[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Rules and Regulations]
[Pages 68021-68028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24111]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 /
Rules and Regulations
[[Page 68021]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Doc. No. AMS-NOP-21-0060]
RIN 0581-AE11
Amendments to the National List of Allowed and Prohibited
Substances per October 2020 and April 2021 NOSB Recommendations
(Handling, Crops)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
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SUMMARY: This rule amends the National List of Allowed and Prohibited
Substances (National List) section of the United States Department of
Agriculture's (USDA) organic regulations to implement recommendations
submitted to the Secretary of Agriculture (Secretary) by the National
Organic Standards Board (NOSB). This rule allows low-acyl gellan gum, a
food additive used as a thickener, gelling agent, and stabilizer, as an
ingredient in processed organic products. This rule also allows paper-
based crop planting aids for organic crop production. Finally, this
rule replaces the term ``wood resin'' on the National List with the
term ``wood rosin'' to reflect the popular spelling of the substance.
DATES: This rule is effective on December 14, 2022.
FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division,
National Organic Program. Telephone: (202) 720-3252. Email:
[email protected].
SUPPLEMENTARY INFORMATION:
Background
On December 21, 2000, the Secretary established the Agricultural
Marketing Service's (AMS) National Organic Program (NOP) and the USDA
organic regulations (65 FR 80547, December 21, 2000). Within the USDA
organic regulations (7 CFR part 205) is the National List of Allowed
and Prohibited Substances (or ``National List''). The National List
identifies the synthetic substances that may be used and the
nonsynthetic (natural) substances that may not be used in organic crop
and livestock production. It also identifies the nonorganic substances
that may be used in or on processed organic products.
AMS is finalizing three amendments to the National List in
accordance with the procedures detailed in the Organic Foods Production
Act of 1990 (OFPA) (7 U.S.C. 6501-6524). OFPA establishes what may be
included on the National List and the procedures that the USDA must
follow to amend the National List (7 U.S.C. 6517). OFPA also describes
the NOSB's responsibilities in proposing amendments to the National
List, including the criteria for evaluating amendments to the National
List (7 U.S.C. 6518).
According to OFPA's requirements, substances on the National List
must be: (1) reviewed every five years by the NOSB, a 15-member Federal
advisory committee; and (2) renewed by the Secretary to remain on the
National List (7 U.S.C. 6517(e)). This action of NOSB review and USDA
renewal is commonly referred to as the ``sunset review'' or ``sunset
process.'' AMS published information about this process in the Federal
Register on September 16, 2013 (78 FR 56811). The sunset date (i.e.,
the date by which the Secretary must renew a substance for the listing
to remain valid on the National List) for each substance is included in
the NOP Program Handbook (document NOP 5611). The sunset date for the
two substances added to the National List by this rule will be five
years after the effective date noted in the DATES section above. The
sunset date for wood rosin is unchanged by this rule and remains March
15, 2027 (86 FR 41699, August 3, 2021).
Overview of Amendments
This rule adds low-acyl gellan gum and paper-based crop planting
aids to the National List. This rule also adds a definition for
``paper-based crop planting aids'' to 7 CFR 205.2. Once this rule
becomes effective, organic crop producers and organic handlers will be
allowed to use these substances in organic crop production and
handling, as applicable. The permitted use of each substance is
discussed in detail below. This rule also replaces the term ``wood
resin'' at 7 CFR 205.605(a) with the term ``wood rosin'' to reflect the
popular spelling of the substance. Additional background on the
petitions and on the NOSB's review of these substances may be found in
the proposed rule (87 FR 5424, February 1, 2022).
During a 60-day comment period that closed on April 4, 2022, AMS
received 45 comments on the proposed rule. See below for a discussion
of the comments received and AMS's responses to comments. Comments can
be viewed at Regulations.gov. Use the search area on the homepage at
https://www.regulations.gov to enter a keyword, title, or docket ID
(the docket ID for this rule is AMS-NOP-21-0060).
A. Low-Acyl Gellan Gum (Sec. 205.605(b))
Section 205.605(b) Nonagricultural synthetic substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).''
Overview
This rule amends the National List to add low-acyl gellan gum to 7
CFR 205.605(b) as a nonagricultural, synthetic substance allowed for
use in organic handling as an ingredient in or on processed products
labeled as ``organic'' or ``made with organic (specified ingredients or
food group(s)).'' Low-acyl gellan gum is a polysaccharide (type of
carbohydrate) produced through fermentation (from the microorganism
Sphingomonas elodea). It is manufactured from high-acyl gellan gum, a
substance allowed in organic production, which is isolated from
microbial fermentation. Low-acyl gellan gum is used in a wide variety
of food products that require gelling, texturizing, stabilizing,
suspending, film-forming, and structuring such as ready-to-eat dessert
gels, icings, and beverages.
AMS is finalizing this amendment to the National List, as
recommended by the NOSB after its October 2020 public meeting,\1\ to
provide organic handlers
[[Page 68022]]
an ingredient for thickening, gelling, and stabilizing. Synthetic low-
acyl gellan gum is made from natural high-acyl gellan gum, which is
already allowed as an ingredient in or on processed products labeled as
``organic'' or ``made with organic (specified ingredients or food
group(s))'' (Sec. 205.605(a)).
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\1\ National Organic Standards Board, formal recommendation,
low-acyl gellan gum, October 30, 2020, https://www.ams.usda.gov/sites/default/files/media/HSLowAcylGellanGumRec_webpost.pdf.
