This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

47242 

Vol. 86, No. 161 

Tuesday, August 24, 2021 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number: AMS–NOP–19–0106; 

NOP–19–03] 

RIN 0581–AD98 

National Organic Program; National 

List of Allowed and Prohibited 

Substances (2022 Sunset) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule. 

SUMMARY: The U.S. Department of 

Agriculture’s Agricultural Marketing 

Service proposes amendments to the 

National List of Allowed and Prohibited 

Substances (National List) section of the 

USDA’s organic regulations to 

implement recommendations submitted 

to the Secretary of Agriculture 

(Secretary) by the National Organic 

Standards Board (NOSB). This rule 

proposes the removal from the National 

List of several substances currently 

allowed for various uses in organic crop 

production, livestock production, and 

manufacture of processed products. 

DATES: Send comments on or before 

October 25, 2021. 

ADDRESSES: You may send comments on 

this proposed rule to the Federal 

eRulemaking Portal at https://

www.regulations.gov/. You can access 

this proposed rule and instructions for 

submitting public comments by 

searching for document number AMS– 

NOP–19–0106. Comments may also be 

sent to Jared Clark, Standards Division, 

National Organic Program, USDA– 

AMS–NOP, 1400 Independence Ave. 

SW, Room 2642-So., Ag Stop 0268, 

Washington, DC 20250–0268. 

Instructions: All comments received 

must include the docket number AMS– 

NOP–19–0106; NOP–19–03, and/or 

Regulatory Information Number (RIN) 

0581–AD98 for this rulemaking. You 

should clearly indicate the topic and 

section number of the proposed rule to 

which your comment refers, state your 

position(s), offer any recommended 

language change(s), and include 

relevant information and data to support 

your position(s) (e.g., scientific, 

environmental, manufacturing, 

industry, or industry impact 

information, etc.). All comments and 

relevant background documents posted 

to https://www.regulations.gov will 

include any personal information 

provided. 

FOR FURTHER INFORMATION CONTACT: 

Jared Clark, Standards Division, 

National Organic Program, Telephone: 

(202) 720–3252. 

SUPPLEMENTARY INFORMATION: In 

addition to comments about the 

proposed removals themselves, AMS is 

requesting comments about whether 

organic operations (producers and 

handlers) require time to implement the 

changes that would be necessary, 

should AMS finalize the amendments in 

this proposed rule. All of the 

substances/ingredients included in this 

rule have a ‘‘sunset date’’ of March 15, 

2022, except for Turkish bay leaves and 

whey protein concentrate (sunset date of 

June 27, 2022). AMS requests comments 

on how much time after the sunset date 

is necessary, if any, for organic 

operations to comply with the proposed 

changes. 

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 (i.e., in 

organic ‘‘handling’’). 

To remain on the National List, 

substances must be: (1) Reviewed every 

five years by the NOSB, a 15-member 

Federal advisory committee; and (2) 

renewed by the Secretary (7 U.S.C. 

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). 

Through the course of the sunset 

review process for the substances below, 

the NOSB determined the substances 

are no longer necessary for organic 

production or handling or otherwise no 

longer comply with the criteria set forth 

in the Organic Foods Production Act at 

7 U.S.C. 6518. 

Based on recommendations submitted 

at the conclusion of the NOSB’s sunset 

review process, AMS is proposing to 

amend the National List by removing 

the following synthetic substances 

currently allowed in organic crop and 

livestock production (7 CFR 205.601 

and 205.603): 

• Sucrose Octanoate Esters (crop 

production) 

• Vitamin B1 (crop production) 

• Oxytocin (livestock production) 

• Procaine (livestock production) 

• Sucrose Octanoate Esters (livestock 

production) 

Additionally, AMS is proposing to 

amend the National List by removing 

the following nonorganic ingredients 

currently allowed in organic handling 

(§§ 205.605 and 205.606): 

• Alginic acid 

• Colors (black currant juice color, 

blueberry juice color, carrot juice 

color, cherry juice color, grape juice 

color, paprika color, pumpkin juice 

color, turmeric extract color) 

• Kelp 

• Konjac flour 

• Sweet potato starch 

• Turkish bay leaves 

• Whey protein concentrate 

The proposed removal of these 

substances from the National List 

addresses National Organic Standards 

Board (NOSB) recommendations 

submitted to the Secretary after the 

conclusion of the NOSB’s public 

meetings on October 29, 2015; 

November 2, 2017; October 26, 2018; 

and October 30, 2020. 

II. Overview of Proposed Amendments 

The following provides an overview 

of the proposed amendments to the 

National List, along with the NOSB and 


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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Proposed Rules 47243 

1NOSB August 17, 2005, Sucrose Octanoate 

Esters Recommendation: https://

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

Sucrose%20Recommendation.pdf. 

2NOSB Fall 2018 Crops Sunset 

Recommendations: https://www.ams.usda.gov/ 

sites/default/files/media/CS2020Sunset

FinalRecOct2018.pdf. 

3NOSB Fall 2018 Livestock Sunset 

Recommendations: http://www.ams.usda.gov/sites/ 

default/files/media/LS2020Sunset

FinalRecOct2018.pdf. 

4https://iaspub.epa.gov/apex/pesticides/ 

f?p=PPLS:1 accessed January 29, 2021. 

