US FDA To Inspect European Food Manufacturers

Nov/11

This article discusses the key points of the Food Safety Modernization Act (FSMA) in the USA and its implications for European food and beverage manufacturers, suppliers, distributors and agents. 

The background to this law is the scale of foodborne illnesses in the US which results in about 48 million Americans getting sick each year, 128,000 being hospitalised and 3000 dying.  It is the recognition that foodborne illness is not just a stomach ache but can cause life-long chronic disease (e.g. arthritis, kidney failure).  It is also the fact that the food supply chain has increased in complexity and globalisation with 15% of food being imported. 

The main themes of the legislation are prevention, inspection, import safety and partnerships.  The import safety element will have a direct impact on European suppliers and manufacturers.  The current system relies upon inspections upon arrival.  This has been recognised as inadequate and now importers are responsible for ensuring that their foreign suppliers have adequate preventative controls in place.  In particular it is worth looking at Sec.201. Targeting of inspection resources - This will result in increased inspection of foreign (and domestic) facilities.  High risk facilities will be identified and inspected.

This selection will be based upon the following factors:

‘‘(A) The known safety risks of the food manufactured, processed, packed, or held at the facility.

‘‘(B) The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.

‘‘(C) The rigor and effectiveness of the facility's hazard analysis and risk-based preventive controls.

‘‘(D) Whether the food manufactured, processed, packed, or held at the facility meets certain criteria.

‘‘(E) Whether the food or the facility that manufactured, processed, packed, or held such food has received an appropriate certification.

‘‘(F) Any other criteria deemed necessary and appropriate for purposes of allocating inspection resources.

In general, the frequency of inspection of all facilities will increase.  In the first year of enactment of the FSMA, it is stated that 600 foreign facilities will be inspected.  The number of inspections will double each year.  This will result in 19200 inspections of foreign facilities by 2015.

We know that already some European food manufacturers and suppliers are already being inspected under this scheme.  Details of how this programme will develop with these very large numbers of inspections is not yet clear.  In addition further clarity is required as to the form the inspections will take, who will do them and how they will be announced.

Click for the full text and FAQs of the Food Safety Modernization Act.