[Federal Register Volume 59, Number 220 (Wednesday, November 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28344]
[[Page Unknown]]
[Federal Register: November 16, 1994]
_______________________________________________________________________
Part V
Department of Agriculture
Agricultural Research Service
Cooperative State Research, Education, and Extension Service
_______________________________________________________________________
Biotechnology Risk Assessment Research Grants Program; Fiscal Year
1995; Solicitation of Applications; Notice
DEPARTMENT OF AGRICULTURE
Agricultural Research Service
COOPERATIVE STATE RESEARCH, EDUCATION, AND EXTENSION SERVICE
Biotechnology Risk Assessment Research Grants Program; Fiscal
Year 1995; Solicitation of Applications
Purpose
Proposals are invited for competitive grant awards under the
Biotechnology Risk Assessment Research Grants Program (the ``Program'')
for fiscal year 1995. The authority for the Program is contained in
section 1668 of Public Law 101-624 (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. (The CSREES was established by
Pub. L. 103-354, the Federal Crop Insurance Reform and Department of
Agriculture Reorganization Act of 1994, and the functions of the
Cooperative State Research Service were transferred to the CSREES by
the Secretary of Agriculture's Memorandum 1010-1.)
The purpose of the Program is to assist Federal regulatory agencies
in making science-based decisions about the safety of introducing
genetically modified plants, animals, and microorganisms into the
environment. The Program accomplishes this purpose by providing
scientific information derived from the risk assessment research
conducted under it. Research proposals submitted to the Program must be
applicable to the purpose of the Program to be considered. Proposals
based upon field research and whole organism-population level studies
are strongly encouraged. Awards will not be made for clinical trials,
commercial product development, product marketing strategies, or other
research not appropriate to risk assessment. Proposals should be
applicable to current regulatory issues surrounding the ecological
impacts of genetically modified organisms, with special emphasis on
natural ecosystem consequences.
Applicant Eligibility
Proposals may be submitted by any United States public or private
research or educational institution or organization.
Available Funding
The amount available for support of the Program in fiscal year 1995
is approximately $1.7 million.
Pursuant to Section 712 of Public Law 103-330 (the Agriculture,
Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act, 1995), funds available in fiscal year 1995 to pay
indirect costs on research grants awarded competitively by CSREES may
not exceed 14 per centum of the total Federal funds provided under each
award.
In addition, pursuant to Sec. 719(b) of Public Law 103-330, in the
case of any equipment or product that may be authorized to be purchased
with the funds provided under this Program, entities are encouraged to
use such funds to purchase only American-made equipment or products.
Program Description
Under the Program, USDA 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 to help regulators develop policies
concerning such introduction. Proposals are invited in the area of
biotechnology risk assessment research as appropriate to agricultural
plants, animals and microbes. Emphasis will be given to risk assessment
research involving genetically modified organisms, but model systems
using nongenetically modified organisms also will be considered if they
can provide information that could lead to improved assessment of
potential risks associated with the introduction of genetically
modified organisms into the environment.
Proposals will be evaluated by the Administrator assisted by a peer
panel of scientists for science quality, relevance for current
regulatory issues, and intent to advance the safe application of
biotechnology to agriculture by providing new knowledge for science-
based regulatory decisions. The development of better risk assessment
methods for field testing genetically modified organisms will also be
considered.
Areas of Research to Be Supported in Fiscal Year 1995
Proposals addressing the following research topics are requested:
1. Development of new risk assessment methods (e.g., monitoring
organism escape, measuring biological impacts), and risk assessment
procedures (e.g., comparative analysis of ecosystems, models to predict
risks) that could be used in risk assessment of genetically modified
fungi, bacteria, viruses (including animal vaccines), plants,
arthropods, fish, birds, and mammals. Applicants should address the
need for, and development of, such new risk assessment methods in the
course of addressing a specific and defined risk assessment issue,
especially as pertains to genetically modified organisms.
