FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: _November 17, 2005________

Subject: __Sunset review of nonsynthetic National List substances used in handling_

Chair: ____Jim Riddle______________________________________

 (sign) 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: ___X____ 

Guidance Statement: ________ 

Other: ___X_____ 

Statement of the Recommendation (including Recount of Vote): The NOSB voted to renew 19 

substances on section 205.605(a) of the National List. The NOSB voted to defer action on 2 

substances on 205.605(a). A complete list of the recommendations to renew and defer appears 

below, along with the vote totals for the subsection. 

Rationale Supporting Recommendation (including consistency with OFPA and NOP): 

Statements from the Handling Committee explaining the rationale supported through NOSB 

action are included in the recommendation presented below. A compilation of all deferred 

substances, complete with specific questions identified by the NOSB, are submitted to the NOP 

under separate cover. 

Response by the NOP:

Updated 2/25/05 
I. List: 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in 

or on processed products labeled as “organic” or “made with organic (specified 

ingredients or food groups.” 

 

(a) Nonsynthetics allowed 

II. Committee Summary: Many commenters are proponents of keeping all materials on 

list 205.605 a. In addition, each substance on the list received many specific comments 

recommending their continued allowance in organic handling. One substance, yeast, had 

several comments supporting the continued use of this material, however a few 

comments objected to its continued use. 

There were comments submitted supporting the continued use of agar-agar and tartaric 

acid. Both materials were listed in the Federal Register ANPR for Sunset Review, but 

because these materials were not on the December 21, 2000, National List, they are not to 

be considered as part of this Sunset review. 

A few commenters stated that it was inappropriate for Section 205.605(a) of the National 

List to retain yeast for handling production because the commenters believe that this 

material is agricultural. The handling committee believes that the issue of agricultural 

versus non-agricultural is not in the scope of the Sunset process, therefore we recommend 

the continued use of this material. 

III. Committee Recommendation(s): 

The handling committee recommends the renewal of the following substances in this use 

category as published in the final rule: 

Acids (Alginic; Citric - produced by microbial fermentation of carbohydrate 

substances; and Lactic). 

Bentonite 

Calcium carbonate 

Calcium chloride 

Carageenan 

Dairy cultures 

Diatomaceous earth-food filtering aid 

Enzymes -must be derived from edible, nontoxic plants, nonpathogenic fungi, or 

nonpathogenic bacteria. 

Kaolin 

Magnesium Sulfate, nonsynthetic sources only. 

Nitrogen-oil-free grades 

Oxygen-oil free grades 

Perlite- for use only as a filter aid in food processing 

Potassium chloride 

Potassium iodide 

Sodium bicarbonate 

Sodium carbonate 
Waxes-nonsynthetic (Carnauba wax; and Wood resin). 

Yeast - nonsynthetic, growth on petrochemical substrate and sulfite waste liquor is 

prohibited (Autolysate; Bakers; Brewers; Nutritional; and Smoked - nonsynthetic 

smoke flavoring process must be documented). 

The handling committee recommends deferring the vote on the following materials until 

further technical information is obtained. The materials to be deferred are: 

Colors-nonsynthetic sources only 

Flavors- nonsynthetic sources only and must not be produced using synthetic 

solvents and carrier systems or any artificial preservative. 

At the time these materials were added to the National List, there was no technical review 

conducted (i.e. TAP). The NOSB has determined that these materials warrant a more indepth review and require additional technical information. The NOSB has requested TAP 

reviews for these materials in order to make recommendations for their continued use or 

prohibition. 

 

The handling committee recommends not renewing the following substances in this use 

category based on the submitted evaluation forms: 

None in this category 

Moved: Julie Weisman Second: Bea James 

Committee vote: 4 yes, 0 no, 1 absent 

Board vote: 14 yes, 0 no 
FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: _November 17, 2005________

Subject: __Sunset review of synthetic National List substances used in handling_

Chair: ____Jim Riddle______________________________________

 (sign) 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: ___X____ 

Guidance Statement: ________ 

Other: ___X_____ 

Statement of the Recommendation (including Recount of Vote): The NOSB voted to renew 34 

substances on section 205.605(b) of the National List. The NOSB voted to defer action on 2 

substances on 205.605(b). The NOSB voted to remove 1 substance from 205.605(b). A complete 

list of the recommendations to renew and defer appears below, along with the vote totals for the 

subsection. 

Rationale Supporting Recommendation (including consistency with OFPA and NOP): 

Statements from the Handling Committee explaining the rationale supported through NOSB 

action are included in the recommendation presented below. A compilation of all deferred 

substances, complete with specific questions identified by the NOSB, are submitted to the NOP 

under separate cover. 

Response by the NOP:

Updated 2/25/05
I. List: 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in 

or on processed products labeled as “organic” or “made with organic (specified 

ingredients or food groups.” 

 

(b) Synthetics allowed 

II. Committee Summary: Many commenters are proponents of keeping all materials on 

List 205.605 b. In addition, each substance on the list received many specific comments 

recommending their continued allowance in organic handling. 