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Low-acyl gellan gum holds unique qualities not found in other
thickener substances on the National List (e.g., high-acyl gellan gum,
carrageenan). While high-acyl gellan gum produces gels that are soft,
elastic, and non-brittle, low-acyl gellan gum can be used to create a
firmer, harder, and non-elastic gel. Food producers can vary the ratios
of both high- and low-acyl gellan gums to produce different textures.
Low-acyl gellan gum can also be used to increase viscosity of beverages
or be used to suspend matter in beverages, such as those containing
fruit pulp or jelly pieces. Additionally, low-acyl gellan gums can be
clarified to create a gel with better clarity than other gums--
important for certain confectionary applications such as icings and
fillings. Gellan gums can better withstand higher temperatures while
maintaining their gel form than other gelling agents, such as gelatin,
can. Additionally, low-acyl gellan gum can be used in standard
processing without additional steps (e.g., compared to pectin, which
requires special handling in gelled confections). Finally, low-acyl
gellan gum provides a vegetarian alternative to gelatin in hard and
soft capsules used for products such as dietary supplements.
NOSB Review and Recommendation
Following review of an August 2019 petition,2 3 the NOSB
recommended that low-acyl gellan gum be added to the National List.\1\
The NOSB's evaluation of low-acyl gellan gum considered comments from
the public, a previously commissioned third-party technical report on
gums,\4\ and the petition itself. The NOSB discussed this petition in
subcommittee calls and at its public meeting in October 2020.\5\
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\2\ Petition for Evaluation of Low Acyl Gellan Gum for Inclusion
on the National List of Substances Allowed in Organic Production and
Handling (7 CFR 205.605(b), CP Kelco U.S., Inc., National List
Petition, August 8, 2019, https://www.ams.usda.gov/sites/default/files/media/PetitionLowAcylGellanGum08082019.pdf.
\3\ Response To Request For Information Low Acyl Gellan Gum, CP
Kelco U.S., Inc., National List Petition Update, March 6, 2020,
https://www.ams.usda.gov/sites/default/files/media/PetitionAddendum_LAGellanGum_ResponsetoNOSB_03062020.pdf.
\4\ National Organic Program, Gums, Nexight Group, technical
report, January 30, 2018, https://www.ams.usda.gov/sites/default/files/media/GumsTRFinal20180130.pdf.
\5\ National Organic Standards Board (NOSB) Meeting--Virtual,
National Organic Standards Board, October 28, 2020, https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-cedar-rapids-iowa.
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After their evaluation, the NOSB concluded that adding low-acyl
gellan gum to the National List is consistent with the evaluation
criteria in OFPA (7 U.S.C. 6518(m)). The NOSB concluded that low-acyl
gellan gum has minimal adverse effects on the environment and human
health. Additionally, the NOSB acknowledged the distinct properties of
low-acyl gellan gum and noted that it can be used to manufacture hard,
non-elastic, brittle gels (unlike high-acyl gellan gum). This property
allows it to be used in the production of capsules used for dietary
supplements. Notably, its allowance by this rule will give organic
handlers an alternative to gelatin to produce vegetarian and vegan
products--an important attribute for a segment of consumers.
The NOSB recommended that low-acyl gellan gum be classified as
``synthetic''. As defined by OFPA and the USDA organic regulations, a
synthetic substance is produced by a chemical process, or by a process
that chemically changes a natural substance (7 U.S.C. 6502(22) and 7
CFR 205.2). As the manufacturing process for low-acyl gellan gum
includes the deacetylation of high-acyl gellan gum (reducing the number
of acetyl groups \6\ by adding potassium, magnesium, calcium, and/or
sodium salts), which is considered a chemical change, the NOSB
determined this is a synthetic substance.
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\6\ The number of acetyl groups determines the firmness of the
gel. An acetyl group is a molecule made up of a methyl group single-
bonded to a carbonyl (CH3CO).
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Comments Received and AMS Responses
AMS received 16 comments in response to the proposed listing of
low-acyl gellan gum from a diverse audience, including: certified
operations, certifying agents, trade groups, substance manufacturers,
and the public. The subjects of these comments and responses from AMS
are covered in this section. AMS is finalizing the addition of low-acyl
gellan gum as drafted in the proposed rule.
The majority of commenters were in favor of adding low-acyl gellan
gum to the National List and agreed with the NOSB's recommendation.
Commenters supported the addition based on the absence of evidence that
low-acyl gellan gum is harmful to human health or the environment and
based on the FDA allowance of low-acyl gellan gum as a food additive.
Additionally, commenters stated this substance is necessary and would
support market development of organic products, due to the lack of
wholly natural thickeners with similar properties.
A few comments were opposed to the addition of the substance to the
National List. Two commenters expressed concern that a manufacturer of
low-acyl gellan gum petitioned for the addition to the National List
and stood to benefit from inclusion of the substance. Another commenter
was opposed due to the processed nature of the substance.
AMS notes that the National List is an optional list of generic
substances that an operation may use in their products. Petitions to
amend the National List may be submitted by any person, and substances
on the National List may be produced by any manufacturer. Furthermore,
OFPA expressly permits nonorganic ingredients in organic handling,
including synthetic ingredients included on the National List for use
in organic processed products. These individual synthetic ingredients
must meet the criteria in OFPA (e.g., not harmful to human health and
the environment), as evaluated by the NOSB and AMS, and undergo
rulemaking to add them to the National List. The NOSB and AMS evaluated
low-acyl gellan gum and determined that it met the statutory
requirements for addition to the National List.
