Professional Documents
Culture Documents
Safety and Risk can be defined as “ product or a project is safe with respect to a
person or a group at a given time, if its risks ere fully known and the risks are
judged to be acceptable in the light of settled perspectives.
Probability of safety = 1 – probability of risk
Risk is a function of level of hazard and the probability of occurrence of the
hazard.
Risk = Probability of occurrence of hazard x consequence in magnitude
Objectives
Regulatory standards for biotechnology-derived pharmaceuticals have
generally been comparable among the European Union, Japan and United States.
All regions have adopted a flexible, case-by-case, science-based approach to
preclinical safety evaluation needed to support clinical development and
marketing authorisation. In this rapidly evolving scientific area, there is a need
for common understanding and continuing dialogue among the regions. The
primary goals of preclinical safety evaluation are: 1) to identify an initial safe
dose and subsequent dose escalation schemes in humans; 2) to identify potential
target organs for toxicity and for the study of whether such toxicity is reversible;
and 3) to identify safety parameters for clinical monitoring. Adherence to the
principles presented in this document is intended to improve the quality and
consistency of the preclinical safety data supporting the development of
biopharmaceuticals.
Scope
This guidance is intended primarily to recommend a basic framework for the
preclinical safety evaluation of biotechnology-derived pharmaceuticals. It applies
to products derived from characterised cells through the use of a variety of
expression systems including bacteria, yeast, insect, plant, and mammalian cells.
The intended indications may include in vivo diagnostic, therapeutic, or
prophylactic uses. The active substances include proteins and peptides, their
derivatives and products of which they are components; they could be derived
from cell cultures or produced using recombinant DNA technology including
production by transgenic plants and animals. Examples include but are not
limited to: cytokines, plasminogen activators, recombinant plasma factors,
growth factors, fusion proteins, enzymes, receptors, hormones, and monoclonal
antibodies.
Risk is a function of the level of hazard and the probability of occurrence of the
hazard. The risk may be defined as the undesirable consequences of an activity in
relation to the likelihood of these consequences being realized. A biohazard is any
imaginable adverse effect that can be identified and measured. Risk assessment
involves determination of the potential and anticipated adverse effect of the
recombinant DNA research to the concerned workers, and of the products of such
research on human health and environment consequent to their accidental or
deliberate release (in case of living organisms) or as a result of their consumption.
Risk assessment should be carried out in a scientifically sound and transparent
manner should be in accordance with recognized risk assessment techniques.
The backbone of the practice of biosafety is risk assessment. While there are
many tools available to assist in the assessment of risk for a given procedure or
experiment, the most important component is professional judgement. Risk
assessments should be performed by the individuals most familiar with the
specific characteristics of the organisms being considered for use, the equipment
and procedures to be employed, animal models that may be used, and the
containment equipment and facilities available. The laboratory director or
principal investigator is responsible for ensuring that adequate and timely risk
assessments are performed and for working closely with the institution’s safety
committee (if existing) and biosafety personnel (if existing) to ensure that
appropriate equipment and facilities are available to support the work being
considered. Once performed, risk assessments should be routinely reviewed and
revised when necessary, taking into consideration acquisition of new data having
a bearing on the degree of risk and other relevant new information from the
scientific literature. One of the most helpful tools available for performing a
microbiological risk assessment is the listing of risk groups for microbiological
agents. However, simple reference to the risk grouping for a particular agent is
insufficient in the conduct of a risk assessment. Other factors that should be
considered, as appropriate, include:
– pathogenicity of the agent and infectious dose
– consideration of the outcome of exposure
– natural route of infection
– other routes of infection, resulting from laboratory manipulations (parenteral,
airborne, ingestion)
– stability of the agent in the environment
– concentration of the agent and volume of concentrated material to be
manipulated
– presence of a suitable host (human or animal)
– information available from animal studies and reports of laboratory-acquired
infections or clinical reports
– laboratory activity planned (concentration, sonication, aerosolization,
centrifugation, etc.)
– any genetic manipulation of the organism that may extend the host range of
the agent or alter the agent’s sensitivity to known, effective treatment
regimens
– local availability of effective prophylaxis or therapeutic interventions.
On the basis of the information ascertained during the risk assessment, a biosafety level
can be assigned to the planned work and appropriate personal protective equipment
selected.
The risk assessment procedure described above works well when there is adequate
information available. However, there are situations when the information is insufficient
to perform an appropriate risk assessment, for example, with clinical specimens or
epidemiological samples collected in the field. In these cases, it is prudent to take a
cautious approach to specimen manipulation. 1. Standard precautions (2) should always
be followed, and barrier protections applied (gloves, gowns, eye protection), whenever
samples are obtained from patients.
2. Basic containment – Biosafety Level 2 practices and procedures should be the
minimum requirement for handling specimens.
3. Transport of specimens should follow national and/or international rules and
regulations.
Some information may be available to assist in determining the risk of handling these
Specimens:
1. Medical data on the patient
2. Epidemiological data (morbidity and mortality data, suspected route of transmission,
other outbreak investigation data)
3. Information on the geographical origin of the specimen.
In the case of outbreaks of disease of unknown etiology, appropriate ad hoc guidelines
may be generated and posted by national competent authorities and/or WHO on the
World Wide Web (as was the case during the 2003 emergence of the severe acute
respiratory syndrome (SARS)) to indicate how specimens should be consigned for
shipment and the biosafety level at which they should be analysed.
Risk assessment and genetically modified microorganisms
Biological expression systems consist of vectors and host cells. A number of criteria must
be satisfied to make them effective and safe to use. An example of such a biological
expression system is plasmid pUC18. Frequently used as a cloning vector in combination
with Escherichia coli K12 cells, the pUC18 plasmid has been entirely sequenced. All
genes required for expression in other bacteria have been deleted from its precursor
plasmid pBR322. E. coli K12 is a non-pathogenic strain that cannot permanently colonize
the gut of healthy humans or animals. Routine genetic engineering experiments can
safely be performed in E. coli K12/pUC18 at Biosafety Level 1, provided the inserted
foreign DNA expression products do not require higher biosafety levels.
1. The expression of DNA sequences derived from pathogenic organisms may increase
the virulence of the GMO
2. Inserted DNA sequences are not well characterized, e.g. during preparation of
genomic DNA libraries from pathogenic microorganisms
3. Gene products have potential pharmacological activity
4. Gene products code for toxins.
Viral vectors for gene transfer
Viral vectors, e.g. adenovirus vectors, are used for the transfer of genes to other cells.
Such vectors lack certain virus replication genes and are propagated in cell lines that
complement the defect. Stocks of such vectors may be contaminated with replication-
competent viruses, generated by rare spontaneous recombination events in the
propagating cell lines, or may derive from insufficient purification. These vectors should
be handled at the same biosafety level as the parent adenovirus from which they are
derived.
Transgenic plants
Transgenic plants expressing genes that confer tolerance to herbicides or resistance to
insects are currently a matter of considerable controversy in many parts of the world.
The discussions focus on the food-safety of such plants, and on the long-term ecological
consequences of their cultivation. Transgenic plants expressing genes of animal or human
origin are used to develop medicinal and nutritional products. A risk assessment should
determine the appropriate biosafety level for the production of these plants.
