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FDA roasted over irradiation petition handling

By Rory Harrington , 22-Mar-2010

A US Congressional watchdog has slammed the Food and Drug Administration (FDA) for a catalogue of failings over its handling of petitions to use irradiation on food.

The Government Accountability Office (GAO) said the food regulatory agency was too slow in reviewing six outstanding irradiation applications, and had failed to meet statutory and regulatory deadlines in which to deliver a verdict.

FDA officials had also consistently not documented its decisions about the petitions and failed to communicate key information to applicants, said the GAO.

“As a result, FDA’s petition review process lacks transparency and leads to understanding and confusion among petitioners,” added the body in a stinging report.

Food irradiation is the process of exposing food to ionizing radiation in order to control foodborne pathogens. Food is irradiated using gamma rays, X-rays or electron beams. Its use is permitted in 56 countries and the process has been declared safe by the World Health Organisation, the US Department of Agriculture and the Food and Drug Administration (FDA). The GAO cited research that said the technology had the capacity to eliminate 99.999 per cent of potentially deadly bacteria such as E.coli, Listeria monocytogenes and Campylobacter.

FDA failures

The report listed how the FDA repeatedly failed to acknowledge receipt of petitions within the prescribed 15-day deadline or notify applicants of their success or failure. The six petitions have been under deliberation for an average of 8.5 years and some for as long as a decade.

The paper noted that FDA employees said the 180-day timeframe to decide on a petition was too short - but added that the agency had never requested a change in the law. The FDA is not obliged to make any reports on an application once the deadline has passed, said the report.

The food safety watchdog was also criticised for its lack of documentation on the outstanding petitions.

“FDA’s petition files contain little or no documentation of its decision-making on the six petitions and in some cases fail to reveal the process FDA used to make decisions”, said the report.

Furan

Giving an example of the FDA’s working practices, the GAO outlined how two petitions for irradiating meat and poultry were held up for almost ten years because the agency had decided to review them in conjunction with a third application for multi-food ingredients to save cost and time – although no record of this decision existed in any file.

The delay appeared to stem from concerns that furan, a carcinogenic colourless liquid, can form during irradiation. However, even though the agency determined in 2003 that furan was not an issue with irradiated meats, those petitions remain blocked in the system because they are still administratively “linked” to the multi-ingredient petition over which FDA concerns persist.

The FDA admitted its mistake in this respect and acknowledged it was possible to move forward with the meat and poultry applications. However, the agency said it had yet to set a deadline to finish it review of those meat applications.

The safety body has also failed to communicate properly with applicants which has limited their ability to understand or respond to FDA actions and decisions, said the oversight office.

The GAO urged the FDA to overhaul its administrative processes by documenting key decisions and communicating more effectively. The agency said it accepted the recommendations and had begun to implement them.