83 FR 53196 - Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 204 (October 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 204 (October 22, 2018)
| Page Range | 53196-53197 | |
| FR Document | 2018-23006 |
[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)] [Proposed Rules] [Pages 53196-53197] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23006] ======================================================================= ----------------------------------------------------------------------- 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No. FDA-2018-D-3631] Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.'' The draft guidance, when finalized, will provide FDA's current thinking and recommendations to help covered farms comply with the final regulation entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' (Produce Safety Rule), which established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption. DATES: Submit either electronic or written comments on the draft guidance by April 22, 2019 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance 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, 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 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 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self- addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. [[Page 53197]] 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 We are announcing the availability of a draft guidance for industry entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.'' We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent 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 alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. We intend to conduct four public meetings in diverse regions of the United States to discuss the draft guidance, and we will provide details about these public meetings in a notice published in the Federal Register. The Produce Safety Rule (80 FR 74353) established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. Requirements of the rule focus on major routes of contamination, including health and hygiene; biological soil amendments of animal origin; domesticated and wild animals; and equipment, tools, and buildings. This draft guidance provides recommendations, examples, and information related to compliance and implementation of the following subparts of the Produce Safety Rule: Subpart A--General Provisions Subpart C--Personnel Qualifications and Training Subpart D--Health and Hygiene Subpart F--Biological Soil Amendments of Animal Origin and Human Waste Subpart I--Domesticated and Wild Animals Subpart K--Growing, Harvesting, Packing, and Holding Activities Subpart L--Equipment, Tools, Buildings, and Sanitation Subpart O--Records Subpart P--Variances This draft guidance is based on FDA's current thinking and we believe that additional information would assist us in developing the final guidance. While we invite comments on all aspects of the draft guidance, we seek specific comments, information, and data on the following: For equipment and tools intended to or likely to contact covered produce: When acquiring equipment and tools, how do you engage with equipment and tool suppliers about the size, design, and construction of your buildings so that they can accommodate the equipment and tools? What information or data can you provide about cleaning, sanitizing, and maintenance practices and procedures for equipment and tools that have wood, foam, or other porous or absorbent materials? For domesticated and wild animals: What data or information can you provide about factors or conditions that would affect the likelihood of contamination of covered produce by animals? Such factors include, for example, historical information and conditions on or near farms that influence animal habitats. II. Paperwork Reduction Act of 1995 This draft 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 21 CFR part 112 have been approved under OMB control number 0910-0816. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: October 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-23006 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
![53196 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Proposed Rules
published at https://www.faa.gov/ Produce for Human Consumption’’ Industry.’’ Received comments will be
training_testing/testing/acs/. (Produce Safety Rule), which placed in the docket and, except for
established science-based minimum those submitted as ‘‘Confidential
Comments Invited
standards for the safe growing, Submissions,’’ publicly viewable at
The FAA invites interested persons to harvesting, packing, and holding of https://www.regulations.gov or at the
join in this notice and comment process produce grown for human consumption. Dockets Management Staff between 9
by filing written comments, data, or DATES: Submit either electronic or a.m. and 4 p.m., Monday through
views. The most helpful comments written comments on the draft guidance Friday.
reference a specific portion of the by April 22, 2019 to ensure that the • Confidential Submissions—To
proposal, explain the reason for any Agency considers your comment on the submit a comment with confidential
recommended change, and include draft guidance before it begins work on information that you do not wish to be
supporting data. To ensure the docket the final version of the guidance. made publicly available, submit your
does not contain duplicate comments, comments only as a written/paper
ADDRESSES: You may submit comments
commenters should send only one copy submission. You should submit two
on any guidance at any time as follows: copies total. One copy will include the
of written comments or, if comments are
filed electronically, commenters should Electronic Submissions information you claim to be confidential
submit only one time. More information with a heading or cover note that states
Submit electronic comments in the
on submitting comments can be found ‘‘THIS DOCUMENT CONTAINS
following way: CONFIDENTIAL INFORMATION.’’ The
in the ADDRESSES section of this • Federal eRulemaking Portal:
document. Agency will review this copy, including
https://www.regulations.gov. Follow the the claimed confidential information, in
The FAA will review all comments it instructions for submitting comments.
