Sunset 2016 Review Summary 

Meeting 1: October 2014

Request for Public Comment

Handling Substances 

September 2014

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 USDA

before their sunset dates in 2016. 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 spring 

2015 public meeting, the NOP is requesting that the public provide comments about these substances to 

the NOSB as part of the fall 2014 public meeting. These comments should be provided 

through www.regulations.gov by October 7, 2014 as explained in the meeting notice published in 

the Federal Register on September 8, 2014.

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. Public comment should also address the continuing need for a substance 

or whether the substance is no longer needed or in demand.

Guidance on Submitting Your Comments

Comments should clearly indicate your position on the allowance or prohibition of substances on the 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 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. 

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 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. 

Written public comments will be accepted through October 7, 2014 via www.regulations.gov. 

Comments received after that date may not be reviewed by the NOSB before the meeting. 
Sunset 2016 Review Summary 

Meeting 1 - Request for Public Comment

Handling Substances

August 27, 2014 

SUNSET 2016: HANDLING SUBSTANCES

Egg white lysozyme Nonsynthetic 

Use - As a nonsynthetic, nonagricultural (nonorganic) substance allowed as an ingredient in or on 

processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Egg white lysozyme (CAS # 9001–63–2)

Technical Report: 2011 TR: Enzymes, 2003 TAP: Enzymes, Plant and Fungal

Petition(s): Egg white lysozyme 06/05/02

Past NOSB Actions: NOSB review and recommendation for addition to the National List 05/2003

Recommendation to relist 11/05/2009 

Regulatory Background: Added to National List 09/11/06, 71 FR 53299 

Renewed 08/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Reference: 7 CFR 205.605(a)

Additional information requested by NOSB

No additional information is requested

L-Malic acid Nonsynthetic 

Use - As a nonsynthetic, nonagricultural (nonorganic) substance allowed as an ingredient in or on 

processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: L-Malic acid (CAS # 97-67-6)

Technical Report: Malic Acid April 2003. New TR requested in 2014

Petition(s): L-Malic Acid 11/01/02

Past NOSB Actions: NOSB review and recommendation for addition to the National List 05/2003

Recommendation to relist 11/05/2009 

Regulatory Background: 

Added to National List 09/11/06 71 FR 53299

Renewed 08/03/2011 76 FR 46595

Sunset Date: 9/12/16

Reference: 7 CFR 205.605(a)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding the essentiality of this substance. We 

encourage current users of this substance to provide detailed comments describing the situations in 

which l-malic acid is the only appropriate substance for a given technical application. 
Microorganisms Nonsynthetic 

Use - As a nonsynthetic, nonagricultural (nonorganic) substance allowed as an ingredient in or on 

processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Microorganisms - any food grade bacteria, fungi, and other microorganism.

Technical Report: 2014 TR, 2003 TAP

Petition(s): Microorganisms 12/10/02

Past NOSB Actions: NOSB review and recommendation for addition to the National List 05/2003 

Recommendation to relist 11/05/09

Regulatory Background: 

Added to National List with annotation 09/11/06 71 FR 53299

Renewed 08/03/2011 76 FR 46595

Sunset Date 9/12/2016

Reference: 7 CFR 205.605(a)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding the following: 

Microorganisms will be first major review of ancillary substances used with the listed substance and the 

HS is trying to follow the Ancillary Substance Policy adopted by the Board in 2013. 

The chart below lists all the ancillary substances by functional class that were identified in the Technical 

Report as well as those that have been turned in by Accredited Certifiers to make sure they are 

reviewed. The HS seeks additional public input on any other ancillary substances that may be in use in 

microorganism products that go into organic food.

Comment is also welcome in favor or against any particular ancillary substances with specific attention 

paid to alternative choices.

Ancillary Substances by Food Additive Functional Class1

Anti-caking & anti-stick agents magnesium stearate, calcium silicate

Carriers and fillers, agricultural or 

nonsynthetic

lactose, maltodextrins, sucrose, dextrose, potato starch, nonGMO soy oil, rice protein, grain (rice, wheat, corn, barley) 

flour, milk, autolyzed yeast, inulin

Carriers and fillers, synthetic micro-crystalline cellulose, propylene glycol, stearic acid

Preservatives sodium benzoate, potassium sorbate

Stabilizers maltodextrin

1 this list does not include ancillary substances that are already on the National List. From the 2014 Technical 

Report and spec sheets.
Cyroprotectants used to freeze-dry 

microorganisms

liquid nitrogen, maltodextrin, magnesium sulfate, dimethyl 

sulfoxide, sodium aspartate, mannitol, sorbitol 

Substrate that may remain in final 

product

milk, lactose, grain (rice, barley, wheat) flour, brewed black tea 

and sugar, soy

 

Activated charcoal Synthetic 

Use - As a synthetic nonagricultural (nonorganic) substance allowed as an ingredient in or on processed 

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Activated charcoal (CAS #s 7440 - 44 - 0; 64365 - 11 - 3) - only from vegetative sources; for use 

only as a filtering aid. 

Technical Report: Activated Carbon 8/14/02

Petition(s): Charcoal/Activated Carbon 5/20/02 

Past NOSB Actions: NOSB review and recommendation for addition to the National List 9/2002

Recommendation to relist 11/05/09

Regulatory Background: 

Added to National List with annotation 9/11/06 71 FR 53299

Renewed 8/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding: 

1. Is this substance still used as a filtering aid by organic handlers as part of their organic 

production process? Could either the handlers themselves or certifiers please confirm that this 

is still being used and thus there still exists a need for its continued listing?

