Notice of Availability of Biotechnology Quality Management System Pilot Project Draft Audit Standard, 26831-26832 [E9-13053]

Download as PDF 26831 Notices Federal Register Vol. 74, No. 106 Thursday, June 4, 2009 This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request June 1, 2009. The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104–13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency’s estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), OIRA_Submission@OMB.EOP.GOV or fax (202) 395–5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250– 7602. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission(s) may be obtained by calling (202) 720–8958. An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to VerDate Nov<24>2008 15:16 Jun 03, 2009 Jkt 217001 the collection of information unless it displays a currently valid OMB control number. Animal and Plant Health Inspection Service Title: Importation of Swine and Swine Products from the European Union. OMB Control Number: 0579–0265. Summary of Collection: The Animal Health Protection Act (AHPA) of 2002 is the primary Federal law governing the protection of animal health. The law gives the Secretary of Agriculture broad authority to detect, control, or eradicate pests or diseases of livestock or poultry. In connection with the disease prevention mission, the Animal and Plant Health Inspection Service (APHIS) regulates the importation of animals and animal products into the United States to guard against the introduction of animal diseases not currently present or prevalent in this country. Need and Use of the Information: To help APHIS ensure that classical Swine fever (CSF) is not introduced into the United States, the regulations allow, under specified conditions, the importation of pork, pork products, and swine from the APHIS-defined European Union (EU) CSF region. These requirements necessitate the use of several information collection activities, including certification statements from the importation of pork, pork products, and swine. Failing to collect this information would increase the chances of CSF being introduced into the United States. Description of Respondents: Federal Government. Number of Respondents: 86. Frequency of Responses: Reporting: On occasion. Total Burden Hours: 816. Ruth Brown, Departmental Information Collection Clearance Officer. [FR Doc. E9–13049 Filed 6–3–09; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Forest Service Agency Information Collection Activities; Proposals, Submissions, and Approvals; Correction June 1, 2009. AGENCY: PO 00000 Forest Service, USDA. Frm 00001 Fmt 4703 Sfmt 4703 ACTION: Notice; correction. SUMMARY: The Department of Agriculture published a document in the Federal Register of May 28, 2009, concerning a request for comments on the information collection ‘‘Special Use Administration’’ OMB control number 0596–0082. The document contained incorrect burden hours. The total burden hours should be 161,365 not 247,107 as published. Charlene Parker, Departmental Information Collection Clearance Officer. [FR Doc. E9–13048 Filed 6–3–09; 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 Pilot Project Draft Audit Standard AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. SUMMARY: We are advising the public that the Animal and Plant Health Inspection Service is seeking comments on the draft audit standard developed for its Biotechnology Quality Management System pilot project. The Biotechnology Quality Management System is a voluntary compliance assistance program designed to help regulated entities develop sound management practices, thus enhancing compliance with the regulatory requirements for environmental releases and movements of regulated articles in accordance with 7 CFR part 340. DATES: We will consider all comments we receive on or before August 3, 2009. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/fdmspublic/ component/ main?main=DocketDetail&d=APHIS– 2008–0098 to submit or view comments and to view supporting and related materials available electronically. • Postal Mail/Commercial Delivery: Please send two copies of your comment to Docket No. APHIS–2008–0098, E:\FR\FM\04JNN1.SGM 04JNN1 26832 Federal Register / Vol. 74, No. 106 / Thursday, June 4, 2009 / Notices Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road Unit 118, Riverdale, MD 20737–1238. Please state that your comment refers to Docket No. APHIS– 2008–0098. Reading Room: You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690–2817 before coming. Other Information: Additional information about APHIS and its programs is available on the Internet at https://www.aphis.usda.gov. FOR FURTHER INFORMATION CONTACT: Dr. Edward Jhee, Biotechnology Quality Management System Program Manager, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 91, Riverdale, MD 20737–1236; (301) 734– 6356, edward.m.jhee@aphis.usda.gov. To obtain copies of the draft audit standard, contact Ms. Cindy Eck at (301) 734–0667, e-mail: cynthia.a.eck@aphis.usda.gov. The draft audit standard is also available on the Internet at https://www.aphis.usda.gov/ biotechnology/news_bqms.shtml. SUPPLEMENTARY INFORMATION: Background The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) regulates the introduction—meaning the importation, interstate movement, and environmental release—of genetically engineered (GE) organisms that are, or may be, plant pests. Such GE organisms and products are considered ‘‘regulated articles.’’ Applicants that are issued permits or received acknowledgment of notifications to introduce GE organisms are required to comply with all APHIS regulations. To enhance improvements in compliance, APHIS initiated development of a voluntary, audit-based compliance assistance program known as the Biotechnology Quality Management System (BQMS). On September 20, 2007, APHIS issued a press release announcing plans to establish a BQMS Pilot Development Project. APHIS selected five volunteer participants for the pilot program after soliciting letters of interest through a notice published in the Federal Register on September 2, 2008 (73 FR 51266– VerDate Nov<24>2008 15:16 Jun 03, 2009 Jkt 217001 51267, Docket No. APHIS–2008–0098). The main component of the BQMS pilot project is the draft audit standard, which provides criteria used for the objective evaluation of quality management systems to determine if a system will be certified as an APHIS Biotechnology Quality Management System during the audit portion of the pilot program. The regulatory requirements of 7 CFR part 340 for performance standards and permit conditions are the foundation for the draft audit standard. The draft audit standard is used by pilot participants to develop sound management practices to enhance compliance with the regulatory requirements of 7 CFR part 340 for environmental releases, importations, and interstate movements of regulated articles. Participants have applied the draft audit standard to their organization’s regulated biotechnology program to plan, implement, document, and examine the efficacy of quality assurance and quality control measures related to introductions of regulated articles. APHIS is soliciting comments for a period of 60 days on the draft audit standard currently used in the BQMS pilot project. Within the draft audit standard, Requirement 7 specifies that participants address critical control points for the introduction of regulated articles by developing containment procedures for regulated articles; developing measures for the identification of regulated articles in storage, being moved, imported, or transferred, and in field locations; developing procedures for planning and monitoring environmental releases of regulated articles; developing methods for post-harvest handling activities and methods to maintain the identity of regulated material; developing procedures for the devitalization and disposition of regulated articles; as well as developing procedures for the submission of regulatory compliance incidents to the appropriate regulatory authorities. APHIS is soliciting comments on the draft audit standard as a whole, and Requirement 7 in particular. 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 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 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? Upon conclusion of the BQMS pilot project, APHIS will consider all comments received during the comment period to revise the draft audit standard to improve the efficacy of this project. This feedback, as well as comments from the participants on the pilot BQMS project, will be used to inform the development of a BQMS audit standard and any future BQMS initiative. The BQMS draft audit standard is available for public review as indicated under the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice. Done in Washington, DC, this 29th day of May 2009. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E9–13053 Filed 6–3–09; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2007–0016] Syngenta Seeds, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Corn Genetically Engineered To Produce an Enzyme That Facilitates Ethanol Production AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice; reopening of comment period. SUMMARY: We are reopening the comment period for a petition submitted by Syngenta Seeds, Inc., seeking a determination of nonregulated status for corn designated as transformation event 3272 and its associated environmental assessment prepared by the Animal and Plant Health Inspection Service under our regulations found at 7 CFR part 340. This action will allow interested persons additional time to prepare and submit comments on the petition, environmental assessment, and the revised plant pest risk assessment. DATES: We will consider all comments that we receive on or before July 6, 2009. E:\FR\FM\04JNN1.SGM 04JNN1

