^ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
I WASHINGTON, D.C. 20460
OFFICE OF
SOLID WASTE AND EMERGENCY RESPONSE
MEDICAL WASTE MANAGEMENT STRATEGY
August 31, 1988
The EPA's Office of Solid Waste (OSW) plans to carry out the
following tasks over the next several months:
o Collect and evaluate information on medical waste
generation and management, the environmental hazards of
existing management practices, and State programs now
in place to control infectious waste;
o Determine what national regulations or guidance are
necessary, e.g., tracking systems, packaging, etc.; and
o Provide educational materials for the public to
explain applicable national requirements or guidance,
and to generally promote good management practices.
In the course of conducting these analyses, OSW will closely
coordinate its program with those activities and studies being
conducted in other EPA offices, such as the hospital waste
combustion study being conducted by EPA's Office of Air Quality
Planning and Standards, and the ocean disposal studies being
conducted by EPA's Office of Marine and Estuary Protection.
Also, OSW will consult with experts in health care and waste
management, with environmental groups, and with State and local
authorities, to obtain a broad spectrum of views on proper
management of medical waste.
The objectives, short- and long-term goals, and end products
of each task are detailed in the attached workplan.
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\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
3 WASHINGTON, D.C. 20460
OFFICE OF
SOLID WASTE AND EMERGENCY RESPONSE
OSW MEDICAL WASTE PROGRAM PLAN
AUGUST 31, 1988
The following 8-point strategy includes the basic elements of
OSW's infectious waste program:
1. Define Medical Waste.
2. Evaluate State and Municipal Programs.
3. Collect and Evaluate Information.
4. Evaluate Management Methods and Enforcement Activities.
5. Assess Need for A National Tracking/Reporting System.
6. Conduct An Environmental/Economic Assessment.
7. Conduct A Regulatory and Non-Regulatory Options Analysis.
8. Provide Education, Information Exchange, and Public
Outreach.
The objectives, short- and long-term goals, and end products of
each activity are detailed in the attached outline.
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1. DEFINITION OF MEDICAL WASTE
Objective: To identify those medical wastes including those
which are potentially infectious that require special handling,
storage, treatment, and disposal. Variations in the definition
of infectious waste result in inconsistent treatment, storage
and disposal practices which, in turn, can affect waste
management costs, worker safety practices, and environmental
releases.
Short-term
Activities:
o Review the existing and accepted definitions of
infectious waste used by EPA, CDC, JCAH, and state and
municipal authorities.
. o Analyze the public comments received in response to the
Federal Register notice (June 2, 1988) to identify
alternative definitions of medical waste to those used
by EPA and CDC. Compare these alternative definitions
to existing ones.
* o Evaluate the implications of establishing medical waste
definitions based on characteristic, type and/or
source. Draw up pros and cons for each, including the
impact of these definitions on the quantities of waste
subject to existing and proposed treatment, storage and
disposal practices.
o Draft a "new" definition of medical waste. Send it to
a selected audience of trade and medical association
representatives, the scientific community,
environmentalists, and public officials (e.g., Federal,
state, city and county public health and/or
environmental departments) for review.
o Consolidate solicited comments and incorporate them
into final draft definition. Evaluate this definition
against criteria such as ease of comprehension,
feasibility, enforceability, etc.
* o Re-convene EPA staff and Panel of Experts to review the
final definition.
End Products
o Options paper on alternative definitions.
o Convene Panel of Experts (11/15/88).
o Federal Register notice, conveying new EPA definition
of infectious waste (12/15/88).
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2. EVALUATE STATE AND MUNICIPAL PROGRAMS
Objective: To evaluate the effectiveness of existing state programs
in controlling the infectious waste problem, and, in particular, to
identify those components of state programs that are successful versus
those that are not so successful.
Short term
Activities:
o Review existing state infectious waste programs, including:
Definition of infectious waste/universe of generators.
State regulatory authority.
Treatment and disposal requirements.
Tracking/Recordkeeping requirements.
Permitting.
Exclusions/Exemptions.
Enforcement.
Training requirements.
(A draft of this report has been prepared that identifies those
states that have infectious waste programs, gaps in existing
data, and a means of obtaining data to evaluate these programs.)
o Obtain and review all state and major municipal regulations.
(This effort is underway).
o Identify criteria for evaluating the effectiveness of state
infectious waste programs (e.g., containment achieved, extent of
public exposure, extent of environmental release, extent of
economic loss).
