Download scientific-methodology complex on discipline

National university of life and enviromental sciences of Ukraine
Department of molecular biology, microbiology and biosafety
"APPROVED"
The dean of faculty of plant
protection, biotechnology and
ecology
______________ M. M. Dolya
“___” _______________ 2016
SCIENTIFIC-METHODOLOGY COMPLEX ON DISCIPLINE
BIOSAFETY (use of biotechnologies)
For grounding of specialists in direction
Direction of training
0514 "Biotechnology"
6.051401 – “Biotechnology”
Specialization
Faculty
of plant protection, biotechnology and ecology
KYIV - 2016
Форма № Н - 3.04
National university of life and enviromental sciences of Ukraine
Department of molecular biology, microbiology and biosafety
"APPROVED"
The dean of faculty of plant
protection, biotechnology and
ecology
______________ M. M. Dolya
“___” _______________ 2016
WORKING EDUCATIONAL PROGRAM OF DISCIPLINE
BIOSAFETY (use of biotechnologies)
For grounding of specialists in direction 0514 "Biotechnology"
Direction of training
6.051401 – “Biotechnology”
Specialization
Faculty
of plant protection, biotechnology and ecology
KYIV - 2016
2
Working program "BIOSAFETY (use of biotechnologies)" for students in direction
0514 "Biotechnology", speciality 6.051401 – “Biotechnology”.
„___” ________, 2016 − 31 с.
Developers: Starodub N.F. Professor of department of molecular biology, microbiology
and biosafety
Working educational program was discussed at the department of molecular biology,
microbiology and biosafety
Report № _____ from _____ .______________2016
Head of department of molecular biology, microbiology and biosafety
______________ (N.F. Starodub)
(signature)
“_____” ______________2016
Decreed by Scientific Council of Faculty of plant protection, biotechnology and ecology
Report № ____ from . ___. _____________2016
“_____”________________2016
Head ______________ (M. M. Dolya)
(signature)
Starodub N.F., 2016
3
1. Description of the discipline
"Biosafety (use of biotechnologies)"
Discipline, direction, speciality, educationally qualifying level
Discipline
0514 "Biotechnology"
Direction
6.051401 – “Biotechnology”
(Code and name)
Speciality
Educationally qualifying level
EQL «Bachelor»
Characteristics of discipline
Type
General amount of hours:
Number of ECTS credits
Amount of the substantial modules
Term paper
Normative
51
2
2
________________________________________
(name)
Form of control
test
Descriptions educational discipline for full-time students
Year of preparation
Semester
Lectures
Practice works
Laboratory training
Independent work
Individual work
A week's hours:
Lectures
Form of studies daily
4
5
15 hours
30 hours
3 hours
39 hours
4
2. The main goals and tasks of discipline
The main goals of discipline are: theoretical and practical training of students for
providing safe environment.
The main task of discipline is forming of specialists which are able:

to provide an analysis of quality and background of different species of
plants, animals and microorganisms used for biotechnological production;

to provide selection of methods staff safety during technological processes.
In result of discipline studying the student should know:

Modern conception about heredity and variability, their origin and
molecular substance;

Understanding consequence of effect of scientific-technical progress on
the planet gene pool, distinguishing positive and negative aspects of interaction of living
organisms with the environment changing in result of climatologic, technical and
informational reorganization;

Main methodological approaches for the control of genetic status of
organisms;

Modern analytical methods for the control of food and feed quality;

Ethical aspects and problems of biosafety;

Main rules and agreements in the field of biosafety which are accepted
in Ukraine and in other countries;

Principles and mechanisms for manipulation with genome,
achievements of genetic engineering and therapy as well as modern biotechnologies,
their advantage and risk for planet biosystem.
Student should be able:

To use scientific, educational and methodical literature which
concerned biosafety;

To analyze possible consequences of active and wide involving of
genetically modified organisms and number of modern biotechnologies on the state of
environment;

To be aligned in the use of the separate achievements of scientifictechnical progress which are most non-destructive for living organisms and how much
these achievements may be used without effect on the genetic pool of living organisms;

