Sunset 2016 Review Summary 

Meeting 2 - Subcommittee Review

Handling Substances

February 25, 2015 

As part of the National List Sunset Review process, the NOSB Handling Subcommittee has evaluated the 

need for the continued allowance for or prohibition of the following substances for use in organic 

handling.

§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)).”

(a) Nonsynthetics allowed:

Egg white lysozyme

Reference: 7 CFR 205.605(a) Egg white lysozyme (CAS # 9001–63–2)

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

Petition(s): 06/2002

Past NOSB Actions: 05/2003 - NOSB review and recommendation for addition to the National List; 11/2009 - 

Recommendation to relist 

Regulatory Background: Added to National List effective 09/12/06 71 FR 53299; Sunset renewal notice 

published 08/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Subcommittee Review

Egg White Lysozyme (EWL) is a purified enzyme preparation extracted from chicken egg whites using an inert 

polymer resin. Following extraction, EWL is stripped from the resin, concentrated, purified and dried. The 

material is commonly used as an antimicrobial in cheese and wine making. EWL has several other 

applications, including health and wellness products. Egg white lysozyme is an antimicrobial protein (i.e., a 

protein with the ability to inhibit or kill microorganisms) comprised of 129 amino acid residues. 

Egg white lysozyme controls the proliferation of bacteria during fermentation or food processing and has been 

shown to possess antimicrobial properties especially in relation to Clostridium tyrobutyricum (Kewpie 

Corporation, 2010; FDA, 2000). Therefore, it is used to improve the shelf life of chilled foods and confectionary 

products and has been used to preserve fresh fruits and vegetables, tofu bean curd, seafood, meats and 

sausages, potato salad, cooked burdock with soy sauce, and varieties of semi-hard cheeses such as Edam, 

Gouda, and some Italian cheeses (Cunningham et al., 1991). Egg white lysozyme is also incorporated into 

casings for frankfurters and in cooked meat and poultry products that are sold as ready-to-eat (FDA, 2000). 

Unlike other enzymes, egg white lysozyme does not inhibit the lactic acid bacteria that are critical for cheese 

fermentation. (TR, lines 161-169)

All international organic standards allow the use of egg white lysozyme in organic production. (TR, lines 406-

435)

To manufacture egg white lysozyme, the lysozyme is extracted from fresh egg white by mixing in an inert 

polymer resin that binds to the lysozyme. The resin carrying the lysozyme is separated from the egg white. 

The lysozyme is then removed from the resin through the addition of salts. The lysozyme is then 

concentrated, purified, and dried. Although the resulting purified protein, on a dry basis is almost 100 percent 

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lysozyme, small amounts of other egg white proteins may be present (FDA, 2000). (TR, lines 483-488)

Because egg white lysozyme does not undergo a chemical change during the manufacturing process, the 

material is considered non-synthetic. Egg white lysozyme was included as part of the tentative final rule (21 

CFR 184) on direct food substances affirmed as GRAS in 1998. In 2000, a GRAS petition was submitted to FDA 

for egg white lysozyme. FDA follow up was identified; however, it is unknown if a conclusion was made on the 

GRAS status of egg white lysozyme (FDA, 2000). Egg white lysozyme does act as a preservative because it 

inhibits the growth of deleterious organisms, prolonging the shelf life of food products. Egg white lysozyme is 

an important preservative in cheese manufacturing and minimizes the process called ‘late blowing,’ which is 

caused by the fermentation of butyric acid. 

Egg white lysozyme is commonly used in food processing to decrease the loss of nutritional quality caused by 

thermal processing. The enzyme acts as an antimicrobial agent and is considered to be thermally stable. The 

use of egg white lysozyme may reduce the amount of thermal processing (including pasteurization and heat 

sterilization) needed during food manufacture, which also minimizes the loss of nutritional quality (Rahman, 

2007). (TR, lines 688-692)

EWL was first added to the National List in 2006 and went through its first Sunset review in 2009. A 2003 TAP 

review concluded the material posed no significant risk to human health or the environment during its 

manufacture, had been used in the organic industry since the inception of organic processed foods, and was 

used as an alternative to harsher preservatives.

This is the second 2016 Sunset presentation of Egg White Lysozyme for public comment. During the first 

round, public comments were received regarding the fact that EWL is made from conventionally raised eggs 

and the question was brought forward as to whether the material could be made with organic eggs. At the 

time of 2003 TAP review, it was possible the newly emerging organic egg market did not have sufficient 

capacity to allow for manufacture of EWL using organic eggs, and no mention was made of the use of organic 

egg whites. 

Request for Public Comments

1. The NOSB Handling Subcommittee seeks input from the public and industry as to whether there currently 

exist EWL manufacturers using organic egg whites to make this material.

 

2. At present, it appears as though the material is essentially pure, without any remaining ancillary 

substances. The Handling Subcommittee seeks input regarding the presence of ancillary substances in EWL 

following the extraction, concentration and purification processes. 

