[Federal Register: March 3, 2000 (Volume 65, Number 43)]
[Notices]
[Page 11705-11709]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03mr00-157]
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Part V
Department of Agriculture
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Agricultural Research Service
Cooperative State Research, Education, and Extension Service
Biology Risk Assessment Research Grants Program for Fiscal Year 2000;
Proposals and Input Request; Notice
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DEPARTMENT OF AGRICULTURE
Agricultural Research Service Cooperative State Research,
Education, and Extension Service
Biotechnology Risk Assessment Research Grants Program for Fiscal
Year 2000; Request for Proposals and Request for Input
AGENCY: Agricultural Research Service; Cooperative State Research,
Education, and Extension Service, USDA.
ACTION: Notice of request for proposals and request for input.
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SUMMARY: The Agricultural Research Service (ARS) and the Cooperative
State Research, Education, and Extension Service (CSREES) are
announcing the Biotechnology Risk Assessment Research Grants Program
(the ``Program'') for fiscal year (FY) 2000. Proposals are hereby
requested from eligible institutions as identified herein for
competitive consideration of Biotechnology Risk Assessment Grant
awards. The authority for the Program is contained in section 1668 of
the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C.
5921). The Program is administered by CSREES and ARS of the U.S.
Department of Agriculture.
CSREES also is soliciting comments regarding this request for
proposals from any interested party. These comments will be considered
in the development of the next request for proposals for this program.
Such comments will be used in meeting the requirements of section
103(c)(2) of the Agricultural Research, Extension, and Education Reform
Act of 1998 (AREERA).
DATES: All proposals must be received at USDA on or before April 10,
2000. Proposals not received on or before this date will not be
considered for funding.
User comments are requested within six months from the issuance of
the request for proposals. Comments received after that date will be
considered to the extent practicable (see Part VII.C.).
ADDRESSES: Proposals must be submitted to the following mailing
address: Biotechnology Risk Assessment Research Grants; Proposal
Services Unit, Office of Extramural Programs, c/o Cooperative State
Research, Education, and Extension Service, U.S. Department of
Agriculture, STOP 2245, 1400 Independence Ave., SW, Washington, DC
20250-2245.
The address for hand-delivered proposals or proposals submitted
using an express mail or overnight courier service is: Biotechnology
Risk Assessment Research Grants, c/o Proposal Services Unit, Office of
Extramural Programs, Cooperative State Research, Education, and
Extension Service, U.S. Department of Agriculture, Room 303, Aerospace
Center, 901 D Street, SW, Washington, DC 20024, telephone: (202) 401-
5048.
Written user comments should be submitted by mail to: Policy and
Program Liaison Staff, Office of Extramural Programs, USDA-CSREES, STOP
2299, 1400 Independence Avenue, SW, Washington, DC 20250-2299; or via
e-mail to: RFP-OEP@reeusda.gov. (This e-mail address is intended only
for receiving stakeholder input comments regarding this RFP, and not
for requesting information or forms.)
FOR FURTHER INFORMATION CONTACT:
Dr. Deborah Sheely, Cooperative State Research, Education, and
Extension Service, U.S. Department of Agriculture, Stop 2241, 1400
Independence Avenue, SW, Washington, DC 20250-2241; telephone: (202)
401-1924, e-mail: dsheely@reeusda.gov; or
Dr. Robert M. Faust, Agricultural Research Service, U.S. Department of
Agriculture, Room 338, Building 005, BARC-West, Beltsville, MD 20705;
telephone: (301) 504-6918, e-mail: rmf@ars.usda.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
Part I. General Information
A. Legislative Authority
B. Applicant Eligibility
Part II. Program Description
A. Purpose of the Program
B. Available Funding
C. Areas of Research to be Supported
Part III. Content of a Proposal
Part IV. How to Obtain Application Materials
Part V. Submission of a Proposal
A. What to Submit
B. Where and When to Submit
C. Acknowledgment of Proposals
Part VI. Proposal Evaluation
Part VII. Supplementary Information
A. Applicable Regulations
B. Programmatic Contact
C. Stakeholder Input
D. Additional Information
Part I. General Information
A. Legislative Authority
The authority for the Program is contained in section 1668 of the
Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 5921).
The administrative regulations for this program are found at 7 CFR part
3415.
B. Applicant Eligibility
Proposals may be submitted by any United States public or private
research or educational institution or organization.
Part II. Program Description
CSREES and ARS will competitively award research grants to support
science-based biotechnology regulation, thereby helping to address
concerns about the effects of introducing genetically modified
organisms into the environment and helping regulators to develop
policies regarding such introduction.
