82 FR 42031 - Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 171 (September 6, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 171 (September 6, 2017)
| Page Range | 42031-42032 | |
| FR Document | 2017-18811 |
[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)] [Rules and Regulations] [Pages 42031-42032] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18811] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 112 [Docket No. FDA-2011-N-0921] Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.'' DATES: The announcement of the guidance is published in the Federal Register on September 6, 2017. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: 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 Office, 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-2011-N-0921 for ``What You Need to Know About the FDA Regulation: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption--Small Entity Compliance Guide.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff Office 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 [[Page 42032]] 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1636. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of November 27, 2015 (80 FR 74353), we issued a final rule entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' (the final rule) that establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. The final rule, which is codified at 21 CFR part 112, became effective January 26, 2016, but has staggered compliance dates starting January 26, 2017. We examined the economic implications of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined that the final rule will have a significant economic impact on a substantial number of small entities. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104- 121, as amended by Pub. L. 110-28), we are making available the SECG to reduce the burden of determining how to comply by further explaining and clarifying the actions that a small entity must take to comply with the rule. We are issuing the SECG consistent with our good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This is not a significant regulatory action subject to Executive Order 12866 and does not impose any additional burden on regulated entities. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 112 have been approved under OMB control number 0910-0816. III. Electronic Access Persons with access to the Internet may obtain the SECG at either https://www.fda.gov/FoodGuidances, or https://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: August 30, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-18811 Filed 9-5-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Rules and Regulations 42031
Standards Branch, FAA, has the authority to Issued in Kansas City, Missouri, on August confidential business information, such
approve AMOCs for this AD, if requested 28, 2017. as a manufacturing process. Please note
using the procedures found in 14 CFR 39.19. Melvin Johnson, that if you include your name, contact
Send information to ATTN: Mike Kiesov, Deputy Director, Policy and Innovation information, or other information that
Aerospace Engineer, Small Airplane Division, Aircraft Certification Service. identifies you in the body of your
Standards Branch, FAA 901 Locust, Room
[FR Doc. 2017–18624 Filed 9–5–17; 8:45 am] comments, that information will be
301, Kansas City, Missouri 64106; telephone:
(816) 329–4144; fax: (816) 329–4090; email: BILLING CODE 4910–13–P posted on https://www.regulations.gov.
mike.kiesov@faa.gov. Before using any
• If you want to submit a comment
approved AMOC on any airplane to which with confidential information that you
the AMOC applies, notify your appropriate DEPARTMENT OF HEALTH AND do not wish to be made available to the
principal inspector (PI) in the FAA Flight HUMAN SERVICES public, submit the comment as a
Standards District Office (FSDO), or lacking written/paper submission and in the
a PI, your local FSDO. Food and Drug Administration manner detailed (see ‘‘Written/Paper
(2) Contacting the Manufacturer: For any Submissions’’ and ‘‘Instructions’’).
requirement in this AD to obtain corrective 21 CFR Part 112
actions from a manufacturer, the action must Written/Paper Submissions
be accomplished using a method approved [Docket No. FDA–2011–N–0921] Submit written/paper submissions as
by the Manager, Small Airplane Standards follows:
Branch, FAA; or the European Aviation Standards for the Growing, Harvesting, • Mail/Hand delivery/Courier (for
Safety Agency (EASA); or if there is a Packing, and Holding of Produce for written/paper submissions): Dockets
delegated foreign airworthiness authority Human Consumption: What You Need Management Staff (HFA–305), Food and
Design Organization Approval (DOA). If To Know About the Food and Drug Drug Administration, 5630 Fishers
approved by the DOA, the approval must Administration Regulation; Small Lane, Rm. 1061, Rockville, MD 20852.
include the DOA-authorized signature. Entity Compliance Guide; Availability • For written/paper comments
(h) Related Information
AGENCY: Food and Drug Administration, submitted to the Dockets Management
Refer to MCAI European Aviation Safety Staff Office, FDA will post your
HHS.
Agency (EASA) AD No. 2017–0074, dated comment, as well as any attachments,
April 28, 2017. You may examine the MCAI ACTION: Notification of availability. except for information submitted,
on the Internet at https:// marked and identified, as confidential,
www.regulations.gov/document?D=FAA-
SUMMARY: The Food and Drug
Administration (FDA, the Agency, or if submitted as detailed in
2017-0638-0002. ‘‘Instructions.’’
