[Federal Register Volume 84, Number 180 (Tuesday, September 17, 2019)]
[Proposed Rules]
[Pages 48809-48815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19862]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 101 and 130
[Docket No. FDA-2019-N-0463]
RIN 0910-A102
Addition of a New Method for the Analysis of Sulfites in Foods
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
amend the requirements
[[Page 48810]]
that specify the analytical method FDA uses to determine the
concentration of sulfites in food. This action, if finalized, would,
among other things, provide a new analytical method that can be used as
an alternative to the existing analytical method and should improve the
efficiency of FDA testing for sulfites in food.
DATES: Submit either electronic or written comments on the proposed
rule by October 17, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 17, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 17, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-N-0463 for ``Amendment to Add a New Method for the Analysis of
Sulfites in Foods.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: 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 Proposed Rule
B. Summary of the Major Provisions of the Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Background
III. Legal Authority
IV. Description of the Proposed Rule
V. Incorporation by Reference
VI. Proposed Effective Date
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. References
I. Executive Summary
A. Purpose of the Proposed Rule
FDA is issuing this proposed 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 could use for determining sulfite concentrations in foods. This
action is part of FDA's implementation of Executive Orders 13771 and
13777. Under these Executive Orders, FDA is comprehensively reviewing
existing regulations to identify opportunities for repeal, replacement,
or modification that will result in meaningful burden reduction while
allowing us to achieve our public health mission and fulfill statutory
obligations.
B. Summary of the Major Provisions of the Proposed Rule
This proposed rule, if finalized, would 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 (21 CFR part 101), as no longer necessary. The
rule would also add a recently developed, accurate, and more efficient
analytical method to determine sulfite concentrations in foods. If
finalized, FDA would use this more modern method; the addition of this
method would not affect parties other than FDA. The addition of this
method would not affect industry's disclosure obligations.
Manufacturers, for example, would be free to use any method to
[[Page 48811]]
determine sulfite concentrations in their foods.
C. Legal Authority
FDA is issuing this proposed rule to amend part 101 under sections
403(i)(2), 403(a), 201(n), and 701(a) (21 U.S.C. 343(i)(2), 21 U.S.C.
343(a), 21 U.S.C. 321(n), and 371(a)) of the FD&C Act.
D. Costs and Benefits
The benefit of this proposed rule would be the cost savings, in the
form of time savings, associated with use of the new method. We
estimate that, at the mean, the present value of the benefits of this
proposed rule is $1.0 million using a 3 percent discount rate and $0.9
million using a 7 percent discount rate (2017$). The cost of this
proposed rule would consist of both one-time validation costs and
materials costs associated with use of the new method. We estimate
that, at the mean, the present value of the costs of this proposed rule
would be $0.2 million using either a 3 or a 7 percent discount rate
(2017$). At the mean, the estimated present value of the net benefits
of this proposed rule would be $0.8 million using a 3 percent discount
rate and $0.7 million using a 7 percent discount rate (2017$).
II. Background
Executive Order 13777, ``Enforcing the Regulatory Reform Agenda''
(https://www.govinfo.gov/content/pkg/FR-2017-03-01/pdf/2017-04107.pdf,
82 FR 12285 (March 1, 2017)) was issued on February 24, 2017. One
provision in the Executive Order requires agencies to evaluate existing
regulations and make recommendations to the Agency head regarding their
repeal, replacement, or modification, consistent with applicable law.
As part of this initiative, FDA is proposing to update regulations that
include an outdated incorporation by reference as specified in this
proposed rule and add 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
more than 10 parts per million (ppm) be labeled on foods. (See Sec.
101.100(a)(4) and Sec. 130.9(a) (21 CFR 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 this document, we propose to update the incorporation by
reference of the analytical method that we use to determine sulfite
concentrations in foods and establish a new, accurate, and more
efficient analytical method that we would also use to determine sulfite
concentrations in foods. We are also proposing to amend the unit of
measure specified in Sec. Sec. 101.100(a)(4) and 130.9(a) to
milligrams per kilogram, which is equivalent to parts per million, to
be consistent with the unit of measure specified in the new analytical
method.
