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Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Rules and Regulations
development and to maintain the usefulness of individual pesticides.3
AMS concluded that the addition of oxalic acid dihydrate to the National List is consistent with the requirements of OFPA sec. 2118c 7 U.S.C. 6517c.
Namely, the substance is not harmful to human health or the environment when used as labeled; is necessary to production because of the unavailability of wholly natural substitute products;
and is consistent with organic farming and handling. The amendment is made following the procedures established in section 2118d of the OFPA 7 U.S.C.
6517d.
NOSB Review and Recommendation Oxalic Acid Dihydrate
lotter on DSK11XQN23PROD with RULES1

NOSB submitted a recommendation to AMS in April 2019 to add oxalic acid dihydrate to the National List.4 NOSB
recommendation followed receipt of a petition to add the substance to the National List in October 2017.5 In NOSBs evaluation of the petition, they considered information from a thirdparty technical evaluation report 6 and comments from the public. NOSB
discussed the petition to amend the National List in subcommittee calls and at its public meetings in October 2018
and April 2019.7
In its recommendation, NOSB
concluded that adding oxalic acid dihydrate to the National List was consistent with OFPA evaluation criteria in section 2119m 7 U.S.C.
6518m. NOSB found that the use of oxalic acid dihydrate as a mite pest control would be compatible with and necessary for organic apiculture, providing additional use benefits over formic acid. NOSB noted that oxalic acid occurs naturally in the environment and noted no concerns about environmental or human health impacts or oxalic acid residues in food products.
3 U.S. Environmental Protection Agency, https
www.epa.gov/pollinator-protection/epa-registeredpesticide-products-approved-use-against-varroamites-bee-hives. Accessed February 1, 2021.
4 NOSB final recommendation for oxalic acid dihydrate, April 26, 2019: https www.ams.
usda.gov/sites/default/files/media/LSOxalicAcid April2019FinalRec.pdf.
5 Oxalic acid petition: https www.ams.usda.gov/
sites/default/files/media/OxalicAcidPetition 10032017.pdf.
6 Technical Evaluation Report for oxalic acid dihydrate, November 26, 2018: https www.ams.
usda.gov/sites/default/files/media/Oxalic AcidTR.pdf.
7 Written and oral public comments submitted for the October 2018 and April 2019 NOSB meetings are available at https www.ams.usda.gov/event/
national-organic-standards-board-nosb-meeting-stpaul-mn and https www.ams.usda.gov/event/
national-organic-standards-board-nosb-meetingseattle-wa.

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Comments Received and AMS
Response Oxalic Acid Dihydrate Apiculture standards. Comments recommended that AMS act on NOSB
recommendations from September 2001
and October 2010 8 to further develop organic apiculture standards. Some believed that AMS should promulgate detailed standards for managing organic bees prior to adding synthetic substances for organic apiculture to the National List.
AMS notes that the USDA organic regulations include nonplant life e.g., bees in the definition of livestock 205.2. Given that AMS permits USDA-accredited certifiers to certify organic apicultural operations under the regulations for livestock production, AMS will continue to consider recommendations from NOSB regarding substances for organic apiculture operations. Additionally, the National List includes other substances that may be used in organic apiculture, including formic acid 205.603b3, which is permitted for the treatment of honeybee hives. Oxalic acid dihydrate provides some advantages compared to formic acid, and AMS is adding the substance to the National List to provide certified organic apiculture operations with an additional option to treat for Varroa.
General opposition. Some comments opposed the addition of oxalic acid dihydrate to the National List because they opposed any use of synthetic substances in organic production. AMS
notes that OFPA permits the use of specific synthetic substances i.e., those on the National List in organic production. OFPA describes the procedures for amending the National List and provides AMS and the NOSB
with criteria and guidelines to consider in evaluating changes to the National List. NOSB and AMS followed these procedures, and this rule adds oxalic acid dihydrate to the National List.
Health effects. Finally, AMS received a comment opposing the addition of oxalic acid dihydrate that cites a source that suggests that the consumption of oxalic acid dihydrate inhibits calcium availability in the human body. AMS
does not find merit in the comment.
AMS notes that EPAs Final Registration Decision for oxalic acid states this compound is only used in beehives when honey supers are not present and that dietary exposures to oxalic acid from in-hive applications is 8 NOSB Apiculture Task Force Report, September 2001: https www.ams.usda.gov/sites/default/files/
media/Rec%20Apiculture%20Standards.pdf; and NOSBs Apiculture Recommendation, October 2010: https www.ams.usda.gov/sites/default/files/
media/NOP%20Livestock%20Final%20Rec%20
Apiculture.pdf.

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indistinguishable from naturally occurring levels.9
Pullulan 205.605
Final Action This final rule amends the National List to add pullulan to 205.605a as an ingredient allowed only in products labeled, Made with organic specified ingredients or food groups or made with. The made with labeling category is distinct from the organic and 100% organic labeling categories under USDA organic regulations 7 CFR
205.301. Products labeled organic or 100% organic cannot contain nonorganic pullulan as an ingredient under this final rule. Additionally, the final rule only permits nonorganic pullulan in tablets and capsules for dietary supplements.
AMS is finalizing this amendment to the National List, as proposed by NOSB, to add pullulan to the National List for use in made with products to provide manufacturers of organic dietary supplements with an option to label products with additional dietary claims e.g., vegan, vegetarian. Nonorganic forms of pullulan are necessary because organic forms of pullulan are not readily available. By adding nonorganic pullulan to 205.605 of the National List with a limitation on use for made with products, AMS is providing a limited exception for use of nonorganic pullulan.
Pullulan is a natural extracellular polysaccharide excretion resulting from carbohydrate fermentation by the yeastlike fungus Aureobasidium pullulans and other non-toxic fungi strains.10 The fungus A. pullulans is ubiquitous in nature and is most common in temperate zones in locations such as forest soil, freshwater, on plant leaves, and on seeds. Pullulan has been selfaffirmed as GRAS Generally Recognized as Safe for multiple uses, including as a multifunctional food ingredient, a film, and an excipient GRN No. 99, pp. 2630.11
AMS concluded that the addition of pullulan to the National List is consistent with the requirements of OFPA sec. 6517c. Namely, the substance is not harmful to human 9 U.S. Environmental Protection Agency, Registration Decision for the New Active Ingredient Oxalic Acid, March 2015, https www.regulations.
gov/document?D=EPA-HQ-OPP-2015-0043-0119.
Accessed February 1, 2021.
10 Pullulan technical evaluation report, September 7, 2018: https www.ams.usda.gov/
sites/default/files/media/PullulanTechnicalReport Final09072018.pdf. Accessed February 1, 2021.
11 GRAS Notice GRN No. 99 and FDAs response to the Notice, are available at: https www.fda.gov/
food/generally-recognized-safe-gras/gras-noticeinventory. Accessed February 1, 2021.

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