[Federal Register Volume 63, Number 242 (Thursday, December 17, 1998)]
[Notices]
[Pages 69986-69989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33550]



[[Page 69985]]

_______________________________________________________________________

Part V





Department of Agriculture





_______________________________________________________________________



Agricultural Research Service



_______________________________________________________________________



Cooperative State Research, Education, and Extension Service, USDA



_______________________________________________________________________



Biotechnology Risk Assessment Research Grants Program for Fiscal Year 
1999; Solicitation of Applications; Notice

  Federal Register / Vol. 63, No. 242 / Thursday, December 17, 1998 / 
Notices  

[[Page 69986]]



DEPARTMENT OF AGRICULTURE

Agricultural Research Service
Cooperative State Research, Education, and Extension Service


Biotechnology Risk Assessment Research Grants Program for Fiscal 
Year 1999; Solicitation of Applications

AGENCY: Agricultural Research Service; Cooperative State Research, 
Education, and Extension Service.

ACTION: Notice of Biotechnology Risk Assessment Research Grants 
Program; Fiscal Year 1999 Solicitation of Applications.

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

SUMMARY: Applications are invited for competitive grant awards under 
the Biotechnology Risk Assessment Research Grants Program (the 
``Program'') for fiscal year (FY) 1999. 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 
the Cooperative State Research, Education, and Extension Service 
(CSREES) and the Agricultural Research Service (ARS) of the U.S. 
Department of Agriculture.

DATES: Proposals are due March 24, 1999.

FOR FURTHER INFORMATION CONTACT: Dr. Edward K. Kaleikau, USDA/CSREES, 
(202) 401-1901, Dr. Robert M. Faust, USDA/ARS, (301) 504-6918, or Dr. 
Deborah Sheely, USDA/CSREES, (202) 401-1924.

SUPPLEMENTARY INFORMATION:

Table of Contents

    Stakeholder Input
    Purpose
    Applicant Eligibility
    Available Funding
    Program Description
    Proposal Evaluation
    Areas of Research to be Supported in Fiscal Year 1999
    Applicable Regulations
    Programmatic Contact
    How to Obtain Application Materials
    Proposal Format
    Compliance with the National Environmental Policy Act (NEPA)
    Proposal Submission and Due Date
    Additional Information

Stakeholder Input

    CSREES is soliciting comments regarding this solicitation of 
applications from any interested party. These comments will be 
considered in the development of the next request for proposals for the 
Program. Such comments will be forwarded to the Secretary or his 
designee for use 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). Written comments should be submitted by first-
class mail to: Office of Extramural Programs; Competitive Research 
Grants and Awards Management; USDA-CSREES; STOP 2299; 1400 Independence 
Avenue, S.W., Washington, D.C. 20250-2299, or via e-mail to: RFP-
[email protected].
    In your comments, please include the name of the program and the 
fiscal year solicitation of applications to which you are responding. 
Comments are requested within six months from the issuance of the 
solicitation of applications. Comments received after that date will be 
considered to the extent practicable.

Purpose

    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, fungi, bacteria, 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.

Applicant Eligibility

    Proposals may be submitted by any United States public or private 
research or educational institution or organization.

Available Funding

    Subject to the availability of funds, the anticipated amount 
available for support of the Program in FY 1999 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). However, Section 
711 of the Agriculture, Rural Development, Food and Drug 
Administration, and Related Agencies Appropriations Act, 1999, Sec. 
107(a), Pub. L. No. 105-277 prohibits CSREES from using the funds 
available for the Program for FY 1999 to pay indirect costs exceeding 
14 percent of the total Federal funds provided under each award on 
competitively awarded research grants.

