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.

Rules and Regulations Federal Register

33479 

Vol. 86, No. 120 

Friday, June 25, 2021 

1USDA Agricultural Research Service https://

www.ars.usda.gov/oc/br/ccd/index/. Accessed 

February 1, 2021. 

2U.S. Environmental Protection Agency, https:// 

www.epa.gov/pollinator-protection/epa-registeredpesticide-products-approved-use-against-varroamites-bee-hives. Accessed February 1, 2021. 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Doc. No. AMS–NOP–19–0053; NOP–19–02] 

RIN 0581–AD92 

National Organic Program: 

Amendments to the National List of 

Allowed and Prohibited Substances 

per April 2019 NOSB 

Recommendations (Livestock and 

Handling) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: This rule amends the National 

List of Allowed and Prohibited 

Substances (National List) section of the 

U.S. Department of Agriculture’s 

(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 group(s));’’ 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) 720–3252. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 21, 2000, the Secretary 

established the Agricultural Marketing 

Service’s (AMS) National Organic 

Program and the USDA organic 

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. 6501–6524). 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 NOSB’s 

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. 6517(e)). 

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 

NOSB’s 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 AMS–NOP–19–0053). 

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 (§ 205.603(b)(3)) 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 


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3U.S. Environmental Protection Agency, https:// 

www.epa.gov/pollinator-protection/epa-registeredpesticide-products-approved-use-against-varroamites-bee-hives. Accessed February 1, 2021. 

4NOSB final recommendation for oxalic acid 

dihydrate, April 26, 2019: https://www.ams.

usda.gov/sites/default/files/media/LSOxalicAcid

April2019FinalRec.pdf. 

5Oxalic acid petition: https://www.ams.usda.gov/ 

sites/default/files/media/OxalicAcidPetition

10032017.pdf. 

6Technical Evaluation Report for oxalic acid 

dihydrate, November 26, 2018: https://www.ams.

usda.gov/sites/default/files/media/Oxalic

AcidTR.pdf. 

7Written 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. 

8NOSB Apiculture Task Force Report, September 

2001: https://www.ams.usda.gov/sites/default/files/ 

media/Rec%20Apiculture%20Standards.pdf; and 

NOSB’s Apiculture Recommendation, October 

2010: https://www.ams.usda.gov/sites/default/files/ 

media/NOP%20Livestock%20Final%20Rec%20

Apiculture.pdf. 

9U.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. 

10Pullulan 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 FDA’s response 

to the Notice, are available at: https://www.fda.gov/ 

food/generally-recognized-safe-gras/gras-noticeinventory. Accessed February 1, 2021. 

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. 2118(c) (7 U.S.C. 6517(c)). 

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 2118(d) of the OFPA (7 U.S.C. 

6517(d)). 

NOSB Review and Recommendation 

(Oxalic Acid Dihydrate) 

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 

NOSB’s 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 2119(m) (7 U.S.C. 

6518(m)). 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. 

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 (§ 205.603(b)(3)), 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 EPA’s 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 

indistinguishable from naturally 

occurring levels.9

Pullulan (§ 205.605) 

Final Action 

This final rule amends the National 

List to add pullulan to § 205.605(a) as an 

ingredient allowed only in products 

labeled, ‘‘Made with organic (specified 

ingredients or food group(s))’’ (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. 26–30).11

AMS concluded that the addition of 

pullulan to the National List is 

consistent with the requirements of 

OFPA sec. 6517(c). Namely, the 

substance is not harmful to human 


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12NOSB final recommendation for pullulan, 

April 26, 2019: https://www.ams.usda.gov/sites/ 

default/files/media/HSPullullanApr2019FinalRec.

pdf. 

13Pullulan petition: https://www.ams.usda.gov/ 

sites/default/files/media/PullulanPetition18131.

pdf. 

14Pullulan technical evaluation report, 

September 7, 2018: https://www.ams.usda.gov/ 

sites/default/files/media/PullulanTechnical

ReportFinal09072018.pdf. 

15Written 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. 

16NOP 5033—Classification of Materials: https:// 

www.ams.usda.gov/sites/default/files/media/NOP5033.pdf. 

17Pullulan Technical Report, September 7, 2018: 

https://www.ams.usda.gov/sites/default/files/ 

media/PullulanTechnicalReportFinal09072018.pdf. 

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. 

6517(d)). 

