The Food & Drug Administration said in the Nov. 14 Federal Register that it is considering revising guidance for industry 80 (GFI 80) titled "Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds," and is seeking comments on this guidance before revisions are made.
FDA said one of the key objectives of GFI 80 is to help sponsors design efficacy studies to support the submission of food additive petitions for food additives intended for anti-salmonella use in food for animals. The agency wants to revise GFI 80 because science, technology, and FDA policy have changed since this guidance was last revised.
GFI 80 currently addresses only chemical food additives intended to maintain feeds or feed ingredients as salmonella-negative, FDA explained, and it intends to expand the scope of this guidance to address other categories of food additives beyond chemical food additives and to cover all food for animals, including pet food.
FDA would like consider the following questions:
1. What intended technical effects can we expect to see in FAPs submitted to FDA for anti-salmonella use of the food additives in food for animals?
2. How should efficacy studies be designed for the intended technical effects described in your response to question 1?
3. Should experimental lots of animal food used in both laboratory and field studies be salmonella-negative, but not sterile, prior to inoculation?
4. What inoculation levels of salmonella are appropriate for experimental lots of animal food used in laboratory and field studies? Please justify your comment with scientific evidence.
5. What methods should be used to inoculate experimental lots of animal food used in laboratory and field studies?
6. What sampling criteria should be used to provide statistical confidence that Salmonella will be captured among samples collected? Please justify your comment with scientific evidence.
7. What methods should be used to enumerate the level(s) of salmonella in animal food?
8. What are the key elements for designing field studies?
9. What are the difficulties faced by sponsors when designing and conducting field studies?
10. What types of facilities are available to conduct field studies?
Electronic versions of GFI 80 are in the docket at www.regulations.gov and on FDA's website at www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm.
Comments may be submitted by Jan. 13, 2014.