Solicitation of Letters of Interest To Participate in Biotechnology Quality Management System Pilot Project, 51266-51267 [E8-20285]
Download as PDF
<![CDATA[
erowe on PROD1PC64 with NOTICES
51266
Federal Register / Vol. 73, No. 170 / Tuesday, September 2, 2008 / Notices
authorized by the PPA concerning the
importation of fruits and vegetables into
the United States from certain parts of
the world are contained in ‘‘Subpart—
Fruits and Vegetables’’ (7 CFR 319.56–
1 through 319.56–47).
Under these regulations, peppers from
Costa Rica, El Salvador, Guatemala,
Honduras, and Nicaragua are subject to
certain conditions before entering the
United States to prevent the
introduction of plant pests into the
United States. The regulations require
the use of information collection
activities including inspections by
Central American national plant
protection organization officials, fruit
fly trapping, monitoring, and
recordkeeping, box labeling, and a
phytosanitary certificate.
We are asking the Office of
Management and Budget (OMB) to
approve our use of these information
collection activities for an additional 3
years.
The purpose of this notice is to solicit
comments from the public (as well as
affected agencies) concerning our
information collection. These comments
will help us:
(1) Evaluate 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;
(2) Evaluate the accuracy of our
estimate of the burden of the collection
of information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, through use, as
appropriate, of automated, electronic,
mechanical, and other collection
technologies; e.g., permitting electronic
submission of responses.
Estimate of burden: The public
reporting burden for this collection of
information is estimated to average
0.0037936 hours per response.
Respondents: National plant
protection organization officials and
growers and shippers of peppers in
Costa Rica, El Salvador, Guatemala,
Honduras, and Nicaragua.
Estimated annual number of
respondents: 245.
Estimated annual number of
responses per respondent: 3,226.653.
Estimated annual number of
responses: 790,530.
Estimated total annual burden on
respondents: 2,999 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
VerDate Aug<31>2005
14:40 Aug 29, 2008
Jkt 214001
number of responses multiplied by the
reporting burden per response.)
All responses to this notice will be
summarized and included in the request
for OMB approval. All comments will
also become a matter of public record.
Done in Washington, DC, this 26th day of
August 2008.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E8–20288 Filed 8–29–08; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2008–0098]
Solicitation of Letters of Interest To
Participate in Biotechnology Quality
Management System Pilot Project
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public
that the Animal and Plant Health
Inspection Service is soliciting letters of
interest to participate in a voluntary
pilot project for its Biotechnology
Quality Management System (BQMS).
The BQMS is a voluntary compliance
assistance program designed to help
stakeholders develop sound
management practices, thus enhancing
compliance with the regulatory
requirements for field trials and
movement of genetically engineered
organisms in 7 CFR part 340. The Pilot
Development Project will test the
applicability of a biotechnology quality
management audit standard and
accompanying guidelines and assist
APHIS in further development of
BQMS. APHIS’ goal for the pilot project
is to obtain feedback from participants
on the strengths and areas for
improvement to the audit standard and
guidelines prior to full implementation
of the system.
DATES: Letters of interest will be
accepted from September 2, 2008, to
October 1, 2008.
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.
SUPPLEMENTARY INFORMATION:
Background
The U.S. Department of Agriculture’s
(USDA) Animal and Plant Health
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
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. It is essential that
applicants approved to introduce
regulated GE organisms comply with all
APHIS regulations and permit
conditions. To improve compliance,
APHIS is developing a voluntary, auditbased compliance assistance program
known as the Biotechnology Quality
Management System (BQMS). BQMS
will help universities, small businesses,
and large companies develop sound
management practices to enhance
compliance with the regulatory
requirements for field trials and
movements of GE organisms in 7 CFR
part 340.
APHIS is seeking voluntary
participants for a BQMS pilot project
who will serve as a broad representation
of the regulated community. APHIS will
select participants who are:
(1) Currently conducting regulated
environmental field release and
movements under notification or
permit, and who
(2) Intend to apply for a renewal or
new notification or permit, annually, for
the next 3 years.
APHIS will select one applicant from
each of the following three categories to
participate in the pilot project: One
applicant from a large corporate
business (greater than 50 employees), 1
applicant from a small business (less
than 15 employees), and 1 applicant
from an academic institution.
Participants in the BQMS Pilot
Development Project will review the
BQMS process and provide feedback.
Specifically, participants will test the
feasibility of the BQMS standards and
guidelines by developing and
implementing a quality management
system for their organization that
proactively manages regulated
movement and field releases.
Participating in the quality management
system will demonstrate an
organization’s commitment to regulatory
accountability, increased transparency,
and identification and implementation
of measures to minimize the occurrence
of compliance infractions.
