| Comment Record|
Mr. Robert F. Nelson ||
2002-08-30 14:33:43 |
National Coffee Association of USA |
| Comments for FDA General |
1. General Comments
August 30, 2002
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Bioterrorism Preparedness
Docket No. 02N-0276 Registration of Food Facilities
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/registration requirements and processes. Further, it is imperative that considerable attention be given to cross-agency coordination, thereby increasing the probability of 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.
The FDA is encouraged to strongly consider defining a facility as a fixed, enclosed structure or structures controlled by a single owner, operator or agency in a manner that would allow for two or more adjacent buildings, or two or more buildings in close proximity to be considered for purposes of the Act as a “facility.” Pursuant to such a definition, two adjacent/close proximity buildings with different United States postal addresses could be designated as a single facility, even in an instance where the company controls each building through a different mechanism, for example ownership and leased property.
The regulations should differentiate between the treatment of food that is in violation of the Act as a result of an administrative paperwork violation, i.e. failure to file facility registration, and food that poses a threat of serious adverse health consequences or death to humans or animals. Specifically, a vehicle should be provided for firms controlling registered facilities to assist unregistered facilities in becoming registered, thereby correcting the administrative violation of not registering and allowing for the use of the food product in a timely manner. It is realistic to presume that although the food was shipped from a registered exporter, in some instances food may have been previously processed at an unregistered facility, regardless of the safeguards to ensure supplier facility registration utilized by manufacturers. Should such a scenario arise, and the manufacturer learns that food product in its possession passed through an unregistered facility, regulations should provide for corrective action to be taken in the form of registering the non-registered facility without the requirement to destroy or needlessly detain an otherwise wholesome product, that may have been mixed with fully lawful product.
The NCA recognizes and supports the need for emphasis being placed on electronic submissions. However, it is imperative that alternate non-electronic registration mechanism(s) be provided for in the regulations. Not all coffee processors or packagers located outside the United States have access to computers, and in some cases processors and packagers may not have access to electricity or phone lines.
The Act requires foreign facility registration for the last facility located outside the United States that “manufacturers, processes, packs or holds food,” provided that food from such facility is exported to the United States without further processing or packaging outside the United States, thereby recognizing that firms not required to register may handle the food prior to arrival in the United States. An example is a firm or facility that samples coffee. For clarification purposes, NCA urges FDA to formally recognize sampling as a de minimus activity, thereby exempting facilities that solely sample coffee or conduct other de minimus activity.
Again, the National Coffee Association appreciates the opportunity to submit the 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