83 FR 53197 - Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft Guidance for Industry; Availability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 | 53197-53199 | |
| FR Document | 2018-23005 |
[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)] [Proposed Rules] [Pages 53197-53199] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23005] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 117 [Docket No. FDA-2018-D-3583] Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Guide to Minimize Food Safety Hazards of Fresh-cut Produce.'' The draft guidance, when finalized, will supersede a previous guidance, entitled ``Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,'' that we issued in 2008. The draft guidance is intended to explain our current thinking on how to comply with recently modernized requirements for current good manufacturing practice (CGMP) and with new requirements for hazard analysis and risk-based preventive controls under our regulation entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' during the production of fresh-cut produce. DATES: Submit either electronic or written comments on the draft guidance by April 22, 2019 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance.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 [[Page 53198]] 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-3583 for ``Guide to Minimize Food Safety Hazards of Fresh- cut Produce: 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 Office of Food Safety, Division of Produce Safety, 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. FOR FURTHER INFORMATION CONTACT: Insook Son, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1648. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a draft guidance for industry entitled ``Guide to Minimize Food Safety Hazards of Fresh-cut Produce.'' 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. The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities under our regulations in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C Act (21 U.S.C. 350d). In 2008, we issued a guidance for industry entitled ``Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables.'' Fresh-cut fruits and vegetables mean any fresh fruit or vegetable or combination thereof that has been physically altered from its whole state after being harvested from the field (e.g., by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing) without additional processing (such as blanching or cooking). That guidance was intended for all fresh-cut produce processing firms to enhance the safety of fresh-cut produce by minimizing the microbial food safety hazards. It explained our thinking on how to comply with CGMP requirements that then were established in a regulation entitled ``Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food'' (21 CFR part 110). In the Federal Register of September 17, 2015 (80 FR 55908), we published a final rule that, among other things, modernized the CGMP requirements and established them in new 21 CFR part 117 (part 117), entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' Part 117 also includes new requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities. The draft guidance that we are making available for public comment is intended to explain our current thinking on how all food establishments that produce fresh-cut produce can comply with the modernized CGMP requirements in part 117. The draft guidance also is intended to explain our current thinking on how fresh-cut produce food facilities that are subject to the new requirements for hazard analysis and risk- based preventive controls can comply with those requirements. 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 [[Page 53199]] Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 117 have been approved under OMB control number 0910-0751. 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. 2018-23005 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
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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
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![Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Proposed Rules 53199
Management and Budget (OMB) under FOR FURTHER INFORMATION CONTACT: If The regulatory text we are proposing
the Paperwork Reduction Act of 1995 you have questions about this proposed appears at the end of this document.
(44 U.S.C. 3501–3520). The collections rulemaking, call or email Petty Officer
IV. Regulatory Analyses
of information in part 117 have been Thomas Welker, U.S. Coast Guard,
approved under OMB control number Sector Delaware Bay, Waterways We developed this proposed rule after
0910–0751. Management Division; telephone 215– considering numerous statutes and
271–4814, email Thomas.j.welker@ Executive orders related to rulemaking.
III. Electronic Access
uscg.mil. Below we summarize our analyses
Persons with access to the internet SUPPLEMENTARY INFORMATION: based on a number of these statutes and
may obtain the draft guidance at either Executive orders and we discuss First
https://www.fda.gov/FoodGuidances or I. Table of Abbreviations Amendment rights of protestors.
https://www.regulations.gov. Use the CFR Code of Federal Regulations
FDA website listed in the previous A. Regulatory Planning and Review
COTP Captain of the Port
sentence to find the most current DHS Department of Homeland Security Executive Orders 12866 and 13563
version of the guidance. FR Federal Register direct agencies to assess the costs and
Dated: October 17, 2018. NPRM Notice of proposed rulemaking benefits of available regulatory
§ Section alternatives and, if regulation is
Leslie Kux, U.S.C. United States Code
Associate Commissioner for Policy.
