Information Notice No. 89-85: EPA's Interim Final Rule on Medical Waste Tracking and Management

                                UNITED STATES
                        NUCLEAR REGULATORY COMMISSION
              OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
                           WASHINGTON, D.C.  20555

                              December 15, 1989


Information Notice No. 89-85:  EPA'S INTERIM FINAL RULE ON MEDICAL WASTE 
                                   TRACKING AND MANAGEMENT

Addressees: 

All medical, academic, industrial, waste broker, and waste disposal site 
licensees. 

Purpose: 

This information notice is provided to inform licensees that the 
Environmental Protection Agency (EPA) has promulgated an interim final rule 
(40 CFR 259) on medical waste tracking and management under a mandate from 
the Medical Waste Tracking Act of 1988.  As of June 6, 1989, EPA has 
determined that the regulation applies to the medical wastes generated in 
five States (known as "Covered States").  These "Covered States" are:  
Connecticut, New Jersey, New York, the Commonwealth of Puerto Rico, and 
Rhode Island.  This notice also identifies and clarifies areas of overlap 
between Nuclear Regulatory Commission (NRC) and EPA requirements.  Licensees 
may wish to review this information for applicability to their programs and 
consider actions, as appropriate, as may be required by rule.  However, 
suggestions contained in this information notice do not constitute NRC 
requirements; therefore, no specification or written response is required by 
NRC.  In addition no specific written response is required by EPA. 

Description of Circumstances: 

On March 24, 1989, an interim final rule on medical waste tracking and 
management under the authority of the Medical Waste Tracking Act of 1988 was 
published in the Federal Register, Vol. 54, No. 56, pp. 12326 - 12395.  On 
June 6, 1989, a supplementary Federal Register Notice, Vol. 54, No. 107, pp. 
24310 - 24311, identified the participating States, identified the effective 
dates of the new rule, and extended the public comment period.  On August 
24, 1989, a Federal Register Notice , Vol. 54, No. 153, pp. 35189 - 35191, 
removed Louisiana and the District of Columbia from the demonstration 
program leaving the States of New York, New Jersey, Connecticut, and Rhode 
Island, and the Commonwealth of Puerto Rico as participants in the program.  
NRC Part 35 licensees constitute one category of medical institutions 
covered by the new EPA rule.  Since radioactive materials are sometimes 
associated with medical wastes, NRC licensees may be affected by that rule. 

Discussion: 

The Medical Waste Tracking Act of 1988 requires the EPA to promulgate 
regulations on the management of medical wastes by establishing a two-year 
demonstration 


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program to track medical waste.  On March 24, 1989, EPA published "Standards 
for the Tracking and Management of Medical Waste; Interim Final Rule and 
Request for Comments" in the Federal Register (54 FR 12326).  In general, 
this EPA rule established criteria and procedures for State participation in 
the demonstration program, EPA's definition of "medical wastes" for use 
under the Act, and the regulations and standards to be used in the 
demonstration program.

The EPA regulation defines the regulated medical wastes applicable to the 
demonstration program, it establishes a waste tracking system, and sets out 
segregation, packaging, storage, labeling, and marking requirements. 

The EPA regulation defines "medical wastes" as "any solid waste which is 
generated in the diagnosis, treatment (e.g., provision of medical services), 
or immunization of human beings or animals, in research pertaining thereto, 
or in the production or testing of biologicals.  The term does not include 
261.4(b)(1) of this chapter."  The 
regulation also defines the "regulated medical waste" subject to the new 
waste tracking requirements.  These "regulated medical wastes" include 
cultures and stocks, pathological wastes, human blood and blood products, 
animal wastes, isolation wastes, and used and unused sharps (syringes, 
needles, scalpel blades, etc.).  Regulated medical waste that has been both 
treated, so as to substantially reduce or eliminate its potential for 
causing disease, and destroyed, is not regulated once the treatment and 
destruction processes have been completed.  However, generators who both 
treat and destroy regulated medical waste on-site are subject to specified 
recordkeeping requirements.  Note that hazardous wastes as defined under the 
Resource Conservation and Recovery Act (RCRA) in 40 CFR Part 261 are not 
covered by the new EPA rule.  Therefore, "mixed waste" (waste with both a 
RCRA hazardous component and a radioactive component) are not included in 
these new requirements.  However, mixtures of RCRA hazardous waste and 
regulated medical waste may be subject to the tracking requirements in some 
circumstances. 

