[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Proposed Rules]
[Pages 5431-5438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00586]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / 
Proposed Rules  

[[Page 5431]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-16-0052; NOP-16-03]
RIN 0581-AD52


National Organic Program (NOP); Sunset 2017 Amendments to the 
National List

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This proposed rule would address recommendations submitted to 
the Secretary of Agriculture (Secretary) by the National Organic 
Standards Board (NOSB) following their October 2015 meeting. These 
recommendations pertain to the 2017 Sunset Review of substances on the 
U.S. Department of Agriculture's (USDA) National List of Allowed and 
Prohibited Substances (National List). Consistent with the 
recommendations from the NOSB, this proposed rule would remove eleven 
substances from the National List for use in organic production and 
handling.

DATES: Comments must be received by March 20, 2017.

ADDRESSES: Interested persons may comment on the proposed rule using 
the following procedures:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Robert Pooler, Standards Division, National Organic 
Program, USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2642-So., Ag 
Stop 0268, Washington, DC 20250-0268.
    Instructions: All submissions received must include the docket 
number AMS-NOP-16-0052; NOP-16-03, and/or Regulatory Information Number 
(RIN) 0581-AD52 for this rulemaking. You should clearly indicate the 
topic and section number of this proposed rule to which your comment 
refers. You should clearly indicate whether you support the action 
being proposed for the substances in this proposed rule. You should 
clearly indicate the reason(s) for your position. You should also 
supply information on alternative management practices, where 
applicable, that support alternatives to the proposed action. You 
should also offer any recommended language change(s) that would be 
appropriate to your position. Please include relevant information and 
data to support your position (e.g. scientific, environmental, 
manufacturing, industry, impact information, etc.). Only relevant 
material supporting your position should be submitted. All comments 
received and any relevant background documents will be posted without 
change to http://www.regulations.gov.
    Document: For access to the document and to read background 
documents or comments received, go to http://www.regulations.gov. 
Comments submitted in response to this proposed rule will also be 
available for viewing in person at USDA-AMS, National Organic Program, 
Room 2642--South Building, 1400 Independence Ave. SW., Washington, DC, 
from 9 a.m. to 12 noon and from 1 p.m. to 4 p.m., Monday through Friday 
(except official Federal holidays). Persons wanting to visit the USDA 
South Building to view comments received in response to this proposed 
rule are requested to make an appointment in advance by calling (202) 
720-3252.

FOR FURTHER INFORMATION CONTACT: Robert Pooler, Standards Division, 
email: [email protected], Telephone: (202) 720-3252; Fax: (202) 
205-7808.

SUPPLEMENTARY INFORMATION:

I. Background

    The National Organic Program (NOP) is authorized by the Organic 
Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501-6522). 
The USDA Agricultural Marketing Service (AMS) administers the NOP. 
Final regulations implementing the NOP, also referred to as the USDA 
organic regulations, were published December 21, 2000 (65 FR 80548), 
and became effective on October 21, 2002. Through these regulations, 
the AMS oversees national standards for the production, handling, and 
labeling of organically produced agricultural products. Since becoming 
effective, the USDA organic regulations have been frequently amended, 
mostly for changes to the National List in 7 CFR 205.601-205.606.
    This National List identifies the synthetic substances that may be 
used and the nonsynthetic substances that may not be used in organic 
production. The National List also identifies synthetic, nonsynthetic 
nonagricultural, and nonorganic agricultural substances that may be 
used in organic handling. The OFPA and the USDA organic regulations, as 
indicated in Sec.  205.105, specifically prohibit the use of any 
synthetic substance in organic production and handling unless the 
synthetic substance is on the National List. Section 205.105 also 
requires that any nonorganic agricultural substance and any 
nonsynthetic nonagricultural substance used in organic handling appear 
on the National List.
    As stipulated by the OFPA, recommendations to propose amendment of 
the National List are developed by the NOSB, operating in accordance 
with the Federal Advisory Committee Act (5 U.S.C. App. 2 et seq.), to 
assist in the evaluation of substances to be used or not used in 
organic production and handling, and to advise the Secretary on the 
USDA organic regulations. The OFPA also requires a sunset review of all 
substances by the NOSB included on the National List within five years 
of their addition to or renewal on the list. If a listed substance is 
not reviewed by the NOSB and renewed by the USDA within the five-year 
period, its allowance or prohibition on the National List is no longer 
in effect. Under the authority of the OFPA, the Secretary can amend the 
National List through rulemaking based upon proposed amendments 
recommended by the NOSB.
    The NOSB's review of existing exemptions and prohibitions include 
the NOSB's evaluation of technical information, public comments, and 
supporting evidence that demonstrate whether the substance is: (a) 
Harmful to human health or the environment; (b) no longer necessary for 
organic production due to the availability of alternative wholly 
nonsynthetic substitute products or practices; or (c) inconsistent with 
organic farming and handling practices (7 U.S.C. 6517(c)).
    In accordance with the sunset review process published in the 
Federal Register on September 16, 2013 (78 FR

[[Page 5432]]

61154), this proposed rule would amend the National List to reflect 
2017 sunset review recommendations submitted to the Secretary by the 
NOSB on October 29, 2015, to amend the National List to remove eleven 
substances allowed as substances used in organic production or as 
ingredients in or on processed products labeled as ``organic.'' The 
exemptions of each substance appearing on the National List for use in 
organic production and handling are evaluated by the NOSB using the 
evaluation criteria specified in the OFPA (7 U.S.C. 6517-6518).

