Sanitary Transportation of Human and Animal Food; Public Meetings on Proposed Rule, 8907-8910 [2014-03277]

Download as PDF Federal Register / Vol. 79, No. 31 / Friday, February 14, 2014 / Proposed Rules responsibilities among the various levels of government. For the reasons discussed above, I certify this proposed regulation: (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866, (2) Is not a ‘‘significant rule’’ under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979), (3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and (4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES Authority: 49 U.S.C. 106(g), 40113, 44701. [Amended] 2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): ■ Rolls-Royce Deutschland Ltd & Co KG: Docket No. FAA–2013–0882; Directorate Identifier 2013–NE–29–AD. (a) Comments Due Date We must receive comments by April 15, 2014. (b) Affected ADs None. tkelley on DSK3SPTVN1PROD with PROPOSALS (c) Applicability This AD applies to all Rolls-Royce Deutschland Ltd & Co KG (RRD) BR700– 725A1–12 turbofan engines. (d) Reason This AD was prompted by reports of wear on the receptors of the double-ended unions in the fuel metering unit (FMU) housing on BR700–725A1–12 engines causing fuel leakage. We are issuing this AD to prevent failure of the FMU, which could lead to damage to one or more engines, and damage to the airplane. VerDate Mar<15>2010 17:41 Feb 13, 2014 Jkt 232001 Comply with this AD within the compliance times specified, unless already done. (1) After the effective date of this AD, before the FMU has accumulated 650 flight hours (FHs) since new, or within 30 days, whichever occurs later, remove FMU part number (P/N) G3000FMU02 or P/N G3000FMU03, and replace it with a part eligible for installation. (2) Thereafter, remove the FMU at intervals not to exceed 650 FHs and replace it with a part eligible for installation. (f) Installation Prohibition (g) Definition For the purpose of this AD, an FMU eligible for installation is a new FMU or an FMU with P/N G3000FMU03 that has accumulated fewer than 650 FHs since installation on any airplane or since last repair using RRD Alert Non-Modification Service Bulletin (NMSB) No. ALERT SB– BR700–73–A900309, Revision 1, dated November 8, 2013. (h) Alternative Methods of Compliance (AMOCs) The Manager, Engine Certification Office, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request. (1) For more information about this AD, contact Glorianne Niebuhr, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781–238–7132; fax: 781–238– 7199; email: glorianne.niebuhr@faa.gov. (2) Refer to MCAI European Aviation Safety Agency AD 2013–0229R1, dated November 21, 2013. You may examine the MCAI in the AD docket on the Internet at https://www.regulations.gov by searching for and locating it in Docket No. FAA–2013– 0882. (3) RRD Alert NMSB No. ALERT SB– BR700–73–A900309, Revision 1, dated November 8, 2013, which is not incorporated by reference in this AD, can be obtained from RRD, using the contact information in paragraph (i)(4) of this AD. (4) For service information identified in this AD, contact Rolls-Royce Deutschland Ltd & Co KG, Eschenweg 11, Dahlewitz, 15827 Blankenfelde-Mahlow, Germany; phone: 49 0 33–7086–1944; fax: 49 0 33–7086–3276. (5) You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781–238–7125. PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 Issued in Burlington, Massachusetts, on February 6, 2014. Colleen M. D’Alessandro, Assistant Directorate Manager, Engine & Propeller Directorate, Aircraft Certification Service. [FR Doc. 2014–03252 Filed 2–13–14; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 After the effective date of this AD, do not install FMU P/N G3000FMU02 onto any engine, or install any engine with FMU P/N G3000FMU02 onto any airplane. (i) Related Information 1. The authority citation for part 39 continues to read as follows: ■ § 39.13 (e) Actions and Compliance 8907 [Docket No. FDA–2013–N–0013] Sanitary Transportation of Human and Animal Food; Public Meetings on Proposed Rule AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meetings. The Food and Drug Administration (FDA or we) is announcing three public meetings to discuss the proposed rule that would establish requirements for shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to help ensure the safety of the food they transport. The proposed rule is part of our larger effort to focus on prevention of food safety problems throughout the food chain and is part of our implementation of the Sanitary Food Transportation Act of 2005 (2005 SFTA) and the FDA Food Safety Modernization Act (FSMA). The purpose of the public meetings is to inform the public of the provisions of the proposed rule and the rulemaking process (including how to submit comments, data, and other information to the rulemaking docket) as well as solicit oral stakeholder and public comments on the proposed rule and to respond to questions about the rule. DATES: See section II, ‘‘How to Participate in the Public Meetings,’’ in the SUPPLEMENTARY INFORMATION section for dates and times of the public meetings, closing dates for advance registration, and information on deadlines for submitting either electronic or written comments to FDA’s Division of Dockets Management. ADDRESSES: See section II, ‘‘How to Participate in the Public Meetings,’’ in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: For questions about registering for the meeting, to register by phone, or to SUMMARY: E:\FR\FM\14FEP1.SGM 14FEP1 8908 Federal Register / Vol. 79, No. 31 / Friday, February 14, 2014 / Proposed Rules submit a notice of participation by mail, fax, or email, contact: Nick Cane, Nakamoto Group, Inc., 11820 Parklawn Dr., Suite 240, Rockville, MD 20852, 240–357–1176, FAX: 301–468–6536, email: nick.cane@nakamotogroup.com. For general questions about the meeting; to request an opportunity to make an oral presentation at the public meeting; to submit the full text, comprehensive outline, or summary of an oral presentation; or for special accommodations due to a disability, contact: Juanita Yates, Center for Food Safety and Applied Nutrition (HFS– 009), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1731, email: juanita.yates@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FSMA (Pub. L. 111–353), was signed into law by President Obama on January 4, 2011, to better protect public health by helping to ensure the safety and security of the food supply. FSMA amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation of a modernized, prevention-based food safety system. FSMA was the first major legislative reform of FDA’s food safety authorities in more than 70 years, even though FDA has increased the focus of its food safety efforts on prevention over the past several years. Among other things, FSMA requires FDA to implement the 2005 SFTA. The 2005 SFTA requires FDA to issue regulations requiring shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices to help ensure that food is not transported under conditions that may render the food adulterated. Isolated incidents of insanitary transportation practices for human and animal food and outbreaks and illnesses caused by contamination of these foods during transport there have resulted in concerns over the past decades about the potential that food can become contaminated during transportation. The goal of the proposed rule is to help ensure that transportation practices do not create food safety risks. FDA is announcing two public meetings entitled ‘‘The Food Safety Modernization Act Public Meeting on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration and Sanitary Transportation of Human and Animal Food’’ and a third public meeting entitled ‘‘The Food Safety Modernization Act Public Meeting on Sanitary Transportation of Human and Animal Food’’ so that the food industry, consumers, foreign governments, and other stakeholders can evaluate and comment on the proposals. As stated, the first two meetings will cover both the focused mitigation strategies to protect food against international adulteration and sanitary transportation of human and animal food proposed rules and will be held in Chicago, IL, and Anaheim, CA; the third meeting in College Park, MD, will cover only the sanitary transport proposed rule during the proposed rule comment period. All three public meetings are intended to facilitate and support the proposed rules’ evaluation and commenting process. II. How To Participate in the Public Meetings FDA is holding the public meetings on the sanitary transport proposed rule to inform the public about the rulemaking process, including how to submit comments, data, and other information to the rulemaking docket; to respond to questions about the proposed rules; and to provide an opportunity for interested persons to make oral presentations. Due to limited space and time, FDA encourages all persons who wish to attend the meetings to register in advance. There is no fee to register for the public meetings, and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited. Onsite registration will be accepted, as space permits, after all preregistered attendees are seated. Those requesting an opportunity to make an oral presentation during the time allotted for public comment at the meetings are asked to submit a request and to provide the specific topic or issue to be addressed. Due to the anticipated high level of interest in presenting public comment and the limited time available, FDA is allocating 3 minutes to each speaker to make an oral presentation. Speakers will be limited to making oral remarks; there will not be an opportunity to display materials such as slide shows, videos, or other media during the meeting. If time permits, individuals or organizations that did not register in advance may be granted the opportunity to make an oral presentation. FDA would like to maximize the number of individuals who make a presentation at the meeting and will do our best to accommodate all persons who wish to make a presentation or express their opinions at the meeting. FDA encourages persons and groups who have similar interests to consolidate their information for presentation by a single representative. After reviewing the presentation requests, FDA will notify each participant before the meeting of the approximate time their presentation is scheduled to begin, and remind them of the presentation format (i.e., 3-minute oral presentation without visual media). While oral presentations 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 rulemaking. All relevant data and documentation should be submitted with the comments to Docket No. FDA–2013–N–0013. Table 1 of this document provides information on participation in the public meetings: TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETINGS AND ON SUBMITTING COMMENTS TO THE RULEMAKING DOCKETS tkelley on DSK3SPTVN1PROD with PROPOSALS Date Chicago, IL, Public Meeting, Transport Session. Chicago, IL, Advance Registration. VerDate Mar<15>2010 Electronic address February 27, 2014 ..... Until February 18, 2014. 