83 FR 54888 - Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry; Public Meetings; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 212 (November 1, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 212 (November 1, 2018)
| Page Range | 54888-54891 | |
| FR Document | 2018-23868 |
[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)] [Proposed Rules] [Pages 54888-54891] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23868] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 112 [Docket No. FDA-2018-D-3631] Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry; Public Meetings; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meetings; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing four public meetings to discuss ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry.'' The purpose of the public meetings is to discuss the draft guidance for compliance and implementation of the ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' rule, which was issued under the FDA Food Safety Modernization Act. DATES: Submit either electronic or written comments on the notice by April 22, 2019. See ``How to Participate in the Public Meetings'' in the SUPPLEMENTARY INFORMATION section of this document for dates and times of the public meetings, closing dates for advance registration, requesting special accommodations due to disability, and other information regarding meeting participation. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 22, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 22, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-D-3631 for ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket [[Page 54889]] and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper 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: For questions about registering for the meetings or to register by phone: Melissa Schroeder, SIDEM, 1775 Eye St. NW, Suite 1150, Washington, DC 20006, 240-393-2901, [email protected]. For general questions about the public meetings or for special accommodations due to a disability: Juanita Yates, Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1731, [email protected]. SUPPLEMENTARY INFORMATION: I. Background ``The Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' rule (the produce safety rule, published in the Federal Register of November 27, 2015 (80 FR 74354) (https://www.fda.gov/fsma)) establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The rule is part of the Agency's ongoing efforts to implement the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353). FSMA also requires FDA to issue guidance for the safe production and harvesting of fresh produce (section 419(e)(1) of the FD&C Act (21 U.S.C. 350h(e)(1))) and to also conduct at least three public meetings in diverse geographical areas of the United States as part of an effort to conduct education and outreach regarding the guidance for interested stakeholders (section 419(e)(2) of the FD&C Act). In the Federal Register of October 22, 2018 (83 FR 53196), we announced the availability of the ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry'' (https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM623178.pdf). The draft guidance provides information on and recommendations for compliance with the requirements of the produce safety rule, which produce and farms are covered by the rule, and whether certain produce or farms may be eligible for exemptions. FDA is announcing a series of public meetings entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry'' so that stakeholders can better evaluate and comment on the draft guidance. These meetings will be held during the formal comment period on the draft guidance.\1\ All four public meetings will cover the same agenda items and are intended to facilitate and support the public's evaluation and commenting process. --------------------------------------------------------------------------- \1\ Under FDA's Good Guidance Practices regulation, anyone may comment on an FDA guidance document at any time (see 21 CFR 10.115(g)(5)). --------------------------------------------------------------------------- While oral presentations \2\ from specific individuals and organizations will be necessarily limited due to time constraints during the public meetings, stakeholders may submit electronic or written comments discussing any issues of concern to the administrative record (the docket) for the draft guidance (Docket No. FDA-2018-D- 3631). --------------------------------------------------------------------------- \2\ Requests to make oral presentations must be made in advance. Please see table 1 for deadlines to request making an oral presentation for each meeting. --------------------------------------------------------------------------- II. Purpose and Format of the Public Meetings The purpose of the public meetings is to provide information and facilitate comment so that stakeholders can better evaluate and provide input on the draft guidance. We invite interested parties to provide information and offer comments related to the produce safety rule draft guidance. During the public meetings we will present information on the various chapters of the draft guidance: General provisions; personnel qualifications and training; health and hygiene; biological soil amendments of animal origin; domesticated and wild animals; growing, harvesting, packing, and holding activities on a farm; equipment, tools, buildings, and sanitation; records; and variances.