Many commenters supported, while one commenter objected, to the continued use of 

lecithin-bleached. One commenter stated that organic soy lecithin is now readily 

available; therefore lecithin-bleached should be removed from the list. The federal 

register notice (re- Sunset Review) asked commenters to provide evidence concerning 

viable alternatives for the substance they believed should be discontinued. Evidence was 

not supplied to support the comment regarding removal of lecithin-bleached, such as 

supply source, supply quantity, functionality, performance, test data and name and 

address of producers who have used the alternative under similar conditions. As a result, 

the handling committee recommends deferring this substance until further information 

can be obtained. 

Many commenters supported, while one commenter objected, to the continued use of 

ethylene. The handling committee discussed the content of the objection and determined 

that the information presented in the objection was not new and did not provide evidence 

as requested in the federal register sunset review notice to support non renewal of 

ethylene. Also the 1999 TAP for ethylene properly considered and addressed the 

concerns of the objection. 

Some commenters supported the continued use of “potassium tartrate made from tartaric 

acid” while one commenter objected. The commenter stated that this substance was 

improperly identified. NOSB commissioned one TAP review in 1995 on “potassium 

tartrate” and the review intent was to consider the substance known as “cream of tartar” 

which is properly known as potassium acid tartrate. Referencing “NOSB Processing 

Materials Decisions, June 2001” which states that potassium acid tartrate was also called 

potassium tartrate made from tartaric acid, the handling committee recommends not 

renewing the later substance because of duplication. 

Some commenters requested a change in classification and/or annotation for certain 

materials, including glycerin, xanthan gum and tocophorols. In addition, some 

commenters requested that substances be added to the list, such as ground limestone and 

acetic acid. These requests are not considered a part of the Sunset Review. Sunset Review 

was established to evaluate the continued use or prohibition of substances currently on 

the National List. Therefore, these comments would require a specific petition to the 

NOP. 
We received comments for inclusion of the following substances that were previously 

recommended by the NOSB to the National List: activated carbon, ammonium 

hydroxide, cyclohexlamine, diethylaminoethanol, octadecylamine and periacetic acid. 

These substances do not fall under the Sunset process, as they were not added to the 

National List on December 21, 2000, and they are currently part of a proposed rule, 

Docket # TM 0401 published September16, 2005. 

III. Committee Recommendation(s): 

The handling committee recommends the renewal of the following substances in this use 

category as published in the final rule: 

Alignates 

Ammonium bicarbonate- for use only as a leavening agent 

Ammonium carbonate- for use only as a leavening agent 

Ascorbic acid 

Calcium citrate 

Calcium hydroxide 

Calcium phosphates (monobasic, dibasic, and tribasic).

Carbon dioxide 

Ethylene - allowed for post-harvest ripening of tropical fruit and degreening of citrus. 

Ferrous sulfate for iron enrichment or fortification of foods when required by regulation 

or recommended (independent organization).

Glycerides (mono and di) - for use only in drum drying of food

Glycerin - produced by hydrolysis of fats and oils.

Hydrogen peroxide 

Magnesium carbonate - for use only in agricultural products labeled "made with 

organic (specified ingredients or food group(s))," prohibited in agricultural products 

labeled "organic." 

Magnesium chloride - derived from sea water.

Magnesium stearate for use only in agricultural products labeled "made with organic 

(specified ingredients or food group(s))," prohibited in agricultural products labeled 

"organic."

Nutrient vitamins and minerals, in accordance with 21 CFR 104.20, Nutritional Quality 

Guidelines For Foods.

Ozone 

Pectin (low-methoxy) 

Phosphoric acid - cleaning of food-contact surfaces and equipment only.

Potassium acid tartrate 

Potassium carbonate 

Potassium citrate 

Potassium hydroxide- - prohibited for use in lye peeling of fruits and vegetables except 

when used for peeling peaches during the Individually Quick Frozen (IQF) production 

process

Potassium iodide - for use only in agricultural products labeled "made with organic 

(specified ingredients or food group(s))," prohibited in agricultural products labeled 

"organic."
Potassium phosphate - for use only in agricultural products labeled "made with organic 

(specified ingredients or food group(s))," prohibited in agricultural products labeled 

"organic."

Silicon dioxide 

Sodium citrate 

Sodium hydroxide - prohibited for use in lye peeling of fruits and vegetables.

Sodium phosphates - for use only in dairy foods. 

Sulfur dioxide for use only in wine labeled "made with organic grapes," Provided, that, 

total sulfite concentration does not exceed 100 ppm.

Tartaric acid 

Tocopherols - derived from vegetable oil when rosemary extracts are not a suitable 

alternative. 

Xanthan gum 

The handling committee recommends deferring the vote on the following materials until 

further technical information is obtained. The materials to be deferred are: 

Lecithin – bleached 

Chlorine materials disinfecting and sanitizing food contact surfaces, Except, That, 

residual chlorine levels in the water shall not exceed the maximum residual disinfectant 

limit under the Safe Drinking Water Act (Calcium hypochlorite; Chlorine dioxide; and 

Sodium hypochlorite). 