receives on or before the closing date for its consideration of comments. The
Comments submitted electronically, second copy, which will have the
the comment period. The FAA will including attachments, to https://
consider comments submitted after the claimed confidential information
www.regulations.gov will be posted to redacted/blacked out, will be available
comment period has closed if it is the docket unchanged. Because your
possible to do so without incurring for public viewing and posted on
comment will be made public, you are https://www.regulations.gov. Submit
expense or delay. The FAA may make solely responsible for ensuring that your
changes based on the comments it both copies to the Dockets Management
comment does not include any Staff. If you do not wish your name and
receives. confidential information that you or a contact information to be made publicly
Issued in Washington, DC, on October 16, third party may not wish to be posted, available, you can provide this
2018. such as medical information, your or information on the cover sheet and not
Lirio Liu, anyone else’s Social Security number, or in the body of your comments and you
Executive Director, Office of Rulemaking, confidential business information, such must identify this information as
Federal Aviation Administration. as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
[FR Doc. 2018–23013 Filed 10–19–18; 8:45 am] that if you include your name, contact as ‘‘confidential’’ will not be disclosed
BILLING CODE 4910–13–P information, or other information that except in accordance with 21 CFR 10.20
identifies you in the body of your and other applicable disclosure law. For
comments, that information will be more information about FDA’s posting
DEPARTMENT OF HEALTH AND posted on https://www.regulations.gov. of comments to public dockets, see 80
HUMAN SERVICES • If you want to submit a comment FR 56469, September 18, 2015, or access
with confidential information that you the information at: https://www.gpo.gov/
Food and Drug Administration do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a 23389.pdf.
21 CFR Part 112 written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
[Docket No. FDA–2018–D–3631]
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Standards for the Growing, Harvesting, Written/Paper Submissions received, go to https://
Packing, and Holding of Produce for www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the
Human Consumption; Draft Guidance
follows: heading of this document, into the
for Industry; Availability
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, written/paper submissions): Dockets and/or go to the Dockets Management
HHS. Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061,
ACTION: Notification of availability. Drug Administration, 5630 Fishers Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any
SUMMARY: The Food and Drug • For written/paper comments guidance at any time (see 21 CFR
Administration (FDA, the Agency, or submitted to the Dockets Management 10.115(g)(5)).
we) is announcing the availability of a Staff, FDA will post your comment, as Submit written requests for single
draft guidance for industry entitled well as any attachments, except for copies of the draft guidance to the
‘‘Standards for the Growing, Harvesting, information submitted, marked and Center for Food Safety and Applied
daltland on DSKBBV9HB2PROD with PROPOSALS
Packing, and Holding of Produce for identified, as confidential, if submitted Nutrition, Food and Drug
Human Consumption.’’ The draft as detailed in ‘‘Instructions.’’ Administration, 5001 Campus Dr.,
guidance, when finalized, will provide Instructions: All submissions received College Park, MD 20740. Send two self-
FDA’s current thinking and must include the Docket No. FDA– addressed adhesive labels to assist that
recommendations to help covered farms 2018–D–3631 for ‘‘Standards for the office in processing your request. See
comply with the final regulation Growing, Harvesting, Packing, and the SUPPLEMENTARY INFORMATION section
entitled ‘‘Standards for the Growing, Holding of Produce for Human for electronic access to the draft
Harvesting, Packing, and Holding of Consumption; Draft Guidance for guidance.
VerDate Sep<11>2014 16:58 Oct 19, 2018 Jkt 247001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\22OCP1.SGM 22OCP1](https://thefederalregister.org/doc/83_FR_53400/page/1.svg)
![Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Proposed Rules 53197
FOR FURTHER INFORMATION CONTACT: Subpart L—Equipment, Tools, DEPARTMENT OF HEALTH AND
Samir Assar, Center for Food Safety and Buildings, and Sanitation HUMAN SERVICES
Applied Nutrition, Food and Drug Subpart O—Records
Administration, 5001 Campus Dr., Food and Drug Administration
College Park, MD 20740, 240–402–1636. Subpart P—Variances
SUPPLEMENTARY INFORMATION: This draft guidance is based on FDA’s 21 CFR Part 117
current thinking and we believe that [Docket No. FDA–2018–D–3583]
I. Background
additional information would assist us
We are announcing the availability of in developing the final guidance. While Guide To Minimize Food Safety
a draft guidance for industry entitled we invite comments on all aspects of the Hazards of Fresh-Cut Produce: Draft
‘‘Standards for the Growing, Harvesting, draft guidance, we seek specific Guidance for Industry; Availability
Packing, and Holding of Produce for comments, information, and data on the AGENCY: Food and Drug Administration,
Human Consumption.’’ We are issuing following: HHS.
the draft guidance consistent with our
good guidance practices regulation (21 For equipment and tools intended to ACTION: Notification of availability.
