| 10/16/2003 Bioterrorism Rules Kick in Dec. 12 - 10/15 Agriculture Law "We're pleased that FDA has better defined 'food' in these rules, moving toward what we requested in our comments. The 'food' definition no longer encompasses materials, such as packaging, or substances that contact food," said Clay Detlefsen, IDFA vice president of regulatory affairs and counsel. "This is particularly significant to many industry suppliers, who now may not have to register their facilities with FDA." In addition, once a facility is registered, subsequent updates to that registration will be required within 60 days - rather than 30 days - of the date of the actual change; these updates are required whenever there is a change to a required data element on FDA's registration form. "However, the bulk of this announcement results in more work for dairy companies, with a very limited amount of time in which to do it," stated Detlefsen. FDA has classified these two rules as "interim final" rules, which means that they will go into effect with all the force of a standard "final" rule, but FDA will take public comments on both rules for another 75 days. This gives FDA the option to revise some aspects of the rules in the future, but will not affect the implementation date. "It's crucial that the companies adhere to these 'interim final' rules by the December 12 deadline for compliance. There is no gray area here," noted Detlefsen. The facility registration rule requires domestic and foreign food facilities that manufacture, process, pack or hold food for consumption in the United States to register with FDA by December 12. FDA believes that the registration requirements will cover about 400,000 domestic and foreign facilities. Registration may be completed online or by a paper submission, with FDA strongly encouraging the Internet option; FDA plans to have its online registration system operational by Thursday at 6:00 p.m. eastern time to begin accepting registrations. The prior notice rule requires that, on or after Dec. 12, importers send an electronic notice to FDA before bringing food into the United States. FDA has decided to work with the established system of the U.S. Bureau of Customs and Border Protection, which already receives such notices from importers, so that companies won't have to submit details twice. Related Link: http://www.agriculturelaw.com |
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