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

The Handling Subcommittee believes that the full board should have the opportunity to complete the review 

of each sunset material by voting. The NOP has stated that to do this a motion to remove should be brought 

from the Subcommittee for each substance. If the Subcommittee motion to remove fails to receive a majority, 

the motion will still be put forward to the full board for review. The motion to remove is voted by the full 

board and needs to receive a 2/3 majority to recommend removal.

Based on the review, the Subcommittee proposes removal of this substance from the National List based on 

the following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): Consistency with 

Organic Production.

The Handling Subcommittee found no concerns regarding the continued listing of Egg white lysozyme on 

the National List. The justification of this motion is that the whole NOSB needs to consider and vote on each 

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material, rather than just the individual Subcommittee, to fulfill its’ responsibility of Sunset Review.

Motion to remove Egg white lysozyme (CAS # 9001–63–2) from 205.605(a)

Motion by: Tracy Favre 

Seconded by: Jean Richardson

Yes: 0 No: 5 Abstain: 0 Recuse: 0 Absent: 3 

L-Malic Acid

Reference: 7 CFR 205.605(a) L-Malic acid (CAS # 97-67-6)

Technical Report: 04/2003 

Petition(s): 11/2002

Past NOSB Actions: 05/2003 - NOSB review and recommendation for addition to the National List; 11/2009 - 

Recommendation to relist

Regulatory Background: Added to National List effective 09/12/06 71 FR 53299; Sunset renewal notice 

published 08/03/2011 76 FR 46595

Sunset Date: 9/12/16

Subcommittee Review

L-Malic acid (CAS #97-67-6) was added to the National List (Federal Register Vol. 71, No. 175) §205.605(a) on 

September 11, 2006. This addition was based on a review of L-malic acid by the NOSB at their May 13-14, 

2003 meeting. This material underwent its first sunset review at the Fall 2009 NOSB meeting, and was relisted. 

L-Malic acid is used as a flavor enhancer, flavoring agent and adjuvant, and for pH control agent in a variety of 

foods.

In the first meeting posting, the HS requested input on the essentiality and current use patterns of L-Malic 

acid. We received public comment from one certifier with 7 current clients using L-Malic acid in the wine, juice 

and bottled tea sectors. Another large producer gave comment confirming their current use and need for this 

substance. Two other commenters expressed concern that the original TAP review evaluated DL-malic acid, 

the synthetic form, rather than L-malic acid, the non-synthetic form currently listed. However, a review of the 

2003 TAP shows that the reviewers very clearly accounted for the fact that there are two forms of this 

substance, very clearly recommended that the synthetic form not be listed, and that L-malic acid be listed on 

605(a). 

This substance is used in handling, and does not include any ancillary substances.

The Subcommittee review indicated that there are no ancillary substances. There have been no ancillary 

substances declared by stakeholders during the public comment periods (both oral and written). Therefore, 

no ancillary substances will be allowed, unless otherwise petitioned and reviewed by the NOSB and the 

appropriate Subcommittee. This completes the ancillary substance review. 

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

The Handling Subcommittee believes that the full board should have the opportunity to complete the review 

of each sunset material by voting. The NOP has stated that to do this a motion to remove should be brought 

from the Subcommittee for each substance. If the Subcommittee motion to remove fails to receive a majority, 

the motion will still be put forward to the full board for review. The motion to remove is voted by the full 

board and needs to receive a 2/3 majority to recommend removal.

Based on the review, the Subcommittee proposes removal of L-Malic Acid from the National List based on the 

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following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): Availability of nonsynthetic alternative protein sources [§ 205.600(b)(1)], alternative substances in use [§6518(m)(6)], lack of 

essentiality for handling organic products [§205.600(b)(6)], inconsistent with organic handling 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

The Handling Subcommittee found no concerns regarding the continued listing of L-Malic on the National 

List. The justification of this motion is that the whole NOSB needs to consider and vote on each material, 

rather than just the individual Subcommittee, to fulfill its’ responsibility of Sunset Review.

Motion to remove L-Malic acid (CAS # 97-67-6) from section 205.605(a)

Motion by Joe Dickson

Seconded Tracy Favre

Yes: 0 No: 5 Abstain: Recuse: Absent: 3

Microorganisms

Reference: 7 CFR 205.605(a) Microorganisms - any food grade bacteria, fungi, and other microorganism. 

Technical Report: 2014 TR, 2003 TAP

Petition(s): 12/2002

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

List; 11/2009 - Recommendation to relist 

Regulatory Background: Added to National List with annotation, effective 09/12/06 71 FR 53299,

Sunset renewal notice published 08/03/2011 76 FR 46595

Sunset Date: 9/12/16

Subcommittee Review

The Listing for "Microorganisms" refers to living organisms added to food. There is some overlap with 

other National List entries such as Dairy Cultures and Yeasts, which are also living organisms. This listing 

is not meant to include either dead microorganisms or substances derived or extracted from 

microorganisms. Each of these latter groups must have separate listings and reviews.

These living organisms consist of bacteria, bacteriophages, fungi, and viruses. The specific types within 

these groups are covered in the 2014 Technical Report (TR) on pages 2 through 5. Algae were not 

covered by the TR and are not considered to be part of this listing.

