FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: _August 17, 2005________

Subject: __Re-structure National List to follow OFPA categories________ 

Chair: ____Jim Riddle______________________________________ 

 (sign) 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: ____X____ 

Guidance Statement: ________ 

Other: ________ 

Statement of the Recommendation (including Recount of Vote):

The NOSB recommends that the NOP revise the National List (s) Sections 205.601 and 

205.603 to be consistent with the OFPA categories in 7 USC 6517 (c)(1)(B)(i). The 

NOSB recommends the adoption of the production aid category to include substances 

such as carriers, stabilizers, adjuvants, fillers, extractants, excipients and solvents that do 

have an active function in the formulations of farm production aids such as fertilizers, 

soil amendments, compost inoculants, sanitizers, aquatic plant extracts, and fish 

emulsions. The production aid category should also include active substances used in 

pest control (disease, weed, insects and nematodes) that do not fit into other OFPA 

categories. 

 

Board vote – August 16, 2005

13 yes, 0 no, 1 absent 

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

Rationale provided in text of recommendation below. 

Response by the NOP:
NOSB Materials Committee 

Proposal to Revise the Organizational Structure of the 

National List to fit OFPA Categories

Adopted by the National Organic Standards Board 

August 16, 2005 

Introduction: 

7 USC 6517 of OFPA outlines the procedures that shall be followed for the development 

and implementation of the National List. It provides the guidelines for inclusion of 

substances on the list, procedures and criteria that must be followed when amending the 

list and outlines the authority of the Secretary and the NOSB. The NOP has requested 

the NOSB Materials Committee to review the substances currently on the list within the 

context of 7 USC 6517. The specific issue to be addressed is that Sec. 2118 National List 

(c) Guidelines for Prohibitions or Exemptions places limits on the types of substances 

that can be included on the list. The committee: 

 1) Reviewed the current list to analyze if all substances currently on the list fall within 

the OFPA categories in 7 USC 6517 (c)(1)(B)(i) 

2) Proposed clarification for the category production aids 

3) Proposed a new model for the restructuring of the National List 

Background: 

The National List of approved synthetic substances is a compilation of substances that 

would otherwise be prohibited in organic production. The OFPA (7USC 6517 (c) (1) 

(B)) states the substance 

(i) is used in production and contains an active synthetic ingredient in the 

following categories: copper and sulfur compounds; toxins derived from 

bacteria; pheromones, soaps, horticultural oil, fish emulsions, treated seed, 

vitamins and minerals; livestock parasiticides and medicines, and production 

aids including netting, tree wraps and seals, insect traps, sticky barriers, row 

covers and equipment cleaners; 

(ii) is used in production and contains synthetic inert ingredients that are not 

classified by the Administrator of the Environmental Protection Agency as 

inerts of toxicological concern; and 

(iii) is used in handling and is non-synthetic but is not organically produced. 

 The production categories that are defined for active synthetic ingredients were 

intentionally included in OFPA to limit the scope of the National List and the use of 

synthetic substances in organic production systems. Many of the material decisions and 

procedures were established by the early members of the NOSB through consultation 

with the NOP, the organic industry, private and State certification organizations and 

through public input. The first proposed National List decisions were made primarily 

during the NOSB meetings between 1994 and 1996. 

The NOP is currently interpreting the National List and its existing annotations 

when certifiers need clarification on materials described in a farm plan and when 
petitioners submit substances for review for inclusion on the National List. In 2004, the 

NOP made two materials interpretations (Phosporic acid to stabilize aquatic plant extracts 

and Potassium Lactate and Sodium Lactate for meat processing) for which the NOSB 

requested a formal clarification in an effort to understand the manner in which the NOP 

interprets the National List. Members of the NOSB have argued that the combination of 

generic substances on the list that result another synthetic reaction would require an 

additional review of the new substance (i.e. Sodium Lactate). Such a substance is 

prohibited unless it was added to the National List. To suggest otherwise goes against the 

intent of the OFPA and established industry norms. 

