UniMd Stat0s
Environmental Protection
Agency
OH'ce of
Soi.d Waste and
Emergency Hesconse
DIRECTIVE NUMBER: 9933.0
TITLE: Medical Warte Enforcement Strategy
APPROVAL DATE:
EFFECTIVE DATE:
MAR
1989
ORIGINATING OFFICE: office of Waste Programs
m Enforcement/RCRA Enforcement Div
D DRAFT
LEVEL OF DRAFT
DA — Signed by AA or OAA
D B — Signed by Office Director
D C — Review & Comment
REFERENCE (other documents):
SWER OSWER OSWER
DIRECTIVE DIRECTIVE Dl
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.93 cnvironmvnvau rrwi^coon AQoncy
Washington. DC 20460
OSWER Directive Initiation Request
1. Directive Number
9933.0
2. Originator Information
Telephone Code
475-6720
Name of Contact Penon
Mary Jean Osborne
3. Title
Medical Waste Enforcement Strategy
4 Summary of Directive (include Dnel statement of purpose)
The purpose of the strategy is to assist Regions and States in
implementing the Medical Waste Tracking Program. The strategy provides
clarification of the EPA's and States' roles, outlines the tracking
& reporting requirements and presents guidelines for prioritizing enforcement
5. Keywords
Ifedical Waste Enforeanent. Manifest, Infectious Waste, State Priorities
6«. Does This Directive Supersede Previous Direcirve(s)?
X
No
b. Does It Supplement Previous Oirective(s)?
X No
Yes Whit directive (number, title)
Yes What directive (number. We)
7. Draft Level
| | A-SignedbyAA/DAA [ | B - Signed by Office Director (""] C - For Review & Comment | | D-tnDevetoprr
8. Document to be distributed to States by Headquarters?
Yea
^^^^•^^^•v
D
No
This Request Meets OSWER Directives System Format Standards.
9. Signature of Lead Office Directives Coordinator >•>.
fJtf^&A^ fYL l^M-^r^
10. Name and Title of Approving Official
Date
Date
EPA Form 1315-17 (Rev. 5-«7) Previous editions are obsolete.
OSWER OSWER OSWER (
VE DIRECTIVE DIRECTIVE DIRECTIVE
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
' WASHINGTON. D.C. 20460
MAD I KJPQ °
l»IHr\ I IOOC7 SOLID WASTE AND EMERGENCY RESPONSE
MEMORANDUM
SUBJECT: Enforcement Strategy for Medical Waste
Tracking Regulation
/• _ yger—
FROM: J. Winston Porter
Assistant Administrator
TO: Regional Administrators
Regions I - X
This memorandum transmits the final Medical Waste Enforcement Strategy
developed by the Office of Waste Programs Enforcement. The purpose of this
strategy is to provide Regions and States with guidance in implementing the
Medical Waste Tracking Regulation which is scheduled for promulgation in
March. The strategy contemplates that the States will be the primary
implementors of the demonstration program and encourages Regions and
States to innovatively utilize resources to maximize benefits during the
limited two-year timeframe of the program. Also provided are a definition of
the EPA's and State's roles/ clarification of enforcement of the Federal
rules/ a summary of reporting requirements and a discussion of planned
.outreach efforts.