17:41 Feb 13, 2014 Jkt 232001 https://www.fda.gov/Food/ GuidanceRegulation/ FSMA/ucm247568.htm https://www.fda.gov/Food/ GuidanceRegulation/ FSMA/ucm247568.htm PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 Address Other information Hilton Chicago, 720 South Michigan Ave., Chicago, IL 60605. We encourage you to use electronic registration if possible.1 Onsite registration from 8 a.m. to 8:30 a.m. E:\FR\FM\14FEP1.SGM There is no registration fee for the public meetings. Early registration is recommended because seating is limited. 14FEP1 Federal Register / Vol. 79, No. 31 / Friday, February 14, 2014 / Proposed Rules 8909 TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETINGS AND ON SUBMITTING COMMENTS TO THE RULEMAKING DOCKETS—Continued Date Electronic address February 10, 2014 ..... https://www.fda.gov/Food/ GuidanceRegulation/ FSMA/ucm247568.htm 2 Chicago, IL, Request Special Accommodations Due to a Disability. Chicago, IL, Closing Date for Electronic or Written Comments. Anaheim, CA, Public Meeting, Transport Session. February 10, 2014 ..... Juanita Yates, email: Juanita.yates@fda.hhs.gov May 31, 2014 ............ March 13, 2014 ......... https://www.fda.gov/Food/ GuidanceRegulation/ FSMA/ucm247568.htm Until March 4, 2014 ... https://www.fda.gov/Food/ GuidanceRegulation/ FSMA/ucm247568.htm Anaheim, CA, Request to make a Public Comment. February 18, 2014 ..... https://www.fda.gov/Food/ GuidanceRegulation/ FSMA/ucm247568.htm 2 Anaheim, CA, Request Special Accommodations Due to a Disability. Anaheim, CA, Closing Date for Electronic or Written Comments. College Park, MD, Public Meeting. February 18, 2014 ..... Juanita Yates, email: Juanita.yates@fda.hhs.gov May 31, 2014 ............ Docket No. FDA–2013–N– 0013. March 20, 2014 ......... https://www.fda.gov/Food/ GuidanceRegulation/ FSMA/ucm247568.htm College Park, MD, Advance Registration. Until March 13, 2014 https://www.fda.gov/Food/ GuidanceRegulation/ FSMA/ucm247568.htm College Park, MD, Request to Make a Public Comment. February 28, 2014 ..... https://www.fda.gov/Food/ GuidanceRegulation/ FSMA/ucm247568.htm Closing Date of Docket May 31, 2014 ............ College Park, MD, Request Special Accommodations Due to a Disability. Closing Date for Electronic or Written Comments to be Included in Docket. February 28, 2014 ..... Docket No. FDA–2013–N– 0013. Juanita Yates, email: Juanita.yates@fda.hhs.gov May 31, 2014 ............ Other information Docket No. FDA–2013–N– 0013. Anaheim, CA, Advance Registration. tkelley on DSK3SPTVN1PROD with PROPOSALS Chicago, IL, Request to Make a Public Comment. Address Requests made on the day of the meeting to make an oral presentation will be granted as time permits. Information on requests to make an oral presentation may be posted without change to https://www.regulations.gov, including any personal information provided. Docket No. FDA–2013–N– 0013. See FOR FURTHER INFORMATION CONTACT Sheraton Park Hotel, 1855 South Harbor Blvd., Anaheim, CA 92802. We encourage you to use electronic registration if possible.1 Onsite registration from 8 a.m. to 8:30 a.m. There is no registration fee for the public meetings. Early registration is recommended because seating is limited. Requests made on the day of the meeting to make an oral presentation will be granted as time permits. Information on requests to make an oral presentation may be posted without change to https://www.regulations.gov, including any personal information provided. See FOR FURTHER INFORMATION CONTACT Wiley Building, 5100 Paint Branch Pkwy., College Park, MD 20740. We encourage you to use electronic registration if possible.1 Onsite registration from 8 a.m. to 8:30 a.m. There is no registration fee for the public meetings. Early registration is recommended because seating is limited. Requests made on the day of the meeting to make an oral presentation will be granted as time permits. Information on requests to make an oral presentation may be posted without change to https://www.regulations.gov, including any personal information provided. See FOR FURTHER 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: Nick Cane, Nakamoto Group, Inc., 11820 Parklawn Dr., Suite 240, Rockville, MD 20852, 240–357–1176, FAX: 301–468–6536, email: nick.cane@nakamotogroup.com. Onsite registration will also be available. VerDate Mar<15>2010 17:41 Feb 13, 2014 Jkt 232001 PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 E:\FR\FM\14FEP1.SGM 14FEP1 8910 Federal Register / Vol. 79, No. 31 / Friday, February 14, 2014 / Proposed Rules 2 You may also request to make an oral presentation at the public meetings via email. Please include your name, title, firm name, address, and phone and fax numbers as well as the full text, comprehensive outline, or summary of your oral presentation and send to: Juanita Yates, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1731, email: juanita.yates@fda.hhs.gov. III. Comments, Transcripts, and Recorded Video Information and data