10930 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 

Responsibilities of Department 

Employees 

§ 1.223 What must I, as an employee, do 

upon receiving a demand? 

(a)(1) If you receive a demand, you 

must immediately notify your 

supervisor, who must in turn notify the 

appropriate Department official. Either 

your supervisor or the appropriate 

Department official must notify the 

Office of the General Counsel contact for 

your region or division for assistance 

with issuing the proper response. 

(2) Demands for Office of Inspector 

General official information or 

testimony should be forwarded 

immediately to the Counsel to the 

Inspector General. 

(b)(1) The appropriate Department 

official will decide whether to grant or 

deny the demand. Before a decision 

granting or denying a demand is made, 

the Office of the General Counsel 

contact for your region or division must 

be consulted for advice. All decisions 

granting or denying a demand must be 

in writing and must receive Office of the 

General Counsel concurrence prior to 

issuance. Absent Office of the General 

Counsel concurrence, a demand 

decision cannot be issued. 

(2) The Counsel to the Inspector 

General will decide whether to grant or 

deny a demand for Office of Inspector 

General information and testimony. 

(c) In the event that the appropriate 

Department official decides to deny the 

demand, the decision shall state that 

you are not authorized to provide 

official information or testimony and, if 

applicable, that you will not personally 

appear in response to the demand. 

§ 1.224 What must I, as an employee, do 

upon becoming aware that a court or other 

authority has ordered compliance with a 

demand? 

(a) If you become aware that a court 

or other authority has ordered 

compliance with a demand, you must 

promptly notify your supervisor, who 

must in turn notify the Office of the 

General Counsel for your region or 

division. 

(b) In the case of compliance orders 

involving a demand for Office of 

Inspector General information and 

testimony, promptly forward them to 

your supervisor and the Counsel to the 

Inspector General. 

Dated: September 2, 2021. 

David Grahn, 

Principal Deputy General Counsel, United 

States Department of Agriculture. 

[FR Doc. 2022–03880 Filed 2–25–22; 8:45 am] 

BILLING CODE 3410–90–P 

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; 

Amendments to the National List of 

Allowed and Prohibited Substances 

(2022 Sunset) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

United States Department of 

Agriculture’s (USDA) organic 

regulations to implement 

recommendations from the National 

Organic Standards Board (NOSB). The 

rule prohibits fourteen nonorganic 

ingredients, which are currently 

allowed in the manufacture of organic 

processed products. The rule also 

prohibits two substances (vitamin B1

and procaine), which are currently 

allowed in organic crop and livestock 

production. Finally, the rule renews an 

allowance for two substances (oxytocin 

and sucrose octanoate esters) in organic 

production. 

DATES:

Effective Date: This rule is effective 

on March 30, 2022. 

Compliance Dates: The compliance 

date for the amendments that remove 

vitamin B1 and procaine from the 

National List is March 15, 2023. The 

compliance date for all other 

amendments that remove substances 

from the National List is March 15, 

2024. Products in the stream of 

commerce after the compliance date that 

are labeled as ‘‘organic’’ or ‘‘made with 

organic (specified ingredients or food 

group(s))’’ may contain substances 

removed in this final rule if 

manufactured prior to the compliance 

date. The final rule renews an allowance 

for two substances (oxytocin and 

sucrose octanoate esters) in organic 

production. This rule maintains the 

current regulatory structure with regard 

to these two substances upon 

publication for up to five years. 

FOR FURTHER INFORMATION CONTACT: 

Jared Clark, Standards Division, 

National Organic Program. Telephone: 

(202) 720–3252 or Email: Jared.Clark@

usda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 21, 2000, the Secretary 

of Agriculture (‘‘Secretary’’) established 

the Agricultural Marketing Service’s 

(AMS) National Organic Program (NOP) 

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 in organic 

crop and livestock production as well as 

the nonsynthetic (natural) substances 

that may not be used. It also identifies 

the nonorganic substances that may be 

used in or on processed organic 

products. 

AMS is finalizing 16 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 the USDA 

must follow to amend the National List 

(7 U.S.C. 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 (7 

U.S.C. 6518). 

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). 

The removal of 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. 

During a 60-day comment period that 

closed on October 25, 2021, AMS 

received 60 comments on the proposed 

rule. See below for a discussion of the 

comments received and AMS’s 

responses to comments. Comments on 

the proposed rule can also be viewed 

through Regulations.gov. Use the search 

area on the homepage at https://

www.regulations.gov to enter a keyword, 


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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 10931 

1Sucrose octanoate esters is cited in NOSB 

recommendation(s) at 7 CFR 205.603(b)(10). The 

current citation for sucrose octanoate esters is 7 

CFR 205.603(b)(11). 

2National Organic Standards Board, Sunset 

Review of Substances Listed at §§ 205.601 and 

205.602, https://www.ams.usda.gov/sites/default/ 

files/media/CS2020SunsetFinalRecOct2018.pdf. 

3National Organic Standards Board, Sunset 

Review of Substances Listed at § 205.603, https://

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

LS2020SunsetFinalRecOct2018.pdf. 

title, or docket ID (the docket number 

for this rule is AMS–NOP–19–0106). 

