waste
as he deems necessary under RCRA
section 11004.
Subpart J—Rail Shipments of
Regulated Medical Waste
§259.90 Applicability.
(a) These requirements apply to
persons engaged in rail transportation of
regulated medical waste generated in £
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(fJ 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 on the 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.
BILLtNO CODE U80-CO-M
-------
Appendix I to 40 CFR Part 259—Medical Waste Tracking Fonn and Instructions
State Tracking Fonti Number (if applicable) . •- ." £ ' ', .._'. :.: I, _ '.'. ;„ n '; - _ " • ;' "
Medical Waste Tracking Form
K
0
1- .
(C
HI
Z
•I
0
1 . Generator's Name and Mailing Address
3. Telephone Number ( )
5. Transporter's Name and Mailing Address
EPA Med. Waste ID No.
I I I I I I I I I I I 1 i
8. Destination Facility Name and Address
2. Tracking Form Number
4. State Permit or ID No.
6. Telephone Number
7. State Transporter Permit or ID No
9. Telephone Number
1 )
10. State Permit or ID No.
11. US EPA Waste Description 12. Total No.
Containers
a. Regulated Medical Waste (Untreated)
b. Regulated Medical Waste (Treated)
c. State Regulated Medical Waste
14. Special Handling Instructions and Additional Information
13. Total Weight
or Volume
15. Generator's Certification:
Under penally of criminal ana civil prosecution for me making or submission of false statements. representaMns. or
omissions, I dedans on benaif of the generator mat the contents ol th,s consignment
aretuliyandaccurawiydesatbedaboveandareaassiiied. packaged, marked.and labeled in accordance*!* all applicable
State and Federal laws ana regulations, and Wall liaw been aulncr.2ed In writing, to makesuci- ceciarai.-onK by ttw person-
in charge ol :ne generators operation.
Printed/ Typed Nam« Signature Da'«.
(0
z
0
o
3
ae
K
(0
Z
ff
Ul
K
ff
O
O.
to
z
K
t-
Z
O
z
t-
M
Ul
O
INSTRUCTIONS FOR COMPLETING MEDICAL VVASTE TRACKING FORM
Copy 1 — GENERATOR COPY: Mailed by Destination Facility to Generator
Copy 2 — DESTINATION FACILITY COPY: Retained by Destination Facility
CODV 3 — TRANSPORTER COPY* R&tainaH hu Trancnnrtor'
Copy 4 — GENERATOR COPY: Retained by Generator
As required under 40 CFR Part 259:
1 . This multi-copy (4-page) shipping document must accompany each shipment of regulated medical
waste generated in a Covered State.
2. Items numbered 1-14, must be completed before the generator can sign the certification. Items'! 7,'
10, 11C.& 19 are optional unless required by the State, Item 22 must be completed by the •
.. destination facility. - . • . .. • ... .
Forassistance in cpmpleting-this form, contact your nearest State' offfce. Regional EPA office', or call
(800) 424-9346. / .; ;/; ; -; - . - - ,. . ;.
16. Transporter 1 (Certification of Receipt of Medical Waste as-described in items I1..J2 & 13) . -".•
17. Transporter 2 or Intermediate Handler (name and address)
v ' ' > , •,."'" ' .. ' ' - .-..-."
'•• - - ^ ' ..„ /- •-- ' . .... ', . .' _•""'-•
EPA Med. Waste ID No. I II I II I I I I I' I J
18. Telephone Number
• ;1 9. State Transporter. :
.; Permit or ID No. -
20. Transporter 2 or Intermediate Handler (Certification of Receipt of Medical Waste as
described in items 11, 12 & 13) •' . :
Printed/ Typed .Name, - - . ,- '.Signature
.'. Date '•• •
21. New Tracking Fp.rm Number (for consolidated or remanifested waste)- '- ;: , ,;'• >
22. Destination Facility (Certification of-Receipt of Medical Waste as:described in items 1:1, 12 & 13) ;
O= Received in accordance with items 11, 12 & 13 '':. ' -'- _ "" • .
Printed'' Typed Name . • Signature , Dale
ill other than destination facility, indicate address, phone, and permit or ID no. in hot 14.)
23. Discrepancy Box (Any discrepant*? should be noted by item number and Initials) ' -
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12384
Federal Register / Vol. 54, No. 56 / Friday, March 24. 1989 / Rules and Regulations
General Instructions
Read all instructions before completing this
form.
This form has been designed for use on a
12-pitch elite typewriter; a firm ballpoint pen
may also be used—press down hard (as you
are writing through multiple copies).
Federal regulations require generators,
transporters, intermediate handlers, and
owners and operators of destination facilities
(treatment, destruction facilities, and disposal
facilities) to use this form for both inter- and
intrastate transportation of regulated medical
waste which is generated in a Covered State.
Generators must obtain the Medical Waste
Tracking Form from the following sources:
(1) If the regulated medical waste is to be
shipped to a Covered State for treatment,
destruction, or disposal, then the generator
must use that Covered State's form.' For
generators who transport or offer for
transport regulated medical waste to another
Covered Stale which requires use of its
version of the tracking form, the transporter
must provide the generator with the receiving
Covered State's form.
(2) If the receiving Covered State does not
require the use of its version of the form, or
the receiving State is a non-Covered State,
then the generator must obtain the form from
the generator's own State.
(3) If the generator's State does not require
the use of that State's version of the tracking
form, then the generator may obtain copies
from other sources or produced them using
the printed version of the Federal form
provided in this appendix.
Section 11007 of the Medical Waste
Tracking Act specifies that any State or local
law which requires submission of a regulated
medical waste tracking form from any person
subject to thia Act shall require that the form
be identical in content and format to the
Medical Waste Tracking Form except that a
State may require the submission of other
information which is supplemental to that on
the form. Such State-required information
may be included through use of additional
sheets or such other means as the State
deems appropriate. The Agency determines
that no additional or supplemental State
information can be required on the form
except as specified below. Generators of
regulated medical waste in Covered States
are advised to be aware of any special
requirements within the Covered States.
