[Federal Register Volume 89, Number 246 (Monday, December 23, 2024)]
[Rules and Regulations]
[Pages 104367-104393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30211]
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Rules and Regulations
Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 /
Rules and Regulations
[[Page 104367]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Doc. No. AMS-NOP-22-0063]
RIN 0581-AE13
National Organic Program; Market Development for Mushrooms and
Pet Food
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
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SUMMARY: The United States Department of Agriculture (USDA)
Agricultural Marketing Service (AMS) is amending the USDA organic
regulations to clarify standards for organic mushrooms and organic pet
food. The topics addressed by the rule include mushroom substrate
composition and sourcing of mushroom spawn in organic mushroom
production, composting requirements for organic mushroom production,
composition and labeling requirements for organic pet food, and the use
of certain synthetic substances, including taurine, in organic pet
food.
DATES:
Effective date: This rule is effective February 21, 2025.
Compliance date: Organic operations must comply with the
requirements of this rule by February 22, 2027.
For additional discussion, see section I.C. of this document.
FOR FURTHER INFORMATION CONTACT: Erin Healy, Director, Standards
Division, National Organic Program. Telephone: 202-720-3252. Email:
[email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. General Information
A. Does this final rule apply to me?
B. Summary of Provisions
C. Implementation and Compliance Dates
II. Background
A. Purpose and Need for the Rule
B. National Organic Standards Board (NOSB) Recommendations on
Mushrooms and Pet Food
C. Community and Stakeholder Feedback
D. Authority
III. Organic Mushroom Standard
A. Mushroom Background
B. Need for Organic Mushroom Standards
C. Overview of Final Rule Policy and Responses to Comments
IV. Organic Pet Food Standard
A. Pet Food Background
B. Need for Organic Pet Food Standards
C. Overview of Final Rule Policy and Responses to Comments
V. Regulatory Analyses
A. Executive Orders 12866, 13563, 14094, and the Regulatory
Flexibility Act
B. Executive Order 12988
C. Executive Order 13132
D. Executive Order 13175
E. Civil Rights Impact Analysis
F. Paperwork Reduction Act
I. General Information
A. Does this final rule apply to me?
You may be affected by this final rule if you are engaged in
organic mushroom production, pet food handling, or related activities.
Potentially affected entities may include, but are not limited to, the
following:
Organic mushroom producers (including organic spawn
producers);
Organic pet food manufacturers;
Individuals or business entities that are considering
organic certification for pet food or mushroom production (or related
activities, such as spawn production);
USDA-accredited certifying agents (or ``certifiers''),
inspectors, and certification review personnel.
This list is not exhaustive but identifies key entities that this
rule may affect. Other types of entities may also be affected. To
determine whether you or your business may be affected by this action,
you should carefully examine the regulatory text and discussion below.
If you have questions regarding the applicability of this rule to a
particular entity, contact the person listed under FOR FURTHER
INFORMATION CONTACT.
B. Summary of Provisions
Through the amendments in this final rule, AMS is establishing
standards for organic mushroom production and pet food handling. The
standards are discussed in detail in this document. In summary, the
rule:
Establishes definitions for mushroom, mushroom mycelium,
mushroom spawn, mushroom spawn media, and mushroom substrate for the
purposes of the USDA organic regulations.
Clarifies that mushrooms are a type of crop and updates
the definition of crops to include mushrooms.
Creates a new section of the organic regulations titled
``Mushroom Production Practice Standard,'' to describe standards
related to the production of mushrooms, mushroom spawn, and products of
mushroom production.
Specifies allowed substances in organic mushroom spawn
media and organic mushroom substrate.
Requires that uncomposted plant materials used in mushroom
substrate be organic when commercially available; requires that
operations describe in their organic system plan the procedures and
criteria used to search for organic materials and the recordkeeping
system used to track purchases of nonorganic plant materials.
Allows nonorganic wood materials in mushroom substrate and
spawn media.
Requires that operations use organic mushroom spawn when
commercially available.
Describes minimum requirements for compost used in
mushroom substrate. (The requirements for compost used in other types
of crop production (i.e., plants) are unchanged.)
Establishes definitions for pet and pet food for the
purposes of the USDA organic regulations and clarifies that pet food is
distinct from livestock feed under these regulations.
Clarifies the requirements for composition and labeling of
organic pet food using the existing regulatory framework for processed
organic products.
Allows use of synthetic taurine (an amino acid) in organic
pet food, as well as other vitamins and minerals that are approved by
the Food and Drug Administration.
C. Implementation and Compliance Dates
As described in the DATES section of this rule, this rule becomes
effective on February 21, 2025. However, AMS is allowing an additional
two (2) years for organic operations to comply with the requirements of
the final rule. Organic
[[Page 104368]]
operations must comply with the final rule by February 22, 2027.
The compliance date establishes the date by which organic
operations must comply with the requirements. However, organic
operations may choose to comply with the final rule prior to the
compliance date. For example, pet food operations may use taurine in
organic pet food starting on the effective date of the final rule.
For a discussion of the public comments related to the rule's
implementation and compliance dates, see ``Responses to Public Comments
on Implementation Timeline'' sections below in III.C. for mushrooms and
IV.C. for pet food.
II. Background
A. Purpose and Need for the Rule
This final rule amends the USDA organic regulations to establish
specific standards for organic mushroom production and organic pet food
handling. The purpose of these amendments is to resolve uncertainty and
inconsistency in how the organic regulations apply to these two
products. Inconsistent certification and enforcement practices for
organic mushrooms and pet food fail to meet one of the purposes of the
Organic Foods Production Act (OFPA): to assure consumers that
organically produced products meet a consistent standard (7 U.S.C.
6501(2)). Based on market penetration data and feedback from
stakeholders, AMS believes that creating more consistency in the market
and ensuring regulatory certainty will create conditions for growth in
these two markets and other latent markets that support them, such as
the markets for mushroom substrate and organic slaughter by-products.
Certifiers have been using the organic crop production standards to
certify organic mushrooms; however, AMS believes new standards are
necessary to adequately address unique aspects of mushroom production
that differ significantly from plant production. Certifiers' attempts
to interpret the existing crop standards for mushroom production are
currently inconsistent, which may lead to producers inconsistently
applying the standards to substrate, spawn, and compost for mushroom
production.
Similarly, the current organic regulations do not specifically
address pet food. Producers and certifiers have been applying a
combination of the handling standards for processed products and the
organic livestock feed standards to certify organic pet food, but their
practices were not uniform. Neither the handling standards nor the
livestock standards are sufficient to address the range of ingredients
and nutrients that are necessary for pets. For example, the livestock
feed standards include allowances for many of the nutrients that are
necessary for pets but prohibit common pet food ingredients, such as
slaughter by-products (e.g., animal and poultry by-product meal, animal
liver).
This rule also addresses feedback from the organic industry, which
has asked USDA to implement outstanding NOSB recommendations, including
standards for these two product categories. Stakeholders encouraged AMS
to prioritize rulemaking for additional practice standards, including
standards for organic pet food and mushrooms, at the March 2022 virtual
listening session hosted by AMS. The changes in this rule are based on
NOSB recommendations for mushroom production and pet food handling in
response to the organic industry's interest in further developing the
organic standards for these markets.
Market penetration data supports the idea that the organic mushroom
and organic pet food markets have a reasonable expectation of growth if
uncertainty and inconsistency are removed as barriers. Both markets
currently lag behind their most-comparable organic sectors. In 2023,
sales of organic produce accounted for a 15.2 percent share of all
produce sales in the United States,\1\ but mushrooms sold as organic
only accounted for 9.6 percent of all mushroom sales during the 2023-
2024 marketing year.\2\ Considering that the consumer experience of
purchasing mushrooms is typically similar to purchasing fruits and
vegetables (they are packaged similarly and found in the same section
of the grocery store), it is reasonable to conclude that some external
barrier is inhibiting the organic mushroom market. Similarly, organic
pet food accounts for only 0.32 percent of all pet food sales. The
closest organic category of comparison for organic pet food is organic
non-food products, which includes other products humans do not eat
(e.g., linen/clothing, supplements, and personal care products). All
other non-food product types tracked by the Organic Trade Association
have at least twice the market share of organic pet food, with the
organic products accounting for between 0.76 percent to 3.3 percent of
their total market sales.\3\
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\1\ Organic Trade Association. (2024). Organic Industry Survey.
p. 41.
\2\ USDA, National Agricultural Statistics Service. (August 21,
2024). ``Mushrooms.''
\3\ Organic Trade Association. (2024). Organic Industry Survey.
p. 69.
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In conclusion, AMS believes that clear and consistent standards for
organic mushrooms and pet food may create the conditions necessary for
organic markets to develop. Regulatory certainty encourages investment
in nascent markets; investment increases production capacity; and
production enables market growth. Clear standards will promote growth
in the development of these markets by increasing consistency in
certification and enforcement and removing uncertainty as a regulatory
barrier to production and certification. Additionally, growth in these
markets is likely to ensure consistent demand for organic inputs in
underdeveloped markets like organic meat and organic slaughter by-
products. Ensuring consistent standards across the organic industry
also protects the integrity of the organic seal by building consumer
trust in the label.
AMS provides additional discussion of the need for organic mushroom
and pet food standards in the respective sections below (see ``III.B.
Need for Organic Mushroom Standards'' and ``IV.B. Need for Organic Pet
Food Standards'').
B. National Organic Standards Board (NOSB) Recommendations on Mushrooms
and Pet Food
The NOSB is a Federal advisory committee established by OFPA (7
U.S.C. 6518) to provide recommendations to USDA on the development of
organic standards and regulations. NOSB recommendations are developed
through a rigorous process involving technical information, stakeholder
input through public comment, open meetings, and a decisive two-thirds
majority vote of the Board. Although the Board cannot direct or bind
USDA through its recommendations, USDA uses the NOSB recommendations to
inform rulemaking, including this rulemaking.
[[Page 104369]]
Several times in its history, the NOSB has recognized the unique
production needs of organic mushrooms and pet food and recommended
standards specific to each market. The Board recommended organic
mushroom standards in April 1995 \4\ and again in October 2001.\5\
Subsequently, the NOSB made a recommendation on organic pet food
standards in November 2008,\6\ and in April 2013, the NOSB recommended
amending the National List of Allowed and Prohibited Substances (or
``National List'') to include taurine for use in pet food.\7\ This
final rule is AMS's first rulemaking action related to these
recommendations. The NOSB recommendations are discussed below.
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\4\ NOSB. (April 24-28, 1995). ``Final minutes of the National
Organic Standards Board full board meeting.'' http://www.dairyprogramhearing.com/getfile32e532e5.pdf?dDocName=STELPRDC5057442.
\5\ NOSB. (2001). ``NOSB Final Recommendation on Mushroom
Practice Standards.'' https://www.ams.usda.gov/sites/default/files/media/Recommended%20Mushroom%20Standards.pdf.
\6\ NOSB. (November 19, 2008). ``Formal Recommendation from NOSB
to NOP: Organic Pet Food Standards.'' https://www.ams.usda.gov/sites/default/files/media/NOP%20Final%20Rec%20Pet%20Food.pdf.
\7\ NOSB. (April 11, 2013). ``Formal Recommendation from NOSB to
NOP: Petition to add Required Synthetic Amino Acids for Pet Food.''
https://www.ams.usda.gov/sites/default/files/media/NOP%20Livestock%20Final%20Rec%20Pet%20Food%20Amino%20Acid%20amended.pdf.
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NOSB Recommendations on Mushroom Production
In 2001, the NOSB recommended standards to:
Prevent contact between organically produced mushrooms or
mushroom growth substrates and prohibited substances;
Require the use of organic spawn when commercially
available;
Require organically produced agricultural materials in
mushroom substrate; and
Allow nonorganic wood materials (e.g., sawdust) in
mushroom substrate if trees have not been treated with prohibited
substances for three years prior to harvest and have not been treated
with prohibited substances after harvest.
NOSB Recommendations on Pet Food
In November 2008, the NOSB recommended that organic claims on pet
food should be regulated under a combination of organic livestock feed
standards and organic processed products labeling requirements.\8\ The
NOSB recommended standards to:
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\8\ NOSB. (November 19, 2008). ``Formal Recommendation from NOSB
to NOP: Organic Pet Food Standards.'' https://www.ams.usda.gov/sites/default/files/media/NOP%20Final%20Rec%20Pet%20Food.pdf.
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Clarify which animals the pet food requirements would
apply to by defining ``pets'' in the regulations;
Label organic pet food using a framework consistent with
labeling for organic human food, allowing the ``organic'' claim that
requires a minimum of 95 percent organic ingredients and the ``made
with organic (specified ingredients or food group(s))'' claim that
requires a minimum of 70 percent organic ingredients;
Clarify that organic slaughter by-products can be a
component of organic pet food; and
Allow taurine for use in pet food by adding it to the
National List of allowed synthetic substances.\9\
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\9\ The 2008 recommendation listed taurine and other additives
as ``materials for possible petition to the National List for use in
Pet Food.'' In 2013, the NOSB passed a motion to specifically
recommend listing taurine ``as a feed additive for use in pet food,
only.'' See NOSB. (April 11, 2013). ``Formal Recommendation from
NOSB to NOP: Petition to add Required Synthetic Amino Acids for Pet
Food.'' https://www.ams.usda.gov/sites/default/files/media/NOP%20Livestock%20Final%20Rec%20Pet%20Food%20Amino%20Acid%20amended.pdf.
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AMS used the NOSB recommendations to inform this rulemaking.
C. Community and Stakeholder Feedback
When developing this Market Development rule, AMS considered
industry and stakeholder requests for specific mushroom and pet food
standards, in addition to the NOSB recommendations. In March 2022, the
National Organic Program (NOP) hosted a public listening session to
give stakeholders the opportunity to comment on NOP's rulemaking
priorities.\10\ During the listening session, many stakeholders
provided written and oral comment to ask AMS to prioritize rulemaking
for products, including mushrooms and pet food, that are currently
being certified without standards specific to their unique production
categories. Several stakeholders specifically suggested developing
mushroom standards and noted that existing crop standards, including
compost requirements, were not suited for mushroom production.
Similarly, some commenters discussed the importance of establishing
consistent pet food standards, naming it as another product that is
currently certified without specific standards.
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\10\ USDA, NOP. (March 21, 2022). ``National Organic Program
priorities listening session.'' https://www.ams.usda.gov/event/national-organic-program-priorities-listening-session.
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AMS also engaged directly with mushroom experts, producers, and
trade associations about organic mushroom production in developing the
proposed rule. These discussions affirmed that, without specific
standards, certifiers are not consistent in how they apply organic
standards to mushroom production. Comments received during the public
comment period for the proposed rule confirmed that certifiers
interpret the existing standards in different ways. Through industry
feedback and comments during the public comment period--submitted by a
range of industry parties--AMS learned what aspects of mushroom
production need specific standards to ensure consistent application
across certifiers and producers. This includes requirements for
compost, origin and composition of substrate materials used for growing
mushrooms, and origin and composition of spawn.
Discussions with experts in the pet food industry, conducted prior
to publishing the proposed rule, revealed that the key challenge with
labeling pet food as organic is uncertainty around the allowance of
specific ingredients. For example, under the current organic
regulation, it is unclear if pet food manufacturers may use meat (i.e.,
the edible part of animal muscle and organs) or slaughter by-products
(i.e., the parts of an animal not typically consumed by humans, such as
poultry by-product meal or animal liver) in organic pet food. It is
also unclear whether some necessary synthetic ingredients in pet food,
such as taurine, are allowed (for additional discussion, see ``Sec.
205.605 National List--Description of Final Policy'' in section IV.C).
Additionally, stakeholders have noted that allowing organic
slaughter by-products in organic pet food will allow livestock
producers and slaughter facilities to earn organic premiums for these
organic slaughter by-products, which would otherwise be sold without a
premium for use in nonorganic products. AMS estimates that this rule
could ensure consistent demand for over 6 million pounds of organic
slaughter by-products annually, which is likely to grow over time.\11\
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\11\ Data from the Institute for Feed Education & Research
indicates that approximately 23 percent of the ingredient weight in
conventional pet food is animal by-product and meal. This estimate
is then applied to the estimate for pounds of organic pet food as
reported by the Organic Trade Association and current market prices.
Institute for Feed Education & Research. (March 2020). ``Pet food
production and ingredient analysis.'' Organic Trade Association.
(2022). Organic Industry Survey. p. 56.
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Overall, this rulemaking addresses a need identified by the NOSB,
industry
[[Page 104370]]
stakeholders, and public comments on the proposed rule. AMS expects
that the specific standards in this final rule will support the
development of organic markets for organic mushrooms and pet food by
reducing uncertainty among certifiers, consumers, producers, and
manufacturers. A full discussion of public comments received on the
proposed rule, and AMS's responses to comments, can be found in later
sections.
D. Authority
OFPA \12\ authorizes the USDA to promulgate regulations to
establish an organic certification program for producers and handlers
of agricultural products that have been produced using organic methods
(7 U.S.C. 6503(a)). This rule establishes new production and
certification standards for two categories of products that are
currently certified but lack specific organic standards. In
establishing these standards, this rule supports the three purposes of
OFPA: ``(1) to establish national standards governing . . . organically
produced products; (2) to assure consumers that organically produced
products meet a consistent standard; and (3) to facilitate interstate
commerce in . . . food that is organically produced'' (7 U.S.C. 6501).
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\12\ The Organic Foods Production Act of 1990, 7 U.S.C. 6501-
6524, is the statute from which the Agricultural Marketing Service
derives authority to administer the NOP, and authority to amend the
regulations as described in this final rule. The text of the
codified statute is available at: https://uscode.house.gov/view.xhtml?path=/prelim@title7/chapter94&edition=prelim.
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This rule clarifies how producers and certifiers should apply
organic regulations to mushroom and pet food production, which will
assure consumers that the organic label on these products meets a
consistent standard. The rule will also assure producers that they
operate in a fair and competitive environment with clear rules that all
must follow.
USDA administers organic standards through the Agricultural
Marketing Service (AMS) National Organic Program (NOP). Final
regulations establishing the NOP and the USDA organic regulations were
published on December 21, 2000 (65 FR 80548) \13\ and were first
implemented on October 21, 2002.\14\ Through these regulations, AMS
oversees national standards for the production, handling, labeling, and
sale of organically produced agricultural products.
