[Federal Register Volume 91, Number 55 (Monday, March 23, 2026)]
[Proposed Rules]
[Pages 13782-13791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-05598]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 91, No. 55 / Monday, March 23, 2026 /
Proposed Rules
[[Page 13782]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Doc. No. AMS-NOP-22-0029; NOP-22-02]
RIN 0581-AE25
National Organic Program: National List of Allowed and Prohibited
Substances per October 2021, October 2022, and October 2024
Recommendations (Crops and Livestock)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would amend the U.S. Department of
Agriculture's (USDA) organic regulations related to organic crop and
livestock production. The proposed rule would provide additional tools
to organic producers, allowing carbon dioxide in organic crop
production and meloxicam as a pain treatment in organic livestock
production. Additionally, this rulemaking would remove overly
burdensome restrictions for methionine, an amino acid, in organic
poultry feed and would affirm that sodium nitrate may be used as a
fertilizer in organic crop production, with certain conditions to
protect soil quality.
DATES: Comments must be received by May 22, 2026.
ADDRESSES: You may send comments, identified by AMS-NOP-22-0029 and/or
RIN 0581-AE25, by any of the following methods:
Federal eRulemaking Portal: www.regulations.gov. Follow
the instructions on the website for sending comments.
Agency Website: www.ams.usda.gov/rules-regulations/proposed-rules. Follow the instructions on the website for sending
comments.
Email: [email protected]. Include the identifier AMS-
NOP-22-0029 and/or RIN 0581-AE25 in the subject line of the message.
Mail: Jared Clark, Assistant Director, Standards Division,
National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW, Room
2642-South, Stop 0268, Washington, DC 20250-0268.
Instructions: All submissions received should include the agency
name and docket number (AMS-NOP-22-0029) or Regulatory Information
Number (RIN) 0581-AE25 for this proposed rule. When submitting a
comment, clearly indicate the proposed rule topic and section number to
which the comment refers. In addition, comments should clearly indicate
whether the commenter supports or opposes the action being proposed and
clearly indicate the reason(s) for the position. Comments can also
include information on alternative management practices, where
applicable, that support alternatives to the proposed amendments.
Comments may also offer any recommended language change(s) to the
regulatory text that would be appropriate to the position. Only
relevant material supporting the position should be submitted. All
comments and materials received will be posted without change,
including any personal identifying information provided, to
www.regulations.gov.
Docket: For access to the docket to read background documents or
comments received, go to www.regulations.gov (search for Docket ID AMS-
NOP-22-0029).
FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division,
National Organic Program; telephone: (202) 720-3252; email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
This proposed rule would amend the USDA organic regulations to
implement recommendations from the National Organic Standards Board
(``NOSB'' or ``Board''). If adopted, this proposed rule would allow two
additional synthetic substances to be used in organic crop and
livestock production (carbon dioxide and meloxicam, respectively).
Additionally, the proposed rule would remove current restrictions on
the use of methionine, an amino acid, in organic poultry feed, thus
allowing producers additional flexibility and making it unnecessary for
organic poultry producers to track the amount of methionine fed to each
poultry flock. Finally, the proposed rule would affirm that sodium
nitrate, a natural fertilizer, is allowed for limited use in organic
crop production by renewing the substance's listing on the National
List of Allowed Substances for 5 years.
Authority
The USDA Agricultural Marketing Service's (AMS) National Organic
Program (NOP) administers the USDA organic regulations (7 CFR part 205)
under the authority granted to it by the Organic Foods Production Act
of 1990 (``OFPA'') (7 U.S.C. 6501-6524). This proposed rule would amend
a portion of the USDA organic regulations known as the National List of
Allowed and Prohibited Substances (or ``National List''), in accordance
with the procedures and criteria set forth in the OFPA (7 U.S.C. 6503,
6517, 6518). OFPA authorizes the Secretary to make amendments to the
National List based on recommendations developed by the Board. OFPA
authorizes the Board to develop recommendations for submission to the
Secretary to amend the National List and to establish a process by
which persons may petition the Board for the purpose of having
substances evaluated for inclusion on, or deletion from, the National
List.
II. General Information
A. Does this proposed rule apply to me?
You may be affected by this proposed rule if you are engaged in
organic crop and/or livestock production. Potentially affected entities
may include, but are not limited to, the following:
Organic crop and/or livestock producers;
Individuals or business entities that are considering
organic certification for crop and/or livestock production;
USDA-accredited certifying agents, inspectors, and
certification review personnel;
Fertilizer, soil amendment, livestock feed supplement, and
animal drug manufacturers;
Material review organizations.
This list is not exhaustive but identifies key entities that this
rulemaking may affect. Other types of entities may also be affected. To
determine whether you or your business may be affected by this action,
you
[[Page 13783]]
should carefully examine the regulatory text and discussion below.
B. What should I consider as I prepare my comments for AMS?
AMS seeks comment from the public and organic stakeholders
regarding the proposed amendments. While all comments submitted are
taken into consideration, the most effective comments:
Clearly state a position (support, opposition, and/or
requested modifications) on the proposed rule or specific parts of the
proposed rule;
Clearly identify which specific parts of the proposed rule
a comment refers to;
Explain why the commenter supports or opposes the proposed
change;
Describe the potential effects of the proposed rule using
examples, data, or personal experience;
If applicable, offer suggested alternatives to the
proposed changes and/or regulatory text, and explain the reasoning for
those suggested changes.
Comments are invited on the entire proposed rule; however, AMS is
especially interested in public input on the following questions:
(1) Is the proposed regulatory language and accompanying discussion
in this document clear enough to allow operations and certifying agents
to comply with the proposed requirements?
(2) Do the proposed amendments create any conflict with current
USDA organic regulations or other Federal regulatory requirements?
(3) Carbon dioxide:
(a) Why is synthetic carbon dioxide necessary for the uses
described in this proposed rule? What are the various sources of
synthetic carbon dioxide that operations would be able to obtain? Which
of these are sourced as a byproduct? Is there adequate supply of
byproduct-sourced synthetic carbon dioxide in the market to meet the
needs of the organic industry for either or both uses of described in
this proposed rule?
(b) Why is natural carbon dioxide insufficient or not available for
the uses described in this proposed rule? Are other allowed natural or
synthetic substances suitable as alternatives? Why or why not?
(c) Should both listings of carbon dioxide at 7 CFR 205.601(a) and/
or 205.601(j) be annotated to only allow carbon dioxide sourced as a
byproduct? Do producers and certifying agents have enough information
to verify compliance with the proposed annotation?
(4) Meloxicam:
(a) Is the proposed annotation clear? Do veterinarians, producers,
and certifying agents have the information they need to establish,
document, and verify the proposed withdrawal period? If not, what
additional information is necessary?
(b) Should the annotation further restrict the use of meloxicam,
such as by specifying a minimum withdrawal period for bovine species,
and/or restricting non-bovine uses to disbudding and dehorning only?
(c) AMS welcomes comments on the NOSB Livestock Subcommittee's
technical analysis appendix published as part of the NOSB final
recommendation.
III. Overview of Proposed Amendments
The following provides an overview of the proposed amendments to
the National List, along with the NOSB recommendations and AMS
justifications for each proposed amendment. AMS welcomes comments on
each proposed amendment. Comments received during the comment period
will inform AMS's decisions for the final rule; specifically, whether
the proposed amendments align with OFPA criteria and are justified.