* o Evaluate effectiveness and successful elements of state programs.
o Perform site-visits to states with active programs (e.g., we are
aware of six states that currently have tracking and enforcement
components) to evaluate administrative, tracking and enforcement
activities. (Two site visits, to Massachusetts and Pennsylvania,
have already been made.)
o Meet with relevant trade associations (NGA, CSG, ASTSWMO) to
discuss results of preliminary research and site visits and
obtain additional information.
o Develop guidance for a model state program.
o Evaluate effectiveness of existing state programs against the
model state program guidance, and refine the guidance.
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3. PROVIDE EDUCATION, INFORMATION EXCHANGE, PUBLIC OUTREACH
Objective: To ensure that the general public and interest groups are
provided with the information necessary to understand the nature -of
this problem and kept fully informed of all program developments,
including program implementation requirements. To provide educational
information for the affected industry and regulators.
Short Term
Activities:
o Develop public outreach materials (e.g., brochures, fact sheets,
press releases) to address public concerns and information needs
and to demonstrate EPA's commitment to the program. Target
audiences are expected to include the general public, health care
institutions and providers, trade associations, waste management
firms, and environmental interest groups. (Several brochures are
presently being developed)
o Work with trade associations (e.g., hospitals, physicians, waste
handlers) to promote sound practices and to identify appropriate
recipients for outreach materials.
o Revise and publish guidance materials on infectious waste
management.
o Prepare and publish a special issue EPA Journal devoted to
infectious waste management issues.
o Develop public outreach plan to define: information needs,
audiences, product format, and distribution channels. Consider
appropriateness of materials such as videos, newsletters, and
electronic bulletin boards.
End Products:
o Target audiences and publish series of public outreach, guidance,
and educational materials (Continuing through FY 89).
o Consider an EPA Journal issue devoted to infectious waste
(FY 89).
o Public outreach program plan (Spring 1989).
Long Term
Activities:
o Continue public outreach activities through the duration of
project.
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Identify regulatory options based on: effectiveness; legal
authority; consistency with existing regulations, programs, or
policies; ease of implementation; enforceability; cost; time
constraints; and data availability. Options could include:
Regulation under various statutes;
Regulation at the state level (e.g., treatment standards,
financial responsibility);
Seek new statutory authority for infectious waste;
Use of guidance.
Analyze regulatory impacts by quantifying, where practical, the
reduction in public health and environmental risks and economic
impacts. Analyze regulatory option feasibility in terms of
implementation, compliance monitoring, enforcement, and signifi-
cance to other regulatory efforts.
Select regulatory options and conduct regulatory impact analysis
(including economic impact analysis and regulatory flexibility
analysis).
Prepare regulatory dockets (e.g., background documents), draft
proposed rules, and guidance manuals.
End Products:
Complete set of regulatory support materials. (Uncertain;
dependent upon data gathering efforts of OAR, CAA, and OSW, and
other Federal and State agencies.)
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7. CONDUCT REGULATORY OPTIONS AND NON-REGULATORY OPTIONS ANALYSIS
Objective: To identify options for managing and tracking infectious
wastes. Once options are identified, conduct a step-wise, but
iterative, progression of analyses to narrow the set of options to a
single, best regulatory or non-regulatory (or combinations of
regulatory and non-reguatory) alternative.
Short Term
Activities:
r o Establish initial set of regulatory and non-regulatory options to
aid focus of short- and long-term data collection efforts.
Options could include:
Regulation under Subtitle C, D, D+, CAA, CWA, MPRSA, MARPOL
or TSCA;
Regulation at the state level (e.g., treatment standards,
financial responsibility);
Establishment of new statutory authority for infectious
waste;
Licensing, liability insurance requirements, accreditation;
No regulation (e.g., guidance).
o Coordinate activities with the regions and with OSHA, FDA, DOT,
CDC, and other appropriate federal agencies.
Evaluate existing and proposed regulations.
Coordinate development of regulations and guidance with
other federal programs.
Identify conflicts or issues in implementation of
regulations or guidance.
o Prepare preliminary options paper citing pros and cons of each
option.
o Develop strategy for analyzing regulatory options. Determine
critical factors that must be considered during options
evaluation.
End Products:
o Paper on regulatory and non-regulatory options for infectious
waste management (Spring 1989).