Genes. Animals with targeted deletions of specific genes (“knock-out” animals) do not
generally present particular biological hazards. Examples of transgenic animals include
animals expressing receptors for viruses normally unable to infect that species. If such
animals escaped from the laboratory and transmitted the transgene to the wild animal
population, an animal reservoir for that particular virus could theoretically be generated.
This possibility has been discussed for poliovirus and is particularly relevant in the
context of poliomyelitis eradication. Transgenic mice expressing the human poliovirus
Hazards associated with the recipient/host
1. Susceptibility of the host
2. Pathogenicity of the host strain, including virulence, infectivity and toxin production
3. Modification of the host range
4. Recipient immune status
5. Consequences of exposure.
Hazards arising from the alteration of existing pathogenic traits Many modifications do
not involve genes whose products are inherently harmful, but adverse effects may arise as
the result of alteration of existing non-pathogenic or
pathogenic traits. Modification of normal genes may alter pathogenicity. In an attempt to
identify these potential hazards, the following points may be considered (the list is not
exhaustive).
1. Is there an increase in infectivity or pathogenicity?
2. Could any disabling mutation within the recipient be overcome as a result of the
insertion of the foreign gene?
3. Does the foreign gene encode a pathogenicity determinant from another organism?
4. If the foreign DNA does include a pathogenicity determinant, is it foreseeable that this
gene could contribute to the pathogenicity of the GMO?
5. Is treatment available?
6. Will the susceptibility of the GMO to antibiotics or other forms of therapy be affected
as a consequence of the genetic modification?
7. Is eradication of the GMO achievable?
Further considerations
The use of whole animals or plants for experimental purposes also requires careful
consideration. Investigators must comply with the regulations, restrictions and
requirements for the conduct of work with GMOs in host countries and institutions.
Countries may have national authorities that establish guidelines for work with GMOs,
and may help scientists classify their work at the appropriate biosafety level. In some
cases classification may differ between countries, or countries may decide to classify
work at a lower or higher level when new information on a particular vector/host system
becomes available. Risk assessment is a dynamic process that takes into account new
developments and the progress of science. The performance of appropriate risk
assessments will assure that the benefits of recombinant DNA technology remain
available to humankind in the years to come.
Risk assessment has a long tradition in regulating human activities with the aim to
minimise or avoid risk to human health and the environment. Examples can be found in
the production of medical products, chemistry or nuclear power. According to European
regulations, the safety of GMOs has to be assessed prior to releases into the environment
and placing on the market. The approach is described in more detail in Directive
2001/18/EC on the deliberate release into the environment of GMOs, which was adopted
in April 2001 and repealed Directive 90/220/EEC in October 2002. In the Annex II of
this Directive the principles 92 3 Regulation, Assessment and Monitoring of GMOs for
the so-called environmental risk assessment, which also includes human health effects,
are laid down. Concerning food, Regulation (EC) 258/97 on Novel Food and Novel Food
Ingredients stipulates risk assessment for foods that have not been used for human
consumption to a significant degree in the European Union before. Foods and feed
containing or consisting of or derived from GMOs are covered by Regulation (EC)
1829/2003, requiring one single risk assessment, carried out by the newly founded
European Food Safety Authority. The overall aim is to release only those GMOs that do
not pose any risk to human health or the environment. Possible positive effects of GMOs
are not subject to risk assessment.
What is Risk Assessment?
Risk assessment, the first part of risk analysis, is followed by risk management and risk
communication. Environmental risk assessment is defined by Directive 2001/18/EC as
the evaluation of risks to human health and the environment, whether direct or indirect,
immediate or delayed, which experimental deliberate release or deliberate release by
placing GMOs on the market may pose. Direct effects refer to primary effects, which are
due to the GMO itself, e.g. allergenicity of the derived novel GM food. In contrast,
indirect effects occur through a causal chain of events, e.g. interaction with other
organisms or effects due to a change of agricultural management due to the use of GM
crops. Immediate effects could be observed during the period of release of the GMO, e.g.
the establishment of weedy GM plants outside the agriculturally used fields. They can be
direct or indirect. Delayed effects would be observable at a later stage as a direct or
indirect effect as such as long-term effects from changed consumption patterns due to
GM food. Additionally, cumulative long-term effects on the environment and human
health have to be assessed. The objective of environmental risk assessment, according to
European legislation, is to identify and evaluate potential adverse effects of a GMO and
to elucidate if there is a need for risk management and suitable measures to be taken. In
the context of this section, the terms hazard and risk are defined as follows: A hazard is a
potential harmful characteristic (here of a GMO), which is an intrinsic property of the
organism investigated. Hazards can give rise to negative consequences. These
consequences can have different orders of magnitude and different likelihood of actually
coming true. Risk can be quantified by combining the likelihood of consequences of a
specific hazard with their magnitude. The principal approach to assess the safety of
GMOs is largely accepted. First of all risk assessment should be science-based and
carried out ensuring a very high scientific standard. For every GMO the risk assessment
is done on a case by- case basis and in a stepwise manner. This means that for example
each GM plant is tested first in the laboratory then on a small scale in a field trial,
followed by a large-scale field trial before authorisation for placing on the market can be
requested. The following step can only be carried out if the preceding step has shown that
the GMO does not pose any risk to human health or the environment. In contrast, the
interpretation and use of the results of the risk assessment differ within the European
Union Member States and internationally, depending for example on the models used for
comparisons. For example, Germany and the UK compare the use and the effects of GM
crops to conventional agriculture, while Austria or Sweden take an organic-oriented input
reduced agriculture as the scale.
The risk of gene transfer to related weed species depends very much on the GM plant
itself. Maize and potato do not have any compatible indigenous related weeds in Europe
that could receive transgenes via pollen flow. In contrast, oilseed
rape is a cross-pollinating species for which several related species exist, so outcrossing
cannot be ruled out. The extent of out-crossing depends on climatic conditions,
agricultural practices, viability of pollen, and availability of out-crossing partners. The
establishment of a trait in the wild population depends on the selective advantage the new
trait might confer. The possibility of gene transfer with in the same crop species depends
on the specific crop. It can present a potential problem for agriculture, as in the case of
organic agriculture where only very low levels of GM plants might be tolerated in the
harvest. The term horizontal gene transfer describes non-sexual gene transfer e.g. from
plant to micro-organisms. Micro-organisms, especially bacteria have the ability to take up
DNA from other organisms or their environment and to integrate the DNA into their
genome.Horizontal gene transfer has been discussed as a risk of gene escape into the
environment without any control. During evolution, horizontal gene transfer has taken
place, but it is considered to be a very rare event. Still, it cannot be ruled out and in the
context of antibiotic-resistance marker genes this possibility has attracted a lot of
attention. According to Directive 2001/18/EC antibiotic-resistance marker genes should
be phased out for GMOs to be placed on the market until the end of 2004. Of course,
alternative marker genes such as those conferring the possibility of metabolising new
substrates, have to undergo new risk assessments.