II. Overview of Proposed Amendments

Nonrenewals

    At the completion of their 2017 sunset review of National List 
substances with five year review periods ending in 2017, the NOSB 
recommended the removal of eleven substances from the National List. 
During this sunset review, the NOSB determined that one substance 
exemption each in Sec.  205.601(a), Sec.  205.603(a), Sec.  205.605(b) 
and eight substance exemptions in Sec.  205.606 are no longer necessary 
for organic production or handling. AMS has reviewed and proposes to 
accept the eleven NOSB recommendations for removal. Based upon these 
NOSB recommendations, this action proposes to amend the National List 
to remove the exemptions for lignin sulfonate, furosemide, magnesium 
carbonate, Chia, dillweed oil, frozen galangal, inulin, frozen 
lemongrass, chipotle chile peppers, turkish bay leaves, and whey 
protein concentrate.
Lignin Sulfonate
    The USDA organic regulations include an exemption on the National 
List for lignin sulfonate for use as a floating agent in postharvest 
handling at Sec.  205.601(l)(1) as follows: Lignin sulfonate. In April 
1995, lignin sulfonate was recommended by the NOSB for addition onto 
the National List as a plant or soil amendment for use as a chelating 
agent, dust suppressant, or floatation agent in organic crop 
production. AMS accepted this NOSB recommendation and included lignin 
sulfonate in the proposed rule and the final rule establishing the 
National Organic Program and the original National List that was 
published in the Federal Register on December 21, 2000 (65 FR 80548). 
Lignin sulfonate was included on the National List in Sec.  
205.601(j)(4) as a chelating agent, dust suppressant, or floatation 
agent, and in Sec.  205.601(l)(1) as a floating agent in post-harvest 
handling. This proposed rule only addresses the listing of lignin 
sulfonate in Sec.  205.601(l)(1). As required by OFPA, the NOSB 
recommended the renewal of lignin sulfonate during the 2007 and 2012 
sunset reviews which was renewed by the Secretary on October 16, 2007 
(72 FR 58469) and June 6, 2012 (77 FR 33290). Subsequently, the NOSB 
completed their 2017 sunset review of the exemption for lignin 
sulfonate at their October 2015 meeting. Two notices of the public 
meetings on the 2017 sunset review, with request for comments, were 
published in Federal Register on March 12, 2015 (80 FR 12975) and 
September 8, 2015 (80 FR 53759). The purpose of these notices was to 
notify the public that the lignin sulfonate exemption discussed in this 
proposed rule would expire on September 12, 2016, if not reviewed by 
the NOSB and renewed by the Secretary. During their 2017 sunset review 
deliberation, the NOSB considered written comments received prior to 
and during the public meetings on all substance exemptions included in 
the 2017 sunset review. These written comments can be viewed at https://www.regulations.gov by searching for the document ID numbers: AMS-NOP-
15-0002 (April 2015 public meeting) and AMS-NOP-15-0037 (October 2015 
public meeting). The NOSB also considered oral comments received during 
these public meetings. The NOSB's recommendation on lignin sulfonate is 
available on the NOP Web site at http://www.ams.usda.gov/nop. During 
their sunset review of lignin sulfonate the NOSB considered two lignin 
sulfonate technical reports that were requested by and developed for 
the NOSB in 2011 and 2013. The latter technical report reviewed lignin 
sulfonate use in aquaculture production. Both technical reports are 
available for review in the petitioned substance database on the NOP 
Web site, https://www.ams.usda.gov/rules-regulations/organic/national-list.
    Public comments received by the NOSB on lignin sulfonate in Sec.  
205.601(l)(1) indicated public support for removing lignin sulfonate as 
a floating agent in postharvest handling from the National List. Based 
upon these comments, the NOSB determined that the exemption for lignin 
sulfonate on the National List in Sec.  205.601(l)(1) is no longer 
necessary or essential for organic postharvest handling. Subsequently, 
the NOSB recommended removal of lignin sulfonate from Sec.  
205.601(l)(1) from the National List at their October 2015 public 
meeting.
    AMS accepts the NOSB's recommendation on removing lignin sulfonate 
from the National List. This proposed rule would amend National List 
Sec.  205.601 by removing the substance exemption for lignin sulfonate 
listed in Sec.  205.601(l)(1). This amendment is proposed to be 
effective on the current sunset date for lignin sulfonate, which is 
June 27, 2017.
Furosemide
    The USDA organic regulations include an exemption on the National 
List for furosemide for use as medical treatment at Sec.  
205.603(a)(10) as follows: Furosemide (CAS #-54-31-9) in accordance 
with approved labeling; except that for use under 7 CFR part 205, the 
NOP requires a withdrawal period of at least two-times that required by 
the FDA. In December 2000, furosemide was petitioned for addition to 
Sec.  205.603(a) for use as a medical treatment--a diuretic that 
reduces edema. In May 2003, the NOSB recommended adding furosemide to 
the National List in Sec.  205.603(a). The NOSB included a restrictive 
annotation for twice the required FDA furosemide withdrawal time within 
their recommendation to add furosemide to the National List.
    AMS accepted the NOSB's recommendation and furosemide was added to 
the National List on December 12, 2007 (72 FR 70479). As required by 
OFPA, the NOSB recommended the renewal of furosemide during their 2012 
sunset review. The Secretary accepted the NOSB's recommendation and 
published a notice renewing the furosemide exemption on the National 
List on June 6, 2012 (77 FR 33290). Subsequently, the exemption for 
furosemide as included on the National List was considered during the 
NOSB's 2017 sunset review. Two notices of the public meetings on the 
2017 sunset review with request for comments were published in Federal 
Register on March 12, 2015 (80 FR 12975) and September 8, 2015 (80 FR 
53759). The purpose of these notices was to notify the public that the 
furosemide exemption discussed in this proposed rule would expire on 
June 27, 2017, if not reviewed by the NOSB and renewed by the 
Secretary.
    During their 2017 sunset review, the NOSB considered written 
comments received prior to and during the public meetings on all 
substance exemptions included in the 2017 sunset review. These written 
comments can be viewed at https://www.regulations.gov by searching for 
the document ID numbers: AMS-NOP-15-0002 (April 2015 public meeting) 
and AMS-NOP-15-0037 (October 2015 public meeting). The NOSB also 
considered oral comments received during these public meetings. The 
NOSB's recommendation on