If States wish to print their own forms, they
may print in the one inch box at the top of the
form the following types of information: (1)
Where to obtain a State printed tracking
form; (2) essential State information (State
addresses or telephone numbers); and (3)
special State instructions (e.g., if the State
requires a five or six part form, that State
might print addresses to which the additional
forms must be sent).
The Medical Waste Tracking Form also
includes a box for a State Tracking Form
Number. If the State requires such a number,
It can be printed on the form in that box. In
addition, some States may require waste
identification or waste authorization
number*. These numbers can be entered by
the generator in box 11 (a-c). In addition.
States may require generators to use box
ll(c) to Identify medical waste regulated
under Stata law but not under Federal law.
Federal regulations require generators,
transporters, intermediate handlers, and
destination facilities to complete the form
according to the following instructions.
Medical Waste Tracking Form Specific
Instructions
The following describes each section of the
Medical Waste Tracking Form and provides
instructions for completing each of these
sections (i.e., boxes). The waste generator
completes Boxes 1-15, the transporter and/or
intermediate handlers completes Boxes 16-
21, and the owner or operator of the
destination facility completes 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 should
be the address to which intermediate handler
or the destination 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 must maintain its records so that
individual waste shipments (identified by a
unique tracking form document 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 must assign
to each shipment of regulated medical waste.
It will ensure that each individual shipment
can be identified and independently tracked
from the site of generation. [The number
could be the date of shipment or some other
notation that the generator wishes to utilize.]
Box 3. Telephone Number. Enter the
telephone number for the generator
representative who can provide additional
information about the shipment in the event
of an emergency, or in the event the
transporter, intermediate handler or
destination facility requires it for other
reasons (e.g., to inform the generator that an
alternative disposal facility must be used).
Box 4. State Permit or ID Number. This is
an optional entry, except when required by
State law. Some States may assign a number
or alphanumeric designation to uniquely
identify each generator, and may require that
the generator include this designation on
each medical waste tracking form it initiates.
Box 5. Transporter's Name, Mailing
Address and EPA Medical Waste
Identification Number. Indicate in this space
the name and address of the regulated
medical waste transporter who will be the
first transporter of the waste listed on the
tracking form. The mailing address should be
the business mailing address of the
transporter. The transporter must fill in his
EPA Medical Waste Identification Number
for the State ki which the waste was
generated. If a number has not yet been
assigned, the transporter must leave this box
blank. The EPA Medical Waste Identification
Number is assigned by EPA when the
transporter notifies EPA.
Box 6. Telephone Number. Enter the
telephone number of the transporter that the
generator, intermediate handler or
destination facility may call to obtain
information regarding medical waste
shipments. -,
Box 7. State Transporter. Permit or ID
Number. This is an optional entry to be
utilized where States have assigned permit or
identification numbers to each medical waste
transporter and require that designation to be
recorded on each tracking form. The number
should be the permit or identification number
used by the State in which the regulated
medical waste was generated.
Box 8. Destination Facility Name and
Address. The generator must enter the name
and site address of the off-site destination
facility (i.e., treatment and destruction or
disposal facility) that the generator has
specified to receive the regulated medical
waste. The site address is necessary to
inform the transporter where the shipment
must be delivered. (If the generator does not
have thia information, the'transporter may
complete this section, but only before the
generator signs the form. Transfer facilities
and other temporary storage facilities used
by transporters for storage of waste during
ordinary transport must hot be listed here as
the destination facility.) Intermediate
handlers used by the generator or transporter
to either treat or destroy the waste (but not
both) must not be listed here either.
Box 9. Telephone Number. Enter the
destination facility's telephone number which
a generator or transporter may call to obtain
information regarding the status of a
shipment. ; •'-• '
Box 10. State Permit or ID Number. This is
an optional box which must be filled Out if
this information is required by the State in
which the destinationiacility is located.
States may require that destination facility
(i.e., treatment and destruction or disposal
facilities) be permitted and they may require
that a State-assigned unique permit or
identification numberfbe entered in this
space. ••• '-'• -
Box 11. U.S.'EPA Waste Description. The
two Federally-regulated medical waste
categories are listed in Boxes ll(a) and ll(b):
Regulated Medical Waste (untreated);
Regulated Medical Waste (treated). Box ll(c)
is available for other State regulated waste.
The generator must determine the categories
of his waste, before completing Boxes 12 and
13. A definition of "waste category" is found
in 40 CFR 259.10. [If States have a waste code.
a waste authorization number, or a similar
requirement, it may be inserted to the right of
the waste category to which it applies.]
Box 12. Total Number Containers. The total
number of containers (e.g.. bags, boxes, pails,
drums, etc.) for each of the applicable waste
categories must be entered in the
corresponding space.
Box 13. Total Weight or Volume. The total
weight of the waete (excluding the container
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Federal Register /-Vol. 54, No. 56 /Friday, March 24, 1989 /Rules and Regulations
123B5
weight), by applicable waste category must
bis entered in the corresponding space. If the
waste is oversized and is riot packaged in a
standard container, a volumetric measure
may be used; however, .the unit of measure
must be noted in that space as well.
Box 14. Special Handling Instructions arid
Additional Information. Generators may use
this space to indicate special transportation,
. beatment, 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 destination facility to certify disposal of
the regulated medical waste through
signature and dating within this box. (Note:
The signature in the Destination Facility
Certification Box (Box 22) is only to be used
to certify receipt of the waste at the time of
delivery to the facility.)
For international shipments, generators
must enter in this space! the point of
departure (city andBtate) for those wastes
destined for treatment and destruction, or
disposal outside the United States. This
space may also be used if there is need to
identify an intermediate handler and/or a
thud transporter. .States .may not require
additional information to be provided in this
space on the tracking form. However, other
State-specific information requirements may
be included on a separate, attached sheet.
This space should also be used to provide
special instructions or additional information
regarding oversized regulated medical 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
treated, the number of pieces, and the
approximate total weight '
Box IS. Generator's Certification. This
statement, when sighed by the generator,
certifies that all information required to be
provided by that generator is accurate
(including any information provided by the
transporter in Boxes 1-14), all documented
wastes are properly, prepared for transport
and all applicable State and Federal
requirements have: been met The generator
mustread, sign by hand, date this
certification statement and enter the name of
the generator into the certification statement.
