[Federal Register Volume 89, Number 48 (Monday, March 11, 2024)]
[Proposed Rules]
[Pages 17322-17338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04973]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 89, No. 48 / Monday, March 11, 2024 /
Proposed Rules
[[Page 17322]]
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: Proposed rule.
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SUMMARY: The United States Department of Agriculture (USDA)
Agricultural Marketing Service (AMS) proposes to amend the USDA organic
regulations to clarify standards for organic mushrooms and organic pet
food. Specific standards for these products do not currently exist.
Instead, these products have been certified organic using the general
organic standards for crops, livestock, and handling. However, this
approach is not ideal as the current regulations do not address unique
aspects of either product. AMS expects this rule would promote
development of these markets by increasing regulatory certainty that
would, in turn, encourage investment in the markets. The topics
addressed by the proposed rule include sourcing of substrate and 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 in organic pet
food.
DATES: Electronic or written comments on the proposed rule must be
submitted by May 10, 2024.
ADDRESSES: You may submit electronic comments on this proposed rule
through the Federal eRulemaking Portal at https://www.regulations.gov
(docket number AMS-NOP-22-0063). Instructions for submitting electronic
comments are available at https://www.regulations.gov. Comments may
also be sent by mail to: Erin Healy, Director, Standards Division,
National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW, Room
2642-So., Ag Stop 0268, Washington, DC 20250-0268.
Instructions: All comments should include the docket number (AMS-
NOP-22-0063), and/or the Regulatory Information Number (RIN 0581-AE13)
for this rulemaking. You should clearly indicate the topic and section
number of this proposed rule to which your comment refers, state your
position(s), offer any recommended language change(s), and include
relevant information and data to support your position(s) (e.g.,
scientific, environmental, manufacturing, industry, or industry impact
information, etc.). All comments and relevant background documents
posted to https://www.regulations.gov will include any personal
information provided.
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. Executive Summary
A. Purpose and Need for the Rule
B. Summary of Provisions
II. General Information
A. Does this proposed rule apply to me?
B. What should I consider as I prepare my comments for AMS?
III. Background
A. Purpose and Need for the Rule
B. NOSB Recommendations on Mushrooms and Pet Food
C. Community and Stakeholder Feedback
D. Authority
IV. Organic Mushroom Standard
A. Mushroom Background
B. Need for Organic Mushroom Standard
C. Overview of Proposed Amendments
V. Organic Pet Food Standard
A. Pet Food Background
B. Need for Organic Pet Food Standard
C. Overview of Proposed Amendments
VI. 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. Executive Summary
A. Purpose and Need for the Rule
This proposed rule would amend the USDA organic regulations to
establish specific standards for organic mushroom production and
organic pet food handling. Specific standards are necessary to resolve
inconsistency and uncertainty in these two markets. AMS is addressing
standards for pet food and mushrooms together in this rule because both
markets are currently hampered by the lack of specific regulations that
are suitable for these particular products. Both markets exhibit
inconsistent interpretations of the organic regulations by certifiers
and uncertainty around regulatory requirements that are likely to deter
investments in the sectors. In addition, the National Organic Standards
Board (NOSB) has made recommendations to revise the regulations for
these organic products, and these changes are supported by the organic
industry. Finally, both organic mushrooms and pet food are developing
markets that would benefit from clearer standards to facilitate and
promote growth.
The organic regulations do not currently include standards specific
to mushrooms and pet food. Although some mushrooms and pet food
products are currently being certified using the general organic
standards, the current regulations are an imperfect fit for both
mushroom and pet food production and do not address unique aspects of
either product. For example, some certifying agents use the current
crop production standards to certify organic mushrooms or the handling
standards for processed products to certify organic pet food. In both
cases, certifying agents and operations extrapolate from the organic
standards to fit organic mushroom and pet food production. This creates
varying and inconsistent interpretations of the organic regulations,
such that some mushroom producers are required to use organic inputs
where others are not, and some pet food manufacturers are allowed to
use slaughter by-products where others are not. The inconsistent
certification and enforcement practices for organic mushrooms and pet
food fail to meet one of the purposes of the Organic Food Production
Act (OFPA), that is, to assure consumers that organically produced
products meet a consistent standard (7 U.S.C. 6501(2)).
[[Page 17323]]
Additionally, the National Organic Program (NOP) has received
feedback from stakeholders that the lack of specific standards for
mushrooms and pet food creates uncertainty that may deter development
in these markets. Clearer and more specific standards would give
businesses certainty about how they should produce organic mushrooms
and pet food, which would create the conditions necessary for the
growth of the organic mushroom and pet food markets. Addressing
uncertainty and inconsistency in organic mushroom and pet food
production is important for market development. Ensuring consistent
standards across the organic industry also protects the integrity of
the organic seal by building customer trust in the label.
B. Summary of Provisions
Through the amendments in this proposed rule, AMS would establish
standards for organic mushroom production and pet food handling. The
proposed rule would:
Add the term ``mushroom'' to the definitions of ``crop''
and ``wild crop;''
Establish definitions for ``mushroom,'' ``mushroom
substrate,'' ``mycelium,'' ``spawn,'' and ``spawn media;''
Create a new section titled Mushroom Production Practice
Standard;
Require that operations use organic mushroom spawn and
substrate when commercially available;
Add mushroom-specific requirements for organic compost
production;
Establish definitions for ``pet'' and ``pet food'' for the
purposes of the USDA organic regulations only;
Add a new paragraph to the organic handling standard
describing the requirements for production and labeling of pet food,
including composition (what can be included in organic pet food) and
labeling requirements; and
Add synthetic taurine (an amino acid) to the National List
to allow its use in organic pet food.
II. General Information
A. Does this proposed rule apply to me?
You may be affected by this proposed rule if you are engaged in
organic mushroom production or pet food handling. Potentially affected
entities may include, but are not limited to, the following:
Organic pet food manufacturers;
Organic mushroom producers;
Individuals or business entities that are considering
organic certification for pet food or mushrooms;
Existing livestock, mushroom, and handling operations that
are currently certified organic under the USDA organic regulations; and
USDA-accredited certifying agents, 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. What should I consider as I prepare my comments for AMS?
AMS seeks comment from the public and organic stakeholders
regarding the proposed amendments, especially on the following topics:
1. Is the regulatory language and accompanying discussion in this
document clear enough to allow producers, handlers, and certifying
agents to comply with the proposed requirements?
2. Do the proposed amendments create any conflict with current
organic regulations?
3. Would a one-year implementation period (from the effective date
of a final rule) be appropriate for affected operations to comply with
these proposed changes? If not, what timeframe would be appropriate?
4. Are there any concerns about the proposed requirements for
compost used in organic mushroom operations? Are there any additional
health and sanitary issues that AMS has not considered? Would the
proposed requirements hinder any current methods of substrate
preparation? Would the proposed changes impact other organic sectors
and if so, how?
5. Are there any concerns about the proposed requirements for
producing certified organic spawn? What are the barriers to producing
certified organic spawn for mushroom production? How would this rule
affect these barriers?
6. Stakeholders and data indicate that many organically produced
mushrooms are sold as conventional mushrooms. Why are certified organic
mushroom operations producing significantly more organic mushrooms than
they are selling as certified organic? What could be included in this
rule to help ensure that mushrooms that are produced organically can be
sold as organic?
7. What factors have kept pet food manufacturers from seeking
organic certification? Are there barriers that the proposed rule does
not address?
8. Are there any additional synthetic, nonsynthetic, or nonorganic
substances required in pet food to meet pet health needs that are not
included in the proposed rule?
9. Are slaughter by-products commonly used in organic pet food? Are
there obstacles to greater use of organic slaughter by-products in
organic pet food? Is there existing data on the organic slaughter by-
product market utilization and prices?
III. Background
A. Purpose and Need for the Rule
This proposed rule would amend 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. Based on market penetration data and
feedback from stakeholders, AMS believes that removing regulatory
uncertainty as a barrier will create conditions that offer a reasonable
expectation for growth in these two markets and other latent markets
that support them, such as mushroom substrate and organic slaughter by-
products.
New rulemaking is needed because the current organic regulations do
not include standards specific to mushrooms and pet food. Some
certifying agents certify organic mushrooms using the current crop
production standards and some certify pet food using a combination of
livestock feed standards and handling standards for processed products;
however, the current regulations do not address the unique needs of
either product. The current crop production standards are intended
primarily for plant production and do not fully address the unique
biology of mushrooms. This is because mushrooms are fungi, not plants,
and have different production practices and materials requirements.
Plants are usually grown outdoors and photosynthesize energy from the
sun; however, mushrooms are most commonly grown in indoor, controlled
environments and draw energy from substrate material. These biological
and production differences mean the organic crop production standards
do not always fit mushrooms well. Certifier requirements are
[[Page 17324]]
currently inconsistent, and producers may be inconsistently applying
the organic standards to aspects such as substrate, spawn, and compost
for mushroom production.
Similarly, the current organic regulations do not address pet food.
