83_FR_14412 83 FR 14347 - National Organic Program: USDA Organic Regulations

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]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 

========================================================================


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



                                                                                                                                                                                           14347

                                           Rules and Regulations                                                                                         Federal Register
                                                                                                                                                         Vol. 83, No. 65

                                                                                                                                                         Wednesday, April 4, 2018



                                           This section of the FEDERAL REGISTER                    80548) and became effective on October                List substances. This renewal occurs
                                           contains regulatory documents having general            21, 2002. Through these regulations,                  after the NOSB review.
                                           applicability and legal effect, most of which           AMS oversees national organic                            In accordance with the sunset review
                                           are keyed to and codified in the Code of                standards for the production, handling,               process, AMS published two notices in
                                           Federal Regulations, which is published under
                                           50 titles pursuant to 44 U.S.C. 1510.
                                                                                                   and labeling of organically produced                  the Federal Register announcing the
                                                                                                   agricultural products.                                NOSB meetings and inviting public
                                           The Code of Federal Regulations is sold by                 Since October 2002, the USDA                       comments pertinent to this renewal
                                           the Superintendent of Documents.                        organic regulations have been frequently              notification: March 16, 2016 (81 FR
                                                                                                   amended, mostly for changes to the                    14079) and August 1, 2016 (81 FR
                                                                                                   National List in 7 CFR 205.601–205.606.               50460). The NOSB also conducted two
                                           DEPARTMENT OF AGRICULTURE                                                                                     public webinars (April 19, 2016 and
                                                                                                   The National List identifies synthetic
                                           Agricultural Marketing Service                          substances that may be used and the                   November 3, 2016), to provide
                                                                                                   nonsynthetic substances that must not                 opportunities for public comment. The
                                           7 CFR Part 205                                          be used in organic production. The                    NOSB received additional public
                                                                                                   National List also identifies synthetic,              comment during the face-to-face
                                           [Document Number AMS–NOP–17–0085;                       nonsynthetic nonagricultural, and                     meetings on April 25–27, 2016 and
                                           NOP–17–05]                                              nonorganic agricultural substances that               November 16–18, 2016.
                                                                                                   may be used in organic handling. The                     At these public meetings, the NOSB
                                           National Organic Program: USDA                          OFPA and USDA organic regulations                     reviewed 17 substances with a 2018
                                           Organic Regulations                                     specifically prohibit the use of any                  sunset date. Table 1 shows the current
                                           AGENCY: Agricultural Marketing Service,                 synthetic substance in organic                        listings for these substances. The NOSB
                                           USDA.                                                   production and handling unless the                    recommended removing one substance,
                                                                                                   synthetic substance is on the National                carrageenan, and completed its sunset
                                           ACTION: Notification of 2018 Sunset
                                                                                                   List. Section 205.105 of the USDA                     review for the 16 other substances. The
                                           Review.                                                 organic regulations also requires that                NOSB recommended removing
                                                                                                   any nonorganic agricultural substance                 carrageenan because they determined
                                           SUMMARY:   This document announces the
                                                                                                   and any nonsynthetic nonagricultural                  that alternative materials, such as gellan
                                           renewal of 17 substances on the
                                                                                                   substance used in organic handling                    gum, guar gum, or xanthan gum, are
                                           National List of Allowed and Prohibited
                                                                                                   appear on the National List.                          available for use in organic products.
                                           Substances (National List) within the
                                           U.S. Department of Agriculture’s                           The OFPA authorizes the NOSB,                         AMS has reviewed NOSB’s sunset
                                           (USDA) organic regulations. This                        operating in accordance with the                      review document and decided to renew
                                           document reflects the outcome of the                    Federal Advisory Committee Act (5                     all 17 substances, including
                                           2018 sunset review process and                          U.S.C. App. 2 et seq.), to assist in the              carrageenan. AMS found sufficient
                                           addresses the recommendations                           evaluation of substances to be allowed                evidence in public comments to the
                                           submitted to the Secretary of                           or prohibited for organic production and              NOSB that carrageenan continues to be
                                           Agriculture (Secretary), through the                    handling and to advise the Secretary on               necessary for handling agricultural
                                           USDA’s Agricultural Marketing Service                   the USDA organic regulations. The                     products because of the unavailability of
                                           (AMS), by the National Organic                          OFPA also requires a review of all                    wholly natural substitutes
                                           Standards Board (NOSB).                                 substances included on the National                   (§ 6517(c)(1)(ii)). Carrageenan has
                                                                                                   List within five years of their addition              specific uses in an array of agricultural
                                           DATES: This document is effective May
                                                                                                   to or renewal on the list. During this                products, and public comments
                                           29, 2018.                                               sunset review, the NOSB considers any                 reported that potential substitutes do
                                           FOR FURTHER INFORMATION CONTACT: Paul                   new information pertaining to a                       not adequately replicate the functions of
                                           Lewis, Ph.D., Director, Standards                       substance’s impact on human health                    carrageenan across the broad scope of
                                           Division, Telephone: (202) 720–3252;                    and the environment, its necessity due                use. Therefore, carrageenan continues to
                                           Fax: (202) 260–9151.                                    to the unavailability of wholly natural               meet the OFPA criteria for inclusion on
                                           SUPPLEMENTARY INFORMATION:                              substances, and its consistency with                  the National List. The renewal of these
                                                                                                   organic production and handling. If a                 17 substances will avoid potential
                                           I. Background                                           listed substance is not reviewed by the               disruptions to the organic industry and
                                             The USDA AMS administers the                          NOSB and renewed by the USDA within                   the public that may otherwise result
                                           National Organic Program (NOP) under                    the five-year period, its allowance or                from their removal from the National
                                           the authority of the Organic Foods                      prohibition on the National List is no                List.
                                           Production Act of 1990 (OFPA), as                       longer in effect.                                        Table 1 lists the 17 synthetic and
                                           amended (7 U.S.C. 6501–6524). The                          AMS published a revision of the                    nonsynthetic substances on the National
                                           regulations implementing the NOP, also                  sunset review process in the Federal                  List that are being renewed. These
amozie on DSK30RV082PROD with RULES