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 

NOSB’s 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. 6518(m)). 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). 

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 

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 § 205.605(a) 

(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 ‘‘[a]ny 

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 

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. 6518(m)). 

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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18See 7 CFR 205.606 and 7 CFR 205.2 for 

definition of ‘‘Commercially available.’’ 

19Available at https://organic.ams.usda.gov/ 

Integrity/Default.aspx. Accessed and searched for 

‘‘collagen gel’’ on February 1, 2021. 

20Collagen gel technical evaluation report, 

January 28, 2019: https://www.ams.usda.gov/sites/ 

default/files/media/CollagenGelGelatinCasings

TechnicalReport01282019.pdf. 

21NOSB final recommendation for collagen gel, 

April 26, 2019: https://www.ams.usda.gov/sites/ 

default/files/media/HSCollagenGelApr2019Final

Rec.pdf. 

22Collagen gel petition: https://www.ams.

usda.gov/sites/default/files/media/CollagenGel

Petition.pdf. 

23Written 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-boardnosb-meeting-st-paul-mn and https://www.ams.

usda.gov/event/national-organic-standards-boardnosb-meeting-seattle-wa. 

24AMS National Organic Program Handbook, 

Guidance NOP 5033–1 Decision Tree for 

Classification of Materials as Synthetic or 

Nonsynthetic, December 2, 2016. https://www.ams.

usda.gov/sites/default/files/media/NOP-SyntheticNonSynthetic-DecisionTree.pdf. 

25Collagen gel technical evaluation report, 

January 28, 2019: https://www.ams.usda.gov/sites/ 

default/files/media/CollagenGelGelatinCasings

TechnicalReport01282019.pdf. 

vegetarian supplement products and 

may cause issues among kosher and 

halal consumers. 

AMS appreciates public engagement 

in the rulemaking process and agrees 

with the general support above which 

mirrors the recommendation by NOSB. 

AMS is moving forward with adding 

this substance to the National List as 

proposed. 

Collagen Gel Casing (§ 205.605) 

Final Action 

This final rule amends the National 

List to add collagen gel as a casing to 7 

CFR 205.605(b) as a nonorganic 

nonagricultural ingredient allowed in 

organic handling. The amendment will 

permit the use of nonorganic forms of 

collagen gel when organic collagen gel 

is not commercially available (i.e., not 

available in an appropriate form, 

quality, or quantity, as determined by 

the certifying agent in the course of 

reviewing the organic plan).18 The final 

rule only permits nonorganic collagen 

gel as a casing. This final rule adds 

collagen gel casing to § 205.605(b) rather 

than to § 205.606, as proposed. The 

change in AMS’ classification of 

collagen gel (and, therefore, its location 

on the National List) is discussed in the 

‘‘Comments Received and AMS’ 

Response’’ section below. 

AMS is finalizing the addition of 

collagen gel casing to the National List, 

as proposed by NOSB, as organic 

collagen gel is not commercially 

available as of the issuance of this final 

rule. This conclusion is based on AMS’ 

review of comments made to NOSB and 

comments received in response to the 

proposed rule. Additionally, AMS 

searched the Organic Integrity Database 

and found no certified organic 

operations with certified organic 

collagen gel.19

AMS expects that the allowance for 

nonorganic forms of collagen gel when 

organic forms are not available will 

encourage organic certification of 

products that have not been previously 

eligible for organic certification. This 

will encourage food manufacturers to 

develop new organic products, which 

could, in turn, create new demand for 

organic production (livestock 

production). There are no alternatives 

on the National List which are suitable 

for use in a co-extrusion system as a 

non-removable edible film. 

Collagen gel is described as a multiingredient product made from collagen 

(3.0–4.5%), cellulose (<3.0%), and 

water (95.5–97.0%) in the 

commissioned third-party technical 

evaluation report.20 Collagen is isolated 

from animal materials (e.g., skin, bones) 

through thermal, acid, base, or 

enzymatic hydrolysis. Once isolated, the 

extract is decalcified and swollen with 

acid (generally hydrochloric or sulfuric) 

prior to use in a co-extrusion process. 

When used in sausage production, 

collagen gel is used to enrobe the 

extruded product. The collagen gel 

forms an edible film that holds the form 

of the product and acts as a protective 

barrier. The collagen casing is an 

ingredient in the final product (i.e., it is 

disclosed on the ingredients list). AMS 

understands that collagen gel may be 

formulated with additional substances 

to improve the appearance (e.g., colors) 

or flavor of the final product. AMS 

expects these additional substances, 

when used, will be evaluated by USDAaccredited certifying agents for 

compliance with the National List and 

the USDA organic regulations. 

