[Federal Register Volume 84, Number 195 (Tuesday, October 8, 2019)]
[Rules and Regulations]
[Pages 53577-53578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21171]



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 Rules and Regulations
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  Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / 
Rules and Regulations  

[[Page 53577]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-19-0035; NOP-18-05]


National Organic Program: USDA Organic Regulations

AGENCY: Agricultural Marketing Service, USDA.

ACTION: 2019 Sunset Review and substance renewals.

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SUMMARY: This document announces the renewal of substance exemptions as 
listed 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 2019 
sunset review process and addresses 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 action is effective October 30, 2019.

FOR FURTHER INFORMATION CONTACT: Robert Pooler, Standards Division, 
Telephone: (202) 720-3252; Fax: (202) 260-9151.

SUPPLEMENTARY INFORMATION: 

I. Background

    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 the synthetic substances allowed to be 
used and nonsynthetic substances prohibited from use in organic 
farming. The National List also identifies synthetic and nonsynthetic 
nonagricultural (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 an exemption for using the synthetic substance is 
provided on the National List. Section 205.105 of the USDA organic 
regulations also requires that any nonorganic agricultural substance 
and any nonagricultural substance used in organic handling be listed as 
allowed on the National List.
    The OFPA at Sec.  6578 authorizes the NOSB, operating in accordance 
with the Federal Advisory Committee Act (Sec.  1 et seq., 5 U.S.C. 
App.2), as amended, to assist in evaluating substances to be allowed or 
prohibited for organic production and handling and to advise the 
Secretary on the USDA organic regulations. The OFPA sunset provision 
(Sec.  6517(e)) also requires a review of all substance exemptions 
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. The NOSB subsequently votes to remove a substance allowance 
or prohibition from the National List.
    The Agricultural Improvement Act of 2018 amended the OFPA at Sec.  
6518(i)(2) to specify that any vote on a motion proposing to amend the 
National List requires \2/3\ of the votes cast at a meeting of the NOSB 
at which a quorum is present to prevail. A substance allowance or 
prohibition remains listed on the National List unless an NOSB motion 
to remove such substance carries with \2/3\ of votes cast, and the 
Secretary renews or amends the listing for such substance. The NOSB 
submits its sunset review and recommendations to the Secretary where, 
as delegated by the Secretary, AMS evaluates the sunset review and 
recommendations for compliance with the National List substance 
evaluation criteria in Sec.  6518(m) and other federal statutes or 
regulations. AMS also considers public comments submitted in 
association with a specific sunset review process.
    AMS published an updated sunset review process in the Federal 
Register on September 16, 2013 (78 FR 56811). In accordance with the 
sunset review process, AMS published two notices in the Federal 
Register announcing the NOSB meetings on April 19-21, 2017, and October 
31-November 2, 2017, and inviting public comments on the 2019 sunset 
review process (November 25, 2016 (81 FR 85205) and May 30, 2017 (82 FR 
24659)). AMS also hosted two public webinars (April 13, 2017 and, 
October 24 and 26, 2017), to provide additional opportunities for 
public comment. The NOSB received additional comment during the public 
meetings. At these public meetings, the NOSB reviewed substance 
exemptions scheduled to sunset from the National List and recommended 
these exemptions not be removed. Table 1 shows the current listings for 
these substance exemptions.
    AMS has reviewed and accepted the NOSB's 2019 sunset review 
recommendations and is renewing the listing of these substance 
exemptions until 2024.\1\ AMS has determined that the substance 
allowances listed in this notice continue to be necessary for organic 
production and/or organic handling because of the unavailability of 
organic forms or wholly natural substitutes for the specified uses 
(Sec.  6517(c)(1)(A)(ii)). The renewal of these substance allowances 
will avoid potential disruptions to the organic industry and consumers 
that may otherwise result from removal from the National List. AMS also 
has determined that the nonsynthetic substance prohibitions listed in 
this notice continue to be necessary because use of the two substances 
is inconsistent with organic production and/or organic handling (Sec.  
6517(c)(2)(A)(ii)).
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    \1\ National List Sunset Dates, NOP 5611, https://www.ams.usda.gov/sites/default/files/media/NOP-SunsetDates.pdf.
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    Five additional substance allowances were also reviewed and 
subsequently recommended for renewal by the NOSB:

[[Page 53578]]

