FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: __March 18, 2005_______

Subject: __Board Policy Manual change to update Materials Review Process___ 

Chair: ___Jim Riddle_______________________________________ 

 (sign)

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: ________ 

Guidance Statement: ________ 

Other: ____X____ 

Statement of the Recommendation (including Recount of Vote):

Updated Materials Review Procedures to be added to NOSB Policies and Procedures Manual 

NOSB Vote March 2, 2005: 13 yes, 0 no, 0 abstain, 1 absent 

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

Material review procedures in policy and procedures manual did not reflect current practices.

Response by the NOP:

Updated 2/25/05 

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NOSB Materials Committee 

Recommendation to add Board Policy Manual to Update the Materials 

Review Process 

Adopted by NOSB on March 2, 2005 

 Evaluation Procedures for Substances Petitioned for Addition or Removal from 

the National List 

Phase 1: Receipt of Petition 

During this phase the National Organic Program (NOP) will: 

• Notify the petitioner via letter and/or electronic mail of receipt of the 

petition. 

Phase 2: Examination of Petition for Completeness and Eligibility 

During this phase the NOP will: 

• Determine whether the petition is complete 

• Determine if the petitioned substance is eligible for petition under the 

Organic Foods Production Act and its implementing regulations; 

document this review using the NOP-OFPA checklist. 

• Determine whether the petitioned use is approved under the statutory 

and regulatory authority of the Environmental Protection Agency 

(EPA) or the Food and Drug Administration (FDA) if applicable; 

• Identify and secure any confidential business information (CBI) 

designated by the petitioner; 

• Notify, as applicable, the petitioner via letter and/or electronic mail of

determination of completeness and eligibility, and acknowledging the 

designation of certain information as CBI. 

• Upon determination of completeness and eligibility, the following 

actions will be taken: 

o Publish the petition on NOP website; and 

o Notify the National Organic Standards Board (NOSB) 

materials committee chairperson and the chairperson of the 

committee that the substance is being petitioned for 

addition or prohibition from the National list (Crops, 

Livestock or Handling). This notification will sent via letter 

and/or electronic mail and inform the chairs that the 

petition is complete, provide OFPA review and EPA/FDA 

determination checklist, and request identification of any 

questions the appropriate committee wishes to be 

specifically addressed in the contractor’s report. The NOSB 

materials committee, working with other applicable NOSB 

committees, has 21 working days to submit any questions 

to the NOP. The questions requested by the committee 

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should include items that need specific background 

information provided and be based on the OFPS criteria. 

o Notify the contractor of the determination of completeness 

and eligibility via letter and/or electronic mail. This letter 

will constitute official notice to the contractor to perform an 

evaluation of the petitioned substance. 

• Notify, as applicable, the petitioner via letter and/or electronic mail of

determining the petition to be incomplete or ineligible. 

Phase 3: Evaluation by Contractor

During this phase, the contractor will: 

• Conduct activities necessary to provide responses to evaluation 

questions contained in the Statement of Work and any additional 

questions identified by the NOSB as described above; 

• Using the evaluation report template, prepare and distribute to the 

NOP a draft evaluation report in electronic format. 

Phase 4: Sufficiency Determination 

During this phase, the NOP will: 

• Submit a copy of the draft evaluation report to the NOSB materials 

committee and the committee that the substance is being petitioned 

for addition or prohibition from the National list (Crops, Livestock or 

Handling)for its review; 

• Review the draft evaluation report against the following performance 

criteria. The report will be acceptable when it: 

o Is consistent in format, level of detail and tone; 

o Is technically objective and free from opinions or 

conjecture; 

o Is written in a style appropriate for non-technical readers 

(e.g. free of technical jargon); 

o Is prepared using a well-defined and consistent procedure 

consisting of information gathering, information synthesis 

and document preparation, and quality assurance; 

o Is based on the best available information that can be 

obtained within the designated time frame; 

o Is thoroughly supported using literature citations; and, 

o Addresses all evaluation questions as set out in the SOW. 

During this phase, the NOSB materials committee and the committee 

that the substance is being petitioned for addition or prohibition from the 

National list (Crops, Livestock or Handling) will: 

• Review the draft evaluation report against the following performance 

criteria. The report will be acceptable when it: 

o Is consistent in format, level of detail and tone; 

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o Is technically objective and free from opinions or 

conjecture; 

o Is written in a style appropriate for non-technical readers 

(e.g. free of technical jargon); 

o Is prepared using a well-defined and consistent procedure 

consisting of information gathering, information synthesis 

and document preparation, and quality assurance; 

o Is based on the best available information that can be 

obtained within the designated time frame; 

o Is thoroughly supported using literature citations; and, 

o Addresses all evaluation questions as set out in the SOW. 

• Notify the NOP in letter and/or electronic mail the acceptance of the 

report within 21 days of receiving the draft report. If the report is not 

accepted by the NOSB materials and the committee that the 

substance is being petitioned for addition or prohibition from the 

National list (Crops, Livestock or Handling ), the committees must 

provide to the NOP in letter and/or electronic mail the specific areas

of the report that were concluded to be insufficient, the rationale for 

drawing such a conclusion and the improvements to be made so that 

the document can be determined sufficient. 

• Upon concurrence by the NOP that the report is insufficient, the NOP

will notify the contractor by letter and/or electronic mail of the areas 

of the report that are insufficient, the rationale for drawing such a 

conclusion and the improvements to be made so that the document 

can be determined sufficient. The time frame required for the 

completion of the changes will be determined through mutual 

agreement between the contractor and the NOP. 

Phase 5: Action by NOSB Materials Chairperson and the committee that 

the substance is being petitioned for addition or prohibition from the National 

list (Crops, Livestock or Handling 

During this phase the NOSB materials chairperson and the committee 

that the substance is being petitioned for addition or prohibition from the 

National list (Crops, Livestock or Handling will: 

• Convene at a mutually convenient time to review, discuss and 

recommend an action on the petitioned substance. The committee 

may convene a Technical Advisory Panel by electronic mail or 

conference call to provide scientific evaluation of the petitioned 

substance, as provided by OFPA 6518(k)(3). The NOSB materials 

committee or delegated committee must convene and recommend an 

action on the petitioned substance no later than 30 days before a 

scheduled meeting of the full NOSB. 

During this phase the NOP will: 

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Publish the recommendation of the NOSB materials committee the committee 

that the substance is being petitioned for addition or prohibition from the 

National list (Crops, Livestock or Handling 

• on the NOP website and request public comment on the 

recommendation. 

Phase 6: Action by full NOSB 

During this phase the NOP will: 

• Set as an agenda item for the next meeting of the NOSB time 

sufficient to discuss and make a recommendation by the full NOSB 

on the petitioned substance. 

Board vote – 

13 yes, 0 no, 1 absent

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