Some commenters misperceived the proposed rule as allowing low-acyl
gellan gum for use by farmers in organic crop production. AMS does not
respond to these comments, as the rule does not allow low-acyl gellan
gum in crop production. The rule allows use of low-acyl gellan gum in
organic handling (i.e., processing). One of these commenters expressed
concern with negative health effects associated with overconsumption of
gellan gum and mentioned an unnamed animal study.
After review of the comment, AMS concluded that allowance of low-
acyl gellan gum is not likely to be harmful to human health. First,
gellan gum is listed by the Food & Drug Administration (FDA) as a safe
food additive permitted for direct addition to food for human
consumption at 21 CFR 172.665. The FDA requires prescribed conditions
for its safe use, including following good manufacturing practices (21
CFR 172.665(e)). Additionally, the rule only allows limited use of low-
acyl gellan gum, as allowed synthetic substances cannot be used at
levels greater than 5 percent (by weight or
[[Page 68023]]
fluid volume, excluding water and salt) in products labeled ``organic''
(Sec. 205.301(b)). As a food additive, low-acyl gellan gum will be
used to thicken, gel, and stabilize processed organic products.
AMS Review
As described in the BACKGROUND section, OFPA establishes what may
be included on the National List and the procedures that AMS must
follow to amend the National List. As directed by OFPA, AMS must show
that a substance: is not harmful to human health or the environment; is
necessary for handling because of the unavailability of wholly natural
substitute products; and is consistent with organic handling. OFPA also
describes the NOSB's responsibilities in recommending amendments to the
National List, including evaluation criteria.
First, AMS agrees with the classification of low-acyl gellan gum as
a ``synthetic'' substance, as the process of removing acetyl groups by
deacetylation fits the definition of ``synthetic'' at 7 CFR 205.2 and 7
U.S.C. 6502 and as described in AMS published guidance on the
classification of materials.\7\
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\7\ National Organic Program, NOP 5033 Classification of
Materials, guidance, December 2, 2016, https://www.ams.usda.gov/sites/default/files/media/NOP-5033.pdf.
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AMS also concludes that the addition of low-acyl gellan gum to the
National List is consistent with the requirements of OFPA (7 U.S.C.
6517(c)(1)(A)). While NOSB determined that low-acyl gellan gum had
minimal adverse effects on the environment and human health, AMS
determined there is no impact. First, low-acyl gellan gum is not
harmful to human health or the environment, as gellan gum is listed by
the Food & Drug Administration (FDA) as a food additive permitted for
direct addition to food for human consumption at 21 CFR 172.665.
Additionally, gellan gum is allowed as an inert ingredient in minimum
risk pesticides (i.e., pesticide products exempt from the requirements
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)) by
the U.S. Environmental Protection Agency (EPA) at 40 CFR
152.25(f)(2)(iv)). Second, low-acyl gellan gum is necessary because of
the absence of wholly natural substitute products, as evidenced by
public comment submitted to the NOSB and as reported in the 2018
technical report. Finally, the use of low-acyl gellan gum is consistent
with organic handling. This amendment follows the NOSB recommendation
according to the procedures established in OFPA (7 U.S.C. 6517(d)).
B. Paper-Based Crop Planting Aids (Sec. 205.601(o)(2))
Section 205.601(o) Synthetic production aids allowed for use in
organic crop production
Overview
This rule amends the National List to add paper-based crop planting
aids to 7 CFR 205.601 as a synthetic substance allowed for use in
organic crop production. This rule also adds a definition for paper-
based crop planting aids to the USDA organic regulations (Sec. 205.2,
Terms defined). Together, these amendments allow use of paper-based
crop planting aids, including those that are placed in or on the soil
and later incorporated into the soil.
AMS is finalizing this amendment to the National List, as
recommended by the NOSB after its April 2021 meeting,\8\ to provide
certified operations an additional tool for planting or transplanting
crops. Paper-based crop planting aids (e.g., individual pots, chain
pots, seed tape, collars) provide an alternative to the slower and more
costly method of planting or transplanting individual crops by hand.
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\8\ National Organic Standards Board, Formal Recommendation,
paper-based crop planting aids, April 30, 2021, https://www.ams.usda.gov/sites/default/files/media/CSPaperBasedCropPlantingAids_FinalRec.pdf.
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NOSB Review and Recommendation
Following review of a petition submitted in August 2018,
9 10 the NOSB recommended adding paper-based crop planting
aids to the National List and recommended a regulatory definition of
these products. In their evaluation of paper-based crop planting aids,
the NOSB considered comments from the public, a commissioned technical
report on paper-pots and containers,\11\ previously commissioned
technical reports on newspaper,12 13 and the petition
itself. The NOSB discussed the petition to amend the National List in
subcommittee calls and at its public meetings in October 2018,\14\
April and October 2019, 15 16 April and October 2020,\17\
and April 2021.\18\
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\9\ Petition for hemp paper or other paper, without glossy or
colored inks, as a plant pot or growing container, Small Farm Works,
National List Petition, August 7, 2018, https://www.ams.usda.gov/sites/default/files/media/PaperPotorContainerPetition080718.pdf.
\10\ Petition Addendum Regarding Paper Pot Adhesives, Small Farm
Works, National List Petition, October 2, 2018, https://www.ams.usda.gov/sites/default/files/media/PetitionAdendumPaperPots10022018.pdf.