\3\ Stakeholder panels will provide discussion on the various issues. There will be an opportunity for questions, as well as an opportunity for open public comment. --------------------------------------------------------------------------- \3\ We have proposed to extend the compliance dates related to the requirements of subpart E of the produce safety rule, which addresses agricultural water, and have provided enforcement discretion until the finalization of that rulemaking (82 FR 42963, 42965; September 13, 2017). Accordingly, the draft guidance does not contain any recommendations related to subpart E, and agricultural water is not on the agenda for these public meetings. Also not on the agenda for these public meetings is the draft guidance issued in January 2017 entitled ``Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations.'' --------------------------------------------------------------------------- III. How To Participate in the Public Meetings There will be a total of four public meetings held in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment on the draft guidance. Table 1 provides information on participation in the public meetings. [[Page 54890]] Table 1--Information on Participating in the Public Meetings and on Submitting Comments to the Produce Safety Rule Draft Guidance Docket ---------------------------------------------------------------------------------------------------------------- Activity Date Electronic address Address Other information ---------------------------------------------------------------------------------------------------------------- First public meeting............ November 27, 2018; .................. Hilton Portland 8:30 a.m.-5 p.m. Downtown, 921 SW Sixth Ave., Portland, OR 97204. View webcast.................... November 27, 2018; Individuals who .................. The webcast will 8:30 a.m.-5 p.m. wish to have closed participate by captioning. webcast are asked to preregister at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Advance registration............ by November 16, https:// We encourage you There is no 2018. www.fda.gov/Food/ to use electronic registration fee NewsEvents/ registration if for the public WorkshopsMeetings possible \1\. meetings. Early Conferences/ registration is default.htm. recommended because seating is limited.\1\ Request to make an oral by November 9, https:// Requests to make presentation. 2018. www.fda.gov/Food/ oral NewsEvents/ presentations WorkshopsMeetings must be made in Conferences/ advance to https:/ default.htm. /www.fda.gov/Food/ NewsEvents/ WorkshopsMeetings Conferences/ default.htm. Submitting either electronic or Submit comments by https:// Dockets Management See ADDRESSES for written comments. April 22, 2019. www.regulations.g Staff (HFA-305), information on ov. Food and Drug submitting Administration, comments. 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Request special accommodations by November 9, .................. See FOR FURTHER due to a disability. 2018. INFORMATION CONTACT. Second Public Meeting........... November 29, 2018; .................. DoubleTree Suites 8:30 a.m.-5 p.m.. by Hilton Anaheim Resort-Convention Center, 2085 S Harbor Blvd., Anaheim, CA 92802. View webcast.................... November 29, 2018; Individuals who .................. The webcast will 8:30 a.m.-5 p.m. wish to have closed participate by captioning. webcast are asked to preregister at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Advance registration............ by November 16, https:// We encourage you There is no 2018. www.fda.gov/Food/ to use electronic registration fee NewsEvents/ registration if for the public WorkshopsMeetings possible \1\. meetings. Early Conferences/ registration is default.htm. recommended because seating is limited.\1\ Request to make an oral by November 9, https:// Requests to make presentation. 2018. www.fda.gov/Food/ oral NewsEvents/ presentations WorkshopsMeetings must be made in Conferences/ advance to https:/ default.htm. /www.fda.gov/Food/ NewsEvents/ WorkshopsMeetings Conferences/ default.htm. Submitting either electronic or Submit comments by https:// Dockets Management See ADDRESSES for written comments. April 22, 2019. www.regulations.g Staff (HFA-305), information on ov. Food and Drug submitting Administration, comments. 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Request special accommodations by November 9, .................. See FOR FURTHER due to a disability. 2018. INFORMATION CONTACT. Third Public Meeting............ December 11, 2018; .................. Hilton Albany, 40 8:30 a.m.-5 p.m. Lodge St., Albany, NY 12207. View webcast.................... December 11, 2018; Individuals who .................. The webcast will 8:30 a.m.-5 p.m. wish to have closed participate by captioning. webcast are asked to preregister at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Advance registration............ by November 23, https:// We encourage you There is no 2018. www.fda.gov/Food/ to use electronic registration fee NewsEvents/ registration if for the public WorkshopsMeetings possible \1\. meetings. Early Conferences/ registration is default.htm. recommended because seating is limited.\1\ Request to make an oral by November 16, https:// Requests to make presentation. 2018. www.fda.gov/Food/ oral NewsEvents/ presentations WorkshopsMeetings must be made in Conferences/ advance to https:/ default.htm. /www.fda.gov/Food/ NewsEvents/ WorkshopsMeetings Conferences/ default.htm. Submitting either electronic or Submit comments by https:// Dockets Management See ADDRESSES for written comments. April 22, 2019. www.regulations.g Staff (HFA-305), information on ov. Food and Drug submitting Administration, comments. 