Proposed Rule2022-01915
National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances per October 2020 and April 2021 NOSB Recommendations (Handling, Crop)
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Published
February 1, 2022
Issuing agencies
Agriculture DepartmentAgricultural Marketing Service
Abstract
The U.S. Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) proposes amendments to the National List of Allowed and Prohibited Substances (National List) section of the USDA's organic regulations to implement recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board (NOSB). This rule proposes to add low-acyl gellan gum, a food additive used as a thickener, gelling agent, and stabilizer; and paper- based crop planting aids to the National List, along with a definition of paper-based crop planting aids. If finalized, low-acyl gellan gum would be allowed as an ingredient in processed organic products, and paper-based crop planting aids would be allowed in organic crop production. The rule also proposes the correction of a spelling error on the National List to change "wood resin" to "wood rosin".
Full Text
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<title>Federal Register, Volume 87 Issue 21 (Tuesday, February 1, 2022)</title>
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[Federal Register Volume 87, Number 21 (Tuesday, February 1, 2022)]
[Proposed Rules]
[Pages 5424-5428]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01915]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-NOP-21-0060; NOP-21-02]
RIN 0581-AE11
National Organic Program; Proposed Amendments to the National
List of Allowed and Prohibited Substances per October 2020 and April
2021 NOSB Recommendations (Handling, Crop)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The U.S. Department of Agriculture's (USDA) Agricultural
Marketing Service (AMS) proposes amendments to the National List of
Allowed and Prohibited Substances (National List) section of the USDA's
organic regulations to implement recommendations submitted to the
Secretary of Agriculture (Secretary) by the National Organic Standards
Board (NOSB). This rule proposes to add low-acyl gellan gum, a food
additive used as a thickener, gelling agent, and stabilizer; and paper-
based crop planting aids to the National List, along with a definition
of paper-based crop planting aids. If finalized, low-acyl gellan gum
would be allowed as an ingredient in processed organic products, and
paper-based crop planting aids would be allowed in organic crop
production. The rule also proposes the correction of a spelling error
on the National List to change ``wood resin'' to ``wood rosin''.
DATES: Send comment on or before April 4, 2022.
ADDRESSES: You may send comments on this proposed rule to the Federal
eRulemaking Portal at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>. You can access this
proposed rule and instructions for submitting public comments by
searching for document number, AMS-NOP-21-0060. Comments may also be
sent to Jared Clark, Standards Division, National Organic Program, AMS,
USDA; 1400 Independence Ave. SW, Room 2642-So., Ag Stop 0268,
Washington, DC 20250-0268, or Email: <a href="/cdn-cgi/l/email-protection#511b302334357f123d30233a11242235307f363e27"><span class="__cf_email__" data-cfemail="7339120116175d301f12011833060017125d141c05">[email protected]</span></a>.
Instructions: All comments received must include the docket number
AMS-NOP-21-0060; NOP-21-02, and/or Regulatory Information Number (RIN)
0581-AE11 for this rulemaking. You should clearly indicate the topic
and section number of this proposed rule to which your comment refers,
state your position(s), offer any recommended language change(s), and
include relevant information and data to support your position(s)
(e.g., scientific, environmental, manufacturing, industry, or industry-
impact information, etc.). All comments and relevant background
documents posted to <a href="https://www.regulations.gov">https://www.regulations.gov</a> will include any
personal information provided.
FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division,
National Organic Program, 202-720-3252, <a href="/cdn-cgi/l/email-protection#440e253621206a072825362f04313720256a232b32"><span class="__cf_email__" data-cfemail="5a103b283f3e7419363b28311a2f293e3b743d352c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Secretary established the Agricultural
Marketing Service's (AMS) National Organic Program and the USDA organic
regulations (65 FR 80547). 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 (i.e., in organic ``handling'').
The Organic Foods Production Act of 1990 (OFPA) (7 U.S.C. 6501-
6524) establishes what may be included on the National List and the
procedures that the USDA must follow to amend the National List (Sec.
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 (Sec. 6518(m)). Section 205.607 of the
USDA organic regulations permits any person to petition to add or
remove a substance from the National List. The petition process is
described in further detail in the Statutory and Regulatory Authority
section below.