To estimate advantages and risk for people, animal and plants; the
application of genetic engineering and modern technologies.
3. The program of educational discipline
Substantial module 1.
Theme 1. Biosafety, its main points and tasks. General characteristics of separate
directions of scientific-technical progress and possible variants of its effect
on the genome of living organisms
5
Unit of heredity – gene. Gene localization. Molecular structure of genes.
Genome. Genome of pro- and eukaryotes. Natural mobile genetic elements,
retrotransposones. Problems of application of hereditary and non-hereditary transgenic
characters. Changing of hereditary during natural and industrial hybridization. Changing
hereditary by methods of genetic engineering. Problems of protection of hereditary of
organisms.
Theme 2. Heredity and variability – basic abilities of living organisms. Molecular basis
of heredity and variety.
Unit of heredity – gene. Gene localization. Molecular structure of genes.
Genome. Genome of pro- and eukaryotes. Natural mobile genetic elements,
retrotransposones. Problems of application of hereditary and non-hereditary transgenic
characters. Changing of hereditary during natural and industrial hybridization. Changing
hereditary by methods of genetic engineering. Problems of protection of hereditary of
organisms.
Theme 3. Horizontal and vertical genes transfer.
Traditional intraspecific and interspecific hybridization (transference of gene
blocks with different dimensions) plants, animals, microorganisms as basis of
evolutionary process.
Theme 4. Practical achievements of modern biotechnology and genetic engineering.
Obtaining of new pharmacological preparations (insulin, vaccine to poliomyelitis).
Expression of human somatotropine (grown hormone) in the tobacco chloroplasts.
Genetically modified plants (transgenic rice sorts, potatoes, maize, tomatoes and
others). Tasks, achievements and problems of genetic engineering. Compensation of
inherent genetic defects of maturity and treatment of diseases aroused during
ontogenesis.
Substantial module 2.
Theme 1. Modern methods of molecular genetics. Characteristics of mutations.
Ferments of restriction. Vectors for the molecular cloning. Plasmids, bacteriophage,
cosmide, shuttle vectors, artificial chromosomes of yeast. Creation of genomic libraries.
Construction of restrictive maps. Southern blot analysis.
Mutations connected with the destruction of genetic code.
Theme 2. Biotechnologies of manipulation with genes. Genetically modified
organisms: their main points, directions of use.
Strategy of genetic engineering works. Preparation of DNA of the needed gene
from genome. Transfer genes in the cells of other organisms: microinjection,
electroporation, transfection, packing in liposomes, bombardment by micro-particles.
Overcoming problems which are connected with the intensive involving: a) the
genetically modified organisms to solve problems of deficit of products in countries of
third world; b) environment recultivation from different types of toxic substances; c)
6
synthesis and obtaining of pharmacological preparations; d) improving quality of the
existing plant sorts and animal species; e) using plants as factories for directed chemical
synthesis of any substances and so on.
Theme 3. Problems of possible ecological consequences from use of genetically
modified organisms.
Possibility of GMO effect on environment. Advantages and risk. Principles of
caution and sufficient equivalence. Marking genetically modified foods, feeds, seed and
medical preparations.
Theme 4. Main rules and agreements in the field of biosafety.
Cartagena protocol and Orchuskaja convencion. Codex of Alimentariusa. Bilbao
and Inujama Declarations. General declaration of JUNESKO about genome and rights
of human.
4. Structure of educational discipline
Theme title
1
Amount of hours
including
Altogether
L P Lab. Ind. i.w.
2
3 4
5
6
7
SUBSTANTIAL MODULE 1.
Theme 1. Biosafety, its main points and tasks. General
6
characteristics of separate directions of scientific-technical
progress and possible variants of its effect on the genome
of living organisms
Theme 2. Heredity and variability – basic abilities of living
6
organisms. Molecular basis of heredity and variety.
Theme 3. Horizontal and vertical genes transfer.
6
Theme 4. Practical achievements of modern biotechnology
3
and genetic engineering.
Together
21
SUBSTANTIAL MODULE 2.
Theme 1. Modern methods of molecular genetics.
6
Characteristics of mutations.
Theme 2. Biotechnologies of manipulation with genes.
6
Genetically modified organisms: their main points,
directions of use.
Theme 3. Problems of possible ecological consequences
6
from use of genetically modified organisms.
Theme 4. Main rules and agreements in the field of
6
biosafety.
Together
24
Amount of hours
Term paper
45
Amount of hours
3
3
3
3
3
2
3
1
11 10
3
3
3
3
3
3
3
3
12 12
23 22
7
5. Topics of seminars
№
Theme title
1
No provided for educational plan
Amount of
hours
6. Themes of practical treinings
№
1
2
3
4
5
6
7
8
Theme title
Structure of DNA and RNA, replication, transcription, and translation.
Construction of genome and chromosome libraries
Classical immune analysis and its use for the determination of quality and
origin foods and feeds
Monoclonal antibodies and their use in immune analysis
Modern immune chemical analysis: varieties and its use at the providing of
biosafety
Documents in the field of biosafety which regulate the use of genetically
modified organisms in different aspects
Familiarization with the fulfillment of ELISA-method
Fulfillment of instrumental analysis for the revealing of individual
substances in samples of water and some foods at the registration of
biospecific interactions by the optical biosensor based on the surface
plasmon resonance
DNA electrophoresis
Amount of
hours
4
3
4
4
4
4
4
3
7. Themes of laboratory training
№
Theme title
1
No provided for educational plan
Amount of
hours
8
8. Teaching methods
The success of learning as a whole depends on the intrinsic activity of students,
the nature of their activities, it is the nature of the activity, degree of autonomy and
creativity should be important criteria in choosing a method.
Explanatory, illustrative technique. Students acquire knowledge by listening to
the story, lecture on educational or instructional materials through the on-screen guide
in the "ready" form. Perceiving and interpreting facts, evaluations, conclusions, they
remain within the reproductive (reproductive) thinking. This method is used widely as
possible to transmit large amount of data. It can be used for presentation and
assimilation of facts, approaches, assessments and conclusions.
Reproductive method. This refers to the application of learned from sample or
regulations. An activity of trainees is algorithmic, ie corresponding instructions, orders,
rules - similar to the present sample situations.
The method of problem presentation. Using any source and means teacher before
teaching material, poses the problem, formulating cognitive tasks, and then exposing the
system is proved by comparing the views, different approaches shows way to solve the
problem. Students are like witnesses and accomplices in scientific research.
Partly-search or heuristic method. Its essence - to organize the active Solver
nominated teacher (or self-contained) or cognitive tasks under the supervision of the
teacher or based on heuristic programs and guidelines. The process of thinking becomes
productive nature, but it gradually directs and supervises the teacher or the students on
the basis of the above programs (including computer) and manuals. This method is one
of the varieties of which are heuristic conversation - a proven way to enhance thinking
and motivation to learning.
The research method. After reviewing the material, production problems and
tasks and short oral or written instruction by those who teach self-study literature
sources are monitoring and measurements and perform other search action. Initiative,
independence, creativity manifested in research activities fully. Methods of training is
directly transferred to the methods which mimic and sometimes implement scientific
research.
So, consider the six approaches to the classification of teaching methods, six
9.
Criteria of appreciation of students knowledge’s on intermediate and
final phases of studying
Student knowledge’s are appreciated according to system of modular-rate control.
Whole programmed material of the “Biosafety” course devided on two blocks – module:
Module A – “Biotechnologies for manipulation with genes”: Module B – “Lows and
ecological-genetic aspects of biosafety”.
Calculated rates of discipline are equal 100 points. Educational rates – 70 points.
Taking into account volume and structure of programmed material of discipline it was
divided it for two appropriate modules. Calculated rate mark of each module was taken on
the level 35 points. Minimal rate mark for each module is 17,5 points.
9
For each module it is planed test which includes 30 questions. Each question
contents 4 answers one of which is right.
Test is in writing and individual for each student.
Rial rate of student with educational work will be estimated according to
obtained points at the module fulfillment. To be present at the test the student should
have no less as 50% of planed rate from the educational work. According to “Rules
about module-rate system of education of students and appreciation of their
knowledge’s” it will be written “credit” in the student's record-book. Rate mark will
be included according to system of ЕСТS (A, B, C, D, E, FX, F) in special list.
The results of studying of discipline by students content a weighted average rate.
Student rate of discipline equal to sum of educational work rate and rate of test.
10.
The methods and scale of students knowledge estimation
The methods of estimation : examinations while the semester; (progect; report;) total written
5 bolls
5
5
5
5
11.
5
10
5
25
30
Sum
Total control
Balls distribution:
Examinations while the semester
The substantial module 1
The substantial module 1I
Common balls quantity
Common balls quantity
Т. 1
Т. 2
Т. 3
Т. 4
Т. 1
Т. 2
Т. 3
Т. 4
Individual
scientific
project
test.
100
Methodological support
Scientific methods of teaching include: state educational standards, curricula and
training programs in all standard and optional subjects, training programs, production
and other practices, books and manuals, instructional and teaching materials for
seminars, practical and laboratory classes , individual teaching and research tasks, test