Program Description

    CSREES and ARS will competitively award research grants to support 
science-based biotechnology regulation and thus help address concerns 
about the effects of introducing genetically modified organisms into 
the environment and help regulators in developing 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. Investigators are encouraged 
to design studies in which answers to three general questions are 
sought: 1) what is the risk (potential risk identification)?; 2) how 
likely is the risk to occur (quantifying the probability of 
occurrence)?; and 3) what is the severity and extent of the effect if 
it occurs (quantifying the effects)? Proposals that address all three 
questions are preferred. However, studies of a single question will 
also be considered if developed within the broader context of risk 
assessment. The Program does not support risk management research, 
which is defined as (1) research aimed primarily at reducing risks of 
specific biotechnology-derived agents and (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.
    Proposals must include a statement describing the relevance of the 
proposed project to one or more of the research topics requested in 
this solicitation. 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.

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

[[Page 69987]]

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; 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.

Areas of Research To Be Supported in Fiscal Year 1999

    Proposals addressing the following topics are requested:
    1. Research relevant to assessing the risk of the introduction into 
the environment of genetically engineered organisms. Potential subject 
areas include but are not limited to: research on the potential for 
recombination between plant viruses and plant-encoded viral transgenes; 
research on the potential for nontarget effects of introduced plant-
defense compounds expressed in genetically modified plant-associated 
microorganisms (e.g., compounds in the phyllosphere or rhizosphere-
inhabiting bateria) or in plants (e.g., Bacillus thuringiensis delta-
endotoxin), especially in regard to persistence of the organisms and 
material in the environment; changes in ecosystem or agro-ecosystem 
function and composition; or research on gene flow from transgenic 
crops to related plants. The data collected may include: survival; 
reproductive fitness; genetic stability; genetic recombination; 
horizontal gene transfer; loss of genetic diversity; or enhanced 
competitiveness. The organisms may include: fungi; bacteria; viruses; 
microorganisms; plants; arthropods; fish; birds; mammals; and other 
animals excluding humans. As long as the data gathered are relevant to 
the assessment of the risk of genetically modified organisms, the 
experiments need not utilize genetically engineered organisms. When 
feasible, measure 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. Studies should attempt to project impacts 
over as large a spatial and temporal scale as feasible. Of particular 
interest are studies that survey transgenic insect and virus resistant 
plants for insects and viral strains that have overcome the resistance 
phenotype. This may be done by monitoring locations where such plants 
are grown on a commercial scale or in large scale production. The 
analysis of resistance-breaking viral strains should include analyzing 
whether the strain arose via recombination between viral transgenes and 
the viral genome. Such projects should survey the production sites for 
two to three years.
    3. Research to develop statistical methodology and quantitative 
measures of risks associated with field testing of genetically modified 
organisms.
    4. The Program will, subject to resource availability, provide 
partial funding to organize a scientific research conference that 
brings together scientists and regulators to review the science-based 
data relevant to risk assessment of genetically modified organisms 
released into the environment. The scientific steering committee for 
the conference should include representatives from a variety of 
relevant disciplines, such as ecology, population biology, pathology, 
production and resource management science, and others, as appropriate. 
The Program will fund a maximum of two conference proposals.

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 Agreements with Institutions 
of Higher Education, Hospitals and Other Nonprofit Organizations.

Programmatic Contact

    For additional information on the Program, please contact:

Dr. Edward K. Kaleikau, 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) 401-1901
    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,
    or
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

How To Obtain Application Materials

    Copies of this solicitation, 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, S.W., Washington, 
D.C. 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 1999 Biotechnology Risk 
Assessment Research Grants Program. The materials will then be mailed 
to you (not e-mailed) as quickly as possible.
    This Solicitation and other application information and materials 
also are available at the Program's website (http://www.reeusda.gov/
crgam/biotechrisk/biotech.htm).

Proposal Format

    The format guidelines for full research proposals, found in the 
administrative provisions for the Program at Sec. 3415.4(d), should be 
followed for the preparation of proposals under the Program in FY 1999. 
In addition, please note the following items: (1) The Department elects 
not to solicit preproposals in FY 1999; (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 
vitae (C.V.) is required. This list is

[[Page 69988]]

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 (and other personnel as described in the 
program 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 five 
years, including current and planned collaborations;
    (B) All co-authors on publications within the past five 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 five years; and
    (D) All thesis or postdoctoral advisees/advisors within the past 
five 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), environmental data for any proposed project is to be provided to 
CSREES and ARS so that CSREES and ARS may determine whether any further 
action is needed. 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 
applicant shall review the following categorical exclusions and 
determine if the proposed project may fall within one of the 
categories:

