48784 Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices 

ACTION: Notice of Issuance and 

Availability of Draft Regulatory Guide, 

DG–6007. 

FOR FURTHER INFORMATION CONTACT: Jack 

Foster, U.S. Nuclear Regulatory 

Commission, Washington, DC 20555– 

0001, telephone: (301) 415–6250 or email to Jack.Foster@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

The U.S. Nuclear Regulatory 

Commission (NRC) is issuing for public 

comment a draft guide in the agency’s 

‘‘Regulatory Guide’’ series. This series 

was developed to describe and make 

available to the public such information 

as methods that are acceptable to the 

NRC staff for implementing specific 

parts of the NRC’s regulations, 

techniques that the staff uses in 

evaluating specific problems or 

postulated accidents, and data that the 

staff needs in its review of applications 

for permits and licenses. 

The draft regulatory guide (DG), 

entitled, ‘‘Establishing Quality 

Assurance Programs for the 

Manufacture and Distribution of Sealed 

Sources and Devices Containing 

Byproduct Material,’’ is temporarily 

identified by its task number, DG–6007, 

which should be mentioned in all 

related correspondence. DG–6007 is a 

proposed Revision 1 of Regulatory 

Guide 6.9, dated February 1995. 

This regulatory guide directs the 

reader to the type of quality assurance 

(QA) and quality control (QC) program 

acceptable to the staff of the NRC during 

the review of an application to 

manufacture or distribute sealed sources 

and devices containing byproduct 

materials. 

Title 10 of the Code of Federal 

Regulations (10 CFR) Part 32, ‘‘Specific 

Domestic Licenses to Manufacture or 

Transfer Certain Items Containing 

Byproduct Material,’’ regulates the 

manufacture and distribution of sealed 

sources or devices containing byproduct 

material. Regulations in 10 CFR 

32.210(c) require the applicant or 

registrant to submit information about 

the QC program in sufficient detail to 

allow the NRC reviewers to ensure that 

the product is manufactured and 

distributed in a manner that is adequate 

to protect health and minimize danger 

to life and property. 

This regulatory guide endorses the 

methods and procedures for a QA/QC 

program described in Section 10.7, 

‘‘Quality Assurance and Quality 

Control’’ of NUREG–1556, Volume 3, 

‘‘Consolidated Guidance About 

Materials Licenses: Applications for 

Sealed Source and Device Evaluation 

and Registration,’’ issued April 2004, as 

a process that the NRC finds acceptable. 

As described in Volume 3 of NUREG– 

1556, the applicant must provide details 

of the QA program that ensure that the 

product is manufactured and distributed 

in accordance with the representations 

made in the application and the 

statements contained in the registration 

certificate for the product. 

II. Further Information 

The NRC staff is soliciting comments 

on DG–6007. Comments may be 

accompanied by relevant information or 

supporting data and should mention 

DG–6007 in the subject line. Comments 

submitted in writing or in electronic 

form will be made available to the 

public in their entirety through the 

NRC’s Agencywide Documents Access 

and Management System (ADAMS). 

Personal information will not be 

removed from your comments. You may 

submit comments by any of the 

following methods: 

1. Mail comments to: Rulemaking and 

Directives Branch, Mail Stop: TWB–05– 

B01M, Office of Administration, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001. 

2. Federal e-Rulemaking Portal: Go to 

http://www.regulations.gov and search 

for documents filed under Docket ID 

[NRC–2009–0418]. Address questions 

about NRC dockets to Carol Gallagher, 

301–492–3668; e-mail 

Carol.Gallagher@nrc.gov. 

3. Fax comments to: Rulemaking and 

Directives Branch, Office of 

Administration, U.S. Nuclear Regulatory 

Commission at (301) 492–3446. 

Requests for technical information about 

DG–6007 may be directed to the NRC 

contact, Jack Foster at (301) 415–6250 or 

e-mail to Jack.Foster@nrc.gov. 

