[Federal Register Volume 86, Number 161 (Tuesday, August 24, 2021)]
[Proposed Rules]
[Pages 47242-47248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17835]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / 
Proposed Rules  

[[Page 47242]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number: AMS-NOP-19-0106; NOP-19-03]
RIN 0581-AD98


National Organic Program; National List of Allowed and Prohibited 
Substances (2022 Sunset)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The U.S. Department of Agriculture's Agricultural Marketing 
Service 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 the removal from the National List of several 
substances currently allowed for various uses in organic crop 
production, livestock production, and manufacture of processed 
products.

DATES: Send comments on or before October 25, 2021.

ADDRESSES: You may send comments on this proposed rule to the Federal 
eRulemaking Portal at https://www.regulations.gov/. You can access this 
proposed rule and instructions for submitting public comments by 
searching for document number AMS-NOP-19-0106. Comments may also be 
sent to Jared Clark, Standards Division, National Organic Program, 
USDA-AMS-NOP, 1400 Independence Ave. SW, Room 2642-So., Ag Stop 0268, 
Washington, DC 20250-0268.
    Instructions: All comments received must include the docket number 
AMS-NOP-19-0106; NOP-19-03, and/or Regulatory Information Number (RIN) 
0581-AD98 for this rulemaking. You should clearly indicate the topic 
and section number of the proposed rule to which your comment refers, 
state your position(s), offer any recommended language change(s), and 
include relevant information and data to support your position(s) 
(e.g., scientific, environmental, manufacturing, industry, or industry 
impact information, etc.). All comments and relevant background 
documents posted to https://www.regulations.gov will include any 
personal information provided.

FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division, 
National Organic Program, Telephone: (202) 720-3252.

SUPPLEMENTARY INFORMATION: In addition to comments about the proposed 
removals themselves, AMS is requesting comments about whether organic 
operations (producers and handlers) require time to implement the 
changes that would be necessary, should AMS finalize the amendments in 
this proposed rule. All of the substances/ingredients included in this 
rule have a ``sunset date'' of March 15, 2022, except for Turkish bay 
leaves and whey protein concentrate (sunset date of June 27, 2022). AMS 
requests comments on how much time after the sunset date is necessary, 
if any, for organic operations to comply with the proposed changes.

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'').
    To remain on the National List, substances must be: (1) Reviewed 
every five years by the NOSB, a 15-member Federal advisory committee; 
and (2) renewed by the Secretary (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).
    Through the course of the sunset review process for the substances 
below, the NOSB determined the substances are no longer necessary for 
organic production or handling or otherwise no longer comply with the 
criteria set forth in the Organic Foods Production Act at 7 U.S.C. 
6518.
    Based on recommendations submitted at the conclusion of the NOSB's 
sunset review process, AMS is proposing to amend the National List by 
removing the following synthetic substances currently allowed in 
organic crop and livestock production (7 CFR 205.601 and 205.603):

 Sucrose Octanoate Esters (crop production)
 Vitamin B1 (crop production)
 Oxytocin (livestock production)
 Procaine (livestock production)
 Sucrose Octanoate Esters (livestock production)

    Additionally, AMS is proposing to amend the National List by 
removing the following nonorganic ingredients currently allowed in 
organic handling (Sec. Sec.  205.605 and 205.606):

 Alginic acid
 Colors (black currant juice color, blueberry juice color, 
carrot juice color, cherry juice color, grape juice color, paprika 
color, pumpkin juice color, turmeric extract color)
 Kelp
 Konjac flour
 Sweet potato starch
 Turkish bay leaves
 Whey protein concentrate

    The proposed removal of these substances from the National List 
addresses National Organic Standards Board (NOSB) recommendations 
submitted to the Secretary after the conclusion of the NOSB's public 
meetings on October 29, 2015; November 2, 2017; October 26, 2018; and 
October 30, 2020.

II. Overview of Proposed Amendments

    The following provides an overview of the proposed amendments to 
the National List, along with the NOSB and

[[Page 47243]]

AMS justifications for each proposed amendment. AMS welcomes comments 
on the proposed amendments. Comments received during the comment period 
will inform AMS's decisions for the final rule--specifically, whether 
the proposed removals remain justified or new information demonstrates 
that renewal(s) (relisting) is warranted and aligned with OFPA 
criteria.

