It may not be fair to poke fun at the venerable U.S. Food and Drug Administration.  Or at the unwittingly tell-tale definition of the scope of the FDA's „interim final regulation" on the registration, prior notification and other administrative requirements which - according to the U.S. Bioterrorism Act of 2002, and unless Congress or a U.S. Court decides otherwise - are to take effect on December 12, 2003 for all locally produced and U.S.-imported "food for humans and other animals" (Federal Register of October 10, 2003, p.59071, § 1.277).  But humor, even if it is involuntary, sometimes helps to better understand and properly deal with well-intended, yet ill-advised, ill-considered and indeed indigestible products. And so the overburdened FDA specialists, who otherwise excelled in their own way, may not take offense by being thus quoted.

To wit (for details see also: www.solami.com/bioterindex) - and not counting associated costs and burdens for foreign growers, manufacturers, processors, warehouses, exporters, transporters, etc. -

1. „FDA finds that this interim final rule would affect 77,427 importers" (op.cit., p.59065).
2. „This interim final rule requires FDA be notified of incoming products electronically before the food arrives at a U.S. port. The annual cost of doing so is about $2,400 per submitter (based on $187.5 million in notification costs/77,427 U.S. importers. ... FDA could not provide flexibility for those importers who do not have electronic transmitting capacity" (op.cit., p.59066). "The rules take effect Dec. 12, 2003, in accordance with the Bioterrorism Act. To assure that the regulations can be implemented efficiently and with minimal disruption, FDA intends to exercise broad enforcement discretion for the prior notice rule for the first four months after implementation. During this time, FDA and Customs will educate importers about how they can comply with the regulations, and will work with trade associations and foreign governments to make sure all importers are well informed of the new requirements. Thereafter, FDA will phase in full implementation of the prior notice requirements." (FDA press release of Oct. 9, 2003: www.fda.gov/oc/bioterrorism/dhhs_release.html)
3. "§1.280 How must you submit prior notice?" "You must submit the prior notice electronically to FDA. You must submit all prior notice information in the English language ... If FDA determines that FDA PN System Interface is not working, ... you must submit prior notice information by e-mail or by fax to FDA. ... If FDA determines that the Operational and Administration System for Import Support (OASIS) is not working, ... all prior notices must be submitted to FDA by e-mail or by fax." "Prior notice information will only be accepted at the listed e-mail or fax locations if FDA determines that the FDA PN System interface or OASIS is not working" (op.cit., p.59072). "... we assume that 6.5 million prior notices will be submitted annually" (op.cit., p.59069).
4. „§1.281 What information must be in a prior notice?" General and specific, each with 18 positions, described with some 2600 words (op.cit., 59072;  extract: www.solami.com/bioter1281).
5. „§1.279 When must prior notice be submitted to FDA?" „If the article of food is arriving by land by road, no less than 2 hours before arriving at the port of arrival", if by rail or air, no less than 4 hours, and if „by water, no less than 8 hours before arriving at the port of arrival." However, in all above cases, „you may not submit prior notice more than 5 calendar days before the anticipated date of arrival of the food at the anticipated port of arrival." „Your prior notice will be considered submitted and the prior notice time will start when the FDA has confirmed your prior notice for review" (op.cit., p.59071).
6. „We estimate that the costs of the interim final rule (option 6) will be about $367 million in the first year and 261 million in later years" (op.cit., p.59063).
7. Total one time annual reporting burden: 3,406,795 hours; total recurring annual burden: 2,836,781 hours (op.cit., Table 53, p.59068).
8. „Requiring prior notice of imported food shipments and defining the required data information will ... improve FDA’s ability to detect accidental and deliberate contamination of food and to deter deliberate contamination. ... Historical evidence suggests that a terrorist or other international strike on the food supply is a low probability ... The potential hazard associated with a single shipment of imported food is large. The FDA prior notice system alone will not prevent such exposures ..." (op.cit., p.59064/5).
9. "FDA has determined that this interim final rule is significant under the Unfunded Mandates Reform Act [Public Law 104-4]" (op.cit., p.59066), providing for a "cost-benefit and other analyses before any rulemaking if the rule would include a ‘Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more ... in any 1 year.’" And it directs the government, prior to a rule’s enactment, to asses a proposed rule’s effects, a.o. on future costs, economic growth, full employment, job creation, exports and trade effects. The FDA’s interim final rule is not seen to adequately meet these obligations. At least in so far as they were not limited to such foreseeable direct effects on the U.S. economy as an administratively or blackout-induced clogging of at least the port system. And in fact may have been meant to cover such areas as U.S. treaty obligations (e.g. WTO), risk of reprisals by adversely affected foreign countries, and risk of litigations by adversely affected U.S. and foreign firms (e.g. Administrative Procedure Act, 5 U.S.C., § 702 and 706).
10. The Office of Management and Budget "OMB has determined that this interim final rule is a major rule for the purpose of congressional review" in the sense of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) which the FDA sees applicable in the event of "an annual effect on the economy of $100 million or more; a major increase in costs or prices; significant adverse effects on competition, employment, productivity, or innovation; or significant adverse effects on the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic or export markets" (op.cit., p.59067).