III. Legal Authority
FDA is issuing this proposed rule to amend part 101 under sections
403(i)(2), 403(a), 201(n), and 701(a) (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)) of the FD&C Act.
Specifically, FDA is proposing to amend Sec. 101.100(a)(4), which
describes the analytical method FDA uses to determine whether there is
a detectable 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 by their common or usual names 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 are also proposing to amend 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 which 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.
This proposed rule would update the incorporation by reference for
the current analytical method in parts 101 and 130 and also identify a
new analytical method that we would use in testing for sulfites in
foods to determine compliance. The rule, if finalized, would 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 method of choice for determining sulfite
concentrations in foods and to use their method of choice as they see
fit, recognizing that FDA would rely on the methods established by any
final rule resulting from this rulemaking.
IV. Description of the Proposed Rule
We are proposing to amend the regulations that specify the method
of analysis that FDA uses when determining sulfite concentrations in
foods. These changes are intended to update an outdated incorporation
by reference in two provisions, remove an obsolete appendix, and
establish a new analytical method that is accurate and more efficient
than the current method.
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 of these regulations establish the method
of analysis in two steps. The first step incorporates by reference
Sec. Sec. 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
[[Page 48812]]
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 to Part 101.
Collectively, the Monier-Williams method with the Appendix A to 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 to 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 to Part 101. As such, this portion of the proposed rule
would modernize our regulations to reflect the citation to the current
AOAC method for determining sulfite concentrations in food, but would
not result in a change in FDA methodology. We are, therefore, proposing
to amend 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,'' (Final Action 1994),
Section 47.3.43, Official Methods of Analysis of AOAC INTERNATIONAL,
21st Edition (2019), and to remove Appendix A to Part 101.
We are also proposing to amend Sec. Sec. 101.100(a)(4) and
130.9(a) to add a recently developed and published new analytical
method for determining sulfite concentrations in foods. A liquid
chromatography (LC) tandem mass spectrometry (MS) method (LC-MS/MS
method) was recently published (Ref. 1). This method proved to be a
faster and more sensitive way to determine sulfite concentrations in
foods. FDA's current methodology is an acceptable method for
quantifying sulfites, but it is time-consuming, has a method detection
limit of 10 ppm, and is unable to accurately determine sulfite
concentrations in some samples. The current method also requires
specialty glassware, strong familiarity with the method, and almost two
hours of distillation, meaning that only three samples per apparatus
can be run in one 8-hour work day.
The newly published 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 (Ref. 2). 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 would
improve efficiency in testing and could better enforce the labeling
requirements for sulfites.
We are also proposing to amend the unit of measure specified in
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.
V. Incorporation by Reference
FDA is proposing to incorporate by reference ``AOAC Official Method
990.28, Sulfites in Foods, Optimized Monier-Williams Method,'' (Final
Action 1994), Section 47.3.43, Official Methods of Analysis of AOAC
INTERNATIONAL, 21st Edition (2019). You may purchase a copy of the
material from AOAC International, 2275 Research Blvd., Ste. 300,
Rockville, MD 20850-3250, 301-924-7077 ext. 170, 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 proposing to incorporate by reference ``Determination
of Sulfite in Food by Liquid Chromatography Tandem Mass Spectrometry:
Collaborative Study,'' Journal of AOAC International Vol. 100, No. 6,
pp. 1785-1794. You may purchase a copy of the material from AOAC
International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-3250,
301-924-7077 ext. 170, www.aoac.org. The study describes a liquid
chromatography tandem mass spectrometry method that FDA would use for
the determination of sulfite concentrations in foods as an alternative
to AOAC Official Method 990.28.
VI. Proposed Effective Date
We are proposing that any final rule resulting from this rulemaking
become effective 30 days after the date of its publication in the
Federal Register.