More information on the NOSB meetings can be found in section IV,
RELATED DOCUMENTS.
A. Carbon Dioxide (Crops)
AMS is proposing to add carbon dioxide to the National List at 7
CFR 205.601(a) and 205.601(j) as a synthetic substance allowed for use
in organic crop production to adjust the pH of irrigation water and for
atmospheric adjustment in indoor crop production environments. This
proposed rule would allow organic crop operations to use synthetic
carbon dioxide, which is commonly sourced as a byproduct from various
commercial processes. This AMS proposal follows two recommendations
from the NOSB following its review of a petition, third-party technical
reports, and public comments.
Background
Synthetic carbon dioxide has been allowed for organic handling (7
CFR 205.605(b)(10)) since the USDA organic regulations were first
established (65 FR 80548, December 21, 2000). Organic handling
operations use synthetic carbon dioxide to carbonate beverages, freeze
foods, extract compounds, prevent spoilage in modified atmosphere
packaging, and control pests in post-harvest storage of grains and
produce. This AMS proposal would expand the current allowance of
synthetic carbon dioxide to allow it in organic crop production for
irrigation water treatment and as a plant and soil amendment.
On November 30, 2020, Eco2Mix, Inc., a water treatment company,
petitioned the NOSB to add carbon dioxide to the National List as an
allowed synthetic substance for use in organic crop production.\1\ The
petition requests carbon dioxide be allowed to adjust the pH of water
used in crop irrigation systems in Sec. 205.601(a), and for use as a
plant or soil amendment in Sec. 205.601(j).
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\1\ Eco2Mix, Inc. carbon dioxide petition, November 30, 2020,
www.ams.usda.gov/sites/default/files/media/PetitionNOBCarbonDioxide2020.pdf.
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Many farming areas have alkaline (high pH) water sources that can
hinder the efficiency of irrigation systems, reduce soil nutrient
availability, and otherwise impair crop-growing conditions. To address
these problems, carbon dioxide can be used to lower the pH of water.
Dissolving carbon dioxide in water creates carbonic acid, which
dissociates into hydrogen and bicarbonate ions, and the hydrogen ions
acidify the water (lower the pH). By reducing the pH of alkaline
irrigation water, operations can reduce mineral or algal buildup and
prevent the clogging of irrigation system equipment (e.g., drip lines,
emitters, sprinklers). Adjusting the pH of irrigation water can also
help improve nutrient availability and plant health by establishing an
ideal pH value (typically neutral or slightly acidic) for crop nutrient
absorption.
The petitioner states that the alternative substances currently
allowed, such as natural carbon dioxide or synthetic sulfurous acid,
are either not commercially available or are not as safe and effective
as synthetic carbon dioxide. Natural carbon dioxide can be produced as
a byproduct of fermentation (e.g., from ethanol production). However,
the petition states that sources of natural carbon dioxide are not
typically available in the market and could have impurities. The
petition describes several sources of synthetic carbon dioxide and
states that most sources reclaim or recapture carbon dioxide from
processes that would otherwise release carbon dioxide into the
atmosphere.
Byproduct-sourced carbon dioxide is trapped and processed in
different ways, depending on the source. Most sources involve the
capture of byproduct gas mixture, purification of the gas, and final
processing for the market as either liquified gas or as ``dry ice''
(solid carbon dioxide). Liquified
[[Page 13784]]
carbon dioxide gas is stored in pressurized refrigeration units or in
tanks. Large quantities can be delivered as tanker trucks while small
quantities can be obtained in 20-50-pound tanks from distributors. Dry
ice is sold as ice blocks or pellets and shipped in insulated boxes.
NOSB Recommendation for Sec. 205.601(a)
In 2022, the NOSB recommended adding synthetic carbon dioxide to
the National List at 7 CFR 205.601(a) for water pH adjustment in
irrigation systems.\2\ In addition to reviewing the petition, the Board
considered a third-party technical report related to synthetic carbon
dioxide used in organic handling and public comments received at public
NOSB meetings in October 2021, April 2022, and October
2022.3 4 5 6 The Board ultimately determined that the
petitioned use of carbon dioxide meets the OFPA criteria (7 U.S.C.
6518(m)) for inclusion on the National List.
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\2\ NOSB recommendation on carbon dioxide, October 2022,
www.ams.usda.gov/sites/default/files/media/CSCarbonDioxidePetitionFinalRec.pdf.
\3\ NOP, carbon dioxide technical report, handling, 2006,
www.ams.usda.gov/sites/default/files/media/CarbonDioxideSyntheticTR2006.pdf.
\4\ NOSB virtual meeting, Fall 2021, www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-sacramento-ca.
\5\ NOSB virtual meeting, Spring 2022, www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-crystal-city-va-1.
\6\ NOSB Sacramento, CA meeting, Fall 2022, www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-sacramento-ca-
2022.
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In its recommendation, the NOSB reasoned that when reclaimed
synthetic carbon dioxide is used as petitioned, it is not harmful to
the environment or human health. The Board acknowledged that carbon
dioxide is a greenhouse gas; \7\ however, the use of synthetic carbon
dioxide as petitioned would not increase carbon dioxide in the
atmosphere. The petitioned form of synthetic carbon dioxide is a
byproduct and, if not captured, would be released into the atmosphere.
Therefore, the Board concluded that the capture of the byproduct for
crop production is akin to recycling.
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\7\ Gases that trap heat in the atmosphere are called greenhouse
gases. Overview of Greenhouse Gases, U.S. Environmental Protection
Agency (EPA), www.epa.gov/ghgemissions/overview-greenhouse-gases.
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The NOSB also noted there are no apparent adverse effects on other
materials used in organic farming systems and that carbon dioxide has
little direct impact on human health. Additionally, carbon dioxide is
already permitted on the National List for use in or on processed
organic products (7 CFR 205.605(b)), which indicates its acceptance as
not harmful to human health.
The NOSB evaluated the suitability of natural alternatives and
determined that natural sources of carbon dioxide are not widely
available due to a lack of infrastructure at ethanol manufacturing
facilities, where natural sources are produced. The Board acknowledged
that some organic farmers have been using sulfurous acid from sulfur
burners (Sec. 205.601(j)(11)) to lower pH levels in irrigation water.
Sulfur burners create sulfurous acid by dissolving the fumes of burning
sulfur in irrigation water, which can irritate human skin, eyes, and
respiratory systems. The Board also considered that carbon dioxide is
safer and more stable than alternatives, because using a weak acid such
as carbon dioxide in the acidification process does not bring the pH of
water below 5.0, well above values considered hazardous to humans.
Overall, the NOSB determined that the use of synthetic carbon
dioxide to adjust the pH of irrigation water would pose little risk to
the environment or human health and is compatible with a system of
sustainable agriculture. The Board's vote was unanimous in recommending
the addition of carbon dioxide to Sec. 205.601(a) for use in
irrigation systems.
NOSB Recommendation for Sec. 205.601(j)
In 2024, the NOSB submitted a second recommendation to AMS related
to the petition's request to add synthetic carbon dioxide to the
National List in Sec. 205.601(j) for use as a crop or soil
amendment.\8\ The petition did not detail the intended use(s), so the
NOSB's Crops Subcommittee requested a new technical report.\9\ The
technical report identified the most prevalent use of carbon dioxide as
an atmospheric enrichment substance in indoor (e.g., greenhouse) crop
production.
