Rule2026-03285
Revocation of Methods of Analysis Regulation
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 19, 2026
Effective
March 23, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to revoke the methods of analysis regulation, which describes an FDA policy to use certain methods of analysis for FDA enforcement programs when the method of analysis is not prescribed in a regulation. FDA is issuing this action because the existing regulation is no longer necessary.
Full Text
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<title>Federal Register, Volume 91 Issue 33 (Thursday, February 19, 2026)</title>
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[Federal Register Volume 91, Number 33 (Thursday, February 19, 2026)]
[Rules and Regulations]
[Pages 7829-7834]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03285]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 2.19
[Docket No. FDA-2020-N-1383]
RIN 0910-AI65
Revocation of Methods of Analysis Regulation
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule to revoke the methods of analysis regulation,
which describes an FDA policy to use certain methods of analysis for
FDA enforcement programs when the method of analysis is not prescribed
in a regulation. FDA is issuing this action because the existing
regulation is no longer necessary.
DATES: This rule is effective on March 23, 2026.
ADDRESSES: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
Managements Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
FOR FURTHER INFORMATION CONTACT: Nadine Dominique, Office of
Inspections and Investigations, Food and Drug Administration, 12420
Parklawn Drive, Rockville, MD 20852, 301-348-1868,
<a href="/cdn-cgi/l/email-protection#046a65606d6a612a606b696d6a6d757161446260652a6c6c772a636b72"><span class="__cf_email__" data-cfemail="640a05000d0a014a000b090d0a0d151101240200054a0c0c174a030b12">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. History of This Rulemaking
B. Need for the Regulation
C. Summary of Comments to the Proposed Rule
D. Clarifications From the Proposed Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
A. Introduction
B. Description of General Comments and FDA Response
C. Comments on Quality Control and FDA Response
D. Comments on How the Language of the Regulation Should Be
Revised and FDA Response
E. Comments on Necessity of the Regulation and FDA Response
VI. Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
[[Page 7830]]
XI. Consultation and Coordination With Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose of the Final Rule
This final rule revokes the methods of analysis regulation, Sec.
2.19 (21 CFR 2.19), which describes an FDA policy to use certain
methods of analysis for FDA enforcement programs when the method of
analysis is not prescribed in a regulation. The regulation is no longer
necessary.
B. Summary of the Major Provisions of the Final Rule
This final rule revokes Sec. 2.19, which states that, where a
method of analysis is not prescribed by regulation, it is FDA policy in
its enforcement programs to utilize the methods of analysis of AOAC
INTERNATIONAL (hereinafter referred to as ``AOAC'') \1\ as published in
the latest edition (13th Ed., 1980) of their publication ``Official
Methods of Analysis of the Association of Official Analytical
Chemists,'' and their supplements thereto, which are incorporated by
reference, when available and applicable.
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\1\ Section 2.19 and the proposed rule refer to AOAC as the
``Association of Analytical Chemists International,'' as it was
previously known. The organization is now known as ``AOAC
INTERNATIONAL,'' which stands for ``ASSOCIATION OF OFFICIAL
ANALYTICAL COLLABORATION (AOAC) INTERNATIONAL.''
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C. Legal Authority
FDA is taking this action under the general administrative
provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
D. Costs and Benefits
There may be qualitative benefits to removing Sec. 2.19 because
there will no longer be any inefficiencies due to keeping unnecessary
regulations on the books. Revocation of Sec. 2.19 will not change
Agency current practice; therefore, there are no costs. Annualized over
10 years, the estimated benefits (i.e., cost savings) of the final rule
will be $0 at both the 3 and 7 percent discount rates. The annualized
costs of the final rule will be $0 at both the 3 and 7 percent discount
rates.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
------------------------------------------------------------------------
Abbreviation/acronym What it means
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AOAC.......................... ASSOCIATION OF OFFICIAL ANALYTICAL
COLLABORATION.
FDA........................... U.S. Food and Drug Administration.
FD&C Act...................... Federal Food, Drug, and Cosmetic Act.
HHS........................... U.S. Department of Health and Human
Services.
OMB........................... U.S. Office of Management and Budget.
OII........................... Office of Inspections and
Investigations.
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III. Background
A. History of This Rulemaking
FDA's regulation concerning its policy of methods of analysis in
enforcement programs dates back more than 50 years (37 FR 16174, Aug.
