FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: 5/9/2007 

Subject: Fish Oil, stabilized using only allowed ingredients on the National List

for addition to National List §205.606 

 

Chair: Andrea Caroe 

 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: __XXX 

Guidance Statement: ________ 

Other: ________ 

Statement of the Recommendation (including Recount of Vote):

The Board recommends adding Fish Oil, stabilized using only allowed ingredients on the 

National List to the National List under §205.606 nonorganically produced agricultural products 

NOSB Vote: Motion: Julie Weisman Second: Steve DeMuri 

Board vote: Yes - 12 No - 0 Abstain - 1 Absent – 2 Recuse - 0 

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

The National List of Allowed and Prohibited Substances § 205.606 

Response by the NOP:
National Organic Standards Board 

Final Recommendation for 

Date: May 9, 2007 

(i) List: (where in FR rule example 205.606) 

National Organic Program Subpart G: The National List of Allowed and Prohibited 

Substances. §205.606 Nonorganically produced agricultural products allowed as 

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

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

(ii) Committee Summary: 

 

On June 9, 2005 a court final order and judgment arising from Harvey v. Johanns, stated that “the 

Secretary must issue a declaratory judgment that 7 CFR § 205.606 shall not be interpreted to 

create a blanket exemption to the National List requirements specified in 7. U.S.C. 6517.” These 

“requirements permit the use of nonorganic agricultural products in or on processed organic 

products when their organic form is not commercially available.” 

Further, “consistent with OFPA, 7 CFR §205.606 shall be interpreted to permit the use of a nonorganically produced agricultural product that has been listed in § 205.606 pursuant to National 

List procedures and when a certifying agent has determined that the organic form of the 

agricultural product is not commercially available.” 

Effort was made through many channels to elicit from manufacturers, petitions for any nonorganically produced agricultural materials that had been using on products labeled and sold as 

“organic.” 

In addition, pursuant to the judgment in Harvey v.Johanns, the NOSB was instructed to develop 

criteria for determining commercial availability, an essential tool in evaluating whether or not 

petitioned materials could be listed on § 205.606. These criteria were finalized in the NOSB 

“Recommendation for the Establishment of Commercial Availability Criteria National List § 

205.606” of October 19, 2006. That recommendation allows for pro-active listing on 205.606 of 

materials which may currently be available in an organic form, but the supply of which has a 

history of fragility due to factors such as limited growing regions, weather or trade-related issues. 

Furthermore, the recommendation reiterates the role of the Accredited Certifying Agent (ACA) in 

making the ultimate decision as to whether a 606-listed material may be used, on a case by case 

basis. 

Petitions received for non-organic agricultural materials contained widely varying amounts 

information with which to assess the current availability or fragility of current supply of organic 

forms of the petitioned material. 

The petitioner for Fish Oil made the case that the National Organic Program does not currently 

have production standards for aquaculture. The National Organic Standards Board approved 

recommended aquaculture standards at the March 2007 meeting, where this Fish Oil petition was 

also considered. Since aquaculture standards do not currently exist, organic fish cannot be 

commercially available as an input to process into fish oil. 
During discussion of this petition, the question of allowed stabilizers was raised. In the past, fish 

meal allowed in organic products contained ethoxyquin which is not compatible with organic 

handling. The petitioner uses tocopherols to stabilize their product. After discussion, the Board 

decided to add an annotation to the recommendation to list Fish Oil to the National List. The 

annotation is “stabilized using only allowed ingredients on the National List.” The Board felt that 

this annotation was not overly prescriptive since a nonorganic material that falls within the 

annotation exists on the market. 

The Handling Committee noted that agricultural substances are only required to be evaluated 

using the criteria specified in the Act (7 U.S.C. 6517 and 6518). 

6517(c)(1)(a) 

(i) would not be harmful to human health or the environment; 

(ii) is necessary to the production or handling of the agricultural product because of 

unavailability of wholly natural substitute products; and 

(iii) is consistent with organic farming and handling; 

Agricultural substances do not need to be evaluated against section 205.600 (b). (i.e. 

essentialness). This additional criteria is only required for any synthetic substance used as a 

processing aid or adjuvant. 

The Handling Committee also considered what constitutes “essential” for organic handling of a 

finished retail product and how that may be different from that of a material used in crop or 

livestock production. The petitioner cited Fish Oil, which contributes desirable nutrients, most 

notably Omega-3-Fatty acids, as an ingredient desired by consumers in the organic products they 

purchase. There were no public comments specifically opposing the listing of Fish Oil on § 

205.606. 

The Handling Committee carefully considered the difference between the availability of a raw 

agricultural product as organic, and the availability of certified organic handlers to process that 

raw material. The petitioner for Fish Oil, stabilized using only allowed ingredients on the National 

List, acknowledged that fish for inputs to process into fish oil cannot be cultivated organically due 

to the lack of organic production standards for fish. 

(iv) Board Recommendation 

The Handling Committee recommends the listing of the following substance in this use Category: 

Fish Oil, stabilized using only allowed ingredients on the National List 

Moved: Julie Weisman Second: Steve DeMuri 

Board vote: Yes – 12 No – 0 Abstain – 1 Absent – 2 Recuse - 0