The potential consequences of the general effects discussed above depend mainly on the
transgenic trait of the GMO.Up to now, the main traits for GM crops are herbicide
tolerance and pest resistance. Herbicide tolerance genes confer tolerance to broad
spectrum herbicides like glyphosate (Round-Up) or glufosinate (Basta). This trait
represented 75% of all GM crops planted commercially in the year 2002.Possible trait-
specific environmental effects, apart from the ones discussed in the previous section, are
mainly due to the application of the respective herbicide and changes in crop
management. Glyphosate and glufosinate are said to be more environmentally friendly
than other herbicides in use.Easier and less applications might lead to less pollution of
soil and ground water. The possibility of a later application during cultivation could lead
to a better soil coverage with plants (weeds) and less erosion. On the other hand a
permanent use could reduce biodiversity of weeds and related animals considerably. In
2002, 17% of commercially planted GM crops world-wide were insect-resistant through
the expression of a toxin from the soil bacterium Bacillus thuringiensis (Bt) (see also
Sect. 2.2). The Bt toxin has been used for many years as a spray in organic agriculture.
Out-crossing of Bt-crops resulting in certain advantage for Bt-producing weeds is a
potential negative effect. Of greater concern are the unintended effects of Bt plants. This
issue has been widely discussed in the context of assumed damage to larvae of the
Monarch butterfly in the USA after being fed pollen of Bt-maize in a laboratory
setting.Adverse effects could not be confirmed by field trials. Soil organisms might come
into contact with the Bt toxin, as it is exuded via the plant roots. The effect on the soil
ecosystem is still unclear. Another important issue is the development of resistance
mechanisms against the toxin by the targeted pests. This is a normal process, taking place
for conventional synthetic pesticides after approximately 10 years.Development of insect
resistance is therefore assumed, which would also render the Bt toxin useless for organic
agriculture. The application of certain risk management strategies, with refuge areas
where non-Bt-plants are grown to delay the development of resistance, is requested in the
USA.
Scientific Uncertainty
In many cases of potential environmental or health risks, the scientific knowledge base is
not good enough to assess potential risks in a quantitative way and with sufficient
certainty. Profound understanding of complex ecological systems is lacking as well as
knowledge to predict the long-term effects of novel food in the diet on the health
status.However, it is important to be aware of the fact that this is not only true for GM
crops and GM food but also for new varieties of conventional crops and novel exotic
foods that have not been consumed in Europe before. It should also be noted that GM
crops and food are examined to a much
higher extent than any other conventional crop or food. As quantitative risk assessment
is not possible in many cases, a qualitative evaluation system has been developed. The
magnitude of potential consequences can be described as negligible, low, moderate and
severe. Also the likelihood that these consequences will come into effect can be assigned
as negligible, low, moderate or high. The risk must then be assessed by combining the
likelihood with the magnitude of consequences. For example, a high magnitude of
consequences of an adverse effect combined with a low likelihood of the adverse effect
being realised could result in a moderate risk. The final evaluation depends on the
specific GMO and needs to be considered on a case-by-case basis.
Risk Management
If the risk assessment identified a risk, a risk management strategy may be developed to
minimise or mitigate it (see also Sect. 4.5). A 100% safety or 0% risk is not achievable as
a result of risk assessment, therefore uncertainty is an unavoidable part of risk assessment
and risk management. Risk management measures could include:
– Confinement strategies, e.g. certain GM crops are only allowed to be grown in
greenhouses.
– Restricted use, e.g. the growth of GM crops could be restricted to certain geographical
areas. Monitoring following experimental release of GM crops or commercialisation of
GM crops or GM food. Monitoring can be used to identify predicted or unforeseen
effects.
– Guidelines and technical support, e.g. introduction of refuge areas to minimise
resistance development of pests or advice for good agricultural practices as such as crop
rotation and weed control to avoid weediness of GM crops and GM volunteer plants.
– Record keeping (the use of documentation), e.g. as foreseen in Regulation (EC)
1830/2003 on traceability of GM crops and food as an important part of risk
management.
In addition, the design of GM crops could be changed towards male sterile varieties or to
the production of sterile seeds (e.g. terminator technology). The latter is especially
controversial as the production of sterile seeds will prevent farmers from saving seeds,
forcing them to buy new seeds every year.
The Precautionary Principle as Part of Risk Management
Very often scientific data is not available or is insufficient to assess a possible risk in
relation to a GM crop in a significant manner. Several questions are not addressed due to
lack of data on fundamental biological phenomena as such as out-crossing behaviour in
oilseed rape or the effects of GM crops on the soil ecosystem. Scientific uncertainty in
risk assessment leads to the question of how to deal with risks that cannot be sufficiently
quantified. The precautionary principle was introduced at the 1992 Rio Conference on the
Environment and Development in Article 15 of the Rio Declaration:
In order to protect the environment the precautionary approach shall be widely applied by
States according to their capability. Where there are threats of serious or irreversible
damage, lack of full scientific certainty shall not be pursued as a reason for postponing
cost-effective measures to prevent environmental degradation. The precautionary
principle is also included amongst the other international treatise and declarations, and
referred to in Directive 2001/18/EC. However, the application of the precautionary
principle is not clearly defined and harmonised and gives rise to different interpretations.
Generally, the precautionary principle encompasses a forward-looking approach, which
includes the prevention of damage, and has a cost-benefit analysis of action or lack of
action and the ratio
of this response refers to the cost-effectiveness of the action. The application of
the precautionary principle should be non-discriminatory and consistent, i.e. comparable
situations should not be treated differently and measures should be consistent with
measures adopted under similar circumstances. Measures taken have to be reviewed as
new scientific developments evolve.
Risk Communication
Risk communication to stakeholders is a key area of risk analysis. The expression
of each risk assessment should be unambiguous, transparent and relevant. Key rules,
identified by the Scientific Steering Committee (SSC) of the European Commission
include:
– Completeness of information
– Public access to documentation
– Transparency of discussions and motivations
– Frank acknowledgement of the various positions and contrasting view, including
speculations
– Clarity in wording and accuracy in use of specific expressions
– Recognition of different interests and stakeholders
– Recognition of social, cultural and ethical issues
Awareness of risk perception is another important factor in communicating risk. Risk
perception of experts and the general public might differ considerably, because personal
opinions are formed by information from different sources and integrated with personal
experiences. Among the factors influencing public perception of risk are, for example,
the extent to which the risk is voluntary, controllability of the risk and the novelty of the
risk form. The SSC suggests expressing conclusions of risk assessment in a more user-
acceptable manner by putting them into some form of context, e.g. through risk ranking
by comparing risk assessments of different, but related, sources of risk, the risk of
possible replacements and by using risk benefit analysis.
Reducing risk
Monitoring of GMOs
Disadvantages of the method are: it does not indicate whether the introduced
DNA (gene) is active; it requires skilled technicians.
Protein Analysis
The method is based on detecting the presence of specific proteins (antigens) with
antibodies, and on enzyme assays that detect the activity of a specific protein.Recently a
very easy and simple test was developed called lateral flow strips, in which colour-dyed
antibodies are fixed to the nitro-cellulose filter are dipped into the extract of the plant
tissue bearing the transgenic proteins. The actual reaction time is less than 10 min and
allows economical and fast visual evaluation of the results. In food industry, enzyme-
linked immunoassays such as ELISA are well-accepted technologies for detection of food
contamination. Advantages of the method are: it indicates whether the new gene is active
and to what extent in the recipient organism as indicated by the detected protein,
sensitivity for the specific questions to be answered, quantitative (expressed on
weight/weight basis),does not need special training or new sophisticated laboratory
equipment. Disadvantages of the method are: quality of the extracted material is
important, cannot be used efficiently on processed food, if the protein to be analysed
changes in structure it may not be detected, proteins are much more easily degraded than
DNA making them more difficult to handle and giving possible false negative results.