Microorganisms are used to create desired "biogenic effects" through fermentation (such as in vinegar 

or miso) or to have a "probiotic effect" by interacting directly with the digestive system (such as yogurt 

with L. bulgaricus). (2014 TR page 5) They may also be used to improve palatability or nutritional value 

of food. Bacteriophages may be used as antimicrobial agents to control bacteria during the production 

or processing of foods. (2014 TR pages 5 and 10) They provide a non-synthetic alternative to cleaning 

agents, sanitizers, and antimicrobial products that are not allowed for use in organic food processing 

and handling.

Evaluation Question #1 (page 17) in the TR describes the fermentation processes for probiotics, starter 

cultures, and bacteriophages. The Subcommittee believes this assessment of fermentation processes to 

be complete enough to enable Materials Review Organizations (MROs) to determine compliance with 

this listing as non-synthetic substances under the existing Materials Classification guidance. 

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Fermentation is a naturally occurring biological process and as such does not need additional criteria 

under the organic law. MROs can evaluate the starting feedstocks, non-GMO affidavits, ancillary 

substances, and purification/ media removal steps without further guidance.

At the first posting for Microorganisms there was a call made for public comment to provide input on a 

chart of existing ancillary substances and to identify additional ancillary substances that may be used in

formulations of microorganisms. While some public comments stated the list was incomplete, the only 

additional ones suggested were a few mentioned in the text of the TR. No public comments were 

received with evidence of compatibility issues that would lead to removal of any ancillary substances. 

Therefore a secondary motion and review form for ancillary substances is provided as a separate 

proposal. It contains the same list as the first posting with the addition of 2 more substances from the 

text of the TR 

Ancillary substances were requested to be identified and reviewed by the TR contractor. In addition, 

dozens of spec sheets on products that were turned in by certifiers were looked at to gather ancillary 

substances for the table presented. The following were reviewed:

Ancillary Substances by Food Additive Functional Class

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

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, cornstarch, sucrose.

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

dicalcium phosphate.

Preservatives sodium benzoate, potassium sorbate, ascorbic acid

Stabilizers maltodextrin

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

The public comment came from a few companies and certifiers in favor of continued allowance and a 

few groups opposed to moving this forward until the list was complete and they were reviewed further. 

A point raised in the comments noted that the materials that are already on the National List are listed 

by specific use, and therefore should be listed in the table provided for this additional use. The 

Subcommittee agrees with this point and the National List substances are now in the table.

The review in the TR included the following statements:

"There is no literature to suggest preservatives used in microbial preparations as ancillary substances 

exert any technical or functional preservative effect in the final fermented product. Typically, Good 

Manufacturing Practices (GMP) dictate that preservatives are added at a maximum level of 0.1% by 

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weight of the finished product to exert the desired effect (FDA 2013b)." (2014 TR page 23)

"There is no literature to suggest that the manufacture or use of microbial preparations with ancillary 

substances is harmful to the environment or biodiversity." (2014 TR page 26)

There is no literature to suggest that microbial preparations with ancillary substances have negative 

effects on human health. (2014 TR page 28)

For microbial preparations with ancillary substances, there are alternative practices to using nonorganic 

carriers and/or growth substrates for cultures. Specifically, nonorganic carriers can be replaced with 

organic carriers and growth substrates. Certification agencies differ in whether growth substrates and 

carriers are required to be organic. (2014 TR page 28)

The latter statement was discussed by the Subcommittee. The NOSB has made several 

recommendations in the past that commercial availability of organic sources should apply to everything 

on the National List. The Handling Subcommittee would like to re-affirm this position in regards to the 

ancillary substances used for Microorganisms and is making a motion on this in conjunction with the 

ancillary substance proposal.

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

The Handling Subcommittee believes that the full board should have the opportunity to complete the 

review of each sunset material by voting. The NOP has stated that to do this a motion to remove should 

be brought from the Subcommittee for each substance. If the Subcommittee motion to remove fails to 

receive a majority, the motion will still be put forward to the full board for review. The motion to 

remove is voted by the full board and needs to receive a 2/3 majority to recommend removal.

Based on the review, the Subcommittee proposes removal of this substance from the National List 

based on the following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if 

applicable): [OFPA criteria at 7 U.S.C. 6158(m), (7) its compatibility with a system of sustainable 

agriculture. 

The Subcommittee found no concerns regarding the continued listing of Microorganisms. The 

justification for this motion is that the whole NOSB needs to consider and vote on each material, 

rather than just a Subcommittee. 

Motion to remove Microorganisms from 205.605(b)

Motion by: Zea Sonnabend

Seconded by: Jean Richardson

Yes: 0 No: 6 Abstain: 0 Recuse: 0 Absent: 2

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§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)).” 

(b) Synthetics allowed:

Activated charcoal

Reference: 7 CFR 205.605(b) Activated charcoal (CAS #s 7440 - 44 - 0; 64365 - 11 - 3) only from 

vegetative sources; for use only as a filtering aid.

