FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: 5/8/2007 

Subject: Whey Protein Concentrate 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 Whey Protein Concentrate to the National List under 

§205.606 nonorganically produced agricultural products 

NOSB Vote: Motion: Julie Weisman Second: Steve DeMuri 

Board vote: Yes - 8 No - 3 Abstain - 0 Absent – 4 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 8, 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-org 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. Two petitions were received for whey protein concentrate materials. They 

were for whey protein concentrate 35% and 80%. Public comment was received to demonstrate 

that these two materials were produced through identical processes and differed only in the 

amount of protein from each other and other whey protein concentrates. The Handling 

Committee recommended, and the Board voted to approve, making a recommendation for Whey 

Protein Concentrate as a class of materials. 
The petitioner for Whey Protein Concentrate made the case that processors capable of 

manufacturing Whey Protein Concentrate are instead choosing to manufacture whey powder. 

Most whey is processed into either whey powder, which is used in dry cheese powders, or 

demineralized whey powder, which is used in organic infant formulas and organic protein bars. 

The processing yield for whey powder is higher than for Whey Protein Concentrate which is 

produced through a multiple step process. The process of producing Whey Protein Concentrate 

results in lactose which can be recovered and sold. Finally, the market for organic Whey Protein 

Concentrate is still relatively small resulting in proportionately small processing runs for organic 

Whey Protein Concentrate. The quantity of lactose recovered from processing of organic Whey 

Protein Concentrate is too small to make recovery economically feasible. This in combination 

with other losses associated with small processing runs and lower processing yield creates an 

economic disincentive for processors to produce Whey Protein Concentrate. 

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. A number of commenters cited Whey Protein Concentrate as an essential 

ingredient in the organic consumer products they make for this reason. There were no public 

comments specifically opposing the listing of Whey Protein Concentrate 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 Whey Protein Concentrate acknowledged that organic milk and 

whey is available organically but that currently no processor with the equipment or technology to 

process Whey Protein Concentrate is willing to use their equipment to fulfill current organic 

requirements. 

III. Board Recommendation 

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

Whey Protein Concentrate 

Moved: Julie Weisman Second: Steve DeMuri 

Board vote: Yes - 8 No - 3 Abstain – 0 Absent – 4 Recuse - 0