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Rule2022-00816

New Method for the Analysis of Sulfites in Foods

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Published

January 18, 2022

Effective

February 17, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or we) is amending the requirements that specify the analytical method FDA uses to determine the concentration of sulfites in food. This action, among other things, provides a new analytical method that can be used as an alternative to the existing analytical method and will help improve the efficiency of FDA testing for sulfites in food.

Full Text

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<title>Federal Register, Volume 87 Issue 11 (Tuesday, January 18, 2022)</title>
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[Federal Register Volume 87, Number 11 (Tuesday, January 18, 2022)]
[Rules and Regulations]
[Pages 2542-2547]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00816]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101 and 130

[Docket No. FDA-2019-N-0463]
RIN 0910-AI02

New Method for the Analysis of Sulfites in Foods

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
requirements that specify the analytical method FDA uses to determine
the concentration of sulfites in food. This action, among other things,
provides a new analytical method that can be used as an alternative to
the existing analytical method and will help improve the efficiency of
FDA testing for sulfites in food.

DATES: This rule is effective February 17, 2022. The incorporation by
reference of certain publications listed in the rule is approved by the
Director of the Federal Register as of February 17, 2022.

ADDRESSES: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the
docket number found in brackets in the heading of this final rule 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: Katherine S. Carlos, Center for Food
Safety and Applied Nutrition (HFS-706), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740-3835, 240-402-1835,
<a href="/cdn-cgi/l/email-protection#a1eac0d5c9c4d3c8cfc48fe2c0d3cdced2e1c7c5c08fc9c9d28fc6ced7"><span class="__cf_email__" data-cfemail="2863495c404d5a41464d066b495a44475b684e4c490640405b064f475e">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. Need for the Regulation/History of This Rulemaking
B. Summary of Comments to the Proposed Rule
C. General Overview of the Final Rule
D. Incorporation by Reference
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
VI. Effective/Compliance Date(s)
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. Reference

I. Executive Summary

A. Purpose of the Final Rule

FDA is issuing this final rule primarily to provide an alternative
to the current analytical method that is incorporated by reference and
establish a new, more efficient analytical method that FDA may use for
determining sulfite concentrations in foods.

B. Summary of the Major Provisions of the Final Rule

The final rule updates the current incorporation by reference of
the AOAC International Official Method of Analysis for determining
sulfite concentrations in foods and removes appendix A to part 101 (21
CFR part 101) as no longer necessary. The final rule also adds a
recently developed,

[[Page 2543]]

accurate, and more efficient analytical method that FDA will use to
determine sulfite concentrations in foods. The addition of this method
does not affect parties other than FDA and will not affect industry's
disclosure obligations. Manufacturers, for example, are free to use any
scientifically adequate method to determine sulfite concentrations in
their foods.

C. Legal Authority

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that
all of the ingredients in a nonstandardized food be declared on the
label of that food unless FDA has exempted the ingredients from such
requirements. The FD&C Act also states that a food is misbranded if its
labeling is false or misleading in any particular and permits FDA to
promulgate regulations for the efficient enforcement of the FD&C Act.
The final rule amends part 101 under sections 403(i)(2), 403(a),
201(n), and 701(a) of the FD&C Act (21 U.S.C. 343(i)(2), 21 U.S.C.
343(a), 21 U.S.C. 321(n), and 21 U.S.C. 371(a)).

D. Costs and Benefits

We estimate that this final rule will produce benefits in the form
of cost savings from time saved by using the liquid chromatography (LC)
tandem mass spectrometry (MS) method (LC-MS/MS method). Over a 10-year
time horizon, at a three percent discount rate, the present value of
estimated benefits is $1.08 million, with a lower bound of $0.57
million and an upper bound of $1.72 million. At a seven percent
discount rate, the present value of estimated benefits is $0.89
million, with a lower bound of $0.47 million and an upper bound of
$1.41 million. Annualized estimated benefits range from $0.07 million
to $0.2 million per year, with a primary estimate of $0.13 million per
year, using either a three or seven percent discount rate.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

