Overview: Sunset Review Process

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Lisa M. Brines, Ph.D.

Agricultural Marketing Service | National Organic Program

NOSB Meeting, April 29, 2014
Sunset Process

• On September 16, 2013, the National 

Organic Program announced a transparent 

and streamlined sunset review and 

renewal process.

• The updated procedure

– Clarifies process

– Provides increased opportunity for 

public comment

– Ensures a decisive, majority vote for all 

recommendations to change the 

National List

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Sunset needed a revamp!

Drawbacks to previous process:

• Each sunset year required 3 separate 

rulemaking documents (ANPR, PR, and FR)

• Substances were discussed in a single public 

meeting

• Removal could occur with a minority of votes 

cast (fewer than required of “decisive” actions)

• Annotation changes during sunset were 

problematic to implement under sunset 

deadlines

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Sunset Provision of OFPA

• No exemption or prohibition contained 

in the National List shall be valid unless 

the NOSB 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

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OFPA, Section 2118(e)
Benefits

• Thorough and transparent review 

process for all substances - provides 2 

public comment opportunities before 

the NOSB completes its review of each 

substance. 

• Ensures that any change to the National 

List (petitioned or sunset) is supported 

by a 2/3 majority of the NOSB.

• Streamlines the administration of the 

National List by simplifying rulemaking 

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Does this change weaken the standards?

• No. NOSB retains its ability to recommend 

removal of substances from the National 

List through the sunset process

• Previously, when there was new evidence 

or when alternatives became available, 

substances removed from the National List 

during Sunset had at least 2/3 votes 

supporting their removal

• Examples: sulfur dioxide for rodent control, 

forms of pectin, forms of lecithin, forms of 

silicon dioxide, hops 

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What is the process?

The Sunset Process is comprised of

two components: 

(1) The NOSB review (Steps 1-6) and 

(2) USDA action (Steps 7-8) on substances 

within 5 years of their addition to or renewal 

on the National List. 

• Key documents used for the review:

(1) Sunset List

(2) Preliminary Review

(3) NOSB Sunset Review

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Process Mechanics

• Step 1 – Meeting announcement in Federal 

Register inviting comment on Sunset List 

(background may include requests for 

specific info from Subcommittees)

• Step 2 – Written public comments 

submitted and analyzed by Subcommittees

• Step 3 (Meeting #1) – Subcommittees 

summarize background and public 

comment & receive oral comment

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Process Mechanics (cont.)

• Step 4 – Subcommittees analyze written 

and oral comments from Meeting #1 and 

prepare Preliminary Review. 

– Preliminary Review includes any

Subcommittee motions for removal, 

including those that did not receive 

majority of Subcommittee votes

– Meeting announcement inviting 

comment on Preliminary Review

published in Federal Register

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Process Mechanics (cont.)

• Step 5 – Subcommittees analyze written 

public comments submitted on 

Preliminary Review before Meeting #2

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Process Mechanics (cont.)

• Step 6 (Meeting #2) – Subcommittees 

present Preliminary Review, receive 

oral comment, and discuss with the full 

Board.

– Board votes on all motions for 

removal from Preliminary Review.

– After Meeting #2, NOSB completes 

Sunset Review. 

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Process Mechanics (cont.)

• Step 7 – AMS reviews NOSB Sunset 

Review and considers rulemaking action 

for any recommended removals

• Step 8 – AMS issues Federal Register 

Notice announcing renewal of 

applicable substances 

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Benefits of Two Meeting Process

• Allows for earlier information gathering 

at first meeting

• Second meeting allows for NOSB to 

recommend removal of substances 

based on information received during 

first meeting

• New information submitted at later 

stages can be handled through petition 

process

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Benefits of Voting Procedure

• Recommendations to remove a 

substance during sunset review requires 

2/3 majority (decisive vote under OFPA)

• Aligns with number of votes needed for 

petitions to remove

• Increases efficiency at NOSB meetings 

since votes are only needed for motions 

to remove substances from the National 

List need

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How does NOSB finish the sunset review?

• For recommended removals:

– Sunset review is complete upon submission 

of recommendation to NOP

• For other reviews:

– Sunset review is complete at the end of the 

second meeting

– Chair will submit NOSB Sunset Review 

document to NOP

– Recommendations are not required for 

sunset renewals

– The two meeting review meets the OFPA 

sunset requirement for NOSB review

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Sunset Review Timelines

• On January 22, 2014, NOP published a 

memo on Sunset Review Timelines

• The memo identifies which two 

meetings the NOSB should use to 

address each substance

• Establishes deadlines for NOSB to 

request technical reports

• Provides a list of substances scheduled 

for sunset in 2014- 2017 (addresses 

sunset dates through 2019)

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Sunset Dates

• Sunset dates are published in Program 

Handbook, NOP 5611

• 5 years is calculated from effective date 

of final rule or renewal

• For efficiency, sunset reviews are 

grouped by calendar year

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Sunset Process - Summary

• Ensures a decisive, majority vote for all 

recommendations to change the 

National List

• Maintains NOSB’s responsibility to 

review substances for National List

• Streamlines NOP’s administration of the 

renewal process

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Questions?

Thank you!