National Organic Standards Board

Materials Committee

Discussion Document

Significant Residues Definition in Classification of Materials Policy

March 27, 2012

This discussion paper addresses a key issue left unresolved in the Materials 

Classification Policy adopted by the Board. The Addendum to November 6, 2009 

Recommendation on Classification of Materials states that, “It is our intent through this 

recommendation that a material would be classified as synthetic when: . . . The material 

contains, at a significant level, a synthetic substance not on the National List of allowed 

synthetics.” However, the Board did not clarify this guidance by defining “significant” in 

this context.

The dictionary defines “significant” as “important” or “of consequence.” However, the 

question that remains is what level of a synthetic impurity found in a material under 

review is determined to be “of consequence” under the Organic Foods Production Act 

(OFPA). This discussion paper asks how the NOSB should apply the framework of 

OFPA to the definition of “significant.” Three different approaches are presented, and 

input is sought on the broad approach as well as details. 

Materials Classification Policy

At the November 2009 National Organic Standards Board (NOSB) meeting, the NOSB 

passed a recommendation on Classification of Materials. The recommendation included 

several “Next Steps” that the NOSB felt are required in order to implement the 

recommendation. In passing the recommendation, the NOSB indicated that further work 

is required of the Board to develop a Guidance Document that the various stakeholders 

(e.g., Accredited Certifying Agents, committees of the NOSB, National Organic Program 

personnel) could use when classifying materials. 

At the April 2010 NOSB meeting, the Joint Materials and Handling Committee 

presented a draft Guidance Document for public input. It was clear from that public input 

that the guidance document needed more work. A key topic left unresolved was the 

question, “What is a significant amount/level of a synthetic input to the process 

remaining in the final material?” Prior to the April 2011 meeting, the Materials 

Committee evaluated two different approaches in the context of work on a classification 

of materials worksheet. They are discussed, along with a third approach, in “Issues and 

Discussion” section below.

OFPA and the Rule

The underlying statutory standard in the Organic Foods Production Act with regard to 

synthetic agents and their allowance is found in Sec. 2118 [7 U.S.C. 6517] National List, 

(c) Guidelines for Prohibitions on Exemptions.– (1) Exemption from Prohibited 

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Substances in Organic Production and Handling Operations.– The National List may 

provide for the use of substances in an organic farming or handling operation that are 

otherwise prohibited under this title only if– (A) the Secretary determines, in consultation 

with the Secretary of Health and Human Services and the Administrator of the 

Environmental Protection Agency, that the use of such substances– (i) would not be 

harmful to human health or the environment...” The list criteria provide the mechanism 

for evaluating harm for all substances by weighing information from the other agencies 

along with the unique organic considerations.

This statutory intent is captured in the “Evaluation Criteria for Substances Added to the 

National List” with the questions, “Is there any harmful effect on human health? [§6517 

(c)(1)(A)(i); 6517(c)(2)(A)(i); §6518(m)(4)]” and, “Is the substance harmful to the 

environment and biodiversity? [§6517c(1)(A)(i);6517(c)(2)(A)i]” The scope of the 

possible harm that OFPA requires the NOSB to examine is identified in the question, “Is 

there environmental contamination during manufacture, use, misuse, or disposal? 

[§6518(m)(3)]”

Issues and Discussion

In the context of OFPA and materials classification, a level of a synthetic impurity is 

“significant” when it is “of consequence” to materials classification and review. A major 

issue in defining “significant” is the degree to which harm must be identified before 

deciding the residue is significant. We also understand that decisions about significant 

residues are made not only by the Board, but also by materials review organizations 

(MROs) and certifiers, and that a definition of “significant synthetic residue” must allow 

MROs and certifiers to act on the information available to them. Two of the three 

approaches outlined below were discussed in the April 2011 Materials Committee 

Recommendation.

The first approach is the one proposed by the Materials Committee in the April 2011 

recommendation, which failed to pass the Board by the required 2/3 margin. This 

approach says that an insignificant level of a synthetic substance in the final material 

means a level below any applicable regulatory limits for the type of substance and 

without any technical and functional effects in the final material. Proponents of this 

approach believe this approach is more consistent with past NOSB practices, is 

consistent with the recommendation of the Materials Working Group and reflects the 

bulk of the public comment received on this topic. Additionally, the majority of the 

Materials Committee was concerned with using an approach of “any known level” 

knowing that technology allows the detection of ever-decreasing amounts of material. 