The persons signing the statement must be
authorized to make the required declarations,
in writing, by the person in charge of the
generator's operations. The generator must
make certain that Boxes 1-14 (except Boxes
4, 7,10, and ll(c), which are optional unless
required by the State) are completed prior to
signing the form. ,
Box 18. Transporter 1 Certification of
Receipt. The first transporter is required to
acknowledge the acceptance of the waste
shipment from the generator by signing the
form in this space and recording the date of
acceptance. Any discrepancies or other'
related information should be noted in the
Discrepancy Box (Box 23) of the tracking
form before signing it. In those instances
when a transporter initiates a tracking form,
he must complete Boxes 1-15 and must also
certify receipt as transporter 1, if he is also
the first transporter as identified in Box 5
(Transporter's Name and Mailing Address).
Box 17. Transporter 2 or Intermediate '
Handler Name and Address, and EPA
Medical Waste Identification Number. In the
event the waste shipment is to be transported
by a second transporter or is taken to an
intermediate handler, that recipient must
enter its name and business mailing address
information in this place, and their EPA
Medical Waste Identification Number, if
available.
Box 18. Telephone Number. Enter the
telephone number of the second transporter
or intermediate handler to be used when
checking or investigating the status of a
shipment.
Box 19. State Transporter Permit or ID
Number. This is an optional entry. The
secondary transporter or intermediate
handler State-assigned permit or
identification number should be entered in
this space (see number 7 above).
Box 20. Transporter 2 or Intermediate
Handler Certification of Receipt. A
secondary transporter or intermediate
handler is required to certify acceptance of
the waste shipment by printing or typing the
name of the person accepting the waste,
recording the date of acceptance, and signing
the form. Any discrepancies or other related
information should be noted in the
Discrepancy Box (Box 23) of the tracking
form before signing this box.
Box 21. New Tracking Form Number. If the
regulated medical waste shipment is
consolidated or reassigned to a new tracking
form, the new tracking form number must be
recorded in this box on the original
generator's form. (If the Covered State
preprints forms and includes a State Tracking
Form Number, that number should be entered
in this space.) If the State does not include a
preprinted number on the form the
transporter or intermediate handler should
enter its own unique tracking form number.
Box 22. Destination Facility. The
authorized representative of the destination
facility certifies receipt and acceptance of the
shipment on behalf of the owner of the.
facility by completing this box. If no
discrepancies are noted, the authorized
representative should place a checkmark
before the statement "received in accordance
with items 11,12, and 13," print or type his
name, record the date of acceptance, and sign
the box. If there are any discrepancies he
should not place a check there. He should,
instead, note the discrepancies in Box 23.
If for some reason the regulated medical
waste was delivered to a facility other than
that indicated in Box 8, then the authorized
representative of the facility that accepted
the waste completes Box 22, as indicated
above, enters in Box 14 the name, address,
telephone number and the facility permit or
identification number, if any, of the facility
accepting the waste.
Box 23. Discrepancy Box. The authorized
representative of the destination (or
alternate) facility, on behalf of the owner or
operator, must note any discrepancy between
the waste described on the tracking form and
the waste actually received at the facility.
(Note: in some instances, due to the
consolidation or remanifesting provisions of
this part, transporters and intermediate
handlers may also need to record
discrepancies.) All discrepancies must be
noted by inclusion in Box 23. Owners and
operators of facilities who cannot resolve
discrepancies within 15 days of receiving a
waste shipment must file a discrepancy report
as required in 40 CFR 259.82. Discrepancy
reports must be submitted to the appropriate
State agencies and to the appropriate EPA
Regional offices, as required in § 259.82 of this
part. EPA Regional office addresses are listed
below.
EPA Regional Administrators
Regional Administrator, U.S. EPA Region I,
J.F. Kennedy Federal Building., Boston, MA
02203
Regional Administrator, U.S. EPA Region n,
26 Federal Plaza, New York, NY 10278
Regional Administrator, U.S. EPA Region ffl,
5th and Walnut Streets, Philadelphia, PA
19108
Regional Administrator, U.S. EPA Region IV,
345 Courtland Street. ME, Atlanta, GA ••
30365
Regional Administrator, U.S. EPA Region V,
230 S. Dearborn Street Chicago, H. 60604
Regional Administrator, U.S. EPA Region VI,
1201 Elm Street, Dallas, TX 75270
Regional Administrator, U.S. EPA Region Vn,
324 East llth Street, Kansas City, MO 64106
Regional Administrator, U.S. EPA Region
VIII, 1860 Lincoln Street, Denver, CO 80295
Regional Administrator, U.S. EPA Region IX,
215 Fremont Street, San Francisco, CA
94105
Regional Administrator, U.S. EPA Region X,
. 1200 Sixth Avenue, Seattle, WA 98101
BILLING CODE 6S60-50-M
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12386
Federal Register / Vol. 54. No. 58 / Friday, March 24,1989 / Rules and Regulations
Appendix H to Part 259—On-Site Medical Waste Incinerator Report and Instructions
ON-S1TE MEDICAL WASiTE INCINERATION REPORT
I. FACILITY INFORMATION
Page 1 of.
1. Reporting Period
_ June 22, 1989 to
December 22 . 1090
June 22, 1990 to
L-1 December 22, 1990
2. Facility Name and Mailing Address
Facility Name
Mailing Address
City
State Zip Code
3. Location of Incineration Facility
D Address of location is the same as
mailing address in Box 2.
or
Street Address
City
State
Zip Code
4. Type of Facility
D Hospital
Laboratory
Facility
D Funeral Home/Crematorium
D Veterinary
Clinic
D Other (Specify,^
Private Practice
or Clinic
5. Contact Person at Facility
Title
Telephone Number
6. Waste Feed Information (total for all incinerators specified in Box 7)
A. Approximate Total (Quantity
of Regulated Medical Waste;
Incinerated:
B. Approximate Percentage of
Total Waste Incinerated
that is Regulated Medical
Waste
C. Approximate Quantity of
Regulated Medical Waste
Received from Sources
Outside this Facility:
I I I I i I I < I I Pounds/six-month reporting .period
I I I I %
I I I I I I I I I I Pounds/six-month reporting period
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Federal Register / Vol. 54, No. 56 /Friday. March 24,1989 / Rules and Regulations
123117
Pacilitv Name
Page_ of.
