[Federal Register Volume 62, Number 247 (Wednesday, December 24, 1997)]
[Notices]
[Pages 67488-67490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33500]
[[Page 67487]]
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Part IV
Department of Agriculture
_______________________________________________________________________
Agricultural Research Service
Cooperative State Research, Education, and Extension Service
_______________________________________________________________________
Biotechnology Risk Assessment Research Grants Program for Fiscal Year
1998; Solicitation of Applications; Notice
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 /
Notices
[[Page 67488]]
DEPARTMENT OF AGRICULTURE
Agricultural Research Service
Cooperative State Research, Education, and Extension Service
Biotechnology Risk Assessment Research Grants Program for Fiscal
Year 1998; Solicitation of Applications
AGENCY: Agricultural Research Service; Cooperative State Research,
Education, and Extension Service, USDA.
ACTION: Notice of Biotechnology Risk Assessment Research Grants
Program; Fiscal Year 1998 solicitation of applications.
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SUMMARY: Applications are invited for competitive grant awards under
the Biotechnology Risk Assessment Research Grants Program (the
``Program'') for fiscal year (FY) 1998. 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, 1998.
FOR FURTHER INFORMATION CONTACT: Dr. Edward K. Kaleikau, USDA/CSREES,
(202) 401-1901, Dr. Daniel D. Jones, USDA/CSREES, (202) 401-6854, or
Dr. Robert M. Faust, USDA/ARS, (301) 504-6918.
SUPPLEMENTARY INFORMATION:
Table of Contents
Purpose
Applicant Eligibility
Available Funding
Program Description
Proposal Evaluation
Areas of Research to be Supported in Fiscal Year 1998
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
Purpose
The purpose of the Program is to assist Federal regulatory agencies
in making science-based decisions about the safety of introducing into
the environment genetically modified organisms, including plants,
microorganisms, fungi, bacteria, viruses, arthropods, fish, birds,
mammals and other animals. 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 1998 is $1.5 million.
Section 712 of the Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies Appropriations Act, 1998 (Pub. L.
105-86), prohibits CSREES from using the funds available for the
Program for FY 1998 to pay indirect costs exceeding 14 per centum of
the total Federal funds provided under each award on competitively
awarded research grants.
Section 716 of the Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies Appropriations Act, 1998,
encourages entities to use grant funds to purchase only American-made
equipment or products in the case of any equipment or product that may
be authorized to be purchased with the funds provided under this
program.
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 research emphasis is on risk assessment and not risk
management. The Program defines risk assessment research 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. The Program defines risk
management as (1) research aimed primarily at reducing risks of
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 topics requested in this
solicitation. In addition, proposals must include detailed descriptions
of the experimental design and appropriate statistical analyses to be
done. The Program strongly encourages the inclusion of statisticians
and risk analysis researchers as co-principal investigators or
contractors.
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 Administrator 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.
Areas of Research To Be Supported in Fiscal Year 1998
Proposals addressing the following topics are requested:
1. Research on the introduction into the environment (not in a
contained facility) of genetically engineered organisms. 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.
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. This may include monitoring locations
where transgenic virus resistant plants (expressing viral transgenes)
are grown on a commercial scale or in large-scale production for viral
strains which overcome the resistance phenotype. The analysis of
resistance-breaking 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
evidence, if any, that the
[[Page 67489]]
introduction of a pest resistance gene into a crop plant poses the risk
of increasing the fitness of weedy, sexually compatible relatives of
the crop plant. Data considered should include the introduction of pest
resistance genes by conventional breeding or by a process involving
recombinant DNA. The conference should provide an opportunity to
address how experiments could be designed to test whether a pest
resistance gene increases the fitness of weeds in the field. The
scientific steering committee for the conference should include a broad
representation of disciplines, including ecology, population biology,
plant pathology, entomology, plant breeding, and others as appropriate.
Evaluation criteria of submitted proposals will include: 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.
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, as amended by 62 FR 45934--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. Daniel D. Jones, Cooperative State Research, Education, and
Extension Service, U.S. Department of Agriculture, STOP 2220, 1400
Independence Avenue, S.W., Washington, D.C. 20250-2220, Telephone:
(202) 401-6854
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
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, Grants Management Branch, 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 may also 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 1998 Biotechnology Risk
Assessment Research Grants Program. The materials will then be mailed
to you (not e-mailed) as quickly as possible.
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 1998.
(Note that the Department elects not to solicit preproposals in FY
1998.)
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
[[Page 67490]]
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 therefor. 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 must be postmarked by March 24, 1998 to be eligible for
the program. Proposals received after the deadline date of March 24,
1998, 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 must be sent to the following
address: Biotechnology Risk Assessment Research Grants Program, c/o
Proposal Services Unit, Grants Management Branch, 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 must be received at the following
address by March 24, 1998 (note that the zip code differs from that
shown above): Biotechnology Risk Assessment Research Grants Program, c/
o Proposal Services Unit, Grants Management Branch, 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 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 15 day of December, 1997.
Colien Hefferan,
Associate Administrator, Cooperative State Research, Education, and
Extension Service.
Edward B. Knipling,
Associate Administrator, Agricultural Research Service.
[FR Doc. 97-33500 Filed 12-23-97; 8:45 am]
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