5Formal Crops Sunset Recommendations from 

NOSB to NOP, November 2, 2017: https://

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

CS2019SunsetsFinalRec.pdf. 

6 2015 Technical Report on Vitamins B1, C, and 

E used in crop production: https://

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

Vitamins%20B1-C-E%20TR%202015.pdf. 

7Formal Livestock Sunset Recommendations 

from NOSB to NOP, November 2, 2017: https://

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

LS2019SunsetsFinalRec.pdf. 

AMS justifications for each proposed 

amendment. AMS welcomes comments 

on the proposed amendments. 

Comments received during the comment 

period will inform AMS’s decisions for 

the final rule—specifically, whether the 

proposed removals remain justified or 

new information demonstrates that 

renewal(s) (relisting) is warranted and 

aligned with OFPA criteria. 

A. Sucrose Octanoate Esters (§§ 205.601 

and 205.603) 

AMS is proposing to remove sucrose 

octanoate esters from the National List. 

Sucrose octanoate esters were added to 

the National List effective December 11, 

2007 (72 FR 69569), were renewed 

through two sunset reviews, and are 

currently listed at §§ 205.601(e)(10) and 

205.603(b)(10). The 2007 rulemaking 

was initiated by an NOSB 

recommendation in August 2005 1 for 

the addition of sucrose octanoate esters 

to the National List for use as an 

insecticide in organic crop production 

and as a miticide for use on honeybees. 

Prior to the NOSB’s 2018 Fall 

meeting, the NOSB received information 

indicating there are no current EPA 

registrations for sucrose octanoate esters 

and therefore no approved pesticide 

applications. Due to this information, as 

referenced in the published NOSB 

recommendations,2 3 the Board voted to 

remove both the crop use listing (at 

§ 205.601(e)(10)) and the livestock 

(honeybee) use (at § 205.603(b)(10)). The 

NOSB reasoned that no argument could 

be made that this substance remains an 

essential tool for organic production if 

there is no current legal use consistent 

with the National List restrictions. 

AMS agrees with the NOSB 

recommendation to remove sucrose 

octanoate esters from the National List 

at §§ 205.601(e)(10) and 205.603(b)(10). 

By 2019, there were no EPA approved 

products with legal uses corresponding 

to the National List allowances. (83 FR 

16087, 16088, 16094). EPA’s April 13, 

2018, notice shows that the registrant of 

sucrose octanoate esters (75197–1, 

75197–2) voluntarily cancelled its 

registrations. Since 2018, EPA’s 

Pesticide Product and Label System 4

now shows two new registrations of 

sucrose octanoate esters (EPA Reg. No. 

94424–1 and 94424–2, registered 

December 17, 2020), but no approved 

labels or uses are available at this time. 

AMS agrees with the NOSB’s 

recommendation to remove sucrose 

octanoate esters because this product’s 

minimal commercial availability shows 

that sucrose octanoate esters are not 

essential for organic production. Public 

comments are requested on whether 

there is additional information available 

regarding the need for this substance in 

organic production and the availability 

of sucrose octanoate esters given the 

recent registrations. 

B. Vitamin B1 (§ 205.601) 

AMS is proposing to remove Vitamin 

B1 from the National List. Vitamin B1

was added to the National List at its 

inception on December 21, 2000 (65 FR 

80547), was renewed through several 

sunset reviews, and is currently listed at 

§ 205.601(j)(9) for use as a plant or soil 

amendment. 

In support of their sunset review 5, the 

NOSB requested a third-party technical 

report 6 on vitamins B1, C, and E, as they 

are used in crop production. The 

technical report found that the previous 

claims on root growth and reduction of 

transplant shock associated with 

vitamin B1 were largely unsubstantiated 

outside of a laboratory environment. 

Due to this and the fact there was no 

support voiced during the public 

comment process regarding efficacy or 

necessity, the NOSB recommended 

removal, citing that given this new 

information they no longer find vitamin 

B1 compatible with a system of organic 

agriculture per 7 U.S.C. 6518(m)(7). 

AMS agrees with the NOSB 

recommendation to remove vitamin B1

as a plant and soil amendment at 

§ 205.601(j)(9). The information 

referenced in the NOSB 

recommendation regarding use and 

efficacy are compelling reasons to 

remove vitamin B1 from the National 

List for organic crop production. 

Further, the 2015 technical report on 

vitamins for crop production identified 

several natural and nonsynthetic 

alternatives to vitamin B1 including 

yeast, various meals (e.g., soybean meal, 

cottonseed meal), and other crop waste 

or residues. Accordingly, AMS proposes 

that vitamin B1 is no longer necessary to 

the production of agricultural product 

and should be removed from the 

National List due to the availability of 

wholly natural substitutes (7 U.S.C. 

6517(c)(1)(A)(ii)). 

C. Oxytocin (§ 205.603) 

AMS is proposing to remove oxytocin 

from the National List. Oxytocin was 

added to the National List at its 

inception on December 21, 2000 (65 FR 

80547), was renewed through several 

sunset reviews, and is currently listed at 

§ 205.603(a)(22) for use in post 

parturition therapeutic applications. 