\11\ National Organic Program, Paper Pots and Containers,
Nexight Group and Organic Materials Review Institute, technical
report, July 26, 2019, https://www.ams.usda.gov/sites/default/files/media/PaperTRFinal7262019.pdf.
\12\ National Organic Program, Newspaper or Other Recycled
Paper, ICF Consulting, technical report, January 27, 2006, https://www.ams.usda.gov/sites/default/files/media/Newspaper%20TR%202006.pdf.
\13\ National Organic Program, Newspaper or Other Recycled
Paper, Organic Materials Review Institute, technical report, January
11, 2017, https://www.ams.usda.gov/sites/default/files/media/Newspaper%20TR%20Final%2001%2011%2017.pdf.
\14\ National Organic Standards Board (NOSB) Meeting--St. Paul,
MN, National Organic Standards Board, October 24, 2018, https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-st-paul-mn.
\15\ National Organic Standards Board (NOSB) Meeting--Seattle,
WA, National Organic Standards Board, April 24, 2019, https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-seattle-wa.
\16\ National Organic Standards Board (NOSB) Meeting--
Pittsburgh, PA, National Organic Standards Board, October 23, 2019,
https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-pittsburgh-pa.
\17\ National Organic Standards Board (NOSB) Meeting--Virtual,
National Organic Standards Board, April 29, 2020, https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-crystal-city-va.
\18\ National Organic Standards Board (NOSB) Meeting--Virtual,
National Organic Standards Board, April 28, 2021, https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-crystal-city-va-0.
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After their evaluation, the NOSB concluded that adding paper-based
crop planting aids to the National List is consistent with evaluation
criteria in OFPA (7 U.S.C. 6518(m)). The NOSB found that the use of
paper-based crop planting aids is compatible with organic crop
production and provides benefits compared to planting or transplanting
crops by hand. The NOSB recommended classifying paper-based crop
planting aids as ``synthetic'' due to the manufacturing process. As
defined by OFPA and the USDA organic regulations, a synthetic substance
is produced by a chemical process or by a process that chemically
changes a natural substance (7 U.S.C. 6502(22) and 7 CFR 205.2).
Manufacturing paper includes breaking down wood chips into paper pulp
through either acidic or alkaline chemical reactions, so it meets this
definition of ``synthetic''. Additionally, paper is classified as
synthetic for other uses on the National List (Sec. 205.601).
Comments Received and AMS Responses
AMS received 38 comments in response to the proposed listing of
paper-based crop planting aids. Most comments supported the addition of
paper-based crop planting aids for organic crop production to the
National List. Many comments were from
[[Page 68024]]
certified organic operations. Commenters supported the use of paper-
based crop planting aids on account of improved efficiency in
transplanting crops. Commenters indicated that these products would
allow smaller operations to exponentially increase planting efficiency
and save money on labor while retaining organic certification. Many
commenters also cited the environmental benefit of reduced plastic
waste, as paper-based crop planting aids could replace plastic seedling
trays and pots.
The subjects of public comments and responses from AMS are
described below. The rule makes minor modifications to the definition
of ``paper-based crop planting aids'' (Sec. 205.2) and to introductory
language in the National List (Sec. 205.601) to clarify the intent and
meaning of the amendments. These comments and changes are discussed
below.
Several commenters, including certifying agents, material review
organizations, and trade groups, recommended removal of the last
sentence in the proposed definition for ``paper-based crop planting
aids'': ``Added nutrients must comply with Sec. Sec. 205.105, 205.203,
and 205.206''. The commenters indicated that the statement was unclear,
inaccurate, and/or unnecessary. They indicated that certified organic
crop operations are already required to comply with overarching
requirements in the USDA organic regulations related to allowed and
prohibited substances, methods, and ingredients (Sec. 205.105) as well
as requirements related to soil fertility and crop nutrient management
(Sec. 205.203). They argued that references to these sections of the
USDA organic regulations would therefore be redundant. Commenters also
indicated that the reference to crop pest, weed, and disease management
practice standards (Sec. 205.206) would be inappropriate because that
section of the regulations does not relate to ``nutrients''.
AMS agrees with the commenters that the references to Sec. Sec.
205.105, 205.203 and 205.206 within the definition of ``paper-based
crop planting aid'' are unnecessary. Sections 205.105 and 205.203 apply
to all certified organic crop operations, and reference to the crop
pest, weed, and disease management practice standards (Sec. 205.206)
is not relevant or necessary to the definition. AMS has modified the
definition of ``paper-based crop planting aid'' in this rule to remove
these references from the definition.
One commenter suggested an update to the regulatory text found in
the introduction to the crop substances section of the National List
(Sec. 205.601). The current language here exempts certain categories
of synthetic substances on the National List from certain provisions of
the USDA organic regulations, specifically, the requirements to first
use crop pest, weed, and disease preventive practices and nonsynthetic
substances prior to the use of synthetic substances on the National
List. For example, synthetic compost feedstocks, plant and soil
amendments, plant growth regulators, and floating agents used in
postharvest handling, are currently allowed in organic crop production
without regard to these preventive practices. The commenter suggested
that AMS update the language to clarify that crop production aids,
including paper-based crop planting aids, may also be used without
regard to those preventive practices. A commenter also suggested that
AMS should clarify that fatty alcohols containing allowed synthetic
inert ingredients (Sec. 205.601(m)) are similarly exempt.
