[Federal Register Volume 65, Number 171 (Friday, September 1, 2000)]
[Notices]
[Pages 53297-53298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22520]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-6863-5]


Regulatory Reinvention (XL) Pilot Projects

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Availability of the Draft Project XL Final Project 
Agreement: Ortho-McNeil Pharmaceutical--Laboratory-Scale High-
Temperature Catalytic Oxidation Process to Treat Low-Level Mixed 
Wastes.

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SUMMARY: The Environmental Protection Agency (EPA) is requesting 
comments on a Draft Project XL Final Project Agreement (FPA) for the 
Ortho-McNeil Pharmaceutical, Inc. (hereafter ``OMP'') pharmaceutical 
research and development facility in Spring House, PA. The FPA is a 
voluntary agreement developed collaboratively by OMP, the Pennsylvania 
Department of Environmental Protection (PADEP), EPA and interested 
stakeholders. Project XL, announced in the Federal Register on May 23, 
1995 (60 FR 27282), gives regulated entities the opportunity to develop 
alternative strategies that will replace or modify specific regulatory 
or procedural requirements on the condition that they produce greater 
environmental benefits.
    As presented in the draft FPA, OMP proposes to determine whether 
dual regulatory oversight (i.e., EPA's Resource Conservation and 
Recovery Act (RCRA) oversight and the Nuclear Regulatory Commission's 
(NRC's) Atomic Energy Act (AEA) oversight) is necessary to ensure 
protection of human health and the environment concerning the small 
volumes of low-level mixed wastes (i.e., wastes that meet both the 
definition of a RCRA hazardous waste and the AEA definition of low-
level radioactive waste) that are treated using a bench-scale high 
temperature catalytic oxidation process in the laboratory where they 
are generated. Specifically, OMP is seeking a waiver of all applicable 
RCRA requirements for the original mixed waste, as well as for the 
treatment residuals resulting from the catalytic oxidation of the 
original mixed waste. The original mixed waste and the treatment 
residuals will continue to be subject to NRC oversight as low-level 
radioactive wastes.
    OMP generates small volumes of mixed wastes (typically less than 50 
liters/year) as a result of radiolabeling undertaken to conduct 
research on a drug's bioabsorption and metabolism in the body. The low-
level mixed wastes that are the focus of this XL project are comprised 
of an organic component (typically a solvent) and a radioactive 
component (typically tritium or carbon-14, depending on the drug being 
studied). Data gathered during a treatability study conducted by OMP 
since 1996 indicate that the high-temperature catalytic oxidation 
process effectively destroys the organic portion of the mixed waste, 
resulting in a low-level radioactive residual. When the sample uses 
tritium as the radioisotope tracer, tritiated water results from the 
treatment process. When the sample uses carbon-14 as the radioisotope 
tracer, the residual is a low-level radioactive carbon dioxide which is 
then converted to low-level radioactive potassium carbonate solution.
    To implement this XL project, EPA and PADEP have agreed to provide 
the regulatory flexibility OMP seeks subject to applicable regulatory 
procedures. Specifically, in the near future, EPA will propose in a 
separate Federal Register notice a site-specific conditional exclusion 
from the definition of hazardous waste in 40 CFR 261.4(b) for the small 
volumes of mixed waste being generated by OMP. PADEP has also agreed to 
adopt the appropriate legal

[[Page 53298]]

implementing mechanism to allow for the XL project to proceed.

DATES: The period for submission of comments on the draft FPA ends on 
September 15, 2000.

ADDRESSES: All comments on the draft Final Project Agreement should be 
sent to: Charles Howland, U.S. EPA Region III (3OR00), 1650 Arch 
Street, Philadelphia, PA 19103-2029. Comments may also be faxed to Mr. 
Howland at (215) 814-2783. Comments may also be received via electronic 
mail sent to: [email protected].

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the draft Final 
Project Agreement, contact: Charles Howland, U.S. EPA Region III 
(3OR00), 1650 Arch Street, Philadelphia, PA 19103-2029, or Mitch 
Kidwell, U.S. EPA (1802), 1200 Pennsylvania Ave., NW, Washington, DC 
20460. The FPA and related documents are also available via the 
Internet at the following location: http://www.epa.gov/ProjectXL. 
Questions to EPA regarding the documents can be directed to Charles 
Howland at (215) 814-2645 or Mitch Kidwell at (202) 260-2515. For 
information on all other aspects of the XL Program, contact Christopher 
Knopes at the following address: Office of Policy, Economics and 
Innovation (1802), U.S. Environmental Protection Agency, 1200 
Pennsylvania Ave., NW, Washington, DC 20460. Additional information on 
Project XL, including documents referenced in this notice, other EPA 
policy documents related to Project XL, regional XL contacts, 
application information, and descriptions of existing XL projects and 
proposals, is available via the Internet at http://www.epa.gov/
projectxl.

    Dated: August 28, 2000.
Elizabeth A. Shaw,
Director, Office of Environmental Policy Innovation.
[FR Doc. 00-22520 Filed 8-31-00; 8:45 am]
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