papers, text and electronic versions of the tests for the current and final testing, training
materials for independent work of students.
12.
The recommended literature
Main
1.
Ghimulev I.F. General and molecular genetics: School-book. –
Novosibirsk, 2003. – 479p.
2.
Tozkij V.М. Genetics. – Odessa: Astroprint, 2002. – 710p.
3.
Sendgher М., Berg P. Genes and genomes. Mir: М., 1999, 2-volumes,
391p.
4.
Sorochinskij B.V., Danil’chenko О.О., Kripka G.V. Biotechnical
(genetically modified) plants. – Kiev: Publ. „КVІZ”, 2007. – 219p.
5.
Frimmel Ch., Brok J. Fundamentals of immunology. М., Мir, 1986, 253p.
6.
Immune enzymatic analysis. Eds. Ngo Т.Т. and Lengoff G. М., Mir, 1988.
10
7.
Lesson of science and technique, Biotechnology: Non-isotopic methods of
immune analysis, v 3, 1987.
8.
Monoclonal antibodies./ Eds. R.G. Кennet.- М.: Medicine, 1983, 416p.
Additional
Nikolajchuk V.І., Gorbatenko І.Ju. Genetic engineering. – Uzhgorod, 1999.
1.
– 189p.
2.
Genetics and Selection in Ukraine at the turn of millenniums: in 4-th
volums /Eds.: V.V. Morgun e.a. – Logos: К, 2001.
3.
Starodub N. F., Starodub V.М. Immune sensors: original, achievements
and perspectives. Ukrainian Biochemical J., 2000, 72, N 4-5, P. 147-163.
4.
Starodub N.F., Starodub V.M. // Biosensors and control of pesticides in
water and foodes. Chemistry and Technology of Water, 2001. v.23. N 6. P.612-638.
11
Форма № Н-5.05
National university of life and enviromental sciences of Ukraine
Faculty of of plant protection, biotechnology and ecology
Speciality 6.05140101 “Biotechnology”
Full-time department
specialists in direction 6.051401 "Biotechnology"
Educational-qualification level "Bachelor's of Science Degree "
Semester - 5
Department of molecular biology, microbiology and biosafety
Discipline “Biosafety (use of biotechnologies)”
Lecturer – Starodub N.F.
“Approved”
Head of department__________ Patyka M.V.
“ ”__________________2016
№1
1
2
3
4
Reaction of immune diffusion is:
Quantitative
Semi-quantitative
Qualitative
None
№2
1
2
3
4
№3
What kind of the listed approach of immune enzymatic analysis cannot be fulfilled:
On the plates
DOT
Blot
In solution
№4
What kind of classical immune analysis is as quantitative?____________________
№5
1
2
3
4
What kind of Immune enzymatic analysis does not exist:
Hetero-phase
Solid-phase
Homogeny
Heterocyclic
№6
№7
1
2
3
4
Data of discovering of modern immune chemical analysis is____________________
№8
1
2
3
4
What kind of listed shortened title reflectes modern immune chemical analysis:
RID
ELISA
FIA
LIA
What kind of label does not use in modern immune chemical analysis____________
Haptens are able:
Induce immune response
To interact with antibodies
To polymerization
To spontaneous interaction with carbohydrates
12
№9
1
2
3
4
Cells in which transformation was made are chosen accordingly to:
Ability to live in the presence of antibiotics or herbicides
Outer view
Ability to form specific colonies
Growth intensity
№10
1
2
3
4
Obtaining genomic libraries does not include:
Preparation total DNA
Fragmentation by restrictases
Conjugation to the vectors
Introduce to the recipient
13
НУБіП України
Ф-7.5-2.1.8-04
Structural scheme of discipline
“Biosafety (use of biotechnologies)”
Number of
module
Charter of
discipline
1
1
1
1
1
1
1
1
1
2
1
2
Topic of lectures
Biosafety, its main points and tasks.
General characteristics of separate
directions of scientific-technical
progress and possible variants of its
effect on the genome of living
organisms
Heredity and variability – basic
abilities of living organisms.
Molecular basis of heredity and
variety.
Horizontal and vertical genes
transfer.
Practical achievements of modern
biotechnology
and
genetic
engineering.
Modern methods of molecular
genetics.
Characteristics
of
mutations.
Biotechnologies of manipulation
with genes. Genetically modified
organisms: their main points,
directions of use.
Problems of possible ecological
consequences
from
use
of
genetically modified organisms.
2
2
Main rules and agreements in the
field of biosafety.
2
2
Topic of practice works
Form of
control
Cartagena protocol and
Orchuskaja convencion
Tesr
Codex of Alimentariusa
Tesr
Bilbao and Inujama
Declarations
General declaration of
JUNESKO about genome
and rights of human
Ukrainian low about
fulfillment of works in the
field of genetic
engineering and GMO
application
Ways of obtaining of
polyclonal antibodies and
their application at the
analysis of food and feed
qualities
New type of instrumental
analytical devices –
biosensors: their varieties
and directions of
application. Bioterrorism:
peculiarities, varieties,
dangerous and ways to
avoid consequences
Water resources: their use
and control. Surface
active substances, their
potential dangerous for
living organisms
Tesr
Tesr
Tesr
Tesr
Tesr
Tesr
14
НУБіП України
Ф-7.5-2.1.8-05
«THE CALENDAR THEMATIC PLAN»
Topic of lectures
1-2
Biosafety, its main
points and tasks.
General
characteristics of
separate directions
of scientifictechnical progress
and possible
variants of its
effect on the
genome of living
organisms
3-4
Heredity and
variability – basic
abilities of living
organisms.
5-6
7
Horizontal and
vertical gene
transfer
Practical
achievements of
modern
biotechnology and
genetic
engineering.
Hours
Week
The calendar thematic plan
For preparation of experts in
direction 0514 "Biotechnology"
from a speciality 6.051401 –
“Biotechnology”
from course “ Biosafety (use of
biotechnologies)”
5st semester
2015/2016 academic year
2
2
2
2
8-9
Modern methods of
molecular genetics.
Characteristics of
mutations.
2
10-11
Biotechnologies of
2
APPROVED:
Dean of Faculty of plant protection, biotechnology
and ecology
M. M. Dolia
/______________
Professor M.F. Starodub
/______________
Number of weeks
15
Lections
15
Practice works
30
Independent work
Term paper
In all
52
Topic of practice
works
Structure of DNA and
RNA, replication,
transcription, and
translation.
Construction of
genome and
chromosome libraries
Classical immune
analysis and its use for
the determination of
quality and origin
foods and feeds
Monoclonal antibodies
and their use in
immune analysis
Modern immune
chemical analysis:
varieties and its use at
the providing of
biosafety
Documents in the field
of biosafety which
regulate the use of
genetically
modified organisms in
different aspects
Familiarization with
Hours
National University of Life
and Environmental Science of
Ukraine
3
3
4
4
4
4
15
manipulation with
genes. Genetically
modified
organisms: their
main points,
directions of use.
the fulfillment of
ELISA-method
12-13
Problems of
possible ecological
consequences from
use of genetically
modified
organisms
2
Fulfillment of
instrumental analysis
for the revealing of
individual substances
in samples of water
and some foods at the
registration of
biospecific interactions
by the optical
biosensor based on the
surface plasmon
resonance
14-15
Main rules and
agreements in the
field of biosafety.
Ecologic-genetical
models.
1
DNA electrophoresis
Lecturer of the course
Chief of department
4
4
_____________________ prof. Starodub N.F
_____________________ M.V. Patyka
16
НУБіП України
Ф-7.5-2.1.8-03
«Protocol coordination of working educational program of discipline with other
disciplines»
Protocol
coordination of working educational program of discipline “Biosafety (use of
biotechnologies)” with other disciplines 6.051401 – “Biotechnology”
Discipline and Family and name,
its sections
academic degree
which are
of lecturer which
before studying
implements
of this
previous
discipline
discipline
Signature
Next discipline
and its divisions
in frame of which
materials of this
discipline are
used
General and
microbiology
Immune genetics
Cell biology
Methodology and
organization of
scientific
experiment
Family and
name, academic
degree of lecturer
which
implements next
discipline
Signature
Chairman of the Academic Council, _______________________________________
17
Summary of lectures
of discipline “Biosafety (use of biotechnologies)”
Substantial module 1.
Lecture 1. Biosafety: main points and tasks
The main aspects which will be considered: 1) what is the definition of biosafety,
2) what are scientific and social problems which should be solved today for the
prevention of non-desirable effect of the science-technical progress on the health of
people, 3) the level of the development and solution of problem of biosafety in the
world and in Ukraine. Biosafety from molecular genetics point may be qualified as the
position when the origin of the dangerous effects on the human health and environment
from the genetics modified organisms may be prevented due to number of government
laws.
Lecture 2.General characteristics of separate directions of scientific-technical
progress and possible variants of its effect on the genome of living organisms.
Genetic engineering biotechnology is raising a whole range of ethical issues, and
a new breed of ‘bioethicists’ have been enlisted to consider not only genetic engineered
(GE) crops, but especially animal and human cloning, genetic screening for diseases,
pre-natal and pre-implantation diagnosis, experiments on human embryos,
xenotransplantation, and gene replacement therapy.
What is genetic engineering? And why is it inherently hazardous? Genetic
engineering is a set of laboratory techniques for isolating, multiplying, cutting and
joining genetic material from different sources, and most of all, for transferring genetic
material between species that can never interbreed in nature.
Science and the precautionary principle. In short, there is sufficient evidence to
warrant the withdrawal of all genetic engineered crops and products from environmental
release until and unless they can be shown to be safe. Furthermore, there is an urgent
need to tighten the regulation over the release of genetic engineered microorganisms,
cell cultures and their genetic material from contained laboratories and industrial use,
and over all the artificial gene constructs and vectors in medical applications. This is in
accordance with the precautionary principle, which can be stated as follows: when there
is reasonable suspicion of serious irreversible harm, lack of scientific certainty or
consensus should not be used as justification for not taking preventative measures.
The fallacy of scientific objectivity. There are deeper problems in the nature of the
science itself and its relationship to society, which must also be addressed before the
ethical implications are fully appreciated. There is a general tendency for people to
believe that scientific ‘progress’ is unstoppable, for better or for worse. This fatalistic
