National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Sunset 2018 Review Summary 

NOSB Final Review

Handling Substances §205.605(a), §205.605(b), §205.606

November 2016

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.

Reference: 7 CFR 205.605(a) Nonagricultural (Nonorganic) substances allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food 

group(s)).’’

Agar-agar

Animal enzymes

Calcium sulfate-mined

Carrageenan

Glucono delta-lactone

Tartaric acid

Reference: 7 CFR 205.605(b) Nonagricultural (Nonorganic) substances allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food 

group(s)).’’

Cellulose

Potassium hydroxide

Silicon dioxide

Reference: 7 CFR §205.606 Nonorganically produced agricultural products allowed as ingredients in or 

on processed products labeled as “organic.”

(d) Colors derived from agricultural products - Must not be produced using synthetic solvents and carrier 

systems or any artificial preservative.

(2) Beta-carotene extract color
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Agar-agar

Reference: §205.605(a)

Technical Report: 1995 TAP; 2011 TR

Petition(s): NA

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2007 recommendation; 05/2012 

recommendation

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review

NOSB Review

There was strong public support for the continued use of agar agar. No new information was brought 

forward to show viable alternatives to use of agar agar or negative impacts on human health. The TR 

indicated limited evidence of effects on biodiversity; All marine materials on the National List, including 

agar agar, are currently being reviewed as a group by the Handling Subcommittee. Included in the 

review is the consideration of sustainable harvesting.

Vote

Motion to remove agar-gar from §205.605(a) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none

Motion by: Lisa de Lima

Seconded by: Ashely Swaffar

Yes: 0 No: 14 Abstain: 0 Absent: 1 Recuse: 0

Outcome: Motion failed. NOSB completed its sunset review. 

Animal enzymes

Reference: §205.605(a) Animal enzymes - (Rennet - animals derived; Catalase - bovine liver; Animal 

lipase; Pancreatin; Pepsin; and Trypsin).

Technical Report: 2000 TAP, 2011 TR, 2015 TR

Petition(s): NA

Past NOSB Actions: 11/2000 meeting minutes and vote; 11/2007 recommendation; 12/2011 

recommendation

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review

NOSB Review
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There was strong public support for the continued use of animal enzymes. Some commenters 

encouraged the industry to look for organic enzymes, which are not currently available to organic 

producers and handlers. Based on the Subcommittee review and public comment, the NOSB finds 

animal enzymes compliant with OFPA criteria.

Vote

Motion to remove animal enzymes - (Rennet - animals derived; Catalase - bovine liver; Animal lipase; 

Pancreatin; Pepsin; and Trypsin) from §205.605(a) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none

Motion by: Lisa de Lima

Seconded by: Ashley Swaffar

Yes: 0 No: 14 Abstain: 0 Absent: 1 Recuse: 0

Outcome: Motion failed. NOSB completed its sunset review. 

Calcium sulfate-mined

Reference: §205.605(a)

Technical Report: 1996 TAP, 2001 TAP

Petition(s): 2000 

Past NOSB Actions: 09/1996 meeting minutes and vote; 11/2007 recommendation; 05/2012 

recommendation

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review

NOSB Review

There was strong public support for continued use of calcium sulfate-mined. Based on the 

Subcommittee review and public comment, the NOSB finds calcium sulfate-mined compliant with OFPA 

criteria, and does not recommend removal from the National List.

Vote 

Motion to remove calcium sulfate-mined, from §205.605(a) based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none

Motion by: Tom Chapman

Seconded by: Ashley Swaffar 

Yes: 0 No: 14 Abstain: 0 Absent: 1 Recuse: 0

Outcome: Motion failed. NOSB completed its sunset review. 
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Carrageenan

Reference: §205.605(a)

Technical Report: 1995 TAP, 2011 TR; 2016 Limited Scope TR

Petition(s): NA

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2007 recommendation; 05/2012 

recommendation

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987 –misspelled as 

‘carageenan’); Sunset renewal notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review

NOSB Review

Because there was intense scrutiny about carrageenan, each OFPA criteria was reviewed carefully and 

all public comment was acknowledged. Here are the results of that evaluation:

OFPA criteria at 7 CFR 6518(m)

(1) The potential of such substances for detrimental chemical interactions with other materials 

used in organic farming systems; not applicable.

(2) The toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence and areas of concentration in the environment; no 

concerns were found about the substance and its breakdown in the environment.