So a material that today has no known level of synthetic input in it may very well 

tomorrow have a detectable level. The majority of the committee felt that using the “any 

known level” approach would be disruptive to the industry as it differs from past practice 

and would lead to an on-going reevaluation of materials on a perpetual basis as 

detection levels change. As this approach was discussed, it was acknowledged that a 

given material may not have any applicable regulatory limits or may have several. In the 

case where no regulatory limit is available, technical and functional effects of any 

remaining synthetic would need to be evaluated. In the case where multiple regulatory 

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limits exist, the reviewer would evaluate which best applies for the classification. For 

example, for a synthetic solvent used to extract a natural sourced material there may be

an OSHA inhalation limit and EPA residue limit. Since the synthetic is present in a 

material to be used in crops, the EPA limit is most appropriate.

The second approach was supported by a minority of the Materials Committee in April 

2011. It would characterize any known or detectable level of a synthetic substance in 

the final material or in the environment, as a result of the substance’s manufacture, use, 

and disposal as a significant level triggering NOSB review. Proponents of this approach 

point to the statutory standard in OFPA §6517(c)(1) with regard to synthetic agents and 

their allowance. Proponents believe this standard of review requires a determination as 

to whether there is harm associated with the use of the synthetic substance, analogous 

to the standard of review used in the process of allowing synthetic substances on the 

National List. The minority felt that citing regulatory standards set under different 

statutory criteria does not meet the OFPA intent or standards, but, like all other 

regulatory standards, we must be prepared to adjust regulatory action to advances in 

good laboratory practices as they improve. Finally, proponents believe that the quantity 

of synthetic residue is not the sole determinant of “harm” in the end product. The 

minimal residue that causes harm may not be known, and harm may be more 

dependent on other factors, like timing of exposure, than dose. Furthermore, OFPA 

requires consideration of the material’s residual harm from manufacture to disposal, 

including its use in organic agriculture or processing.

A third approach acknowledges that MROs and certifiers have to make frequent 

evaluations of a variety of residues that occur in both food processing and crop inputs 

that do not always come to the attention of the NOSB because they are not petitioned or 

may change frequently. Therefore, the NOSB would need to offer guidelines to screen 

these potential synthetic residues rather than review each one. What would emerge 

would be a screen for all synthetic residues by evaluating them against a list of known 

harmful chemicals created by governmental and international organizations to 

determine whether they are significant. This process might be applied in field situations 

by Material Review Organization (MROs) and certifiers when a full NOSB review is not 

practical. Slightly different screens for crop inputs and food ingredients may be used

because there are different sources of information on them and they are handled 

differently in the regulation. The first two steps in the screening process would be, 

"What chemical is it?" "Is it measurable?" Then, it would be compared to lists of known

harmful materials. If the chemical is found on one of the lists of known harmful 

materials, then the residues would be considered significant and this would trigger a full 

NOSB review. In this scenario the guidelines would appear in the NOP Program 

Handbook or in guidelines for MROs and the individual impurity chemicals would not 

have to appear on the National List.

Comments Requested

The Committee requests comments on the following questions:

1. Under what circumstances, should the presence of a synthetic impurity trigger an 

examination of the impacts of the synthetic in relation to OFPA criteria?

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2. Do any of the three approaches described make sense? If so, why?

3. Is it reasonable to tie the definition of “significance” in materials classification to 

the need for review under OFPA? If not, is there another way to ensure that the 

presence of a synthetic impurity in levels of consequence under OFPA trigger a 

review? And how would “significance” be defined in the context of materials 

classification if not in relation to the need for review under OFPA?

4. The need for defining a significant residue arises from the Classification of 

Materials Policy adopted earlier that says that the use of a synthetic extractant or 

reactant does not affect the classification of a material, thereby allowing the use 

of synthetic extractants, reactants, or processing aids that may end up as 

impurities in the material. Should that policy be changed instead?

5. When residues of a certain synthetic impurity are identified as significant, how 

should the review proceed (a) if the material containing the impurity is under 

review by a MRO prior to use, (b) if the significant residues are discovered by a 

MRO/ACA when the material is in use, (c) if the material is under review by the 

NOSB?

Committee Vote:

The Materials Committee moves to accept this document and present it for full Board 

discussion at the spring 2012 NOSB meeting:

Moved: Jay Feldman _ Second: __Jennifer Taylor__ 

Yes: __5__ No: __0__ Abstain: __0__ Absent: __1__ 

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