WASHINGTON, Dec 22: Firms from India and other nations supplying food to the US may soon find it costlier to do businesses with the US proposing a new rule that requires them to address vulnerable processes in operations to prevent facilities from being target of “intentional adulteration”.
Initial estimates suggest that companies, both domestic and overseas, might have to spend nearly USD 500 million in ten years to comply to the proposed rule requirements.
The proposed new norms by food regulator FDA comes in the backdrop of constant fears of intentional harm to US health system and consumers via its food supply chain.
Facilities would have to identify and implement strategies to address these vulnerabilities, establish monitoring procedures and corrective actions, verify that the system is working and maintain certain records, among others.
However, these rules are not intended to apply to farms and food for animals as of now.
The proposed rule, under the FDA Food Safety Modernisation Act, would require domestic and overseas suppliers to have a written food defence plan that addresses any potential vulnerabilities in a food operation.
“Acts of intentional adulteration may take several forms, including those where the intention is to cause large-scale public health harm; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration,” the FDA (Food and Drug Administration) said.
With some exceptions, this proposed rule would apply to both domestic and foreign facilities that manufacture, process, pack, or hold food and are required to register as a food facility.
“The proposed rule is aimed at preventing intentional adulteration from acts intended to cause massive public health harm, including acts of terrorism … The cost of the proposed rule to both domestic and foreign firms, annualised over 10 years at a 7 per cent discount rate, is between USD 260 million and USD 470 million,” the FDA added.
Justifying the additional burden, the American regulator said that the expected benefit of preventing a catastrophic terrorist attack on the US food supply is about USD 130 billion. “…Means that the benefits of this rule outweigh the costs to Americans if the rule has a 1 in 730 or better annual chance of preventing such an attack,” it said.
In addition to the rule on intentional adulteration, the FDA has already proposed preventive controls for human food and separately for animal food; standards for produce safety.
The FDA has also proposed two rules related to imports: the Foreign Supplier Verification Programme for importers as well as a programme for the accreditation of third-party auditors to conduct food safety audits of foreign facilities and the foods for humans and animals they produce. (AGENCIES)
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