I hope that the guidelines presented in the strategy will assist the
Regions and States in prioritizing compliance monitoring and enforcement
activities. I encourage you to develop innovative methods of promoting
compliance with the Medical Waste Tracking Regulation. If you have any
questions or concerns, please contact Bruce Diamond, Director, Office
of Waste Programs Enforcement. *
Attachment
>
cc: Waste^Management Division Directors, Regions I - X
RCRA Branch Chiefs, Regions I - X
Regional Counsels, Regions I - X
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OSWER DIRECTIVE 9933.0
U.S. ENVIRONMENTAL PROTECTION AGENCY
Medical Waste Enforcement Strategy
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OSEER DIRECTIVE 9933.0
Medical Waste Enforcement Strategy
TABLE OF CONTENTS
I. Introduction 1
II. Goals 2
III. Summary of The Demonstration Program Requirements ,3
IV. The Relationship Between EPA and The States 7
V. Reports to Congress 10
VI. Prioritizing Inspection/Enforcement Activities 11
VII. Innovative Compliance Monitoring and Enforcement 11
VIII. Outreach/Education 12
IX. Federal Facilities 13
X. Indian Lands '.. 13
XI. Conclusion 14
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OSWER DIRECTIVE 9933.0
Medical Waste Enforcement Strategy
I. Introduction
In October 1988, Congress passed the Medical Waste Tracking
Act of 1988 (Act). The Act amends the Solid Waste Disposal Act
by creating a new Subtitle J. The Act requires EPA to implement
a two-year demonstration program to track certain medical wastes
generated in the States of New Jersey, New York, Connecticut, and
States contiguous to the Great Lakes (these States are:
Pennsylvania, Ohio, Indiana, Illinois, Michigan, Wisconsin and
Minnesota). The States participating in the program are
classified as "covered"•States. . Those not participating in the
demonstration program would be classified as "non-covered"
States. States designated under the Act (e.g., the ten indicated
above) may elect to "opt-out" of the program. If so, New York,
New Jersey and Connecticut would first have to demonstrate to the
Administrator that they have a program in place that is no less
stringent than that of the Federal program. The Great Lakes
States may opt-out by providing a written notification to the '*v
Administrator within 30 days of publication of the Medical Waste
Tracking Program in the Federal Register. Additionally, States
may elect to participate or "opt-in" to the program; however,
their participation is subject to the approval of the Administra'
tor. Once the "opt-in" and "opt-out" period is completed, a list
of the States participating in the demonstration program will be
published in the Federal Register.
Compliance and enforcement provisions in the Act include
the authority to conduct inspections and initiate enforcement
actions. EPA (or a duly designated representative) is authorized
to conduct inspections and to interview any individual at any
establishment where medical waste is being or has been handled.
It is important to note that,,if medical waste is found in a
covered State, it will be presumed to have been generated in that
covered State. It will be the responsibility of that waste
handler to provide documentation to prove that the waste was not
generated in the covered Statev EPA may issue administrative
orders or., commence a civil action and assess or seek civil
penalties (in accordance with the "RCRA Civil Penalty Policy") of
a maximum of $25,000/day of noncompliance per violation. The
United States may seek criminal penalties of a maximum of
$50,000 for each day of violation or imprisonment of up to five
years. For cases involving knowing endangerment, individuals may
be fined up to $250,000 and/or be subject to a prison term not
exceeding 15 years. Organizations would be subject to a fine of
not more than $1,000,000. Section 11007 of the Act provides that
States may conduct inspections and take enforcement actions "to
the same extent as the Administrator."
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OSWER DIRECTIVE 9933.0
To initiate the two-year demonstration program, EPA is
publishing an- interim-final rule that will be effective 90 days
after publication. Preliminary results from EPA's draft
Regulatory Impact Analysis indicate that there are approximately
145,970 generators of medical waste and approximately 1,000
medical waste transporters in the ten States designated under the
Act. The Agency has limited information on the number of
disposal facilities accepting medical waste from facilities in
covered States.
In addition to establishing tracking, segregation, handling,
labeling, and marking requirements (discussed in greater detail
later in this document), the rule sets certain management
standards for medical waste generators, transporters, treaters,
and disposers. These management standards apply to medical waste
generated in a covered State regardless of where it is transpor-
ted and ultimately treated or disposed. The management standards
require that, prior to transport, regulated medical waste must be
segregated into three categories: (1) sharps and residual
fluids; (2) fluids greater than 20 ccs; and (3) other regulated
medical wastes. Prior to transport, regulated medical wastes
must be stored in a non-putrescent state in areas with restricted
access, sheds, tractor trailers or other secure containers. -In
addition to pre-transport and storage standards, there are also
decontamination requirements for reusable containers. Any
container used for the storage and or transport of regulated
medical waste and designated for reuse once emptied, must be
rendered free of visible contamination prior to reuse if the
container shows visible signs of contamination. The sole
distinction between management standards for small generators
(those that generate less than 50 pounds/month and ship in
quantities of less than 50 pounds per shipment) and large
generators, is the need for the latter group to initiate a
tracking form.
The purpose of this strategy is to assist Regions and
States in implementing the Medicad. Waste Tracking Program. This
strategy provides clarification of the EPA's and States1 roles,
outlines the tracking and reporting requirements as well as
presents guidelines for Region* and States to utilize in
prioritizing enforcement activities. The strategy also is
intended to encourage Regions and States to utilize resources to
maximize benefits during the limited two-year time frame of the
demonstration program.