submitted voluntarily to FDA during the public meetings will become part of the administrative record for the rulemaking and will be accessible to the public at https://www.regulations.gov. The transcript of the proceedings from the public meetings will become part of the administrative record for the rulemaking. Please be advised that as soon as a transcript is available, it will be accessible at https:// www.regulations.gov and at FDA’s FSMA Web site at: https://www.fda.gov/ Food/GuidanceRegulation/FSMA/ default.htm. It may also be viewed at the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD– ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM–1029), 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Additionally, FDA will be video recording and live Web casting all of the public meetings. Once the recorded video is available, it will be accessible at FDA’s FSMA Web site at https://www.fda.gov/Food/ GuidanceRegulation/FSMA/ default.htm. Dated: February 11, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–03277 Filed 2–13–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF JUSTICE Bureau of Prisons 28 CFR Part 552 [BOP–1162–P] tkelley on DSK3SPTVN1PROD with PROPOSALS RIN 1120–AB62 Searches of Housing Units, Inmates, and Inmate Work Areas: Use of X-ray Devices—Clarification of Terminology Bureau of Prisons, Justice. Proposed rule. AGENCY: ACTION: In this document, the Bureau of Prisons (Bureau) proposes to clarify that body imaging search devices are ‘‘electronic search devices’’ for routine SUMMARY: VerDate Mar<15>2010 17:41 Feb 13, 2014 Jkt 232001 or random use in searching inmates, and are distinguished from medical x-ray devices, which require the inmate’s consent, or Regional Director approval, for use as search devices. DATES: Comments are due by April 15, 2014. FOR FURTHER INFORMATION CONTACT: Sarah Qureshi, Office of General Counsel, Bureau of Prisons, phone (202) 307–2105. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received are considered part of the public record and are available for public inspection online at www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online, you must include the phrase ‘‘PERSONAL IDENTIFYING INFORMATION’’ in the first paragraph of your comment. You must also locate all the personal identifying information you do not want posted online in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment but do not want it to be posted online, you must include the phrase ‘‘CONFIDENTIAL BUSINESS INFORMATION’’ in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment contains so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted on www.regulations.gov. Personal identifying information identified and located as set forth above will be placed in the agency’s public docket file, but not posted online. Confidential business information identified and located as set forth above will not be placed in the public docket file. If you wish to inspect the agency’s public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph. PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 Proposed Rule The Bureau proposes to amend its regulation on searches of inmates using x-ray devices and technology (28 CFR part 552, subpart B). We propose to change this regulation to clarify that body imaging search devices are ‘‘electronic search devices’’ for routine or random use in searching inmates, and are distinguished from medical x-ray devices, the use of which require the inmate’s consent, or Regional Director approval, for use as search devices. Section 552.11 Searches of inmates. The Bureau’s regulation on searching inmates using electronic devices currently lists only metal detectors and ion spectrometry devices as examples of such devices. We now propose to clarify that the provision for ‘‘electronic search devices’’ includes the use of body imaging search devices which use x-ray technology, but which are functionally different from medical x-ray devices as described in § 552.13. Section 552.13 Medical x-ray device, major instrument, or surgical intrusion. To conform with the change made in § 552.11, we likewise propose to alter § 552.13 to further clarify that body imaging search devices are functionally different from the medical x-ray devices as described in this regulation. To do this, we remove the generic term ‘‘xray’’ and replace it with ‘‘medical x-ray device’’ in § 552.13. We also revise § 552.13(a) to delete the term ‘‘fluoroscope.’’ It is inaccurate to state that the Bureau uses fluoroscopes in the same way as major instruments (including anoscope or vaginal speculum) or surgical intrusion (i.e., only for medical reasons and with the inmate’s consent). In fact, as we continue to state in subparagraph (b), medical x-rays devices such as fluoroscopes are also used to detect contraband under specifically delineated circumstances: Only when ‘‘determined necessary for the security, good order, or discipline of the institution,’’ and only ‘‘upon approval of the Regional Director.’’ Except for the change in terminology from ‘‘x-ray’’ to ‘‘medical x-ray device’’, the remainder of § 552.13 is unchanged. Executive Order 12866 This regulation has been drafted and reviewed in accordance with Executive Order 12866, ‘‘Regulatory Planning and Review’’ section 1(b), Principles of Regulation. The Department of Justice E:\FR\FM\14FEP1.SGM 14FEP1