Comments would be most helpful if 

received by November 21, 2009. 

Comments received after that date will 

be considered if it is practical to do so, 

but the NRC is able to ensure 

consideration only for comments 

received on or before this date. 

Although a time limit is given, 

comments and suggestions in 

connection with items for inclusion in 

guides currently being developed or 

improvements in all published guides 

are encouraged at any time. 

Electronic copies of DG–6007 are 

available through the NRC’s public Web 

site under Draft Regulatory Guides in 

the ‘‘Regulatory Guides’’ collection of 

the NRC’s Electronic Reading Room at 

http://www.nrc.gov/reading-rm/doccollections/. Electronic copies are also 

available in ADAMS (http:// 

www.nrc.gov/reading-rm/adams.html), 

under Accession No. ML091670485. 

In addition, regulatory guides are 

available for inspection at the NRC’s 

Public Document Room (PDR) located at 

11555 Rockville Pike, Rockville, 

Maryland. The PDR’s mailing address is 

USNRC PDR, Washington, DC 20555– 

0001. The PDR can also be reached by 

telephone at (301) 415–4737 or (800) 

397–4205, by fax at (301) 415–3548, and 

by e-mail to pdr.resource@nrc.gov. 

Regulatory guides are not 

copyrighted, and Commission approval 

is not required to reproduce them. 

Dated at Rockville, Maryland, this 17th day 

of September 2009. 

For the Nuclear Regulatory Commission. 

Andrea D. Valentin, 

Chief, Regulatory Guide Development Branch, 

Division of Engineering, Office of Nuclear 

Regulatory Research. 

[FR Doc. E9–23041 Filed 9–23–09; 8:45 am] 

BILLING CODE 7590–01–P 

NUCLEAR REGULATORY 

COMMISSION 

[NRC–2009–0410; Docket No. 030–35904] 

Notice of Availability of Environmental 

Assessment and Finding of No 

Significant Impact for License 

Amendment to Byproduct Materials 

License No. 29–30707–01, for 

Termination of the License and 

Unrestricted Release of the Memory 

Pharmaceuticals Corporation Facility 

Located in Montvale, 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– 

30707–01. This license is held by 

Memory Pharmaceuticals Corporation 

(the Licensee) for its facility located at 

100 Philips Parkway in Montvale, New 

Jersey (the Facility). Issuance of the 

amendment would authorize release of 

the Facility for unrestricted use and 

termination of the NRC license. The 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices 48785 

Licensee requested this action in a letter 

dated June 25, 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 June 25, 2009 license 

amendment request, resulting in release 

of the Facility for unrestricted use and 

the termination of its NRC materials 

license. The license for this facility was 

originally issued, pursuant to 10 CFR 

part 30, to Memory Pharmaceuticals 

Corporation on May 15, 2000. At that 

time, the corporate mailing address for 

Memory Pharmaceuticals Corporation 

was located in the State of New York so 

License No. 31–30570–01 was assigned. 

On January 7, 2002, License No. 31– 

30570–01 was terminated and replaced 

with License No. 29–30707–01 

following the licensee’s change of 

mailing address to a location in the 

State of New Jersey. License No. 29– 

30707–01 has been amended 

periodically since that time. The 

License authorized the licensee to use 

byproduct material for purposes of 

conducting research and development 

activities on laboratory bench tops and 

in hoods. 

The Facility occupies 53,362 square 

feet of space within a 74,000 square foot 

complex and consists of office, storage, 

and laboratory space. The Facility is 

located in a commercial area. Within the 

Facility, use of licensed materials was 

confined to 4,605 square feet of space. 

During April 2008, 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 

and for license termination. 

Need for the Proposed Action 

The Licensee has ceased conducting 

licensed activities at the Facility, and 

seeks the unrestricted use of its Facility 

and the termination of its NRC materials 

license. Termination of its license 

would end the Licensee’s obligation to 

pay annual license fees to the NRC. 

