New Zealand’s food safety regulator ‘shopped’ for alternative advice when a report it had commissioned from ESR questioned the safety of a GM food.
The original report by Dr Lou Gallagher said there were toxicological concerns over MON863 corn that could not be refuted without further study. She was evaluating a French study that newly reported signs of organ toxicity in rats fed this variety of GM corn.
NZFSA first delayed providing the Gallagher report to its minister. Then ten weeks after receiving the report in June 2007, and two days after the Ombudsman wrote to NZFSA following its refusal to release it to the Sustainability Council, NZFSA asked ESR for an “updated” report.
The new document was produced by a different ESR division to the group Gallagher belonged to. However, instead of an “updated” report, NZFSA accepted a letter that carried no clear reference to the Gallagher Report or its scientific conclusions. In place of a formal peer-reviewed report that had answered NZFSA’s brief and was prepared by a scientist with the appropriate expertise, NZFSA accepted a letter that carried just four sentences in response to the original brief, and was signed off by a group that NZFSA knew had originally passed on the work after stating they lacked the appropriate expertise. The letter indicated there was no scientific evidence that MON863 is unsafe to eat.
NZFSA had been told by ESR when it sought the “updated” report that the Gallagher report would be withdrawn. NZFSA assumed this when it provided both the Gallagher report and the letter to its minister in November 2007. The effect was fundamental, as no minister could be expected to weigh seriously a withdrawn document. However ESR did not withdraw the Gallagher report and its concerns remain to be answered. A full analysis is detailed in the Sustainability Council’s report: Food Safety Integrity.
This case follows last year’s controversial approval of another form of GM corn that carried high levels of lysine. The assessment for it did not investigate key health concerns and failed to evidence precaution. Further, this animal feed was approved when there were no credible public benefits to making it a legal food.
In light of these two cases, safety regulation for new foods now has zero credibility, the Sustainability Council concludes. Without regulatory credibility, public trust cannot be sustained. These events also raise questions about other aspects of food safety regulation beyond new foods.
The Government’s September 18 announcement of a revised mandate for NZFSA only begins to scratch the surface of the reform required. The new mandate’s clear focus on consumer welfare is important for a new food safety ethos. However, a root problem with new food approvals has been a failure to take a precautionary approach when assessing risk. While the Government has instructed NZFSA to apply precaution, NZFSA has fought off a key recommendation of the Slorach Review to make it a legal, and so enforceable, requirement for NZFSA to apply the precautionary approach when faced with scientific uncertainty.
If NZFSA’s new mandate is to be observed, Government cannot credibly let the approval of MON863 rest without further investigation. Gallagher states that the results of experiments to date leave “significant uncertainty” that needs to be addressed. Scientific uncertainty is precisely the condition that is meant to trigger precaution. Precaution requires that either more research is undertaken to determine why the MON863 trials produced so many unexpected results, or else the MON863 approval is revoked for want of evidence that it is safe.
The wider problem is that there is only limited ability to give practical effect to NZFSA’s new mandate without also changing the policy of the trans-Tasman safety regulator, FSANZ, or going around it. FSANZ undertakes the assessment of all new foods for both countries and NZFSA acts as check regulator.
New Zealand can in theory go its own way and decline approval for a particular new food. However, this requires “exceptional grounds”. Further, having contracted out primary responsibility for the scientific assessment, New Zealand has a much reduced capacity to devise and defend any independent stance. NZFSA is more a notional regulator of new foods – the appearance of sovereign regulation, but without the capacity to deliver on this public expectation.
New Zealand needs to examine its big picture options to regaining true sovereign control of its food safety regulation. These include:
- Renegotiation of the trans-Tasman treaty:The highest priority is to achieve an unrestricted right to differentiate from Australia.
- Negotiating cooperation arrangements with other regulators: The broad alternative to a subordinate relationship with Australia is establishing cooperation arrangements with one or more other selected regulators.