II. Goals
During the limited two-year demonstration program, one of
EPA's goals will be to gain experience in dealing with the
problem of medical waste, and to incorporate the knowledge and
information garnered from the pilot program into the summary
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OSWER DIRECTIVE 9933.0
Report to Congress. This will assist in the development of
future legislation/regulations regarding medical waste. It
be EPA's goal to encourage States to implement the program by
providing the" States with significant flexibility to encourage
alternative methods of implementation, and to develop innovative
approaches to compliance and enforcement. In addition, EPA will
develop guidance (e.g., model State programs) to allow States to \J
supplement the tracking rules with other appropriate controls.
Due to the size and diversity of the universe of medical
waste handlers, EPA and the States should seek to maximize
voluntary compliance through outreach and education efforts. In
order to promote compliance, a concerted effort by all levels of
government to involve and educate individual citizens (who must
become aware of their own waste generation/disposal practices) is
necessary. Although the States will be the primary implementors
of the program, EPA will provide assistance in establishing a
coordinated interstate approach to medical waste tracking. The
Federal Medical Waste Tracking Demonstration Program will
complement existing State tracking programs.
III. Summary of The Demonstration Program Requirements
This section summarizes the major requirements of the
regulation, including the use of the tracking form, information
collection and reporting requirements, and pre-transport
requirements. It is hot intended to provide a discussion of al
specific regulatory requirements, or to be used as a substitute
for the actual regulatory text.
A. Utilization of Uniform Tracking Form
Section 11003(a)(3) of the Act requires the use of a
uniform form for tracking medical waste in the States included in
the demonstration program. A copy of the tracking form, and
associated instructions for completing it, can be found in
Appendix I of the medical waste tracking regulations in 40 CFR
Part 259.
v
The form is comprised of three main sections: one each for
generators, transporters, and treatment or disposal facilities.
Generators are required to cerfify that they have properly
classified, packaged, marked, and labeled their wastes.
Subsequent handlers (transporter(s), and treatment destruction or
disposal facilities) must sign and date the form upon receipt of
the waste, retain a copy, and return a copy to the generator as
evidence of delivery (if the facility treats or disposes of the
waste). EPA requires that regulated medical waste be classified
as "treated" or "untreated." States may require reporting of
additional information on the tracking form (e.g., if State laws
are more stringent and cover additional waste categories).
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OSWER DIRECTIVE 9933.0
The hierarchy for acquisition of the form (259.52(b)) by
generators of medical waste is similar to that for hazardous
waste generators (40 CFR 262.21). The generator should take the
following steps:
If the waste is to be shipped out of State to a
facility located in another covered State, and that
State prints the form, the generator should request a
copy from the transporter. The transporter is required
to provide a copy to the generator
If the disposal facility is not in a covered State or
it does not print the form, the generator should
obtain the form from his own State
If the form is not available in the generator's State,
it must use the Federal form in Appendix I.
B. Reporting Requirements/Information Collection
The Medical Waste Tracking Act and associated regulation
(40 CFR Part 259) contain reporting and information collection
requirements to ensure compliance with the tracking regulation in
the demonstration States and to provide data for requisite
Reports to Congress on the success of the program. Reporting
requirements contained in the regulations are discussed, followed
by a summary of the statutory enforcement-related information
requests anticipated by EPA to prepare the requisite Reports to
Congress.
The regulation contains four reporting requirements and one
notification requirement as follows:
Section 259.55 - Generator exception reports
Section 259.62 - On-site incinerator reports
Section 259.72 - Transporter notification
Section 259.78 - Transporter semi-annual reports
Section 259.82 - Tracking form discrepancies
Generator exception reports and tracking form
discrepancies must be submitted^ to both the affected EPA Region
and the appropriate State agency. The transporter notifications
and semi-annual reports must be sent to EPA Headquarters, with an
additional copy of the notification and semi-annual report sent
to the appropriate State agency. The on-site incinerator reports
must also be submitted to EPA Headquarters. Each reporting? -
requirement is summarized.briefly.
Generators
A generator of regulated medical waste that is subject to
the tracking requirements must submit an exception report if a.
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OSWER DIRECTIVE 9933.
copy of the original form is not received from the designated
treatment, destruction/ or disposal facility within 45 days.
report must include a legible copy of the original tracking form
and a brief letter outlining the generator's efforts to locate
the waste.