A draft audit standard for the BQMS
program and a series of guidelines to
assist participants in using this
compliance assistance program to
proactively comply with APHIS
regulations are presently undergoing a
technical review with audit industry
experts. This review will be completed
before the pilot project begins.
Organizations that wish to participate
in the BQMS Pilot Development Project
E:\FR\FM\02SEN1.SGM
02SEN1
Federal Register / Vol. 73, No. 170 / Tuesday, September 2, 2008 / Notices
should submit a letter of interest (1–2
pages) that includes the following:
(1) A short description of current
active notifications and permits; and
(2) A statement of the organization’s
commitment to:
• Develop and implement a BQMS
program within their organization;
• Attend all required training
sessions on the development and
implementation of a BQMS to be held
by APHIS-BRS-Regulatory Operations
Programs (ROP);
• Establish methods and procedures
for monitoring critical processes and
procedures for the movement and field
testing of regulated GE agriculture;
• Provide required data and provide
feedback to APHIS-BRS-ROP on how to
improve the BQMS program standard
and guidelines;
• Participate in surveys after
completing training modules; and
• Submit to a third-party external
verification audit.
APHIS will accept letters of interest
through October 1, 2008. APHIS will
evaluate letters and notify all applicants
of its final selections. You may submit
participation letters of interest by mail
or e-mail to the person listed under FOR
FURTHER INFORMATION CONTACT at the
beginning of this notice.
Done in Washington, DC, this 26th day of
August 2008.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E8–20285 Filed 8–29–08; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2008–0054]
University of Florida; Availability of
Petition and Environmental
Assessment for Determination of
Nonregulated Status for Papaya
Genetically Engineered for Resistance
to the Papaya Ringspot Virus
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
erowe on PROD1PC64 with NOTICES
AGENCY:
SUMMARY: We are advising the public
that the Animal and Plant Health
Inspection Service has received a
petition from the University of Florida
seeking a determination of nonregulated
status for papaya genetically engineered
for resistance to the papaya ringspot
virus derived from a transformation
event designated as X17–2. The petition
has been submitted in accordance with
VerDate Aug<31>2005
14:40 Aug 29, 2008
Jkt 214001
our regulations concerning the
introduction of certain genetically
engineered organisms and products. In
accordance with those regulations, we
are soliciting comments on whether this
genetically engineered papaya is or
could be a plant pest. We are also
making available for public comment a
draft environmental assessment for the
proposed determination of nonregulated
status.
We will consider all comments
we receive on or before November 3,
2008.
DATES:
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 =0054 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–2008–0054,
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–
2008–0054.
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.
ADDRESSES:
51267
Background
The regulations in 7 CFR part 340,
‘‘Introduction of Organisms and
Products Altered or Produced Through
Genetic Engineering Which Are Plant
Pests or Which There Is Reason To
Believe Are Plant Pests,’’ regulate,
among other things, the introduction
(importation, interstate movement, or
release into the environment) of
organisms and products altered or
produced through genetic engineering
that are plant pests or that there is
reason to believe are plant pests. Such
genetically engineered organisms and
products are considered ‘‘regulated
articles.’’
The regulations in § 340.6(a) provide
that any person may submit a petition
to the Animal and Plant Health
Inspection Service (APHIS) seeking a
determination that an article should not
be regulated under 7 CFR part 340.
Paragraphs (b) and (c) of § 340.6
describe the form that a petition for a
determination of nonregulated status
must take and the information that must
be included in the petition.
On December 2, 2004, APHIS received
a petition seeking a determination of
nonregulated status (APHIS No. 04–
337–01p) from the University of Florida,
Institute of Food and Agricultural
Sciences (UFL–IFAS) of Homestead, FL,
for papaya (Carica papaya L.)
designated as transformation event X17–
2, which has been genetically
engineered for resistance to the papaya
ringspot virus (PRSV), stating that
papaya line X17–2 does not present a
plant pest risk and, therefore, should
not be a regulated article under APHIS’
regulations in 7 CFR part 340. UFL–
IFAS responded to APHIS’ subsequent
requests for additional information and
clarification and submitted revisions to
their petition on January 12, 2007, and
June 14, 2007. The petition is available
for public review and comment.
FOR FURTHER INFORMATION CONTACT:
Analysis
SUPPLEMENTARY INFORMATION:
As described in the petition, papaya
transformation event X17–2 has been
genetically engineered with a sequence
from the PRSV. This sequence was
derived from the PRSV coat protein (cp)
gene and introduced into X17–2 papaya
along with one plant-expressed
selectable marker gene, nptII, via
Agrobacterium-mediated
transformation. The marker gene is
commonly used and enables researchers
to select those plant tissues that have
been successfully transformed with the
gene of interest. The resistance to PRSV
appears to be conferred through post
transcriptional gene silencing.