[[Page 5433]]

furosemide is available on the NOP Web site at http://www.ams.usda.gov/nop. During their sunset review of furosemide the NOSB considered a 
furosemide technical report that were requested by and developed for 
the NOSB in 2003. This technical report is available for review in the 
petitioned substance database on the NOP Web site, https://www.ams.usda.gov/rules-regulations/organic/national-list.
    Public comments received by the NOSB on furosemide indicated 
alternatives to furosemide are available to organic livestock 
producers. Based upon these comments, the NOSB determined that the 
exemption for furosemide in Sec.  205.603(a)(10) is no longer necessary 
or essential for organic livestock production. Subsequently, the NOSB 
recommended the removal of furosemide from Sec.  205.603(a)(10) from 
the National List at their October 2015 public meeting.
    AMS accepts the NOSB's recommendation on removing furosemide from 
the National List. This proposed rule would amend National List Sec.  
205.603 by removing the substance exemption for furosemide sulfonate 
listed in Sec.  205.603(a)(10). This amendment is proposed to be 
effective on the current sunset date for furosemide, which is June 27, 
2017.
Magnesium Carbonate
    The USDA organic regulations include an exemption on the National 
List for magnesium carbonate as a synthetic ingredient for use in or on 
processed products at Sec.  205.605(b) as follows: Magnesium 
carbonate--for use only in agricultural products labeled ``made with 
organic (specified ingredients or food group(s)),'' prohibited in 
agricultural products labeled ``organic.'' In September 1996, magnesium 
carbonate was petitioned for addition to the National List under Sec.  
205.605(b). The NOSB recommended that magnesium carbonate be added to 
the National List under Sec.  205.605(b) with an annotation limiting 
its use to products labeled ``made with organic (specified ingredients 
or food group(s))''. AMS accepted this recommendation and included 
magnesium carbonate in the proposed and the final rule establishing the 
National Organic Program and the original National List that was 
published in the Federal Register on December 21, 2001 (65 FR 80548). 
In this final rule, magnesium carbonate was included on the National 
List under Sec.  205.605(b)(16).
    As required by OFPA, the NOSB recommended the renewal of magnesium 
carbonate during the 2007 and 2012 sunset reviews, which were renewed 
by the Secretary on October 16, 2007 (72 FR 58469) and June 6, 2012 (77 
FR 33290). The NOSB completed their 2017 sunset review of the exemption 
for magnesium carbonate at their October 2015 meeting. Two notices of 
the public meetings on the 2017 sunset review with request for comments 
were published in the Federal Register on March 12, 2015 (80 FR 12975) 
and September 8, 2015 (80 FR 53759). The purpose of these notices was 
to alert the public that the exemption for magnesium carbonate would 
expire on June 27, 2017 if not reviewed and recommended by the NOSB and 
renewed by the Secretary. During their 2017 sunset review, the NOSB 
considered written comments received prior to and during the public 
meetings on all substance exemptions included in the 2017 sunset 
review. These written comments can be viewed at https://www.regulations.gov by searching for the document ID numbers: AMS-NOP-
15-0002 (April 2015 public meeting) and AMS-NOP-15-0037 (October 2015 
public meeting). The NOSB also considered oral comments received during 
these public meetings. The NOSB's recommendation on magnesium carbonate 
is available on the NOP Web site at http://www.ams.usda.gov/nop.
    Public comments received by the NOSB regarding magnesium carbonate 
under Sec.  205.605 (b) indicated that the material is not a necessity 
and recommended its removal from the National List. Based on the review 
of the material and the public comments received, the NOSB determined 
that magnesium carbonate is no longer necessary for organic production. 
As a result, the NOSB recommended the removal of magnesium carbonate 
from the National List at their October 2015 meeting.
    AMS accepts the NOSB's recommendation to remove magnesium carbonate 
from the National List. This proposed rule would amend National List 
Sec.  205.605 by removing the substance exemption for magnesium 
carbonate at Sec.  205.605 (b). This amendment is proposed to be 
effective on the current sunset date for magnesium carbonate, which is 
June 27, 2017.
Chia
    The USDA organic regulations include an exemption on the National 
List for Chia for use as an ingredient in or on processed products 
labeled as ``organic'' at Sec.  205.606 (c) as follows: Chia (Salvia 
hispanica L.). In January 2007, Chia was petitioned for addition to 
Sec.  205.606 as an ingredient due to the lack of availability of 
certified organic Chia. In April 2007, the NOSB recommended that Chia 
be added to the National List under Sec.  205.606. AMS accepted this 
recommendation and included Chia in the proposed rule and the final 
rule amending the National List that was published in the Federal 
Register on June 27, 2007 (72 FR 35137). As required by OFPA, the NOSB 
recommended the renewal of Chia during the 2012 sunset review, which 
was renewed by the Secretary on June 6, 2012 (77 FR 33290). The NOSB 
completed their 2017 sunset review of the exemption for Chia at their 
October 2015 meeting. Two notices of the public meetings on the 2017 
sunset review with request for comments were published in the Federal 
Register on March 12, 2015 (80 FR 12975) and September 8, 2015 (80 FR 
53759). The purpose of these notices was to alert the public that the 
exemption for Chia would expire on June 27, 2017 if not reviewed and 
recommended by the NOSB and renewed by the Secretary. During their 2017 
sunset review deliberation, the NOSB considered written comments 
received prior to and during the public meetings on all substance 
exemptions included in the 2017 sunset review. These written comments 
can be viewed at http://www.regulations.gov by searching for the 
document ID numbers: AMS-NOP-15-0002 (April 2015 public meeting) and 
AMS-NOP-15-0037 (October 2015 public meeting). The NOSB also considered 
oral comments received during these public meetings. The NOSB's 
recommendation on Chia is available on the NOP Web site at http://www.ams.usda.gov/nop.
    Regarding Chia, the NOSB requested information from the public 
related to (1) commercial demand, (2) commercial availability, (3) 
alternatives, and (4) necessity and use. Several comments from a cross-
section of the organic community were received in support of delisting 
Chia noting its wide commercial availability. No specific comments 
received supported relisting or addressed commercial unavailability of 
Chia. Based on the review of Chia and the public comments received, the 
NOSB determined that this material is now widely available from organic 
sources. Subsequently, the NOSB recommended the removal of Chia from 
Sec.  205.606 of the National List at their October 2015 meeting. AMS 
accepts the NOSB's recommendation to remove Chia from the National 
List. This proposed rule would amend National List Sec.  205.606 by 
removing the substance exemption for Chia at

