[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 [email protected] 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