II. Overview of Amendments 

This rule removes fourteen 

ingredients and two substances from the 

National List and retains (or ‘‘renews’’) 

two substances on the National List. 

Additional background on the NOSB’s 

review of the substances may be found 

in the proposed rule (86 FR 47242; 

August 24, 2021). 

This final rule removes the following 

synthetic substances, which are 

currently allowed in organic crop and 

livestock production (7 CFR 205.601 

and 205.603): 

• Vitamin B1 (crop production); and 

• Procaine (livestock production). 

As noted in the DATES section, AMS 

is providing a one-year implementation 

period for these changes to provide time 

for certifying agents to communicate the 

changes to organic operations and for 

organic producers to cease use. 

Additionally, AMS is removing the 

following nonorganic ingredients, 

which are 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; and 

• Whey protein concentrate. 

Finally, this rule renews sucrose 

octanoate esters for organic crop and 

livestock production and oxytocin for 

organic livestock production. The new 

sunset date for the two substances (three 

listings on the National List) is March 

15, 2027. 

Below, AMS describes each substance 

in alphabetical order, sorted by use (i.e., 

crop production, livestock production, 

handling). Sucrose octanoate esters is 

discussed first because it is used in both 

crop and livestock production. For each 

substance, AMS outlines the NOSB’s 

sunset review, discusses comments 

received, and describes the final action 

by this rule. 

Implementation Period. As noted in 

the DATES section, AMS is providing a 

one-year implementation period for 

producers to cease use of vitamin B1 and 

procaine. For all other substances 

removed by this final rule, AMS is 

providing a two-year implementation 

period. A shorter implementation 

period for vitamin B1 and procaine is 

appropriate because there is no 

evidence these substances are currently 

used in organic production. A 2-year 

implementation period is provided for 

organic handling operations to cease use 

of the nonorganic ingredients (including 

alginic acid) above. AMS believes that a 

two-year implementation period 

provides certifying agents with the 

necessary time to communicate the 

changes to organic operations and for 

operations to source organic forms of 

the ingredients (if necessary), revise 

labels, and/or adjust recipes. Public 

comment indicated a two-year 

implementation period would be 

adequate. AMS notes that while the 

final rule provides a two-year 

implementation period, organic 

handlers may not use nonorganic forms 

of ingredients when organic forms of the 

ingredients are commercially available 

(see 7 CFR 205.301(f)(6)). 

Sucrose Octanoate Esters (§ 205.601 and 

§ 205.603) 

This final rule renews the allowances 

for sucrose octanoate esters at 7 CFR 

205.601(e)(10) and 205.603(b)(11).1

Sucrose octanoate esters is a pesticide 

that targets mites (e.g., Varroa mites, a 

pest that attacks honeybees) and certain 

soft-bodied insects (e.g., aphids). 

NOSB Review and Recommendation 

Following the sunset review of 

sucrose octanoate esters, the NOSB 

recommended removing sucrose 

octanoate esters from the National List. 

As described in the Background section, 

the sunset process is a system of regular 

evaluation of National List substances 

against criteria in the OFPA. If a 

substance is found to no longer satisfy 

these criteria, the NOSB may 

recommend removal of the substance. 

Prior to the NOSB’s 2018 Fall 

meeting, the NOSB received information 

indicating there were no current U.S. 

Environmental Protection Agency (EPA) 

registrations for sucrose octanoate esters 

at the time and therefore no approved 

pesticide applications. Based on this 

information, the NOSB reasoned that no 

argument could be made that this 

substance remains an essential tool for 

organic production if there was no 

current legal use consistent with the 

National List restrictions. The Board 

then voted to remove both the crop use 

listing (at § 205.601(e)) and the livestock 

use listing (at § 205.603(b)).2 3 In both 

organic crop and livestock production, 

sucrose octanoate esters are allowed as 

an insecticide and parasiticide, with the 

latter including treatment of Varroa 

mites in honeybees. Honeybees are 

regulated as livestock under the USDA 

organic regulations (see definition of 

‘‘livestock’’ at § 205.2), allowing 

substances on the National List for 

livestock production to be used in 

organic apiculture (beekeeping). 

Comments Received 

Most comments on the proposed rule 

related to the proposed removal of 

sucrose octanoate esters from the 

National List. 

Lack of approved alternatives. Most 

comments supported keeping sucrose 

octanoate esters on the National List. 

Commenters stated that removing this 

substance would have a negative impact 

on organic farmers and beekeepers, as it 

is a primary ingredient in 

OrganiShield—a common product used 

in Integrated Pest Management (IPM) 

systems. Commenters stressed that there 

is no comparable product on the market 

that is safe, effective, and approved for 

use in organic crop and livestock 

production. 

Environmentally friendly pesticide. 

Commenters noted that the use of 

sucrose octanoate esters benefits cropfriendly insects such as pollinators, 

biodegrades rapidly after use, and does 

not negatively impact the environment. 

Multiple commenters highlighted that 

sucrose octanoate esters play a key role 

as an organic pesticide, specifically in 

controlling Varroa mites. 

Change in market situation. 

Commenters highlighted that the NOSB 

voted to remove both the crop use 

listing at § 205.601(e) and the livestock 

use at § 205.603(b) during the Fall 2018 

meeting. The NOSB’s rationale was that 

sucrose octanoate esters could not be 

considered an essential tool for organic 

production if there were no legally 

approved uses (i.e., there were no active 

EPA pesticide registrations at the time). 

