03-7488. Environmental Assessment and Finding of No Significant Impact

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Notice of Environmental Assessment and Finding of No Significant Impact related to license amendment of Byproduct Material License No. 29-08978-02, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) is considering the issuance of a license amendment to Byproduct Material License No. 29-08978-02 to authorize release of its facility in Summit, New Jersey, for unrestricted use and has prepared an Environmental Assessment in support of this action. Based upon the Environmental Assessment, the NRC has concluded that a Finding of No Significant Impact is appropriate, and, therefore, an Environmental Impact Statement is unnecessary.

FOR FURTHER INFORMATION CONTACT:

Donna Janda, Division of Nuclear Materials Safety, U.S. Nuclear Regulatory Commission, Region I, 475 Allendale Road, King of Prussia, Pennsylvania 19406; telephone [phone] or e-mail [e-mail].

SUPPLEMENTARY INFORMATION:

The U. S. Nuclear Regulatory Commission (NRC) is considering amending Byproduct Materials License No. 29-08978-02 and authorizing the release of the licensee's facility in Summit, New Jersey, for unrestricted use and has prepared an Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) in support of this action.

SUMMARY:

The NRC reviewed the results of the decommissioning of the Novartis Pharmaceuticals Corporation (Novartis) facility in Summit, New Jersey. Novartis was formed in 1997 from the merger of Ciga-Geigy Corporation and Sandoz Corporation. From 1963 to 1997, Ciba-Geigy was authorized by NRC under Materials License No. 29-00459-03 to use radioactive materials for research and development purposes at the Summit facility. After the merger, Novartis continued to perform the same activities at the Summit facility under Materials License No. 29-00459-03 until 1998, when the license was terminated and the facility was added to Novartis' Materials License No. 29-08978-02. In January 2003, Novartis ceased operations with licensed materials at the Summit site, and in February 2003, requested that NRC release the facility for unrestricted use. Novartis has conducted surveys of the Summit facility and determined that the facility meets the license termination criteria in subpart E of 10 CFR part 20. The NRC staff has evaluated Novartis' request and results of the surveys, and has developed an Environmental Assessment (EA) in accordance with the requirements of 10 CFR part 51. Based on the staff evaluation, the conclusion of the EA is a Finding of No Significant Impact (FONSI) on human health and the environment for the proposed licensing action.

Introduction

Novartis requested release for unrestricted use of the entire facility at 556 Morris Avenue, Summit, New Jersey, as authorized by the NRC License No. 29-08978-02. License No. 29-08978-02 was issued in 1968 and amended in March 1998 to include the Summit site. It authorizes Novartis to perform activities in Buildings 130, L, LX, and U at 556 Morris Avenue, Summit, New Jersey. NRC-licensed activities at the Summit site were limited to laboratory procedures typically performed on bench tops and in hoods. A variety of radionuclides were used primarily for research and development. No outdoor areas were affected by the use of licensed materials.

Licensed activities ceased completely in January 2003, and the licensee requested release of the facility for unrestricted use. Based on the licensee's historical knowledge of the site and the conditions of the facility, the licensee determined that only routine decontamination activities, in accordance with the licensee's radiation safety procedures, were required. A decommissioning plan was not required to be submitted to NRC. The licensee surveyed the facility, decontaminated or remediated areas as needed, and provided documentation that the facility meets the license termination criteria, specified in subpart E of 10 CFR part 20, and does not require additional decommissioning activities to be performed. NRC inspectors inspected the decommissioning activities at the Summit facility on November 26, 2002, December 19, 2002, January 10, 2003, and February 12, 2003. The inspectors observed surveys and wipe tests being performed and reviewed the licensee's records related to decommissioning and survey activities. The licensee subsequently requested that the Novartis facility in Summit, New Jersey be released for unrestricted use.

The Proposed Action

The proposed action is to amend Byproduct Materials License No. 29-08978-02 and release the facility at 556 Morris Avenue, Summit, New Jersey for unrestricted use. By letter dated February 6, 2003, Novartis provided survey results which demonstrate that the Summit site is in compliance with the radiological criteria for license termination in subpart E, 10 CFR part 20, “Radiological Criteria for License Termination.”

