Federal Register - August 24, 2021

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Source: Federal Register

lotter on DSK11XQN23PROD with PROPOSALS1

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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Proposed Rules
proposing the removal of oxytocin from the National List at 205.603a22.

removal of procaine from the National List at 205.603b8.

D. Procaine 205.603

E. Alginic Acid 205.605
AMS is proposing to remove alginic acid from the National List. Alginic acid was added to 205.605a 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 205.605b for use in organic handling.
In support of their sunset review of alginic acid, the NOSB received a thirdparty 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.
6518m6.
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.
6517c1Aii. As such, AMS
proposes the removal of alginic acid from the National List at 205.605b.

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 205.603b8 for use as a local anesthetic.
In support of the NOSBs 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 205.603b5, 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. 6518m6, due to lidocaine being more effective and because procaine is not available i.e., compounded without prohibited antibiotics.
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. 6517c1Aii.
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 FDAs animal drug database https
animaldrugsatfda.fda.gov/ indicates that all sixteen of the FDA approved drugs that contain procaine also contain an antibiotic e.g., Penicillin G
Procaine. This information supports the fact that procaine is not used in organic production and that an exemption is not necessary 7 U.S.C. 6517c1Aii. As procaine no longer appears to meet the requirements for inclusion on the National List, AMS is proposing the 8 Formal Livestock Sunset Recommendations from NOSB to NOP, November 2, 2017: https
www.ams.usda.gov/sites/default/files/media/
LS2019SunsetsFinalRec.pdf.

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F. Colors 205.606
AMS is proposing to remove eight nonorganic colors from the National List at 205.606d:
Black currant juice colorderived from Ribes nigrum L.
Blueberry juice colorderived from blueberries Vaccinium spp..
Carrot juice colorderived from Daucus carota L.
Cherry juice colorderived from Prunus avium L. L. or Prunus cerasus L.
Grape juice colorderived from Vitis vinifera L.
Paprika colorderived from dried powder or vegetable oil extract of Capsicum annuum L.
9 Alginic
Acid Technical Report, February 5, 2015: https www.ams.usda.gov/sites/default/files/
media/Alginic%20Acid%20TR.pdf.

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Pumpkin juice colorderived from Cucurbita pepo L. or Cucurbita maxima Duchesne.
Turmeric extract colorderived 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 205.606d 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.
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 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 10 Formal Handling Sunset Recommendations from the NOSB to the NOP, October 30, 2020:
https www.ams.usda.gov/sites/default/files/
media/HS2022SunsetRecs_webpost.pdf.

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Federal Register - August 24, 2021

TitreFederal Register

PaysÉtats-Unis

Date24/08/2021

Page count181

Edition count7798

Première édition14/03/1936

Dernière édition18/06/2026

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