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: Update of the Petition and Technical Review Process

August 27, 2013

Reviewed December 10, 2013 - No revisions

Introduction

The National Organic Program (NOP) has asked the NOSB for input on revising the procedures 

for petitions and technical review. These procedures are encompassed by a 2007 Federal 

Register notice, 72 FR 2167, and sections of the NOSB Policy and Procedures Manual (PPM) 

appearing on pages 34, 35, 37 and 38 of the current version.

This effort is aimed at making it clearer for petitioners to submit complete petitions and to know 

what to expect in the petition process, for the NOSB to have clear policies for reviewing petitions 

in a consistent way, and for the public to have transparency in how petitions are received, 

evaluated and reviewed.

Subjects covered in this proposal include petitioning to add or remove substances to the National 

List, how such petitions proceed once they are received, and how the NOSB determines which 

substances are on the National List. Also covered is the subject of adding, removing or changing 

and annotation placed on a listed substance.

Used throughout this proposal is the strikethrough for old language to be removed, and 

an underline for new language to be added.

Part 1. Procedures for Submitting National List Petitions

Any person may submit a petition requesting a substance to be reviewed by the NOP and NOSB 

at any time. Each substance to be evaluated for the National List must be submitted in a 

separate petition. Only single substances may be petitioned for evaluation; formulated products 

cannot appear on the National List. When submitting petitions, an official petition contact should 

be designated for all correspondence and the petition should provide specific contact information 

including name, address, phone number, fax number and e-mail address.

To facilitate timely NOP review and NOSB consideration of petitions, petitioners must provide 

concise yet comprehensive responses to the required petition information items described under 

the guideline heading ‘‘Information to be included in a Petition.’’ Upon receipt, the NOP will 

review the petition for completeness of the required petition information. If the required petition 

information is incomplete, the petition will be returned to the petitioner with a request for 

additional information.

Petitions for substance evaluations to add a substance onto, remove a substance from, or 

amend a substance presently on the National List involves a public and open 

process. Confidential Business Information (CBI) is no longer accepted in petitions. Petition 

information not categorized and accepted by USDA, pursuant to 7 CFR 1.27(d), as Confidential 

Business Information (CBI) will be considered available to the public for inspection. Published 

information usually cannot be claimed as confidential. When a petition is considered complete 

and forwarded for NOSB evaluation, except for CBI, the petition will be made available for public 

inspection. Substance petitions that are complete and under evaluation by the NOSB will be 

posted on the NOP Web site at: http://www.ams.usda.gov/nop. Public comments may be 
submitted to either the NOSB or the NOP for any petitioned substance being evaluated by the 

NOSB. Comments also will be posted on the NOP Web site.

Information To Be Included in a Petition 

The guidelines for required information to be included in a petition are as follows: 

Item A—Please indicate which section or sections the petitioned substance will be 

included on and/or removed from the National List. For petitions to change or add an 

annotation to an already listed substance, please indicate in which category of OFPA 

§6517 (c)(1)(B)(i) the substance is listed.

• Synthetic substances allowed for use in organic crop production, § 205.601. 

• Non-synthetic substances prohibited for use in organic crop production, § 205.602. 

• Synthetic substances allowed for use in organic livestock production, § 205.603. 

• Non-synthetic substances prohibited for use in organic livestock production, § 205.604. 

• Non-agricultural (non-organic) substances allowed in or on processed products labeled 

as ‘‘organic’’ or ‘‘made with organic (specified ingredients),’’ § 205.605. 

• Non-organic agricultural substances allowed in or on processed products labeled as 

‘‘organic,’’ § 205.606. 

Item B—Please provide concise and comprehensive responses in providing all of the following 

information items on the substance being petitioned (petitions to change annotations for an 

already listed substance need only complete #s 1, 2 (contact name), 3, 4, 12 (research backing 

up the change) & 13 (petition justification statement): 

1. The substance’s chemical and/or material common name. 

2. The petitioners name address and telephone number, the manufacturer’s or producer’s 

name, address and telephone number (if different) and other contact information of the 

manufacturer/producer of the substance listed in the petition. 

