National Organic Standards Board

Policy Development Committee

Sunset Review Process – Policy Proposal

August 28, 2010

Introduction

This document discusses the Policy Development Committee’s proposed policy on Sunset 

Review, regarding the need for clarification and adjustment to the process of review by the 

NOSB. The proposed policy will be presented at the Fall 2010 Board meeting for a vote.

Background

The current process for Sunset Review is guided by statutory language in the Organic Foods 

Production Act, Sec. 2118(e),

1 the NOSB Policy and Procedures Manual (PPM),2 and several

Federal Register3

The Federal Register notices reinforce the notion that the sunset process is a complete review 

that assesses those materials on the list in accordance with the standards of Section 2118. As 

a result, the notices seek public input in three categories: “Category 1. Adverse impacts on 

humans or the environment?; Category 2. Is the substance essential for organic production?, 

and; Category 3. Is the substance compatible with organic production practices?”

notices that describe the process. 

While the statute does not define the process for validating an exemption or prohibition, it 

requires the NOSB to review “as provided in” Section 2118 of the act. In the strict sense of the 

law, this language would seem to require that the National List to be reevaluated to ensure that 

the list is in conformance with the standards as spelled out in Section 2118; “that the use of 

such substances – (i) would not be harmful to human health or the environment; (ii) is 

necessary to the production or handling of the agricultural product because of the unavailability 

of wholly natural substitute products; and, (iii) is consistent with organic farming and handling.” 

This reasoning would extend to the other provisions of this section as it applies to prohibitions 

and exemptions reviewed in the sunset process.

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1 §2118 [7 U.S.C. 6517] NATIONAL LIST. (e) SUNSET PROVISION.-No exemption or 

prohibition contained in the National List shall be valid unless the National Organic Standards 

Board has reviewed such exemption or prohibition as provided in this section within 5 years of 

such exemption or prohibition being adopted or reviewed and the Secretary has renewed such 

exemption or prohibition.

2 NOSB: Policy and Procedures Manual (Revised May, 2006), pp.56-59.

3 70FR35177 (2005), 72FR73668 (2008).

4 See Evaluation Criteria for Substances Added to the National List, 72FR73670 

(Dec. 28, 2007)
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The document entitled “Sunset and the National List of Allowed and Prohibited Substances” 

(NOSB Materials Committee Draft) includes in its section on background the following: “We 

consider the Congressionally-mandated sunset of exemptions and prohibitions contained in 

the National List to be a similar review and renewal process – that of the conditions that 

justified the exemption or prohibition in the first instance.”

The NOP has previously taken the position that the Board has narrow authority under the 

sunset process. As such, the PPM establishes limitations on the sunset process not found in 

the other documents. The PPM clearly states the following:

Sunset is a regulatory process for determining the continued listing of a material already 

approved or prohibited on the National List for use in organic agriculture production and 

handling. It is not used to petition to add a new substance nor is it used to change an 

existing annotation. If the review and renewal process is not concluded by the expiration 

date, the use of the material will become prohibited. 

Since sunset is defined as the reviewing of regulations to ensure the continued relevance 

and not the creation of new regulation, all substance [sic] must be renewed as listed. If 

there is a need to consider changing an annotation or moving a material from one list to 

another, this may be accomplished through the existing procedures for petition.

In a February 16, 2010 document entitled “Sunset Review Under the National Organic 

Program (NOP),” the program has provided an interpretation of OFPA that enables broader 

Board authority to modify and amend annotations, and a shifting of the burden of proof to 

the public to retain exempted materials. With respect to burden of proof, NOP states that, 

“During the sunset review process, the NOSB may: . . .3) Recommend the removal of an 

exempted material from the National List due to a lack of public comment substantiating the 

importance of a continued listing.” NOP cites that public comments should demonstrate 

that the renewal of removal of a substance on the National List meets the standards of 

Section 2118, OFPA. In addition, most importantly, NOP concurs with those who have 

interpreted a broad authority for the Board under the sunset process. NOP says,

There is nothing in OFPA to prohibit the NOSB from making a recommendation to modify 

or amend an annotation during the sunset review process. However the NOSB Policy 

Manual states in the sunset review procedures that amending or creating new annotations 

is not part of the sunset review process. The NOSB would need to amend their sunset 

review policy in order to recommend amending annotations during the sunset review 

process. No annotation can be changed without going through the rulemaking process.

There is general agreement that the sunset review process must be informed a the outset by 

input from the public.