AMS concluded that the addition of 

collagen gel to the National List is 

consistent with the requirements of 

OFPA sec. 6517(c). Namely, the 

substance is not harmful to human 

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. 

6517(d)). 

NOSB Review and Recommendation 

(Collagen Gel) 

NOSB submitted a recommendation 

to AMS in April 2019 to add collagen 

gel to the National List.21 NOSB 

recommendation followed receipt of a 

petition to add the substance to the 

National List in February 2018.22 In 

NOSB’s evaluation of the petition, they 

considered information from a thirdparty technical evaluation report 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 2019.23

In its recommendation, NOSB 

concluded that adding collagen gel to 

the National List was consistent with 

OFPA criteria (sec. 6518(m)). In its 

recommendation, NOSB noted that 

adding collagen gel to the National List 

would increase opportunity for 

production of organic products that are 

not possible with current ingredients on 

the National List, such as single-species 

sausage and meat products. 

Comments Received and AMS’ 

Response (Collagen Gel Casing) 

Classification. In the proposed rule, 

AMS requested additional information 

on whether the use of acid induces 

chemical change(s) in the collagen gel 

which should cause the substance to be 

classified as a nonagricultural, synthetic 

substance. In response, AMS received a 

comment stating that AMS guidance 24

indicates that synthetic acids used in a 

hydrolysis process would result in a 

synthetic product. The comment also 

stated that under this interpretation of 

program guidance, the use of synthetic 

acids as described in the technical 

evaluation report 25 would not be 

allowed in the production of 

nonsynthetic collagen gel. 

Some comments received were 

neutral, neither in support of nor in 

opposition to the addition of collagen 

gel casing. One comment supported 

classifying collagen gel casing as an 

agricultural substance should it be 

added to the National List. This same 

comment also acknowledged that 

collagen gel casing’s classification as an 

agricultural substance could be 

challenged during future NOSB 

meetings. However, the comment also 

stated that since the source material for 

collagen gel casing source is 

agricultural, its inclusion on § 205.606 

would be appropriate. 

Upon further review of the 

manufacturing process of collagen, as 

described in the petition and technical 

evaluation report, AMS agrees with the 

comment that the acid hydrolysis step 

typical in the manufacturing process of 

collagen is a non-biological chemical 

change that results in its classification 


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26Collagen Gel Technical Report, January 28, 

2019: https://www.ams.usda.gov/sites/default/files/ 

media/CollagenGelGelatinCasingsTechnicalReport

01282019.pdf. 

27Table of Small Business Size Standards 

Matched to North American Industrial 

Classification System Codes, August 19, 2019: 

https://www.naics.com/wp-content/uploads/2017/ 

10/SBA_Size_Standards_Table.pdf. 

28U.S. Department of Agriculture, National 

Agricultural Statistics Service. 2019 Census of 

Agriculture. https://www.nass.usda.gov/ 

Publications/AgCensus/2017/Online_Resources/ 

Organics/ORGANICS.pdf. 

29Organic Integrity Database: https://organic.ams.

usda.gov/Integrity/. Accessed February 1, 2021. 

as a nonagricultural, synthetic 

substance. In order to preserve the 

intent of NOSB to encourage future 

availability of certified organic collagen 

gel, AMS is listing collagen gel casing as 

a synthetic nonagricultural substance at 

§ 205.605(b) with the annotation ‘‘may 

be used only when organic collagen gel 

is not commercially available.’’ 

AMS understands that there are many 

different manufacturing processes for 

the production of collagen gel.26 It is our 

understanding that while there are 

many different processes for 

manufacturing collagen gel, the current 

predominant manufacturing process 

renders the final collagen gel as 

synthetic. While the main 

manufacturing process results in a 

synthetic product, there are 

manufacturing processes described 

which would result in a nonsynthetic 

product and are consistent with 

§ 205.270 (i.e., could be a certifiable 

process). Aware of the fact that the 

addition of collagen gel to the National 

List would allow for the production of 

additional organic products, we 

classified collagen gel as synthetic due 

to the predominant manufacturing 

process to provide access to organic 

producers. Given that there are 

processing methods which could be 

certified, we are maintaining the 

commercial availability requirement to 

encourage the development of 

nonsynthetic, certified organic products. 