The handling committee recommends not renewing the following substances in this use 

category based on the submitted evaluation forms: 

Potassium tartrate made from tartaric acid 

Moved: Goldie Second: Andrea 

Committee vote: Yes – 5 No- 0 

11-8-05 

Background: There was a discussion and recommendation to defer lecithin - unbleached 

in 205.606 until the HC can obtain additional information. In order to be consistent in our 

presentation at the board meeting re this substance and to be clear on the distinct 

differences in the two classifications for lecithin (agricultural, synthetic) the following 

motion was accepted.

 

Motion to "revise the current 205.605b recommendation to defer lecithin-bleached until 

we obtain additional information". 

 

Moved: Goldie Second: Bea 

Committee vote: Yes – 4 No- 0 Absent - 1 

11-17-05 

Background: After discussion and review of the comment objecting to the continued use 

of ethylene and the 1999 TAP the following motion was accepted.
Motion to "revise the current 205.605b recommendation to renew ethylene.

 

Moved: Goldie Second: Andrea 

Committee vote: Yes – 4 No- 0 Absent - 1 

11-17-05 

Background: In order to allow time to review the proposed TAP covering chlorine 

materials the following motion was accepted.

Motion to "defer chlorine materials” 

 

Moved: Andrea Second: Julie 

Committee vote: Yes – 4 No- 0 Absent - 1 

NOSB vote: 14 yes, 0 no 
FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: _November 17, 2005________

Subject: __Sunset review of nonorganic agricultural substances on the National List 

used in handling_

Chair: ____Jim Riddle______________________________________

 (sign) 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: ___X____ 

Guidance Statement: ________ 

Other: ___X_____ 

Statement of the Recommendation (including Recount of Vote): The NOSB voted to renew 4 

substances on section 205.606 of the National List. The NOSB voted to defer action on 1 

substance on 205.606. A complete list of the recommendations to renew and defer appears below, 

along with the vote totals for 205.606. 

Rationale Supporting Recommendation (including consistency with OFPA and NOP): 

Statements from the Handling Committee explaining the rationale supported through NOSB 

action are included in the recommendation presented below. A compilation of all deferred 

substances, complete with specific questions identified by the NOSB, are submitted to the NOP 

under separate cover. 

Response by the NOP:

Updated 2/25/05
I. List: 205.606 Non-organically produced agricultural products allowed as 

ingredients in or on processed products labeled as “organic” or “made with organic 

(specified ingredients or food group(s)).” 

 

II. Committee Summary: Many comments were received supporting the retention of all 

five substances in section 205.606. In addition, comments were received opposing the relisting of the substances on Section 205.606. These comments did not include adequate 

information supporting the removal of substances from the List as specified in the 

Federal Register notice regarding the Sunset of materials on the National List. The 

committee did not have data or evidence to support the position to remove any of the 

substances listed in Section 205.606. 

Four of the five materials on list 205.606 received a substantial number of comments in 

favor of their continued need in organic handling. Several commenters cited that some 

substances were available in organic form, such as soy lecithin, and had concerns that 

there will be no market for the organically produced substance if the non-organically 

produced substance remained on the list. However, other commenters noted that the 

organic form is either insufficient in quantity or inadequate in form. No commenters 

provided adequate data to support their position. 

Soy lecithin received conflicting comments regarding it’s availability in sufficient form. 

The TAP review of soy lecithin conducted in 1995 did not provide adequate information 

to help the committee make a determination for removal or continuation. Therefore, the 

committee recommends this substance be deferred until further information can be 

obtained. 

Comments specifically opposing continued use of cornstarch, gums – water-extracted 

only, and kelp were based on the commenter’s assertion that these items are now 

commercially available in organic form. Information such as supply source, supply 

quantity, functionality, performance, test data, and name and address of producers, who 

have used the material under similar conditions, was not supplied by the commenters for 

the Board to make a decision to discontinue the use of these materials under section 

205.606. In addition, no comments were received from manufacturers or suppliers of 

these substances regarding availability in appropriate form, quality or quantity. Because 

such information was not provided in any of the comments the handling committee 

recommends the continued use of these materials. 

There were no comments specifically opposing the continued use of Pectin (highmethoxy). 

III. Committee Recommendation(s): 

The handling committee recommends the renewal of the following substances in this use 

category:

 Cornstarch (native) 
 Gums – water-extracted only (Arabic, guar, locust bean, carob bean) 

 Kelp – for use only as a thickener and dietary supplement 

 Pectin (high-methoxy) 

The handling committee recommends deferring the vote on the following materials until 

further technical information is obtained. The materials to be deferred are: 

 Lecithin-unbleached 

 

The handling committee recommends not renewing the following substances in this use 

category based on the submitted evaluation forms: 

None in this category 

Moved: Julie Weisman Second: Bea James 

Committee vote: Yes 4 No 0 Absent 1 

NOSB vote: 13 yes, 0 no, 1 abstain