(1) Department of Agriculture Categorical Exclusions (7 CFR 1b.3)

    (i) Policy development, planning and implementation which are 
related to routine activities such as personnel, organizational 
changes, or similar administrative functions;
    (ii) Activities which deal solely with the funding of programs, 
such as program budget proposals, disbursements, and transfer or 
reprogramming of funds;
    (iii) Inventories, research activities, and studies, such as 
resource inventories and routine data collection when such actions are 
clearly limited in context and intensity;
    (iv) Educational and informational programs and activities;
    (v) Civil and criminal law enforcement and investigative 
activities;
    (vi) Activities which are advisory and consultative to other 
agencies and public and private entities; and
    (vii) Activities related to trade representation and market 
development activities abroad.

(2) CSREES and ARS Categorical Exclusions (7 CFR 3407.6 and 7 CFR 
520.5)

    Based on previous experience, the following categories of CSREES 
and ARS actions are excluded because they have been found to have 
limited scope and intensity and to have no significant individual or 
cumulative impacts on the quality of the human environment:
    (i) The following categories of research programs or projects of 
limited size and magnitude or with only short-term effects on the 
environment:
    (A) Research conducted within any laboratory, greenhouse, or other 
contained facility where research practices and safeguards prevent 
environmental impacts;
    (B) Surveys, inventories, and similar studies that have limited 
context and minimal intensity in terms of changes in the environment; 
and
    (C) Testing outside of the laboratory, such as in small, isolated 
field plots, which involves the routine use of familiar chemicals or 
biological materials.
    (ii) Routine renovation, rehabilitation, or revitalization of 
physical facilities, including the acquisition and installation of 
equipment, where such activity is limited in scope and intensity.
    In order for CSREES and ARS to determine whether any further action 
is needed with respect to NEPA, pertinent information regarding the 
possible environmental impacts of a particular project is necessary; 
therefore, a separate statement must be included in the proposal 
indicating whether the applicant is of the opinion that the project 
falls within a categorical exclusion and the reasons therefore. If it 
is the applicant's opinion that the project proposed falls within the 
categorical exclusions, the specific exclusions must be identified. The 
information submitted shall be identified as ``NEPA Considerations'' 
and the narrative statement shall be placed after the coversheet of the 
proposal.
    Even though a project may fall within the categorical exclusions, 
CSREES and ARS may determine that an Environmental Assessment or an 
Environmental Impact Statement is necessary for an activity, if 
substantial controversy on environmental grounds exists or if other 
extraordinary conditions or circumstances are present which may cause 
such activity to have a significant environmental effect.

Proposal Submission and Due Date

What To Submit

    An original and 14 copies of a proposal must be submitted. 
Proposals should be typed on one side of the page only. 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.

Where and When To Submit

    Proposals sent by First Class, an express mail service, or courier 
service must be postmarked on or by March 24, 1999, to be eligible for 
the program. Proposals hand-delivered must be received on or by March 
24, 1999. Proposals received after the deadline date of March 24, 1999, 
as indicated either by the postmark date on First Class or express 
mail, or by the date on a courier bill of lading, will be returned 
without review. Proposals sent via First Class must 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, Telephone: (202) 401-5048.
    Proposals delivered by hand, express mail, or overnight courier 
must be sent to the following address (note that the zip code differs 
from that shown above): 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, 
S.W., Washington, D.C. 20024, Telephone: (202) 401-5048.

Additional Information

    The Biotechnology Risk Assessment Research Grants Program is listed 
in the

[[Page 69989]]

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 (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 third day of December, 1998.
Colien Hefferan,
Acting Administrator, Cooperative State Research, Education, and 
Extension Service.
Floyd Horn,
Administrator, Agricultural Research Service.
[FR Doc. 98-33550 Filed 12-16-98; 8:45 am]
BILLING CODE 3410-22-P