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\8\ NOSB recommendation on carbon dioxide, October 2024,
www.ams.usda.gov/sites/default/files/media/CS_NOSBRec_CarbonDioxide.pdf.
\9\ NOP, carbon dioxide technical report, crops, 2023,
www.ams.usda.gov/sites/default/files/media/CarbonDioxide_Crops.pdf.
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The NOSB considered the petition, technical report, and public
comments received at its public meetings in April 2024 and October
2024.10 11 The Board ultimately determined that synthetic
carbon dioxide, when sourced as a byproduct and used for atmospheric
adjustment in indoor crop production, meets the OFPA criteria (7 U.S.C.
6518(m)) for inclusion in the National List.
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\10\ NOSB Milwaukee, WI meeting, Spring 2024, www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-milwaukee-wi.
\11\ NOSB Portland, OR meeting, Fall 2024, www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-portland-or.
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In its recommendation, the NOSB explained the necessity of carbon
dioxide supplementation in indoor crop production. An optimal
concentration of atmospheric carbon dioxide for plant growth in a
greenhouse environment is 800-1,000 parts per million. Plants consume
atmospheric carbon dioxide as they grow, depleting carbon dioxide from
the atmosphere inside the greenhouse. Supplemental carbon dioxide
sources can be used to replenish the depleted atmospheric carbon
dioxide within the greenhouse.
The NOSB discussed alternative practices for adjusting atmospheric
carbon dioxide, such as venting (exchanging air between inside and
outside the greenhouse); however, venting is not a practical solution
in colder climates due to the need for a controlled environment and
consistent temperature for crop production.
The NOSB evaluated the commercial sources of synthetic carbon
dioxide and recommended allowing synthetic carbon dioxide only when
sourced as a byproduct. The recommendation noted that synthetic carbon
dioxide is available as a byproduct of manufacturing processes and
propane heaters in greenhouses. The recommendation also noted that all
commercial sources of synthetic carbon dioxide on the market are
byproducts of other manufacturing processes. Restricting synthetic
carbon dioxide to byproduct (recycled) sources only would ensure that
the use of carbon dioxide will not have adverse effects on the
environment. The Board also reaffirmed its assessment that natural
sources are inadequate to meet commercial needs.
AMS Review of NOSB Recommendations
AMS agrees with both NOSB recommendations to add synthetic carbon
dioxide to 7 CFR 205.601(a) and 205.601(j), as these uses meet the
requirements for adding a synthetic substance to the National List
under OFPA at 7 U.S.C. 6517(c)(1)(A). AMS reviewed all documentation
that the Board considered as part of their recommendations, including
the petition and public comments.
AMS agrees with the NOSB's conclusion that the recommended uses of
carbon dioxide in crop production are not harmful to human health or
the environment. This assessment is consistent with prior AMS
determinations that supported the listing of synthetic carbon dioxide
on the National List in 7 CFR 205.605(b) for
[[Page 13785]]
use in organic processing. Additionally, carbon dioxide is generally
recognized as safe by the U.S. Food and Drug Administration (FDA) and
permitted for direct addition to food for human consumption (21 CFR
184.1240). The U.S. Environmental Protection Agency (EPA) also allows
carbon dioxide for pest control on food commodities in storage (40 CFR
180.1049), and as an inert ingredient in EPA-registered pesticides (40
CFR 180.910) and minimum risk pesticide products (40 CFR 152.25(f)(2)).
The EPA allowance for these uses is based on its assessment that the
substance is not hazardous to public health or the environment.
AMS also agrees with the NOSB's conclusions that allowed natural
and synthetic alternatives to the specific petitioned uses of synthetic
carbon dioxide are not commercially available. AMS invites additional
comments on the necessity of synthetic carbon dioxide for the uses
described in this proposed rule, including whether synthetic substances
already on the National List or natural substances are suitable
alternatives.
If finalized, this proposed rule would add two listings for
synthetic carbon dioxide to the National List for use in organic crop
production. First, the rule proposes adding carbon dioxide to 7 CFR
205.601(a), allowing organic crop producers to use synthetic carbon
dioxide as an algicide, disinfectants, and sanitizer, including
irrigation system cleaning. This listing would allow carbon dioxide to
be used to adjust irrigation water pH to inhibit mineral and algae
buildup, preventing the clogging of irrigation system equipment.
Second, the rule proposes adding carbon dioxide, when sourced as a
byproduct, to Sec. 205.601(j), allowing organic crop producers to use
synthetic carbon dioxide as a crop or soil amendment. This listing
would allow carbon dioxide to be used to adjust the atmosphere in
indoor crop production systems, such as greenhouses. This listing also
would allow carbon dioxide to be used to adjust irrigation water pH to
establish ideal pH values for crop nutrient availability and protect
soil quality from alkaline irrigation water.
This proposed rule would not supersede or conflict with applicable
FDA or EPA legal authority regarding the uses of carbon dioxide for
irrigation water treatment or greenhouse atmospheric enrichment. For
example, producers using substances to treat irrigation water would
need to do so in a manner that complies with relevant provisions of the
FDA Produce Safety rules for agricultural water (21 CFR part 112,
subpart E).
AMS requests comments about whether the proposed listing in 7 CFR
205.601(a) should include the same annotation limiting the sources of
carbon dioxide proposed in Sec. 205.601(j). Adding the annotation,
``must be sourced as a byproduct,'' at Sec. 205.601(a), in addition to
Sec. 205.601(j), would support consistency among the listings. AMS
welcomes comments on whether adding the restriction, ``must be sourced
as a byproduct,'' to Sec. 205.601(a) would preclude the intended uses
of carbon dioxide as described in the petition and recommended by the
Board. AMS also welcomes comments on whether any annotation related to
the source of carbon dioxide is necessary for either listing.
B. Sodium Nitrate (Crops)
This rule proposes renewing the listing for sodium nitrate on the
National List at 7 CFR 205.602 as a natural substance allowed for
limited use in organic crop production. This AMS proposal follows a
recommendation from the NOSB in October 2021 to reinstate the listing
for this substance. The listing for sodium nitrate is currently expired
for reasons further described in Background below. If finalized, this
proposed rule would allow for application of natural sodium nitrate as
a nitrogen fertilizer for up to 20 percent of a crop's total nitrogen
requirement,\12\ the same as prior to October 21, 2012, when the
listing for sodium nitrate expired.
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\12\ For example, if a producer determines that their corn crop
requires 120 pounds of nitrogen per acre, they may apply up to 20
percent, or 24 pounds, of nitrogen from sodium nitrate. A typical
sodium nitrate fertilizer contains 16% nitrogen, so a producer could
apply such a fertilizer at a maximum rate of 150 pounds per acre to
supply 24 pounds of nitrogen per acre to comply with the annotation.
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Background
The OFPA ``sunset provision'' requires that the NOSB reviews, and
that AMS renews, each exception (``listing'') on the National List
every 5 years (7 U.S.C. 6517(e)) for the listing to remain valid. This
recurring re-review process is referred to as ``sunset review.'' For
each substance on the National List, AMS calculates a ``sunset date''
that establishes the last date a substance listing is valid, calculated
as 5 years after the date that AMS last renewed the listing. AMS
publishes a complete list of sunset dates on its website.\13\
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\13\ Sunset dates for substances on the National List are
included in the ``NOSB Work Agenda,'' accessible online at:
www.ams.usda.gov/rules-regulations/organic/nosb.