CFR 10.115). The draft guidance, when or likely to contact covered produce:
SUMMARY: The Food and Drug
finalized, will represent the current • When acquiring equipment and Administration (FDA, the Agency, or
thinking of FDA on this topic. It does tools, how do you engage with we) is announcing the availability of a
not establish any rights for any person equipment and tool suppliers about the draft guidance for industry entitled
and is not binding on FDA or the public. size, design, and construction of your ‘‘Guide to Minimize Food Safety
You can use an alternate approach if it buildings so that they can accommodate Hazards of Fresh-cut Produce.’’ The
satisfies the requirements of the the equipment and tools? draft guidance, when finalized, will
applicable statutes and regulations. This supersede a previous guidance, entitled
guidance is not subject to Executive • What information or data can you
‘‘Guide to Minimize Microbial Food
Order 12866. provide about cleaning, sanitizing, and
Safety Hazards of Fresh-cut Fruits and
We intend to conduct four public maintenance practices and procedures
Vegetables,’’ that we issued in 2008. The
meetings in diverse regions of the for equipment and tools that have wood, draft guidance is intended to explain
United States to discuss the draft foam, or other porous or absorbent our current thinking on how to comply
guidance, and we will provide details materials? with recently modernized requirements
about these public meetings in a notice For domesticated and wild animals: for current good manufacturing practice
published in the Federal Register. • What data or information can you (CGMP) and with new requirements for
The Produce Safety Rule (80 FR provide about factors or conditions that hazard analysis and risk-based
74353) established science-based preventive controls under our regulation
would affect the likelihood of
minimum standards for the safe entitled ‘‘Current Good Manufacturing
contamination of covered produce by
growing, harvesting, packing, and Practice, Hazard Analysis, and Risk-
animals? Such factors include, for
holding of produce grown for human Based Preventive Controls for Human
consumption. The rule sets forth example, historical information and
Food’’ during the production of fresh-
procedures, processes, and practices conditions on or near farms that
cut produce.
that minimize the risk of serious adverse influence animal habitats.
DATES: Submit either electronic or
health consequences or death, including II. Paperwork Reduction Act of 1995 written comments on the draft guidance
those reasonably necessary to prevent by April 22, 2019 to ensure that the
the introduction of known or reasonably This draft guidance refers to Agency considers your comment on the
foreseeable biological hazards into or previously approved collections of draft guidance before it begins work on
onto produce and to provide reasonable information found in FDA regulations. the final version of the guidance.
assurances that the produce is not These collections of information are ADDRESSES: You may submit comments
adulterated on account of such hazards. subject to review by the Office of on any guidance at any time as follows:
Requirements of the rule focus on major Management and Budget (OMB) under
routes of contamination, including the Paperwork Reduction Act of 1995 Electronic Submissions
health and hygiene; biological soil (44 U.S.C. 3501–3520). The collections Submit electronic comments in the
amendments of animal origin; of information in 21 CFR part 112 have following way:
domesticated and wild animals; and been approved under OMB control • Federal eRulemaking Portal:
equipment, tools, and buildings. number 0910–0816. https://www.regulations.gov. Follow the
This draft guidance provides instructions for submitting comments.
recommendations, examples, and III. Electronic Access Comments submitted electronically,
information related to compliance and including attachments, to https://
implementation of the following Persons with access to the internet www.regulations.gov will be posted to
subparts of the Produce Safety Rule: may obtain the draft guidance at either the docket unchanged. Because your
Subpart A—General Provisions https://www.fda.gov/FoodGuidances or comment will be made public, you are
Subpart C—Personnel Qualifications https://www.regulations.gov. Use the solely responsible for ensuring that your
and Training FDA website listed in the previous comment does not include any
daltland on DSKBBV9HB2PROD with PROPOSALS
Subpart D—Health and Hygiene sentence to find the most current confidential information that you or a
Subpart F—Biological Soil version of the guidance. third party may not wish to be posted,
Amendments of Animal Origin and Dated: October 17, 2018. such as medical information, your or
Human Waste Leslie Kux,
anyone else’s Social Security number, or
Subpart I—Domesticated and Wild confidential business information, such
Associate Commissioner for Policy.
Animals as a manufacturing process. Please note
Subpart K—Growing, Harvesting, [FR Doc. 2018–23006 Filed 10–19–18; 8:45 am] that if you include your name, contact
Packing, and Holding Activities BILLING CODE 4164–01–P information, or other information that
VerDate Sep<11>2014 16:58 Oct 19, 2018 Jkt 247001 PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 E:\FR\FM\22OCP1.SGM 22OCP1](https://thefederalregister.org/doc/83_FR_53400/page/2.svg)
Document Created: 2018-10-20 01:50:25
Document Modified: 2018-10-20 01:50:25
| 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 availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by April 22, 2019 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance. | |
| 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 | 83 FR 53196 |
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