11, 1972). Early versions of the regulation stated that unless a
regulation prescribed a specific method of analysis, it would be FDA's
policy to use the methods of analysis in the ``latest edition of [the
AOAC's] publication . . . and the supplements thereto . . .'' 21 CFR
3.89 (later reorganized and republished as 21 CFR 2.19 (42 FR 15559
(Mar. 22, 1977))). However, in 1982, 1 CFR 51.1 was amended to limit
incorporation by reference of a publication to the edition of the
publication that is approved, and to exclude future amendments or
revisions of the publication.
FDA has revised the methods of analysis regulation several times,
including in 1982 to meet the drafting requirements for incorporation
by reference set forth in 1 CFR 51.1(f), and after to make several
editorial amendments to update names and addresses. However, since the
1982 revision, the regulation has referred to the methods of analysis
in the 13th Edition, 1980 of AOAC's publication and supplements thereto
(``Changes in Methods'' as published in the March issues of the
``Journal of the Association of Official Analytical Chemists''). FDA is
now revoking the methods of analysis regulation as specified in this
final rule.
B. Need for the Regulation
The Agency believes that the methods of analysis regulation is
unnecessary as a general matter. Absent a method of analysis specified
in statute or regulation, FDA believes it is more appropriate,
flexible, and efficient to identify the Agency's preferred methods of
analysis in documents such as compliance program guidance documents,
Agency methods compendia, and other resources. FDA is revoking this
rule because it is not FDA's preferred policy to always use the 13th
edition of the ``Official Methods of Analysis of the Association of
Official Analytical Chemists,'' or the supplements thereto, for
enforcement programs when the method is not prescribed by statute or
regulation. Unless a method of analysis is specified in law, FDA
believes it is more appropriate, flexible, and efficient to identify
the Agency's preferred and validated methods of analysis in documents
that can be updated more frequently and efficiently as the science and
technologies advance while continuing to maintain transparency about
FDA analytical methods.
C. Summary of Comments to the Proposed Rule
We published a proposed rule entitled ``Revocation of Methods of
Analysis Regulation'' (the proposed rule) in the Federal Register on
July 15, 2022 (87 FR 42398). The comment period closed on September 28,
2022. We received comments supporting and opposing the proposed rule.
Some comments expressed concerns that revoking Sec. 2.19 would result
in a lack of quality control or in FDA using non-validated methods.
Some comments recommended retaining the regulation with updated
language.
D. Clarifications from the Proposed Rule
We are making some clarifications in this final rule. In the
proposed rule, under the Analysis of Environmental Impact section, we
stated that, in accordance with 21 CFR 25.31(h), this action does not
individually or cumulatively have a significant effect on the human
environment. However, the correct applicable exemption for this rule is
21 CFR 25.30(h).
In the proposed rule we also stated that, absent specifying a
method of analysis in law, FDA believes it is more appropriate,
flexible, and efficient to identify the Agency's preferred methods of
analysis in documents such as the Office of Inspections and
Investigations'
[[Page 7831]]
(OII's) Laboratory Procedures Manual, FDA compliance programs, and
other resources. However, OII's laboratory manual does not contain
actual methods of analysis; rather, it describes policy on methods of
validation and verification, irrespective of the source of the method.
Further, we identify methods of analysis in Agency methods compendia.
Therefore, we are clarifying that FDA believes it is more appropriate,
flexible, and efficient to identify preferred methods of analysis in
documents such as compliance programs, Agency methods compendia, and
other resources.
IV. Legal Authority
FDA is issuing this final rule under the following provisions of
the (FD&C Act): 21 U.S.C. 321, 331, 335, 342, 343, 346a, 348, 351, 352,
355, 360b, 361, 362, 371, 372, 374.
V. Comments on the Proposed Rule and FDA Response
A. Introduction
We received approximately 40 comments on the proposed rule by the
close of the comment period, each containing one or more comments on
one or more issues. We received comments from consumers, food
associations, accreditation bodies, laboratory associations,
laboratories, consumer groups, and other organizations.
We describe and respond to the comments in sections V.B through E
of this document. We have numbered each comment to help distinguish
between different comments. We have grouped similar comments together
under the same number, and, in some cases, we have separated different
issues discussed in the same comments and designated them as distinct
comments for purposes of our responses. The number assigned to each
comment or comment topic is purely for organizational purposes and does
not signify the comment's value, importance, or the order in which
comments were received. After review and consideration of all relevant
comments, as stated above, FDA is removing the prescriptive
requirements of Sec. 2.19.