Producers and certifiers apply a combination of the handling standards
for processed products and the organic livestock feed standards, but
their practices are not uniform. The handling standards are appropriate
for verifying the processing, handling, product composition, and
labeling requirements for multi-ingredient processed agricultural
products but lack specific allowances for nutrients that are necessary
for pets. The livestock feed standards include allowances for many of
those nutrients but include prohibitions on common pet food
ingredients, such as slaughter by-products. Slaughter by-products
(e.g., animal and poultry by-product meal; animal liver) make up
approximately 23 percent of the composition of conventional pet food,
in part to meet protein levels required by federal and state
regulations on pet food.\1\ Applying the livestock feed regulations to
organic pet food production inhibits the market for organic slaughter
by-products. These contradictions create uncertainty for businesses
that currently produce organic pet food and are a barrier to businesses
that would like to produce organic pet food or sell slaughter by-
products into that market. AMS estimates that this rule could ensure
consistent demand for over 14 million pounds of organic meat and
organic slaughter by-products annually, with approximately half of that
demand being for organic slaughter by-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 specific rules.
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\1\ Institute for Feed Education & Research. (March 2020). ``Pet
food production and ingredient analysis.''
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This rule would also address feedback from the organic industry,
which has asked USDA to implement NOSB recommendations more generally,
including implementing standards for these two products. AMS hosted a
virtual prioritization listening session in spring 2022. Oral and
written comments encouraged AMS to prioritize rulemaking for additional
practice standards, including organic pet food and mushrooms. The
proposed 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.
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 2021,
sales of organic fruits and vegetables accounted for a 15.5 percent
share of all fruit and vegetable sales in the United States,\2\ but
organic mushrooms only accounted for 10.8 percent of all mushroom
sales.\3\ Considering that the consumer experience of purchasing
mushrooms is typically no different than 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 0.41 percent of all pet food sales, whereas
sales of organic non-food products (the closest analog to pet food, as
a product that is purchased not for humans to eat) accounted for 1.2
percent of all non-food sales.\4\
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\2\ Organic Trade Association. (2022). Organic Industry Survey.
p. 56. Note that AMS uses the 2021 data available in the Organic
Trade Association's 2022 survey because that was the data available
while our economic analysis was under development. The 2022 data
(released in May 2023), however, also demonstrates lagging market
penetration: Mushroom sales lagged the 14.9 percent share that
organic fruits and vegetables claimed, and organic pet food
accounted for only 0.38 percent of all pet food sales.
\3\ USDA, National Agricultural Statistics Service, Agricultural
Statistics Board. (August 26, 2022). ``Mushrooms.'' https://www.nass.usda.gov/Publications/Todays_Reports/reports/mush0822.pdf.
\4\ Organic Trade Association. (2022). Organic Industry Survey.
p. 5.
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In short, 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 would 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 slaughter by-products.
Because mushrooms and pet food have unique growing conditions and
requirements, AMS provides additional discussion of the need for
organic standards in each industry in their respective sections below
(see ``IV. Mushrooms, B. Need for Organic Mushroom Standard'' and ``V.
Pet Food, B. Need for Organic Pet Food Standard'').
B. NOSB Recommendations on Mushrooms and Pet Food
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 \5\ and again in October 2001.\6\
Subsequently, the NOSB made a recommendation on organic pet food
standards in November 2008,\7\ and in April 2013, the NOSB proposed
amending the National List to allow taurine for use in pet food.\8\
This proposed rule is AMS's first rulemaking action related to these
recommendations; we discuss the NOSB's recommendations below.
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\5\ NOSB. (April 24-28, 1995). ``Final minutes of the National
Organic Standards Board full board meeting.'' http://www.dairyprogramhearing.com/getfile32e532e5.pdf?dDocName=STELPRDC5057442.
\6\ USDA, AMS. ``NOSB recommendations: Fall 2011.'' Accessed May
8, 2023. https://www.ams.usda.gov/rules-regulations/organic/nosb/recommendations/fall2001.
\7\ The NOSB's November 2008 recommendation on organic pet food
is available online at: https://www.ams.usda.gov/rules-regulations/organic/nosb/recommendations/fall2008.
\8\ USDA, NOP. (April 2013). ``The Organic Integrity
Quarterly.'' https://www.ams.usda.gov/sites/default/files/media/NOP%202013%20April%20Newsletter.pdf.
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NOSB Recommendations on Mushroom Production
In 2001, the NOSB recommended:
Preventing contact between organically produced mushrooms
or mushroom growth substrates and prohibited substances;
Requiring the use of organic spawn when commercially
available;
Requiring organically produced agricultural materials in
mushroom substrate; and
Allowing nonorganic wood products (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.
AMS investigated rulemaking following this recommendation but did
not publish a proposed rule.
[[Page 17325]]
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.\9\ The
NOSB recommended:
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\9\ NOSB. (November 19, 2008). ``Formal recommendation by the
National Organic Standards Board (NOSB) to the National Organic
Program (NOP).'' https://www.ams.usda.gov/sites/default/files/media/NOP%20Final%20Rec%20Pet%20Food.pdf.
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Clarifying which animals the pet food requirements would
apply to by defining ``pets'' in the regulations;
Labeling 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;
Clarifying that organic slaughter by-products can be a
component of organic pet food; and
Adding taurine for use in pet food to the National List of
allowed synthetic substances.\10\
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\10\ 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:
National Organic Standards Board (NOSB) to: the National Organic
Program (NOP).'' https://www.ams.usda.gov/sites/default/files/media/NOP%20Livestock%20Final%20Rec%20Pet%20Food%20Amino%20Acid%20amended.pdf.
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This proposed rule is the first rulemaking action from AMS to
address these recommendations on organic pet food.
C. Community and Stakeholder Feedback
When developing this proposed 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.\11\ During the listening session, many
stakeholders asked that AMS prioritize rulemaking for products that are
currently being certified without standards specific to their unique
production categories. This includes mushrooms and pet food. Several
stakeholders specifically suggested developing mushroom standards and
noted that existing crop standards, including compost requirements, are
not appropriate for mushroom production. Similarly, some commenters
discussed the importance of establishing consistent pet food standards,
naming it as another product currently being certified without
standards specific to its unique production demands.
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\11\ 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. These discussions
affirmed that specific standards for the production and handling of
organic mushrooms are needed. These industry stakeholders stated that
recognizing mushrooms as a fungal crop cultivated under unique and
specialized conditions would foster greater consistency in how organic
mushrooms are cultivated and certified. AMS also learned what aspects
of mushroom production need mushroom-specific requirements: compost
requirements, origin and composition of substrate materials used for
growing mushrooms, and origin and composition of spawn.
Discussions with experts in the pet food industry revealed that the
key challenge with labeling pet food as organic is uncertainty around
the allowance of certain ingredients. For example, under the current
organic regulation, it is unclear if pet food manufacturers may use
meat (e.g., edible part of animal muscle and organs) or slaughter by-
products (e.g., animal and poultry by-product meal; animal liver) in
organic pet food, and whether some necessary synthetic ingredients in
pet food, such as taurine, are allowed. Inconsistencies in organic
claims on pet food can also contribute to consumer uncertainty or
mistrust of organic labels. Additionally, stakeholders have noted that
allowing organic slaughter by-products in organic pet food would 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 7 million pounds of
organic slaughter by-products annually, which is likely to grow over
time.\12\
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\12\ 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 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 incorporates several NOSB recommendations
and stakeholder feedback to address the need for specific standards for
mushrooms and pet food. Adding these specific standards is expected to
support the development of organic markets for these industries by
reducing uncertainty among certifiers, consumers, producers, and
manufacturers.
D. Authority
The Organic Foods Production Act of 1990 (OFPA) \13\ authorizes the
USDA to promulgate regulations to establish an organic certification
program for producers and handlers of agricultural products (7 U.S.C.
6503(a)). This proposed rule would establish new production and
certification standards for two products that currently lack specific
standards. This proposed rule would, in turn, support 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). The proposed rule would clarify how producers and
certifiers should interpret existing organic regulations as they
pertain to mushroom or pet food production, which would assure
consumers that the organic label on these products guarantees a
consistent standard. The proposed rule would assure producers that they
operate in a fair and competitive environment with clear rules that all
must follow.
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\13\ 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 proposed rule. This document is
available at: https://uscode.house.gov/view.xhtml?path=/prelim@title7/chapter94&edition=prelim.
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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) \14\ and were first
implemented on October 21,
[[Page 17326]]
2002.\15\ Through these regulations, AMS oversees national standards
for the production, handling, labeling, and sale of organically
produced agricultural products.
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\14\ 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.
\15\ 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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IV. Organic Mushroom Standard
A. Mushroom Background
Mushroom Biology and Production
Mushrooms are the fleshy, spore-bearing, fruiting body of some
species of fungus. Mushrooms grow from mycelium, which grows below the
surface as a root-like network of cells. Commercial mushrooms are grown
from spawn, a combination of mycelium and a media (like grains or
minerals to carry the mycelium), in controlled indoor environments. In
commercial mushroom production, spawn is introduced onto mushroom
substrate to grow mushrooms, comparable to how seeds are planted to
grow crops.
The mushroom lifecycle is a circular phenomenon that cultivators
seek to mimic. In this cycle, spores germinate and then produce hyphae
that form mycelium. Mycelium grows by consuming nearby organic material
in the cropping container substrate. Fruiting (i.e., formation of
mushrooms) occurs when particular conditions are met, such as when the
mycelium is well developed, and the humidity and temperature conditions
are favorable. The fruiting bodies (i.e., the mushrooms) then create
more spores to continue the cycle.
Mushroom growers use spawn--a small amount of material with
mycelium growing on it--to produce mushrooms. Spawn can be compared to
plant seeds in an agricultural setting; however, an important
distinction is that spawn lacks the energy storage of a seed. Seeds
store energy to use during germination, whereas spawn must draw energy
from substrate materials such as compost. Because of this dependence on
the production substrate and the fact that spawn consumes the
substrate, the materials used in it are an important part of the
composition and growth of the mushrooms.
