[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Rules and Regulations]
[Pages 10930-10938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03851]


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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; Amendments to the National List of 
Allowed and Prohibited Substances (2022 Sunset)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: This final rule amends the United States Department of 
Agriculture's (USDA) organic regulations to implement recommendations 
from the National Organic Standards Board (NOSB). The rule prohibits 
fourteen nonorganic ingredients, which are currently allowed in the 
manufacture of organic processed products. The rule also prohibits two 
substances (vitamin B<INF>1</INF> and procaine), which are currently 
allowed in organic crop and livestock production. Finally, the rule 
renews an allowance for two substances (oxytocin and sucrose octanoate 
esters) in organic production.

DATES: 
    Effective Date: This rule is effective on March 30, 2022.
    Compliance Dates: The compliance date for the amendments that 
remove vitamin B<INF>1</INF> and procaine from the National List is 
March 15, 2023. The compliance date for all other amendments that 
remove substances from the National List is March 15, 2024. Products in 
the stream of commerce after the compliance date that are labeled as 
``organic'' or ``made with organic (specified ingredients or food 
group(s))'' may contain substances removed in this final rule if 
manufactured prior to the compliance date. The final rule renews an 
allowance for two substances (oxytocin and sucrose octanoate esters) in 
organic production. This rule maintains the current regulatory 
structure with regard to these two substances upon publication for up 
to five years.

FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division, 
National Organic Program. Telephone: (202) 720-3252 or Email: 
<a href="/cdn-cgi/l/email-protection#db91baa9bebff598b7baa9b09baea8bfbaf5bcb4ad"><span class="__cf_email__" data-cfemail="773d1605121359341b16051c370204131659101801">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2000, the Secretary of Agriculture (``Secretary'') 
established the Agricultural Marketing Service's (AMS) National Organic 
Program (NOP) 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 in organic 
crop and livestock production as well as the nonsynthetic (natural) 
substances that may not be used. It also identifies the nonorganic 
substances that may be used in or on processed organic products.
    AMS is finalizing 16 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).
    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).
    The removal of 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.
    During a 60-day comment period that closed on October 25, 2021, AMS 
received 60 comments on the proposed rule. See below for a discussion 
of the comments received and AMS's responses to comments. Comments on 
the proposed rule can also be viewed through Regulations.gov. Use the 
search area on the homepage at https://www.regulations.gov to enter a 
keyword,

[[Page 10931]]

title, or docket ID (the docket number for this rule is AMS-NOP-19-
0106).

II. Overview of Amendments

    This rule removes fourteen ingredients and two substances from the 
National List and retains (or ``renews'') two substances on the 
National List. Additional background on the NOSB's review of the 
substances may be found in the proposed rule (86 FR 47242; August 24, 
2021).
    This final rule removes the following synthetic substances, which 
are currently allowed in organic crop and livestock production (7 CFR 
205.601 and 205.603):
    <bullet> Vitamin B<INF>1</INF> (crop production); and
    <bullet> Procaine (livestock production).
    As noted in the DATES section, AMS is providing a one-year 
implementation period for these changes to provide time for certifying 
agents to communicate the changes to organic operations and for organic 
producers to cease use.
    Additionally, AMS is removing the following nonorganic ingredients, 
which are currently allowed in organic handling (Sec. Sec.  205.605 and 
205.606):
    <bullet> Alginic acid;
    <bullet> 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);
    <bullet> Kelp;
    <bullet> Konjac flour;
    <bullet> Sweet potato starch;
    <bullet> Turkish bay leaves; and
    <bullet> Whey protein concentrate.
    Finally, this rule renews sucrose octanoate esters for organic crop 
and livestock production and oxytocin for organic livestock production. 
The new sunset date for the two substances (three listings on the 
National List) is March 15, 2027.
    Below, AMS describes each substance in alphabetical order, sorted 
by use (i.e., crop production, livestock production, handling). Sucrose 
octanoate esters is discussed first because it is used in both crop and 
livestock production. For each substance, AMS outlines the NOSB's 
sunset review, discusses comments received, and describes the final 
action by this rule.
    Implementation Period. As noted in the DATES section, AMS is 
providing a one-year implementation period for producers to cease use 
of vitamin B<INF>1</INF> and procaine. For all other substances removed 
by this final rule, AMS is providing a two-year implementation period. 
A shorter implementation period for vitamin B<INF>1</INF> and procaine 
is appropriate because there is no evidence these substances are 
currently used in organic production. A 2-year implementation period is 
provided for organic handling operations to cease use of the nonorganic 
ingredients (including alginic acid) above. AMS believes that a two-
year implementation period provides certifying agents with the 
necessary time to communicate the changes to organic operations and for 
operations to source organic forms of the ingredients (if necessary), 
revise labels, and/or adjust recipes. Public comment indicated a two-
year implementation period would be adequate. AMS notes that while the 
final rule provides a two-year implementation period, organic handlers 
may not use nonorganic forms of ingredients when organic forms of the 
ingredients are commercially available (see 7 CFR 205.301(f)(6)).