Technical Report: 08/2002 Activated Carbon

Petition(s): 05/2002 Charcoal/Activated Carbon 

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

11/2009 - Recommendation to relist

Regulatory Background: Added to National List with annotation, effective 09/12/06 71 FR 

53299; Sunset renewal notice published 08/03/2011 76 FR 46595

Sunset Date: 9/12/16

Subcommittee Review

Activated charcoal is an important filtering aid used in organic handling. It is widely used to filter water 

and a variety of other substances that are used in organic handling such as refined oils, grape juice, clear 

liquid products, and used in many distilleries.

Activated charcoal (carbon) was added to the National List on September 12, 2006, with the annotation, 

“only from vegetative sources: for use only as a filtering aid. (It is also on the National List under: 

§205.603 for use in Livestock). The Handling Subcommittee has reviewed this material in accordance 

with the required Sunset review process as stated by the September 2013 NOP notice to the NOSB and 

also the required ancillary substance review as requested in the February 3, 2014 Memorandum to the 

National Organic Standards Board from the NOP.

The first of two required postings for public comment was done prior to the October 2014 Fall NOSB 

Meetings. The second and final posting for this sunset review cycle is scheduled for the April 2015 

Spring NOSB meeting. During the first round of public comments there were 11 written public 

comments on activated charcoal. Of those comments 7 were in support of relisting, 3 were in support of 

relisting only with an annotation to limit use to filtering water (as suggested by one of the reviewers in 

the original 2002 TAP) and require steam activation as the source of the material, and 1 commenter 

taking a neutral position because a new TR had not been requested to provide information updates. (It 

should be noted that an annotation may not be made to a material that is under Sunset Review as the 

Rule currently is listed).

There was no new evidence provided that identified any unacceptable risks to the environment, human 

or animal health resulting from the use or manufacture of activated charcoal as annotated. One concern 

raised was pertaining to the spent material and that was answered during oral comment period that the 

spent material was reconditioned by the manufacturer of the material and that was subject to review as 

part of the annual certification renewal process. There was no new information presented to the 

Handling Sub-committee or the NOSB that would call this material into question and prompt a more 

extensive review. 

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Activated charcoal use has increased during this past sunset cycle, as stated from responses provided 

during public comment. There are advances in alternatives such as: steam activated coal, as a source (it 

is uncertain what the actual availability of this source of material is at this time) – which OMRI considers 

to be a non-synthetic. While it appears that activated charcoal as currently listed is still needed by 

organic handlers, progress has been made in looking for alternatives to the current listed material. The 

NOSB would like to encourage stakeholders to continue to pursue these organic alternatives if available 

and whenever possible.

This substance is used in handling, and does not include any ancillary substances.

The Subcommittee review indicated that there are no ancillary substances in this material. There have 

been no ancillary substances declared by stakeholders during the public comment periods (both oral 

and written). Therefore, no ancillary substances will be allowed, unless otherwise petitioned and 

reviewed by the NOSB and the appropriate Subcommittee. This completes the ancillary substance 

review. 

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

The Handling Subcommittee believes that the full board should have the opportunity to complete the 

review of each sunset material by voting. The NOP has stated that to do this a motion to remove should 

be brought from the Subcommittee for each substance. If the Subcommittee motion to remove fails to 

receive a majority, the motion will still be put forward to the full board for review. The motion to 

remove is voted by the full board and needs to receive a 2/3 majority to recommend removal.

Based on the review, the Subcommittee proposes removal of this substance from the National List 

based on the following criteria in the Organic Foods Production Act (OFPA) criteria 7 U.S.C. 6518(m)(6) 

the alternatives to using the substance in terms of practices or other available materials: and (7) its 

compatibility with a system of sustainable agriculture.

The Handling Subcommittee found no concerns regarding the continued listing of Activated Charcoal 

on the National List. The justification of this motion is that the whole NOSB needs to consider and 

vote on each material, rather than just the individual Subcommittee, to fulfill its’ responsibility of 

Sunset Review.

Motion to remove activated charcoal (CAS #s 7440–44–0; 64365–11–3) from §205.605(b).

Motion by: Harold Austin

Seconded by: Tracy Favre

Yes: 0 No: 5 Abstain: 0 Absent: 3 Recuse: 0 

Peracetic acid

Reference: 7 CFR 205.605(b) Peracetic acid/Peroxyacetic acid (CAS # 79 -21- 0). Peracetic 

acid/Peroxyacetic acid (CAS # 79-21-0)—for use in wash and/or rinse water according to FDA limitations. 

For use as a sanitizer on food contact surfaces.

Technical Report: 2000 TAP (for processing)

Petition(s): 2008 Peracetic Acid

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

alternate name as periacetic in meeting notes). 11/5/09 - Recommendation to renew

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Regulatory Background: Added to National List, effective 09/12/06 71 FR 53299. Sunset renewal notice 

published 08/03/2011 76 FR 46595 

Sunset Date: 9/12/16

Subcommittee Review

Peracetic acid/Peroxyacetic acid is an important sanitizer used in organic handling. It is widely used as a 

sanitizer on food contact surfaces and as a disinfectant for fruits and vegetables. Peracetic 

acid/Peroxyacetic acid was added to the National List on September 12, 2006, with the annotation, “for 

use in wash and/or rinse water according to FDA limitations. For use as a sanitizer on food contact 

surfaces.” (It is also list on the National List under: §205.601 and §205.603 for use in Crops and 

Livestock respectively). The Handling Subcommittee has reviewed this material in accordance with the 

required sunset review process as stated by the September 2013 NOP notice to the NOSB and the 

required ancillary substance review as requested in the February 3, 2014 Memorandum to the National 

Organic Standards Board from the NOP.

