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 Department of Agriculture Agricultural Marketing Service 7 CFR Part 205
[Document Number AMS-NOP-21-0042]
 AGENCY: Agricultural Marketing Service, USDA.
 ACTION: 2021 and 2022 sunset review and renewals.
 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 (§  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. § 6517(c)). AMS has determined that the substance allowances listed in this document continue to meet the requirements in OFPA at § 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 § 6517(c)(2)(A). The NOSB also recommended to the Secretary the removal of several National List substances at the 
                    ( print 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. *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§ 205.601 Synthetic substances allowed for use in organic crop production:Hydrogen peroxide
As described under § 205.601(a)(4).Hydrogen peroxide
As described under § 205.601(i)(5).Soaps, ammonium
As described under § 205.601(d).Horticultural oils
As described under § 205.601(e)(7).Horticultural oils
As described under § 205.601(i)(7).Pheromones
As described under § 205.601(f).Ferric phosphate
As described under § 205.601(h)(1).Potassium bicarbonate
As described under § 205.601(i)(9).Magnesium sulfate
As described under § 205.601(j)(6).Hydrogen chloride
As described under § 205.601(n).§ 205.602 Nonsynthetic substances prohibited for use in organic crop production:Ash from manure burning
As described under § 205.602(a).Sodium fluoaluminate
As described under § 205.602(g).§ 205.603 Synthetic substances allowed for use in organic livestock production:Atropine
As described under § 205.603(a)(3).Fenbendazole
As described under § 205.603(a)(23)(i).Hydrogen peroxide
As described under § 205.603(a)(15).Iodine
As described under § 205.603(a)(16).Iodine
As described under § 205.603(b)(4).Magnesium sulfate
As described § 205.603(a)(19).Moxidectin
As described under § 205.603(a)(23)(ii).Peroxyacetic/Peracetic acid
As described under § 205.603(a)(24).Xylazine
As described under § 205.603(a)(30).DL-Methionine
As described under § 205.603(d)(1).Trace Minerals
As described under § 205.603(d)(2).Vitamins
As described under § 205.603(d)(3).§ 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 fermentation of carbohydrate substances; and Lactic)
As described under § 205.605(a).Calcium chloride
As described under § 205.605(a).Enzymes
As described under § 205.605(a).L-malic acid
As described under § 205.605(a).Magnesium sulfate
As described under § 205.605(a).Microorganisms
As described under § 205.605(a).Perlite
As described under § 205.605(a).Potassium iodide
As described under § 205.605(a).Yeast
As described under § 205.605(a).Activated charcoal
As described under § 205.605(b).Ascorbic acid
As described under § 205.605(b).Calcium citrate
As described under § 205.605(b).Ferrous sulfate
As described under § 205.605(b).Hydrogen peroxide
As described under § 205.605(b).Nutrient vitamins and minerals
As described under § 205.605(b).Peracetic acid/Peroxyacetic acid
As described under § 205.605(b).Potassium citrate
As described under § 205.605(b).Potassium phosphate
As described under § 205.605(b).Sodium acid pyrophosphate
As described under § 205.605(b).Sodium citrate
As described under § 205.605(b).Tocopherols
As described under § 205.605(b).§ 205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic:”Celery powder
As described under § 205.606(c).Fish oil
As described under § 205.606(e).Gelatin
As described under § 205.606(g).Orange pulp (dried)
As described under § 205.606(n).Seaweed, Pacific kombu
As described under § 205.606(r).Wakame seaweed (
                            *Undaria pinnatifida*)
As described under § 205.606(v).
 
 
 *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§ 205.601 Synthetic substances allowed for use in organic crop production:Soap-based algicide/demossers
As described under § 205.601(a)(7).Ammonium Carbonate
As described under § 205.601(e)(1).Soaps, insecticidal
As described under § 205.601(e)(8).Vitamin D
                            3
As described under § 205.601(g).Aquatic plant extracts
As described under § 205.601(j)(1).Lignin sulfonate
As described under § 205.601(j)(4).Sodium silicate
As described under § 205.601(l).EPA List 4
As described under § 205.601(m)(1).§ 205.602 Nonsynthetic substances prohibited for use in organic crop production:Arsenic
As described under § 205.602(b).Strychnine
As described under § 205.601(i).§ 205.603 Synthetic substances allowed for use in organic livestock production:Butorphanol
As described under § 205.603(a)(5).Flunixin
As described under § 205.603(a)(12).Magnesium hydroxide
As described under § 205.603(a)(18).Poloxalene
As described under § 205.603(a)(26).Formic acid
As described under § 205.603(b)(3).EPA List 4
As described under § 205.603(e)(1).Excipients
As described under § 205.603(f).§ 205.604 Nonsynthetic substances prohibited for use in organic livestock production:Strychnine
As described under § 205.604(a).§ 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 § 205.605(a).Sodium bicarbonate
As described under § 205.605(a).Waxes
As described under § 205.605(a).Ammonium bicarbonate
As described under § 205.605(b).Ammonium Carbonate
As described under § 205.605(b).Calcium phosphates
As described under § 205.605(b).Ozone
As described under § 205.605(b).Sodium hydroxide
As described under § 205.605(b).§ 205.606 Nonorganically produced agricultural ingredients allowed as ingredients in or on processed products labeled as “organic:”Carnauba wax
As described under § 205.606(a).Beet juice extract color
As described under § 205.606(d)(1).Black/purple carrot juice color
As described under § 205.606(d)(4).Chokeberry, aronia juice color
As described under § 205.606(d)(8).Elderberry juice color
As described under § 205.606(d)(9).Grape skin extract color
As described under § 205.606(d)(11).Purple sweet potato juice color
As described under § 205.606(d)(14).Red cabbage extract color
As described under § 205.606(d)(15).Red radish extract color
As described under § 205.606(d)(16).Saffron extract color
As described under § 205.606(d)(17).Glycerin
As described under § 205.606(h).Inulin-oligofructose enriched
As described under § 205.606(j).Orange shellac-unbleached
As described under § 205.606(o).Cornstarch (native)
As described under § 205.606(s)(1).
 Authority:
                    7 U.S.C. 6501-6524. Erin Morris, Associate Administrator, Agricultural Marketing Service.


# Footnotes

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). Back to Citation


[FR Doc. 2021-16518 Filed 8-2-21; 8:45 am] BILLING CODE P