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\13\ USDA, AMS. (December 21, 2000). ``National Organic
Program.'' Final Rule. 65 FR 80548 (codified at 7 CFR part 205).
https://www.federalregister.gov/documents/2000/12/21/00-32257/national-organic-program.
\14\ USDA, AMS. (March 20, 2001). ``National Organic Program;
Correction of the effective date under Congressional Review Act
(CRA).'' Final Rule. 66 FR 15619. https://www.federalregister.gov/documents/2001/03/20/01-6836/national-organic-program-correction-of-the-effective-date-under-congressional-review-act-cra.
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III. Organic Mushroom Standard
A. Mushroom Background
Mushroom Biology and Production
Mushrooms are the fleshy, spore-bearing, fruiting body of some
species of fungus. Mushrooms are just a portion of the fungal organism,
which is mostly composed of mycelium, a root-like network of fungal
structures (hyphae). Commercially grown mushrooms are typically
produced in a stepwise process that propagates (increases) mycelium to
ultimately produce mushrooms.
In commercial mushroom production, mycelium is added to media
(``spawn media''), such as grains, wood materials, or minerals, that
supports its initial development. The mycelium draws nutrients and
energy from this media to support its growth. The mycelium-colonized
media is called ``spawn.'' Spawn is then inoculated into larger volumes
of substrate--a base composed of materials such as grains, wood
materials, composted materials, and/or other agricultural materials--
where the mycelium develops further, growing throughout the substrate.
Depending on the mushroom species, this stage of production may occur
in open beds (common for Agaricus bisporus) or in blocks (common for
specialty mushrooms), though other methods are also used. Producers can
trigger fruiting (i.e., the formation of mushrooms) of the inoculated
substrate by establishing the right environmental conditions for that
variety--e.g., humidity, temperature, air, and light. Depending on the
variety and production system, the inoculated substrate may continue to
fruit after the first harvest, and producers may harvest multiple crops
of mushrooms from one batch of inoculated substrate in a given
production cycle. Once the production cycle is complete and all
mushrooms are harvested, a new batch of spawn inoculated into a new
batch of substrate is generally needed to produce more mushrooms.
[[Page 104371]]
[GRAPHIC] [TIFF OMITTED] TR23DE24.226
Commercial mushroom production mostly occurs in controlled indoor
environments where temperature and humidity can be controlled. However,
mushroom production can also occur outdoors, either in managed
conditions or by harvesting wild mushrooms. This final rule establishes
new production standards for managed mushroom production, whether it
occurs indoors or outdoors. It revises the definition of wild crop to
include mushrooms, but it does not establish separate production
standards for wild mushrooms. Producers who harvest wild mushrooms
should continue to follow the wild crop harvesting practice standard at
Sec. 205.207.
In some cases, a producer may propagate mycelium but not harvest
mushrooms. For example, some producers may only produce and sell spawn
(colonized media) that other producers will use to inoculate substrate
and produce mushrooms. In other cases, a producer may never aim to
produce mushrooms (i.e., the fruiting bodies) but will instead produce
mycelium biomass that is used in processed products for direct human
consumption.
This final rule specifies the production requirements for
mushrooms, spawn, and mushroom products sold as organic. It does not
alter the requirements related to processed fungi products. The final
rule describes the existing crop production requirements that apply to
mushroom producers, but, primarily, it specifies requirements for the
spawn media, spawn, and substrate used in mushroom production. AMS is
aware that some in the mushroom industry use the terms ``media'' and
``substrate'' interchangeably. As defined in this final rule, mushroom
spawn media is the initial base material that is colonized by mycelium
to produce spawn, and mushroom substrate is the mid-stage base material
that is used in larger volumes, inoculated by spawn, and on which
mushroom fruiting occurs.
The term ``mushroom production'' is used throughout the rule to
collectively refer to the production of mushrooms, spawn, and other
mushroom products, even if a producer is not harvesting or selling the
fruiting bodies (mushrooms). For example, an organic spawn producer may
not harvest mushrooms, but this final rule still applies to organic
spawn producers.
The U.S. Mushroom Market
In the 2023-2024 growing season (July 2023 to June 2024), the U.S.
mushroom crop volume was 659 million pounds with sales of $1.09
billion.\15\ The Agaricus bisporus species of mushrooms accounted for
approximately 98 percent of the total sales volume and approximately 92
percent of the total value.\16\ Agaricus includes white mushrooms
(including common, button, and champignon varieties, among others) and
brown mushrooms (including crimini/cremini, Swiss, Roman, Italian, and
Portobello/Portabello/Portabella varieties, among others). Outside of
the Agaricus varieties, there are a multitude of cultivated
``specialty'' mushrooms, including shiitake, oyster, enoki, maitake,
pompom, lion's mane, Reishi, and others. Specialty mushrooms include
foraged (wild) mushrooms (e.g., chanterelles, morels) and mushrooms
that are intentionally cultivated outdoors.
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\15\ USDA, National Agricultural Statistics Service,
Agricultural Statistics Board. (August 21, 2024). ``Mushrooms.''
https://downloads.usda.library.cornell.edu/usda-esmis/files/r781wg03d/9593wm52z/9306vq05c/mush0824.pdf.
\16\ USDA, National Agricultural Statistics Service,
Agricultural Statistics Board. (August 21, 2024). ``Mushrooms.''
https://downloads.usda.library.cornell.edu/usda-esmis/files/r781wg03d/9593wm52z/9306vq05c/mush0824.pdf.
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Organic mushrooms lag behind the overall organic produce market in
terms of market share. In 2023-2024, 9.6 percent of all mushrooms
produced were sold as organic.\17\ The Organic Trade Association
reports that organic produce they tracked had a higher market share,
with 15.2 percent of all produce being sold as organic in 2023.\18\
Agaricus mushrooms accounted for approximately 83 percent of the total
production volume of organic mushrooms; the remainder were specialty
mushrooms.\19\
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\17\ USDA, National Agricultural Statistics Service,
Agricultural Statistics Board. (August 21, 2024). ``Mushrooms.''
https://downloads.usda.library.cornell.edu/usda-esmis/files/r781wg03d/9593wm52z/9306vq05c/mush0824.pdf.
\18\ Organic Trade Association. 2024 Organic Industry Survey. p.
41. https://ota.com/market-analysis/organic-industry-survey/organic-industry-survey.
\19\ USDA, National Agricultural Statistics Service,
Agricultural Statistics Board. (August 21, 2024). ``Mushrooms.''
https://downloads.usda.library.cornell.edu/usda-esmis/files/r781wg03d/9593wm52z/9306vq05c/mush0824.pdf.
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B. Need for Organic Mushroom Standards
This final rule creates specific standards for organic mushroom
[[Page 104372]]
production to promote consistency, fair competition, and market growth.
As of August 2024, at least 42 certifying agents certify 288 organic
mushroom operations.\20\ The lack of mushroom-specific standards means
there is significant variation in how these operations are certified.
Some certifying agents require mushroom substrate components to be
organic while others do not. Likewise, some certifying agents require
spawn to be organic while others do not.
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\20\ USDA, Organic Integrity Database. https://organic.ams.usda.gov/Integrity/Home. Advanced search features can be
accessed at https://organic.ams.usda.gov/Integrity/Search. Certified
mushroom producers may be found by narrowing a certified product
search for ``mushrooms'' to operations with a certification status
of ``certified'' and limiting results to the ``Crops'' scope. Output
was manually cleaned to remove unrelated entries. Accessed August
27, 2024.
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This mushroom-specific rule is necessary because mushrooms and
mushroom products involve unique production practices and inputs that
are not addressed in the current organic standards. There are notable
biological differences between mushrooms (which are fungi) and plants.
Unlike plants, mushrooms do not photosynthesize to convert energy from
light to process nutrients drawn from soil. Instead, they draw on the
nutrition and energy found in the substrates on which they grow. The
absence of mushroom-specific standards, their unique biological
differences, and the resulting inconsistent enforcement, creates an
uneven playing field for certified operations. For example, some
operations may be required to source organic inputs, incurring
additional expenses, whereas others are not. Unfair competition caused
by different interpretations of the organic mushroom standards, as well
as the possibility of future regulatory changes, may have reduced the
willingness of businesses to invest in this sector.
This rule aims to address these problems by developing one clear
standard for organic mushroom production, ensuring consistency as
directed by OFPA. Certifying agents will have clear rules to follow,
and competition among operations will be more fair. This will give
businesses greater confidence in the stability of the industry and
encourage them to invest in organic mushroom growing operations and
organic mushroom inputs.
C. Overview of Final Rule Policy and Responses to Comments
This rule amends the USDA organic regulations (7 CFR part 205) to
add new provisions for producing mushrooms, spawn, and other mushroom
products (collectively ``mushroom production'') that are sold, labeled,
or represented as organic. This action prescribes consistent standards
for organic mushroom production, as detailed below.
Table 1--Overview of Regulatory Changes To Establish Organic Mushroom
Production Standards
------------------------------------------------------------------------
Section title Type of action Rulemaking action
------------------------------------------------------------------------
205.2................ Adds new terms.. Adds Mushroom; Mushroom
mycelium; Mushroom spawn;
Mushroom spawn media; Mushroom
substrate.
205.2................ Revises existing Modifies Compost; Crop; Wild
terms. crop.
205.210.............. Adds new section Adds mushroom production
standards to Subpart C.
205.601.............. Revises language Replaces the term ``plant''
at (i)-(j). with the term ``crop''.
------------------------------------------------------------------------
Sec. 205.2 (Terms Defined)
Description of Final Policy
The final rule amends Sec. 205.2 by adding five new terms:
mushroom, mushroom mycelium, mushroom spawn, mushroom spawn media, and
mushroom substrate. The rule also revises three existing terms:
compost, crop, and wild crop. The additions and revisions are discussed
below.
1. Compost
The final rule revises the definition of compost to recognize that
compost for mushroom production may be different than compost for plant
production. The prior definition of ``compost'' included production
requirements (e.g., time, temperature, and carbon-to-nitrogen ratio
requirements) that are more applicable to plant production; however,
compost for mushroom production is typically produced under different
conditions. The final rule removes from the definition those specific
compost production requirements, which duplicated the practice
standards for other crop production already included in the organic
regulations at Sec. 205.203(c)(2). The resulting definition of compost
is more general, to encompass the production of compost for either
plants or mushrooms. The amended definition also notes that compost may
be used in mushroom production as a component of mushroom substrate.
These revisions to the definition of the term compost are in no way
meant to change existing requirements, policies, or guidance about the
use of compost in organic plant production. Likewise, the revision is
not intended to expand the definition of compost to include all
agricultural inputs transformed by microorganisms, such as anaerobic
digestate or manure. Terms for the various soil amendments and
fertilizers used in organic production are well established by AMS and
material review organizations and are not affected by this rule. AMS's
intent is to remove the requirements embedded in the definition to
account for the fact that compost for mushroom production is not
necessarily produced in the same way that compost for plant production
is produced.
As noted above, the specific compost production requirements that
AMS removed from the definition remain in the regulations at Sec.
205.203(c)(2)--Soil fertility and crop nutrient management practice
standard. This final rule does not change those requirements. Organic
producers of crops other than mushrooms that use compost must comply
with the requirements at Sec. 205.203(c)(2). Separately, this final
rule adds mushroom-specific requirements for compost used in mushroom
substrate at Sec. 205.210(c)(1), as described below in the section
titled ``Mushroom production practice standard''.
AMS is aware of ongoing discussions by the NOSB that may result in
a recommendation to update the definition of compost. The changes in
this final rule do not prevent or supersede future recommendations on
this topic from the NOSB.
2. Crop and Wild Crop
This final rule revises the terms crop and wild crop to include
mushrooms. AMS includes mushrooms in these definitions to clarify that
operations
[[Page 104373]]
may use certain crop and wild crop practice standards in subpart C of 7
CFR part 205 to produce mushrooms.
3. Mushroom
The final rule defines mushroom as the fleshy, spore-bearing
fruiting body of a fungus, although the term ``mushroom production'' in
this rule refers to production of mushrooms, spawn, and other mushroom
products. The word ``mushroom'' is also used to qualify other terms
(below) related to mushroom production.
4. Mushroom Mycelium
AMS defines mushroom mycelium as a mass of branching, thread-like
hyphae (fungal structures). Mushroom mycelium is the main, root-like,
mass of a fungus, which can support formation of fruiting bodies
(mushrooms).
5. Mushroom Spawn
AMS defines mushroom spawn as mushroom spawn media that has been
colonized by mycelium. Mushroom spawn can be used to inoculate mushroom
substrate.
6. Mushroom Spawn Media
AMS defines mushroom spawn media as the base material, such as
grain, sawdust, other wood materials, vermiculite, or other minerals,
used to make mushroom spawn. Mushroom spawn media, once colonized with
mycelium, is defined separately as mushroom spawn by these regulations.
7. Mushroom Substrate
AMS defines mushroom substrate as the base material (such as grain,
wood materials, composted materials, and/or other agricultural
materials) on which mushroom production occurs. Components of mushroom
substrate can vary depending on the species to be cultivated. After
mushroom spawn inoculates mushroom substrate, the mushroom substrate
provides the energy and nutrients required for mycelium to flourish and
produce mushrooms (although the definition of mushroom substrate does
not depend on whether mushrooms are produced or not).
AMS separately defines two types of ``base materials'' used in
mushroom production: mushroom spawn media and mushroom substrate. For
the purposes of organic regulation, the essential difference between
them is that mushroom spawn media is the base material used to create
mushroom spawn, while mushroom substrate is the base material that is
inoculated by mushroom spawn to produce mushrooms. They are defined
separately because the rule includes different requirements for
mushroom spawn media and mushroom substrate. The composition
requirements for mushroom spawn media and mushroom substrate are
described at Sec. Sec. 205.210(d) and (c), respectively.
Changes From Proposed to Final Rule
AMS made the following revisions to the proposed definitions in
this final rule to clarify intent and meaning:
AMS made minor changes to each definition related to
mushroom production to clarify intent and meaning. AMS added the word
``mushroom'' at the beginning of several terms so that the terms
related to mushroom production appear together in Sec. 205.2.
AMS removed the word ``edible'' from the definition of
mushroom, as edibility is not unique to the mushroom's fruiting body
(i.e., various parts of mushroom varieties may be edible), and
edibility is not necessarily an attribute of all mushrooms. The word
``edible'' is not required to describe the term mushroom.
Responses to Public Comment
Public comments related to definitions for the mushroom standards
and AMS's responses are discussed below.
Media/Substrate
(Comment) Some commenters from the mushroom industry argued that
some mushroom producers use the terms ``substrate'' and ``media''
interchangeably and that defining the terms separately is unnecessary
and potentially confusing.
(Response) AMS recognizes that these two terms can be used
synonymously to refer to the ``base materials'' on which fungus grows.
However, for the purposes of the organic regulations, AMS believes
distinct definitions for mushroom spawn media and mushroom substrate
are necessary to address requirements for distinct stages of organic
mushroom production. The separate definitions allow AMS to regulate the
inputs and management of mushroom spawn media and mushroom substrate
differently in Sec. 205.210(c) and Sec. 205.210(d), respectively. To
clarify the distinction in the regulations, AMS revised the definition
of mushroom spawn media to more closely mirror the definition of
mushroom substrate and more clearly highlight the essential difference
between the terms as they are used in the final rule.
Compost
(Comment) Some comments stated that removing the composting process
from the definition of compost at Sec. 205.2 would make the definition
too broad and incorporate other forms of microbial decomposition other
than composting. Commenters noted that products such as sauerkraut,
yogurt, beer, and manure digester products such as digestate and biogas
could fall under the shortened definition.
(Response) The revision of the term compost in the final rule is
not intended to broaden the meaning of the term beyond the commonly
accepted interpretation of the term. Outside this rule's allowance for
compost in mushroom production, compost is currently allowed in organic
crop production only as provided in Sec. 205.203(c)(2), which includes
specific requirements that limit the types of processes that may be
used. AMS chose not to leave the specific requirements in the
definition for the term because of differences in requirements,
formulation, and production of compost for mushroom production at Sec.
205.210(c) and the requirements for other uses at Sec. 205.203.
(Comment) Some comments requested that AMS amend the definition of
compost to acknowledge that compost may be made with allowed synthetic
compost feedstocks on the National List (Sec. 205.601). Other comments
suggested that the definition be revised to allow compostable plastic
materials, which is a subject currently on the NOSB work agenda.\21\
Several comments suggested that AMS adopt the definition of compost
used by the American Association of Plant Food Control Officials
(AAPFCO).
---------------------------------------------------------------------------
\21\ USDA, NOP. (October 11, 2023). ``Work Agenda Request:
Compost Production for Organic Agriculture.'' https://www.ams.usda.gov/sites/default/files/media/NOSBMemoCompostWorkAgenda23.pdf.
---------------------------------------------------------------------------
(Response) AMS has not revised the compost definition to reference
the synthetic compost feedstocks on the National List, adopt AAPFCO's
definition, or include compostable plastics (bioplastics) as compost
feedstocks. This final rule amended the definition of compost only as
needed to accommodate the new mushroom production practice standards.
The compost feedstocks that currently appear on the National List
(e.g., newspaper) continue to be allowed under the regulations. AMS
recognizes that the NOSB is currently working on recommendations
related to the definition of compost and the requirements for compost
in organic crop production in Sec. 205.203(c) (which are not changed
by this rule). AMS has not received final recommendations from NOSB and
is not making any
[[Page 104374]]
additional changes related to those topics in this rule at this time.
This final rule does not conflict with or preclude future
recommendations or rulemaking related to the current NOSB work agenda
topics related to compost. If AMS seeks to revise the definition of
compost or the compost requirements in the future, AMS will solicit
public comments.
Mushroom
(Comment) Some comments stated that the proposed definition of
mushroom was too restrictive by referring only to the fruiting body.
Comments noted that the term could be revised to include all parts of
the organism to clarify that the regulations in the rule apply to the
production of any part of the organism, such as mycelium, spores, and
primordia (pinheads).