Long Term
Activities:
o Evaluate the effect of alternative infectious waste definitions
on regulatory options.
o Identify and collect information (e.g., waste characterization
data, cost data) required to support regulatory development
(conducted under Task Area 3).
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6. CONDUCT ENVIRONMENTAL/ECONOMIC ASSESSMENT
Objective: To determine the environmental, economic, and health risks
of improper disposal of infectious wastes.
Short Term
Activities:
o Identify major potential impacts of infectious wastes and categorize
them by environmental, economic, and health effects.
o Determine which of the potential impacts are supported by data
through a review of current literature and convening work groups
with trade associations.
End Products:
o Preliminary report on the identification of the potential impacts of
the universe of infectious wastes (Summer 1989).
o Identify future study needs for a general analysis of economic and
environmental impacts (Summer 1989).
Long Term
Activities:
o Obtain data to support or refute reported risks through new studies
(e.g., infectiousness of infectious waste after release to the
environment, economic impact of environmental release).
o Perform a comprehensive study of the sources, probabilities of
releases, environmental transport, and significant impacts
nationwide.
o Identify health effects data gaps through research and development
and scientific studies.
End Products:
o Final report on economic and environmental impacts (early 1991).
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End products
o Technical report on management effectiveness (9/30/89).
o Develop enforcement strategy (Fall 1989).
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5. EVALUATE MANAGEMENT METHODS AND ENFORCEMENT ACTIVITIES
Objective: To determine which transportation, treatment, storage and
disposal methods are most effective in minimizing environmental release
by each waste type, and what resource requirements (e.g., for
enforcement) are required for each method.
Short term
Activities:
o Develop flow chart of treatment, storage, and disposal scenarios by
waste type.
o Assess potential for release and ultimate fate of wastes by waste
type and by management method.
o Evaluate magnitude of release and relative ease of remediation by
. waste type. ..,
o Coordinate with other programs (e.g., OAQPS, OW, OMEP) to identify
the regulatory limitations and multi-media impacts of specific
management methods.
o Identify enforcement activities required by each management method.
o Evaluate resource requirements for enforcement of existing laws
prohibiting release.
End products:
o Flow charts of treatment, storage, and disposal scenarios (early
1989).
o Matrices of mismanagement events and consequences (early 1989).
o Report on enforcement activities (Spring 1989).
Long term
Activities:
o Determine effectiveness of current management methods and compare
effectiveness of alternative methods.
o Develop criteria to assess effectiveness of methods (e.g., magnitude
of potential release, potential for containment and remediation).
o Develop minimum standards for collection, treatment (e.g.,
autoclaving, incineration, chlorination), storage, and disposal
under Subtitle D or other statute.
o Recommend enforcement strategy for compliance monitoring and
enforcement to ensure proper management of infectious waste.
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Develop national data base, similar to Biennial Reports, if
necessary, to establish on-going capability to evaluate compliance,
waste generation amounts, transportation and management practices,
and compliance costs.
End Products:
Evaluate effectiveness of pilot tracking system and suitability for
a national system one year following implementation of the pilot
tracking system (about 1 year following implementation of the pilot
system).
Determination of what wastes need to be tracked and when wastes no
longer need to be tracked.
In conjunction with above analyses, evaluation of alternative
approaches to tracking and reporting infectious waste and plan for
implementation of a national system.
Implementation of national tracking system or detailed guidance to
the states including the associated OMB, regulatory, and Federal
Register notice documents, as necessary based on above -analysis.
Development of a national data base including the preparation of
OSVER's system life cycle support documents.
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4. NATIONAL TRACKING AND REPORTING SYSTEM
Objective: To develop the most effective means of tracking and
reporting the handling of infectious waste and to ensure the proper
containment and destruction of the waste.
Short Term
Activities:
o Evaluate tracking systems currently being used by the states and
those documented in other readily available information sources
(e.g., public comments) to determine the most effective means of
tracking infectious waste. (Based on information obtained during
State Evaluation Activity.)
o Work with Congress on the development of a pilot tracking system.
If legislation is passed, develop the regulations required to
implement the provisions of the legislation.
End Products:
o Evaluation of current tracking and reporting systems (Winter 1988).
o Completion of regulations for pilot tracking system within time
frame specified in the legislation.