The Program's emphasis is on risk assessment, which is defined as
the science-based evaluation and interpretation of factual information
in which a given hazard, if any, is identified, and the consequences
associated with the hazard are explored. Research funded through this
program will be relevant to risk assessment and the regulatory process.
When evaluating transgenic organisms, regulators must answer the
following four general questions: (1) Is there a hazard (potential
hazard identification)? (2) How likely is the hazard to occur
(quantifying the probability of occurrence)? (3) What is the severity
and extent of the hazard if it occurs (quantifying the effects)? and
(4) Is there an effect above and beyond what might occur with an
organism, with similar traits, developed using other technologies?
Although investigators are not required to perform actual risk
assessments in the research they propose, they should design studies
that will provide information useful to regulators for making science-
based decisions in their assessments of genetically-modified organisms.
Accordingly, program applicants are encouraged to address the following
questions in their proposals: (1) What is the relevance of this
research to the evaluation of transgenic organisms? (2) What
information will be provided by this research to help regulators
adequately assess transgenic organisms? and (3) How does this research
model appropriate studies necessary to identify and/or characterize
hazards associated with introducing genetically-modified organisms into
the environment?
The Program does not support risk management research, which is
defined to include either: (1) Research aimed primarily at reducing
effects of specific biotechnology-derived agents; or (2) a policy and
decision-making process that uses risk assessment data in deciding how
to avoid or mitigate the consequences identified in a risk assessment.
Proposals must be relevant to risk assessment to be eligible for this
Program.
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In addition to addressing the questions posed above, proposals must
include a statement describing the relevance of the proposed project to
one or more of the research topics requested in this request for
proposals. In addition, proposals should include detailed descriptions
of the experimental design and appropriate statistical analyses to be
done.
Awards will not be made for clinical trials, commercial product
development, product marketing strategies, or other research deemed not
appropriate to risk assessment.
A. Purpose of the Program
The purpose of the Program is to assist Federal regulatory agencies
in making science-based decisions about the effects of introducing into
the environment genetically modified organisms, including plants,
microorganisms (including fungi, bacteria, and viruses), arthropods,
fish, birds, mammals and other animals excluding humans. Investigations
of effects on both managed and natural environments are relevant. The
Program accomplishes this purpose by providing scientific information
derived from the risk assessment research that it funds. Research
proposals submitted to the Program must be applicable to the purpose of
the Program to be considered.
B. Available Funding
Subject to the availability of funds, the anticipated amount
available for support of the Program in FY 2000 is $1.5 million. The
agency intends to award these funds for project proposals in the
targeted areas with no more than two awards for conference proposals.
CSREES is prohibited from paying indirect costs exceeding 19
percent of the total Federal funds provided under each award on
competitively awarded research grants (7 U.S.C. 3310; Pub. L. No. 106-
78, sec. 711).
C. Areas of Research To Be Supported
Proposals addressing the following topics are requested:
1. Research relevant to assessing the effects of the introduction
into the environment of genetically engineered organisms. Potential
subject areas include but are not limited to:
(a) Research on the potential for recombination between plant
viruses and plant-encoded viral transgenes;
(b) Research on the potential for non-target effects of introduced
foreign gene products expressed in genetically modified plant-
associated microorganisms (e.g., compounds in phyllosphere or
rhizosphere-inhabiting bacteria) or in plants (e.g., Bacillus
thuringiensis delta-endotoxin), especially in regard to persistence of
the organisms and material in the environment, including their impact
on beneficial or soil organisms;
(c) Changes in ecosystem or agro-ecosystem function and
composition;
(d) Research on gene flow from transgenic crops to related plants
and exploration of factors influencing gene transfer rates. Gene flow
experiments on crops with a high potential for gene introgression into
wild or weedy relatives (e.g., those with high rates of outcrossing and
with overlapping habitats are of particular interest);
(e) Research on the role that insects and/or pathogens play in
limiting populations of crops and weeds as this relates to acquisition
of transgenic pest protection by crops and/or weeds; and
(f) Research on how transgenic plants, especially grasses, that are
resistant or tolerant to environmental stresses (such as drought or
salt) affect land use practices (new habitats or tillage), water use
(irrigation) patterns, and species displacement.
The data collected may include: survival; reproductive fitness;
genetic stability (e.g., transgene retained during backcrossing);
genetic recombination; horizontal gene transfer; loss of genetic
diversity; or enhanced competitiveness. As long as the data gathered
are relevant to the assessment of the effects of genetically modified
organisms, the experiments need not utilize transgenic organisms. When
feasible, measures of risk should include estimates of expected
frequency and impact, and address the availability of effective
mitigation measures to reduce or avoid impacts.