(Response) AMS agrees that the standards at Sec. 205.210 can apply
to production of other parts of the organism. However, we have not
revised the definition of mushroom to include other parts of the
organism in the final rule. The term mushroom refers specifically to
the fruiting body, and this definition is similar to how the term is
understood and interpreted broadly. The term ``mushroom production'' in
this rule, however, can refer to production of mushrooms, spawn, and
other mushroom products. Also see AMS's response to comments about
requirements for mycelium biomass used as a direct ingredient for human
consumption below in ``Sec. 205.210 (Mushroom production practice
standards)'', ``Responses to Public Comment'', ``Mycelial Biomass
Ingredients.''
(Comment) Some comments suggested broadening the definitions and
applicability of this rulemaking to include a broader spectrum of
species in the Fungi Kingdom (e.g., yeast). Comments suggested that AMS
describe the rule as a fungi production practice standard by revising
``mushroom'' to ``fungi''. Comments from organic advocacy groups also
argued that fungi should have its own scope of certification separate
from crops, with fungi-specific production standards and specific
sections of the National List for materials used in fungi production.
(Response) AMS has not expanded the standards to apply to all
fungi. Fungi is an extremely large and diverse taxonomic kingdom, of
which mushrooms are only a small subset. Expanding the standards to
other fungal products, such as yeasts, is beyond the scope of the rule.
Developing new regulations for fungi other than mushrooms would require
more input and assessment of impacts, as this was not included in the
proposed rule.
AMS also has not created a new scope of certification for mushrooms
or fungi. ``Scope'' is a term typically used to describe one of the
four areas of operation that a certifying agent may be accredited to
certify. As defined in Sec. 205.2, the four areas of operation are
crop, livestock, handling, and wild crop, or any combination thereof.
These four scopes align with the types of Organic Plans listed in OFPA
(7 U.S.C. 6513) and inform a range of other requirements and
procedures, such as the determination of inspector qualifications and
the issuance of certificates from the Organic Integrity Database.
Creating a new scope of certification would require a range of
regulatory amendments, as well as administrative and technological
changes related to certification, accreditation, inspector
qualifications, and certificates of organic operation. Furthermore, as
with including fungi in the applicability of this rulemaking, the
impacts of establishing a new scope of certification for fungi would
require more input and assessment.
AMS does not find that a new scope is necessary to accomplish the
goals of this rule to provide consistent and clear standards for
organic mushroom production that reflect the unique biology of
mushrooms. AMS finds it appropriate to include mushrooms in the
definition of crop and within the crops scope of certification. OFPA
does not define or limit ``crops'' to include only organisms in the
plant kingdom, and currently certified mushrooms are certified under
the crop scope of the USDA organic regulations. Additionally, the
organic regulations list mushroom inputs in the ``crops'' section of
the National List of Allowed and Prohibited Substances (see 7 CFR
205.601(o)). Across USDA programs, mushrooms are commonly considered a
type of agricultural crop similar to other produce, vegetables, and
specialty crops. Crops are a highly diverse group of agricultural
products that are produced using similarly diverse production systems.
The final rule acknowledges this diversity and clarifies how the
organic regulations apply to the unique production requirements for
mushrooms. The organic regulations continue to ensure certifying agents
and inspectors have qualifications and expertise relevant to the scope
and complexity of the operations (Sec. 205.501(a)(4)).
Wild Crop
(Comment) One comment argued the lack of a definition for wild
mushrooms could cause confusion since mushrooms are grown and/or
harvested with a wide spectrum of production practices. Another comment
requested that NOP develop standards for wild-grown mushrooms.
(Response) The final rule amends the definition of wild crop to
include mushrooms, thereby clarifying that wild mushrooms can be
certified organic under the wild crop standards at Sec. 205.207.
Amendments to the wild crop standards were not included in the proposed
rule and are beyond the scope of this rulemaking.
Sec. 205.210 (Mushroom Production Practice Standard)
Description of Final Policy
The final rule adds a new section (Sec. 205.210) to the USDA
organic regulations to add provisions for producing mushrooms, spawn,
and other mushroom products (collectively ``mushroom production'') that
are sold, labeled, or represented as organic.
Many of the existing production requirements in subpart C of the
USDA organic regulations (7 CFR part 205) can be applied to mushroom
production. However, mushroom production also relies on practices that
are different from plant production practices. The final rule clarifies
which of the existing crop production requirements apply to mushroom
production and also adds requirements specific to mushroom production,
as described below.
Applicability of Crop Standards in Subpart C--Sec. 205.210(a)
AMS requires in Sec. 205.210(a) that organic mushroom operations
follow most of the existing regulations governing crop production,
including Sec. Sec. 205.200, 205.201, 205.202 as applicable,
205.203(e), 205.206(a)(2)-(3), and 205.206(b)-(f). These sections cover
general production requirements (Sec. 205.200); organic production and
handling system plans (Sec. 205.201); land requirements (Sec.
205.202); nutrient management prohibitions (Sec. 205.203(e)); and crop
pest, weed, and disease management (Sec. 205.206). In addition,
organic mushroom operations may follow the nutrient management
practices in Sec. 205.203(d).
Organic mushroom operations, like all other organic operations,
must have an organic system plan that describes how the operation
complies with applicable parts of the USDA organic regulations.
However, because the methods used to produce mushrooms are different
than
[[Page 104375]]
those to produce plants, the final rule clarifies that not all existing
crop production requirements apply to organic mushroom production.
Mushroom operations do not need to follow all the requirements in the
soil fertility and crop nutrient management practice standard at Sec.
205.203, the seeds and planting stock practice standard at Sec.
205.204, or the crop rotation practice standard at Sec. 205.205. The
final rule clarifies that mushroom producers are subject to the same
nutrient management prohibitions as plant producers described in Sec.
205.203(e) and may optionally follow the nutrient management practices
in Sec. 205.203(d). Conversely, mushroom production does not involve
seeds or planting stock, and mushrooms are not grown in rotations for
fertility or disease suppression, so the final rule does not require
producers to comply with Sec. Sec. 205.204-205.205.
Management of Mushroom Substrate and Mushroom Spawn Media--Sec.
205.210(b)
Paragraph 205.210(b) requires operations to manage mushroom
substrate and mushroom spawn media in a way that avoids environmental
contamination. The rule requires that mushroom substrate, mushroom
spawn media, spent mushroom substrate, and spent mushroom spawn media
be managed to avoid the contamination of any crops, mushroom spawn,
mushroom substrate, soil, or water by pathogenic organisms, heavy
metals, or residues of prohibited substances. This provision is similar
to the requirement in Sec. 205.203(c) for other organic crop
operations to prevent environmental contamination from materials
applied to soil. Likewise, this requirement relates to and supports the
requirement in Sec. 205.200 to maintain or improve the natural
resources of the operation, including soil and water quality. Paragraph
205.210(b) requires operations to manage materials in a way that avoids
contamination throughout the entire mushroom production process, from
mushroom spawn creation, to growing mushrooms, to disposal of spent
substrate.
Operations that only produce organic mushroom spawn and do not
produce organic mushrooms are also subject to the provisions in
paragraph (b). Mushroom spawn media is usually incorporated into
mushroom substrate. In cases where a mushroom spawn producer disposes
of spawn, the operation needs to dispose of spent mushroom spawn media
in a manner that avoids contamination of crops, mushroom spawn,
mushroom substrate, soil or water by pathogenic organisms, heavy
metals, or residues of prohibited substances (Sec. 205.210(b)).
Composition of Mushroom Substrate--Sec. 205.210(c)
Paragraph 205.210(c) describes the materials allowed in mushroom
substrate. The paragraph addresses the acceptable use of five types of
materials in mushroom substrate: composted plant and animal materials,
uncomposted plant materials, wood materials, nonsynthetic substances,
and synthetic substances.
Paragraph 205.210(c)(1) describes requirements for composted plant
and animal materials in mushroom substrate. This section details time,
temperature, and composition requirements for composting plant and
animal materials for use in mushroom production. The final rule
requires that compost feedstock reach at least 131 [deg]F for at least
three days during the composting process. AMS does not include a
maximum temperature for mushroom compost production. The minimum
temperature and duration requirements allow mushroom producers the
flexibility to compost feedstocks at higher temperatures and/or for
longer periods, if warranted. The compost must not be treated with any
prohibited substances per the existing requirements at Sec.
205.203(e)(1).
AMS specifies in Sec. 205.210(c)(2) that uncomposted plant
materials used in mushroom substrate must be organically produced when
commercially available. The term commercially available is defined at
Sec. 205.2. This requirement does not apply to plant materials that
are used as compost feedstocks; it applies to plant materials added to
mushroom substrate that do not undergo a composting step. Plant
materials that are pasteurized or sterilized only, but not composted,
are subject to the requirements of this paragraph, meaning they must be
organic when commercially available. The requirement for organic plant
materials also does not apply to wood materials (see Sec.
205.210(c)(3)).
Paragraph 205.210(c)(2) allows for nonorganically produced,
uncomposted plant materials in mushroom substrate when a ``functionally
equivalent'' organically produced input is not commercially available.
Functional equivalence references a material's ability to fulfill an
essential function in a system of organic production, as described in
the definition of commercially available at Sec. 205.2. For the
purposes of this exception, an ``essential function'' is a function of
the same nature (e.g., the nutritional or structural characteristics
the material provides in the mushroom substrate). When a functionally
equivalent organic material is not commercially available, nonorganic
plant materials may be used in substrate, except that prohibited
substances must not be applied to any nonorganic plant material after
harvest of the plant material.
Paragraphs 205.210(c)(2)(i) through (iii) include specific
requirements for operations that use nonorganically produced,
uncomposted plant materials in mushroom substrate. Those operations
must include additional elements in their organic system plan (OSP) as
described below. The additional information is intended to provide
certifiers with the information they require to determine whether
functionally equivalent organically produced materials are commercially
available for purposes of Sec. 205.210(c)(2).
Paragraph 205.210(c)(2)(i) requires operations to describe in their
OSP the procedures used to search for organic materials, as well as the
records kept to document searches for organic materials. Procedures
should demonstrate that operations contacted a sufficient number of
sources to ascertain the commercial availability of organically
produced plant materials. A producer must make a reasonable effort to
search for organic materials from reasonable sources (i.e., those known
to sell organic products). Procedures may include details about how an
operation identifies potential sources (or suppliers) of organic
materials and how the operation contacts those sources. The operation
must also describe the types of records that are kept to document
searches. This should include a description of the types of records
kept and a description of the recordkeeping system, such as how the
operation stores these records. Records may include, but are not
limited to letters, email correspondence, phone logs, catalogs,
searches of organic databases, receipts, receiving documents, invoices,
and inventory control documents.
Paragraph 205.210(c)(2)(ii) requires operations to describe in
their OSP the criteria they use to evaluate if functionally equivalent
organic materials are commercially available. Operations should
describe how they determine the essential function (a function of the
same nature, like the nutritional or structural characteristics) that
they are not able to meet with organic plant materials, how they
identify ``functionally equivalent'' organic plant materials to search
for, and how they verify that ``functionally equivalent'' organic plant
materials are
[[Page 104376]]
not commercially available to fulfill that essential function.
Operations must establish an essential function to accurately
verify if organic plant materials are commercially available. An
operation may outline how they identify the essential function needed
for a substrate material in their OSP. Additionally, an operation may
identify essential functions they need in certain types of production
in their OSP to ensure consistent searches.
Operations should have criteria for identifying organic materials
that would fulfill the essential function needed in their mushroom
substrate in their OSP. This may include resources for determining
functionally equivalent organic materials, methods for determining
characteristics of materials, or testing procedures. In most cases, the
direct organic analog(s) to the nonorganic plant material used should
be included in the commercial availability search as a functionally
equivalent material. Additionally, organic varieties of different plant
materials may need to be considered in the search (e.g., organic
soybean hulls may be reviewed as an alternative for conventional cotton
seed hulls).
An operation's OSP should include a description of how they
evaluate if organic alternatives reviewed are not commercially
available in the appropriate form, quality, or quantity to fulfill the
essential function of the nonorganic plant material. Form
considerations may include, but are not limited to method of harvest,
processing, and preparation. Quality considerations may include, but
are not limited to, the presence of residues, bacteria, fungus, or
other micro-organisms, shelf life, and stability. Quantity
considerations may include evidence that quantities are not available
in sufficiently large or small amounts, given the scale of the
operation. Price cannot be a consideration for the determination of
commercial availability.
Certifiers should verify that an operation has considered a
sufficient number of plant materials in its search to fulfill an
essential function in the mushroom substrate. Certifiers must use the
definition of commercially available (see Sec. 205.2) and the
requirements at Sec. 205.210(c)(2) to verify an operation's claim that
organically produced plant materials necessary for mushroom production
are not commercially available and should verify that a sufficient
number of sources have been contacted.
Paragraph 205.210(c)(2)(iii) requires that operations describe in
their OSP the recordkeeping system used to document purchases of
nonorganic plant materials (not including wood materials allowed under
Sec. 205.210(c)(3)). The OSP must describe how the recordkeeping
system can be used to summarize, by type, the amount of nonorganic
plant materials purchased. Operations are obligated, generally, to
maintain records and make them available for inspection (see Sec.
205.103), but the additional information and summarization, in this
case, will allow both certifiers and AMS to verify compliance.
Summarized information will allow certifiers to assess the extent to
which operations are utilizing nonorganic plant materials.
Additionally, it will allow certifiers to compare an operation's use of
nonorganic plant material year-to-year to identify trends or patterns.
AMS could also request summarized information (via certifiers or from
operations directly) to understand the practices around use of
nonorganic plant materials in the industry, to target enforcement
efforts, and/or inform future rulemaking priorities.
Paragraph 205.210(c)(3) allows mushroom operations to use
nonorganic wood materials (wood chips, sawdust, logs, or other
materials derived from wood) in mushroom substrate. These materials
must not be treated with prohibited substances after harvest of the
tree or wood source. An operation does not need to search for organic
forms of these wood materials (or document any search for organic
forms), but it does need to verify that the wood materials were not
treated with prohibited substances after harvest. The operation must
keep records documenting the verification process.
Paragraphs 205.210(c)(4) and (5), together with the amendment to
the definition of crop in Sec. 205.2 to include mushrooms,
specifically allow mushroom operations to use natural (nonsynthetic)
substances and/or certain synthetic substances in mushroom substrate,
in accordance with the National List of Allowed and Prohibited
Substances (``National List'') for organic crop production. These
provisions align with the requirements related to allowed and
prohibited substances described at Sec. 205.105(a)-(b). Paragraph
205.210(c)(4) allows the use of natural (nonsynthetic) substances in
mushroom substrate. Examples include mined gypsum, chalk, and clay.
However, operations must not use nonsynthetic substances prohibited for
use in organic crop production in Sec. 205.602 of the National List.
Paragraph 205.210(c)(5) permits mushroom producers to use certain
synthetic substances that are included in the National List at Sec.
205.601 as ``allowed'' for organic crop production. For example,
microcrystalline cheesewax listed at Sec. 205.601(o)(1) may be used as
a production aid in log-grown mushrooms. Again, Sec. 205.210(c)(5),
together with the revision to the definition of crop in Sec. 205.2 to
include mushrooms, clarifies that mushrooms are a type of crop and that
the synthetic substances included on the National List at Sec. 205.601
are allowed in organic mushroom production. (For additional discussion,
see the section below titled ``Sec. 205.601 National List--Crop'').
Any use of these allowed, synthetic substances in mushroom production
must follow all applicable substance-specific restrictions from the
National List, as well as Federal and State laws and regulations.
Requirements for Mushroom Spawn--Sec. 205.210(d)
Paragraph 205.210(d) establishes requirements for spawn used in
organic mushroom production. Producers must use organic spawn when
commercially available, as defined at Sec. 205.2. When an equivalent
organic spawn is not commercially available, a producer may use
nonorganic spawn. An equivalent spawn could be a spawn of the same
mushroom variety but on a different spawn media. For example, if
millet-based spawn is equivalent to sorghum-based spawn and one is
commercially available as organic, then the operation must use the
organic spawn. Operations that use nonorganic spawn must keep records
that demonstrate organic spawn was not commercially available. These
records are necessary to comply with the recordkeeping requirements at
Sec. 205.103. Records should demonstrate that the operation made an
appropriate search for organic spawn and demonstrate that equivalent
spawn was not available in the appropriate form, quality, or quantity.
Paragraph 205.210(d)(1) describes the requirements for organic
mushroom spawn. Agricultural materials in spawn media must be organic,
except for wood materials, such as sawdust (Sec. 205.210(d)(1)(i)). If
the mushroom spawn media contains wood materials, those materials must
not be treated with prohibited substances after harvest, in accordance
with Sec. 205.210(c)(3). The requirements do not allow for any
nonorganic agricultural materials in organic mushroom spawn, except for
wood materials.
In addition to any agricultural materials, Sec. 205.210(d)(1)(ii)
allows for organic spawn to contain natural (nonsynthetic) and
synthetic substances that are allowed in organic production
[[Page 104377]]
as described in Sec. 205.210(c)(4) and (c)(5). Allowed natural
substances are any nonsynthetic substances that do not appear on the
National List of prohibited nonsynthetic substances (Sec. 205.602).
Allowed synthetic substances are substances that appear on the National
List of allowed synthetic substances (Sec. 205.601). Any use of these
allowed synthetic substances in mushroom production must follow all
applicable substance-specific restrictions included in the National
List, as well as Federal and State laws and regulations. If a substance
on the National List of allowed synthetic substances (Sec. 205.601) is
restricted to a specific use(s) outside of mushroom production, it is
not allowed in mushroom production. Additionally, Sec.
205.210(d)(1)(ii) clarifies that compost as described in Sec.
205.210(c)(1) is an allowed component of spawn media. Finally, Sec.
205.210(d)(1)(iii) specifies that organic spawn must be under
continuous organic management after the application of mycelium to
mushroom spawn media.
Paragraph 205.210(d)(2) includes requirements for operations that
make their own spawn for their own mushroom production. In these cases,
if a producer is unable to produce organic spawn that meets all the
requirements at Sec. 205.210(d)(1), including (d)(1)(i) through (iii),
they are still subject to a requirement to use organic agricultural
materials when commercially available (except for wood materials, which
do not need to be organic) in spawn media. Operations that use
nonorganic materials must keep records that demonstrate organic
materials were not commercially available. These records are necessary
to comply with the recordkeeping requirements at Sec. 205.103. Records
should demonstrate that the operation adequately searched for organic
materials but could not find functionally equivalent materials in the
required form, quality, or quantity.
