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National Organic Program: USDA Organic Regulations

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Agricultural Marketing Service, USDA.


Notice of 2015 Sunset Review.


This document addresses the 2015 Sunset Review submitted to the Secretary of Agriculture (Secretary) through the Agricultural Marketing Service's (AMS) National Organic Program (NOP) by the National Organic Standards Board (NOSB) following the NOSB's May and October 2014 meetings. The 2015 Sunset Review pertains to the NOSB's review of the need for the continued allowance for seven substances on the U.S. Department of Agriculture's (USDA) National List of Allowed and Prohibited Substances (National List). Consistent with the NOSB's review, this publication provides notice on the renewal of three synthetic and two nonsynthetic substances on the National List, along with any restrictive annotations. For substances that have been renewed on the National List, this document completes the 2015 National List Sunset Process.


This document is effective June 22, 2015.

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Requests for a copy of this document should be sent to Jennifer Tucker, Ph.D., Associate Deputy Administrator, National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2646-S., Ag Stop 0268, Washington, DC 20250-0268. Telephone: (202) 720-3252, email: or by accessing the Web site at​nop.

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The National Organic Program (NOP) is authorized by the Organic Foods Protection Act (OFPA) of 1990, as amended (7 U.S.C. 6501—6522). The USDA Agricultural Marketing Service (AMS) administers the NOP. Final regulations implementing the NOP, also referred to as the USDA organic regulations, were published December 21, 2000 (65 FR 80548), and became effective on October 21, 2002. Through these regulations, the AMS oversees national standards for the production, handling, and labeling of organically produced agricultural products. Since becoming fully effective, the USDA organic regulations have been frequently amended, mostly for changes to the National List in 7 CFR 205.601-205.606.

This National List identifies the synthetic substances that may be used and the nonsynthetic (natural) substances that may not be used in organic production. The National List also identifies synthetic, nonsynthetic nonagricultural, and nonorganic agricultural substances that may be used in organic handling. The OFPA and the USDA organic regulations, as indicated in § 205.105, specifically prohibit the use of any synthetic substance in organic production and handling unless the synthetic substance is on the National List. Section 205.105 also requires that any nonorganic agricultural substance, and any nonsynthetic nonagricultural substance used in organic handling appear on the National List.

As stipulated by OFPA, recommendations to propose or amend the National List are developed by the 15 member NOSB, organized under the Federal Advisory Committee Act (5 U.S.C. App. 2 et seq.) to assist in the evaluation of substances to be used or not used in organic production and handling, and to advise the Secretary on the USDA organic regulations. OFPA also requires a review of all substances included on the National List within 5 years of their addition to or renewal on the list. If a listed substance is not reviewed by NOSB and renewed by USDA within the five year period, its allowance or prohibition on the National List is no longer in effect. The NOSB sunset review includes considering any new information pertaining to a substance's impact on human health and the environment, its necessity, and its compatibility with organic production and handling.

To implement the sunset review requirement, AMS initially published an advanced notice of proposed rulemaking on the National List sunset review process on June 17, 2005 (70 FR 35177). This document described the process used by the NOSB to complete their responsibility to review National List substances within the OFPA required five year period. Since announcing the first sunset review process, the NOSB and the USDA completed five separate sunset reviews in 2007 (72 FR 58469), 2008 (73 FR 59479), 2011 (76 FR 46595), 2012 (77 FR 33290) and in 2013 (78 FR 61154).

AMS published a revised sunset review process in the Federal Register on September 16, 2013 (78 FR 56811). This provides public notice on the renewal of National List substances. This renewal occurs after the NOSB review.

At its May and October 2014 meetings, the NOSB considered seven substances that were added to the National List in 2010. AMS has reviewed and accepted the NOSB sunset review and recommendations. Substances in Table 1 having final actions of “renew” will continue to be listed on the National List and will be included in the 2020 sunset review.Start Printed Page 35178

Table 1—Overview of Final Action for Sunset 2015

National list sectionSubstance listingFinal action
Synthetic substances allowed for use in organic crop production
§ 205.601(a)(8)Sodium carbonate peroxyhydrate (CAS #-15630-89-4)—Federal law restricts the use of this substance in food crop production to approved food uses identified on the product labelRenew.
§ 205.601(e)(2)Aqueous potassium silicate (CAS #-1312-76-1)—the silica, used in the manufacture of potassium silicate, must be sourced from naturally occurring sandRenew.
§ 205.601(i)(1)Aqueous potassium silicate (CAS #-1312-76-1)—the silica, used in the manufacture of potassium silicate, must be sourced from naturally occurring sandRenew.
§ 205.601(j)(9)Sulfurous acid (CAS # 7782-99-2) for on-farm generation of substance utilizing 99% purity elemental sulfur per paragraph (j)(2) of this sectionRenew.
Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).”
§ 205.605(a)Gellan gum—(CAS # 71010-52-1)—high-acyl form onlyRenew.
Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic.”
§ 205.606(w)Tragacanth gum (CAS #-9000-65-1)Renew.
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Authority: 7 U.S.C. 6501-6522.

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Rex A. Barnes,

Associate Administrator, Agricultural Marketing Service.

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[FR Doc. 2015-14865 Filed 6-18-15; 8:45 am]