Docket Management
Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC -13

Accepted - Volume 2

Comment Record
Commentor Mrs. Elizabeth Nelson Date/Time 2002-08-30 11:56:08
Organization Kemin Industries, Inc.
Category Company

Comments for FDA General
Questions
1. General Comments Kemin Industries, Inc. is a family-owned company established in 1961 with its worldwide headquarters in Des Moines, Iowa. Kemin has annual sales in excess of $150 million. We manufacture and market products that are regulated under the Federal Food, Drug and Cosmetic Act. Our product applications include, but are not limited to, uses in animal feeds, pet foods, human foods, dietary supplements and personal care items. We do business in over 60 countries around the world. Following are our comments on Section 305 associated with the aforementioned Act: Section 305 We note that a better definition of owner, operator or agent is needed, such that if products are produced or toll-manufactured for a firm by a third party, who has responsibility to register the facility with FDA? We are unclear if overseas entities that are our subsidiaries, affiliates or toll manufacturers that import into the US are required to register with the FDA or not. We are also unclear on the restrictions of product purchased from domestic, non-food establishments. The regulations need to clearly articulate what companies are required to do to satisfy this requirement of the statute. Finally, we are unclear on imports from international suppliers of food ingredients regarding registration, i.e., will a foreign supplier be required to have an FDA establishment number? We thank you in advance for the opportunity to comment on this pending legislation. If we can provide further information, please do not hesitate to contact me at 515/559-5347 or at the address listed above. Sincerely, KEMIN INDUSTRIES, INC. Elizabeth A. Nelson Corporate Counsel EAN:kk




EC -13