Notice of Availability of Environmental Assessment and Finding of No Significant Impact for License Amendment to Byproduct Materials License No. 29-02608-03 for the Unrestricted Release of the Johnson & Johnson Pharmaceutical Research and Development, LLC's Facility in Raritan, NJ, 47975-47976 [E9-22556]

Download as PDF Federal Register / Vol. 74, No. 180 / Friday, September 18, 2009 / Notices • Committee Chairman’s Remarks • Management and Operation of the National Astronomy and Ionosphere Center • Design for the Deep Underground Science and Engineering Laboratory Committee on Strategy and Budget (CSB) Closed Session: 10:50 a.m.–11:05 a.m., Bob Evans Auditorium • Approval of CSB Minutes, August 9, 2009 • Committee Chairman’s Remarks • NSF Budget Update: FY 2011 Budget Request to OMB • Other Committee Business Plenary Executive Closed Closed Session: 11:05 a.m.–11:15 a.m., Bob Evans Auditorium • Approval of Plenary Executive Closed Minutes, August 2009 • Board Member Proposal Plenary Closed Closed Session: 11:15 a.m.–11:30 a.m., Bob Evans Auditorium • Approval of Plenary Closed Minutes, August 2009 • Awards and Agreements • Closed Committee Reports Ann Ferrante, Technical Writer/Editor. [FR Doc. E9–22643 Filed 9–16–09; 4:15 pm] BILLING CODE 7555–01–P NUCLEAR REGULATORY COMMISSION [NRC–2009–0411; Docket No. 030–10814] Notice of Availability of Environmental Assessment and Finding of No Significant Impact for License Amendment to Byproduct Materials License No. 29–02608–03 for the Unrestricted Release of the Johnson & Johnson Pharmaceutical Research and Development, LLC’s Facility in Raritan, NJ erowe on DSK5CLS3C1PROD with NOTICES AGENCY: Nuclear Regulatory Commission. ACTION: Issuance of Environmental Assessment and Finding of No Significant Impact for License Amendment. FOR FURTHER INFORMATION CONTACT: Dennis Lawyer, Health Physicist, Commercial and R&D Branch, Division of Nuclear Materials Safety, Region I, 475 Allendale Road, King of Prussia, Pennsylvania; telephone 610–337–5366; fax number 610–337–5269 or by e-mail: dennis.lawyer@nrc.gov. SUPPLEMENTARY INFORMATION: VerDate Nov<24>2008 15:10 Sep 17, 2009 Jkt 217001 I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is considering the issuance of a license amendment to Byproduct Materials License No. 29– 02608–03. This license is held by Johnson & Johnson Pharmaceutical Research and Development, LLC (the Licensee), for its Ortho Clinical Diagnostics Facility (the Facility), located at 1001 U.S. Route #202 North in Raritan, New Jersey. Issuance of the amendment would authorize release of the Facility for unrestricted use. The Licensee requested this action in a letter dated March 27, 2009. The NRC has prepared an Environmental Assessment (EA) in support of this proposed action in accordance with the requirements of Title 10, Code of Federal Regulations (CFR), Part 51 (10 CFR Part 51). Based on the EA, the NRC has concluded that a Finding of No Significant Impact (FONSI) is appropriate with respect to the proposed action. The amendment will be issued to the Licensee following the publication of this FONSI and EA in the Federal Register. II. Environmental Assessment Identification of Proposed Action The proposed action would approve the Licensee’s March 27, 2009, license amendment request, resulting in release of the Facility for unrestricted use. License No. 29–02608–03 was issued on April 8, 1975, pursuant to 10 CFR Part 30, and has been amended periodically since that time. This license authorized the Licensee to use unsealed byproduct material for purposes of conducting research and development activities on laboratory bench tops and in hoods. The Facility is situated in a 572,000 square foot building on 66 acres of property and consists of office space, laboratories, manufacturing, and shipping areas. The Facility is located in a commercial area with some residential use nearby. Within the Facility, use of licensed materials by the licensee was confined to 1,528 square feet of laboratory space. In February 2007, the Licensee ceased licensed activities and initiated a survey and decontamination of the Facility. 