Let’s start with a really basic proposition:

  1. emerging technologies often represent unknown risks to human health and the environment;
  2. before these technologies are introduced into the body or environment, the safety of these new technologies and products must be determined; and
  3. the onus of proof rests with those who would introduce the technology or product.

This is basically the position of the World Health Organisation (WHO), which has noted that for all new materials used in food and food processing, the potential health and environmental risks of nanoscale materials need to be assessed before they are introduced into food. It is hard to imagine an argument against this and yet in the regulatory world of nanotechnology in Australia, this is not the reality. The reality instead is to assume the safety of products containing new technologies, to depend on a self-regulatory system to ‘catch’ problems and to regulate only as a last resort.

This piece will look specifically at the regulatory failure of Food Standards Australia New Zealand (FSANZ) in the regulation of nanomaterials in food and food contact materials, but it is a story repeated, with variations, in virtually every federal agency that has jurisdiction over nanotechnology in Australia.

The use of nanotechnology in food and food contact materials is now widespread. Nanomaterials are used as whiteners, flavour enhancers, antimicrobials, ‘trickle and flow’ aids. They are used in packaging, coatings, storage facilities, appliances, containers, cutlery and surfaces. They are now ubiquitous but remain invisible. The role of FSANZ is both to protect public health and to achieve a high level of consumer confidence in the quality and safety of food produce and sold in Australia and New Zealand. They are also charged with having an ‘effective, transparent and accountable regulatory framework within which the food industry can work efficiently.’ FSANZ hasn’t been ignoring nanotechnology. They have, in fact, taken an active interest in the issue for well over five years. Yet that ‘interest’ is the evidence of its regulatory failure.

Government review

In 2007 a whole of government review of regulations applicable to nanotechnology was undertaken, which included a review of the adequacy of the regulatory regime of FSANZ. The broad conclusion of the review was that: “Whilst there is no immediate need for major changes to the regulatory regimes, there are many areas of our regulatory regimes which, potentially, will need amending, and this will be a long term effort across multiple regulators and regulatory agencies as nanoproducts arise and as new knowledge on hazards, exposure and monitoring tools becomes available.”

The review cited six important gaps that needed to be addressed if the regulatory regime was to keep up with the development of nanotechnology. A follow up review in 2012 found that these gaps were still unaddressed and were often ignored by relevant agencies. FSANZ has taken several steps in relation to the presence of nanomaterials in the food chain. It has amended its Application Handbook to ‘support’ new food regulations. The Handbook now contains a requirement that, “in cases where particle size is important to achieving the functionality or may relate to a difference in nutritional status or toxicity, the applicant must provide information on particle size, size distribution, and morphology, as well as any size-dependent properties.”

The website also notes that FSANZ has advised the industry about these amendments and asked them “about proposed nanotechnology applications.” In a journal article two FSANZ staff state that FSANZ will require a risk assessment of “novel nano-particulates in the event that we receive an Application.” As of June 2014, there have been no applications, and accordingly, FSANZ is “not aware of any manufactured nanomaterials being used in food available in Australia.”

Nanotechnology and food

In our recent report on nanotechnology and food, ‘Way too little‘ Friends of the Earth identified a number of products that contain nanomaterials that are available in Australia. These include Mentos, M&Ms, Cadbury’s chocolate, various chewing gums and doughnuts. There is no doubt that food and food contact materials containing nanomaterials are here, but FSANZ is not looking. They appear to be waiting for the mountain to come to them.

FSANZ was asked in Senate Estimates whether they had undertaken any testing of food to determine if nanomaterials are in foods available here. The answer was no. They were asked whether they had conducted any surveys of manufacturers or importers to determine if nanomaterials were being used in food they produced or imported. They answered no.

Perhaps the explanation for inaction is here. “Any new foods manufactured using nanotechnologies that may present safety concerns will have to undergo a comprehensive scientific safety assessment before they can be legally supplied in Australia and New Zealand.” This language is much more ambiguous than that contained in the Food Risk Analysis Journal piece above.

In light of the lack of proactive work by FSANZ it is fair to presume that manufacturers and importers make this threshold decision and if they are of the view that the food containing nanomaterials doesn’t ‘present safety concerns’ no further action is required. But if you do apply, we are told that foods containing nanomaterials will be subject to a comprehensive safety assessment. Or maybe not. Even FSANZ doesn’t seem clear about its own rules. “The regulatory pathway for materials with a history of use that are already approved under existing Standards, and which could be marketed with particle sizes in the nanoscale, is less certain than for new or novel nanoscale materials.”

If FSANZ can’t figure out what materials and products its safety testing rules apply to, it’s pretty certain the industry won’t know either − and won’t be asking for clarification. So, in theory there is a regulation, but in practice it is both ambiguous and unused despite clear evidence of nanomaterials in the Australian food chain. Ultimately, one has to expect, someone, somewhere in a fit of paranoia or even concern, will apply for approval of a food containing nanomaterials.

What constitutes a nanomaterial?

Once that occurs, the next impediments raise their heads. There is no statutory nor agreed definition of what constitutes a nanomaterial in Australia. This extraordinary vacuum means that regulators cannot easily enforce rules relating to nanomaterials in food. It means manufacturers wanting to do the right thing have no clarity regarding what materials or products are subject to these rules. Even worse, it’s not clear that currently accepted tests in Australia can actually detect nanomaterials in food − and even more whether those tests would hold up under legal scrutiny.

As Karinne Ludlow points out “even if the FSANZ is made aware that a nanomaterial is present, current risk assessment methodologies may not be adequate for determining potential risks of food and food contact materials containing nanomaterials to human health. For example, it is not known whether current toxicology testing techniques are suitable for nanomaterials. It is not clear that current testing methods and techniques for measuring nanomaterials are adequate for detecting nanomaterials in food and food contact materials” Even if we manage to penetrate the maze of red tape preventing regulation and make it to that mystical point where a safety assessment will occur, reality strikes again.

As Kath Wilson points out, in relation to the ‘safety testing’ of genetically modified food, FSANZ relies almost solely on company data and has approved every single GM food to pass over its desk. There is no reason to think that we are likely to see anything different with nanomaterials in food and food contact materials. Based on the way in which FSANZ has responded to similar criticisms in the past, perhaps it will simply dismiss the regulatory sham as irrelevant as there is no evidence that any of these nanomaterials cause human health problems. Apart from the obvious problem, that FSANZ isn’t looking for evidence, the claim also isn’t true.

Health concerns

There is a mounting body of evidence that suggests there are health concerns associated with some of the nanomaterials currently being used in food and food contact materials. In particular, nano titanium dioxide, probably the most used nanomaterial in food, nano-silver, nano silica and nano zinc have all caused health problems in live animal studies. So, instead of a determination of safety, we have a regulatory structure that one could swear was designed to avoid regulation.

Perhaps we don’t have regulatory failure but what Lawrence Lessig describes as institutional corruption. In response to ‘agents of influence’, agencies begin to act on behalf of interests other than the public interest. They embrace assumptions about markets and business and innovation and reorient themselves in subtle ways to support the industries they are supposed to regulate. The regulations themselves are designed to catch little or nothing.

Lessig says that one can see institutional corruption not in the processes in place but in what he calls the ordinary outcomes of those processes. The ordinary outcome here is that despite 6 years of ‘regulation’ no foods or food contact materials containing nanomaterials are actually regulated.

Jeremy Tager is an Emerging Tech Project Campaigner with Friends of the Earth, Australia.