In the sunset review, the NOSB 

recommended 7 the removal of oxytocin 

from the National List. The NOSB 

determined that there are now 

numerous alternative methods and 

materials for addressing the health 

issues where oxytocin would be used 

and that the use of oxytocin no longer 

meets the criteria at 7 U.S.C. 6518(m)(6). 

Additionally, the NOSB found that use 

of oxytocin is not compatible with a 

system of sustainable agriculture (7 

U.S.C. 6518(m)(7)). The NOSB requested 

public comment on whether this 

substance is essential for organic 

production or if there are alternative 

materials and methods that render it 

unnecessary. The public comment 

received in response to the request 

indicated that this substance is no 

longer necessary and supported its 

removal. 

AMS tentatively agrees with the 

NOSB recommendation. While the 

NOSB states there are other practices or 

materials that render oxytocin 

unnecessary for organic production, 

AMS did not find supporting comments 

to that effect, and NOSB did not 

specifically state what the alternatives 

are. Further, it was stated in public 

comment to the NOSB that while some 

operations still use oxytocin as a 

medical treatment (assisting in clearing 

placenta), other operations may be using 

it in ways inconsistent with the listing 

or no longer find it necessary in organic 

production. AMS is seeking comments 

on whether suitable alternatives for the 

use of oxytocin exist, and if so, 

specifically what alternative practices or 

materials might replace the use of 

oxytocin. Further, AMS seeks 

information on oxytocin use that may be 

inconsistent with the listing. If 

comments show that the use of oxytocin 

no longer meets the exemption 

requirements at 7 U.S.C. 

6517(c)(1)(A)(ii) and (iii), AMS is 


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47244 Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Proposed Rules 

8Formal Livestock Sunset Recommendations 

from NOSB to NOP, November 2, 2017: https://

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

LS2019SunsetsFinalRec.pdf. 

9Alginic Acid Technical Report, February 5, 

2015: https://www.ams.usda.gov/sites/default/files/ 

media/Alginic%20Acid%20TR.pdf. 

10Formal Handling Sunset Recommendations 

from the NOSB to the NOP, October 30, 2020: 

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

media/HS2022SunsetRecs_webpost.pdf. 

proposing the removal of oxytocin from 

the National List at § 205.603(a)(22). 

D. Procaine (§ 205.603) 

AMS is proposing to remove procaine 

from the National List. Procaine was 

added to the National List at its 

inception on December 21, 2000 (65 FR 

80547), was renewed through several 

sunset reviews, and is currently listed at 

§ 205.603(b)(8) for use as a local 

anesthetic. 

In support of the NOSB’s sunset 

review of procaine, public comment was 

requested to determine if procaine is 

used in organic livestock production 

and whether procaine is only available 

in the U.S. in animal drugs 

compounded with antibiotics (which 

are not permitted in organic production) 

or whether procaine can be sourced by 

itself. The comments received indicated 

that procaine is rarely used, is not as 

effective as lidocaine (allowed in 

organic livestock production at 

§ 205.603(b)(5)), and is only available in 

combination with prohibited antibiotics. 

Further comments received were in 

support of removing procaine from the 

National List. Based on the information 

received during the public comment 

period, the NOSB recommended 8

removal of procaine, given that it no 

longer meets the criteria stipulated by 

OFPA at 7 U.S.C. 6518(m)(6), due to 

lidocaine being more effective and 

because procaine is not available (i.e., 

compounded without prohibited 

antibiotics). 

AMS agrees with the NOSB 

recommendation. Given that there is 

another National List material, 

lidocaine, that renders procaine 

unnecessary for organic production, 

procaine no longer meets the exemption 

requirement at 7 U.S.C. 6517(c)(1)(A)(ii). 

Further, the NOSB referenced in their 

recommendation that procaine is not 

available on its own (i.e., not 

compounded with an antibiotic). A 

search of the FDA’s animal drug 

database (https://

animaldrugsatfda.fda.gov/) indicates 

that all sixteen of the FDA approved 

drugs that contain procaine also contain 

an antibiotic (e.g., Penicillin G 

Procaine). This information supports the 

fact that procaine is not used in organic 

production and that an exemption is not 

necessary (7 U.S.C. 6517(c)(1)(A)(ii)). As 

procaine no longer appears to meet the 

requirements for inclusion on the 

National List, AMS is proposing the 

removal of procaine from the National 

List at § 205.603(b)(8). 

E. Alginic Acid (§ 205.605) 

AMS is proposing to remove alginic 

acid from the National List. Alginic acid 

was added to § 205.605(a) of the 

National List at its inception on 

December 21, 2000 (65 FR 80547), was 

renewed through several sunset reviews, 

and was reclassified as synthetic on 

December 27, 2018 (83 FR 66559), 

which moved alginic acid to its current 

listing at § 205.605(b) for use in organic 

handling. 

In support of their sunset review of 

alginic acid, the NOSB received a thirdparty technical report 9 in 2015 and 

solicited public comment at their Spring 

2019 meeting. The NOSB received no 

comments in support of continuing the 

allowance or reporting use of alginic 

acid. In addition, no certifying agents 

(‘‘certifiers’’) reported this material 

being used by their certified operations. 