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

    This final rule renews the allowances for sucrose octanoate esters 
at 7 CFR 205.601(e)(10) and 205.603(b)(11).\1\ Sucrose octanoate esters 
is a pesticide that targets mites (e.g., Varroa mites, a pest that 
attacks honeybees) and certain soft-bodied insects (e.g., aphids).
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    \1\ Sucrose octanoate esters is cited in NOSB recommendation(s) 
at 7 CFR 205.603(b)(10). The current citation for sucrose octanoate 
esters is 7 CFR 205.603(b)(11).
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NOSB Review and Recommendation
    Following the sunset review of sucrose octanoate esters, the NOSB 
recommended removing sucrose octanoate esters from the National List. 
As described in the Background section, the sunset process is a system 
of regular evaluation of National List substances against criteria in 
the OFPA. If a substance is found to no longer satisfy these criteria, 
the NOSB may recommend removal of the substance.
    Prior to the NOSB's 2018 Fall meeting, the NOSB received 
information indicating there were no current U.S. Environmental 
Protection Agency (EPA) registrations for sucrose octanoate esters at 
the time and therefore no approved pesticide applications. Based on 
this information, the NOSB reasoned that no argument could be made that 
this substance remains an essential tool for organic production if 
there was no current legal use consistent with the National List 
restrictions. The Board then voted to remove both the crop use listing 
(at Sec.  205.601(e)) and the livestock use listing (at Sec.  
205.603(b)).<SUP>2 3</SUP> In both organic crop and livestock 
production, sucrose octanoate esters are allowed as an insecticide and 
parasiticide, with the latter including treatment of Varroa mites in 
honeybees. Honeybees are regulated as livestock under the USDA organic 
regulations (see definition of ``livestock'' at Sec.  205.2), allowing 
substances on the National List for livestock production to be used in 
organic apiculture (beekeeping).
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    \2\ National Organic Standards Board, Sunset Review of 
Substances Listed at Sec. Sec.  205.601 and 205.602, https://www.ams.usda.gov/sites/default/files/media/CS2020SunsetFinalRecOct2018.pdf.
    \3\ National Organic Standards Board, Sunset Review of 
Substances Listed at Sec.  205.603, https://www.ams.usda.gov/sites/default/files/media/LS2020SunsetFinalRecOct2018.pdf.
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Comments Received
    Most comments on the proposed rule related to the proposed removal 
of sucrose octanoate esters from the National List.
    Lack of approved alternatives. Most comments supported keeping 
sucrose octanoate esters on the National List. Commenters stated that 
removing this substance would have a negative impact on organic farmers 
and beekeepers, as it is a primary ingredient in OrganiShield--a common 
product used in Integrated Pest Management (IPM) systems. Commenters 
stressed that there is no comparable product on the market that is 
safe, effective, and approved for use in organic crop and livestock 
production.
    Environmentally friendly pesticide. Commenters noted that the use 
of sucrose octanoate esters benefits crop-friendly insects such as 
pollinators, biodegrades rapidly after use, and does not negatively 
impact the environment. Multiple commenters highlighted that sucrose 
octanoate esters play a key role as an organic pesticide, specifically 
in controlling Varroa mites.
    Change in market situation. Commenters highlighted that the NOSB 
voted to remove both the crop use listing at Sec.  205.601(e) and the 
livestock use at Sec.  205.603(b) during the Fall 2018 meeting. The 
NOSB's rationale was that sucrose octanoate esters could not be 
considered an essential tool for organic production if there were no 
legally approved uses (i.e., there were no active EPA pesticide 
registrations at the time). Commenters noted that the market situation 
has changed since the NOSB's 2018 decision, as there have since been 
new EPA registrations for sucrose octanoate esters.
AMS Response
    AMS had tentatively suggested removal of sucrose octanoate esters 
in the proposed rule based on the lack of EPA-approved uses for this 
substance back when the NOSB recommended its removal in 2018 (86 FR 
47242, August 24, 2021). Following the 2018 NOSB

[[Page 10932]]

meeting, the EPA received product registrations for sucrose octanoate 
esters in December 2020. Subsequent comments demonstrated that the 
market situation had changed since the 2018 NOSB recommendation, with 
recent product registrations and increased use of sucrose octanoate 
esters. Additionally, comments noted this substance is not harmful to 
the environment and cited the lack of alternatives approved for organic 
use. In response to comments identifying the recent registration, 
increased use, and a lack of alternatives, AMS is not removing sucrose 
octanoate esters from the National List at Sec. Sec.  205.601(e)(10) 
and 205.603(b)(11). The substance will undergo another sunset review 
prior to the new March 15, 2027 sunset date. At that time, the Board 
will have another opportunity to evaluate the substance against OFPA 
criteria considering this recent registration and increase in use.

Vitamin B<INF>1</INF> (Sec.  205.601)