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 their NRCapproved, operating radiation safety procedures, were required. The Licensee was not required to submit a decommissioning plan to the NRC because worker cleanup activities and procedures are consistent with those approved for routine operations. The PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 47975 Licensee conducted surveys of the Facility and provided information to the NRC to demonstrate that it meets the criteria in Subpart E of 10 CFR Part 20 for unrestricted release. Need for the Proposed Action The Licensee has ceased conducting licensed activities at the Facility and seeks the unrestricted use of its Facility. Environmental Impacts of the Proposed Action The historical review of licensed activities conducted at the Facility shows that such activities involved use of the following radionuclides with halflives greater than 120 days: Hydrogen3 and carbon-14. Prior to performing the final status survey, the Licensee conducted decontamination activities, as necessary, in the areas of the Facility affected by these radionuclides. The Licensee conducted a final status survey on May 14, 2009. This survey covered the 1,528 square feet of laboratory space. The final status survey report was attached to the Licensee’s additional information letter dated May 29, 2009. The Licensee elected to demonstrate compliance with the radiological criteria for unrestricted release as specified in 10 CFR 20.1402 by using the screening approach described in NUREG–1757, ‘‘Consolidated NMSS Decommissioning Guidance,’’ Volume 2. The Licensee used the radionuclide-specific derived concentration guideline levels (DCGLs), developed there by the NRC, which comply with the dose criterion in 10 CFR 20.1402. These DCGLs define the maximum amount of residual radioactivity on building surfaces, equipment, and materials that will satisfy the NRC requirements in Subpart E of 10 CFR Part 20 for unrestricted release. The Licensee’s final status survey results were below these DCGLs and are in compliance with the As Low As Reasonably Achievable (ALARA) requirement of 10 CFR 20.1402. The NRC thus finds that the Licensee’s final status survey results are acceptable. Based on its review, the staff has determined that the affected environment and any environmental impacts associated with the proposed action are bounded by the impacts evaluated by the ‘‘Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRCLicensed Nuclear Facilities’’ (NUREG– 1496) Volumes 1–3 (ML042310492, ML042320379, and ML042330385). The staff finds there were no significant environmental impacts from the use of radioactive material at the Facility. The E:\FR\FM\18SEN1.SGM 18SEN1 47976 Federal Register / Vol. 74, No. 180 / Friday, September 18, 2009 / Notices NRC staff reviewed the docket file records and the final status survey report to identify any non-radiological hazards that may have impacted the environment surrounding the Facility. No such hazards or impacts to the environment were identified. The NRC has identified no other radiological or non-radiological activities in the area that could result in cumulative environmental impacts. The NRC staff finds that the proposed release of the Facility for unrestricted use is in compliance with 10 CFR 20.1402. Based on its review, the staff considered the impact of the residual radioactivity at the Facility and concluded that the proposed action will not have a significant effect on the quality of the human environment. Environmental Impacts of the Alternatives to the Proposed Action Due to the largely administrative nature of the proposed action, its environmental impacts are small. Therefore, the only alternative the staff considered is the no-action alternative, under which the staff would leave things as they are by simply denying the amendment request. This no-action alternative is not feasible because it conflicts with 10 CFR 30.36(d), requiring that decommissioning of byproduct material facilities be completed and approved by the NRC after licensed activities cease. The NRC’s analysis of the Licensee’s final status survey data confirmed that the Facility meets the requirements of 10 CFR 20.1402 for unrestricted release. Additionally, denying the amendment request would result in no change in current environmental impacts. The environmental impacts of the proposed action and the no-action alternative are therefore similar, and the no-action alternative is accordingly not further considered. erowe on DSK5CLS3C1PROD with NOTICES Conclusion The NRC staff has concluded that the proposed action is consistent with the NRC’s unrestricted release criteria specified in 10 CFR 20.1402. Because the proposed action will not significantly impact