Reference Material
Detection and analysis of GM samples is useful only if both the positive (certified
reference material) and negative controls are available for comparison with the analysed
GM samples. These comparisons will greatly increase the confidence and ability to make
meaningful conclusions about the analysed samples.
Future Trends
The future developments in the monitoring of GMOs will depend primarily on
three issues:
1. Advancements in the detection technologies
2. Improvements in the baseline knowledge
3. Trends in international agreements in as far as labelling and monitoring of
GMOs is concerned
Further developments in PCR technology may lead to lowering of the 0.9% detection and
labelling threshold. Already today, it is possible, although not consistently, to detect
GMOs when representing only 0.1% of the product being tested. Improvements in
baseline knowledge will require that more research money is spent in characterising and
assessing non-GM counterparts. Finally, international trade requirements, public opinion
and advances in scientific knowledge will likely influence the scope and type of
monitoring activities. Internationally agreed-upon traceability and labelling requirements
may reduce the costs of monitoring in the long run.
According to researchers running the study, these differences were not significant, nor of
the type to cause concern. The scientific panel on GMOs in EFSA came to a similar
conclusion, and EFSA recommended MON 863 for approval by EU politicians (EFSA,
2004b). In the course of the approval process, this recommendation was sent to the
national authorities of Member States, and at this point a French scientist expressed
doubts about whether it would be safe to approve the maize on the basis of these data.
Later the NGO Greenpeace asked to see the report with the data; they were denied access
as the report was confidential. Greenpeace did, however, obtain permission for a scientist
who was critical of GMOs to read and comment on the report. This scientist concluded
that the data could not be interpreted to show that the MON 863 would be a food hazard;
but that nor could it be concluded that it was safe either, and that therefore additional
experiments were needed (Greenpeace, 2005). This case and the resulting controversy
raise several questions about the risk assessment. First, how can an expert panel
unanimously agree that the data did not give rise to a genuine concern when several
scientists beyond the panel were to become concerned? A plausible explanation is that
panel members had similar features from the beginning in order to be appointed for this
job. Second, the members may influence each other by collectively drawing conclusions
about the scientific data put forward. Third, the scientist disagreed about the quantity of
experimental data needed to make an informed decision; and fourth, this case raised
questions about
transparency of the process and information on which the decision was made; in
particular, the critics here were not allowed full access to the report in question.
There is a specific issue here about impacts on organic production, since gene-flow from
GM crops may undermine the claim of an organic producer to be GM-free. This issue has
given rise to strong reactions from organic producers and consumer organisations.
Responding to this problem, the EU commission recommended in 2003 that Member
States issue guidelines on the development of national strategies and best practice to
ensure the co-existence of genetically modified crops with conventional and organic
farming. ‘Co-existence’ here refers to the ability of farmers to make a practical choice
between conventional, organic
and GM-crop production — a choice meeting the legal requirements for labelling and/or
purity standards. The conditions under which European farmers work are extremely
diverse. For this reason the Commission, expressed a preference for an approach that
would leave it up to Member States to develop and implement management measures for
co-existence. The role of the Commission would include gathering and coordinating
relevant information based on on-going studies at community and national level, and
offering advice and issuing guidelines which may assist Member States in establishing
best practice for co-existence (Commission recommendation of 23 July 2003,
2003/556/EC). So far, only Germany, Denmark, Italy and five regions of Austria have
laws regulating GMO cultivation. The main Dutch farming organisations have reached a
voluntary agreement; another eight countries are drafting legislation, and in this process
Spain, Luxembourg, Portugal, Poland and the Czech Republic are most advanced (Smith,
2005). The Danish regulation, which was the first to be introduced, stipulates certain
kinds of crop cultivation and management practice. Thus growers of GM crops must
follow rules on the distance between fields grown with
GM crops and neighbouring conventional or organic fields; neighbours must be informed
if they have fields within a certain distance, depending on the GM crop, in speech;
farmers must attend a course in the cultivation and management of GM crops; and
information about the whereabouts of these fields must be available to the public (Danish
law about growing of genetically modified crops, LOV nr 436 af 09/06/2004). Even with
strict regulations governing the cultivation and segregation of GM and non-GM crops,
trace-levels of GM material.
RBMK reactor 4 at the Chernobyl Nuclear Power Plant was due to temporarily close for
routine maintenance on April 25 1986. The personnel decided this would be the perfect
opportunity to run a particular test on this reactor. This test was to ensure that during a
shutdown, enough electrical power would be available to run the emergency equipment
and the water cooling supply until the diesel power came on. Here is the sequence of
events on April 25 and 26 which ended in the disaster.
The test started in the morning of April 25. Part of the test was to shutdown the
emergency core cooling system (ECCS) so it wouldn't interrupt to the test later on. This
shutdown of the ECCS was not a cause of the accident, although, had it not been shut
down the severity of the accident may have been reduced. With this shutdown the reactor
was carried on at half the power. At about 23.00h on April 25 the power was reduced
further. The reason it was so late on in the day was because the grid controller had
requested the reactor operator to keep delivering electricity throughout the working hours
causing a delay of the test.
Once the reduction of power had recommenced the reactor should have been stabilised at
1000MW before it was shutdown, but an operational error made the power drop to about
30MW where the positive void coefficient became a problem (this is additional steam in
the cooling channels) . The operators did their best to redeem the problem by freeing the
control rods manually, this way they managed to stabilise the reactor at 200MW.
Shorly after that, the coolant flow increased and the steam pressure dropped requiring the
operators to remove almost all the rods, making the reactor very unstable. There is a
minimum requirement of 20 rods that need to be inserted in the reactor at any time. There
were probably only about 6 left after the operators had finished removing them but the
automatic rods in the reactor increase this number towards 20. The operators had to
maintain the steam pressure, they managed to do this by reducing the flow of feed water.
The cooling of the reactor became less and less because the pumps powered by turbine
were slowing down as the turbine was slowing down. This meant the positive void
coefficient occurred and the operators were now unable to control the power surge.
The temperature increased rapidly causing part of the fuel to rupture. This fuel then got
into the water and fuel particles started reacting with the water causing a steam explosion,
this then destroyed the core of the reactor and 2 minutes later a second explosion due to
expansion of fuel vapour occurred causing more destruction to the reactor. These 2
explosions resulted in the pile cap lifting up allowing air to enter the reactor and to react
with the graphite moderator blocks producing carbon monoxide (CO). CO is a very
flammable gas and ignited easily causing a fire in the reactor.
About 8 of the 140 tonnes of fuel, containing plutonium and other highly radioactive
fission products, were released from the reactor along with the graphite moderator which
is was also highly radioactive. Along with this vapours from caesium and iodine were
released with the explosion and the fire which burnt long after.
There was not one cause of this accident, there were several which all contributed to it.