Further, the 2015 technical report cited 

other National List materials, including 

agar-agar, carrageenan, gellan gum, and 

xanthan gum, as possible alternatives to 

alginic acid. Based on this, the NOSB 

determined that there are readily 

available alternatives and recommended 

removal based on alginic acid no longer 

meeting the OFPA criteria at 7 U.S.C. 

6518(m)(6). 

AMS agrees with the NOSB 

recommendation. Given that there were 

no reports of operations using alginic 

acid and the availability of possible 

alternatives on the National List (as 

referenced in the technical report), this 

substance no longer appears to meet the 

requirements for inclusion on the 

National List at 7 U.S.C. 

6517(c)(1)(A)(ii). As such, AMS 

proposes the removal of alginic acid 

from the National List at § 205.605(b). 

F. Colors (§ 205.606) 

AMS is proposing to remove eight 

nonorganic colors from the National List 

at § 205.606(d): 

• Black currant juice color—derived 

from Ribes nigrum L. 

• Blueberry juice color—derived from 

blueberries (Vaccinium spp.). 

• Carrot juice color—derived from 

Daucus carota L. 

• Cherry juice color—derived from 

Prunus avium (L.) L. or Prunus cerasus 

L. 

• Grape juice color—derived from 

Vitis vinifera L. 

• Paprika color—derived from dried 

powder or vegetable oil extract of 

Capsicum annuum L. 

• Pumpkin juice color—derived from 

Cucurbita pepo L. or Cucurbita maxima 

Duchesne. 

• Turmeric extract color—derived 

from Curcuma longa L. 

These colors were added to the 

National List effective June 21, 2007 (72 

FR 35137), were renewed through 

several sunset reviews, and are 

currently listed at § 205.606(d) as 

allowed nonorganic agricultural 

ingredients in organic products when 

organic versions are not commercially 

available. 

The NOSB recommended 10 the 

removal of the above colors at their Fall 

2020 meeting. The effect of this action 

is that only organic forms of these colors 

would be allowed in organic handling. 

The NOSB referenced public comments 

as being mixed on the availability and 

necessity of these colors and also noted 

that comments from some 

manufacturers stated that organic 

versions of these colors are available. 

Additionally, in the case of carrot juice 

color and grape juice color, the NOSB 

noted that the availability of these crops 

in organic forms should provide an 

adequate supply of organic carrot juice 

and organic grape juice for color 

production and cited that as a reason for 

their recommended removal. 

AMS is proposing to remove these 

colors from the National List, as 

recommended by the NOSB. AMS is 

seeking comments about whether these 

colors remain necessary for organic 

production or if there are suitable 

organic versions available. While public 

comments to the NOSB were mixed, as 

noted in the NOSB recommendation, 

most of the comments were in favor of 

relisting these colors. Because these 

colors are listed in § 205.606, certified 

operations are required to use organic 

versions of these colors unless the 

organic versions are not commercially 

available (i.e., not available in an 

appropriate form, quality, or quantity). 

Many of the comments supporting 

relisting were from organic handlers 

claiming that while one or more of these 

colors are available in organic form, 

they are not available in the same form 

or quality as the nonorganic version. 

Some comments from color 

manufacturers, however, stated that 

they have sufficient quantity of these 

colors in organic form. 

AMS welcomes public comments that 

provide more information on whether 

there are sufficient amounts of the 

organic versions of the above colors to 


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11Formal Handling Sunset Recommendations 

from the NOSB to the NOP, October 30, 2020: 

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

media/HS2022SunsetRecs_webpost.pdf. 

12Organic Integrity Database, accessed February 

12, 2021: https://organic.ams.usda.gov/integrity/ 

Search.aspx. 

13NOSB Meeting Minutes & Transcripts 1992– 

2009: https://www.ams.usda.gov/sites/default/files/ 

media/NOSB%20Meeting%20Minutes%26

Transcripts%201992-2009.pdf. 

14NOSB Formal Handling Sunset 

Recommendations, November 2, 2017: https://

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

HS2019SunsetsFinalRec.pdf. 

15USDA Organic Integrity Database, accessed 

February 12, 2021: https://organic.ams.usda.gov/ 

integrity/default.aspx. 

16NOSB Meeting Minutes & Transcripts 1992– 

2009: https://www.ams.usda.gov/sites/default/files/ 

media/NOSB%20Meeting%20Minutes%26

Transcripts%201992-2009.pdf. 

17Formal Handling Sunset Recommendations 

from the NOSB to the NOP, October 30, 2020: 

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

media/HS2022SunsetRecs_webpost.pdf. 

18USDA Organic Integrity Database, accessed 

February 8, 2021: https://organic.ams.usda.gov/ 

integrity/default.aspx. 

meet demand and on the availability of 

organic colors in suitable form and 

quality. If any of these colors are still 

necessary in their nonorganic form, 

comments should provide specific 

information on the attributes of the 

nonorganic form that are not yet 

sufficiently available in the organic 

forms. If any or all of the above colors 

are not currently commercially available 

in organic form, we request comment on 

whether they should be relisted (i.e. not 

removed in the final rule) or whether 

the final rule should provide an 

implementation period to provide time 

for sufficient quantity, quality, and/or 

form of the color(s) to be developed. 

G. Kelp (§ 205.606) 

AMS is proposing to remove 

nonorganic kelp from the National List. 