we) is announcing the availability of a
(i) Material Incorporated by Reference Instructions: All submissions received
guidance for industry entitled
must include the Docket No. FDA–
(1) The Director of the Federal Register ‘‘Standards for the Growing, Harvesting,
approved the incorporation by reference 2011–N–0921 for ‘‘What You Need to
Packing, and Holding of Produce for
(IBR) of the service information listed in this Know About the FDA Regulation:
Human Consumption: What You Need
paragraph under 5 U.S.C. 552(a) and 1 CFR Standards for the Growing, Harvesting,
to Know About the FDA Regulation:
part 51. Packing, and Holding of Produce for
Small Entity Compliance Guide.’’ The
(2) You must use this service information Human Consumption—Small Entity
as applicable to do the actions required by
small entity compliance guide (SECG) is
Compliance Guide.’’ Received
this AD, unless this AD specifies otherwise. intended to help small entities comply
comments will be placed in the docket
(i) Diamond Aircraft Industries GmbH with the final rule entitled ‘‘Standards
and, except for those submitted as
Mandatory Service Bulletin MSB 42–126/ for the Growing, Harvesting, Packing,
‘‘Confidential Submissions,’’ publicly
MSB 42NG–066, dated March 27, 2017 and Holding of Produce for Human
viewable at https://www.regulations.gov
(single document). Consumption.’’
(ii) Diamond Aircraft Industries GmbH or at the Dockets Management Staff
Work Instruction WI–MSB 42–126/WI–MSB
DATES: The announcement of the Office between 9 a.m. and 4 p.m.,
42NG–066, dated March 27, 2017 (single guidance is published in the Federal Monday through Friday.
document). Register on September 6, 2017. • Confidential Submissions—To
(3) For Diamond Aircraft Industries GmbH ADDRESSES: You may submit either submit a comment with confidential
service information identified in this AD, electronic or written comments on information that you do not wish to be
contact Diamond Aircraft Industries GmbH, Agency guidances at any time as made publicly available, submit your
N.A. Otto-Stra+e 5, A–2700 Wiener Neustadt, follows: comments only as a written/paper
Austria, telephone: +43 2622 26700; fax: +43 submission. You should submit two
2622 26780; email: office@diamond-air.at; Electronic Submissions copies total. One copy will include the
Internet: http://www.diamondaircraft.com.
(4) You may view this service information
Submit electronic comments in the information you claim to be confidential
at the FAA, Policy and Innovation Division, following way: with a heading or cover note that states
901 Locust, Kansas City, Missouri 64106. For • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
information on the availability of this https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
material at the FAA, call (816) 329–4148. In instructions for submitting comments. Agency will review this copy, including
addition, you can access this service Comments submitted electronically, the claimed confidential information, in
information on the Internet at http:// including attachments, to https:// its consideration of comments. The
www.regulations.gov by searching for and www.regulations.gov will be posted to second copy, which will have the
locating Docket No. FAA–2017–0638. the docket unchanged. Because your claimed confidential information
(5) You may view this service information
nlaroche on DSKBBV9HB2PROD with RULES
comment will be made public, you are redacted/blacked out, will be available
that is incorporated by reference at the
National Archives and Records
solely responsible for ensuring that your for public viewing and posted on
Administration (NARA). For information on comment does not include any https://www.regulations.gov. Submit
the availability of this material at NARA, call confidential information that you or a both copies to the Dockets Management
202–741–6030, or go to: http:// third party may not wish to be posted, Staff. If you do not wish your name and
www.archives.gov/federal-register/cfr/ibr- such as medical information, your or contact information to be made publicly
locations.html. anyone else’s Social Security number, or available, you can provide this
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![42032 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Rules and Regulations
information on the cover sheet and not regulation (21 CFR 10.115(c)(2)). The ADDRESSES: The docket for this
in the body of your comments and you SECG represents the current thinking of deviation, USCG–2017–0807, is
must identify this information as FDA on this topic. It does not establish available at http://www.regulations.gov.
‘‘confidential.’’ Any information marked any rights for any person and is not Type the docket number in the
as ‘‘confidential’’ will not be disclosed binding on FDA or the public. You can ‘‘SEARCH’’ box and click ‘‘SEARCH’’.
except in accordance with 21 CFR 10.20 use an alternative approach if it satisfies Click on Open Docket Folder on the line
and other applicable disclosure law. For the requirements of the applicable associated with this deviation.
more information about FDA’s posting statutes and regulations. This is not a FOR FURTHER INFORMATION CONTACT: If
of comments to public dockets, see 80 significant regulatory action subject to you have questions on this temporary
FR 56469, September 18, 2015, or access Executive Order 12866 and does not deviation, call or email James M. Moore,
the information at: https://www.gpo.gov/ impose any additional burden on Bridge Management Specialist, First
fdsys/pkg/FR-2015-09-18/pdf/2015- regulated entities. District Bridge Branch, U.S. Coast
23389.pdf. Guard; telephone 212–514–4334, email
II. Paperwork Reduction Act of 1995
Docket: For access to the docket to James.M.Moore2@uscg.mil.
read background documents or the This guidance refers to previously SUPPLEMENTARY INFORMATION: The owner
electronic and written/paper comments approved collections of information of the bridge, the New York City
received, go to https:// found in FDA regulations. These Department of Transportation, requested
www.regulations.gov and insert the collections of information are subject to a temporary deviation in order to
docket number, found in brackets in the review by the Office of Management and facilitate planned repairs of the bridge
heading of this document, into the Budget (OMB) under the Paperwork including replacement of the grease
‘‘Search’’ box and follow the prompts Reduction Act of 1995 (44 U.S.C. 3501– piping system as well as installation of
and/or go to the Dockets Management 3520). The collections of information in new span lock shoes, steel shims and
Staff, 5630 Fishers Lane, Rm. 1061, part 112 have been approved under horizontal/vertical bolts.
