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Materials Update and

Process Overview

Lisa M. Brines, Ph.D.

National Organic Standards Board Meeting

April 29, 2014

San Antonio, Texas
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Outstanding Petitions - Crops

• This meeting:

– Laminarin

– Magnesium oxide

– Streptomycin

– Vinasse

Petitions are posted on the NOP website
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Outstanding Petitions - Crops

• Under Subcommittee review:

– Exhaust gas (carbon monoxide)*

– Allyl isothiocyanate*

– Aluminum sulfate

– Propylene carbonate (inert)

* Technical report in development

Petitions are posted on the NOP website
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Outstanding Petitions - Livestock

• This meeting:

– Methionine

– Acidified sodium chlorite

– Aquaculture petitions
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Aquaculture petitions – this meeting

– Chlorine

– Tocopherols

– Minerals

– Vitamins

– Biologics: Vaccines

– Micronutrients (plants)

– Carbon dioxide (plants)

– Chlorine (plants)

– Lignin sulfonate (plants)

– Vitamins B1, B12, H 

(plants)
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Outstanding Petitions - Livestock

• Under Subcommittee review:

– Aluminum sulfate

• Withdrawn:

– Lignin sulfonate (aquatic animals)

Petitions are posted on the NOP website
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Outstanding Petitions - Handling

• This meeting:

– Ammonium hydroxide

– Glycerin

– Polyalkylene Glycol Monobutyl Ether (PGME)
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Outstanding Petitions - Handling

• Under Subcommittee review:

– Gibberellic acid

– Triethyl citrate

– Whole algal flour

Petitions are posted on the NOP website
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Sunset 2015 Materials - Crops

• Three sunset substances

– Aqueous potassium silicate (2 listings)

– Sodium carbonate peroxyhydrate

– Sulfurous acid

• Updated technical reports available for all three 

substances
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Sunset 2015 Materials - Handling

• Four sunset substances:

– Gellan gum

– Marsala wine

– Sherry wine

– Tragacanth gum

• No new technical reports
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Petition Process Overview

• Petition Submission

• NOP Review

• Subcommittee Review

• Technical Report

• Subcommittee Proposal

• Public Comment

• NOSB recommendation
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Petition Process

The Organic Foods Production Act:

Sec. 2119. [7 U.S.C. 6518] National Organic 

Standards Board.

(n) Petitions.—The Board shall establish procedures 

under which persons may petition the Board for the 

purpose of evaluating substances for inclusion on 

the National List.
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Petition Process

USDA Organic Regulations, 7 CFR Part 205

§205.607 Amending the National List.

(a) Any person may petition the National Organic Standards Board for 

the purpose of having a substance evaluated by the Board for 

recommendation to the Secretary for inclusion on or deletion 

from the National List in accordance with the Act. 

(b) A person petitioning for amendment of the National List should 

request a copy of the petition procedures from the USDA at the 

address in §205.607(c). 
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Petition Guidelines

• Most recent version of petition guidelines were published 

in the Federal Register on January 18, 2007 [72 FR 2167]

• Guidelines explain what information must be included in a 

petition

• No specific template or form is required

• No fee or cost to petition

• Petitions may contain confidential business information 

(CBI). CBI is not available to NOSB or public.
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NOP’s Process

• NOP confirms receipt of petition

• NOP reviews incoming petition for eligibility 

and sufficiency (generally within 30 days of 

submission)

• NOP is the primary point of contact for any 

correspondence between NOSB and petitioner
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• Ensures that petitions are eligible and 

complete when they are distributed to the 

Subcommittee

• Checklists are completed by NOP staff to 

verify that petitions meet the eligibility 

criteria and petition guidelines

NOP’s Review
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NOP’s Review

• Acceptance of a petition by NOP for NOSB 

review is an administrative matter and does 

not reflect a decision by NOP on the 

substantive merits of the petition.
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NOSB Subcommittee Process

Petitions are posted on the NOP website at the time they are 

sent to the NOSB for review

Initial Subcommittee review should be completed within 60 days 

of receipt of petition

At this stage, the Subcommittee may request:

a) Additional information from petitioner

b) Technical report
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Updated Petitions

• Petition updates include

– Responses to Subcommittee requests

– Updated (unsolicited) information after petition 

has been sent to NOSB

• Updates are posted alongside petition on NOP 

website
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Technical report content

• Technical reports are completed by third-party 

contractors

• Technical report evaluation questions align with OFPA 

criteria. Content does not include:

– Proprietary information

– Economic impact information

• NOP accepts quality, accuracy and completeness of 

technical reports
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Technical reports, cont.