------------------------------------------------------------------------
Abbreviation What it means
------------------------------------------------------------------------
CFR................................. Code of Federal Regulations.
FD&C Act............................ Federal Food, Drug, and Cosmetic
Act.
FR.................................. Federal Register.
LC.................................. Liquid chromatography.
MS.................................. Mass spectrometry.
ppm................................. Parts per million.
U.S.C............................... United States Cod.
------------------------------------------------------------------------

III. Background

A. Need for the Regulation/History of This Rulemaking

FDA is updating regulations that include an outdated incorporation
by reference as specified in this final rule and adding a recently
developed, accurate, and more efficient analytical method of analysis
for determining sulfite concentrations in foods.
FDA's food labeling regulations require that sulfites present at 10
parts per million (ppm) or more be labeled on foods. (See Sec. Sec.
101.100(a)(4) and 130.9(a) (21 CFR 101.100(a)(4) and 130.9(a))).
Sulfites are widely used food preservatives that have been shown to
produce allergic-type responses in humans, and the presence of sulfites
in foods may have serious health implications for those persons who are
intolerant of sulfites. The analytical method we use for determining
sulfite concentrations in foods is specified at Sec. Sec.
101.100(a)(4) and 130.9(a), partially through incorporation by
reference.
In the Federal Register of September 17, 2019 (84 FR 48809), we
published a proposed rule that would:
<bullet> Provide an alternative to the current analytical method
that is incorporated by reference and establish a new, more efficient
analytical method that FDA could use for determining sulfite
concentrations in foods;
<bullet> Amend the unit of measure specified in two regulations to
be consistent with the unit of measure used in the new analytical
method;
<bullet> Update the current incorporation by reference of the AOAC
International Official Method of Analysis for determining sulfite
concentrations in foods; and
<bullet> Remove appendix A to part 101, as no longer necessary.

B. Summary of Comments to the Proposed Rule

Two comments to the proposed rule expressed general support. For
example, one comment said that we should ``take up this new method''
and should do all that we can ``to continue to use the best science
available'' to protect consumers. The other comment said that the rule
would benefit consumer safety. We received no other comments.

C. General Overview of the Final Rule

The final rule:
<bullet> Amends Sec. Sec. 101.100(a)(4) and 130.9(a) to replace
the existing incorporation by reference with ``AOAC Official Method
990.28, Sulfites in Foods, Optimized Monier-Williams Method,'' Section
47.3.43, Official Methods of Analysis, 21st Edition (2019), and to
remove appendix A to part 101. The existing incorporation by reference
was to the 14th edition, which was published in 1984;
<bullet> Amends Sec. Sec. 101.100(a)(4) and 130.9(a) to add an LC-
MS/MS method for determining sulfite concentrations in foods; and
<bullet> Amends the unit of measure specified in Sec. Sec.
101.100(a)(4) and 130.9(a) to include milligrams per kilogram, which is
equivalent to parts per million, to be consistent with the unit of
measure specified in the new LC-MS/MS method.

D. Incorporation by Reference

FDA is incorporating by reference ``AOAC Official Method 990.28,
Sulfites in Foods, Optimized Monier-Williams Method,'' Section 47.3.43,
Official Methods of Analysis, 21st Edition (2019). A copy of the
material can be obtained from AOAC International, 2275 Research Blvd.,
Ste. 300, Rockville, MD 20850-3250, 301-924-7077 ext. 170, <a href="https://www.aoac.org/">https://www.aoac.org/</a>. This method is an updated version of the method
currently referenced in FDA's regulations as the method that FDA uses
to determine sulfite concentrations in foods.
FDA is also incorporating by reference ``Determination of Sulfite
in Food by Liquid Chromatography Tandem Mass Spectrometry:
Collaborative Study,'' Katherine S. Carlos and Lowri S. De Jager,
Journal of AOAC International, Vol. 100, No. 6 pp. 1785-1794. A copy of
the material can be obtained from AOAC International, 2275 Research
Blvd., Ste. 300, Rockville, MD 20850-3250, 301-924-7077 ext. 170,
<a href="https://www.aoac.org/">https://www.aoac.org/</a>. The study describes an LC-MS/MS method that FDA
can use as an alternative to AOAC Official Method 990.28 to determine
sulfite concentrations in foods.
On our own initiative, we have revised the rule to add another
location where the referenced materials can be found. For example, the
proposed rule, at Sec. 101.100(a)(4)(i) and (ii), stated that the
referenced materials are available from AOAC International and are
available for inspection at the National Archives and Records
Administration (NARA). The final rule now contains a new Sec.
101.100(j), which states that the referenced materials are available
from AOAC International, are available for inspection at NARA, and also
are available at FDA's Dockets Management Staff, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. We made a similar change to Sec. 130.9.

