Formal Recommendation 

 From: National Organic Standards Board (NOSB)

 To: the National Organic Program (NOP)

Date: 

Subject: 

Chair: 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action:

Guidance Statement:

Other:

Statement of Recommendation:;DŽƚŝŽŶηϭͿ

 

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

 

Committee Vote:

 

Moved: 

Seconded: 

Yes: No: Abstain: Absent: Recuse: 

 

 

 Page 1 revised 04/13 ma
National Organic Standards Board

Materials Subcommittee

Proposal: Confidential Business Information in Petitions

July 23, 2013

Reviewed February 25, 2014 - No revisions

Introduction

In preparation for the Spring 2013 NOSB meeting, the Materials Subcommittee submitted for 

Board review and public input a discussion document “Confidential Business Information in 

Petitions”. That document discussed the procedures currently being used to address 

Confidential Business Information (CBI) as it relates to petitions for materials for inclusion on the 

National List, and the challenges associated with evaluation of petitioned materials without full 

and complete information, some of which could be classified as CBI. The document put forth 

two possible recommendations for modification of the current CBI policy, along with the request 

for feedback from the public. 

Possible Recommendation 1:

CBI is not allowed in petitions. Petitioners must provide complete information about 

manufacturing processes and ingredients so that the NOSB and the public can fully evaluate 

each petitioned material. A modified version of this choice would be to not allow CBI for 

manufacturing processes or ingredients but to allow back up research and references to be 

submitted as CBI to assist the TR development.

Possible Recommendation 2:

CBI be allowed in petitions with the following stakeholder responsibilities:

For the National Organic Program

A. The NOP will allow only information meeting the strict definition of CBI to be deleted 

from petitions considered by the board and posted for public viewing. 

B. The NOP must make it clear to petitioners what happens to the CBI submitted and who 

does and does not have access to it, preferably by revising the Petition Guidelines. It 

should be very clear to petitioners that the NOSB does not see the confidential 

information.

C. The Technical Review contractor will have access to the CBI upon request. The 

contractor may then evaluate the CBI and conduct additional research to verify similar 

information.

D. The TR contractor will indicate that they looked at CBI in the course of their review.

For Petitioners

E. Petitioners are highly urged to provide complete information in their petitions, and keep 

CBI to the absolute minimum.

F. Petitions Guideline B.13 requires a statement of reasons for the CBI. This statement 

needs to be clearly stated, and is part of the public petition that will be seen by the 

NOSB.
G. Petitions will not be considered unless the rules in the Petitions Guidelines for CBI are 

followed completely.

H. Petitioners need to be aware that petitions containing CBI are rarely approved by the 

NOSB and the board reserves the right to reject such a petition that does not give 

complete manufacturing information. The NOSB may also send back a petition as 

incomplete if there is simply not enough information to make a decision.

For the National Organic Standards Board

I. The Policy and Procedures Manual will be updated to reflect any changes to CBI 

procedures based on this recommendation and the NOP revising the petition guidelines.

J. Petitions that come in with CBI will be looked at in the usual way by the subcommittees 

and any that have withheld too much information to allow the Board to make an informed 

decision may be returned to the petitioner. Others will move forward for a Technical 

Review.

K. If a petition is rejected because of CBI, the petitioner may re-petition and disclose the 

CBI. However, the NOSB will treat this at the lower level of priority with other repetitioned substances.

Summary of Public Comments

Not surprisingly, there were differences of opinion regarding the need for allowances for CBI. 

Generally, public comments expressed the need for sufficient information for the NOSB to make 

determinations regarding the classification of materials – synthetic/non-synthetic and or 

agricultural/non-agricultural, and to determine the impact on human health and the environment. 

The majority of commenters expressed the opinion that a full list of ingredients should be 

disclosed. However, some commenters expressed the need for complete transparency 

regarding the full list of ingredients and manufacturing processes in the petitioned material. 

Others had concerns about protection of manufacturing processes and/or recipes of petitioned 

materials, and the potential for impact to participation in the National Organic Program, should 

CBI not be protected. The proposal for an affidavit process was generally either rejected 

outright or the opinion was expressed that the affidavit process would need more detail before it 

could be determined whether or not it would be effective. 

Feedback pointed out the administrative difficulty in maintaining confidentiality of CBI provided 

to the NOSB and not the public and further stated that the transparency of the petition process 

and the relationship of the NOSB to the public could be adversely affected if such a procedure 

was implemented. 

In order for the NOSB to discharge its responsibility for the proper evaluation of a petitioned 

material, the following information should be provided:

1. A complete list of ingredients included in the petitioned material. The exact recipes or 

formulations are not required; only sufficient information so that the NOSB can evaluate 

the impact on human health and the agro-ecosystem;

2. Sufficient information regarding the manufacturing process to allow for determining the 

classification of that material as either synthetic or non-synthetic and/or agricultural/nonagricultural and sufficient information regarding the manufacturing process to allow for 

an assessment of adverse health and environment effects that may be associated with 
the product's production. Detailed, proprietary information regarding the manufacturing 

process is not required, except as it relates to the statement above.

Petitioners are encouraged to review the Classification of Materials Draft Guidance (NOP 5033), 

the Synthetic/Non-Synthetic Decision Tree (NOP 5033-1), and the Agricultural/Non-Agricultural 

Decision Tree (NOP 5033-2) for draft guidance on what minimum information is necessary for 

determination of Classification of Petitioned Materials.

Conclusion and Recommendation

The NOSB recognizes the investment and risk associated with development of proprietary 

materials and processes. The board’s intention is not to place petitioners at economic risk 

through information provided as part of a petition process. However, the importance of 

transparency of the petition process, the right of the public to fully know the materials included in

or on certified organic products, and the potential for an untenable administrative burden of 

management of CBI precludes the provision of CBI in materials petitions. 

For this reason, the Materials Subcommittee is recommending a revision to the Material Petition 

process to eliminate the provision for Confidential Business Information. 

Subcommittee Vote

The Materials Subcommittee moves to accept this recommendation and present it for full Board 

discussion at the fall 2013 NOSB meeting.

Motion by: Tracy Favre

Seconded by: Jay Feldman

Yes: 7 No: 0 Absent: 0 Abstain: 0 Recuse: 0

Approved by Zea Sonnabend, Subcommittee Chair, to transmit to NOSB August 27, 2013