Mushroom substrate is generally made of composted and/or
uncomposted materials, depending on the species of mushroom, and may
contain grain, wood, vermiculite, or other ingredients. In mushroom
production, inoculation refers to the introduction of spawn to mushroom
substrate. Inoculation methods vary depending on the species of
mushroom and the mushroom substrate material it grows on. Mycelium
grows within the production substrate after it is inoculated,
ultimately producing mushrooms. Depending on the type of mushroom,
producers may sometimes harvest multiple crops of mushrooms from one
batch of inoculated substrate. Once the production cycle is complete
and mushrooms are harvested, a new batch of inoculated mushroom
substrate is generally needed to produce a new batch of mushrooms.
The U.S. Mushroom Market
For the 2021-2022 growing season, the U.S. mushroom crop volume was
702 million pounds with sales of $1.02 billion.\16\ The Agaricus
bisporus species of mushrooms accounted for approximately 97 percent of
the total sales volume and approximately 93 percent of the total
value.\17\ 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, and others. Some of these
specialty mushrooms include foraged (wild) mushrooms and specialty
mushrooms that are intentionally cultivated outdoors. In 2021, 10.8
percent of all mushrooms produced were sold as organic, compared to
15.5 percent of all fruits and vegetables.18 19 Agaricus
mushrooms accounted for approximately 82 percent of the total
production volume of organic mushrooms; the remainder were specialty
mushrooms.\20\
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\16\ USDA, National Agricultural Statistics Service,
Agricultural Statistics Board. (August 26, 2022). ``Mushrooms.''
https://www.nass.usda.gov/Publications/Todays_Reports/reports/mush0822.pdf.
\17\ USDA, National Agricultural Statistics Service,
Agricultural Statistics Board. (August 26, 2022). ``Mushrooms.'' .
https://www.nass.usda.gov/Publications/Todays_Reports/reports/mush0822.pdf.
\18\ Organic Trade Association. 2022 Organic Industry Survey. p.
56. https://ota.com/market-analysis/organic-industry-survey/organic-industry-survey.
\19\ USDA, National Agricultural Statistics Service,
Agricultural Statistics Board. (August 26, 2022). ``Mushrooms.''
https://www.nass.usda.gov/Publications/Todays_Reports/reports/mush0822.pdf.
\20\ USDA, National Agricultural Statistics Service,
Agricultural Statistics Board. (August 26, 2022). ``Mushrooms.''
https://www.nass.usda.gov/Publications/Todays_Reports/reports/mush0822.pdf.
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B. Need for Organic Mushroom Standard
This proposed rule would create specific standards for organic
mushroom production to promote consistency, fair competition, and
market growth. As of June 2023, at least 39 certifying agents certify
272 organic mushroom operations.\21\ However, the lack of mushroom-
specific standards means there is significant variation in how these
operations are certified. About 75 percent of certifying agents that
oversee organic mushroom production use the organic regulations' crop
standards to certify mushrooms, and the remaining 25 percent either
follow the NOSB's recommendations on mushrooms, or other standards such
as those of the European Union. More specifically, some certifying
agents require mushroom substrate to be organic, and some do not.
Likewise, some certifying agents require spawn to be organic, and some
do not.
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\21\ 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.
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A key challenge is that the organic crop standards are designed for
terrestrial plants, while mushrooms are the fruiting bodies of fungi--a
different kingdom of organisms. Fungi require different growing
conditions than plants. Mushrooms are grown from spawn, not seed.
Generally, mushrooms are not grown in soil like plants; they are grown
in substrate material made of composted plant material, minerals,
sawdust, and/or logs. Finally, mushrooms do not photosynthesize like
plants; they absorb compounds from their environment to use as sources
of energy.
The current organic regulations do not address the unique
biological differences noted above. Specifically, the regulations lack
detail and requirements for spawn, substrate, and compost used in
organic production. Consequently, certifying agents have developed
their own policies about spawn, substrate, and compost in mushroom
production, leading to variation in how organic mushrooms are certified
and creating confusion around what practices operations should use. The
absence of consistent standards also creates an uneven playing field
and encourages ``certifier shopping''--as operations learn about
discrepancies,
[[Page 17327]]
they may pressure their certifier to change their interpretation of the
standards or switch to another certifier.
Unfair competition caused by different interpretations of the
organic mushroom standards, as well as the possibility of future
regulatory changes, could reduce the willingness of businesses to
invest in this sector. AMS aims to address these problems by developing
one clear standard for organic mushroom production. Certifying agents
would have clear rules to follow and competition among operations would
be fairer. This would give businesses greater confidence in the
stability of the industry and would encourage them to invest in organic
mushroom growing operations and organic mushroom inputs.
C. Overview of Proposed Amendments
This proposed rule would amend the USDA organic regulations (7 CFR
part 205) by adding new provisions for producing mushrooms that are
sold, labeled, or represented as organic. This action would prescribe
consistent standards for producers of organic mushrooms, as detailed
below.
Table 1--Overview of Proposed Regulatory Changes To Establish Organic
Mushroom Production Standard
------------------------------------------------------------------------
Section title Type of action Proposed action
------------------------------------------------------------------------
205.2......................... Adds new terms... Mushroom; Mushroom
substrate; Mycelium;
Spawn; Spawn media.
205.2......................... Amends existing Compost; Crop; Wild
terms. crop.
205.210....................... Adds new section. Adds mushroom-
specific standards
to Subpart C.
205.601....................... Amends language Replaces the term
at (i)-(j). ``plant'' with the
term ``crop''.
------------------------------------------------------------------------
Sec. 205.2 (Terms Defined)
AMS proposes to amend Sec. 205.2 by adding five new terms
(``mushroom,'' ``mushroom substrate,'' ``mycelium,'' ``spawn media,''
and ``spawn'') and revising three existing terms (``compost,''
``crop,'' and ``wild crop''), as described below.
1. Mushroom
AMS proposes to define ``mushroom'' as the fruiting body of a
fungus. The term ``mushroom'' is primarily used to describe the
agricultural product that consumers purchase.
2. Mushroom Substrate
AMS proposes to define ``mushroom substrate'' as the base material
from which mushrooms are cultivated or grown. This substrate acts as a
media for fungus to grow on to produce mushrooms and provides the
energy and nutrients required for mushrooms to grow. This substrate may
be composed of composted material, uncomposted materials, or both, as
described under Sec. 205.210(c).
3. Mycelium
AMS proposes to define ``mycelium'' as a mass of branching, thread-
like hyphae (fungal structures). Mycelium is the main body portion of a
fungus from which mushrooms grow. In commercial mushroom production,
mycelium is also used to colonize or inoculate spawn media to produce
spawn and a subsequent crop of mushrooms.
4. Spawn Media
AMS proposes to define ``spawn media'' as a carrier, such as grains
or minerals, that, when colonized with fungal mycelium, creates spawn.
Spawn media, once combined with mycelium, is defined separately as
``spawn.'' Grain, sawdust, and vermiculite are common ingredients in
spawn media.
5. Spawn
AMS proposes to define ``spawn'' as spawn media that has been
colonized by fungal mycelium, which is used to inoculate mushroom
substrate (i.e., mushrooms are not harvested from spawn). Spawn, a
combination of mycelium and spawn media, is used to inoculate mushroom
substrate. Mushrooms grow from mushroom substrate after spawn is
applied to (and inoculates) the mushroom substrate.
6. Compost
AMS proposes to simplify the definition of ``compost'' so that the
definition would cover compost for use in mushroom production. The
current definition of ``compost'' includes compost production
requirements (e.g., minimum time and temperature) that are specific to
plant production. However, compost for mushroom production is typically
made using lower temperatures and shorter timeframes. The current
definition of compost, with its plant production-specific details, is
therefore not ideal for producers who need to create or use compost for
mushroom production.
This rulemaking proposes to remove the plant production-specific
composting requirements from the current definition of compost and add
``or substrate'' to the end of the definition. This leaves a general
definition that allows the production of compost that meets the
specific needs of either plants or mushrooms: 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 substrate. Plant production-specific composting requirements
remain in the regulation at Sec. 205.203(c)(2)--Soil fertility and
crop nutrient management practice standard. This rule also adds
mushroom-specific composting requirements, as described below in the
section titled Mushroom production practice standard (Sec. 205.210).
7. Crop and Wild Crop
AMS proposes to amend the terms ``crop'' and ``wild crop'' to
include mushrooms. AMS proposes to include mushrooms in these
definitions to clarify that operations may use certain crop production
standards in subpart C to produce mushrooms.
Sec. 205.210 (Mushroom Production Practice Standard)
AMS proposes to add a new section (Sec. 205.210) to the USDA
organic regulations to describe production practice standards for
organic mushrooms. Many of the existing production requirements in
subpart C can be applied to mushroom production. However, because of
their unique biology, mushroom production demands certain practices
that are different from plant production. This new section clarifies
which of the existing crop production requirements a mushroom producer
should use and adds several mushroom-specific requirements.
AMS proposes in Sec. 205.210(a) that mushroom operations must
manage their operations following most of the existing regulations
governing crop production, including Sec. Sec. 205.200, 205.201,
205.202 as applicable, 205.206(a)(2) and (3), and 205.206(b) through
(f). These sections cover general production requirements (Sec.
205.200); organic production and handling system plans (Sec. 205.201);
land requirements
[[Page 17328]]
(Sec. 205.202); and crop pest, weed, and disease management (Sec.
205.206). 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.
