Notice of Availability of Biotechnology Quality Management System Audit Standard and Evaluation of Comments, 61413-61414 [2010-24995]

Download as PDF mstockstill on DSKH9S0YB1PROD with NOTICES Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices the state agency or the individual fire department. A cooperative agreement collects information from the participating state agency and outlines the requirements and rules for the cooperation. Each state forestry agency shall provide an Accountable Officer who will be responsible for the integrity of the program within their respective state. For this reason, FEPP and FFP collect the state forestry agency contact information, the information of the Accountable Officer, and the requirements of participation in the FEPP and FFP programs. A cooperative agreement will be prepared by each state forestry agency that desires to participate in one or both of the programs. Participating state agencies must submit separate agreements if they desire to be participants in both programs. Agreements will be processed and maintained at the United States Department of Agriculture, Forest Service, Fire and Aviation Management, Partnerships, Cooperative Programs branch in each Forest Service Regional Office. The authority to provide surplus supplies to state agencies comes from Federal Property and Administration Services Act of 1949, 40 U.S.C., Sec 202. Authority to loan excess supplies comes from 10 U.S.C., Subtitle A, Part IV, Chapter 153, 2576b grants the authority for the FFP program. Estimate of Annual Burden: 1 hour. Type of Respondents: State Foresters. Estimated Annual Number of Respondents: 10. Estimated Annual Number of Responses per Respondent: 2. Estimated Total Annual Burden on Respondents: 20 hours. Comment is Invited: Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the Agency, including whether the information will have practical or scientific utility; (2) the accuracy of the Agency’s estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. All comments received in response to this notice, including names and VerDate Mar<15>2010 18:36 Oct 04, 2010 Jkt 223001 addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission request toward Office of Management and Budget approval. Dated: September 28, 2010. John Phipps, Associate Deputy Chief, State and Private Forestry. [FR Doc. 2010–24879 Filed 10–4–10; 8:45 am] BILLING CODE 3410–11–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2008–0098] Notice of Availability of Biotechnology Quality Management System Audit Standard and Evaluation of Comments Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public that the Animal and Plant Health Inspection Service has developed an audit standard for its biotechnology compliance assistance program. The audit standard, which was made available in draft form for comment in an earlier notice, will be used by participating regulated entities to develop and implement sound management practices, thus enhancing compliance with the regulatory requirements for field trials and movement of genetically engineered organisms in 7 CFR part 340. We are also making available a document containing our evaluation of the comments we received on the draft audit standard. FOR FURTHER INFORMATION CONTACT: Dr. Edward Jhee, Chief, Compliance Assistance Branch, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 91, Riverdale, MD 20737– 1236; (301) 734–6356, e-mail: edward.m.jhee@aphis.usda.gov. To obtain copies of the audit standard or our evaluation of comments submitted on the draft audit standard, contact Ms. Cindy Eck at (301) 734–0667, e-mail: cynthia.a.eck@aphis.usda.gov. Those documents may also be viewed on the APHIS Web site at the address provided at the end of this document. SUPPLEMENTARY INFORMATION: SUMMARY: Background The Animal and Plant Health Inspection Service (APHIS) regulates the introduction—the importation, interstate movement, and environmental PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 61413 release—of genetically engineered (GE) organisms that are, or may be, plant pests. In September 2007, APHIS’ Biotechnology Regulatory Services announced it was developing a voluntary, audit-based compliance assistance program known as the Biotechnology Quality Management System Program (BQMS Program) to assist regulated entities in achieving and maintaining compliance with the regulatory requirements for field trials and movements of GE organisms in 7 CFR part 340. Under the BQMS Program, APHIS provides support for an entity’s voluntary adoption