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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2021-N-0929]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of public meeting; request for comments.

# SUMMARY:

The Food and Drug Administration (FDA or we) is announcing a virtual public meeting entitled “FDA New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers.” The purpose of the public meeting is to engage with stakeholders and invite input on various topics pertaining to the implementation of Core Element 3.1 of the New Era of Smarter Food Safety Blueprint. We intend to use information resulting from the public meeting to determine what action(s), if any, should be taken to help ensure the safe production and delivery of human and animal foods sold through new e-commerce business models.

# DATES:

                        The public meeting will be held over 3 days on October 19, 2021, from 11:30 a.m. to 5:30 p.m. Eastern Time; October 20, 2021, from 11:30 a.m. to 5:15 p.m. Eastern Time, and October 21, 2021, from 11:30 a.m. to 3:45 p.m. Eastern Time. Submit either electronic or written comments on this public meeting by November 20, 2021. See “Participating in the Public Meeting” in the                         **SUPPLEMENTARY INFORMATION**                         section of this document for registration and other information regarding meeting participation.                    

# ADDRESSES:

                        The public meeting will be held virtually. For more information on the public meeting, see:                         *https://www.fda.gov/​food/​workshops-meetings-webinars-food-and-dietary-supplements/​new-era-smarter-food-safety-summit-e-commerce-ensuring-safety-foods-ordered-online-and-delivered.*

                        You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 20, 2021. The                         *https://www.regulations.gov*                         electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 20, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.                    

### Electronic Submissions

Submit electronic comments in the following way:
      -  Federal eRulemaking Portal: https://www.regulations.gov.                      Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to                      https://www.regulations.gov                      will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on                      https://www.regulations.gov. 
      - If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).       ( print page 50131)      

### 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-2021-N-0929 for “FDA New Era of Smarter Food Safety Summit on E-Commerce.” Received comments, those filed in a timely manner (see                     **ADDRESSES**                    ), 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, 240-402-7500.                
      - 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.” We will review this copy, including the claimed confidential information, in our 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.govinfo.gov/​content/​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, 240-402-7500.                

# FOR FURTHER INFORMATION CONTACT:

                        Juanita Yates, Center for Food Safety and Applied Nutrition, (HFS-009), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1731,                         *juanita.yates@fda.hhs.gov.*

# SUPPLEMENTARY INFORMATION:

## I. Background

                    In April 2019, we announced the New Era of Smarter Food Safety initiative and in July 2020, we released the New Era of Smarter Food Safety Blueprint (see                     *https://www.fda.gov/​food/​new-era-smarter-food-safety/​new-era-smarter-food-safety-blueprint*) (Blueprint). The Blueprint outlines the effort to modernize approaches to food safety as we respond to unique demands on our food system and work to ensure the safety and security of our food supply. This virtual public meeting (Summit) will focus on Core Element 3.1: Ensure Safety of Food Produced or Delivered Using New Business Models. Specifically, we invite discussion and input on human and animal foods sold through Business to Consumer (B2C) e-commerce. B2C e-commerce is the manufacturing, packaging, labeling, storage, and delivery of human and animal foods sold directly to consumers, through commercial transactions conducted electronically on the internet.                

The Summit is an opportunity for us to share our current understanding of human and animal foods sold through new business models and hear from the public. The Summit will enhance our knowledge of possible food safety risks related to these new business models and help us identify what additional courses of action, if any, are needed to address potential food safety vulnerabilities.

We invite industry, consumers, consumer and public health organizations, academia, Federal, State, local, and tribal governments, foreign governments, and other interested parties to join the discussion and provide their perspectives on these issues.

## II. Topics for Discussion at the Public Meeting

The Summit will address a variety of topics related to human and animal foods sold through B2C e-commerce, including:
    - Types of B2C e-commerce models ( e.g.,                      produce and meal kit subscription services, ghost kitchens, dark stores);                
    - Safety risks associated with foods sold through B2C e-commerce;
    - Standards of care used by industry to control these safety risks;
    - Types of delivery models ( e.g.,                      third-party delivery, autonomous delivery models);                
    - Regulatory approaches to food sold through B2C e-commerce, including challenges and gaps that need to be addressed; and
    - Labeling of foods sold through B2C e-commerce.

During the Summit, experts from FDA, industry, academia, consumer and public health organizations, domestic and foreign governments will be asked to address these topics. Each day, there will also be an opportunity for registered participants to ask questions and engage with these experts, as well as to offer open public comment for those who select this option when registering (see Part III, “Participating in the Public Meeting”).

                    Before the meeting date, we will post the agenda and additional background materials on the internet at:                     *https://www.fda.gov/​food/​workshops-meetings-webinars-food-and-dietary-supplements/​new-era-smarter-food-safety-summit-e-commerce-ensuring-safety-foods-ordered-online-and-delivered.*                     Registered participants will be notified when these materials are posted. There will be an opportunity for interested stakeholders to submit written comments following the meeting.                

## III. Participating in the Public Meeting

*Registration:*                     To register for the public meeting, please visit the following website to register:                     *https://www.fda.gov/​food/​workshops-meetings-webinars-food-and-dietary-supplements/​new-era-smarter-food-safety-summit-e-commerce-ensuring-safety-foods-ordered-online-and-delivered.*                     Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.                

                    This is a virtual public meeting. Registration is free and will be open through the day of the meeting. Persons interested in attending this public meeting must register at:                     *https://www.fda.gov/​food/​workshops-meetings-webinars-food-and-dietary-supplements/​new-era-smarter-food-safety-summit-e-commerce-ensuring-safety-foods-ordered-online-and-delivered.*                     Upon registering, they will receive a confirmation email with a link for the public meeting. Approximately                           ( print page 50132)                        24 to 48 hours before the event, registrants will receive an email with the meeting link and a formal calendar invitation.                

*Request to Provide Open Public Comment:*                     During online registration, you may indicate if you wish to make open public comments during the public meeting and which topic(s) you would like to address. All requests to make public comments must be received by October 8, 2021 at 11:59 p.m. Eastern Time. We will do our best to accommodate requests to make public comments. We are seeking to have a broad representation of ideas and issues presented at the meeting. Individuals and organizations with common interests are urged to consolidate or coordinate their comments. FDA will determine the amount of time allotted to each commenter, the meeting day, the approximate time open public comments are to be provided and notify all registrants who requested to make public comments.                

*Streaming Webcast of the Public Meeting:*                     This public meeting will be broadcast via YouTube.                

*Transcripts:*                     Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at                     *https://www.regulations.gov.*                     It may be viewed at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20850. A link to the transcript will also be available on the internet at:                     *https://www.fda.gov/​food/​workshops-meetings-webinars-food-and-dietary-supplements/​new-era-smarter-food-safety-summit-e-commerce-ensuring-safety-foods-ordered-online-and-delivered.*

Dated: August 31, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

[FR Doc. 2021-19219 Filed 9-3-21; 8:45 am]

BILLING CODE 4164-01-P