Incinerators
Generators that incinerate regulated medical waste on site
must submit two reports detailing information contained in the
facility's operating record six months plus 45 days after the
effective date of the tracking regulations, and again eighteen
months plus 45 days after the effective date.
The reports must summarize information collected in the
operating record during the first and third six-month period
after the effective date of the demonstration program. In
addition to information on the incineration technology, the
reports must include the following waste feed information:
The approximate total quantity of all regulated
medical waste incinerated during the period
The approximate percentage of total waste incinerated
that is regulated medical waste
Approximate quantity of regulated medical waste
received from sources from outside the facility.
Transporters
Transporters of regulated medical waste must submit a one-
time notification that includes the transporter's name, address,
State permit number (if applicable), EPA Hazardous Waste
identification Number (if applicable), and a statement that the
transporter understands the tracking regulation.
Transporters must also submit reports twice annually, on
specifically designated dates, detailing the names of generators
from which the waste was received, amount and type of waste
received from each generator, aggregate amounts of regulated
waste transported (detailing treated vs. non-treated), names and
addresses of each treatment, destruction or disposal facility to
which the wastes were transported, and finally the volume or
weight delivered to each facility.
Medical Waste Management Facilities
A tracking form discrepancy report must be submitted by a
'treatment, destruction or disposal facility that receives
regulated medical waste shipments containing:
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OSWER DIRECTIVE 9933
Different numbers of containers, total or by category,
of regulated medical waste than is indicated on the
tracking form
Waste shipments that have not been packaged as required
by Section 259.41
Or, shipments that are known to contain regulated
medical waste generated in a covered State, but have
not been accompanied by a tracking form, or where the
tracking form is incomplete or unsigned.
The report must be submitted within 15 days from the date
the waste was received. A letter describing the discrepancy and
the owner/operator's attempts to reconcile the situation, as well
as a legible copy of the tracking form, must be submitted to the
affected Region arid appropriate State agency.
Copies of all reports discussed herein must be maintained
for at least three years. They must also be made available to
State and EPA personnel in the event of a facility inspection.
C. Pre-Transport Requirements
Regulated medical wastes transported for subsequent
management (treatment, destruction or disposal) off site, are
subject to pre-transport requirements (40 CFR Part 259, Subpart
E) including waste segregation, packaging, labeling and marking.
Segregation (259.40)
Prior to being placed in containers for eventual transport,
wastes must be segregated by type as follows:
Sharps and residual fluids
Fluids greater than 20 cubic centimeters
Other regulated medical wastes.
Packaging (259.41) **
Before transporting, or offering for transport/ regulated
medical waste shipments, generators must package waste following
standards for each segregated category. All wastes must be
packaged in rigid, leak resistant containers. In addition,
sharps must be packaged in puncture resistant containers and
fluids in break resistant containers. Generators may use any
number of containers to meet these packaging requirements, though
double packaging will often be necessary.
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OSWER DIRECTIVE 9933.0
Labeling (259.44)
Untreated regulated medical wastes must have a water
resistant, plastic label affixed to the outside of the
packaging that says "Infectious Waste", "Medical Waste" or
displays the universal biohazard symbol. If a plastic bag is
used for primary (inner) packaging, it must either be red, or
display the universal biohazard symbol. Treated wastes are not
subject to this requirement. •
Marking (259.45)
The packaging (containers) encasing regulated medical waste,
must be marked with tags that contain identifying information as
specified in the regulations. In addition, each transporter
managing a particular waste shipment must individually mark it
with a separate tag.
IV. The Relationship Between EPA and The States
Section 11005 of the Medical Waste Tracking Act gives the
Administrator authority to issue compliance orders, to assess or
seek civil penalties and to seek injunctive relief in United -v
States District Court for past or current violations. It also
gives the United States the authority to seek criminal penalties
for knowing violations of the Act and knowing endangerment.
Section 11004 gives the Administrator, or his representative,
authority to conduct inspections and obtain information. In
addition to these Federal authorities, States are encouraged to'
implement State authority as a basis for their enforcement
efforts. Section 11007 further provides that States may conduct
inspections and take enforcement actions against any person "to
the same extent as the Administrator." EPA and State roles are
addressed in the following sections.
The State Role
The task of implementing th6 Medical Waste Tracking
Program will lie primarily with the States. States will have
the lead for conducting inspections related to, and enforcement
of, the medical waste trackings-program. Where there has been a
violation^ States may use applicable State authority to bring an
enforcement action. If a State uses its own authority, the
involvement of the EPA Regions will be limited. States are a
person for the purposes of RCRA, therefore a State may bring a
citizen suit under Section 7002 of RCRA against any violator of
the Act.