Because mushrooms have unique biology and production needs, not all
existing crop production requirements apply to organic mushroom
production. This means that 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. Unlike plants, which acquire energy from
photosynthesis, mushrooms absorb sources of energy (like sugars and
other organic compounds) from their surroundings. Therefore, most of
the soil fertility and nutrient management practices in Sec. 205.203
are not appropriate for mushroom production. However, mushroom
producers would have to follow the same nutrient management
requirements as plant producers described in Sec. 205.203(d)(1)
through (5) and (e). These paragraphs describe acceptable and
prohibited forms of nutrient management.
Similarly, mushroom production does not involve seeds or planting
stock, and mushrooms are not grown in rotations for fertility or
disease suppression, so Sec. Sec. 205.204-205.205 are not appropriate
for mushroom production.
Proposed paragraph 205.210(b) would require operations to manage
mushroom substrates and spawn media in a way that avoids environmental
contamination. AMS proposes that mushroom substrates, spawn media,
spent mushroom substrates, and spent spawn media must be managed to
avoid the contamination of any mushrooms, spawn, substrate, soil, or
water by pathogenic organisms, heavy metals, or residues of prohibited
substances. This provision aligns with the requirement in Sec.
205.203(c), which requires operations to prevent environmental
contamination from materials applied to soil. Likewise, this proposed
requirement also aligns with the requirement in Sec. 205.200 to
protect natural resources. Section 205.210(b) would require operations
to handle materials in a way that avoids contamination throughout the
entire mushroom production process, from spawn creation, to growing
mushrooms, to disposal of spent substrate.
Operations that only produce organic spawn and do not produce
organic mushrooms would also be subject to the provisions in paragraph
(b). Spawn media is usually incorporated into the substrate when spawn
is applied to a mushroom production bed. In cases where a spawn
producer decides not to use a batch of spawn and disposes of the spawn,
the operations would need to dispose of spent spawn media in a manner
that avoids contamination of mushrooms, spawn, substrate, soil or water
by pathogenic organisms, heavy metals, or residues of prohibited
substances.
In Sec. 205.210(c), AMS proposes requirements for what mushroom
substrate and spawn media can be made of and what materials may be used
in substrate production. This proposed paragraph is divided into
subparagraphs to address the acceptable use of four types of materials:
composted plant and animal materials, uncomposted plant materials, non-
agricultural natural substances, and synthetic substances.
Proposed paragraph (c)(1) describes requirements for composted
plant and animal materials for use in mushroom substrate and spawn
media. This section details time, temperature, and composition
requirements for composting plant and animal materials for use in
mushroom production. The proposed rule would require that compost
feedstock reach at least 131 [deg]F for at least three days during the
composting process. The compost must not be treated with any prohibited
substances per the existing requirements at Sec. 205.203(e)(1). AMS
does not propose a maximum temperature for mushroom compost production.
The proposed mushroom compost requirements are consistent with industry
standards. The proposed minimum temperature requirement would allow
mushroom producers the flexibility to compost their feedstock at higher
temperatures for a longer period if warranted.
AMS proposes in Sec. 205.210(c)(2) that uncomposted plant
materials for use in mushroom substrate and spawn media must be
organically produced if commercially available. However, nonorganically
produced uncomposted plant materials may be used in mushroom production
when an equivalent organically produced variety is not commercially
available. In this case, prohibited substances may not be applied to
the nonorganically produced uncomposted plant materials after harvest.
Certifiers must use the definition of commercial availability in Sec.
205.2 to validate an operation's claim that organically produced plant
materials necessary for mushroom production are not commercially
available.
Paragraphs (c)(3) and (4), together with the proposed amendment to
the definition of ``crop'' in Sec. 205.2 to include mushrooms, would
allow mushroom operations to use natural (nonsynthetic) substances and/
or synthetic substances in accordance with the National List of Allowed
and Prohibited Substances for organic crop production. These provisions
are appropriate for crop operations and are consistent with the
framework in Sec. 205.105(a) and (b) regarding allowed and prohibited
substances in organic production. Paragraph (c)(3) would allow the use
of natural (nonsynthetic) substances in mushroom substrate and spawn
media. Examples include mined gypsum, chalk, and clay. However,
operations must not use nonsynthetic substances prohibited for use in
organic production in Sec. 205.602 of the National List. Paragraph
(c)(4) would also permit the use of synthetic substances allowed for
use in organic crop production listed at Sec. 205.601 of the National
List. Examples include sanitizers, including chlorine products (like
sodium hypochlorite) and hydrogen peroxide; micronutrients listed at
Sec. 205.601(j)(7); and microcrystalline cheesewax (which is on the
National List at Sec. 205.601(o)(1) and annotated for use as a
production aid exclusively in log-grown mushrooms). Use of these
substances in mushroom substrate and spawn media must also follow all
applicable substance-specific restrictions included in the National
List. Paragraph (c)(4), along with the proposed revision to the
definition of ``crop'' in Sec. 205.2 to include mushrooms, would
enable mushroom operations to select from the already familiar list of
substances allowed in crop production.
AMS proposes in Sec. 205.210(d) that spawn used in organic
mushroom production must be organic. Organic spawn must (1) use organic
agricultural products (e.g., organic grain) in the spawn media and (2)
the spawn must be under continuous organic management once mycelium is
applied to the organic spawn media. However, if organic spawn is not
commercially available, an operation may use nonorganic spawn to
produce a crop of organic mushrooms. Certifiers must use the definition
of commercial availability in Sec. 205.2 to validate an operation's
claim that organic spawn is not commercially available.
Sec. 205.601 (National List)
Finally, AMS proposes to update Sec. 205.601 to clarify that
mushrooms are within the scope of organic crop production. The current
regulations at Sec. 205.601(i) and (j) use the phrases ``As
[[Page 17329]]
plant disease control'' and ``As plant or soil amendments'' to describe
types of synthetic substances, grouped by function, that may be used in
organic crop production. AMS proposes to replace the term ``plant''
with ``crop'' in these phrases. Because AMS is proposing to revise the
definition of crop (Sec. 205.2) to include mushrooms, the proposed
changes would allow the use of the materials on the National List in
paragraphs (i) and (j) in mushroom production. This is discussed in
additional detail above (see Sec. 205.210(c)(3) and (4)). AMS notes
that certifying agents who currently apply the crop production
standards to mushroom production currently permit these substances in
mushroom production.
V. Organic Pet Food Standard
A. Pet Food Background
AMS proposes in this rule to regulate organic claims on pet food
using 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 would allow organic pet food to be labeled and sold as
``100% organic,'' ``organic,'' or ``made with organic (specified
ingredients or food group(s)).'' The proposed changes would 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 proposed 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 proposed 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 (such as large
cats) falls outside the scope of the proposed definitions for pet food,
since zoo animals fall outside the definition of ``pet''--they are not
domestic animals.
This rule proposes to regulate only the organic claims of organic
pet food: specifically, what it can contain and how it must be labeled.
Other aspects of the manufacture, marketing, and sale of pet food--
including its healthfulness and safety, nutritional value and
composition, and suitability for pets--fall under the Food and Drug
Administration's (FDA) authority. All pet food manufacturers, organic
or otherwise, must comply with relevant federal and state regulations
pertaining to pet food safety. The framework for pet food regulation,
summarized below, provides context for several provisions in the
proposed organic pet food standards.
Pet Food Regulations
Pet food labels are regulated at the federal and state levels. At
the federal level, the FDA is responsible for overseeing and enacting
the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C
Act), which requires that pet food be safe, properly manufactured, and
adequately labeled.\22\ The FDA requires certain information on all
animal feed labels: proper identification of the product, net quantity
statement, name and place of manufacturer or distributor, and a proper
listing of all ingredients.\23\ Some states enforce their own labeling
regulations in addition to those administered by FDA. Most of these
states follow the recommendations of the Association of American Feed
Control Officials (AAFCO), an independent trade organization. They
require a product name that complies with AAFCO pet food labeling
rules, the species of pet for which the product is intended, a
guaranteed analysis showing the basic nutrient composition, and in some
cases a statement of nutritional adequacy and feeding directions.\24\
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\22\ FDA. (February 17, 2022). ``FDA's regulation of pet food.''
https://www.fda.gov/animal-veterinary/animal-health-literacy/fdas-regulation-pet-food.
\23\ 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.
\24\ AAFCO. ``Labeling & labeling requirements.'' Accessed May
1, 2023. https://www.aafco.org/resources/startups/labeling-labeling-requirements/.
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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 and supplemental nutrients to
meet the nutrient requirements of the animal. These ingredients
(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).\25\ 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. The NRC has listed and described
essential nutrients in its 2006 publication, ``Nutrient Requirements of
Dogs and Cats.'' \26\ AAFCO maintains on its website 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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\25\ 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.
\26\ NRC. (2006). ``Nutrient requirements of dogs and cats.''
https://nap.nationalacademies.org/catalog/10668/nutrient-requirements-of-dogs-and-cats.
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This proposed rule would not supersede the requirements of the FDA
or state regulatory bodies, including nutrient requirements established
according to the guidance of NRC or AAFCO. Instead, this rule is
intended to work jointly with those requirements and more narrowly
regulate what manufacturers must do to label their pet food ``organic''
or claim it is ``made with organic (specified ingredients or food
group(s)).'' Additionally, by including organic pet food in the organic
regulations, the proposed rule would clarify 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
The U.S. pet food market is a large and growing market in the
United States. According to recent data from the American Pet Products
Association (APPA), 66 percent of U.S. households own a pet, which is
around roughly 86.9 million homes.\27\ In 2022, the pet food market in
the United States was valued at $58.1 billion and is projected to
increase to $62.7 billion in 2023. While the conventional pet food
market is already substantial, the organic pet food market is
relatively new, with few organic brands able to penetrate the market.
