[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





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Agricultural Research Service



Cooperative State Research, Education, and Extension Service



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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.

-----------------------------------------------------------------------

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 [email protected] 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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