Agencies

[Federal Register Volume 79, Number 31 (Friday, February 14, 2014)]
[Proposed Rules]
[Pages 8907-8910]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03277]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2013-N-0013]

Sanitary Transportation of Human and Animal Food; Public Meetings
on Proposed Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meetings.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
three public meetings to discuss the proposed rule that would establish
requirements for shippers, carriers by motor vehicle and rail vehicle,
and receivers engaged in the transportation of food, including food for
animals, to use sanitary transportation practices to help ensure the
safety of the food they transport. The proposed rule is part of our
larger effort to focus on prevention of food safety problems throughout
the food chain and is part of our implementation of the Sanitary Food
Transportation Act of 2005 (2005 SFTA) and the FDA Food Safety
Modernization Act (FSMA). The purpose of the public meetings is to
inform the public of the provisions of the proposed rule and the
rulemaking process (including how to submit comments, data, and other
information to the rulemaking docket) as well as solicit oral
stakeholder and public comments on the proposed rule and to respond to
questions about the rule.

DATES: See section II, ``How to Participate in the Public Meetings,''
in the SUPPLEMENTARY INFORMATION section for dates and times of the
public meetings, closing dates for advance registration, and
information on deadlines for submitting either electronic or written
comments to FDA's Division of Dockets Management.

ADDRESSES: See section II, ``How to Participate in the Public
Meetings,'' in the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: For questions about registering for
the meeting, to register by phone, or to

[[Page 8908]]

submit a notice of participation by mail, fax, or email, contact: Nick
Cane, Nakamoto Group, Inc., 11820 Parklawn Dr., Suite 240, Rockville,
MD 20852, 240-357-1176, FAX: 301-468-6536, email:
nick.cane@nakamotogroup.com. For general questions about the meeting;
to request an opportunity to make an oral presentation at the public
meeting; to submit the full text, comprehensive outline, or summary of
an oral presentation; or for special accommodations due to a
disability, contact: Juanita Yates, Center for Food Safety and Applied
Nutrition (HFS-009), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240-402-1731, email:
juanita.yates@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FSMA (Pub. L. 111-353), was signed into law by President Obama on
January 4, 2011, to better protect public health by helping to ensure
the safety and security of the food supply. FSMA amends the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation
of a modernized, prevention-based food safety system. FSMA was the
first major legislative reform of FDA's food safety authorities in more
than 70 years, even though FDA has increased the focus of its food
safety efforts on prevention over the past several years. Among other
things, FSMA requires FDA to implement the 2005 SFTA. The 2005 SFTA
requires FDA to issue regulations requiring shippers, carriers by motor
vehicle or rail vehicle, receivers, and other persons engaged in the
transportation of food to use sanitary transportation practices to help
ensure that food is not transported under conditions that may render
the food adulterated. Isolated incidents of insanitary transportation
practices for human and animal food and outbreaks and illnesses caused
by contamination of these foods during transport there have resulted in
concerns over the past decades about the potential that food can become
contaminated during transportation. The goal of the proposed rule is to
help ensure that transportation practices do not create food safety
risks.
FDA is announcing two public meetings entitled ``The Food Safety
Modernization Act Public Meeting on Focused Mitigation Strategies to
Protect Food Against Intentional Adulteration and Sanitary
Transportation of Human and Animal Food'' and a third public meeting
entitled ``The Food Safety Modernization Act Public Meeting on Sanitary
Transportation of Human and Animal Food'' so that the food industry,
consumers, foreign governments, and other stakeholders can evaluate and
comment on the proposals. As stated, the first two meetings will cover
both the focused mitigation strategies to protect food against
international adulteration and sanitary transportation of human and
animal food proposed rules and will be held in Chicago, IL, and
Anaheim, CA; the third meeting in College Park, MD, will cover only the
sanitary transport proposed rule during the proposed rule comment
period. All three public meetings are intended to facilitate and
support the proposed rules' evaluation and commenting process.

