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

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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

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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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