[Federal Register Volume 86, Number 146 (Tuesday, August 3, 2021)]
[Rules and Regulations]
[Pages 41699-41701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16518]



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 Rules and Regulations
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  Federal Register / Vol. 86, No. 146 / Tuesday, August 3, 2021 / Rules 
and Regulations  

[[Page 41699]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-21-0042]


National Organic Program: 2021 and 2022 Sunset Review and 
Substance Renewals

AGENCY: Agricultural Marketing Service, USDA.

ACTION: 2021 and 2022 sunset review and renewals.

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SUMMARY: This document announces the renewal of substances listed on 
the National List of Allowed and Prohibited Substances (National List) 
within the U.S. Department of Agriculture's (USDA) organic regulations. 
This document reflects the outcome of the 2021 and 2022 sunset review 
processes and addresses recommendations submitted to the Secretary of 
Agriculture (Secretary), through the USDA's Agricultural Marketing 
Service (AMS), by the National Organic Standards Board (NOSB).

DATES: Applicable September 12, 2021.

FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division, 
Telephone: (202) 720-3252; Fax: (202) 260-9151.

SUPPLEMENTARY INFORMATION:

Background

    AMS administers the National Organic Program (NOP) under the 
authority of the Organic Foods Production Act of 1990 (OFPA), as 
amended (7 U.S.C. 6501-6524). The regulations implementing the NOP, 
also referred to as the USDA organic regulations (7 CFR part 205), were 
published on December 21, 2000 (65 FR 80548) and became effective on 
October 21, 2002. Through these regulations, AMS oversees national 
organic standards for the production, handling, and labeling of 
organically produced agricultural products. Since October 2002, the 
USDA organic regulations have been frequently amended, mostly for 
changes to the National List in 7 CFR 205.601-205.606.
    The National List identifies the synthetic substances allowed to be 
used and the nonsynthetic substances prohibited from use in organic 
farming. The National List also identifies nonagricultural substances 
and nonorganic agricultural substances that may be used in organic 
handling. The OFPA and USDA organic regulations specifically prohibit 
the use of any synthetic substance in organic production and handling 
unless an exemption for using the synthetic substance is provided on 
the National List. Section 205.105 of the USDA organic regulations also 
requires that any nonorganic agricultural substance and any 
nonagricultural substance used in organic handling be listed as allowed 
on the National List.
    The OFPA at 7 U.S.C. 6518 authorizes the NOSB, operating in 
accordance with the Federal Advisory Committee Act (Sec.  1 et seq., 5 
U.S.C. App.2), to assist in evaluating substances to be allowed or 
prohibited for organic production and handling and to advise the 
Secretary on the USDA organic regulations. The OFPA sunset provision (7 
U.S.C. 6517(e)) also requires a review of all substances included on 
the National List within five years of their addition to or renewal on 
the list. During this sunset review, the NOSB considers any new 
information pertaining to a substance's impact on human health and the 
environment, its necessity due to the unavailability of wholly natural 
substances, and its consistency with organic production and handling. 
The NOSB subsequently votes on whether to remove a substance from the 
National List.
    The Agricultural Improvement Act of 2018 amended the OFPA at 7 
U.S.C. 6518(i)(2) to specify that any vote on a motion proposing to 
amend the National List requires \2/3\ of the votes cast at a meeting 
of the NOSB at which a quorum is present to prevail. A substance 
remains on the National List unless an NOSB motion to remove that 
substance carries with \2/3\ of votes cast, and the Secretary 
subsequently renews or amends the listing for the substance. The NOSB 
submits its sunset review and recommendations to the Secretary. As 
delegated by the Secretary, AMS evaluates the sunset review and 
recommendations for compliance with the National List substance 
evaluation criteria set forth in OFPA at 7 U.S.C. 6518(m) and other 
federal statutes or regulations. AMS also considers public comments 
submitted during the sunset review process.
    AMS published an updated sunset review process in the Federal 
Register on September 16, 2013 (78 FR 56811). In accordance with the 
sunset review process, AMS published notices in the Federal Register 
announcing the NOSB meetings and invited written public comments on the 
2021 and 2022 sunset review of the substances included in Table 1 and 
Table 2 below. AMS also hosted oral public comment sessions to provide 
opportunities for public comment prior to NOSB meetings. Oral public 
comments were also heard at the start of the spring 2019 & 2020 and 
fall 2019 & 2020 NOSB meetings. At these public meetings, the NOSB 
reviewed substance listings scheduled to sunset from the National List 
and recommended that listings either be removed or remain on the 
National List. The NOSB's recommendations for sunset reviews completed 
in 2019 and 2020 can be found at https://www.ams.usda.gov/rules-regulations/organic/nosb/recommendations/.
    AMS has reviewed and accepted the NOSB's sunset review 
recommendations and is renewing the listings of the substances in Table 
1 and Table 2. These renewals align with the NOSB's conclusions and 
have been reviewed by AMS against the OFPA criteria (7 U.S.C. Sec.  
6517(c)). AMS has determined that the substance allowances listed in 
this document continue to meet the requirements in OFPA at Sec.  
6517(c)(1)(A). The renewal of these substance allowances will allow for 
continued use by organic operations. AMS also has determined that the 
four prohibited nonsynthetic substances listed in this document--ash 
from manure burning, sodium fluoaluminate, arsenic, and strychnine--
should remain prohibited, as recommended by the NOSB, because use of 
the substances continues to meet the criteria for prohibition at Sec.  
6517(c)(2)(A).
    The NOSB also recommended to the Secretary the removal of several 
National List substances at the