General Opposition. AMS received 

comments opposed to adding collagen 

gel casing to the National List. Some of 

the opposing comments want organic 

products to be composed only of organic 

ingredients. AMS notes that OFPA 

permits the use of specific nonorganic 

substances (i.e., those on the National 

List) in organic production and 

handling. 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 

collagen gel to the National List. 

Misleading to Consumers. A comment 

argued AMS will confuse consumers, 

especially vegan consumers, should 

collagen gel casings be allowed for use 

in organic plant-based sausage products. 

AMS understands that labeling 

requirements implemented by other 

agencies would require disclosure of 

collagen casings in a product’s 

ingredient list. AMS believes that 

disclosure of the collagen casing as an 

ingredient provides sufficient 

transparency for consumers. 

III. Related Documents 

AMS published notices in the Federal 

Register on August 9, 2018, announcing 

the Fall 2018 NOSB Meeting (83 FR 

39376) and on November 26, 2018, 

announcing the Spring 2019 NOSB 

meeting (83 FR 60373). These notices 

invited public comments on NOSB 

recommendations addressed in this 

final rule. The AMS proposed rule that 

preceded this final rule was published 

on June 8, 2020 (85 FR 35011). 

IV. Statutory and Regulatory Authority 

OFPA authorizes the Secretary to 

make amendments to the National List 

based on recommendations developed 

by NOSB. Sections 6518(k) and 6518(n) 

of OFPA authorize NOSB to develop 

recommendations for submission to the 

Secretary to amend the National List 

and establish a process by which 

persons may petition NOSB for the 

purpose of having substances evaluated 

for inclusion on or deletion from the 

National List. Section 205.607 of the 

USDA organic regulations permits any 

person to petition to add or remove a 

substance from the National List and 

directs petitioners to obtain the petition 

procedures from USDA. The current 

petition procedures published in the 

Federal Register (81 FR 12680; March 

10, 2016) for amending the National List 

can be accessed through the NOP 

Program Handbook on the NOP website 

at https://www.ams.usda.gov/rulesregulations/organic/handbook. 

A. Executive Order 12866 and 

Regulatory Flexibility Act 

This final rule has been determined to 

be not significant for purposes of 

Executive Order 12866, and, therefore, 

has not been reviewed by the Office of 

Management and Budget (OMB). 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612) requires agencies to 

consider the economic impact of each 

rule on small entities and evaluate 

alternatives that would accomplish the 

objectives of the rule without unduly 

burdening small entities or erecting 

barriers that would restrict their ability 

to compete in the market. The purpose 

of RFA is to fit regulatory actions to the 

scale of businesses subject to the action. 

Section 605 of the RFA allows an 

agency to certify a rule, in lieu of 

preparing an analysis, if the rulemaking 

is not expected to have a significant 

economic impact on a substantial 

number of small entities. 

The Small Business Administration 

(SBA) sets size criteria for each industry 

described in the North American 

Industry Classification System (NAICS) 

to delineate which operations qualify as 

small businesses.27 SBA has classified 

small agricultural producers that engage 

in crop and animal production as those 

with average annual receipts of less than 

$1,000,000 (13 CFR 121.201). Handlers 

are involved in a broad spectrum of food 

production activities and fall into 

various categories in the NAICS Food 

Manufacturing sector. The small 

business thresholds for food 

manufacturing operations are based on 

the number of employees and range 

from 500 to 1,250 employees, depending 

on the specific type of manufacturing. 

Certifying agents fall under the NAICS 

subsector, ‘‘all other professional, 

scientific, and technical services.’’ For 

this category, the small business 

threshold is average annual receipts of 

less than $16.5 million. 

Producers. AMS has considered the 

economic impact of this final 

rulemaking on small agricultural 

entities. Data collected by USDA’s 

National Agricultural Statistics Service 

(NASS) and NOP indicate most of the 

certified organic production operations 

in the United States would be 

considered small entities. According to 

the 2019 Census of Agriculture, 16,585 

organic farms in the United States 

reported sales of organic products and 

total farmgate sales more than $9.9 

billion.28 Based on that data, organic 

sales average just under $600,000 per 

farm. Assuming a normal distribution of 

producers, we expect that most of these 

producers would fall under the 

$1,000,000 sales threshold to qualify as 

a small business. 