The first of two required postings for public comment was done prior to the October 2014 Fall NOSB 

Meeting. The second and final posting for this sunset review cycle is scheduled for the April 2015 Spring 

NOSB meeting. During the first round of public comments there were 22 written and verbal public 

comments on Peracetic acid/Peroxyacetic acid. Of those comments 9 were from industry, 3 from 

individuals, 2 from non-profit organizations, 2 from manufacturers of the substances, 2 from certifiers, 1 

from a trade association, and 1 from a USDA research scientist (2 comment were redundant 

verbal/written). 21 commenters were in support of relisting, 1 commenter was neutral. 1 commenter 

noted the TR was old and should be updated but still supported relisting. Another commenter noted 

the need for a more robust public discussion but still supported relisting. One comment noted the 

potential presence of ancillary substances. 

There was no new evidence provided about unacceptable adverse impacts on human health or the 

environment. Commenters noted Peracetic acid/Peroxyacetic acid had less adverse impact than 

allowed alternatives. There was no new evidence presented that refuted the substance’s essentiality 

for organic production. Several industry members noted the ongoing essentiality of the substance, 

particularly in the dairy, beverage, fresh and cut fruit/vegetable industries. Two certifiers commented 

on the wide use of this substance by their clients. Several commenters noted its criticality to ensuring 

food safety. There was no new evidence provided about the substances incompatibility with organic 

production practices. Several commenters noted its compatibility given the substance breaks down to 

relatively benign complement (acetic acid [same acid found in vinegar] and hydrogen peroxide [which in 

turn breakdown to water and hydrogen]). There was no new information presented to the Handling 

Subcommittee or the NOSB that would call this material into question and prompt a more extensive 

review. 

This substance is used in handling, and does not include any ancillary substances.

The Subcommittee review indicated that there are no ancillary substances. There have been no ancillary 

substances declared by stakeholders during the public comment periods (both oral and written). 

Therefore, no ancillary substances will be allowed, unless otherwise petitioned and reviewed by the 

NOSB and the appropriate Subcommittee. This completes the ancillary substance review for peracetic 

acid.

The 2000 TR notes that “Stock commercial preparations usually contain a synthetic stabilizer such as 1-

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hydroxyethylidene-1,1-diphosphonic acid (HEDP) or 2,6-pyridinedicarboxylic (dipicolinic) acid to slow 

the rate of oxidation or decomposition.” No ancillary substances were identified during public comment 

however one commenter noted this section of the TR. Since Peracetic acid/Peroxyacetic acid needs to 

be registered with the EPA when used as an antimicrobial these substances are considered inerts and 

are not subject to review under the ancillary substance review. Furthermore, the annotation currently 

states “for use in wash and/or rinse water according to FDA limitation”, which define the permitted 

stabilizers. 

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting.

The Handling Subcommittee believes that the full board should have the opportunity to complete the 

review of each sunset material by voting. The NOP has stated that to do this a motion to remove should 

be brought from the Subcommittee for each substance. If the Subcommittee motion to remove fails to 

receive a majority, the motion will still be put forward to the full board for review. The motion to 

remove is voted by the full board and needs to receive a 2/3 majority to recommend removal.

Based on the review, the Subcommittee proposes removal of this substance from the National List 

based on the following criteria in the Organic Foods Production Act (OFPA) criteria 7 U.S.C. 6518(m)(6) 

the alternatives to using the substance in terms of practices or other available materials: and (7) its 

compatibility with a system of sustainable agriculture.

The Handling Subcommittee found no concerns regarding the continued listing of Peracetic 

acid/Peroxyacetic acid on the National List. The justification of this motion is that the whole NOSB 

needs to consider and vote on each material, rather than just the individual Subcommittee, to fulfill 

its’ responsibility of Sunset Review.

Motion to remove Peracetic Acid (CAS # 79–21–0), from §205.605b 

Motion by: Tom Chapman

Seconded by: Zea Sonnabend

Yes: 0 No: 7 Abstain: 0 Recuse: 0 Absent: 1

Cyclohexylamine

Reference: 7 CFR 205.605(b) Cyclohexylamine (CAS # 108 - 91 - 8) for use only as a boiler water additive 

for packaging sterilization.

Technical Report: 02/2001

Petition(s): 11/2000 Cyclohexylamine

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

List; 11/2009 - Recommendation to relist

Regulatory Background: Added to National List 09/12/06 71 FR 53299, Sunset renewal notice published

08/03/2011 76 FR 46595

Sunset Date: 9/12/16

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Subcommittee Review

Cyclohexylamine, a volatile amine, is a boiler water additive used to prevent corrosion in boilers and 

boiler distribution lines. 