Based on conversations with the NOP staff, their current position is that once an 

active substance is listed (active being defined by categories in OFPA) then all additives 

to the active are allowed unless restricted in the annotation that may accompany a 

substance. This is inconsistent with both the philosophy of what annotations were used 

for when they accompanied a substance on the List and with the historical view of what 

needed to be petitioned to the List1,2

 . The annotations that accompanied many of the 

substances on the List were utilized to narrow the use of the substance within the organic 

systems (i.e. hydrated lime, lignin sulfonate, lidocaine). For substances extracted from 

plants, animals or mineral sources they were added to distinguish the synthetic forms 

from the non-synthetic forms 3

. They were not used to place restrictions on formulations 

 

1

Orlando 4/95 (starting line 980): Prior to returning to the discussion of materials, Baker reported to the Board that the impromptu 

task force had agreed on the following principles:

1. Non-synthetic and allowed synthetic materials may not be combined in formulations with prohibited materials. 

2. Carriers, diluents, fillers, emulsifiers, preservatives, excipients, stabilizers, surfactants, wetting agents and other ingredients 

of formulated products must be consistent with the inerts policy. 

3. The use of all materials approved for production must be consistent with their corresponding annotations under the NOP 

Farm Plan guidelines and with the individual Farm Plan. 

4. Procedures to address brand name products will be established at a later time. 

The Board agreed in principle without taking a vote. 

2 Santa Fe (6/94 starting line 425) states, “A paper prepared by Zea relating to the natural/synthetic dichotomy discussed was taken 

up next by the Board. Theuer explained his ideas regarding a progressive approach (from synthetic to natural to organic) for 

substances used for extraction. After agreeing with Zea that solvents would be included on the National List, Friedman moved and 

Stoneback seconded that “Synthetic substances may be used to extract a substance from a natural source provided that: 1) the chemical 

structure of the final extracted substance is not changed by the extraction; 2) none of the synthetic substances used to extract remain in 

the final extracted product; and 3) the substance used to extract the product is approved on the National List “. VOTE: Yes-11, 

Opposed -0, Absent-2. Motion Passed. 

3 Orlando 4/95 (starting at line 787): Hydrolyzed Aquatic Plant Extracts- Reviewed by Donald Blackeney, Bruce Spencer and 

James Johnson. Determined to be non-synthetic; Vote: 13 aye/0 opposed, 1 abstention. By the nature of the National List no further 

action was necessary on this material. An informative discussion ensued before the vote on hydrolyzed aquatic plant extracts. Baker 

noted that stability is a problem in some solutions, especially plant and fish extracts, and that otherwise non-synthetic formations 

contain preservatives and/or stabilizers to allow marketability. Sligh and Merrigan stated that the NOSB should just vote on active 

ingredients at this time and postpone review of inerts and confidential information. Sonnabend introduced the question of whether the 

solvent used in extraction should affect the determination of whether the active ingredient is classified as synthetic or non-synthetic, 

noting that the solvents used for plant extraction may be water potassium hydroxide. Sonnabend also asked whether inerts and 

stabilizers should affect the synthetic/non-synthetic status. Baker noted that the NOSB has not yet decided that extraction with a 

substance such as potassium hydroxide or ammonia hydroxide makes the end substance synthetic. 

Austin 9/95 (starting line 605): Aquatic Plant Extracts (other than hydrolyzed) (NOSB defined hydrolysis in relation to this 

substance as a reaction of a substance with water in “NOSB Final Recommendation Addendum 25 Definitions and 

Interpretations, Austin, 1995”)- Reviewed by Donald Blakeney, Bruce Spencer. Determined to be synthetic; Vote 11 aye/2 absent. 

The NOSB’s decision to allow this material for use in organic production; Vote 10 aye/1 abstension/2 absent. Annotation: Extraction 

Process is limited to the use of potassium hydroxide; solvent amount used is limited to that amount necessary for extraction. 
of the substance when used in a brand name product or other commercial formulations 

(trademarks). In the preamble to the second proposed rule 4

,

5

 the NOP concurred with 

members within the organic industry 6

in their recognition that the National list would 

include all in agricultural inputs and formulated products and detailed how the primary 

role of the NOSB would be the review of substances and the development of the National 

List. 