[[Page 41700]]

conclusion of the sunset review.\1\ These removals from the National 
List will be addressed in a separate notice and comment rulemaking and 
are not included in this document.
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    \1\ National Organic Program; Proposed Amendments to the 
National List of Allowed and Prohibited Substances (2022 Sunset). 
AMS-NOP-19-0106 (both 2019 mtgs and 2020 mtgs).
---------------------------------------------------------------------------

    Table 1 lists the substance exemptions being renewed through this 
document that were reviewed by the NOSB in calendar year 2019. These 
specific substance allowances and prohibitions continue as listed on 
the National List with a new sunset date of September 12, 2026.

                                    Table 1--National List Substances Renewed
                                           [Reviewed by NOSB in 2019]
----------------------------------------------------------------------------------------------------------------
                Substance                                              Use conditions
----------------------------------------------------------------------------------------------------------------
Sec.   205.601 Synthetic substances
 allowed for use in organic crop
 production:
    Hydrogen peroxide....................  As described under Sec.   205.601(a)(4).
    Hydrogen peroxide....................  As described under Sec.   205.601(i)(5).
    Soaps, ammonium......................  As described under Sec.   205.601(d).
    Horticultural oils...................  As described under Sec.   205.601(e)(7).
    Horticultural oils...................  As described under Sec.   205.601(i)(7).
    Pheromones...........................  As described under Sec.   205.601(f).
    Ferric phosphate.....................  As described under Sec.   205.601(h)(1).
    Potassium bicarbonate................  As described under Sec.   205.601(i)(9).
    Magnesium sulfate....................  As described under Sec.   205.601(j)(6).
    Hydrogen chloride....................  As described under Sec.   205.601(n).
Sec.   205.602 Nonsynthetic substances
 prohibited for use in organic crop
 production:
    Ash from manure burning..............  As described under Sec.   205.602(a).
    Sodium fluoaluminate.................  As described under Sec.   205.602(g).
Sec.   205.603 Synthetic substances
 allowed for use in organic livestock
 production:
    Atropine.............................  As described under Sec.   205.603(a)(3).
    Fenbendazole.........................  As described under Sec.   205.603(a)(23)(i).
    Hydrogen peroxide....................  As described under Sec.   205.603(a)(15).
    Iodine...............................  As described under Sec.   205.603(a)(16).
    Iodine...............................  As described under Sec.   205.603(b)(4).
    Magnesium sulfate....................  As described Sec.   205.603(a)(19).
    Moxidectin...........................  As described under Sec.   205.603(a)(23)(ii).
    Peroxyacetic/Peracetic acid..........  As described under Sec.   205.603(a)(24).
    Xylazine.............................  As described under Sec.   205.603(a)(30).
    DL-Methionine........................  As described under Sec.   205.603(d)(1).
    Trace Minerals.......................  As described under Sec.   205.603(d)(2).
    Vitamins.............................  As described under Sec.   205.603(d)(3).
Sec.   205.605 Nonagricultural
 (nonorganic) substances allowed as
 ingredients in or on processed products
 labeled as ``organic'' or ``made with
 organic (specified ingredients or food
 group(s)):''
    Acids (Citric--produced by microbial   As described under Sec.   205.605(a).
     fermentation of carbohydrate
     substances; and Lactic).
    Calcium chloride.....................  As described under Sec.   205.605(a).
    Enzymes..............................  As described under Sec.   205.605(a).
    L-malic acid.........................  As described under Sec.   205.605(a).
    Magnesium sulfate....................  As described under Sec.   205.605(a).
    Microorganisms.......................  As described under Sec.   205.605(a).
    Perlite..............................  As described under Sec.   205.605(a).
    Potassium iodide.....................  As described under Sec.   205.605(a).
    Yeast................................  As described under Sec.   205.605(a).
    Activated charcoal...................  As described under Sec.   205.605(b).
    Ascorbic acid........................  As described under Sec.   205.605(b).
    Calcium citrate......................  As described under Sec.   205.605(b).
    Ferrous sulfate......................  As described under Sec.   205.605(b).
    Hydrogen peroxide....................  As described under Sec.   205.605(b).
    Nutrient vitamins and minerals.......  As described under Sec.   205.605(b).
    Peracetic acid/Peroxyacetic acid.....  As described under Sec.   205.605(b).
    Potassium citrate....................  As described under Sec.   205.605(b).
    Potassium phosphate..................  As described under Sec.   205.605(b).
    Sodium acid pyrophosphate............  As described under Sec.   205.605(b).
    Sodium citrate.......................  As described under Sec.   205.605(b).
    Tocopherols..........................  As described under Sec.   205.605(b).
Sec.   205.606 Nonorganically produced
 agricultural products allowed as
 ingredients in or on processed products
 labeled as ``organic:''
    Celery powder........................  As described under Sec.   205.606(c).
    Fish oil.............................  As described under Sec.   205.606(e).
    Gelatin..............................  As described under Sec.   205.606(g).
    Orange pulp (dried)..................  As described under Sec.   205.606(n).
    Seaweed, Pacific kombu...............  As described under Sec.   205.606(r).
    Wakame seaweed (Undaria pinnatifida).  As described under Sec.   205.606(v).
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[[Page 41701]]