The NOSB submitted recommendations to the Secretary after the
conclusion of its public meetings on October 30, 2020 and April 30,
2021. In its 2020 \1\ and 2021 \2\ recommendations, the NOSB concluded
that adding paper-based crop planting aids and low-acyl gellan gum, a
food additive used as a thickener, gelling agent, and stabilizer, to
the National List was consistent with OFPA evaluation criteria (7
U.S.C. 6518(m)). This proposed rule addresses these NOSB
recommendations to add low-acyl gellan gum and paper-based crop
planting aids to the National List and to add a definition of paper-
based crop planting aids to Sec. 205.2 (Terms Defined).
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\1\ NOSB recommendation for low-acyl gellan gum, October 30,
2020. Available at: <a href="https://www.ams.usda.gov/sites/default/files/media/HSLowAcylGellanGumRec_webpost.pdf">https://www.ams.usda.gov/sites/default/files/media/HSLowAcylGellanGumRec_webpost.pdf</a>.
\2\ NOSB recommendation for paper-based crop planting aids,
April 30, 2021. Available at: <a href="https://www.ams.usda.gov/sites/default/files/media/CSPaperBasedCropPlantingAids_FinalRec.pdf">https://www.ams.usda.gov/sites/default/files/media/CSPaperBasedCropPlantingAids_FinalRec.pdf</a>.
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II. Overview of Proposed Amendments
The following provides an overview of the proposed amendments to
the National List, along with the NOSB and AMS justifications for each
proposed amendment. AMS welcomes comments on each proposed amendment.
Comments received during the comment period will inform AMS's decisions
for the final rule; specifically, whether the proposed amendments align
with OFPA criteria and are justified.
A. Low-Acyl Gellan Gum (Sec. 205.605(b))
AMS is proposing to add low-acyl gellan gum to the National List at
Sec. 205.605(b) as a nonagricultural, synthetic substance allowed for
use in organic handling. If finalized, low-acyl gellan gum would be
allowed as an ingredient in processed organic and ``made with organic''
products. This AMS proposal follows a recommendation to AMS from the
NOSB. The NOSB's recommendation was based on their review of CP Kelco's
August 2019 petition, <SUP>3 4</SUP> stakeholder comments, and a third-
party technical report.
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\3\ August 2019 low-acyl gellan gum petition: <a href="https://www.ams.usda.gov/sites/default/files/media/PetitionLowAcylGellanGum08082019.pdf">https://www.ams.usda.gov/sites/default/files/media/PetitionLowAcylGellanGum08082019.pdf</a>.
\4\ March 2020 low-acyl gellan gum petition: <a href="https://www.ams.usda.gov/sites/default/files/media/PetitionAddendum_LAGellanGum_ResponsetoNOSB_03062020.pdf">https://www.ams.usda.gov/sites/default/files/media/PetitionAddendum_LAGellanGum_ResponsetoNOSB_03062020.pdf</a>.
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Background
Gellan gums are used in food products as thickeners, gelling
agents, and stabilizers, and they can be used in products that require
gelling, texturizing, stabilizing, suspending, film-forming, and
structuring (e.g., capsules used for dietary supplements). The
petitioner argues that low-acyl gellan gum is necessary in organic
handling as it holds unique qualities not found in other thickener
substances on the National List, including: The ability to create a
stable fluid gel with suspended matter in beverages containing fruit
pulp or jelly pieces; product clarity not offered by high-acyl gellan
gum; heat stability in acid systems unlike carrageenan; the ability to
be used in standard processing without additional steps (e.g., compared
to pectin, which requires special handling in gelled confections); and
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providing a carrageenan-free, vegetarian alternative for hard and soft
capsules (e.g., dietary supplements).
As described in the third-party technical report,\5\ there are two
forms of gellan gum: High-acyl and low-acyl. High-acyl gellan gum is
listed on the National List (at Sec. 205.605(a)) as a nonsynthetic,
nonagricultural substance allowed in organic handling. To manufacture
the low-acyl form, high-acyl gellan gum is deacetylated using potassium
hydroxide and heat resulting in a synthetic substance per the
definition of ``synthetic'' at Sec. 205.2. Acid is then used to lower
the pH, and the low-acyl gellan gum is recovered from the solution by
alcohol precipitation.
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\5\ Gums technical report, 2018: <a href="https://www.ams.usda.gov/sites/default/files/media/GumsTRFinal20180130.pdf">https://www.ams.usda.gov/sites/default/files/media/GumsTRFinal20180130.pdf</a>.