A. Sucrose Octanoate Esters (Sec. Sec.  205.601 and 205.603)

    AMS is proposing to remove sucrose octanoate esters from the 
National List. Sucrose octanoate esters were added to the National List 
effective December 11, 2007 (72 FR 69569), were renewed through two 
sunset reviews, and are currently listed at Sec. Sec.  205.601(e)(10) 
and 205.603(b)(10). The 2007 rulemaking was initiated by an NOSB 
recommendation in August 2005 \1\ for the addition of sucrose octanoate 
esters to the National List for use as an insecticide in organic crop 
production and as a miticide for use on honeybees.
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    \1\ NOSB August 17, 2005, Sucrose Octanoate Esters 
Recommendation: https://www.ams.usda.gov/sites/default/files/media/Sucrose%20Recommendation.pdf.
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    Prior to the NOSB's 2018 Fall meeting, the NOSB received 
information indicating there are no current EPA registrations for 
sucrose octanoate esters and therefore no approved pesticide 
applications. Due to this information, as referenced in the published 
NOSB recommendations,2 3 the Board voted to remove both the 
crop use listing (at Sec.  205.601(e)(10)) and the livestock (honeybee) 
use (at Sec.  205.603(b)(10)). The NOSB reasoned that no argument could 
be made that this substance remains an essential tool for organic 
production if there is no current legal use consistent with the 
National List restrictions.
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    \2\ NOSB Fall 2018 Crops Sunset Recommendations: https://www.ams.usda.gov/sites/default/files/media/CS2020SunsetFinalRecOct2018.pdf.
    \3\ NOSB Fall 2018 Livestock Sunset Recommendations: http://www.ams.usda.gov/sites/default/files/media/LS2020SunsetFinalRecOct2018.pdf.
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    AMS agrees with the NOSB recommendation to remove sucrose octanoate 
esters from the National List at Sec. Sec.  205.601(e)(10) and 
205.603(b)(10). By 2019, there were no EPA approved products with legal 
uses corresponding to the National List allowances. (83 FR 16087, 
16088, 16094). EPA's April 13, 2018, notice shows that the registrant 
of sucrose octanoate esters (75197-1, 75197-2) voluntarily cancelled 
its registrations. Since 2018, EPA's Pesticide Product and Label System 
\4\ now shows two new registrations of sucrose octanoate esters (EPA 
Reg. No. 94424-1 and 94424-2, registered December 17, 2020), but no 
approved labels or uses are available at this time.
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    \4\ https://iaspub.epa.gov/apex/pesticides/f?p=PPLS:1 accessed 
January 29, 2021.
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    AMS agrees with the NOSB's recommendation to remove sucrose 
octanoate esters because this product's minimal commercial availability 
shows that sucrose octanoate esters are not essential for organic 
production. Public comments are requested on whether there is 
additional information available regarding the need for this substance 
in organic production and the availability of sucrose octanoate esters 
given the recent registrations.

B. Vitamin B1 (Sec.  205.601)

    AMS is proposing to remove Vitamin B1 from the National 
List. Vitamin B1 was added to the National List at its 
inception on December 21, 2000 (65 FR 80547), was renewed through 
several sunset reviews, and is currently listed at Sec.  205.601(j)(9) 
for use as a plant or soil amendment.
    In support of their sunset review \5\, the NOSB requested a third-
party technical report \6\ on vitamins B1, C, and E, as they 
are used in crop production. The technical report found that the 
previous claims on root growth and reduction of transplant shock 
associated with vitamin B1 were largely unsubstantiated 
outside of a laboratory environment. Due to this and the fact there was 
no support voiced during the public comment process regarding efficacy 
or necessity, the NOSB recommended removal, citing that given this new 
information they no longer find vitamin B1 compatible with a 
system of organic agriculture per 7 U.S.C. 6518(m)(7).
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    \5\ Formal Crops Sunset Recommendations from NOSB to NOP, 
November 2, 2017: https://www.ams.usda.gov/sites/default/files/media/CS2019SunsetsFinalRec.pdf.
    \6\ 2015 Technical Report on Vitamins B1, C, and E 
used in crop production: https://www.ams.usda.gov/sites/default/files/media/Vitamins%20B1-C-E%20TR%202015.pdf.
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    AMS agrees with the NOSB recommendation to remove vitamin 
B1 as a plant and soil amendment at Sec.  205.601(j)(9). The 
information referenced in the NOSB recommendation regarding use and 
efficacy are compelling reasons to remove vitamin B1 from 
the National List for organic crop production. Further, the 2015 
technical report on vitamins for crop production identified several 
natural and nonsynthetic alternatives to vitamin B1 
including yeast, various meals (e.g., soybean meal, cottonseed meal), 
and other crop waste or residues. Accordingly, AMS proposes that 
vitamin B1 is no longer necessary to the production of 
agricultural product and should be removed from the National List due 
to the availability of wholly natural substitutes (7 U.S.C. 
6517(c)(1)(A)(ii)).