The effect of this action is that only 

organic forms of kelp would be allowed 

in organic handling. Kelp was added to 

the National List at its inception on 

December 21, 2000 (65 FR 80547), was 

renewed through several sunset reviews, 

and is currently listed at § 205.606(k) for 

use only as a thickener and dietary 

supplement only when an organic 

version is not commercially available. 

After the Fall 2020 meeting, the NOSB 

recommended 11 the removal of kelp 

from the National List at § 205.606. 

During this sunset review, the NOSB 

received comments in support of 

removing as well as relisting kelp. In 

this sunset review, the NOSB 

determined that there were alternatives 

to kelp on the National List (namely 

kombu and wakame), which rendered 

the kelp listing no longer necessary. 

Because kelp no longer meets the 

requirement of OFPA at 7 U.S.C. 

6518(m)(6) due to the existence of 

alternatives, the NOSB voted to 

recommend the removal of kelp from 

the National List at § 205.606. 

AMS agrees with the NOSB 

recommendation. According to the 

Organic Integrity Database,12 there are 

currently 106 certified crop, wild crop, 

and handling operations that list ‘‘kelp’’ 

as a certified organic product. Organic 

kelp appears to be commercially 

available; therefore, this substance no 

longer appears to be necessary and no 

longer meets the requirements for 

inclusion on the National List at 7 

U.S.C. 6517(c)(1)(A)(ii). As such, AMS 

proposes the removal of nonorganic 

kelp from the National List at 

§ 205.606(k). 

H. Konjac Flour (§ 205.606) 

AMS is proposing to remove 

nonorganic konjac flour from the 

National List. The effect of this action is 

that only organic forms of konjac flour 

would be allowed in organic handling. 

Konjac flour was added to the National 

List effective June 21, 2007 (72 FR 

35137), renewed through two sunset 

reviews, and is currently listed at 

§ 205.606(l). The 2007 rulemaking was 

initiated by an NOSB 

recommendation 13 for the addition of 

konjac flour to the National List only 

when an organic version is not 

commercially available. 

After the Fall 2017 meeting, the NOSB 

recommended 14 the removal of konjac 

flour. In support of their 

recommendation, the NOSB solicited 

public comment regarding the use and 

necessity of konjac flour in organic 

handling and the availability of organic 

konjac flour. The NOSB received little 

feedback from industry in response. One 

trade organization reported one organic 

producer using konjac flour but was 

unsure if it was for organic products. 

Several certifiers stated they had not 

received any feedback from their clients 

regarding the need for or use of 

nonorganic konjac flour in their 

products. Ultimately, the NOSB voted to 

recommend removal of konjac flour 

from the National List at § 205.606(l) 

due to the availability of alternatives, as 

well as the fact that nonorganic konjac 

flour no longer meets the OFPA 

requirements at 7 U.S.C. 6518(m)(6). 

AMS agrees with the NOSB 

recommendation. A search in the 

Organic Integrity Database 15 for 

‘‘konjac’’ shows 30 operations with 

some form of certified organic konjac 

products (e.g., powder, starch, konjac 

tubers). Given the lack of reported use 

of, or need for, nonorganic konjac flour 

and the availability of organic konjac 

flour and konjac tubers, nonorganic 

konjac flour appears to no longer meet 

the requirements for inclusion on the 

National List at 7 U.S.C. 

6517(c)(1)(A)(ii). As such, AMS 

proposes the removal of nonorganic 

konjac flour from the National List at 

§ 205.606(l). 

I. Sweet Potato Starch (§ 205.606) 

AMS is proposing to remove 

nonorganic sweet potato starch from the 

National List. The effect of this action is 

that only organic forms of sweet potato 

starch would be allowed in organic 

handling. Sweet potato starch was 

added to the National List effective June 

21, 2007 (72 FR 35137), was renewed 

through two sunset reviews, and is 

currently listed at § 205.606(s)(2). The 

2007 rulemaking was initiated by an 

NOSB recommendation 16 for the 

allowance of nonorganic sweet potato 

starch for bean thread production only 

when an organic version is not 

commercially available. 

After the Fall 2020 meeting, the NOSB 

recommended 17 the removal of sweet 

potato starch from the National List at 

§ 205.606. NOSB solicited comment on 

the use and necessity of sweet potato 

starch and received little feedback. The 

comments that were received suggested 

scant use of nonorganic sweet potato 

starch, readily available alternatives, 

and the availability of organic forms of 

sweet potato starch. Further, comments 

noted that the continued listing of 

nonorganic sweet potato starch is 

inhibiting increased production of 

organic forms of sweet potato starch. 

Based on this information, the NOSB 

determined that there are available 

alternatives to nonorganic sweet potato 

starch and recommended the removal of 

this substance because its use no longer 

meets the OFPA criteria at 7 U.S.C. 

6518(m)(6). 

AMS agrees with the NOSB 

recommendation. A search in the 

Organic Integrity Database 18 for ‘‘potato 

starch’’ shows 54 operations with some 

form of certified organic potato starch 

and another 25 operations with some 

form of certified organic pea starch, a 

cited alternative to sweet potato starch. 

Given the low reported use of 

nonorganic sweet potato starch and the 

availability of organic sweet potato 

starch and pea starch, nonorganic sweet 

potato starch appears to no longer meet 

the requirements for inclusion on the 

National List at 7 U.S.C. 