II. INCINERATION INFORMATION
7. Total Number of Incinerators that Incinerate Regulated Medical Waste at this Facility:
LJLJ ••'•:•' •'.- •'••••'•'••
8 a. Incinerator Design Information
A Age of
Incineration unit:
E Type of Unit:
I I I Years
Q Excess Air
O Starved Air
O Rotary Kiln
D Other (Specify,.
C. Number of
Combustion
Chambers:<
D. Design Charging
Capacity:
Q One Chamber
CD Two Chambers
O Three or more Chambers
I I 1 I I I I Pounds per hour
8 b. Incinerator Design Information
A. Age of
Incineration unit:
B. Type of Unit:
I II Years
O Excess Air
Q Starved Air
D Rotary Kiln
Q Other (Specify,.
_)
C. Number of
Combustion
Chambers:
D. Design Charging
Capacity;
Q One Chamber
C] Two Chambers
Q Three or more Chambers
I ' I' ' ' I Pounds per hour
9. Certification
I certify that I have personally examined and am familiar with the information suomuieo
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 tru6, accurate, and complete.
Name and official title of owner or owner's authorized representative.
Name
BILLING CODE «S6O-60-C,
Title
Date
.,^^.>-.i,,.. ... ^ ,.,,;.. ..
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12388 Federal Register / VoL 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations
General Instructions
Authority
This Information is required by EPA under
the authorities of sections 11003 and 11004 of
the Resource Conservation and Recovery
Act. EPA expects that you will provide this
information based on reasonably available
records, or, in the absence of such records, on
your knowledge.
Who Must Complete This Form?
This form must be completed by generators
of regulated medical waste who:
• Are located in Covered States; and
• Use an on-site incinerator to burn
regulated medical waste during the reporting
periods described below.
Only complete this form for Incinerators that
burn regulated medical waste. Refer to 40
CFR 259.61 for recordkeeping requirements
pertaining to this reporting form.
When to Complete This Form?
Generators who incinerate regulated
medical waste on-site are required to submit
the On-slte Medical Waste Incinerator Report
to EPA for two separate reporting periods.
The first report covers the period from June
22,1089, to December 22,1989. The
submission date for tho first reporting period
is February 8,1990.
The second report covers the period from
Juno 22,1990, to December 22,1990. The
submission date for the second reporting
period is February 6,1991.
Where to send this Report?
In each reporting period, submit two copies
to: Chief, Waste Characterization Branch,
Office of Solid Waste (OS-332), U.S.
Environmental Protection Agency, 401M
Street SW., Washington, DC 20460.
Instructions for Completing the Form
Boxes 1 through 5 require general
informatlgn about the facility. Boxes 6
through 8 require specific information about
the waste incinerated and technical
information regarding the incinerators
themselves. Box 9 requires the facility owner
or operator to certify the accuracy of the
informatioasubmltted. Begin with Box 1 and
continue sequentially to each box. If there is
more than one on-site Incinerator used to
incinerate regulated medical waste, complete
Box 8{a) for the First incinerator and Box 8(b)
for the second incinerator; for more than two
incinerators, you will need to use an
additional sheet(s) to provide the required
incinerator information.
You will also need to sign the certification
Box (Box 9) on each additional sheet.
Box 1. Reporting Period. Mark an "X" in
the box that specifies the reporting period for
the information you are submitting.
Box 2. Facility Name and Mailing Address.
Enter the name and mailing address of the
incineration facility.
Box 3. Location of Incineration Facility, If
the location address of the incineration
facility is the same as the mailing address
entered in Box 2, mark an "X" in the
designated box. If the location address is
different from the mailing address, enter the
location information.
Box 4. Type of Facility. Mark an "X" in the
box that classifies the business or
organization that owns or operates the
incineration facility. If the categories do not
accurately represent your facility, mark the
"Other" category and specify the facility type
in the space provided.
Box 5. Contact Person at the Facility. Enter
the name, title, and telephone number of the
person who is most knowledgeable about the
incineration operations at your facility.
Box 6. Waste Feed Information. The
questions in this box ask about quantities of
regulated medical waste incinerated at your
facility. When entering a response, right
justify the entry (e.g., | | |2 |0 |0 |0 |0 |
Pounds). '
A. Approximate Total Quantity of
Regulated Medical Waste Incinerated. Enter
the total weight (in pounds) of the regulated
medical waste incinerated at your facility
(total of all incinerator units) during the six-
month reporting period. To identify the
quantities o'f regulated medical waste
incinerated, refer to the operating logs kept
for each incinerator at your facility as
required under 40 CFR 259.61.
B. Approximate Percentage of the Total
Waste Incinerated that is Regulated Medical
Waste. Using the information from your
operating log, calculate the percentage (by
weight) of the total waste incinerated that is
regulated medical waste. To do this, divide
the amount of regulated medical waste
incinerated by the total amount of waste
incinerated. Multiply the result by 100. Enter
the number in the space provided.
C. Approximate Quantity of Regulated
Medical Waste Received from Sources
Outside this Facility. Enter the total weight
(in pounds) of regulated medical waste
received from sources outside your facility
during the six-month reporting period.
An example of outside sources would "
Include a facility that receives waste from a
physician with an office several miles away.
Box 7. Total Number of Incinerators at this
facility. Enter the total number of
incinerators that burn regulated medical
waste at your facility. Only include
incinerators that incinerate regulated medical
waste.
Box 8. Incinerator Design Information. To
complete Items A through D in this box, refer
to design blue prints, manufacturer's
information, or other sources.
A. Age of Unit. Enter the age of the
incinerator unit in years.
B. Type of Unit. Mark an "X" in the box
that describes this incinerator type.