In 2022, the organic pet food market was valued at $129 million but had
substantial growth of 5.3 percent over 2021, which was the highest
recorded growth since 2013.\28\ As of 2021, the organic pet food market
is still less than one percent of the total pet
[[Page 17330]]
food market,\29\ and AMS believes there is potential for further
growth.
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\27\ American Pet Products Association. ``Pet industry market
size, trends & ownership statistics.'' Retrieved May 5, 2023.
https://www.americanpetproducts.org/press_industrytrends.asp.
\28\ Organic Trade Association. 2022 Organic Industry Survey. p.
108. https://ota.com/market-analysis/organic-industry-survey/organic-industry-survey.
\29\ Organic Trade Association. 2022 Organic Industry Survey. p.
108.
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AMS expects that as the number of organic options for pets
increases, an untapped market of organic consumers may seek out and
purchase organic pet food for the same reasons that they purchase other
organic foods. Additionally, demand for pet food was driven up by the
COVID-19 pandemic when many people chose to adopt pets while living and
working from home. According to an American Society for the Prevention
of Cruelty to Animals (ASPCA) survey, around 23 million homes (nearly
one in five homes in the United States) adopted a cat or dog during the
pandemic.\30\
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\30\ ASPCA. ``New ASPCA survey: Vast majority of dogs and cats
acquired during pandemic still in their homes.'' Retrieved May 5,
2023. https://www.aspcapro.org/resource/new-aspca-survey-vast-majority-dogs-and-cats-acquired-during-pandemic-still-their-homes.
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Most dry and wet pet foods are multi-ingredient products because
multiple ingredients are needed to meet the nutritional needs of a pet.
The multi-ingredient nature of most pet foods creates a challenge for
manufacturers--the organic regulations describe requirements for
processed human food, but it is not clear if pet food should follow the
same rules. In addition, there is uncertainty about which ingredients
are allowed and how certain ingredients can be used in organic pet
food. An example is synthetic taurine, which is a necessary ingredient
in some pet food, but is not on the National List for use in organic
pet food. This limits the types of pet food that can be certified as
organic to single-ingredient pet food and treats, in turn limiting the
size of the organic pet food market overall. Revising the organic
regulations to clearly state how pet food can be labeled organic would
allow companies to produce multi-ingredient dry and wet food products
that are certified organic and still meet the complete nutritional
needs of pets. Additionally, under the current organic regulations, it
is unclear if pet food manufacturers may use meat or slaughter by-
products in organic pet food, which likely limits the production of
organic pet food. AMS expects that these changes would encourage
additional growth in the small organic pet food market and other latent
organic markets that support it, such as organic slaughter by-products.
B. Need for Organic Pet Food Standard
The lack of specific standards for organic pet food creates
inconsistency and uncertainty around labeling and composition
requirements for organic pet food. These regulatory gaps increase the
risk for businesses in the organic pet food market, hinder production
innovation, and limit the market for organic slaughter by-products.
For example, 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 pets' nutrient needs.
Specifically, the organic livestock feed composition requirements
(Sec. 205.301(e)(2)) state that livestock feed must be produced ``in
conformance with Sec. 205.237.'' Section 205.237(a) requires that all
agricultural ingredients be organically produced and handled, and Sec.
205.237(b)(5) prohibits feeding slaughter by-products to mammals or
poultry; however, slaughter by-products are a commonly used protein
source in pet food. Furthermore, although the organic livestock feed
standards allow the use of vitamins and minerals (Sec. 205.603(d)),
the composition requirements for livestock feed do not allow certain
synthetic amino acids that are commonly used in pet food, such as
taurine. In some cases, certifying agents may not adhere strictly to
the livestock feed standards and some may allow organic slaughter by-
products while others do not. This type of inconsistency creates
uncertainty for companies considering entering the market. It also
reduces the organic premiums that livestock producers and
slaughterhouses could otherwise gain.
While some certifying agents have used the composition requirements
for organic livestock feed (Sec. 205.301(e)) to certify pet food as
organic, others have used only the handling standards in Sec. 205.270
to certify pet foods as organic. These standards allow organic
ingredients (e.g., organic slaughter by-products) and allow nonorganic
ingredients that appear on the National List at Sec. Sec. 205.605 and
205.606, but the standards do not explicitly allow the vitamin and
mineral ingredients that appear on the National List for livestock
production at Sec. 205.603(d).
This proposed rule would resolve these problems by, first,
establishing that pet food is not to be regulated as organic livestock
feed and thereby allowing organic slaughter by-products in organic pet
food. Allowing slaughter by-products in organic pet food would also
increase demand for certified organic slaughter by-products and create
new income streams for organic livestock producers and slaughterhouses.
Second, the proposed rule would clarify that vitamins, minerals, and
taurine are allowed ingredients in organic pet food. Third, the rule
would clarify that certain nonorganic content is permitted in pet food,
in accordance with the labeling categories at Sec. 205.301(a) through
(d).
The product that forms the largest share of the entire pet food
market--kibble \31\ or dry ``complete and balanced'' \32\ pet food
intended to supply a pet's daily nutritional needs--is a processed
product, but the current handling regulations do not allow additive
nutrients and vitamins (such as taurine) that pets need to meet
nutritional requirements. The proposed rule would resolve this problem
by explicitly allowing the vitamin and mineral feed additives
referenced in Sec. Sec. 205.603(d)(2) and (3) for use in pet food and
by adding taurine to the National List in Sec. 205.605(b) as an
allowed substance in pet food. The natural form of taurine, which is
present in raw meat, is lost when heated--a step in the processing of
many pet food products.\33\ Because of this, synthetic forms of taurine
are often added to certain pet foods. By adding synthetic taurine to
the National List for use in organic pet food only, this proposed rule
would provide for the use of taurine in organic pet food.
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\31\ Kibble was 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.
\32\ FDA. (February 28, 2020). ``Complete and Balanced Pet
Food.'' https://www.fda.gov/animal-veterinary/animal-health-literacy/complete-and-balanced-pet-food.
\33\ 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.
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Additionally, this proposed rule would regulate pet food under the
composition and labeling requirements for processed products referenced
in Sec. 205.270. This would allow producers to use both the
``organic'' and ``made with organic (specified ingredient or food
group(s))'' labeling claims on multi-ingredient products that contain
some nonorganic content. These two 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. ``Organic''
products must contain at least 95 percent organic ingredients, while
``made with organic'' products must contain at least 70 percent organic
ingredients. In both cases, any nonorganic ingredient(s) must also meet
specific criteria.\34\ This
[[Page 17331]]
proposed rule would provide pet food manufacturers flexibility to use
organic ingredients in a ``made with organic'' pet food product without
having to reach the higher 95 percent ingredient threshold for
``organic'' products. This clarification would allow pet food companies
to increase organic content in their product line.
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\34\ USDA, AMS. (April 2018). ``Organic Labels Explained.''
https://www.ams.usda.gov/sites/default/files/media/OrganicLabelsExplained.png.
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Finally, under the current organic regulations, it is unclear if
pet food manufacturers may use meat or slaughter by-products in organic
pet food, limiting the production of pet food and demand for organic
slaughter by-products based on certifier interpretation. AMS estimates
that by clarifying slaughter by-products are allowed, this rule will
allow for more flexible and affordable organic pet food options and
could ensure consistent demand for over 7 million pounds of organic by-
products annually.\35\ Based on feedback from stakeholders, AMS finds
it likely that this clarification will also increase growth in these
markets.
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\35\ 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 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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In conclusion, this rule would address inconsistencies in how
certifying agents are applying the current organic regulations to pet
food. It would also resolve regulatory uncertainties that artificially
increase risk in the organic pet food market. Addressing these
inconsistencies and uncertainties would create the conditions necessary
for the organic pet food and related markets to grow.
C. Overview of Proposed Amendments
This proposed rule would amend 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 would integrate organic pet food standards
into existing USDA organic labeling categories for agricultural
products (subpart D of part 205) and specify the ingredients that can
be included in pet food labeled ``organic'' or ``made with organic
(specified ingredients or food group(s)).'' Table 2 provides a summary
of the proposed amendments to the USDA organic regulations to
incorporate pet food composition and labeling standards.
Table 2--Overview of Proposed Regulatory Changes To Establish Pet Food
Standards
------------------------------------------------------------------------
Summary of proposed
Section title Type of action action
------------------------------------------------------------------------
205.2......................... Adds new terms... Defines terms ``pet''
and ``pet food''.
205.270....................... Adds new Adds composition and
paragraph. labeling
requirements
specific to pet
food.
205.605(b).................... Adds substance to Adds taurine to the
the National National List as an
List. allowed ingredient
in pet food.
------------------------------------------------------------------------
Sec. 205.2 (Terms Defined)
AMS is proposing to amend Sec. 205.2 by adding two new terms,
``pet'' and ``pet food.''
1. Pet
AMS is proposing to define ``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 would not apply to organic pet food, and
vice versa.
By creating a regulatory distinction between pets and other animals
whose feed is subject to organic regulation, the proposed rule would
allow organic pet food to contain organic slaughter by-products (except
when prohibited by Federal or State laws and regulations, see proposed
Sec. 205.270(c)). This distinction is significant for pet food
production because current regulations do not allow slaughter by-
products in livestock feed (Sec. 205.237(b)(5)), but slaughter by-
products are commonly used as a protein source in pet food.