Agencies

[Federal Register Volume 74, Number 106 (Thursday, June 4, 2009)]
[Notices]
[Pages 26831-26832]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13053]


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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 
Pilot Project Draft Audit Standard

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service is seeking comments on the draft audit standard 
developed for its Biotechnology Quality Management System pilot 
project. The Biotechnology Quality Management System is a voluntary 
compliance assistance program designed to help regulated entities 
develop sound management practices, thus enhancing compliance with the 
regulatory requirements for environmental releases and movements of 
regulated articles in accordance with 7 CFR part 340.

DATES: We will consider all comments we receive on or before August 3, 
2009.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0098 to submit or view comments and 
to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2008-0098,

[[Page 26832]]

Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comment refers to Docket No. APHIS-2008-0098.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room is located in room 1141 of 
the USDA South Building, 14th Street and Independence Avenue SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at https://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Edward Jhee, Biotechnology Quality 
Management System Program Manager, Biotechnology Regulatory Services, 
APHIS, 4700 River Road Unit 91, Riverdale, MD 20737-1236; (301) 734-
6356, edward.m.jhee@aphis.usda.gov. To obtain copies of the draft audit 
standard, contact Ms. Cindy Eck at (301) 734-0667, e-mail: 
cynthia.a.eck@aphis.usda.gov. The draft audit standard is also 
available on the Internet at https://www.aphis.usda.gov/biotechnology/news_bqms.shtml.

SUPPLEMENTARY INFORMATION: 

Background

    The U.S. Department of Agriculture's (USDA) Animal and Plant Health 
Inspection Service (APHIS) regulates the introduction--meaning the 
importation, interstate movement, and environmental release--of 
genetically engineered (GE) organisms that are, or may be, plant pests. 
Such GE organisms and products are considered ``regulated articles.'' 
Applicants that are issued permits or received acknowledgment of 
notifications to introduce GE organisms are required to comply with all 
APHIS regulations.
    To enhance improvements in compliance, APHIS initiated development 
of a voluntary, audit-based compliance assistance program known as the 
Biotechnology Quality Management System (BQMS). On September 20, 2007, 
APHIS issued a press release announcing plans to establish a BQMS Pilot 
Development Project.
    APHIS selected five volunteer participants for the pilot program 
after soliciting letters of interest through a notice published in the 
Federal Register on September 2, 2008 (73 FR 51266-51267, Docket No. 
APHIS-2008-0098). The main component of the BQMS pilot project is the 
draft audit standard, which provides criteria used for the objective 
evaluation of quality management systems to determine if a system will 
be certified as an APHIS Biotechnology Quality Management System during 
the audit portion of the pilot program. The regulatory requirements of 
7 CFR part 340 for performance standards and permit conditions are the 
foundation for the draft audit standard.
    The draft audit standard is used by pilot participants to develop 
sound management practices to enhance compliance with the regulatory 
requirements of 7 CFR part 340 for environmental releases, 
importations, and interstate movements of regulated articles. 
Participants have applied the draft audit standard to their 
organization's regulated biotechnology program to plan, implement, 
document, and examine the efficacy of quality assurance and quality 
control measures related to introductions of regulated articles.
    APHIS is soliciting comments for a period of 60 days on the draft 
audit standard currently used in the BQMS pilot project. Within the 
draft audit standard, Requirement 7 specifies that participants address 
critical control points for the introduction of regulated articles by 
developing containment procedures for regulated articles; developing 
measures for the identification of regulated articles in storage, being 
moved, imported, or transferred, and in field locations; developing 
procedures for planning and monitoring environmental releases of 
regulated articles; developing methods for post-harvest handling 
activities and methods to maintain the identity of regulated material; 
developing procedures for the devitalization and disposition of 
regulated articles; as well as developing procedures for the submission 
of regulatory compliance incidents to the appropriate regulatory 
authorities. APHIS is soliciting comments on the draft audit standard 
as a whole, and Requirement 7 in particular.
    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?
    Upon conclusion of the BQMS pilot project, APHIS will consider all 
comments received during the comment period to revise the draft audit 
standard to improve the efficacy of this project. This feedback, as 
well as comments from the participants on the pilot BQMS project, will 
be used to inform the development of a BQMS audit standard and any 
future BQMS initiative. The BQMS draft audit standard is available for 
public review as indicated under the ADDRESSES and FOR FURTHER 
INFORMATION CONTACT sections of this notice.

    Done in Washington, DC, this 29th day of May 2009.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-13053 Filed 6-3-09; 8:45 am]
BILLING CODE 3410-34-P
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