3. The intended or current use of the substance such as use as a pesticide, animal feed 

additive, processing aid, nonagricultural ingredient, sanitizer or disinfectant. If the substance is 

an agricultural ingredient, the petition must provide a list of the types of product(s) (e.g., cereals, 

salad dressings) for which the substance will be used and a description of the substance’s 

function in the product(s) (e.g., ingredient, flavoring agent, emulsifier, processing aid). 

4. A list of the crop, livestock or handling activities for which the substance will be used. If 

used for crops or livestock, the substance’s rate and method of application must be described. If 

used for handling (including processing), the substance’s mode of action must be described. 

5. The source of the substance and a detailed description of its manufacturing or processing 

procedures from the basic component(s) to the final product. Petitioners with concerns for 

confidential business information may follow the guidelines in the Instructions for Submitting CBI

listed in #13. 

6. For Handling substances provide information about the ancillary substances (such as, but 

not limited to, carriers, emulsifiers or stabilizers) that may be included with the petitioned 

substance, including function, type of substance, and source if known.

7. A summary of any available previous reviews by State or private certification programs or 

other organizations of the petitioned substance. If this information is not available, the petitioner 

should state so in the petition. 

8. Information regarding EPA, FDA, and State regulatory authority registrations, including 

registration numbers. The information provided must confirm that the intended use of the 

substance is permitted under EPA or FDA regulations, as applicable. If this information does not 

exist or is not applicable, the petitioner should state so in the petition. 

9. The Chemical Abstract Service (CAS) number or other product numbers of the substance 

and labels of products that contains the petitioned substance. If the substance does not have an 

assigned product number, the petitioner should state so in the petition. 

10. The substance’s physical properties and chemical mode of action including 
(a) Chemical interactions with other substances, especially substances used in organic 

production;

(b) toxicity and environmental persistence;

(c) environmental impacts from its use and/ or manufacture;

(d) effects on human health; and,

(e) effects on soil organisms, crops, or livestock. 

11. Safety information about the substance including a Material Safety Data Sheet (MSDS) 

and a substance report from the National Institute of Environmental Health Studies. If this 

information does not exist, the petitioner should state so in the petition. 

12. Research information about the substance which includes comprehensive substance 

research reviews and research bibliographies, including reviews and bibliographies which 

present contrasting positions to those presented by the petitioner in supporting the substance’s 

inclusion on or removal from the National List. For petitions to include substances onto the 

National List for organic handling, this information item should include research concerning why 

the substance should be permitted in the production or handling of an organic product, including 

the availability of organic alternatives. Commercial availability does not depend upon geographic 

location or local market conditions. If research information does not exist for the petitioned 

substance or for the contrasting position, the petitioner should state so in the petition. 

13. A ‘‘Petition Justification Statement’’ which provides justification for any of the following 

actions requested in the petition: 

A. Inclusion of a Synthetic on the National List, §§ 205.601, 205.603, 205.605(b) 

. • Explain why the synthetic substance is necessary for the production or handling of an 

organic product. 

. • Describe any non-synthetic substances, synthetic substances on the National List or 

alternative cultural methods1 that could be used in place of the petitioned synthetic substance. 

. • Describe the beneficial effects to the environment, human health, or farm ecosystem 

from use of the synthetic substance that support its use instead of the use of a non-synthetic 

substance or alternative cultural methods. 

B. Removal of a Synthetic From the National List, §§ 205.601, 205.603, 205.605(b) 

. • Explain why the synthetic substance is no longer necessary or appropriate for the 

production or handling of an organic product, making sure to cover all uses of the listed 

substance. 

. • Describe any non-synthetic substances, synthetic substances on the National List or 

alternative cultural methods that could be used in place of the petitioned synthetic substance, 

and their availability and applicability to all situations where the substance is used. 

C. Inclusion of a Prohibition of a Non-Synthetic, §§ 205.602 and 205.604 

. • Explain why the non-synthetic substance should not be permitted in the production of an 

organic product. 