Additionally, organic livestock must consume only organic agricultural
products (Sec. 205.237(a)), whereas the proposed rule would allow
nonorganic agricultural ingredients to be used in pet food under the
same labeling categories as other processed organic foods. Together,
these clarifications are expected to increase the types of usable
ingredients in organic pet food production and increase the commercial
viability of organic pet food.
2. Pet Food
AMS is proposing to define ``pet food'' as ``any commercial feed
prepared and distributed for pet consumption.'' The proposed definition
for ``pet food'' distinguishes organic pet food products from organic
livestock feed products. This action is consistent with the NOSB
recommendation.\36\ It also addresses a concern expressed by pet food
manufacturers that applying the livestock feed composition requirements
to pet food could limit product formulation and participation in the
organic market because of the lack of available organic protein
sources, particularly rendered products such as 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
(such as large cats) is not included in the proposed definition, as zoo
animals are not domestic animals and therefore fall outside the
definition of ``pets.''
---------------------------------------------------------------------------
\36\ 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.
---------------------------------------------------------------------------
Sec. 205.270 (Organic Handling Requirements)
This proposed rule would add a new paragraph (c) to Sec. 205.270--
Organic handling requirements--to describe requirements for the
composition, processing, and labeling of organic pet food. The
requirements would permit the types of processing allowed in paragraph
(a) and the types of nonorganic ingredients allowed in paragraph (b)
and proposed paragraph (c), and prohibit the practices and materials
not allowed in paragraph (d) (please note that the proposed rule would
redesignate, or rearrange, current paragraph (c) of this section as
[[Page 17332]]
paragraph (d)). By including pet food criteria as part of the handling
standards but clearly separating the criteria from the livestock feed
composition and labeling standards, the proposed rule would ensure that
pet food is not subject to the prohibition of slaughter by-products
that exists for livestock feed. The proposed rule would allow 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).
Paragraph (b) would permit organic pet food, like any other
processed organic product, to contain nonagricultural and nonorganic
substances allowed by the National List in Sec. 205.605 (such as
taurine, as proposed) and Sec. 205.606. These ingredients may be used
in processed pet food products sold as ``organic'' or ``made with
organic (specified ingredients or food group(s)).'' Additionally, the
proposed rule would allow vitamins and minerals in Sec. 205.603(d)(2)
and (3) for enrichment or fortification of pet food. Vitamins and
minerals are often required to meet the nutritional needs of pets.
The proposed rule would also clarify that pet food labeled as
organic must be labeled pursuant to the applicable portions of subpart
D of the organic regulations (proposed Sec. 205.270(c)). In
particular, this means that organic pet food should be labeled
according to the product composition requirements at Sec. 205.301(a)
through (d), and that pet food may use the following labeling
categories: (1) ``100 percent organic;'' (2) ``organic,'' (3) ``made
with organic (specified ingredients or food group(s));'' or (4)
products containing less than 70 percent organic ingredients. This
proposed action would allow the labeling of organic pet food using the
same framework as most processed organic products (rather than the
labeling requirements for livestock feed at Sec. 205.301(e)).
The proposed changes to Sec. 205.270 would not replace or modify
requirements pertaining to pet food that are applicable under other
federal or state laws or regulations. Any ingredients in pet food must
comply with all applicable federal and state laws and regulations. AMS
only regulates the organic claims of organic pet food. All other
aspects of pet food production and sale must follow the relevant
federal and state laws and regulations.
Sec. 205.605 (National List)
AMS proposes to modify the National List to allow the use of
synthetic taurine in pet food. The rule proposes to add taurine to
Sec. 205.605, which describes nonagricultural substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).'' The
proposed listing for taurine also specifies that taurine can be used
only in pet food and not in other organic multi-ingredient products.
Taurine is an amino sulfonic acid that many pets (all cats and some dog
breeds) require but cannot obtain in adequate amounts by consuming pet
food that does not contain added taurine. For that reason, AAFCO's cat
nutrient profiles require taurine, and it is a common synthetic
additive in pet foods.
This proposed addition follows an NOSB recommendation to add
taurine to the National List as an allowed substance for use
exclusively in pet foods. The NOSB concluded that taurine is necessary
to meet nutritional requirements for cats. Also, based on public
comment, the NOSB determined that taurine can also be necessary for
dogs' nutrition, and, therefore, recommended taurine be allowed in pet
food generally. AMS agrees with the NOSB's rationale and recommendation
since taurine is essential for pet health and adequate taurine levels
cannot be achieved using organic agricultural ingredients alone when
pet food is cooked. This proposed rule, if finalized, would amend the
regulations to provide for the use of taurine.
Individuals may petition to add other substances to the National
List for use in organic pet food. 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 would also be evaluated
according to the existing criteria in OFPA (7 U.S.C. 6517 and 6518) and
the USDA organic regulations (Sec. 205.600).
VI. 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 of the RFA
allows an agency to certify a rule in place of preparing an analysis if
the rulemaking is not expected to have a significant economic impact on
a substantial number of small entities. AMS has concluded that this
rule, if promulgated, will not have a significant economic impact on a
substantial number of small entities, and, 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.\37\
---------------------------------------------------------------------------
\37\ 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.\38\ AMS estimates that out of 229 domestic operations reporting
sales of organic mushrooms, 14 operations exceed that threshold.\39\
While most organic mushroom operations that would be affected by this
rule are small entities, this rule has the potential to impose only
minor costs on them related to paperwork burden (see Paperwork
Reduction Action section below) and costs associated with
[[Page 17333]]
sourcing organic spawn and substrate materials, when commercially
available. AMS concludes that this rule, if promulgated, will not have
a significant economic impact on a substantial number of these small
entities.
---------------------------------------------------------------------------
\38\ U.S. SBA. (March 17, 2023). Table of size standards.
https://www.sba.gov/document/support-table-size-standards.
\39\ 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 2017 Census of Agriculture, available here: https://www.nass.usda.gov/Publications/AgCensus/2017/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.\40\ AMS estimates that given the small size of
the organic pet food market, most 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 proposed rule
would establish standards for organic pet food handling that align with
many existing industry practices. Additionally, the rule could allow
operations to use additional inputs (e.g., taurine) in pet food. AMS
concludes that this rule, if promulgated, will not have a significant
economic impact on a substantial number of these small entities.
---------------------------------------------------------------------------
\40\ U.S. SBA. (March 17, 2023). Table of size standards.
https://www.sba.gov/document/support-table-size-standards.
---------------------------------------------------------------------------
Certifying agents. This proposed rule would also affect 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
74 USDA-accredited certifying agents, and AMS believes most of these
certifying agents are small entities. Certifying agents must already
comply with the current regulations and already certify these
operations. Certifying agents may incur minor one-time paperwork costs
(see Paperwork Reduction Act section below). However, this rule would
reduce the current burden of creating and maintaining individual
policies for organic mushroom production and organic pet food handling.
AMS concludes that this rule, if promulgated, 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 proposed rule complies
with these requirements. This rule would not 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 would 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 only pertains to regulations with clear federalism
implications.
AMS has determined that this proposed rule conforms with the
principles of federalism described in E.O. 13132. The rule would not
impose substantial direct costs or effects on States, would not alter
the relationship between States and the federal government, and would
not alter the distribution of powers and responsibilities among the
various levels of government. States have the opportunity to comment on
any potential federalism implications during this proposed rule's
comment period. AMS will consider these comments when assessing the
federalism implications of any final rule.
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 has determined that a Tribal consultation for this
rulemaking is not necessary, as it is unlikely to impact Tribes.
However, AMS will conduct a Tribal consultation if stakeholders request
one.
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 that there
is no evidence that this proposed rule would have
[[Page 17334]]
adverse civil rights impacts on organic producers identifying as
minorities, women, and/or persons with disabilities. Additionally, this
proposed rule would not impose any requirements related to eligibility
for benefits and services on protected classes, nor would 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.'' Section 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 851 hours for the reporting and recordkeeping
requirements contained in this proposed 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 approved 0581-0191
collection. 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 this proposed 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-NEW.
Expiration Date of Approval: Three years from OMB date of approval.
Type of Request: New collection.
Abstract: Information collection would be necessary to implement
reporting required by the proposed standards for organic mushroom
production and pet food handling under the USDA organic regulations
(Sec. Sec. 205.210 and 205.270). This proposed rule would establish
USDA organic requirements in these sectors to support consistent
interpretation and remove regulatory uncertainty. By doing so, it would
support the purposes of OFPA, ``to assure consumers that organically
produced products meet a consistent standard'' and to ``establish
national standards'' for products marketed as organic (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 would be required to
demonstrate compliance with proposed new Sec. 205.210 and proposed
amendments to Sec. 205.270 of the USDA organic regulations, 7 CFR part
205, that establish standards for mushroom production and pet food
handling. Historically, while mushrooms have been managed as a crop and
pet food has been manufactured in compliance with the livestock feed
and/or handling standards, AMS has received reports that the lack of
specific standards for mushrooms and pet food handling deters business
investment and creates inefficiencies in these markets.