IV. Legal Authority

FDA is issuing this final rule to amend part 101 under sections
403(i)(2), 403(a), 201(n), and 701(a) of the FD&C Act. Specifically,
FDA is amending Sec. 101.100(a)(4), which describes the analytical
method FDA uses to determine whether there is a detectable

[[Page 2544]]

amount of sulfite in a finished nonstandardized food.
Section 403(i)(2) of the FD&C Act requires that all of the
ingredients in a nonstandardized food be declared on the label of that
food unless FDA has exempted the ingredients from such requirements.
FDA established such an exemption in Sec. 101.100(a)(3) for
``incidental additives'' that are present in foods at insignificant
levels and that do not have any technical or functional effect in the
foods. Under Sec. 101.100(a)(4), sulfiting agents will be considered
to be present in foods in insignificant amounts only if no detectable
amount of sulfite is present in the finished food; a detectable amount
of a sulfiting agent is 10 parts per million (ppm) or more.
Additionally, section 701 of the FD&C Act permits FDA to promulgate
regulations for the efficient enforcement of the FD&C Act. Updating the
analytical method FDA will use to determine whether there is a
detectable amount of sulfites in a finished nonstandardized food will
allow FDA to use current scientific technology for the efficient
enforcement of the food labeling requirements.
We also are amending parts 101 and 130 under sections 403(a) and
201(n) of the FD&C Act. Pursuant to Sec. 130.9, standardized foods
containing sulfiting agents that are functional or that are present in
the finished food at a detectable amount (10 ppm or more) are deemed
misbranded unless the presence of the sulfiting agents is declared on
the label. This provision also describes the analytical methods, which
are the same as in part 101, for determining the presence of sulfiting
agents in food. Section 403(a) of the FD&C Act states that a food is
misbranded if its labeling is false or misleading in any particular.
Under section 201(n) of the FD&C Act, the extent to which labeling
fails to reveal material facts with respect to the consequences that
may result from the use of an article under the conditions of use in
the labeling or as customary or usual shall be taken into account in
determining whether the labeling of that article is misleading. Because
sulfiting agents can cause allergic-type responses of unpredictable
severity, the presence of a detectable amount of sulfites (as defined
at Sec. Sec. 101.100(a)(4) and 130.9 as 10 ppm or more of sulfites) in
a food is a material fact. Therefore, the failure to label a food as
containing sulfiting agents renders that label misleading and the food
misbranded under sections 403(a) and 201(n) of the FD&C Act.
The final rule updates the incorporation by reference for the
current analytical method in parts 101 and 130 and also identifies a
new analytical method that we can use in testing for sulfites in foods
to determine compliance. The final rule does not require other entities
to use these methods. Other entities are free to determine the
correlation between the official FDA-designated methods and the
entity's scientifically appropriate method of choice for determining
sulfite concentrations in foods and to use their method of choice as
they see fit, recognizing that FDA will rely on the methods established
by this rulemaking.