If a producer is not producing organic spawn that meets the
requirements at Sec. 205.210(d)(1) but organic spawn of the same
mushroom species/variety is commercially available, certifiers should
place particular attention on evaluating an operation's claim that a
suitable organic spawn cannot be made in compliance with Sec.
205.210(d)(1). This paragraph does not allow for the sale of organic
spawn that does not meet all requirements at Sec. 205.210(d)(1). In
the case of an operation that produces organic spawn for sale as
organic, all agricultural materials (except wood materials) in spawn
media must be organic (Sec. 205.210(d)(1)(i)).
Changes From Proposed to Final Rule
AMS made several changes to the regulatory text of the proposed
rule when writing this final rule. Changes to the final rule are
discussed below and are followed by specific topics and themes from
public comment.
Mushroom spawn and mushroom spawn media requirements
(Sec. 205.210(d)) are now described in a paragraph separate from the
mushroom substrate requirements (Sec. 205.210(c)).
Wood materials are specifically noted as an allowed
nonorganic agricultural material for mushroom substrate (Sec.
205.210(c)(3)) and mushroom spawn media (Sec. 205.210(d)(1)(i)).
Requirements are added for operations to describe in the
organic system plan how they search for organic materials for mushroom
substrate, evaluate available organic alternatives, and keep records of
nonorganic materials used in mushroom substrate (Sec.
205.210(c)(2)(i)-(iii)).
Spawn production requirements are clarified for mushroom
producers that make spawn on-site for their own organic mushroom
production (Sec. 205.210(d)(2)).
Responses to Public Comment
Below is a summary of comments received regarding organic mushroom
production requirements and AMS's responses.
Commercial Availability for Mushroom Substrate
(Comment) Some mushroom producers and trade groups asserted that it
is essential to allow nonorganic materials for mushroom substrate when
organic materials are not commercially available (also referred to as
the ``commercial availability exception'' in this document). They said
it would be impossible to source enough organic materials for
substrate. Producers highlighted that substitution or variation of
substrate materials can lead to detrimental yield drops and that
organic materials are not consistently available year-round. It is
unclear if some comments recognized that organic materials would not be
required when composted, as some comments provided examples of inputs
that are typically composted. A few certifiers and producers voiced
support for a commercial availability exception but did not express
broader concerns about sourcing.
In contrast, many commenters voiced the desire to remove the
proposed commercial availability exception to require only organic
materials for uncomposted portions of substrate. These commenters
included some smaller mushroom operations, certifiers, advocacy groups,
and trade associations. Some argued that a commercial availability
exception would inhibit growth of the market for organic inputs and
result in minimal difference between organic and conventional
mushrooms. Some commenters requested that organic inputs be required
because mushrooms consume the substrate. Some of these commenters also
argued that the commercial availability exception would create a cost
disadvantage for small producers, who could not claim that organic
inputs are unavailable in sufficient quantity as often as large
producers. Comments noted that substrate composition is a key
difference between organic and nonorganic mushrooms and argued that
there should be substantive differences in production methods to
justify any organic cost premium.
(Response) AMS appreciates commenters' requests for the use of only
organic substrate by all mushroom operations. We also recognize that
the commercial availability exception for uncomposted plant inputs is a
necessity in organic mushroom production for many organic mushroom
operations. We remain uncertain if the industry could implement this
rule and produce organic mushrooms using only organic inputs without
loss of existing production. Therefore, AMS is maintaining commercial
availability exceptions in the final rule, as proposed. However, we are
adding requirements in the final rule for operations that use
nonorganic uncomposted plant materials for mushroom substrate. To use
these nonorganic materials for mushroom substrate, operations must
describe, in their OSP, the methods and procedures used to search for
organic materials; the criteria they use to evaluate if organic
materials are commercially available, including comparable substrate
materials; and the recordkeeping system used to document purchases of
nonorganic materials.
AMS is aware of commenters' concerns that large producers could be
able to use the commercial availability exception more often compared
to small producers. AMS understands that operations may need to utilize
commercial availability exceptions differently based on a number of
factors including geographic location, size, and type of mushroom
grown. However, AMS believes this is a function of the flexibility of
the commercial availability exception, and the additional requirements
in the final rule will
[[Page 104378]]
increase fairness and consistency of implementation for both small and
large producers.
(Comment) Some commenters stated that commercial availability
criteria should be strengthened, and that AMS should include specific
requirements related to how operations must search for organic
materials.
(Response) In the final rule, AMS is requiring operations that use
nonorganic uncomposted plant materials in mushroom substrate to
describe in their organic system plan (OSP) how they searched for
organic materials, evaluated if organic materials were commercially
available, and documented these searches. The final rule requires that
an operation must look at functionally similar organic alternatives
(i.e., at materials that are comparable but not identical) to ensure
that various organic alternatives are considered. The OSP requirements
will, in turn, better equip certifiers to verify that producers are
making sufficient and appropriate efforts to search for organic
materials and only using nonorganic materials when organic options are
not commercially available. Certifiers will be able to verify
compliance by reviewing a producer's OSP and the associated records
that document their searches and purchases.
Requirements for Wood Materials
(Comment) The proposed rule stated that uncomposted plant materials
(which could include wood products) must be organically produced when
commercially available. Additionally, the proposed rule stated that any
nonorganic plant materials must not be treated with prohibited
substances after harvest. Some comments noted that it was not clear if
AMS considered wood and wood-based materials (e.g., sawdust, wood
chips) to be a type of ``plant material'' that is subject to the
requirements for other plant materials. Comments requested that AMS
clarify how wood materials are classified under the organic
regulations; specifically, commenters asked if they should be
considered a plant material (that must be organic unless not
commercially available), or a nonsynthetic material that is not
otherwise prohibited at Sec. 205.602 of the National List.
(Response) The final rule clarifies the requirements for wood
materials used in mushroom production. AMS revised the final rule to
clearly and specifically allow for the use of nonorganic wood
materials. Producers do not need to document that organic forms are not
commercially available to use wood materials. Nonorganic wood materials
must not be treated with prohibited materials after harvest.
(Comment) In regard to the requirement that uncomposted plant
materials be organic unless commercially unavailable, most commenters
stated it would be almost impossible to source organic wood materials
for mushroom substrate and mushroom spawn media and that there would
need to be different requirements for wood inputs. A few commenters
advocated for wood materials to be free from prohibited substances for
3 years before harvest, rather than just free of prohibited treatments
post-harvest, as proposed under the requirement for all uncomposted
plant materials. In contrast, a few other comments noted that sawmills
do not and could not track information on the three years of forest/
timber management prior to tree harvest. Overall, comments noted that
organic wood-based products are not available and that requiring
organic wood in mushroom products would pose an impossible barrier to
organic production.
(Response) AMS revised the final rule to clarify that wood
materials used in mushroom substrate and mushroom spawn media do not
need to be organic, but prohibited substances must not be applied after
harvest. AMS considered comments that requested three years of
management before harvest without the use of prohibited substances but
has not adopted this requirement in the final rule. While a few
operations and certifiers currently verify this condition, it does not
seem to be a universal practice in the industry. Requiring
documentation that wood materials have been free of prohibited
materials for three years before harvest could be costly and require
new documentation for entities outside the organic industry.
Additionally, this requirement may limit the amount of sawdust, a key
mushroom substrate input, that could be available for organic
production, as wood from sawmills can be aggregated from many sources.
This would require mushroom producers to gather information from many
sources to confirm that trees were not treated with prohibited
materials for the 3 years prior to harvest. In many cases, this
information would not be available, as a sawmill would not likely be
able to provide the necessary information. However, sawmills should
have information about any treatments made after harvest and should be
able to readily provide this information to mushroom producers.
Requirements for Compost
(Comment) Some commenters expressed concern that altering the time,
temperature, and turning requirements in mushroom compost could lead to
food safety risks.
(Response) AMS established composting requirements for mushrooms
(Sec. 205.210(c)(1)) that accommodate special processes used to
prepare substrate for mushroom production. These processes are
presently used to produce mushrooms and include the minimum composting
time and temperatures required for compost in other organic crop
production. Compost must still meet other regulatory requirements for
food safety, as applicable, like those related to the Food Safety
Modernization Act, including the Product Safety Rule and the Pre-
Harvest Agricultural Water Final Rule.
(Comment) Some commenters requested that AMS clarify if
sterilization of substrate is considered equivalent to composting. Some
commenters requested that AMS allow the use of nonorganic sterilized
materials in organic mushroom production.
(Response) The final rule allows nonorganic plant materials as
compost feedstocks, but the sterilization process is different from
composting. The composting process transforms starting materials
(feedstocks) through biological processes; sterilization eradicates
microbes and other life but does not transform starting material(s).
Plant materials that are sterilized but never composted to meet the
minimum requirements of Sec. 205.210(c)(1) may be used in accordance
with Sec. 205.210(c)(2). This means they must be organic unless they
are not commercially available, in which case nonorganic plant
materials may be used. Wood-based components, such as sawdust, may be
used in sterilized products without first seeking an organic form, in
accordance with Sec. 205.210(c)(3).
(Comment) Some commenters stated that the proposed requirements for
compost in mushroom production, specifically the requirement that
compost reach a temperature of at least 131 [deg]F for a minimum of
three days, did not accurately reflect the entirety of the composting
process used by mushroom producers (especially for Agaricus mushrooms).
Specifically, these producers often use a two-phase composting process.
Temperatures in the first phase typically go well above 131 [deg]F. In
the second phase, temperatures are also brought higher than 131 [deg]F
in a pasteurization step but
[[Page 104379]]
do not persist. Comments noted that composting practices are varied and
diverse, especially between Agaricus and specialty mushroom producers,
and questioned if the minimum requirements accommodate the variety of
composting methods that mushroom producers may use to prepare compost.
Relatedly, some comments requested clarification about how guidance
documents related to heat-treated manure (NOP 5006) and alternative
composting methods (NOP 5021) relate to this rule.
(Response) The final rule maintains that composted plant and animal
materials prepared for mushroom substrate must meet minimum
requirements of maintaining a temperature of at least 131 [deg]F for at
least three days. AMS recognizes that mushroom producers use a wide
variety of processes to prepare substrate for mushroom production but
is not aware of composting processes for mushrooms that do not achieve
the minimum standard of 131 [deg]F for three days. Additionally, the
final rule does not require producers to use compost. If a producer
uses a process that does not meet the minimum temperature and time
requirements of the final rule for compost, the agricultural materials
must be organic, unless the material is not commercially available in
organic form under Sec. 205.210(c)(2) or the input is a wood material
meeting the requirements of Sec. 205.210(c)(3). Producers may continue
to use a variety of processes, provided that the producer complies with
the organic regulations and the minimum requirements for composted
nonorganic plant and animal materials used in mushroom substrate.
Spawn
(Comment) Several comments stated that spawn and spawn media
requirements were not clearly distinguished from requirements for
mushroom substrate or that the proposed rule included contradictory
requirements for spawn. For example, comments questioned whether
nonagricultural products or synthetic substances on the National List
are allowed in organic spawn media.
(Response) The final rule separates spawn and spawn media
requirements from the requirements related to the mushroom substrate
(substrate inoculated by spawn). This revision is intended to clearly
distinguish the requirements for mushroom spawn media from the
requirements for mushroom substrate. Paragraph 205.210(d) indicates
that allowed synthetic substances and nonorganic wood materials may be
added to spawn media and clarifies other composition requirements for
organic spawn.
(Comment) Some comments argued the rule should always require
organic spawn media, without exception. Commenters argued that organic
materials are available in sufficient quantity for organic spawn.
Other commenters stated that there are not enough organic inputs to
support organic spawn production. Specifically, a comment argued that
there are not enough organic products to supply organic spawn at even a
fraction of the total need. The comment noted that 750 to 850 million
pounds of Agaricus mushrooms are produced annually in the United
States, requiring hundreds of thousands of acres of straw and hay.
(Response) AMS finds that there is likely sufficient organic spawn
media to produce organic spawn in most cases. While 750 to 850 million
pounds of Agaricus mushrooms are produced in the United States, less
than 110 million pounds are produced organically.\22\ These organic
mushrooms will use hundreds of millions of pounds of agricultural
materials, mostly in their growing substrate (where composting and
commercial availability provide flexibility for organic producers).
Spawn materials make up less than five percent of the total need for
agricultural materials in Agaricus production.\23\ The United States
produced nearly 2.4 billion pounds of organic hay and straw in 2021, so
AMS believes that there should be sufficient organic hay and straw for
organic spawn production that requires these inputs.\24\
---------------------------------------------------------------------------
\22\ USDA, National Agricultural Statistics Service,
Agricultural Statistics Board. (August 21, 2024). ``Mushrooms.''
https://downloads.usda.library.cornell.edu/usda-esmis/files/r781wg03d/9593wm52z/9306vq05c/mush0824.pdf.
\23\ PennState Extension. (March 6, 2023). ``Seeding Substate
and Management of Growing Agaricus Bisporus.'' https://extension.psu.edu/seeding-substrate-and-management-of-growing-agaricus-bisporus.
\24\ USDA, National Agricultural Statistics Service. (December
2022). ``Certified Organic Survey 2021 Summary.'' https://www.nass.usda.gov/Publications/AgCensus/2022/index.php.
---------------------------------------------------------------------------
However, AMS understands there may be limited circumstances when
needed organic materials may not always be commercially available in
all regions at all times of the year. Additionally, AMS understands
that sawdust is often used as a spawn media and there are little to no
organic wood products available. Because of this, the final rule
maintains the proposed requirement that spawn must be organic when
commercially available but provides limited exceptions for using
nonorganic wood in organic spawn media and nonorganic spawn media when
organic spawn and spawn media are not commercially available. This
flexibility of the final rule will ensure that mushroom producers can
consistently produce spawn to meet the needs of organic mushroom
production.
(Comment) A comment noted that spawn requirements did not clearly
differentiate between the requirements for mushroom producers that only
source spawn (from outside their operation) and producers that make
their own spawn. Commenters questioned how commercial availability
requirements (for sourcing spawn) apply to producers that make their
own spawn on-site.
(Response) AMS agrees that the rule should more fully consider
those operations that not only source spawn but produce their own spawn
for their mushroom production. The final rule more clearly describes
spawn requirements for producers that make their own spawn (see Sec.
205.210(d)(2)). The final rule clarifies that producers who produce
their own spawn for their own mushroom production must use organic
inputs for their spawn media, when commercially available. This
revision will allow producers that make their own spawn to continue to
do so but also clarifies that the same standard for organic
agricultural uncomposted materials that applies to mushroom substrate
also applies to spawn media. In the case that organic inputs are not
used by a producer for spawn media when organic spawn is commercially
available in the market, certifiers should pay close attention to
claims that the spawn cannot be made to comply with organic spawn
requirements.
(Comment) Several comments from certifiers asked for clarification
about how to review the ingredients in mycelium cultures used to
inoculate spawn media (e.g., ingredients in agar plates) and whether
those ingredients are subject to the same requirements as spawn and/or
spawn media.
(Response) The rule does not specify requirements for mycelium
culture materials (e.g., ingredients in agar plates, liquid cultures,
or slants). Organic mushroom spawn must be under continuous organic
management after the mycelium is applied to the mushroom spawn media
(Sec. 205.210(d)(1)(iii)). Other requirements for spawn and spawn
media are described in Sec. 205.210(d).
Commercial Availability for Mushroom Spawn
(Comment) A mushroom trade association stated the ``variety'' of
spawn media was not relevant to
[[Page 104380]]
commercial availability searches, as proposed. The commenter states
that the availability of specific spawn media may be impacted by
factors even within a media variety (e.g., organic grain in one
location may have different contaminants than the same grain grown in
another location). Other commenters asked that the term ``variety'' be
removed from the proposed regulatory text related to commercial
availability as it is inconsistent with the existing regulatory
definition of commercially available.
(Response) AMS agrees that the emphasis on variety creates
confusion with the commercial availability criteria. In this final
rule, AMS has removed the proposed reference to ``variety'' in favor of
functional equivalence for both spawn media and substrate. This change
more clearly aligns with the definition of commercially available. This
requirement may mean operations need to check the organic variety of a
nonorganic input in many cases. Commercial availability allows for
determinations based on quality of the product, which may include
contaminants.
(Comment) Some comments argued the rule should always require
organic spawn, without exception. Comments argued that requiring
organic spawn would support organic spawn producers. Some comments
noted that removing any allowance for nonorganic spawn could also help
assure consumers that organic mushrooms meet a consistent standard.
Other comments acknowledged the need for a commercial availability
exception for organic spawn. A mushroom trade association stated that
many mushroom strains are proprietary, and if a given strain is not
produced in organic form, it likely cannot be obtained or produced by
any other source.
(Response) A key goal of the final rule is to establish consistent
standards for mushroom production, which includes the production of
spawn and other related products. However, AMS disagrees with comments
that argue organic spawn is available for all spawn production and
should be required without any exceptions. AMS recognizes that organic
spawn, especially for certain proprietary strains, may not be
available. The final rule allows for use of nonorganic spawn when
organic spawn is not commercially available. Producers will be able to
continue using these strains if equivalent organic spawn is not
commercially available.
``Ready-to-Use'' Products
(Comment) Comments asked for clarification about how the standards
apply to ``ready-to-use'' or ``ready-to-fruit'' mushroom logs, blocks,
or kits, and whether a 2019 NOP memo to certifiers on the topic remains
in effect. Comments noted that these products commonly contain
nonorganic wood products (e.g., sawdust) as substrate, and questioned
whether this would continue to be allowed under the final rule.
(Response) This final rule replaces the 2019 memo from NOP to
certifiers and continues to allow the use of nonorganic wood materials
as mushroom substrate (Sec. 205.210(c)(3)). These products
(collectively referred to here as ``RTU products'' or ``RTUs'') are
sometimes marketed as ``ready-to-use spawn'' or ``spawn kits,'' but
they can be generally described as mushroom substrate that has been
inoculated with spawn and is readily able to produce harvestable
mushrooms in situ with proper humidity and temperature control. In
contrast, spawn does not contain substrate necessary to readily grow
mushrooms and needs to be combined with substrate to produce a crop. As
such, RTU products do not fall under the definition and description of
``spawn'' in this final rule.
