[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Notices]
[Pages 45497-45500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18713]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2381]


Horizontal Approaches to Food Standards of Identity 
Modernization; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is

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announcing a public meeting entitled ``Horizontal Approaches to Food 
Standards of Identity Modernization.'' The purpose of the public 
meeting is to give interested persons an opportunity to discuss FDA's 
effort to modernize food standards of identity (SOI) and provide 
information about changes we could make to existing SOI, particularly 
changes that could be made across categories of standardized foods 
(i.e., horizontal changes), to provide flexibility for the development 
of healthier foods. We are also interested in discussing horizontal 
changes that would better facilitate innovation. This effort is part of 
the FDA's comprehensive, multiyear Nutrition Innovation Strategy (NIS) 
designed to improve healthy dietary behavior and help reduce 
preventable death and disease related to poor nutrition by, among other 
things, providing incentives for food manufacturers to produce products 
that have more healthful attributes.

DATES: The public meeting will be held on September 27, 2019, from 8:30 
a.m. to 5 p.m. Submit either electronic or written comments on this 
public meeting notice and request for comments by November 12, 2019. 
See the SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public meeting will be held at the Hilton Washington DC/
Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852. For more 
information on the hotel see http://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-rockville-hotel-and-executive-meeting-ctr-IADMRHF/index.html.
    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 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 12, 2019. 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'').

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-N-2381 for ``Horizontal Approaches to Food Standards of 
Identity Modernization.'' 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.
     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.gpo.gov/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.

FOR FURTHER INFORMATION CONTACT: 
    For questions about registering for the meeting or to register by 
phone: Mark Gifford, SIDEM, 1775 Eye St. NW, Suite 1150, Washington, DC 
20006, telephone: 240-393-4496, Fax: 202-495-2901, email: 
[email protected].
    For general questions about the meeting or for special 
accommodations due to a disability: 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, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

A. Introduction

    On January 11, 2018, FDA released its 2018 Strategic Policy Roadmap 
(https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm591993.htm), which focuses, in part, on efforts to empower consumers 
to make better and more informed decisions about their diets and 
health, foster the development of healthier food options, and expand 
the opportunities to use nutrition to reduce morbidity and mortality 
due to chronic disease. The roadmap highlights FDA's commitment to 
finding approaches to advance policies that better achieve these goals.
    On March 29, 2018, the Commissioner of Food and Drugs announced a 
comprehensive, multiyear FDA Nutrition Innovation Strategy

