[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 [www.gpo.gov]
[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 https://www.regulations.gov 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 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, https://www.aoac.org/. 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, 
https://www.aoac.org/. 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..............................
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year..        0.02        0.02        0.03        2019           7          10  .....................................
                                                 0.02        0.02        0.02        2019           3          10  .....................................
    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 
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

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 https://www.regulations.gov. 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 https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

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 protected]</span></a> or go to www.archives.gov/federal-register/cfr/ibr-locations.html.
    (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 protected]</span></a> or go to 
www.archives.gov/federal-register/cfr/ibr-locations.html.
    (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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