FIEO Moves Ministry To Seek Clarification On US Bioterrorism Act

Chennai, Nov 9: | Updated: Nov 10 2003, 05:30am hrs
The Federation of Indian Export Organisations (FIEO) has requested the Union commerce ministry to take up some critical issues with the US Food and Drug Administration (US FDA) regarding the Bio-terrorism Preparedness and Response Act of 2002, better known as the Bioterrorism Act.

Top FIEO sources told FE that the Bioterrorism Act has left some issues vague and these need to be clarified as soon as possible. There is ambiguity regarding some clauses in the Act. We have requested the commerce ministry to take up these issues with US officials and get the clarifications before the 75 day comment period ends in March 2004, sources said.

Among the issues to be clarified include the process of identifying an agent in the US, prior shipment information five days in advance, the responsibilities of merchant exporters and the additional tests to be carried out etc, sources said.

The Bioterrorism Act has made it mandatory for all the domestic and foreign facilities that manufacture or process, pack or hold food for animal or human consumption in the US to register by December 12. Under the Act, FDA must also receive advance notice of each shipment of products. The registration under the Act commenced on October 16.

According to FIEO, it was not clear how the proposed measure may impact on Indias food export to the US. Since it is equally applicable to the domestic and foreign facilities it is not discriminatory, they feel. But there are concerns that the requirements of registration and prior notice may add to the transaction cost and could become another non-tariff barrier.

The US law is also viewed as a bar on flow of international trade. Imposition of a multitude of import-related requirements by different countries would lead to increased costs and delays in international trade of food products.

For India, seafood is one of the major export items that comes under the FDA regulation. Herbs and herbal products and fruits are other food items that could be affected by the US law.

Of this seafood is most important as Rs 2,000 crore worth of sea food, 30 per cent of total marine products exports, goes to the US.

All the dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), fruits and vegetables, fish and seafood, dairy products and shell eggs, raw agricultural commodities for use as food or components of food, canned and forzen foods, bakery goods, snack food and candy (including chewing gum) live food animals and animal feeds and pet feeds will come under the definition of food under the Act.

FDA is providing a 75-day comment period on specific issues related to the interim final rule. The agency will reopen the comment period for another 30 days beginning in March 2004. Hence the final regulation on food imports and sales in the US will be in place by May 2004.

During the initial months following December 12, FDA would put in place a policy that emphasises assisting covered entities in understanding the requirement and how to apply. The agency is expected to publish a notice of availability for a Compliance Policy Guide that will outline how FDA generally intends to exercise enforcement discretion.

When a foreign facility that manufactures/processes, packs or holds food sends it to another foreign facility or further manufacturing/processing or packaging before the food is exported to the US only the second foreign facility is required to register.

If the second foreign facility performs only a minimum activity like putting a label, both the facilities would be required to register. Also any foreign facility that packs or holds food after the last foreign manufacturer/processor of the food must also register. Registration is required only once for each food facility. However, the required registration information must be updated if it changes.

Facilities like private residences of individuals, even if food may be manufactured, processed, packed or held there, transport vehicles that hold food only in the usual course of their business as farms, restaurants, retail food establishments, non profit food establishments, fishing vessels need not have to register. If an Indian or any other foreign facility that has to register with FDA but fails to do so, food from that facility offered for import into the US is subject to being held within the port of entry for the article unless otherwise directed by FDA or the Bureau of Customs and Border Protection (CBP). FDA would be issuing enforcement guidance regarding the agencys policies on refusals of imported food.

According to the FDA rule facilities can register online via the internet, by completing a paper form or submitting to FDA a CD-ROM with relevant registration information.

The Act stipulates that each registration must include the name, address, and phone number for the facility and its parent company, the name, address and phone number of the owner, operator or agent in charge, all trade names the facility uses, and applicable food product categories as identified in FDAs regulation etc.

A foreign facility must also provide the name, address, and phone number of its US agent and provide the emergency contact phone number for its US agent.