AMS agrees that the introductory text at Sec. 205.601 should be
updated to include crop production aids as exempt from the provisions
set forth in Sec. 205.206(a) through (d). Crop production aids
specifically included at Sec. 205.601(o) may be used by producers
without first considering other alternative practices or nonsynthetic
substances for preventing crop pests, weeds, and diseases. For example,
paper-based chain pots are used to transplant seedlings into a field.
It would be confusing and impractical for the USDA organic regulations
to first require the use of transplanting by hand, or first require the
use of nonsynthetic substances, prior to allowing use of paper-based
chain pots. The rule updates the introductory text for this section of
the National List (the specific modifications to the regulatory text
can be found at the bottom of this document). AMS is not updating the
text to address the comment related to fatty alcohols containing inert
ingredients, as the substance was not included or discussed as part of
the proposed rule. AMS may consider additional changes to the
introductory text for this section of the National List in a future
proposed rule.
In the proposed rule, AMS specifically requested public comment on
the interpretation of the wording in the proposed definition that
references the qualifications of people tasked with determining the
biobased content of these products. As discussed in the proposed rule,
AMS interprets ``qualified personnel'' to be a third-party (i.e.,
certifying agent or material review organization, see NOP Program
Handbook NOP 3012 ``Material Review--Interim Instruction'' ) \19\
capable and qualified to make limited biobased determinations. AMS
stated that if the biobased nature of the ingredients were clear (e.g.,
a product composed entirely of paper and coconut coir), then the review
of the product could be performed by qualified personnel without a
laboratory test (ASTM D6866). A discussion of comments received on this
topic follows. The rule makes no changes related to ``qualified
personnel''.
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\19\ National Organic Program, NOP 3012 Material Review, Interim
Instruction, August 30, 2016, https://www.ams.usda.gov/sites/default/files/media/NOP%203012%20Material%20Review.pdf.
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Several commenters, including certifying agents, material review
organizations, and trade groups, agreed that ``qualified personnel''
would include certifying agents and material review organizations. Of
these commenters, a certifying agent and material review organization
expressed confidence in their ability to evaluate the biobased content
of some paper-based crop planting aids outside of an ASTM D6866
laboratory result. Several paper-based crop planting aid manufacturers
also submitted comments. These manufacturers indicated that they
currently produce products that meet the composition requirements. Some
stated that they plan to work with a material review organization to
verify compliance with the USDA organic regulations following
publication of this rule.
One commenter, a certifying agent, expressed concern that the
definition lacked clarification on what constitutes ``qualified
personnel''. This commenter also expressed overall concerns with the
composition requirements. The commenter stated that they deviate
significantly from current industry standards and practices, as no
products currently available cite third-party standards or provide
detailed information on the percentage of biobased or cellulose
content. This commenter indicated that the detailed requirements
regarding cellulose and biobased content would require both product
manufacturers and certifying agents to perform multiple calculations,
demanding more time and expense of certifying agents without affording
significant tangible benefits to organic integrity. This commenter
requested that AMS clearly set out minimum qualifications to meet the
definition of ``qualified personnel'' and specify methods to be used to
determine
[[Page 68025]]
biobased content outside of an ASTM D6866 laboratory result.
AMS appreciates the public comments in response to AMS's questions
set forth in the proposed rule. AMS is not making additional changes
from the proposed rule in this rule regarding ``qualified personnel''.
Formulation review of products composed of allowed substances is a
common practice among certifiers and material review organizations to
ensure that products are compliant with the USDA organic regulations.
If the biobased nature of the ingredients is unclear, then the
composition of the product should be determined by a laboratory test
(ASTM D6866). AMS expects much of the paper-based crop planting aids
review process to fit into current product formulation evaluation
processes and via the ASTM D6866 standard. AMS encourages certifying
agents and material review organizations and other qualified third
parties to consult guidance previously set forth by AMS, which
encourages certifying agents to consult with each other regarding
material review.\19\
One commenter expressed concern with specific reference to only
synthetic substances allowed as plant or soil amendments--on the
National List at Sec. 205.601(j))--in the definition of ``paper-based
crop planting aids.'' This commenter suggested that it is not necessary
to refer to these substances because material reviewers should review
added ingredients against the relevant subsection of the National List.
AMS disagrees with the suggestion to remove reference to synthetic
substances allowed as plant and soil amendments (Sec. 205.601(j)) from
the definition, thereby allowing the inclusion of any synthetic
substances on the National List for organic crop production. The rule
aligns with the NOSB's recommendation on this topic. During the
development of their recommendation, the NOSB considered whether the
non-cellulose content of these products could include synthetic pest
and disease control substances from the National List. The NOSB
discarded this option, stating, for example, that pesticides embedded
in these products could have adverse impacts on biodiversity.
AMS agrees that organic producers may only use synthetic substances
on the National List for crop pest, weed, and disease control when
other practices (see Sec. 205.206) are insufficient to prevent or
control crop pests, weeds, and diseases. The rule does not allow
synthetic pesticides in paper-based crop planting aids, as inclusion of
these substances would likely lead to prophylactic use of synthetic
substance(s). The use of synthetic substances in this manner is not
permitted by the USDA organic regulations (Sec. 205.206(e)).
In accordance with the NOSB recommendation, the rule only permits
the addition of the following synthetic substances in paper-based crop
planting aids: substances on the National List in Sec. 205.601(j) as
plant and soil amendments; and ingredients used in strengthening
fibers, adhesives, or resins.
