| Comment Record|
Mr. Robert F. Nelson ||
2002-08-30 14:23:58 |
National Coffee Association of USA |
| Comments for FDA General |
1. General Comments
July 31, 2002
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Bioterrorism Preparedness
Docket No. 02N-0278 Prior Notice of Imported Food Shipments
Dear Sir or Madam:
The National Coffee Association of USA (NCA) appreciates the opportunity to provide input on the development of regulations relating to and required pursuant to the Bioterrorism Act (Act).
NCA represents the US coffee industry, which generates $18 billion annually sales and conducts $3 billion in trade with 30 countries from Asia, Africa and Latin America. In addition to the more than one thousand roasters and importers, the industry is comprised of some 10,000 coffee cafés employing persons in every state and region. Through retail, restaurant and coffee café sales the industry serves 177 million consumers annually. NCA membership, consisting, in part, of exporters, importers and roasters, will be impacted by the Bioterrorism legislation and associated regulations.
The NCA strongly encourages the FDA to incorporate existing records and systems to the maximum degree possible in fulfilling the legislative mandate, as opposed to developing new record keeping requirements and processes. Further, it is imperative that considerable attention be given to cross-agency coordination, thereby increasing the probability compliance from the onset. Maximizing the use of existing records and systems, and developing a high level of cross-agency synergy, between the regulations and operations of the various agencies, will greatly lessen the economic impact of the legislation for FDA and the industry, and lead to a greater level of security.
It is critical that, when the Act becomes effective, products already in the distribution chain be exempt from the applicable record keeping and registration requirements. In the case of coffee, it is not unusual for surplus stocks to be in storage for three to four years, or more, before processing. These stocks may be held in US warehouses or warehouses in producing nations. As a result, much of the information required in the record keeping provisions, for example country of origin or prior ownership, is non-existent. Failure to “grandfather” these products will have place tremendous economic burden on US coffee companies, with no corresponding security benefit accruing to the nation or consumers.
In an effort to strengthen security and safety and allow for a greater focus on food product that presents a higher probability for concern, FDA is strongly urged to develop a system that provides for low risk product, as well as product being imported by low risk companies, to move through the import process in an expedited manner. It is suggested that results from the FDA’s food product risk assessments be a basis for such a system.
Pursuant to the Act, prior notice is required to include information specifying the product’s country of origin. As such, regulatory language is needed to clearly define country of origin for purposes of this Act, especially considering the current debate at the World Trade Organization’s Rules of Origin Committee. In formulating defining language, FDA is strongly urged to clarify that coffee from more than one country blended together becomes a product of the country where it was blended. Further, FDA is strongly urged to develop regulatory language defining the country of origin of roasted coffee as the country where the coffee was roasted.
Again, the National Coffee Association appreciates the opportunity to submit comments. We look forward to the possibility of submitting subsequent comments following the publication of proposed regulations.
Robert F. Nelson
President and Chief Executive Officer
National Coffee Association of USA