. • Describe other non-synthetic substances or synthetic substances on the National List or 

alternative cultural methods that could be used in place of the petitioned substance. 

D. Removal of a Prohibited Non-Synthetic From the National List, §§ 205.602 and 

205.604 

. • Explain why the non-synthetic substance should be permitted in the production of an 

organic product. 

1 Cultural methods. Methods used to enhance crop health and prevent weed, pest, or disease problems 

without the use of substances; examples include the selection of appropriate varieties and planting sites; 

proper timing and density of plantings; irrigation; and extending a growing season by manipulating the 

microclimate with green houses, cold frames, or wind breaks.

 
. • Describe the beneficial effects to the environment, human health, or farm ecosystem 

from use of the non-synthetic substance that supports its use instead of the use of other 

non-synthetic or synthetic substances on the National List or alternative cultural methods. 

E. Inclusion of a Non-Synthetic, Non-Agricultural Substance Onto the National List, § 

205.605(a) 

. • Explain why the substance is necessary for use in organic handling. 

. • Describe non-synthetic or synthetic substances on the National List or alternative 

cultural methods that could be used in place of the petitioned synthetic substance. 

. • Describe any beneficial effects on the environment, or human health from the use of the 

substance that support its use instead of the use of non-synthetic or synthetic substances on the 

National List or alternative cultural methods. 

F. Removal of a Non-Synthetic, Non-Agricultural Substance From the National List, § 

205.605(a) 

. • Explain why the substance is no longer necessary for use in organic handling. 

. • Describe any non-synthetic or synthetic substances on the National List or alternative 

cultural methods that could be used in place of the petitioned substance, making sure to cover all 

uses. 

G. Inclusion of a Non-Organically Produced Agricultural Substance Onto the National 

List, § 205.606 

. • Provide a comparative description on why the non-organic form of the substance is 

necessary for use in organic handling. 

. • Provide current and historical industry information/research/evidence that explains how 

or why the substance cannot be obtained organically in the appropriate form, appropriate quality, 

and appropriate quantity to fulfill an essential function in a system of organic handling. 

• Describe industry information on substance non-availability of organic sources 

including but not limited to the following guidance regarding commercial availability evaluation 

criteria: (1) Regions of production, including factors such as climate and number of regions; (2) 

Number of suppliers and amount produced; (3) Current and historical supplies related to 

weather events such as hurricanes, floods, and droughts that may temporarily halt production or 

destroy crops or supplies; (4) Trade related issues such as evidence of hoarding, war, trade 

barriers, or civil unrest that may temporarily restrict supplies, and 

(5) Other issues which may present a challenge to a consistent supply. 

H. Removal of a Non-Organically Produced Agricultural Substance From the National 

List, § 205.606 

• Provide a comparative description as to why the non-organic form of the substance is 

not necessary for use in organic handling. 

• Provide current and historical industry information/research/evidence that explains how 

or why the substance can be obtained organically in the appropriate form, appropriate 

quality, and appropriate quantity to fulfill an essential function in a system of organic 

handling. 

• Provide new industry information on substance availability of organic sources including 

but not limited to the following guidance commercial availability evaluation criteria:

(1) Region of production, including factors such as climate and number of regions;

(2) Number of suppliers and amount produced;

(3) Current and historical supplies related to weather events such as hurricanes, floods, 

 or droughts that temporarily halt production or destroy crops or supplies;

(4) Trade related issues such as evidence of hoarding, war, trade barriers, and civil 

 unrest that may temporarily restrict supplies and;

(5) Any other issues which may present a challenge to a consistent supply.
 

I. Adding, amending, or removing an annotation for a listed substance in all sections 

• Provide evidence that the existing annotation is flawed, unnecessary, or outdated.

• Indicate why an annotation is needed or a change to existing one is needed.

• Explain what revision is needed to the annotation and why, with reference to the review 

 criteria. 

