It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. Following the recommendations in this guidance will not shield any person or any food from appropriate enforcement under the Federal Food, Drug, and Cosmetic Act if adulterated food is distributed in interstate commerce. In the fall of 1999, the exemption was renewed for another year. However, in order to ensure continued availability of this treatment, registrants should be actively pursuing a full registration under section 3 in 2000.
Antimicrobials are either pesticides chemicals or food additives, depending on where they are used.