Long Term
Activities:
o Evaluate effectiveness of pilot tracking system and suitability for
a national system.
o Evaluate alternative approaches to tracking and reporting on
infectious waste transport and management based on the pilot and
additional data obtained during the data collection and management
evaluation activities. Alternative approaches include: generator
or transporter manifest; generator reporting; state or federal
tracking systems.
o Determine what wastes need to be tracked and when wastes drop out of
the system.
o Evaluate existing manifest tracking and reporting systems to
determine strengths and weaknesses, and identify methods to overcome
identified problems.
o Develop national tracking and reporting system and/or provide
detailed guidance to states on tracking and reporting system
requirements.
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Long Tern
Activities
o Determine whether a comprehensive nationwide survey of infectious
waste generators, storage, treatment, and disposal facilities is
needed to quantify the amount generated, the current storage,
treatment, disposal methods, and compliance costs or if a smaller
independent random sample of medical facilities is sufficient to
validate the models developed above.
o If needed, design a comprehensive nationwide survey or a smaller
survey to validate the models. Identify the universe that will be
required to complete the survey. A representative statistical
survey may be necessary given the number of small quantity
generators.
o Obtain OMB approval for the survey including preparation of all
required recordkeeping clearance packages.
o Conduct survey pretest and modify survey as required if
comprehensive nationwide, or smaller, survey is necessary.
o Implement and administer survey and develop analytical tools
including data management systems.
o Analyze survey results: volumes of waste generated by type of wastes
and type of generator; collection and storage methods; treatment,
storage, and disposal practices; compliance costs; and environmental
impacts.
o Modify national estimates of waste generation.
End Products:
o Option paper and management decision on necessity of conducting
detailed survey (early 1989).
o Nationwide survey of infectious waste generators, transporters, and
TSDFs, including required OMB support documents (FY 1989).
o Preparation of draft and final results of survey (FY 1990).
o Data base and quantitative information of the generation,
transportation, treatment, storage and disposal practices, and
compliance costs (late FY 1990).
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3. COLLECT AND EVALUATE INFORMATION
Objective: To quantify the extent of the problem by determining the
amount and types of infectious waste that are generated, the treatment
and disposal practices, relative contribution of each source (doctors
offices, clinics, hospitals), and compliance costs.
Short Term
Activities:
o Collect readily available information on the amount and type of
infectious waste generated by type of generator (e.g., doctors
offices, veterinarians, clinics, medical laboratories, small
hospitals, and large hospitals using DHHS Medicare/Medicaid
definitions) and conduct site visits under RCRA 3007.
Information sources include public comments, trade associations,
states, generators, commercial haulers and TSDFs, and Centers for
Disease Control.
o Develop generic generator models (e.g., doctors offices,
veterinarians, clinics, medical laboratories, small hospitals,
and large hospitals) that can be used to estimate the volume of
waste generated on a national basis. Models may be developed for
rural, suburban, and urban areas depending on the variability in
the type and amount of waste generated. Models will be based on
such factors as number of beds, patient visits or employees.
o Review generic generator models with trade associations and Panel
of Experts and seek specific information on volumes of waste
generated.
o Collect information to fill data gaps and characterize waste
(e.g., send RCRA 3007 letters and conduct site visits).
o Develop national estimates (and to the extent possible, state
estimates) of amount of infectious waste generated;
transportation patterns including collection and storage;
•treatment and disposal practices; and compliance costs.
o Identify trends in the medical industry that may impact the model
assumptions such as growth of group practices or health
maintenance organizations.
End Products
o Generic generator models (to be reviewed by a subgroup of the
Panel of Experts) (Winter 1988).
o Preliminary national estimates of amount of infectious waste
generated (early 1989).
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End Products
o Preliminary state report, "Analysis of Existing Conditions"
including relevant case studies and detailed matrices of elements
of state programs (Winter 1988).
o Preliminary guidance for a model state program (Winter 1988).
o Draft Final Report, "Effectiveness of State Programs", to
evaluate how well each state manages infectious wastes, how much
they follow the guidelines of the model state program, and how
much they adhere to EPA's definition of infectious wastes.
o Final Report, "Effectiveness of State Programs" (Spring 1989).
•;
o Final guidance for a model state program (lace Spring 1989).
Long term
Activities:
o Develop a network that will provide for continued monitoring of
activities at the state level.
o As regulation of infectious wastes is in a state of flux,
continue to monitor activities of the various states.
o Modify model state program guidance as necessary.
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