This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

41699 

Vol. 86, No. 146 

Tuesday, August 3, 2021 

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. 

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 


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41700 Federal Register / Vol. 86, No. 146 / Tuesday, August 3, 2021 / Rules and Regulations 

1National 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). 

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). 


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

§ 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 D3 .................................................................................................................................... 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. 

[FR Doc. 2021–16518 Filed 8–2–21; 8:45 am] 

BILLING CODE P 


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