 One category specified in OFPA 6517(c)(B)(i) stipulates that the substance “is 

used in production and contains an active synthetic ingredient as a production aid 

including netting, tree wraps and seals, insect traps, sticky barriers, row covers and 

equipment cleaners. The production aid category is the appropriate section to include 

substances such as carriers, stabilizers, adjuvants, fillers, extractants, excipients and 

solvents that do have an active function in the formulations of farm production aids such 

as fertilizers, soil amendments, compost inoculants, sanitizers, aquatic plant extracts, and 

fish emulsions. Some of these substances are used in the formulations of brand name 

products while others may be used after a substance is extracted to put it in a form that is 

functional for on-farm utilization. These substances are intentionally used for a specific 

purpose and therefore are ‘active’ for the purposes of the regulation. The production aid 

 

4

The Preamble to the second proposed rule, March 13 2000 Page 80612 states, “synthetic ingredients in any formulated products 

used as organic production inputs, including pesticides, fertilizers, animal drugs, and feeds, must be included on the National List. As 

sanctioned by OFPA, synthetic substances can be used in organic production and handling as long as they appear on the National List. 

The organic industry should clearly understand that NOSB evaluation of the wide variety of inert ingredients and other nonactive 

substances will require considerable coordination between the NOP, the NOSB, and industry.” 

5 The preamble to Second Proposed Rule, March 13, 2000 Pages 13589-90: states, “We recognize that inert ingredients in 

pesticides and similar substances in other formulated products pose one of the most problematic examples of the use of synthetic 

materials in organic production. For example, verifying the use of inerts and similar substances such as fillers, carriers, additives, and 

excipients has been difficult because they are not required to appear on ingredient labels, and formulators typically treat product 

formulas as confidential information. At times, certifying agents have been unable to determine the exact composition of formulated 

products proposed for use in organic production. In other instances, organic producers have applied formulated products containing 

inert ingredients and similar substances that are not specifically allowed. We are challenged with balancing standard practice with the 

strict statutory requirement that producers and handlers apply only those synthetic substances added to the National List. As 

sanctioned by OFPA, synthetic substances can be used in organic production as long as they appear on the National List. The 

development and maintenance of the National List has been and will be designed to allow the use of a minimal number of 

synthetic substances that are acceptable to the organic industry and meet the OFPA criteria.” 

6 Organic Materials Review Institutes comments on the proposed and final rule to the NOSB: 

The Organic Materials Review Institute commented about the Rule and specifically in regard to substances which include carriers and 

fillers in organic fertilizers and microbial productions. In their document they state “In general, OMRI supports the proposed rule’s 

requirement for all synthetics to appear on the National List. For the previous rule, OMRI commented that it opposed the extension of 

the inert ingredients policy to formulated products other than EPA registered pesticides. OMRI raised concerns based on actual

experience with the use of synthetic nutrients to fortify products and the inclusion of sewage sludge and industrial hazardous waste as 

a filler in fertilizer. However, there is a need for a number of synthetic non-active ingredients used as carriers and adjuvants in nonpesticide formulations, particularly fertilizers and foliar applied microbial products. The final rule needs to take into account foodgrade preservatives used to stabilize aquatic plant and fish products, in addition to the synthetic acids and bases included in the 

proposed National List. Most fermentation media to produce compost and soil inoculants are composed primarily of non-synthetic

media or synthetic substances on the National List. However, such media may also contain small amounts of nutrients. Small traces 

of such substances are likely to be present in the final media of some products currently used by organic farmers. These can be safely 

assumed to have no significant value as synthetic fertilizers. OMRI standards do not allow the use of synthetic biocides to stabilize 

microbial products that are not on the National List. Various production aids and adjuvants are used to apply soil microbial 

inoculants. These generic categories appear as synthetics on the National List and therefore it is appropriate for those products to be 

stabilized though not fortified, with a limited choice of synthetics. Ideally, these will all appear on the National List. As with inert 

ingredients in pesticides it will take a period of adjustment for the organic industry. OMRI recommends that the NOSB develop a 

parallel policy to that for pesticide formulations. OMRI suggests another category to be added to the regulatory text to provide a place 

of listing these items, when recommended by NOSB”. 
category should include active substances used in pest control (disease, weed, insects and 

nematodes) that do not fit into the OFPA categories described above (i.e. copper, sulfur, 

toxins derived from bacteria, horticultural oils, parasiticides, medicines, soaps, and mined 

minerals). This would allow for the placement of disease disinfectants such as hydrogen 

peroxide and peracetic acid to fall into an OFPA category. Clearly it was the intent of 

