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September 27, 2012

MEMORANDUM TO THE NATIONAL ORGANIC STANDARDS BOARD 

FROM: Miles McEvoy

Deputy Administrator

National Organic Program (NOP)

SUBJECT: National Organic Standards Board Recommendations (May 2012)

This memorandum responds to recommendations made at the May 22 to 25, 2012 business meeting of 

the National Organic Standards Board (NOSB) in Albuquerque, New Mexico. The NOSB recommended

that the NOP: 

1) Renew six material listings, three with recommended annotation changes, on the National List 

of Allowed and Prohibited Substances (National List) scheduled to expire November 3, 2013.

2) Add choline and inositol to § 205.605(b) with restrictions.

3) Add citrus hystrix and curry leaf to § 205.606.

4) Develop guidance materials to material review organizations.

5) Transmit a letter to Secretary Vilsack regarding the establishment of a Genetically Modified 

Organism (GMO) ad-hoc NOSB sub-committee.

6) Encourage USDA research agencies to prioritize funding for emerging organic research needs 

as recommended by NOSB on an annual basis.

7) Provide additional information to the NOSB on GMO vaccines.

NOP DISCUSSION AND RESPONSE: 

1. Sunset 2013

The NOSB is mandated by the Organic Foods Production Act (OFPA) of 1990 to review all substances 

listed on the National List and determine if their exemptions or prohibitions should be renewed for 

another five years; this is referred to as Sunset. During their Sunset review, the NOSB evaluated the 

available technical information, public comments, and alternatives to six material listings scheduled to 

expire on November 3, 2013. The NOSB recommended renewing the existing listing for three of the six 

substances with no annotation changes. The NOSB recommended amending annotations for three of 

the six substances (summarized in Table 1). For each of these three substances, the NOSB also 

recommended to renew the existing listing. The NOSB recommendations to renew the listings are 

provided to the NOP to allow for a continuation of the current use of a substance if it is not possible to 

amend the annotation during the sunset rulemaking. The NOP plans to evaluate each of the Sunset 

2013 recommendations and issue a proposed rule for public comment to address these material 

listings. 
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Table 1: Recommended Sunset 2013 Material Listings at May 2012 Meeting

Substance Section NOSB Recommendation

EPA List 3 Inerts § 205.601(m) 1. Relist with the following annotation: Inert ingredients 

exempt from the requirement of a tolerance under 40 

CFR 180.1122 that were formerly on EPA List 3 in 

passive polymeric dispenser products may be used until 

October 21, 2017. The NOSB also recommended the 

addition of a definition for the term “passive polymeric 

dispenser products” and modification of the introductory 

text of § 205.601(m) as part of their recommendation. 

2. Renew existing listing.

Agar-Agar § 205.605(a) Renew existing listing.

Calcium Sulfate § 205.605(a) Renew existing listing.

Carrageenan § 205.605(a) 1. Relist with the following annotation: CAS # 9000-07-1 

(general), 9062-07-1 (iota), 11114-20-8 (kappa), and 

9064-57-7 (lambda). Carrageenan would

not be allowed for use in infant formulas.

2. Renew existing listing.

Glucono DeltaLactone§ 205.605(a) Renew existing listing.

Cellulose § 205.605(b) 1. Relist with the following annotation: For use in 

regenerative casing, powdered cellulose as an anticaking agent (non-chlorine bleached) and

filtering aid.

2. Renew existing listing.

In August 2011, the NOP commented on the Sunset process for annotation changes as part of our 

response to the NOSB’s April 2011 recommendations. In our response, the NOP stated that the NOSB 

should ensure that proposals for annotation changes through the NOSB’s Sunset policy are fully vetted 

during the process and supported by information provided in public comment and/or technical reports. 
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In the absence of information to support a change, the NOP suggested that the NOSB avoid making 

changes to an annotation during the Sunset process. The NOP communicated our concern that 

annotation changes that may occur during deliberations at a NOSB meeting may not have the full 

benefit of public comment, and the NOP must ensure that changes to the regulations are clear and 

consistent.

The NOP is making reference to these comments as part of this response as they are also applicable to 

the process followed for the NOSB’s review of Sunset 2013 materials. The NOP requests that the 

NOSB consider these issues regarding annotation changes for materials in their future Sunset reviews. 