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NOSB Recommendation
The NOSB recommended the addition of low-acyl gellan gum to the
National List, at Sec. 205.605(b), as a synthetic nonagricultural
substance allowed in organic handling. After the NOSB reviewed the low-
acyl gellan gum petition, a 2018 third-party technical report on gums,
and public comments, they determined that the petitioned use of low-
acyl gellan gum meets the OFPA criteria for inclusion in the National
List in accordance with 7 U.S.C. 6518(m). In the rationale supporting
their recommendation, the NOSB noted minimal adverse effects on the
environment and distinct properties of low-acyl gellan gum, including a
hard, non-elastic, brittle gel (unlike high-acyl gellan gum) and being
a vegetarian option for the manufacture of capsules used for dietary
supplements. The NOSB recommended that low-acyl gellan gum be
classified as ``synthetic,'' as the manufacturing process includes
deacetylation (the removal of acetyl group(s) from molecules), which is
a chemical change.
AMS Review of NOSB Recommendation
AMS agrees that low-acyl gellan gum appears to meet the
requirements for addition to the National List under 7 U.S.C.
6517(c)(1)(A). Public comments submitted to the NOSB and the 2018
third-party technical report indicate low-acyl gellan gum is necessary
due to the apparent unavailability of wholly natural substitute
products. Additionally, low-acyl gellan gum does not appear to be
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). AMS also agrees with the NOSB's recommendation to
classify low-acyl gellan gum as a ``synthetic'' substance because the
process of removing acetyl groups by the deacetylation portion meets
the definition of ``synthetic'' under Sec. 205.2.
As low-acyl gellan gum appears to meet the requirements at 7 U.S.C.
6517(c)(1)(A), AMS proposes the addition of low-acyl gellan gum to the
National List at 7 CFR 205.605(b) as a nonagricultural synthetic
substance allowed for use in ``organic'' and ``made with organic
(specified ingredients or food group(s))'' processed products.
B. Paper-Based Crop Planting Aids (Sec. 205.601(o)(2))
AMS is proposing to add paper-based crop planting aids to the
National List at Sec. 205.601(o)(2) as a synthetic substance allowed
for use in organic crop production and add a definition of paper-based
crop planting aids to Sec. 205.2 (Terms Defined). If finalized, paper-
based crop planting aids would be allowed in organic crop production.
This AMS proposal follows a recommendation to AMS from the NOSB from
their review of Small Farm Works and Stone Circle Farm's August 2018
petition,<SUP>6 7</SUP> a third-party technical report, and public
comment.
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\6\ August 2018 paper planting pots petition: <a href="https://www.ams.usda.gov/sites/default/files/media/PaperPotorContainerPetition080718.pdf">https://www.ams.usda.gov/sites/default/files/media/PaperPotorContainerPetition080718.pdf</a>.
\7\ August 2018 paper planting pots petition addendum: <a href="https://www.ams.usda.gov/sites/default/files/media/PetitionAdendumPaperPots10022018.pdf">https://www.ams.usda.gov/sites/default/files/media/PetitionAdendumPaperPots10022018.pdf</a>.
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Background
Paper-based crop planting aids are used to transplant closely
spaced crops, such as onions, beets, baby salad greens, etc. The
petitioner argued that paper-based crop planting aids are necessary in
organic crop production as they allow crop producers to replace the
slower and more costly method of transplanting by hand. These paper-
based crop planting aids, typically in the form of individual paper
pots or paper chain pots, are generally used by small scale farming
operations to transplant closely spaced crops using non-motorized
equipment.
As described in the 2019 Technical Report on paper-pots and
containers,\8\ most paper-based crop planting aids contain kraft-
manufactured paper, a synthetic substance. Paper-pots and other paper-
based crop planting aids also contain a variety of synthetic,
nonsynthetic, biobased, and/or biodegradable strengthening, adhesive
and binding, fiber reinforcement, and antimicrobial additives.
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\8\ Paper pots and containers technical report, 2019: <a href="https://www.ams.usda.gov/sites/default/files/media/PaperTRFinal7262019.pdf">https://www.ams.usda.gov/sites/default/files/media/PaperTRFinal7262019.pdf</a>.
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NOSB Recommendation
The NOSB recommended the addition of paper-based crop planting aids
to Sec. 205.2 Terms Defined as well as to the National List, at Sec.