Mushrooms are not plants. They do not photosynthesize and are
generally grown in controlled environments. While mushrooms can comply
with most of the existing regulations governing crop production,
including Sec. Sec. 205.200-202 and 205.206, they have very distinct
growing requirements that differ from plant crops and are not directly
addressed in the current organic regulations. AMS is proposing to add
Sec. 205.210 to the USDA organic regulations to describe the specific
practice standards for mushrooms that codify the processes and
materials allowed in organic mushroom operations. This includes
mushroom substrate requirements instead of the soil fertility and crop
nutrient management requirements in Sec. 205.203 and spawn production
requirements in lieu of the parallel seeds and planting stock practice
requirements in Sec. 205.204.
AMS is proposing to apply the existing framework for the organic
handling requirements at Sec. 205.270 to pet food composition and
labeling. Some parties interested in creating organic feed stated that
it was not clear if organic pet food was allowed to contain slaughter
by-products, which are prohibited in livestock feed. This proposed rule
would clearly permit the use of slaughter by-products from organic
livestock in organic pet food by establishing pet food regulations
outside of the livestock feed standards.
These amendments would 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 would need to review their existing organic system
plans for compliance, certifiers would have to review the updated
plans, and certifiers/inspectors would need training on the new
regulation. The reporting burden for new and exempt operations in these
sectors would remain unchanged from the current ICR, and recordkeeping
burdens from the current ICR would remain unchanged for all
respondents. Beyond the first year, AMS expects no increase in
reporting and recordkeeping burden for any respondents. The continuing
reporting and recordkeeping requirements are routine activities that
are currently identified in the NOP's approved ICR.
[[Page 17335]]
Respondents
Six respondent types--certified operations (producers and
handlers), accredited certifying agents, inspectors, foreign
governments, state organic programs, and petitioners--have been
identified in our currently approved information collection (0581-
0191). AMS has identified three primary types of entities (respondents)
that would need to submit new information because of this proposed
rule: certified organic operations, accredited certifying agents, and
organic inspectors. AMS does not expect this rule to impact any new
operation, foreign governments, state organic programs, and petitioners
as it only seeks to establish specific standards for mushroom and pet
food operations, which would only require changes from existing
operations and certifiers. The reporting burden for new and exempt
operations in these sectors would remain unchanged from the ICR, and
recordkeeping burdens from the current ICR would remain unchanged for
all respondents.
Calculating Reporting and Recordkeeping Burden
AMS identifies three types of entities (respondents) that would
need to submit and maintain information to participate in organic pet
food and mushroom certification:
1. Organic pet food and mushroom operations.
2. Accredited certifying agents.
3. Inspectors.
To understand the reporting and recordkeeping costs of this
rulemaking more precisely, AMS calculated the potential impacts
utilizing domestic and foreign labor rates (per hour) plus benefits.
AMS calculates the time burden of the new reporting and
recordkeeping requirements of this rulemaking by estimating the
following:
1. The number of respondents.
2. Frequency of response.
3. Total number of burden hours per year.
The number of respondents is based on operation, certifier,
inspector, and State Organic Program data from the Organic Integrity
Database. The frequency of responses is estimated to be the total
annual responses and the number of responses per respondent in twelve
months. The total number of burden hours per year is estimated to be
the total annual responses multiplied by the number of hours per
response.
AMS estimates the cost (financial) burden of the new reporting and
recordkeeping requirements of this rulemaking by estimating the
following:
1. Total hours per respondent.
2. Total hours for all respondents.
3. Capital and other non-labor costs per respondent.
4. Total capital and other non-labor costs for all respondents.
The total hours per respondent and for all respondents were
estimated based on the number of respondents and the amount of time AMS
estimates would be needed to report and record new information based on
this rulemaking.
1. Operations: Mushroom Producers and Pet Food Manufacturers
Domestic and foreign producers and handlers that are updating their
organic system plan must address how their operation complies with the
proposed mushroom or pet food standards. Operations would be required
to update any changes in their operation or practices to their
certifying agent at least annually. AMS has identified 229 domestic and
43 foreign-based operations that produce mushrooms and 31 domestic and
5 foreign-based operations that manufacture pet food requiring 308
reporting responses.\41\
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\41\ 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 May 9, 2023.
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The proposed mushroom production and pet food handling standards
are estimated to require each current mushroom producer or pet food
manufacturer to spend one hour to verify the compliance of their
organic system plan with the proposed standards. AMS estimates the
costs of the one-time reporting burden for all mushroom producers and
pet food manufacturers to review and verify the compliance of their new
or updated organic system plan at $15,391.55. This is based on 260
labor hours at $52.18 per labor hour (including benefit costs) \42\ for
260 domestic operations, totaling $13,565.64; and 48 labor hours at
$38.04 per labor hour (including benefit costs) \43\ for 48 foreign
operations, totaling $1,825.91 (See Table 3: USDA Certified Operations
Reporting Burden). No new recordkeeping burden is incurred by this
proposed rule as these operations are already certified and covered by
existing recording keeping in the current Information Collection
Request.\44\
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\42\ The cost of labor per hour for domestic operations was
obtained by calculating the sum of the mean hourly wage for
agricultural workers and the hourly cost of worker benefits. In May
2022, the mean hourly wage for Farmers, Ranchers, and Other
Agricultural Managers (Standard Occupational Classification code 11-
9013) was $40.29. U.S. Bureau of Labor Statistics. (April 25, 2023).
``Occupational employment and wage statistics: May 2022 national
occupational employment and wage estimates United States.'' https://www.bls.gov/oes/current/oes_nat.htm#top. Domestic benefits were
reported to be 29.5 percent of total average civilian employer
compensation costs. U.S. Bureau of Labor Statistics. (June 16,
2023). ``Employer costs for employee compensation summary.'' USDL-
23-0488. https://www.bls.gov/news.release/ecec.nr0.htm.
\43\ Wages in foreign countries are estimated to be 70.15
percent of U.S wages. This percentage was derived by dividing the
World Bank estimates of Organization for Economic Co-Operation and
Development (OECD) member countries in 2021 by the wages of the
United States in 2021. The World Bank. ``GDP per capita PPP--OECD
members.'' Accessed August 2023. https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD?locations=OE. Foreign worker benefit
rates are based on the average OECD member countries' tax wedge rate
of 34.59 percent in 2021. OECD. ``Taxing Wages--Comparative
tables.'' Accessed May 9, 2023. https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP.
\44\ The current Information Collection Request can be found at
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202001-0581-001.
Table 3--USDA Certified Operations (Mushroom Producers and Pet Food Handlers) Reporting Burden
----------------------------------------------------------------------------------------------------------------
Total
Respondent categories Number of Wage + reporting Total costs
respondents benefits hours
----------------------------------------------------------------------------------------------------------------
USDA Certified Producers & Handlers--Domestic... 260 $52.18 260 $13,565.64
USDA Certified Producers & Handlers--Foreign.... 48 38.04 48 1,825.91
---------------------------------------------------------------
USDA Organic Operations--All................ 308 .............. 308 15,391.55
----------------------------------------------------------------------------------------------------------------
[[Page 17336]]
2. Certifying Agents
Certifying agents are State, private, or foreign entities
accredited by the USDA to certify domestic and foreign producers and
handlers as organic in accordance with OFPA and the USDA organic
regulations. Certifying agents determine whether a producer or handler
meets the organic requirements, using detailed information from the
operation about its specific practices and on-site inspection reports
from organic inspectors. There are 39 certifying agents (31 domestic
and 8 foreign) accredited by USDA certifying organic mushroom
operations and 12 certifying agents (8 domestic and 4 foreign)
accredited by USDA certifying organic pet food processing that would
require 308 reporting responses to certify each organic operation and
51 responses for staff training.\45\
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\45\ 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 May 9, 2023.
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The proposed mushroom production and pet food handling standards
would require certifying agents of current mushroom producers and pet
food manufacturers to spend one hour for each producer or manufacturer
to verify their compliance with the proposed standards. In addition, it
is estimated that certifying agents would need to provide one hour of
training regarding the proposed mushroom production and pet food
handling standards to their certification review personnel. Each
certifying agent certifying organic mushroom production would incur
approximately eight hours of first-time reporting burden (one hour for
training and seven hours for approximately seven operations per
certifier) \46\ but no new recordkeeping burden due to this proposed
rule. Each certifying agent certifying organic pet food processing
would incur approximately four hours of first-time reporting burden
(one hour for training and three hours for approximately three
operations per certifier) \47\ but no new recordkeeping burden due to
this proposed rule. AMS estimates the costs of the one-time reporting
burden for all certifying agents to review and verify the compliance of
the new or updated organic system plan of mushroom producers and pet
food manufacturers and the provision of training at $16,170.00. This is
based on 279 labor hours at $47.93 per labor hour (including benefit
costs) \48\ for 39 domestic certifying agents, totaling $13,381.73; and
80 labor hours at $34.94 per labor hour (including benefit costs) \49\
for 12 foreign certifying agents, totaling $2,788.27. (See Table 4:
USDA Certifying Agents Reporting Burden).
---------------------------------------------------------------------------
\46\ This is the calculated average number of mushroom
operations (272) per certifier certifying mushrooms (39).
\47\ This is the calculated average number of pet food
operations (36) per certifier certifying pet food (12).
\48\ The cost of labor per hour for domestic certifying agents
was obtained by calculating the sum of the mean hourly wage for
compliance officers and the hourly cost of worker benefits. In May
2022, the mean hourly wage for Compliance Officers (Standard
Occupational Classification (SOC) code 13-1041) was $37.01. U.S.
Bureau of Labor Statistics. (April 25, 2023). ``Occupational
employment and wage statistics: May 2022 national occupational
employment and wage estimates United States.'' https://www.bls.gov/oes/current/oes_nat.htm#top. Domestic benefits were reported to be
29.5 percent of total average civilian employer compensation costs.
