Risk Assessment

Risk assessment: the use of bad science for the benefit of the multinationals

'Risk assessment' is not a sexy or fashionable term. But it's the mechanism that is being used by regulators around the world, and decision-makers in Codex, to limit our freedoms in natural healthcare.

Risk assessment is used in three main ways:

1. To ban or limit ingredients allowed in natural health products

2. To limit maximum dosages of nutrients and phytochemicals

3. To limit what we can say or write about, particularly as it relates to health benefits of particular products.

The purpose? To supposedly protect us from hurting ourselves. It's all very plausible until you realise that there's virtually no evidence that anyone is actually doing themselves any harm by taking these products. Quite the contrary—people are making themselves healthier and healthier....and therein lies the real threat!

Risk assessment science is being increasingly used in virtually all walks of life—ranging from the safety of motor vehicles, to the safety of schools and the workplace. This new branch of science—considered by some to be more of a quasi-science give the amount of subjectivity it often uses—has been applied to food safety for some time. However its main application has been to ensure that unsafe levels of pathogens and toxins within foods, such as E.coli and other bacteria, food additives, preservatives and pesticide residues, are avoided. The fact that many harmful additives and pesticides are still common in foods is testament to how risk assessment has been manipulated to the benefit of those interests which profit from chemically contaminated foods.

To find out how flawed risk assessment is at risk of being used to dumb down European supplements through the EU Food Supplements Directive—and eventually, globally, see the ANH's Codex campaign and our Freedom of Health Choice campaign. This will happen unless the authorities respond to common sense, good science—as well as the will of hundreds of thousands of people around the world.

Get involved in the ANH campaign and help future generations have the option of natural health.

WRONG TOOL FOR THE JOB? Should we apply the same risk assessment methods to assess these pollution agents as for the nutrients in food?

Applying the risk assessment models used for toxic chemicals to nutrients

But now risk assessment science is being applied to nutrients and botanicals used for health promotion—yet this science completely avoids any consideration of the benefits conferred.

In Europe, the European Commission, the European Food Safety Authority and the Federal Institute for Risk Assessment (BfR, in Germany) are the key instigators of risk assessment for nutrients, while at an international level, it is the World Health Organization and the Codex Alimentarius that are the main protagonists of this approach.

What’s wrong with conventional risk assessment approaches?

In 2002, the ANH issued a detailed consultation to the UK Expert Group on Vitamins and Minerals (EVM), which heavily criticised the EVM’s approach to risk assessment.

In 2003, the ANH submitted a detailed critique of conventional risk assessment as applied to nutrients in its consultation response to the FAO/WHO nutrient risk assessment project.

Building on ANH’s work, in 2005, Dr Jaap Hanekamp and Professor Alt Bast of the HAN (Heidelberg Appeal Nederland) Foundation in the Netherlands commenced work on deconstructing the problems associated with risk assessment and the European regulatory model as applied to natural health products.

The following are key outputs from their research, published in 2006 and 2007:

Hanekamp (2006) on the precautionary principle in the context of the EU Food Supplements Directive.

Hanekamp & Bast (2007): food supplements within a precautionary context.

Hanekamp & Bast (2007): food supplements and fortified foods—and the the EC's patriarchal precautionary perspective on public health.

ANH summary of problems with conventional risk assessment as applied to nutrients

Some of the key limitations of common risk assessment determinations, as performed by the SCF, EVM and the US Institute of Medicine (IOM) are: 

1. Selective (and therefore incomplete) use of relevant published scientific findings, and lack of consideration of other relevant scientific or medical data, such as clinical data derived from years of practice of clinical nutrition. The avoidance of particular relevant studies and lack of inclusion of recent studies is a major reason for the low Upper Levels (ULs) for vitamins beta-carotene, B6, C and D and others.
    
2. Upper Levels are generally determined in the absence of adequate dose-response data (in humans), meaning ULs are based around No Observable Adverse Effect Levels (NOAELs) which may be much lower than those which might first trigger adverse events, even in sensitive people.
    
3. Upper Levels are based on the most toxic form of a given nutrient group. For example, the UL for iron is based on iron sulphate (used medically to treat anaemia) which causes gastrointestinal upset. This level is then applied to all iron forms including ferrous bisglycinate which has no side effects at considerably higher dose ranges. Another example which well illustrates the problem is that of vitamin D. The vitamin D UL of 25 mcg used in the EU (set by the SCF) is determined using older studies, on the basis of potential side effects of vitamin D2 (ergocalciferol), which is not produced in the body or consumed in foods, except yeasts, as well as by consideration of the very small proportion of people who have renal insufficiency or vitamin D hypersensitivity syndromes e.g. primary hyperparathyroidism, granulomatus disease. This level is then applied to vitamin D3, which is both produced in the body following exposure to sunlight and consumed in foods such as oily fish. The 25 mcg level equates to around a quarter of the amount of vitamin D3 found in a healthy person, and one-tenth of the least amount made in the body following around 30 minutes of full body exposure to sunlight (approx. 10,000 IU or 250 mcg) . Using a more appropriate approach to the methodology of risk assessment in relation to vitamin D, as well as consideration of recent human trials, a recently published risk assessment of vitamin D yielded this much more reasonable level of 250 mcg  as the safe upper level, ten times the SCF‘s proposed UL (i.e. the equivalent of the amount made by the body following 30 minutes total body exposure to sunlight). 

   When determining ULs for normal, healthy populations, it is completely inappropriate to apply the level determined for one nutrient form on another which is known to be considerably safer, as well as to use incomplete data or data from diseased populations. This process results in ULs which are known to be lower than the amounts required for beneficial effects in the vast majority of healthy individuals.
    

4. The UL does not take into account the use-pattern of the nutrient. For instance, for some sensitive individuals, a single 2000 mg dose of vitamin C may induce bowel upset, while probably no adult would respond adversely to this dosage being taken in four 500 mg divided doses.
    
5. Studies used to underpin the ULs are often marred by unrecognised confounding, as usefully revealed by the German authors of a recent study of vitamin and mineral consumers in a very large German cohort study31. This problem of unrecognised confounding is considered in more detail below, in the section entitled Using the four criteria to develop MPLs.
    
6. Guidance levels and average intake levels are sometimes used as surrogates for scientifically determined upper safe levels. In the case of many nutrients, there are inadequate human (dose-response) data to be able to calculate a scientifically meaningful UL. In such cases, guidance or average intake levels are established, but these are then inappropriately used as surrogates for the Safe Upper Level (SUL) when in many cases it is known that a ‘true’ ‘highest safe level’ would be considerably higher. Refer to Table 1 for some examples. Of the 30 nutrient group risk assessments conducted by the EVM in 2003, only 8 SULs were generated, as compared with 22 guidance levels.
    
7. Risk assessment models used are not tested properly. Any proper, scientific risk assessment methodology requires testing of the risk assessment model used. Testing typically involves comparing the model outputs with ‘real’ data, and in the field of nutritional interventions, the largest data set in which a wide range of dose-responses are recorded can be found in the field of clinical nutrition (not in the published clinical trial literature). When the SCF, EVM or IOM models used in risk assessment are tested in this way, they are clearly found to be wanting, given that they yield ULs that are within or even below the ‘normal range’ for given nutrient forms. In many cases, even published literature relating to particular nutrient forms demonstrates that the UL for the corresponding nutrient groups is excessively precautionary.

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