[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Rules and Regulations]
[Pages 56811-56816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22388]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-13-0057; NOP-13-03]


National Organic Program--Sunset Process

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Notification of sunset process.

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SUMMARY: This document describes the sunset review and renewal process 
for substances on the National List of Allowed and Prohibited 
Substances (National List), a subpart of the U.S. Department of 
Agriculture (USDA) organic regulations. The Organic Foods Production 
Act of 1990 (OFPA) requires that the National Organic Standards Board 
(NOSB), a 15-member federal advisory committee, review all substances 
and that the Secretary of Agriculture (Secretary) renew these 
substances, within 5 years of their addition to or renewal on the 
National List. This action of NOSB review and USDA renewal is commonly 
referred to as the ``Sunset Process.'' This document informs 
stakeholders about the process that the NOSB will use to complete their 
responsibility to review substances under OFPA's sunset provision. This 
document also informs stakeholders about the process that the Secretary 
and the Agricultural Marketing Service's (AMS) National Organic Program 
(NOP) will use to complete the USDA's responsibilities under OFPA's 
sunset provision.

DATES: The process announced by this document is effective on September 
17, 2013.

FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Ph.D., Director, 
Standards Division, Telephone: (202) 720-3252; Fax: (202) 205-7808.

SUPPLEMENTARY INFORMATION:

I. Background

What is the National List?

    The OFPA authorized the establishment of a National List of Allowed 
and Prohibited Substances (National List) (7 U.S.C. 6517). The National 
List, a subpart of the USDA organic regulations, identifies the 
synthetic substances that are allowed (exemptions) and the nonsynthetic 
(natural) substances that are not allowed (prohibitions) in organic 
production (7 CFR 205.601-604). Nonsynthetic substances are generally 
permitted to be used in organic production and are not required to be 
included on the National List. The USDA organic regulations 
specifically prohibit the use of any synthetic substance in organic 
production and handling unless the synthetic substance is on the 
National List (Sec.  205.105). The National List also identifies the 
nonorganic substances that may be used in organic handling (Sec. Sec.  
205.605-205.606). Any nonorganic substance used in organic handling 
must also be included on the National List (Sec.  205.105).
    Changes to the National List may be requested by any individual or 
organization through the National List Petition Process. Petitioners 
may submit a petition requesting the addition of a substance, the 
removal of a substance, or an amendment to a substance already on the 
National List. Section 205.607 of the USDA organic regulations 
addresses amending the National List. In addition, AMS published in the 
Federal Register guidelines regarding the submission of petitions for 
the National List on January 18, 2007 (72 FR 2167). This information 
can also be accessed through the NOP Web site at http://www.ams.usda.gov/nop.

What is the National Organic Standards Board?

    The NOSB is a 15-member Federal Advisory Committee that assists in 
the development of standards for substances to be used in organic 
production and handling (7 U.S.C. 6518(a)). The NOSB

[[Page 56812]]

is responsible for developing proposed amendments to the National List 
for submission to the Secretary (7 U.S.C. 6518(k)(2)). Specifically, 
the NOSB reviews petitions received through the National List Petition 
Process and evaluates petitioned substances using specific criteria in 
OFPA (7 U.S.C. 6518(m)) and the USDA organic regulations (Sec.  
205.600). These criteria address the impact of the use of the substance 
on human health and the environment, the necessity of the substance, 
and its compatibility with organic production and handling. Depending 
on the petitioned use of the substance, the petition will be reviewed 
by an NOSB subcommittee: Crops, livestock, or handling. Proposals from 
the subcommittees are posted for public comment prior to the NOSB 
issuing a final recommendation. In developing their final 
recommendation, NOSB considers information from the petition, third 
party technical information, and written and in-person comments at 
public meetings. After NOSB provides a final recommendation to the 
Secretary, AMS reviews the recommendation and, if warranted, considers 
action to amend the National List through rulemaking. Under the 
authority of OFPA, the Secretary can amend the National List based on 
proposed amendments developed by the NOSB (7 U.S.C. 6517(d)(1)).