2. Creation of information systems and computer models to support
regulatory agency decision-making in regards to potential impacts to
the environment over time (e.g., computer models to describe the
interaction of environmental and organismal factors especially for
establishment and dispersal of the organism).
3. Risk assessment of the environmental fate (e.g., survival,
reproduction fitness, genetic stability, horizontal gene transfer) as
correlated with effects (e.g., loss of genetic diversity, enhanced
competition) of genetically modified fungi, bacteria, viruses, plants,
arthropods, fish, birds and mammals introduced into the environment
(i.e., not in a contained laboratory, greenhouse or building); and
studies or identification of traits which may influence fate and
effects.
In response to requests to Program Directors and Federal regulatory
agencies, as stipulated in the authorizing legislation for the Program,
section 1668 of Public Law 101-624, the following specific areas of
risk assessment research have been identified as eligible for
competition as research topics for this year.
4. The bidirectional rates, effects of selection pressures,
mechanisms and impact of gene transfer between currently genetically
transformable crop species and existing North American wild relatives
of those crops including studies of methods of mitigation of potential
gene exchange. Species specifically identified by the Animal and Plant
Health Inspection Service include rye, oats, barley, sorghum and
turfgrasses. Research could rely on reanalysis of published information
and/or laboratory/field studies.
5. The potential for recombination between plant viruses and plant-
encoded noncapsid viral genes (e.g., replicase), especially for those
viruses in supergroup B (carmovirus, tombusvirus, luteovirus,
sobemovirus). Such studies should identify recombination potentials
and, if demonstrated, define frequencies and effect on symptom
expression.
6. The potential for plants to express nonviral genes using
noncoding regulatory sequences (promoters, translational enhancers,
termination sequences) derived from plant viruses that naturally infect
the plants (e.g., cauliflower mosaic virus and Brassica spp.). The
potential for changes in expression of introduced genes or other
aspects of host physiology when the transgenic plant becomes infected
with plant viruses, especially those from which the noncoding sequence
was derived or from related viruses.
7. Changes in viral host ranges or the types of viral vectors as a
result of the use of transgenic plants expressing viral genes.
8. The potential for nontarget effects of introduced plant-defense
compounds 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.
9. Identification of genes which can confer additional
pathogenicity to animal pathogens. Pathogenic organisms specifically
identified by the Animal and Plant Health Inspection Service as being
of interest are Marek's disease virus, laryngo tracheitis virus, bovine
leukemia virus, eastern equine encephalomyelitis virus, bovine diarrhea
virus, Erysipelothrix rhusiopathiae and Haemophilus somnus.
10. Environmental risk analysis of 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.
All research proposals submitted should include a statement
describing the relevance of the proposed project to one or more of the
research topics requested. When appropriate, detailed descriptions of
statistical analyses to be done should be included in the proposal. The
inclusion of statisticians as co-principal investigators or contractors
is encouraged.
Note: Individual investigators whose research projects are
funded under the Program will be required to attend and present data
on the results of their research at an Annual Conference. Attendance
costs at such a conference do not need to be included in the budgets
of proposed research projects; such costs will be paid from funds
provided under a cooperative agreement between CSREES and the
University of Maryland for an annual risk assessment symposium.
Additionally, a final project report on research results will be
required in a fixed protocol, electronic format, suitable for
distribution by USDA on CD-ROM.
Applicable Regulations
This Program is subject to the administrative provisions found in 7
CFR part 3415 (58 FR 65646, December 15, 1993), 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 1.1--USDA implementation of the Freedom of
Information Act;
7 CFR Part 1c--USDA implementation of the Federal Policy for the
Protection of Human Subjects;
7 CFR Part 3--USDA implementation of OMB Circular A-129
regarding debt collection;
7 CFR Part 15, Subpart A--USDA implementation of Title VI of the
Civil Rights Act of 1964;
7 CFR Part 520--ARS implementation of the National Environmental
Policy Act;
7 CFR Part 3015--USDA Uniform Federal Assistance Regulations,
implementing OMB directives (i.e., Circular Nos. A-110, A-21, and A-
122) and incorporating provisions of 31 U.S.C. 6301-6308 (formerly,
the Federal Grant and Cooperative Agreement Act of 1977, Pub. L. No.