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Request special accommodations by November 16, .................. See FOR FURTHER due to a disability. 2018. INFORMATION CONTACT. Fourth Public Meeting........... December 13, 2018; .................. Embassy Suites 8:30 a.m.-5 p.m. Atlanta at Centennial Olympic Park, 267 Marietta St., Atlanta, GA 30313. [[Page 54891]] View webcast.................... December 13, 2018; Individuals who .................. The webcast will 8:30 a.m.-5 p.m. wish to have closed participate by captioning. webcast are asked to preregister at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Advance registration............ by November 23, https:// We encourage you There is no 2018. www.fda.gov/Food/ to use electronic registration fee NewsEvents/ registration if for the public WorkshopsMeetings possible \1\. meetings. Early Conferences/ registration is default.htm. recommended because seating is limited.\1\ Request to make an oral by November 16, https:// Requests to make presentation. 2018. www.fda.gov/Food/ oral NewsEvents/ presentations WorkshopsMeetings must be made in Conferences/ advance to https:/ default.htm. /www.fda.gov/Food/ NewsEvents/ WorkshopsMeetings Conferences/ default.htm. Submitting either electronic or Submit comments by https:// Dockets Management See ADDRESSES for written comments. April 22, 2019. www.regulations.g Staff (HFA-305), information on ov. Food and Drug submitting Administration, comments. 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Request special accommodations by November 16, .................. See FOR FURTHER due to a disability. 2018. INFORMATION CONTACT. ---------------------------------------------------------------------------------------------------------------- \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, [email protected]. 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 Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. You may also view the transcript at the Dockets Management Staff (see ADDRESSES). Dated: October 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-23868 Filed 10-31-18; 8:45 am] BILLING CODE 4164-01-P
![54888 Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Proposed Rules
Congress intended to preclude: the Association, 1899 L Street, NW, Ste 350, considered. Electronic comments must
adoption of standards that would Washington, D.C. 20036, (202) 466–7200 be submitted on or before April 22,
achieve higher efficiency by eliminating Email: mcaldarera@npga.org. 2019. The https://www.regulations.gov
currently available ‘‘performance Bert Kalisch, electronic filing system will accept
characteristics’’ (including ‘‘features’’) President & CEO, American Public Gas comments until 11:59 p.m. Eastern Time
that are important to many purchasers. Association, 201 Massachusetts Avenue, at the end of April 22, 2019. Comments
Conclusion NE, Suite C–4, Washington, DC 20002, received by mail/hand delivery/courier
202.464.2742 (for written/paper submissions) will be
DOE’s rulemaking proceedings Email: bkalisch@apga.org. considered timely if they are
concerning standards for residential postmarked or the delivery service
furnaces and commercial water heaters Mike Murray,
General Counsel, American Gas acceptance receipt is on or before that
have been fatally undermined by their date.
failure to recognize that EPCA precludes Association, 400 North Capitol Street
the adoption of standards that would NW, Suite 450, Washington, DC 20001, Electronic Submissions
effectively eliminate fuel gas products 202.824.7000 Submit electronic comments in the
that do not use condensing combustion Email: mmurray@aga.org. following way:
technology. Petitioners believe that [FR Doc. 2018–23885 Filed 10X–31–18; 8:45 am] • Federal eRulemaking Portal:
prompt action to correct that failure is BILLING CODE 6450–01–P https://www.regulations.gov. Follow the
both warranted and necessary to instructions for submitting comments.
facilitate any reasonably efficient path Comments submitted electronically,
forward in those rulemaking DEPARTMENT OF HEALTH AND including attachments, to https://
proceedings. Accordingly, Petitioners HUMAN SERVICES www.regulations.gov will be posted to
respectfully request that DOE—after the docket unchanged. Because your
soliciting and appropriately considering Food and Drug Administration comment will be made public, you are
public comment on this Petition— solely responsible for ensuring that your
promptly take final action by: 21 CFR Part 112 comment does not include any
• Issuing an interpretive rule confidential information that you or a
[Docket No. FDA–2018–D–3631]
confirming that energy conservation third party may not wish to be posted,
standards limiting the market for Standards for the Growing, Harvesting, such as medical information, your or
natural gas and/or propane gas Packing, and Holding of Produce for anyone else’s Social Security number, or
furnaces or water heaters to products Human Consumption; Draft Guidance confidential business information, such
using condensing combustion for Industry; Public Meetings; Request as a manufacturing process. Please note
technology would result in the for Comments that if you include your name, contact
unavailability of ‘‘performance information, or other information that
characteristics’’ within the meaning of AGENCY: Food and Drug Administration, identifies you in the body of your
42 U.S.C. §§ 6295(0)(4) and HHS. comments, that information will be
6313(a)(6)(B)(iii)(II), and ACTION: Notification of public meetings; posted on https://www.regulations.gov.