This accident happened while testing an RMBK reactor. A chain reaction occurred in the
reactor and got out of control, causing explosions and a huge fireball which blew off the
heavy concrete and steel lid on the reactor. These are the causes:
1. Design fault in RBMK reactor
2. A violation of procedures
3. Breakdown of communication
4. Lack of a 'Safety Culture' in the power plant
Consequences:
Environmental consequences
The radioactive fallout caused radioactive material to deposit itself over a large areas of
ground. It has had an effect over most of the northern hemisphere in one way or another.
In some local ecosystems within a 6 mile (10km) radius of the power plant the radiation
is lethally high especially in small mammals such as mice and coniferous trees. Luckily
within 4 years of the accident nature began to restore itself, but genetically these plants
may be scarred for life.
2. Health effects
Firstly, there was a huge increase in Thyroid Cancer in Ukranian children (from birth to
15 years old). From 1981-1985 there was an average of 4-6 patients per million but
between 1986 and 1997 this increased to an average of 45 patients per million. It was also
established that 64% of Thyroid Cancer patients lived in the most contaminated areas of
the Ukraine (Kiev province, Kiev city, provinces of Rovno, Zhitomir, Cherkassy and
Chernigov).
Thyroid Cancer is cancer of the tyroid gland, a gland found near the larynx that
secretes growth and metabolism hormones.
There have also been increases in other cancers, mainly in the population living in the
most contaminated areas and the people who helped clean up the accident.
3. Psycological consequences
There has been an increase in psycological disorders such as anxiety, depression,
helplessness and other disorders which lead to mental stress. These disorders are not a
consequence of radiation, but a consequence from the stress of evacuation, the lack of
information given after the accident and the stress of knowing that their health and their
children's health could be affected.
4. Economic, political and social consequences
The worst contaminated areas were economically, socially and politically declining as the
birth rate had decreased and emigration numbers had substantially risen which had
caused a shortage in labour force. These areas could not evolve industrially or
agriculturally because of strict rules that were introduced because the area was too
contaminated. The few products made were hard to sell or export because people were
aware that it had come from the Ukraine and so were scared of being affected, this caused
a further economic decline. Socially people have been limited on their activities making
everyday life very difficult.
Now in the year 2000, everything is looking a lot better and is starting to rise again and
probably in about 10 years time almost everything will be as good as normal in the
Ukraine.
Within seconds of the shutdown, the pilot-operated relief valve (PORV) on the reactor
cooling system opened, as it was supposed to. About 10 seconds later it should have
closed. But it remained open, leaking vital reactor coolant water to the reactor coolant
drain tank. The operators believed the relief valve had shut because instruments showed
them that a "close" signal was sent to the valve. However, they did not have an
instrument indicating the valve's actual position.
Operators responded by reducing the flow of replacement water. Their training told them
that the pressuriser water level was the only dependable indication of the amount of
cooling water in the system. Because the pressuriser level was increasing, they thought
the reactor system was too full of water. Their training told them to do all they could to
keep the pressuriser from filling with water. If it filled, they could not control pressure in
the cooling system and it might rupture.
Steam then formed in the reactor primary cooling system. Pumping a mixture of steam
and water caused the reactor cooling pumps to vibrate. Because the severe vibrations
could have damaged the pumps and made them unusable, operators shut down the
pumps. This ended forced cooling of the reactor core. (The operators still believed the
system was nearly full of water because the pressuriser level remained high.) However,
as reactor coolant water boiled away, the reactor?s fuel core was uncovered and became
even hotter. The fuel rods were damaged and released radioactive material into the
cooling water.
At 6:22 am operators closed a block valve between the relief valve and the pressuriser.
This action stopped the loss of coolant water through the relief valve. However,
superheated steam and gases blocked the flow of water through the core cooling system.
Throughout the morning, operators attempted to force more water into the reactor system
to condense steam bubbles that they believed were blocking the flow of cooling water.
During the afternoon, operators attempted to decrease the pressure in the reactor system
to allow a low pressure cooling system to be used and emergency water supplies to be put
into the system.
Cooling Restored
By late afternoon, operators began high-pressure injection of water into the reactor
cooling system to increase pressure and to collapse steam bubbles. By 7:50 pm on 28
March, they restored forced cooling of the reactor core when they were able to restart one
reactor coolant pump. They had condensed steam so that the pump could run without
severe vibrations.
Radioactive gases from the reactor cooling system built up in the makeup tank in the
auxiliary building. During March 29 and 30, operators used a system of pipes and
compressors to move the gas to waste gas decay tanks. The compressors leaked, and
some radioactive gas was released to the environment.
When the reactor's core was uncovered, on the morning of 28 March, a high-temperature
chemical reaction between water and the zircaloy metal tubes holding the nuclear fuel
pellets had created hydrogen gas. In the afternoon of 28 March, a sudden rise in reactor
building pressure shown by the control room instruments indicated a hydrogen burn had
occurred. Hydrogen gas also gathered at the top of the reactor vessel.
From 30 March through 1 April operators removed this hydrogen gas "bubble" by
periodically opening the vent valve on the reactor cooling system pressuriser. For a time,
regulatory (NRC) officials believed the hydrogen bubble could explode, though such an
explosion was never possible since there was not enough oxygen in the system.
Cold Shutdown
When the TMI-2 accident is recalled, it is often in the context of what happened on
Friday and Saturday, March 30-31. The height of the TMI-2 accident-induced fear, stress
and confusion came on those two days. The atmosphere then and the reasons for it are
described well in the book "Crisis Contained, The Department of Energy at Three Mile
Island," by Philip L Cantelon and Robert C. Williams, 1982. This is an official history of
the Department of Energy's role during the accident.
"Friday appears to have become a turning point in the history of the accident because of
two events: the sudden rise in reactor pressure shown by control room instruments on
Wednesday afternoon (the "hydrogen burn") which suggested a hydrogen explosion?
became known to the Nuclear Regulatory Commission [that day]; and the deliberate
venting of radioactive gases from the plant Friday morning which produced a reading of
1,200 millirems (12 mSv) directly above the stack of the auxiliary building.
Throughout the book, Cantelon and Williams note that hundreds of environmental
samples were taken around TMI during the accident period by the Department of Energy
(which had the lead sampling role) or the then-Pennsylvania Department of
Environmental Resources. But there were no unusually high readings, except for noble
gases, and virtually no iodine. Readings were far below health limits. Yet a political
storm was raging based on confusion and misinformation.
No Radiological Health Effects
The TMI-2 accident caused concerns about the possibility of radiation-induced health
effects, principally cancer, in the area surrounding the plant. Because of those concerns,
the Pennsylvania Department of Health for 18 years maintained a registry of more than
30,000 people who lived within five miles of Three Mile Island at the time of the
accident. The state's registry was discontinued in mid 1997, without any evidence of
unusual health trends in the area.
Indeed, more than a dozen major, independent health studies of the accident showed no
evidence of any abnormal number of cancers around TMI years after the accident. The
only detectable effect was psychological stress during and shortly after the accident.
Case Studies:
The studies found that the radiation releases during the accident were minimal, well
below any levels that have been associated with health effects from radiation exposure.
