Sunset 2015 Review List - Request for Public Comment

Handling Substances 

September 5, 2013

Introduction

As part of the Sunset Process, the National Organic Program (NOP) announces substances on the 

National List of Allowed and Prohibited Substances (National List) that are coming up for sunset review 

by the National Organic Standard Board (NOSB). The following list announces substances that are on the 

National List for use in organic handling which must be reviewed by the NOSB and renewed by the NOP 

before their sunset dates in 2015. This list provides the substance’s current status on the National List, 

use description, references to past technical reports, past NOSB actions, and regulatory history, as 

applicable. If a new technical report has been requested for a substance, this is noted in this list. To see 

if any new technical report is available, please check for updates under the substance name in the 

Petitioned Substances Database. 

Request for Comments

While the NOSB will not complete its review and any recommendations on these substances until the 

Spring 2014 public meeting, the NOP is requesting that the public provide comments about these 

substances to the NOSB as part of the Fall 2013 public meeting. These comments should be provided 

through www.regulations.gov by October 1, 2013 as explained in the meeting notice published in the 

Federal Register on September 5, 2013. 

These comments are necessary to guide the NOSB’s review of each substance against the criteria in the 

Organic Foods Production Act (7 U.S.C. 6518(m)) and the USDA organic regulations (7 CFR 205.600). The 

current substances on the National List were originally recommended by the NOSB based on evidence 

available to the NOSB at the time of their last review which demonstrated that the substances were 

found to be: (1) not harmful to human health or the environment, (2) necessary because of the 

unavailability of wholly nonsynthetic alternatives, and (3) consistent and compatible with organic 

practices. 

Public comments should focus on providing new information about a substance since its last NOSB 

review. Such information could include research or data that may support a change in the NOSB’s 

determination for a substance. 

Guidance on Submitting Your Comments

Comments should clearly indicate your position on continuing the allowance of substances on this list 

and explain the reasons for your position. You should include relevant information and data to support 

your position (e.g., scientific, environmental, manufacturing, industry impact information, etc.). 

For Comments That Support Substances Under Review:

If you provide comments in support of an allowance of a substance on the National List, you should 

provide new information demonstrating that the substance is: 

(1) not harmful to human health or the environment;

(2) necessary to the production of the agricultural products because of the unavailability of wholly 

nonsynthetic substitute products; and 

(3) consistent with organic handling. 

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For Comments That Do Not Support Substances Under Review: 

If you provide comments that do not support a substance on the National List, you should provide 

reasons why the use of the substance should no longer be allowed in organic production or handling. 

Specifically, comments that support the removal of a substance from the National List should provide 

new information since its last NOSB review to demonstrate that the substance is: 

(1) harmful to human health or the environment; 

(2) unnecessary because of the availability of alternatives; and 

(3) inconsistent with organic handling. 

For Comments Addressing the Availability of Alternatives: 

Comments may present information about the viability of alternatives for a substance under sunset 

review. Viable alternatives include, but are not limited to:

o Alternative management practices that would eliminate the need for the specific 

substance; 

o Other currently exempted substances that are on the National List, which could 

eliminate the need for this specific substance; and

o Other organic or nonorganic agricultural substances. 

Your comments should address whether any alternatives have a function and effect equivalent to or 

better than the allowed substance, and whether you want the substance to be allowed or removed from 

the National List. Assertions about alternative substances, except for those alternatives that already 

appear on the National List, should, if possible, include the name and address of the manufacturer of the 

alternative. Further, your comments should include a copy or the specific source of any supportive 

literature, which could include product or practice descriptions; performance and test data; reference 

standards; names and addresses of producers or handlers who have used the alternative under similar 

conditions and the date of use; and an itemized comparison of the function and effect of the proposed 

alternative(s) with substance under review. The following table can help you describe recommended 

alternatives in place of a current substance that you do not want to be continued.

For Comments on Nonorganic Agricultural Substances at Section 205.606. 

For nonorganic agricultural substances on section 205.606, the NOSB Handling Subcommittee requests 

current industry information regarding availability of and history of unavailability of an organic form of 

the substance in the appropriate form, quality, or quantity of the substance. The NOSB Handling 

Subcommittee would like to know if there is a change in supply of organic forms of the substance or 

demand for the substance (i.e. is an allowance for the nonorganic form still needed), as well as any new 

information about alternative substances that the NOSB did not previously consider. 

Table 1. Guidance on submitting comments for alternatives to substances on the National List.

If the currently listed 

substance is used in... And is a... Then the recommended alternative should be a (an)... 

Handling Nonsynthetic (nonagricultural) substance

- Agricultural substance; or

- Management practice. 

Handling Synthetic substance

- Another currently listed synthetic substance;

- Nonsynthetic (non-agricultural) substance; or

- Management practice. 

 

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Written public comments will be accepted through Tuesday, October 1, 2013 via www.regulations.gov. 

Comments received after that date may not be reviewed by the NOSB before the meeting. 

SUNSET 2015: HANDLING SUBSTANCES

Gellan gum Nonsynthetic 

Use – As a nonagricultural (nonorganic) substance allowed as ingredient in or on processed products.

Listing: Gellan gum (CAS # 71010-52-1) – high acyl form only.

Technical Report: 2006

Petition(s): Gellan gum (2004) 

Past NOSB Actions: NOSB review and recommendation for addition to the National List – 04/22/08

Regulatory Background: Proposed rule (including justification) published 06/03/09 (74 FR 26591), 

Added to National List 12/13/2010 (75 FR 7751). 

Sunset Date: 12/14/2015

Reference: 7 CFR 205.605(a)

Marsala Nonorganic Agricultural

Use – As nonorganically produced agricultural product allowed as ingredient in or on processed 

products.

Listing: Fortified cooking wines. (1) Marsala 

Technical Report: none

Petition(s): Marsala, (2007).

Past NOSB Actions: NOSB review and recommendation for addition to the National List 11/30/07. 

Regulatory Background: Proposed rule (including justification) published 06/03/09 (74 FR 26591), 

Added to National List 12/13/2010 (75 FR 7751). 

Sunset Date: 12/14/2015

Reference: 7 CFR 205.606(g)(1)

Sherry Nonorganic Agricultural

Use – As nonorganically produced agricultural product allowed as ingredient in or on processed 

products.

Listing: Fortified cooking wines. (2) Sherry

Technical Report: none

Original Petition: Sherry (2007). 

Past NOSB Actions: NOSB review and recommendation for addition to the National List, 05/08

Regulatory Background: Proposed rule (including justification) published 06/03/09 (74 FR 26591), 

Added to National List 12/13/2010 (75 FR 7751).

Sunset Date: 12/14/2015

Reference: 7 CFR 205.606(g)(2)

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Tragacanth gum Nonorganic Agricultural

Use – As nonorganically produced agricultural product allowed as ingredient in or on processed 

products.

Listing: Tragacanth gum (CAS #-9000-65-1).

Technical Report: none

Original Petition: Tragacanth Gum (PDF) (2007)

Past NOSB Actions: NOSB review and recommendation for addition to the National List 5/08

Regulatory Background: Proposed rule (including justification) published 06/03/09 (74 FR 26591), 

Added to National List 12/13/2010 (75 FR 7751).

Sunset Date: 12/14/2015

Reference: 7 CFR 205.606(x)

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