The material can pose serious risks to human health and the environment, and is an irritant and should 

be handled as such. Cyclohexylamine is often used in conjunction with other volatile amines. 

Volatile amines are characterized by their high solubility in water and reactivity. These very chemical 

properties that make them effective as boiler water additives make them extremely difficult to remove 

from the steam, NOSB TAP Review Compiled by OMRI, 2001. Given this characteristic, it makes it 

possible that Cyclohexylamine could come into contact with food items. For this reason, its used has 

been limited to use only for packaging sterilization. 

In August 2014, the NOSB put forth a request for information regarding the continued use of this 

material in boiler systems and received limited information regarding its continued use in organic 

processing. Some information received by the NOSB suggests that most manufacturers have already 

begun a move away from this material. This information, in conjunction with the potential for harm to 

human health and the environment, is the reason the Handling Subcommittee is recommending 

removal from the National List.

This substance is used in handling, and does not include any ancillary substances.

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

The Handling Subcommittee believes that the full board should have the opportunity to complete the 

review of each sunset material by voting. The NOP has stated that to do this a motion to remove should 

be brought from the Subcommittee for each substance. If the Subcommittee motion to remove fails to 

receive a majority, the motion will still be put forward to the full board for review. The motion to 

remove is voted by the full board and needs to receive a 2/3 majority to recommend removal.

Based on the Subcommittee’s review, the Subcommittee proposes removal of Cyclohexylamine from 

the National List based on the following criteria in the Organic Foods Production Act (OFPA) and/or 7 

CFR 205.600(b): lack of essentiality for handling organic products [§205.600(b)(6)], inconsistent with 

organic handling [§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

Motion to remove the boiler amines, Cyclohexylamine (CAS # 108 -91-8), Diethylaminoethanol (CAS # 

100–37–8), and Octadecylamine (CAS # 124-30-1), all three with the annotation “for use only as a boiler 

water additive for packaging sterilization”, from section 205.605(b)

Motion by: Tracy Favre

Seconded: Jean Richardson

Yes: 5 No: 0 Abstain: 0 Recuse: 0 Absent: 3

Diethylaminoethanol

Reference: 7 CFR 205.605(b) Diethylaminoethanol (CAS # 100 -37- 8) for use only as a boiler water 

additive for packaging sterilization.

Technical Report: 2/2001 TAP

Petition(s): 11/2000

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

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11/5/09 - Recommendation to relist

Regulatory Background: Added to National List, effective 09/12/06 71 FR 53299, Sunset renewal notice 

published 08/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Subcommittee Review

Diethylaminoethanol (DEAE), a volatile amine, is a boiler water additive used to prevent corrosion in 

boilers and boiler distribution lines. It neutralizes carbonic acid the boiler lines by scavenging free 

oxygen. 

The material can pose serious risks to human health and the environment, and is an irritant and should 

be handled as such. Diethylaminoethanol is poisonous when ingested. DEAE is often used in 

conjunction with other volatile amines. 

Volatile amines are characterized by their high solubility in water and reactivity. These very chemical 

properties that make them effective as boiler water additives make them extremely difficult to remove 

from the steam, NOSB TAP Review Compiled by OMRI, 2001. Given this characteristic, it makes it 

possible that Diethylaminoethanol could come into contact with food items. For this reason, its used 

has been limited to use only for packaging sterilization. 

In August 2014, the NOSB put forth a request for information regarding the continued use of this 

material in boiler systems and received limited information regarding its continued use in organic 

processing. Some information received by the NOSB suggests that most manufacturers have already 

begun a move away from DEAE. This information, in conjunction with the potential for harm to human 

health and the environment is the reason the Handling Subcommittee is recommending removal from 

the National List.

This substance is used in handling, and does not include any ancillary substances.

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

The Handling Subcommittee believes that the full board should have the opportunity to complete the 

review of each sunset material by voting. The NOP has stated that to do this a motion to remove should 

be brought from the Subcommittee for each substance. If the Subcommittee motion to remove fails to 

receive a majority, the motion will still be put forward to the full board for review. The motion to 

remove is voted by the full board and needs to receive a 2/3 majority to recommend removal.

Based on the review, the Subcommittee proposes removal of Diethylaminoethanol from the National 

List based on the following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): 

lack of essentiality for handling organic products [§205.600(b)(6)], inconsistent with organic handling 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

Motion to remove the boiler amines, Cyclohexylamine (CAS # 108 -91-8), Diethylaminoethanol (CAS # 

100–37–8), and Octadecylamine (CAS # 124-30-1), all three with the annotation “for use only as a boiler 

water additive for packaging sterilization”, from section 205.605(b)

Motion by Tracy Favre

Seconded Jean Richardson

Yes: 5 No: 0 Abstain: 0 Recuse: 0 Absent: 3

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Octadecylamine

Reference: 7 CFR 205.605(b) Octadecylamine (CAS # 124–30–1) for use only as a boiler water additive 

for packaging sterilization.