OFPA to include other pest control options in this category because of the specific listing 

of sticky barriers, tree wraps and seals, insect traps, row covers and netting which can all 

be used for pest control. 

 The following appendices provide an analysis of the current National List in relation 

to the OFPA categories. Sections 205.601 (Synthetic substances allowed for use in 

organic crop production) and 205.603 (Synthetic substances allowed for use in organic 

livestock production) are not consistent with the OFPA categories. The categories that 

are included in these sections are related to use restrictions for the substances. For 

example, 205.601 (i) disease control, lists the synthetic substances that may be used for 

disease. To be more consistent with OFPA, the category should read Copper and Sulfur 

compounds and list annotated uses (i.e. for disease control) followed by the substances 

that contain copper and/or sulfur. This would eliminate most of the categories on the 

current list such as rodenticides, herbicides and compost feed stocks. Appendices 1 and 2 

provides a revised view of Section 205.601 and 205.603 using an ordering system that 

utilizes the OFPA categories as the first order in the hierarchy. It also demonstrates in 

the production aid category how substances such as stabilizers, fillers, adjuvants and 

disinfectants used for pest control could be included (see category f, Appendix 1). 

Committee Recommendation: 

The NOSB recommends that the NOP revise the National List (s) Sections 205.601 and 

205.603 to be consistent with the OFPA categories in 7 USC 6517 (c)(1)(B)(i). The 

NOSB recommends the adoption of the production aid category to include substances 

such as carriers, stabilizers, adjuvants, fillers, extractants, excipients and solvents that do 

have an active function in the formulations of farm production aids such as fertilizers, 

soil amendments, compost inoculants, sanitizers, aquatic plant extracts, and fish 

emulsions. The production aid category should also include active substances used in 

pest control (disease, weed, insects and nematodes) that do not fit into other OFPA 

categories. 

Committee Vote: 

5 favor 

0 against 

0 abstain

NOSB Vote: 

13 yes, 0 no, 1 absent 
Appendix 1: Viewing Section 205.601 Synthetic substances allowed for use in organic 

crop production using the OFPA Categories (Substances on list up to October 21, 2002) 

 (a) OFPA Category: Soaps

As herbicides, weed barriers, as applicable.

(1) Herbicides, soap-based - for use in farmstead maintenance (roadways, ditches, right of ways, 

building perimeters) and ornamental crops. 

As animal repellents 

 (1)Soaps, ammonium - for use as a large animal repellant only, no contact with soil or edible 

portion of crop. 

(2) Soaps, insecticidal. 

(b) OFPA Category: Pheromones 

 As insect control 

(c) OFPA Category: Copper and sulfur compounds 

As insecticides. 

(1) Copper Sulfate - for use as tadpole shrimp control in aquatic rice production, is limited to one 

application per field during any 24-month period. Application rates are limited to levels which do 

not increase baseline soil test values for copper over a timeframe agreed upon by the producer 

and accredited certifying agent. 

(2) Elemental sulfur. 

(3) Lime sulfur - including calcium polysulfide. 

 As rodenticides. 

(1) Sulfur dioxide - underground rodent control only (smoke bombs). 

As plant disease control. 

(1) Coppers, fixed - copper hydroxide, copper oxide, copper oxychloride, includes products 

exempted from EPA tolerance, Provided, That, copper-based materials must be used in a 

manner that minimizes accumulation in the soil and shall not be used as herbicides. 
(2) Copper sulfate - Substance must be used in a manner that minimizes accumulation of copper 

in the soil. 