necessary, to select regulatory
II. Background, Purpose, and Legal approaches that maximize net benefits.
[FR Doc. 2018–23005 Filed 10–19–18; 8:45 am]
Basis Executive Order 13771 directs agencies
BILLING CODE 4164–01–P
On September 14, 2018, Rexel, Inc to control regulatory costs through a
notified the Coast Guard that it will be budgeting process. This NPRM has not
conducting a fireworks display from been designated a ‘‘significant
DEPARTMENT OF HOMELAND regulatory action,’’ under Executive
SECURITY 8:35 p.m. to 8:55 p.m. on November 14,
2018. The fireworks are to be launched Order 12866. Accordingly, the NPRM
from a barge in the Delaware River has not been reviewed by the Office of
Coast Guard
adjacent to the Battleship New Jersey Management and Budget (OMB), and
Museum and Memorial, Camden, NJ. pursuant to OMB guidance it is exempt
33 CFR Part 165
Hazards from fireworks displays include from the requirements of Executive
[Docket Number USCG–2018–0948]
accidental discharge of fireworks, Order 13771.
RIN 1625–AA00 dangerous projectiles, and falling hot This regulatory action determination
embers or other debris. The Captain of is based on the size, location, duration,
Safety Zone; Delaware River; Camden, the Port Delaware Bay (COTP) has and time-of-day of the safety zone.
NJ; Fireworks Display determined that potential hazards Vessel traffic would be able to safely
associated with the fireworks to be used transit around this safety zone which
AGENCY: Coast Guard, DHS. would impact a small designated area of
in this display would be a safety
ACTION: Notice of proposed rulemaking. concern for anyone within a 600-foot the Delaware River for one hour during
radius of the barge. the evening when vessel traffic is
SUMMARY: The Coast Guard proposes to normally low. Moreover, the Coast
establish a temporary safety zone on a The purpose of this rulemaking is to
ensure the safety of vessels and the Guard would issue a Broadcast Notice to
portion of the Delaware River in Mariners via VHF–FM marine channel
Camden, NJ. This action is necessary to navigable waters within a 600-foot
radius of the fireworks barge before, 16 about the zone, and the rule would
protect the surrounding public and allow vessels to seek permission to enter
vessels on these navigable waters during, and after the scheduled event.
The Coast Guard proposes this the zone.
adjacent to the Battleship New Jersey
Museum and Memorial, Camden, NJ, rulemaking under authority in 33 U.S.C. B. Impact on Small Entities
during a fireworks display on November 1231.
The Regulatory Flexibility Act of
14, 2018. This proposed rulemaking III. Discussion of Proposed Rule 1980, 5 U.S.C. 601–612, as amended,
would prohibit persons and vessels The COTP is proposing to establish a requires Federal agencies to consider
from entering, transiting, or remaining safety zone from approximately 8:15 the potential impact of regulations on
within the safety zone unless authorized p.m. through 9:15 p.m. on November 14, small entities during rulemaking. The
by the Captain of the Port Delaware Bay 2018. The safety zone would cover all term ‘‘small entities’’ comprises small
or a designated representative. We navigable waters within 600 feet of a businesses, not-for-profit organizations
invite your comments on this proposed fireworks barge in the Delaware River that are independently owned and
rulemaking. adjacent to the Battleship New Jersey operated and are not dominant in their
DATES: Comments and related material Museum and Memorial, Camden, NJ. fields, and governmental jurisdictions
must be received by the Coast Guard on The barge will be anchored in with populations of less than 50,000.
or before November 6, 2018. approximate position 39°56′20″ N The Coast Guard certifies under 5 U.S.C.
ADDRESSES: You may submit comments Latitude, 075°08′08″ W Longitude. The 605(b) that this proposed rule would not
identified by docket number USCG– duration of the zone is intended to have a significant economic impact on
daltland on DSKBBV9HB2PROD with PROPOSALS
2018–0948 using the Federal ensure the safety of vessels and these a substantial number of small entities.
eRulemaking Portal at http:// navigable waters before, during, and While some owners or operators of
www.regulations.gov. See the ‘‘Public after the scheduled 8:35 p.m. to 8:55 vessels intending to transit the safety
Participation and Request for p.m. fireworks display. No vessel or zone may be small entities, for the
Comments’’ portion of the person would be permitted to enter, reasons stated in section IV.A above,
SUPPLEMENTARY INFORMATION section for transit, or remain within the safety zone this proposed rule would not have a
further instructions on submitting without obtaining permission from the significant economic impact on any
comments. COTP or a designated representative. vessel owner or operator.
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Document Created: 2018-10-20 01:50:26
Document Modified: 2018-10-20 01:50:26
| 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 | Insook Son, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1648. | |
| FR Citation | 83 FR 53197 |
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