Micronutrients, Sec.  205.601(j); chlorhexidine, Sec.  205.603(a); 
lidocaine, Sec.  205.603(b); chlorine materials, Sec.  205.605(b); and 
potassium acid tartrate, Sec.  205.605(b). These five substance 
allowances are not included in this renewal notice, because these 
substances were already amended on the National List as a result of 
final rules published on December 27, 2018 (83 FR 66559) and on April 
30, 2019 (84 FR 18133). The sunset date for micronutrients, Sec.  
205.601(j); chlorhexidine, Sec.  205.603(a); lidocaine, Sec.  
205.603(b); and chlorine materials, Sec.  205.605(b) is January 28, 
2024. The sunset date for potassium acid tartrate, Sec.  205.605(b), is 
May 30, 2024.
    The NOSB also reviewed and subsequently recommended to the 
Secretary the removal of the listed exemptions for use of vitamin 
B1 (Sec.  205.601), oxytocin (Sec.  205.603), procaine 
(Sec.  205.603), and konjac flour (Sec.  205.606). AMS is reviewing the 
NOSB recommendations to remove these substance allowances from the 
National List. Any removals from the National List would be addressed 
in a separate notice and comment rulemaking. AMS plans to take action 
on these substances before their sunset date of March 15, 2022.
    Table 1 lists the substance exemptions being renewed through this 
document. These specific substance allowances and prohibitions continue 
as listed on the National List with a new sunset date of October 30, 
2024.

     Table 1--National List Substances Renewed in 2019 Sunset Review
------------------------------------------------------------------------
               Substance                          Use conditions
------------------------------------------------------------------------
   Sec.   205.601 Synthetic substances allowed for use in organic crop
                               production.
------------------------------------------------------------------------
Chlorine materials: Calcium              As described under Sec.
 hypochlorite, Chlorine dioxide, Sodium   205.601(a)(2)(i, ii and iv).
 hypochlorite.
Herbicides, soap-based.................  As described under Sec.
                                          205.601(b)(1).
Mulches: Biodegradable biobased mulch    As described under Sec.
 film.                                    205.601(b)(2)(iii).
Boric acid.............................  As described under Sec.
                                          205.601(e)(3).
Sticky traps/barriers..................  As described under Sec.
                                          205.601(e)(9).
Coppers, fixed.........................  As described under Sec.
                                          205.601(i)(2).
Copper sulfate.........................  As described under Sec.
                                          205.601(i)(3).
Humic acids............................  As described under Sec.
                                          205.601(j)(3).
Vitamins, C, and E.....................  As described in Sec.
                                          205.601(j)(9).
------------------------------------------------------------------------
  Sec.   205.602 Nonsynthetic substances prohibited for use in organic
                            crop production.
------------------------------------------------------------------------
Lead salts.............................  As described under Sec.
                                          205.602(d).
Tobacco dust (nicotine sulfate)........  As described under Sec.
                                          205.602(j).
------------------------------------------------------------------------
Sec.   205.603 Synthetic substances allowed for use in organic livestock
                               production.
------------------------------------------------------------------------
Chlorine materials: Calcium              As described under Sec.
 hypochlorite, Chlorine dioxide, Sodium   205.603(a)(10)(i, ii and iv).
 hypochlorite.
Glucose................................  As described under Sec.
                                          205.603(a)(13).
Tolazoline (CAS # 59-98-3).............  As described under Sec.
                                          205.603(a)(29).
Copper sulfate.........................  As described under Sec.
                                          205.603(b)(1).
------------------------------------------------------------------------
    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)).''
------------------------------------------------------------------------
Attapulgite............................  As described under Sec.
                                          205.605(a).
Bentonite..............................  As described under Sec.
                                          205.605(a).
Diatomaceous earth.....................  As described under Sec.
                                          205.605(a).
Nitrogen...............................  As described under Sec.
                                          205.605(a).
Sodium carbonate.......................  As described under Sec.
                                          205.605(a).
Acidified sodium chlorite..............  As described under Sec.
                                          205.605(b).
Carbon dioxide.........................  As described under Sec.
                                          205.605(b).
Magnesium chloride.....................  As described under Sec.
                                          205.605(b).
Sodium phosphates......................  As described under Sec.
                                          205.605(b).
------------------------------------------------------------------------
 Sec.   205.606 Nonorganically produced agricultural products allowed as
     ingredients in or on processed products labeled as ``organic.''
------------------------------------------------------------------------
Casings................................  As described under Sec.
                                          205.606(b).
Pectin.................................  As described under Sec.
                                          205.606(p).
------------------------------------------------------------------------


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

    Dated: September 25, 2019.
Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2019-21171 Filed 10-7-19; 8:45 am]
 BILLING CODE 3410-02-P