    This final rule amends the National List to prohibit use of 
synthetic vitamin B<INF>1</INF> in organic crop production by removing 
vitamin B<INF>1</INF> from 7 CFR 205.601(j)(9).
    NOSB Review and Recommendation
    Following the sunset review of vitamin B<INF>1</INF>, the NOSB 
recommended removing vitamin B<INF>1</INF> from the National List. As 
described in the Background section, the sunset process is a system of 
regular evaluation of National List substances against criteria in the 
OFPA. If a substance is found to no longer satisfy these criteria, the 
NOSB may recommend removal of the substance.
    In support of their sunset review,\4\ the NOSB requested a third-
party technical report on the use of vitamins B<INF>1</INF>, C, and E 
in crop production.\5\ The technical report stated these vitamins are 
generally used for stimulation of crop growth and plant protection but 
found that previous claims about root growth and reduction of 
transplant shock associated with vitamin B<INF>1</INF> were largely 
unsubstantiated outside of a laboratory environment. Due to this, and 
the lack of support voiced during the public comment process regarding 
efficacy or necessity, the NOSB recommended removal.
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    \4\ National Organic Standards Board, Crops 2019 Sunset 
Substances, https://www.ams.usda.gov/sites/default/files/media/CS2019SunsetsFinalRec.pdf.
    \5\ Pesticide Research Institute, Technical Evaluation Report: 
Vitamins B1, C and E, https://www.ams.usda.gov/sites/default/files/media/Vitamins%20B1-C-E%20TR%202015.pdf.
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Comments Received
    AMS received no comments in support of keeping synthetic vitamin 
B<INF>1</INF> on the National List for organic crop production. One 
commenter requested the NOP allow for a 12-month implementation 
timeline.
AMS Response
    As commenters noted, the NOSB voted to remove vitamin B<INF>1</INF> 
from the National List at the Fall 2017 meeting on the basis that it is 
not essential for organic crop production and because its primary use 
for root growth and reduction of transplant shock was not substantiated 
by technical information. Given this information regarding use and 
efficacy, AMS is removing vitamin B<INF>1</INF> from the National List 
for organic crop production. Further, the 2015 technical report on 
vitamins for crop production identified several natural (nonsynthetic) 
alternatives to vitamin B<INF>1,</INF> including yeast, various meals 
(e.g., soybean meal, cottonseed meal), and other crop waste or 
residues. After considering public comments, technical reports, and the 
NOSB review, AMS is finalizing the removal of vitamin B<INF>1</INF> 
from the National List at Sec.  205.601(j)(9). As specified in the 
DATES section, organic crop producers will have until March 15, 2023, 
to comply with this change.

Oxytocin (Sec.  205.603)

    This final rule renews the allowance for oxytocin (an animal drug) 
for use in post-parturition (birth) therapeutic applications at 7 CFR 
205.603(a)(22). Oxytocin will not be prohibited, as proposed, in 
organic livestock production. A discussion of the compliant uses under 
the annotation, ``postparturition therapeutic applications,'' is 
included below in AMS's response.
NOSB Review and Recommendation
    Following its sunset review of oxytocin, the NOSB recommended 
removing oxytocin from the National List.\6\ As described in the 
Background section, the sunset process is a system of regular 
evaluation of National List substances against criteria in the OFPA. If 
a substance is found to no longer satisfy these criteria, the NOSB may 
recommend removal of the substance.
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    \6\ National Organic Standards Board, Livestock 2019 Sunset 
Substances, https://www.ams.usda.gov/sites/default/files/media/LS2019SunsetsFinalRec.pdf.
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    The NOSB requested public comment on whether the substance was 
essential for organic production and whether there were natural 
alternative materials and methods that render it unnecessary. In 
response, the NOSB received public comments indicating the substance 
was no longer necessary and generally supporting its removal. The NOSB 
concluded there are numerous alternative methods and materials to 
oxytocin and that the use of oxytocin no longer meets the criteria at 7 
U.S.C. 6518(m)(6). Additionally, the NOSB noted that oxytocin is a 
synthetic hormone and that hormones are not otherwise permitted in 
organic production (Sec. Sec.  205.237(b)(1) and 205.238(c)(3)).
Comments Received
    AMS received several comments in response to the proposed sunset 
removal of oxytocin from the National List.
    General opposition. A certifying agent (``certifier'') noted that 
35 of the organic dairies they certify include the substance in their 
Organic System Plans for use in post-parturition therapeutic 
applications. The commenter stated that those operations use oxytocin 
for various uses, including uterine care, milk letdown for first-time 
heifers or as a mastitis treatment, retained placenta, and strained 
labor treatment. The commenter noted they do not allow routine or 
repeated use of oxytocin nor permit operations to use oxytocin to 
promote milk production. The commenter requested that any prohibition 
of the substance occur following the 2022 spring birthing season.
    A dairy manufacturer requested retention for oxytocin on the 
National List due to a lack of alternatives. The commenter also stated 
oxytocin is a veterinary control drug that should only be administered 
or prescribed under veterinary instruction. The commenter recognized 
alternatives can assist with topical inflammation; however, for uses to 
assist with inflammation caused by animals withholding milk or to 
assist with uterine cleaning, the commenter stated there were no 
compliant alternatives. Another commenter also requested oxytocin to 
remain an allowed substance on account of its effectiveness as a post-
parturition therapeutic to transition a dry cow to a lactating cow.
    General agreement. A comment stated that natural alternatives are 
available to address certain post-parturition complications that can 
arise in organic dairy cattle and that use of oxytocin would prevent 
organic producers from claiming their products are ``hormone-free.'' 
The commenter requested an implementation period of 12 months to

