Proposed Rule2021-17835
National Organic Program; National List of Allowed and Prohibited Substances (2022 Sunset)
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Published
August 24, 2021
Issuing agencies
Agriculture DepartmentAgricultural Marketing Service
Abstract
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.
Full Text
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-17835]
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Proposed Rules
Federal Register
________________________________________________________________________
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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>. You can access this
proposed rule and instructions for submitting public comments by
searching for document number AMS-NOP-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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> will include any
personal information provided.
FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division,
National Organic Program, 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):
<bullet> Sucrose Octanoate Esters (crop production)
<bullet> Vitamin B<INF>1</INF> (crop production)
<bullet> Oxytocin (livestock production)
<bullet> Procaine (livestock production)
<bullet> 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):
<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
<bullet> 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: <a href="https://www.ams.usda.gov/sites/default/files/media/Sucrose%20Recommendation.pdf">https://www.ams.usda.gov/sites/default/files/media/Sucrose%20Recommendation.pdf</a>.
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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,<SUP>2 3</SUP> 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: <a href="https://www.ams.usda.gov/sites/default/files/media/CS2020SunsetFinalRecOct2018.pdf">https://www.ams.usda.gov/sites/default/files/media/CS2020SunsetFinalRecOct2018.pdf</a>.
\3\ NOSB Fall 2018 Livestock Sunset Recommendations: <a href="http://www.ams.usda.gov/sites/default/files/media/LS2020SunsetFinalRecOct2018.pdf">http://www.ams.usda.gov/sites/default/files/media/LS2020SunsetFinalRecOct2018.pdf</a>.
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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\ <a href="https://iaspub.epa.gov/apex/pesticides/f?p=PPLS:1">https://iaspub.epa.gov/apex/pesticides/f?p=PPLS:1</a> 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 B<INF>1</INF> from the National
List. Vitamin B<INF>1</INF> 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 B<INF>1</INF>, 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 B<INF>1</INF> 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 B<INF>1</INF> 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: <a href="https://www.ams.usda.gov/sites/default/files/media/CS2019SunsetsFinalRec.pdf">https://www.ams.usda.gov/sites/default/files/media/CS2019SunsetsFinalRec.pdf</a>.
\6\ 2015 Technical Report on Vitamins B<INF>1</INF>, C, and E
used in crop production: <a href="https://www.ams.usda.gov/sites/default/files/media/Vitamins%20B1-C-E%20TR%202015.pdf">https://www.ams.usda.gov/sites/default/files/media/Vitamins%20B1-C-E%20TR%202015.pdf</a>.
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AMS agrees with the NOSB recommendation to remove vitamin
B<INF>1</INF> 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 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 and nonsynthetic alternatives to vitamin B<INF>1</INF>
including yeast, various meals (e.g., soybean meal, cottonseed meal),
and other crop waste or residues. Accordingly, AMS proposes that
vitamin B<INF>1</INF> 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: <a href="https://www.ams.usda.gov/sites/default/files/media/LS2019SunsetsFinalRec.pdf">https://www.ams.usda.gov/sites/default/files/media/LS2019SunsetsFinalRec.pdf</a>.
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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: <a href="https://www.ams.usda.gov/sites/default/files/media/LS2019SunsetsFinalRec.pdf">https://www.ams.usda.gov/sites/default/files/media/LS2019SunsetsFinalRec.pdf</a>.
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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 (<a href="https://animaldrugsatfda.fda.gov/">https://animaldrugsatfda.fda.gov/</a>)
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: <a href="https://www.ams.usda.gov/sites/default/files/media/Alginic%20Acid%20TR.pdf">https://www.ams.usda.gov/sites/default/files/media/Alginic%20Acid%20TR.pdf</a>.
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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):
<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.
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: <a href="https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf">https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf</a>.
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AMS 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: <a href="https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf">https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf</a>.
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AMS 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:
<a href="https://organic.ams.usda.gov/integrity/Search.aspx">https://organic.ams.usda.gov/integrity/Search.aspx</a>.
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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: <a href="https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%201992-2009.pdf">https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%201992-2009.pdf</a>.
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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: <a href="https://www.ams.usda.gov/sites/default/files/media/HS2019SunsetsFinalRec.pdf">https://www.ams.usda.gov/sites/default/files/media/HS2019SunsetsFinalRec.pdf</a>.
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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: <a href="https://organic.ams.usda.gov/integrity/default.aspx">https://organic.ams.usda.gov/integrity/default.aspx</a>.
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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: <a href="https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%201992-2009.pdf">https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%201992-2009.pdf</a>.
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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: <a href="https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf">https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf</a>.
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AMS 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:
<a href="https://organic.ams.usda.gov/integrity/default.aspx">https://organic.ams.usda.gov/integrity/default.aspx</a>.
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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: <a href="https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%201992-2009.pdf">https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%201992-2009.pdf</a>.
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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: <a href="https://www.ams.usda.gov/sites/default/files/media/HS%202017%20Sunset%20Final%20Rvw%20605%28a%29_%28b%29_606_final%20rec.pdf">https://www.ams.usda.gov/sites/default/files/media/HS%202017%20Sunset%20Final%20Rvw%20605%28a%29_%28b%29_606_final%20rec.pdf</a>.
\21\ Formal Handling Sunset Recommendations from the NOSB to the
NOP, October 30, 2020: <a href="https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf">https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf</a>.
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AMS 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).
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\22\ USDA Organic Integrity Database, accessed February 8, 2021:
<a href="https://organic.ams.usda.gov/integrity/default.aspx">https://organic.ams.usda.gov/integrity/default.aspx</a>.
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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.
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\23\ NOSB Meeting Minutes & Transcripts 1992-2009; <a href="https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%2019">https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%2019</a>.
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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).
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\24\ Formal Handling Sunset Recommendation from the NOSB to the
NOP, October 2015: <a href="https://www.ams.usda.gov/sites/default/files/media/HS%202017%20Sunset%20Final%20Rvw%20605%28a%29_%28b%29_606_final%20rec.pdf">https://www.ams.usda.gov/sites/default/files/media/HS%202017%20Sunset%20Final%20Rvw%20605%28a%29_%28b%29_606_final%20rec.pdf</a>.
\25\ Formal Handling Sunset Recommendations from the NOSB to the
NOP, October 30, 2020: <a href="https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf">https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf</a>.
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AMS 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).
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\26\ USDA Organic Integrity Database, accessed February 8, 2021:
<a href="https://organic.ams.usda.gov/integrity/default.aspx">https://organic.ams.usda.gov/integrity/default.aspx</a>.
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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
<a href="https://www.ams.usda.gov/rules-regulations/organic/handbook">https://www.ams.usda.gov/rules-regulations/organic/handbook</a>.
[[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.
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\27\ U.S. Department of Agriculture, National Agricultural
Statistics Service. 2019 Census of Agriculture. <a href="https://www.nass.usda.gov/Publications/AgCensus/2017/Online_Resources/Organics/ORGANICS.pdf">https://www.nass.usda.gov/Publications/AgCensus/2017/Online_Resources/Organics/ORGANICS.pdf</a>.
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According to the NOP's Organic Integrity Database, there are 19,059
organic handlers 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.
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\28\ Organic Integrity Database: <a href="https://organic.ams.usda.gov/Integrity/">https://organic.ams.usda.gov/Integrity/</a>. Accessed on January 29, 2021.
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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
</pre></body>
</html>Indexed from Federal Register on August 24, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.