FDA Seeks Comments on Standards for Anti-Salmonella Chemical Food Additives

The U.S. Food and Drug Administration (FDA) has issued a request for comments on proposed revisions to its “Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds.” With the aim of helping sponsors design efficacy studies to support the submission of food additive petitions (FAPs) related to preventing Salmonella in food for animals, FDA noted that a revision is necessary because science, technology and FDA policy have changed since the guidance was last revised.

Because current guidance addresses only chemical food additives intended to
maintain feeds or feed ingredients as Salmonella-negative, the agency intends
to expand the scope to address other categories of food additives beyond
chemical food additives and to cover all food for animals, including pet food.

Among other things, FDA seeks comment on the following questions: (i) what
intended technical effects will the agency see in FAPs for anti-Salmonella
use of the food additives in food for animals; (ii) how should efficacy studies
be designed for the intended technical effects; (iii) should experimental lots
of animal food used in laboratory and field studies be Salmonella-negative,
but not sterile, before inoculation; (iv) what inoculation levels of Salmonella
are appropriate for experimental lots of animal food used in laboratory and
field studies; (v) what methods should be used to inoculate experimental
lots of animal food used in laboratory and field studies; (vi) what sampling
criteria should be used; and (vii) what methods should be used to enumerate
the level(s) of Salmonella in animal food? Comments will be accepted until
January 13, 2014. See Federal Register, November 14, 2013.