13. A Confidential Business Information Statement which describes the specific required 

information contained in the petition that is considered to be Confidential Business Information 

(CBI) or confidential commercial information and the basis for that determination. Petitioners 

should limit their submission of confidential information to that needed to address the areas for 

which this notice requests information. Final determination regarding whether to afford CBI 

treatment to submitted petitions will be made by USDA pursuant to 7 CFR 1.27(d). Instructions 

for submitting CBI to the National List Petition process are presented in the instructions below: 

.(a) Financial or commercial information the petitioner does not want disclosed for competitive 

reasons may be claimed as CBI. Applicants must submit a written justification to support each 

claim. 

.(b) ‘‘Trade secrets’’ (information relating to the production process, such as formulas, 

processes, quality control tests and data, and research methodology) may be claimed as CBI. 

This information must be (1) commercially valuable, (2) used in the applicant’s business, and (3) 

maintained in secrecy. 

.(c) Each page containing CBI material must have ‘‘CBI Copy’’ marked in the upper right corner 

of the page. In the right margin, mark the CBI information with a bracket and ‘‘CBI.’’ 

.(d) The CBI-deleted copy should be a facsimile of the CBI copy, except for spaces occurring in 

the text where CBI has been deleted. Be sure that the CBI-deleted copy is paginated the same 

as the CBI copy (The CBI-deleted copy of the application should be made from the same copy of 

the application which originally contained CBI). Additional material (transitions, paraphrasing, or 

generic substitutions, etc.) should not be included in the CBI-deleted copy. 

.(e) Each page with CBI-deletions should be marked ‘‘CBI-deleted’’ at the upper right corner of 

the page. In the right margin, mark the place where the CBI material has been deleted with a 

bracket and ‘‘CBI-deleted.’’ 

.(f) If several pages are CBI-deleted, a single page designating the numbers of deleted pages 

may be substituted for blank pages. (For example, ‘‘pages 7 through 10 have been 

CBI-deleted.’’) 

.(g) All published references that appear in the CBI copy should be included in the reference list 

of the CBI-deleted copy. Published information cannot be claimed as confidential. 

(h) Final determination regarding whether to afford CBI treatment to submitted petitions will be 

made by USDA pursuant to 7 CFR 1.27(d). If a determination is made to deny CBI treatment, the 

petitioner will be afforded an opportunity to withdraw the submission.

Part 2. NOSB Policy and Procedures Manual proposed revisions

PPM, pp. 34-35:

MATERIALS REVIEW PROCESS

This section presents the procedures followed by the NOSB to evaluate petitions. First, the NOP 

material review process is presented. Second, a review of the NOSB process for selecting and 

reviewing the work of technical advisory panels is provided followed by a description needed in a 

formal petition. Third, the process for NOSB material review is provided. This section concludes 

by providing a graphical description of the sunset review process.
Evaluation Procedures for Substances Petitioned for Addition or Removal from the 

National List.

The petition process is open to all, including members of the NOSB. The priority system for 

determining in which order petitions are reviewed will be applied to all petitions (Section VIII). 

These procedures also apply to petitions to add, remove, or change an annotation to an already 

listed substance.

Phase 1: Receipt of Petition and Examination of Petition for Completeness and Eligibility 

During this phase the NOP will: 

• Notify the petitioner via letter and/or electronic mail of receipt of the petition. Determine whether 

the petition is complete 

• Determine whether 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); the Food and Drug 

Administration (FDA); or other appropriate federal agency 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 acknowledge 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, Handling or other pertinent committees). This 

notification will be sent via letter and/or electronic mail and inform the chairs that the petition is 

complete and 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. 

 

P. 35

Phase 2: Determine whether a Third Party Technical Review is Required 

During this phase: 

• The NOSB materials committee, working with other applicable NOSB committee has 60 days to 

submit any questions to the NOP. The questions requested by the committee should include 

items that need specific background information, recommended technical expertise, and be 

based on the OFPA criteria. 

• Per the NOP materials review process, the NOSB should review the petition and using the NOP 

checklists for the material determine the following: 

1) Whether the material is deemed appropriate for consideration on the National List (pending 

criteria). If the answer is no to this question, an explanation is required. 