C. Oxytocin (Sec.  205.603)

    AMS is proposing to remove oxytocin from the National List. 
Oxytocin was added to the National List at its inception on December 
21, 2000 (65 FR 80547), was renewed through several sunset reviews, and 
is currently listed at Sec.  205.603(a)(22) for use in post parturition 
therapeutic applications.
    In the sunset review, the NOSB recommended \7\ the removal of 
oxytocin from the National List. The NOSB determined that there are now 
numerous alternative methods and materials for addressing the health 
issues where oxytocin would be used and that the use of oxytocin no 
longer meets the criteria at 7 U.S.C. 6518(m)(6). Additionally, the 
NOSB found that use of oxytocin is not compatible with a system of 
sustainable agriculture (7 U.S.C. 6518(m)(7)). The NOSB requested 
public comment on whether this substance is essential for organic 
production or if there are alternative materials and methods that 
render it unnecessary. The public comment received in response to the 
request indicated that this substance is no longer necessary and 
supported its removal.
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    \7\ Formal Livestock Sunset Recommendations from NOSB to NOP, 
November 2, 2017: https://www.ams.usda.gov/sites/default/files/media/LS2019SunsetsFinalRec.pdf.
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    AMS tentatively agrees with the NOSB recommendation. While the NOSB 
states there are other practices or materials that render oxytocin 
unnecessary for organic production, AMS did not find supporting 
comments to that effect, and NOSB did not specifically state what the 
alternatives are. Further, it was stated in public comment to the NOSB 
that while some operations still use oxytocin as a medical treatment 
(assisting in clearing placenta), other operations may be using it in 
ways inconsistent with the listing or no longer find it necessary in 
organic production. AMS is seeking comments on whether suitable 
alternatives for the use of oxytocin exist, and if so, specifically 
what alternative practices or materials might replace the use of 
oxytocin. Further, AMS seeks information on oxytocin use that may be 
inconsistent with the listing. If comments show that the use of 
oxytocin no longer meets the exemption requirements at 7 U.S.C. 
6517(c)(1)(A)(ii) and (iii), AMS is

[[Page 47244]]

proposing the removal of oxytocin from the National List at Sec.  
205.603(a)(22).

D. Procaine (Sec.  205.603)

    AMS is proposing to remove procaine from the National List. 
Procaine was added to the National List at its inception on December 
21, 2000 (65 FR 80547), was renewed through several sunset reviews, and 
is currently listed at Sec.  205.603(b)(8) for use as a local 
anesthetic.
    In support of the NOSB's sunset review of procaine, public comment 
was requested to determine if procaine is used in organic livestock 
production and whether procaine is only available in the U.S. in animal 
drugs compounded with antibiotics (which are not permitted in organic 
production) or whether procaine can be sourced by itself. The comments 
received indicated that procaine is rarely used, is not as effective as 
lidocaine (allowed in organic livestock production at Sec.  
205.603(b)(5)), and is only available in combination with prohibited 
antibiotics. Further comments received were in support of removing 
procaine from the National List. Based on the information received 
during the public comment period, the NOSB recommended \8\ removal of 
procaine, given that it no longer meets the criteria stipulated by OFPA 
at 7 U.S.C. 6518(m)(6), due to lidocaine being more effective and 
because procaine is not available (i.e., compounded without prohibited 
antibiotics).
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    \8\ Formal Livestock Sunset Recommendations from NOSB to NOP, 
November 2, 2017: https://www.ams.usda.gov/sites/default/files/media/LS2019SunsetsFinalRec.pdf.
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    AMS agrees with the NOSB recommendation. Given that there is 
another National List material, lidocaine, that renders procaine 
unnecessary for organic production, procaine no longer meets the 
exemption requirement at 7 U.S.C. 6517(c)(1)(A)(ii). Further, the NOSB 
referenced in their recommendation that procaine is not available on 
its own (i.e., not compounded with an antibiotic). A search of the 
FDA's animal drug database (https://animaldrugsatfda.fda.gov/) 
indicates that all sixteen of the FDA approved drugs that contain 
procaine also contain an antibiotic (e.g., Penicillin G Procaine). This 
information supports the fact that procaine is not used in organic 
production and that an exemption is not necessary (7 U.S.C. 
6517(c)(1)(A)(ii)). As procaine no longer appears to meet the 
requirements for inclusion on the National List, AMS is proposing the 
removal of procaine from the National List at Sec.  205.603(b)(8).

