National Organic Program: 2023 and 2024 Sunset Review and Substance Renewals
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 (U...
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 2023 and 2024 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 May 29, 2023.
FOR FURTHER INFORMATION CONTACT:
Jared Clark, Standards Division, Telephone: (202) 720-3252; Fax: (202) 260-9151.
SUPPLEMENTARY INFORMATION:
Background
On December 21, 2000, the Secretary established the Agricultural Marketing Service's (AMS) National Organic Program (NOP) and the USDA organic regulations (65 FR 80547, December 21, 2000). 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.
The Organic Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501-6524), and the USDA organic regulations specifically prohibit the use of any synthetic substance in organic production and handling unless the synthetic substance is on the National List (§§ 205.601, 205.603 and 205.605(b)). Section 205.105 also requires that any nonorganic agricultural substance and any nonsynthetic nonagricultural substance used in organic handling be on the National List (§§ 205.605(a) and 205.606).
The OFPA at 7 U.S.C. 6518 authorizes the NOSB, operating in accordance with the Federal Advisory Committee Act (section 1
et seq.,
5 U.S.C. App.2), to evaluate substances 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)) requires review of all substances included on the National List within five years of their addition to or renewal on the list.
As required in OFPA, the NOSB considered any new information about a substance's impact on human health and the environment, its necessity, and its consistency with organic production and handling. The NOSB then voted on whether to remove the substance from the National List, with a
2/3
majority needed to recommend removal of a substance.
As delegated by the Secretary, AMS evaluates the NOSB's reviews and recommendations for compliance with the National List substance evaluation criteria in the OFPA at 7 U.S.C. 6518(m) and other federal statutes or regulations. AMS also considers public comments submitted in association with the sunset review process, as described in the notice published on September 16, 2013 (78 FR 56811).
AMS published notices in the
Federal Register
announcing the NOSB meetings (Spring 2021 & 2022 and Fall 2021 & 2022) and invited public comments on the 2023 and 2024 sunset review of the substances included in the tables below. AMS also hosted public webinars prior to these NOSB meetings to provide additional opportunities for public comment. At these public meetings, the NOSB reviewed substances scheduled to sunset from the National List and recommended that they either be removed or remain on the National List.
AMS has reviewed and accepted all NOSB sunset review recommendations for substances with sunset dates in 2023 and 2024. AMS is renewing the listings of these substances until 2028 and 2029, respectively.[1]
AMS determined that the substance allowances listed in this notice are still necessary because of the unavailability of organic forms or wholly natural substitutes for the specified uses (section 6517(c)(1)(A)(ii)). The renewal of these substances will avoid potential disruptions to the organic industry that may otherwise result from removal from the National List. AMS also has determined that the prohibited nonsynthetic substances listed in this notice should remain prohibited because their use remains inconsistent with organic production (section 6517(c)(2)(A)(ii)).
In 2016, the NOSB passed a proposal to redistribute material reviews across several years. Because most materials were added to the National List when the organic regulations published, the majority of sunset reviews occurred in the same year. This resulted in an inefficient use of resources and time. To adjust this, the NOSB and NOP redistributed the National List substances more evenly over a five-year span. To maintain this distribution, some substances in this notice will have a sunset date less than five years from their current date. This document covers the last year of this redistribution.[2]
In addition to the substances in the tables below, this document renews beta-carotene extract color, included on the National List at § 205.606(d)(2). This substance currently has a sunset date of May 29, 2023, but was reviewed early by the NOSB in 2020 along with the other allowed agricultural, non-organic colors. AMS discussed these meetings and renewals in the 2021 and 2022 sunset renewals (August 3, 2021; 86 FR 41699). This document renews beta-carotene extract color and establishes a
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new sunset date for this substance of March 15, 2027, to match the sunset dates of the other colors.
The following tables list specific substance allowances and prohibitions renewed by this notice.
Table 1—National List Substances Renewed Until May 29, 2028
Substance
Use conditions
§ 205.601 Synthetic substances allowed for use in organic crop production.
Calcium hypochlorite
As described under § 205.601(a)(2)(i).
Chlorine dioxide
As described under § 205.601(a)(2)(ii).
Hypochlorous acid—generated from electrolyzed water
As described under § 205.601(a)(2)(iii).
Sodium hypochlorite
As described under § 205.601(a)(2)(v).
Copper sulfate
As described under § 205.601(a)(3).
Ozone gas
As described under § 205.601(a)(5).