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Typically, as the sunset date for a substance approaches, AMS
either announces in the Federal Register that a substance on the
National List is renewed (i.e., retained on the National List for
another 5 years) or AMS proposes a rule to remove a substance from the
National List. The removal of a substance is only complete if AMS
publishes a final rule that follows such a proposal, as rulemaking is
required to add, remove, or revise listings on the National List.
A substance listing can expire (i.e., become invalid) if AMS does
not complete rulemaking actions to either renew or remove a substance
from the National List by the sunset date. This is the case with sodium
nitrate. Sodium nitrate still appears on the National List at 7 CFR
205.602, but AMS has not renewed its listing through rulemaking since
October 21, 2007 (72 FR 58469, October 16, 2007). As announced in 2012,
AMS considered possible regulatory action on sodium nitrate, (77 FR
1996, January 12, 2012; 77 FR 33290, June 06, 2012), by either renewing
the listing or by prohibiting sodium nitrate--both recommended by the
NOSB in April 2011.\14\ However, AMS did not complete rulemaking.
Therefore, the listing has expired.
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\14\ NOSB recommendation on sodium nitrate, April 2011, https://www.ams.usda.gov/sites/default/files/media/Sodium%20Nitrate%20Final%20Rec.pdf.
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The fact that the expired listing of sodium nitrate continues to
appear on the National List creates confusion that this proposed rule
seeks to remedy. If finalized, this rule would renew the listing and
establish a new sunset date of 5 years after the effective date of a
final rule. The proposed rule would retain the same limitations for use
of sodium nitrate that were in place prior to the October 21, 2012
sunset date and described at Sec. 205.602. Specifically, this proposed
rule retains the maximum use rate for sodium nitrate of 20 percent of a
crop's total nitrogen requirement.
Finally, this proposal would remove obsolete language in the
annotation stating that use of sodium nitrate in spirulina production
is unrestricted until October 21, 2005. Spirulina producers were
restricted in their use of sodium nitrate from October 21, 2005, until
October 21, 2012. AMS has no information that spirulina production
requires a different limit than other types of crop production.
NOSB Recommendation
In October 2021, the NOSB unanimously recommended that AMS renew
the listing for sodium nitrate on
[[Page 13786]]
the National List.\15\ In its recommendation, the Board explained that
reinstatement was necessary to resolve the confusion with this listing
and to create uniform enforcement among certifying agents. The Board
also reasoned that a reinstatement was necessary to resume sunset
reviews, as directed by OFPA.
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\15\ NOSB recommendation on sodium nitrate, October 2021,
www.ams.usda.gov/sites/default/files/media/CSSodiumNitrateFinalRec.pdf.
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The NOSB evaluated over 60 public comments submitted at the October
2021 public meeting on this topic.4 Most organic crop producers and
certifying agents supported the reinstatement of sodium nitrate, as the
action would provide clarity. Several certifying agents explained that
they would have no issues verifying compliance with the restriction, as
verification using crop nitrogen calculations was a common practice
prior to 2012 when the listing was valid. One certifying agent stated
that restricting the allowable amount is unnecessary because operations
are using sodium nitrate at rates well below the limit of 20 percent of
a crop's total nitrogen requirement. Some comments stated they would
prefer a complete prohibition of sodium nitrate out of concern that
highly soluble nitrogen sources like sodium nitrate only feed the plant
and do not protect soil quality. The Board weighed all comments and
finalized their unanimous recommendation for AMS to reinstate the
listing of sodium nitrate on the National List and allow its use for up
to 20 percent of a crop's total nitrogen requirement, which protects
soil quality.
AMS Review of NOSB Recommendation
AMS agrees with the NOSB's recommendation to reinstate the listing
of sodium nitrate on the National List. The fact that sodium nitrate
appears on the National List as an expired listing creates confusion.
This proposed rule would resolve this confusion by affirming that the
use of sodium nitrate as annotated (i.e., comprising less than 20
percent of the crops' nitrogen requirements) is valid for 5 years from
the effective date of a final rule. The proposed action, if finalized,
would then allow the Board to subsequently review sodium nitrate
according to the OFPA sunset provision (7 U.S.C. 6517(e)). The proposed
rule would also implement a technical correction to remove obsolete
language exempting spirulina production from the use limits that
expired on October 21, 2005.
AMS also considered resolving the expired listing by removing
sodium nitrate from the National List. However, OFPA requires a
recommendation from the NOSB to revise the National List (7 U.S.C.
6517(c)(1)(C) and 6517(d)(1)), and the Board has made no such
recommendation. Therefore, AMS believes this proposed action to
reinstate the listing is the simplest and most effective approach to
resolve the confusion around the sodium nitrate listing. If finalized,
the rule would provide a path forward for the Board and AMS to resume a
regular sunset review schedule for the sodium nitrate listing, like all
other substances on the National List.
C. Meloxicam (Livestock)
AMS is proposing to add meloxicam to the National List at 7 CFR
205.603(a) as a synthetic substance allowed for use in organic
livestock production. Meloxicam is a nonsteroidal anti-inflammatory
drug (NSAID) used primarily to treat pain and inflammation. Organic
livestock producers petitioned for use of meloxicam because they
identified a need in their industry for more tools to improve pain
management in their operations, for both dairy and meat animals. This
AMS proposal follows a recommendation from the NOSB after their review
of the petition as well as public comment.
Background
On February 6, 2024, a group of organic dairy operations submitted
a petition to the NOSB to allow synthetic meloxicam as a medical
treatment in organic livestock production at 7 CFR 205.603(a).\16\
Meloxicam is an NSAID that works by reducing hormones that cause pain
and inflammation in the body. Nonorganic dairy operations often use it
as an easy and effective treatment of pain related to common veterinary
procedures, such as disbudding (the removal of the soft tissue that
would otherwise form horns on livestock) and dehorning. It is also used
to manage pain related to castration and other surgical procedures and
medical conditions. Meloxicam is typically administered to livestock in
oral tablet form, though it is also available as an injection. Its
therapeutic effect lasts 24-48 hours with a single dose.
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\16\ CROPP Cooperative/Organic Valley/Organic Prairie, Horizon
Organic Dairy, Lactalis Yogurt US/Stonyfield Farms, and Aurora
Organic Dairy petition, February 06, 2024, www.ams.usda.gov/sites/default/files/media/NOPPetitionMeloxicamV2.pdf.
---------------------------------------------------------------------------
While other pain management substances are available for organic
livestock producers to use, petitioners explained that they are
difficult to administer. The petition argues that meloxicam is easier
to administer and/or more effective. For example, flunixin can only be
administered by intravenous injection or by transdermal (i.e., pour-on)
solution. Using intravenous flunixin requires the producer to have the
technical skills necessary to administer the injection. Administering
transdermal flunixin requires caution to avoid spills or accidental
human absorption while pouring the medicine on the animal. Neither
application method of flunixin, the petition argues, is as easy nor as
safe as the orally administered meloxicam pill. The petition also
describes other alternatives as being less effective than meloxicam,
e.g., lidocaine has shorter-lived therapeutic effects, and natural
remedies or tinctures show inconsistent effects in scientific studies.