[[Page 5434]]

Sec.  205.606 (c). This amendment is proposed to be effective on the 
current sunset date for Chia, which is June 27, 2017.
Dillweed Oil
    The USDA organic regulations include an exemption on the National 
List for dillweed oil for use as an ingredient in or on processed 
products labeled as ``organic'' at Sec.  205.606 (e) as follows: 
Dillweed oil (CAS #458-37-7). In December 2006, dillweed oil was 
petitioned for addition to Sec.  205.606. In April 2007, the NOSB 
recommended that dillweed oil be added to the National List under Sec.  
205.606. AMS accepted this recommendation and included dillweed oil in 
the proposed rule and the final rule amending the National List that 
was published in the Federal Register on June 27, 2007 (72 FR 35137). 
As required by OFPA, the NOSB recommended the renewal of dillweed oil 
during the 2012 sunset review, which was renewed by the Secretary on 
June 6, 2012 (77 FR 33290). The NOSB completed their 2017 sunset review 
of the exemption for dillweed oil at their October 2015 meeting. Two 
notices of the public meetings on the 2017 sunset review with request 
for comments were published in the Federal Register on March 12, 2015 
(80 FR 12975) and September 8, 2015 (80 FR 53759). The purpose of these 
notices was to alert the public that the exemption for dillweed oil 
would expire on June 27, 2017 if not reviewed and recommended by the 
NOSB and renewed by the Secretary. During their 2017 sunset review, the 
NOSB considered written comments received prior to and during the 
public meetings on all substance exemptions included in the 2017 sunset 
review. These written comments can be viewed at http://www.regulations.gov by searching for the document ID numbers: AMS-NOP-
15-0002 (April 2015 public meeting) and AMS-NOP-15-0037 (October 2015 
public meeting). The NOSB also considered oral comments received during 
these public meetings. The NOSB's recommendation on dillweed oil is 
available on the NOP Web site at http://www.ams.usda.gov/nop.
    In the review of dillweed oil, the NOSB requested information from 
the public related to (1) commercial demand, (2) commercial 
availability, (3) alternatives, and (4) necessity and use. No specific 
comments were received that supported relisting or addressed commercial 
unavailability of dillweed oil. Based on the NOSB's review of dillweed 
oil and the public comments received, the NOSB determined that this 
substance is now available from organic sources. Subsequently, the NOSB 
recommended the removal of dillweed oil from Sec.  205.606 of the 
National List at their October 2015 meeting. AMS accepts the NOSB's 
recommendation to remove dillweed oil from the National List. This 
proposed rule would amend National List Sec.  205.606 by removing the 
substance exemption for dillweed oil at Sec.  205.606 (e). This 
amendment is proposed to be effective on the current sunset date for 
dillweed oil, which is June 27, 2017.
Galangal, Frozen
    The USDA organic regulations include an exemption on the National 
List for galangal for use as an ingredient in or on processed products 
labeled as ``organic'' at Sec.  205.606 (h) as follows: Galangal 
(frozen). In November 2006, galangal was petitioned for addition to 
Sec.  205.606. In April 2007, the NOSB recommended that galangal be 
added to the National List under Sec.  205.606. AMS accepted this 
recommendation and included galangal in the proposed rule and the final 
rule amending the National List that was published in the Federal 
Register on June 27, 2007 (72 FR 35137). As required by OFPA, the NOSB 
recommended the renewal of galangal during the 2012 sunset review, 
which was renewed by the Secretary on June 6, 2012 (77 FR 33290). The 
NOSB completed their 2017 sunset review of the exemption for galangal 
at their October 2015 meeting. Two notices of the public meetings on 
the 2017 sunset review with request for comments were published in the 
Federal Register on March 12, 2015 (80 FR 12975) and September 8, 2015 
(80 FR 53759). The purpose of these notices was to alert the public 
that the exemption for galangal would expire on June 27, 2017 if not 
reviewed and recommended by the NOSB and renewed by the Secretary. 
During their 2017 sunset review deliberation, the NOSB considered 
written comments received prior to and during the public meetings on 
all substance exemptions included in the 2017 sunset review. These 
written comments can be viewed at http://www.regulations.gov by 
searching for the document ID numbers: AMS-NOP-15-0002 (April 2015 
public meeting) and AMS-NOP-15-0037 (October 2015 public meeting). The 
NOSB also considered oral comments received during these public 
meetings. The NOSB's recommendation on galangal is available on the NOP 
Web site at http://www.ams.usda.gov/nop.
    In its review of galangal, the NOSB requested information from the 
public related to (1) commercial demand, (2) commercial availability, 
(3) alternatives, and (4) necessity and use. No specific comments were 
received that supported relisting or addressed commercial 
unavailability of frozen galangal. Based on the NOSB's review of 
galangal and the public comments received, the NOSB determined that 
this material is now available from organic sources. Subsequently, the 
NOSB recommended the removal of galangal from Sec.  205.606 of the 
National List at their October 2015 meeting. AMS accepts the NOSB's 
recommendation to remove galangal from the National List. This proposed 
rule would amend National List Sec.  205.606 by removing the substance 
exemption for galangal at Sec.  205.606 (h). This amendment is proposed 
to be effective on the current sunset date for galangal, which is June 
27, 2017.
Inulin--Oligofructose Enriched
    The USDA organic regulations include an exemption on the National 
List for inulin--oligofructose enriched, allowed as an ingredient in or 
on processed products labeled as ``organic'' in Sec.  205.606(l) as 
follows: inulin--oligofructose enriched (CAS # 9005-80-5). In January 
2007, inulin was petitioned for addition to Sec.  205.606 for use as an 
ingredient in or on organic processed products. In April 2007, the NOSB 
recommended adding inulin--oligofructose enriched to the National List 
in Sec.  205.606.
    AMS accepted the NOSB's recommendation and inulin--oligofructose 
enriched was added to the National List on June 27, 2007 (72 FR 35137). 
As required by OFPA, the NOSB recommended the renewal of inulin--
oligofructose enriched during their 2012 sunset review. The Secretary 
accepted the NOSB's recommendation and published a notice renewing the 
inulin--oligofructose enriched exemption on the National List on June 
6, 2012 (77 FR 33290). Subsequently, the exemption for inulin--
oligofructose enriched on the National List was considered during the 
NOSB's 2017 sunset review. Two notices of the public meetings on the 
2017 sunset review with request for comments were published in Federal 
Register on March 12, 2015 (80 FR 12975) and September 8, 2015 (80 FR 
53759). The purpose of these notices was to notify the public that the 
inulin--oligofructose enriched exemption discussed in this proposed 
rule would expire on June 27, 2017, if not reviewed by the NOSB and 
renewed by the Secretary.
    During their 2017 sunset review, the NOSB considered written 
comments received prior to and during the public meetings on all 
substance exemptions included in the 2017 sunset review.