Handlers. According to the NOP’s 

Organic Integrity Database, there are 

19,059 organic handlers that are 

certified under the USDA organic 

regulations.29 The Organic Trade 

Association’s 2020 Organic Industry 

Survey has information about 

employment trends among organic 

manufacturers. The reported data are 

stratified into three groups by the 

number of employees per company: 

Fewer than 5; 5 to 49; and 50 plus. 

These data are representative of the 

organic manufacturing sector and the 

lower bound (50) of the range for the 


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larger manufacturers is significantly 

smaller than SBA’s small business 

thresholds (500 to 1,250). Therefore, 

AMS expects that most organic handlers 

would qualify as small businesses. 

Certifying agents. SBA defines ‘‘all 

other professional, scientific, and 

technical services,’’ which include 

certifying agents, as those having annual 

receipts of less than $16,500,000 (13 

CFR 121.201). There are currently 77 

USDA-accredited certifying agents, 

based on a query of NOP certified 

organic operations database, who 

provide organic certification services to 

producers and handlers. While many 

certifying agents are small entities that 

would be affected by this proposed rule, 

we do not expect that these certifying 

agents would incur significant costs as 

a result of this action as certifying 

agents already must comply with the 

current regulations (e.g., maintaining 

certification records for organic 

operations). 

AMS does not expect the economic 

impact on entities affected by this rule 

to be significant. The effect of this final 

rule will allow the use of three 

additional substances in organic crop 

production and organic handling. 

Adding three substances to the National 

List will increase regulatory flexibility 

and provide small entities with more 

options to use in day-to-day operations. 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. 

This final rule is not intended to have 

a retroactive effect. Accordingly, to 

prevent duplicative regulation, states 

and local jurisdictions are preempted 

under OFPA from creating programs of 

accreditation for private persons or state 

officials who want to become certifying 

agents of organic farms or handling 

operations. A governing State official 

would have to apply to USDA to be 

accredited as a certifying agent, as 

described in section 6514(b) of OFPA. 

States are also preempted under 

sections 6503 through 6507 of OFPA 

from creating certification programs to 

certify organic farms or handling 

operations unless the State programs 

have been submitted to, and approved 

by, the Secretary as meeting the 

requirements of OFPA. 

Pursuant to section 6507(b)(2) of 

OFPA, a State organic certification 

program that has been approved by the 

Secretary may, under certain 

circumstances, contain additional 

requirements for the production and 

handling of agricultural products 

organically produced in the State and 

for the certification of organic farm and 

handling operations located within the 

State. Such additional requirements 

must (a) further the purposes of OFPA, 

(b) not be inconsistent with OFPA, (c) 

not be discriminatory toward 

agricultural commodities organically 

produced in other States, and (d) not be 

effective until approved by the 

Secretary. 

In addition, pursuant to § 6519(c)(6) 

of OFPA, this final rule does not 

supersede or alter the authority of the 

Secretary under the Federal Meat 

Inspection Act (21 U.S.C. 601–624), the 

Poultry Products Inspection Act (21 

U.S.C. 451–471), or the Egg Products 

Inspection Act (21 U.S.C. 1031–1056), 

concerning meat, poultry, and egg 

products, respectively, nor any of the 

authorities of the Secretary of Health 

and Human Services under the Federal 

Food, Drug and Cosmetic Act (21 U.S.C. 

301 et seq.), nor the authority of the 

Administrator of EPA under the Federal 

Insecticide, Fungicide and Rodenticide 

Act (7 U.S.C. 136 et seq.). 

C. Paperwork Reduction Act 

No additional collection or 

recordkeeping requirements are 

imposed on the public by this final rule. 

Accordingly, OMB clearance is not 

required by the Paperwork Reduction 

Act of 1995, 44 U.S.C. 3501, Chapter 35. 

D. Executive Order 13175 

This final rule has been reviewed 

under Executive Order 13175— 

Consultation and Coordination with 

Indian Tribal Governments. Executive 

Order 13175 requires Federal agencies 

to consult and coordinate with tribes on 

a government-to-government basis on: 

(1) Policies that have tribal implication, 

including regulation, legislative 

comments, or proposed legislation; and 

(2) other policy statements or actions 

that have substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

AMS has assessed the impact of this 

final rule on Indian tribes and 

determined that this rule would not 

have tribal implications that require 

consultation under Executive Order 

13175. AMS hosts a quarterly 

teleconference with tribal leaders where 

matters of mutual interest regarding the 

marketing of agricultural products are 

discussed. Information about the 

proposed changes to the regulations will 

be shared during an upcoming quarterly 

call, and tribal leaders will be informed 

about the proposed revisions to the 

regulation and the opportunity to 

submit comments. AMS will work with 

USDA’s Office of Tribal Relations to 

ensure meaningful consultation is 

provided as needed with regards to the 

NOP regulations. 

E. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), the Office of 

Information and Regulatory Affairs 

designated this rule as not a major rule, 

as defined by 5 U.S.C. 804(2). 

G. General Notice of Public Rulemaking 

This final rule reflects 

recommendations submitted by NOSB 

to the Secretary to add three substances 

to the National List. 

List of Subjects in 7 CFR Part 205 

Administrative practice and 

procedure, Agricultural commodities, 

Agriculture, Animals, Archives and 

records, Fees, Imports, Labeling, 

Organically produced products, Plants, 

Reporting and recordkeeping 

requirements, Seals and insignia, Soil 

conservation. 

For the reasons set forth in the 

preamble, 7 CFR part 205 is amended as 

follows: 

PART 205—NATIONAL ORGANIC 

PROGRAM 

■ 1. The authority citation for part 205 

is revised to read as follows: 

Authority: 7 U.S.C. 6501–6524. 

■ 2. Amend § 205.603 by redesignating 

paragraphs (b)(8) through (b)(11) as 

paragraphs (b)(9) through (b)(12) and 

adding paragraph (b)(8) to read as 

follows: 

§ 205.603 Synthetic substances allowed 

for use in organic livestock production. 

* * * * * 

(b) * * * 

(8) Oxalic acid dihydrate—for use as 

a pesticide solely for apiculture. 

* * * * * 

■ 3. Amend § 205.605 by: 

■ a. In paragraph (a), adding in 

alphabetical order the term ‘‘Pullulan;’’ 

and 

■ b. In paragraph (b), adding in 

alphabetical order the term ‘‘Collagen 

gel.’’ 

The additions read as follows: 

§ 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) * * * 


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Pullulan—for use only in tablets and 

capsules for dietary supplements 

labeled ‘‘made with organic (specified 

ingredients or food group(s)).’’ 

* * * * * 

(b) * * * 

Collagen gel—as casing, may be used 

only when organic collagen gel is not 

commercially available. 

* * * * * 

Erin Morris, 

Associate Administrator, Agricultural 

Marketing Service. 

[FR Doc. 2021–13323 Filed 6–24–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF AGRICULTURE 

Federal Crop Insurance Corporation 

7 CFR Part 457 

[Docket ID FCIC–21–0002] 

RIN 0563–AC73 

Common Crop Insurance Regulations; 

Small Grains Crop Insurance 

Provisions 

AGENCY: Federal Crop Insurance 

Corporation, U.S. Department of 

Agriculture (USDA). 

ACTION: Final rule with request for 

comments. 

SUMMARY: The Federal Crop Insurance 

Corporation (FCIC) amends the 

Common Crop Insurance Regulations, 

Small Grains Crop Insurance Provisions 

and Malting Barley Price and Quality 

Endorsement. For the Small Grains Crop 

Insurance Provisions, the intended 

effect of this action is to allow 

enterprise units by type for wheat, to 

clarify policy provisions for consistency 

with other crop provisions that offer 

coverage on both winter and springplanted acreage of the crop. For the 

Malting Barley Price and Quality 

Endorsement, the intended effect is to 

remove and reserve this section. The 

changes will be effective for the 2022 

and succeeding crop years. 

DATES:

Effective date: June 25, 2021. 

Comment date: We will consider 

comments that we receive by the close 

of business August 24, 2021. FCIC may 

consider the comments received and 

may conduct additional rulemaking 

based on the comments. 

ADDRESSES: We invite you to submit 

comments on this rule. You may submit 

comments by either of the following 

methods, although FCIC prefers that you 

submit comments electronically through 

the Federal eRulemaking Portal: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov and search 

for Docket ID FCIC–21–0002. Follow the 

instructions for submitting comments. 

• Mail: Director, Product 

Administration and Standards Division, 

Risk Management Agency (RMA), U.S. 

Department of Agriculture, P.O. Box 

419205, Kansas City, MO 64133–6205. 