Technical Report: 02/2001 TAP

Petition(s): 11/2000

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

List 11/5/09 - Recommendation to renew

Regulatory Background: Added to National List, effective 09/12/06 71 FR 53299, Sunset renewal notice 

published 08/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Subcommittee Review

Octadecylamine, a volatile amine, is a boiler water additive used to prevent corrosion in boilers and 

boiler distribution lines. It forms a thin film on the inside of boiler water lines and prevents the 

formation of carbolic acid from carbon dioxide contained in the boiler water.

The material can pose serious risks to human health and the environment, and is an irritant and should 

be handled as such. Octadecylamine is poisonous when ingested. Octadecylamine is often used in 

conjunction with other volatile amines. 

Volatile amines are characterized by their high solubility in water and reactivity. These very chemical 

properties that make them effective as boiler water additives make them extremely difficult to remove 

from the steam, NOSB TAP Review Compiled by OMRI, 2001. Given this characteristic, it makes it 

possible that Octadecylamine could come into contact with food items. For this reason, its used has 

been limited to use only for packaging sterilization. 

In August 2014, the NOSB put forth a request for information regarding the continued use of this 

material in boiler systems and received limited information regarding its continued use in organic 

processing. Some information received by the NOSB suggests that most manufacturers have already 

begun a move away from Octadecylamine. This information, in conjunction with the potential for harm 

to human health and the environment is the reason the Handling Subcommittee is recommending 

removal from the National List.

This substance is used in handling, and does not include any ancillary substances.

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

The Handling Subcommittee believes that the full board should have the opportunity to complete the 

review of each sunset material by voting. The NOP has stated that to do this a motion to remove should 

be brought from the Subcommittee for each substance. If the Subcommittee motion to remove fails to 

receive a majority, the motion will still be put forward to the full board for review. The motion to 

remove is voted by the full board and needs to receive a 2/3 majority to recommend removal.

Based on the review, the Subcommittee proposes removal of Octadecylamine from the National List 

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based on the following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): 

lack of essentiality for handling organic products [§205.600(b)(6)], inconsistent with organic handling 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

Motion to remove the boiler amines, Cyclohexylamine (CAS # 108 -91-8), Diethylaminoethanol (CAS # 

100–37–8), and Octadecylamine (CAS # 124-30-1), all three with the annotation “for use only as a boiler 

water additive for packaging sterilization”, from section 205.605(b)

Motion by Tracy Favre

Seconded Jean Richardson

Yes: 5 No: 0 Abstain: 0 Recuse: 0 Absent: 3 

Sodium acid pyrophosphate

Reference: 7 CFR 205.605(b) Sodium acid pyrophosphate (CAS # 7758-16-9) - for use only as a leavening 

agent.

Technical Report: 09/2001 TAP (report is for Sodium Phosphates as a group).

Petition(s): 10/2002: 06/2009 petition for expanded use

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

List; 11/2009 - recommendation to relist; 04/2011 - recommendation on expanded use 

Regulatory Background: Added to National List, effective 09/12/06 71 FR 53299, Sunset renewal notice 

published 08/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Subcommittee Review

Sodium Acid Pyrophosphate (SAPP) was first petitioned on 10/31/02 and added to the National List 

§205.605(b) effective on September 12, 2006 by Final Rule TM-04-01FR based on the NOSB 

recommendation of May 2003. It most recently underwent sunset review at the Fall 2009 meeting, and 

was relisted by the NOSB. 

Sodium acid pyrophosphate (CAS # 7758-16-9) was originally petitioned for use as a leavening acid in 

baked goods, and was given the annotation “for use only as a leavening agent” when originally 

recommended for listing by the NOSB. It is a relatively common food additive with USDA and FDA 

approval for many functions in conventional foods. In this intended use, it is used as an acid to react 

with sodium bicarbonate (baking soda) to produce a controlled release of the CO2 that leavens the 

baked good. SAPP is prepared by partial neutralization of phosphoric acid with sodium hydroxide or 

sodium carbonate to form monosodium phosphate, which is followed by molecular dehydration of that 

substance under controlled conditions at 250 degrees C to form SAPP. Environmental impact from 

manufacture and use is minimal, and it is not considered toxic to humans.

In the first meeting posting, the HS requested input on the essentiality and current use patterns of 

SAPP. We received comment from one certifier who noted that this substance is in current use by six 

clients, and is used in five of the six baking powder formulas it has reviewed. A trade organization, the 

International Food Additives Council (IFAC), supported its continued listing, noted that it is widely used 

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and essential in baked good. IFAC also noted that “Delisting SAPP would significantly limit the quality, 

variety and availability of organic bakery products, negatively impacting organic consumers who 

currently purchase organic bakery items.” One large processor commented that they currently widely 

use SAPP in a variety of products. 

Two other comments commented in opposition to relisting SAPP, on the grounds that the TAP review 

was focused on the use of sodium phosphates in non-dairy milk, rather than as a leavening agent. 

However, the HS believes that the technical information contained in the original TAP, along with the 

additional detail contained in the SAPP petition, the 2010 TR prepared for the evaluation of SAPP for use 

in produce, independent research, public comment and the food science expertise contained within this 

and past Handling Subcommittees is sufficient for a thorough review of this substance and that a new 

TR is not needed. 