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(hereinafter the ``NIS'') (to access the speech, visit https://www.fda.gov/NewsEvents/Speeches/ucm603057.htm). The NIS focuses, among 
other things, on providing incentives for food manufacturers to produce 
products that have more healthful attributes. Under the NIS, FDA is 
seeking to modernize food SOI in a manner that will achieve three 
primary goals: (1) Protect consumers against economic adulteration; (2) 
maintain the basic nature, essential characteristics, and nutritional 
integrity of food; and (3) promote industry innovation and provide 
flexibility to encourage manufacturers to produce more healthful foods. 
To inform this effort, we seek information from interested stakeholders 
to learn what changes have occurred in food production and 
manufacturing that impact industry's ability to comply with current SOI 
regulations and what we should be aware of when reviewing and exploring 
how to modernize our SOI regulations. We are also interested in 
learning whether we can achieve our SOI modernization goals in ways 
that produce cost savings.
    Many foods have definitions and SOI established by law. FDA began 
establishing SOI to promote honesty and fair dealing in the interest of 
consumers shortly after the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) was enacted in 1938. Since then, we have established more than 280 
SOI for a wide variety of food products. SOI typically set forth 
permitted ingredients, both mandatory and optional, and sometimes 
specify the amount or proportion of each ingredient. Many SOI also 
designate the method of production. A food is misbranded if it purports 
to be or is represented as a food for which a SOI has been established 
but fails to conform to the standard. See 21 U.S.C. 343(g). Because we 
issued many SOI decades ago, various stakeholders have expressed 
concerns that many SOI are out of date and may impede innovation, 
including the ability to produce healthier foods.
    SOI protect consumers against economic adulteration and reflect 
consumers' expectations about food. They may also describe the basic 
nature and essential characteristics, including nutritional 
characteristics, of the food (see FDA's May 20, 2005, proposed rule 
entitled, ``Food Standards; General Principles and Food Standards 
Modernization'' (70 FR 29214) for a discussion of the ``basic nature'' 
and ``essential characteristics'' of food). As consumers continue to 
seek more nutritious and healthful food options, we seek to ensure that 
SOI meet these expectations. Modernizing SOI can give manufacturers the 
flexibility to improve the nutrition and healthfulness of standardized 
foods, promote honesty and fair dealing in the interest of consumers, 
and help achieve the goals of the NIS.
    On July 26, 2018, FDA held a public meeting to discuss the NIS 
(including SOI modernization) and give interested parties an 
opportunity to provide input. During the public meeting, many 
participants expressed general support for FDA exploring modernization 
options that could promote changes across all, or broad categories of, 
SOI to facilitate innovation and flexibility to reformulate products to 
produce more nutritious foods. Several participants highlighted that 
rapid advances in technology and science necessitated revisions to 
certain SOI. The participants, however, also stated that updating 
individual standards (some stakeholders have referred to this as a 
``vertical'' approach) would be time-consuming and may not be feasible 
given FDA's limited resources. They proposed that a horizontal approach 
that permits additional flexibility across all or broad categories of 
standardized foods could help resolve this issue by allowing FDA to 
efficiently make comprehensive changes that could impact many 
standardized foods. For example, several participants cited FDA's 
regulation entitled, ``Requirements for foods named by use of a 
nutrient content claim and a standardized term'' (21 CFR 130.10) as a 
potential model. This regulation provides for modified versions of 
certain standardized foods that bear descriptive names that are 
meaningful to consumers (e.g., ``fat free'' and ``low calorie''). Some 
participants also said we should consider consumer demand for healthful 
and nutritious foods as we explore how to modernize in ways that will 
allow food manufacturers to produce more nutritious food options. The 
NIS public meeting docket closed on October 11, 2018, and resulted in 
more than 5,000 comments. We have reviewed the comments and are using 
information provided to inform our strategy moving forward.
    There has been broad interest from stakeholders regarding 
horizontal approaches to SOI modernization. Some offered concrete 
proposals about the design and content of a regulation that creates a 
horizontal standard to advance SOI modernization. For example, in 
October 2006, the Grocery Manufacturers Association (GMA) submitted a 
Citizen Petition asking FDA to amend 21 CFR part 130 to modernize food 
standards (see Docket ID: FDA-2007-P-0463-0367). The Citizen Petition 
identified six categories of variations from food standards that GMA 
believed should be permitted to provide flexibility. Several comments 
submitted to the NIS docket cited variations outlined in the GMA 
Citizen Petition as examples of horizontal standard options we should 
consider as part of SOI modernization.
    To maximize our limited resources, we must consider efficient 
modernization approaches that will have the greatest potential impacts. 
As such, we are interested in learning more about horizontal approaches 
to SOI modernization that will encourage production of healthier foods 
and/or facilitate innovation, specifically allowing for use of new 
technologies and new or novel ingredients. We believe this focus 
supports the NIS goals of reducing the burden of chronic disease 
through improved nutrition. Furthermore, this will allow FDA to provide 
manufacturers with additional flexibility without adversely impacting 
the basic nature and essential characteristics of standardized foods.
    FDA is issuing this request for comment and will hold a public 
meeting on September 27, 2019, to gather data and information from 
stakeholders regarding horizontal approaches to SOI modernization.

B. Legal Authority

    Our authority to establish food standards is set forth in section 
401 of the FD&C Act (21 U.S.C. 341). Section 401 of the FD&C Act 
authorizes us to issue regulations fixing and establishing for any 
food, under its common or usual name so far as practicable, a 
reasonable definition and standard of identity, a reasonable standard 
of quality, or reasonable standards of fill of container when such 
action promotes honesty and fair dealing in the interest of consumers. 
The standards of identity, quality, and fill of container for foods 
regulated by FDA are codified in 21 CFR parts 130 to 169. FDA food 
standards are established under the common or usual name of a food.