Because RTU products contain both substrate and spawn, both must be
produced and managed according to the applicable requirements of this
final rule in order to produce organic mushrooms. Organic RTU mushroom
production products must be produced by a certified organic operation
in accordance with Sec. 205.210. The spawn used to inoculate the
substrate must comply with Sec. 205.210(d). The substrate must comply
with Sec. 205.210(c), which includes an allowance for nonorganic wood
materials. This final rule ensures that RTU products must follow the
same regulations as other inoculated mushroom substrate under Sec.
205.210 for organic mushroom production.
Mycelial Biomass Ingredients
(Comment) Comments asked AMS to change the standards or clarify how
the standards apply to edible ``mycelial biomass'' used as an
ingredient in food, beverages, supplements, and other processed
products for direct human consumption. Comments also referred to these
ingredients by other terms, such as ``mycelium biomass,'' ``mycomass,''
``full spectrum mycoproduct material,'' ``mycofermented mycelium,''
``mycofermented grain,'' or ``myceliated grain.'' Comments generally
described these ingredients as being produced similarly to spawn, but
with a longer growth time after the mycelium is applied to substrate.
In general, a substrate material (e.g., grain, such as millet or rice)
is inoculated with a culture and grown (or fermented) until nearly all
the substrate is consumed by the mycelium and bio-converted into fungal
tissue. The entire mycelial mass, including any un-converted substrate,
may be dried or otherwise processed and used as an ingredient.
(Response) AMS appreciates the detailed technical comments
submitted about these ingredients (collectively referred to as
``mycelial biomass'' in this response). AMS agrees with comments
recognizing the differences between mycelial biomass used as an
ingredient for direct human consumption, versus spawn used as a crop
input to produce fruiting bodies which are then harvested for direct
human consumption. AMS also recognizes that organic spawn meeting the
requirements at Sec. 205.210(d)(1) for use as a crop input to produce
organic mushrooms may not comply with the requirements for use as an
ingredient in an organic processed product.
AMS has not developed standards that are specific to mycelial
biomass ingredients. However, this rule does not preclude or prevent
the ongoing organic certification of mycelial biomass ingredients used
in processed products. Ingredients used in organic processed products
must follow the handling requirements in Sec. 205.270 and ingredient
composition requirements in Sec. 205.301. Given that the substrate
used to produce the mycelial biomass is included as part of the
mycelial biomass ingredient in a processed product, the substrate must
comply with the requirements at Sec. 205.301 for agricultural
substances to be organic. Additionally, any non-agricultural or
nonorganic ingredients must comply with applicable provisions of the
National List of substances allowed in processed products (Sec. Sec.
205.605 and 205.606). AMS understands, based on comments received on
the proposed rule, that this reflects the current practice of
certifiers that currently certify edible mycelial biomass ingredients
for direct human consumption and other processed products that may
contain these ingredients.
Exemptions
(Comment) Some comments expressed a concern that exempting mushroom
producers from certain crop production requirements could lead to other
types of crop production systems
[[Page 104381]]
being allowed to avoid applicable regulations.
(Response) This rule does not create or change the requirements for
crop production other than mushrooms. Section 205.210 specifically
recognizes the provisions of the organic crop standards that apply to
organic mushroom production and establishes specific requirements that
allow for the different production practices used to grow mushrooms.
Establishing practice standards for other specialized crop production
systems is outside the scope of this rule. This rule does not preclude
future rulemaking regarding other types of specialized crop production
systems.
(Comment) A comment argued that mushroom producers should not be
exempt from crop rotation requirements that apply to plant producers.
They noted that rotation could support broad organic requirements to
improve natural resources, support nutrient cycling, promote ecological
balance, and conserve biodiversity.
(Response) The rule does not require that mushroom producers rotate
crops, or species of mushrooms, on their operations. Due to the nature
of mushroom production, it is not clear how a mushroom producer would
conduct crop rotations. Mushroom operations, however, must meet
requirements at Sec. 205.200 to maintain or improve the natural
resources of the operation, including soil and water quality. For these
reasons, the final rule does not require mushroom operations to follow
crop rotation standards at Sec. 205.205.
Sec. 205.601 (National List--Crop)
Description of Final Policy
Section 205.105 of the organic regulations describes the allowed
and prohibited substances in organic production and handling. That
section states that synthetic substances may be used in organic
production only if they are specifically included on the National List
of allowed synthetic substances (Sec. 205.601).
The final rule revises the definition of crop (Sec. 205.2) to
clarify that mushrooms are a type of crop. This means that the National
List for crop production is applicable to mushroom production.
The final rule also updates the paragraph headings at Sec.
205.601(i) and (j) to replace the term ``plant'' with ``crop'' in the
phrases ``As plant disease control'' and ``As plant or soil
amendments.'' These paragraphs describe the types of synthetic
substances, grouped by function, that may be used in organic crop
production. The revisions are intended to clarify that subsections
205.601(i) and (j) of the National List, along with other substances
for crop production listed throughout Sec. 205.601, are relevant for
mushroom production.
Substances used in mushroom production must also be used in
accordance with any restrictions or annotations noted on the National
List and only if permitted under applicable Federal and State laws and
regulations. For example, the U.S. Environmental Protection Agency
reviews pesticide product labels as part of the licensing/registration
process and must approve the label language before a pesticide can be
sold or distributed in the United States. It is a violation of Federal
law to use a pesticide in a manner inconsistent with its labeling.
Changes From Proposed to Final Rule
Following analysis of public comments, AMS has not made any changes
to the proposed National List modifications in this final rule.
Responses to Public Comment
Below is a summary of comments received regarding these changes to
the National List (Sec. 205.601) and AMS's responses.
(Comment) Some of the comments that argued for a new scope of
certification for fungi (described earlier) also argued that AMS should
create a new section of the National List for fungi inputs that is
separate from the list for crop production in Sec. 205.601. Comments
argued that substances on the National List for crop production do not
apply to mushroom production, and those substances should be
specifically petitioned for addition to the new section of the National
List.
(Response) AMS is not creating a separate section of the National
List for fungi inputs, as requested, nor is AMS requiring inputs
currently on the National List for use in crop production to be
reviewed again for use in mushroom production. The crops section of the
National List (Sec. Sec. 205.601 and 602) is already an established
location for identifying mushroom production inputs, like the listing
of microcrystalline cheesewax at Sec. 205.601(o)(2) for use in log
grown mushroom production.
Use of the crops section of the National List is also consistent
with current practices of certifiers that certify mushrooms as a crop.
These certifiers refer to the regulations and Sec. 205.105 and the
crops section of the National List (Sec. Sec. 205.601 and 205.602) to
determine allowed and prohibited materials for organic mushroom
production. Furthermore, materials on the National List are subject to
specific restrictions and annotation and may not be allowed for
mushrooms. For these reasons, AMS does not view this as an expansion of
allowable inputs, but rather, maintaining current practice.
Stakeholders may refer to the National List Petition Guidelines for
information on amending the National List.\25\
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\25\ USDA, NOP. ``How to File a Petition.'' https://www.ams.usda.gov/rules-regulations/organic/national-list/filing-petition#NLpetitionGuidelines.
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Responses to Public Comment on Implementation Timeline
In the proposed rule, AMS specifically requested feedback about
whether a one-year implementation period would be appropriate for the
rule and what an appropriate implementation timeframe would be if one
year was not appropriate. Comments on this topic as it related to the
mushroom standards, and AMS's responses to comments, are discussed
below.
(Comment) Some comments argued that an extended implementation
period would be needed if the final rule were to include specific
changes they requested. For example, comments that requested AMS create
a separate standard and scope of certification for all fungi also
suggested that five years would be necessary for changes so sweeping.
Others argued that a five-year implementation period would be adequate
if the rule were to require that all mushroom substrate inputs be
organic without exception.
(Response) As previously discussed, AMS has declined to expand the
standards to apply to all fungi or create a separate scope of
certification for all fungal products, and AMS has retained an
exception in the final rule for mushroom operations to use nonorganic
inputs under specific conditions (see ``Responses to Public Comment''
in the above subsections labeled ``Sec. 205.2 (Terms defined)'' and
``Sec. 205.210 (Mushroom production practice standards)''). As these
changes were not adopted, a five-year implementation period is not
necessary.
(Comment) Some mushroom producers and a mushroom industry
association stated that a one-year implementation period would be
inadequate because there is not enough supply of organic agricultural
or forestry byproduct to meet the demand.
(Response) In response to these and other comments, the final rule
allows nonorganic wood materials (i.e., sawdust, chips, logs, or other
wood materials). Furthermore, it allows for nonorganic plant materials
in
[[Page 104382]]
mushroom substrate when organic is not commercially available. For
these reasons, AMS does not agree with the comment that the rule
requires a long implementation period.
However, in recognition of the changes in the final rule, AMS is
providing a two-year implementation period to allow operations to
update organic system plans, procedures, and recordkeeping systems to
comply with the final rule.
(Comment) Some commenters argued that a one-year implementation
period would be too brief. Certifiers noted that one year does not
allow enough time to notify operations of changes, collect updated
organic system plan forms, and conduct inspections to the new
requirements. Additionally, some certifiers said the recent
Strengthening Organic Enforcement final rule is demanding certifier
resources. These commenters requested a longer (e.g., two- to three-
year) implementation period for the rule.
(Response) AMS is selecting an implementation approach for the
final rule that recognizes time is required for certifiers and
operations to understand the rule and then update forms, procedures,
and recordkeeping systems. AMS believes that a two-year implementation
period, for both the mushroom standards and the pet food standards,
provides the regulatory certainty that the rule seeks to establish and
will minimize business disruptions for organic operations and
certifying agents.
IV. Organic Pet Food Standard
A. Pet Food Background
This final rule regulates organic claims on pet food by amending
the existing regulatory framework for processed organic products (Sec.
205.270, Organic handling requirements) to clarify the composition and
labeling requirements for organic pet food. These amendments allow
organic pet food to be labeled and sold as ``100% organic,''
``organic,'' or ``made with organic (specified ingredients or food
group(s)).'' The changes clarify that pet food is distinct from
livestock feed, which has its own composition and labeling requirements
(see Sec. Sec. 205.237 and 205.301(e)). This rule defines pet as ``Any
domestic animal not used for the production and sale of food, fiber, or
other agricultural-based consumer products.'' The rule defines pet food
as ``Any commercial feed prepared and distributed for pet
consumption.'' Throughout this rule, the term pet food is used to refer
to all pet foods, including food for pets other than dogs and cats,
unless otherwise noted. Feed for zoo animals falls outside the scope of
this rule, as zoo animals are not domestic animals and do not fit the
definition of pet.
This rule regulates what organic pet food can contain and how
organic claims may be used on pet food. Other aspects of the
manufacturing, marketing, and sale of pet food--including its
healthfulness and safety, nutritional value, and suitability for pets--
fall under the authority of the Food and Drug Administration (FDA) and
State regulatory bodies. All pet food manufacturers, organic or
otherwise, must comply with relevant Federal and State laws and
regulations pertaining to pet food safety.
General Overview of U.S. Pet Food Regulations
Pet food labels are regulated at the Federal and State levels. At
the Federal level, FDA is responsible for overseeing and enacting the
requirements of the Federal Food, Drug, and Cosmetic Act, which
requires pet food to be safe, properly manufactured, and adequately
labeled.\26\ FDA requires certain information on pet food labels:
Proper identification of the product, a net quantity statement, the
name and place of the manufacturer or distributor, and a proper listing
of all ingredients.\27\ Some States enforce their own labeling
regulations in addition to those administered by FDA. Most of these
States follow versions of the Model Bill recommendations of the
Association of American Feed Control Officials (AAFCO), an independent
non-profit organization.\28\
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\26\ FDA. (February 17, 2022). ``FDA's regulation of pet food.''
https://www.fda.gov/animal-veterinary/animal-health-literacy/fdas-regulation-pet-food.
\27\ FDA. (February 3, 2023). ``Pet food.'' https://www.fda.gov/animal-veterinary/animal-food-feeds/pet-food. FDA's animal food
labeling regulations are located at 21 CFR part 501.
\28\ AAFCO. ``Labeling & labeling requirements.'' https://www.aafco.org/resources/startups/labeling-labeling-requirements/.
Accessed May 1, 2023.
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Pet food is often formulated as a complete nutrition product--i.e.,
the sole source of nourishment for pets. It typically contains
ingredients from agricultural sources, minerals, vitamins or other
nutrients, flavorings, preservatives, and processing aids to meet the
nutrient requirements of the animal and the processing needs for the
pet food.\29\ Many ingredients from agricultural sources such as meat,
poultry, and grains are considered safe and do not require FDA's pre-
market approval. Other substances (including supplemental nutrients) do
not require FDA's pre-market approval if they are on an FDA-maintained
list of ingredients Generally Recognized as Safe (GRAS), otherwise they
must have approval as food additives.\30\ The National Academy of
Sciences' National Research Council (NRC) and AAFCO provide information
on the nutrient requirements of dogs and cats at each stage of life
(e.g., growth, reproduction, adult maintenance) to guide the
formulation of nutritionally adequate pet foods. NRC has listed and
described essential nutrients in its 2006 publication ``Nutrient
Requirements of Dogs and Cats.'' \31\ On its website, AAFCO maintains
more recently updated Nutrient Profiles for the various stages of life.
The minimum nutrient levels specified in the AAFCO Nutrient Profiles
are generally consistent with NRC Nutrient Requirement tables and are
updated periodically as NRC recommendations change.
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\29\ FDA. (February 15, 2024). ``Pet Food.'' https://www.fda.gov/animal-veterinary/animal-food-feeds/pet-food.
\30\ FDA. (August 4, 2023). ``Current animal GRAS notices
inventory.'' https://www.fda.gov/animal-veterinary/generally-recognized-safe-gras-notification-program/current-animal-food-gras-notices-inventory.
\31\ National Research Council. (2006). ``Nutrient requirements
of dogs and cats.'' https://nap.nationalacademies.org/catalog/10668/nutrient-requirements-of-dogs-and-cats.
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This rule does not supersede the requirements of FDA or State
regulatory bodies. Instead, this rule is intended to work jointly with
those requirements and more narrowly regulate what manufacturers must
do to label their pet food ``100% organic,'' ``organic,'' or ``made
with organic (specified ingredients or food group(s)).'' Additionally,
by including organic pet food in the organic regulations, the rule
clarifies the process for adding substances to the National List
specifically for use in organic pet food. Future amendments to the
National List could be made, as necessary, in accordance with the
process, requirements, and criteria described in OFPA (see 7 U.S.C.
6517 and 6518).
Organic Pet Food Industry and Market
Pet food is a large and growing market in the United States.
According to recent data from the American Pet Products Association
(APPA), roughly 82 million homes own a pet.\32\ Pet ownership increased
during the COVID-19 pandemic when many people chose to adopt pets while
working from home. According to an American Society for the Prevention
of Cruelty to Animals
[[Page 104383]]
(ASPCA) survey, around 23 million homes (nearly one in five homes in
the United States) adopted a cat or dog during the pandemic.\33\
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\32\ American Pet Products Association. ``Pet industry market
size, trends & ownership statistics.'' Retrieved September 3, 2024.
https://americanpetproducts.org/industry-trends-and-stats. Accessed
September 3, 2024.
\33\ ASPCA. ``New ASPCA survey: Vast majority of dogs and cats
acquired during pandemic still in their homes.'' https://www.aspcapro.org/resource/new-aspca-survey-vast-majority-dogs-and-cats-acquired-during-pandemic-still-their-homes. Accessed September
3, 2024.
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In 2023, the pet food/treat market in the United States was valued
at $64.4 billion and was projected to increase to $66.9 billion in
2024.\34\ However, the organic pet food market remains small in
comparison: as of 2021, the organic pet food market was less than one
percent of the total pet food market.\35\ In 2023, sales of organic pet
food dropped to $120 million, a decline of 7.4 percent from the
previous year.\36\ The organic pet food market is relatively new, with
few organic brands having been able to penetrate the market. AMS
expects that as the number of organic options for pets increases, an
untapped market of consumers may seek to purchase organic pet food for
the same reasons that they purchase other organic foods.
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\34\ American Pet Products Association. ``Pet industry market
size, trends & ownership statistics.'' https://americanpetproducts.org/industry-trends-and-stats. Accessed
September 3, 2024.
\35\ Organic Trade Association. (2022). Organic Industry Survey.
p. 108.
\36\ Organic Trade Association. (2024). Organic Industry Survey.
p. 74.
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B. Need for Organic Pet Food Standards
The lack of specific standards for organic pet food has created
inconsistency and uncertainty around labeling and composition
requirements for organic pet food. Certifiers have used various
combinations of the standards for livestock feed and processed
products, neither of which are entirely sufficient. The handling
standards are appropriate for verifying the processing, handling,
product composition, and labeling requirements for multi-ingredient
processed agricultural products, but they lack specific allowances for
nutrients that are necessary for pets. Conversely, the livestock feed
standards include allowances for many of the nutrients that are
necessary for pets, but they prohibit common pet food ingredients, such
as slaughter by-products.
These regulatory gaps have increased the risk for businesses in the
organic pet food market, hindered production innovation, and limited
the market for organic slaughter by-products. This rule addresses these
inconsistencies and creates clearer regulatory standards specifically
for slaughter by-products and nutrients in organic pet food.
Organic Slaughter By-Products
The term ``organic slaughter by-products'' refers to the parts of
an organic animal, managed and slaughtered according to the organic
regulations, that humans do not typically eat, such as offal, gristle,
and bone. These by-products come from organically managed animals, but
livestock producers do not often receive organic premiums for them due
to an insufficient market for organically produced slaughter by-
products.