Peracetic acid
As described under § 205.601(a)(6).
Copper sulfate
As described under § 205.601(e)(4).
Magnesium oxide
As described under § 205.601(j)(5).
Peracetic acid
As described under § 205.601(i)(8).
EPA List 3—Inerts of unknown toxicity
As described under § 205.601(m)(2).
§ 205.602 Nonsynthetic substances prohibited for use in organic crop production.
Calcium chloride
As described under § 205.602(c).
Rotenone
As described under § 205.602(f).
§ 205.603 Synthetic substances allowed for use in organic livestock production.
Activated Charcoal
As described under § 205.603(a)(6).
Calcium borogluconate
As described under § 205.603(a)(7).
Calcium propionate
As described under § 205.603(a)(8).
Calcium hypochlorite
As described under § 205.603(a)(10)(i).
Chlorine dioxide
As described under § 205.603(a)(10)(ii).
Hypochlorous acid—generated from electrolyzed water
As described under § 205.603(a)(10)(iii).
Sodium hypochlorite
As described under § 205.603(a)(10)(iv).
Kaolin pectin
As described under § 205.603(a)(17).
Mineral oil
As described under § 205.603(a)(20).
Nutritive supplements
As described under § 205.603(a)(21).
Propylene glycol
As described under § 205.603(a)(27).
Sodium chlorite, acidified
As described under § 205.603(a)(28).
Sodium chlorite, acidified
As described under § 205.603(b)(9).
Zinc sulfate
As described under § 205.603(b)(11).
§ 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)).”
Agar-agar
As described under § 205.605(a)(2).
Animal enzymes
As described under § 205.605(a)(3).
Calcium sulfate—mined
As described under § 205.605(a)(8).
Carrageenan
As described under § 205.605(a)(9).
Glucono delta-lactone
As described under § 205.605(a)(14).
Tartaric acid
As described under § 205.605(a)(28).
Cellulose
As described under § 205.605(b)(11).
Calcium hypochlorite
As described under § 205.605(b)(12)(i).
Chlorine dioxide
As described under § 205.605(b)(12)(ii).
Hypochlorous acid—generated from electrolyzed water
As described under § 205.605(b)(12)(iii).
Sodium hypochlorite
As described under § 205.605(b)(12)(iv).
Potassium hydroxide
As described under § 205.605(b)(26).
Potassium lactate
As described under § 205.605(b)(27).
Silicon dioxide
As described under § 205.605(b)(29).
Sodium lactate
As described under § 205.605(b)(33).
Table 2—National List Substances Renewed Until January 28, 2029
Substance
Use conditions
§ 205.601 Synthetic substances allowed for use in organic crop production.
Soluble boron products
As described under § 205.601(j)(7)(i).
Sulfates, carbonates, oxides, or silicates of zinc, copper, iron manganese, molybdenum, selenium, and cobalt
As described under § 205.601(j)(7)(ii).
Squid byproducts—from waste processing only
As described under § 205.601(j)(10).
§ 205.603 Synthetic substances allowed for use in organic livestock production.
Chlorhexidine
As described under § 205.603(a)(9).
Elemental sulfur
As described under § 205.603(b)(2).
Lidocaine
As described under § 205.603(b)(5).
§ 205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic.”
Potassium acid tartrate
As described under § 205.606(p).
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Table 3—National List Substances Renewed Until October 30, 2029
Substance
Use conditions
§ 205.601 Synthetic substances allowed for use in organic crop production.
§ 205.602 Nonsynthetic substances prohibited for use in organic crop production.
Lead salts
As described under § 205.602(d).
Tobacco dust (nicotine sulfate)
As described under § 205.602(j).
§ 205.603 Synthetic substances allowed for use in organic livestock production.
Glucose
As described under § 205.603(a)(13).
Tolazoline
As described under § 205.603(a)(29).
Copper sulfate
As described under § 205.603(b)(1).
§ 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)).”
Attapulgite
As described under § 205.605(a)(4).
Bentonite
As described under § 205.605(a)(5).
Diatomaceous earth
As described under § 205.605(a)(10).
Magnesium chloride
As described under § 205.605(a)(17).
Nitrogen—oil free grades
As described under § 205.605(a)(20).
Sodium carbonate
As described under § 205.605(a)(27).
Acidified sodium chlorite
As described under § 205.605(b)(1).
Carbon dioxide
As described under § 205.605(b)(10).
Sodium phosphates
As described under § 205.605(b)(34).
§ 205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic.”