• Withdrawing its proposed standards request for comments. • If you want to submit a comment
for residential furnaces and with confidential information that you
commercial water heaters on the SUMMARY: The Food and Drug do not wish to be made available to the
grounds of appropriate written Administration (FDA, the Agency, or public, submit the comment as a
findings as specified by 42 U.S.C. we) is announcing four public meetings written/paper submission and in the
§§ 6295(0)(4) and 6313(a)(6)(B)(iii)(II), to discuss ‘‘Standards for the Growing, manner detailed (see ‘‘Written/Paper
respectively. Harvesting, Packing, and Holding of Submissions’’ and ‘‘Instructions’’).
Further deliberation in the two Produce for Human Consumption; Draft
Written/Paper Submissions
pending rulemaking proceedings can Guidance for Industry.’’ The purpose of
then occur, with appropriate the public meetings is to discuss the Submit written/paper submissions as
consideration—as EPCA requires—of draft guidance for compliance and follows:
any need for separate standards (and implementation of the ‘‘Standards for • Mail/Hand delivery/Courier (for
separate product classes) for products the Growing, Harvesting, Packing, and written/paper submissions): Dockets
that use condensing combustion Holding of Produce for Human Management Staff (HFA–305), Food and
technology and those that do not.26 Consumption’’ rule, which was issued Drug Administration, 5630 Fishers
Respectfully submitted, under the FDA Food Safety Lane, Rm. 1061, Rockville, MD 20852.
Mark Darrell, Modernization Act. • For written/paper comments
Senior VP, General Counsel & Chief submitted to the Dockets Management
DATES: Submit either electronic or
Compliance Officer, Staff, FDA will post your comment, as
written comments on the notice by
Spire Inc., 700 Market Street, St. Louis, well as any attachments, except for
April 22, 2019. See ‘‘How to Participate
MO 63101 information submitted, marked and
in the Public Meetings’’ in the
Email: mark.darrell@spireenergy.com. identified, as confidential, if submitted
SUPPLEMENTARY INFORMATION section of
Dena E. Wiggins, as detailed in ‘‘Instructions.’’
this document for dates and times of the Instructions: All submissions received
President and CEO, Natural Gas Supply
amozie on DSK3GDR082PROD with PROPOSALS1
public meetings, closing dates for must include the Docket No. FDA–
Association, 1620 Eye St NW, Suite 700,
advance registration, requesting special 2018–D–3631 for ‘‘Standards for the
Washington, D.C. 20006, 202.326.9300
E-mail: dena.wiggins@ngsa.org. accommodations due to disability, and Growing, Harvesting, Packing, and
other information regarding meeting Holding of Produce for Human
Mike Caldarera,
participation. Consumption; Draft Guidance for
Vice President, Regulatory & Technical
Services, National Propane Gas ADDRESSES: You may submit comments Industry.’’ Received comments, those
as follows. Please note that late, filed in a timely manner (see
26 See 42 U.S.C. § 6295(q)(1). untimely filed comments will not be ADDRESSES), will be placed in the docket
VerDate Sep<11>2014 20:21 Oct 31, 2018 Jkt 247001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\01NOP1.SGM 01NOP1](https://thefederalregister.org/doc/83_FR_55100/page/1.svg)
![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](https://thefederalregister.org/doc/83_FR_55100/page/4.svg)
Document Created: 2018-11-01 01:05:28
Document Modified: 2018-11-01 01:05:28
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification of public meetings; request for comments. | |
| Dates | Submit either electronic or written comments on the notice by April 22, 2019. See ``How to Participate in the Public Meetings'' in the SUPPLEMENTARY INFORMATION section of this document for dates and times of the public meetings, closing dates for advance registration, requesting special accommodations due to disability, and other information regarding meeting participation. | |
| Contact | For questions about registering for the meetings or to register by phone: Melissa Schroeder, SIDEM, 1775 Eye St. NW, Suite 1150, Washington, DC 20006, 240-393-2901, [email protected] | |
| FR Citation | 83 FR 54888 |
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