Agency Response Letter GRAS Notice No. GRN 000630
Return to inventory listing: GRAS Notice Inventory
See also Generally Recognized as Safe (GRAS).
CFSAN/Office of Food Additive Safety
June 13, 2016
Nieuwe Kanaal 7P
6709 PA Wageningen
Re: GRAS Notice No. GRN 000630
Dear Dr. Hagens:
The Food and Drug Administration (FDA) is responding to the notice, dated December 11, 2015, that you submitted in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on February 6, 2016, filed it on March 2, 2016, and designated it as GRAS Notice No. GRN 000630.
The subject of the notice is a preparation containing bacterial monophages FO1a and S16, specific to Salmonella serovars (Salmonella phage preparation). The notice informs FDA of the view of Micreos B.V. that Salmonella phage preparation is GRAS, through scientific procedures, for use as an antimicrobial to control Salmonella serovars on beef and certain vegetables at levels up to 108 plaque forming units per gram of food.
FDA recommended in an email sent to you on April 5, 2016, that Micreos B.V. submit a request that FDA cease evaluation of GRN 000630 in order for you to collect information regarding the subjects raised by FDA in the April 5th email. For transparency, FDA further recommended that Micreos B.V. resubmit its GRAS submission for these additional uses of Salmonella phage preparation as a supplement to GRN 000468. (GRN 000468 contains the data and information submitted by Micreos B.V. in support of its GRAS determination for the use of Salmonella phage preparation as an antimicrobial on certain pork and poultry products.)
In a letter dated May 10, 2016, you asked that FDA cease to evaluate your notice and instead review the additional use of Salmonella phage preparation as a supplement to GRN 000468. Your letter included supplementary information (1) supporting your GRAS determination for the additional uses of Salmonella phage preparation and (2) incorporating efficacy data from GRN 000630, by reference, to support the additional use as an antimicrobial on beef and certain vegetables. Given your request, we ceased to evaluate your GRAS notice, effective May 17, 2016, the date that we received the email containing your letter, and we are reviewing the information supporting the additional uses of Salmonella phage preparation as a supplement to GRN 000468.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000630, as well as copies of the information in GRNs 000468 and 000630 that conform to the information in the GRAS exemption claim (proposed 21 CFR 170.36 (c) (1)), are available for public review and copying via the FDA home page at http://www.fda.gov/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: William K. Shaw Jr., Ph.D.
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