States also may choose to exercise Federal authority under
Section 11007 of the Act to enforce the medical waste regulation
However, when the President signed the Act into law, he cautioned
that "I have also been advised that Section 11007 of this bill,
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OSWER DIRECTIVE 9933.0
which authorizes states to take enforcement action against any
person 'to the. same extent as the Administrator1, may raise
serious constitutional problems. To the extent that Congress
provided for States to prosecute crimes or exercise other
executive branch authority, it could be inconsistent with the
Appointments Clause of the Constitution." Therefore, States are
encouraged to develop comparable State authorities to the Act,
and to take action against violators of the Medical Waste
Tracking Program under State law or to use the citizen suit
provision of RCRA.
If a State nonetheless, elects to enforce under the
Federal authority, it is required (by Section 11007(a) of the
Act), to notify EPA in writing. This notification must be sent
to the Administrator of the EPA and to the EPA Regional
Administrator for the Region in which the violation is alleged to
have occurred. The notification must include a copy of the
complaint. EPA Headquarters will forward a copy of the notifica-
tion and the complaint or comparable filing to the Assistant
Attorney General for the Land and Natural Resources Division of
the Department of Justice. Moreover, if a State chooses to
pursue enforcement under the Federal authority it is not acting
as an agent of the Federal government or the EPA, and State
actions should not be viewed as binding EPA as a matter of policy
or precedent. Further, if any penalties are obtained in a State
initiated enforcement action using Federal authorities, they must
go to the Federal Treasury (U.S.C. Title 31 Section 3302(b)).
In response to the new authority provided to the Administra-
tor under Subtitle J, EPA is promulgating, as part of the interim
final rule, a regulation that extends the applicability of the
Consolidated Rules of Practice (which governs the administrative
assessment of civil penalties and the revocation and suspension
of permits, 40 CFR Part 22), to administrative enforcement
actions taken pursuant to Section 11005 of RCRA. The
Consolidated Rules of Practice are applicable only to enforcement
actions initiated by the Administrator. If States choose to use
Federal authorities, and do not have penalty assessment proced-
ures which satisfy the Act and constitutional requirements for
due process, they will need to institute them. In light of the
above considerations, states that participate in this two-year-
demonstration are strongly urged to develop and implement their
own authorities to regulate medical waste.
When a covered State receives an exception or discrepancy
report that indicates improper handling of shipments of regulated
medical waste into an non-covered State, the covered State may
either notify the non-covered State directly, or the EPA Regional
Administrator of the Region in which the covered State is
located. The Regional Administrator will either contact the non-
covered State directly, if it is in the same Region, or notify
the appropriate EPA Region, who will then contact the non-covered
•
8
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OSWER DIRECTIVE 9933.0
State. The non-covered State will be given the opportunity and
is encouraged to take action. If the non-covered State does not
adequately follow up on the tracking exception or discrepancy,
EPA will investigate, and if appropriate, take action.
EPA Role
EPA's role in implementing the Act is to ensure compliance
by providing information and guidance to the States, to assist
States in implementing the objectives of the Act, and to enforce
the Act when appropriate. Although the States have a major role
in implementing the objectives of the Act, the EPA role includes
the following:
The development of rules, an enforcement strategy, and
a penalty guidance document, to provide guidance as to
how the objectives of the Act should be implemented and
enforced pursuant to State and Federal law
The development of handbooks, brochures, and other
informational materials
Technical assistance
The maintenance of data bases, including transporter
notifications and reports and incinerator reports
Handling, as necessary, specific cases involving
discrepancies and exceptions in non-covered States
Evaluation of the success of the program, and submittal
of a comprehensive Report to Congress.
EPA's Office of Solid Waste (OSW) will maintain computerized
data bases of all transporter notifications and semi-annual
reports submitted by transporters. OSW will also maintain all
incinerator reports. The EPA Regions should keep a consolidated
hard-copy file of all exception and discrepancy reports so that
they are easily accessible. States are encouraged to do the
same.