• An "excess air" unit is usually a compact
box-like structure with chambers and baffles,
and it operates with high air flows to assure
adequate combustion. It is usually loaded
manually through a charging door.
• A "starved air" unit is usually
cylindrical, but can be rectangular, and it
typically has combustion air fed through the
floor or on the sides. The waste is usually
manually loaded, although larger units can be
mechanically loaded.
• A "rotary kiln" unit is cylindrical and
rotates about the lengthwise axis. If this
incinerator is not described by any of the
three groups listed, mark an "X" in the box
labelled "other" and describe the unit in the
space provided. If necessary, attach
additional sheets.
. C. Number of Combustion Chambers. Mark
an "X" in the box that describes the number
of combustion chambers in this incinerator.
D. Design Charging Capacity. Enter the
maximum amount of waste that this
incinerator is designed to burn, in pounds per,
hour. If you cannot locate any records,
estimate the number of pounds per hour that
this unit is designed to burn. [NOTE: When
entering a quantitative response, such as,
rates, weights or .time, right justify the entry
(e.g.. | |2|0|0|0|0| }}.
Box 9. Certification. After completing this
form, the facility owner or an authorized
representative must sign and date the
certification and indicate his or her position.
BILLING CODE 6560-SO-M
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Federal Register / Vol. 54, No. 56 / Friday, March 24,1989 / Rules and Regulations
12389
Appendix in to Part 259—Transporter Report Form and Instructions
TRANSPORTER REPORT
1. TRANSPORTER IDENTIFICATION INFORMATION
Page 1 of
1 . Reporting Period
D June 23, 198v to Dcccnt^r
D June 18, 1990 to Decanber 1A; 1990
Q Decanber 20, 1989 to June 17, 1990 Q December 15, 1990 to June 12, 1991
2. Transporter Name and Mailing Address
Name
Address
City
State
Zip Code
3. EPA Medical Waste Identification Number
1 1 1 I I I l 1 1 1 I I I
4. Certification for intermediate Transporter
D Yes
D No Signature
5. Contact Person
Name
Title
Telephone Number
6. Certification
1 certify that 1 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,
believe that the submitted information is true, accurate, and complete.
Name and official title of owner or owner's authorized representative.
Signature
Title
Date
II. DISPOSITION INFORMATION
7
r. Total Quantity of Regula
A. Untreated Waste
B. Treated Waste
ted Medical Waste by Category ;
Second Transporter or
Transfer Facility
i ! 1 1 1 1 1 1 1 i Pounds
1 1 1 1 1 1 1 1 1 IPnimHe
and Destination
Intermediate Handler or
Destination Facility
1 1 1 1 1 1 1 1 1 iPni'mrie
1 1 1 1 1 1 1 1 1 IP™,nHs
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12390
Federal Register / Vol. 54, No. 56 / Friday, March 24,1989 / Rules and Regulations
Transporter Name or ID number.
page
III. GENERATOR IDENTIFICATION
8. Total Number of Generators From Whom Regulated Medical Waste was Accepted
(tt your anpwer t& "0", skip to section IV) | |,..l l._ 1 1 1 1 1
9. Identity of Generators please complete se
A. Name and Location of Generator
Generator Name
Street Address
City State Zip Code
A. Name and Location of Generator
Generator Name
Street Address
City State Zip Code
A. Name and Location of Generator
Generator Name
Street Address
City State Zip Code
A. Name and Location of Generator
Generator Name
Street Address
City State Zip Code
Actions A, B, and C for each Generator
B. Type of Generator i-i
Refer to instructions for code
C. Quantity of Regulated Medical
Waste Accepted From the Generator
Untreated | | | 1 1 1 1 1 1 Pounds
Treated 1 1 1 1 1 1 1 1 1 Pounds
B. Type of Generator 1-1
Refer to instructions for coda
C. Quantity of Regulated Medical
Waste Accepted From the Generator
Untreated | f 1 1 1 1 1 1 1 Pounds
Treated 1 { | | | 1 1 1 1 Pounds
B. Type of Generator 1-1
Refer to instructions for code
C. Quantity of Regulated Medical
Waste Accepted From the Generator
Untreated | | | | | | | | | Pounds
Treated 1 1 1 1 1 1 1 1 1 Pounds
B. Type of Generator i_l
Refer to instructions for code
C. Quantity of Regulated Medical
Waste Accepted From the Generator
1 fntmated ( | J | | { j 1 1 Pounds
Treated 1 1 1 1 1 1 1 1 1 Pounds
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Federal Register / Vol. 54, No. 56 / Friday, March 24,1989 / Rules and Regulations
12391
Transporter Name or ID Number.
page of
IV. INTERMEDIATE HANDLER OR DESTINATION FACILITY IDENTIFICATION
10. Total Number of Intermediate Handlers or Destination Facilities to which Regulated
Medical Waste was Delivered . . . . . . . . . (if your answer is "0", do not
11. Identity of Intermediate Handlers or Destination Facilities
P&teise Complete Sections A and B for each Facility
A. Name and Location of Facility j B. Type of Facility J_L
1 Refer to instructions for code
Facility Name
i
i
Street Address
City
A. Name and
State Zip Code"
'
Location of Facility
Facility Name
Street Address
City
A. Name and
State Zip Code
Location of Facility
Facility Name
Street Address
City
A. Name and
Facility Name
Street Address
City
State Zip Code
Location of Facility
- -
State Zip Code
C. Quantity of Regulated Medical
Waste Delivered to the Facility
Untreated 1 1 1 1 1 1 1 1 1 Pounds
Treated 1 1 1 1 1 1 1 1 1 Pounds
B. Type of Facility i-i
Refer to instructions for code
C. Quantity of Regulated Medica!
Waste Delivered to the Facility
Untreated 1 1 1 1 ! 1 1 1 1 Pounds
Treated 1 II II III! Pounds
B. Type of Facility LJ.
Refer to instructions for code
C. Quantity of Regulated Medical
Waste Delivered to the Facility
Untreated 1 1 1 1 1 1 1 1 1 Pounds
Treated 1 1 1 1 1 1 1 1 1 Pounds
B. Type of Facility J-l
.
