New Method for the Analysis of Sulfites in Foods, 2542-2547 [2022-00816]
Download as PDF
<![CDATA[
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
khammond on DSKJM1Z7X2PROD with RULES
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:
16:23 Jan 14, 2022
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
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.
VerDate Sep<11>2014
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
Jkt 256001
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
New Method for the Analysis of
Sulfites in Foods
I. Executive Summary
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: 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.
AGENCY:
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
SUMMARY:
PO 00000
Frm 00020
Fmt 4700
Sfmt 4700
A. Purpose of the Final Rule
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,
E:\FR\FM\18JAR1.SGM
18JAR1
Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations
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 .................
FD&C Act ........
Code of Federal Regulations.
Federal Food, Drug, and Cosmetic
Act.
Federal Register.
Liquid chromatography.
Mass spectrometry.
Parts per million.
United States Cod.
khammond on DSKJM1Z7X2PROD with RULES
FR ....................
LC ....................
MS ...................
ppm .................
U.S.C. ..............
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
16:23 Jan 14, 2022
Jkt 256001
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
III. Background
VerDate Sep<11>2014
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.
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
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
2543
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
E:\FR\FM\18JAR1.SGM
18JAR1
khammond on DSKJM1Z7X2PROD with RULES
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
VerDate Sep<11>2014
16:23 Jan 14, 2022
Jkt 256001
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
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
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.
E:\FR\FM\18JAR1.SGM
18JAR1
2545
Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations
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 10year 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
Benefits:
Annualized Monetized $millions/year ...........................
Annualized Quantified ...................................................
Primary
estimate
Low
estimate
High
estimate
$0.13
0.13
..................
..................
$0.07
0.07
..................
..................
$0.20
0.20
..................
..................
2019
2019
..................
..................
7
3
7
3
10
10
..................
..................
0.02
0.02
..................
..................
0.02
0.02
..................
..................
0.03
0.02
..................
..................
2019
2019
..................
..................
7
3
7
3
10
10
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
7
3
..................
..................
Year
dollars
Discount
rate
(%)
Period
covered
(years)
Qualitative ............................................................................
Costs:
Annualized Monetized $millions/year ...........................
Annualized Quantified ...................................................
khammond on DSKJM1Z7X2PROD with RULES
Qualitative ............................................................................
Transfers:
Federal Annualized Monetized $millions/year ..............
From/To .........................................................................
Other Annualized Monetized $millions/year .................
VerDate Sep<11>2014
16:23 Jan 14, 2022
Jkt 256001
PO 00000
From:
..................
..................
Frm 00023
To:
..................
..................
Fmt 4700
..................
..................
Sfmt 4700
..................
..................
E:\FR\FM\18JAR1.SGM
7
3
18JAR1
..................
..................
Notes
Are cost savings.
Are cost savings.
2546
Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations
TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF THE PROPOSED RULE—Continued
[Millions of 2019$]
Units
Primary
estimate
Category
Low
estimate
From/To .........................................................................
High
estimate
Discount
rate
(%)
Year
dollars
Period
covered
(years)
From:
Notes
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.
khammond on DSKJM1Z7X2PROD with RULES
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
VerDate Sep<11>2014
16:23 Jan 14, 2022
Jkt 256001
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.
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
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,
E:\FR\FM\18JAR1.SGM
18JAR1
Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations
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]
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.
Appendix A to Part 101 [Removed and
Reserved]
Dated: January 11, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
3. Remove and reserve appendix A to
part 101.
■
[FR Doc. 2022–00816 Filed 1–14–22; 8:45 am]
BILLING CODE 4164–01–P
PART 130—FOOD STANDARDS:
GENERAL
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
4. The authority citation for part 130
continues to read as follows:
■
Food and Drug Administration
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:
■
khammond on DSKJM1Z7X2PROD with RULES
§ 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 Monier-
VerDate Sep<11>2014
16:23 Jan 14, 2022
Jkt 256001
21 CFR Part 870
[Docket No. FDA–2021–N–0914]
Medical Devices; Cardiovascular
Devices; Classification of the
Electrocardiograph Software for Overthe-Counter Use
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Final amendment; final order.
AGENCY:
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:
SUMMARY:
I. Background
Upon request, FDA has classified the
electrocardiograph software for overthe-counter use as class II (special
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
2547
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
E:\FR\FM\18JAR1.SGM
18JAR1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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,
[email protected].
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:
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 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;
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
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:
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.)
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.
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.
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
[email protected] 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 [email protected] 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