6517(c)(1)(A)(ii). As such, AMS 

proposes the removal of nonorganic 


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47246 Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Proposed Rules 

19NOSB Meeting Minutes & Transcripts 1992– 

2009: https://www.ams.usda.gov/sites/default/files/ 

media/NOSB%20Meeting%20Minutes%26

Transcripts%201992-2009.pdf. 

20Formal Handling Sunset Recommendation 

from the NOSB to the NOP, October 2015: https:// 

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

HS%202017%20Sunset%20Final%

20Rvw%20605%28a%29_%28b%29_606_

final%20rec.pdf. 

21Formal Handling Sunset Recommendations 

from the NOSB to the NOP, October 30, 2020: 

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

media/HS2022SunsetRecs_webpost.pdf. 

22USDA Organic Integrity Database, accessed 

February 8, 2021: https://organic.ams.usda.gov/ 

integrity/default.aspx. 

23NOSB Meeting Minutes & Transcripts 1992– 

2009; https://www.ams.usda.gov/sites/default/files/ 

media/NOSB%20Meeting%20Minutes%26

Transcripts%2019. 

24Formal Handling Sunset Recommendation 

from the NOSB to the NOP, October 2015: https:// 

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

HS%202017%20Sunset%20Final%20Rvw%

20605%28a%29_%28b%29_606_final%20rec.pdf. 

25Formal Handling Sunset Recommendations 

from the NOSB to the NOP, October 30, 2020: 

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

media/HS2022SunsetRecs_webpost.pdf. 

26USDA Organic Integrity Database, accessed 

February 8, 2021: https://organic.ams.usda.gov/ 

integrity/default.aspx. 

sweet potato starch from the National 

List at § 205.606(s)(2). 

J. Turkish Bay Leaves (§ 205.606) 

AMS is proposing to remove 

nonorganic Turkish bay leaves from the 

National List. The effect of this action is 

that organic forms only of Turkish bay 

leaves would be allowed in organic 

handling. Turkish bay leaves were 

added to the National List effective June 

21, 2007 (72 FR 35137), were renewed 

through two sunset reviews, and are 

currently listed at § 205.606(v). The 

2007 rulemaking was initiated by an 

NOSB recommendation 19 for the 

addition of Turkish bay leaves to the 

National List for use in organic 

production only when organic versions 

are not commercially available. 

After the Fall 2015 meeting, the NOSB 

recommended 20 removal of Turkish bay 

leaves from § 205.606. This 

recommendation was not finalized by 

AMS (82 FR 31241) because public 

comments requested AMS maintain the 

allowance. Comments reported that 

organic whole Turkish bay leaves were 

not available in the quantity or quality 

to meet organic handling needs. During 

the 2020 sunset review, the NOSB 

received many comments supporting 

the removal of Turkish bay leaves due 

to the availability of organic versions. 

The NOSB cited one commenter, who 

uses Turkish bay leaves in a wide range 

of canned soups and stated there is full 

availability of organic forms of Turkish 

bay leaves. Further comments from 

certifiers indicated that few, if any, of 

their operations use nonorganic Turkish 

bay leaves. Based on this information, 

the NOSB determined that there are 

available alternatives to nonorganic 

Turkish bay leaves and recommended 21

the removal of this substance because it 

no longer meets the OFPA criteria at 7 

U.S.C. 6518(m)(6). 

AMS agrees with the NOSB 

recommendation. A search in the 

Organic Integrity Database 22 for ‘‘bay 

leaves’’ shows 100 crop and handling 

operations with some form of certified 

organic bay leaves. A search using the 

term ‘‘Turkish bay leaves’’ shows five 

operations, as it appears that only one 

certifier identifies bay leaves with that 

level of specificity in the Organic 

Integrity Database. Given that comments 

to the NOSB indicated organic Turkish 

bay leaves are readily available in all 

forms and the high number of 

operations reported in the Organic 

Integrity Database with organic bay 

leaves (of which a subset are Turkish 

bay leaves), nonorganic Turkish bay 

leaves appear to no longer meet the 

requirements for inclusion on the 

National List at 7 U.S.C. 

6517(c)(1)(A)(ii). As such, AMS 

proposes the removal of nonorganic 

Turkish bay leaves from the National 

List at § 205.606(v). 

K. Whey Protein Concentrate (§ 205.606) 

AMS is proposing to remove 

nonorganic whey protein concentrate 

from the National List. The effect of this 

action is that only organic forms of 

whey protein concentrate would be 

allowed in organic handling. Whey 

protein concentrate was added to the 

National List effective June 21, 2007 (72 

FR 35137), was renewed through two 

sunset reviews, and is currently listed at 

§ 205.606(x). The 2007 rulemaking was 

initiated by an NOSB recommendation 

made at the March 2007 23 NOSB 

meeting for the addition of whey protein 

concentrate to the National List for 

organic production only when an 

organic version is not commercially 

available. 

After the Fall 2015 meeting, the NOSB 

recommended 24 removal of whey 

protein concentrate from § 205.606. This 

recommendation was not finalized by 

AMS (82 FR 31243) because public 

comment asserted that whey protein 

concentrate was essential to organic 

processed products, and there was no 

commercially available organic product. 

