[Federal Register Volume 60, Number 175 (Monday, September 11, 1995)]
[Notices]
[Pages 47236-47238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22464]



      

[[Page 47235]]

_______________________________________________________________________

Part III





Department of Agriculture





_______________________________________________________________________



Agricultural Research Service Cooperative State Research, Education and 
Extension Service



_______________________________________________________________________



Biotechnology Risk Assessment Research Grants Program; Fiscal Year 
1996; Solicitation of Applications; Notice

  Federal Register / Vol. 60, No. 175 / Monday, September 11, 1995 / 
Notices  

[[Page 47236]]


DEPARTMENT OF AGRICULTURE

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


Biotechnology Risk Assessment Research Grants Program; Fiscal 
Year 1996; Solicitation of Applications

Purpose

    Applications are invited for competitive grant awards under the 
Biotechnology Risk Assessment Research Grants Program (the ``Program'') 
for fiscal year 1996. The authority for the Program is contained in 
section 1668 of Pub. L. No. 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 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. Awards will 
not be made for clinical trials, commercial product development, 
product marketing strategies, or other research not appropriate to risk 
assessment.

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 fiscal year 1996 is $1.7 
million.
    It is expected that Congress, in the final version of the 
Agriculture, Rural Development, Food and Drug Administration, and 
Related Agencies Appropriations Act, 1996 (H.R. 1976), will prohibit 
CSREES from using the funds available for fiscal year 1996 to pay 
indirect costs exceeding 14 per centum of the total Federal funds 
provided under each award on competitively-awarded research grants.
    In addition, it is expected that, pursuant to the final version of 
the Agriculture, Rural Development, Food and Drug Administration, and 
Related Agencies Appropriations Act, 1996 (H.R. 1976), in the case of 
any equipment or product that may be authorized to be purchased with 
the funds provided under this Program, entities will be 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. Proposals based upon field research and 
whole organism-population level studies are strongly encouraged. 
Although emphasis will be given to risk assessment research involving 
genetically modified organisms, 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 should be applicable to current regulatory 
issues surrounding the ecological impacts of genetically modified 
organisms.

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 for current regulatory 
issues.

Areas of Research to be Supported in Fiscal Year 1996

    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, new risk assessment methods in the course 
of addressing a specific and defined risk assessment issue, especially 
as pertains to genetically modified organisms. The development of 
better risk assessment methods for field testing genetically modified 
organisms also will be considered.
    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, 
reproductive 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 weedy, free 
living relatives of those crops including studies of methods of 
mitigation of potential gene exchange. 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. Comparisons with recombination frequencies between 
naturally occurring viral sequences are encouraged.
    6. Changes in viral host ranges or the types of viral vectors as a 
result of the use of transgenic plants expressing viral genes.
    7. 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 

[[Page 47237]]
plants (e.g., Bacillus thuringiensis delta-endotoxin), especially in 
regard to persistence of the organisms and material in the environment.
    8. Identification of genes which can confer additional 
pathogenicity to animal pathogens.
    9. Environmental risk analysis of large scale deployment of 
genetically engineered organisms; especially commercial uses of such 
organisms, with special reference to consideration 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, present data 
and provide a manuscript 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.

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. Edward K. Kaleikau, Cooperative State Research, Education, and 
Extension Service, U.S. Department of Agriculture, Ag Box 2241, 
Washington, DC 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.

How to Obtain Application Materials

    Copies of this solicitation, the administrative provisions for the 
Program (7 CFR Part 3415), and 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 [email protected] which states that you wish to receive a copy of 
the application materials for the Fiscal Year 1996 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 1996. (Note that the Department elects not to solicit preproposals 
nor conference grant proposals in fiscal year 1996.)

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;

[[Page 47238]]

    (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 exists 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 must be received by 4:30 p.m. eastern standard time on 
December 11, 1995. Proposals sent by First Class mail 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

    Proposals that are delivered by Express mail, a courier service, or 
by hand must be submitted to the following address (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, 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 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, DC, on this 1st day of September, 1995.
William D. Carlson,
Acting Administrator, Cooperative State Research, Education, and 
Extension Service.

Robert J. Reginato,
Acting Administrator, Agricultural Research Service.
[FR Doc. 95-22464 Filed 9-8-95; 8:45 am]
BILLING CODE 3410-22-M