of a customized biotechnology quality management system (BQMS) to improve their management of domestic research and development of regulated GE organisms. The BQMS audit standard provides criteria for the development, implementation, and objective evaluation of the entity’s BQMS. On June 4, 2009, APHIS published a notice 1 in the Federal Register (74 FR 26831–26832, Docket No. APHIS–2008– 0098) announcing the availability of the BQMS draft audit standard. Comments on the BQMS draft audit standard were to have been received on or before August 3, 2009. APHIS subsequently published a notice in the Federal Register on August 24, 2009 (74 FR 42644, Docket No. APHIS–2008–0098), reopening the comment period on the draft audit standard for an additional 60 days ending October 23, 2009. APHIS solicited comments on the draft audit standard in general and sought specific input on the following four questions: 1. Do the critical control points in Requirement 7 of the draft audit standard identify all areas and elements that organizations should focus on in order to maintain compliance with the regulatory requirements under 7 CFR part 340? 2. Is the draft audit standard consistent with current best practices used by the regulated community? 3. Can the public identify incentives USDA might employ to encourage participation in the voluntary program by commercial industry as well as academic institutions? 4. The BQMS is designed to be flexible according to the size of the participating organization. Is this flexibility apparent in the draft audit standard? APHIS also received input on the draft audit standard from organizations 1 All notices mentioned in this docket, as well as comments received and supporting and related materials, can be viewed at https:// www.regulations.gov/fdmspublic/component/ main?main=DocketDetail&d=APHIS–2008–0098. E:\FR\FM\05OCN1.SGM 05OCN1 61414 Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices that participated in a BQMS pilot development project conducted during 2009. Five organizations participated in the pilot development project and assisted APHIS in evaluating the draft audit standard, program training sessions, and audit procedures established for the BQMS Program. Following the pilot development project and after evaluating the comments submitted on the BQMS draft audit standard, APHIS made adjustments to the BQMS audit standard. You may view the public comments submitted on the draft audit standard, APHIS’ evaluation of the comments received, and the revised BQMS audit standard on the Regulations.gov Web site (see footnote 1 for a link). The revised audit standard and the comment evaluation document, as well as additional information about the BQMS Program, may be found on the APHIS Web site at https:// www.aphis.usda.gov/biotechnology/ news_bqms.shtml. Copies of those documents may also be obtained from the person listed under FOR FURTHER INFORMATION CONTACT. Done in Washington, DC, this 29th day of September 2010. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2010–24995 Filed 10–4–10; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Rural Utilities Service Basin Electric Power Cooperative: South Dakota PrairieWinds Project Rural Utilities Service, USDA. Notice of Availability of Record of Decision. AGENCY: ACTION: The Rural Utilities Service, hereinafter referred to as RUS and/or the Agency, has issued a Record of Decision (ROD) for the Environmental Impact Statement (EIS) for the proposed South Dakota PrairieWind Project (Project) in Aurora, Bule and Jerauld Counties, South Dakota. The Administrator of RUS has signed the ROD, which is effective upon signing. The EIS was prepared pursuant to the National Environmental Policy Act of 1969 (NEPA) (U.S.C. 4231 et seq.) and in accordance with the Council on Environmental Quality’s (CEQ) regulations for implementing the procedural provisions of NEPA (40 CFR Parts 1500–1508), RUS’s NEPA implementing regulations (7 CFR Part mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:36 Oct 04, 2010 Jkt 223001 1794), and the Western Area Power Administration’s (Western) NEPA implementing regulations (10 CFR Part 1021). RUS and Western are serving as co-lead agencies in preparation of the EIS as defined at 40 CFR 1501.5. Each agency is issuing a separate ROD for the project. The purpose of the EIS was to evaluate the potential environmental impacts of and alternatives to Basin Electric Power Cooperative’s (Basin Electric) application for a RUS loan and a Western interconnection agreement to construct the