[Federal Register Volume 85, Number 35 (Friday, February 21, 2020)]
[Proposed Rules]
[Pages 10107-10110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03437]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 130
[Docket No. FDA-1995-N-0062 (Formerly 1995N-0294)]
RIN 0910-AC54
Food Standards; General Principles and Food Standards
Modernization; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; reopening of the comment period.
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SUMMARY: The Food and Drug Administration (FDA or we) is reopening the
comment period for the proposed rule, published in the Federal Register
of May 20, 2005, entitled ``Food Standards; General Principles and Food
Standards Modernization,'' to establish a set of general principles for
food standards for FDA to use when considering whether to establish,
revise, or eliminate a food standard. The proposed rule was issued
jointly with the United States Department of Agriculture (USDA) and,
while FDA will continue to engage with USDA regarding the proposed
rule, we are reopening the comment period to receive new data,
information, or further comments only on FDA-specific aspects of the
proposed rule, including FDA's 13 general principles.
DATES: We are reopening the comment period on the proposed rule that
published in the Federal Register of May 20, 2005 (70 FR 29214). Submit
either electronic or written comments by April 21, 2020.
ADDRESSES: 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 April 21, 2020. The https://www.regulations.gov
[[Page 10108]]
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of April 21, 2020. 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-1995-N-0062 (formerly 1995N-0294) for ``General Principles and Food
Standards Modernization; Reopening of the Comment Period.'' 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.'' FDA 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.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.
FOR FURTHER INFORMATION CONTACT: Rumana Yasmeen, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-6060.
SUPPLEMENTARY INFORMATION:
I. Background on the Proposed Rule
In the Federal Register of May 20, 2005 (70 FR 29214), FDA and USDA
jointly issued a proposed rule entitled ``Food Standards; General
Principles and Food Standards Modernization,'' as a first step in
instituting a process to modernize FDA definitions and standards of
identity (and standards of quality and fill of container) consistent
with section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
341), and USDA's definitions and standards of identity or composition
under the Federal Meat Inspection Act and the Poultry Products
Inspection Act (21 U.S.C. 607(c) and 457(b)) (and standards of fill of
container). The proposed rule, if finalized, would establish general
principles that FDA and USDA would consider when determining whether to
establish, revise, or eliminate a food standard.
Although the general principles were mostly consistent between FDA
and USDA, a few principles were not identical. Because FDA and USDA
regulate different products under different statutory authorities, some
principles were developed to reflect specific FDA or USDA regulatory
needs and perspectives. FDA and USDA stated that adherence to
principles identified in the proposed rule would result in standards
that would (1) better promote honesty and fair dealing in the interest
of consumers and protect the public; (2) allow for technological
advances in food production; (3) be consistent with international food
standards to the extent feasible; and (4) be clear, simple, and easy to
use for both manufacturers and the agencies that enforce compliance
with the standards.
The Preliminary Regulatory Impact Analysis (PRIA) of the proposed
rule anticipated that the associated social costs of finalizing both
FDA and USDA principles would be small, however would likely yield
substantial benefits. The PRIA noted that:
Standards that contain unnecessary elements or that fail to
provide flexibility in terms of allowable food technology, may
generate unnecessary production costs, and impede technological
innovation in the food industry. Such standards may also serve as
effective barriers to competition, thereby raising product prices
and transferring resources from consumers to producers. Finally,
some standards may be inconsistent with international standards,
which may impede international trade. Impeding international trade
may also restrict competition and lead to higher product prices.
The PRIA stated that applying the principles set forth in the
proposed rule could help address these issues and that the benefits of
establishing the proposed principles outweighed the costs.
Interested persons were originally given until August 18, 2005, to
comment on these proposed general principles and to provide additional
information as described in the Request for Comments section of the
proposed rule. While comments received were generally supportive, FDA
and USDA did not finalize the proposed rule due
[[Page 10109]]
to resource constraints and competing priorities.
II. FDA Principles in the Proposed Rule
In the proposed rule, FDA proposed a set of 13 general principles
we would consider when establishing, revising, or eliminating a food
standard (see 70 FR 29214 at 29234 to 29235 (proposed 21 CFR 130.5(b)).
The first four general principles stated the purpose or function of a
food standard and were the most fundamental principles addressing
consumer economic protection. Therefore, if a food standard is
inconsistent with any one of these four principles, we would consider
eliminating it. The proposed rule also would revise or establish a new
food standard if it was consistent with the full set of 13 principles:
1. Promotes honesty and fair dealing in the interest of consumers.
2. Describes the basic nature of the food to ensure that consumers
are not misled by the name of the food and to meet consumers'
expectations of product characteristics and uniformity.
3. Reflects the essential characteristics of the food--or those
that define or distinguish a food or describe the distinctive
properties of a food and that may contribute to achieving the food's
basic nature or may reflect relevant consumer expectations of a food
product.
4. Ensures food does not appear to be better or of a greater value
than it is. May be used as a vehicle to improve the overall nutritional
quality of the food supply.
5. Contains clear and easily understood requirements to facilitate
compliance by food manufacturers.