E. Alginic Acid (Sec.  205.605)

    AMS is proposing to remove alginic acid from the National List. 
Alginic acid was added to Sec.  205.605(a) of the National List at its 
inception on December 21, 2000 (65 FR 80547), was renewed through 
several sunset reviews, and was reclassified as synthetic on December 
27, 2018 (83 FR 66559), which moved alginic acid to its current listing 
at Sec.  205.605(b) for use in organic handling.
    In support of their sunset review of alginic acid, the NOSB 
received a third-party technical report \9\ in 2015 and solicited 
public comment at their Spring 2019 meeting. The NOSB received no 
comments in support of continuing the allowance or reporting use of 
alginic acid. In addition, no certifying agents (``certifiers'') 
reported this material being used by their certified operations. 
Further, the 2015 technical report cited other National List materials, 
including agar-agar, carrageenan, gellan gum, and xanthan gum, as 
possible alternatives to alginic acid. Based on this, the NOSB 
determined that there are readily available alternatives and 
recommended removal based on alginic acid no longer meeting the OFPA 
criteria at 7 U.S.C. 6518(m)(6).
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    \9\ Alginic Acid Technical Report, February 5, 2015: https://www.ams.usda.gov/sites/default/files/media/Alginic%20Acid%20TR.pdf.
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    AMS agrees with the NOSB recommendation. Given that there were no 
reports of operations using alginic acid and the availability of 
possible alternatives on the National List (as referenced in the 
technical report), this substance no longer appears to meet the 
requirements for inclusion on the National List at 7 U.S.C. 
6517(c)(1)(A)(ii). As such, AMS proposes the removal of alginic acid 
from the National List at Sec.  205.605(b).

F. Colors (Sec.  205.606)

    AMS is proposing to remove eight nonorganic colors from the 
National List at Sec.  205.606(d):
     Black currant juice color--derived from Ribes nigrum L.
     Blueberry juice color--derived from blueberries (Vaccinium 
spp.).
     Carrot juice color--derived from Daucus carota L.
     Cherry juice color--derived from Prunus avium (L.) L. or 
Prunus cerasus L.
     Grape juice color--derived from Vitis vinifera L.
     Paprika color--derived from dried powder or vegetable oil 
extract of Capsicum annuum L.
     Pumpkin juice color--derived from Cucurbita pepo L. or 
Cucurbita maxima Duchesne.
     Turmeric extract color--derived from Curcuma longa L.
    These colors were added to the National List effective June 21, 
2007 (72 FR 35137), were renewed through several sunset reviews, and 
are currently listed at Sec.  205.606(d) as allowed nonorganic 
agricultural ingredients in organic products when organic versions are 
not commercially available.
    The NOSB recommended \10\ the removal of the above colors at their 
Fall 2020 meeting. The effect of this action is that only organic forms 
of these colors would be allowed in organic handling. The NOSB 
referenced public comments as being mixed on the availability and 
necessity of these colors and also noted that comments from some 
manufacturers stated that organic versions of these colors are 
available. Additionally, in the case of carrot juice color and grape 
juice color, the NOSB noted that the availability of these crops in 
organic forms should provide an adequate supply of organic carrot juice 
and organic grape juice for color production and cited that as a reason 
for their recommended removal.
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    \10\ Formal Handling Sunset Recommendations from the NOSB to the 
NOP, October 30, 2020: https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf.
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    AMS is proposing to remove these colors from the National List, as 
recommended by the NOSB. AMS is seeking comments about whether these 
colors remain necessary for organic production or if there are suitable 
organic versions available. While public comments to the NOSB were 
mixed, as noted in the NOSB recommendation, most of the comments were 
in favor of relisting these colors. Because these colors are listed in 
Sec.  205.606, certified operations are required to use organic 
versions of these colors unless the organic versions are not 
commercially available (i.e., not available in an appropriate form, 
quality, or quantity). Many of the comments supporting relisting were 
from organic handlers claiming that while one or more of these colors 
are available in organic form, they are not available in the same form 
or quality as the nonorganic version. Some comments from color 
manufacturers, however, stated that they have sufficient quantity of 
these colors in organic form.
    AMS welcomes public comments that provide more information on 
whether there are sufficient amounts of the organic versions of the 
above colors to

[[Page 47245]]

meet demand and on the availability of organic colors in suitable form 
and quality. If any of these colors are still necessary in their 
nonorganic form, comments should provide specific information on the 
attributes of the nonorganic form that are not yet sufficiently 
available in the organic forms. If any or all of the above colors are 
not currently commercially available in organic form, we request 
comment on whether they should be relisted (i.e. not removed in the 
final rule) or whether the final rule should provide an implementation 
period to provide time for sufficient quantity, quality, and/or form of 
the color(s) to be developed.