During the 2020 sunset review, the 

NOSB received many comments 

supporting the removal of whey protein 

concentrate due to the availability of 

organic versions. The NOSB cited 

several commenters who demonstrated 

that they produce a robust supply of 

organic whey protein concentrate in 

several forms and sell excess to the 

conventional market. A comment noted 

that the international supply chain of 

organic whey-based products is also 

robust. Further comment from at least 

one certifier indicated that none of their 

operations are using nonorganic whey 

protein concentrate. Based on this 

information, the NOSB determined that 

there are available alternatives to 

nonorganic whey protein concentrate 

and recommended 25 the removal of this 

substance because it no longer meets the 

OFPA criteria at 7 U.S.C. 6518(m)(6). 

AMS agrees with the NOSB 

recommendation. A search in the 

Organic Integrity Database 26 for ‘‘whey 

protein concentrate’’ shows 22 

operations with some form of certified 

organic whey protein concentrate. The 

NOSB also received comments stating 

that there is a substantial supply of all 

forms of organic whey protein 

concentrate and cited the diversion of 

some quantity to the conventional 

market as evidence that there is enough 

supply to meet the demand for organic 

whey protein concentrate. Given the 

comments submitted to the NOSB 

outlining the lack of use and stated 

abundance of supply, nonorganic whey 

protein concentrate appears to no longer 

meet the requirements for inclusion on 

the National List at 7 U.S.C. 

6517(c)(1)(A)(ii). As such, AMS 

proposes the removal of nonorganic 

whey protein concentrate from the 

National List at § 205.606(x). 

III. Statutory and Regulatory Authority 

The OFPA authorizes the Secretary to 

make amendments to the National List 

based on recommendations developed 

by the NOSB. Sections 6518(k) and 

6518(n) of the OFPA authorize the 

NOSB to develop recommendations for 

submission to the Secretary to amend 

the National List and establish a process 

by which persons may petition the 

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. 


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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Proposed Rules 47247 

27U.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. 

28Organic Integrity Database: https://

organic.ams.usda.gov/Integrity/. Accessed on 

January 29, 2021. 

A. Executive Orders 12866 and 13563 

and the Regulatory Flexibility Act 

This proposed rule does not meet the 

criteria of a significant regulatory action 

under Executive Order 12866 as 

supplemented by Executive Order 

13563. Therefore, the Office of 

Management and Budget (OMB) has not 

reviewed this rule under those Orders. 

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 the RFA is to fit regulatory actions to 

the scale of businesses subject to the 

action. 

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. The 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. 

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. 

AMS has considered the economic 

impact of this proposed rulemaking on 

small agricultural entities. Data 

collected by the USDA National 

Agricultural Statistics Service (NASS) 

and the 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.27 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 

$750,000 sales threshold to qualify as a 

small business. 

According to the NOP’s Organic 

Integrity Database, there are 19,059 

organic handlers that are certified under 

the USDA organic regulations.28 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: Less 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 

larger manufacturers is significantly 

smaller than the SBA’s small business 

thresholds (500 to 1,250). Therefore, 

AMS expects that most organic handlers 

would qualify as small businesses. 

SBA defines small agricultural service 

firms, which include certifying agents, 

as those having annual receipts of less 

than $8,000,000 (13 CFR 121.201). 

There are currently 77 USDA-accredited 

certifying agents; based on a query of 

the NOP certified organic operations 

database. 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. Certifying agents already must 

comply with the current regulations, 

e.g., maintaining certification records 

for organic operations. 

AMS has determined that this rule 

would not have a significant impact on 

a substantial number of small entities, 

as defined by SBA. The effect of this 

rule, if implemented as final, would be 

to remove the allowance of seventeen 

substances in organic production and 

organic handling. The removal of these 

substances, while numerous, is due to 

the fact that alternatives have rendered 

them no longer necessary, they are no 

longer in use, or organic versions have 

become available. AMS invites 

comments on the anticipated costs of 

this proposed rule, including the 

impacts on small businesses. 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations to avoid unduly 

burdening the court system. 

Accordingly, to prevent duplicative 

regulation, states and local jurisdictions 

are preempted under the 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 the OFPA. States are also 

preempted under sections 6503 through 

6507 of the 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 the OFPA. 

Pursuant to section 6507(b)(2) of the 

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 the 

OFPA, (b) not be inconsistent with the 

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 section 

6519(c)(6) of the OFPA, this proposed 

rule would 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 the 

EPA under the Federal Insecticide, 

Fungicide and Rodenticide Act (7 U.S.C. 

136 et seq.). 

This proposed rule is not intended to 

have a retroactive effect. 

C. Paperwork Reduction Act 

No additional collection or 

recordkeeping requirements are 

imposed on the public by this proposed 

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 proposed 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: 


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47248 Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Proposed Rules 

(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 

proposed 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 

the USDA Office of Tribal Relations to 

ensure meaningful consultation is 

provided as needed with regards to the 

NOP regulations. 

E. General Notice of Public Rulemaking 

This proposed rule reflects 

recommendations submitted by the 

NOSB to the Secretary to add three 

substances to the National List. A 60- 

day period for interested persons to 

comment on this rule is provided. 

