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 80548, 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. chapter 94), 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 (7 CFR 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).

Under OFPA, 7 U.S.C. 6518, the National Organic Standards Board (“NOSB” or “Board”), operating in accordance with the Federal Advisory Committee Act (5 U.S.C. chapter 10), is authorized 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 5 years of their addition to, or renewal on, the list. A list of all National List sunset dates is posted online for public access in the “NOSB Work Agenda” document on the NOP's NOSB web page, www.ams.usda.gov/​rules-regulations/​organic/​nosb.

As required by the OFPA, during a sunset review, the NOSB considers 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 votes on proposals to remove individual substances 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 and 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).

Review of Sunset Substances

AMS published notices in the Federal Register announcing the Spring 2024 (89 FR 8398, February 07, 2024) and Fall 2024 (89 FR 70591, August 30, 2024) NOSB meetings and invited public comments on the 2026 sunset review of the substances included in the table below. AMS hosted public webinars prior to these NOSB meetings to provide additional opportunities for public comment. The NOSB also heard oral comments during the first day of each Spring and Fall in-person meeting. 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 the Board's sunset review recommendations for substances with sunset dates in 2026 and 2029. AMS is renewing the listings of these substances until 2031. 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 (7 U.S.C. 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 natural substances listed in this notice should remain prohibited because their use remains inconsistent with organic production (7 U.S.C. 6517(c)(2)(A)(ii)).

Sunset Renewals

This document renews all 56 substances for another 5 years past the first sunset date of July 26, 2026.

The substances renewed in this notice currently have three sunset dates: July 26, 2026 (3 substances: oxalic acid dihydrate, pullulan, and collagen gel); September 12, 2026 (52 substances not covered by the July or October sunset dates); and October 30, 2029 (1 substance: tolazoline). Tolazoline was originally scheduled to be reviewed by the NOSB in 2027 but was reviewed early to align with xylazine as they are generally used together.

This notice establishes a new sunset date for the following substances as outlined in the header for Table 1 below.

Authority: 7 U.S.C. chapter 94.