The average radiation dose to people living within 10 miles of the plant was 0.08
millisieverts, with no more than 1 millisievert to any single individual. The level of 0.08
mSv is about equal to a chest X-ray, and 1 mSv is about a third of the average
background level of radiation received by U.S. residents in a year.
In June 1996, 17 years after the TMI-2 accident, Harrisburg U.S. District Court Judge
Sylvia Rambo dismissed a class action lawsuit alleging that the accident caused health
effects. The plaintiffs have appealed Judge Rambo's ruling. The appeal is before the U.S.
Third Circuit Court of Appeals. However, in making her decision, Judge Rambo cited:
· Findings that exposure patterns projected by computer models of the releases compared
so well with data from the TMI dosimeters (TLDs) available during the accident that the
dosimeters probably were adequate to measure the releases.
· That the maximum offsite dose was, possibly, 100 millirem (1 mSv), and that projected
fatal cancers were less than one.
· The plaintiffs' failure to prove their assertion that one or more unreported hydrogen
"blowouts" in the reactor system caused one or more unreported radiation "spikes",
producing a narrow yet highly concentrated plume of radioactive gases.
Judge Rambo concluded: "The parties to the instant action have had nearly two decades
to muster evidence in support of their respective cases.... The paucity of proof alleged in
support of Plaintiffs' case is manifest. The court has searched the record for any and all
evidence which construed in a light most favourable to Plaintiffs creates a genuine issue
of material fact warranting submission of their claims to a jury. This effort has been in
vain."
More than a dozen major, independent studies have assessed the radiation releases and
possible effects on the people and the environment around TMI since the 1979 accident at
TMI-2. The most recent was a 13-year study on 32,000 people. None has found any
adverse health effects such as cancers which might be linked to the accident.
Disciplines in training, operations and event reporting that grew from the lessons of the
TMI-2 accident have made the nuclear power industry demonstrably safer and more
reliable. Those trends have been both promoted and tracked by the Institute for Nuclear
Power Operations (INPO). To remain in good standing, a nuclear plant must meet the
high standards set by INPO as well as the strict regulation of the US Nuclear Regulatory
Commission.
A key indicator is the graph of significant plant events, based on data compiled by the
Nuclear Regulatory Commission. The number of significant events decreased from 2.38
per reactor unit in 1985 to 0.10 at the end of 1997.
On the reliability front, the median capability factor for nuclear plants - the percentage of
maximum energy that a plant is capable of generating - increased from 62.7 percent in
1980 to almost 90 percent in 2000. (The goal for the year 2000 was 87 percent.)
Other indicators for US plants tracked by INPO and its world counterpart, the World
Association of Nuclear Operators (WANO) are the unplanned capability loss factor,
unplanned automatic scrams, safety system performance, thermal performance, fuel
reliability, chemistry performance, collective radiation exposure, volume of solid
radioactive waste and industrial safety accident rate. All are reduced, that is, improved
substantially, from 1980.
• The reactor's fuel core became uncovered and more than one third of the fuel
melted.
• Inadequate instrumentation and training programs at the time hampered operators'
ability to respond to the accident.
• The accident was accompanied by communications problems that led to
conflicting information available to the public, contributing to the public's fears
• Radiation was released from the plant. The releases were not serious and were not
health hazards. This was confirmed by thousands of environmental and other
samples and measurements taken during the accident.
• The containment building worked as designed. Despite melting of about one-third
of the fuel core, the reactor vessel itself maintained its integrity and contained the
damaged fuel.
Longer-Term Impacts:
All of us are aware, out of our own experience, that it is not easy to be obedient to
authority. It appears that there is an innate desire on the part of all of us to be independent
and to have our own way. This seems to be an inborn, natural, universal tendency of man.
Even our children do not like to be told when to get up, how to dress, what to eat, what to
do, and where to go. Any superimposed authority from outside ourselves is likely to be
met with resentment. I sometimes think of the human race as like a herd of wild horses,
running free on the open range of our western mountain country. Occasionally we have
seen pictures of wild horses enjoying the freedom of the open range. Then we have seen
men ensnare some of these horses and put them in corrals. Imagine if you can a
particularly handsome young stallion fenced in for the first time in his life. He stamps the
ground; he snorts and whinnies; he rears on his hind legs. He resents the loss of his
freedom and is ready to fight anything that comes near him. Then, watch as a skilled
trainer over a period of days and weeks struggles to get a bridle in his mouth. Then, later
on, a saddle on his back. It does not come easily, but eventually the wild range horse is
brought under control and tamed. Now, and this is the point, he is ready to do some work
that is worthwhile. Until his wild, restless spirit is tamed and his powerful strength is
harnessed he accomplishes nothing. Only when he is brought under control does he do
any worthwhile work. The same is true with the proud rebellious spirit of man.
Similarly, while it is always possible to bring out unwanted/unethical results using GMO.
But we should be resisted to ourselves to obey to the authority and follow the guidelines
prescribed so that the others get the maximum benefit out of it.
Collective bargaining
Collective bargaining is the process whereby workers organize collectively and bargain
with employers regarding the workplace. In various national labor and employment law
contexts collective bargaining takes on a more specific legal meaning. In a broad sense,
however, it is the coming together of workers to negotiate their employment.
A Collective agreement is a labor contract between an employer and one or more unions.
Collective bargaining consists of the process of negotiation between representatives of a
union and employers (represented by management, in some countries by employers'
organization) in respect of the terms and conditions of employment of employees, such as
wages, hours of work, working conditions and grievance-procedures, and about the rights
and responsibilities of trade unions. The parties often refer to the result of the negotiation
as a Collective Bargaining Agreement (CBA) or as a Collective Employment Agreement
(CEA).
Theories
A number of theories – from the fields of industrial relations, economics, political
science, history and sociology (as well as the writings of activists, workers and labor
organizations) – have attempted to define and explain collective bargaining.
One theory suggests that collective bargaining is a human right and thus deserving of
legal protection. Article 23 of the Universal Declaration of Human Rights identifies the
ability to organise trade unions as a fundamental human right. Item 2(a) of the
International Labor Organization's Declaration on Fundamental Principles and Rights at
Work defines the "freedom of association and the effective recognition of the right to
collective bargaining" as an essential right of workers.
In June 2007 the Supreme Court of Canada extensively reviewed the rationale for
considering collective bargaining to be a human right. In the case of Facilities Subsector
Bargaining Assn. v. British Columbia, the Court made the following observations:
• The right to bargain collectively with an employer enhances the human dignity,
liberty and autonomy of workers by giving them the opportunity to influence the
establishment of workplace rules and thereby gain some control over a major
aspect of their lives, namely their work.
• Collective bargaining is not simply an instrument for pursuing external ends…
rather [it] is intrinsically valuable as an experience in self-government.
• Collective bargaining permits workers to achieve a form of workplace democracy
and to ensure the rule of law in the workplace. Workers gain a voice to influence
the establishment of rules that control a major aspect of their lives.