Section 205.237(b)(5) prohibits feeding slaughter by-products to
mammals or poultry. This is a necessary precaution for livestock raised
as food for human consumption; however, slaughter by-products are a
commonly used protein source in pet food. In the past, some certifying
agents have used the composition requirements for organic livestock
feed (Sec. 205.301(e)) to certify pet food as organic, but livestock
feed produced under the organic standards may not sufficiently address
the nutritional needs of pets. Some certifying agents have allowed
organic slaughter by-products in pet food, while other certifiers have
not. These contradictions create uncertainty for businesses that
currently produce organic pet food and are a barrier to businesses that
would like to start producing organic pet food or selling slaughter by-
products to the organic pet food market.
Slaughter by-products make up approximately 23 percent of the
composition of conventional pet food, in part to meet protein levels
required by Federal and State regulations.\37\ AMS estimates that there
are currently over 12 million pounds of organic meat and organic
slaughter by-products used in pet food annually. Prior to the
publication of this final rule, it was unclear if pet food
manufacturers could use meat or slaughter by-products in organic pet
food. This uncertainty has likely limited the growth of the organic pet
food market. By clarifying that these products can be used in organic
pet food, this rule could broaden the market and increase demand for
those organic livestock products. Based on feedback from stakeholders,
AMS finds it likely that organic meat and slaughter by-product demand
will grow over time beyond this estimate after implementation of this
rule.
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\37\ Institute for Feed Education & Research. (March 2020).
``Pet food production and ingredient analysis.''
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Vitamins, Minerals, and Amino Acids
Most dry and wet pet foods are multi-ingredient products, as
multiple ingredients are needed to meet the nutritional needs of a pet.
The product that forms the largest share of the pet food market is
kibble,\38\ or dry ``complete and balanced'' \39\ pet food, which is
intended to supply a pet's daily nutritional needs of essential
vitamins, minerals, and amino acids.
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\38\ Kibble accounted for 62.8 percent of all pet food sales in
2020. Pet Food Processing. (December 1, 2020). ``State of the US pet
food and treat industry, 2020.'' https://www.petfoodprocessing.net/articles/14294-state-of-the-us-pet-food-and-treat-industry-2020.
\39\ FDA. (February 28, 2020). ``Complete and Balanced Pet
Food.'' https://www.fda.gov/animal-veterinary/animal-health-literacy/complete-and-balanced-pet-food.
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Prior to the publication of this rule, there has been uncertainty
about which nutrients are allowed in organic pet food. Some certifying
agents have used the composition requirements for organic livestock
feed (Sec. 205.301(e)) to identify allowable nutrients in organic pet
food. Those standards allow the use of FDA-approved vitamins and
minerals that appear on the National List of allowed substances for
livestock production (Sec. 205.603(d)(2) and (3)), many of which are
commonly used in pet foods. Other certifiers have used the handling
standards in Sec. 205.270, which allow nutrient vitamins and minerals
that appear on the National List of allowed substances for processing/
handling at Sec. Sec. 205.605 and 205.606. However, these standards do
not explicitly allow the vitamin and mineral ingredients that appear on
the National List for livestock production at Sec. 205.603(d), which
may also be important for pet food. Neither the livestock production
nor the processing/handling lists of allowed synthetic nutrient
vitamins and minerals is sufficient to address the range of essential
nutrients for pet food.
Furthermore, neither section of the National List allows for
certain synthetic amino acids, such as taurine, that are commonly used
in pet food. Taurine is a synthetic amino sulfonic acid that is a
necessary part of a healthy diet for many pets (all cats and some dog
breeds). For that reason, AAFCO's cat nutrient profiles require
taurine, and it is a common synthetic additive in pet foods for other
pets. Taurine is essential for pet health and adequate taurine levels
cannot always be achieved using organic agricultural ingredients alone.
The natural form of taurine is present in raw meat but not in processed
pet food in its final form, as taurine is destroyed by heat, which is
applied during pet food processing to comply with pet food
[[Page 104384]]
safety standards.\40\ To compensate for this loss, pet food
manufacturers often add synthetic forms of taurine to certain pet
foods. As synthetic taurine was previously not approved for organic pet
food, some certifiers limited the types of pet food that could be
certified as organic to single-ingredient treats. This limited the
growth of the overall organic pet food market.
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\40\ Spitze, A.R., Wong, D.L., Rogers, Q.R., & Fascetti, A.J.
(2003). ``Taurine concentrations in animal feed ingredients; cooking
influences taurine content.'' Journal of Animal Physiology and
Animal Nutrition, 87(7-8), 251-262. https://pubmed.ncbi.nlm.nih.gov/12864905/.
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Final Rule Response
This final rule resolves these problems by, first, establishing
that organic pet food is regulated as a processed product rather than
as livestock feed. This allows organic pet food to include slaughter
by-products from certified organic animals, which remain under
continuous organic management through the slaughter process. This
clarification creates consistency between certifying agents, removes
uncertainty for pet food manufacturers, and expands the market for
organic livestock producers who sell slaughter by-products. Allowing
slaughter by-products in organic pet food will likely increase demand
for certified organic slaughter by-products and create additional
income streams for organic livestock producers and meat processors. AMS
expects that the changes brought about by this final rule will
encourage additional growth in the small organic pet food market and
other latent organic markets that support it, such as the market(s) for
organic slaughter by-products.
Second, this final rule clarifies the vitamins, minerals, and amino
acids that are allowed as ingredients in organic pet food to ensure
that pet food manufactures can formulate pet foods that meet the daily
nutritional needs of pets. It permits the use of the vitamin and
mineral feed additives referenced in Sec. Sec. 205.603(d)(2) and (3)
in pet food, and it adds taurine to the National List at Sec.
205.605(b) as an allowed nonorganic ingredient in organic pet food.
Revising the organic regulations to clearly allow the essential
nutrients required in pet food will allow companies to produce multi-
ingredient dry and wet pet food products that are certified organic and
meet the complete nutritional needs of pets.
Third, this rule regulates pet food under the existing composition
and labeling requirements for processed products referenced in Sec.
205.270 rather than under the requirements for livestock feed. This
allows producers to make the organic labeling claims: ``100 percent
organic,'' ``organic,'' or ``made with organic (specified ingredient or
food group(s)).'' These labeling claims are regulated under the USDA
organic regulations (Sec. Sec. 205.301, 205.303, and 205.304) and are
used extensively by certified organic handlers. ``100 percent organic''
is used to label any product with 100 percent organic ingredients,
``organic'' products must contain at least 95 percent organic
ingredients, and ``made with organic'' products must contain at least
70 percent organic ingredients. The regulations established in this
final rule also permit the identification of organically produced
ingredients in the ingredient statement of certain products (Sec. Sec.
205.301(d) and 205.305). In the first three cases, any nonorganic
ingredient(s) must also meet specific criteria.\41\
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\41\ USDA, AMS. (April 2018). ``Organic Labels Explained.''
https://www.ams.usda.gov/sites/default/files/media/OrganicLabelsExplained.png.
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By clarifying that pet food can be labeled with the various organic
claims described above, the rule provides pet food manufacturers with
the flexibility to make and market a range of products that contain
organic ingredients. In turn, AMS expects the rule could increase the
availability of organic products for consumers and bolster markets for
organic ingredients by increasing demand.
In conclusion, this rule addresses inconsistencies in how
certifying agents are applying the current organic regulations to pet
food. It also resolves regulatory uncertainties that artificially
increase risk in the organic pet food market. Addressing these
inconsistencies and uncertainties should create the conditions
necessary for organic pet food and related markets to grow.
C. Overview of Final Rule Policy and Responses to Comments
This final rule amends the USDA organic regulations (7 CFR part
205) by defining ``pet'' and ``pet food'' in the regulations and adding
a new paragraph for pet food in Sec. 205.270, organic handling
requirements. This action integrates organic pet food standards into
existing USDA organic labeling categories for agricultural products
(subpart D of part 205) and specifies the ingredients that can be
included in pet food labeled ``100 percent organic,'' ``organic,''
``made with organic (specified ingredients or food group(s)),'' or in
products with less than 70 percent organic ingredients (ingredient list
claims only). Table 2 summarizes the amendments to the USDA organic
regulations that add pet food composition and labeling standards.
Table 2--Overview of Regulatory Changes To Establish Pet Food Standards
------------------------------------------------------------------------
Section title Type of action Rulemaking action
------------------------------------------------------------------------
205.2........................ Adds new terms...... Defines terms pet
and pet food.
205.270...................... Adds new paragraph.. Adds composition
and labeling
requirements
specific to pet
food.
205.605(b)................... Adds substance to Adds taurine to the
the National List. National List as
an allowed
ingredient in pet
food.
------------------------------------------------------------------------
Sec. 205.2 (Terms Defined)
Description of Final Policy
The final rule amends Sec. 205.2 by adding two new terms, pet and
pet food.
1. Pet
The rule defines pet as ``any domestic animal not used for the
production and sale of food, fiber, or other agricultural-based
consumer products.'' This term establishes a distinction between
animals raised as pets and animals raised for food or fiber (i.e.,
``livestock,'' as defined at Sec. 205.2). Animals used for food or in
the production of food, fiber, feed, or other agricultural-based
consumer products are ``livestock'' under the USDA organic regulations
(Sec. 205.2) and must be produced under all applicable organic
livestock requirements. Feed requirements for organic livestock are
described at Sec. 205.237 and do not apply to organic pet food, and
vice versa.
2. Pet Food
The rule defines pet food as ``any commercial feed prepared and
distributed for pet consumption.'' The definition for pet food
distinguishes organic pet food products from organic livestock feed
products. This action is
[[Page 104385]]
consistent with the NOSB's recommendation.\42\ It also addresses
concerns from pet food manufacturers that applying livestock feed
composition requirements to pet food could limit product formulation
and participation in the organic market due to the lack of available
organic protein sources, especially rendered products like poultry
meal. Unless otherwise noted, the term pet food refers to all pet
foods, including food for pets other than dogs and cats. Feed for zoo
animals is not included in the definition, as zoo animals are not
domestic animals and therefore fall outside the definition of pets.
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\42\ NOSB. (November 19, 2008). ``Formal recommendation by the
National Organic Standards Board (NOSB) to the National Organic
Program (NOP): Organic pet food standards recommendation.'' https://www.ams.usda.gov/sites/default/files/media/NOP%20Final%20Rec%20Pet%20Food.pdf.
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Changes From Proposed to Final Rule
Following analysis of public comments, AMS has not made any changes
to the proposed definitions of pet and pet food in this final rule. See
the following section for a more detailed discussion of public comments
on these definitions and AMS's response to those comments.
Responses to Public Comment
Below is a summary of comments received regarding organic pet food
definitions and AMS's responses.
(Comment) Some commenters, including AAFCO, requested that AMS
align its definitions with the AAFCO Model Bill and State feed laws.
AAFCO suggested that the proposed definition of pet should be changed
to align with the Model Bill which defines a pet as a dog or a cat
only. AAFCO also suggested that AMS consider additional definitions for
specialty pet (``any animal normally maintained in a household, such
as, but not limited to, rodents, ornamental birds, ornamental fish,
reptiles, amphibians, ferrets, hedgehogs, marsupials, and rabbits not
raised for food or fur'' and specialty pet food (``any commercial feed
prepared and distributed for consumption by specialty pets''). In
contrast, other commenters, including a feed industry association and
several organic certifying agencies, supported AMS's definitions for
pet and pet food, stating that the definitions are clear and would work
well within the existing regulatory frameworks for pet food.
(Response) AMS acknowledges and appreciates AAFCO's work developing
industry standards. However, AMS has chosen not to modify or add to the
proposed definitions of pet or pet food in this final rule. AMS
acknowledges that the definition of pet in this rule is broader than
AAFCO's definition, but this rule regulates organic food for all types
of pets equally and does not present unique requirements for different
categories of pets or specialty pets. Without any differences in
labeling or composition requirements for different types of pets in
this rule, AMS does not find it necessary to distinguish between types
of pets and prefers to use a single and inclusive term (pet) for all
types of pets. Importantly, this rule does not change a manufacturer's
obligations to comply with Federal or State requirements that may have
different requirements for pet food and specialty pet food. AMS's
decision to use a broad and inclusive definition of pet in this rule
ensures that the organic regulations are flexible to accommodate any
other detailed Federal and State requirements for pet food and specific
types of pets.
(Comment) Some comments questioned AMS's definition of pet food as
a type of ``commercial feed . . . for pet consumption.'' These comments
stated that standards for ``food'' products and ingredients are higher
than standards for ``feed'' products and ingredients, with differences
in quality and safety standards. They argued that defining pet food as
a type of feed would confuse consumers about whether organic pet food
was human grade.
(Response) The final rule does not revise the definition of pet
food, as we do not believe that the market expects the term pet food to
mean a product meets human grade food standards. Therefore, we do not
expect that the term will mislead consumers. For the purposes of the
organic regulations, AMS finds that the broad and common term pet food
is most appropriate. See additional discussion of comments related to
human grade standards for pet food in section ``Sec. 205.270 (Organic
handling requirements)'' below.
Sec. 205.270 (Organic Handling Requirements)
Description of Final Policy
This final rule adds a new paragraph (d) to Sec. 205.270--organic
handling requirements--to describe requirements for the composition,
processing, and labeling of organic pet food. New paragraph (d)
specifies the types of processing aids and ingredients that are allowed
in organic pet food. By including pet food as part of the organic
handling requirements in Sec. 205.270, and therefore clearly
separating pet food standards from the livestock feed composition and
labeling standards, the rule ensures that pet food is not subject to
the prohibition on the use of slaughter by-products that exists for
livestock feed. The rule allows slaughter by-products in pet food under
the same composition and labeling requirements for other multi-
ingredient products described at Sec. 205.301(a) through (d) and (f).
The term organic slaughter by-products refers to the parts of organic
animals that humans do not typically eat, such as offal, gristle, and
bone. It does not refer to substandard animal products from diseased
animals, uninspected animals, condemned animals, or animals deemed
unfit for human consumption.
The final rule (Sec. 205.270(d)) permits organic pet food, like
other processed organic products regulated under Sec. 205.270, to
contain nonorganic substances allowed by the National List in Sec.
205.605 (such as taurine, as finalized by this rule) and Sec. 205.606.
These ingredients may be used in processed pet food products labeled as
``organic'' or ``made with organic (specified ingredients or food
group(s)),'' in accordance with Sec. 205.301(b) and (c), respectively.
Additionally, the rule allows the feed additive vitamins and minerals
in Sec. 205.603(d)(2) and (3) to also be used for enrichment or
fortification of pet food.
Paragraph 205.270(d) also clarifies that pet food with organic
claims must be labeled pursuant to subpart D of the organic
regulations. For instance, organic pet food must be labeled according
to the product composition requirements at Sec. 205.301(a) through (d)
and (f). In addition, pet food may use the following labeling
categories: (a) ``100 percent organic;'' (b) ``organic,'' (c) ``made
with organic (specified ingredients or food group(s));'' or (d)
products containing less than 70 percent organic ingredients (organic
ingredients identified on the ingredient statement only). This action,
in combination with the new definition for pet food, as distinct from
livestock feed, allows the labeling of organic pet food using the same
framework as multi-ingredient processed food products (rather than the
requirements for livestock feed). The requirements for livestock feed
composition (Sec. 205.301(e)) and livestock feed labeling (Sec.
205.306) do not apply to pet food.
The changes to Sec. 205.270 do not replace or modify requirements
pertaining to pet food that are applicable under other Federal or State
laws or regulations. This rule regulates only the organic claims on pet
food. All other aspects of pet food formulation,
[[Page 104386]]
production, labeling, and sale must follow the relevant Federal and
State laws and regulations.
Changes From Proposed to Final Rule
Following analysis of public comments, AMS has not made any
substantive changes to the proposed organic handling requirements in
this final rule. The final rule adds pet food requirements at Sec.
205.270(d) rather than Sec. 205.270(c), as proposed, to minimize
impacts related to documents and policies that currently reference the
requirements at Sec. 205.270(c). The final rule also removes
references to ``the applicable portions of'' Subpart D, as proposed, in
favor of a clear and direct reference to Subpart D. AMS expects all
operations, including pet food manufacturers, to comply with the
applicable portions of Subpart D that are relevant to the product types
and claims of the certified product. This rule clarifies that livestock
feed composition and labeling are not applicable to pet food.
Responses to Public Comment
Below is a summary of comments received regarding organic pet food
handling requirements and AMS's responses.
(Comment) Several thousand commenters, responding to a mass comment
campaign initiated by an organic advocacy group, requested that AMS
ensure that organic pet food, including any livestock products used as
ingredients in pet food, meet ``human grade'' food standards.
(Response) This final rule does not require the use of ``human
grade'' standards for organic pet food or its ingredients. All organic
livestock products are subject to the organic regulations, as well as
other State and Federal regulations that may apply. AMS understands
that other organizations, including AAFCO, have defined ``human grade''
and/or have recommended detailed guidelines for use of the ``human
grade'' claim on pet food. For example, under the ``human grade''
guidelines recommended by AAFCO, each ingredient must be stored,
handled, processed, and transported under human food laws and
regulations, and facilities must be registered with the FDA as a human
food and animal food facility, among other requirements. Adopting such
standards in the final rule would go well beyond the scope of the
proposed requirements. However, nothing in this rule prevents organic
pet food operations from additionally making truthful ``human grade''
claims on organic pet food products.
(Comment) The mass comment campaign noted above also requested that
no fallen or condemned animals (or portions of animals) or animals that
die by means other than slaughter be allowed in organic pet food. Some
other individual commenters echoed these requests, requesting that AMS
require USDA inspection of slaughtered animals or facilities
slaughtering animals to ensure no condemned animals are used in pet
food.
(Response) AMS agrees with the commenters that organic pet food
must not contain condemned, diseased, or otherwise unsanitary animal
products, and the final rule should in no way be misconstrued to permit
them. AMS has not revised the final rule to address these topics
because AMS did not propose specific language on this topic and because
other laws and regulations, including organic regulations, exist that
address these issues. Under the current regulations, organic slaughter
facilities must be certified organic and are subject to annual on-site
inspections from their certifier. The organic regulations specifically
prohibit seriously crippled and non-ambulatory animals from being sold
or slaughtered as organic (Sec. 205.242(a)(2)).