G. Kelp (Sec.  205.606)

    AMS is proposing to remove nonorganic kelp from the National List. 
The effect of this action is that only organic forms of kelp would be 
allowed in organic handling. Kelp was added to the National List at its 
inception on December 21, 2000 (65 FR 80547), was renewed through 
several sunset reviews, and is currently listed at Sec.  205.606(k) for 
use only as a thickener and dietary supplement only when an organic 
version is not commercially available.
    After the Fall 2020 meeting, the NOSB recommended \11\ the removal 
of kelp from the National List at Sec.  205.606. During this sunset 
review, the NOSB received comments in support of removing as well as 
relisting kelp. In this sunset review, the NOSB determined that there 
were alternatives to kelp on the National List (namely kombu and 
wakame), which rendered the kelp listing no longer necessary. Because 
kelp no longer meets the requirement of OFPA at 7 U.S.C. 6518(m)(6) due 
to the existence of alternatives, the NOSB voted to recommend the 
removal of kelp from the National List at Sec.  205.606.
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    \11\ Formal Handling Sunset Recommendations from the NOSB to the 
NOP, October 30, 2020: https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf.
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    AMS agrees with the NOSB recommendation. According to the Organic 
Integrity Database,\12\ there are currently 106 certified crop, wild 
crop, and handling operations that list ``kelp'' as a certified organic 
product. Organic kelp appears to be commercially available; therefore, 
this substance no longer appears to be necessary and no longer meets 
the requirements for inclusion on the National List at 7 U.S.C. 
6517(c)(1)(A)(ii). As such, AMS proposes the removal of nonorganic kelp 
from the National List at Sec.  205.606(k).
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    \12\ Organic Integrity Database, accessed February 12, 2021: 
https://organic.ams.usda.gov/integrity/Search.aspx.
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H. Konjac Flour (Sec.  205.606)

    AMS is proposing to remove nonorganic konjac flour from the 
National List. The effect of this action is that only organic forms of 
konjac flour would be allowed in organic handling. Konjac flour was 
added to the National List effective June 21, 2007 (72 FR 35137), 
renewed through two sunset reviews, and is currently listed at Sec.  
205.606(l). The 2007 rulemaking was initiated by an NOSB recommendation 
\13\ for the addition of konjac flour to the National List only when an 
organic version is not commercially available.
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    \13\ NOSB Meeting Minutes & Transcripts 1992-2009: https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%201992-2009.pdf.
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    After the Fall 2017 meeting, the NOSB recommended \14\ the removal 
of konjac flour. In support of their recommendation, the NOSB solicited 
public comment regarding the use and necessity of konjac flour in 
organic handling and the availability of organic konjac flour. The NOSB 
received little feedback from industry in response. One trade 
organization reported one organic producer using konjac flour but was 
unsure if it was for organic products. Several certifiers stated they 
had not received any feedback from their clients regarding the need for 
or use of nonorganic konjac flour in their products. Ultimately, the 
NOSB voted to recommend removal of konjac flour from the National List 
at Sec.  205.606(l) due to the availability of alternatives, as well as 
the fact that nonorganic konjac flour no longer meets the OFPA 
requirements at 7 U.S.C. 6518(m)(6).
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    \14\ NOSB Formal Handling Sunset Recommendations, November 2, 
2017: https://www.ams.usda.gov/sites/default/files/media/HS2019SunsetsFinalRec.pdf.
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    AMS agrees with the NOSB recommendation. A search in the Organic 
Integrity Database \15\ for ``konjac'' shows 30 operations with some 
form of certified organic konjac products (e.g., powder, starch, konjac 
tubers). Given the lack of reported use of, or need for, nonorganic 
konjac flour and the availability of organic konjac flour and konjac 
tubers, nonorganic konjac flour appears to no longer meet the 
requirements for inclusion on the National List at 7 U.S.C. 
6517(c)(1)(A)(ii). As such, AMS proposes the removal of nonorganic 
konjac flour from the National List at Sec.  205.606(l).
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    \15\ USDA Organic Integrity Database, accessed February 12, 
2021: https://organic.ams.usda.gov/integrity/default.aspx.
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I. Sweet Potato Starch (Sec.  205.606)