    Table 2 lists the substance exemptions being renewed through this 
document that were reviewed by the NOSB in calendar year 2020. These 
specific substance allowances and prohibitions continue as listed on 
the National List with a new sunset date of March 15, 2027.

                                    Table 2--National List Substances Renewed
                                           [Reviewed by NOSB in 2020]
----------------------------------------------------------------------------------------------------------------
                 Substance                                              Use conditions
----------------------------------------------------------------------------------------------------------------
Sec.   205.601 Synthetic substances allowed
 for use in organic crop production:
    Soap-based algicide/demossers..........  As described under Sec.   205.601(a)(7).
    Ammonium Carbonate.....................  As described under Sec.   205.601(e)(1).
    Soaps, insecticidal....................  As described under Sec.   205.601(e)(8).
    Vitamin D3.............................  As described under Sec.   205.601(g).
    Aquatic plant extracts.................  As described under Sec.   205.601(j)(1).
    Lignin sulfonate.......................  As described under Sec.   205.601(j)(4).
    Sodium silicate........................  As described under Sec.   205.601(l).
    EPA List 4.............................  As described under Sec.   205.601(m)(1).
Sec.   205.602 Nonsynthetic substances
 prohibited for use in organic crop
 production:
    Arsenic................................  As described under Sec.   205.602(b).
    Strychnine.............................  As described under Sec.   205.601(i).
Sec.   205.603 Synthetic substances allowed
 for use in organic livestock production:
    Butorphanol............................  As described under Sec.   205.603(a)(5).
    Flunixin...............................  As described under Sec.   205.603(a)(12).
    Magnesium hydroxide....................  As described under Sec.   205.603(a)(18).
    Poloxalene.............................  As described under Sec.   205.603(a)(26).
    Formic acid............................  As described under Sec.   205.603(b)(3).
    EPA List 4.............................  As described under Sec.   205.603(e)(1).
    Excipients.............................  As described under Sec.   205.603(f).
Sec.   205.604 Nonsynthetic substances
 prohibited for use in organic livestock
 production:
    Strychnine.............................  As described under Sec.   205.604(a).
Sec.   205.605 Nonagricultural (nonorganic)
 substances allowed as ingredients in or on
 processed products labeled as ``organic''
 or ``made with organic (specified
 ingredients or food group(s)):''
    Kaolin.................................  As described under Sec.   205.605(a).
    Sodium bicarbonate.....................  As described under Sec.   205.605(a).
    Waxes..................................  As described under Sec.   205.605(a).
    Ammonium bicarbonate...................  As described under Sec.   205.605(b).
    Ammonium Carbonate.....................  As described under Sec.   205.605(b).
    Calcium phosphates.....................  As described under Sec.   205.605(b).
    Ozone..................................  As described under Sec.   205.605(b).
    Sodium hydroxide.......................  As described under Sec.   205.605(b).
Sec.   205.606 Nonorganically produced
 agricultural ingredients allowed as
 ingredients in or on processed products
 labeled as ``organic:''
    Carnauba wax...........................  As described under Sec.   205.606(a).
    Beet juice extract color...............  As described under Sec.   205.606(d)(1).
    Black/purple carrot juice color........  As described under Sec.   205.606(d)(4).
    Chokeberry, aronia juice color.........  As described under Sec.   205.606(d)(8).
    Elderberry juice color.................  As described under Sec.   205.606(d)(9).
    Grape skin extract color...............  As described under Sec.   205.606(d)(11).
    Purple sweet potato juice color........  As described under Sec.   205.606(d)(14).
    Red cabbage extract color..............  As described under Sec.   205.606(d)(15).
    Red radish extract color...............  As described under Sec.   205.606(d)(16).
    Saffron extract color..................  As described under Sec.   205.606(d)(17).
    Glycerin...............................  As described under Sec.   205.606(h).
    Inulin-oligofructose enriched..........  As described under Sec.   205.606(j).
    Orange shellac-unbleached..............  As described under Sec.   205.606(o).
    Cornstarch (native)....................  As described under Sec.   205.606(s)(1).
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    Authority: 7 U.S.C. 6501-6524.

Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2021-16518 Filed 8-2-21; 8:45 am]
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