[Federal Register Volume 59, Number 18 (Thursday, January 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1729]


[[Page Unknown]]

[Federal Register: January 27, 1994]


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Part VIII





Department of Agriculture





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Cooperative State Research Service



Agricultural Research Service



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Biotechnology Risk Assessment Research Grants Program; Solicitation of 
Applications; Notice
DEPARTMENT OF AGRICULTURE

Cooperative State Research Service
Agricultural Research Service

 

Biotechnology Risk Assessment Research Grants Program; Fiscal 
Year 1994; Solicitation of Applications

Purpose

    Proposals are invited for competitive grant awards under the 
Biotechnology Risk Assessment Research Grants Program (the ``Program'') 
for fiscal year 1994. The authority for the Program is contained in 
section 1668 of Pub. L. 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 Service (CSRS) and the Agricultural 
Research Service (ARS) of the U.S. Department of Agriculture.
    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 public or private research or 
educational institution or organization.

Available Funding

    The approximate amount available for support of the program in 
fiscal year 1994 is $1,700,000.
    Pursuant to Section 719 of Pub. L. 103-111 (the Agriculture, Rural 
Development, Food and Drug Administration, and Related Agencies 
Appropriations Act, 1994), funds available in fiscal year 1994 to pay 
indirect costs on research grants awarded competitively by CSRS may not 
exceed 14 per centum of the total Federal funds provided under each 
award.
    In addition, pursuant to sec. 727(b) of Pub. L. 103-111, 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 a peer panel of scientists for, 
among other things, 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 methods for field testing 
genetically modified organisms will also be considered.

Areas of Research To Be Supported in Fiscal Year 1994

    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 
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 (i.e., loss of genetic diversity, enhanced 
competition) of genetically modified fungi, bacteria, viruses, plants, 
arthropods, fish, birds and mammals introduced into the environment 
(e.g., 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 Pub. L. 101-624, the following specific areas of risk 
assessment research have been identified as priorities for this year:

--The bidirectional rates, 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/filed studies.
--The potential for recombination between plant viruses and plant-
encoded nocapsid 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.
--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 supp.). 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 related viruses.
--Changes in viral host ranges or the types of insects which can serve 
as viral vectors due to the use of transgenic plants expressing viral 
genes.
--The potential for nontarget effects of 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.
--Identification of the minimal gene sequence(s) in an animal pathogen 
which could confer pathogencity on a nonpathogenic organism. Pathogenic 
organisms specially 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.

    Note: Individual investigators whose research projects are 
funded under the Program will be required to attend and present data 
on 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 borne from funds 
previously awarded under the Program as part of a conference grant. 
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. 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--CSRS 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. David MacKenzie or Dr. Ann Lichens-Park, Cooperative State Research 
Service, U.S. Department of Agriculture, Ag Box 2220, Washington, DC 
20250-2220, Telephone: (202) 401-4892

      or

Dr. Robert Faust, Agricultural Research Service, U.S. Department of 
Agriculture, room 336, Building 005, BARC-West, Beltsville, MD 20705, 
Telephone: (301) 504-5059.

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 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 1994 
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 s3415.4(d), should be 
followed for the preparation of proposals under the Program in fiscal 
year 1994 (Note that the Department elects not to solicit preproposals 
nor conference grant proposals in fiscal year 1994).

Compliance With the National Environmental Policy Act (NEPA)

    As outlined in 7 CFR part 3407 and 7 CFR part 520 (the CSRS and ARS 
regulations implementing the National Environmental Policy Act of 
1969), environmental data for any proposed project is to be provided to 
CSRS and ARS so that CSRS 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) CSRS and ARS Categorical Exclusions (7 CFR 3407.6 and 7 CFR 520.5)

    Based on previous experience, the following categories of CSRS 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 CSRS 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, 
CSRS 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 
March 22, 1994, and must be sent to the following address: Proposal 
Services Branch, Awards Management Division, Cooperative State Research 
Service, U.S. Department of Agriculture, Ag Box 2245, Washington, DC 
20250-2245, Telephone: (202) 401-5048.
    Hand-delivered proposals must be submitted by close of business on 
March 22, 1994, to an express mail or courier service or brought to the 
following address (note that the zip code differs from that shown 
above): Proposal Services Branch, Awards Management Division, 
Cooperative State Research Service, U.S. Department of Agriculture, 
room 303, Aerospace Center, 901 D Street, SW., 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 291115, 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, DC, on this 10th day of January, 1994.
John Patrick Jordan,
Administrator, Cooperative State Research Service.
Essex E. Finney, Jr.,
Acting Administrator, Agricultural Research Service.
[FR Doc. 94-1729 Filed 1-26-94; 8:45 am]
BILLING CODE 3410-22-M