Commenters noted that the market 

situation has changed since the NOSB’s 

2018 decision, as there have since been 

new EPA registrations for sucrose 

octanoate esters. 

AMS Response 

AMS had tentatively suggested 

removal of sucrose octanoate esters in 

the proposed rule based on the lack of 

EPA-approved uses for this substance 

back when the NOSB recommended its 

removal in 2018 (86 FR 47242, August 

24, 2021). Following the 2018 NOSB 


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10932 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 

4National Organic Standards Board, Crops 2019 

Sunset Substances, https://www.ams.usda.gov/ 

sites/default/files/media/CS2019SunsetsFinal

Rec.pdf. 

5Pesticide Research Institute, Technical 

Evaluation Report: Vitamins B1, C and E, https://

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

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

6National Organic Standards Board, Livestock 

2019 Sunset Substances, https://

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

LS2019SunsetsFinalRec.pdf. 

meeting, the EPA received product 

registrations for sucrose octanoate esters 

in December 2020. Subsequent 

comments demonstrated that the market 

situation had changed since the 2018 

NOSB recommendation, with recent 

product registrations and increased use 

of sucrose octanoate esters. 

Additionally, comments noted this 

substance is not harmful to the 

environment and cited the lack of 

alternatives approved for organic use. In 

response to comments identifying the 

recent registration, increased use, and a 

lack of alternatives, AMS is not 

removing sucrose octanoate esters from 

the National List at §§ 205.601(e)(10) 

and 205.603(b)(11). The substance will 

undergo another sunset review prior to 

the new March 15, 2027 sunset date. At 

that time, the Board will have another 

opportunity to evaluate the substance 

against OFPA criteria considering this 

recent registration and increase in use. 

Vitamin B1 (§ 205.601) 

This final rule amends the National 

List to prohibit use of synthetic vitamin 

B1 in organic crop production by 

removing vitamin B1 from 7 CFR 

205.601(j)(9). 

NOSB Review and Recommendation 

Following the sunset review of 

vitamin B1, the NOSB recommended 

removing vitamin B1 from the National 

List. As described in the Background 

section, the sunset process is a system 

of regular evaluation of National List 

substances against criteria in the OFPA. 

If a substance is found to no longer 

satisfy these criteria, the NOSB may 

recommend removal of the substance. 

In support of their sunset review,4 the 

NOSB requested a third-party technical 

report on the use of vitamins B1, C, and 

E in crop production.5 The technical 

report stated these vitamins are 

generally used for stimulation of crop 

growth and plant protection but found 

that previous claims about root growth 

and reduction of transplant shock 

associated with vitamin B1 were largely 

unsubstantiated outside of a laboratory 

environment. Due to this, and the lack 

of support voiced during the public 

comment process regarding efficacy or 

necessity, the NOSB recommended 

removal. 

Comments Received 

AMS received no comments in 

support of keeping synthetic vitamin B1

on the National List for organic crop 

production. One commenter requested 

the NOP allow for a 12-month 

implementation timeline. 

AMS Response 

As commenters noted, the NOSB 

voted to remove vitamin B1 from the 

National List at the Fall 2017 meeting 

on the basis that it is not essential for 

organic crop production and because its 

primary use for root growth and 

reduction of transplant shock was not 

substantiated by technical information. 

Given this information regarding use 

and efficacy, AMS is removing vitamin 

B1 from the National List for organic 

crop production. Further, the 2015 

technical report on vitamins for crop 

production identified several natural 

(nonsynthetic) alternatives to vitamin 

B1, including yeast, various meals (e.g., 

soybean meal, cottonseed meal), and 

other crop waste or residues. After 

considering public comments, technical 

reports, and the NOSB review, AMS is 

finalizing the removal of vitamin B1

from the National List at § 205.601(j)(9). 

As specified in the DATES section, 

organic crop producers will have until 

March 15, 2023, to comply with this 

change. 

Oxytocin (§ 205.603) 

This final rule renews the allowance 

for oxytocin (an animal drug) for use in 

post-parturition (birth) therapeutic 

applications at 7 CFR 205.603(a)(22). 

Oxytocin will not be prohibited, as 

proposed, in organic livestock 

production. A discussion of the 

compliant uses under the annotation, 

‘‘postparturition therapeutic 

applications,’’ is included below in 

AMS’s response. 

NOSB Review and Recommendation 

Following its sunset review of 

oxytocin, the NOSB recommended 

removing oxytocin from the National 

List.6 As described in the Background 

section, the sunset process is a system 

of regular evaluation of National List 

substances against criteria in the OFPA. 

If a substance is found to no longer 

satisfy these criteria, the NOSB may 

recommend removal of the substance. 

The NOSB requested public comment 

on whether the substance was essential 

for organic production and whether 

there were natural alternative materials 

and methods that render it unnecessary. 

In response, the NOSB received public 

comments indicating the substance was 

no longer necessary and generally 

supporting its removal. The NOSB 

concluded there are numerous 

alternative methods and materials to 

oxytocin and that the use of oxytocin no 

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

6518(m)(6). Additionally, the NOSB 

noted that oxytocin is a synthetic 

hormone and that hormones are not 

otherwise permitted in organic 

production (§§ 205.237(b)(1) and 

205.238(c)(3)). 