the quality of the human environment, the NRC staff concludes that the proposed action is the preferred alternative. Agencies and Persons Consulted NRC provided a draft of this Environmental Assessment to the New Jersey Department of Environmental Protection for review on June 25, 2009. On August 7, 2009, the New Jersey Department of Environmental Protection responded by letter. The State agreed VerDate Nov<24>2008 15:10 Sep 17, 2009 Jkt 217001 with the conclusions of the EA, and otherwise had no comments. The NRC staff has determined that the proposed action is of a procedural nature, and will not affect listed species or critical habitat. Therefore, no further consultation is required under Section 7 of the Endangered Species Act. The NRC staff has also determined that the proposed action is not the type of activity that has the potential to cause effects on historic properties. Therefore, no further consultation is required under Section 106 of the National Historic Preservation Act. III. Finding of No Significant Impact The NRC staff has prepared this EA in support of the proposed action. On the basis of this EA, the NRC finds that there are no significant environmental impacts from the proposed action, and that preparation of an environmental impact statement is not warranted. Accordingly, the NRC has determined that a Finding of No Significant Impact is appropriate. IV. Further Information Documents related to this action, including the application for license amendment and supporting documentation, are available electronically at the NRC’s Electronic Reading Room at https://www.nrc.gov/ reading-rm/adams.html. From this site, you can access the NRC’s Agencywide Documents Access and Management System (ADAMS), which provides text and image files of NRC’s public documents. The documents related to this action are listed below, along with their ADAMS accession numbers. 1. NUREG–1757, ‘‘Consolidated NMSS Decommissioning Guidance’’; 2. Title 10, Code of Federal Regulations, Part 20, Subpart E, ‘‘Radiological Criteria for License Termination’’; 3. Title 10, Code of Federal Regulations, Part 51, ‘‘Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions’’; 4. NUREG–1496, ‘‘Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRCLicensed Nuclear Facilities’’; 5. Johnson & Johnson Pharmaceutical Research and Development, LLC, amendment request letter dated March 27, 2009 (ML090960269); 6. Johnson & Johnson Pharmaceutical Research and Development, LLC, additional information letter dated April 28, 2009 (ML091200252); 7. Johnson & Johnson Pharmaceutical Research and Development, LLC, PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 additional information letter dated May 29, 2009 (ML091490762); and 8. Johnson & Johnson Pharmaceutical Research and Development, LLC, additional information letter dated June 16, 2009 (ML091730375). 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 1–800–397–4209, 301– 415–4737, or by e-mail PDR.Resource@nrc.gov. These 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 Region I, 475 Allendale Road, King of Prussia, PA this 11th day of September 2009. For the Nuclear Regulatory Commission. James P. Dwyer, Chief, Commercial and R&D Branch, Division of Nuclear Materials Safety, Region I. [FR Doc. E9–22556 Filed 9–17–09; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION [NRC–2009–0408] Exemption From the Specific Import License Requirements 1.0 Request/Action US Ecology Idaho (USEI), a subsidiary of American Ecology, operates a hazardous waste and low-activity radioactive disposal facility near Grand View, Idaho. By letter dated March 19, 2009 (Agency Documents Access Management System [ADAMS] Accession No. ML091600258), USEI requested an exemption from the requirements in 10 CFR Part 110, ‘‘Export and Import of Nuclear Equipment and Material,’’ for a specific license to import waste from Canada. Pursuant to 10 CFR 110.10, the Commission may, upon application by any interested person or upon its own initiative, grant exemptions for the requirements for a specific license in 10 CFR Part 110, when the import is (1) authorized by law; (2) is not inimical to the common defense and security of the United States; and (3) will not constitute an unreasonable risk to the public health and safety. 2.0 Background USEI requested an exemption from the requirements in 10 CFR 110.27 for a specific license to import and dispose E:\FR\FM\18SEN1.SGM 18SEN1

