Amendments to the National List of Allowed and Prohibited Substances per October 2020 and April 2021 NOSB Recommendations (Handling, Crops), 68021-68028 [2022-24111]

Agencies

• Agricultural Marketing Service
• DEPARTMENT OF AGRICULTURE

[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
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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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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/.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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