(3) Lime sulfur 

(4) Elemental sulfur 

As an algicide 

1) Copper sulfate--for use as an algicide in aquatic rice systems, is limited to one application per 

field during any 24-month period. Application rates are limited to those which do not increase 

baseline soil test values for copper over a timeframe agreed upon by the producer and accredited 

certifying agent. 

(d) OFPA Category: Toxins derived from bacteria, 

As a method of fire blight control 

(1) Streptomycin, fo apples and pears only. 

(2) Tetracycline (oxytetracycline calcium complex) 

(e) OFPA Category: Horticultural oils: 

As insecticides 

(1) Oils, horticultural - narrow range oils as dormant, suffocating, and summer oils 

As plant disease control 

(1) Oils, horticultural, narrow range oils as dormant, suffocating, and summer oils. 

(f) OFPA Category: Production aids 

As Equipment Cleaners- algicides, disinfectants, and sanitizers, including irrigation system 

cleaning systems. 

(1) Alcohols. 

(i) Ethanol. 

(ii) Isopropanol. 

(2) Chlorine materials - Except, That, residual chlorine levels in the water shall not exceed the 

maximum residual disinfectant limit under the Safe Drinking Water Act. 

(i) Calcium hypochlorite. 

(ii) Chlorine dioxide. 

(iii) Sodium hypochlorite. 
(4) Hydrogen peroxide. 

(5) Ozone gas--for use as an irrigation system cleaner only. 

(6) Peracetic acid--for use in disinfecting equipment, seed, and asexually propagated planting 

material. 

(7) Soap-based algicide/demossers. 

As weed barriers 

(1) Mulches. 

(i) Newspaper or other recycled paper, without glossy or colored inks. 

(ii) Plastic mulch and covers (petroleum-based other than polyvinyl chloride (PVC)). 

 As compost feedstocks.

(1)Newspapers or other recycled paper, without glossy or colored inks. 

As insecticides 

(1)Sticky traps/barriers 

(i) Ammonium carbonate - for use as bait in insect traps only, no direct contact with crop or soil. 

As floating agents in postharvest handling.

(1) Lignin sulfonate. 

(2) Sodium silicate - for tree fruit and fiber processing. 

As plant growth regulators. 

(1) Ethylene gas - for regulation of pineapple flowering. 

As Disinfectants for Disease Control 

(1) Hydrogen peroxide 

(2) Peracetic acid - for use to control fire blight bacteria. 

As fillers in fertilizers 

As stabilizers in aquatic plant extracts 

(1) Liquid fish products- can be pH adjusted with sulfuric, citric or phosphoric acid. The amount of 

acid used shall not exceed the minimum needed to lower the pH to 3.5. 
As adjuvants in fertilizers 

(g) OFPA Category: Fish emulsion 

 As plant or soil amendments 

1) Aquatic plant extracts (other than hydrolyzed) - Extraction process is limited to the use of 

potassium hydroxide or sodium hydroxide; solvent amount used is limited to that amount 

necessary for extraction. 

(2) Liquid fish products - can be pH adjusted with sulfuric, citric or phosphoric acid. The amount 

of acid used shall not exceed the minimum needed to lower the pH to 3.5. 

(h) OFPA Category: Vitamins and Minerals 

As plant or soil amendments 

(1) Elemental sulfur. 

(2) Humic acids - naturally occurring deposits, water and alkali extracts only. 

(3) Lignin sulfonate - chelating agent, dust suppressant, floatation agent. 

(4) Magnesium sulfate - allowed with a documented soil deficiency. 

(5) Micronutrients - not to be used as a defoliant, herbicide, or desiccant. Those made from 

nitrates or chlorides are not allowed. Soil deficiency must be documented by testing. 

(6) Soluble boron products. 

(7) Sulfates, carbonates, oxides, or silicates of zinc, copper, iron, manganese, molybdenum, 

selenium, and cobalt. 

(8) Vitamins, B1, C, and E. 

As Rodenticides 

(1) Vitamin D3. 

As Fungicides 

(1)Potassium bicarbonate 

(2) Hydrated lime. 

As Insecticides 

(1) Boric acid - structural pest control, no direct contact with organic food or crops. 

