The new rules, once adopted after an ongoing public consultation process, would apply to all foreign companies supplying food products for human as well as animals in the US and would vary as per the type of food product (such as processed foods, farm produce, and dietary supplements) and category of the importer.
The regulations would require importers, from countries including India, to go through a screening process that ensures that food being imported has been produced in compliance with the processes and procedures required for the US FDA (Food and Drug Administration) standards.
About 15 per cent of all food consumed in the US is imported, while the ratio is even higher at 20 per cent for fresh vegetables and as high as 50 per cent of fresh fruit.
According to FDA, India is the second largest drug exporter and seventh largest food exporter to the US. At the same time, India also figures among the top countries in terms of import refusal of food products by the FDA.
Besides, several food-borne disease outbreaks have been traced to imported food, including outbreaks resulting from consumption of imported fruits, vegetables, and nuts.
Amid recent concerns related to imported food, tighter rules have been designed to provide the same level of public health protection as those required under the hazard analysis and risk-based preventive controls and standards for produce safety sections of US Federal Food, Drug, and Cosmetic Act.
Although FDA applies the same safety standards to domestic and imported food marketed in the US, the regulator has long taken different regulatory compliance approaches to the products produced domestically and abroad.
The logistics associated with conducting unannounced onsite inspections in most foreign countries make it difficult for the FDA to conduct inspections similar to those in the US.
The same is true of "for cause" inspections when FDA has evidence of a compliance problem. FDA also has to overcome very significant hurdles to conduct foreign civil and criminal investigations and prosecutions when violations occur.
These difficulties associated with foreign inspection and enforcement are compounded as there are more foreign firms registered with FDA than domestic firms.
In addition, FDA is able to physically examine only a small fraction of the food that is offered for import into this country. The number of food import lines has grown significantly over the past decade, reaching nearly 10.5 million lines in fiscal year 2011, and FDA expects this trend to continue in the coming years.