FDA Allowance
Meloxicam is FDA-approved for use in humans and in certain
companion animals (per approved labeling for dogs and/or cats) but only
authorized for use in food-producing livestock under the conditions
established by FDA at 21 CFR part 530. This practice, called extralabel
use, was established by the Animal Medicinal Drug Use Clarification Act
of 1994 (AMDUCA).\17\ Extralabel use is when a drug is used in a manner
that is not in accordance with the approved labeling (21 CFR 530.3).
---------------------------------------------------------------------------
\17\ Animal Medicinal Drug Use Clarification Act of 1994
(AMDUCA), www.fda.gov/animal-veterinary/guidance-regulations/animal-medicinal-drug-use-clarification-act-1994-amduca.
---------------------------------------------------------------------------
FDA regulations at 21 CFR part 530 establish the conditions under
which a licensed veterinarian may prescribe the extralabel use of FDA-
approved drugs for treatment of meat- or dairy-producing animals. FDA
regulations require veterinarians to use scientific information to
establish an appropriate withdrawal period, i.e., the required time
between administering the treatment and the marketing of milk, meat, or
other edible products from the animal (21 CFR 530.20(a)(2)(ii)). The
withdrawal period must assure that no drug residues that could present
a risk to public health remain in the animal (21 CFR 530.20(a)(2)(iv);
21 CFR 530.11).
The Food Animal Residue Avoidance Databank (FARAD) is a resource of
science-based recommendations regarding safe withdrawal periods of
drugs in food-producing animals.\18\ Veterinarians use FARAD to
determine
[[Page 13787]]
appropriate withdrawal periods that comply with FDA regulations for
extralabel drug use.
---------------------------------------------------------------------------
\18\ Food Animal Residue Avoidance Databank, www.farad.org.
---------------------------------------------------------------------------
NOSB Recommendation
In October 2024, the NOSB recommended adding meloxicam to 7 CFR
205.603(a) for use in organic livestock production.\19\ The Board
concluded that meloxicam is a synthetic substance and that the
petitioned use of meloxicam meets the OFPA criteria for allowing a
synthetic substance in organic production (7 U.S.C. 6517-6518). The
Board voted in favor of adding meloxicam to the National List.
---------------------------------------------------------------------------
\19\ NOSB recommendation on meloxicam, October 2024,
www.ams.usda.gov/sites/default/files/media/LS_MeloxicamFinalRec.pdf.
---------------------------------------------------------------------------
The NOSB's recommendation involved a thorough evaluation of the
petition and public comments received during its October 2024 meeting.
The petition included substantial technical information and numerous
appendices with scientific literature to support the Board's review.
Comments were provided from a range of stakeholders including farmers,
manufacturers, veterinarians, researchers, trade associations, advocacy
groups, certifying agents, inspectors, and consumers. There were more
than 40 substantive written and oral comments provided to the Board
specific to meloxicam, the majority of which supported the NOSB
recommendation to allow meloxicam in organic production.
In the recommendation, the NOSB noted that the use of meloxicam has
minimal adverse effects on the environment or human health (7 U.S.C.
6517(c)(1)(A)(i); 7 U.S.C. 6518(m)(1)-(5)). Specifically, the Board
described that after the drug is administered to livestock, it is
metabolized into biologically inactive metabolites, which have no
adverse impacts on soil organisms or biodiversity when excreted from
livestock through feces and urine. Several licensed veterinarians and
university research centers submitted comments to the Board stating
that meloxicam has been legally and safely administered to livestock
with no observed negative side effects. Regarding human health, the FDA
approved meloxicam for human use by prescription, and it is considered
safe when taken according to the physician's recommendation. As noted
above, FDA regulations at 21 CFR part 530 require that the
administration of meloxicam to livestock is followed by a sufficient
withdrawal period to ensure no residues enter the human food supply
that would present a risk to public health.
The NOSB thoroughly discussed and evaluated the process that
licensed veterinarians use to comply with AMDUCA and its implementing
regulations at 21 CFR part 530. This included evaluating the veterinary
procedures for diagnosing a specific condition or illness and obtaining
scientific information to determine withdrawal periods for the specific
dose, duration, and other confounding factors. The Board also received
feedback from organic certifying agents, inspectors, and certified
producers about the procedures currently in place for documenting
treatments and verifying compliance with withdrawal times. The Board
recommended that the withdrawal period for meloxicam in organic
livestock should be double that required by the FDA for compliance with
AMDUCA.
NOSB evaluated alternatives and determined that meloxicam is
necessary for organic livestock production (7 U.S.C. 6517(c)(1)(A)(ii);
7 U.S.C. 6518(m)(6)). The Board recognized that the petition was
submitted by a varied cross-section of the organic dairy industry
representing a majority of U.S. organic dairy operations. Information
in the petition and provided by public comments from livestock
operators indicate a need for safe and effective pain management tools
in both organic meat- and milk-producing animals. Specifically, the
Board cited that meloxicam is easier to administer, provides longer
therapeutic effectiveness, and requires fewer treatments in a specified
period compared to alternatives.
The NOSB determined that alternative NSAIDs are insufficient
replacements for meloxicam. Flunixin, whether in an injectable or pour-
on form, is more difficult to apply than meloxicam, which can be
administered by an oral tablet. Aspirin is another NSAID currently on
the National List for use in livestock, but the FDA clarified that
aspirin products are not permitted for use in lactating dairy
cattle.\20\ Lidocaine is on the National List for use in livestock as a
local numbing relief, typically during disbudding, but its efficacy
duration is far shorter that meloxicam (less than 2 hours for lidocaine
compared to 24-48 hours for meloxicam). According to the Board's review
of studies submitted with the petition and public comments, natural
alternatives such as herbal tinctures or willow bark are not effective
in managing pain.
---------------------------------------------------------------------------
\20\ FDA Dear Veterinarian Letter regarding use of aspirin
products in lactating dairy cattle. October 11, 2024, www.fda.gov/animal-veterinary/product-safety-information/dear-veterinarian-letter-regarding-use-aspirin-products-lactating-dairy-cattle.
---------------------------------------------------------------------------
The NOSB determined that the petitioned use of meloxicam is
consistent with organic farming and compatible with sustainable
agriculture (7 U.S.C. 6517(c)(1)(A)(iii); 7 U.S.C. 6518(m)(7)). The
Board noted that safe and effective pain management is important for
protecting animal welfare. The Board received comments from animal
welfare groups supporting the allowance of meloxicam for organic
livestock.
The NOSB explained that organic producers need access to
appropriate pain management tools for dairy- and meat-producing
livestock of all species and stages of life. A few comments suggested
that meloxicam should be limited to disbudding bovine calves younger
than 1 year of age. Other comments from producers and veterinarians
cited the benefits of meloxicam as a pain relief tool for older
animals, for non-bovine animals, and for treatments of pain other than
disbudding, such as castration. The NOSB recommendation states that all
animals need to receive pain management in accordance with veterinarian
recommendations.