Rockville, MD 20852. OMB control number 0910–0816. The Pulaski Bridge across Newtown
See the SUPPLEMENTARY INFORMATION Creek, mile 0.6 at New York City, New
III. Electronic Access
section for electronic access to the York is a double-leaf bascule bridge
SECG. Persons with access to the Internet with a vertical clearance of 39 feet at
may obtain the SECG at either https:// mean high water and 43 feet at mean
FOR FURTHER INFORMATION CONTACT:
www.fda.gov/FoodGuidances, or https:// low water in the closed position. The
Samir Assar, Center for Food Safety and
www.regulations.gov. Use the FDA Web existing drawbridge operating
Applied Nutrition, Food and Drug
site listed in the previous sentence to regulations are listed at 33 CFR
Administration, 5001 Campus Dr.,
find the most current version of the 117.801(g)(1)–(2).
College Park, MD 20740, 240–402–1636.
guidance. The temporary deviation will allow
SUPPLEMENTARY INFORMATION:
Dated: August 30, 2017. the Pulaski Bridge to remain closed each
I. Background Anna K. Abram, Tuesday, Wednesday, Thursday, Friday
In the Federal Register of November Deputy Commissioner for Policy, Planning, and Saturday from 12:01 a.m. to 5 a.m.
27, 2015 (80 FR 74353), we issued a Legislation, and Analysis. beginning September 19, 2017 until
final rule entitled ‘‘Standards for the [FR Doc. 2017–18811 Filed 9–5–17; 8:45 am]
December 30, 2017. The waterway is
Growing, Harvesting, Packing, and transited by tug/barge traffic of various
BILLING CODE 4164–01–P
Holding of Produce for Human sizes. Coordination with waterway users
Consumption’’ (the final rule) that has indicated no objections to the
establishes science-based minimum proposed closure of the draw.
DEPARTMENT OF HOMELAND Vessels that can pass under the bridge
standards for the safe growing, SECURITY
harvesting, packing, and holding of without an opening may do so at all
produce, meaning fruits and vegetables Coast Guard times. The bridge will not be able to
grown for human consumption. The open for emergencies. There is no
final rule, which is codified at 21 CFR 33 CFR Part 117 alternate route for vessels to pass.
The Coast Guard will also inform the
part 112, became effective January 26, [Docket No. USCG–2017–0807] users of the waterways through our
2016, but has staggered compliance
Local and Broadcast Notices to Mariners
dates starting January 26, 2017. Drawbridge Operation Regulation; of the change in operating schedule for
We examined the economic Newtown Creek, New York, NY the bridge so vessel operators may
implications of the final rule as required
AGENCY: Coast Guard, DHS. arrange their transits to minimize any
by the Regulatory Flexibility Act (5
impact caused by the temporary
U.S.C. 601–612) and determined that ACTION:Notice of deviation from
deviation.
the final rule will have a significant drawbridge regulation. In accordance with 33 CFR 117.35(e),
economic impact on a substantial the drawbridge must return to its regular
number of small entities. In compliance SUMMARY: The Coast Guard has issued a
temporary deviation from the operating operating schedule immediately at the
with section 212 of the Small Business end of the effective period of this
Regulatory Enforcement Fairness Act schedule that governs the Pulaski Bridge
across Newtown Creek, mile 0.6 at New temporary deviation. This deviation
(Pub. L. 104–121, as amended by Pub. from the operating regulations is
L. 110–28), we are making available the York City, New York. This deviation is
necessary to facilitate planned repairs authorized under 33 CFR 117.35.
nlaroche on DSKBBV9HB2PROD with RULES
SECG to reduce the burden of
determining how to comply by further and will allow the owner to temporarily Dated: August 31, 2017.
explaining and clarifying the actions close the draw during weeknights for Christopher J. Bisignano,
that a small entity must take to comply periods not to exceed five hours. Supervisory Bridge Management Specialist,
with the rule. DATES: This deviation is effective from First Coast Guard District.
We are issuing the SECG consistent 12:01 a.m. on September 19, 2017 [FR Doc. 2017–18822 Filed 9–5–17; 8:45 am]
with our good guidance practices through 5 a.m. on December 30, 2017. BILLING CODE 9110–04–P
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Document Created: 2017-09-06 00:56:41
Document Modified: 2017-09-06 00:56:41
| 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 | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on September 6, 2017. | |
| Contact | Samir Assar, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1636. | |
| FR Citation | 82 FR 42031 |
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