II. How To Participate in the Public Meetings

FDA is holding the public meetings on the sanitary transport
proposed rule to inform the public about the rulemaking process,
including how to submit comments, data, and other information to the
rulemaking docket; to respond to questions about the proposed rules;
and to provide an opportunity for interested persons to make oral
presentations. Due to limited space and time, FDA encourages all
persons who wish to attend the meetings to register in advance. There
is no fee to register for the public meetings, and registration will be
on a first-come, first-served basis. Early registration is recommended
because seating is limited. Onsite registration will be accepted, as
space permits, after all preregistered attendees are seated.
Those requesting an opportunity to make an oral presentation during
the time allotted for public comment at the meetings are asked to
submit a request and to provide the specific topic or issue to be
addressed. Due to the anticipated high level of interest in presenting
public comment and the limited time available, FDA is allocating 3
minutes to each speaker to make an oral presentation. Speakers will be
limited to making oral remarks; there will not be an opportunity to
display materials such as slide shows, videos, or other media during
the meeting. If time permits, individuals or organizations that did not
register in advance may be granted the opportunity to make an oral
presentation. FDA would like to maximize the number of individuals who
make a presentation at the meeting and will do our best to accommodate
all persons who wish to make a presentation or express their opinions
at the meeting.
FDA encourages persons and groups who have similar interests to
consolidate their information for presentation by a single
representative. After reviewing the presentation requests, FDA will
notify each participant before the meeting of the approximate time
their presentation is scheduled to begin, and remind them of the
presentation format (i.e., 3-minute oral presentation without visual
media).
While oral presentations 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 rulemaking. All relevant data and
documentation should be submitted with the comments to Docket No. FDA-
2013-N-0013.
Table 1 of this document provides information on participation in
the public meetings:

Table 1--Information on Participation in the Meetings and on Submitting Comments to the Rulemaking Dockets
----------------------------------------------------------------------------------------------------------------
Electronic Other
Date address Address information
----------------------------------------------------------------------------------------------------------------
Chicago, IL, Public Meeting, February 27, 2014.......... https:// Hilton Chicago, Onsite
Transport Session. www.fda.gov/ 720 South registration
Food/ Michigan Ave., from 8 a.m. to
GuidanceRegulat Chicago, IL 8:30 a.m.
ion/FSMA/ 60605.
ucm247568.htm
Chicago, IL, Advance Until February 18, 2014.... https:// We encourage you There is no
Registration. www.fda.gov/ to use registration
Food/ electronic fee for the
GuidanceRegulat registration if public
ion/FSMA/ possible.\1\ meetings. Early
ucm247568.htm registration is
recommended
because seating
is limited.

[[Page 8909]]