    AMS is proposing to remove nonorganic sweet potato starch from the 
National List. The effect of this action is that only organic forms of 
sweet potato starch would be allowed in organic handling. Sweet potato 
starch was added to the National List effective June 21, 2007 (72 FR 
35137), was renewed through two sunset reviews, and is currently listed 
at Sec.  205.606(s)(2). The 2007 rulemaking was initiated by an NOSB 
recommendation \16\ for the allowance of nonorganic sweet potato starch 
for bean thread production only when an organic version is not 
commercially available.
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    \16\ NOSB Meeting Minutes & Transcripts 1992-2009: https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%201992-2009.pdf.
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    After the Fall 2020 meeting, the NOSB recommended \17\ the removal 
of sweet potato starch from the National List at Sec.  205.606. NOSB 
solicited comment on the use and necessity of sweet potato starch and 
received little feedback. The comments that were received suggested 
scant use of nonorganic sweet potato starch, readily available 
alternatives, and the availability of organic forms of sweet potato 
starch. Further, comments noted that the continued listing of 
nonorganic sweet potato starch is inhibiting increased production of 
organic forms of sweet potato starch. Based on this information, the 
NOSB determined that there are available alternatives to nonorganic 
sweet potato starch and recommended the removal of this substance 
because its use no longer meets the OFPA criteria at 7 U.S.C. 
6518(m)(6).
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    \17\ Formal Handling Sunset Recommendations from the NOSB to the 
NOP, October 30, 2020: https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf.
---------------------------------------------------------------------------

    AMS agrees with the NOSB recommendation. A search in the Organic 
Integrity Database \18\ for ``potato starch'' shows 54 operations with 
some form of certified organic potato starch and another 25 operations 
with some form of certified organic pea starch, a cited alternative to 
sweet potato starch. Given the low reported use of nonorganic sweet 
potato starch and the availability of organic sweet potato starch and 
pea starch, nonorganic sweet potato starch appears to no longer meet 
the requirements for inclusion on the National List at 7 U.S.C. 
6517(c)(1)(A)(ii). As such, AMS proposes the removal of nonorganic

[[Page 47246]]

sweet potato starch from the National List at Sec.  205.606(s)(2).
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    \18\ USDA Organic Integrity Database, accessed February 8, 2021: 
https://organic.ams.usda.gov/integrity/default.aspx.
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J. Turkish Bay Leaves (Sec.  205.606)

    AMS is proposing to remove nonorganic Turkish bay leaves from the 
National List. The effect of this action is that organic forms only of 
Turkish bay leaves would be allowed in organic handling. Turkish bay 
leaves were added to the National List effective June 21, 2007 (72 FR 
35137), were renewed through two sunset reviews, and are currently 
listed at Sec.  205.606(v). The 2007 rulemaking was initiated by an 
NOSB recommendation \19\ for the addition of Turkish bay leaves to the 
National List for use in organic production only when organic versions 
are not commercially available.
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    \19\ NOSB Meeting Minutes & Transcripts 1992-2009: https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%201992-2009.pdf.
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    After the Fall 2015 meeting, the NOSB recommended \20\ removal of 
Turkish bay leaves from Sec.  205.606. This recommendation was not 
finalized by AMS (82 FR 31241) because public comments requested AMS 
maintain the allowance. Comments reported that organic whole Turkish 
bay leaves were not available in the quantity or quality to meet 
organic handling needs. During the 2020 sunset review, the NOSB 
received many comments supporting the removal of Turkish bay leaves due 
to the availability of organic versions. The NOSB cited one commenter, 
who uses Turkish bay leaves in a wide range of canned soups and stated 
there is full availability of organic forms of Turkish bay leaves. 
Further comments from certifiers indicated that few, if any, of their 
operations use nonorganic Turkish bay leaves. Based on this 
information, the NOSB determined that there are available alternatives 
to nonorganic Turkish bay leaves and recommended \21\ the removal of 
this substance because it no longer meets the OFPA criteria at 7 U.S.C. 
6518(m)(6).
---------------------------------------------------------------------------

    \20\ Formal Handling Sunset Recommendation from the NOSB to the 
NOP, October 2015: https://www.ams.usda.gov/sites/default/files/media/HS%202017%20Sunset%20Final%20Rvw%20605%28a%29_%28b%29_606_final%20rec.pdf.
    \21\ Formal Handling Sunset Recommendations from the NOSB to the 
NOP, October 30, 2020: https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf.
---------------------------------------------------------------------------

    AMS agrees with the NOSB recommendation. A search in the Organic 
Integrity Database \22\ for ``bay leaves'' shows 100 crop and handling 
operations with some form of certified organic bay leaves. A search 
using the term ``Turkish bay leaves'' shows five operations, as it 
appears that only one certifier identifies bay leaves with that level 
of specificity in the Organic Integrity Database. Given that comments 
to the NOSB indicated organic Turkish bay leaves are readily available 
in all forms and the high number of operations reported in the Organic 
Integrity Database with organic bay leaves (of which a subset are 
Turkish bay leaves), nonorganic Turkish bay leaves appear to no longer 
meet the requirements for inclusion on the National List at 7 U.S.C. 
6517(c)(1)(A)(ii). As such, AMS proposes the removal of nonorganic 
Turkish bay leaves from the National List at Sec.  205.606(v).
---------------------------------------------------------------------------