2. Research on large-scale deployment of genetically engineered
organisms, especially commercial uses of such organisms, with special
reference to considerations that may not be revealed through small-
scale evaluations and tests and may address cumulative effect concerns.
Studies should attempt to project impacts over as large a spatial and
temporal scale as feasible. Potential focus areas include but are not
limited to:
(a) Studies of insects and viruses that have developed resistance
to plants possessing transgenic protection from them. This may be done
by monitoring locations where such plants are grown on a commercial
scale or in large scale production. The analysis of resistant viral
strains should include analyzing whether the strain arose via
recombination between viral transgenes and the viral genome and an
analysis of how the resistance was effected (e.g., changed coat protein
with increased seed or insect vector transmissibility). The potential
for transcapsidation in transgenic plants to alter seed transmission
can be evaluated by comparing the levels of infected seed from
transgenic plants inoculated with a virus, that could be
transcapsidated, with seed from nontransgenic plants inoculated in a
similar manner. Analysis should include the presence of satellite RNA
(satRNA) which may replicate with the help of a suitable helper virus.
Such projects should survey the production sites for two to three
years.
(b) Studies to assess the impact of transgenic plants, especially
insect resistant or herbicide tolerant plants, on biodiversity of agro-
ecosystems. This could include changes in population dynamics and
species diversity of nontarget arthropods (particularly beneficial
predators, parasites, and pollinators), plants, mammals, avian or
microbial species (including both pathogenic or beneficial fungi or
bacteria associated with the crop plant). These studies should be
conducted in such a way as to compare the impacts of transgenic plants
to nontransgenic cultivars with otherwise similar phenotypes using the
commonly recommended or adopted practices for tillage, irrigation, and
control of pests or weeds. Also, effects of these plants on soil
erosion or water quality could be included. Extensive documentation of
agricultural practices will be a necessary component.
(c) Monitoring for the occurrence of individual or stacked
resistance traits in wild/weedy relatives of commercialized transgenic
crops, and subsequently, any effects of such genes on fitness,
competitiveness, and weediness.
3. Research to assess the effects of transgenes in wild relatives
of crop species. This research could evaluate the potential for
unexpected fitness effects by comparing fitness characteristics in
hybrids or introgressants between a transgenic line and the wild
relative to hybrids or introgressants between the nontransgenic line
and the wild relatives, or could evaluate fitness effects of the
introduced trait by evaluating survival or reproductive success under
natural conditions, or through planned competition experiments. Crop
species could include those with compatible wild relatives in the U.S.
which have been deregulated (e.g., rice, rapeseed, melon, and squash)
or are being developed (e.g., sunflower, turfgrasses, strawberry).
Introduced traits could include those
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that have potential effects on fitness (e.g., pest or disease
resistance), or that have potential physiological or metabolic effects.
4. Research to assess the effects of genetically engineered plants
with ``stacked'' resistance genes or genes that confer broad resistance
to insects or diseases. These genes may give recipient plants a greater
selective advantage and lead to less predictable ecological
consequences. Possible areas of research include, but are not limited
to: (a) The impact of gene stacking on non-target species; (b) the
effects of stacked genes on pest populations; (c) transmission and
establishment of multiple resistance genes into weedy relatives; (d)
influence of genetic factors such as linkage on the transmission and
establishment of multiple genes; and (e) ecological importance in weedy
hosts of pest complexes sufficiently variable as to require broad
resistance or stacked genes for their control.
5. Research to develop statistical methodology and quantitative
measures of risks associated with field testing of genetically modified
organisms.
6. The Program will, subject to resource availability, provide
partial funding to organize a conference that brings together
scientists, regulators, and others to review the science-based data
relevant to risk assessment of genetically modified organisms released
into the environment. The steering committee for the conference should
include representatives from a variety of relevant scientific
disciplines, such as ecology, population biology, pathology, production
and resource management science, as well as educators, extension
specialists and others, as appropriate. The goals of such a conference
may include sharing of scientific information and identification of
gaps in knowledge, and/or public education and outreach, among others.
Publication of the proceedings will be required. The Program will fund
a maximum of two conference proposals.
Part III. Content of a Proposal
The format guidelines for full research proposals, found in the
administrative provisions for the Program at 7 CFR 3415.4(d), should be
followed for the preparation of proposals under the Program in FY 2000.