The proposed sunset policy seeks to clarify the authority and procedures of the NOSB in the 

sunset review of materials to include (i) a thorough review of the previous and updated 

scientific assessments and essentiality determination, and (ii) modifications or amendments to

annotations, to the extent necessary to meet the statutory standards. 
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Relevant Areas in NOSB Policy and Procedures Manual and OFPA

Sunset Review Process (pp56-59, PPM), 7 U.S.C. 6517, NATIONAL LIST. (e) Sunset 

Provision. §2118 [7 U.S.C. 6517] NATIONAL LIST. (e) SUNSET PROVISION.-No exemption 

or prohibition contained in the National List shall be valid unless the National Organic 

Standards Board has reviewed such exemption or prohibition as provided in this section within 

5 years of such exemption or prohibition being adopted or reviewed and the Secretary has 

renewed such exemption or prohibition.

Discussion

There is agreement that the sunset process should not be disruptive to the organic market. In 

this context, there are two key factors that drive the analysis under the sunset review process,

the burden of materials review and the limitations on material use. First, should those in the 

organic market (users) be required to justify (or defend) current materials on the list (burden of 

proof)? Second, to what extent can the limitations on the use of the listed materials be 

changed to reflect current information (revised annotations)?

The statute embraces the idea that if the system of organic farming and handling is based on 

risk or hazard avoidance, then it should avoid reliance on synthetic inputs to the greatest 

extent possible. It is in this spirit that the law mandates a periodic sunset review that 

consistently updates the analysis that supports the listing. So, the review should not allow the 

use of a material just because it meets a prescribed health and environmental standard, as is 

the case with environmental or health laws. Rather, OFPA requires an assessment of 

essentiality. As a result, the evaluation criteria ask, “Is there another practice that would make 

the substance unnecessary,” and other questions of compatibility. This process should be 

constantly asking how or if the reliance on listed materials can be reduced. Those requiring the 

use of the inputs on the list should supply the NOSB with a specific justification for why 

continued use of the listed material is essential. At the same time, to the extent that the 

previous Board decisions do not have a complete record of review, clarity is needed on an

appropriate process to fill the documented gaps in knowledge.

Once a material is defended or data is received that questions the listing, the process should 

allow for the amending of annotations. Since the statute subjects the sunset process to the 

same review standards as the original National List process, it follows that the same tools for 

restricting the use of those materials should be available to the Board. In an attempt to best 

protect against disruption in the organic market, annotations rather than complete prohibitions 

are called for in the face of available data.

In its Federal Register notices on sunset, the NOP stated at the outset, “Because these 

substances may be critical to the production and handling of a wide array of raw and 

processed organic agricultural products, their expiration could cause disruption of wellestablished and accepted organic production, handling, and processing systems.” The sunset 

process is the statutory mandate to periodically question what is established and accepted and 

reaffirm or alter previous decisions as needed.
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The sunset process to be optimally effective requires close collaboration with and resources of 

the NOP. Ultimately, the effectiveness of this process reflects on the credibility, integrity, and 

growth of the organic market. Organic agriculture represents a dramatic difference from 

conventionally produced food, both because of the organic systems plan and the strict 

limitation on allowable synthetic materials. The Committee notes that the statute holds that 

synthetics should not be easy to get on the National List, nor should they be easy to keep on 

the National List. To be truly responsive and to truly fulfill the mission of protecting consumers

and ultimately farmers, the NOSB should be able to regulate the use of a material with 

annotations during the sunset process.

The recommendation addresses three areas of attention that are central to a comprehensive 

sunset review.

1. Thorough and comprehensive review.

Sunset review must be a rigorous and comprehensive review process that is supported 

by a technical review document and public input that reevaluates and updates previous 

findings to ensure that a decision to renew or restrict a currently listed material is fully 

informed and in compliance with the statutory standards. 

2. Listed materials subject to sunset review.

Allowed materials under §205.601 and §205.603, §205.605, and §205.606 are 

sunsetted or removed from the National List unless the Board takes affirmative action to 

retain their uses. Similarly, prohibited uses under sections §205.602 and §205.604 will 

sunset unless the the Board takes action to relist.

3. Annotations.

The ability to add or change annotations (restrictions) on applicable National List 

materials may be important to the Board’s sunset decision, given changes in the use 

patterns of allowed materials and scientific understanding. Sunset decisions by the 

Board are arrived at through a two-step consecutive process that separates the decision 

on annotations from the final sunset decision. Under this process, first the assigned 

committee and then the Board reviews the technical review document(s) and public 

input to determine whether the material continues to comply with the statutory 

standards. If the committee identifies the need for a use restriction or clarification, it may 

propose the annotation in the form of an amendment to a motion to renew. The 

committee and subsequently the Board will first take up the annotation amendment and 

then vote on the material’s renewal. The public will have an opportunity to comment on 

the proposed final sunset decision. An annotation to expand the use of a substance 

cannot be done through the sunset review process.