6. Permits maximum flexibility in the technology used to prepare
the food provided the technology does not alter the basic nature or
essential characteristics, or adversely affect the nutritional quality
or safety, of the food. Provides for any suitable, alternative
manufacturing process that accomplishes the desired effect, and
describes ingredients as broadly and generically as feasible.
7. Harmonizes with international food standards to the extent
feasible.
8. Is simple, easy to use, and consistent among all food standards.
Includes only those elements that are necessary to define the basic
nature and essential characteristics of a particular food, without
unnecessary details.
9. Allows for variations in the physical attributes of the food.
Where necessary to provide for specific variations in the physical
attributes of a food within the standard, variations are consolidated
into a single food standard.
10. Incorporates general requirements that pertain to multiple food
standards of a commodity group into general regulatory provisions that
address the commodity group whenever possible.
11. Considers other relevant regulations. Any specific requirements
for foods intended for further manufacturing are incorporated within
the reference standard rather than provided as a separate standard.
12. Provides terms that can be used to name a food and allows terms
to be used in any order that is not misleading to consumers.
13. Names of ingredients and functional use categories in a food
standard should be consistent with other food standards and relevant
regulations in this chapter, and, when appropriate, incorporate current
scientific nomenclature.
III. FDA's Current Food Standards Modernization Efforts
Since publication of the proposed rule, FDA announced our Nutrition
Innovation Strategy (NIS) with the goal of helping to reduce
preventable death and disease related to poor nutrition. The NIS
focuses on, among other things, providing incentives for food
manufacturers to produce products that have more healthful attributes.
Under the NIS, FDA is seeking to modernize food standards 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.
In July 2018, FDA held a public meeting on the NIS.\1\ At the
meeting, we led a breakout session to discuss our food standards
modernization goals and, among other things, to learn from stakeholders
what FDA should be aware of when reviewing our food standard
regulations and exploring how to modernize. At this public meeting, and
in comments submitted to the public meeting docket, stakeholders
expressed general support for FDA continuing its work with USDA to
finalize the proposed rule. However, stakeholders also shared that,
given the time that has passed since its publication, we should reopen
the comment period to allow the public the opportunity to provide data
and information on changes that have occurred in manufacturing, food
technology, market trends, and nutrition science that FDA should
consider when determining next steps for the proposed rule.
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\1\ For more information, please visit FDA's website at: https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-discuss-fdas-nutrition-innovation-strategy-07262018-07262018 or see the public docket FDA-2018-N-2381.
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While FDA intends to work with USDA if we pursue finalization of
the proposed rule, for purposes of this notice we are only interested
in comments, data, and information on FDA-specific aspects of the
proposed rule, including the 13 general principles listed above.
IV. Additional Issues for Consideration
In response to stakeholder comments and to inform our decision
regarding whether to proceed with finalizing the proposed rule, we seek
new information and public comment on how we could create general
principles for establishing new food standards and for revising or
eliminating existing food standards. While FDA and USDA jointly issued
the proposed rule, we are only seeking comments on the FDA-specific
aspects of the proposal. We encourage comments to be as specific as
possible and, when possible, to provide data and information for FDA to
consider.
While the public may comment on any FDA aspects of the proposed
rule, we are particularly interested in comments on the following
questions:
1. Should FDA finalize the proposed rule? Why or why not?
2. Are there general FDA principles that should be added,
eliminated, revised, or retained?
a. What is the specific principle?
b. Why should the principle be added, eliminated, revised, or
retained?
c. Are there specific product examples that illustrate why a
principle should be added, eliminated, revised, or retained?
3. What specific revisions should FDA make to the proposed rule's
principles or framework to better reflect our modernization goals of:
a. Protecting consumers against economic adulteration?
b. Ensuring standardized foods continue to meet consumer
expectations?
c. Maintaining the basic nature, essential characteristics, and
nutritional integrity of food?
d. Promoting industry innovation?
e. Providing flexibility to produce more healthful foods?
f. Facilitating additional flexibility across all or broad
categories of standardized foods?
4. How should FDA weigh the general principles?
a. The proposed rule stated that the first four principles were the
most fundamental to addressing consumer
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economic protection and therefore, FDA would consider eliminating a
food standard if it is inconsistent with any of these four principles.
i. Please explain whether you agree with this framework.
ii. If you do not agree, what principles should FDA consider when
deciding whether to eliminate a food standard?
b. The proposed rule explained that FDA would consider revising or
establishing a new food standard only if it was consistent with all 13
principles.
i. Please explain whether you agree with this framework.
ii. If you do not agree, what principles should FDA consider when
deciding whether to revise or establish a new food standard?
5. What explanation is needed to provide more clarity, certainty,
or context regarding:
a. The rationale for the principles?
b. How FDA will consider the principles when evaluating whether to
eliminate, revise, or establish a new food standard?
c. How stakeholders should use the principles to inform the
preparation of petitions requesting that FDA eliminate, revise, or
establish a new food standard?
6. What additional information should FDA consider when evaluating
the costs, benefits, and estimates of the annual reporting burden of
the proposed rule?
Dated: February 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03437 Filed 2-20-20; 8:45 am]
BILLING CODE 4164-01-P