From: Redenbaugh, Keith [Keith.Redenbaugh@seminis.com] Sent: Wednesday, December 24, 2003 1:42 PM To: fdadockets@oc.fda.gov Subject: Public Comments on Docket Nos. 02N-0276 and 2002N-0278 December 24, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Seminis' Comments on the Bioterrorism Act Regulations for Facilities Registration and Prior Notice of Food Shipments Docket No. 02N-0276: Registration with FDA of all domestic and foreign food facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States Docket No. 2002N-0278: Advance notice to FDA of any shipment of human or animal food imported or offered for import beginning Dec. 12, 2003. Dear Sir or Madam: Seminis, Inc., and its subsidiaries worldwide, including its primary first tier subsidiary Seminis Vegetable Seeds, Inc., would respectfully like to comment on the Bioterrorism Act Regulations, specifically on the Facilities Registration (Section 305) and Prior Notice (Section 307) provisions in the Interim Final Rule, and to request clarification on a number of points. The avowed purpose of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the "Act") is to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. Further, Congress has expressed a need for the United States and its government agencies to be able to respond in a timely manner to emerging or existing bioterrorist threats to the food and agricultural system of the United States. Seminis wholeheartedly supports these goals and understands the underlying needs and urgency. At the same time, Seminis, and it believes some of its other counterparts in the seed industry, is confused about the applicability of the registration and prior notice requirements specifically on the seed industry and requests further guidance and clarification. The FDA has stated in its guidance documents that it is necessary to collection information about food facilities to facilitate rapid communications between the FDA and those facilities, investigation of those facilities, and surveillance operations on those facilities, if there is an actual or potential bioterrorist attack or other food-related emergency." An additional need identified by the FDA in its guidance documents specifically related to imported products is for detailed prior notice of those imports for verification of identification of the food products and determination of where those products were produced. The primary business of seed companies is to produce seed for plant production. Any food or feed use of such seed, such as where there is remnant or culled seed, is ancillary to the business of such seed companies and is done primarily to efficiently and cost-effectively dispose of remnant and culled seed that is originally intended to be used for plant production but which for a variety of reasons is not so used. The principle business of seed companies such as Seminis is not to "manufacture/process, pack, or hold food," but instead to produce seed for farmers. It is unclear to Seminis whether vegetable seed, flower seed, turf seed and other seed companies are required to register as Food Facilities with the FDA, and then to provide advance notice to the FDA of shipments of seeds imported into the US. Seminis has sought the advice of specialized legal counsel, industry experts, and FDA employees, and has received conflicting opinions, necessitating official clarification from the FDA. Seed production involves the following: * Stock seed is provided in small quantities to a farmer, who may be an employee of the seed company or an independent contractor using his or her own farm or a farm leased from the owner * * The farmer then produces, harvests and partially cleans the seed by increasing the stock seed in the ordered quantities (i.e., by planting the stock seed and harvesting the increased seed) * * The seed is then transported to the seed company that ordered it, who may or may not be located in the same country as the farmer who increased the seed * * The seed company then cleans, mills and packages the seed, which is then stored until it is sold or licensed to third parties for the production of plants bearing fruits and/or vegetables * * Once the seed company receives an order for the seed, the seed is re-packaged (generally from warehoused bulk packaging into smaller packaging) and shipped to the farmer or seed dealer that placed the order * * At any stage in this process, from the time the seed is harvested to several years after it is shipped to the seed company (either from growers inside the United States or after being imported into the United States from growers outside the United States) and stored by the seed company, the seed may be determined to be unsuitable for use as planting seed. For example, the seed may have a low germination rate, small size, or be a variety that is no longer desired by farmers. In any given year, the amount of such seed (called "remnant" or "culled" seed) found unsuitable for use as planting seed could be hundreds or thousands of pounds (depending on the size of the seed company). * * Remnant or culled seed is suitable for use as animal feed (and to a far lesser degree, as food for human consumption) and is generally sold by the seed company as such. This is done to avoid enormous losses from the seed company's investment in the increase of the seed, to mitigate waste, and to efficiently address animal feed needs. Despite such usage of the remnant or culled seed for animal feed and occasionally for human food, seed companies such as Seminis do not produce seed with the intention of selling it for feed or food use; such use is a result of the fact that some remnant or culled seed cannot be avoided. * * For some vegetatively propagated crops, such as onions, bulbs are sold to farmers and are used for propagation and plant production. These bulbs may also be used as feed or, in limited cases, as food if they are determined to be remnant or culled. Seminis believes that the FDA should provide specific limitations on the definitions of "reasonably believes" and "reasonably expected" ("whether the owner, importer or agent in charge reasonably believes that the substance is reasonably expected to be directed to a food use") that take into consideration that the seed produced by seed companies is intended to be used for planting crops, even though it is understood that there inevitably will be some remnant seed and culls. Without such limitations, the rule is unreasonably broad, imposes a burden on seed companies primarily marketing seeds for planting purposes that is out of proportion to the protective goals of the Act, and is subject to widely varying interpretations. Seminis does not believe that such is the intent of the Act or its drafters, as imposing such a burden on companies that have only an incidental and unintended foray into the feed or food market and that this does not serve to allow either the FDA or the seed companies to prevent, prepare for, or respond to bioterrorism and other public health emergencies. Respectfully, it is Seminis' opinion that seed companies are not food facilities in the sense originally intended by the Act and should not be subject to the registration and importation requirements under the Act. Seminis also respectfully requests clarification on the points raised in this comment. Respectfully submitted, Dr. Keith Redenbaugh Associate Director Regulatory Affairs, Licensing and Technology Acquisition Seminis Vegetable Seeds 37437 State Highway 16 Woodland, California 95695 > Phone: 530 669 6170 > Fax: 530 666 4426 > E-mail: keith.redenbaugh@seminis.com