What is the Sunset Process?

    OFPA specifies that the NOSB must review all substances on the 
National List and that the Secretary renew substances within 5 years of 
their addition to or renewal on the National List. This action of NOSB 
review and USDA renewal is commonly referred to as the ``Sunset 
Process.'' It is essential for the NOSB to complete this review and the 
Secretary to complete any renewals in a timely manner because these 
substances are critical to the production and handling of a wide array 
of raw and processed organic agricultural products. Failure to complete 
this process could cause disruption of well-established and accepted 
organic production, handling, and processing systems.
    The NOSB has previously evaluated and determined that all 
substances currently on the National List are consistent with OFPA and 
the USDA organic regulations. As of publication of this document, the 
NOSB has completed five Sunset reviews since the establishment of the 
National List in October 21, 2002. AMS has addressed these reviews 
through multiple rulemaking actions. A complete list of Federal 
Register notices pertinent to NOSB reviews and AMS rules that address 
NOSB's Sunset Reviews is available on the NOP Web site at: 
www.ams.usda.gov/nopfederalregisternotices.

What does this document do?

    This document describes the process that NOSB will use to complete 
its responsibility to review substances on the National List under 
OFPA's sunset provision. This document also describes the process that 
AMS' National Organic Program (NOP) will use to complete the 
Secretary's responsibility to renew the National List under OFPA's 
sunset provision.
    The Sunset Process described in this document will be used for 
future Sunset reviews and renewals, unless AMS replaces or updates this 
document. This document replaces the process that AMS described in the 
first Advanced Notice of Proposed Rulemaking (ANPR) for Sunset Review 
published in the Federal Register on June 17, 2005 (70 FR 35177).

II. The Sunset Process

    The Sunset Process is comprised of two components: (1) The NOSB 
review and (2) USDA action on substances within 5 years of their 
addition to or renewal on the National List. The Sunset Process is 
completed for each substance through the steps shown in Figure 1 and 
described below.

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Step 1--AMS Announces Substance(s) for Sunset Review

    AMS will publish a list of substances that will be undergoing the 
sunset review and renewal process in a given calendar year. The list 
will be published on the NOP Web site with enough lead time (e.g., two 
years) to provide for both NOSB review and USDA action on these 
substances. The list will be divided by subcommittee and provides the 
following information for each substance: Current listing, use 
description, references to past technical reports, past NOSB actions, 
and regulatory history (e.g., links to proposed and final rules), as 
applicable. An example of the structure and content of this type of 
list is available at: www.ams.usda.gov/nop.

Step 2--Public Submits Comments on Substance's Status and Impact

    AMS will also publish a Federal Register document announcing an 
NOSB meeting and request public comments on each substance under sunset 
review. This request for comments will direct the public to provide 
information that aids in NOSB review of the substance against the 
criteria in OFPA and under the USDA organic regulations. This request 
is for new information about a substance since its addition to the 
National List or its previous Sunset Review. Such information could 
include research or data that may support a change in the NOSB's 
determination for a substance. This may include information on a 
substance's impact on human health and the environment, its necessity, 
and its continued compatibility with organic production and handling.
    In advance of the NOSB meeting, the public can submit written 
comments on the substances undergoing sunset review. At the NOSB 
meeting, the public can also provide in-person comments to NOSB on 
these substances. Members of the public interested in providing in-
person comments may request a slot in advance. Instructions for such 
requests are available in the Federal Register document announcing the 
NOSB meeting.

Step 3--Public Meeting 1: NOSB Discusses Substance, No Action 
Taken

    At the first public meeting, each NOSB Subcommittee presents a 
brief background summary for each substance and describes any public 
comments received. The NOSB does not take action on this substance at 
this meeting. Instead, the purpose of the first meeting is for the NOSB 
to hear about any new information about each substance under

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review. Through the process of public comment, NOSB may identify and 
discuss key issues about a substance that needs further examination. 
Each Subcommittee will consider these issues as it develops its 
preliminary sunset review for the next public NOSB meeting.