Refer to instructions for code
C. Quantity of Regulated Medical
Waste Delivered to the Facility
Untreated 1 1 1 1 1 1 1 1 1 Pounds
Treated 1 1 1 1 1 1 1 1 1 Pounds
KLUtM COOC SWO-KM5
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12392
Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations
General Information
Authority
This Information is required by EPA under
the authorities of Section 11003 and 11004 of
the Resource Conservation and Recovery
Act. EPA expects that you will provide this
information based on the records you are
required to keep as a medical waste
transporter.
Who Must Complete This Report?
This report must be completed by
transporters of regulated medical waste who
accept and transport regulated medical waste
generated in a Covered State, and who are
required to obtain an EPA Medical Waste
Identification Number under § 259.72 of this
Part.
What Type of Information Is Required By
This Report?
The Transporter Report Form collects
Information on the source and disposition of
regulated medical waste handled by a
transporter. The form is divided into four
sections:
I. Transporter Identification Information
n. Disposition Information
III. Generator Identification
IV. Intermediate Handlers and Destination
Facility Identification
How to Complete These Forms?
A separate copy of this form must be
completed for each Covered State in which
the regulated medical waste which you have
transported, during the reporting period was
generated.
[Note: If you did not transport regulated
medical waste generated in a Covered State
during a reporting period, you do not have to
submit a Transporter Report Form for that
Covered State for that reporting period]. The
examples described below illustrate who (i.e.,
those transporters) must report, and for
which Covered States:
Example 1: Company X accepts waste
generated in New York. (In this scenario New
York is assumed to be a Covered State and
New Hampshire, a non-Covered State.)
Company X accepts regulated medical
waste from six generators located in New
York and transports the waste for disposal to
two facilities in New Hampshire. (Because
New York is a Covered State under the
demonstration program, Company X must
notify EPA that it accepts and transports
regulated medical waste generated in a
Covered State. EPA will issue an EPA
Medical Waste Identification Number to
Company X for the State of New York.)
in this case. Transporter X only accepts
and transports regulated medical waste from
one Covered State and, thus, will only have
to complete one report, for the State of New
York.
Example 2: Company Y accepts regulated
medical waste generated in New Jersey and
New York. (In this scenario both New Jersey
and New York are assumed to be Covered
States, and New Hampshire a non-Covered
Slate.)
Company Y accepts regulated medical
waste from four generators In New York and
from fivB generators in New Jersey. Company
Y delivers the waste accepted from these
generators to a destination facility in New
Hampshire. (Company Y notifies EPA that it
accepts and transports regulated medical
waste that is generated in two Covered
States. EPA issues two EPA Medical Waste
Identification Numbers to Company Y, the
first identification number is for the transport
of regulated medical waste generated in New
York and the second number is for the
transport of regulated medical waste
generated in New Jersey.)
Because Company Y has accepted waste
generated in two Covered States, the
company will be required to complete and
submit two Transporter Report Forms, one
for the waste from the four generators in New
York and a separate Transporter Report Form
for the five generators in New Jersey.
Example 3: Three transporter companies,
Company X, Company B, and Company Y,
transport regulated medical waste generated
in New York. (Again, in this scenario New
York is assumed to be a Covered State and
New Hampshire, a non-Covered State.)
Company X accepts regulated medical
waste from six generators located in New
York and transports the waste to Company B
who is an intermediate transporter located in
New Hampshire. Company B accepts the
waste from Company X and transports the
waste to Company Y, also located in New
Hampshire, who then delivers the waste to a
destination facility in New Hampshire.
(Because New York is a Covered State, all
three companies (X, B, and Y) must notify
EPA that they accept and transport regulated
medical waste generated in a Covered State.)
Each transporter company must also
complete a separate Transporter Report
Form. In completing the form, Company X
must supply information on each New York
generator from whom it accepts regulated
medical waste, and on the quantities it
accepted. Company Y must supply
information on the disposal facility to which
it delivers the regulated medical waste and
the quantities it delivered. Company B must
only supply information to verify it is an
"intermediate transporter" as it neither
accepted waste directly from a generator nor
delivered waste to an intermediate handler or
destination facility.
When to Complete the Report?
Complete each Transporter Report using
the information that can be obtained from the
tracking forms and transporter logs. Use only
those tracking forms and logs that have
certification receipt dates in Box 16 of the
tracking form, that fall within the reporting
periods identified below. Submit the report
no later than 45 days following each reporting
period. The schedule of submission dates are
as follows:
Reporting period
December 15, 1990 to
June 12, 1991.
• Submission date
July 27, 1991.
Reporting period
June 23.1989 to
December 19,1989.
December 20,1988 to
June 17,1990.
June 18,1990 to
December 14,1990.
Submission date
February 2.1990.
August 1. 1990.
January 28,1991.
Where to Send This Report?
Copies of each report must be submitted as
follows:
(1) One copy must be submitted to: Chief,
Waste Characterization Branch (OS-332),
Office of Solid Waste, U.S. Environmental
Protection Agency, 401M. Street SW.,
Washington, DC 24060.
(2) A second copy musf be submitted to the
Director of the waste management agency in
the State for which the transporter has
compiled the report. .
Instructions for Completing the Form
The item by item instructions that follow
explain for each type of transporter which
Sections I-FV they must complete.
[Note: If your company accepts and
transports regulated medical waste from
generators located in a Covered State and
you have not been issued an EPA Medical
Waste Identification Number, you still must
complete this form for each Covered State's
waste which you have transported during the
reporting period.
After completing the entire form, number
each page appropriately in the space
provided (e.g., page 14 of 15) J
Section I. Transporter Identification
Information
Boxes 1 through 6 requires the submittal of
information on the reporting period and your
transporter operations. Begin with Box 1 and
continue sequentially with each Box. ,
Box 1. Reporting Periqd. Mark an "X" in
the box that specifies the reporting period for
the information you are submitting.
Box 2. Transporter Name and Mailing
Address, Enter the name and the mailing
address of the transporter who is completing
this report.