This substance is used in handling, and does not include any ancillary substances.

The Subcommittee review indicated that there are no ancillary substances. There have been no ancillary 

substances declared by stakeholders during the public comment periods (both oral and written). 

Therefore, no ancillary substances will be allowed, unless otherwise petitioned and reviewed by the 

NOSB and the appropriate Subcommittee. This completes the ancillary substance review for Sodium 

Acid Pyrophosphate (SAPP). 

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

The Handling Subcommittee believes that the full board should have the opportunity to complete the 

review of each sunset material by voting. The NOP has stated that to do this a motion to remove should 

be brought from the Subcommittee for each substance. If the Subcommittee motion to remove fails to 

receive a majority, the motion will still be put forward to the full board for review. The motion to 

remove is voted by the full board and needs to receive a 2/3 majority to recommend removal.

Based on the review, the Subcommittee proposes removal of Sodium Acid pyrophosphate from the 

National List based on the following criteria in the Organic Foods Production Act (OFPA) criteria 7 U.S.C. 

6518(m)(6) the alternatives to using the substance in terms of practices or other available materials: and 

(7) its compatibility with a system of sustainable agriculture.

The Handling Subcommittee found no concerns regarding the continued listing of SAPP on the 

National List. The justification of this motion is that the whole NOSB needs to consider and vote on 

each material, rather than just the individual sub-committee, to fulfill its’ responsibility of Sunset 

Review.

Motion to remove Sodium acid pyrophosphate (SAPP) (CAS # 7758-16-9) -for use only as a leavening 

agent, from 205.605(b) 

Motion by: Joe Dickson

Seconded by: Tracy Favre

Additional discussion: none

Yes: 0 No: 5 Abstain: 0 Absent: 3 Recuse: 0 

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Tetrasodium pyrophosphate (TSPP)

Reference: 7 CFR 205.605(b) Tetrasodium pyrophosphate (CAS # 7722–88–5) - for use only in meat 

analog products.

Technical Report: 2002 TAP; 2014 Limited Scope TR

Petition(s): 12/2001

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

11/5/09 - Sunset Recommendation to relist

Regulatory Background: Added to National List with annotation, effective 09/12/06 71 FR 

53299, Sunset renewal notice published 08/03/2011 76 FR 46595 

Sunset Date: 9/12/2016

Subcommittee Review

Tetrasodium Pyrophosphate (TSPP) is a processing aid that is used to make certain types of meat 

analogs. As a processing aid it does not appear on a food label and does not contain any ancillary 

substances.

In reviewing the historical background for Tetrasodium Pyrophosphate (TSPP), the Handling 

Subcommittee (HS) had concerns that this substance was put on the list by the former NOSB in spite of 

the fact that the majority of the 2002 TAP reviewers were against it, it was marked on the checklist as 

failing the criteria, and the information about which products it was used in (and therefore why it was 

specifically necessary for those products) was proprietary. Therefore a new TR was commissioned to try 

to further evaluate the alternatives.

In the first meeting posting the HS requested public comment on the specific uses of the substance and 

experience with alternatives, as well as the issue of whether TSPP was primarily used to restore texture 

after complex (and possibly excessive) processing of vegetable protein.

Very little public comment was received for this substance. No users of TSPP came forward and no 

certifiers stated that their clients used this material. One industry association wrote in favor of this as 

well as the other food additives in sunset, but gave no specifics on uses or alternatives. Several groups 

opposed this material along with many other synthetics on the National List, but none gave specific 

information that was unique to this substance.

The HS has determined from the 2014 TR and lack of clear input from the organic community that there 

are ample alternatives to the use of TSPP and some of the other criteria in the rule are not sufficiently 

met. Therefore a checklist is presented to go into some of the specific issues. A motion is being put 

forward to remove TSPP from the National List.

This substance is used in handling, and does not include any ancillary substances.

Supplemental Review Information 

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting.

The Handling Subcommittee believes that the full board should have the opportunity to complete the 

review of each sunset material by voting. The NOP has stated that to do this a motion to remove should 

be brought from the Subcommittee for each substance. If the Subcommittee motion to remove fails to 

receive a majority, the motion will still be put forward to the full board for review. The motion to 

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remove is voted by the full board and needs to receive a 2/3 majority to recommend removal.

Based on the review, the Subcommittee proposes removal of Tetrasodium Pyrophosphate from the 

National List based on the following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 

205.600(b): Availability of non-synthetic alternative protein sources [§ 205.600(b)(1)], alternative 

substances in use [§6518(m)(6)], lack of essentiality for handling organic products [§205.600(b)(6)], 

inconsistent with organic handling [§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

Motion to remove Tetrasodium Pyrophosphate (CAS # 7722–88–5) - for use only in meat analog 

products, from 205.605(b). 

Motion by: Zea Sonnabend 

Seconded by: Tracy Favre

Yes: 6 No: 0 Abstain: 0 Recuse: 0 Absent: 2

Approved by Harold Austin, Subcommittee Chair, to transmit to NOSB February 25, 2015

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