    \22\ USDA Organic Integrity Database, accessed February 8, 2021: 
https://organic.ams.usda.gov/integrity/default.aspx.
---------------------------------------------------------------------------

K. Whey Protein Concentrate (Sec.  205.606)

    AMS is proposing to remove nonorganic whey protein concentrate from 
the National List. The effect of this action is that only organic forms 
of whey protein concentrate would be allowed in organic handling. Whey 
protein concentrate was added to the National List effective June 21, 
2007 (72 FR 35137), was renewed through two sunset reviews, and is 
currently listed at Sec.  205.606(x). The 2007 rulemaking was initiated 
by an NOSB recommendation made at the March 2007 \23\ NOSB meeting for 
the addition of whey protein concentrate to the National List for 
organic production only when an organic version is not commercially 
available.
---------------------------------------------------------------------------

    \23\ NOSB Meeting Minutes & Transcripts 1992-2009; https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%2019.
---------------------------------------------------------------------------

    After the Fall 2015 meeting, the NOSB recommended \24\ removal of 
whey protein concentrate from Sec.  205.606. This recommendation was 
not finalized by AMS (82 FR 31243) because public comment asserted that 
whey protein concentrate was essential to organic processed products, 
and there was no commercially available organic product. During the 
2020 sunset review, the NOSB received many comments supporting the 
removal of whey protein concentrate due to the availability of organic 
versions. The NOSB cited several commenters who demonstrated that they 
produce a robust supply of organic whey protein concentrate in several 
forms and sell excess to the conventional market. A comment noted that 
the international supply chain of organic whey-based products is also 
robust. Further comment from at least one certifier indicated that none 
of their operations are using nonorganic whey protein concentrate. 
Based on this information, the NOSB determined that there are available 
alternatives to nonorganic whey protein concentrate and recommended 
\25\ the removal of this substance because it no longer meets the OFPA 
criteria at 7 U.S.C. 6518(m)(6).
---------------------------------------------------------------------------

    \24\ Formal Handling Sunset Recommendation from the NOSB to the 
NOP, October 2015: https://www.ams.usda.gov/sites/default/files/media/HS%202017%20Sunset%20Final%20Rvw%20605%28a%29_%28b%29_606_final%20rec.pdf.
    \25\ Formal Handling Sunset Recommendations from the NOSB to the 
NOP, October 30, 2020: https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf.
---------------------------------------------------------------------------

    AMS agrees with the NOSB recommendation. A search in the Organic 
Integrity Database \26\ for ``whey protein concentrate'' shows 22 
operations with some form of certified organic whey protein 
concentrate. The NOSB also received comments stating that there is a 
substantial supply of all forms of organic whey protein concentrate and 
cited the diversion of some quantity to the conventional market as 
evidence that there is enough supply to meet the demand for organic 
whey protein concentrate. Given the comments submitted to the NOSB 
outlining the lack of use and stated abundance of supply, nonorganic 
whey protein concentrate appears to no longer meet the requirements for 
inclusion on the National List at 7 U.S.C. 6517(c)(1)(A)(ii). As such, 
AMS proposes the removal of nonorganic whey protein concentrate from 
the National List at Sec.  205.606(x).
---------------------------------------------------------------------------

    \26\ USDA Organic Integrity Database, accessed February 8, 2021: 
https://organic.ams.usda.gov/integrity/default.aspx.
---------------------------------------------------------------------------

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 NOP website at 
https://www.ams.usda.gov/rules-regulations/organic/handbook.

[[Page 47247]]

A. Executive Orders 12866 and 13563 and the 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.
    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. 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. 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 $16.5 million.
    AMS has considered the economic impact of this proposed 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 Census of Agriculture, 
16,585 organic farms in the United States reported sales of organic 
products and total farmgate sales more than $9.9 billion.\27\ 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 $750,000 sales threshold to qualify as a 
small business.
---------------------------------------------------------------------------

    \27\ U.S. Department of Agriculture, National Agricultural 
Statistics Service. 2019 Census of Agriculture. https://www.nass.usda.gov/Publications/AgCensus/2017/Online_Resources/Organics/ORGANICS.pdf.
---------------------------------------------------------------------------

    According to the NOP's Organic Integrity Database, there are 19,059 
organic handlers that are certified under the USDA organic 
regulations.\28\ 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.
---------------------------------------------------------------------------

    \28\ Organic Integrity Database: https://organic.ams.usda.gov/Integrity/. Accessed on January 29, 2021.
---------------------------------------------------------------------------

    SBA defines small agricultural service firms, which include 
certifying agents, as those having annual receipts of less than 
$8,000,000 (13 CFR 121.201). There are currently 77 USDA-accredited 
certifying agents; based on a query of the NOP certified organic 
operations database. 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.
    AMS has determined that this rule would not have a significant 
impact on a substantial number of small entities, as defined by SBA. 
The effect of this rule, if implemented as final, would be to remove 
the allowance of seventeen substances in organic production and organic 
handling. The removal of these substances, while numerous, is due to 
the fact that alternatives have rendered them no longer necessary, they 
are no longer in use, or organic versions have become available. AMS 
invites comments on the anticipated costs of this proposed rule, 
including the impacts on small businesses.