[[Page 5435]]

These written comments can be viewed at https://www.regulations.gov by 
searching for the document ID numbers: AMS-NOP-15-0002 (April 2015 
public meeting) and AMS-NOP-15-0037 (October 2015 public meeting). The 
NOSB also considered oral comments received during these public 
meetings. The NOSB's recommendation on inulin--oligofructose enriched 
is available on the NOP Web site at http://www.ams.usda.gov/nop. During 
their sunset review of inulin--oligofructose enriched the NOSB 
considered an inulin--oligofructose enriched technical report that was 
requested by and developed for the NOSB in 2015. This technical report 
is available for review in the petitioned substance database on the NOP 
Web site, https://www.ams.usda.gov/rules-regulations/organic/national-list.
    Public comments on inulin--oligofructose enriched received by the 
NOSB during their 2017 Sunset review indicated that organic inulin--
oligofructose enriched sources are available to organic processors. 
Based upon these comments, the NOSB determined that the exemption for 
inulin--oligofructose enriched in Sec.  205.606(l) is no longer 
necessary or essential for organic handling/processing. From this 
determination, the NOSB recommended the removal of inulin--
oligofructose enriched from Sec.  205.603(l) from the National List at 
their October 2015 public meeting. AMS accepts the NOSB's 
recommendation on removing inulin--oligofructose enriched from the 
National List. This proposed rule would amend National List Sec.  
205.606 by removing the substance exemption for inulin--oligofructose 
enriched as listed in Sec.  205.606(l). This amendment is proposed to 
be effective on the current sunset date for inulin--oligofructose 
enriched, which is June 27, 2017.
Lemon Grass, Frozen
    The USDA organic regulations include an exemption on the National 
List for lemon grass, allowed as an ingredient in or on processed 
products labeled as ``organic'' in Sec.  205.606(p) as follows: lemon 
grass, frozen. In November 2006, lemon grass was petitioned for 
addition onto Sec.  205.606 for use as an ingredient in or on organic 
processed products. In March 2007, the NOSB recommended adding lemon 
grass to the National List in Sec.  205.606.
    AMS accepted the NOSB's recommendation and lemon grass was added to 
the National List on June 27, 2007 (72 FR 35137). As required by OFPA, 
the NOSB recommended the renewal of lemon grass during their 2012 
sunset review. The Secretary accepted the NOSB's recommendation and 
published a notice renewing the lemon grass exemption on the National 
List on June 6, 2012 (77 FR 33290). Subsequently, the exemption for 
lemon grass was considered during the NOSB's 2017 sunset review. Two 
notices of the public meetings on the 2017 sunset review with request 
for comments were published in Federal Register on March 12, 2015 (80 
FR 12975) and September 8, 2015 (80 FR 53759). The purpose of these 
notices was to notify the public that the lemon grass exemption 
discussed in this proposed rule would expire on June 27, 2017, if not 
reviewed by the NOSB and renewed by the Secretary.
    During their 2017 sunset review, the NOSB considered written 
comments received prior to and during the public meetings on all 
substance exemptions included in the 2017 sunset review. These written 
comments can be viewed at https://www.regulations.gov by searching for 
the document ID numbers: AMS-NOP-15-0002 (April 2015 public meeting) 
and AMS-NOP-15-0037 (October 2015 public meeting). The NOSB also 
considered oral comments received during these public meetings. The 
NOSB's recommendation on lemon grass is available on the NOP Web site 
at http://www.ams.usda.gov/nop. Since the NOSB has not requested the 
development of a technical review on lemon grass, either for the 
original lemon grass petition process or for sunset reviews, the NOSB 
did not review a technical report on lemon grass during their 2017 
sunset review.
    Public comments on lemon grass received by the NOSB during their 
2017 Sunset review indicated that sources of organic lemon grass are 
available to organic processors. Based upon these comments, the NOSB 
determined that the exemption for lemon grass in Sec.  205.606(p) is no 
longer necessary or essential for organic handling/processing. From 
this determination, the NOSB recommended the removal of lemon grass 
from Sec.  205.606(p) from the National List at their October 2015 
public meeting. AMS accepts the NOSB's recommendation on removing lemon 
grass from the National List. This proposed rule would amend National 
List Sec.  205.606 by removing the substance exemption for lemon grass 
as listed in Sec.  205.606(p). This amendment is proposed to be 
effective on the current sunset date for lemon grass, which is June 27, 
2017.
Peppers (Chipotle Chile)
    The USDA organic regulations include an exemption on the National 
List for chipotle chile peppers for use as an ingredient in or on 
processed products labeled as ``organic'' at Sec.  205.606 (s) as 
follows: Peppers (Chipotle chile). Chipotle chile peppers were 
petitioned for addition to Sec.  205.606 in November 2006 and January 
2007. In April 2007, the NOSB recommended that chipotle chile peppers 
be added to the National List under Sec.  205.606. AMS accepted this 
recommendation and included chipotle chile peppers in the proposed rule 
and the final rule amending the National List that was published in the 
Federal Register on June 27, 2007 (72 FR 35137). As required by OFPA, 
the NOSB recommended the renewal of chipotle chile peppers during the 
2012 sunset review, which was renewed by the Secretary on June 6, 2012 
(77 FR 33290). The NOSB completed their 2017 sunset review of the 
exemption for chipotle chile peppers at their October 2015 meeting. Two 
notices of the public meetings on the 2017 sunset review with request 
for comments were published in the Federal Register on March 12, 2015 
(80 FR 12975) and September 8, 2015 (80 FR 53759). The purpose of these 
notices was to alert the public that the exemption for chipotle chile 
peppers would expire on June 27, 2017 if not reviewed and recommended 
by the NOSB and renewed by the Secretary. During their 2017 sunset 
review deliberation, the NOSB considered written comments received 
prior to and during the public meetings on all substance exemptions 
included in the 2017 sunset review. These written comments can be 
viewed at http://www.regulations.gov by searching for the document ID 
numbers: AMS-NOP-15-0002 (April 2015 public meeting) and AMS-NOP-15-
0037 (October 2015 public meeting). The NOSB also considered oral 
comments received during these public meetings. The NOSB's 
recommendation on chipotle chile peppers is available on the NOP Web 
site at http://www.ams.usda.gov/nop.
    Regarding chipotle chile, the NOSB requested information from the 
public related to (1) commercial demand, (2) commercial availability, 
(3) alternatives, and (4) necessity and use. Several comments from a 
cross-section of the organic community were received in support of 
delisting chipotle chiles noting commercial availability. No specific 
comments received supported relisting or addressed commercial 
unavailability of chipotle chiles. Based on the NOSB's review of 
chipotle chile peppers and the public comments received, the NOSB 
determined that this