2. Have the stakeholders that have relied upon this substance as part of their handling production 

process looked at other practices or alternatives as a possible replacement? If so could you give 

us examples of what other alternatives you have looked at and are they suitable replacements 

for activated charcoal?

3. Has the use of this substance increased or declined during the current sunset cycle? (This 

question would apply to Handlers- for your specific operation and for certifiers – for those 

operations that you certify and inspect on an annual basis).

4. Have the sources changed for where activated charcoal comes from, that might impact the need 

to continue its listing on the National List or not? (natural source versus synthetic source).
Peracetic acid Synthetic 

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

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Peracetic acid/Peroxyacetic acid (CAS # 79 -21- 0). For use as a sanitizer on food contact 

surfaces.

Technical Report: 11/3/2000 TAP (for processing)

Petition(s): none

Past NOSB Actions: NOSB review and recommendation for addition to the National List 11/15/2000

Recommendation to relist at 205.605(b) 11/5/09 

Regulatory Background: 

Added to National List with annotation 9/11/06 71 FR 53299

Renewed: 8/03/2011 76 FR 46595 

Sunset Date: 9/12/16

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

No additional information is requested

Cyclohexylamine Synthetic 

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

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Cyclohexylamine (CAS # 108 - 91 - 8) for use only as a boiler water additive for packaging 

sterilization. 

Technical Report: 02/2001

Petition(s): Cyclohexylamine 11/29/2000

Past NOSB Actions: NOSB review and recommendation for addition to the National List 10/2001

Recommendation to relist: 11/5/09

Regulatory Background: 

Added to National List: 09/11/06 71 FR 53299

Renewed 8/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding: 

1. How common is the use of this material in organic handling operations?

2. Are there alternative practices or materials that would make the use of this material obsolete?

3. Could ammonium hydroxide, if it were approved for use, serve as a possible substitute for this 

material? 

4. Have there been any changes (increase or decline) in the use of this substance during the 

current sunset cycle?
Diethylaminoethanol Synthetic 

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

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Diethylaminoethanol (CAS # 100 -37- 8) for use only as a boiler water additive for packaging

sterilization. 

Technical Report: 2/2001 TAP

Petition(s): Diethylaminoethanol 11/29/00

Past NOSB Actions: NOSB review and recommendation for addition to the National List 5/2002

Recommendation to relist: 11/5/09

Regulatory Background:

Added to National List 09/11/06 71 FR 53299

Renewed 8/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding: 

1. How common is the use of this material in organic handling operations?

2. Are there alternative practices or materials that would make the use of this material obsolete?

3. Could ammonium hydroxide, if it were approved for use, serve as a possible substitute for this 

material? 

4. Have there been any changes (increase or decline) in the use of this substance during the 

current sunset cycle?

Octadecylamine Synthetic 

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

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Octadecylamine (CAS # 124–30–1) for use only as a boiler water additive for packaging

sterilization. 

Technical Report: 2/2001 TAP

Petition(s): Octadecylamine 11/29/00

Past NOSB Actions: NOSB review and recommendation for addition to the National List 10/2001

Recommendation to renew: 11/5/09

Regulatory Background: 

Added to National List: 09/11/06 71 FR 53299

Renewed 8/03/2011 76 FR 46595

Sunset Date: 9/11/2016

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding: 
1. How common is the use of this material in organic handling operations?

2. Are there alternative practices or materials that would make the use of this material obsolete?

3. Could ammonium hydroxide, if it were approved for use, serve as a possible substitute for this 

material? 

4. Have there been any changes (increase or decline) in the use of this substance during the 

current sunset cycle?

Sodium acid 

pyrophosphate

Synthetic 

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

products labeled as “organic” or “made with organic (specified ingredients or food group(s)). 

Listing: Sodium acid pyrophosphate (CAS # 7758-16-9)

Technical Report: 9/2001 TAP (report is for Sodium Phosphates as a group).

Petition(s): Sodium acid pyrophosphate 10/31/02 

Past NOSB Actions: NOSB review and recommendation for addition to the National List 5/13/2003

Recommendation to relist 11/5/09 

Regulatory Background: 

Added to National List 09/12/06 71 FR 53299 

Renewed 8/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding the essentiality of this substance. We 

encourage current users of this substance to provide detailed comments describing the situations in 

which sodium acid pyrophosphate is the only appropriate leavening agent for a given technical 

application. 

Tetrasodium 

pyrophosphate (TSPP)

Synthetic 

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

products labeled as “organic” or “made with organic (specified ingredients or food group(s)). 

Listing: Tetrasodium pyrophosphate (CAS # 7722–88–5) - for use only in meat analog products.

Technical Report: 2014 Limited Scope TR, 2002 TAP 

Petition(s): TSPP 12/10/2001

Past NOSB Actions: NOSB review and recommendation for addition to the National List 9/17/2002

Sunset Recommendation to relist: 11/5/09

Regulatory Background: 

Added to National List 09/12/06 71 FR 53299
Renewed 8/03/2011 76 FR 46595 

Sunset Date: 9/12/2016

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding the following: 

The 2014 Technical Report elaborated on many alternatives to the use of this substance, both 

alternative vegetarian protein sources and alternative ways of processing this protein. The 

subcommittee would like public comment that is very specific about situations in which using TSPP 

would be the only viable choice and the reasons why.

The subcommittee has also raised the concern about the sole function of this input being to restore 

texture after complex processing and this runs counter to §205.600(4): "The substance's primary use is 

not as a preservative or to recreate or improve flavors, colors, textures, or nutritive value lost during 

processing, except where the replacement of nutrients is required by law". Input is sought on this 

subject.

Preliminary discussion among the Handling subcommittee is leading towards an inclination to remove 

this substance because of the concerns mentioned above.