faith in ‘scientific progress’ is more dangerous than the runaway technologies that the
science inspires. It is why we have failed to avert the disasters time and again.
The two-way connection between science and society. There is a two-way
connection between science and society. Science is both shaped by the politics and the
mores of society and it can reinforce them. But science can also transcend the status quo
and bring about social change, if we consciously will to do so. In the wake of the
18
quantum revolution, it is clear that we are participants in evolution and not merely
subject to external forces over which we have no control.
Lecture 3. Heredity and variability – basic abilities of living organisms.
Heredity is usually defined as the ability of parents to transmit their
characteristics and peculiarities of development to their offspring. Every animal and
plant species maintains its characteristic features in a number of generations, and under
whatever conditions it may be placed will reproduce its peculiarities provided it still
maintains its ability to reproduce. Heredity ensures material and functional succession
between generations of organisms, while it also maintains a definite order in the
variability of living organisms. The multitudes of various organic forms are grouped in
definite systematic units, such as species, genera, families or orders. This systematic
pattern of existence of organisms is possible only because of the existence of the
mechanism of heredity which ensures the maintenance of not only the traits of
resemblance within every group of animals or plants but also the distinctions between
them. Heredity is inseparably connected with the process of reproduction, and
reproduction is related to the division of the cell and the reproduction of its structure
and functions. The ensuring of the succession of properties is only one aspect of
heredity; another aspect is the ensuring of the accurate transmission of a specific type of
development, the formation in the process of ontogenesis of definite characters and
properties, a definite type of biosynthesis and metabolism. Whatever their type of
reproduction, in most of the organisms (except unicellular ones), separate somatic or
sex cells do have properties and peculiarities characteristic of the multicellular
organism. These characters and properties are formed in strictly consecutive order in the
process of individual development under particular environmental conditions. The
clear-cut pattern of the individual development of every organism is determined by its
heredity.
The hereditary constitution is formed by a number of various genes. The entire set
of these genes is called a genotype. Consequently, the concept of genotype is identical
to that of genetic constitution. The term phenotype implies the outward appearance and
the state of the individual at a given moment. This state is a result of the interaction
between the genotype and the environment. The entire process of the development of an
individual from the fertilized ovum to the adult organism takes place under the
controlling influence of the genotype, this influence interacting continuously with the
multitude of environmental conditions under which the growing organism finds itself.
Thus the properties of an individual depend on two main factors, viz., the hereditary
constitution (the genotype) and the environment in which the organism occurs and with
which its genotype interacts. Individuals belonging to any species, either animal or
plant, differ from each other in a great number of individual peculiarities. The analysis
of these distinctions reveals some regularities in their distribution among the individuals
descending from particular parent forms as well as among individuals living under
particular environmental conditions. An experimental analysis allows a deeper
understanding of the very essence of these distinctions. Some of them, once appearing
in a certain individual, are again similarly expressed in the offspring; others, appearing
in all individuals under particular conditions, disappear in the progeny if the latter
19
develops under different environmental conditions. In the first case it is not possible to
establish any apparent relationship between the environmental factors and the specific
hereditary reaction of the organism. Darwin believed this to be mainly determined by
the individual properties of every individual and called these changes individual and
“indefinite”. Now they are known as mutations. In the second case a relationship may
easily be established between particular environmental factors and the pattern of
changes in the organism. The specific reactions are evidently determined mainly by the
organism itself, and Darwin called these mass or “definite” changes. Now they are
called modifications. Their expression undoubtedly depends on the hereditary properties
of an organism - on the general hereditary properties of the particular species as a whole
rather than on properties of the individual organism. Usually modifications are of an
adaptive nature and they are replicated in different individuals of a particular species.
The ability to form particular adaptive modifications is the result of a long historical
development of organisms under particular environmental conditions.
For a long time a dispute has been going on about what is more important for the
formation of an individual - the environment or the genetic constitution. Those working
in the field of genetics are often reproached for underestimating the role of environment.
However, this reproach is absolutely groundless for the main thesis of genetics is, as has
been mentioned earlier, that a phenotype is the result of the interaction between a
genotype and the environment. Thus it is claimed that there always exists an interaction
between environment and heredity. By conducting investigations on suitable material it
is possible to reveal to some extent the relative role of the environment and the
genotype. For this, two methods are used. The first consists of studying genotypically
different individuals under as similar environmental conditions as possible. For
example, several different kinds of the same plant species may be grown side by side on
an experimental plot and the distinctions observed may be studied, which in this case
may be considered to be genetic distinctions.
Nature of biological variability. Formerly, when variability on the basis of
recombinations was something which still remained to be learned, it was believed that
biological variability was always determined by the direct influence of environmental
conditions on the properties of individuals. These concepts were most fully developed
in 1809 by the French biologist J. Lamarck. Lamarck emphasized that organs which
were not used by an individual would become poorly developed and weak, whereas
those organs which were often used would improve more and more. According to
Lamarck such individual adaptations, both direct and indirect, which occur due to
exercising or not exercising particular organs, are to some extent inherited.
Darwin (1867) accepted Lamarck's ideas of the inheritability of individual
adaptations and supplemented them with his own theories about the hereditary trend of
organisms towards non-directional variability. This means that in some of the progeny
of one individual some character will deviate to one side, whereas in others it will
deviate to the other side as compared to its state in parent individuals. If natural
selection affects such mixed material and the effect is favourable so that this particular
character is strengthened, then the average significance of this character will gradually
increase.
20
Recent investigations confirm that natural selection is an extremely important
factor. On the other hand it appears that Darwin's (op.cit.) ideas about the inherent trend
of organisms towards non-directional variability and the consequent ability to change
continuously and unlimitedly are erroneous.
One of the principal achievements in the field of genetics was the discovery that
biological variability was an intricate phenomenon depending on several absolutely
different causes. Thus, for example, within a pure line we can select the biggest or the
smallest seeds in any number of generations, but the average size typical of this line will
nevertheless remain unchanged.
In populations of cross-fertilizing individuals there are better possibilities for
selection in a definite direction than in populations of self-fertilizing individuals. This is
related to the fact that cross-fertilizing individuals are characterized by a higher degree
of heterozygosis and intensive variability conditioned by recombinations. Selection in
such populations often brings good results. However, in spite of the large number of
possible combinations of genes in such populations, we also have some limits here
which cannot be exceeded. These limits are determined by the fact that in a population
there exists a finite number of original genes which are subject to selection. When the
entire gene pool has been used in forming combinations which are favoured by
selection, the selection in this direction is terminated.
However, there is one more possibility of further changes. Completely new genes
may be formed as a result of mutations, i.e., changes in the hereditary constitutions
which are not recombinations of genes. (Mutations are considered in detail elsewhere in
this seminar. Thus, variation is conditioned by three different causes: (I) environmental
effects; (II) recombinations, and (III) mutations.
Lecture 4. Horizontal and vertical gene transfer.
In population genetics, gene flow (also known as gene migration) is the transfer
of alleles of genes from one population to another.
Migration into or out of a population may be responsible for a marked change in
allele frequencies (the proportion of members carrying a particular variant of a gene).
Immigration may also result in the addition of new genetic variants to the established
gene pool of a particular species or population.
There are a number of factors that affect the rate of gene flow between different
populations. One of the most significant factors is mobility, as greater mobility of an
individual tends to give it greater migratory potential. Animals tend to be more mobile
than plants, although pollen and seeds may be carried great distances by animals or
wind.
Maintained gene flow between two populations can also lead to a combination of
the two gene pools, reducing the genetic variation between the two groups. It is for this