One commenter opposed the allowance of synthetic strengthening
fibers, adhesives, and resins in the definition of paper-based crop
planting aids. The commenter indicated that the synthetic allowances
are unnecessary and that the proposed composition requirements would
not drive manufacturers to develop products with fewer synthetic
ingredients. They indicated that a pot, made from only paper, could be
dipped in natural rubber and yield the same labor-saving advantages as
the proposed paper-based crop planting aids.
AMS disagrees with prohibiting synthetic strengthening fibers,
adhesives, and resins. First, as outlined in the OVERVIEW section,
paper-based crop planting aids include not only individual pots but
also products such as chain pots, seed tape, and collars. Second,
paper-based crop planting aids require strengthening additives to
increase ``wet strength'' so that they will not breakdown prior to
transplanting. These additional synthetic substances allow paper-based
crop planting aids to hold their structure and resist breakdown in the
presence of water, soil media, and plant roots.\11\
One commenter urged AMS to update the reference to the ASTM
standard ASTM D6866 in future rulemaking, as incorporated into the USDA
organic regulations by reference (see Sec. 205.3, Incorporation by
reference). They also urged AMS to include regular review of the
incorporated references listed in Sec. 205.3, such as when National
List substances go through the sunset review process.
AMS recognizes that the standards incorporated into the USDA
organic regulations by reference are subject to change over time, and
AMS understands a newer version of the ASTM D6866 standard has been
adopted by ASTM (currently ASTM D6866-22, adopted in 2022 compared to
ASTM D6866-12 referenced in the USDA organic regulations and adopted in
2012). AMS intends to update the reference to ASTM D6866-12 and to
other references (Sec. 205.3) in future rulemaking.
AMS Review
AMS concludes that adding paper-based crop planting aids to the
National List is consistent with the requirements of OFPA (7 U.S.C.
6517(c)(1)(A)), and this amendment adopts the NOSB recommendation
according to OFPA procedures (7 U.S.C. 6517(d)). Paper-based crop
planting aids appear to be necessary due to the lack of wholly
nonsynthetic (natural) substitute products. Additionally, paper-based
crop planting aids are expected to readily break down in the soil and
do not appear to be harmful to human health or the environment when
used for crop planting or transplanting purposes. This conclusion is
supported by the presence of paper on EPA's list of ``inert ingredients
permitted in minimum risk pesticide products'' at 40 CFR
152.25(f)(2)(iv). Furthermore, the addition of paper for these uses is
consistent with the other allowed uses of paper under the USDA organic
regulations, namely, as a mulch (7 CFR 205.601(b)(2)(i)) and compost
feedstock (Sec. 205.601(c)). AMS also notes and agrees with comments
that allowance of paper-based crop planting aids could reduce use of
plastic, thereby providing an environmental benefit.
Finally, AMS agrees with the NOSB's classification of paper-based
crop planting aids as a ``synthetic'' substance, as the acid-base
reactions included in the kraft process of manufacturing paper, as well
as the inclusion of additional synthetic substances to improve
performance, fit the definition of ``synthetic'' as described in the
USDA organic regulations (7 CFR 205.2) and AMS published guidance on
the classification of materials.\7\
C. Wood Rosin (sic. Resin; Sec. 205.605(a))
Section 205.605(a) Nonagricultural nonsynthetic substances allowed
as ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).''
Overview
This rule amends the National List to update the spelling of ``wood
resin'' to ``wood rosin'' in the definition of ``waxes'' at 7 CFR
205.605(a).
NOSB Review and Recommendation
Following the 2022 sunset review for wood resin, the NOSB
recommended a correction to the spelling of ``wood resin'' (to ``wood
rosin'') on the National List. ``Wood resin'' is currently included on
the National List as an allowed nonorganic substance in or on processed
products labeled as ``organic'' or ``made with organic (specified
ingredients or
[[Page 68026]]
food group(s)).'' \20\ The NOSB stated in this recommendation that
``wood rosin'' is the more accurate and current spelling and that AMS
should replace the word ``resin'' with ``rosin''. The NOSB discussed
the recommendation for this technical correction in subcommittee calls
and at its public meeting in October 2020.\5\
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\20\ National Organic Standards Board, formal recommendation,
handling 2022 sunset reviews, October 30, 2020, https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf.
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AMS Review and Comments Received
AMS concludes that ``resin'' can also refer to ``rosin''--as noted
by AMS in a 1997 proposed rule (62 FR 65850, December 16, 1997)--but
AMS agrees ``rosin'' is the preferred term because it is more specific
to the wood product and aligns more closely with the use of the term in
the market. Additionally, the spelling ``rosin'' more closely aligns
with FDA (21 CFR 178.3870, Rosins and rosin derivatives) and World
Health Organization definitions for food-grade rosin.\21\ AMS does not
expect this spelling modification to have any impact on organic
handlers.
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\21\ Joint FAO/WHO Expert Committee on Food Additives. (1975).
Toxicological Evaluation of Some Food Colours, Enzymes, Flavour
Enhancers, Thickening Agents, and Certain Food Additives (No. 6).
World Health Organization.
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AMS received six comments in response to the proposed technical
correction of ``wood resin'' to ``wood rosin''. All public submissions
supported the correction. The rule replaces the term ``Wood resin''
with ``Wood rosin'' at 7 CFR 205.605(a).