proposed Project. The proposed Project’s facility would include a new 151.5-megawatt windpowered generation facility. ADDRESSES: To obtain copies of the ROD, or for further information, contact: Mr. Dennis Rankin, Environmental Protection Specialist, USDA, Rural Utilities Service, 1400 Independence Avenue, SW., Stop 1571, Room 2239–S, Washington, DC 20250–1571, telephone: (202) 720–1453, fax: (202) 690–0649, or e-mail: dennis.rankin@wdc.usda.gov. A copy of the ROD can be viewed online at: https://www.usda.gov/rus/water/ees/ eis.htm. SUPPLEMENTARY INFORMATION: Basin Electric’s proposed Project is to construct, own, operate, and maintain the Project. The proposed Project includes a 151.5-megawatt (MW) nameplate capacity wind-powered energy generation facility that would feature 101 wind turbine generators; 6,000-square-foot operations and maintenance building and fence perimeter; 64 miles of underground communication system and electrical collector lines (within the same trench); 34.5-kilovolt (kV) to 230-kV collector substation and microwave tower; 11mile-long overhead 230-kV transmission line; temporary equipment/material storage or lay-down areas; temporary crane walks; and 81 miles of new and/ or upgraded service roads to access the facilities in Aurora, Brule and Jerauld Counties in eastern South Dakota. The purpose for the proposed Project is to meet Basin Electric’s load growth responsibilities, State mandated Renewable Portfolio Standards and Renewable Energy Objectives and renewable energy goals. In accordance with NEPA, the CEQ regulations for implementing the procedural provisions of NEPA, and applicable agency NEPA implementing regulations, RUS and Western prepared an EIS to assess the potential environmental impacts associated with the proposed Project. The decision being documented in RUS’s ROD is that the Agency agrees to consider, subject to loan approval, funding the proposed Project at the PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 Crow Lake location. More details regarding RUS’s regulatory authority, rationale for the decision, and compliance with applicable regulations are included in the ROD. Because two distinct federal actions are being proposed, RUS and Western decided to issue separate RODs. On April 7, 2009, RUS and Western published in the Federal Register a Notice of Intent to prepare an EIS for the proposed Project. The U.S. Environmental Protection Agency acknowledged receipt of the Draft EIS on January 15, 2010. The 45-day comment period ended on March 1, 2010. A public hearing to receive comments on the Draft EIS was held in Chamberlain, South Dakota, on February 11, 2010. All comments received were addressed in the Final EIS, The U.S. Environmental Protection Agency acknowledged receipt of the Final EIS on July 30, 2010. The 30-day review period ended on August 28, 2010. Two comment letters were received; they were addressed in RUS’s ROD. After considering various ways to meet its purpose and need, Basin Electric identified construction of the proposed Project as its best course of action. This EIS considered four alternative methods to provide renewable energy and six alternative site locations. These alternatives were evaluated in terms of cost-effectiveness, technical feasibility, and environmental factors (e.g., soils, topography and geology, water resources, air quality, biological resources, the acoustic environment, recreation, cultural and historic resources, visual resources, transportation, farmland, land use, human health and safety, the socioeconomic environment, environmental justice, and cumulative effects). The EIS analyzes in detail the No Action Alternative and the Action Alternative (construction of the Project) at two separate locations: The Crow Lake site (approximately 36,000 acres 15 miles north of the City of White Lake within Brule, Aurora and Jerald Counties, South Dakota), and the Winner site (approximately 83,000 acres eight miles south of the City of Winner in Tripp County, South Dakota). The No Action Alternative would not meet the state’s and Basin Electric’s renewable energy goals. The resources or environmental factors that could be affected by the proposed Project were evaluated in detail in the EIS. These issues are summarized in Table ES–1: ‘‘Summary of Potential Impacts of South Dakota PrairieWinds Project,’’ of the EIS. E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61413-61414]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24995]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2008-0098]


