[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)]
[Proposed Rules]
[Page 54891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23946]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. FDA-2018-F-3932]


Bonamar Corp.; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Bonamar Corp., proposing 
that we amend our food additive regulations to provide for the safe use 
of sources of ionizing radiation to control food-borne pathogens in 
finfish and flatfish.

DATES: The food additive petition was filed on September 27, 2018.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this document into 
the ``Search'' box and follow the prompts, and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1075.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice 
that we have filed a food additive petition (FAP 8M4822), submitted by 
Bonamar Corp., c/o Robert P. Smith, Department of Biological Sciences, 
Nova Southeastern University, 3301 College Ave., Fort Lauderdale, FL 
33314. The petition proposes to amend the food additive regulations in 
Sec.  179.26 (21 CFR 179.26) Ionizing radiation for the treatment of 
food to provide for the safe use of sources of ionizing radiation to 
control food-borne pathogens in: (1) Chilled or frozen raw finfish and 
flatfish; and (2) frozen, raw vacuum-packed finfish and flatfish.
    The petitioner has claimed that this action is categorically 
excluded from the need to prepare an environmental assessment or an 
environmental impact statement under 21 CFR 25.32(j), because the 
petition requests approval for a source of irradiation which is a piece 
of permanent equipment intended for repeated use. In addition, the 
petitioner has stated that, to the petitioner's knowledge, no 
extraordinary circumstances exist. If FDA determines a categorical 
exclusion applies, neither an environmental assessment nor an 
environmental impact statement is required. If FDA determines a 
categorical exclusion does not apply, we will request an environmental 
assessment and make it available for public inspection.

    Dated: October 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23946 Filed 10-31-18; 8:45 am]
BILLING CODE 4164-01-P