Economic theories also provide a number of models intended to explain some aspects of
collective bargaining. The first is the so-called Monopoly Union Model (Dunlop, 1944),
according to which the monopoly union has the power to maximise the wage rate; the
firm then chooses the level of employment. This model is being abandoned by the recent
literature. The second is the Right-to-Manage model, developed by the British school
during the 1980s (Nickell). In this model, the labour union and the firm bargain over the
wage rate according to a typical Nash Bargaining Maximin (written as Ώ = U βΠ1-β, where
U is the utility function of the labour union, Π the profit of the firm and β represents the
bargaining power of the labour unions). The third model is called efficient bargaining
(McDonald and Solow, 1981), where the union and the firm bargain over both wages and
employment (or, more realistically, hours of work)
Confidentiality
Confidentiality has been defined by the International Organization for Standardization
(ISO) as "ensuring that information is accessible only to those authorized to have access"
and is one of the cornerstones of Information security. Confidentiality is one of the
design goals for many cryptosystems, made possible in practice by the techniques of
modern cryptography.
Confidentiality also refers to an ethical principle associated with several professions (eg,
medicine, law, religion, professional psychology, journalism, and others). In ethics, and
(in some places) in law and alternative forms of legal dispute resolution such as
mediation, some types of communication between a person and one of these
professionals are "privileged" and may not be discussed or divulged to third parties. In
those jurisdictions in which the law makes provision for such confidentiality, there are
usually penalties for its violation.
Confidentiality of information, enforced in an adaptation of the military's classic "need-
to-know" principle, forms the cornerstone of information security in today's corporates.
The so called 'confidentiality bubble' restricts information flows, with both positive and
negative consequences.[1]
Legal confidentiality
Lawyers are often required by law to keep confidential anything pertaining to the
representation of a client. The duty of confidentiality is much broader than the attorney-
client evidentiary privilege, which only covers communications between the attorney and
the client.
Both the privilege and the duty serve the purpose of encouraging clients to speak frankly
about their cases. This way, lawyers will be able to carry out their duty to provide clients
with zealous representation. Otherwise, the opposing side may be able to surprise the
lawyer in court with something which he did not know about his client, which makes
both lawyer and client look stupid. Also, a distrustful client might hide a relevant fact
which he thinks is incriminating, but which a skilled lawyer could turn to the client's
advantage (for example, by raising affirmative defenses like self-defense).
However, most jurisdictions have exceptions for situations where the lawyer has reason
to believe that the client may kill or seriously injure someone, may cause substantial
injury to the financial interest or property of another, or is using (or seeking to use) the
lawyer's services to perpetrate a crime or fraud.
In such situations the lawyer has the discretion, but not the obligation, to disclose
information designed to prevent the planned action. Most states have a version of this
discretionary disclosure rule under Rules of Professional Conduct, Rule 1.6 (or its
equivalent).
A few jurisdictions have made this traditionally discretionary duty mandatory. For
example, see the New Jersey and Virginia Rules of Professional Conduct, Rule 1.6. In
some jurisdictions the lawyer must try to convince the client to conform his or her
conduct to the boundaries of the law before disclosing any otherwise confidential
information.
Note that these exceptions generally do not cover crimes that have already occurred, even
in extreme cases where murderers have confessed the location of missing bodies to their
lawyers but the police are still looking for those bodies. The U.S. Supreme Court and
many state supreme courts have affirmed the right of a lawyer to withhold information in
such situations. Otherwise, it would be impossible for any criminal defendant to obtain a
zealous defense.
California is famous for having one of the strongest duties of confidentiality in the world;
its lawyers must protect client confidences at "every peril to himself or herself." Until an
amendment in 2004, California lawyers could not breach their duty even if they knew
that a client was about to commit murder.
Recent legislation in the UK curtails the confidentiality professionals like lawyers and
accountants can maintain at the expense of the state. Accountants, for example, are
required to disclose to the state any suspicions of fraudulent accounting and, even, the
legitimate use of tax saving schemes if those schemes are not already known to the tax
authorities.
Clinical psychology
The ethical principle of confidentiality requires that information shared by the client with
the therapist in the course of treatment is not shared with others. This is important for the
therapeutic alliance, as it promotes an environment of trust. However, there are important
exceptions to confidentiality, namely where it conflicts with the clinician's duty to warn
or duty to protect. This includes instances of suicidal or homicidal ideation, child abuse,
elder abuse and dependent adult abuse.
Conflicts of Interest
A conflict of interest is a situation in which someone in a position of trust, such as a
lawyer, insurance adjuster, a politician, executive or director of a corporation or a
medical research scientist or physician, has competing professional or personal interests.
Such competing interests can make it difficult to fulfill his or her duties impartially. A
conflict of interest exists even if no unethical or improper act results from it. A conflict of
interest can create an appearance of impropriety that can undermine confidence in the
person, profession, or court system. A conflict can be mitigated by third party verification
or third party evaluation noted below—but it still exists.
However, conflicts of interest do not only apply to professionals. A conflict of interest
arises when anyone has two duties which conflict - for example an employee's duty to
well and faithfully perform their work as purchasing manager, and that same employee's
familial duty to their sibling who happens to be tendering for the sale of widgets to the
employee's employer. In that case the employee has a conflict of interest, despite the fact
that they are not a lawyer, doctor, politician etc.
Conflict of Interest generally (unrelated to the practice of law)
More generally, conflict of interest can be defined as any situation in which an individual
or corporation (either private or governmental) is in a position to exploit a professional or
official capacity in some way for their personal or corporate benefit.
Depending upon the law or rules related to a particular organization, the existence of a
conflict of interest may not, in and of itself, be evidence of wrongdoing. In fact, for many
professionals, it is virtually impossible to avoid having conflicts of interest from time to
time. A conflict of interest can, however, become a legal matter for example when an
individual tries (and/or succeeds in) influencing the outcome of a decision, for personal
benefit. A director or executive of a corporation will be subject to legal liability if a
conflict of interest breaches their Duty of Loyalty.
There often is confusion over these two situations. Someone accused of a conflict of
interest may deny that a conflict exists because he/she did not act improperly. In fact, a
conflict of interest does exist even if there are no improper acts as a result of it. (One way
to understand this is to use the term "conflict of roles". A person with two roles - an
individual who owns stock and is also a government official, for example - may
experience situations where those two roles conflict. The conflict can be mitigated - see
below - but it still exists. In and of itself, having two roles is not illegal, but the differing
roles will certainly provide an incentive for improper acts in some circumstances.)
Types of conflicts of interests
The following are the most common forms of conflicts of interest:
• Self-dealing, in which public and private interests collide, for example issues
involving privately held business interests.
• Outside employment, in which the interests of one job contradict another,
• Family interests, in which a spouse, child, or other close relative is employed (or
applies for employment) or where goods or services are purchased from such a
relative or a firm controlled by a relative. For this reason, many employment
applications ask if one is related to a current employee. If this is the case, the
relative could then recuse from any hiring decisions.
• Gifts from friends who also do business with the person receiving the gifts. (Such
gifts may include non-tangible things of value such as transportation and lodging.)
• Pump and dump, A stock broker (from a boiler room down the street to a big
broker uptown) which owns a security artificially inflates the price by
"upgrading" it or spreading rumors, sells the security and adds short position, then
"downgrade" the security or spread negative rumors to push the price down.