[[Page 5436]]

material is now available from organic sources. Subsequently, the NOSB 
recommended the removal of chipotle chile peppers from Sec.  205.606 of 
the National List at their October 2015 meeting. AMS accepts the NOSB's 
recommendation to remove chipotle chile peppers from the National List. 
This proposed rule would amend National List Sec.  205.606 by removing 
the substance exemption for chipotle chile peppers at Sec.  205.606 
(s). This amendment is proposed to be effective on the current sunset 
date for chipotle chile peppers, which is June 27, 2017.
Turkish Bay Leaves
    The USDA organic regulations include an exemption on the National 
List for Turkish bay leaves, allowed as an ingredient in or on 
processed products labeled as ``organic'' in Sec.  205.606(w) as 
follows: Turkish bay leaves. In November 2006, Turkish bay leaves was 
petitioned for addition to Sec.  205.606 for use as an ingredient in or 
on organic processed products. In April 2007, the NOSB recommended 
adding Turkish bay leaves to the National List in Sec.  205.606. AMS 
accepted the NOSB's recommendation and Turkish bay leaves was added to 
the National List on June 27, 2007 (72 FR 35137). As required by OFPA, 
the NOSB recommended the renewal of Turkish bay leaves during their 
2012 sunset review. The Secretary accepted the NOSB's recommendation 
and published a notice renewing the Turkish bay leaves exemption on the 
National List on June 6, 2012 (77 FR 33290). Subsequently, the 
exemption for Turkish bay leaves on the National List was considered 
during the NOSB's 2017 sunset review. Two notices of the public 
meetings on the 2017 sunset review with request for comments were 
published in Federal Register on March 12, 2015 (80 FR 12975) and 
September 8, 2015 (80 FR 53759). The purpose of these notices was to 
notify the public that the Turkish bay leaves exemption discussed in 
this proposed rule would expire on June 27, 2017, if not reviewed by 
the NOSB and renewed by the Secretary.
    During their 2017 sunset review, the NOSB considered written 
comments received prior to and during the public meetings on all 
substance exemptions included in the 2017 sunset review. These written 
comments can be viewed at https://www.regulations.gov by searching for 
the document ID numbers: AMS-NOP-15-0002 (April 2015 public meeting) 
and AMS-NOP-15-0037 (October 2015 public meeting). The NOSB also 
considered oral comments received during these public meetings. The 
NOSB's recommendation on Turkish bay leaves is available on the NOP Web 
site at http://www.ams.usda.gov/nop. During their sunset review of 
Turkish bay leaves the NOSB did not review a technical report on 
Turkish bay leaves since the NOSB has not requested the development of 
a Turkish bay leaves technical report for the original petition review 
or any subsequent sunset reviews.
    Public comments on Turkish bay leaves received by the NOSB during 
their 2017 Sunset review indicated that organic Turkish bay leaves 
sources are available to organic handlers/processors. The original 
petitioner of Turkish bay leaves also commented they now use organic 
Turkish bay leaves for their products. Based upon these comments, the 
NOSB determined that the exemption for Turkish bay leaves in Sec.  
205.606(w) is no longer necessary or essential for organic handling/
processing. From this determination, the NOSB recommended the removal 
of Turkish bay leaves from Sec.  205.606(w) from the National List at 
their October 2015 public meeting. AMS accepts the NOSB's 
recommendation on removing Turkish bay leaves from the National List. 
This proposed rule would amend National List Sec.  205.606 by removing 
the substance exemption for Turkish bay leaves listed in Sec.  
205.606(w). This amendment is proposed to be effective on the current 
sunset date for Turkish bay leaves, which is June 27, 2017.
Whey Protein Concentrate
    The USDA organic regulations include an exemption on the National 
List for whey protein concentrate, allowed as an ingredient in or on 
processed products labeled as ``organic'' in Sec.  205.606(y) as 
follows: whey protein concentrate. In February 2007, whey protein 
concentrate was petitioned for addition to Sec.  205.606 for use as an 
ingredient in or on organic processed products. In April 2007, the NOSB 
recommended adding whey protein concentrate to the National List in 
Sec.  205.606. AMS accepted the NOSB's recommendation and whey protein 
concentrate was added to the National List on June 27, 2007 (72 FR 
35137). As required by OFPA, the NOSB recommended the renewal of whey 
protein concentrate during their 2012 sunset review. The Secretary 
accepted the NOSB's recommendation and published a notice renewing the 
whey protein concentrate exemption on the National List on June 6, 2012 
(77 FR 33290). Subsequently, the exemption for whey protein concentrate 
on the National List was considered during the NOSB's 2017 sunset 
review. Two notices of the public meetings on the 2017 sunset review 
with request for comments were published in Federal Register on March 
12, 2015 (80 FR 12975) and September 8, 2015 (80 FR 53759). The purpose 
of these notices was to notify the public that the whey protein 
concentrate exemption discussed in this proposed rule would expire on 
June 27, 2017, if not reviewed by the NOSB and renewed by the 
Secretary.
    During their 2017 sunset review deliberation, the NOSB considered 
written comments received prior to and during the public meetings on 
all substance exemptions included in the 2017 sunset review. These 
written comments can be viewed at https://www.regulations.gov by 
searching for the document ID numbers: AMS-NOP-15-0002 (April 2015 
public meeting) and AMS-NOP-15-0037 (October 2015 public meeting). The 
NOSB also considered oral comments received during these public 
meetings. The NOSB's recommendation on whey protein concentrate is 
available on the NOP Web site at http://www.ams.usda.gov/nop. During 
their sunset review of whey protein concentrate the NOSB considered a 
whey protein concentrate technical report that were requested by and 
developed for the NOSB in 2015. This technical report is available for 
review in the petitioned substance database on the NOP Web site, 
https://www.ams.usda.gov/rules-regulations/organic/national-list.
    Public comments on whey protein concentrate received by the NOSB 
during their 2017 Sunset review indicated that organic whey protein 
concentrate sources are available to organic processors. Based upon 
these comments, the NOSB determined that the exemption for whey protein 
concentrate in Sec.  205.606(y) is no longer necessary or essential for 
organic handling/processing. From this determination, the NOSB 
recommended the removal of whey protein concentrate from Sec.  
205.606(y) from the National List at their October 2015 public meeting. 
AMS accepts the NOSB's recommendation on removing whey protein 
concentrate from the National List. This proposed rule would amend 
National List Sec.  205.606 by removing the substance exemption for 
whey protein concentrate listed in Sec.  205.606(y). This amendment is 
proposed to be effective on the current sunset date for whey protein 
concentrate, which is June 27, 2017.