Chicago, IL, Request to Make February 10, 2014.......... https:// Requests made on
a Public Comment. www.fda.gov/ the day of the
Food/ meeting to make
GuidanceRegulat an oral
ion/FSMA/ presentation
ucm247568.htm will be granted
\2\ as time
permits.
Information on
requests to
make an oral
presentation
may be posted
without change
to https://www.regulations.gov, including
any personal
information
provided.
Chicago, IL, Request Special February 10, 2014.......... Juanita Yates, See FOR FURTHER
Accommodations Due to a email: INFORMATION
Disability. Juanita.yates@f CONTACT
da.hhs.gov
Chicago, IL, Closing Date for May 31, 2014............... Docket No. FDA- ................
Electronic or Written 2013-N-0013.
Comments.
Anaheim, CA, Public Meeting, March 13, 2014............. https:// Sheraton Park Onsite
Transport Session. www.fda.gov/ Hotel, 1855 registration
Food/ South Harbor from 8 a.m. to
GuidanceRegulat Blvd., Anaheim, 8:30 a.m.
ion/FSMA/ CA 92802.
ucm247568.htm
Anaheim, CA, Advance Until March 4, 2014........ https:// We encourage you There is no
Registration. www.fda.gov/ to use registration
Food/ electronic fee for the
GuidanceRegulat registration if public
ion/FSMA/ possible.\1\ meetings. Early
ucm247568.htm registration is
recommended
because seating
is limited.
Anaheim, CA, Request to make February 18, 2014.......... https:// Requests made on
a Public Comment. www.fda.gov/ the day of the
Food/ meeting to make
GuidanceRegulat an oral
ion/FSMA/ presentation
ucm247568.htm will be granted
\2\ as time
permits.
Information on
requests to
make an oral
presentation
may be posted
without change
to https://www.regulations.gov, including
any personal
information
provided.
Anaheim, CA, Request Special February 18, 2014.......... Juanita Yates, See FOR FURTHER ................
Accommodations Due to a email: INFORMATION
Disability. Juanita.yates@f CONTACT
da.hhs.gov
Anaheim, CA, Closing Date for May 31, 2014............... Docket No. FDA- ................
Electronic or Written 2013-N-0013.
Comments.
College Park, MD, Public March 20, 2014............. https:// Wiley Building, Onsite
Meeting. www.fda.gov/ 5100 Paint registration
Food/ Branch Pkwy., from 8 a.m. to
GuidanceRegulat College Park, 8:30 a.m.
ion/FSMA/ MD 20740.
ucm247568.htm
College Park, MD, Advance Until March 13, 2014....... https:// We encourage you There is no
Registration. www.fda.gov/ to use registration
Food/ electronic fee for the
GuidanceRegulat registration if public
ion/FSMA/ possible.\1\ meetings. Early
ucm247568.htm registration is
recommended
because seating
is limited.
College Park, MD, Request to February 28, 2014.......... https:// Requests made on
Make a Public Comment. www.fda.gov/ the day of the
Food/ meeting to make
GuidanceRegulat an oral
ion/FSMA/ presentation
ucm247568.htm will be granted
as time
permits.
Information on
requests to
make an oral
presentation
may be posted
without change
to https://www.regulations.gov, including
any personal
information
provided.
Closing Date of Docket....... May 31, 2014............... Docket No. FDA- ................
2013-N-0013.
College Park, MD, Request February 28, 2014.......... Juanita Yates, See FOR FURTHER ................
Special Accommodations Due email: INFORMATION
to a Disability. Juanita.yates@f CONTACT
da.hhs.gov
Closing Date for Electronic May 31, 2014............... Docket No. FDA- ................
or Written Comments to be 2013-N-0013.
Included in Docket.
----------------------------------------------------------------------------------------------------------------
\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: Nick Cane, Nakamoto Group, Inc., 11820
Parklawn Dr., Suite 240, Rockville, MD 20852, 240-357-1176, FAX: 301-468-6536, email:
nick.cane@nakamotogroup.com. Onsite registration will also be available.

[[Page 8910]]

\2\ You may also request to make an oral presentation at the public meetings via email. Please include your
name, title, firm name, address, and phone and fax numbers as well as the full text, comprehensive outline, or
summary of your oral presentation and send to: Juanita Yates, Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1731, email:
juanita.yates@fda.hhs.gov.

III. Comments, Transcripts, and Recorded Video

Information and data submitted voluntarily to FDA during the public
meetings will become part of the administrative record for the
rulemaking and will be accessible to the public at https://www.regulations.gov. The transcript of the proceedings from the public
meetings will become part of the administrative record for the
rulemaking. Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov and at
FDA's FSMA Web site at: https://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm. It may also be viewed at the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. A transcript will also be available in
either hardcopy or on CD-ROM, after submission of a Freedom of
Information request. Written requests are to be sent to the Division of
Freedom of Information (ELEM-1029), 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. Additionally, FDA will be video recording and live
Web casting all of the public meetings. Once the recorded video is
available, it will be accessible at FDA's FSMA Web site at https://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm.

Dated: February 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03277 Filed 2-13-14; 8:45 am]
BILLING CODE 4160-01-P

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