83 FR 14347 - National Organic Program: USDA Organic Regulations

DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service

Federal Register Volume 83, Issue 65 (April 4, 2018)

Page Range14347-14348
FR Document2018-06867

This document announces the renewal of 17 substances on the National List of Allowed and Prohibited Substances (National List) within the U.S. Department of Agriculture's (USDA) organic regulations. This document reflects the outcome of the 2018 sunset review process and addresses the recommendations submitted to the Secretary of Agriculture (Secretary), through the USDA's Agricultural Marketing Service (AMS), by the National Organic Standards Board (NOSB).

Federal Register, Volume 83 Issue 65 (Wednesday, April 4, 2018)
[Federal Register Volume 83, Number 65 (Wednesday, April 4, 2018)]
[Rules and Regulations]
[Pages 14347-14348]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06867]



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Rules and Regulations
                                                Federal Register
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Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Rules 
and Regulations

[[Page 14347]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-17-0085; NOP-17-05]


National Organic Program: USDA Organic Regulations

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Notification of 2018 Sunset Review.

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

SUMMARY: This document announces the renewal of 17 substances on the 
National List of Allowed and Prohibited Substances (National List) 
within the U.S. Department of Agriculture's (USDA) organic regulations. 
This document reflects the outcome of the 2018 sunset review process 
and addresses the recommendations submitted to the Secretary of 
Agriculture (Secretary), through the USDA's Agricultural Marketing 
Service (AMS), by the National Organic Standards Board (NOSB).

DATES: This document is effective May 29, 2018.

FOR FURTHER INFORMATION CONTACT: Paul Lewis, Ph.D., Director, Standards 
Division, Telephone: (202) 720-3252; Fax: (202) 260-9151.

SUPPLEMENTARY INFORMATION:

I. Background

    The USDA AMS administers the National Organic Program (NOP) under 
the authority of the Organic Foods Production Act of 1990 (OFPA), as 
amended (7 U.S.C. 6501-6524). The regulations implementing the NOP, 
also referred to as the USDA organic regulations (7 CFR part 205), were 
published on December 21, 2000 (65 FR 80548) and became effective on 
October 21, 2002. Through these regulations, AMS oversees national 
organic standards for the production, handling, and labeling of 
organically produced agricultural products.
    Since October 2002, the USDA organic regulations have been 
frequently amended, mostly for changes to the National List in 7 CFR 
205.601-205.606. The National List identifies synthetic substances that 
may be used and the nonsynthetic substances that must 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 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. Section 205.105 of the USDA organic regulations also 
requires that any nonorganic agricultural substance and any 
nonsynthetic nonagricultural substance used in organic handling appear 
on the National List.
    The OFPA authorizes 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 allowed or prohibited for organic 
production and handling and to advise the Secretary on the USDA organic 
regulations. The OFPA also requires a review of all substances included 
on the National List within five years of their addition to or renewal 
on the list. During this sunset review, the NOSB considers any new 
information pertaining to a substance's impact on human health and the 
environment, its necessity due to the unavailability of wholly natural 
substances, and its consistency with organic production and handling. 
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.
    AMS published a revision of the sunset review process in the 
Federal Register on September 16, 2013 (78 FR 56811). This revised 
process provides public notice on the renewal of National List 
substances. This renewal occurs after the NOSB review.
    In accordance with the sunset review process, AMS published two 
notices in the Federal Register announcing the NOSB meetings and 
inviting public comments pertinent to this renewal notification: March 
16, 2016 (81 FR 14079) and August 1, 2016 (81 FR 50460). The NOSB also 
conducted two public webinars (April 19, 2016 and November 3, 2016), to 
provide opportunities for public comment. The NOSB received additional 
public comment during the face-to-face meetings on April 25-27, 2016 
and November 16-18, 2016.
    At these public meetings, the NOSB reviewed 17 substances with a 
2018 sunset date. Table 1 shows the current listings for these 
substances. The NOSB recommended removing one substance, carrageenan, 
and completed its sunset review for the 16 other substances. The NOSB 
recommended removing carrageenan because they determined that 
alternative materials, such as gellan gum, guar gum, or xanthan gum, 
are available for use in organic products.
    AMS has reviewed NOSB's sunset review document and decided to renew 
all 17 substances, including carrageenan. AMS found sufficient evidence 
in public comments to the NOSB that carrageenan continues to be 
necessary for handling agricultural products because of the 
unavailability of wholly natural substitutes (Sec.  6517(c)(1)(ii)). 
Carrageenan has specific uses in an array of agricultural products, and 
public comments reported that potential substitutes do not adequately 
replicate the functions of carrageenan across the broad scope of use. 
Therefore, carrageenan continues to meet the OFPA criteria for 
inclusion on the National List. The renewal of these 17 substances will 
avoid potential disruptions to the organic industry and the public that 
may otherwise result from their removal from the National List.
    Table 1 lists the 17 synthetic and nonsynthetic substances on the 
National List that are being renewed. These substances continue to be 
included on the National List with a new sunset date of May 29, 2023.

