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Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Rules and Regulations health or the environment; 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 OFPA sec.
6517d.
NOSB Review and Recommendation Pullulan NOSB submitted a recommendation to AMS in April 2019 to add pullulan to the National List.12 NOSB
recommendation followed receipt of a petition to add the substance to the National List in January 2018.13 In NOSBs evaluation of the petition, they considered information from a thirdparty technical evaluation report 14 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 2019.15
In its recommendation, NOSB
concluded that adding pullulan to the National List was consistent with OFPA
criteria sec. 6518m. In its recommendation, NOSB noted that there are few, if any, other encapsulation options available compliant with organic composition requirements at 205.301 for consumers seeking a suitable alternative to gelatin for religious and dietary requirements e.g., vegan, halal, kosher.

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Comments Received and AMS
Response Pullulan Classification. In the proposed rule, AMS requested comments on whether pullulan should be classified as a nonsynthetic, nonagricultural substance, as proposed, or whether it should be considered as an agricultural substance that may be certifiable as organic.
An opposing comment argued that production of pullulan should be considered a form of agricultural production and compared production of A. pullulans to other types of fungi 12 NOSB final recommendation for pullulan, April 26, 2019: https www.ams.usda.gov/sites/
default/files/media/HSPullullanApr2019FinalRec.
pdf.
13 Pullulan petition: https www.ams.usda.gov/
sites/default/files/media/PullulanPetition18131.
pdf.
14 Pullulan technical evaluation report, September 7, 2018: https www.ams.usda.gov/
sites/default/files/media/PullulanTechnical ReportFinal09072018.pdf.
15 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-organicstandards-board-nosb-meeting-st-paul-mn and https www.ams.usda.gov/event/national-organicstandards-board-nosb-meeting-seattle-wa.

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production. The comment suggested that pullulan is better described as an agricultural product than a nonagricultural product.
AMS also received comments that agreed with the classification of pullulan as nonagricultural. Comments that argued that pullulan is a nonsynthetic state that other products of microbial fermentation at 205.605a e.g., citric acid, enzymes, microorganisms are classified as nonsynthetic.
AMS received several comments that AMS classification of pullulan as nonagricultural does not mean that pullulan cannot also be certified organic i.e., that pullulan could be certified organic if manufactured by alternative processes. Commenters pointed to published AMS guidance and to examples of other substances on the National List at 205.605 that can be found in certified organic form e.g., yeast, flavors, citric acid.
AMS agrees with the classification of pullulan as nonsynthetic. The referenced guidance 16 provides examples and clarity on the definitions of agricultural, synthetic, and nonsynthetic natural as presented in 205.2. Nonsynthetic substances are defined as A substance that is derived from mineral, plant, or animal matter and does not undergo a synthetic process . . .. Given that pullulan is manufactured by the isolation of a byproduct of fungal fermentation of a carbohydrate substrate,17 it fits the definition of nonsynthetic and will be classified as such rather than agricultural, defined as any agricultural commodity or product, whether raw or processed, including any commodity or product derived from livestock . . ..
Comments were received which argued both that pullulan could and could not be certified under the USDA
organic regulations. These comments offer differing interpretations of whether any of the manufacturing processes would result in a product which would be certifiable. AMS will maintain the requirement that nonorganic pullulan be used only in made with products, as we are aware there are certified organic pullulan products on the international market.
This final rule adds pullulan to the National List as a nonagricultural ingredient. AMS notes that similar National List substances produced by 16 NOP 5033Classification of Materials: https
www.ams.usda.gov/sites/default/files/media/NOP5033.pdf.
17 Pullulan Technical Report, September 7, 2018:
https www.ams.usda.gov/sites/default/files/
media/PullulanTechnicalReportFinal09072018.pdf.

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microbial fermentation are classified as nonagricultural e.g., citric acid, xanthan gum, and gellan gum. AMS
agrees with NOSB determination that pullulan is a nonagricultural substance, as described in our response to comments regarding classification. The classification of pullulan as nonagricultural does not preclude the production of certified organic pullulan, as long as the process meets the requirements of 205.105 and 205.301.
Genetically modified organisms. A
comment was opposed to the addition of pullulan to the National List because of the potential that genetically modified organisms GMOs might be used in the production of pullulan e.g., substrates as nutrient sources for the fermentation process.
AMS understands concerns regarding the use of genetically modified organisms in the production of National List materials. The USDA organic regulations 205.105 include a prohibition on ingredients produced or handled with the use of excluded methods including genetic engineering as defined in 205.2.
Digestibility concern. A comment cited a study comparing human digestion of pullulan to digestion of maltodextrin. AMS understands that NOSB considered the effects of slow digestion including increased flatulence, as cited in the comment and did not conclude these effects to be sufficiently detrimental to human health to disqualify the substance from addition to the National List per OFPA
7 U.S.C. 6518m.
General opposition. Two comments generally opposed changes to the National List and were opposed to the addition of pullulan. 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 NOSB with criteria and guidelines to consider in evaluating changes to the National List. These procedures were followed by NOSB and AMS, and this rule adds pullulan to the National List.
General support. Comments supporting the addition of pullulan cited its potential to be used as a vegetarian alternative for capsules used for oral supplements. These comments argued that while gelatin is on the National List and is used for capsules, it is an animal byproduct, which vegan and vegetarian consumers choose not to use. Another comment stated that gelatin-based capsules are not appropriate for many vegan and
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