Comments Received 

AMS received several comments in 

response to the proposed sunset 

removal of oxytocin from the National 

List. 

General opposition. A certifying agent 

(‘‘certifier’’) noted that 35 of the organic 

dairies they certify include the 

substance in their Organic System Plans 

for use in post-parturition therapeutic 

applications. The commenter stated that 

those operations use oxytocin for 

various uses, including uterine care, 

milk letdown for first-time heifers or as 

a mastitis treatment, retained placenta, 

and strained labor treatment. The 

commenter noted they do not allow 

routine or repeated use of oxytocin nor 

permit operations to use oxytocin to 

promote milk production. The 

commenter requested that any 

prohibition of the substance occur 

following the 2022 spring birthing 

season. 

A dairy manufacturer requested 

retention for oxytocin on the National 

List due to a lack of alternatives. The 

commenter also stated oxytocin is a 

veterinary control drug that should only 

be administered or prescribed under 

veterinary instruction. The commenter 

recognized alternatives can assist with 

topical inflammation; however, for uses 

to assist with inflammation caused by 

animals withholding milk or to assist 

with uterine cleaning, the commenter 

stated there were no compliant 

alternatives. Another commenter also 

requested oxytocin to remain an 

allowed substance on account of its 

effectiveness as a post-parturition 

therapeutic to transition a dry cow to a 

lactating cow. 

General agreement. A comment stated 

that natural alternatives are available to 

address certain post-parturition 

complications that can arise in organic 

dairy cattle and that use of oxytocin 

would prevent organic producers from 

claiming their products are ‘‘hormonefree.’’ The commenter requested an 

implementation period of 12 months to 


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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 10933 

7OMRI, Technical Evaluation Report: Alginic 

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

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

allow for industry time to comply with 

the final rule. 

AMS Response 

After reviewing public comments, 

AMS is renewing the listing for oxytocin 

in this final rule. The substance will 

remain on the National List, with a new 

sunset date of March 15, 2027. AMS 

agrees with commenters that synthetic 

oxytocin remains essential to organic 

livestock production in the absence of 

alternative nonsynthetic (natural) 

medical treatments for post-parturition 

emergency treatments (i.e., treatment for 

severe complications resulting from 

labor). AMS notes that under current 

FDA regulations, ‘‘Federal law restricts 

[oxytocin] to use by or on the order of 

a licensed veterinarian.’’ (21 CFR 

522.1680(c)(3)). Although some 

annotations on the National List for 

animal drugs specify that they may be 

used only by or on the order of a 

veterinarian, the absence of this 

phrasing in the annotation for oxytocin 

would not alter a producer’s obligations 

to comply with other federal laws. 

By retaining oxytocin on the National 

List, organic livestock producers will 

continue to be permitted to use the drug 

to treat specific conditions within a 

limited timeframe following parturition 

without forfeiting the animal’s organic 

status. Additional discussion of the 

permitted uses of the substance in 

organic production follows. 

Annotation Discussion 

AMS is aware there is some confusion 

around what uses comply with the 

annotation for oxytocin that reads, ‘‘use 

in postparturition therapeutic 

treatments’’ (§ 205.603(a)(22)). This 

discussion is meant to inform certifying 

agents and organic operations of AMS’s 

current thinking on uses that comply 

with the annotation. 

The current annotation allows 

producers to use oxytocin to treat 

conditions related to labor and to an 

animal’s postpartum survival. Its use is 

not permitted on a routine basis (i.e., as 

protocol). Instead, it is available for 

emergency situations and severe 

complications in the immediate 

postpartum (following birth of young) 

period. It may not be administered to 

increase an animal’s milk production 

(volume) or for milk letdown. As 

previously noted in this document, 

Federal law restricts this drug to use by 

or on the order of a licensed 

veterinarian (21 CFR 522.1680(c)(3)). 

AMS’s interpretation of the 

annotation for oxytocin at § 205.603, 

‘‘for postparturition therapeutic 

applications,’’ is informed and 

supported by its prior discussion of 

oxytocin in its March 13, 2000 proposed 

rule (65 FR 13511). AMS believes that 

discussion is relevant to the meaning of 

the current annotation in the USDA 

organic regulations. In the discussion in 

the proposed rule, AMS noted that 

oxytocin, ‘‘has some uses that do not 

involve lactation but are instead related 

to an animal’s postpartum survival’’ and 

that oxytocin was permitted by some 

certifiers for ‘‘animals that experience 

severe complications resulting from 

labor,’’ and described those as 

‘‘emergency situations’’ (65 FR 13511, 

13588). 

AMS’s expectation is that certifiers 

will always review an organic 

operation’s use of oxytocin to ensure it 

is used only in postparturition 

therapeutic applications. 

Procaine (§ 205.603) 

This final rule amends the National 

List to remove procaine at 7 CFR 

205.603(b)(9) and prohibit its use in 

organic livestock production. 

NOSB Review and Recommendation 

Following the sunset review of 

procaine, the NOSB recommended 

removing procaine from the National 

List. As described in the Background 

section, the sunset process is a system 

of regular evaluation of National List 

substances against criteria in the OFPA. 

