E5-4709. Issuance of Environmental Assessment and Finding of No Significant Impact Regarding a Proposed License Amendment for Endocyte Incorporated 1205 Kent Avenue Facility, West Lafayette, IN

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Issuance of environmental assessment and finding of no significant impact.

FOR FURTHER INFORMATION CONTACT:

Gene Bonano, Health Physicist, Decommissioning Branch, Division of Nuclear Materials Safety, Region III, U.S. Nuclear Regulatory Commission, 2443 Warrenville Road, Lisle, Illinois 60532; telephone: [phone]; fax number: [phone]; e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The Nuclear Regulatory Commission (NRC) is considering issuing a license amendment to Material License No. 13-32212-01 issued to Endocyte Incorporated (the licensee), to authorize release of its 1205 Kent Avenue facility, West Lafayette, Indiana, for unrestricted use. This Environmental Assessment (EA) is issued in support of this amendment in accordance with the requirements of 10 CFR Part 51. Based on this EA, the NRC has concluded that a Finding of No Significant Impact (FONSI) is appropriate. The amendment will be issued following the publication of this EA/FONSI.

I. Environmental Assessment

Identification of Proposed Action

The NRC staff has prepared this EA to support the Endocyte Incorporated May 26, 2005 (ML052340684) request to release its 1205 Kent Avenue, West Lafayette, Indiana facility for unrestricted use. Endocyte's 1205 Kent Avenue facility is one of two authorized facilities listed under Material License Number 13-32212-01. The licensee transferred all licensed material from the 1205 Kent Avenue facility to its 3000 Kent Avenue facility. Endocyte was granted a license on December 9, 1999, and initiated licensed activities in April 2000 at the 1205 Kent Avenue facility. The 3000 Kent Avenue facility was added to the license on April 4, 2005. Endocyte is authorized to use byproduct material for the research and development of medical products. Endocyte identified three isotopes, which are listed in the license, with half-lives greater than 120 days (hydrogen-3, carbon-14, technetium-99), which had been used at the 1205 Kent Avenue facility. The licensee conducted surveys of the facility and provided information to the NRC to demonstrate that the radiological condition of the building is consistent with criteria specified in 10 CFR Part 20, Subpart E for unrestricted use. No radiological remediation activities are required to complete the proposed action.

Need for the Proposed Action

The licensee is requesting this license amendment because it no longer plans to conduct NRC-licensed activities at the 1205 Kent Avenue location. The NRC is fulfilling its responsibilities under the Atomic Energy Act to make a decision on the proposed action for decommissioning that ensures that residual radioactivity is reduced to a level that is protective of the public health and safety and the environment.

Environmental Impacts of the Proposed Action

The NRC staff reviewed the information provided and surveys performed by Endocyte to demonstrate that the release of the 1205 Kent Avenue, West Lafayette, Indiana facility complies with radiological criterial for unrestricted use in 10 CFR 20.1402.

Alternatives to the Proposed Action

The only alternative to the proposed action of releasing the facility for unrestricted use is to take no action. Under the no-action alternative, the 1205 Kent Avenue facility would remain under an NRC license and would not be released for unrestricted use. Denial of the license amendment request would result in no change to current conditions at the facility. The no-action alternative is not acceptable because it is inconsistent with the NRC's Timeliness Rule, 10 CFR 30.36 “Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings or Outdoor Areas,” which requires licensees who have ceased licensed activities to request termination of their radioactive materials license. This alternative also would impose an unnecessary regulatory burden and limit potential benefits from future uses of the facility.

Conclusion

The NRC staff concluded that the proposed action is consistent with the NRC's unrestricted release use specified in 10 CFR Part 20, Subpart E. The staff found that the radiological environmental impacts from the proposed action are bounded by the “Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRC-Licensed Nuclear Facilities” (NUREG-1496). Additionally, no non-radiological or cumulative impacts were identified. Therefore, the NRC has determined that the proposed action will not have a significant effect on the quality of the human environment.

Agencies and Persons Consulted

The NRC staff has determined that the proposed action will not affect listed species or critical habitats. Therefore, no further consultation is required under Section 7 of the Endangered Species Act. Likewise, the NRC has determined that the proposed action is not a type of activity that has potential to cause effect on historic properties. Therefore, consultation under Section 106 of the National Historic Preservation Act is not required.

The NRC consulted with the Indiana State Department of Health, Indoor and Radiologic Health Division. The Indiana State Department of Health was provided the draft EA for comment on August 1, 2005, and responded back on the same day. The State did not need any additional information, and agreed with the NRC's finding of No Significant Impact for the License/Facility.

II. Finding of No Significant Impact

On the basis of the EA in support of the proposed license amendment to release the site for unrestricted use, the NRC has determined that the proposed action will not have a significant effect on the quality of the human environment. Thus, the NRC has determined not to prepare an environmental impact statement for the proposed action.

Further Information

A copy of this document will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of the NRC's document system. From this site, you can access the NRC's Agencywide Document Access and Management System (ADAMS), which provides text and image files of NRC's public documents. The following references are available for inspection at NRC's Public Electronic Reading Room at http://www.nrc.gov/​reading-rm/​adams.html (the Public Electronic Reading Room). ADAMS accession numbers are located in parentheses following the reference.

1. Leamon, Christopher P., Ph.D., Radiation Safety Officer, Endocyte Incorporated, letter to U.S. Nuclear Regulatory Commission, May 26, 2005 (ML052340684).

2. Decommissioning Report (Final Status Survey Report), 1205 Kent Avenue, West Lafayette, Indiana, May 26, 2005 (ML052340684).

3. U.S. Nuclear Regulatory Commission, “Environmental Review Guidance for Licensing Actions Associated with NMSS Programs,” NUREG-1748, August 2003.

4. U.S. Nuclear Regulatory Commission, “Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRC-Licensed Nuclear Facilities,” NUREG-1496, August 1994.

5. NRC, NUREG-1757, “Consolidated NMSS Decommissioning Guidance,” Volumes 1-3, September 2003.

If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC Public Document Room (PDR) reference staff at [phone], [phone] or by e-mail to [e-mail]. Documents may also be viewed electronically on the public computers located at the NRC's PDR, O 1 F21, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852. The PDR reproduction contractor will copy documents for a fee.

Dated at Lisle, Illinois, this 22nd day of August, 2005.

James L. Cameron,

Chief, Decommissioning Branch, Division of Nuclear Materials Safety, RIII.