[[Page 10933]]

allow for industry time to comply with the final rule.
AMS Response
    After reviewing public comments, AMS is renewing the listing for 
oxytocin in this final rule. The substance will remain on the National 
List, with a new sunset date of March 15, 2027. AMS agrees with 
commenters that synthetic oxytocin remains essential to organic 
livestock production in the absence of alternative nonsynthetic 
(natural) medical treatments for post-parturition emergency treatments 
(i.e., treatment for severe complications resulting from labor). AMS 
notes that under current FDA regulations, ``Federal law restricts 
[oxytocin] to use by or on the order of a licensed veterinarian.'' (21 
CFR 522.1680(c)(3)). Although some annotations on the National List for 
animal drugs specify that they may be used only by or on the order of a 
veterinarian, the absence of this phrasing in the annotation for 
oxytocin would not alter a producer's obligations to comply with other 
federal laws.
    By retaining oxytocin on the National List, organic livestock 
producers will continue to be permitted to use the drug to treat 
specific conditions within a limited timeframe following parturition 
without forfeiting the animal's organic status. Additional discussion 
of the permitted uses of the substance in organic production follows.
Annotation Discussion
    AMS is aware there is some confusion around what uses comply with 
the annotation for oxytocin that reads, ``use in postparturition 
therapeutic treatments'' (Sec.  205.603(a)(22)). This discussion is 
meant to inform certifying agents and organic operations of AMS's 
current thinking on uses that comply with the annotation.
    The current annotation allows producers to use oxytocin to treat 
conditions related to labor and to an animal's postpartum survival. Its 
use is not permitted on a routine basis (i.e., as protocol). Instead, 
it is available for emergency situations and severe complications in 
the immediate postpartum (following birth of young) period. It may not 
be administered to increase an animal's milk production (volume) or for 
milk letdown. As previously noted in this document, Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian (21 CFR 522.1680(c)(3)).
    AMS's interpretation of the annotation for oxytocin at Sec.  
205.603, ``for postparturition therapeutic applications,'' is informed 
and supported by its prior discussion of oxytocin in its March 13, 2000 
proposed rule (65 FR 13511). AMS believes that discussion is relevant 
to the meaning of the current annotation in the USDA organic 
regulations. In the discussion in the proposed rule, AMS noted that 
oxytocin, ``has some uses that do not involve lactation but are instead 
related to an animal's postpartum survival'' and that oxytocin was 
permitted by some certifiers for ``animals that experience severe 
complications resulting from labor,'' and described those as 
``emergency situations'' (65 FR 13511, 13588).
    AMS's expectation is that certifiers will always review an organic 
operation's use of oxytocin to ensure it is used only in 
postparturition therapeutic applications.

Procaine (Sec.  205.603)

    This final rule amends the National List to remove procaine at 7 
CFR 205.603(b)(9) and prohibit its use in organic livestock production.
NOSB Review and Recommendation
    Following the sunset review of procaine, the NOSB recommended 
removing procaine from the National List. As described in the 
Background section, the sunset process is a system of regular 
evaluation of National List substances against criteria in the OFPA. If 
a substance is found to no longer satisfy these criteria, the NOSB may 
recommend removal of the substance.
    In support of their sunset review, the NOSB solicited public 
comment over two meetings on use of procaine and whether procaine can 
be sourced without prohibited antibiotics. The comments stated procaine 
is rarely used, is only available in drug formulations that are 
combined with prohibited antibiotics, and is not as effective as 
lidocaine (allowed for organic livestock use at Sec.  205.603(b)(5)). 
After their review, the NOSB recommended removal of procaine from the 
National List.
Comments Received
    AMS received no comments opposed to removing procaine from the 
National List. A certifying agent noted the importance of pain 
relievers but stated that procaine was not an active ingredient in any 
product currently used by organic operations that it certifies. Another 
comment highlighted that procaine products are already prohibited for 
use because they are always formulated with antibiotics that are 
prohibited in organic livestock production. One commenter requested an 
implementation timeline of 12 months to allow industry time to comply 
with the final rule.
AMS Response
    As the NOSB referenced in their recommendation, 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 16 of the FDA approved 
drugs that contain procaine also contain an antibiotic (e.g., 
Penicillin G Procaine). Furthermore, another National List material, 
lidocaine, could be used to perform the same function (as a local 
anesthetic). This information supports that procaine is not currently 
used in organic production and no longer meets the exemption 
requirement (7 U.S.C. 6517(c)(1)(A)(ii)). AMS agrees with commenters 
and the NOSB that procaine is not essential to organic livestock 
production. AMS is finalizing the removal of synthetic procaine from 
the National List at Sec.  205.603(b)(9) to prohibit its use in organic 
livestock production. As specified in the DATES section, organic 
livestock producers will have until March 15, 2023, to comply with this 
change.

Alginic Acid (Sec.  205.605)

    This final rule amends the National List to remove alginic acid at 
7 CFR 205.605(b) and prohibit its use in organic processed products.
NOSB Review and Recommendation
    Following the sunset review of alginic acid, the NOSB recommended 
removing alginic acid from the National List. As described in the 
Background section, the sunset process is a system of regular 
evaluation of National List substances against criteria in the OFPA. If 
a substance is found to no longer satisfy these criteria, the NOSB may 
recommend removal of the substance.
    In support of their sunset review of alginic acid, the NOSB 
received a third-party technical report in 2015 and solicited public 
comment at their Spring 2019 meeting.\7\ The NOSB received no comments 
in support of continuing the allowance of, or stating use of, alginic 
acid. In addition, no certifying agents (``certifiers'') reported this 
material in use 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

[[Page 10934]]

determined that there are readily available alternatives and 
recommended removal.
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    \7\ OMRI, Technical Evaluation Report: Alginic Acid, https://www.ams.usda.gov/sites/default/files/media/Alginic%20Acid%20TR.pdf.
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Comments Received
    AMS received no comments in favor of retaining alginic acid on the 
National List. One comment agreed with the NOSB's rationale for 
removing alginic acid from the National List and requested a 24-month 
implementation period to comply with the final rule.
AMS Response
    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). AMS is finalizing the removal of alginic acid from 
the National List at Sec.  205.605(b) to prohibit its use in organic 
processed products. As identified in the DATES section, organic 
processors will have until March 15, 2024, to comply with this change.

