&EPA
                        United States
                        Environmental Protection
                        Agency
                               Office of the
                               Administrator
                               (Mail Code 1802]
EPA-100-F-00-037
September 2000
(http://www.epa.gov)
 Project  XL:   Ortho-McNeil
 On-Site   Treatment  of
 Mixed   Wastes
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 WHAT  IS
 PROJECT  XL?
   ,* * t'roli'ft

 SUMMARY OF
 THE ORTHO-
 MCNEIL XL
 PROJECT
SUPERIOR
ENVIRONMENTAL
PERFORMANCE
Project XL, which stands for "excellence and Leadership," is a national initiative that
tests innovative ways of achieving better and more cost-effective public health and
environmental protection. The information and lessons learned from Project XL are
being used to assist the U.S. Environmental Protection Agency (EPA) in redesigning
its current regulatory and policy-setting  approaches. Project XL encourages testing of
cleaner, cheaper, and smarter ways to attain environmental results superior to those
achieved  under current regulations and  policies, in conjunction with  greater
accountability to stakeholders. It is vital  that each project tests new  ideas with the
potential for wide application and broad environmental benefits. As  of September
2000, over thirty pilot experiments are being implemented and several additional
projects are in various stages of development.

The Ortho-McNeil Pharmaceutical Corporation (OMP) and the Pennsylvania
Department of Environmental Protection (PADEP) have signed an agreement with the
U.S. Environmental Protection Agency (EPA) to test an  innovative way to treat OMP's
small volume (less than 50 liters per year) of mixed wastes at its Spring House,
Pennsylvania, research facility. OMP's research process produces small quantities  of
waste solutions that contain both radioactive material and an organic compound. This
combined waste, termed low-level mixed waste (LLMW). is regulated by both the
Nuclear Regulatory Commission and the EPA, respectively.  Presently, the only
permitted treatment option for LLMW like OMP's involves off-site transportation and
disposal at a treatment, storage and disposal facility (TSDF)  licensed by the NRC and
permitted under the Resource Conservation and Recovery Act (RCRA). However,
there are very few licensed and approved treatment facilities that can accept mixed
waste in the United  States. To treat LLMW, commercially permitted TSDFs use
incineration, which destroys the RCRA hazardous waste component, or solidification
and land disposal. Neither method allows the radioactive material in the LLMW to be
recovered for reuse.

Through this XL project, Ortho-McNeil proposes to use a high-temperature catalytic
oxidation (HTCO) process that destroys the hazardous waste component and captures
the radioactive material from the waste mixture on-site. This process produces
radioactive carbon dioxide and radioactive water both of which are considered a low-
level radioactive waste, and can  be stabilized easily and disposed of at various
facilities licensed by NRC throughout the country. This XL Project, EPA's 37th, was
signed on September 22, 2000.

Using this new technology is an environmentally superior way to dispose of small
quantities of LLMW compared to current disposal methods for two reasons: 1) waste
handled in the laboratory where it is created reduces the already low risk of off-site
spills and releases due to storage, transportation, and handling; and 2) the captured
radioactive materials can be recycled.

Additionally, this technology reduces the costs related to disposing of LLMW, allowing
OMP to reallocate savings to the development of new medicines, new advancements
in science, and other environmentally beneficial projects. OMP is sharing this new
technology with other research institutions, government  agencies such as the National
Institutes of Health, colleges and universities, and hospitals that also generate LLMW.
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 FLEXIBILITY
 STAKEHOLDER
 INVOLVEMENT
To implement this new technology, EPA and PADEP plan to modify the current
regulatory framework to exclude the LLMW from the RCRA definition of hazardous
waste. This essentially would remove certain RCRA regulatory controls and oversight
of the mixed wastes, while maintaining the NRC regulatory controls and oversight for
the remaining low-level radioactive material. EPA, however, would retain authority
over OMP's LLMW as a solid waste, if necessary

OMP has launched an extensive effort to measure and ascertain stakeholder
involvement and support for this project. OMP focused on a number of stakeholder
groups, including the local community, Ortho-McNeil Spring House employees, state
and federal regulatory agencies, and local, state and national environmental groups.
To date, support for the project has been generally positive from all stakeholders.
  APPROACHES
  TO BE TESTED
Through this XL project, EPA expects to gain valuable information concerning the
need to maintain RCRA regulatory oversight over the on-site treatment of small
volumes of LLMW, or whether, in situations like the OMP facility, NRC oversight is
sufficient. EPA also expects to gain more data on the performance of the HTCO
process.
 CONTACTS
FOR ELECTRONIC
INFORMATION
                        EPA Region 3:
                        EPA/XL HQ:
                        EPA Office of Solid Waste:
                        Ortho-McNeil:
                        Pennsylvania DEP:
                          Charlie Howland
                          Mitch Kidwell
                          David Pagan
                          Mike Esposito
                          Ronald Furlan
215-814-2645
202-260-2515
703-308-0603
2156285261
570-327-3740
More information about this XL project, or the Project XL Program, is available on the
Internet at http://www.epa.gov/proiectxl under "Information on Specific XL Projects," 01
via Project XL's Information Line at (202) 260-5754.
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