205.601(o)(2), as a synthetic substance allowed in organic crop
production. The recommended definition is:
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 non-
synthetic, other permitted synthetic ingredients at 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). Added nutrients
must comply with Sec. 205.105, 205.203, and 205.206.
The NOSB recommended an annotated listing for paper-based crop
planting aids at Sec. 205.601(o)(2) as:
Production Aids: Paper-based crop planting aids as defined in
205.2. Virgin or recycled paper without glossy paper or colored
inks.
After the NOSB reviewed the paper-based crop planting aid petition,
a 2019 Technical Report on paper pots and containers, two January 2006
\9\ and January 2017 \10\ technical reports on newspaper, and public
comments, the NOSB determined that the petitioned use of paper-based
crop planting aids meets the OFPA criteria for allowed synthetic
substances in organic crop production at 7 U.S.C. 6518(m).
Specifically, the NOSB stated that allowing paper-based crop planting
aids will assist small farmers in growing organic crops that would
otherwise be prohibitive to grow due to the manual
[[Page 5426]]
labor involved in transplanting. The NOSB recommended that paper-based
crop planting aids be classified as ``synthetic,'' as the manufacturing
process includes acid-base chemical reactions.
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\9\ Newspaper or Other Recycled Paper, January 2006: <a href="https://www.ams.usda.gov/sites/default/files/media/Newspaper%20TR%202006.pdf">https://www.ams.usda.gov/sites/default/files/media/Newspaper%20TR%202006.pdf</a>.
\10\ Newspaper or Other Recycled Paper, January 2017: <a href="https://www.ams.usda.gov/sites/default/files/media/Newspaper%20TR%20Final%2001%2011%2017.pdf">https://www.ams.usda.gov/sites/default/files/media/Newspaper%20TR%20Final%2001%2011%2017.pdf</a>.
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AMS Review of NOSB Recommendation
AMS agrees with the NOSB recommendation on paper-based crop
planting aids, including: The classification of paper-based crop
planting aids as a ``synthetic'' substance, the recommended definition
of ``paper-based crop planting aid,'' and the annotation listing at
Sec. 205.601.
AMS determined that paper-based crop planting aids, as presented in
the recommended definition, appear to meet the requirements for
addition to the National List under 7 U.S.C. 6517(c)(1)(A). Paper-based
crop planting aids are expected to readily break down in the soil and
are not expected to be harmful to human health or the environment in
the amounts used for this purpose. This determination 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). Further,
paper-based crop planting aids appear to be necessary due to the lack
of wholly natural substitute products. Public comments and a 2019
third-party technical report also found that these planting aids were
consistent with organic farming, because a similar substance
(newspaper) is currently allowed as a mulch and/or compost feedstock,
and paper planting aids reduce plastic use.
AMS agrees with the 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'' under Sec. 205.2 and further described in
NOP 5033.\11\
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\11\ NOP 5033--Guidance: Classification of Materials: <a href="https://www.ams.usda.gov/sites/default/files/media/NOP-5033.pdf">https://www.ams.usda.gov/sites/default/files/media/NOP-5033.pdf</a>.
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AMS reviewed public comments submitted to the NOSB prior to the
October 2020 and April 2021 NOSB meetings. Many commentors requested
clarification on the term ``qualified personnel'' in the proposed
definition of Paper-based crop planting aid. AMS interprets ``qualified
personnel'' to be a third-party (i.e., certifier or material review
organization) capable and qualified to make limited biobased
determinations based on product-specific formulation. AMS views this
allowance as an alternative verification process when the biobased
nature of the ingredients is clear (e.g., a product composed entirely
of paper and coconut coir). AMS seeks comment on the interpretation of
``qualified personnel'' and the additional considerations outlined
within NOSB's recommendation.
As paper-based crop planting aids appear to meet the requirements
at 7 U.S.C. 6517(c)(1)(A), AMS proposes the following: An addition of a
definition of ``paper-based crop planting aids'' to 7 CFR 205.2, and
the addition of paper-based crop planting aids to the National List at
7 CFR 205.601(o)(ii) as a synthetic substance allowed for use in
organic crop production. The addition of paper-based crop planting aids
at Sec. 205.601(o)(2) would result in a redesignation of
microcrystalline cheesewax to Sec. 205.601(o)(1), with both present
under Sec. 205.601(o) ``As production aids.'' Additionally, in support
of the proposed definition, AMS will explore updating the reference to
ASTM D6866-12 at Sec. 205.3 to the current standard in a future
rulemaking.