Colors (Sec.  205.606)

    This final rule amends the National List to remove eight nonorganic 
colors from the National List at Sec.  205.606(d):
    <bullet> Black currant juice color--derived from Ribes nigrum L.;
    <bullet> Blueberry juice color--derived from blueberries (Vaccinium 
spp.);
    <bullet> Carrot juice color--derived from Daucus carota L.;
    <bullet> Cherry juice color--derived from Prunus avium (L.) L. or 
Prunus cerasus L.;
    <bullet> Grape juice color--derived from Vitis vinifera L.;
    <bullet> Paprika color--derived from dried powder or vegetable oil 
extract of Capsicum annuum L.;
    <bullet> Pumpkin juice color--derived from Cucurbita pepo L. or 
Cucurbita maxima Duchesne;
    <bullet> Turmeric extract color--derived from Curcuma longa L.
NOSB Review and Recommendation
    The NOSB recommended the removal of these colors at their Fall 2020 
meeting.\8\ The effect of these removals means that only organic forms 
of these colors will be allowed in organic handling. The NOSB solicited 
public comments in support of their sunset review of these colors at 
the Spring and Fall 2020 meetings. The NOSB noted these public comments 
were mixed regarding the availability and necessity of these colors. 
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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    \8\ National Organic Standards Board, 2022 Sunset Reviews--
Handling (Sec. Sec.  205.605, 205.606), https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf.
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Comments Received
    AMS received few comments in response to the proposed removal of 
eight nonorganic colors from the National List.
    General opposition. A comment requested retaining turmeric extract 
color on the National List because there is no readily available 
organic alternative in the marketplace. Another comment requested 
retaining paprika color on the National List as there are no 
commercially-available, organic alternatives for the color; however, 
the commenter stated there are readily-available, organic raw materials 
that may allow an organic version of the color to be developed. The 
commenter estimated a two-year implementation period would provide 
enough time for color development, shelf-life trials, and 
commercialization.
    General agreement. A certifier noted limited use of the nonorganic 
colors in this final rule among the organic handlers they certify. The 
comment noted there is limited use of nonorganic paprika color, grape 
juice color, and cherry juice powder. A certifying agent was 
particularly concerned about an insufficient supply of blueberry juice 
color, carrot juice color, paprika color, and turmeric extract color. 
The commenter cited an internal survey (of organic operations) that 
indicated the supply of organic colors is fragile and that removal from 
the National List may be premature, especially without a substantial 
implementation period. The commenter requested an implementation 
timeline of 24 months to allow industry time to comply with the final 
rule.
AMS Response
    In the rule proposing removal of these colors, AMS requested 
comments regarding whether any of these colors are necessary and 
whether there are enough organic versions available to meet demand. 
Comments received suggested there may not be sufficient supplies of 
certain organic colors but that supply would likely develop over the 
course of the 24-month implementation period. None of these comments 
suggested an inability to produce or develop organic versions of these 
colors, given sufficient time. As such, AMS is finalizing the removal 
of these non-organic colors from the National List at Sec.  205.606(d). 
To support the development of an adequate supply of organic colors, as 
requested by commentors, organic processors will have until March 15, 
2024 (a 24-month implementation period) to comply with these changes.

Kelp (Sec.  205.606)

    This final rule amends the National List to remove kelp at 7 CFR 
205.606(k) and prohibit its use. Wakame seaweed and Pacific kombu 
remain allowed in Sec.  205.606 in organic processed products.
NOSB Review and Recommendation
    Following the sunset review of kelp at their Fall 2020 meeting, the 
NOSB recommended removing kelp from the National List. Only organic 
forms of kelp (other than wakame seaweed and Pacific kombu, which 
remain allowed in Sec.  205.606), would be allowed in organic handling. 
As described in the Background section, the sunset process is a system 
of regular evaluation of National List substances against criteria in 
the OFPA. If a substance is found to no longer satisfy these criteria, 
the NOSB may recommend removal of the substance.
    During its sunset review, the NOSB received comments in support of 
removing, as well as relisting, kelp. The NOSB determined that there 
were alternatives to kelp on the National List (namely Pacific kombu 
and wakame) and therefore recommended removing kelp from the National 
List in Sec.  205.606.
Comments Received
    AMS received no comments in favor of retaining nonorganic kelp on 
the National List for organic handling. A comment requested an 
implementation period of 24 months to allow industry time to comply 
with the final rule.
AMS Response
    According to the Organic Integrity Database, there are currently 
104 certified crop, wild crop, and handling operations that list 
``kelp'' as a certified organic product.\9\ Organic kelp appears to be 
commercially available; therefore, this substance is no longer 
necessary and no longer meets the requirements for inclusion on the 
National List at 7 U.S.C. 6517(c)(1)(A)(ii). AMS did not receive any 
comments challenging this conclusion and is finalizing the removal of 
non-organic kelp from the National List at Sec.  205.606(k). As 
identified in the