If a substance is found to no longer 

satisfy these criteria, the NOSB may 

recommend removal of the substance. 

In support of their sunset review, the 

NOSB solicited public comment over 

two meetings on use of procaine and 

whether procaine can be sourced 

without prohibited antibiotics. The 

comments stated procaine is rarely 

used, is only available in drug 

formulations that are combined with 

prohibited antibiotics, and is not as 

effective as lidocaine (allowed for 

organic livestock use at § 205.603(b)(5)). 

After their review, the NOSB 

recommended removal of procaine from 

the National List. 

Comments Received 

AMS received no comments opposed 

to removing procaine from the National 

List. A certifying agent noted the 

importance of pain relievers but stated 

that procaine was not an active 

ingredient in any product currently 

used by organic operations that it 

certifies. Another comment highlighted 

that procaine products are already 

prohibited for use because they are 

always formulated with antibiotics that 

are prohibited in organic livestock 

production. One commenter requested 

an implementation timeline of 12 

months to allow industry time to 

comply with the final rule. 

AMS Response 

As the NOSB referenced in their 

recommendation, procaine is not 

available on its own (i.e., not 

compounded with an antibiotic). A 

search of the FDA’s animal drug 

database (https://animaldrugs

atfda.fda.gov/) indicates that all 16 of 

the FDA approved drugs that contain 

procaine also contain an antibiotic (e.g., 

Penicillin G Procaine). Furthermore, 

another National List material, 

lidocaine, could be used to perform the 

same function (as a local anesthetic). 

This information supports that procaine 

is not currently used in organic 

production and no longer meets the 

exemption requirement (7 U.S.C. 

6517(c)(1)(A)(ii)). AMS agrees with 

commenters and the NOSB that 

procaine is not essential to organic 

livestock production. AMS is finalizing 

the removal of synthetic procaine from 

the National List at § 205.603(b)(9) to 

prohibit its use in organic livestock 

production. As specified in the DATES

section, organic livestock producers will 

have until March 15, 2023, to comply 

with this change. 

Alginic Acid (§ 205.605) 

This final rule amends the National 

List to remove alginic acid at 7 CFR 

205.605(b) and prohibit its use in 

organic processed products. 

NOSB Review and Recommendation 

Following the sunset review of alginic 

acid, the NOSB recommended removing 

alginic acid from the National List. As 

described in the Background section, 

the sunset process is a system of regular 

evaluation of National List substances 

against criteria in the OFPA. If a 

substance is found to no longer satisfy 

these criteria, the NOSB may 

recommend removal of the substance. 

In support of their sunset review of 

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

solicited public comment at their Spring 

2019 meeting.7 The NOSB received no 

comments in support of continuing the 

allowance of, or stating use of, alginic 

acid. In addition, no certifying agents 

(‘‘certifiers’’) reported this material in 

use 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 


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8National Organic Standards Board, 2022 Sunset 

Reviews—Handling (§§ 205.605, 205.606), https:// 

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

HS2022SunsetRecs_webpost.pdf. 

9Organic Integrity Database, accessed January 5, 

2022: https://organic.ams.usda.gov/integrity/ 

Search.aspx. 

determined that there are readily 

available alternatives and recommended 

removal. 

Comments Received 

AMS received no comments in favor 

of retaining alginic acid on the National 

List. One comment agreed with the 

NOSB’s rationale for removing alginic 

acid from the National List and 

requested a 24-month implementation 

period to comply with the final rule. 

AMS Response 

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). AMS is 

finalizing the removal of alginic acid 

from the National List at § 205.605(b) to 

prohibit its use in organic processed 

products. As identified in the DATES

section, organic processors will have 

until March 15, 2024, to comply with 

this change. 

Colors (§ 205.606) 

This final rule amends the National 

List 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. 

NOSB Review and Recommendation 

The NOSB recommended the removal 

of these colors at their Fall 2020 

meeting.8 The effect of these removals 

means that only organic forms of these 

colors will be allowed in organic 

handling. The NOSB solicited public 

comments in support of their sunset 

review of these colors at the Spring and 

Fall 2020 meetings. The NOSB noted 

these public comments were mixed 

regarding the availability and necessity 

of these colors. 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. 

Comments Received 

AMS received few comments in 

response to the proposed removal of 

eight nonorganic colors from the 

National List. 

General opposition. A comment 

requested retaining turmeric extract 

color on the National List because there 

is no readily available organic 

alternative in the marketplace. Another 

comment requested retaining paprika 

color on the National List as there are 

no commercially-available, organic 

alternatives for the color; however, the 

commenter stated there are readilyavailable, organic raw materials that 

may allow an organic version of the 

color to be developed. The commenter 

estimated a two-year implementation 

period would provide enough time for 

color development, shelf-life trials, and 

commercialization. 

General agreement. A certifier noted 

limited use of the nonorganic colors in 

this final rule among the organic 

handlers they certify. The comment 

noted there is limited use of nonorganic 

paprika color, grape juice color, and 

cherry juice powder. A certifying agent 

was particularly concerned about an 

insufficient supply of blueberry juice 

color, carrot juice color, paprika color, 

and turmeric extract color. The 

commenter cited an internal survey (of 

organic operations) that indicated the 

supply of organic colors is fragile and 

that removal from the National List may 

be premature, especially without a 

substantial implementation period. The 

commenter requested an 

implementation timeline of 24 months 

to allow industry time to comply with 

the final rule. 