VII. Economic Analysis of Impacts
We have examined this proposed rule under Executive Order 12866,
Executive Order 13563, Executive Order 13771, 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). Executive Order 13771 requires that the costs associated
with significant new regulations ``shall, to the extent permitted by
law, be offset by the elimination of existing costs associated with at
least two prior regulations.'' We believe that this proposed rule would
not be a significant regulatory action as defined by Executive Order
12866 and would be a deregulatory action for purposes of Executive
Order 13771.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. This proposed rule would amend the regulations that specify
the method of analysis that FDA uses to determine the concentration of
sulfites in foods and would not require other entities to use these
methods. Hence, the scope of this proposed rule is limited to FDA. We,
therefore, propose to certify that this proposed rule would 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 $154
million, using the most current (2018) Implicit Price Deflator for the
Gross Domestic Product. This proposed rule would not result in an
expenditure in any year that meets or exceeds this amount.
This proposed rule would amend 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. This rule proposes to update the
incorporation by reference for FDA's current methodology and add 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 would serve as the primary method used by FDA to determine
sulfite concentrations in foods if this proposed rule becomes
finalized.
The benefit of this proposed rule would be the cost savings, in the
form of time savings, associated with use of the LC-MS/MS method. There
would be no impact from the update to the incorporation by reference
for FDA's
[[Page 48813]]
current methodology (i.e., the optimized Monier-Williams method)
because only the reference would change, not the method. Using a
standard 10-year time horizon, we estimate that the present value of
the benefits of this proposed rule ranges from $0.5 million to $1.7
million, with a mean estimate of $1.0 million, using a 3 percent
discount rate, and ranges from $0.4 million to $1.4 million, with a
mean estimate of $0.9 million, using a 7 percent discount rate (2017$).
Annualized benefits, which are illustrated below in table 1, are
estimated to range from $0.06 million per year to $0.2 million per
year, with a mean estimate of $0.1 million per year, using either a 3
percent or a 7 percent discount rate (2017$).
The cost of this proposed rule would consist of both one-time
validation costs and materials costs associated with use of the LC-MS/
MS method. Using a standard 10-year time horizon, we estimate that the
present value of the total costs of this proposed rule is $0.2 million,
using a 3 percent discount rate, and ranges from $0.1 million to $0.2
million, with a mean estimate of $0.2 million, using a 7 percent
discount rate (2017$). We estimate that annualized costs, which are
presented below in table 1, are $0.02 million per year, using either a
3 percent or a 7 percent discount rate (2017$).
The estimated net benefits of this proposed rule are defined as the
difference between the estimated benefits and the estimated costs of
the rule. Using a standard 10-year time horizon, we estimate that the
present value of the net benefits of this proposed rule ranges from
$0.3 million to $1.5 million, with a mean estimate of $0.8 million,
using a 3 percent discount rate, and ranges from $0.3 million to $1.2
million, with a mean estimate of $0.7 million, using a 7 percent
discount rate (2017$). Annualized net benefits are estimated to range
from $0.04 million per year to $0.18 million per year, with a mean
estimate of $0.09 million per year, using a 3 percent discount rate,
and from $0.04 million per year to $0.17 million per year, with a mean
estimate of $0.10 million per year, using a 7 percent discount rate
(2017$).
Table 1--Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule
[Millions of 2017$]
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Units
Primary ---------------------------------------------------
Category estimate Low estimate High estimate Discount rate Period covered Notes
Year dollars (%) (years)
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Benefits:
Annualized Monetized $0.10 $0.06 $0.20 2017 7 10............... Are cost savings.
$millions/year.
$0.10 $0.06 $0.20 2017 3 10............... Are cost savings.
Annualized Quantified..... .............. .............. .............. .............. 7
.............. .............. .............. .............. 3
Qualitative...............
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Costs:
Annualized Monetized $0.02 $0.02 $0.02 2017 7 10.
$millions/year. 0.02 0.02 0.02 2017 3 10...............
Annualized Quantified..... .............. .............. .............. .............. 7
.............. .............. .............. .............. 3
Qualitative...............
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Transfers:
Federal Annualized .............. .............. .............. .............. 7
Monetized $millions/year. .............. .............. .............. .............. 3
-------------------------------------------------------------------------------------------------------------------------
From/To................... From:
To:
-------------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized .............. .............. .............. .............. 7
$millions/year. .............. .............. .............. .............. 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To................... From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government:
Small Business:
Wages:
Growth:
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In line with Executive Order 13771, in table 2 we estimate present
and annualized values of costs and cost savings over an infinite time
horizon. Based on these cost savings, this proposed rule would be
considered a deregulatory action under Executive Order 13771.