Related Documents
AMS published notices in the Federal Register announcing the Fall
2020 NOSB Meeting (85 FR 54343, September 1, 2020) and announcing the
Spring 2021 NOSB meeting (86 FR 10161, February 18, 2021). These
notices invited public comments on the NOSB recommendations addressed
in this rule. The AMS proposed rule, which preceded this rule, was
published on February 1, 2022 (87 FR 5424).
Statutory and Regulatory Authority
OFPA authorizes the Secretary to make amendments to the National
List based on recommendations developed by the NOSB. OFPA authorizes
the NOSB to develop recommendations for submission to the Secretary to
amend the National List and to establish a process by which persons may
petition the NOSB for the purpose of having substances evaluated for
inclusion on or deletion from the National List (7 U.S.C. 6518(k) and
(n)). Section 205.607 of the USDA organic regulations permits any
person to petition to add or remove a substance from the National List
and directs petitioners to obtain the petition procedures from USDA (7
CFR 205.607). The current petition procedures published in the Federal
Register (81 FR 12680, March 10, 2016) for amending the National List
can be accessed through the NOP Program Handbook on the AMS website at
https://www.ams.usda.gov/rules-regulations/organic/handbook.
Executive Orders 12866 and 13563 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. 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 lieu of preparing an analysis, if the rulemaking is not
expected to have a significant economic impact on a substantial number
of small entities.
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.\22\
The SBA classifies small agricultural producers that engage in crop and
animal production as those with average annual receipts of less than $2
million (13 CFR 121.201). Handlers are involved in a broad spectrum of
food production activities and fall into various categories in the
NAICS Food Manufacturing sector. The small business thresholds for food
manufacturing operations are based on the number of employees and range
from 500 to 1,250 employees, depending on the specific type of
manufacturing. Certifying agents fall under the NAICS subsector ``all
other professional, scientific and technical services.'' For this
category, the small business threshold is average annual receipts of
less than $17 million.
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\22\ U.S. Small Business Administration (SBA), Table of Small
Business Size Standards Matched to North American Industry
Classification System Codes, May 2, 2022, https://www.sba.gov/document/support-table-size-standards.
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Producers. AMS has considered the economic impact of this
rulemaking on small agricultural entities. Data collected by the USDA
National Agricultural Statistics Service (NASS) and the NOP indicate
most of the certified organic production operations in the United
States would be considered small entities. According to the 2019
Certified Organic Survey, 16,524 organic farms in the United States
reported total sales of organic products and total farmgate sales more
than $9.9 billion.\23\ Based on that data, organic sales average
$601,000 per farm. Assuming a normal distribution of producers, we
expect that most of these producers would fall under the $2 million
sales threshold to qualify as a small business.
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\23\ USDA, National Agricultural Statistics Service (NASS), 2017
Census of Agriculture, Volume 1, Chapter 1 US, https://www.nass.usda.gov/Publications/AgCensus/2017/Full_Report/Volume_1,_Chapter_1_US/.
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Handlers. According to the NOP's Organic Integrity Database (OID),
there are 10,896 U.S.-based organic handlers that are certified under
the USDA organic regulations.\24\ The Organic Trade Association's 2021
Organic Industry Survey has information about employment trends among
organic manufacturers.\25\ The reported data are stratified into three
groups by the number of employees per company: fewer than 5; 5 to 49;
and 50 plus. These data are representative of the organic manufacturing
sector, and the lower bound (50) of the range for the larger
manufacturers is notably smaller than the SBA's small business
thresholds (500 to 1,250). Therefore, AMS expects that most organic
handlers would qualify as small businesses.
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\24\ USDA, Agricultural Marketing Service, Organic Integrity
Database, Accessed June 9, 2022, https://organic.ams.usda.gov/Integrity/.
\25\ Organic Trade Association (OTA), U.S. Organic Industry
Survey 2021, available for purchase from https://ota.com/market-analysis/organic-industry-survey/organic-industry-survey.
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Certifying agents. The SBA defines ``all other professional,
scientific, and technical services,'' which include certifying agents,
as those having annual receipts of less than $17 million (13 CFR
121.201). There are currently 75 USDA-accredited certifying agents,\24\
based on a query of the OID database, who provide organic certification
services to producers and handlers. While many certifying agents are
small entities that would be affected by this rule, we do not expect
that these certifying agents would incur significant costs as a result
of this action, as certifying agents already must comply with the
current
[[Page 68027]]
regulations (e.g., maintaining certification records for organic
operations).
AMS concludes that this rule will not have any significant economic
impact on small entities or affect a substantial number of small
entities. The effect of this rule is that additional substances will be
allowed in organic handling and organic crop production (low-acyl
gellan gum and paper-based crop planting aids). The allowance of these
substances will provide entities, including small entities, with more
options in their day-to-day operations.
Executive Order 12988
Executive Order 12988 instructs each executive agency to adhere to
certain requirements in the development of new and revised regulations
in order to avoid unduly burdening the court system. This rule is not
intended to have a retroactive effect. Accordingly, to prevent
duplicative regulation, states and local jurisdictions are preempted
under OFPA from creating programs of accreditation for private persons
or state officials who want to become certifying agents of organic
farms or handling operations. A governing state official would have to
apply to the USDA to be accredited as a certifying agent, as described
in OFPA (7 U.S.C. 6514(b)). States are also preempted from creating
certification programs to certify organic farms or handling operations
unless the state programs have been submitted to, and approved by, the
Secretary as meeting the requirements of OFPA (7 U.S.C. 6503-6507).