Recommendation

The Policy Development Committee recommends that the section entitled “SUNSET REVIEW 

PROCESS” (NOSB Policy and Procedures Manual, pages 56-57) be amended as follows (text 

in italics indicates proposed new language, and text in parenthesis indicates language to be 

deleted).
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SUNSET REVIEW PROCESS 

Background 

Sunset is a regulatory process for determining the continued listing of a material already 

approved or prohibited on the National List for use in organic agriculture production and 

handling. It is not used to petition to add a new substance (nor is it used to change an 

existing annotation) or new uses of a listed substance. If the review and renewal process is 

not concluded by the expiration date, the use of the material will become prohibited. (Since 

sunset is defined as the reviewing of regulations to ensure the continued relevance and not 

the creation of new regulation, all substance must be renewed as listed. If there is a need 

to consider changing an annotation or moving a material from one list to another, this may 

be accomplished through the existing procedures for petition.)

Since the sunset review process is an assessment of National List substances to ensure 

their continued compliance with regulatory standards, the NOSB may determine that new 

restrictions in the form of annotations are necessary given changes in use patterns and 

scientific understanding. An annotation to expand the use of a substance does not fall 

within the purview of the sunset process and must only be considered through the petition 

process. 

The Organic Foods Production Act of 1990 (OFPA) authorized a National List of Allowed 

and Prohibited Substances (Section 6517). Sections 6517 (e) mandates a Sunset Provision 

as follows: 

“No exception or prohibition in the National list shall be valid unless the National Organic 

Standards Board has reviewed such exemption or prohibition as provided in this section 

within 5 years of such exemption or prohibition being adopted and the Secretary has 

reviewed such exemption or prohibition.”

The National List that was implemented in October 21, 2002 contained over 200 

substances. The first sunset review of listed materials was completed in October, 2007. 

Decisions made through the Sunset review must be transparent, non-arbitrary, based on 

the best current information and in the interest of the organic community and public at 

large.

Steps followed in Sunset Process 

Not all listed materials reach sunset status at the same time, but the review process 

includes these steps:

1. A public notice is placed in the Federal register (Advance Notice of Proposed Rule 

Making or ANPR of the pending sunset of the listed materials. The public has 60 

days after the publication date to provide written comment (see Chart 1 below). The 

committee may request a third party technical review in anticipation of scientific 

evidence and claims likely to be made during public comment to the ANPR.

2. Public comments are collected and forward to the NOSB (see Chart 2).

3. The appropriate NOSB committee begins review of the material with the intent of 

providing a recommendation to the entire Board for the material’s removal, renewal, 
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or renewal with the addition of an annotation. The review is conducted based on 

“Force of Evidence” as presented by Board members, public comments, and 

scientific data from other sources (see Chart 3). This includes the original 

recommendation from the Board to list. The committee may request a third party 

technical review, if needed, to verify scientific evidence and claims made during 

public comment to the ANPR.

4. The reviewing NOSB committee provides its recommendation to the full Board 60 

days prior to the Board Meeting. At the same time, the committee recommendations 

are posted on the NOSB website and open to public comments. The 

recommendation may consist of a (i) simple motion to remove or renew the listing of 

the substance or (ii) motion to renew accompanied by an amendment containing the 

addition of an annotation to the listing. Regarding the addition of an annotation, the 

committee will, in a two-step process, first vote on the amendment with the 

annotation, then on the motion to renew. Should the amendment prevail in 

committee, the Board in its consideration will also vote first on the amendment to 

annotate, then the motion to renew. If the amendment to annotate does not advance 

out of committee, the Board will vote on the motion to renew and, per its normal 

process, entertain amendments from the Board.

5. At the public NOSB business meeting, the NOSB hears additional public comment, 

discusses the force of evidence, and votes on the committee’s recommendation.

6. The NOP reviews the NOSB recommendation and accompanying documentation 

and publishes a proposed rule to review the National List. The public has 90 days 

after the publication date to comment. All comments are made available on the NOP 

website.

The NOP will review public comment and draft the final rule. The final rule will 

proceed through interagency (i.e. OGC , OMB, and departmental) and congressional 

review, and upon receiving clearance from the appropriate parties, the NOP will 

publish the final rule in the Federal Register. The final rule process is illustrated in 

Chart 4.

7. If the clearance process required for an annotation during sunset is not able to be 

completed prior to the substance’s expiration under the sunset process, the Board 

has the authority to revisit the question of the substance’s removal or renewal prior 

to its expiration. 

Committee Vote:

Motion: Jay Feldman Second: Barry Flamm

Yes: 5 No: 0 Abstain: 0 Absent: 0