In addition, please note the following items: (1) The Department elects
not to solicit preproposals in FY 2000; (2) a proposal's project
summary may not exceed one single- or double-spaced page. Include on
this page the proposal title, as well as names and institutions of each
investigator; and (3) a separate conflict of interest list must be
submitted with the proposal for each investigator for whom a curriculum
vita (C.V.) is required. This list is necessary to assist program staff
in excluding from proposal review those individuals who have conflicts
of interest with the project personnel in the grant proposal.
For each investigator (as described in the proposal project
description), list alphabetically the full names of only the
individuals in the following categories. It is not necessary to list
individuals in each category separately; rather, a single alphabetized
list for each investigator is preferred. Additional pages may be used
as necessary. A conflict of interest list must be submitted before a
proposal is considered complete. Inclusion of a C.V. or publication
list in lieu of a conflict of interest list is not sufficient. Other
investigators working in the applicant's specific research area are not
in conflict of interest with the applicant unless those investigators
fall within one of the categories listed below:
(A) All collaborators on research projects within the past four
years, including current and planned collaborations;
(B) All co-authors on publications within the past four years,
including pending publications and submissions;
(C) All persons in your field with whom you have had a consulting
or financial arrangement within the past four years; and
(D) All thesis or postdoctoral advisees/advisors within the past
four years.
Compliance With the National Environmental Policy Act (NEPA)
As outlined in 7 CFR part 3407 and 7 CFR part 520 (the CSREES and
ARS regulations implementing the National Environmental Policy Act of
1969 (NEPA), as amended (42 U.S.C. 4321 et seq.)), environmental data
or documentation for the proposed project is to be provided to CSREES
and ARS in order to assist CSREES and ARS in carrying out their
responsibilities under NEPA. These responsibilities include determining
whether the project requires an Environmental Assessment (EA) or an
Environmental Impact Statement (EIS) or whether it can be excluded from
this requirement on the basis of the categorical exclusions listed in 7
CFR 3407.6. To assist CSREES and ARS in this determination, the
applicant should review the categories defined for exclusion to
ascertain whether the proposed project may fall within one of the
exclusions.
Form CSREES-1234, NEPA Exclusions Form (copy in Application Kit),
indicating the applicant's opinion of whether or not the project falls
within one or more categorical exclusions, along with supporting
documentation, must be included in the proposal. The information
submitted in association with NEPA compliance should be identified in
the Table of Contents as ``NEPA Considerations'' and Form CSREES-1234
and supporting documentation should be placed after the Form CSREES-
661, Application for Funding, in the proposal.
Even though the applicant considers that a proposed project may
fall within a categorical exclusion, CSREES and ARS may determine that
an EA or an EIS is necessary for an activity if substantial controversy
on environmental grounds exists or if other extraordinary conditions or
circumstances are present that may cause such activity to have a
significant environmental effect.
Part IV. How To Obtain Application Materials
Copies of this request for proposals, the administrative provisions
for the Program (7 CFR part 3415), and the Application Kit, which
contains required forms, certifications, and instructions for preparing
and submitting applications for funding, may be obtained by contacting:
Proposal Services Unit, Office of Extramural Programs, Cooperative
State Research, Education, and Extension Service, U.S. Department of
Agriculture, STOP 2245, 1400 Independence Avenue, SW, Washington, DC
20250-2245; telephone Number: (202) 401-5048.
Application materials also may be requested via Internet by sending
a message with your name, mailing address (not e-mail) and telephone
number to psb@reeusda.gov which states that you wish to receive a copy
of the application materials for the FY 2000 Biotechnology Risk
Assessment Research Grants Program. The materials will then be mailed
to you (not e-mailed) as quickly as possible.
This request for proposals and other application information and
materials also are available at the Program's website (http://
www.reeusda.gov/crgam/biotechrisk/biotech.htm).
Part V. Submission of a Proposal
A. What to Submit
An original and 14 copies of a proposal must be submitted.
Proposals should be typed on 8\1/2\" x 11" white paper, single- or
double-spaced, and one side of the page only. The text of the proposal
should be prepared using no type smaller than 12 point font size and
one-inch margins. Each copy of each
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proposal must be stapled securely in the upper lefthand corner. (DO NOT
BIND.) All copies of the proposal must be submitted in one package.