95-224), as well as general policy requirements applicable to
recipients of Departmental financial assistance;
7 CFR Part 3016--USDA Uniform Administrative Requirements for
Grants and Cooperative Agreements to State and Local Governments;
7 CFR Part 3017, as amended--USDA implementation of
Governmentwide Debarment and Suspension (Nonprocurement) and
Governmentwide Requirements for Drug-Free Workplace (Grants);
7 CFR Part 3018--USDA implementation of New Restrictions on
Lobbying. Imposes new prohibitions and requirements for disclosure
and certification related to lobbying on recipients of Federal
contracts, grants, cooperative agreements, and loans;
7 CFR Part 3051--Audits of Institutions of Higher Education and
Other Nonprofit Institutions;
7 CFR Part 3407--CSREES implementation of the National
Environmental Policy Act;
29 U.S.C. 794, section 504--Rehabilitation Act of 1973, and 7
CFR Part 15B (USDA implementation of the statute), prohibiting
discrimination based upon physical or mental handicap in Federally
assisted programs;
35 U.S.C. 200 et seq.--Bayh-Dole Act, controlling allocation of
rights to inventions made by employees of small business firms and
domestic nonprofit organizations, including universities, in
Federally assisted programs (implementing regulations are contained
in 37 CFR Part 401).
Programmatic Contact
For additional information on the Program, please contact:
Dr. Ann Lichens-Park, Cooperative State Research, Education, and
Extension Service, U.S. Department of Agriculture, Ag Box 2220,
Washington, DC 20250-2220, Telephone: (202) 401-4892
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 will be made
available upon request. The Application Kit contains required forms,
certifications, and instructions for preparing and submitting grant
applications. The administrative provisions include guidelines for
proposal format.
Copies of this solicitation, the administrative provisions, and the
Application Kit may be obtained by contacting:
Proposal Services Branch, Awards Management Division, Cooperative State
Research, Education, and Extension Service, U.S. Department of
Agriculture, Ag Box 2245, Washington, DC 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@csrees.esusda.gov which states that you wish to receive a
copy of the application materials for the Fiscal Year 1995
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 fiscal
year 1995. (Note that the Department elects not to solicit preproposals
nor conference grant proposals in fiscal year 1995).
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. 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 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 exist or if other
extraordinary conditions or circumstances are present which may cause
such activity to have a significant environmental effect.
Proposal Submission
What to Submit
An original and 14 copies of a proposal must be submitted. 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 submitted through the regular mail must be received by
January 13, 1995, and must be sent to the following address:
Proposal Services Branch, Awards Management Division, Cooperative State
Research, Education, and Extension Service, U.S. Department of
Agriculture, Ag Box 2245, Washington, DC 20250-2245, Telephone: (202)
401-5048
Hand-delivered proposals must be brought to the following address
by c.o.b. (4:30 p.m.) on January 13, 1995 (note that the zip code
differs from that shown above):
Proposal Services Branch, Awards Management Division, Cooperative State
Research, Education, and Extension Service, U.S. Department of
Agriculture, Room 303, Aerospace Center, 901 D Street, S.W.,
Washington, DC 20024, Telephone: (202) 401-5048
Supplementary 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 1980 (44
U.S.C. 3504(h)), 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 7th day of November, 1994.
Sarah J. Rockey,
Acting Administrator, Cooperative State Research, Education, and
Extension Service.
Richard L. Dunkle,
Acting Associate Administrator, Agricultural Research Service.
[FR Doc. 94-28344 Filed 11-15-94; 8:45 am]
BILLING CODE 3410-22-M