•*»
EPA anticipates relatively little Federal enforcement
action in States that are implementing an effective compliance
and inspection program. EPA enforcement initiatives generally
will be limited to situations where State enforcement is
unsuccessful or inadequate, or to where States solicit Agency
intervention. In addition, EPA involvement may be appropriate in
the following instances:
At Federal facilities when the State requests EPA
assistance
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OSWER DIRECTIVE 9933.0
In following up on regulated medical wastes transported
to non-covered States and on Indian lands where there
is "no comparable State or Indian Tribal statute.
V. Reports to Congress
The Act requires EPA to submit three Reports to Congress:
two during the demonstration program, and one summary Report
subsequent to completion of the program. The two interim Reports
will contain information (on topics listed in Section 11008(a) of
the Act) available to the Administrator at the time of submis-
sion. The first Report is due nine months after the enactment of
Subtitle J, and the second twelve months after the effective date
of the medical waste tracking regulation. The summary Report,
due three months after the expiration of the demonstration
program, will include more detailed and complete information on
the same topics identified in Section 11008.
Items 8, 9, and 10 in Section 11008(a) address enforcement-
related issues. To comply with the Act, EPA may solicit
information from the affected State agencies on:
Existing State and local controls on the handling,
storage, transportation, treatment, and disposal of!
medical waste, including the enforcement and regulatory
supervision thereof
The appropriateness of using any existing State
requirements or requirements contained in Subtitle C as
nationwide standards to monitor and control medical
waste
The appropriateness of the penalties provided in
Section 11005 for ensuring compliance with the
requirements of Subtitle J, including a review of the
level of penalties imposed under this Subtitle.
EPA strongly suggests that Regions and States keep accurate,
organized information on inspections, violations and enforcement
actions under Federal and State authorities, that can be readily
retrieved for use in enforcement proceedings and in the evalua-
tion of the effectiveness of the demonstration program. In order
to facilitate a smooth transfer of enforcement related informa-
tion between the States and the Regions as well as the Regions
and Headquarters, it is necessary for the Regions to designate a
medical waste contact person. EPA will make a concerted effort
to minimize the burden on State agencies when soliciting
information to complete these Reports to Congress.
10
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OSWER DIRECTIVE 9933
VI. Prioritizing Inspection/Enforcement Activities
The medical waste regulation addresses several categories of,
medical waste generated by a variety of medical facilities/
entities. Due to the size and nature (e.g., previously unregu-
lated handlers) of the regulated universe and the limited
duration of the tracking program, the Regions and States will
have to utilize creative methods for targeting medical waste
handlers/facilities for inspections, investigating unresolved
exception reports, and other enforcement activities. Some States
with medical waste programs currently in place may have
information available on the compliance history of medical waste
handlers within the State. This information will assist in
identifying violators and targeting inspections and enforcement
actions. States without existing medical waste programs can
utilize the demonstration program to begin developing compliance
histories on their medical waste handlers. The required
notifications and semi-annual reports from the transporters will
provide information on the universe of generators, as well as the
types and quantities of medical waste handled. This information
may assist Regions and States in identifying problem handlers.
Each covered State may have specific problem areas/regions
that may require special enforcement attention. Although the.'
medical waste regulation is required to be implemented throughou
the State, resources could be focused on areas with a history o
and the greatest potential for/ problems. Because medical waste
has created a public health concern, inspections and enforcement
could be targeted in areas- where there is the most risk to the
population (e.g., handlers suspected of contaminating public
beaches). In addition to focusing on specific problem areas,
promoting voluntary compliance through outreach and education is
critical to the success of the demonstration tracking program,
especially due to the fact that many medical waste handlers have
not previously been subject to RCRA.
VII. Innovative Compliance Monitoring and-Enforcement
%
Due to the short timeframe for implementing the tracking
program, it may be useful for the Regions and States to devise
innovative methods of inspection and creative settlement
agreements. Hospital accreditation boards or self-auditing
programs for medical waste handlers may provide mechanisms for
promoting and assisting in evaluating compliance with the medical
waste regulation and management standards. Cooperative efforts
could be initiated with local health and transportation depart-
ments that already conduct inspections at medical facilities. In
addition, major medical waste handlers could be encouraged to
develop their own compliance audit plans.
For example, creative settlements, in addition to collecting
penalties pursuant to EPA's RCRA Civil^Penalty Policy or under
11
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OSWER DIRECTIVE 9933.(
appropriate State authority, could require violators (especially
major medical waste handlers) to develop in-house training
programs on the proper handling of medical waste or cleanup
measures for potentially affected locations. Outside the
context of settlement agreements, publicizing well-chosen cases
of serious non-compliance in the local newspapers or in televis-
ion broadcasts would be another technique that could be used to
encourage compliance.