III. Related Documents

    Two notices of public meetings with request for comments were 
published in

[[Page 5437]]

Federal Register on March 12, 2015 (80 FR 12975) and on September 8, 
2015 (80 FR 53759) in order to notify the public that the 2017 sunset 
review listings discussed in this proposed rule would expire on June 
27, 2017, if not reviewed by the NOSB and renewed by the Secretary.

IV. Statutory and Regulatory Authority

    OFPA, as amended (7 U.S.C. 6501-6522), authorizes the Secretary to 
make amendments to the National List based on proposed recommendations 
developed by the NOSB. Sections 6518(k)(2) and 6518(n) of OFPA 
authorize the NOSB to develop proposed amendments to the National List 
for submission to the Secretary and establish a petition process by 
which persons may petition the NOSB for the purpose of having 
substances evaluated for inclusion on or deletion from the National 
List. The National List petition process is implemented under Sec.  
205.607 of the USDA organic regulations. The current petition process 
was published on March 10, 2016 (81 FR 12680) and can be accessed 
through the NOP Web site at http://www.ams.usda.gov/nop.

A. Executive Order 12866

    This action has been determined to be not significant for purposes 
of Executive Order 12866, and therefore, has not been reviewed by the 
Office of Management and Budget.

B. Executive Order 12988

    Executive Order 12988 instructs each executive agency to adhere to 
certain requirements in the development of new and revised regulations 
in order to avoid unduly burdening the court system. This proposed rule 
is not intended to have a retroactive effect.
    States and local jurisdictions are preempted under OFPA from 
creating programs of accreditation for private persons or State 
officials who want to become certifying agents of organic farms or 
handling operations. A governing State official would have to apply to 
USDA to be accredited as a certifying agent, as described in section 
2115(b) of OFPA (7 U.S.C. 6514(b)). States are also preempted under 
section 2104 through 2108 of OFPA (7 U.S.C. 6503 through 6507) from 
creating certification programs to certify organic farms or handling 
operations unless the State programs have been submitted to, and 
approved by, the Secretary as meeting the requirements of OFPA.
    Pursuant to section 2108(b)(2) of OFPA (7 U.S.C. 6507(b)(2)), a 
State organic certification program may contain additional requirements 
for the production and handling of organically produced agricultural 
products that are produced in the State and for the certification of 
organic farm and handling operations located within the State under 
certain circumstances. Such additional requirements must: (a) Further 
the purposes of OFPA, (b) not be inconsistent with OFPA, (c) not be 
discriminatory toward agricultural commodities organically produced in 
other States, and (d) not be effective until approved by the Secretary.
    Pursuant to section 2120(f) of OFPA (7 U.S.C. 6519(f)), this 
proposed rule would not alter the authority of the Secretary under the 
Federal Meat Inspection Act (21 U.S.C. 601-624), the Poultry Products 
Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act 
(21 U.S.C. 1031-1056), concerning meat, poultry, and egg products, nor 
any of the authorities of the Secretary of Health and Human Services 
under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301-399), nor 
the authority of the Administrator of EPA under the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136-136(y)).
    Section 2121 of OFPA (7 U.S.C. 6520) provides for the Secretary to 
establish an expedited administrative appeals procedure under which 
persons may appeal an action of the Secretary, the applicable governing 
State official, or a certifying agent under this title that adversely 
affects such person or is inconsistent with the organic certification 
program established under this title. OFPA also provides that the U.S. 
District Court for the district in which a person is located has 
jurisdiction to review the Secretary's decision.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires 
agencies to consider the economic impact of each rule on small entities 
and evaluate alternatives that would accomplish the objectives of the 
rule without unduly burdening small entities or erecting barriers that 
would restrict their ability to compete in the market. The purpose of 
the RFA is to fit regulatory actions to the scale of businesses subject 
to the action. Section 605 of the RFA allows an agency to certify a 
rule, in lieu of preparing an analysis, if the rulemaking is not 
expected to have a significant economic impact on a substantial number 
of small entities.
    Pursuant to the requirements set forth in the RFA, AMS performed an 
economic impact analysis on small entities in the final rule published 
in the Federal Register on December 21, 2000 (65 FR 80548). AMS has 
also considered the economic impact of this action on small entities. 
The impact on entities affected by this proposed rule would not be 
significant. The effect of this proposed rule would be to prohibit the 
use of eleven non-organic non-agricultural or non-organic agricultural 
substances that have limited public support and may no longer be used 
since alternatives to these substances may have been developed and 
