US plans tough norms for food imports from India
6 Aug 2013 4:37 AM IST
Indian food companies seeking to enter American markets may soon face a tough screening process, as the the United States health watchdog, Food and Drug Administration (FDA), has proposed a new Foreign Supplier Verification Programme for such products.
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 America 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 FDA 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 the FDA, India is the second largest drug exporter and seventh largest food exporter to the USA. At the same time, India also figures among the top countries in terms of import refusal of food products by 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 United States Federal Food, Drug, and Cosmetic Act.
Although the FDA applies the same safety standards to domestic and imported food marketed in America, 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 FDA to conduct inspections similar to those in the USA. The same is true of ‘for cause’ inspections when FDA has evidence of a compliance problem. The Administration 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 the Food and Drug Administration 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 the Food and Drug Administration expects this trend to continue in the coming years.
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 America 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 FDA 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 the FDA, India is the second largest drug exporter and seventh largest food exporter to the USA. At the same time, India also figures among the top countries in terms of import refusal of food products by 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 United States Federal Food, Drug, and Cosmetic Act.
Although the FDA applies the same safety standards to domestic and imported food marketed in America, 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 FDA to conduct inspections similar to those in the USA. The same is true of ‘for cause’ inspections when FDA has evidence of a compliance problem. The Administration 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 the Food and Drug Administration 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 the Food and Drug Administration expects this trend to continue in the coming years.
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