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:

[[Page 47248]]

(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 three 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, Agriculture, Animals, Animal 
drugs, Dairy products, Food grades and standards, Foods, Labeling, 
Livestock, Meat and meat products, Organically produced products, 
Reporting and recordkeeping requirements, Seals and insignia.
    For the reasons set forth in the preamble, AMS proposes to amend 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.  205.601 by removing paragraph (e)(10) and revising 
paragraph (j)(9).
    The revision to read as follows:


Sec.  205.601  Synthetic substances allowed for use in organic crop 
production.

* * * * *
    (j) * * *
    (9) Vitamins C and E.
* * * * *


Sec.  205.603  [Amended]

0
3. Amend Sec.  205.603 by:
0
a. Removing paragraph (a)(22);
0
b. Redesignating paragraphs (a)(23) through (30) as paragraphs (a)(22) 
through (29), respectively;
0
c. Removing paragraphs (b)(8) and (10); and
0
d. Redesignating paragraphs (b)(9), (11) and (12) as paragraphs (b)(8) 
through (10), respectively.


Sec.  205.605  [Amended]

0
4. In Sec.  205.605(b) remove the words ``Alginic acid (CAS # 9005-32-
7)''.
0
5. Revise Sec.  205.606 to read as follows:


Sec.  205.606   Nonorganically produced agricultural products allowed 
as ingredients in or on processed products labeled as ``organic.''

    Only the following nonorganically produced agricultural products 
may be used as ingredients in or on processed products labeled as 
``organic,'' only in accordance with any restrictions specified in this 
section, and only when the product is not commercially available in 
organic form.
    (a) Carnauba wax.
    (b) Casings, from processed intestines.
    (c) Celery powder.
    (d) Colors derived from agricultural products--Must not be produced 
using synthetic solvents and carrier systems or any artificial 
preservative.
    (1) Beet juice extract color--derived from Beta vulgaris L., except 
must not be produced from sugarbeets.
    (2) Beta-carotene extract color--derived from carrots (Daucus 
carota L.) or algae (Dunaliella salina).
    (3) Black/purple carrot juice color--derived from Daucus carota L.
    (4) Chokeberry, aronia juice color--derived from Aronia arbutifolia 
(L.) Pers. or Aronia melanocarpa (Michx.) Elliott.
    (5) Elderberry juice color--derived from Sambucus nigra L.
    (6) Grape skin extract color--derived from Vitis vinifera L.
    (7) Purple sweet potato juice color--derived from Ipomoea batatas 
L. or Solanum tuberosum L.
    (8) Red cabbage extract color--derived from Brassica oleracea L.
    (9) Red radish extract color--derived from Raphanus sativus L.
    (10) Saffron extract color--derived from Crocus sativus L.
    (e) Fish oil (Fatty acid CAS #'s: 10417-94-4, and 25167-62-8)--
stabilized with organic ingredients or only with ingredients on the 
National List, Sec. Sec.  205.605 and 205.606.
    (f) Fructooligosaccharides (CAS # 308066-66-2).
    (g) Gelatin (CAS # 9000-70-8).
    (h) Glycerin (CAS # 56-81-5)--produced from agricultural source 
materials and processed using biological or mechanical/physical methods 
as described under Sec.  205.270(a).
    (i) Gums--water extracted only (Arabic; Guar; Locust bean; and 
Carob bean).
    (j) Inulin-oligofructose enriched (CAS # 9005-80-5).
    (k) Lecithin--de-oiled.
    (l) Orange pulp, dried.
    (m) Orange shellac-unbleached (CAS # 9000-59-3).
    (n) Pectin (non-amidated forms only).
    (o) Potassium acid tartrate.
    (p) Seaweed, Pacific kombu.
    (q) Starches.
    (1) Cornstarch (native).
    (2) [Reserved]
    (r) Tamarind seed gum.
    (s) Tragacanth gum (CAS # 9000-65-1).
    (t) Wakame seaweed (Undaria pinnatifida).

Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2021-17835 Filed 8-23-21; 8:45 am]
BILLING CODE P