(3) The probability of environmental contamination during manufacture, use, misuse, or disposal of 

such substance; there may be negative impacts on the environment from harvesting wild 

seaweed. Indications are that most of this species of seaweed is now farmed, and some farming 

methods are more sustainable and ecologically sound than others. It appears that it might be 

possible for the seaweed to be farmed organically, and this might improve the environmental 

footprint. Additionally, there are several ways to manufacture the carrageenan from seaweed. 

Some of these would result in a non-synthetic version, while at least one method might be 

considered a synthetic extraction.

(4) The effect of the substance on human health; The research indicating that there may be 

negative health effects on all humans in terms of inflammation, glucose intolerance, or tumors 

does not seem to be replicated in the large body of scientific literature. There are many 

anecdotal reports of sensitivity to carrageenan in foods from individuals in public comments. 

These concerns have not been studied in the literature, however they are acknowledged. This 

was not seen as a primary reason to remove carrageenan since it is listed on the labels as a food 

ingredient.

(5) The effects of the substance on biological and chemical interactions in the agroecosystem; No 

concerns noted except as above in (3).

(6) The alternatives to using the substance in terms of practices or other available materials; an

extensive list was prepared of all the food product categories in which carrageenan is used. In 

most of the product types there are versions that are currently being sold that do not contain 

carrageenan. These often contain other types of gums such as gellan, guar, or xanthan. Products 

for vegetarians where carrageenan is used in place of gelatin will be the most difficult to 

produce without it, but the majority of NOSB members were not concerned about this class of 

products being impacted.

(7) Its compatibility with a system of sustainable agriculture; A majority of NOSB members believed 

that this ingredient is not compatible with sustainable agriculture because it is so controversial 
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and they wanted to invoke the Precautionary Principle. Also invoked were the NOSB Guidance 

on Compatibility from the Appendix of the NOSB Policy and Procedures Manual that poses this 

factor (out of 12) for consideration, “Does the substance satisfy expectations of organic 

consumers regarding the authenticity and integrity of organic products”?

Vote 

Motion to remove carrageenan from §205.605(a) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: OFPA 6518(m)(6) - availability of 

alternatives.

Motion by: Zea Sonnabend

Seconded by: Ashley Swaffar

Yes: 10 No: 3 Abstain: 1 Absent: 1 Recuse: 0

Outcome: Motion passed. The NOSB recommends removal of carrageenan from the National List.

Glucono delta-lactone

Reference: §205.605(a) Glucono delta-lactone—production by the oxidation of D-glucose with bromine 

water is prohibited.

Technical Report: 2002 TAP; 2016 TR

Petition(s): 2002

Past NOSB Actions: 09/2002 meeting minutes and vote; 11/2007 recommendation; 05/2012 

recommendation

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review

NOSB Review

Based on the Subcommittee review and strong support from public comment, the NOSB finds glucono 

delta-lactone compliant with OFPA criteria, and does not recommend removal from the National List.

Vote

Motion to remove glucono delta-lactone from §205.605(a) based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none

Motion by: Tom Chapman

Seconded by: Ashley Swaffar

Yes: 0 No: 13 Abstain: 1 Absent: 1 Recuse: 0

Outcome: Motion failed. NOSB completed its sunset review
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Tartaric acid

Reference: §205.605(a) Tartaric acid - made from grape wine.

Technical Report: 2011 TR

Petition(s): 2011 Petition to remove from 205.605(b) - made from malic acid

Past NOSB Actions: NOSB meeting review 11/1995; 11/2005 recommendation; 12/2011 

recommendation

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review

NOSB Review

There was strong public support for the continued use of tartaric acid. Based on the Subcommittee 

review and public comment, the NOSB finds Tartaric Acid compliant with OFPA criteria, and does not 

recommend removal from the National List

Vote

Motion to remove tartaric acid - made from grape wine, from §205.605(a) based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: None

Motion by: Ashley Swaffar

Seconded by: Zea Sonnabend

Yes: 0 No: 14 Abstain: 0 Absent: 1 Recuse: 0

Outcome: Motion failed. NOSB completed its sunset review. The NOSB finds tartaric acid to still be 

compliant with OFPA criteria and does not recommend removal from the National List.

Cellulose

Reference: §205.605(b) Cellulose - for use in regenerative casings, as an anti-caking agent (non-chlorine 

bleached) and filtering aid.

Technical Report; 2016 TR

Petition(s): 2001

Past NOSB Actions: 10/2001 meeting minutes and vote; 11/2007 recommendation; 05/2012 

recommendation

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review
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NOSB Review

Review of previous documents including the original recommendation, prior committee discussions, as 

well as information provided by the new Technical Evaluation Report (2/11/2016), public comments 

from both the spring and fall NOSB meetings via oral testimony (webinar and in-person) and written 

submitted comments, assisted the committee in this sunset review process. Comments submitted 

helped to provide the full Board with a detailed rationale as to why this material is still essential to 

organic handlers, even though some have found alternative processes to work for their specific needs. 