C. Wood Rosin (sic. Resin; Sec. 205.605(a))
AMS is proposing a spelling correction to ``wood resin'' listed in
the definition of ``waxes'' at 7 CFR 205.605(b). In their sunset
recommendation \12\ for this substance, the Board noted that ``wood
resin'' is the incorrect term and that the corrected listing should
read ``wood rosin.'' Though it appears that resin can also refer to
rosin, AMS agrees that rosin is the preferred term because it is more
specific to the wood product and would provide more clarity on the
substance allowed.
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\12\ Formal Recommendation, 2022 Sunset Reviews--Handling,
October 30, 2020: <a href="https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf">https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf</a>.
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AMS proposes amending the listing at Sec. 205.605(a) ``Waxes--
nonsynthetic (Wood resin)'' to read ``Waxes--nonsynthetic (Wood
rosin)''.
III. Statutory and Regulatory Authority
The OFPA authorizes the Secretary to make amendments to the
National List based on recommendations developed by the NOSB. Sections
6518(k) and 6518(n) of the OFPA authorize the NOSB to develop
recommendations for submission to the Secretary to amend the National
List and 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. 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. 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 in ``Section I Other'' at <a href="https://www.ams.usda.gov/rules-regulations/organic/handbook">https://www.ams.usda.gov/rules-regulations/organic/handbook</a>.
A. Executive Order 12866 and Regulatory Flexibility Act
This proposed 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.\13\
The SBA has classified small agricultural producers that engage in crop
and animal production as those with average annual receipts of less
than $1,000,000. 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. For this category, the small business threshold is
average annual receipts of less than $16.5 million.
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\13\ Table of Small Business Size Standards Matched to North
American Industrial Classification System Codes, August 19, 2019:
<a href="https://www.naics.com/wp-content/uploads/2017/10/SBA_Size_Standards_Table.pdf">https://www.naics.com/wp-content/uploads/2017/10/SBA_Size_Standards_Table.pdf</a>.
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AMS has considered the economic impact of this proposed rulemaking
on
[[Page 5427]]
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 Census of Agriculture,
16,585 organic farms in the United States reported total sales of
organic products and total farmgate sales more than $9.9 billion.\14\
Based on that data, organic sales average just under $600,000 per farm.
Assuming a normal distribution of producers, we expect that most of
these producers would fall under the $1,000,000 sales threshold to
qualify as a small business.
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\14\ U.S. Department of Agriculture, National Agricultural
Statistics Service. 2019 Census of Agriculture. <a href="https://www.nass.usda.gov/Publications/AgCensus/2017/Online_Resources/Organics/ORGANICS.pdf">https://www.nass.usda.gov/Publications/AgCensus/2017/Online_Resources/Organics/ORGANICS.pdf</a>.
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According to the NOP's Organic Integrity Database, there are 19,059
organic handlers certified under the USDA organic regulations, as of
January 2021.\15\ The Organic Trade Association's 2020 Organic Industry
Survey has information about employment trends among organic
manufacturers. The reported data are stratified into three groups by
the number of employees per company: Less 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
significantly 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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\15\ Organic Integrity Database: <a href="https://organic.ams.usda.gov/Integrity/">https://organic.ams.usda.gov/Integrity/</a>. Accessed on January 29, 2021.
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The SBA defines small agricultural service firms, which include
certifying agents under the NAICS subsector ``All other professional,
scientific, and technical services,'' as those having annual receipts
of less than $16,500,000 (13 CFR 121.201). There are currently 77 USDA-
accredited certifying agents; based on a query of the NOP certified
organic operations database.\16\ While many certifying agents are small
entities that would be affected by this proposed rule, we do not expect
that these certifying agents would incur significant costs as a result
of this action. Certifying agents already must comply with the current
regulations, e.g., maintaining certification records for organic
operations.
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\16\ Organic Integrity Database, Certifier Locator: <a href="https://organic.ams.usda.gov/Integrity/Certifiers/CertifiersLocationsSearchPage.aspx">https://organic.ams.usda.gov/Integrity/Certifiers/CertifiersLocationsSearchPage.aspx</a>. Accessed February 25, 2021.