U.S. Bureau of Labor Statistics. (June 16, 2023). ``Employer costs
for employee compensation summary.'' USDL-23-0488. https://www.bls.gov/news.release/ecec.nr0.htm.
\49\ See footnote 48.
Table 4--USDA Certifying Agents (Certifying Mushroom Producers and Pet Food Handlers) Reporting Burden
----------------------------------------------------------------------------------------------------------------
Total
Respondent categories Number of Wage + reporting Total costs
respondents benefits hours
----------------------------------------------------------------------------------------------------------------
USDA U.S.-Based Certifiers--Mushrooms........... 31 $47.93 247.21 $11,848.04
USDA Foreign-Based Certifiers--Mushrooms........ 8 34.94 64.79 2,229.18
USDA U.S.-Based Certifiers--Pet food............ 8 47.93 32 1,533.69
USDA Foreign-Based Certifiers--Pet food......... 4 34.94 16 559.09
---------------------------------------------------------------
USDA Certifiers--All........................ * 51 .............. 359 16,170.00
----------------------------------------------------------------------------------------------------------------
* Some certifiers may certify both pet food and mushroom operations but are counted as separate entities in this
column.
3. Organic Inspectors
Inspectors conduct on-site inspections of certified operations and
operations applying for certification and report the findings to the
certifying agent. Inspectors may be independent contractors or
employees of certifying agents. Inspectors provide an inspection report
to the certifying agent for each operation inspected (Sec.
205.404(a)). Currently, AMS estimates that inspectors would receive one
hour of training on the proposed mushroom production and pet food
handling standards. Inspectors do not have recordkeeping obligations,
as certifying agents maintain the records of inspection reports.
According to the International Organic Inspectors Association,
there are approximately 184 inspectors in the world that inspect
organic crop, livestock, handling, and/or wild crop operations'
compliance with USDA organic standards.\50\ Thus, the proposed rule
would require approximately 184 reporting responses from inspectors.
AMS estimates the costs of the one-time reporting burden for all
inspectors to receive one hour of training on the proposed mushroom
production and pet food handling standards at $5,111.82. This is based
on 123 labor hours for 123 U.S.-based inspectors to receive training in
the U.S. at $30.52 per labor hour, (including benefit costs),\51\
totaling $3,754.35 in costs; and 61 labor hours for 61 foreign-based
inspectors to receive training at $22.25 per hour (including benefit
costs),\52\ totaling $1,357.47 in costs. (See Table 5: Inspectors
Reporting Burden).
---------------------------------------------------------------------------
\50\ This estimate is based on data from the International
Organic Inspectors Association Membership Directory, available at:
https://www.ioia.net/member-directory.
\51\ The cost of labor per hour for domestic inspectors was
obtained by calculating the sum of the mean hourly wage for
agricultural inspectors and the hourly cost of worker benefits. In
May 2022, the mean hourly wage for Agricultural Inspectors (Standard
Occupational Classification (SOC) code 45-2011) was $23.57. U.S.
Bureau of Labor Statistics. (April 25, 2023). ``Occupational
employment and wage statistics: May 2022 national occupational
employment and wage estimates United States.'' https://www.bls.gov/oes/current/oes_nat.htm#top. Domestic benefits were reported to be
29.5 percent of total average civilian employer compensation costs.
U.S. Bureau of Labor Statistics. (June 16, 2023). ``Employer costs
for employee compensation summary.'' USDL-23-0488. https://www.bls.gov/news.release/ecec.nr0.htm.
\52\ See footnote 48.
[[Page 17337]]
Table 5--Inspectors Reporting Burden
----------------------------------------------------------------------------------------------------------------
Total
Respondent categories Number of Wage + reporting Total costs
respondents benefits hours
----------------------------------------------------------------------------------------------------------------
USDA U.S.-based Inspectors...................... 123 $30.52 123 $3,754.35
USDA Foreign based inspectors................... 61 22.25 61 1,357.47
---------------------------------------------------------------
USDA Inspectors--All........................ 184 .............. 184 5,111.82
----------------------------------------------------------------------------------------------------------------
Summary of Reporting Burden
Total (Domestic and Foreign) Information Collection Cost (Reporting) of
Proposed Rule: $36,673.37 (See Table 6: Total Reporting Burden)
AMS estimates the public reporting burden for this information
collection to be 851 hours at a total cost of $36,673.37 with a total
number of 543 respondents. Respondents comprise currently certified
organic mushroom producers and pet food manufacturers, USDA accredited
certifying agents, and inspectors.
Table 6--Total Reporting Burden
----------------------------------------------------------------------------------------------------------------
Total number of
reporting Total reporting Total all costs
respondents hours--all
----------------------------------------------------------------------------------------------------------------
Summary of Tables 1, 2, & 3.................................. 543 851 $36,673.37
----------------------------------------------------------------------------------------------------------------
Total All Reporting Burden Cost: $36,673.37.
Estimate of Burden: Public reporting burden for the collection of
information is estimated to average 1.57 hours per year per response.
Respondents: Certified operations, certifying agents, and
inspectors.
Estimated Number of Reporting Respondents: 543.
Estimated Number of Reporting Responses: 851.
Estimated Total Reporting Burden on Respondents: 851 hours.
Estimated Total Annual Reporting Hours per Reporting Respondent:
1.57 reporting hours per reporting respondent.
Estimated Total Annual Reporting Responses per Reporting
Respondent: 1.57 reporting responses per reporting respondent.
Estimated Total Annual Reporting Hours per Reporting Response: 1.57
hours per reporting response.
Total Domestic Reporting Burden Cost: $30,701.72
Respondents: Certified operations, certifying agents, and
inspectors.
Estimated Number of Domestic Reporting Respondents: 422
respondents.
Estimated Number of Domestic Reporting Responses: 662 responses.
Estimated Total Annual Reporting Burden on Domestic Respondents:
662 hours.
Total Foreign Reporting Burden Cost: $5,971.65
Respondents: Certified operations, certifying agents, and
inspectors.
Estimated Number of Foreign Reporting Respondents: 121 respondents.
Estimated Number of Foreign Reporting Responses: 189 responses.
Estimated Total Annual Reporting Burden on Foreign Respondents: 189
hours.
Summary of Recordkeeping Burden
There are no expected recordkeeping burdens as a result of the
proposed rule.
Comments
AMS is inviting comments from all interested parties concerning the
information collection that would be required as a result of the
proposed amendments to 7 CFR part 205. AMS seeks comment on the
following subjects:
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.
List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agricultural commodities,
Agriculture, Animals, Archives and records, Fees, Imports, Labeling,
Livestock, National List, National Organic Standards Board (NOSB),
Organically produced products, Plants, Reporting and recordkeeping
requirements, Seals and insignia, Soil conservation, Sunset.
For the reasons stated in the preamble, AMS proposes to amend 7 CFR
part 205 as follows:
PART 205--NATIONAL ORGANIC PROGRAM
0
1. The authority citation for 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 substrate'', ``Mycelium'', ``Pet'', ``Pet food'', ``Spawn'',
and ``Spawn media''; and
0
c. Revising the definition of ``Wild crop''.
[[Page 17338]]
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 edible, fleshy, spore-bearing fruiting body of a
fungus.
Mushroom substrate. The base material, such as grain, wood, and/or
other agricultural materials, from which mushrooms are cultivated or
grown. This base material can include composted material.
Mycelium. A mass of branching, thread-like hyphae (fungal
structures).
* * * * *
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.
* * * * *
Spawn. Spawn media that has been colonized by mycelium, which is
used to inoculate mushroom substrates.
Spawn media. A carrier, such as grains or minerals, that, when
colonized with mycelium, creates spawn.
* * * * *
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.
* * * * *
0
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), 205.206(a)(2) and(3), and 205.206(b) through (f). The
producer may manage crop nutrients for mushroom production in
accordance with the provisions of Sec. 205.203(d)(1) through (5).
(b) The producer must manage mushroom substrate and spawn media,
including spent mushroom substrate and spawn media, in a manner that
does not contribute to contamination of crops, spawn, mushroom
substrate, soil, or water by pathogenic organisms, heavy metals, or
residues of prohibited substances.
(c) Mushroom substrate and spawn media may be composed of the
following materials in accordance with the conditions specified in this
paragraph (c):
(1) Composted plant and animal materials. Compost used in mushroom
production 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 in mushroom production when an
equivalent organically produced variety is not commercially available.
Prohibited substances may not be applied to nonorganically produced
uncomposted plant materials after harvest.
(3) Nonsynthetic substances, except those on the National List of
nonsynthetic substances prohibited for use in organic crop production
(Sec. 205.602); and
(4) Synthetic substances on the National List of synthetic
substances allowed for use in organic crop production (Sec. 205.601).
(d) Spawn must be organic: Except, that, nonorganic spawn may be
used to produce an organic crop when an equivalent organically managed
variety is not commercially available. Organic spawn must use organic
agricultural products as the spawn media and be under continuous
organic management after the mycelium is applied to the organic spawn
media.
0
4. Amend Sec. 205.270 by redesignating paragraph (c) as paragraph (d)
and adding new paragraph (c) to read as follows:
Sec. 205.270 Organic handling requirements.
* * * * *
(c) 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 labeled as
organic must be labeled pursuant to the applicable portions of 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.
* * * * *
0
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. 2024-04973 Filed 3-8-24; 8:45 am]
BILLING CODE 3410-02-P