Table 2--Executive Order 13771 Summary Table
[Millions of 2016$, over an infinite time horizon]
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Primary Lower estimate Upper estimate Primary Lower estimate Upper estimate
Item estimate (7%) (7%) (7%) estimate (3%) (3%) (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs.................................. $0.2 $0.2 $0.2 $0.6 $0.6 $0.6
Present Value of Cost Savings........................... 1.4 0.7 2.2 3.6 1.9 5.8
Present Value of Net Costs.............................. (1.2) (0.5) (2.0) (3.0) (1.3) (5.2)
Annualized Costs........................................ 0.02 0.02 0.02 0.02 0.02 0.02
Annualized Cost Savings................................. 0.10 0.05 0.20 0.10 0.06 0.20
[[Page 48814]]
Annualized Net Costs.................................... (0.08) (0.04) (0.14) (0.09) (0.04) (0.16)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: All amounts are in 2016$ and have been discounted relative to year 2016 from year 2019, the latter which is the estimated year in which the
proposed rule would become effective if finalized.
We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 3) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
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
FDA tentatively concludes that this proposed 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 proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the proposed 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 proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
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. We invite comments from tribal officials
on any potential impact on Indian Tribes from this proposed action.
XII. References
The following references marked with an asterisk (*) are on display
in the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
1. Robbins, K.S., Shah, R., MacMahon, and de Jager, L.S. (2015),
``Development of a Liquid Chromatography-Tandem Mass Spectrometry
Method for the Determination of Sulfite in Food,'' Journal of
Agricultural and Food Chemistry 63, 5126-5132, https://www.ncbi.nlm.nih.gov/pubmed/25695590.
2. Carlos, K.S. and L.S. de Jager (2017), ``Determination of Sulfite
in Food by Liquid Chromatography Tandem Mass Spectrometry:
Collaborative Study,'' Journal of AOAC International,: 100, 6, 1785-
1794, https://www.ncbi.nlm.nih.gov/pubmed/29137699.
*3. FDA, ``Amendment to Add a New Method for the Analysis of
Sulfites in Foods: Preliminary Regulatory Impact Analysis,'' 2018,
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, we propose
that 21 CFR parts 101 and 130 be 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) 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 will be determined
using either:
(i) ``Determination of Sulfite in Food by Liquid Chromatography
Tandem Mass Spectrometry,'' in Journal of AOAC International, Vol. 100,
No. 6, pp. 1785-1794, which is incorporated by reference. A copy of
Journal of AOAC International, Vol. 100, No. 6, is available from AOAC
International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-3250,
or 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: https://www.archives.gov/federal-register/cfr/ibr-locations.html; or
[[Page 48815]]
(ii) ``AOAC Official Method 990.28, Sulfites in Foods, Optimized
Monier-Williams Method,'' in Official Methods of Analysis of AOAC
International, Sec. 47.3.43 (2019), which is incorporated by reference.
A copy of AOAC Official Method 990.28 is available from AOAC
International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-3250,
or 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: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
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) 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,'' in Journal of AOAC International, Vol. 100,
No. 6, pp. 1785-1794, which is incorporated by reference. A copy of
Journal of AOAC International, Vol. 100, No. 6 is available from AOAC
International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-3250,
or 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: https://www.archives.gov/federal-register/cfr/ibr-locations.html; or
(2) ``AOAC Official Method 990.28, Sulfites in Foods, Optimized
Monier-Williams Method,'' in Official Methods of Analysis of AOAC
International, Sec. 47.3.43 (2019), which is incorporated by reference.
A copy of AOAC Official Method 990.28 is available from AOAC
International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-3250,
or 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: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
Dated: July 16, 2019.
Norman E. Sharpless,
Acting Commissioner of Food and Drugs.
Dated: September 3, 2019.
Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.
[FR Doc. 2019-19862 Filed 9-16-19; 8:45 am]
BILLING CODE 4164-01-P