AMS Response 

In the rule proposing removal of these 

colors, AMS requested comments 

regarding whether any of these colors 

are necessary and whether there are 

enough organic versions available to 

meet demand. Comments received 

suggested there may not be sufficient 

supplies of certain organic colors but 

that supply would likely develop over 

the course of the 24-month 

implementation period. None of these 

comments suggested an inability to 

produce or develop organic versions of 

these colors, given sufficient time. As 

such, AMS is finalizing the removal of 

these non-organic colors from the 

National List at § 205.606(d). To support 

the development of an adequate supply 

of organic colors, as requested by 

commentors, organic processors will 

have until March 15, 2024 (a 24-month 

implementation period) to comply with 

these changes. 

Kelp (§ 205.606) 

This final rule amends the National 

List to remove kelp at 7 CFR 205.606(k) 

and prohibit its use. Wakame seaweed 

and Pacific kombu remain allowed in 

§ 205.606 in organic processed products. 

NOSB Review and Recommendation 

Following the sunset review of kelp at 

their Fall 2020 meeting, the NOSB 

recommended removing kelp from the 

National List. Only organic forms of 

kelp (other than wakame seaweed and 

Pacific kombu, which remain allowed in 

§ 205.606), would be allowed in organic 

handling. As described in the 

Background section, the sunset process 

is a system of regular evaluation of 

National List substances against criteria 

in the OFPA. If a substance is found to 

no longer satisfy these criteria, the 

NOSB may recommend removal of the 

substance. 

During its sunset review, the NOSB 

received comments in support of 

removing, as well as relisting, kelp. The 

NOSB determined that there were 

alternatives to kelp on the National List 

(namely Pacific kombu and wakame) 

and therefore recommended removing 

kelp from the National List in § 205.606. 

Comments Received 

AMS received no comments in favor 

of retaining nonorganic kelp on the 

National List for organic handling. A 

comment requested an implementation 

period of 24 months to allow industry 

time to comply with the final rule. 

AMS Response 

According to the Organic Integrity 

Database, there are currently 104 

certified crop, wild crop, and handling 

operations that list ‘‘kelp’’ as a certified 

organic product.9 Organic kelp appears 

to be commercially available; therefore, 

this substance is no longer necessary 

and no longer meets the requirements 

for inclusion on the National List at 7 

U.S.C. 6517(c)(1)(A)(ii). AMS did not 

receive any comments challenging this 

conclusion and is finalizing the removal 

of non-organic kelp from the National 

List at § 205.606(k). As identified in the 


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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 10935 

10Organic Integrity Database, accessed January 5, 

2022: https://organic.ams.usda.gov/integrity/ 

Search.aspx. 

11Organic Integrity Database, accessed January 5, 

2022: https://organic.ams.usda.gov/integrity/ 

Search.aspx. 

12National Organic Standards Board, 2022 Sunset 

Reviews—Handling (§§ 205.605, 205.606), https://

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

HS2022SunsetRecs_webpost.pdf. 

DATES section, organic processors will 

have until March 15, 2024, to comply 

with this change. 

Konjac Flour (§ 205.606) 

This final rule amends the National 

List to remove konjac flour at 7 CFR 

205.606(l) and prohibit its use in 

organic processed products. 

NOSB Review and Recommendation 

Following the sunset review of konjac 

flour at their Fall 2017 meeting, the 

NOSB recommended removing konjac 

flour from the National List. As 

described in the Background section, 

the sunset process is a system of regular 

evaluation of National List substances 

against criteria in the OFPA. If a 

substance is found to no longer satisfy 

these criteria, the NOSB may 

recommend removal of the substance. 

In support of their recommendation, 

the NOSB solicited public comment 

regarding the use and necessity of 

konjac flour in organic handling as well 

as 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 products sold as 

‘‘organic.’’ 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 available alternatives. 

Comments Received 

AMS received no comments in favor 

of retaining nonorganic konjac flour on 

the National List for organic handling. A 

comment requested an implementation 

period of 24 months to allow industry 

time to comply with the final rule. 

AMS Response 

A search in the Organic Integrity 

Database for ‘‘konjac’’ shows 30 

operations with some form of certified 

organic konjac products (e.g., powder, 

starch, konjac tubers).10 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 

no longer meets the requirements for 

inclusion on the National List at 7 

U.S.C. 6517(c)(1)(A)(ii). AMS did not 

receive any comments challenging this 

conclusion and, as such, is finalizing 

the removal of non-organic konjac flour 

from the National List at § 205.606(l). As 

identified in the DATES section, organic 

processors will have until March 15, 

2024, to comply with this change. 

Sweet Potato Starch (§ 205.606) 

This final rule amends the National 

List to remove sweet potato starch at 7 

CFR 205.606(s)(2) and prohibit the use 

of non-organic sweet potato starch in 

organic products. 