Board members on the NOSB's Livestock Subcommittee
(``Subcommittee'') used their expertise in livestock management and
relevant disciplines to evaluate technical information during their
consideration of the meloxicam petition. The Subcommittee determined
that the technical information provided in the petition was thorough,
objective, and sufficient to evaluate meloxicam in conjunction with the
Subcommittee members' own technical expertise and information-gathering
effort. To verify sufficiency of the petition's technical information,
the Subcommittee produced a technical appendix document that references
how each question typically covered in a third-party technical report
is directly addressed in the petition. The technical appendix document
is attached to the Board's final recommendation, available on the AMS
website, but was not published with the Subcommittee's original
proposal prior to its meeting.\21\
---------------------------------------------------------------------------
\21\ The Livestock Subcommittee's technical analysis appendix
begins on page 8 of the final recommendation: www.ams.usda.gov/sites/default/files/media/LS_MeloxicamFinalRec.pdf.
---------------------------------------------------------------------------
During the NOSB deliberation at the public meeting, some Board
members stated they would have preferred the Subcommittee to publish
its technical analysis appendix for public visibility prior to the
meeting. Some commenters
[[Page 13788]]
also said that more technical information was needed and requested the
issue be returned to the Subcommittee for further study. With support
from the majority of commenters, the Board determined that there was
sufficient technical information to support their recommendation,
citing the robustness of the petition and public comments (including
technical expertise of veterinarians and producers who authored the
petition and submitted comments), in combination with the
Subcommittee's own expertise in livestock production. Ultimately, the
Board voted in favor of the recommendation. The Subcommittee's
technical analysis appendix is publicly available on the AMS website as
part of the NOSB final recommendation, and AMS welcomes comments from
the public during this comment period.
AMS Review of NOSB Recommendation
AMS agrees with the NOSB recommendation to allow meloxicam as a
medical treatment for organic livestock, as meloxicam meets the
requirements for adding a substance to the National List under 7 U.S.C.
6517(c)(1)(A). AMS reviewed all documentation that the Board considered
as part of its recommendation, including the petition and public
comments, and consulted with the FDA to inform this determination. AMS
also agrees with the Board's recommendation to classify meloxicam as
synthetic because it is manufactured through a process that meets the
definition of ``synthetic'' at 7 CFR 205.2.
AMS has reviewed and agrees with the NOSB's conclusion that the
petitioned use of meloxicam is not harmful to human health or the
environment (7 U.S.C. 6517(c)(1)(A)(i)). The FDA regulations that
implement AMDUCA (21 CFR part 530) are sufficient to ensure that
meloxicam is used in a manner that does not pose harm to human health.
Scientific information reviewed by the Board and AMS indicates that
metabolites of meloxicam excreted by livestock do not pose harm to the
environment.
Consistent with the NOSB's recommendation, AMS proposes that the
withdrawal period for meloxicam would be calculated to be twice as long
as what a licensed veterinarian determines to be required for
compliance with FDA regulations (AMDUCA (21 CFR 530.20(a)(2)(ii))). For
example, if a licensed veterinarian determines that a 5-day milk
withdrawal period is appropriate for extralabel use of meloxicam under
full compliance with AMDUCA, then the withdrawal time would be doubled
to 10 days for compliance with the USDA organic regulations for use in
organic livestock.
AMS understands that veterinarians determine withdrawal periods for
each animal based on the individual animal's conditions, diagnosis,
dosage, and other case-specific factors in full compliance with AMDUCA.
This approach may result in some variation in withdrawal times between
animals with different conditions. However, it is an approach that
relies on well-established FDA legal oversight of the use of animal
drugs and the sound expertise of licensed veterinarians to determine
appropriate prescriptions of each treated animal.
The extended withdrawal period proposed in this rule is only
relevant for use of the substance under USDA organic regulations.
Organic livestock producers are prohibited from administering animal
drugs in violation of the Federal Food, Drug, and Cosmetic Act (7 CFR
205.238(c)(6)). This proposed rule would not supersede or conflict with
the FDA's authority to approve drugs and determine the withdrawal
periods for animal drugs.
AMS agrees with the NOSB determination that the use of meloxicam is
necessary to the production or handling of the agricultural product
because of the unavailability of natural substitutes (7 U.S.C.
6517(c)(1)(A)(ii)). Meloxicam is easy to administer as an oral pill
compared to alternatives that require an intravenous or transdermal
(pour-on) application. Meloxicam also has longer efficacy duration and
requires fewer treatments in a given period than any alternatives. The
majority of public comments and the Board vote indicate a broad range
of support across the organic industry for the allowance of meloxicam
in organic livestock production.
AMS further agrees with the NOSB determination that the use of
meloxicam is consistent with organic farming (7 U.S.C.
6517(c)(1)(A)(iii)). USDA organic regulations require producers to
establish and maintain preventive health care practices. Physical
alterations and surgical procedures must be performed in a manner that
minimizes pain, stress, and suffering, and with the use of allowed
anesthetics, analgesics, and sedatives, as appropriate (7 CFR
205.238(a)(5) and 205.238(a)(7)). USDA organic regulations provide for
the allowance of medications to alleviate pain or suffering and when
preventive practices are inadequate to prevent sickness (7 CFR
205.238(b)). The use of meloxicam for pain management is consistent
with the USDA organic regulations for minimizing pain and stress in
organic livestock.
AMS finds that meloxicam meets OFPA requirements and proposes
adding it to the National List at Sec. 205.603(a) as a synthetic
substance allowed in organic livestock production. If this proposal is
finalized, meloxicam would be allowed for use as a medical treatment in
organic livestock production. The proposed listing would require that
meloxicam be used in full compliance with AMDUCA and 21 CFR part 530 of
the FDA regulations. The proposed annotation further requires that
meloxicam may only be used in organic production by the lawful written
order of a licensed veterinarian, and the withdrawal period must be at
least twice that required by FDA. Excipients added to product
formulations would need to comply with 7 CFR 205.603(f).\22\
---------------------------------------------------------------------------
\22\ Excipients are ingredients that are intentionally added to
livestock medications but do not exert therapeutic or diagnostic
effects at the intended dosage, although they may act to improve
product delivery (7 CFR 205.2).
---------------------------------------------------------------------------
To comply with the proposed withdrawal period, AMS expects that
veterinarians, organic livestock operations, and certifying agents
would follow the same process for determining, documenting, and
verifying compliance of withdrawal periods for meloxicam as is done for
other synthetic substances on the National List that are used in
accordance with AMDUCA. The proposed annotation to double the FDA
withdrawal period is consistent with other synthetic livestock
medications on the National List for which the FDA-required withdrawal
period is doubled (e.g., flunixin).
AMS welcomes comments on whether the proposed annotation is clear
enough to allow producers to comply with the proposed requirements. If
elements of the annotation are unclear, AMS welcomes suggestions for
language to clarify the annotation to achieve the intended outcomes
described in this proposed rule.
In developing this proposed rule, AMS considered alternative
annotation language that would further restrict the use of meloxicam.
For instance, AMS considered proposing a specific minimum withdrawal
time for bovine species (i.e., cattle and calves). The minimum
withdrawal period could, for example, be calculated by doubling the
longest recommended withdrawal times indicated by public comments: a
meat withdrawal period of at least 56 days after administering to
bovine livestock intended for slaughter, and a milk
[[Page 13789]]
discard period of at least 10 days after administering to bovine dairy
animals. AMS welcomes comments on whether a specified minimum
withdrawal period is necessary, and if so, what specific duration is
appropriate for meat- and milk-producing bovine species. AMS also
welcomes comments on whether further restrictions are appropriate, such
as whether meloxicam should only be allowed for treating pain resulting
from disbudding and dehorning, or whether meloxicam should be limited
to certain species (e.g., allowed for cattle but not allowed for goats
and sheep).