reason that gene flow strongly acts against speciation, by recombining the gene pools of
the groups, and thus, repairing the developing differences in genetic variation that
would have led to full speciation and creation of daughter species.
Ther are analysed the next questions: 1) barrier to gene flow; 2) gene flow in
humans; 3) gene flow between species; 4) genetic pollution; 5) gene flow mitigation.
21
Lecture 5. Practical achievements of modern biotechnology and genetic
engineering.
Genetically modified (GM) foods are foodstuffs produced from genetically
modified organisms (GMO) that have had their genome altered through genetic
engineering. GM Foods have been available since the 1990s. The most common
modified foods are derived from plants: soybean, corn, canola and cotton seed oil and
wheat. The process of producing a GMO used for GM Foods may involve taking DNA
from one organism, modifying it in a laboratory, and then inserting it into the target
organism's genome to produce new and useful traits (trei) or phenotypes. Such GMOs
are generally referred to as transgenics. Other methods of producing a GMO include
increasing or decreasing the number of copies of a gene already present in the target
organism, silencing or removing a particular gene or modifying the position of a gene
within the genome.
The first commercially grown genetically modified whole food crop was the
Flavr Savr tomato, which was made more resistant to rotting by Californian company
Calgene. Calgene was allowed to release the tomatoes into the market in 1994 without
any special labeling. It was welcomed by consumers that purchased the fruit at two to
five times the price of regular tomatoes. However, production problems and competition
from a conventionally bred, longer shelf-life variety prevented the product from
becoming profitable. A variant of the Flavr Savr was used by Zeneca to produce tomato
paste which was sold in Europe during the summer of 1996. The labeling and pricing
were designed as a marketing experiment, which proved, at the time, that European
consumers would accept genetically engineered foods.
The attitude toward GM foods would be drastically changed after outbreaks of
Mad Cow Disease weakened consumer trust in government regulators, and protesters
rallied against the introduction of Monsanto's "Roundup-Ready" soybeans. The next
GM crops included insect-protected cotton and herbicide-tolerant soybeans both of
which were commercially released in 1996. GM crops have been widely adopted in the
United States. They have also been extensively planted in several other countries
(Argentina, Brazil, South Africa, India, and China) where agriculture is a major part of
the total economy. Other GM crops include insect-protected maize and herbicidetolerant maize, cotton, and rapeseed varieties.
Abundance of GM crops. Between 1995 and 2005, the total surface area of land
cultivated with GMOs had increased by a factor of 50, from 17,000 km² (4.2 million
acres) to 900,000 km² (222 million acres), of which 55 percent were in the United
States. Although most GM crops are grown in North America, in recent years there has
been rapid growth in the area sown in developing countries. For instance in 2005 the
largest increase in crop are planted to GM crops (soybeans) was in Brazil (94,000 km²
in 2005 versus 50,000 km² in 2004.) There has also been rapid and continuing
expansion of GM cotton varieties in India since 2002. (Cotton is a major source of
vegetable cooking oil and animal feed.) It is predicted that in 2006/7 32,000 km² of GM
cotton will be harvested in India (up more than 100 percent from the previous season).
Indian national average cotton yields of GM cotton were seven times lower in 2002,
because the parental cotton plant used in the genetic engineered was not well suited to
the climate of India and failed. The publicity given to transgenic trait Bt insect
22
resistance has encouraged the adoption of better performing hybrid cotton varieties, and
the Bt trait has substantially reduced losses to insect predation. Economic and
environmental benefits of GM cotton in India to the individual farmer have been
documented.
In 2003, countries that grew 99 percent of the global transgenic crops were the
United States (63 percent), Argentina (21 percent), Canada (6 percent), Brazil (4
percent), China (4 percent), and South Africa (1 percent). The Grocery Manufacturers
of America estimate that 75 percent of all processed foods in the U.S. contain a GM
ingredient. In particular, Bt corn, which produces the pesticide within the plant itself is
widely grown, as are soybeans genetically designed to tolerate glyphosate herbicides.
These constitute "input-traits" are aimed to financially benefit the producers, have
indirect environmental benefits and marginal cost benefits to consumers.
In the US, by 2006 89% of the planted area of soybeans, 83 percent of cotton, and
61 percent maize was genetically modified varieties. Genetically modified soybeans
carried herbicide tolerant traits only, but maize and cotton carried both herbicide
tolerance and insect protection traits (the latter largely the Bacillus thuringiensus Bt
insecticidal protein). In the period 2002 to 2006, there were significant increases in the
area planted to Bt protected cotton and maize, and herbicide tolerant maize also
increased in sown area.
Lecture 6. Modern methods of molecular genetics.
Experimental breeding. Genetically diverse lines of organisms can be crossed in
such a way to produce different combinations of alleles in one line. For example,
parental lines are crossed, producing an F1 generation, which is then allowed to undergo
random mating to produce offspring that have purebreeding genotypes (i.e., AA, bb, cc,
or DD). This type of experimental breeding is the origin of new plant and animal lines,
which are an important part of making laboratory stocks for basic research. When
applied to commerce, transgenic commercial lines produced experimentally are called
genetically modified organisms (GMOs). Many of the plants and animals used by
humans today (e.g., cows, pigs, chickens, sheep, wheat, corn (maize), potatoes, and
rice) have been bred in this way.
Cytogenetic techniques. Cytogenetics focuses on the microscopic examination of
genetic components of the cell, including chromosomes, genes, and gene products.
Older cytogenetic techniques involve placing cells in paraffin wax, slicing thin sections,
and preparing them for microscopic study. The newer and faster squash technique
involves squashing entire cells and studying their contents. Dyes that selectively stain
various parts of the cell are used; the genes, for example, may be located by selectively
staining the DNA of which they are composed. Radioactive and fluorescent tags are
valuable in determining the location of various genes and gene products in the cell.
Tissue-culture techniques may be used to grow cells before squashing; white blood cells
can be grown from samples of human blood and studied with the squash technique. One
major application of cytogenetics in humans is in diagnosing abnormal chromosomal
complements such as Down syndrome (caused by an extra copy of chromosome 21) and
Klinefelter syndrome (occuring in males with an extra X chromosome). Some diagnosis
is prenatal, performed on cell samples from amniotic fluid or the placenta.
23
Biochemical techniques. Biochemistry is carried out at the cellular or subcellular
level, generally on cell extracts. Biochemical methods are applied to the main chemical
compounds of genetics—notably DNA, RNA, and protein. Biochemical techniques are
used to determine the activities of genes within cells and to analyze substrates and
products of gene-controlled reactions. In one approach, cells are ground up and the
substituent chemicals are fractionated for further analysis. Special techniques (e.g.,
chromatography and electrophoresis) are used to separate the components of proteins so
that inherited differences in their structures can be revealed. For example, more than
100 different kinds of human hemoglobin molecules have been identified. Radioactively
tagged compounds are valuable in studying the biochemistry of whole cells. For
example, thymine is a compound found only in DNA; if radioactive thymine is placed
in a tissue-culture medium in which cells are growing, genes use it to duplicate
themselves. When cells containing radioactive thymine are analyzed, the results show
that, during duplication, the DNA molecule splits in half, and each half synthesizes its
missing components.
Molecular techniques. Although overlapping with biochemical techniques,
molecular genetics techniques are deeply involved with the direct study of DNA. This
field has been revolutionized by the invention of recombinant DNA technology. The
DNA of any gene of interest from a donor organism (such as a human) can be cut out of
a chromosome and inserted into a vector to make recombinant DNA, which can then be
amplified and manipulated, studied, or used to modify the genomes of other organisms
by transgenesis. A fundamental step in recombinant DNA technology is amplification.
This is carried out by inserting the recombinant DNA molecule into a bacterial cell,
which replicates and produces many copies of the bacterial genome and the recombinant
DNA molecule (constituting a DNA clone). A collection of large numbers of clones of
recombinant donor DNA molecules is called a genomic library. Such libraries are the
starting point for sequencing entire genomes such as the human genome. Today
genomes can be scanned for small molecular variants called single nucleotide
polymorphisms, or SNPs (“snips”), which act as chromosomal tags to associated
specific regions of DNA that have a property of interest and may be involved in a
human disease or disorder.
Lecture 7. Characteristics of mutations.
In biology, mutations are changes to the nucleotide sequence of the genetic
material of an organism. Mutations can be caused by copying errors in the genetic
material during cell division, by exposure to ultraviolet or ionizing radiation, chemical
mutagens, or viruses, or can be induced by the organism itself, by cellular processes
such as hypermutation. In multicellular organisms with dedicated reproductive cells,
mutations can be subdivided into germ line mutations, which can be passed on to
descendants through the reproductive cells, and somatic mutations, which involve cells
outside the dedicated reproductive group and which are not usually transmitted to
descendants. If the organism can reproduce asexually through mechanisms such as