NOSB Review and Recommendation 

Following the sunset review of sweet 

potato starch at their Fall 2020 meeting, 

the NOSB recommended removing 

sweet potato starch from the National 

List. As described in the Background 

section, the sunset process is a system 

of regular evaluation of National List 

substances against criteria in the OFPA. 

If a substance is found to no longer 

satisfy these criteria, the NOSB may 

recommend removal of the substance. 

During its sunset review, the NOSB 

solicited public comment on the use 

and necessity of sweet potato starch but 

received little feedback. The comments 

suggested there is scant use of 

nonorganic sweet potato starch, that 

alternatives are readily available, and 

that organic sweet potato starch is 

available. Further, comments noted that 

the continued listing of nonorganic 

sweet potato starch is inhibiting 

production of organic forms of sweet 

potato starch. Based on this information, 

the NOSB recommended the removal of 

this substance due to available 

alternatives. 

Comments Received 

AMS received no comments in favor 

of retaining nonorganic sweet potato 

starch on the National List for organic 

handling. A comment requested an 

implementation period of 24 months to 

allow industry time to comply with the 

final rule. 

AMS Response 

A search in the Organic Integrity 

Database for ‘‘potato starch’’ shows 60 

operations with some form of certified 

organic potato starch and another 27 

operations with some form of certified 

organic pea starch, a cited alternative to 

sweet potato starch.11 Given the low 

reported use of nonorganic sweet potato 

starch and the availability of organic 

sweet potato starch and organic pea 

starch, nonorganic sweet potato starch 

no longer meets the requirements for 

inclusion on the National List at 7 

U.S.C. 6517(c)(1)(A)(ii). AMS did not 

receive any comments challenging this 

conclusion and, as such, is finalizing 

the removal of non-organic sweet potato 

starch from the National List at 

§ 205.606(s)(2). As identified in the 

DATES section, organic processors will 

have until March 15, 2024, to comply 

with this change. 

Turkish Bay Leaves (§ 205.606) 

This final rule amends the National 

List to remove Turkish bay leaves at 7 

CFR 205.606(v) to prohibit its use in 

organic products. 

NOSB Review and Recommendation 

Following the sunset review of 

Turkish bay leaves at their Fall 2020 

meeting, the NOSB recommended 

removing Turkish bay leaves from the 

National List. As described in the 

Background section, the sunset process 

is a system of regular evaluation of 

National List substances against criteria 

in the OFPA. If a substance is found to 

no longer satisfy these criteria, the 

NOSB may recommend removal of the 

substance. 

During its sunset review, the NOSB 

received many comments supporting 

the removal of Turkish bay leaves due 

to the availability of organic versions. 

The NOSB called attention to one 

comment received at its Fall 2020 

meeting from an organic producer who 

uses Turkish bay leaves in a wide range 

of organic canned soups. This food 

manufacturer noted that organic forms 

of Turkish bay leaves are readily 

available. Further comments from 

certifiers indicated that few, if any, of 

their operations use nonorganic Turkish 

bay leaves. Based on this information, 

the NOSB recommended the removal of 

this substance due to available 

alternatives.12

Comments Received 

AMS received no comments in favor 

of retaining nonorganic Turkish bay 

leaves on the National List for organic 

handling. A commenter noted that the 

NOSB received multiple comments 

supporting the removal of Turkish bay 

leaves from the National List during the 

2020 sunset review. The commenter 

stated that Turkish bay leaves only 

remained on the National List after the 

NOSB’s Fall 2015 meeting due to the 

lack of available, organic alternatives. 

AMS Response 

Previously, AMS proposed removing 

Turkish bay leaves from § 205.606 

following a Fall 2015 NOSB 


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10936 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 

13National Organic Standards Board, Sunset 2017 

NOSB Final Review Handling Substances, https:// 

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

HS%202017%20Sunset%20Final%20

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

final%20rec.pdf. 

14Organic Integrity Database, accessed January 5, 

2022: https://organic.ams.usda.gov/integrity/ 

Search.aspx. 

15National Organic Standards Board, 2022 Sunset 

Reviews—Handling (§§ 205.605, 205.606),https://

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

HS2022SunsetRecs_webpost.pdf. 

16National Organic Standards Board, Sunset 2017 

NOSB Final Review Handling Substances, https:// 

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

HS%202017%20Sunset%20Final%20Rvw%20605

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

recommendation.13 At the time, AMS 

received comments stating organic 

whole Turkish bay leaves were not 

available in the quantity or quality to 

meet organic handling needs. As a 

result, AMS did not finalize removing 

Turkish bay leaves (82 FR 31241, July 6, 

2017), and its sunset date was extended 

five years. 

A search in the Organic Integrity 

Database for ‘‘bay leaves’’ shows 143 

crop and handling operations with some 

form of certified organic bay leaves. A 

search using the term ‘‘Turkish bay 

leaves’’ shows six operations, as it 

appears that only one certifying agent 

identifies bay leaves with that level of 

specificity in the Organic Integrity 

Database.14 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 no longer 

meet the requirements for inclusion on 

the National List at 7 U.S.C. 

6517(c)(1)(A)(ii). During this current 

rulemaking, AMS received no 

comments challenging this conclusion 

and is removing non-organic Turkish 

bay leaves from the National List at 

§ 205.606(v). As identified in the DATES

section, organic processors will have 

until March 15, 2024, to comply with 

this change. 