• NOP reviews all TRs before they are distributed to the 

Subcommittee to ensure they meet the requirements of 

the contract

• NOP ensures that TRs are sufficient and complete when 

they are distributed to the Subcommittee 

• Date listed on technical report reflects the date the report 

was submitted to NOP
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Technical reports, cont.

• Occasionally, NOP will request that a subject 

matter expert from the Agricultural Research 

Service review a draft copy of the report. When 

this occurs, it will be noted when NOP 

distributes the report to the Subcommittee
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Evaluation Criteria for Materials

• Criteria are provided for in the Organic Foods 

Production Act of 1990 (OFPA)

• Technical report questions and NOSB checklists 

align with OFPA criteria

• Different criteria for production uses vs. handling

• Additional criteria for synthetic processing aids and 

adjuvants at § 205.600(b)
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NOSB Process - Checklists

• The NOSB checklists are a tool to facilitate and 

document evaluation of the petitioned 

substance against the OFPA criteria

• OFPA does not require checklists, but requires 

that Board shall consider seven different 

criteria
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NOSB Review Checklists:

• Checklists document NOSB’s review against 

various OFPA criteria

• In general, narrative responses address uses 

that are within the scope of the petition 

(although there may be exceptions, such as 

effects from misuse)
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Substantive Changes to Proposals

• Subcommittee may make changes to proposals 

based on written or in-person public comment

• If there are substantive changes to a proposal 

based on public comment, the proposal should be 

taken back to Subcommittee for revision

• This allows for another public comment 

opportunity on the revised proposal
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Voting Procedures

• For petitioned substances, NOSB votes on two 

motions:

– 1st motion: Classification (if not previously classified)

• Synthetic / Nonsynthetic

• Agricultural / Nonagricultural

– 2nd motion: To list/remove/amend

• 2/3 majority needed for decisive vote (10 votes / 15 

members)
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NOSB 

Recommendation

Petition

Technical 

Report

Subcommittee

Proposal

Public 

Comment

OFPA 

Criteria
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Update

NOSB-NOP-EPA Working Group

on Inert Ingredients

National Organic Standards Board Meeting

April 28, 2014

San Antonio, Texas
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Working Group on Inert Ingredients

• NOSB: Jay Feldman, Zea Sonnabend

• NOP: Emily Brown Rosen, Lisa M. Brines 

• EPA: Chris Pfeifer (BPPD), Kerry Leifer

(Registration Division, Inerts)
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Background

• The Organic Foods Production Act of 1990 indicates 

that the National List may provide for the use of 

inerts in pesticides that are not classified by EPA as 

“inerts of toxicological concern”

• NOP definition of “inert ingredient” follows from 

FIFRA definitions (i.e., not necessarily 

chemically/biologically “inert”)
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NOP Rule - National List

• List 4 – Inerts of Minimal Concern

– Synthetic inert ingredients classified as List 4A 

and 4B by EPA are allowed in pesticides for 

organic use (§ 205.601(m) and §205.603(e))

• List 3 inerts are allowed in passive pheromone 

dispensers only (§205.601(m)(2))

• Both are subject to sunset review, List 4 must be 

renewed or changed by October, 2017
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Issue

• EPA put inerts into lists according to toxicology and use 

pattern

• EPA revised system of assessment in 2006 and no 

longer uses or maintains Lists 1-4

• NOP is operating with obsolete list of inerts, last 

updated August 2004

• Manufacturers are petitioning for use of inerts that do 

not appear on the old lists
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Timeline of actions 

• April 2010 initial NOSB recommendation 

– Proposed to work with EPA for review of inerts

– Various options for review and listing

• Oct 2010 - NOSB renewed List 4 inerts due to 

sunset in 2012

• Dec 2010, IWG established
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Timeline of actions 

• October 2012, NOSB recommendation

– proposed policy to review all known inerts by groups, with 

individual inclusion on National List

• Oct 2012 - May 2013

– IWG developed lists of known inerts, grouping for review

– IWG developed plan for public notification and comment
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Timeline of actions 

• May 2013-April 2014

– NOP met with EPA staff, Design for the Environment

• A voluntary label program for safer chemical products

• Publishes a Safer Chemical Ingredient List

• Detailed criteria also published

http://www.epa.gov/dfe

– IWG reviewed aspects of the program, developed questions

– DfE responded

• compared list of known inerts in organic to those reviewed by DfE
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Current status

• NOP is consulting with OGC

– Options for collaboration with EPA

• IWG continues to meet and plan

• If DfE option is viable, next steps will be 

further consultation with NOSB

– Public notification and comment
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Questions?