cuttings or budding the distinction can become blurred. For example, plants can
sometimes transmit somatic mutations to their descendants asexually or sexually where
flower buds develop in somatically mutated parts of plants. A new mutation that was
24
not inherited from either parent is called a de novo mutation. The source of the mutation
is unrelated to the consequence, although the consequences are related to which cells
were mutated.
Mutations create variation within the gene pool. Less favorable (or deleterious)
mutations can be reduced in frequency in the gene pool by natural selection, while more
favorable (beneficial or advantageous) mutations may accumulate and result in adaptive
evolutionary changes. For example, a butterfly may produce offspring with new
mutations. The majority of these mutations will have no effect; but one might change
the color of one of the butterfly's offspring, making it harder (or easier) for predators to
see. If this color change is advantageous, the chance of this butterfly surviving and
producing its own offspring are a little better, and over time the number of butterflies
with this mutation may form a larger percentage of the population.
Neutral mutations are defined as mutations whose effects do not influence the
fitness of an individual. These can accumulate over time due to genetic drift. It is
believed that the overwhelming majority of mutations have no significant effect on an
organism's fitness. Also, DNA repair mechanisms are able to mend most changes before
they become permanent mutations, and many organisms have mechanisms for
eliminating otherwise permanently mutated somatic cells.
Mutation is generally accepted by the scientific community as the mechanism
upon which natural selection acts, providing the advantageous new traits that survive
and multiply in offspring or disadvantageous traits that die out with weaker organisms.
Lecture 8. Biotechnologies of manipulation with genes.
Genetic
engineering,
recombinant
DNA
technology,
genetic
modification/manipulation (GM) and gene splicing are terms that apply to the direct
manipulation of an organism's genes. Genetic engineering is different from traditional
breeding, where the organism's genes are manipulated indirectly. Genetic engineering
uses the techniques of molecular cloning and transformation to alter the structure and
characteristics of genes directly. Genetic engineering techniques have found some
successes in numerous applications.
There are a number of ways through which genetic engineering is accomplished.
Essentially, the process has five main steps:
1.
Isolation of the genes of interest
2.
Insertion of the genes into a transfer vector
3.
Transfer of the vector to the organism to be modified
4.
Transformation of the cells of the organism
5.
Selection of the genetically modified organism (GMO) from those that
have not been successfully modified
Isolation is achieved by identifying the gene of interest that the scientist wishes to
insert into the organism, usually using existing knowledge of the various functions of
genes. DNA information can be obtained from cDNA or gDNA libraries, and amplified
using PCR techniques. If necessary, i.e. for insertion of eukaryotic genomic DNA into
prokaryotes, further modification may be carried out such as removal of introns or
ligating prokaryotic promoters.
25
Insertion of a gene into a vector such as a plasmid can be done once the gene of
interest is isolated. Other vectors can also be used, such as viral vectors, bacterial
conjugation, liposomes, or even direct insertion using a gene gun. Restriction enzymes
and ligases are of great use in this crucial step if it is being inserted into prokaryotic or
viral vectors. Daniel Nathans and Hamilton Smith received the 1978 Nobel Prize in
Physiology or Medicine for their isolation of restriction endonucleases.
Once the vector is obtained, it can be used to transform the target organism.
Depending on the vector used, it can be complex or simple. For example, using raw
DNA with gene guns is a fairly straightforward process but with low success rates,
where the DNA is coated with molecules such as gold and fired directly into a cell.
Other more complex methods, such as bacterial transformation or using viruses as
vectors have higher success rates.
After transformation, the GMO can be selected from those that have failed to take
up the vector in various ways. One method is screening with DNA probes that can stick
to the gene of interest that was supposed to have been transplanted. Another is to
package genes conferring resistance to certain chemicals such as antibiotics or
herbicides into the vector. This chemical is then applied ensuring that only those cells
that have taken up the vector will survive.
Lecture 9. Genetically modified organisms: their main points, directions of use.
A genetically modified organism (GMO) or genetically engineered organism
(GEO) is an organism whose genetic material has been altered using genetic
engineering techniques. These techniques, generally known as recombinant DNA
technology, use DNA molecules from different sources, which are combined into one
molecule to create a new set of genes. This DNA is then transferred into an organism,
giving it modified or novel genes. Transgenic organisms, a subset of GMOs, are
organisms which have inserted DNA that originated in a different species. Some GMOs
contain no DNA from other species and are therefore not transgenic but cisgenic.
GMOs have widespread applications. They are used in biological and medical
research, production of pharmaceutical drugs, experimental medicine (e.g. gene
therapy), and agriculture (e.g. golden rice). The term "genetically modified organism"
does not always imply, but can include, targeted insertions of genes from one species
into another. For example, a gene from a jellyfish, encoding a fluorescent protein called
GFP, can be physically linked and thus co-expressed with mammalian genes to identify
the location of the protein encoded by the GFP-tagged gene in the mammalian cell.
Such methods are useful tools for biologists in many areas of research, including those
who study the mechanisms of human and other diseases or fundamental biological
processes in eukaryotic or prokaryotic cells.
To date the broadest application of GMO technology is patent-protected food
crops which are resistant to commercial herbicides or are able to produce pesticidal
proteins from within the plant, or stacked trait seeds, which do both. The largest share
of the GMO crops planted globally are owned by Monsanto according to the company.
In 2007, Monsanto’s trait technologies were planted on 246 million acres (1,000,000
km2) throughout the world, a growth of 13 percent from 2006.
26
In the corn market, Monsanto’s triple-stack corn – which combines Roundup
Ready 2 weed control technology with YieldGard Corn Borer and YieldGard Rootworm
insect control – is the market leader in the United States. U.S. corn farmers planted
more than 17 million acres (69,000 km2) of triple-stack corn in 2007, and it is estimated
the product could be planted on 45 million to 50 million acres (200,000 km2) by 2010.
In the cotton market, Bollgard II with Roundup Ready Flex was planted on nearly 3
million acres (12,000 km2) of U.S. cotton in 2007. Rapid growth in the total area
planted is measurable by Monsanto's growing share. On January 3, 2008, Monsanto
Company (MON.N) said its quarterly profit nearly tripled, helped by strength in its corn
seed and herbicide businesses, and raised its 2008 forecast. According to the
International Service for the Acquisition of Agri-Biotech Applications (ISAAA), of the
approximately 8.5 million farmers who grew biotech crops in 2005, some 90% were
resource-poor farmers in developing countries. These include some 6.4 million farmers
in the cotton-growing areas of China, an estimated 1 million small farmers in India,
subsistence farmers in the Makhathini flats in KwaZulu Natal province in South Africa,
more than 50,000 in the Philippines and in seven other developing countries where
biotech crops were planted in 2005. ISAAA estimated that by 2008, 13.3 million
farmers were growing GM crops, including 12.3 million in developing counties,. These
comprised 7.1 million in China (Bt cotton), 5.0 million in India (Bt cotton), and 200,000
in the Philippines.
"The Global Diffusion of Plant Biotechnology: International Adoption and
Research in 2004", a study by Dr. Ford Runge of the University of Minnesota, estimates
the global commercial value of biotech crops grown in the 2003–2004 crop year at
US$44 billion. In the United States the United States Department of Agriculture
(USDA) reports on the total area of GMO varieties planted. According to National
Agricultural Statistics Service, the States published in these tables represent 81-86
percent of all corn planted area, 88-90 percent of all soybean planted area, and 81-93
percent of all upland cotton planted area (depending on the year). See more on the
extent of adoption at: http://www.ers.usda.gov/Data/BiotechCrops/. USDA does not
collect data for global area. Estimates are produced by the International Service for the
Acquisition of Agri-biotech Applications (ISAAA) and can be found in the report,
Global Status of Commercialized Transgenic Crops: 2007. Transgenic animals are also
becoming useful commercially. On 6 February 2009 the U.S. Food and Drug
Administration approved the first human biological drug produced from such an animal,
a goat. The drug, ATryn, is an anticoagulant which reduces the probability of blood
clots during surgery or childbirth. It is extracted from the goat's milk.
Lecture 10. Problems of possible ecological consequences from use of
genetically modified organisms.
Genetically-modified foods have the potential to solve many of the world's
hunger and malnutrition problems, and to help protect and preserve the environment by
increasing yield and reducing reliance upon chemical pesticides and herbicides. Yet
there are many challenges ahead for governments, especially in the areas of safety
testing, regulation, international policy and food labeling. Many people feel that genetic
engineering is the inevitable wave of the future and that we cannot afford to ignore a
27
technology that has such enormous potential benefits. However, we must proceed with
caution to avoid causing unintended harm to human health and the environment as a
result of our enthusiasm for this powerful technology.
WHO will take an active role in relation to GM foods, primarily for two reasons:
(1) on the grounds that public health could benefit enormously from the potential
of biotechnology, for example, from an increase in the nutrient content of foods,
decreased allergenicity and more efficient food production; and (2) based on the need to
examine the potential negative effects on human health of the consumption of food
produced through genetic modification, also at the global level. It is clear that modern
technologies must be thoroughly evaluated if they are to constitute a true improvement
in the way food is produced. Such evaluations must be holistic and all-inclusive, and
cannot stop at the previously separated, non-coherent systems of evaluation focusing
solely on human health or environmental effects in isolation.
Work is therefore under way in WHO to present a broader view of the evaluation
of GM foods in order to enable the consideration of other important factors. This more
holistic evaluation of GM organisms and GM products will consider not only safety but
also food security, social and ethical aspects, access and capacity building. International
work in this new direction presupposes the involvement of other key international
organizations in this area. As a first step, the WHO Executive Board will discuss the
content of a WHO report covering this subject in January 2003. The report is being
developed in collaboration with other key organizations, notably FAO and the United
Nations Environment Programme (UNEP). It is hoped that this report could form the
basis for a future initiative towards a more systematic, coordinated, multi-organizational
and international evaluation of certain GM foods.
Ecological risks. The potential impact on nearby ecosystems is one of the greatest
concerns associated with transgenic plants. Transgenes have the potential for significant
ecological impact if the plants can increase in frequency and persist in natural
populations. These concerns are similar to those surrounding conventionally bred plant
breeds. Several risk factors should be considered:
•
Is the transgenic plant capable of growing outside a cultivated area?
•
Can the transgenic plant pass its genes to a local wild species, and are the
offspring also fertile?
•
Does the introduction of the transgene confer a selective advantage to the
plant or to hybrids in the wild?
Many domesticated plants can mate and hybridise with wild relatives when they
are grown in proximity, and whatever genes the cultivated plant had can then be passed
to the hybrid. This applies equally to transgenic plants and conventionally bred plants,
as in either case there are advantageous genes that may have negative consequences to
an ecosystem upon release. This is normally not a significant concern, despite fears over
'mutant superweeds' overgrowing local wildlife: although hybrid plants are far from
uncommon, in most cases these hybrids are not fertile due to polyploidy, and will not
multiply or persist long after the original domestic plant is removed from the
environment. However, this does not negate the possibility of a negative impact.
In some cases, the pollen from a domestic plant may travel many miles on the
wind before fertilising another plant. This can make it difficult to assess the potential
28
harm of crossbreeding; many of the relevant hybrids are far away from the test site.
Among the solutions under study for this concern are systems designed to prevent
transfer of transgenes, such as Terminator Technology, and the genetic transformation
of the chloroplast only, so that only the seed of the transgenic plant would bear the
transgene. With regard to the former, there is some controversy that the technologies
may be inequitable and might force dependence upon producers for valid seed in the
case of poor farmers, whereas the latter has no such concern but has technical
constraints that still need to be overcome. Solutions are being developed by EU funded
research programmes such as Co-Extra and Transcontainer.
There are at least three possible avenues of hybridization leading to escape of a
transgene:
•
Hybridization with non-transgenic crop plants of the same species and
variety.
•
Hybridization with wild plants of the same species.
•
Hybridization with wild plants of closely related species, usually of the
same genus.
However, there are a number of factors which must be present for hybrids to be
created.
•
The transgenic plants must be close enough to the wild species for the
pollen to reach the wild plants.
•
The wild and transgenic plants must flower at the same time.
•
The wild and transgenic plants must be genetically compatible.
In order to persist, these hybrid offspring:
•
Must be viable, and fertile.
•
Must carry the transgene.
Studies suggest that a possible escape route for transgenic plants will be through
hybridization with wild plants of related species.
1.
It is known that some crop plants have been found to hybridize with wild
counterparts.
2.
It is understood, as a basic part of population genetics, that the spread of a
transgene in a wild population will be directly related to the fitness effects of the gene in
addition to the rate of influx of the gene to the population. Advantageous genes will
spread rapidly, neutral genes will spread with genetic drift, and disadvantageous genes
will only spread if there is a constant influx.
3.
The ecological effects of transgenes are not known, but it is generally
accepted that only genes which improve fitness in relation to abiotic factors would give
hybrid plants sufficient advantages to become weedy or invasive. Abiotic factors are
parts of the ecosystem which are not alive, such as climate, salt and mineral content,
and temperature. Genes improving fitness in relation to biotic factors could disturb the
(sometimes fragile) balance of an ecosystem. For instance, a wild plant receiving a pest
resistance gene from a transgenic plant might become resistant to one of its natural
pests, say, a beetle. This could allow the plant to increase in frequency, while at the
same time animals higher up in the food chain, which are at least partly dependent on
that beetle as food source, might decrease in abundance. However, the exact
29
consequences of a transgene with a selective advantage in the natural environment are
almost impossible to predict reliably.
It is also important to refer to the demanding actions that government of
developing countries had been building up among the last decades.
Agricultural impact of transgenic plant. Outcrossing of transgenic plants not only
poses potential environmental risks, it may also trouble farmers and food producers.
Many countries have different legislations for transgenic and conventional plants as
well as the derived food and feed, and consumers demand the freedom of choice to buy
GM-derived or conventional products. Therefore, farmers and producers must separate
both production chains. This requires coexistence measures on the field level as well as
traceability measures throughout the whole food and feed processing chain. Research
projects such as Co-Extra, SIGMEA and Transcontainer investigate how farmers can
avoid outcrossing and mixing of transgenic and non-transgenic crops, and how
processors can ensure and verify the separation of both production chains.
Lecture 11. Main rules and agreements in the field of biosafety.
The Cartagena Protocol on Biosafety regulates genetic engineering. It is a
remarkable achievement in international law, given the determination of GMO
producer/exporter countries and the biotechnology industry to block global regulation.
The following article outlines the progress so far and examines the challenges ahead.
THE Cartagena Protocol on Biosafety (CPB) entered into force on 11 September 2003.
The EU Directive on the deliberate release of GMOs into the environment
(Directive 2001/18/EC) has been applicable since 17 October 2002. It applies to the
deliberate release into the environment of GMOs and the placing on the market of
GMOs as such or in products. The Directive strengthens previous legislation, requiring
more detailed pre-market scientific evaluation and risk assessment of GMOs, and
specifically refers to the Precautionary Principle. Mandatory post-market monitoring
and general surveillance will allow potential longer-term effects to be followed.
The Regulation on GM food and feed (Regulation (EC) No 1829/2003) applies to
the evaluation, authorisation and labelling of GM food and feed. It has been in force
since 7 November 2003 and will be applicable as of April 2004. This legislation extends
the scope of previous regulation to now include feed produced from GMOs and all
products derived from GMOs, irrespective of whether the DNA or protein is detectable.
It also improves on the approvals process and can require post-market monitoring. The
threshold that triggers labelling has been lowered from 1.0% to 0.9%, provided the
presence of the authorised GMO in the final product is ‘technically unavoidable’.
The Regulation on traceability and labelling of GMOs and the traceability of food
and feed produced from GMOs (Regulation (EC) No 1830/2003) provides a traceability
framework for GMOs, GM food and GM feed. It entered into force on 7 November
2003. Traceability is defined as the ability to trace GMOs and products produced from
GMOs at all stages throughout the production and distribution chains. Apart from
providing the possibility of withdrawing products when problems arise, it is also
important for meaningful labelling of GMOs and in addressing liability issues.
The Regulation on trans-boundary movements of GMOs (Regulation (EC) No
1946/2003) implements the EU’s obligations under the Protocol. In accordance with the
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Protocol’s AIA procedure, no first export of GMOs intended for deliberate release into
the environment can be carried out without the prior written express consent of the
importing country. The regulation recognises the flexibilities in the Protocol that
preserve the right of importing countries to take (stricter) decisions according to their
domestic regulatory frameworks, for GMOs intended for deliberate release and for food,
feed and processing. It also recognises the right of countries to set standards for
contained use and to regulate transit of GMOs. In the absence of domestic legislation,
the provisions of the CPB apply and the prior written express consent provision holds.
In the United States the Coordinated Framework for Regulation of Biotechnology
governs the regulation of transgenic organisms, including plants. The three agencies
involved are:

USDA Animal and Plant Health Inspection Service - who state that:
The Biotechnology Regulatory Services (BRS) program of the U.S. Department
of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is
responsible for regulating the introduction (importation, interstate movement, and field
release) of genetically engineered (GE) organisms that may pose a plant pest risk. BRS
exercises this authority through APHIS regulations in Title 7, Code of Federal
Regulations, Part 340 under the Plant Protection Act of 2000. APHIS protects
agriculture and the environment by ensuring that biotechnology is developed and used
in a safe manner. Through a strong regulatory framework, BRS ensures the safe and
confined introduction of new GE plants with significant safeguards to prevent the
accidental release of any GE material. APHIS has regulated the biotechnology industry
since 1987 and has authorized more than 10,000 field tests of GE organisms. In order to
emphasize the importance of the program, APHIS established BRS in August 2002 by
combining units within the agency that dealt with the regulation of biotechnology.
Biotechnology, Federal Regulation, and the U.S. Department of Agriculture, February
2006, USDA-APHIS Fact Sheet.

EPA - evaluates potential environmental impacts, especially for genes
which encode for pesticide production.

DHHS, Food and Drug Administration (FDA) - evaluates human health
risk if the plant is intended for human consumption.
Ukraine has adopted its Law ”On the State System of Biosafety in Creating,
Testing, Transporting and Using Genetically-Modified Organisms”, which regulates
relations between executive authorities, manufacturers, vendors (suppliers), developers,
researchers, scholars and consumers of genetically-modified organisms and products
manufactured by technologies envisaging their development, creation, testing, study,
transportation, import, export, marketing, discharge to the environment and use of
genetically modified organisms in the Ukraine, and ensuring biological and genetic
safety. The Law shall not apply to humans, tissues and individual cells being part of a
human body. Since November 1st, 2007 Ukraine also enforced the Government’s
Decree #985 from August 1st, 2007 ”On Matters Related to the Circulation of Food
Products Containing Genetically Modified Organisms and/or Microorganisms”, which
enacts compulsory labeling of such products and bans ”import, manufacturing, and sales
of children’s food products containing genetically modified organisms and/or
microorganisms”. According to the text of the resolution such measures are taken ”…in
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order to bring Ukrainian laws into compliance with the standards of the European
Union”.
Law of Ukraine #1103-V “On State Safety System while Creating, Testing,
Transporting and Implementing Genetically Modified Organisms” of May 31, 2007, is
an important step forward in regulating application of GMO to minimize biological risk
and to guarantee customer’s right to make a choice. At the same time the law is missing
clear definitions of key terms and ideas (for example, “biological safety”). There is no
regulation for classifying risks. But the main disadvantage is a lack of a competent
controlling body to ensure safety measures for creating, testing, registering,
transporting, using and utilizing GMO. Greens are convinced that efficiency of law
implementation depends on developing by-law normative-legal base to regulate
handling of GMO.
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