In your comment, specify docket ID 

FCIC–21–0002. 

Comments will be available for 

viewing online at www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Francie Tolle; telephone (816) 926– 

7829; or email francie.tolle@usda.gov. 

Persons with disabilities who require 

alternative means for communication 

should contact the USDA Target Center 

at (202) 720–2600 or 844–433–2774 

(toll-free nationwide). 

SUPPLEMENTARY INFORMATION: 

Background 

The FCIC serves America’s 

agricultural producers through effective, 

market-based risk management tools to 

strengthen the economic stability of 

agricultural producers and rural 

communities. FCIC is committed to 

increasing the availability and 

effectiveness of Federal crop insurance 

as a risk management tool. Approved 

Insurance Providers (AIP) sell and 

service Federal crop insurance policies 

in every state through a public-private 

partnership. FCIC reinsures the AIPs 

who share the risks associated with 

catastrophic losses due to major weather 

events. FCIC’s vision is to secure the 

future of agriculture by providing world 

class risk management tools to rural 

America. 

FCIC amends the Common Crop 

Insurance Regulations by revising 7 CFR 

457.101, Small Grains Crop Insurance 

Provisions, and by removing and 

reserving 7 CFR 457.118, Malting Barley 

Price and Quality Endorsement, to be 

effective for the 2022 and succeeding 

crop years. 

The changes to 7 CFR 457.101, Small 

Grains Crop Insurance Provisions, are as 

follows: 

1. Throughout the Crop Provisions, 

FCIC is replacing all references of the 

‘‘fall’’ type with ‘‘winter’’ type. Fall and 

spring-planted acreage are insured 

under the ‘‘winter’’ commodity type and 

‘‘spring’’ commodity type, respectively, 

in the actuarial documents. This change 

is necessary for consistency between the 

Crop Provisions and actuarial 

documents. 

2. Throughout the Crop Provisions, 

FCIC is replacing the phrase ‘‘initially 

planted’’ with the phrase ‘‘initiallyplanted,’’ where appropriate. 

3. Throughout the Crop Provisions, 

FCIC is replacing all references of 

‘‘growers’’ with ‘‘producers’’ to be 

consistent with the terminology used in 

the Common Crop Insurance Policy 

Basic Provisions. 

4. Section 1—FCIC is revising the 

definition of ‘‘Khorasan’’ by replacing 

the phrase ‘‘is considered to be’’ with 

‘‘is considered.’’ The phrase ‘‘to be’’ is 

not necessary. 

FCIC is revising the definition of 

‘‘latest final planting date’’ to replace all 

references to fall and spring-planted 

acreage to winter and spring types. This 

change will eliminate any confusion of 

whether a winter final planting date 

exists in the actuarial documents if the 

Winter Coverage Endorsement is not 

selected. For example, Asotin County, 

Washington lists a winter final planting 

date for barley that is only applicable if 

the Winter Coverage Endorsement is 

elected. Otherwise, there is no 

applicable date in the fall and only 

spring final planting dates exist for the 

spring types. The intent of these 

provisions is to address when a county 

has both winter and spring types 

designated in the Special Provisions, 

regardless if the Winter Coverage 

Endorsement is elected. 

FCIC is revising the definition of 

‘‘small grains’’ to allow the flexibility to 

insure additional small grains varieties 

that are not currently listed in the 

actuarial documents. This allows for 

insurance coverage to be offered via 

actuarial documents for varieties 

currently not insured when data become 

available, and it is appropriate to do so. 

5. Section 2—FCIC is designating the 

undesignated paragraph in section 2 as 

paragraph (b) and adding a new 

paragraph (a) to allow enterprise units 

by type for wheat. For example, if 

insured has winter and spring types, 

they may elect one enterprise unit for 

the spring type or one enterprise unit for 

the winter type, or separate enterprise 

units for both types. 

For the wheat types, allowing separate 

enterprise units allows producers to be 

indemnified separately by type. The 

benefit for producers is that a loss on 

one type will not be offset by the gain 

on another type. 

If an insured elects enterprise units by 

type, these enterprise units are not 

allowed to be further divided by 

practice and the insured may not elect 

enterprise or optional units by irrigation 

practices for the policy. 

Additionally, the insured must 

separately meet the requirements in 

section 34(a)(4) of the Basic Provision 

for each enterprise unit they elect to 

have. 


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