Other improper acts that are sometimes classified as conflicts of interest are probably
better classified elsewise. Accepting bribes can be classified as corruption; almost
everyone in a position of authority, particularly public authority, has the potential for
such wrongdoing. Similarly, use of government or corporate property or assets for
personal use is fraud, and classifying this as a conflict of interest does not improve the
analysis of this problem. Nor should unauthorized distribution of confidential
information, in itself, be considered conflict of interest. For these improper acts, there is
no inherent conflict of roles (see above), unless being a (fallible) human being rather than
(say) a robot in a position of power or authority is considered to be a conflict.
Codes of ethics
Generally, codes of ethics forbid conflicts of interest. Often, however, the specifics can
be controversial. Should therapists, such as psychiatrists, be allowed to have
extraprofessional relations with patients? Ex-patients? Should a faculty member be
allowed to have an extraprofessional relationship with a student, and should that depend
on whether the student is in a class of, or being advised by, the faculty member?
Codes of ethics help to minimize problems with conflicts of interest because they can
spell out the extent to which such conflicts should be avoided, and what the parties
should do where such conflicts are permitted by a code of ethics (disclosure, recusal,
etc.). Thus, professionals cannot claim that they were unaware that their improper
behavior was unethical. As importantly, the threat of disciplinary action (for example, a
lawyer being disbarred) helps to minimize unacceptable conflicts or improper acts when a
conflict is unavoidable.
As codes of ethics cannot cover all situations, some governments, e.g., Canada, have
established an office of the ethics commissioner. Ethics commissioner should be
appointed by the legislature and should report to the legislature.
Occupational Crime
Occupational crime is crime that is committed through opportunity created in the course
of legal occupation. Thefts of company property, vandalism, the misuse of information
and many other activities come under the rubric of occupational crime.The concept of
occupational crime - as one of the principal forms of white collar crime - has been quite
familiar and widely invoked since the publication of Clinard and Quinney's influential
Criminal Behavior Systems: A Typology. More recently, however, the term occupational
crime has been applied to activities quite removed from the original meaning of white
collar crime, and it has been used interchangeably with such terms as occupational
deviance and workplace crime. In the interest of greater conceptual clarity within the
field of white collar crime the argument is made here for restricting the term
'occupational crime' to illegal and unethical activities committed for individual financial
gain - or to avoid financial loss - in the context of a legitimate occupation. The term
'occupational deviance' is better reserved for deviation from occupational norms (e.g.
drinking on the job; sexual harassment), and the term 'workplace crime' is better reserved
for conventional forms of crime committed in the workplace (e.g. rape; assault). The
conceptual conflation of fundamentally dissimilar activities hinders theoretical, empirical,
and policy-related progress in the field of white collar crime studies.
Professional rights
The U.S. media and state and federal policymakers have devoted a great deal of attention
this year to the issue of pharmacists refusing to dispense emergency contraception and
other prescription contraceptives. Little about this issue is, in fact, new; policymakers
have engaged for decades in an ever-broadening debate over whether and in what
circumstances individuals or institutions involved in the provision of health care or
related services can refuse to provide services or information on moral or religious
grounds What has often been absent from this debate over providers’ rights has been any
serious discussion about providers’ responsibilities—to their patients, colleagues,
employers and the public. Some of these obligations are encoded in law; perhaps more
importantly, they are enshrined in professional codes of ethics that define what it means
to be a health care professional and supplemented by individual professional
associations’ policy statements on various issues.
The Values at Stake
Although different associations and professions frame the issues differently, core values
that are generally agreed upon across health care professions and in the field of bioethics
underlie the rights and the responsibilities of all health care providers:
• Beneficence requires the provider to act in the best interest of the patient and her
welfare and is closely related to nonmaleficence, the basic obligation to do no harm.
• Justice underlies the principle of non discrimination and the obligation of health care
providers to work for the public good.
• Respect for autonomy leads to such principles as informed consent and confidentiality,
as well as respect for the decisions of colleagues. These core values have been translated
into more specific ethical principles by numerous professional associations. Such
guidelines are necessary in part because these values can at times conflict or appear to
point in different directions. In the absence of respect for autonomy, for instance,
beneficence can easily turn into paternalism in the hands of a highly trained health care
provider caring for patients with inferior knowledge. And, while the International Code
of Medical Ethics of the World Medical Association (WMA) asserts that “a physician
shall always bear in mind the obligation of preserving human life,” in a separate
declaration on abortion, the WMA discusses how the “diversity of attitudes towards the
life of the unborn child” can lead to differences in how to interpret this obligation.
Professional standards help to mediate these differences. Despite the complexities of
balancing these values, the professional medical associations have been remarkably
consistent when it comes to the concept of refusal. In essence, professional standards
typically endorse a provider’s right to step away, or “withdraw,” from providing a health
care service that violates his or her moral or religious beliefs. At the same time, these
standards make clear that there must be limits to this right in order to ensure that patients
receive the information, services and dignity to which they are entitled. Although not
always spelled out in one place or in every association’s guidelines, this balancing leads
to several clear obligations, including that:
• providers must impart full, accurate and unbiased information so patients can make
informed decisions about their health care;
• patients must always have access to services in emergency circumstances;
• providers must not abandon patients but instead must refer them to another provider
willing and ready to take over care; and
• providers seeking to “step away” must give adequate and timely notice to patients,
employers and others who will be affected by their doing so. It should come as no
surprise that many of the most detailed standards and policy statements about refusal
focus on abortion, contraception and other forms of reproductive health care, along with
end-of-life care. These services have often generated controversy among policymakers
and the general public. The professional associations have made their position clear,
however: A health care
provider’s moral or religious beliefs cannot justify attempts to override a patient’s
autonomy. The right to withdraw from services cannot be used as a pretext for blocking
or denying patients’ own rights to care.
Employee Right
IPR discrimination
The international environment with respect to intellectual property has changed
considerably with the conclusion of the TRIPs Agreement. The TRIPs Agreement
accommodates the demands of the industrialized countries for higher international
standards of protection by mandating the extension of patentability to virtually all fields
of technology recognized in developed country patent systems, by prolonging the patent
protection for a uniform term of twenty years, and by providing legal recognition of the
patentee’s exclusive rights to import the patented products. The patent rights are
enjoyable without discrimination as to the place of invention, the field of technology and
whether products are imported or locally produced. All the signatories to the trade
negotiations are, therefore, obliged to adhere to the minimum standards prescribed by
TRIPs Agreement and to provide product patents for pharmaceuticals and chemicals. The
coverage of the patent protection has also been expanded by the provision for patents on
micro-organisms and protection of plant varieties either by patents or by an effective sui
generis system or by any combination thereof. The full implementation of the TRIPs
Agreement is likely to have an important bearing on the patterns of development in
developing countries. In what follows we briefly review some of the important
dimensions of these effects.
GIST to Remember:
• Objectives of safety and risk
• Microbiological risk assessment
• Infective microorganisms by risk group
• Biosafety considerations for biological expression systems
• Transgenic Plants and Risk assessment for Genetically Modified Systems
• Spreading risk assessment in environment
• Genetransfer
• Risk Management
• Monitoring of GMO
• Socio-economic issues
• Three mile and Chernobyl Island disasters
• Collegiality and Loyalty
• Confidentiality and Occupational Crime
• Rights of the employees
Reference