[Federal Register Volume 66, Number 10 (Tuesday, January 16, 2001)]
[Notices]
[Pages 3533-3537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1018]


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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 2001; 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) 2001. 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 requests comments regarding this request for proposals 
(RFP) from any interested party. These comments will be considered in 
the development of the next RFP 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 March 15, 
2001. 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 
this notice. Comments received after that date will be considered to 
the extent practicable.

ADDRESSES: Proposals must be submitted to the following mailing 
address: 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; 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 1307, 
Waterfront Centre; 800 9th Street, S.W.; 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: [email protected]. (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: [email protected]; 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: [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

Stakeholder Input
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. Additional Information

Stakeholder Input

    CSREES is requesting comments regarding this RFP from any 
interested party. In your comments, please include the name of the 
program and the fiscal year of the RFP to which you are responding. 
These comments will be considered in the development of the next RFP 
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

[[Page 3534]]

ADDRESS and DATES portions of this Notice.

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.
    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 RFP. 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 2001 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.
    Pursuant to section 1462 of NARETPA, 7 U.S.C. 3310, indirect costs 
charged against a grant awarded under this program may not exceed 19 
percent of the total Federal funds provided under the grant award. (An 
alternative method to calculate this limitation is to multiply total 
direct costs by 23.456 percent.)

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; (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

[[Page 3535]]

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 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 2001. 
In addition, please note the following items: (1) the Department elects 
not to solicit preproposals in FY 2001; (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; (3) Proposal budgets (Form CSREES-55) must include funds 
sufficient for travel by all principal investigators to Washington, 
D.C. for one meeting during the period of the award. The purpose of 
this meeting is to report on the progress of the research to USDA 
program and regulatory staff; and (4) a separate conflict of interest 
list must be submitted with the proposal for all key personnel 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 all key personnel (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 all key personnel 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.

[[Page 3536]]

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 RFP, 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 [email protected] which states that you wish to receive a copy 
of the application materials for the FY 2001 Biotechnology Risk 
Assessment Research Grants Program. The materials will then be mailed 
to you (not e-mailed) as quickly as possible.
    This RFP 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 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 March 15, 
2001, 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 1307; Waterfront Centre; 800 9th 
Street, S.W.; Washington, D.C. 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 March 15, 2001. Proposals submitted through the U.S. mail should 
be sent to 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; STOP 2245; 1400 
Independence Avenue, S.W.; Washington, D.C. 20250-2245.

C. Acknowledgment of Proposals

    The receipt of all proposals will be acknowledged 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 Grant and 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, S.W.; Washington, D.C. 20250-2241; Telephone: (202) 401-1924; 
e-mail: [email protected]; or Dr. Robert M.

[[Page 3537]]

Faust; Agricultural Research Service; U.S. Department of Agriculture; 
Room 338, Building 005, BARC-West; Beltsville, MD 20705; Telephone: 
(301) 504-6918; e-mail: [email protected].

C. 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, D.C., on this 4th day of January, 2001.
Colien Hefferan,
Administrator, Cooperative State Research, Education, and Extension 
Service.
Edward B. Knipling,
Acting Administrator, Agricultural Research Service.
[FR Doc. 01-1018 Filed 1-12-01; 8:45 am]
BILLING CODE 3410-22-P