II. Topics for Discussion at the Public Meeting

    The public meeting will explore horizontal approaches to SOI 
modernization that will support the goals of the NIS. We are interested 
in learning more about horizontal changes that would improve the 
nutrition or healthfulness of standardized foods and/or provide for 
flexibility and innovation in their production. We are considering all 
horizontal approaches that will ensure the basic nature and

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essential characteristics of food are maintained. We also invite 
comment on how these changes could be efficiently accomplished. For 
example, we would like to know whether horizontal SOI might be a means 
for implementing the changes and how such standards could be 
structured.
    The public meeting will begin with a plenary session, followed by 
breakout sessions that will discuss key topics relating to horizontal 
approaches to SOI modernization. Approximately 2 weeks before the 
meeting, we will post the public meeting agenda and additional 
background materials on the internet at: https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements. 
In addition to the opportunity to comment at the public meeting, there 
will be an opportunity for interested stakeholders to submit written 
comments following the meeting (see DATES).
    The first breakout session will explore nutrition topics. We are 
interested in learning what changes to existing SOI would encourage 
production of more nutritious foods. We are interested in hearing 
stakeholder perspectives regarding the role of nutrition in SOI 
modernization and how a horizontal approach to modernization could 
encourage production of more nutritious foods. We want to learn if 
current SOI pose barriers to production of more nutritious foods and, 
if so, understand how horizontal changes to standardized foods could 
help overcome these barriers. We also invite comments regarding how we 
could design a horizontal standard to provide manufacturers of 
standardized foods with the flexibility to reflect future advances in 
science and technology as they relate to improved nutrition.
    The second breakout session will discuss issues related to 
innovation and what horizontal approaches to modernization could better 
accommodate advances in science and technology. We are interested in 
learning how horizontal changes could provide the flexibility necessary 
to accommodate future industry innovation while ensuring standardized 
foods continue to meet consumer expectations and maintain the basic 
nature and essential characteristics of food. We are particularly 
interested in learning about horizontal changes to manufacturing 
processes and permitted ingredients that could promote innovation. We 
request that comments indicate the foods to which a proposed horizontal 
change would apply, the current requirement(s) in the SOI to which the 
change would apply, and the specific change requested (e.g., additional 
manufacturing processes permitted or ingredients permitted).
    The third breakout session will discuss issues related to consumer 
expectations and standardized foods. We are interested in learning what 
flexibility we can provide in a horizontal approach to modernization, 
while ensuring standardized foods continue to meet consumer 
expectations. We want to learn about consumers' shifting expectations 
and how horizontal changes could allow innovation and product 
reformulation to meet such demands. For example, comments to the NIS 
public meeting docket highlighted that consumers now demand healthier 
foods and products that meet specific dietary needs (e.g., ``gluten 
free'' products). As SOI are issued to ``promote honesty and fair 
dealing in the interest of consumers,'' we believe the consumer 
perspective is critical to understanding what flexibility we should 
consider when exploring horizontal changes to current SOI and invite 
comments on what, if any, limitations are appropriate to ensure 
standardized foods continue to meet consumer expectations.
    We will consider all comments made at this public meeting or 
received through the docket (see ADDRESSES) as we consider how 
horizontal changes could support our SOI modernization goals. 
Information concerning the FDA's NIS and more information on our work 
to modernize SOI can be found at https://www.fda.gov/food/food-labeling-nutrition/fda-nutrition-innovation-strategy.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website: https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability. Persons 
interested in attending this public meeting must register by 11:59 p.m. 
on September 20, 2019. Early registration is recommended because 
seating is limited; therefore, FDA may limit the number of participants 
from each organization. Registrants will receive confirmation when they 
have been accepted.
    If you need special accommodations due to a disability, please 
contact Juanita Yates (see FOR FURTHER INFORMATION CONTACT) no later 
than September 12, 2019.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during a public comment session or 
participate in a specific session, and which topic(s) you wish to 
address. We will do our best to accommodate requests to make public 
comments. We urge individuals and organizations with common interests 
to consolidate or coordinate their presentations, and request time for 
a joint presentation, or submit requests for designated representatives 
to participate in the focused sessions. All requests to make oral 
presentations must be received by September 12, 2019. We will determine 
the amount of time allotted to each presenter and the approximate time 
each oral presentation is to begin, and will select and notify 
participants. 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. No commercial or promotional 
material will be permitted to be presented or distributed at the public 
meeting.
    Persons attending FDA's public meetings are advised that FDA is not 
responsible for providing access to electrical outlets.
    Streaming Webcast of the public meeting: This public meeting will 
also be webcast. Webcast participants are asked to preregister at 
https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements.
    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 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements.

    Dated: August 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18713 Filed 8-28-19; 8:45 am]
 BILLING CODE 4164-01-P