D. Methionine (Livestock)
This rule proposes amending the current allowance of methionine, an
amino acid, in poultry diets by removing the limits on the amount of
synthetic methionine a producer can add to poultry feed rations. This
AMS proposal follows a unanimous recommendation from the NOSB. If
finalized, producers will have greater flexibility in using methionine
to meet the health and nutrition requirements of organic poultry
flocks.
Background
Methionine is an essential amino acid for poultry. It is a critical
building block for proteins that form muscles, tissues, feathers, and
support immune response. Without sufficient methionine, poultry are at
risk of several significant health and production issues, including
growth impairment, compromised immune function, poor feathering,
reduced egg production, and behavioral problems like nervousness,
feather picking, and cannibalism.
Poultry cannot synthesize methionine on their own, so they must
obtain it from protein sources in their diets. Common plant-based
feedstuffs typically lack a sufficient supply of methionine. Therefore,
synthetic methionine is commonly added to poultry feed rations to meet
nutritional needs of poultry.
The USDA organic regulations have allowed synthetic methionine for
organic livestock production since 2003 (68 FR 61987, October 31,
2003). Methionine has undergone several amendments on the National List
to restrict its use in various ways, including the use of expiration
dates and maximum use limits. The current restriction, which has been
effective since 2019, limits its use to no more than 2 to 3 pounds of
methionine per ton of feed, depending on the type and species of
poultry, calculated as an average over the life of the flock.\23\ In
this rulemaking, AMS is proposing to remove these limits and to allow
the use of methionine as an organic poultry feed additive without
restriction beyond the existing general practice standards for
livestock feed in Sec. 205.237.
---------------------------------------------------------------------------
\23\ The full text of the current annotation is, ``for use only
in organic poultry production at the following pounds of synthetic
100 percent methionine per ton of feed in the diet, maximum rates as
averaged per ton of feed over the life of the flock: Laying
chickens--2 pounds; broiler chickens--2.5 pounds; turkeys and all
other poultry--3 pounds.'' 7 CFR 205.603(d)(1).
---------------------------------------------------------------------------
NOSB Recommendation
In October 2024, the NOSB unanimously recommended amending the
National List to remove the limit on the amount of methionine that
organic producers may feed to poultry.\24\ The Board recommended
removing this limit primarily to give organic producers more
flexibility to use methionine to support bird health and to reduce
overly burdensome recordkeeping requirements.
---------------------------------------------------------------------------
\24\ NOSB recommendation on methionine, October 2024,
www.ams.usda.gov/sites/default/files/media/LS_DLMethionineAnnotChangeFinalRec.pdf.
---------------------------------------------------------------------------
In the rationale supporting its recommendation, the NOSB noted the
challenges caused by the current annotation. The current limits have
prevented some producers from being able to feed their poultry adequate
methionine. To address this deficiency, some producers increased the
amount of feed ingredients that are high in methionine, like soybean
meal. However, these dietary adjustments (e.g., feeding more soybean
meal to address methionine deficits) can increase crude protein levels,
which can negatively affect bird health, create problems with manure
management, and result in increased ammonia concentration in poultry
housing. To give producers more flexibility to provide healthy balanced
feed rations, without resorting to over-feeding protein and creating
secondary problems, the Board recommended removing the limit on
methionine.
The NOSB recommendation also noted the ongoing lack of natural
alternatives to synthetic methionine. One of the historical
justifications for limiting synthetic methionine was preserving the
incentive to develop viable natural methionine alternatives. Over the
years, the organic industry has explored a number of possible sources
of natural methionine, such as insects and fermentation products.
However, these products have not achieved widespread adoption or
developed the production scale necessary to adequately address the
needs of the organic poultry industry. Because the limit on synthetic
methionine has not meaningfully accelerated a natural alternative, the
Board reasoned that a limit is not effective for this purpose.
The NOSB also explained its recommendation is intended to better
align USDA organic regulations with those of our trading partners. For
example, neither the European Union (EU) nor Canada limit the amount of
methionine in organic feed. EU organic regulations permit a certain
percentage of non-organic ingredients in grain-based poultry diets,
which allows organic producers in the EU to include high-methionine
ingredients (e.g., corn gluten meal) in poultry feed to meet birds'
needs. Similarly, Canada permits the addition of synthetic methionine
when naturally occurring sources are not adequate to meet a flock's
needs.
The NOSB recommendation was informed by public comments at the
October 2024 meeting.\11\ The majority of comments were supportive of
removing the limits on methionine, citing benefits such as reduced
paperwork burden for producers, inspectors, and certifying agents, as
well as better health outcomes for poultry flocks. Comments from
organic poultry operations and organic certification agencies indicated
the recordkeeping burden was especially difficult for small farms and
farms with mixed flocks of multiple poultry species that each required
separate calculations. Calculating lifetime averages can also be
challenging for flocks that change ownership or locations, requiring a
combination of records from multiple operations. Commenters also
continued to note that no viable natural alternatives to methionine
have been found.
AMS Review of NOSB Recommendation
AMS agrees with the NOSB recommendation to allow methionine as an
organic poultry feed additive without limits on the amount of
methionine that may be added to organic poultry rations. This
deregulatory action will give producers maximum flexibility in using
methionine to meet the health and nutrition needs of their flocks.
Furthermore, this proposed action will lift a recordkeeping burden from
organic producers, who will no longer need to maintain records
documenting pounds of methionine fed per ton of feed over the lifetime
of each flock.
AMS also agrees with the NOSB's determination that synthetic
methionine continues to be necessary for organic poultry production due
to the absence of natural alternatives. Although existing limits were
intended to
[[Page 13790]]
incentivize the development of natural alternatives, it does not appear
that the limits have been effective for this purpose. Viable natural
alternatives have not been developed and are not commercially available
to the extent necessary to support the organic poultry industry.
Removing the limit on synthetic methionine should not deter future
development of natural alternatives.
AMS concludes that all criteria at 7 U.S.C. 6517(c)(1)(A) would
continue to be met under this proposed rule, even in the absence of the
current limits. This supports the inclusion of synthetic methionine on
the National List. Synthetic methionine is not harmful to human health
or the environment, is necessary to the organic poultry production
because of the unavailability of wholly natural substitute products and
is consistent with organic farming and handling practices.
If this proposed amendment is finalized, producers will maintain
access to synthetic methionine for use as a feed additive in organic
poultry production. Producers would be allowed to use methionine in
poultry feed in a way that complies with USDA organic regulations to
meet the nutritional requirements of the animal (7 CFR 205.237 and
205.238(a)(2)).
IV. Related Documents
AMS published 5 notices in the Federal Register announcing the
public NOSB meetings and inviting public comments on the NOSB
recommendations addressed in this proposed rule: Fall 2021 (86 FR
29738, June 3, 2021), Spring 2022 (87 FR 12074, March 3, 2022), Fall
2022 (87 FR 37495, June 23, 2022), Spring 2024 (89 FR 8398, February 7,
2024), and Fall 2024 (89 FR 70591, August 30, 2024). Meeting
transcripts and public comments received by the NOSB can be found on
the AMS website at: www.ams.usda.gov/rules-regulations/organic/nosb/meetings.