V. Comments on the Proposed Rule and FDA Response

There were two comments to the proposed rule. Both comments
expressed general support for the rule.
As the comments did not raise any issues, we have not revised the
rule in response to the comments. However, as mentioned earlier, we
have, on our own initiative, revised the citation to refer to the
``Official Methods of Analysis'' instead of ``Official Methods of
Analysis of AOAC INTERNATIONAL'' to correspond to how the publication
is named currently.
We describe the final rule as follows:
<bullet> Our regulations at Sec. Sec. 101.100(a)(4) and 130.9(a)
specify the analytical method that FDA uses for determining sulfite
concentrations in food. Both regulations establish the method of
analysis in two steps. The first step incorporates by reference
Sections 20.123-20.125, ``Total Sulfurous Acid,'' in ``Official Methods
of Analysis of the Association of Official Analytical Chemists,'' 14th
Ed. (1984); this method is known as the Monier-Williams method. The
second step refines the Monier-Williams method to improve accuracy and
reproducibility and make the method suitable for detecting sulfite
concentrations as low as 10 ppm; the modifications are included in
appendix A at part 101. Collectively, the Monier-Williams method with
the appendix A at part 101 modifications is referred to as the
``optimized Monier-Williams method.''
After we incorporated by reference the Monier-Williams method and
implemented the modifications to that method in appendix A at part 101,
the AOAC amended the Official Methods of Analysis to include ``Official
Method 990.28, Optimized Monier-Williams Method,'' which is the same as
the two-step process in FDA's regulations; i.e., the Monier-Williams
method and the refinements to the Monier-Williams method in appendix A
at part 101. Consequently, the final rule revises our regulations to
reflect the citation to the current AOAC method for determining sulfite
concentrations in food but does not result in a change in FDA
methodology. Specifically, the final rule amends Sec. Sec.
101.100(a)(4) and 130.9(a) to replace the existing incorporation by
reference with ``AOAC Official Method 990.28, Sulfites in Foods,
Optimized Monier-Williams Method,'' Section 47.3.43, Official Methods
of Analysis, 21st Edition (2019), and to remove appendix A at part 101.
(On our own initiative, we also revised the citation to refer to the
Official Methods of Analysis instead of Official Methods of Analysis of
AOAC INTERNATIONAL to correspond to how the publication is named
currently.)
<bullet> The final rule also amends Sec. Sec. 101.100(a)(4) and
130.9(a) to add an LC-MS/MS method for determining sulfite
concentrations in foods. This method is a faster and more sensitive way
to determine sulfite concentrations in foods. FDA's current methodology
is an acceptable method for quantifying sulfites, but (among other
things) is time-consuming, has a method detection limit of 10 ppm, and
is unable to accurately determine sulfite concentrations in some
samples. The LC-MS/MS method is a more rapid, specific alternative to
Official Method 990.28, with a lower detection limit, and has been
validated by other labs to ensure its accuracy for widespread use.
Sample preparation using the LC-MS/MS method involves routine
extraction techniques that can easily be batched, allowing for the
completion of as many as 30 samples by a single analyst in a single
day. By using the LC-MS/MS method, FDA can improve efficiency in
testing and better enforce the labeling requirements for sulfites.
<bullet> The final rule also amends the unit of measure specified
in Sec. Sec. 101.100(a)(4) and 130.9(a) to include milligrams per
kilogram, which is equivalent to parts per million, to be consistent
with the unit of measure specified in the new analytical method.
<bullet> As explained earlier in section III, we also revised the
final rule to restate where the referenced materials can be found and
included FDA's Dockets Management Staff as a location where the
referenced materials can be found.

VI. Effective/Compliance Date(s)

The preamble to the proposed rule said that we would make any final
rule resulting from the rulemaking effective 30 days after its date of
publication in the Federal Register (84 FR 48809 at 48812).
We did not receive any comments on the proposed effective date.
Therefore, the final rule will become effective on February 17, 2022.

[[Page 2545]]