Additionally, organic regulations require that organic livestock be
slaughtered in compliance with USDA Food Safety Inspection Service
(FSIS) regulations, FSIS Directives, and other laws (Sec. 205.242(b)
and (c)). The FSIS regulations (e.g., 9 CFR part 309 and part 314)
include specific regulations related to handling condemned (e.g.,
diseased) animals/or animal parts. They also include regulations
related to animals that have died other than by slaughter (i.e., dead
animals) and diseased, dying, and disabled animals.
Finally, AMS is not including a requirement for USDA inspection of
slaughter plants associated with organic slaughter for pet food. Not
all animals in the United States are slaughtered at USDA-inspected
facilities. For example, some facilities are inspected by States only.
Therefore, AMS is not including a requirement that slaughter facilities
be USDA-inspected; however, organic facilities, including slaughter
facilities, are still subject to annual on-site inspections by their
organic certifier.
(Comment) Several commenters asked for clarification about how
vitamins and minerals listed in Sec. Sec. 205.603(d)(2) and (3) should
be reviewed for use in organic pet food. Commenters asked about whether
AAFCO-approved vitamins and minerals would be allowed, and other
questions related to the applicability of NOP Guidance 5030,
``Evaluating Allowed Ingredients and Sources of Vitamins and Minerals
for Organic Livestock Feed''.
(Response) The final rule permits the vitamin and mineral feed
additives referenced in Sec. 205.603(d)(2) and (3), which include
vitamins and minerals that are FDA approved. AMS defers to applicable
FDA regulations and guidance in determining which specific substances
are FDA approved.\43\ Section 4.2.3 of NOP Guidance 5030, ``Evaluating
Allowed Ingredients and Sources of Vitamins and Minerals for Organic
Livestock Feed,'' contains additional information to help determine
whether certain vitamins or minerals are allowed under Sec.
205.603(d)(2) and (3). For the purpose of determining compliance for
organic pet food, if the vitamin or mineral is allowed under Sec.
205.603(d)(2) or (3), then it is also allowed for use in organic pet
food.
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\43\ FDA has recently announced that it would not renew its MOU
with AAFCO and review its procedures for reviewing animal food
ingredients. To assist with the transition, FDA has released two
draft Guidance for Industry documents:
FDA. (August 2024). ``CVM GFI #293--FDA Enforcement Policy for
AAFCO-Defined Animal Feed Ingredients.'' https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-293-fda-enforcement-policy-aafco-defined-animal-feed-ingredients.
FDA. (August 2024). ``CVM GFI #294--Animal Food Ingredient
Consultation (AFIC).'' https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-294-animal-food-ingredient-consultation-afic.
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Sec. 205.605 (National List)
Description of Final Policy
The final rule modifies the National List to allow the use of
synthetic taurine in pet food. The rule adds taurine to Sec. 205.605,
which describes nonorganic nonagricultural substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).'' The
amendment for taurine also specifies that taurine can be used only in
pet food and not in other organic multi-ingredient products.
This addition implements an NOSB recommendation to add taurine to
the National List as an allowed substance for use exclusively in pet
foods. AMS agrees with NOSB's rationale and recommendation. As
described above, taurine is essential for pet health and adequate
taurine levels cannot always be achieved using organic agricultural
ingredients alone.
Changes From Proposed to Final Rule
Following analysis of public comments, AMS has not made any changes
to the proposed National List modifications (Sec. 205.605) in this
final rule.
[[Page 104387]]
Responses to Public Comment
Below is a summary of comments received regarding organic pet food
National List standards and AMS's responses.
(Comment) One commenter, a pet food trade association, argued that
the rule should allow for the use of a broader range of amino acids in
organic pet food, rather than allowing taurine only. They suggested
replacing the proposed rule's addition of taurine to the National List
with the statement ``Amino acids, used for enrichment or fortification
when FDA-approved for use only in pet food.''
(Response) AMS understands the potential need for other amino acids
in pet food production apart from taurine. However, taurine is a common
synthetic additive in pet food that is vital nutrition for all cat
breeds (and some dog breeds) and cannot be obtained in adequate amounts
from pet food that does not include synthetic taurine. This decision
follows NOSB's recommendation to add only taurine to the National List.
NOSB has not recommended other animo acids for use in organic pet food.
Therefore, this rule only includes the addition of taurine to the
National List.
Individuals may petition to add other substances to the National
List for use in organic pet food, following the National List Petition
Guidelines.\44\ Because organic pet food must meet all applicable
Federal and State laws and regulations, any person or organization
petitioning to add a substance to the National List for use in organic
pet food must ensure the use of that substance is consistent with
applicable Federal and State laws and rules. Synthetic substances
petitioned for use in pet food will be evaluated according to the
existing criteria in OFPA (7 U.S.C. 6517 and 6518) and the USDA organic
regulations (7 CFR 205.600).
---------------------------------------------------------------------------
\44\ USDA, NOP. How to File a Petition. https://www.ams.usda.gov/rules-regulations/organic/national-list/filing-petition#NLpetitionGuidelines.
---------------------------------------------------------------------------
(Comment) Some commenters claimed that it is not necessary to
include taurine on the National List because it exists naturally in
foods such as eggs, red algae, and meats. Additionally, some commenters
asked if taurine should be allowed in all pet food or just cat food,
because cats need additional taurine in food whereas dogs are able to
physiologically synthesize taurine by consuming foods containing the
amino acids cysteine and methionine. Other commenters requested that
taurine should be included as an allowed substance specifically for
cats and dogs, rather than for pets generally.
(Response) In 2013, the NOSB Livestock Subcommittee proposed adding
taurine to the National List as an allowed substance for use
exclusively in pet foods to meet nutritional requirements for cats.
After public comments argued that taurine can also be necessary for
dogs' nutrition, NOSB issued its final recommendation for taurine to be
allowed in pet food generally. AMS agrees with NOSB's rationale and
recommendation on the basis that taurine is essential for pet health
and that synthetic taurine must be added to pet food, in certain cases,
to reach the levels that are necessary for pet health.
Responses to Public Comment on Implementation Timeline
AMS requested feedback about whether a one-year implementation
period would be appropriate for the rule. Comments that are
specifically related to the pet food standards implementation, and
AMS's responses to comments, are discussed below.
(Comment) Some commenters stated that an extended implementation
period is not necessary for the pet food portion of the rule, as the
rule does not restrict operations compared to current practices. A
commenter noted that certifiers already use the framework described in
the proposed rule for the certification of pet food. Commenters noted
that if the final rule adopted the proposed rule as-is, a one-year
implementation timeline would be sufficient.
(Response) AMS agrees that pet food operations will not need to
make any major changes to comply with the final rule. In fact, by
allowing the use of taurine (an amino acid) in organic pet food, the
final rule is less restrictive than existing standards. However, AMS is
providing a two-year implementation period for the final rule,
including the pet food requirements, to allow operations and certifying
agents time to understand the rule and update forms and inspection
procedures to reflect the final rule.
AMS notes that operations are not restricted from complying with
the final rule prior to the compliance date. For example, pet food
operations may use taurine in organic pet food starting on the
effective date of the final rule.
V. Regulatory Analyses
Executive Orders 12866, 13563, 14094, and the Regulatory Flexibility
Act
This rule does not meet the criteria of a ``significant regulatory
action'' under Executive Order 12866, as supplemented by Executive
Order 13563 and updated by Executive Order 14094. Therefore, the Office
of Management and Budget (OMB) has not reviewed this rule under those
orders.
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(b) of the RFA
allows an agency to certify that a rule will not have a significant
economic impact on a substantial number of small entities instead of
preparing a regulatory flexibility analysis, provided that the agency
sets forth the factual basis for such certification. AMS has concluded
and hereby certifies that this rule will not have a significant
economic impact on a substantial number of small entities; therefore,
an analysis is not included. Below, AMS presents information about the
industry and the possible effects of the rule on small entities to
support this conclusion.
The Small Business Administration (SBA) sets size criteria for each
industry described in the North American Industry Classification System
(NAICS) to delineate which operations qualify as small businesses.
SBA's size standards are expressed in terms of number of employees or
annual receipts and indicate the maximum allowed for an entity to be
considered small.\45\
---------------------------------------------------------------------------
\45\ U.S. SBA. (March 17, 2023). Table of size standards.
https://www.sba.gov/document/support-table-size-standards.
---------------------------------------------------------------------------
Mushroom Producers. AMS has considered the economic impact of this
rulemaking on small mushroom producers. At the time of this analysis,
small organic mushroom producers were listed under NAICS code 111411
(Mushroom Production) as grossing equal to or less than $4,500,000 per
year.\46\ AMS estimates that out of 239 domestic operations reporting
sales of organic mushrooms, approximately 4 operations exceed that
threshold.\47\
[[Page 104388]]
While most organic mushroom operations that would be affected by this
rule are small entities, this rule only has the potential to impose
minor costs on them related to paperwork burden (see ``Paperwork
Reduction Act'' section below) and costs associated with sourcing
organic spawn and substrate materials, when commercially available. AMS
concludes that this rule will not have a significant economic impact on
a substantial number of these small entities.
---------------------------------------------------------------------------
\46\ U.S. SBA. (March 17, 2023). Table of size standards.
https://www.sba.gov/document/support-table-size-standards.
\47\ The National Agricultural Statistics Service was unable to
supply a precise tabulation of large organic operations due to
disclosure concerns. AMS estimated the number of large mushroom
operations and sales from large mushroom operations using the
proportion of conventional mushroom operations by sales from the
USDA's 2022 Census of Agriculture, available here: https://www.nass.usda.gov/Publications/AgCensus/2022/index.php. The same
distribution is assumed to apply to organic mushroom operations.
---------------------------------------------------------------------------
Pet Food Operations. AMS has considered the economic impact of this
rulemaking on small organic pet food producers. At the time of this
analysis, small organic pet food producers were listed under NAICS code
311111 (Dog and Cat Food Manufacturing) as employing equal to or fewer
than 1,250 employees.\48\ AMS estimates that given the small size of
the organic pet food market, most of the 29 domestic organic pet food
operations are small entities. Pet food operations may incur small one-
time paperwork costs (see ``Paperwork Reduction Act'' section below),
but the rule establishes standards for organic pet food handling that
align with many existing industry practices. Additionally, the rule
allows operations to use additional inputs (e.g., taurine) in organic
pet food, which provides pet food operations more production options
without additional costs. AMS concludes that this rule will not have a
significant economic impact on a substantial number of these small
entities.
---------------------------------------------------------------------------
\48\ U.S. SBA. (March 17, 2023). Table of size standards.
https://www.sba.gov/document/support-table-size-standards.
---------------------------------------------------------------------------
Certifying agents. This final rule also affects certifying agents
that certify organic mushroom or pet food operations. At the time of
this analysis, the SBA defined small agricultural service firms, which
include certifying agents, as those having annual receipts equal to or
less than $19,500,000 (NAICS code 541990--All Other Professional,
Scientific and Technical Services). There are currently 73 USDA-
accredited certifying agents, and AMS believes most of these certifying
agents are small entities. Certifying agents must already comply with
existing regulations and already certify these operations. Certifying
agents may incur minor one-time paperwork costs (see ``Paperwork
Reduction Act'' section below). However, this rule reduces the current
burden of creating and maintaining certifier-level policies for the
certification of organic mushroom production and organic pet food
handling. AMS concludes that this rule will not have a significant
economic impact on a substantial number of these small entities.
Executive Order 12988
Executive Order 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 rule complies with
these requirements. This rule cannot be applied retroactively.
Additionally, to prevent duplicative regulation, States and local
jurisdictions are preempted under OFPA from creating accreditation
programs 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 USDA to be accredited as a
certifying agent, as described in OFPA (7 U.S.C. 6514(b)). States are
also preempted under sections 6503 through 6507 of OFPA 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.
Pursuant to section 6507(b)(2) of OFPA, 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 toward agricultural commodities organically
produced in other States, and (d) not be effective until approved by
the Secretary.
In addition, pursuant to section 6519(c)(6) of OFPA, this
rulemaking 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. 301-399i), nor the authority of the Administrator of the
Environmental Protection Agency under the Federal Insecticide,
Fungicide and Rodenticide Act (7 U.S.C. 136-136y).
OFPA at 7 U.S.C. 6520 provides for the Secretary to establish an
expedited administrative appeals procedure under which persons may
appeal an action of the Secretary, the applicable governing State
official, or a certifying agent under the statute that adversely
affects such person or is inconsistent with the organic certification
program established under OFPA. OFPA also provides that the U.S.
District Court for the district in which a person is located has
jurisdiction to review the Secretary's decision.
Executive Order 13132
Executive Order 13132 mandates that Federal agencies consider how
their policymaking and regulatory activities impact the policymaking
discretion of States and local officials and how well such efforts
conform to the principles of federalism defined in said order. This
executive order pertains only to regulations with clear federalism
implications.
AMS has determined that this rulemaking conforms with the
principles of federalism described in E.O. 13132. The rule does not
impose substantial direct costs or effects on States, does not alter
the relationship between States and the Federal government, and does
not alter the distribution of powers and responsibilities among the
various levels of government. States had the opportunity to comment on
any potential federalism implications during the proposed rule's
comment period. No States provided public comment on the federalism
implications of this rule. Therefore, AMS has concluded that this
rulemaking does not have federalism implications.
Executive Order 13175
Executive Order 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. Additionally, 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 also require
consultation. After consultation with the USDA Office of Tribal
Relations, AMS determined that a Tribal consultation for this
rulemaking was not necessary, as it was unlikely to impact Tribes. If a
Tribe requests consultation in the future, AMS will work with the
[[Page 104389]]
Office of Tribal Relations to ensure meaningful consultation is
provided.
Civil Rights Impact Analysis
AMS has reviewed this rulemaking in accordance with the
Departmental Regulation 4300-4, Civil Rights Impact Analysis, to
address any major civil rights impacts the rule might have on
minorities, women, and/or persons with disabilities. After a careful
review of the rule's intent and provisions, AMS determined there is no
evidence that this final rule will have adverse civil rights impacts on
organic producers identifying as minorities, women, and/or persons with
disabilities. Additionally, this final rule does not impose any
requirements related to eligibility for benefits and services on
protected classes, nor does the rule have the purpose or effect of
treating classes of persons differently.
Protected individuals have the same opportunity to participate in
NOP as non-protected individuals. USDA organic regulations prohibit
discrimination by certifying agents. Specifically, 7 CFR 205.501(d) of
the current regulations for accreditation of certifying agents provides
that ``No private or governmental entity accredited as a certifying
agent under this subpart shall exclude from participation in or deny
the benefits of the National Organic Program to any person due to
discrimination because of race, color, national origin, gender,
religion, age, disability, political beliefs, sexual orientation, or
marital or family status.'' Paragraph 205.501(a)(2) requires certifying
agents to ``[d]emonstrate the ability to fully comply with the
requirements for accreditation set forth in this subpart,'' including
the prohibition on discrimination. The granting of accreditation to
certifying agents under Sec. 205.506 requires the review of
information submitted by the certifying agent and an on-site review of
the certifying agent's client operation. Further, if certification is
denied, Sec. 205.405(d) requires that the certifying agent notify the
applicant of their right to file an appeal to the AMS Administrator in
accordance with Sec. 205.681.
These regulations provide protections against discrimination,
thereby permitting all producers, regardless of race, color, national
origin, gender, religion, age, disability, political beliefs, sexual
orientation, or marital or family status, who voluntarily choose to
adhere to the rules and qualify, to be certified as meeting NOP
requirements by an accredited certifying agent. This action in no way
changes any of these protections against discrimination.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3521) (PRA), AMS is requesting OMB approval for a new information
collection totaling 2,371 hours for the reporting and recordkeeping
requirements contained in this final rule. OMB previously approved
information collection requests (ICR) associated with the NOP and
assigned OMB control number 0581-0191. AMS intends to merge this new
information collection, upon OMB approval, into the previously approved
collection request (OMB control number 0581-0191). Below, AMS describes
and estimates the annual burden (i.e., the amount of time and cost of
labor) for entities to prepare and maintain information to participate
in the voluntary labeling program. OFPA, as amended, provides authority
for this action.
Title: National Organic Program: Market Development for Mushrooms
and Pet Food.
OMB Control Number: 0581-0347.
Expiration Date of Approval: Three years from OMB date of approval.
Type of Request: New collection.
Abstract
Information collection is necessary to implement the reporting
requirements for organic mushroom production and pet food handling
under the USDA organic regulations (7 CFR 205.210 and 205.270). This
final rule establishes USDA organic requirements in the mushroom and
pet food sectors to support consistent interpretation and remove
regulatory uncertainty. By doing so, it supports the purposes of OFPA,
namely, ``to establish national standards'' for products marketed as
organic and ``to assure consumers that organically produced products
meet a consistent standard.'' (7 U.S.C. 6501). Additional information
on the purpose and need for this rule is included in the BACKGROUND
section of this rule.
Overview
Information collection and recordkeeping will be required to
demonstrate compliance with new provisions in Sec. 205.210 and
amendments to Sec. 205.270 of the USDA organic regulations, 7 CFR part
205, that establish standards for mushroom production and pet food
handling. These amendments will require one-time additional reporting
for already certified pet food and mushroom operations, accredited
certifying agents, and inspectors. Existing organic mushroom and pet
food operations will need to read the rule and review their organic
system plans (OSPs) for compliance. Certifiers will have to read the
rule and review the updated plans, and certifiers and inspectors will
require training on the new regulation.
Additionally, the final rule adds allowances for nonorganic plant
materials to be used in mushroom substrate when functionally equivalent
organic materials are not commercially available. This allowance will
require additional documentation for organic mushroom operations. AMS
is estimating that organic mushroom operations will have annual
reporting and recordkeeping paperwork burdens to utilize this
exception. The estimates have been updated to reflect this change.
Burden Estimates
This burden estimate accounts for certified organic mushroom
operations and certified organic pet food operations updating OSPs,
mushroom operations verifying and keeping records of commercial
availability exceptions for organic substrate, certifiers reviewing
updated OSPs, and certifiers training inspectors to comply with the
final rule.
Number of Respondents: 519.
Frequency of Response: One time only and annual (for mushroom
operations).
Annual Hour Burden: 2,371 total hours; 1,219 one-time hours; 1,152
annual hours.