Agencies

[Federal Register Volume 74, Number 180 (Friday, September 18, 2009)]
[Notices]
[Pages 47975-47976]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22556]


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NUCLEAR REGULATORY COMMISSION

[NRC-2009-0411; Docket No. 030-10814]


Notice of Availability of Environmental Assessment and Finding of 
No Significant Impact for License Amendment to Byproduct Materials 
License No. 29-02608-03 for the Unrestricted Release of the Johnson & 
Johnson Pharmaceutical Research and Development, LLC's Facility in 
Raritan, NJ

AGENCY: Nuclear Regulatory Commission.

ACTION: Issuance of Environmental Assessment and Finding of No 
Significant Impact for License Amendment.

-----------------------------------------------------------------------

FOR FURTHER INFORMATION CONTACT: Dennis Lawyer, Health Physicist, 
Commercial and R&D Branch, Division of Nuclear Materials Safety, Region 
I, 475 Allendale Road, King of Prussia, Pennsylvania; telephone 610-
337-5366; fax number 610-337-5269 or by e-mail: dennis.lawyer@nrc.gov.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    The U.S. Nuclear Regulatory Commission (NRC) is considering the 
issuance of a license amendment to Byproduct Materials License No. 29-
02608-03. This license is held by Johnson & Johnson Pharmaceutical 
Research and Development, LLC (the Licensee), for its Ortho Clinical 
Diagnostics Facility (the Facility), located at 1001 U.S. Route 
202 North in Raritan, New Jersey. Issuance of the amendment 
would authorize release of the Facility for unrestricted use. The 
Licensee requested this action in a letter dated March 27, 2009. The 
NRC has prepared an Environmental Assessment (EA) in support of this 
proposed action in accordance with the requirements of Title 10, Code 
of Federal Regulations (CFR), Part 51 (10 CFR Part 51). Based on the 
EA, the NRC has concluded that a Finding of No Significant Impact 
(FONSI) is appropriate with respect to the proposed action. The 
amendment will be issued to the Licensee following the publication of 
this FONSI and EA in the Federal Register.

II. Environmental Assessment

Identification of Proposed Action

    The proposed action would approve the Licensee's March 27, 2009, 
license amendment request, resulting in release of the Facility for 
unrestricted use. License No. 29-02608-03 was issued on April 8, 1975, 
pursuant to 10 CFR Part 30, and has been amended periodically since 
that time. This license authorized the Licensee to use unsealed 
byproduct material for purposes of conducting research and development 
activities on laboratory bench tops and in hoods.
    The Facility is situated in a 572,000 square foot building on 66 
acres of property and consists of office space, laboratories, 
manufacturing, and shipping areas. The Facility is located in a 
commercial area with some residential use nearby. Within the Facility, 
use of licensed materials by the licensee was confined to 1,528 square 
feet of laboratory space.
    In February 2007, the Licensee ceased licensed activities and 
initiated a survey and decontamination of the Facility. 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 their NRC-approved, operating radiation 
safety procedures, were required. The Licensee was not required to 
submit a decommissioning plan to the NRC because worker cleanup 
activities and procedures are consistent with those approved for 
routine operations. The Licensee conducted surveys of the Facility and 
provided information to the NRC to demonstrate that it meets the 
criteria in Subpart E of 10 CFR Part 20 for unrestricted release.

Need for the Proposed Action

    The Licensee has ceased conducting licensed activities at the 
Facility and seeks the unrestricted use of its Facility.

Environmental Impacts of the Proposed Action

    The historical review of licensed activities conducted at the 
Facility shows that such activities involved use of the following 
radionuclides with half-lives greater than 120 days: Hydrogen-3 and 
carbon-14. Prior to performing the final status survey, the Licensee 
conducted decontamination activities, as necessary, in the areas of the 
Facility affected by these radionuclides.
    The Licensee conducted a final status survey on May 14, 2009. This 
survey covered the 1,528 square feet of laboratory space. The final 
status survey report was attached to the Licensee's additional 
information letter dated May 29, 2009. The Licensee elected to 
demonstrate compliance with the radiological criteria for unrestricted 
release as specified in 10 CFR 20.1402 by using the screening approach 
described in NUREG-1757, ``Consolidated NMSS Decommissioning 
Guidance,'' Volume 2. The Licensee used the radionuclide-specific 
derived concentration guideline levels (DCGLs), developed there by the 
NRC, which comply with the dose criterion in 10 CFR 20.1402. These 
DCGLs define the maximum amount of residual radioactivity on building 
surfaces, equipment, and materials that will satisfy the NRC 
requirements in Subpart E of 10 CFR Part 20 for unrestricted release. 
The Licensee's final status survey results were below these DCGLs and 
are in compliance with the As Low As Reasonably Achievable (ALARA) 
requirement of 10 CFR 20.1402. The NRC thus finds that the Licensee's 
final status survey results are acceptable.
    Based on its review, the staff has determined that the affected 
environment and any environmental impacts associated with the proposed 
action 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) Volumes 1-3 (ML042310492, ML042320379, and ML042330385). 
The staff finds there were no significant environmental impacts from 
the use of radioactive material at the Facility. The

[[Page 47976]]

NRC staff reviewed the docket file records and the final status survey 
report to identify any non-radiological hazards that may have impacted 
the environment surrounding the Facility. No such hazards or impacts to 
the environment were identified. The NRC has identified no other 
radiological or non-radiological activities in the area that could 
result in cumulative environmental impacts.
    The NRC staff finds that the proposed release of the Facility for 
unrestricted use is in compliance with 10 CFR 20.1402. Based on its 
review, the staff considered the impact of the residual radioactivity 
at the Facility and concluded that the proposed action will not have a 
significant effect on the quality of the human environment.

