[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$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Units
                                    Primary                                    ---------------------------------------------------
           Category                estimate      Low estimate    High estimate                   Discount rate    Period covered           Notes
                                                                                 Year dollars         (%)            (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
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...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
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:
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              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

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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.

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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.

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3. Remove and reserve Appendix A to Part 101.

PART 130--FOOD STANDARDS: GENERAL

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

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

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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