Step 4--NOSB Subcommittee Completes Preliminary Review

    After the first public meeting, the NOSB Subcommittees will review 
public comment and technical information to draft a preliminary review 
of substances undergoing sunset review in a given year. AMS will 
publish this preliminary review on the NOP Web site. For substances 
that continue to meet the criteria for substances on the National List, 
the Subcommittee will summarize relevant information regarding its 
review of this substance. The review will also summarize information 
from any available technical report(s) on the substance and describe 
any new information pertaining to substance's impact on human health 
and the environment, its necessity, and its compatibility with organic 
production and handling. If the Subcommittee determines that a 
substance should remain on the National List, and there are no 
proposals to remove the substance, then the Subcommittee's preliminary 
review moves to the next step in this process. The Subcommittee does 
not vote on a motion to retain a substance on the National List.
    As part of this review, the Subcommittee may identify new 
information that merits consideration of a substance for removal from 
the National List. If warranted, the NOSB Subcommittees can develop 
proposals to remove substances as part of their preliminary review. Any 
proposals to remove a substance must be justified using the evaluation 
criteria in OFPA and the USDA organic regulations. Proposals to remove 
a substance must be part of the preliminary review that is posted in 
advance of the NOSB meeting.
    If the Subcommittee identifies new information that it believes 
merits reconsideration of a use restriction for a substance (e.g., to 
expand its use, further restrict its use, or correct its restrictive 
annotation), then a member of the Subcommittee or a member of the 
public can file a petition to change the use of a substance through the 
National List Petition Process. Changes to or addition of annotations 
to substances already on the National List cannot be proposed during 
the Sunset Process. Additional information in support of this procedure 
is described below under Discussion.

Step 5--Public Submits Comments on Preliminary Review

    AMS will publish a Federal Register document announcing the second 
NOSB meeting and request public comments on each Subcommittee's 
preliminary review. This request for comments will again direct the 
public to provide information that aids in NOSB review of each 
substance against the criteria in OFPA and under the USDA organic 
regulations. This request is for new information on the status of a 
substance since its addition to the National List or its previous 
Sunset Review. Such information could include research or data that may 
support a change in the NOSB's determination for a substance. This may 
include information on a substance's impact on human health and the 
environment, its necessity, and its continued compatibility with 
organic production and handling.
    In advance of the second NOSB meeting, the public can respond to 
this Federal Register document by submitting written comments on the 
substances undergoing review. At the NOSB meeting, the public can also 
provide in-person comments to NOSB on these substances. Members of the 
public interested in providing in-person comments may request a slot in 
advance. Instructions for such requests are available in the Federal 
Register document announcing the NOSB meeting.

Step 6--Public Meeting 2: NOSB Completes Sunset Review

    At the second public meeting, each Subcommittee will present a 
brief background summary of its preliminary review and summarize any 
public comments received. Each Subcommittee Chair leads the full NOSB 
discussion on that Subcommittee's preliminary reviews and any 
associated proposals to remove substances from the National List.
    After NOSB discussion of each preliminary review and any proposals, 
the NOSB will vote on any motions to remove substances from the 
National List. If a Subcommittee had published a proposal to remove a 
substance, then a member of the NOSB can make a motion to remove that 
substance from the National List. As specified by OFPA, two-thirds of 
the votes cast at the meeting shall be decisive of any motion (7 U.S.C. 
6518(i)). For motions to remove a substance, this means that two-thirds 
of votes cast must be in favor of removal of the substance. A motion to 
remove a substance that does not receive two-thirds of the votes cast 
fails, and the substance will remain on the National List.
    Proposals to remove substances from the National List can only be 
considered by the NOSB if they were published as part of the 
Subcommittee's preliminary review for public comment in advance of the 
NOSB meeting. If the Subcommittee identifies new information at the 
meeting that it believes merits reconsideration of the conclusions 
presented in the preliminary review, that information will be 
considered untimely for purposes of the Sunset Review process. However, 
a member of the Subcommittee or a member of the public then can file a 
petition for removal or changes to the use of a substance through the 
National List Petition Process.
    After NOSB votes on any proposals to remove substances, the NOSB 
discusses the overall review of substances under their consideration. 
At the conclusion of this discussion, the NOSB Chair confirms that the 
NOSB review is complete. The NOSB Chair compiles the preliminary 
reviews from each Subcommittee and any NOSB recommendations for 
removals into a comprehensive NOSB Sunset Review document. The NOSB 
Chair accepts this document as complete and transmits this document to 
AMS for consideration and for public posting on the NOP Web site at 
www.ams.usda.gov/nop. This action completes the NOSB's responsibility 
to review substances on the National List through OFPA's sunset 
provision (7 U.S.C. 6517(e)).