B. Description of General Comments and FDA Response
Some comments make remarks supporting or opposing the proposed rule
without focusing on a particular proposed provision. In the following
paragraphs, we discuss and respond to such general comments.
(Comment 1) The comments generally support the revocation of the
methods of analysis regulation and do not foresee the revocation as
having a negative impact. Comments go on to say that the proposed
revocation may encourage more laboratories to adopt a laboratory
quality systems approach and adopt a more flexible technology strategy.
(Response 1) We appreciate the support expressed in the comments
received. Revoking the methods of analysis regulation is intended to
make it more flexible and efficient for the Agency to use its preferred
methods of analysis by identifying those analyses in documents such as
compliance program guidance documents and other resources.
(Comment 2) One comment suggests the loss of AOAC as a Federal
partner would be very expensive and add a large economic burden to the
Federal Government.
(Response 2) This rulemaking does not preclude FDA from using AOAC
official methods or working with AOAC as a partner. FDA may continue to
use AOAC official methods when they are appropriate for the particular
analysis needed. In fact, as some of the comments point out, FDA has
existing manuals and guidelines that recommend FDA use AOAC official
methods for certain analyses. Revoking this regulation does not affect
those recommendations. The comment does not provide any evidence of the
rule being expensive or how it would create an economic burden to the
Federal Government.
C. Comments on Quality Control and FDA Response
(Comment 3) Many comments express concerns about the lack of
quality control that may follow from the rule, and how AOAC's rigorous
standards and systematic evaluations are heavily relied upon. Some of
the comments assert that the withdrawal of this regulation by FDA would
undermine the credibility of many analytical methods used by industry
and governments. Other comments maintain that AOAC's official methods
are used as a basis for most of their tests, and that revoking the
regulation would make test results less transparent and accurate.
(Response 3) As previously mentioned, revoking Sec. 2.19 will not
end FDA's use of AOAC's official methods of analysis when these methods
are appropriate. Methods used by the Agency undergo rigorous
qualification, validation, and fitness-of-use in accordance with
international standards, including the International Organization for
Standardization/International Electrotechnical Commission (ISO/IEC)
17025 accreditation framework. FDA remains committed to using the
appropriate methods for any given analysis, whether or not the methods
are AOAC official methods. FDA has and does use non-AOAC-approved
methods for analyses unrelated to enforcement, such as for scientific
research and risk assessment, and we did not receive any comments that
challenged the validity of these methods.
For example, with the issuance of the FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111-353) Final Rule on Laboratory Accreditation for
Analyses of Foods (LAAF) in 2021,\2\ many private laboratories
conducting analyses of FDA regulated products are now governed by an
Agency-approved accrediting body. Under the LAAF regulation, that
accreditation body must ensure that the methods, and scientific results
are valid, adequate, and reliable, regardless of the method source.\3\
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\2\ 86 FR 68728 (Dec. 3, 2021).
\3\ 21 CFR 1.1120.
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To the extent comments suggest that revoking the methods of
analysis regulation would undermine the credibility of methods or tests
used by industry, the regulation only established a policy for FDA to
use AOAC official methods. This rulemaking does not create new testing
requirements for the regulated industry nor prevent industry from using
AOAC official methods. Neither revoking nor maintaining the regulation
affects what industry uses for analytical testing, as they are still
free to use AOAC official methods as appropriate and permissible.
(Comment 4) One comment claims that revoking Sec. 2.19 would
undermine the standing of thousands of methods of analysis used by
industry and governments worldwide. As an example, this comment
explains how AOAC methods have been used as a basis to arbitrate trade
disputes under the General Agreement on Tariffs and Trade (GATT, pre-
1995) and the World Trade Organization (WTO) agreements. The commenter
asserted that, without a codified recognition of AOAC methods, the
United States will likely be at a disadvantage in future trade
disputes.
