Federal Register / Vol. 50, No. 60 / Thursday, March 28, 1985 / Notices 
12457 
depend on the properties of the parental 
organism and the effect of the 
modification on these properties. 
Approval of small-scale field tests will 
depend upon the results of laboratory 
and greenhouse testing of the properties 
of the modified organism. We anticipate 
that monitoring of small-scale field tests 
will provide data on environmental 
effects of the modified organism. Such 
data may be a necessary part of the 
consideration of requests for approval of 
large-scale tests and commercial 
applications. 
I. Summary 
Present a summary of the proposed 
trial including objectives, significance, 
and justification for the request. 
II. Genetic Considerations of Modified 
Organism to be Tested 
A. Characteristics of the Nonmodified 
Parental Organism 
1. Information on identification, 
taxonomy, source, and strain. 
2. Information on organism’s 
reproductive cycle and capacity for 
genetic transfer. 
B. Molecular Biology of the Modified 
Organism 
1. Introduced Genes 
a. Source and function of the DNA 
sequence used to modify the organism to 
be tested in the environment. 
B. Identification, taxonomy, source, 
and strain or organism donating the 
DNA. 
2. Construction of the Modified 
Organism 
a. Describe the method(s) by which 
the vector with insert(s) has been 
constructed. Include diagrams as 
appropriate. 
b. Describe the method of introduction 
of the vector carrying the insert into the 
organism to be modified and the 
procedure for selection of the modified 
organism. 
c. Specify the amount and nature of 
any vector and/or donor DNA 
remaining in the modified organism. 
d. Give the laboratory containment 
conditions specified by the NIH 
Guidelines for the modified organism. 
3. Genetic Stability and Expression 
Present results and interpretation of 
preliminary tests designed to measure 
genetic stability and expression of the 
introduced DNA in the modified 
organism. 
III. Environmental Considerations 
The intent of gathering ecological 
information is to assess to the effects of 
survival, reproduction, and/or dispersal 
of the modified organism. For this 
purpose, information should be provided 
where possible and appropriate on: (i) 
Relevant ecological characteristics of 
the nonmodified organism; (ii) the 
corresponding characteristics of the 
modified organism: and (iii) the 
physiological and ecological role of 
donated genetic sequences in the donor 
and in the modified organism(s). For the 
following points, provide information 
where possible and appropriate on the 
nonmodified organism and a prediction 
of any change that may be elicited by 
the modification. 
A. Habitat and Geographic Distribution 
B. Physical and Chemical Factors 
Which Can Affect Survival 
Reproduction, and Dispersal C. 
Biological Interactions 
1. Host range. 
2. Interactions with and effects on 
other organisms in the environment 
including effects on competitors, prey, 
hosts, symbionts, predators, parasites, 
and pathogens. 
3. Pathogenicity, inTecti vity, toxicity, 
virulence, or as a carrier (vector) of 
pathogens. 
4. Involvement in biogeochemical or in 
biological cycling processes (e g., 
mineral cycling, cellulose and lignin 
degradation, nitrogen fixation, pesticide 
degradation). 
5. Frequency with which populations 
undergo shifts in important ecological 
characteristics such as those listed in 
III— C points 1 through 4 above. 
6. Likelihood of exchange of genetic 
information between the modified 
organism and other organisms in nature. 
IV. Proposed Field Trials 
A. Pre-Field Trial Considerations 
Provide data related to any 
anticipated effects of the modified 
microorganism on target and nontarget 
organisms from microcosm, greenhouse, 
and/or growth chamber experiments 
that simulate trial conditions. The 
methods of detection and sensitivity of 
sampling techniques and periodicity of 
sampling should be indicated. These 
studies should include, where relevant, 
assessment of the following items: 
1. Survival of the modified organism. 
2. Replication of the modified 
organism. 
3. Dissemination of the modified 
organism by wind, water, soil, mobile 
organisms, and other means. 
B. Conditions of the Trial 
Describe the trail involving release of 
the modified organism into the 
environment: 
1. Numbers of organisms and methods 
of application. 
2. Provide information including 
diagrams of the experimental location 
and the immediate surroundings. 
Describe characteristics of the site that 
would influence containment or 
dispersal. 
3. If the modified organism has a 
target organism, provide the following: 
a. Identification and taxonomy. 
b. The anticipated mechanism and 
result of the interaction between the 
released microorganism and the target 
organism. 
C. Containment 
Indicate containment procedures in 
the event of accidental release as well 
as intentional release and procedures 
for emergency termination of the 
experiment. Specify access and security 
measures for the area(s) in which the 
tests will be performed. 
D. Monitoring 
Describe monitoring procedures and 
their limits of detection for survival, 
dissemination, and nontarget 
interactions of the modified 
microorganism. Include periodicity of 
sampling and rationale for monitoring 
procedures. Collect data to compare the 
modified organisms with the 
nonmodified microorganism most 
similar to the modified organism at the 
site of the trial. Results of monitoring 
should be submitted to the RAC 
according to a schedule specified at the 
time of approval. 
V. Risk Analysis 
Results of testing in artificial 
contained environments together with 
careful consideration of the genetics, 
biology, and ecology of the nonmodified 
and the modified organisms will enable 
a reasonable prediction of whether or 
not significant risk of environmental 
damage will result from the release of 
the modified organism in the small-scale 
field test. In this section, the information 
requested in Sections II, III, and IV 
should be summarized to present an 
analysis of possible risks to the 
environment in the test as it is proposed. 
The issues addressed might include but 
not be limited to the following items: 
A. The Nature of the Organism 
1. The role of the nonmodified 
organism in the environment of the test 
site, including any adverse effects on 
other organisms. 
2. Evaluation of whether or not the 
specific genetic modification (e.g., 
deletion, insertion, modification of 
[ 83 ] 