                                           referred to as the USDA organic                         Register on September 16, 2013 (78 FR                 substances continue to be included on
                                           regulations (7 CFR part 205), were                      56811). This revised process provides                 the National List with a new sunset date
                                           published on December 21, 2000 (65 FR                   public notice on the renewal of National              of May 29, 2023.




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                                           14348                       Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Rules and Regulations

                                                                                             TABLE 1—SUBSTANCES RENEWED IN 2018 SUNSET REVIEW
                                              National list                                                                             Substance listing
                                                section

                                                                                        § 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 pe-
                                                                         riod. 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 hydro-
                                                                         gen peroxide formulations as allowed in § 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
                                                                         § 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 sub-
                                                                         stances or synthetic substances listed in this section and used as an active pesticide ingredient in accordance with any limi-
                                                                         tations on the use of such substances.
                                           (2) ...................     EPA List 3—Inerts of unknown toxicity—for use only in passive pheromone dispensers.

                                                                                  § 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 asso-
                                                                        ciated with calcium uptake.

                                            § 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.

                                              § 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.                               DEPARTMENT OF AGRICULTURE                             SUMMARY:   The Department of
                                             Dated: March 30, 2018.                                                                                              Agriculture adopts as final without
                                                                                                           Agricultural Marketing Service                        change, an interim rule implementing a
                                           Bruce Summers,
                                                                                                                                                                 recommendation from the Citrus
                                           Acting Administrator, Agricultural Marketing                    7 CFR Part 905
                                           Service.
                                                                                                                                                                 Administrative Committee (Committee)
                                                                                                                                                                 to relax the minimum size requirements
                                           [FR Doc. 2018–06867 Filed 4–3–18; 8:45 am]
                                                                                                           [Doc. No. AMS–SC–17–0064; SC17–905–2                  currently prescribed under the
                                           BILLING CODE 3410–02–P                                          FIR]                                                  Marketing Order for oranges, grapefruit,
                                                                                                                                                                 tangerines, and pummelos grown in
                                                                                                           Oranges, Grapefruit, Tangerines, and
                                                                                                                                                                 Florida (Order). This final rule also
                                                                                                           Pummelos Grown in Florida; Change
amozie on DSK30RV082PROD with RULES




                                                                                                           in Size Requirements for Oranges                      continues in effect administrative
                                                                                                                                                                 revisions to the subpart heading to bring
                                                                                                           AGENCY:    Agricultural Marketing Service,            the language into conformance with the
                                                                                                           USDA.                                                 Office of Federal Register requirements.
                                                                                                           ACTION:   Final rule.                                 DATES:    Effective April 5, 2018.



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Document Created: 2018-11-01 09:11:41
Document Modified: 2018-11-01 09:11:41
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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