Pursuant to OFPA (7 U.S.C. 6507(b)(2)), a state organic
certification program that has been approved by the Secretary may,
under certain circumstances, contain additional requirements for the
production and handling of agricultural products organically produced
in the state and for the certification of organic farm and handling
operations located within the state. Such additional requirements must
(a) further the purposes of OFPA, (b) not be inconsistent with OFPA,
(c) not be discriminatory toward agricultural commodities organically
produced in other States, and (d) not be effective until approved by
the Secretary.
In addition, pursuant to 7 U.S.C. 6519(c)(6), this rule does not
supersede or alter the authority of the Secretary under the Federal
Meat Inspection Act (21 U.S.C. 601-624), the Poultry Products
Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act
(21 U.S.C. 1031-1056) concerning meat, poultry, and egg products,
respectively, nor any of the authorities of the Secretary of Health and
Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C.
301 et seq.), nor the authority of the Administrator of the EPA under
the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et
seq.).
Paperwork Reduction Act
Routine collection, reporting, and recordkeeping related to the use
of substances on the National List is included in NOP's approved
information collection request (OMB control number 0581-0191). No
additional collection or recordkeeping requirements are imposed on the
public by this rule. Accordingly, OMB clearance is not required by the
Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35.
Executive Order 13175
This rule has been reviewed under Executive Order 13175--
Consultation and Coordination with Indian Tribal Governments. 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 reviewing this rule, the Office of Tribal Relations (OTR) has
determined that tribal consultation is not required. If a tribe
requests consultation in the future, AMS will work with OTR to ensure
meaningful consultation is provided.
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 rule conforms with the principles of
federalism described in Executive Order 13132. The rule does not impose
substantial direct costs or effects on States, does not alter the
relationship between States and the Federal Government, and it does not
alter the distribution of powers and responsibilities among the various
levels of government. States had the opportunity to comment on the
proposed rule. No States provided public comment on the federalism
implications of this rule. Therefore, AMS has concluded that this rule
does not have federalism implications.
Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a major rule, as defined by 5 U.S.C. 804(2).
General Notice of Public Rulemaking
This rule reflects recommendations submitted by the NOSB to the
Secretary to add two substances to the National List and updates the
spelling of one substance on the National List.
List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agricultural commodities,
Agriculture, Animals, Archives and records, Fees, Imports, Labeling,
Livestock, Organically produced products, Plants, Reporting and
recordkeeping requirements, Seals and insignia, Soil conservation.
For the reasons set forth in the preamble, AMS amends 7 CFR part
205 as follows:
PART 205--NATIONAL ORGANIC PROGRAM
0
1. The authority citation for 7 CFR part 205 continues to read as
follows:
Authority: 7 U.S.C. 6501-6524.
0
2. Amend Sec. 205.2 by adding, in alphabetical order, a definition for
``Paper-based crop planting aid'' to read as follows:
Sec. 205.2 Terms defined.
* * * * *
Paper-based crop planting aid. A material that is comprised of at
least 60% cellulose-based fiber by weight, including, but not limited
to, pots, seed tape, and collars that are placed in or on the soil and
later incorporated into the soil, excluding biodegradable mulch film.
Up to 40% of the ingredients can be nonsynthetic, other permitted
synthetic ingredients in Sec. 205.601(j), or synthetic strengthening
fibers, adhesives, or resins. Contains no less than 80% biobased
content as verified by a qualified third-party assessment (e.g.,
laboratory test using ASTM D6866 or composition review by qualified
personnel).
* * * * *
[[Page 68028]]
0
3. Amend Sec. 205.601 by revising the introductory text and paragraph
(o) to read as follows:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
In accordance with restrictions specified in this section, the
following synthetic substances may be used in organic crop production:
Provided, That, use of such substances do not contribute to
contamination of crops, soil, or water. Substances allowed by this
section, except disinfectants and sanitizers in paragraph (a) and those
substances in paragraphs (c), (j), (k), (l), and (o) of this section,
may only be used when the provisions set forth in Sec. 205.206(a)
through (d) prove insufficient to prevent or control the target pest.
* * * * *
(o) Production aids.
(1) Microcrystalline cheesewax (CAS #'s 64742-42-3, 8009-03-08, and
8002-74-2)--for use in log grown mushroom production. Must be made
without either ethylene-propylene co-polymer or synthetic colors.
(2) Paper-based crop planting aids as defined in Sec. 205.2.
Virgin or recycled paper without glossy paper or colored inks.
* * * * *
0
4. Amend Sec. 205.605 by:
0
a. In paragraph (a):
0
i. In the heading, removing the colon and adding a period in its place.
0
ii. Designating the entries as paragraphs (a)(1) through (30).
0
iii. Revising newly designated paragraph (a)(29).
0
b. In paragraph (b):
0
i. In the heading, removing the colon and adding a period in its place.
0
ii. Designating the entries as paragraphs (b)(1) through (36).
0
iii. Further redesignating newly designated paragraphs (b)(12)i.
through iv. as paragraphs (b)(12)(i) through (iv).
0
iv. Redesignating newly designated paragraphs (b)(18) through (36) as
paragraphs (b)(19) through (37).
0
v. Adding new paragraph (b)(18).
The revision and addition 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)).''
* * * * *
(a) * * *
(29) Waxes--nonsynthetic (Wood rosin).
* * * * *
(b) * * *
(18) Low-acyl gellan gum.
* * * * *
Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2022-24111 Filed 11-10-22; 8:45 am]
BILLING CODE P