The 519 respondents include 322 certified organic operations (288
mushroom operations and 34 pet food operations), 56 certifying agents,
and 141 inspectors.
Table 3--Total Paperwork Burden
----------------------------------------------------------------------------------------------------------------
Total number of Total
Total reporting burden reporting Total reporting recordkeeping Total all
respondents hours--all hours--all costs
----------------------------------------------------------------------------------------------------------------
Summary of Tables 4, 5, & 6................... 519 1,795 576 $121,696.63
----------------------------------------------------------------------------------------------------------------
[[Page 104390]]
Certified Organic Operations
AMS estimates that 322 certified organic mushroom and organic pet
food operations may need to update their OSPs to comply with the final
rule.\49\
---------------------------------------------------------------------------
\49\ USDA. Organic Integrity Database. https://organic.ams.usda.gov/IntegrityPlus/Search.aspx. To obtain the
relevant data, search for ``mushroom'' and ``pet, dog, canine, cat,
feline'' in the ``Certified Products'' field. Accessed August 27,
2024.
---------------------------------------------------------------------------
AMS estimates that each certified organic mushroom and pet food
operation will require one response of two reporting hours to read the
rule and update their OSPs. AMS estimates that each respondent will
require no additional recordkeeping hours, as these operations already
have and store OSPs. This results in a total one-time hour burden of
644 hours for certified organic mushroom and pet food operations across
322 responses.
Because the rule allows organic mushroom operations to use
nonorganic plant inputs in mushroom substrate if an organic input of a
similar function is not commercially available, the operation must
verify and record if organic inputs of similar function are not
commercially available. AMS estimates that each operation will need to
verify and document inputs approximately two times a year. Each
verification will require one response of one reporting hour and one
recordkeeping hour. This results in a total annual hour burden of 1,152
hours for certified organic mushroom operations across 576 responses.
See table 4 below for a summary of these estimates for certified
organic operations.
Table 4--Certified Organic Operations
----------------------------------------------------------------------------------------------------------------
Wage \50\ \51\ + Total Total
Respondent categories Number of benefits \52\ reporting recordkeeping Total costs
respondents \53\ hours hours
----------------------------------------------------------------------------------------------------------------
USDA Certified Mushroom Producers & 268 $56.22 536 0 $30,134
Pet Food Handlers--Domestic (One-
time)..............................
USDA Certified Mushroom Producers & 54 42.22 108 0 4,560
Pet Food Handlers--Foreign (One-
time)..............................
USDA Certified Mushroom Producers-- 239 56.22 478 478 53,746
Domestic (Annual--Commercial
Availability)......................
USDA Certified Mushroom Producers-- 49 42.22 98 98 8,275
Foreign (Annual--Commercial
Availability)......................
---------------------------------------------------------------------------
USDA Organic Operations--All.... 322 ................ 1,220 576 96,715
----------------------------------------------------------------------------------------------------------------
Certifying Agents
AMS estimates that 56 certifying agents will need to review 322
OSPs from certified organic mushroom and pet food operations.
---------------------------------------------------------------------------
\50\ Domestic hourly wage rates are based on the National
Compensation Survey: Occupational Employment and Wages, May 2023,
published by the Bureau of Labor Statistics. Bureau of Labor
Statistics. ``May 2023 National Occupational Employment and Wage
Estimates.'' https://www.bls.gov/oes/current/oes_nat.htm. Accessed
August 27, 2024.
\51\ International wage rates are estimated based on the
proportional average of World Bank GDP per capita rates for
Organization for Economic Co-Operation and Development (OECD)
countries compared to the U.S. (72.2%). World Bank. ``GDP per
capita, PPP (current international $).'' https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD. Accessed August 27, 2024.
\52\ Domestic benefit rates are based on data from Bureau of
Labor Statistics News Release on Employer Costs for Employee
Compensation. Wages account for 70.3% and Benefits account for 29.7%
of total average employer compensation costs. Bureau of Labor
Statistics. (June 18, 2024). ``Employer Costs for Employee
Compensation Summary.'' https://www.bls.gov/news.release/ecec.nr0.htm. Accessed August 27, 2024.
\53\ International benefit rates are based on an average tax
wedge of OECD countries (34.9% of wage rates). OECD. ``OECD
comparative indicators.'' https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP. Accessed August 27, 2024.
---------------------------------------------------------------------------
AMS estimates that on average, certifying agents will require one
response of one reporting hour to review OSPs for each organic mushroom
and pet food operation they certify, resulting in a total of 322 hours
over 322 responses. Additionally, AMS estimates each certifying agent
will require one response of two hours to read the rule and provide
training to staff and inspectors on the new requirements. AMS estimates
that these are one-time burdens and each respondent requires no
additional reporting/recordkeeping hours as these operations already
review and store OSPs (the burden to review and store these is captured
under the existing ICR, OMB control number 0581-0191). This results in
a total one-time hour burden of 434 hours for certifying agents across
378 responses. See table 5 below for a summary of the estimates for
certifying agents.
[[Page 104391]]
Table 5--Certifying Agents
----------------------------------------------------------------------------------------------------------------
Wage \54\ \55\ + Total
Respondent categories Number of benefits \56\ reporting Total costs
respondents \57\ hours
----------------------------------------------------------------------------------------------------------------
USDA U.S.-Based Certifiers--Mushrooms................ 32 $50.00 303 $15,150
USDA Foreign-Based Certifiers--Mushrooms............. 10 37.54 69 2,590
USDA U.S.-Based Certifiers--Pet food................. 10 50.00 49 2,450
USDA Foreign-Based Certifiers--Pet food.............. 4 37.54 13 488
----------------------------------------------------------
USDA Certifiers--All............................. \58\ 56 ................ 434 20,678
----------------------------------------------------------------------------------------------------------------
Inspectors
---------------------------------------------------------------------------
\54\ Domestic hourly wage rates are based on the National
Compensation Survey: Occupational Employment and Wages, May 2023,
published by the Bureau of Labor Statistics. Bureau of Labor
Statistics. ``May 2023 National Occupational Employment and Wage
Estimates.'' https://www.bls.gov/oes/current/oes_nat.htm. Accessed
August 27, 2024.
\55\ International wage rates are estimated based on the
proportional average of World Bank GDP per capita rates for
Organization for Economic Co-Operation and Development (OECD)
countries compared to the U.S. (72.2%). World Bank. ``GDP per
capita, PPP (current international $).'' https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD. Accessed August 27, 2024.
\56\ Domestic benefit rates are based on data from Bureau of
Labor Statistics News Release on Employer Costs for Employee
Compensation. Wages account for 70.3% and Benefits account for 29.7%
of total average employer compensation costs. Bureau of Labor
Statistics. (June 18, 2024). ``Employer Costs for Employee
Compensation Summary.'' https://www.bls.gov/news.release/ecec.nr0.htm. Accessed August 27, 2024.
\57\ International benefit rates are based on an average tax
wedge of OECD countries (34.9% of wage rates). OECD. ``OECD
comparative indicators.'' https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP. Accessed August 27, 2024.
\58\ Some certifiers may certify both pet food and mushroom
operations but are counted as separate entities in this column.
---------------------------------------------------------------------------
AMS estimates that 141 organic inspectors will need to receive
training on the final rule.\59\
AMS estimates that each organic inspector will require one response
of one reporting hour to receive training on the final rule. AMS
estimates that each respondent will require no additional recordkeeping
hours. This results in a total annual hour burden of 141 hours for
organic inspectors across 141 responses. See table 6 below for a
summary of these estimates for inspectors.
---------------------------------------------------------------------------
\59\ This estimate is based on data from the International
Organic Inspectors Association (IOIA) Membership Directory,
available at https://www.ioia.net/member-directory. Based on
adjustments due to public comment (see ``Comments,'' below), AMS
estimates that half of inspectors are present in the IOIA Membership
Directory and adjusts the number of inspectors receiving training
proportionally by the percentage of certifiers certifying organic
mushroom or pet food operations.
\60\ Domestic hourly wage rates are based on the National
Compensation Survey: Occupational Employment and Wages, May 2023,
published by the Bureau of Labor Statistics. Bureau of Labor
Statistics. ``May 2023 National Occupational Employment and Wage
Estimates.'' https://www.bls.gov/oes/current/oes_nat.htm. Accessed
August 27, 2024.
\61\ International wage rates are estimated based on the
proportional average of World Bank GDP per capita rates for
Organization for Economic Co-Operation and Development (OECD)
countries compared to the U.S. (72.2%). World Bank. ``GDP per
capita, PPP (current international $).'' https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD. Accessed August 27, 2024.
\62\ Domestic benefit rates are based on data from Bureau of
Labor Statistics News Release on Employer Costs for Employee
Compensation. Wages account for 70.3% and Benefits account for 29.7%
of total average employer compensation costs. Bureau of Labor
Statistics. (June 18, 2024). ``Employer Costs for Employee
Compensation Summary.'' https://www.bls.gov/news.release/ecec.nr0.htm. Accessed August 27, 2024.
\63\ International benefit rates are based on an average tax
wedge of OECD countries (34.9% of wage rates). OECD. ``OECD
comparative indicators.'' https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP. Accessed August 27, 2024.
Table 6--Inspectors
----------------------------------------------------------------------------------------------------------------
Wage 60 61 + Total
Respondent categories Number of benefits 62 63 reporting Total costs
respondents hours
----------------------------------------------------------------------------------------------------------------
USDA U.S.-based Inspectors........................... 106 $32.53 106 $3,448
USDA Foreign based Inspectors........................ 35 $24.43 35 855
----------------------------------------------------------
USDA Inspectors--All............................. 141 ................ 141 4,303
----------------------------------------------------------------------------------------------------------------
Comments
AMS published a proposed rule and request for public comment in the
Federal Register on March 11, 2024 (89 FR 17322). The 60-day notice
regarding paperwork impacts is embedded in the proposed rule and
provides stakeholders an opportunity to comment on the accuracy of the
information collection request. The 60-day comment period ended on May
10, 2024. AMS asked four specific information collection request
questions in the proposed rule:
1. Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information would have practical utility.
2. The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used.
3. Ways to enhance the quality, utility, and clarity of the
information to be collected.
4. Ways to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology.
During the comment period, AMS received two comments (discussed
below) that provided feedback on the initial paperwork burden of the
rule.
(Comment) A comment stated that the number of inspectors estimated
by AMS in the proposed rule's paperwork burden was too low because the
directory of inspectors from the International Organic Inspectors
Association does not include non-
[[Page 104392]]
members or members that do not wish to share their information.
Additionally, the comment stated that the estimated wages were too low.
(Response) AMS has adjusted the estimated number of total
inspectors based on this comment. Absent specific data, we assume that
the IOIA database contains half (50 percent) of all inspectors,
changing our total number from 185 inspectors present in the IOIA
database as of August 27, 2024, to 370 inspectors. AMS acknowledges
that without specific input this estimate may be imprecise. To further
account for this adjustment and acknowledge that not all inspectors
will inspect the 288 mushroom or pet food facilities, AMS adjusted the
percentage of inspectors impacted by the paperwork costs to be
proportional to the percentage of certifiers that certify operations
for mushroom production or pet food handling.
AMS did not adjust the source for hourly wages in the burden
estimates for the final rule. AMS acknowledges that costs may be higher
for inspectors in some areas. However, without comprehensive data from
another source, AMS believes that the Bureau of Labor Statistics
estimates for wages remain the most accurate estimates for wages to use
in burden estimates.
(Comment) One comment argues the requirement in Sec. 205.210(b)
that mushroom operations manage substrate in such a way to avoid
environmental contamination may be duplicative with Sec. 205.203(c),
given that both would seem to apply to mushroom operations. On the
other hand, another comment states that reiterating the requirement for
mushroom operations is critical.
(Response) Paragraph 205.210(b) specifically adds requirements that
operations must prevent mushroom substrate and spawn media from
contaminating crops, spawn, mushroom substrate, soil, or water. AMS
acknowledges that this is similar to Sec. 205.203(c). However, the
regulatory text at Sec. 205.210(a) specifies the crop requirements
applicable to organic mushroom production and specifically excludes
Sec. 205.203(c) to prevent duplicative requirements. AMS is not
adjusting these requirements and finds them to be necessary and non-
duplicative.
List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agricultural commodities,
Agriculture, Animals, Archives and records, Fees, Imports, Labeling,
Livestock, Organically produced products, Plants, Reporting and
recordkeeping requirements, Seals and insignia, Soil conservation.
For the reasons set forth in the preamble, the Agricultural
Marketing Service amends 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. 205.2 by:
0
a. Revising the definitions of ``Compost'' and ``Crop'';
0
b. Adding in alphabetical order definitions for ``Mushroom'',
``Mushroom Mycelium'', ``Mushroom spawn'', ``Mushroom spawn media'',
``Mushroom substrate'', ``Pet'', and ``Pet food''; and
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c. Revising the definition of ``Wild crop''.
The revisions and additions read as follows:
Sec. 205.2 Terms defined.
* * * * *
Compost. The product of a managed process through which
microorganisms break down plant and animal materials into more
available forms suitable for application to the soil or as a component
of mushroom substrate.
* * * * *
Crop. Pastures, cover crops, green manure crops, catch crops,
mushrooms, or any plant or part of a plant intended to be marketed as
an agricultural product, fed to livestock, or used in the field to
manage nutrients and soil fertility.
* * * * *
Mushroom. The fleshy, spore-bearing fruiting body of a fungus.
Mushroom mycelium. A mass of branching, thread-like hyphae (fungal
structures).
Mushroom spawn. Mushroom spawn media colonized by mushroom mycelium
that can be used to inoculate mushroom substrate.
Mushroom spawn media. The base material, such as grain, wood
materials, or minerals, used to make mushroom spawn.
Mushroom substrate. The base material, such as grain, wood
materials, composted materials, and/or other agricultural materials, on
which mushroom production occurs.
* * * * *
Pet. Any domestic animal not used for the production and sale of
food, fiber, or other agricultural-based consumer products.
Pet food. Any commercial feed prepared and distributed for pet
consumption.
* * * * *
Wild crop. Any mushroom, plant, or portion of a plant that is
collected or harvested from a site that is not maintained under
cultivation or other agricultural management.
* * * * *
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3. Add Sec. 205.210 to read as follows:
Sec. 205.210 Mushroom production practice standard.
(a) The producer must manage mushroom production in accordance with
the provisions of Sec. Sec. 205.200, 205.201, 205.202 as applicable,
205.203(e), and 205.206(a)(2) and (3) and (b) through (f). The producer
may manage crop nutrients for mushroom production in accordance with
the provisions of Sec. 205.203(d).
(b) The producer must manage mushroom substrate and mushroom spawn
media, including spent mushroom substrate and mushroom spawn media, in
a manner that does not contribute to contamination of crops, mushroom
spawn, mushroom substrate, soil, or water by pathogenic organisms,
heavy metals, or residues of prohibited substances.
(c) Mushroom substrate may be composed of the following materials
in accordance with the conditions specified in this paragraph:
(1) Composted plant and animal materials. Compost used in mushroom
substrate must be described in the organic system plan. It must be
produced through a process that maintains a temperature of at least 131
[deg]F for at least three days;
(2) Uncomposted plant materials. Uncomposted plant materials must
be organically produced: Except, that, nonorganically produced
uncomposted plant materials may be used when a functionally equivalent
organically produced material is not commercially available. Prohibited
substances must not be applied to nonorganically produced uncomposted
plant materials after harvest. Operations that use nonorganically
produced uncomposted plant materials in mushroom substrate (except for
wood materials allowed under paragraph (c)(3) of this section) must
describe in the organic system plan:
(i) The procedures used to search for organic materials and the
records kept to document searches;
(ii) The criteria used to evaluate if functionally equivalent
organic materials are commercially available; and
[[Page 104393]]
(iii) The recordkeeping system used to document purchases of
nonorganic materials, including a summary of the type(s) and total
amount of each nonorganic material used in mushroom substrate.
(3) Wood chips, sawdust, logs, or other materials derived from wood
that have not been treated with a prohibited substance after harvest;
(4) Nonsynthetic substances, except those on the National List of
nonsynthetic substances prohibited for use in organic crop production
(Sec. 205.602); and
(5) Synthetic substances on the National List of synthetic
substances allowed for use in organic crop production (Sec. 205.601).
(d) Mushroom spawn must be organic: Except, that, nonorganic
mushroom spawn may be used to produce an organic crop when an
equivalent organic mushroom spawn is not commercially available.
(1) Organic mushroom spawn requirements.
(i) Agricultural materials used as mushroom spawn media must be
organic: Except, that, nonorganic wood materials in compliance with
paragraph (c)(3) of this section are allowed.
(ii) Mushroom spawn media may contain materials allowed in mushroom
substrate at paragraphs (c)(1), (4), and (5) of this section.
(iii) Organic mushroom spawn must be under continuous organic
management after the mycelium is applied to the mushroom spawn media.
(2) Organic mushroom operations that produce their own mushroom
spawn for their own organic mushroom production must use organic
agricultural materials for mushroom spawn media, unless a functionally
equivalent organic agricultural material is not commercially available:
Except that, wood materials in compliance with paragraph (c)(3) of this
section are allowed.
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4. Amend Sec. 205.270 by adding paragraph (d) to read as follows:
Sec. 205.270 Organic handling requirements.
* * * * *
(d) In addition to the substances described in paragraph (b) of
this section, substances allowed under Sec. 205.603(d)(2) and (3) may
be used in or on pet food intended to be sold, labeled, or represented
as ``organic'' or ``made with organic (specified ingredients or food
group(s)),'' pursuant to Sec. 205.301(b) and (c). Pet food must be
labeled pursuant to subpart D of this part.
0
5. Amend Sec. 205.601 by revising paragraphs (i) introductory text and
(j) introductory text to read as follows:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
* * * * *
(i) As crop disease control.
* * * * *
(j) As crop or soil amendments.
* * * * *
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6. Amend Sec. 205.605 by redesignating paragraphs (b)(36) and (37) as
paragraphs (b)(37) and (38), respectively and adding new paragraph
(b)(36) to read as follows:
Sec. 205.605 Nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).''
* * * * *
(b) * * *
(36) Taurine--for use only in pet food.
* * * * *
Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2024-30211 Filed 12-20-24; 8:45 am]
BILLING CODE P