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 final status 

surveys during April–July 2009. The 

final status survey report was attached 

to the Licensee’s amendment request 

dated June 25, 2009, as supplemented 

by additional information letters dated 

July 10 and 14, 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, and in soils, 

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 

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 and the termination of the NRC 

materials license 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 and 

for license termination. 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 


srobinson on DSKHWCL6B1PROD with NOTICES
48786 Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices 

Jersey Department of Environmental 

Protection for review on June 25, 2009. 

On August 11, 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 http://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. Memory Pharmaceuticals 

Corporation Termination Request Letter 

dated June 25, 2009 [ML091950247]; 

6. Memory Pharmaceuticals 

Corporation Additional Information 

Letter dated July 10, 2009 

[ML091950568]; and 

7. Memory Pharmaceuticals 

Corporation Additional Information 

Letter dated July 14, 2009 

[ML091970047]. 

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 to 

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 17th 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. E9–23040 Filed 9–23–09; 8:45 am] 

BILLING CODE 7590–01–P 

NUCLEAR REGULATORY 

COMMISSION 

[Docket No. 030–04192; NRC–2009–0420] 

Notice of Environmental Assessment 

Related to the Issuance of a License 

Amendment to Byproduct Material 

License No. 12–10243–01, for 

Unrestricted Use of Environmental 

Protection Agency Facilities in 

Chicago, IL 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Issuance of Environmental 

Assessment and Finding of No 

Significant Impact for License 

Termination. 

FOR FURTHER INFORMATION CONTACT: 

Katie Streit, Health Physicist, Materials 

Control, ISFSI, and Decommissioning 

Branch, Division of Nuclear Materials 

and Safety, Region III, U.S. Nuclear 

Regulatory Commission, 2443 

Warrenville Road, Lisle, Illinois 60532; 

Telephone: (630) 829–9621; fax number: 

(630) 515–1259; or by e-mail at 

Katherine.Streit@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

The U.S. Nuclear Regulatory 

Commission (NRC) is considering the 

issuance of an amendment to terminate 

NRC Byproduct materials License No. 

12–10243–01, which is held by the U.S. 

Environmental Protection Agency 

(licensee). The issuance of the 

amendment would authorize the 

unrestricted use of the licensee’s 

laboratory facilities located at 536 South 

Clark Street, Chicago, Illinois, and 

similar facilities onboard the Research 

Vessel (R.V.) Lake Guardian 

(collectively, the Facilities). 

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 amendment request dated 

October 9, 2008 (ML082890377), and 

approve release of the Facilities for 

unrestricted use in accordance with 10 

CFR Part 20, Subpart E. License No. 12– 

10243–01 was issued on August 20, 

1964, pursuant to 10 CFR Part 30, and 

has been amended periodically since 

that time. The licensee used unsealed 

Carbon-14 for primary productivity 

analyses in laboratories located on the 

seventh and tenth floor of 536 South 

Clark Street, Chicago, Illinois from 

November 1977. Unsealed Carbon-14 

was also used onboard the R.V. Lake 

Guardian from August 1992. Nickel-63 

sealed sources were used for gas 

chromatography at the 536 South Clark 

Street laboratories. Other authorized 

locations for use of licensed materials 

under License No. 12–10243–01 were 

released for unrestricted use pursuant to 

previous license amendments. The 

licensee ceased licensed activities in the 

mid-1990s and disposed of all material 

licensed under License No. 12.10243–01 

by 2005, and has thus requested that its 

license be terminated. 

Based on the licensee’s historical 

knowledge of the site and the conditions 

of the Facilities, the licensee determined 

that only routine decontamination 

activities, in accordance with its NRC 

approved, operating radiation safety 

procedures, were required. The licensee 

was not required to submit a 

decommissioning plan to NRC because 

worker cleanup activities and surveys 

are consistent with those approved for 

routine operations. The licensee 

submitted a Historical Site Assessment 

and Final Status survey report to the 


srobinson on DSKHWCL6B1PROD with NOTICES