implemented by organic producers or organic handlers (food processors). 
AMS concludes that the economic impact of removing lignin sulfonate, 
furosemide, magnesium carbonate, Chia, dillweed oil, frozen galangal, 
inulin, frozen lemongrass, chipotle chile peppers, Turkish bay leaves, 
and whey protein concentrate from the National List would be minimal to 
small agricultural firms since alternative products or ingredients may 
be commercially available. As such, these substances are proposed to be 
removed from the National List under this rule. Accordingly, AMS 
certifies that this rule will not have a significant economic impact on 
a substantial number of small entities.
    Small agricultural service firms, which include producers, 
handlers, and accredited certifying agents, have been defined by the 
Small Business Administration (SBA) (13 CFR 121.201) as those having 
annual receipts of less than $7,000,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000.
    According to USDA, National Agricultural Statistics Service (NASS), 
certified organic acreage exceeded 3.6 million acres in 2014.\1\ 
According to NOP's Accreditation and International Activities Division, 
the number of certified U.S. organic crop and livestock operations 
totaled over 21,764 in March 2016. The list of certified operations is 
available on the NOP Web site at http://apps.ams.usda.gov/nop/. AMS 
believes that most of these entities would be considered small entities 
under the criteria established by the SBA. U.S. sales of organic food 
and non-food have grown from $1 billion in 1990 to $43 billion in 
2015.\2\ In addition, the USDA has 80 accredited certifying agents who 
provide certification services to producers and handlers. A complete 
list of names and addresses of accredited certifying agents may be 
found on the AMS NOP Web site, at http://

[[Page 5438]]

www.ams.usda.gov/nop. AMS believes that most of these accredited 
certifying agents would be considered small entities under the criteria 
established by the SBA.
---------------------------------------------------------------------------

    \1\ U.S. Department of Agriculture, National Agricultural 
Statistics Service. 2014 Organic Survey, https://www.agcensus.usda.gov/Publications/2012/Online_Resources/Organics/organics_1_001_001.pdf.
    \2\ Organic Trade Association. 2015. Organic Industry Survey. 
www.ota.com.
---------------------------------------------------------------------------

D. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this proposed rule. Accordingly, OMB clearance is not 
required by section 350(h) of the Paperwork Reduction Act of 1995, 44 
U.S.C. 3501, Chapter 35, or OMB's implementing regulations at 5 CFR 
part 1320.

E. Executive Order 13175

    This proposed rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. The review reveals that this regulation 
will not have substantial and direct effects on Tribal governments and 
will not have significant Tribal implications.

F. General Notice of Public Rulemaking

    This proposed rule reflects recommendations submitted to the 
Secretary by the NOSB for substances on the National List of Allowed 
and Prohibited Substances that, under the Sunset review provisions of 
OFPA, would otherwise expire on June 27, 2017. A 60-day period for 
interested persons to comment on this rule is provided. Sixty days is 
deemed appropriate because the review of these listings was widely 
publicized through two NOSB meeting notices; the use or prohibition of 
these substances, as applicable, are critical to organic production and 
handling; and this rulemaking must be completed before the sunset date 
of June 27, 2017.

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agriculture, Animals, 
Archives and records, Imports, Labeling, Organically produced products, 
Plants, Reporting and recordkeeping requirements, Seals and insignia, 
Soil conservation.

    For the reasons set forth in the preamble, 7 CFR part 205 is 
proposed to be amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

0
1. The authority citation for 7 CFR part 205 continues to read as 
follows:

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

0
2. Amend Sec.  205.601 by revising paragraph (l) to read as follows:


Sec.  205.601   Synthetic substances allowed for use in organic crop 
production.

* * * * *
    (l) As floating agents in postharvest handling. Sodium silicate--
for tree fruit and fiber processing.
* * * * *


Sec.  205.603   [Amended]

0
3. Amend Sec.  205.603 by removing paragraph (a)(10) and redesignating 
paragraphs (a)(11) through (a)(23) as paragraphs (a)(10) through 
(a)(22).


Sec.  205.605   [Amended]

0
4. Amend Sec.  205.605 by removing the entry ``Magnesium carbonate--for 
use only in agricultural products labeled ``made with organic 
(specified ingredients or food group(s)),'' prohibited in agricultural 
products labeled ``organic'' from paragraph (b).


Sec.  205.606   [Amended]

0
5. Amend Sec.  205.606 by removing paragraphs (c), (e), (h), (k), (o), 
(s), (w) and (y) and redesignating paragraphs (d), (f), (g), (i), 
(j),(l), (m), (n), (p), (q), (r), (t), (u) and (x) as paragraphs (c) 
through (q).

    Dated: January 9, 2017.
Elanor Starmer,
Administrator, Agricultural Marketing Service.
[FR Doc. 2017-00586 Filed 1-17-17; 8:45 am]
 BILLING CODE 3410-02-P