Informal enforcement mechanisms are an integral component of
an effective comprehensive compliance monitoring and enforcement
program. Less resource-intensive, informal enforcement actions
may be warranted in many cases, due to the newness of the
program, the large size of the regulated universe and the diverse
nature of the medical community. Some of the more commonly
employed informal enforcement techniques include warning letters
and notices of violation.
Formal enforcement actions consist primarily of administra-
tive compliance orders and penalty assessments or judicial
actions; however, there may be additional enforcement mechanisms
available under State authorities. Formal enforcement action may
be appropriate for serious types of violations of the medical
waste tracking regulation such as: ;
Transporting, or delivering/offering for transporta-
tion, regulated medical waste without a tracking form
Improper labeling of the regulated medical waste
Failure of the medical waste transporter to comply
with the one-time notification to EPA
Failure of generators to file exception reports or
owner/operators of TSOs to file discrepancy reports.
In addition, it may be appropriate to pursue criminal
enforcement actions in cases where generators have falsified -
information on the tracking form. Criminal actions may also be
appropriate against generators who fail to use the form.
<*
VIII. Outreach/Education
EPA's OSW will develop several written communication
materials that describe the requirements of the medical waste
tracking program. In February 1989, there will be a general
public brochure available that summarizes the provisions of the
demonstration program. In April 1989, OSW plans to publish a
generator booklet detailing the tracking program requirements
from the generator's perspective. Transporter and disposal
facility brochures describing their respective responsibilities
will also be published and distributed. In addition, posters
12
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OSWER DIRECTIVE 9933
targeted to the non-regulated community (e.g., diabetics) on the
safe handling and disposal of medical waste, will be posted in
appropriate public places (e.g., pharmacies). OSW is also
developing a bibliography of abstracts on infectious waste
studies, articles and other literature as well as an information
clearinghouse on medical wastes. OSW will determine the
distribution mechanism of these documents once they are
finalized.
Some States have already undertaken outreach and educational
efforts. For example, the States of New York and New Jersey have
developed a 14-point action plan, which includes provisions for
waste minimization, public education and guidance on handling
medical waste mismanagement incidents. Both States have also
conducted meetings and briefings with hospital associations.
IX. Federal Facilities
Section 11006 of the Act waives the sovereign immunity of
Federal facilities from regulatory requirements contained in 40
CFR Part 259 as well as all local and State medical waste
requirements, if they are located in a covered State. The Act
provides that Federal facilities may be exempted from the ^
regulation when deemed in the national interest by the President.
These exemptions will likely be rare, must be renewed each fiscal
budgetary year, and must be reported to Congress.
States will have primary enforcement responsibility at
Federal facilities, as with all facilities within their jurisdic-
tion. EPA will assist the States in pursuing compliance of the
medical waste tracking regulation at non-compliant Federal
facilities where requested by the affected State agency or as
otherwise necessary. .
X. Indian Lands
EPA is the only body with authority to enforce a Federal
Act on lands held in trust for, pr under the jurisdiction of, a
Federally-recognized Indian Tribe. Where a Tribe has its own law
to track medical waste, EPA encourages the Tribe to take
enforcement action under TribaJ. law.
When a covered State receives an exception or discrepancy
report that indicates that medical waste has entered Indian land
from a covered State, that State should notify the affected EPA
Regional Administrator and the head of the Tribal government.
EPA will work cooperatively with Indian Tribes to ensure
coordination and to avoid duplication of effort in inspections
and enforcement actions.
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OSWER DIRECTIVE 9933.0
XI. Conclusion
The goals of the Medical Waste Tracking Demonstration
Program will be achieved through promoting compliance with the
regulation. EPA's compliance and enforcement strategy will rely
primarily on promoting compliance through the development and
support of State compliance and enforcement programs. EPA
Regions will work with States to identify and resolve State-
specific enforcement issues and assist States in developing
programs. EPA will provide assistance and tools to help the
States. The tools will include providing information as well as
developing and sharing effective methods to promote compliance.
EPA recognizes that voluntary compliance will not be achieved in
all cases. State and local enforcement actions are a necessary
foundation for an effective compliance effort. In addition,
there may be instances where Federal enforcement presence will be
appropriate.
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