VII. Economic Analysis of Impacts

We have examined the impacts of this rule under Executive Order
12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C.
601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 12866 and 13563 direct us to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). We believe
that the final rule is not a significant regulatory action as defined
by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the scope of this rule is limited to FDA, we certify
that the final rule will not have a significant economic impact on a
substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $158
million, using the most current (2020) Implicit Price Deflator for the
Gross Domestic Product. The final rule will not result in an
expenditure in any year that meets or exceeds this amount.
The final rule amends the regulations that specify the method of
analysis that FDA uses to determine the concentration of sulfites in
foods. The currently specified method of analysis is the optimized
Monier-Williams method. The final rule updates the incorporation by
reference for FDA's current methodology and adds to this a recently
developed, accurate, and more efficient analytical method of analysis,
referred to as the LC-MS/MS method. The LC-MS/MS method will serve as
the primary method used by FDA to determine sulfite concentrations in
foods.
The benefits of this final rule are the cost savings, in the form
of time savings, associated with use of the LC-MS/MS method. There is
no impact from the update to the incorporation by reference for FDA's
current methodology (i.e., the optimized Monier-Williams method)
because only the reference will change, not the method. Over a 10-year
time horizon, at a three percent discount rate, the present value of
estimated benefits is $1.08 million, with a lower bound of $0.57
million and an upper bound of $1.72 million. At a seven percent
discount rate, the present value of estimated benefits is $0.89
million, with a lower bound of $0.47 million and an upper bound of
$1.41 million. In table 1, annualized estimated benefits range from
$0.07 million to $0.2 million per year, with a primary estimate of
$0.13 million per year, using either a three or seven percent discount
rate.
The cost of this final rule consists of both one-time validation
costs and recurring materials costs associated with use of the LC-MS/MS
method. Over a 10-year time horizon, at a three percent discount rate,
the present value of total estimated costs is $0.20 million, with a
lower bound of $0.19 million and an upper bound of $0.21 million. At a
seven percent discount rate, the present value of total estimated costs
is $0.17 million, with a lower bound of $0.16 million and an upper
bound of $0.18 million. In table 1, estimated annualized costs are
$0.02 million per year, using either a three or seven percent discount
rate.
The estimated net benefits of this final rule are defined as the
difference between the estimated benefits and the estimated costs of
the rule. Over a 10-year time horizon, at a three percent discount
rate, the present value of estimated net benefits ranges from $0.38
million to $1.51 million, with a primary estimate of $0.88 million. At
a seven percent discount rate, the present value of estimated net
benefits ranges from $0.31 million to $1.24 million, with a primary
estimate of $0.72 million. Using either a three or seven percent
discount rate, annualized estimated net benefits range from $0.04
million to $0.18 million per year, with a primary estimate of $0.10
million per year.

Table 1--Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule
[Millions of 2019$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year.. $0.13 $0.07 $0.20 2019 7 10 Are cost savings.
0.13 0.07 0.20 2019 3 10 Are cost savings.
Annualized Quantified................ .......... .......... .......... .......... 7 .......... .....................................
.......... .......... .......... .......... 3 .......... .....................................
--------------------------------------------------------------------------------------------------------------
Qualitative..............................

--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized .......... .......... .......... .......... 7 .......... .....................................
$millions/year. .......... .......... .......... .......... 3 .......... .....................................
--------------------------------------------------------------------------------------------------------------
From/To.............................. From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized $millions/ .......... .......... .......... .......... 7 .......... .....................................
year. .......... .......... .......... .......... 3 .......... .....................................
--------------------------------------------------------------------------------------------------------------

[[Page 2546]]

From/To.............................. From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government....
Small Business.......................
Wages................................
Growth...............................
--------------------------------------------------------------------------------------------------------------------------------------------------------

We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 1) and at
<a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.

VIII. Analysis of Environmental Impact

We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

X. Federalism

We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that would have a substantial direct effect on one
or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive order and,
consequently, a tribal summary impact statement is not required.

XII. Reference

The following reference is on display in the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

1. FDA, ``Amendment to Add a New Method for the Analysis of Sulfites
in Foods: Final Regulatory Impact Analysis,'' 2020. Also available
at <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.

List of Subjects

21 CFR Part 101

Food labeling, Incorporation by reference, Nutrition, Reporting and
recordkeeping requirements.

21 CFR Part 130

Food additives, Food grades and standards, Incorporation by
reference.

Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
parts 101 and 130 are amended as follows:

PART 101--FOOD LABELING

0
1. The authority citation for part 101 continues to read as follows:

Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
2. Amend Sec. 101.100 by revising paragraph (a)(4) and adding
paragraph (j) to read as follows:

Sec. 101.100 Food; exemptions from labeling.