List of Subjects in 7 CFR Part 205 

Administrative practice and 

procedure, Agriculture, Animals, 

Animal drugs, Dairy products, Food 

grades and standards, Foods, Labeling, 

Livestock, Meat and meat products, 

Organically produced products, 

Reporting and recordkeeping 

requirements, Seals and insignia. 

For the reasons set forth in the 

preamble, AMS proposes to amend 7 

CFR part 205 as follows: 

PART 205—NATIONAL ORGANIC 

PROGRAM 

■ 1. The authority citation for 7 CFR 

part 205 continues to read as follows: 

Authority: 7 U.S.C. 6501–6524. 

■ 2. Amend § 205.601 by removing 

paragraph (e)(10) and revising paragraph 

(j)(9). 

The revision to read as follows: 

§ 205.601 Synthetic substances allowed 

for use in organic crop production. 

* * * * * 

(j) * * * 

(9) Vitamins C and E. 

* * * * * 

§ 205.603 [Amended] 

■ 3. Amend § 205.603 by: 

■ a. Removing paragraph (a)(22); 

■ b. Redesignating paragraphs (a)(23) 

through (30) as paragraphs (a)(22) 

through (29), respectively; 

■ c. Removing paragraphs (b)(8) and 

(10); and 

■ d. Redesignating paragraphs (b)(9), 

(11) and (12) as paragraphs (b)(8) 

through (10), respectively. 

§ 205.605 [Amended] 

■ 4. In § 205.605(b) remove the words 

‘‘Alginic acid (CAS # 9005–32–7)’’. 

■ 5. Revise § 205.606 to read as follows: 

§ 205.606 Nonorganically produced 

agricultural products allowed as ingredients 

in or on processed products labeled as 

‘‘organic.’’ 

Only the following nonorganically 

produced agricultural products may be 

used as ingredients in or on processed 

products labeled as ‘‘organic,’’ only in 

accordance with any restrictions 

specified in this section, and only when 

the product is not commercially 

available in organic form. 

(a) Carnauba wax. 

(b) Casings, from processed intestines. 

(c) Celery powder. 

(d) Colors derived from agricultural 

products—Must not be produced using 

synthetic solvents and carrier systems or 

any artificial preservative. 

(1) Beet juice extract color—derived 

from Beta vulgaris L., except must not 

be produced from sugarbeets. 

(2) Beta-carotene extract color— 

derived from carrots (Daucus carota L.) 

or algae (Dunaliella salina). 

(3) Black/purple carrot juice color— 

derived from Daucus carota L. 

(4) Chokeberry, aronia juice color— 

derived from Aronia arbutifolia (L.) 

Pers. or Aronia melanocarpa (Michx.) 

Elliott. 

(5) Elderberry juice color—derived 

from Sambucus nigra L. 

(6) Grape skin extract color—derived 

from Vitis vinifera L. 

(7) Purple sweet potato juice color— 

derived from Ipomoea batatas L. or 

Solanum tuberosum L. 

(8) Red cabbage extract color—derived 

from Brassica oleracea L. 

(9) Red radish extract color—derived 

from Raphanus sativus L. 

(10) Saffron extract color—derived 

from Crocus sativus L. 

(e) Fish oil (Fatty acid CAS #’s: 

10417–94–4, and 25167–62–8)— 

stabilized with organic ingredients or 

only with ingredients on the National 

List, §§ 205.605 and 205.606. 

(f) Fructooligosaccharides (CAS # 

308066–66–2). 

(g) Gelatin (CAS # 9000–70–8). 

(h) Glycerin (CAS # 56–81–5)— 

produced from agricultural source 

materials and processed using biological 

or mechanical/physical methods as 

described under § 205.270(a). 

(i) Gums—water extracted only 

(Arabic; Guar; Locust bean; and Carob 

bean). 

(j) Inulin-oligofructose enriched (CAS 

# 9005–80–5). 

(k) Lecithin—de-oiled. 

(l) Orange pulp, dried. 

(m) Orange shellac-unbleached (CAS 

# 9000–59–3). 

(n) Pectin (non-amidated forms only). 

(o) Potassium acid tartrate. 

(p) Seaweed, Pacific kombu. 

(q) Starches. 

(1) Cornstarch (native). 

(2) [Reserved] 

(r) Tamarind seed gum. 

(s) Tragacanth gum (CAS # 9000–65– 

1). 

(t) Wakame seaweed (Undaria 

pinnatifida). 

Erin Morris, 

Associate Administrator, Agricultural 

Marketing Service. 

[FR Doc. 2021–17835 Filed 8–23–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 915 

[Doc. No. AMS–SC–21–0040] 

Avocados Grown in South Florida; 

Increased Assessment Rate 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

implement an Avocado Administrative 

Committee recommendation to increase 

the assessment rate established for the 

2021–22 and subsequent fiscal years. 

The proposed assessment rate would 

remain in effect indefinitely unless 

modified, suspended, or terminated. 

DATES: Comments must be received by 

September 23, 2021. 

ADDRESSES: Interested persons are 

invited to submit written comments 

concerning this proposed rule. 

Comments must be submitted on the 

internet at: https://www.regulations.gov. 

Comments should reference the 

document number and the date and 

page number of this issue of the Federal 

Register and will be available for public 


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