Box 3. EPA Medical Waste Identification
Number. Enter the 12 digit identification
number assigned to your company's
transporter operations in the Covered State
for which you are completing this form. If you
do not have an identification number, enter
the name of the Covered State for which you
are completing this form.
Box 4. Certification for Intermediate
Transporter. Transporters who (1) solely
accept regulated medical waste from
transporters who have, themselves,
transported the waste, and (2) deliver such
waste only to another transporter for further
movement, are considered "intermediate
transporters" and need Only complete Boxes 1
through 6. If you are an intermediate
transporter, mark an "X" in the box
corresponding to "YES" and enter your
signature after the box. If you are not an .
intermediate transporter, mark an "X" in the
box corresponding to "NO". In both cases,
continue on to Box 5.
Box 5. Contact Person. Enter the name,
title, and telephone number of the person
who is most knowledgeable about your .
transportation operations, or the person who
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Federal Register / Vol. 54, No. 56 / Friday, March 24, 1989 / Rules and Regulations 12393
is responsible for the information in this
reporc.
Box 6. Certification. After completing this
form, the comp.any owner or an authorized
representative must sign and date the
certification and indicate his or her title or
position. If your organization has no legal
owner (e.g., a local government entity), the
individual within'your organization who is
responsible for the information in this report
must sign and date the certification and
indicate his or her position.
If you were an intermediate transporter
during the reporting period marked in Box 1,
you do not need to complete the remaining
sections of this report. If, however, you
accepted regulated medical waste directly
from a generator located in a Covered State,
or you delivered such waste to an
• intermediate handler or destination facility
during the reporting period marked in Box 1,
continue with Sections II, HI and IV and
follow the instructions. •
Section H. Disposition Information
This section requires submittal of"
information on the quantities of regulated
medical waste you transported during the
reporting period marked in Box i.
Box 7. Total Quantity of Regulated
Medical Waste by Category and Destination.
This box requests information on the total
quantity of (A) untreated and (B) treated
regulated medical waste you accepted for
transport during the reporting period. The
total quantity of waste should only include
the regulated medical waste you transported
that was generated in the Covered State for
which you are completing this form. For each
category of waste, enter the quantity of waste
(in pounds) that was delivered (I) to a second
transporter or transfer facility and (2) to an
intermediate handler or destination facility. If
either category of waste was not delivered to
a facility, enter "0* for that category and
facility combination. If you did not deliver
waste to one of the types of facilities, enter
"0" for that facility type. Right justify each
entry (e.g., | |2|0|OJO|).
Section III. Generator Identification
This section requires the submittal of
information regarding the generators from
whom you accepted regulated medical waste
during the reporting period marked in Box 1.
Box 8. Total Number of Generators from
whom Regulated Medical Waste was
Accepted. Enter the total number of
generators from whom you accepted
regulated medical, waste for transport during
the reporting period. Include only those
generators located in the Covered State for
which you are completing this form. If your
company did not pick up any regulated
medical waste directly from a generator.
enter "0" in the box and skip to Section IV.
Right justify each entry (e.g.,] | |1 |4 [3 |).
Box 9. Identity of Generators. Complete
Boxes 9A through 9C on each individual
generator in the Covered State from whom
you accepted regulated medical waste during
the reporting period. This form provides
space for identification of four generators. If
you accepted waste from more than four
generators, copy this page as needed and
provide the information on each-generator.
The number of generators entered in Box 8
must equal the total number of all generators
identified in Box 9.
9A. Name and Location of Generator. Enter
the name and the address representing the
physical location of the generator (i.e., the
location at which the waste is picked up).
9B. Type of Generator. Enter one of the
following codes that best classifies the type
of generator. Use your best judgment as to
the generator's type. ... ,
Code
01
02
03
04
05
06
07
08
09
Generator type
Hospital—includes waste generated in all
laboratories and departments.
Laboratory—including clinical and research
laboratories generating regulated medical
waste.
Clinic—includes group-practice facilities that
provide ambulatory care of one or more
specialties such as hemodialysis, prena-
tal, or post partum care, surgical centers,
family practice centers, etc. Also includes
outpatient drug treatment facilities, and
nonresktential medical day care facilities.
Physician—includes single and multiple pri-
vate-practice physician offices.
Dentist—includes single and multiple pri-
vate-practice dentist offices.
Veterinarian—includes single and multiple
private-practice veterinarian offices.
Long Term or Residential Health Care Facil-
ity—includes facilities providing skilled or
non-skilled care such as nursing homes
and residential drug treatment centers.
Blood Banks—includes freestanding blood
banks (not at a hospital) and their mobile
off-site activities.
Other—includes any other facility generating
regulated medical waste such as ambu-
lance services, infirmaries, etc. If you
enter this code, specify the type of gener-
ator in the space after the code.
9C. Quantity of Regulated Medical Waste
Accepted from the Generator. For each
category (untreated and treated), enter the
amount of waste (in pounds) that you
accepted from the generator during the
reporting period. If you did not accept waste
in one of the categories, enter "0." Right
justify each entry (e^.. | | |2|0|0|0|0|
pounds). —i—
Section IV. Intermediate Handlers or
Destination Facilities Identifiction
Boxes 10 and 11 requires the submittal of
information regarding the intermediate
handlers and destination facilities to which
you delivered regulated medical waste during
the reporting period marked in Box I.
Box 10. Total Number of Intermediate
Handlers and Destination Facilities to which
Regulated Medical Waste was Delivered.
Enter the total number of intermediate
handlers and destination facilities to which
you delivered regulated medical waste during
the reporting period. This box should include
all facilities (in both Covered and non-
Covered States) that accepted the regulated
medical waste listed in Box 7. If you did not
deliver any regulated medical waste to an
intermediate handler or destination facility
• during the reporting period enter "0" in the
Box and do not complete the remainder of
this section. Right justify your entry (e.g..
I I |2|9|).
Box 11. Identity of Intermediate Handlers
and Destination Facilities. Complete Boxes
11A through 11C identifying each individual
intermediate handler and destination facility
to which you delivered regulated medical
waste generated in the Covered State for
which this form is completed. This form
provides spaces for identification of four
, facilities. If you delivered waste to more than
four facilities, copy this page as needed and
provide the requested information for each
facility. The number of facilities entered in
Box 10 must equal the number of facilities
identified in Box 11.