[[Page 10935]]

DATES section, organic processors will have until March 15, 2024, to 
comply with this change.
---------------------------------------------------------------------------

    \9\ Organic Integrity Database, accessed January 5, 2022: 
https://organic.ams.usda.gov/integrity/Search.aspx.
---------------------------------------------------------------------------

Konjac Flour (Sec.  205.606)

    This final rule amends the National List to remove konjac flour at 
7 CFR 205.606(l) and prohibit its use in organic processed products.
NOSB Review and Recommendation
    Following the sunset review of konjac flour at their Fall 2017 
meeting, the NOSB recommended removing konjac flour from the National 
List. As described in the Background section, the sunset process is a 
system of regular evaluation of National List substances against 
criteria in the OFPA. If a substance is found to no longer satisfy 
these criteria, the NOSB may recommend removal of the substance.
    In support of their recommendation, the NOSB solicited public 
comment regarding the use and necessity of konjac flour in organic 
handling as well as 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 products sold as ``organic.'' 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 available alternatives.
Comments Received
    AMS received no comments in favor of retaining nonorganic konjac 
flour on the National List for organic handling. A comment requested an 
implementation period of 24 months to allow industry time to comply 
with the final rule.
AMS Response
    A search in the Organic Integrity Database for ``konjac'' shows 30 
operations with some form of certified organic konjac products (e.g., 
powder, starch, konjac tubers).\10\ 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 no longer meets 
the requirements for inclusion on the National List at 7 U.S.C. 
6517(c)(1)(A)(ii). AMS did not receive any comments challenging this 
conclusion and, as such, is finalizing the removal of non-organic 
konjac flour from the National List at Sec.  205.606(l). As identified 
in the DATES section, organic processors will have until March 15, 
2024, to comply with this change.
---------------------------------------------------------------------------

    \10\ Organic Integrity Database, accessed January 5, 2022: 
https://organic.ams.usda.gov/integrity/Search.aspx.
---------------------------------------------------------------------------

Sweet Potato Starch (Sec.  205.606)

    This final rule amends the National List to remove sweet potato 
starch at 7 CFR 205.606(s)(2) and prohibit the use of non-organic sweet 
potato starch in organic products.
NOSB Review and Recommendation
    Following the sunset review of sweet potato starch at their Fall 
2020 meeting, the NOSB recommended removing sweet potato starch from 
the National List. As described in the Background section, the sunset 
process is a system of regular evaluation of National List substances 
against criteria in the OFPA. If a substance is found to no longer 
satisfy these criteria, the NOSB may recommend removal of the 
substance.
    During its sunset review, the NOSB solicited public comment on the 
use and necessity of sweet potato starch but received little feedback. 
The comments suggested there is scant use of nonorganic sweet potato 
starch, that alternatives are readily available, and that organic sweet 
potato starch is available. Further, comments noted that the continued 
listing of nonorganic sweet potato starch is inhibiting production of 
organic forms of sweet potato starch. Based on this information, the 
NOSB recommended the removal of this substance due to available 
alternatives.
Comments Received
    AMS received no comments in favor of retaining nonorganic sweet 
potato starch on the National List for organic handling. A comment 
requested an implementation period of 24 months to allow industry time 
to comply with the final rule.
AMS Response
    A search in the Organic Integrity Database for ``potato starch'' 
shows 60 operations with some form of certified organic potato starch 
and another 27 operations with some form of certified organic pea 
starch, a cited alternative to sweet potato starch.\11\ Given the low 
reported use of nonorganic sweet potato starch and the availability of 
organic sweet potato starch and organic pea starch, nonorganic sweet 
potato starch no longer meets the requirements for inclusion on the 
National List at 7 U.S.C. 6517(c)(1)(A)(ii). AMS did not receive any 
comments challenging this conclusion and, as such, is finalizing the 
removal of non-organic sweet potato starch from the National List at 
Sec.  205.606(s)(2). As identified in the DATES section, organic 
processors will have until March 15, 2024, to comply with this change.
---------------------------------------------------------------------------

    \11\ Organic Integrity Database, accessed January 5, 2022: 
https://organic.ams.usda.gov/integrity/Search.aspx.
---------------------------------------------------------------------------

Turkish Bay Leaves (Sec.  205.606)

    This final rule amends the National List to remove Turkish bay 
leaves at 7 CFR 205.606(v) to prohibit its use in organic products.
NOSB Review and Recommendation
    Following the sunset review of Turkish bay leaves at their Fall 
2020 meeting, the NOSB recommended removing Turkish bay leaves from the 
National List. As described in the Background section, the sunset 
process is a system of regular evaluation of National List substances 
against criteria in the OFPA. If a substance is found to no longer 
satisfy these criteria, the NOSB may recommend removal of the 
substance.
    During its sunset review, the NOSB received many comments 
supporting the removal of Turkish bay leaves due to the availability of 
organic versions. The NOSB called attention to one comment received at 
its Fall 2020 meeting from an organic producer who uses Turkish bay 
leaves in a wide range of organic canned soups. This food manufacturer 
noted that organic forms of Turkish bay leaves are readily available. 
Further comments from certifiers indicated that few, if any, of their 
operations use nonorganic Turkish bay leaves. Based on this 
information, the NOSB recommended the removal of this substance due to 
available alternatives.\12\
---------------------------------------------------------------------------