Purpose and Need for the Proposed Action

The purpose of the proposed action is to amend NRC Byproduct Materials License No. 29-08978-02 and release the Novartis site in Summit, New Jersey for unrestricted use. NRC is fulfilling its responsibilities under the Atomic Energy Act to make a decision on a proposed license amendment for release of a facility for unrestricted use that ensures protection of public health and safety and the environment.

Alternative to the Proposed Action

Since the facility at the Summit site has already been surveyed and found acceptable for release for unrestricted use, the only alternative to the proposed action of amendment of the license and release of the Summit site for unrestricted use is no action. The no-action alternative would be to keep the facility on the license, which is not acceptable because the licensee does not plan to perform any activities with licensed materials at this location and does not plan to maintain staff to perform licensed activities. Maintaining the areas under a license would provide negligible, if any, environmental benefit and would reduce options for future use of the property.

The Affected Environment and Environmental Impacts

The NRC staff has reviewed the surveys performed by Novartis to demonstrate compliance with the 10 CFR 20.1402 license termination criteria. Based on its review, the staff has determined that the affected environment and environmental impacts associated with the release for unrestricted use of the Novartis Summit facility are bounded by the impacts evaluated by the “Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRC-Licensed Nuclear Facilities' (NUREG-1496). The staff also finds that the proposed release for unrestricted use of the Novartis facility is in compliance with Title 10, Code of Federal Regulations, part 20.1402, “Radiological Criteria for Unrestricted Use.” The NRC has found no other activities in the area that could result in cumulative impacts.

Agencies and Persons Consulted, and Sources Used

This EA was prepared entirely by the NRC staff. The State Office of Historical Preservation, the State Fish and Wildlife Service, and the U.S. Fish and Wildlife Service were not contacted because release of the Novartis facility for unrestricted use does not affect historical or cultural resources, nor will it affect threatened or endangered species. No other sources were used beyond those referenced in this EA.

NRC provided a draft of its Environmental Assessment to the State of New Jersey Department of Environmental Protection (NJDEP) for review. On March 10, 2003, the NJDEP responded by letter and agreed with the conclusions of the EA.

Conclusion and Finding of No Significant Impact

Based on its review, the NRC staff has concluded that the completed action complies with 10 CFR part 20. NRC has prepared this EA in support of the proposed license amendment to release the facility at 556 Morris Avenue, Summit, New Jersey, for unrestricted use. On the basis of the EA, NRC has concluded that the environmental impacts from the proposed action are expected to be insignificant and has determined not to prepare an environmental impact statement for the proposed action.

List of Preparers

Donna M. Janda, Health Physicist, Division of Nuclear Materials Safety, Region 1.

List of References

1. NRC License Nos. 29-08978-02 and 29-00459-03 inspection and licensing records.

2. Letter dated December 3, 2001, with attachment from Novartis Pharmaceuticals Corporation. [ADAMS Accession No. ML013550047]

3. Letter dated September 6, 2002, with attachment from Novartis Pharmaceuticals Corporation. [ADAMS Accession No. ML022660406]

4. Letter dated February 6, 2003, with attachment from Novartis Pharmaceuticals Corporation. [ADAMS Accession Nos. ML030510365, ML030510378, and ML030510379]

5. Title 10, Code of Federal Regulations, Part 20, Subpart E, “Radiological Criteria for License Termination.”

6. Title 10, Code of Federal Regulations, Part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.”

The application for the license amendment and supporting documentation are available for inspection at NRC's Public Electronic Reading Room at http://www.nrc.gov/​reading-rm/​ADAMS.html. Any questions with respect to this action should be referred to Donna Janda, Nuclear Materials Safety Branch 2, Division of Nuclear Materials Safety, Region 1, 475 Allendale Road, King of Prussia, Pennsylvania 19406, telephone [phone], fax [phone].

Dated at King of Prussia, Pennsylvania this 21st day of March, 2003.

For the Nuclear Regulatory Commission.

John D. Kinneman,

Chief, Nuclear Materials Safety Branch 2, Division of Nuclear Materials Safety, Region I.