Environmental Impacts of the Alternatives to the Proposed Action

    Due to the largely administrative nature of the proposed action, 
its environmental impacts are small. Therefore, the only alternative 
the staff considered is the no-action alternative, under which the 
staff would leave things as they are by simply denying the amendment 
request. This no-action alternative is not feasible because it 
conflicts with 10 CFR 30.36(d), requiring that decommissioning of 
byproduct material facilities be completed and approved by the NRC 
after licensed activities cease. The NRC's analysis of the Licensee's 
final status survey data confirmed that the Facility meets the 
requirements of 10 CFR 20.1402 for unrestricted release. Additionally, 
denying the amendment request would result in no change in current 
environmental impacts. The environmental impacts of the proposed action 
and the no-action alternative are therefore similar, and the no-action 
alternative is accordingly not further considered.

Conclusion

    The NRC staff has concluded that the proposed action is consistent 
with the NRC's unrestricted release criteria specified in 10 CFR 
20.1402. Because the proposed action will not significantly impact the 
quality of the human environment, the NRC staff concludes that the 
proposed action is the preferred alternative.

Agencies and Persons Consulted

    NRC provided a draft of this Environmental Assessment to the New 
Jersey Department of Environmental Protection for review on June 25, 
2009. On August 7, 2009, the New Jersey Department of Environmental 
Protection responded by letter. The State agreed with the conclusions 
of the EA, and otherwise had no comments.
    The NRC staff has determined that the proposed action is of a 
procedural nature, and will not affect listed species or critical 
habitat. Therefore, no further consultation is required under Section 7 
of the Endangered Species Act. The NRC staff has also determined that 
the proposed action is not the type of activity that has the potential 
to cause effects on historic properties. Therefore, no further 
consultation is required under Section 106 of the National Historic 
Preservation Act.

III. Finding of No Significant Impact

    The NRC staff has prepared this EA in support of the proposed 
action. On the basis of this EA, the NRC finds that there are no 
significant environmental impacts from the proposed action, and that 
preparation of an environmental impact statement is not warranted. 
Accordingly, the NRC has determined that a Finding of No Significant 
Impact is appropriate.

IV. Further Information

    Documents related to this action, including the application for 
license amendment and supporting documentation, are available 
electronically at the NRC's Electronic Reading Room at https://www.nrc.gov/reading-rm/adams.html. From this site, you can access the 
NRC's Agencywide Documents Access and Management System (ADAMS), which 
provides text and image files of NRC's public documents. The documents 
related to this action are listed below, along with their ADAMS 
accession numbers.
    1. NUREG-1757, ``Consolidated NMSS Decommissioning Guidance'';
    2. Title 10, Code of Federal Regulations, Part 20, Subpart E, 
``Radiological Criteria for License Termination'';
    3. Title 10, Code of Federal Regulations, Part 51, ``Environmental 
Protection Regulations for Domestic Licensing and Related Regulatory 
Functions'';
    4. NUREG-1496, ``Generic Environmental Impact Statement in Support 
of Rulemaking on Radiological Criteria for License Termination of NRC-
Licensed Nuclear Facilities'';
    5. Johnson & Johnson Pharmaceutical Research and Development, LLC, 
amendment request letter dated March 27, 2009 (ML090960269);
    6. Johnson & Johnson Pharmaceutical Research and Development, LLC, 
additional information letter dated April 28, 2009 (ML091200252);
    7. Johnson & Johnson Pharmaceutical Research and Development, LLC, 
additional information letter dated May 29, 2009 (ML091490762); and
    8. Johnson & Johnson Pharmaceutical Research and Development, LLC, 
additional information letter dated June 16, 2009 (ML091730375).
    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 1-800-397-4209, 301-415-4737, or 
by e-mail PDR.Resource@nrc.gov. These 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 Region I, 475 Allendale Road, King of Prussia, PA this 
11th day of September 2009.

    For the Nuclear Regulatory Commission.
James P. Dwyer,
Chief, Commercial and R&D Branch, Division of Nuclear Materials Safety, 
Region I.
[FR Doc. E9-22556 Filed 9-17-09; 8:45 am]
BILLING CODE 7590-01-P
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