    \12\ National Organic Standards Board, 2022 Sunset Reviews--
Handling (Sec. Sec.  205.605, 205.606), https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf.
---------------------------------------------------------------------------

Comments Received
    AMS received no comments in favor of retaining nonorganic Turkish 
bay leaves on the National List for organic handling. A commenter noted 
that the NOSB received multiple comments supporting the removal of 
Turkish bay leaves from the National List during the 2020 sunset 
review. The commenter stated that Turkish bay leaves only remained on 
the National List after the NOSB's Fall 2015 meeting due to the lack of 
available, organic alternatives.
AMS Response
    Previously, AMS proposed removing Turkish bay leaves from Sec.  
205.606 following a Fall 2015 NOSB

[[Page 10936]]

recommendation.\13\ At the time, AMS received comments stating organic 
whole Turkish bay leaves were not available in the quantity or quality 
to meet organic handling needs. As a result, AMS did not finalize 
removing Turkish bay leaves (82 FR 31241, July 6, 2017), and its sunset 
date was extended five years.
---------------------------------------------------------------------------

    \13\ National Organic Standards Board, Sunset 2017 NOSB Final 
Review Handling Substances, https://www.ams.usda.gov/sites/default/files/media/HS%202017%20Sunset%20Final%20Rvw%20605%28a%29_%28b%29_606_final%20rec.pdf.
---------------------------------------------------------------------------

    A search in the Organic Integrity Database for ``bay leaves'' shows 
143 crop and handling operations with some form of certified organic 
bay leaves. A search using the term ``Turkish bay leaves'' shows six 
operations, as it appears that only one certifying agent identifies bay 
leaves with that level of specificity in the Organic Integrity 
Database.\14\ 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 no longer meet the requirements for inclusion on the 
National List at 7 U.S.C. 6517(c)(1)(A)(ii). During this current 
rulemaking, AMS received no comments challenging this conclusion and is 
removing non-organic Turkish bay leaves from the National List at Sec.  
205.606(v). As identified in the DATES section, organic processors will 
have until March 15, 2024, to comply with this change.
---------------------------------------------------------------------------

    \14\ Organic Integrity Database, accessed January 5, 2022: 
https://organic.ams.usda.gov/integrity/Search.aspx.
---------------------------------------------------------------------------

Whey Protein Concentrate (Sec.  205.606)

    This final rule amends the National List to remove whey protein 
concentrate at 7 CFR 205.606(x) and prohibit its use in organic 
processed products.
NOSB Review and Recommendation
    Following the sunset review of whey protein concentrate at their 
Fall 2020 meeting, the NOSB recommended removing whey protein 
concentrate from the National List. As described in the Background 
section, the sunset process is a system of regular evaluation of 
National List substances against criteria in the OFPA. If a substance 
is found to no longer satisfy these criteria, the NOSB may recommend 
removal of the substance.
    During this sunset review, the NOSB received many comments 
supporting the removal of whey protein concentrate due to the 
availability of organic versions. The NOSB highlighted 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 comments 
from at least one certifier indicated that none of their operations are 
using nonorganic whey protein concentrate. Based on this information, 
the NOSB recommended the removal of this substance based on available 
alternatives.\15\
---------------------------------------------------------------------------

    \15\ National Organic Standards Board, 2022 Sunset Reviews--
Handling (Sec. Sec.  205.605, 205.606),https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf.
---------------------------------------------------------------------------

Comments Received
    AMS received no comments in favor of retaining nonorganic whey 
protein concentrate on the National List for organic handling. A 
certifier noted that an organic operation they certify previously used 
non-organic whey protein concentrate but no longer does. Another 
commenter noted that the NOSB received many comments supporting the 
removal of whey protein from the National List during the 2020 sunset 
review, including from several manufacturers who demonstrated they 
produce a robust supply of organic whey protein concentrate. The 
commenter noted that removing the allowance of a nonorganic form will 
help support organic cheese manufacturers. A comment requested an 
implementation period of 24 months to allow industry time to comply 
with the final rule.
AMS Response
    Previously, AMS proposed removing whey protein concentrate from 
Sec.  205.606, following a Fall 2015 NOSB recommendation.\16\ At that 
time, AMS received comments stating organic whey protein concentrate 
was essential for organic processed products and that there were no 
commercially available, organic products. As a result, AMS did not 
finalize the removal of whey protein concentrate from the National List 
(82 FR 31241, July 6, 2017).
---------------------------------------------------------------------------

    \16\ National Organic Standards Board, Sunset 2017 NOSB Final 
Review Handling Substances, https://www.ams.usda.gov/sites/default/files/media/HS%202017%20Sunset%20Final%20Rvw%20605%28a%29_%28b%29_606_final%20rec.pdf.
---------------------------------------------------------------------------

    A search in the Organic Integrity Database for ``whey protein 
concentrate'' shows 23 operations with some form of certified organic 
whey protein concentrate. The NOSB also received comments suggesting 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 no longer meets the requirement for inclusion 
on the National List at 7 U.S.C. 6517(c)(1)(A)(ii). During this current 
rulemaking, AMS received no comments challenging this conclusion and is 
removing non-organic whey protein concentrate from the National List at 
Sec.  205.606(x). As identified in the DATES section, organic 
processors will have until March 15, 2024, to comply with this change.