[[Page 14348]]



            Table 1--Substances Renewed in 2018 Sunset Review
------------------------------------------------------------------------
  National list section                  Substance listing
------------------------------------------------------------------------
   Sec.   205.601 Synthetic substances allowed for use in organic crop
                               production.
------------------------------------------------------------------------
(a).....................  As algicide, disinfectants, and sanitizer,
                           including irrigation system cleaning systems.
(3).....................  Copper Sulfate--for use as an algicide in
                           aquatic rice systems, is limited to one
                           application per field during any 24-month
                           period. Application rates are limited to
                           those which do not increase baseline soil
                           test values for copper over a timeframe
                           agreed upon by the producer and accredited
                           certifying agent.
(5).....................  Ozone gas--for use as an irrigation system
                           cleaner only.
(6).....................  Peracetic acid--for use in disinfecting
                           equipment, seed, and asexually propagated
                           planting material. Also permitted in hydrogen
                           peroxide formulations as allowed in Sec.
                           205.601(a) at concentration of no more than
                           6% as indicated on the pesticide product
                           label.
(e).....................  As insecticides (including acaricides or mite
                           control).
(4).....................  Copper Sulfate--for use as tadpole shrimp
                           control in aquatic rice production, is
                           limited to one application per field during
                           any 24-month period. Application rates are
                           limited to levels which do not increase
                           baseline soil test values for copper over a
                           timeframe agreed upon by the producer and
                           accredited certifying agent.
(i).....................  As plant disease control.
(8).....................  Peracetic acid--for use to control fire blight
                           bacteria. Also permitted in hydrogen peroxide
                           formulations as allowed in Sec.   205.601(i)
                           at concentration of no more than 6% as
                           indicated on the pesticide product label.
(m).....................  As synthetic inert ingredients as classified
                           by the Environmental Protection Agency (EPA),
                           for use with nonsynthetic substances or
                           synthetic substances listed in this section
                           and used as an active pesticide ingredient in
                           accordance with any limitations on the use of
                           such substances.
(2).....................  EPA List 3--Inerts of unknown toxicity--for
                           use only in passive pheromone dispensers.
------------------------------------------------------------------------
  Sec.   205.602 Nonsynthetic substances prohibited for use in organic
                            crop production.
------------------------------------------------------------------------
(c).....................  Calcium chloride, brine process is natural and
                           prohibited for use except as a foliar spray
                           to treat a physiological disorder associated
                           with calcium uptake.
------------------------------------------------------------------------
    Sec.   205.605 Nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or ``made
        with organic (specified ingredients or food group(s)).''
------------------------------------------------------------------------
(a).....................  Nonsynthetics allowed:
                             Agar-agar.
                             Animal enzymes--(Rennet-animals derived;
                              Catalase-bovine liver; Animal lipase;
                              Pancreatin; Pepsin; and Trypsin).
                             Calcium sulfate--mined.
                             Carrageenan.
                             Glucono delta-lactone--production by the
                              oxidation of D-glucose with bromine water
                              is prohibited.
                             Tartaric acid--made from grape wine.
(b).....................  Synthetics allowed:
                          Cellulose--for use in regenerative casings, as
                           an anti-caking agent (non-chlorine bleached)
                           and filtering aid.
                          Potassium hydroxide--prohibited for use in lye
                           peeling of fruits and vegetables except when
                           used for peeling peaches.
                          Silicon dioxide--Permitted as a defoamer.
                           Allowed for other uses when organic rice
                           hulls are not commercially available.
------------------------------------------------------------------------
 Sec.   205.606 Nonorganically produced agricultural products allowed as
     ingredients in or on processed products labeled as ``organic.''
------------------------------------------------------------------------
Only the following nonorganically produced agricultural products may be
 used as ingredients in or on processed products labeled as ``organic,''
 only in accordance with any restrictions specified in this section, and
 only when the product is not commercially available in organic form.
------------------------------------------------------------------------
(c).....................  Colors derived from agricultural products--
                           Must not be produced using synthetic solvents
                           and carrier systems or any artificial
                           preservative.
(2).....................  Beta-carotene extract color--derived from
                           carrots or algae (pigment CAS# 7235-40-7).
------------------------------------------------------------------------


    Authority: 7 U.S.C. 6501-6524.

    Dated: March 30, 2018.
Bruce Summers,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2018-06867 Filed 4-3-18; 8:45 am]
BILLING CODE 3410-02-P


Current View
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionNotification of 2018 Sunset Review.
DatesThis document is effective May 29, 2018.
ContactPaul Lewis, Ph.D., Director, Standards Division, Telephone: (202) 720-3252; Fax: (202) 260-9151.
FR Citation83 FR 14347 

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