(a) * * *
(4) For the purposes of paragraph (a)(3) of this section, any
sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite,
potassium bisulfite, sodium metabisulfite, and potassium metabisulfite)
that has been added to any food or to any ingredient in any food and
that has no technical effect in that food will be considered to be
present in an insignificant amount only if no detectable amount of the
agent is present in the finished food. A detectable amount of sulfiting
agent is 10 parts per million (ppm or mg/kg) or more of the sulfite in
the finished food. Compliance with this paragraph (a)(4) will be
determined using either:
(i) Determination of Sulfite in Food by Liquid Chromatography
Tandem Mass Spectrometry; or
(ii) AOAC Official Method 990.28.
* * * * *
(j) The standards required in this section are incorporated by
reference into this section with the approval of the Director of the
Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved
material is available for inspection at the Food and Drug
Administration's, Dockets Management Staff, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, and available from the other
sources listed in this paragraph (j). It is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, email
<a href="/cdn-cgi/l/email-protection#4a2c2f2e382f2d64262f2d2b260a242b382b642d253c"><span class="__cf_email__" data-cfemail="3a5c5f5e485f5d14565f5d5b567a545b485b145d554c">[email&#160;protected]</span></a> or go to <a href="http://www.archives.gov/federal-register/cfr/ibr-locations.html">www.archives.gov/federal-register/cfr/ibr-locations.html</a>.
(1) AOAC International, 2275 Research Blvd., Ste. 300, Rockville,
MD 20850-3250.
(i) AOAC Official Method 990.28, Sulfites in Foods, Optimized
Monier-Williams Method, Section 47.3.43,

[[Page 2547]]

Official Methods of Analysis, 21st edition, 2019.
(ii) Determination of Sulfite in Food by Liquid Chromatography
Tandem Mass Spectrometry: Collaborative Study, Katherine S. Carlos and
Lowri S. De Jager; Journal of AOAC International, Vol. 100, No. 6,
2017, pp. 1785-1794.
(2) [Reserved]

Appendix A to Part 101 [Removed and Reserved]

0
3. Remove and reserve appendix A to part 101.

PART 130--FOOD STANDARDS: GENERAL

0
4. The authority citation for part 130 continues to read as follows:

Authority: 21 U.S.C. 321, 336, 341, 343, 371.

0
5. Amend Sec. 130.9 by revising paragraph (a) and adding paragraph (c)
to read as follows:

Sec. 130.9 Sulfites in standardized food.

(a) Any standardized food that contains a sulfiting agent or
combination of sulfiting agents that is functional and provided for in
the applicable standard or that is present in the finished food at a
detectable concentration is misbranded unless the presence of the
sulfiting agent or agents is declared on the label of the food. A
detectable amount of sulfiting agent is 10 parts per million (ppm or
mg/kg) or more of the sulfite in the finished food. The concentration
of sulfite in the finished food will be determined using either:
(1) Determination of Sulfite in Food by Liquid Chromatography
Tandem Mass Spectrometry; or
(2) AOAC Official Method 990.28.
* * * * *
(c) The standards required in this section are incorporated by
reference into this section with the approval of the Director of the
Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved
material is available for inspection at the Food and Drug
Administration, Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500, and available from AOAC
International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-3250.
It is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, email <a href="/cdn-cgi/l/email-protection#224447465047450c4e4745434e624c4350430c454d54"><span class="__cf_email__" data-cfemail="b2d4d7d6c0d7d59cded7d5d3def2dcd3c0d39cd5ddc4">[email&#160;protected]</span></a> or go to
<a href="http://www.archives.gov/federal-register/cfr/ibr-locations.html">www.archives.gov/federal-register/cfr/ibr-locations.html</a>.
(1) AOAC Official Method 990.28, Sulfites in Foods, Optimized
Monier-Williams Method, Section 47.3.43, Official Methods of Analysis,
21st edition, 2019.
(2) Determination of Sulfite in Food by Liquid Chromatography
Tandem Mass Spectrometry: Collaborative Study, Katherine S. Carlos and
Lowri S. De Jager; Journal of AOAC International, Vol. 100, No. 6,
2017, pp. 1785-1794.

Dated: January 11, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2022-00816 Filed 1-14-22; 8:45 am]
BILLING CODE 4164-01-P

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