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Rules and Regulations
Federal Register Vol. 86, No. 120
Friday, June 25, 2021

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.

DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service 7 CFR Part 205
Doc. No. AMSNOP190053; NOP1902
RIN 0581AD92

National Organic Program:
Amendments to the National List of Allowed and Prohibited Substances per April 2019 NOSB
Recommendations Livestock and Handling Agricultural Marketing Service, USDA.
ACTION: Final rule.
AGENCY:

This rule amends the National List of Allowed and Prohibited Substances National List section of the U.S. Department of Agricultures USDA organic regulations to implement recommendations submitted to the Secretary of Agriculture Secretary by the National Organic Standards Board NOSB. This rule adds the following allowed substances to the National List: Oxalic acid dihydrate as a pesticide for organic apiculture beekeeping; pullulan for use in organic handling in products labeled, Made with organic specified ingredients or food groups; and collagen gel as a nonorganic nonagricultural substance for use as a casing in organic handling when organic forms of collagen gel are not commercially available.
DATES: This rule is effective on July 26, 2021.
FOR FURTHER INFORMATION CONTACT:
Jared Clark, Standards Division, National Organic Program. Telephone:
202 7203252.
SUPPLEMENTARY INFORMATION:

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SUMMARY:

I. Background On December 21, 2000, the Secretary established the Agricultural Marketing Services AMS National Organic Program and the USDA organic
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regulations 65 FR 80547. Within the USDA organic regulations 7 CFR part 205 is the National List of Allowed and Prohibited Substances or National List.
The National List identifies the synthetic substances that may be used and the nonsynthetic natural substances that may not be used in organic crop and livestock production.
It also identifies the nonorganic substances that may be used in or on processed organic products.
AMS is finalizing three amendments to the National List in accordance with the procedures detailed in the Organic Foods Production Act of 1990 OFPA 7
U.S.C. 65016524. OFPA establishes what may be included on the National List and the procedures that USDA must follow to amend the National List sec.
6517. OFPA also describes the NOSBs responsibilities in proposing amendments to the National List, including the criteria for evaluating amendments to the National List sec.
6518.
This final rule adds oxalic acid dihydrate, pullulan, and nonorganic collagen gel to the National List. Once effective, producers and handlers of organic products will be allowed to use these substances in organic production and in organic products. The permitted use of each substance is discussed in detail below.
To remain on the National List, these substances must be: 1 Reviewed every 5 years by the NOSB, a 15-member federal advisory committee; and 2
renewed by the Secretary sec. 6517e.
This action of NOSB review and USDA
renewal is commonly referred to as the sunset review or sunset process.
AMS published information about this process in the Federal Register on September 16, 2013 78 FR 56811. The sunset date i.e., the date by which the Secretary must renew a substance for the listing to remain valid on the National List for each substance is included in the NOP Program Handbook document NOP 5611. The first sunset date for the substances in this final rule will be 5 years from the effective date in the DATES section of this final rule above.
II. Overview of Amendments This rule adds oxalic acid, pullulan, and nonorganic collagen gel to the National List for use in organic livestock production or handling. Additional background on the petitions and the
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NOSBs review of the substances may be found in the proposed rule 85 FR
35011; June 8, 2020.
During a 60-day comment period that closed on August 7, 2020, AMS received 20 comments on the proposed rule. See below for a discussion of the comments received and AMS responses to comments. Comments can be viewed through Regulations.gov. Use the search area on the homepage at https
www.regulations.gov to enter a keyword, title, or docket ID the docket folder for this rule is AMSNOP190053.
Oxalic Acid Dihydrate 205.603
Final Action The final rule amends the National List to add oxalic acid dihydrate to 7
CFR 205.603 as a synthetic substance allowed for use in organic apiculture beekeeping only. Oxalic acid dihydrate is a pesticide used for Varroa mite control on bees. Oxalic acid is a naturally occurring substance, but this rule allows for the use of the synthetic form i.e., synthesized via chemical process of oxalic acid dihydrate.
AMS is finalizing this amendment to the National List, as proposed by NOSB, to provide beekeepers that manage organic bees with an additional option to combat parasitic Varroa mites. Since arriving to the United States in 1987, Varroa mites have caused the death of massive numbers of honey bee colonies, and beekeepers have identified Varroa mites as their single most serious problem causing colony losses.1 The mites damage honey bees both directly by attaching to bees and by serving as a vector for pathogenic viruses.
Oxalic acid dihydrate is one of a dozen substances currently registered by the EPA for the control of Varroa mites,2
and only a subset of these are allowed under USDA organic regulations. For example, the National List includes formic acid 205.603b3 as a pesticide to treat hives. The addition of oxalic acid dihydrate will be important addition to the National List, as rotating products to combat Varroa mites is an important tactic to prevent resistance 1 USDA Agricultural Research Service https
www.ars.usda.gov/oc/br/ccd/index/. Accessed February 1, 2021.
2 U.S. Environmental Protection Agency, https
www.epa.gov/pollinator-protection/epa-registeredpesticide-products-approved-use-against-varroamites-bee-hives. Accessed February 1, 2021.

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