Mr.
John Cordts, Biotechnology Regulatory
Services, APHIS, 4700 River Road Unit
147, Riverdale, MD 20737–1236; (301)
734–5531, e-mail:
john.m.cordts@aphis.usda.gov. To
obtain copies of the petition or the
environmental assessment, contact Ms.
Cindy Eck at (301) 734–0667, e-mail:
cynthia.a.eck@aphis.usda.gov. The
petition and the environmental
assessment are also available on the
Internet at https://www.aphis.usda.gov/
brs/aphisdocs/04_33701p.pdf and
https://www.aphis.usda.gov/brs/
aphisdocs/04_33701p_ea.pdf.
PO 00000
Frm 00004
Fmt 4703
Sfmt 4703
E:\FR\FM\02SEN1.SGM
02SEN1
]]>Agencies
[Federal Register Volume 73, Number 170 (Tuesday, September 2, 2008)]
[Notices]
[Pages 51266-51267]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20285]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2008-0098]
Solicitation of Letters of Interest To Participate in
Biotechnology Quality Management System Pilot Project
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 soliciting letters of interest to participate in
a voluntary pilot project for its Biotechnology Quality Management
System (BQMS). The BQMS is a voluntary compliance assistance program
designed to help stakeholders develop sound management practices, thus
enhancing compliance with the regulatory requirements for field trials
and movement of genetically engineered organisms in 7 CFR part 340. The
Pilot Development Project will test the applicability of a
biotechnology quality management audit standard and accompanying
guidelines and assist APHIS in further development of BQMS. APHIS' goal
for the pilot project is to obtain feedback from participants on the
strengths and areas for improvement to the audit standard and
guidelines prior to full implementation of the system.
DATES: Letters of interest will be accepted from September 2, 2008, to
October 1, 2008.
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.
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.
It is essential that applicants approved to introduce regulated GE
organisms comply with all APHIS regulations and permit conditions. To
improve compliance, APHIS is developing a voluntary, audit-based
compliance assistance program known as the Biotechnology Quality
Management System (BQMS). BQMS will help universities, small
businesses, and large companies develop sound management practices to
enhance compliance with the regulatory requirements for field trials
and movements of GE organisms in 7 CFR part 340.
APHIS is seeking voluntary participants for a BQMS pilot project
who will serve as a broad representation of the regulated community.
APHIS will select participants who are:
(1) Currently conducting regulated environmental field release and
movements under notification or permit, and who
(2) Intend to apply for a renewal or new notification or permit,
annually, for the next 3 years.
APHIS will select one applicant from each of the following three
categories to participate in the pilot project: One applicant from a
large corporate business (greater than 50 employees), 1 applicant from
a small business (less than 15 employees), and 1 applicant from an
academic institution.
Participants in the BQMS Pilot Development Project will review the
BQMS process and provide feedback. Specifically, participants will test
the feasibility of the BQMS standards and guidelines by developing and
implementing a quality management system for their organization that
proactively manages regulated movement and field releases.
Participating in the quality management system will demonstrate an
organization's commitment to regulatory accountability, increased
transparency, and identification and implementation of measures to
minimize the occurrence of compliance infractions.
A draft audit standard for the BQMS program and a series of
guidelines to assist participants in using this compliance assistance
program to proactively comply with APHIS regulations are presently
undergoing a technical review with audit industry experts. This review
will be completed before the pilot project begins.
Organizations that wish to participate in the BQMS Pilot
Development Project
[[Page 51267]]
should submit a letter of interest (1-2 pages) that includes the
following:
(1) A short description of current active notifications and
permits; and
(2) A statement of the organization's commitment to:
Develop and implement a BQMS program within their
organization;
Attend all required training sessions on the development
and implementation of a BQMS to be held by APHIS-BRS-Regulatory
Operations Programs (ROP);
Establish methods and procedures for monitoring critical
processes and procedures for the movement and field testing of
regulated GE agriculture;
Provide required data and provide feedback to APHIS-BRS-
ROP on how to improve the BQMS program standard and guidelines;
Participate in surveys after completing training modules;
and
Submit to a third-party external verification audit.
APHIS will accept letters of interest through October 1, 2008.
APHIS will evaluate letters and notify all applicants of its final
selections. You may submit participation letters of interest by mail or
e-mail to the person listed under FOR FURTHER INFORMATION CONTACT at
the beginning of this notice.
Done in Washington, DC, this 26th day of August 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-20285 Filed 8-29-08; 8:45 am]
BILLING CODE 3410-34-P
