2542 Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations 

The Rule 

This amendment to 14 CFR part 71 

amends the Class E airspace extending 

upward from 700 feet above the surface 

to within a 6.7-mile (increased from a 

6.6-mile) radius of Hereford Municipal 

Airport, Hereford, TX; and updates the 

geographic coordinates of the airport to 

coincide with the FAA’s aeronautical 

database. 

This action are the result of an 

airspace review caused by the 

decommissioning of the Hereford NDB 

which provided guidance to instrument 

procedures at this airport. 

FAA Order JO 7400.11, Airspace 

Designations and Reporting Points, is 

published yearly and effective on 

September 15. 

Regulatory Notices and Analyses 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current, is non-controversial and 

unlikely to result in adverse or negative 

comments. It, therefore: (1) Is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that only affects air traffic 

procedures and air navigation, it is 

certified that this rule, when 

promulgated, does not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

Environmental Review 

The FAA has determined that this 

action qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with FAA 

Order 1050.1F, ‘‘Environmental 

Impacts: Policies and Procedures,’’ 

paragraph 5–6.5.a. This airspace action 

is not expected to cause any potentially 

significant environmental impacts, and 

no extraordinary circumstances exist 

that warrant preparation of an 

environmental assessment. 

Lists of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for part 71 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g); 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order JO 7400.11F, 

Airspace Designations and Reporting 

Points, dated August 10, 2021, and 

effective September 15, 2021, is 

amended as follows: 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

ASW TX E5 Hereford, TX [Amended] 

Hereford Municipal Airport, TX 

(Lat. 34°51′39′′ N, long. 102°19′33′′ W) 

That airspace extending upward from 700 

feet above the surface within a 6.7-mile 

radius of Hereford Municipal Airport. 

Issued in Fort Worth, Texas, on January 10, 

2022. 

Martin A. Skinner, 

Acting Manager, Operations Support Group, 

ATO Central Service Center. 

[FR Doc. 2022–00566 Filed 1–14–22; 8:45 am] 

BILLING CODE 4910–13–P 

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. 

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, 

Katherine.Carlos@fda.hhs.gov. 

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, 


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Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations 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 §§ 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 

§§ 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: 

• 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; 

• Amend the unit of measure 

specified in two regulations to be 

consistent with the unit of measure used 

in the new analytical method; 

• Update the current incorporation by 

reference of the AOAC International 

Official Method of Analysis for 

determining sulfite concentrations in 

foods; and 

• 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: 

• Amends §§ 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; 

• Amends §§ 101.100(a)(4) and 

130.9(a) to add an LC–MS/MS method 

for determining sulfite concentrations in 

foods; and 

• Amends the unit of measure 

specified in §§ 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 § 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 § 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 § 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 

§ 101.100(a)(4), which describes the 

analytical method FDA uses to 

determine whether there is a detectable 


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2544 Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations 

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 § 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 

§ 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 § 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 §§ 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: 

• Our regulations at §§ 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 MonierWilliams 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 twostep 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 §§ 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.) 

• The final rule also amends 

§§ 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. 

• The final rule also amends the unit 

of measure specified in §§ 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. 

• 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. 


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Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations 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$] 

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

Benefits: 

Annualized Monetized $millions/year ........................... $0.13 

0.13 

$0.07 

0.07 

$0.20 

0.20 

2019 

2019 

7 

3 

10 

10 

Are cost savings. 

Are cost savings. 

Annualized Quantified ................................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ............................................................................ 

Costs: 

Annualized Monetized $millions/year ........................... 0.02 

0.02 

0.02 

0.02 

0.03 

0.02 

2019 

2019 

7 

3 

10 

10 

Annualized Quantified ................................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ............................................................................ 

Transfers: 

Federal Annualized Monetized $millions/year .............. ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

From/To ......................................................................... From: To: 

Other Annualized Monetized $millions/year ................. ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................


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2546 Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations 

TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF THE PROPOSED RULE—Continued 

[Millions of 2019$] 

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

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-impactanalyses-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-impactanalyses-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 

■ 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. 

■ 2. Amend § 101.100 by revising 

paragraph (a)(4) and adding paragraph 

(j) to read as follows: 

§ 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 fedreg.legal@nara.gov 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 MonierWilliams Method, Section 47.3.43, 


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Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations 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] 

■ 3. Remove and reserve appendix A to 

part 101. 

PART 130—FOOD STANDARDS: 

GENERAL 

■ 4. The authority citation for part 130 

continues to read as follows: 

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

371. 

■ 5. Amend § 130.9 by revising 

paragraph (a) and adding paragraph (c) 

to read as follows: 

§ 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 fedreg.legal@nara.gov or go to 

www.archives.gov/federal-register/cfr/ 

ibr-locations.html. 

(1) AOAC Official Method 990.28, 

Sulfites in Foods, Optimized MonierWilliams 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2021–N–0914] 

Medical Devices; Cardiovascular 

Devices; Classification of the 

Electrocardiograph Software for Overthe-Counter Use 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the electrocardiograph 

software for over-the-counter use into 

class II (special controls). The special 

controls that apply to the device type 

are identified in this order and will be 

part of the codified language for the 

electrocardiograph software for overthe-counter use’s classification. We are 

taking this action because we have 

determined that classifying the device 

into class II (special controls) will 

provide a reasonable assurance of safety 

and effectiveness of the device. We 

believe this action will also enhance 

patients’ access to beneficial innovative 

devices. 

DATES: This order is effective January 

18, 2022. The classification was 

applicable on September 11, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Luke Ralston, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2311, Silver Spring, 

MD 20993–0002, 301–796–6362, 

Luke.Ralston@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

electrocardiograph software for overthe-counter use as class II (special 

controls), which we have determined 

will provide a reasonable assurance of 

safety and effectiveness. In addition, we 

believe this action will enhance 

patients’ access to beneficial innovation, 

by placing the device into a lower 

device class than the automatic class III 

assignment. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

section 513(i) of the FD&C Act (see 21 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

We determine whether a new device is 

substantially equivalent to a predicate 

device by means of the procedures for 

premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act. Section 207 of the Food and 

Drug Administration Modernization Act 

of 1997 established the first procedure 

for De Novo classification (Pub. L. 105– 

115). Section 607 of the Food and Drug 

Administration Safety and Innovation 

Act modified the De Novo application 

process by adding a second procedure 

(Pub. L. 112–144). A device sponsor 

may utilize either procedure for De 

Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 


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