(i) OFPA Category: Treated Seeds 
(j) OFPA Category: As synthetic inert ingredients as classified by the Environmental 

Protection Agency (EPA), for use with nonsynthetic substances or synthetic substances 

listed in this section and used as an active pesticide ingredient in accordance with any 

limitations on the use of such substances. 

(1) EPA List 4 - Inerts of Minimal Concern. 

(2) EPA List 3 - Inerts of unknown toxicity 

(a) for use only in passive pheromone dispensers. 
Appendix 2: Viewing Section 205.603 Synthetic substances allowed for use in organic 

livestock production using the OFPA Categories (Substances on list up to October 21, 

2002) 

(a) OFPA Category: Production aids 

As Equipment Cleaners

(1) Alcohols. 

(i) Ethanol-disinfectant and sanitizer only, prohibited as a feed additive. 

(ii) Isopropanol 

(2) Chlorine materials – disinfecting and sanitizing facilities and equipment. Residual chlorine 

levels in the water shall not exceed the maximum residual disinfectant limit under the Safe 

Drinking Water Act. 

(i) Calcium hypochlorite. 

(ii) Chlorine dioxide. 

(iii)Sodium hypochlorite. 

(3) Phosphoric acid- allowed as an equipment cleaner. Provided , That no direct contact with 

organically managed livestock or land occurs. 

(b) OFPA Category: Livestock parasiticides and medicines 

(1) Chlorohexidine –Allowed for surgical procedures conducted by a veterinarian. Allowed for use 

as a teat tip when alternative germicidal agents and/or physical barriers have lost their 

effectiveness. 

(2) Electrolytes-without antibiotics 

(3) Glucose 

(4) Glycerine- Allowed as a livestock teat dip, must be produced through the hydrolysis of fats or 

oils. 

(5) Iodine 

(6) Hydrogen peroxide 

(7) Magnesium sulfate 

(8) Oxytocin- use in postparturition therapeutic applications 
(9) Parasiticides- Ivermectin- prohibited in slaughter stock, allowed in emergency treatment for 

dairy and breeder stock when organic system plan approved preventive management does not 

prevent infestation. Milk or milk products from a treated animal cannot be labeled as provided for 

in subpart D of this part for 90 days following treatment. In breeder stock, treatment cannot occur 

during the last third of gestation if the progeny will be sold as organic and must not be used 

during the lactation period of breeding stock. 

(10) Biologics-Vaccines 

(11) Lidocaine- as a local anesthetic. Use requires a withdrawal period of 90 days after 

administering to livestock intended for slaughter and 7 days after administering to dairy animals. 

 (12) mineral oil- for topical use and as a lubricant 

(13) Procaine- as a local anesthetic use requires a withdrawal period of 90 days after 

administering to livestock intended for slaughter and 7 days after administering to dairy animals. 

(14) Aspirin- approved for health care use to reduce inflammation 

(15) Isopropanol-disinfectant only 

 (c) OFPA Category: Copper and sulfur compounds 

As topical treatment, external parasiticide or local anesthetic as applicable 

(1) lime, hydrated-(bordeaux mixes) not permitted to cauterize physical alterations or deodorize 

animal wastes. 

(2) copper sulfate 

As a feed additive 

(1) DL Methionine, DL-Methionine-hydroxy analog, and DL-Methionine-hydroxy analog calciumfor use only in organic poultry production until October 21, 2005. 

(d) OFPA Category Vitamins and Minerals 

As feed additives 

(a) Trace minerals, used for enrichment or fortification when FDA approved including 

(1) copper sulfate 

(2) magnesium sulfate 

(e) OFPA Category: Soaps

(f) OFPA Category: Pheromones

(g) OFPA Category: Toxins derived from bacteria
(h) OFPA Category: Horticultural oils 

(i) OFPA Category: Fish emulsion 

(j) OFPA Category: Treated Seed

(k) OFPA Category: As synthetic inert ingredients as classified by the Environmental 

Protection Agency (EPA), for use with nonsynthetic substances or synthetic substances 

listed in this section and used as an active pesticide ingredient in accordance with any 

limitations on the use of such substances. 

(1) EPA List 4 - Inerts of Minimal Concern.