V. Regulatory Analyses
A. Executive Order (E.O.) 12866 and E.O. 13563
USDA is issuing this proposed rule in conformance with Executive
Orders (E.O.) 12866, ``Regulatory Planning and Review,'' and E.O.
13563, ``Improving Regulation and Regulatory Review.'' This proposed
rule has been determined to be not significant for purposes of
Executive Order 12866, and, therefore, has not been reviewed by the
Office of Management and Budget (OMB).
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires
agencies to consider the economic impact of each rule on small entities
and evaluate alternatives that would accomplish the objectives of the
rule without unduly burdening small entities or erecting barriers that
would restrict their ability to compete in the market. The purpose of
the RFA is to fit regulatory actions to the scale of businesses subject
to the action. Section 605 of the RFA allows an agency to certify a
rule, in lieu of preparing an analysis, if the final rule is not
expected to have a significant economic impact on a substantial number
of small entities.
AMS does not expect the economic impact on entities affected by
this rulemaking to be significant. This proposed rule would allow two
additional substances in organic crop and livestock production and
would remove restrictions on the use of one substance, thus removing
paperwork and regulatory burdens. The amendments would provide small
entities with more options to use in day-to-day operations. The
proposed rule would also affirm the validity of current USDA organic
regulations related to the use of sodium nitrate as a nitrogen
fertilizer. AMS does not expect any significant economic impact related
to this action for small entities, as certified operations are already
required to maintain records of all activities (e.g., input
applications) and transactions.
C. E.O. 12988
E.O. 12988 instructs each executive agency to adhere to certain
requirements in the development of new and revised regulations to avoid
unduly burdening the court system. This proposed rule is not intended
to have a retroactive effect. Accordingly, to prevent duplicative
regulation, states and local jurisdictions are preempted under OFPA
from creating programs of accreditation for private persons or state
officials who want to become certifying agents of organic farms or
handling operations. A governing state official would have to apply to
the USDA to be accredited as a certifying agent, as described in OFPA
(7 U.S.C. 6514(b)). States are also preempted from creating
certification programs to certify organic farms or handling operations
unless the state programs have been submitted to, and approved by, the
Secretary as meeting the requirements of OFPA (7 U.S.C. 6501-6524).
Pursuant to OFPA (7 U.S.C. 6507(b)(2)), a state organic
certification program that has been approved by the Secretary may,
under certain circumstances, contain additional requirements for the
production and handling of agricultural products organically produced
in the state and for the certification of organic farm and handling
operations located within the state. Such additional requirements must
(a) further the purposes of OFPA, (b) not be inconsistent with OFPA,
(c) not be discriminatory towards agricultural commodities organically
produced in other states, and (d) not be effective until approved by
the Secretary.
In addition, pursuant to 7 U.S.C. 6519(c)(6) of the OFPA, this
proposed rule does not supersede or alter the authority of the
Secretary under the Federal Meat Inspection Act (21 U.S.C. 601-624),
the Poultry Products Inspection Act (21 U.S.C. 451-471), or the Egg
Products Inspection Act (21 U.S.C. 1031-1056) concerning meat, poultry,
and egg products, respectively, nor any of the authorities of the
Secretary of Health and Human Services under the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 301 et seq.), nor the authority of the
Administrator of the EPA under the Federal Insecticide, Fungicide and
Rodenticide Act (7 U.S.C. 136 et seq.).
D. Paperwork Reduction Act
Routine collection, reporting and recordkeeping related to the use
of substances on the National List are covered under OMB Number 0581-
0191. No additional collection or recordkeeping requirements are
imposed on the public by this proposed rule. Accordingly, OMB clearance
is not required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501,
chapter 35.
E. E.O. 13175
E.O. 13175 requires Federal agencies to consult and coordinate with
Tribes on a government-to-government basis on policies that have Tribal
implications, including regulations, legislative comments or proposed
legislation, and other policy statements or actions that have
substantial direct effects on one or more Indian Tribes, the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. AMS has assessed the impact of this
proposed rule on Indian Tribes and determined that this rulemaking
would not have Tribal implications that require consultation under E.O.
13175.
F. Unfunded Mandates Reform Act
This proposed rule does not contain Federal mandates under the
regulatory
[[Page 13791]]
provisions of title II of the Unfunded Mandates Reform Act of 1995 (2
U.S.C. chapter 25) (UMRA) for State, local and Tribal governments, or
the private sector of $100 million or more in any one year. Thus, the
proposed rule is not subject to the requirements of sections 202 and
205 of the UMRA.
List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agriculture, Agricultural
commodities, Animals, Archives and records, Crops, Disinfectants, Fees,
Imports, Labeling, Livestock, National List, National Organic Standards
Board (NOSB), Organically produced products, Plants, Reporting and
recordkeeping requirements, Sanitizers, Seals and insignia, Soil
conservation, Sunset.
For the reasons stated in the preamble, AMS proposes to amend 7 CFR
part 205 as follows:
PART 205--NATIONAL ORGANIC PROGRAM
0
1. The authority citation for 7 CFR part 205 continues to read as
follows:
Authority: 7 U.S.C. 6501-6524.
0
2. Amend Sec. 205.601 by:
0
a. Redesignating paragraphs (a)(2) through (8) as paragraphs (a)(3)
through (9);
0
b. Adding new paragraph (a)(2);
0
c. Redesignating paragraphs (j)(2) through (11) as paragraphs (j)(3)
through (12); and
0
d. Adding new paragraph (j)(2).
The additions read as follows:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
* * * * *
(a) * * *
(2) Carbon dioxide.
* * * * *
(j) * * *
(2) Carbon dioxide--must be sourced as a byproduct.
* * * * *
0
3. Amend Sec. 205.602 by revising paragraph (h) to read as follows:
Sec. 205.602 Nonsynthetic substances prohibited for use in organic
crop production.
* * * * *
(h) Sodium nitrate--unless use is restricted to no more than 20% of
the crop's total nitrogen requirement.
* * * * *
0
4. Amend Sec. 205.603 by:
0
a. Redesignating paragraphs (a)(20) through (30) as paragraphs (a)(21)
through (31);
0
b. Adding new paragraph (a)(20); and
0
c. Revising paragraph (d)(1).
The addition and revision read as follows:
Sec. 205.603 Synthetic substances allowed for use in organic
livestock production.
* * * * *
(a) * * *
(20) Meloxicam (CAS #71125-38-7)--Federal law restricts this drug
to use by or on the lawful written or oral order of a licensed
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of
the Food and Drug Administration regulations. Also, for use under 7 CFR
part 205, the NOP requires:
(i) Use by or on the lawful written order of a licensed
veterinarian; and
(ii) A withdrawal period of at least two times that required by the
FDA.
* * * * *
(d) * * *
(1) DL-methionine, DL-methionine-hydroxy analog, and DL-methionine-
hydroxy analog calcium (CAS #'s 59-51-8, 583-91-5, 4857-44-7, and 922-
50-9)--for use only in organic poultry production.
* * * * *
Erin Morris,
Administrator, Agricultural Marketing Service.
[FR Doc. 2026-05598 Filed 3-20-26; 8:45 am]
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