11 A. Name and Location of Facility. Enter
the name and the address representing the
physical location of the facility.
11B. Type of Facility. Enter one of the
following codes that best classifies the type
of facility:
Code
1
2
3
4
5
Facility type
Landfill.
Incinerator.
Treatment (other than incinerator).
Destruction Facility (other than incinerator).
Treatment and Destruction Facility (other
than incinerator).
11C. Quantity of Regulated Medical Waste
Delivered to the Facility. For each category
(untreated and treated) enter the quantity of
waste (in pounds) that you accepted for
transport to the intermediate handler or
destination facility during the reporting
period. If you did not deliver waste in one of
the categories enter "0" for that category.
Right justify each entry (e.g., |0|0|2|0|0|0|
pounds).
B1LUNO CODE 40SO-SO-*
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12394
Federal Register / Vol. 54, No. 56 /Friday, March 24. 1989 / Rules and Regulations
Appendix IV to 40 CFR Part 259 Recommended Medical Waste Transporter Notification Form and Instructions
United Slates
Environmental Protection
Agency
Medical WasteTransporter
Notification Form
FOR OFFICIAL EPA USE ONLY
Identification No.: I 1 1—
Date Received: I I
Receiving Official:
(Please Type or Print Clearly)
1 . Covered State for which you are notifying
2, Transporter Name and Mailing Address
Name
Addrass
Cny
State
Zip Code
Contact
Area Code/Telephone Number
3. EPA Hazardous Waste ID Number
(The ID number entered should be for tha facility identified in Box 2)
, . . , .
4. Transporter's Facility Locations)
(use additional sheets if necessary)
Address
C,ty
State
Zip Code
Am» Code/ Telephone Number
'Any cum.nl State Identification number(s) (permit or license, required to hand.e
mcKfccat of infectious waste
•4-
Addrass
City
State
Zip Code
Area C"^ Telephone Number
*"£%?££££%!£ '°" """^ ^^ " ^"^ "*"'"* * **"**
Addrtm
AddTess
State
Zip Code
City
State
Zip Code
Am Cods/ Telephone Number
Area Code/ Telephone Number
Any current Slate Identification number's) (permit or license) required to handle
modtcsl of infocttous wasts
^'^ (Pe™1 * ^"^ "*"*' * **"**
-t"
Address
State
Zip Code
City
State
Zip Code
A™ CcM Telephone Number
Area Cod* Telephone Number
Any currant State .donation numbers, (perm,t or license) required to handto
fnOOtCW Of IfSjOCttOOS Vr3S*9
5. Certification
Act.
Signature
Title
MUJNO CODC *«0-SO-C
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Federal Register / Vol. 54, No. 56'/ Friday1, March 24, 1989 / Rules and Regulations
12395
Instructions for Completing the Medical
Waste Transporter Notification Form
General Information
Authority
This information is required by the EPA
under authority of Section 11003 and 11004 of
the Resource Conservation and Recovery
Act
Who Must Notify: Transporters who
transport regulated medical waste that is
generated hi a Covered State must notify the
U.S. Environmental Protection Agency for '
each Covered State's regulated medical
waste they intend to transport. This
requirement extends to transporters who do
not actually transport the waste within that
Covered State's boundaries but who
transport the waste, generated in the Covered
State, outside that Covered State's
boundaries.
Transporters planning such activity may
either complete a Notification Form or submit
a letter containing the information required in
40 CFR 259.72(b). EPA will then issue a
Medical Waste Identification Number unique
to that transporter for each Covered State for
which they are notifying. That number will be
used to identify regulated medical waste
transporters and can be used by generators
to verify that the transporter has notified EPA
of his intent to transport waste from their
Covered State.
When to Notify: Notification must be
submitted for a Covered State before the
transporter may accept regulated medical
waste generated in that Covered State.
Transporters may, however, accept such
waste once they have submitted their
notification, but before receiving their
identification number. Upon receipt of that
number, the transporter must enter it in Box S
of the Medical Waste Tracking Form, when
that form is required. Additionally, the
transporter must enter that number in Box 17
of the Tracking Form when acting as a
secondary transporter, and in Box 1 when
initiating a tracking form for load
consolidation purposes.
Where to Send Notification: Two copies of
the completed Notification Form, for each
Covered State, must be sent to: Chief, Waste
Characterization Branch, Environmental
Protection Agency (OS-332) 401 M Street,
SW., Washington, D.C. 20460,
One copy must also be sent to the Director
of the waste management agency in the State
for which the transporter is notifying.
Notification Form Instructions
Note: All information must be typed or
printed clearly.
Box 1. Covered State for which voa are
notifying. Enter the name of the Covered
State of origin of the regulated medical
waste(s) you intend to collect and/or
• transport. Enter only one State in this space;
if you intend to transport waste from more
than one Covered State you must submit a
separate Notification Form for each of those
States.
Box 2. Transporter Name and Mailing
Address. Enter your organization's name.
mailing address, the name of a contact
person at that location who is knowledgeable
about your operations, and include that
person's telephone number.
Box 3. EPA Hazardous Waste
Identification Numbers. If the facility
identified in Box 2 has an EPA Hazardous
Waste Identification Number, enter the. EPA -
assigned 12-character hazardous waste
identification number for the facility.
Box 4. Transporter's Facility LocationfsJ.
Enter the address, facility telephone number
and any current State medical or infectious
waste permit or license numbers for each
transportation or transfer facility located
within the Covered State identified in Box 1.
If there are more than four such facilities in
that Covered State you will need to use an
additional sheet(s) to provide the required
facility information; attach the additional
sheets to the first.
Box 5. Certification. The Certification
Statement must be read and hand signed by a
corporate officer or the owner/operator of the
transporter company.
[FR Doc. 89-6304 Filed 3-23-fl9; 8:45 am)
BILLING CODE 6S60-54-M
U.S. GOVERNMENT PRINTING OFFICE: 1969 0-942-208
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