B. Where and When To Submit
Hand-delivered proposals (brought in person by the applicant or
through a courier service) must be received on or before April 10,
2000, at the following address: Biotechnology Risk Assessment Research
Grants Program; c/o Proposal Services Unit; Office of Extramural
Programs; Cooperative State Research, Education, and Extension Service;
U.S. Department of Agriculture, Room 303, Aerospace Center; 901 D
Street, SW; Washington, DC 20024. The telephone number is (202) 401-
5048. Proposals transmitted via a facsimile (fax) machine will not be
accepted.
Proposals submitted through the U.S. mail must be received on or
before April 10, 2000. Proposals submitted through the U.S. mail should
be sent to the following address: Biotechnology Risk Assessment
Research Grants Program; Proposal Services Unit; Office of Extramural
Programs, Cooperative State Research, Education, and Extension Service,
U.S. Department of Agriculture; STOP 2245; 1400 Independence Avenue,
SW; Washington, DC 20250-2245.
C. Acknowledgment of Proposals
The receipt of all proposals will be acknowledged in writing or via
the Internet (e-mail). Therefore, it is important to include your e-
mail address on Form CSREES-661 when applicable. This acknowledgment
will contain a proposal identification number. Once your proposal has
been assigned a proposal number, please cite that number in future
correspondence.
Part VI. Proposal Evaluation
Proposals will be evaluated by the Administrators of ARS and CSREES
assisted by a peer panel of scientists for scientific merit,
qualifications of project personnel, adequacy of facilities, and
relevance to both risk assessment research and regulation of
agricultural biotechnology. Proposals for funding a scientific research
conference grant will be evaluated on the following criteria: choice of
topics and selection of speakers; general format of the conference,
especially with regard to its appropriateness for fostering scientific
exchange and/or public understanding; provisions for wide participation
from the scientific and regulatory community and others as appropriate;
qualifications of the organizing committee and appropriateness of
invited speakers to the topic areas being covered; and appropriateness
of the budget requested and qualifications of the project personnel.
All proposals are considered together in making award decisions.
However, no more than two conference grants will be awarded.
Part VII. Supplementary Information
A. Applicable Regulations
This Program is subject to the administrative provisions found in 7
CFR part 3415, which set forth procedures to be followed when
submitting grant proposals, rules governing the evaluation of
proposals, the awarding of grants, and post-award administration of
such grants. Several other Federal statutes and regulations apply to
grant proposals considered for review or to grants awarded under this
Program. These include but are not limited to: 7 CFR Part 3019--USDA
implementation of OMB Circular A-110, Uniform Administrative
Requirements for Grants and Other Agreements with Institutions of
Higher Education, Hospitals and Other Nonprofit Organizations.
B. Programmatic Contact
For additional information on the Program, please contact:
Dr. Deborah Sheely, Cooperative State Research, Education, and
Extension Service; U.S. Department of Agriculture; Stop 2241; 1400
Independence Avenue, SW; Washington, DC 20250-2241; Telephone: (202)
401-1924; e-mail: dsheely@reeusda.gov; or
Dr. Robert M. Faust; Agricultural Research Service; U.S. Department of
Agriculture; Room 338, Building 005, BARC-West; Beltsville, MD 20705;
telephone: (301) 504-6918, e-mail: rmf@ars.usda.gov.
C. Stakeholder Input
CSREES is soliciting comments regarding this solicitation of
applications from any interested party. In your comments, please
include the name of the program and the fiscal year of the request for
proposals to which you are responding. These comments will be
considered in the development of the next request for proposals for the
program. Such comments will be used in meeting the requirements of
section 103(c)(2) of the Agricultural Research, Extension, and
Education Reform Act of 1998 (7 U.S.C. 7613(c)(2)). Comments should be
submitted as provided for in the ADDRESSES and DATES portions of this
notice.
D. Additional Information
The Biotechnology Risk Assessment Research Grants Program is listed
in the Catalog of Federal Domestic Assistance under No. 10.219. For
reasons set forth in the final rule-related Notice to 7 CFR part 3015,
subpart V (48 FR 29115, June 24, 1983), this Program is excluded from
the scope of Executive Order No. 12372 which requires intergovernmental
consultation with State and local officials.
Under the provisions of the Paperwork Reduction Act of 1995, as
amended (44 U.S.C. chapter 35), the collection of information
requirements contained in this Notice have been approved under OMB
Document No. 0524-0022.
Done at Washington, DC, on this 28th day of February, 2000.
Charles W. Laughlin,
Administrator, Cooperative State Research, Education, and Extension
Service.
Edward B. Knipling,
Acting Administrator, Agricultural Research Service.
[FR Doc. 00-5174 Filed 3-2-00; 8:45 am]
BILLING CODE 3410-22-P
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