2) If the answer to question #1 is yes, the NOSB committee assigned for the review (as identified 

by the Materials Committee Chair) must decide whether

a) there is sufficient information in the petition, 

b) the committee can reasonably research any pending technical information, or 

c) there is the need to secure a technical review from a third party expert (see section 

titled Procedures for Handling Technical Reviews) 
3) If the answer to question #1 is no, the appropriate sub Materials Committee Chair will inform 

the NOP that the petition is incomplete and will include an explanation. If the reviewing 

committee concludes there is a need for a third party technical review, the Materials Committee 

Chair will proceed to make the request to the Program. 

• Notify the petitioner, via letter and/or electronic mail, that the petition is incomplete or ineligible; 

or (proceed to Phase 3: Evaluation by a Third Party Expert)

pp. 37-38

PROCEDURES FOR HANDLING TECHNICAL REVIEWS 

The NOSB’s role involves reviewing specific materials; however, a petition could involve a wide 

range of topics. Although members of the Board represent several areas of the organic 

community and hold advanced degrees in different scientific areas, they might lack the expertise, 

or time, required to address the data needs of a petition. In such cases the Board has the option 

of requesting the assistance of third party experts and expecting from these experts a written 

technical review or report. 

Third party experts can consist of the following: 

1. Employees of the USDA such as AMS Science & Technology, Agriculture Research Service, 

or other federal agencies with appropriate expertise, as needed.

2. Consultants or contractors. 

A subcommittee should follow these steps in deciding the need for third party expert: 

1. Define whether the subcommittee has the expertise needed to address the questions related 

to the petition, mainly: 

a. Impact on the environment 

b. Impact to human health 

c. Sustainability and compatibility with organic principles. 

2. If the subcommittee does not have the expertise or resources (e.g., time), the Subcommittee 

chair should make a request to the Chair of the Materials Committee for a third party expert 

specifying: 

a. The third party expert’s required background and level of expertise 

b. Existence of potential sources of conflict that could result in biased reviews. 

3. When requesting the assistance of a third party expert to evaluate a material, a subcommittee 

must identify the main technical issues needed to be addressed including, but not limited to: 

a. All uses of the petitioned material beyond what the petitioner has requested 

b. All uses of the petitioned material in combination with other material(s) that have been already 

approved on the same section of the National List 

c. Interactions of the petitioned material, not addressed by the petitioner, and that may involve 

materials currently on the same section of the National List. 

d. All possible manufacturing methods for a petitioned material. 

e. Potential effects on public health and biodiversity 

f. Environmental risks and hazards including, but not limited to potential for developing pesticide 

resistance, or long-term effects on sustainability 

g. Ancillary substances that may be used in conjunction with handling materials, such are 

carriers, stabilizers or emulsifiers.

4. If required, The Subcommittee should conduct a final review of the technical report and 

complete an assessment on the quality of work performed by the third party expert. 
These are basic principles that should be considered when dealing with a third party expert: 

1. A Subcommittee cannot proceed with a recommendation on a material if it is determined that 

there is insufficient limited valid scientific information on that material’s impact on the 

environment, human health and its compatibility with organic principles. 

2. The decision to request third party expert needs to be made independent of the availability of 

funds. If there is a lack of funding to secure third party expert advice, the review of the material 

should be placed on hold. 

3. Although the Board has the final word on the approval or rejection of a petition, the decision to 

request a third party expert is the responsibility of the subcommittee reviewing the material. 

4. The decision to define the expertise needed in the third party expert is the responsibility of 

the subcommittee reviewing the material or issue. 

5. To incorporate a diversity of opinions and to minimize the risk of bias, a subcommittee should 

aim to work with a range of technical experts (individuals, or institutions). 

Once the Technical Reports are submitted to the requesting subcommittee, that committee 

determines if the issues have been addressed sufficiently. If there are remaining questions, the 

subcommittee can go back for further clarification and expansion of the technical report. Once 

the information is deemed sufficient, the report is acceptable for public posting.

Subcommittee Vote

Motion to accept the proposal on Updating the petition and TR process as described above and 

voted on August 27

Motion by: Zea Sonnabend

Seconded by: Tracy Favre

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

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