III. Related Documents

    AMS published notices in the Federal Register to announce the NOSB 
meetings where the Board discussed these substances. The notices 
invited public comments on the NOSB recommendations addressed in this 
final rule. Transcripts of the meetings, along with the NOSB 
recommendations, can be found on the AMS website at: https://www.ams.usda.gov/rules-regulations/organic/nosb/meetings. The AMS 
proposed rule that preceded this final rule was published on August 24, 
2021 (86 FR 47242).

IV. Statutory and Regulatory Authority

    The OFPA authorizes the Secretary to make amendments to the 
National List based on recommendations developed by the NOSB. The OFPA 
authorizes 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 (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 Handbook on the NOP 
website as document NOP 3011 at https://www.ams.usda.gov/rules-regulations/organic/handbook.

[[Page 10937]]

A. Executive Order 12866 and Regulatory Flexibility Act

    This final 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.\17\ 
The SBA classifies small agricultural producers that engage in crop and 
animal production as those with average annual receipts of less than 
$1,000,000 (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 $16.5 million.
---------------------------------------------------------------------------

    \17\ ``Table of Small Business Size Standards Matched to North 
American Industry Classification System Codes,'' U.S. Small Business 
Administration, August 19, 2019, https://www.naics.com/wp-content/uploads/2017/10/SBA_Size_Standards_Table.pdf.
---------------------------------------------------------------------------

    Producers. AMS has considered the economic impact of this final 
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 2017 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.\18\ 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.
---------------------------------------------------------------------------

    \18\ ``2019 Organic Survey,'' 2017 Census of Agriculture, U.S. 
Department of Agriculture National Agricultural Statistics Service, 
table 1, https://www.nass.usda.gov/Publications/AgCensus/2017/Online_Resources/Organics/ORGANICS.pdf.
---------------------------------------------------------------------------

    Handlers. According to the NOP's Organic Integrity Database (OID), 
there are 10,971 U.S.-based organic handlers that are certified under 
the USDA organic regulations.\19\ 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: 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 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.
---------------------------------------------------------------------------

    \19\ Organic Integrity Database, U.S. Department of Agriculture, 
accessed October 27, 2021, https://organic.ams.usda.gov/Integrity.
---------------------------------------------------------------------------

    Certifying agents. The SBA defines ``all other professional, 
scientific, and technical services,'' which include certifying agents, 
as those having annual receipts of less than $16,500,000 (13 CFR 
121.201). There are currently 76 USDA-accredited certifying agents, 
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 final 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 regulations (e.g., maintaining certification records for 
organic operations).
    AMS does not expect this rule to have a significant economic impact 
on entities affected by this rule. Alternatives exist to the substances 
that this rule prohibits, as determined by the NOSB and AMS. 
Additionally, AMS is providing a 12- to 24-month implementation period, 
depending on the substance or ingredient, to allow affected entities 
time to modify practices.

B. 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 final 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 the 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 the OFPA (7 U.S.C. 6503-6507).
    Pursuant to the 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 final 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.).

C. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this final rule. Accordingly, Office of Management and 
Budget (OMB) clearance is not required

[[Page 10938]]

by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501, Chapter 
35.

D. Executive Order 13175

    This final 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 final 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 are shared 
during quarterly calls with Tribal leaders, who have the opportunity to 
submit comments. AMS works with the USDA Office of Tribal Relations to 
ensure meaningful consultation is provided as needed with regards to 
the NOP regulations.

E. 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).

F. General Notice of Public Rulemaking

    This final rule reflects recommendations submitted by the NOSB to 
the Secretary to remove fourteen nonorganic ingredients and two 
substances from the National List. This final rule retains (or 
``renews'') two substances 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, 
Organically produced products, Plants, Reporting and recordkeeping 
requirements, Seals and insignia, Soil conservation.

    For the reasons set forth in the preamble, 7 CFR part 205 is 
amended 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 revising paragraph (j)(9) 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 removing paragraph (b)(9) and redesignating 
paragraphs (b)(10) through 12 as paragraphs (b)(9) through (11).


Sec.  205.605   [Amended]

0
4. Amend Sec.  205.605(b) by removing the words ``Alginic acid (CAS 
#9005-32-7)''.

0
5. Amend Sec.  205.606 by revising paragraphs (d) through (t) and 
removing paragraphs (u) through (w).
    The revisions read as follows:


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

* * * * *
    (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) Cornstarch (native).
    (f) 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.
    (g) Fructooligosaccharides (CAS # 308066-66-2).
    (h) Gelatin (CAS # 9000-70-8).
    (i) 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).
    (j) Gums--water extracted only (Arabic; Guar; Locust bean; and 
Carob bean).
    (k) Inulin--oligofructose enriched (CAS # 9005-80-5).
    (l) Lecithin--de-oiled.
    (m) Orange pulp, dried.
    (n) Orange shellac--unbleached (CAS # 9000-59-3).
    (o) Pectin (non-amidated forms only).
    (p) Potassium acid tartrate.
    (q) Seaweed, Pacific kombu.
    (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. 2022-03851 Filed 2-25-22; 8:45 am]
BILLING CODE P


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