Notice of Availability of Biotechnology Quality Management System 
Audit Standard and Evaluation of Comments

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has developed an audit standard for its 
biotechnology compliance assistance program. The audit standard, which 
was made available in draft form for comment in an earlier notice, will 
be used by participating regulated entities to develop and implement 
sound management practices, thus enhancing compliance with the 
regulatory requirements for field trials and movement of genetically 
engineered organisms in 7 CFR part 340. We are also making available a 
document containing our evaluation of the comments we received on the 
draft audit standard.

FOR FURTHER INFORMATION CONTACT: Dr. Edward Jhee, Chief, Compliance 
Assistance Branch, Biotechnology Regulatory Services, APHIS, 4700 River 
Road Unit 91, Riverdale, MD 20737-1236; (301) 734-6356, e-mail: 
edward.m.jhee@aphis.usda.gov. To obtain copies of the audit standard or 
our evaluation of comments submitted on the draft audit standard, 
contact Ms. Cindy Eck at (301) 734-0667, e-mail: 
cynthia.a.eck@aphis.usda.gov. Those documents may also be viewed on the 
APHIS Web site at the address provided at the end of this document.

SUPPLEMENTARY INFORMATION:

Background

    The Animal and Plant Health Inspection Service (APHIS) regulates 
the introduction--the importation, interstate movement, and 
environmental release--of genetically engineered (GE) organisms that 
are, or may be, plant pests. In September 2007, APHIS' Biotechnology 
Regulatory Services announced it was developing a voluntary, audit-
based compliance assistance program known as the Biotechnology Quality 
Management System Program (BQMS Program) to assist regulated entities 
in achieving and maintaining compliance with the regulatory 
requirements for field trials and movements of GE organisms in 7 CFR 
part 340.
    Under the BQMS Program, APHIS provides support for an entity's 
voluntary adoption of a customized biotechnology quality management 
system (BQMS) to improve their management of domestic research and 
development of regulated GE organisms. The BQMS audit standard provides 
criteria for the development, implementation, and objective evaluation 
of the entity's BQMS.
    On June 4, 2009, APHIS published a notice \1\ in the Federal 
Register (74 FR 26831-26832, Docket No. APHIS-2008-0098) announcing the 
availability of the BQMS draft audit standard. Comments on the BQMS 
draft audit standard were to have been received on or before August 3, 
2009. APHIS subsequently published a notice in the Federal Register on 
August 24, 2009 (74 FR 42644, Docket No. APHIS-2008-0098), reopening 
the comment period on the draft audit standard for an additional 60 
days ending October 23, 2009. APHIS solicited comments on the draft 
audit standard in general and sought specific input on the following 
four questions:
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    \1\ All notices mentioned in this docket, as well as comments 
received and supporting and related materials, can be viewed at 
https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0098.
---------------------------------------------------------------------------

    1. Do the critical control points in Requirement 7 of the draft 
audit standard identify all areas and elements that organizations 
should focus on in order to maintain compliance with the regulatory 
requirements under 7 CFR part 340?
    2. Is the draft audit standard consistent with current best 
practices used by the regulated community?
    3. Can the public identify incentives USDA might employ to 
encourage participation in the voluntary program by commercial industry 
as well as academic institutions?
    4. The BQMS is designed to be flexible according to the size of the 
participating organization. Is this flexibility apparent in the draft 
audit standard?
    APHIS also received input on the draft audit standard from 
organizations

[[Page 61414]]

that participated in a BQMS pilot development project conducted during 
2009. Five organizations participated in the pilot development project 
and assisted APHIS in evaluating the draft audit standard, program 
training sessions, and audit procedures established for the BQMS 
Program.
    Following the pilot development project and after evaluating the 
comments submitted on the BQMS draft audit standard, APHIS made 
adjustments to the BQMS audit standard. You may view the public 
comments submitted on the draft audit standard, APHIS' evaluation of 
the comments received, and the revised BQMS audit standard on the 
Regulations.gov Web site (see footnote 1 for a link).
    The revised audit standard and the comment evaluation document, as 
well as additional information about the BQMS Program, may be found on 
the APHIS Web site at https://www.aphis.usda.gov/biotechnology/news_bqms.shtml. Copies of those documents may also be obtained from the 
person listed under FOR FURTHER INFORMATION CONTACT.

    Done in Washington, DC, this 29th day of September 2010.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-24995 Filed 10-4-10; 8:45 am]
BILLING CODE 3410-34-P