(Response 4) As the proposed rule explained, Sec. 2.19 states, in
part, that where a method of analysis is not prescribed by regulation,
it is FDA policy in its enforcement programs to utilize the methods of
analysis of the AOAC as published in the latest edition (13th Ed.,
1980) of their publication ``and the supplements thereto.'' Section
2.19 does not address or establish which methods of analysis are used
``as a basis for trade disputes under [the WTO]'' or
[[Page 7832]]
any other forum external to FDA. The comment does not provide
information as to how the WTO determines which methods of analysis to
use as a basis to arbitrate trade disputes. Additionally, the WTO is
still free to reference AOAC Official Methods as a basis to arbitrate
trade disputes with or without Sec. 2.19, as this regulation pertains
only to methods of analyses used by FDA. Thus, revoking Sec. 2.19 does
not affect or preclude the reference to AOAC official methods in trade
disputes arbitrated by the WTO.
(Comment 5) Several comments express concern about revoking a
policy that commits to using a validated method and assert that
revoking Sec. 2.19 would result in FDA using non-validated methods of
analysis.
(Response 5) The revocation of FDA's policy of only using AOAC
methods in its enforcement programs does not condone the use of
unvalidated methods of analysis. FDA is a science-based agency and is
committed to using only methods that are validated. For instance, in
the foods program, FDA's Compendium of Analytical Methods contains
analytical methods that have a defined validation status and are
currently used by FDA regulatory laboratories. In these cases, the
validation status of a method may have been established through the FDA
Foods Program Method Development, Validation, and Implementation
Program using the Foods Program Method Validation Guidelines or by
internal FDA Foods Program committees that have established the
equivalency of the method validation level to the FDA guidelines.\4\
The regulatory laboratories are all accredited to an ISO standard that
requires FDA to validate the methods. Further, FDA has developed a
methods portal that is publicly facing on FDA's website.\5\
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\4\ FDA's Method Validation Guidelines are available at <a href="https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines">https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines</a>.
\5\ <a href="https://www.fda.gov/food/laboratory-methods-food/foods-program-compendium-analytical-laboratory-methods">https://www.fda.gov/food/laboratory-methods-food/foods-program-compendium-analytical-laboratory-methods</a>.
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D. Comments on How the Language of the Regulation Should Be Revised and
FDA Response
(Comment 6) Some comments recommend retaining the regulation with
updated language reflecting the use of the latest versions of AOAC
Official Methods of Analysis.
(Response 6) Retaining the regulation only to update it with the
latest version would still be a policy of using only AOAC official
methods at the exclusion of other, potentially more suitable methods.
Our revocation of this rule is intended to allow FDA the discretion to
use methods more fit for the purpose of any given analysis, as science
and technologies continually evolve, and FDA needs the flexibility to
use other methods that might be more recent, accurate, and efficient.
E. Comments on Necessity of the Regulation and FDA Response
(Comment 7) Some comments suggest that revoking the regulation
could weaken the validity of many analytical methods used by industries
and governments globally, potentially harming the Agency's operations.
(Response 7) The rule does not govern analytical methods used by
industry and foreign governments, so revoking it will not impact the
validity of methods used by industry and governments worldwide. FDA may
continue, as appropriate, to use AOAC official methods and will
encourage and refer stakeholders to use methods that are best for the
given analysis. AOAC official methods are widely regarded as the
default standard rather than the sole standard. FDA acknowledges AOAC's
significant influence and methodologies, yet believes that in certain
cases, alternative methods may be more suitable and fit for purpose.
(Comment 8) Several comments express concern about revoking a
policy that provides a level of certainty to stakeholders about which
methods of analysis FDA will use and claim that revoking the regulation
will reduce predictability about the methods FDA will use for any given
analysis.
(Response 8) FDA has multiple public-facing resources that provide
the methods FDA intends to use for any given analysis, and therefore,
does not agree that revoking this regulation will result in uncertainty
as to what methods FDA may use. For example, FDA's web page on
laboratory methods for foods has resources containing some of the
analytical laboratory methods the Agency uses FDA to help ensure food
safety.\6\ These include validated methods for chemical,
microbiological, and microanalytical analyses. FDA also has published
Compliance Policy Guides (CPGs), such as CPG Sec. 150.500 Analytical
Methodology Used by FDA--Drugs,\7\ that set forth specific analytical
methods. Compliance programs issued by FDA, such as Compliance Program
7321.008 Dietary Supplements--Foreign and Domestic Inspections,
Sampling, and Imports,\8\ may also specify tailored analytical methods
used by FDA laboratories.
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\6\ <a href="https://www.fda.gov/food/science-research-food/laboratory-methods-food">https://www.fda.gov/food/science-research-food/laboratory-methods-food</a>.
