83_FR_55103 83 FR 54891 - Bonamar Corp.; Filing of Food Additive Petition

83 FR 54891 - Bonamar Corp.; Filing of Food Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 212 (November 1, 2018)

Page Range54891-54891
FR Document2018-23946

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.

Federal Register, Volume 83 Issue 212 (Thursday, November 1, 2018) 
[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)]
[Proposed Rules]
[Page 54891]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23946]


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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.

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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

Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Proposed Rules 54891 TABLE 1—INFORMATION ON PARTICIPATING IN THE PUBLIC MEETINGS AND ON SUBMITTING COMMENTS TO THE PRODUCE SAFETY RULE DRAFT GUIDANCE DOCKET—Continued Activity Date Electronic address Address Other information View webcast ......... December 13, Individuals who wish to participate by .............................................................. The webcast will have closed cap- 2018; 8:30 a.m.– webcast are asked to preregister at tioning. 5 p.m. https://www.fda.gov/Food/ NewsEvents/WorkshopsMeetings Conferences/default.htm. Advance registra- by November 23, https://www.fda.gov/Food/NewsEvents/ We encourage you to use electronic There is no registration fee for the tion. 2018. WorkshopsMeetingsConferences/de- registration if possible 1. public meetings. Early registration is fault.htm. recommended because seating is limited.1 Request to make by November 16, https://www.fda.gov/Food/NewsEvents/ Requests to make oral presentations an oral presen- 2018. WorkshopsMeetingsConferences/de- must be made in advance to https:// tation. fault.htm. www.fda.gov/Food/NewsEvents/ WorkshopsMeetingsConferences/de- fault.htm. Submitting either Submit comments https://www.regulations.gov ................. Dockets Management Staff (HFA– See ADDRESSES for information on electronic or writ- by April 22, 2019. 305), Food and Drug Administration, submitting comments. ten comments. 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Request special ac- by November 16, .............................................................. See FOR FURTHER INFORMATION commodations 2018. CONTACT. due to a disability. 1 You may also register via email, mail, or Fax. Please include your name, title, firm name, address, and phone and Fax numbers in your registration information and send to: Melissa Schroeder, SIDEM, 1775 Eye St. NW, Suite 1150, Washington, DC 20006, 240–393–4496, Fax: 202–495–2901, EventSupport@ Sidemgroup.com. Onsite registration will be available at all four meetings, however, please note that if we have reached capacity, we will not be able to accommodate those who have not pre-registered. IV. Transcripts ADDRESSES: For access to the docket to for repeated use. In addition, the Please be advised that as soon as a read background documents or petitioner has stated that, to the transcript is available, it will be comments received, go to https:// petitioner’s knowledge, no accessible at https:// www.regulations.gov and insert the extraordinary circumstances exist. If www.regulations.gov. You may also docket number found in brackets in the FDA determines a categorical exclusion view the transcript at the Dockets heading of this document into the applies, neither an environmental Management Staff (see ADDRESSES). ‘‘Search’’ box and follow the prompts, assessment nor an environmental and/or go to the Dockets Management impact statement is required. If FDA Dated: October 26, 2018. Staff, 5630 Fishers Lane, Rm. 1061, determines a categorical exclusion does Leslie Kux, Rockville, MD 20852. not apply, we will request an Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: environmental assessment and make it [FR Doc. 2018–23868 Filed 10–31–18; 8:45 am] Molly A. Harry, Center for Food Safety available for public inspection. BILLING CODE 4164–01–P and Applied Nutrition, Food and Drug Dated: October 29, 2018. Administration, 5001 Campus Dr., Leslie Kux, College Park, MD 20740, 240–402–1075. Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: Under the [FR Doc. 2018–23946 Filed 10–31–18; 8:45 am] HUMAN SERVICES Federal Food, Drug, and Cosmetic Act BILLING CODE 4164–01–P Food and Drug Administration (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice that we have filed 21 CFR Part 179 a food additive petition (FAP 8M4822), DEPARTMENT OF HEALTH AND submitted by Bonamar Corp., c/o Robert HUMAN SERVICES [Docket No. FDA–2018–F–3932] P. Smith, Department of Biological Sciences, Nova Southeastern University, Food and Drug Administration Bonamar Corp.; Filing of Food Additive 3301 College Ave., Fort Lauderdale, FL 33314. The petition proposes to amend 21 CFR Parts 807, 1002, 1010, and 1040 Petition the food additive regulations in § 179.26 [Docket Nos. FDA–2011–N–0070 and FDA– AGENCY: Food and Drug Administration, (21 CFR 179.26) Ionizing radiation for 2016–N–2491] HHS. the treatment of food to provide for the ACTION: Notification of petition. safe use of sources of ionizing radiation RIN 0910–AG79 and 0910–AF87 to control food-borne pathogens in: (1) SUMMARY: The Food and Drug Chilled or frozen raw finfish and Withdrawal of the Laser Products; Administration (FDA or we) is flatfish; and (2) frozen, raw vacuum- Proposed Amendment to Performance announcing that we have filed a packed finfish and flatfish. Standard and the Electronic Submission of Labeling for Certain amozie on DSK3GDR082PROD with PROPOSALS1 petition, submitted by Bonamar Corp., The petitioner has claimed that this proposing that we amend our food Home-Use Medical Devices action is categorically excluded from the additive regulations to provide for the need to prepare an environmental AGENCY: Food and Drug Administration, safe use of sources of ionizing radiation assessment or an environmental impact HHS. to control food-borne pathogens in statement under 21 CFR 25.32(j), ACTION: Proposed rule; withdrawal. finfish and flatfish. because the petition requests approval DATES: The food additive petition was for a source of irradiation which is a SUMMARY: The Food and Drug filed on September 27, 2018. piece of permanent equipment intended Administration (FDA, Agency, we) is VerDate Sep<11>2014 20:21 Oct 31, 2018 Jkt 247001 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 E:\FR\FM\01NOP1.SGM 01NOP1


Document Created: 2018-11-01 01:05:40
Document Modified: 2018-11-01 01:05:40
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotification of petition.
DatesThe food additive petition was filed on September 27, 2018.
ContactMolly A. Harry, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1075.
FR Citation83 FR 54891 
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