Step 7--AMS Reviews NOSB Sunset Review

    Upon receipt of the NOSB's Sunset Review document, AMS reviews the 
outcome for each substance to consider AMS' next action and to ensure 
accuracy and completeness of the document.

Step 8--AMS Announces Renewal of Substance

    After AMS' review, AMS may publish a document in the Federal 
Register listing all the substances that will remain on the National 
List until the next five year sunset review. This action addresses the 
Secretary's responsibility to renew substances on the National List 
through OFPA's sunset provision (7 U.S.C. 6517(e)). If the NOSB has 
recommended removal of any substance from the National List, then AMS 
may take the following actions to remove the substance:

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Removal 1--AMS Proposes To Remove Substance

    AMS will review any NOSB recommendations to remove a substance from 
the National List. If warranted, AMS will publish a proposed rule in 
the Federal Register to propose removal of these substances from the 
National List.

Removal 2--Public Submits Comments on Proposal

    AMS will request comments on the proposed rule for any removals. 
AMS may specifically request comments on the NOSB's justification for 
removal of the substance, information on the availability of 
alternatives to the substance (e.g., other substances, cultural or 
management practices), and information on the potential impacts 
(benefits and costs) of removing the substance from the National List.

Removal 3--AMS Publishes Final Rule

    AMS will review the comments received on the proposed rule and 
determine whether to finalize the rule as proposed. If AMS publishes a 
final rule to remove one or more substances, then these substances will 
be removed from the National List on the effective date of the final 
rule. On this date, their authorized use or prohibition in organic 
production or handling expires.

III. Discussion

What are the benefits of this action?

    The Sunset Process described in this document is designed to 
improve public participation and transparency and ensure well-informed 
decision making about substances that are critical in organic 
production and handling.
    Over the last few Sunset Reviews, AMS identified a number of ways 
that the process could be improved by:
     Increasing opportunities for the public to submit comments 
directly to NOSB;
     Clarifying the NOSB's voting approach and requirements for 
decisive votes under OFPA; and
     Ensuring that NOSB proposals are exposed to robust public 
comment and can be addressed in a timely manner through the AMS' 
process.
    Therefore, the Sunset Process described in this document will 
create greater efficiency and will ensure that:
     Members of the public receive the full benefit of public 
comment on NOSB Sunset decisions over the course of two public 
meetings;
     There is consistency in NOSB review of substances across 
the Sunset Process and the National List Petition Process; and
     There is flexibility in the regulatory process to provide 
the organic industry with the regulatory certainty required for 
successful production and marketing of organic products.

How does this Sunset Process enhance public participation?

    Since the NOSB represents all sectors of the organic community, the 
NOSB's review provides AMS with critical information about which 
substances should be allowed or prohibited in organic agriculture. This 
Sunset Process enhances the NOSB's ability to thoroughly review sunset 
substances over the course of two public meetings. The first meeting 
enables the public to provide NOSB Subcommittees with new information 
about substances under review and may prompt their requests for 
additional technical information. The second meeting enables the public 
to comment specifically on the outcomes of the NOSB Subcommittee's 
preliminary review, including any proposals to remove substances from 
the National List. The AMS rulemaking process provides an additional 
opportunity for the public to comment on any NOSB recommendation to 
remove a substance from the National List.