20.311 requires that wastes shipped to a 
commercial low-level radioactive waste disposal site meet the waste 
classification and waste form requirements in 10 CFR Part 61.  The low-level 
radioactive waste regulations, 10 CFR Part 61, require that hazardous, 
biological, pathogenic, or infectious material be treated to reduce to the 
maximum extent practical the potential hazard from the non-radiological 
materials.  Hazardous wastes are covered under the EPA requirements in 40 
CFR 260-270.  However, radioactive medical wastes having a biological, 
pathogenic, or infectious component need to be treated prior to shipment for 
disposal.  Since treated wastes must also be destroyed in order to be 
exempted from the new EPA regulation, we expect some impact on low-level 
radioactive waste disposal facility licensees for tracking biological, 
pathogenic, and infectious wastes.  Licensees in the Covered States 
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who treat and destroy radioactive medical wastes would need to track these 
wastes up to the point of treatment and destruction.  Because some medical 
wastes regulated under the new EPA regulation are only treated, but not 
destroyed, and some medical wastes (e.g., unused radioactive material in 
syringes) may not require treatment under 10 CFR Part 61, some radioactive 
medical wastes would need to be tracked to the disposal site. 

The EPA tracking system will provide assurance that regulated medical waste 
is properly handled and managed.  The regulations require each person in the 
chain-of-custody of medical waste management to take responsibility for 
assuring that the waste reaches the proper treatment or disposal facility.  
A tracking form, described in the new regulation, is required to be used.  

The EPA regulation requires generators of regulated medical wastes in the 
Covered States to segregate sharps and fluids from other regulated medical 
waste and general refuse, to the extent practicable, prior to transport 
off-site.  The regulation also prescribes packaging in rigid, leak-resistant 
containers.  Storage of medical wastes must be (a) performed in a manner and 
location that maintains the integrity of the packaging and affords 
protection from water, rain, and wind, and (b) maintained in a nonputrescent 
state.  Specific labeling and marking requirements are also set out.

It should be noted that the low-level radioactive waste disposal regulation, 
10 CFR Part 61, prohibits the use of cardboard and fiberboard containers.  
These requirements were adopted due to several instances where low-level 
waste disposal operators injured themselves on needles that penetrated card-
board and fiberboard package containing medical wastes.  Since radioactive 
medical wastes are generally shipped for disposal in DOT 17H steel drums, no 
impact to licensees is expected. 

The EPA regulations include a new tracking form for covered medical 
materials.  In the Federal Register notice it is stated that the EPA 
tracking forms would be sufficient for meeting the NRC manifest requirements 
under 10 CFR 20.311 for radioactive wastes provided that the additional 10 
CFR 20.311 information is included in Box 14 of the form.  This statement 
needs clarification.  Commercial low-level radioactive waste disposal sites 
have very different manifest information requirements that could not be 
placed on the available space on the EPA form.  In addition, Agreement 
States regulating commercial low-level radioactive waste disposal sites 
require approval of new manifest formats.  Consequently, licensees in 
Covered States who ship regulated medical waste offsite for treatment or 
disposal would need to attach the low-level radioactive waste disposal site 
manifest forms to the EPA medical waste tracking forms. 

In some cases, generators of regulated medical waste in Covered States may 
use waste brokers or processors in non-Covered States.  Also, the three 
commercial low-level radioactive waste disposal sites are located in 
non-Covered States (Nevada, South Carolina, and Washington).  The new EPA 
regulations apply throughout the country, but only to wastes generated in 
Covered States.  
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Therefore, waste brokers, processors, and disposal site operators in 
non-Covered States will need to comply with the new EPA medical waste 
tracking requirements when they handle, process, or dispose of wastes 
generated in Covered States. 

This information notice is issued for information only and should not be 
construed as a legal interpretation of the EPA regulation.  No specification 
or written response is required by this information notice.  If you have any 
questions about this information notice, please contact Timothy C. Johnson 
at 301-492-0558 of this office.  If you have any questions on the new EPA 
regulations, please contact the toll-free RCRA/Superfund Hotline at 
800-424-9346 or 202-382-3000 in Washington, DC or Mary Greene, 202-475-8551, 
Office of Solid Waste, U.S. Environmental Protection Agency, OS-332, 401 M 
Street, S.W., Room S-242, Washington, D.C.  20460.  Copies of the new EPA 
regulations are available by calling the RCRA/Superfund Hotline. 




                              Richard L. Bangart, Director 
                              Division of Low-Level Waste Management 
                                and Decommissioning 
                              Office of Nuclear Material Safety 
                                and Safeguards

Technical Contact:  Timothy C. Johnson, NMSS 
                    301-492-0557 

Attachments:  
1.  List of Recently Issued NMSS Information Notices 
2.  List of Recently Issued NRC Information Notices

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