\7\ <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-150500-analytical-methodology-used-fda-drugs">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-150500-analytical-methodology-used-fda-drugs</a>.
\8\ <a href="https://www.fda.gov/food/compliance-enforcement-food/food-compliance-programs#food_ds">https://www.fda.gov/food/compliance-enforcement-food/food-compliance-programs#food_ds</a>.
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(Comment 9) One comment references the U.S. Office of Management
and Budget (OMB) Circular A-119, which states that voluntary consensus
standards are appropriate or adaptable for the government's purposes.
These standards ``eliminate the cost to the government of developing
its own standards'' and ``promote efficiency and economic competition
through harmonization of standards.'' The comment maintains that this
final rule appears in conflict with the circular.
(Response 9) Revoking the methods of analysis regulation is not
inconsistent with OMB Circular A-119. FDA agrees that voluntary
standards are appropriate for government purposes and relieve FDA of
developing its own standards. However, FDA is not in favor of
maintaining a Federal regulation that establishes a policy for FDA to
utilize a singular approving body's standard or method for all analyses
not prescribed by regulation in its enforcement programs. It is in the
public's best interest for FDA to have the flexibility to select the
methods or standards deemed more suitable for a specific analysis.
VI. Effective Date
This rule is effective on the date of publication in the Federal
Register.
VII. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 14192, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review
Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801,
Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4).
Executive Orders 12866 and 13563 direct us to assess all benefits
and costs of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits.
Rules are economically significant under Executive Order 12866 if they
have an annual effect on the economy of $100 million or more; or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities. The Office of Information
[[Page 7833]]
and Regulatory Affairs (OIRA) has determined that this final rule is
not a significant regulatory action under Executive Order 12866.
Executive Order 14192 requires that any new incremental 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 10 prior regulations.'' This final rule is an
Executive Order 14192 deregulatory action because it eliminates an
unnecessary regulation.
Because this rule is not likely to result in an annual effect on
the economy of $100 million or more or to meet other criteria specified
in the Congressional Review Act/Small Business Regulatory Enforcement
Fairness Act, OIRA has determined that this rule does not fall within
the scope of 5 U.S.C. 804(2).
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this final rule does not add any new regulatory
burden on the industry, 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 estimates of
anticipated impacts, 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 1 year.''
The current threshold after adjustment for inflation is $187 million,
using the most current (2024) Implicit Price Deflator for the Gross
Domestic Product. This final rule will not result in an expenditure in
any year that meets or exceeds this amount.
B. Overview of Benefits, Costs, and Transfers
This final rule will revoke 21 CFR 2.19 Methods of analysis, which
states that FDA policy is to use the Association of Official Analytical
Chemists (AOAC) methods of analysis as published in the 1980 edition of
``Official Methods of Analysis of the Association of Official
Analytical Chemists'' to analyze samples in FDA enforcement programs
when the method of analysis is not prescribed in a regulation. FDA is
proposing this action because a general reference to the 1980 edition
of the ``Official Methods of Analysis of the Association of Official
Analytical Chemists'' is unnecessary and because newer, updated methods
of analysis may exist. FDA believes it is more appropriate, flexible,
and efficient to identify the Agency's preferred methods of analysis in
documents such as the Agency methods compendium, FDA compliance
programs, and other resources. Thus, Sec. 2.19 is an unnecessary
policy. We expect the economic impact on FDA resulting from revoking an
unnecessary regulation to be minimal.
Table 1 summarizes the estimated benefits and costs of the final
rule. Annualized over 10 years, the estimated benefits (i.e., cost
savings) of the final rule will be $0 at both the 3 and 7 percent
discount rates. The present value of the estimated benefits (i.e., cost
savings) of the final rule will also be $0 at both the 3 and 7 percent
discount rates. The annualized costs of the final rule will be $0 at
both the 3 and 7 percent discount rates. The present value of costs of
the final rule will also be $0 at both the 3 and 7 percent discount
rates.
Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
[Millions of 2024 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year...... $0 $0 $0 2024 7 10
0 0 0 2024 3 10
Annualized Quantified.................... .......... .......... .......... .......... .......... ..........
.......... .......... .......... .......... .......... ..........
----------------------------------------------------------------------------------------------------------
Qualitative.............................. There will no longer be any .......... .......... ..........
inefficiencies due to keeping
unnecessary regulations on the
books.
----------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized $millions/year...... 0 0 0 2024 7 10
0 0 0 2024 3 10
Annualized Quantified.................... .......... .......... .......... .......... 7 ..........