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The economic impact on entities affected by this rule would not be
significant. The effect of this rule, if implemented as final, would be
to allow the use of an additional substance in organic handling. Adding
a substance to the National List would increase regulatory flexibility
and would give small entities more tools to use in day-to-day
operations. Therefore, AMS concludes that the economic impact of this
addition, if any, would be minimal. Accordingly, USDA certifies that
this rule would not have a significant economic impact on a substantial
number of small entities.
B. Executive Order 12988
Executive Order 12988 instructs each executive agency to adhere to
certain requirements in the development of new and revised regulations
to avoid unduly burdening the court system. Accordingly, to prevent
duplicative regulation, states and local jurisdictions are preempted
under the 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 USDA to be accredited as a certifying agent, as
described in section 6514(b) of the OFPA. States are also preempted
under sections 6503 through 6507 of the OFPA from creating
certification programs to certify organic farms or handling operations
unless the state programs have been submitted to, and approved by, the
Secretary as meeting the requirements of the OFPA.
Pursuant to section 6507(b)(2) of the OFPA, a state organic
certification program that has been approved by the Secretary may,
under certain circumstances, contain additional requirements for the
production and handling of agricultural products organically produced
in the state and for the certification of organic farm and handling
operations located within the state. Such additional requirements must
(a) further the purposes of the OFPA, (b) not be inconsistent with the
OFPA, (c) not be discriminatory toward agricultural commodities
organically produced in other States, and (d) not be effective until
approved by the Secretary.
In addition, pursuant to section 6519(c)(6) of the OFPA, this
proposed rule would not supersede or alter the authority of the
Secretary under the Federal Meat Inspection Act (21 U.S.C. 601-624),
the Poultry Products Inspection Act (21 U.S.C. 451-471), or the Egg
Products Inspection Act (21 U.S.C. 1031-1056), concerning meat,
poultry, and egg products, respectively, nor any of the authorities of
the Secretary of Health and Human Services under the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 301 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.).
This proposed rule is not intended to have a retroactive effect.
C. Paperwork Reduction Act
No additional collection or recordkeeping requirements are imposed
on the public by this proposed rule. Accordingly, OMB clearance is not
required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501,
Chapter 35.
D. Executive Order 13175
This proposed 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: (1) Policies that have
tribal implication, including regulation, legislative comments, or
proposed legislation; and (2) other policy statements or actions that
have substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes.
AMS has assessed the impact of this proposed rule on Indian tribes
and determined that this rule would not have tribal implications that
require consultation under Executive Order 13175. AMS hosts a quarterly
teleconference with tribal leaders where matters of mutual interest
regarding the marketing of agricultural products are discussed.
Information about the proposed changes to the regulations will be
shared during an upcoming quarterly call, and tribal leaders will be
informed about the proposed revisions to the regulation and the
opportunity to submit comments. AMS will work with the USDA Office of
Tribal Relations to ensure meaningful consultation is provided as
needed with regards to the NOP regulations.
E. General Notice of Public Rulemaking
This proposed rule reflects recommendations submitted by the NOSB
to the Secretary to add two substances to the National List. A 60-day
period for interested persons to comment on this rule is provided.
List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agricultural commodities,
Agriculture, Animals, Archives and records; Fees, Imports, Labeling,
[[Page 5428]]
Livestock, Organically produced products, Plants, Reporting and
recordkeeping requirements, Seals and insignia, Soil conservation.
For the reasons set forth in the preamble, the Agricultural
Marketing Service proposes to amend 7 CFR part 205 as follows:
PART 205--NATIONAL ORGANIC PROGRAM
0
1. The authority citation for part 205 continues to read as follows:
Authority: 7 U.S.C. 6501-6524.
0
2. Amend Sec. 205.2 by adding, in alphabetical order, the definition
for ``Paper-based crop planting aid''.
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 at 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). Added nutrients must comply with Sec. Sec. 205.105,
205.203, and 205.206.
* * * * *
0
3. Amend Sec. 205.601 by revising paragraph (o) to read as follows:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
* * * * *
(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), revising the entry for ``Waxes''.
0
b. In paragraph (b), adding, in alphabetical order, an entry for ``Low-
acyl gellan gum.''.
The addition and revision to read as follows:
Sec. 205.605 Nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).''
* * * * *
(a) * * *
Waxes--nonsynthetic (Wood rosin).
* * * * *
(b) * * *
Low-acyl gellan gum.
* * * * *
Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2022-01915 Filed 1-31-22; 8:45 am]
BILLING CODE 3410-02-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.