Use of the precautionary principle
in the Directive
45. We sought to establish whether the Directive
was based on the precautionary principle, as understood in the
Commission. The ICNIRP guidelines which underpin the Directive
are based, according to Dr McKinlay, on a "cautious approach
in the interpretation of the science" rather than a "precautionary"
difference between the two has been defined by the NRPB as follows:
- "'caution' and 'cautious'
are used strictly to describe the approach taken in evaluating
scientific data and in particular the uncertainties associated
with these data and in making judgements as to their relevance
to exposure restrictions.
- 'precaution' and 'precautionary' are used strictly
in relation to possible additional measures that might be considered
in the light of the uncertainties with the evidence of long-term
adverse effects of exposure."
By this definition, the Directive, which excludes
long-term health effects, could be said to be cautious in its
approach rather than precautionary. However, the Commission definition
does not include the above distinction. It does provide some guidance
on application. This requires decision makers to apply general
principles of risk management, including an "examination
of the benefits and costs of action or lack of action".
Such benefits include economic, socio-economic and, in certain
circumstances, non-economic considerations such as the protection
of public health. The guidance goes further, and confirms the
implications of European Court case law that consideration of
public health should "undoubtedly be given greater weight
than economic considerations."
This elaboration does not help decision-makers establish how to
proceed in respect of the EMF Directive, when the economic costs
of regulation as well as any other potential adverse impacts need
to be weighed against the avoidance of health risks associated
with occupational exposure to EMF.
46. The potential health risks were certainly given
a higher priority than economic factors in this case, but there
was no evaluation of the potential negative impacts on medicine
and research. It could be argued that, by failing to give due
consideration to the potential benefits afforded by MRI diagnosis
and treatment that might be lost under the Directive, the Commission
did not follow its own guidelines on applying the precautionary
principle. Professor Blakemore referred to the "intransigence"
of the Commission in dealing with the concerns expressed in a
manner which infringes the principles outlined in the Commission's
paper. The Directive
does not allow for an overall risk-benefit assessment to be made
on a case by case basis, taking into account the benefits for
the patient in using MRI, for example instead of X-ray, and setting
these against a slightly higher exposure level for health workers.
Mr Biosca de Sagastuy explained this position: "With a patient
you can balance risks against benefits but with a worker you cannot.
There is an obligation under general health and safety legislation
to eliminate the risk or reduce it to the lowest achievable limit
You cannot cure one person and injure the health of another
find this approach both simplistic and out of step with reality.
It is certainly not in line with the type of risk-benefit analysis
demanded by the precautionary principle. While there should
be an obligation to reduce risks to a reasonable level, to actually
pursue the "lowest achievable limit" would entail health
and safety practices which most would consider unnecessary and
economically unviable, if not counter-productive in certain circumstances.
Risks need to be balanced against gains, rather than necessarily
47. It is well established that workers may be required
to subject themselves to a higher degree of risk than the general
public in order to achieve some wider benefit, whether economic,
health or other. Indeed, the health risks of the hospital environment
itself are greater than many other working environments. The International
Society for Magnetic Resonance in Medicine states that "In
health employment it is common to accept certain hazards, whilst
controlling these very carefully, for the benefit of the individuals
The 1998 ICNIRP guidelines themselves set different lower exposure
limits for the general public than for workers. The 2004 ICNIRP
guidelines recommend that the medical practitioner should be responsible
for assessing the need for an MRI scan and for the safety of the
This is entirely sensible. Equally, employers have duty of care
towards employees, and are required to make judgments on the basis
of the latest available guidelines, taking into account the role
that employees are fulfilling. At present, employers and physicians
have the flexibility to make these judgements; under the Directive,
they will not.
48. The Commission's own guidelines on the precautionary
principle include provision for some account to be taken of the
benefits as well as the costs of the action in question. The Directive
considers only the health and safety of workers. Because the impact
assessment for the Directive did not identify any potential impact
on MRI usage, any health benefits lost as a result of implementation
were not considered. We discuss in chapter 7 the steps the Commission
is now taking to explore further the impact of the Directive on
MRI procedures. Regardless of the impact on current MRI procedures,
any attempt to consider the health of workers in isolation from
all other factors would be against the spirit of the precautionary
principle, as set out by the Commission. We hope that the agreement
of the Commission to undertake further work on the potential impact
of the Directive indicates a willingness to accept the need for
a wider risk-benefit analysis.
49. We found no evidence in Brussels that these
arguments on the application of the precautionary principle were
rehearsed in relation to this Directive, either in its formulation
or its consideration in Council and Parliament. Indeed, we were
given no clear response at all to questions to officials on the
use of the precautionary principle in the formulation of the Directive.