2. Choline and Inositol - § 205.605(b)

In an April 2010 memo to the NOSB, the NOP stated that its previous interpretation of the nutrient 

vitamins and minerals annotation at § 205.605(b) was incorrect. The memo described NOP’s 

consultation with the Food and Drug Administration (FDA) to review the existing annotation in the 

USDA organic regulations, which references FDA guidelines at 21 CFR 104.20. The FDA and NOP 

identified certain substances, including choline and inositol, which were allowed under the previous 

(incorrect) interpretation of 21 CFR 104.20. 

The NOSB Handling Committee reviewed petitions to add choline and inositol as separate listings on 

§ 205.605(b). The NOSB weighed information from the petitions and technical reports, in addition to 

public comments representing a wide spectrum of perspectives. The NOSB voted to list both of these 

nutrients on the National List with the following annotations:

Choline. Choline chloride (CAS # 67-48-1) and Choline bitartrate (CAS # 87-67-2) for use in infant 

formula and medical nutritional enteral products.

Inositol. CAS # 87-89-8 (myo-inositol) and 6917-35-7 (non-specific isomer) for use in infant 

formula and medical nutritional enteral products.

The NOP plans to move forward with proposed rules for public comment once the NOSB has 

completed review of all nutrient petitions currently under consideration. 

3. Citrus Hystrix and Curry Leaf - § 205.606

In response to petitions, the NOSB recommending adding two substances to § 205.606: citrus hystrix

(kaffir lime) and curry leaf. The NOP intends to initiate rulemaking for public comment to add these 

substances to the National List. If finalized, non-organic citrus hystrix or curry leaf could only be added 

to processed organic products if organic forms were not commercially available.

4. Material Review Organizations

In December 2011, the NOSB recommended that all material review organizations be accredited or 

formally recognized in a new material review scope. At the May 2012 meeting, the NOSB 
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recommended that the NOP develop guidance materials to material review organizations to promote 

consistency and uniformity in the short term. The recommendation outlined a range of criteria and 

processes that these groups should use when reviewing substances. 

The NOP recognizes the need for additional guidance in this important area. The NOP is currently 

developing guidance for the classification of materials and permitted substances for crop production. 

Based on recommendations by the NOSB, the classification of materials guidance will help material 

review organizations consistently determine if a given substance is synthetic or nonsynthetic, and 

agricultural or nonagricultural. The permitted substances list will help organic farmers and certifying 

agents determine which synthetic and nonsynthetic substances are allowed in organic crop production.

The NOP looks forward to receiving public comments on both of these important resources.

5. Letter to Secretary Vilsack

The NOSB voted to send a letter to the Secretary of Agriculture regarding their establishment of a GMO 

ad-hoc sub-committee. The letter outlined some of the issues this sub-committee intends to address. 

The NOP transmitted this letter to Secretary Vilsack on May 25, 2012. 

6. Organic Research Priorities

The NOSB recommended a set of criteria for identifying research needs and a process for the NOSB to 

develop and publish a yearly recommendation on emerging research needs. When the NOP receives

such a recommendation it will then, as it has before, formally request that USDA research agencies, 

such as the Agricultural Research Service and the National Institute of Food and Agriculture, respond 

to those recommendations with specific actions to pursue the identified priorities. 

7. GMO Vaccines

The NOSB requested additional information from the NOP before it makes additional recommendations

to address the status of GMO vaccines in organic livestock production. To address this important issue, 

the NOP has established a working group consisting of two NOP staff, two NOSB members, and a staff 

member from the Animal and Plant Health Inspection Service. The working group plans to present an 

update at the fall 2012 NOSB meeting.

8. Summary

The NOP recognizes and sincerely appreciates the number of hours each NOSB member volunteers 

each month during their five-year term. 
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This was also the first meeting for five members who joined the NOSB on January 24, 2012: 

Carmela Beck, Producer

Andrea (Zea) Sonnabend, Scientist

Tracy Favre, Environmentalist

Harold V. Austin, IV, Handler

Jean Richardson, Ph.D., Consumer / Public Interest

We look forward to continuing to facilitate all of your important work in a collaborative manner to protect 

organic integrity from farm to table.