Can NOSB recommend a change to or addition of an annotation to a 
substance during Sunset Review? Can the NOSB recommend moving a 
substance to a different section of the National List during the Sunset 
Review?

    No. For substances already on the National List, changes to or 
addition of annotations, or changes to the location of a substance on 
the National List (e.g., agricultural versus nonagricultural), cannot 
be proposed during the Sunset Process. In the past, NOSB made 
recommendations to further restrict the use of substances during Sunset 
Review. At times, these recommendations have not been exposed to robust 
public comment and have been difficult for AMS to implement through 
rulemaking actions by the sunset date. The difficulties with 
implementing these recommendations include the level of analysis 
required to assess how organic stakeholders may be affected by the 
recommendation and the deadline for completion of the Sunset Process.
    If the NOSB identifies new information that it believes merits 
reconsideration of a use restriction on a substance (e.g., to expand 
its use, further restrict its use, or correct its restrictive 
annotation) or the location of a substance on the National List, then a 
member of the NOSB or a member of the public can file a petition for 
changes to the use or classification of a substance through the 
National List Petition Process (www.ams.usda.gov/nop).

Do all NOSB members have to agree to recommend removal of a substance 
during the Sunset Process?

    No. Two-thirds of the votes cast at the meeting must be in favor of 
removal for a motion to remove to pass (7 U.S.C. 6518(i)). A motion to 
remove a substance that does not receive two-thirds of the votes cast 
fails to be ``decisive'' under OFPA and the substance will remain on 
the National List.

How does this document clarify the requirements for decisive votes 
under OFPA and the NOSB's voting approach for Sunset review?

    The ``decisive votes'' provision in OFPA states that two-thirds of 
the votes cast by NOSB is decisive of any motion (7 U.S.C. 6518(i)). 
Through this document, AMS is clarifying that removal of a substance 
during Sunset Review requires a two-thirds majority or ``decisive'' 
vote. In the past, the NOSB voted on a motion to ``renew'' each 
substance under Sunset Review. If a two-thirds majority wasn't reached 
on a motion to renew a substance, then the outcome, by default, was 
considered an NOSB recommendation to remove the substance from the 
National List. Ensuring that a two-thirds majority vote is reached for 
any decisive action (e.g. removal of a substance) would bring greater 
consistency with OFPA.
    The previous approach also was not aligned with the National List 
Petition Process, a process by which stakeholders can request removal 
of a substance from the National List. For the petition review, a two-
thirds majority vote is required for the NOSB to recommend removal of a 
substance. Under the process described in this Federal Register 
document, the NOSB voting approach requires that, regardless of whether 
the substance is under Sunset Review or petition review, the NOSB will 
need a two-thirds majority vote to recommend removal of a substance 
from the National List.

What is the importance of submitting public comments to the NOSB at 
their first public meeting?

    It is important for the public to engage in the Sunset Process 
early because the Subcommittees will use comments from their first 
public meeting to develop any proposals for removal of substances 
leading up to the second public meeting. As discussed in Step 6, 
proposals to remove substances from the National List can only be 
considered by the NOSB if they were published as part

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of the Subcommittee's preliminary review for public comment in advance 
of the second NOSB meeting. Allowing changes to proposals or addition 
of new proposals at the public meeting does not provide stakeholders 
who submitted written comments in advance of this meeting any 
opportunity to comment on substantive changes or additions that occur 
at the in-person meeting. Therefore, public participation during the 
first public meeting of this Sunset Process will provide the NOSB with 
the greatest amount of information available to aid in a thorough 
review.

    Authority: 7 U.S.C. 6501-6522.

    Dated: September 10, 2013.
Rex A. Barnes,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2013-22388 Filed 9-13-13; 8:45 am]
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