3 ..........
Quantified............................... .......... .......... .......... .......... .......... ..........
Transfers:
Federal Annualized Monetized $millions/ .......... .......... .......... .......... 7 ..........
year. 3 ..........
----------------------------------------------------------------------------------------------------------
From/To.................................. From:
To:
----------------------------------------------------------------------------------------------------------
Other Annualized Monetized $millions/year .......... .......... .......... .......... 7 ..........
3
----------------------------------------------------------------------------------------------------------
From/To.................................. From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None.............................................................................................................
Small Business: None................................................................................................................................
Wages: None.........................................................................................................................................
Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 7834]]
In line with Executive Order 14192, in table 2 we estimate present
and annualized values of costs, cost savings, and net costs over a
perpetual time horizon. We estimate that this rule will generate $0
million in annualized net costs at a 7 percent discount rate,
discounted relative to year 2024 over a perpetual time horizon.
Table 2--Executive Order 14192 Summary Table
[Millions of 2024 dollars, discounted over a perpetual time horizon relative to year 2024 at a 7 percent
discount rate]
----------------------------------------------------------------------------------------------------------------
Primary estimate Low estimate High estimate
----------------------------------------------------------------------------------------------------------------
Present Value of Costs.............................. $0 $0 $0
Present Value of Cost Savings....................... 0 0 0
Present Value of Net Costs.......................... 0 0 0
Annualized Costs.................................... 0 0 0
Annualized Cost Savings............................. 0 0 0
Annualized Net Costs................................ 0 0 0
----------------------------------------------------------------------------------------------------------------
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. 5) and at
<a href="https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria">https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria</a>.
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 concludes that this final rule contains no collection of
information. Therefore, clearance by OMB under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520) 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 this final
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 this final
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 final rule in accordance with the principles
set forth in Executive Order 13175. We have determined that this final
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. References
The following references are on display at 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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>. Although FDA
has verified the website addresses as of the date this document
publishes in the Federal Register, please note that websites are
subject to change over time.
1. Laboratory Accreditation for Analyses of Foods, December 3, 2021.
<a href="https://www.govinfo.gov/content/pkg/FR-2021-12-03/pdf/2021-25716.pdf">https://www.govinfo.gov/content/pkg/FR-2021-12-03/pdf/2021-25716.pdf</a>. Accessed April 19. 2024.
2. FDA Foods Program Compendium of Analytical Laboratory Methods,
2024. <a href="https://www.fda.gov/food/laboratory-methods-food/foods-program-compendium-analytical-laboratory-methods">https://www.fda.gov/food/laboratory-methods-food/foods-program-compendium-analytical-laboratory-methods</a>. Accessed April 19,
2024.
3. FDA Laboratory Methods (Food), 2021. <a href="https://www.fda.gov/food/science-research-food/laboratory-methods-food">https://www.fda.gov/food/science-research-food/laboratory-methods-food</a>. Accessed April 19,
2024.
4. Compliance Policy Guide Sec. 150.500 Analytical Methodology Used
by FDA--Drugs, 2020. <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-150500-analytical-methodology-used-fda-drugs">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-150500-analytical-methodology-used-fda-drugs</a>. Accessed April 19, 2024.
5. FDA/Economics Staff, ``Revocation of Methods of Analysis
Regulation, Preliminary Regulatory Impact Analysis, Preliminary
Regulatory Flexibility Analysis, Unfunded Mandates Reform Act
Analysis,'' 2020. <a href="https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm">https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm</a>. Accessed April 19, 2024.
6. Food Compliance Programs, 2025. <a href="https://www.fda.gov/food/compliance-enforcement-food/food-compliance-programs#food_ds">https://www.fda.gov/food/compliance-enforcement-food/food-compliance-programs#food_ds</a>.
Accessed August 29, 2025.
List of Subjects in 21 CFR Part 2
Administrative practice and procedure, Cosmetics, Drugs, Foods.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 2, is amended as follows:
PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
0
1. The authority citation for part 2 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 335, 342, 343, 346a, 348, 351,
352, 355, 360b, 361, 362, 371, 372, 374; 42 U.S.C. 7671 et seq.
Sec. 2.19 [Removed and Reserved]
0
2. Remove and reserve Sec. 2.19.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2026-03285 Filed 2-18-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on February 19, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.