Whilst one official asserted that the precautionary principle
was "not used at all", 
another told us that the Directive, like other EU legislation,
was based on it. This lack of clarity highlights the inadequacy
of the current definition and application of the principle. We
accept that there are no straightforward answers. Indeed, it is
difficult to see how any definition or general guidance could
provide definitive instruction in a situation in which the potential
but uncertain adverse health effects on a relatively small number
of workers has to be weighed against the potential but uncertain
loss of techniques known to be of significant benefit to relatively
large numbers of patients. In this situation, as in most others,
there is a scientific but also a political judgment to be made.
No principle can obviate the need for such difficult decisions.
We have found no explanation as to how the precautionary principle
was, or was not, applied to the development and agreement of the
Directive. The fact that such confusion remains confirms our view
that the Commission's guidelines on its application are of limited
practical use, even if there were a desire to refer to them.
A precautionary approach
50. In the UK, there is no legal recognition or Government
definition of the precautionary principle. Witnesses in our over-arching
inquiry have shown little enthusiasm for existing definitions
or usage of the precautionary principle. Professor Blakemore,
for example, argued that "there are serious problems with
the precautionary principle because of the variety of interpretations
of it" and that a "serious piece of work" on it
would be very helpful.
The Government Chief Scientific Adviser prefers to talk of a precautionary
approach rather than a principle. According to the Government,
such an approach applies where "the scientific evidence is
incomplete or inconclusive, and there is the possibility of severe
and irreversible consequences."
This approach is similar to the one adopted by the Stewart Report.
It elaborates on the precautionary approach as follows:
"The precautionary approach is not all or nothing
in nature. Rather, it is a matter of degree. In essence, it requires
that before accepting a new development we should have positive
evidence that any risks from it are acceptably low, and not simply
an absence of convincing evidence that risks are unacceptably
In the case of mobile phones, it recommended that
this precautionary approach be adopted "until much more detailed
and scientifically robust information on any health effects becomes
It recommended that ICNIRP guidelines be adopted for mobile phone
51. The Government's definition of the precautionary
approach does not provide any explanation of how it should be
applied in any given set of circumstances. Rather, it provides
for a further judgment to be made, alongside other risk management
principles such as consistency, proportionality and cost-benefit
analyses. We believe that it is more realistic and less misleading
to frame the debate in terms of an "approach" rather
than a "principle", to indicate that it provides another
factor to consider when managing risks rather than a precise formula
to be applied in any given situation. In fact, this is very close
to what the Commission's guidance provides. Like the principle
defined by the Commission, the precautionary approach is at present
ill-defined and certainly unsatisfactory as a tool for practical
use. There is, as Lord Hunt acknowledged, a balance to be struck
between the desirability of maintaining some flexibility in application,
and a very precise definition of a principle.
Similarly, the Head of the Government Economic Service, Sir Nick
Stern, doubted whether risk analysis could be reduced to one particular
principle or rule.
The nature of this balance and the means by which it might be
achieved is not easily identified, and still less easily agreed.
We will draw on the whole evidence we take in our over-arching
inquiry to consider the desirability and nature of further action
to elaborate on how a precautionary approach could be usefully
defined and applied in practice. In the meantime, we recommend
Government and its agencies desist from using the term "precautionary
principle" in order to explain policy decisions or judgments.
We also urge Ministers to propose a similar approach in discussions
in the EU Council.
107 EU Commission, Communication from the Commission
on the Precautionary Principle, COM (2000) 1, 2 February 2000
As above, p 33 Back
As above, p 10 Back
Gary Marchant and Kenneth Mossman, Arbitrary and Capricious,
The Precautionary Principle in the EU Courts, 2005 Back
Ragnar E. Lofstedt, Risk Communication and management in the
Twenty-First Century, International Public Management Journal,
7 (3), pp 335-346, 2004 Back
Q 918 Back
NRPB-W59, July 2004, p 17 Back
Communication from the Commission on the precautionary principle,
COM(2000) 1, p 18 Back
As above, p 20 Back
Q 850 Back
Qq 762-63 Back
Ev 39 Back
ICNIRP (2004), Health Physics 87, p 207 Back
Ev 64 Back
Q 750 Back
Q 851 Back
Government memorandum, para 39 (to be published in HC 900-II,
Session 2005-06) Back
Stewart Report, para 6.16 Back
Stewart Report, para 6.40 Back
Q 916 Back
Q 1054 (to be published in HC 900-II, Session 2005-06) Back