There was no information presented that made this committee feel this material should not be re-listed. 

This material is compliant with the organic principles of compatibility, and essentiality criteria under 

§205.600. 

During the comment period, commenters, identified additional ancillary substances for cellulose, 

therefore, the NOSB Handling Subcommittee will develop a follow-up proposal to include the ancillaries.

Vote 

Motion to remove cellulose from §205.605(b) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: None.

Motion by: Harold V. Austin IV

Seconded by: Lisa De Lima

Yes: 2 No: 11 Abstain: 0 Absent: 1 Recuse: 0

Outcome: Motion failed. NOSB completed its sunset review.

Potassium hydroxide

Reference: §205.605(b) Potassium hydroxide - prohibited for use in lye peeling of fruits and vegetables 

except when used for peeling peaches.

Technical Report: 2001 TAP; 2016 TR

Petition(s): 2001 petition, 2011 petition to amend annotation

Past NOSB Actions: 10/1995 meeting minutes and vote; 11/2005 recommendation; 12/2011 

recommendation

Recent Regulatory Background: Added to the National list 12/21/2000 (65 FR 80548); National List 

amended 11/03/2003 (68 FR 62215); National List amended 05/28/2013 (78 FR 31815)

Sunset Date: 5/29/2018

Subcommittee Review

NOSB Review

There was strong public support for the continued use of potassium hydroxide. Based on the 

Subcommittee review and public comment, the NOSB finds potassium hydroxide compliant with OFPA 

criteria, and does not recommend removal from the National List.

Vote 

Motion to remove potassium hydroxide from §205.605(b) based on the following criteria in the Organic 

Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: None
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Motion by: Ashley Swaffar

Seconded by: Scott Rice

Yes: 0 No: 14 Abstain: 0 Absent: 1 Recuse: 0

Outcome: Motion failed. NOSB completed its sunset review

Silicon dioxide

Reference: §205.605(b) Silicon dioxide - Permitted as a defoamer. Allowed for other uses when organic 

rice hulls are not commercially available.

Technical Report: 1996 TAP, 2010 TR

Petition(s): 2010 petition to remove

Past NOSB Actions: 09/1996 minutes and vote; 11/2005 recommendation; 12/2011 recommendation

Recent Regulatory Background: Added to NL 12/21/2000 (65 FR 80548); National list amended 

05/28/2013 (effective 11/03/2013) (78 FR 31815)

Sunset Date: 11/03/2018

Subcommittee Review

NOSB Review

Based on the Subcommittee review and strong support from public comment, the NOSB finds silicon 

dioxide compliant with OFPA criteria, and does not recommend removal from the National List.

Vote 

Motion to remove silicon dioxide from §205.605(b) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none

Motion by: Lisa de Lima

Seconded by: Tom Chapman

Yes: 0 No: 14 Abstain: 0 Absent: 1 Recuse: 0

Outcome: Motion failed. NOSB completed its sunset review

Colors: Beta-carotene extract

Reference: §205.606(d) Colors derived from agricultural products - Must not be produced using 

synthetic solvents and carrier systems or any artificial preservative

(2) Beta-carotene extract color - derived from carrots or algae (pigment CAS# 7235-40-7).

Technical Report: 2011 TR

Petition(s): 2007, 2009

Past NOSB Actions: 04/2007 recommendation, 12/2011 recommendation

Recent Regulatory Background: National List amended 06/27/2007 (72 FR 35137); National List 

amended 05/28/2013 (78 FR 31815)

Sunset Date: 5/29/2018
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Subcommittee Review

NOSB Review

Public comment regarding beta-carotene extract color was mixed. Producers were in support of keeping 

beta-carotene on the National List, some certifiers indicated that the material is not widely used, and 

consumer groups consider this color non-essential (205.600(b)(6)), and not compatible with sustainable 

agriculture. 

Vote

Motion to remove beta-carotene extract color - derived from carrots or algae (pigment CAS# 7235-40-7) 

from §205.606(d) based on the following criteria in the Organic Foods Production Act (OFPA) 6518 (m) 

(7) and 7 CFR 205.600(b) (1) and (4) and (7).

Motion by: Jean Richardson

Seconded by: Ashley Swaffar

Yes: 6 No: 8 Abstain: 0 Absent: 1 Recuse: 0

Outcome: Motion failed. NOSB completed its sunset review