Whey Protein Concentrate (§ 205.606) 

This final rule amends the National 

List to remove whey protein concentrate 

at 7 CFR 205.606(x) and prohibit its use 

in organic processed products. 

NOSB Review and Recommendation 

Following the sunset review of whey 

protein concentrate at their Fall 2020 

meeting, the NOSB recommended 

removing whey protein concentrate 

from the National List. As described in 

the Background section, the sunset 

process is a system of regular evaluation 

of National List substances against 

criteria in the OFPA. If a substance is 

found to no longer satisfy these criteria, 

the NOSB may recommend removal of 

the substance. 

During this sunset review, the NOSB 

received many comments supporting 

the removal of whey protein concentrate 

due to the availability of organic 

versions. The NOSB highlighted 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 comments from at least 

one certifier indicated that none of their 

operations are using nonorganic whey 

protein concentrate. Based on this 

information, the NOSB recommended 

the removal of this substance based on 

available alternatives.15

Comments Received 

AMS received no comments in favor 

of retaining nonorganic whey protein 

concentrate on the National List for 

organic handling. A certifier noted that 

an organic operation they certify 

previously used non-organic whey 

protein concentrate but no longer does. 

Another commenter noted that the 

NOSB received many comments 

supporting the removal of whey protein 

from the National List during the 2020 

sunset review, including from several 

manufacturers who demonstrated they 

produce a robust supply of organic 

whey protein concentrate. The 

commenter noted that removing the 

allowance of a nonorganic form will 

help support organic cheese 

manufacturers. A comment requested an 

implementation period of 24 months to 

allow industry time to comply with the 

final rule. 

AMS Response 

Previously, AMS proposed removing 

whey protein concentrate from 

§ 205.606, following a Fall 2015 NOSB 

recommendation.16 At that time, AMS 

received comments stating organic whey 

protein concentrate was essential for 

organic processed products and that 

there were no commercially available, 

organic products. As a result, AMS did 

not finalize the removal of whey protein 

concentrate from the National List (82 

FR 31241, July 6, 2017). 

A search in the Organic Integrity 

Database for ‘‘whey protein 

concentrate’’ shows 23 operations with 

some form of certified organic whey 

protein concentrate. The NOSB also 

received comments suggesting 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 no longer meets the 

requirement for inclusion on the 

National List at 7 U.S.C. 

6517(c)(1)(A)(ii). During this current 

rulemaking, AMS received no 

comments challenging this conclusion 

and is removing non-organic whey 

protein concentrate from the National 

List at § 205.606(x). As identified in the 

DATES section, organic processors will 

have until March 15, 2024, to comply 

with this change. 

III. Related Documents 

AMS published notices in the Federal 

Register to announce the NOSB 

meetings where the Board discussed 

these substances. The notices invited 

public comments on the NOSB 

recommendations addressed in this 

final rule. Transcripts of the meetings, 

along with the NOSB recommendations, 

can be found on the AMS website at: 

https://www.ams.usda.gov/rulesregulations/organic/nosb/meetings. The 

AMS proposed rule that preceded this 

final rule was published on August 24, 

2021 (86 FR 47242). 

IV. Statutory and Regulatory Authority 

The OFPA authorizes the Secretary to 

make amendments to the National List 

based on recommendations developed 

by the NOSB. The OFPA authorizes 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 (7 U.S.C. 

6518(k) and (n)). 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 (7 CFR 205.607). 

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 Handbook on 

the NOP website as document NOP 

3011 at https://www.ams.usda.gov/ 

rules-regulations/organic/handbook. 


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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 10937 

17 ‘‘Table of Small Business Size Standards 

Matched to North American Industry Classification 

System Codes,’’ U.S. Small Business 

Administration, August 19, 2019, https://

www.naics.com/wp-content/uploads/2017/10/SBA_

Size_Standards_Table.pdf. 

18 ‘‘2019 Organic Survey,’’ 2017 Census of 

Agriculture, U.S. Department of Agriculture 

National Agricultural Statistics Service, table 1, 

https://www.nass.usda.gov/Publications/AgCensus/ 

2017/Online_Resources/Organics/ORGANICS.pdf. 

19Organic Integrity Database, U.S. Department of 

Agriculture, accessed October 27, 2021, https://

organic.ams.usda.gov/Integrity. 

A. Executive Order 12866 and 

Regulatory Flexibility Act 

This final 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. 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.17 The SBA classifies 

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 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 2017 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.18 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 (OID), there 

are 10,971 U.S.-based organic handlers 

that are certified under the USDA 

organic regulations.19 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 

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. 

Certifying agents. The 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 76 

USDA-accredited certifying agents, 

based on a query of the OID database, 

who provide organic certification 

services to producers and handlers. 

While many certifying agents are small 

entities that would be affected by this 

final 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 this rule to have 

a significant economic impact on 

entities affected by this rule. 

Alternatives exist to the substances that 

this rule prohibits, as determined by the 

NOSB and AMS. Additionally, AMS is 

providing a 12- to 24-month 

implementation period, depending on 

the substance or ingredient, to allow 

affected entities time to modify 

practices. 

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 the USDA to be 

accredited as a certifying agent, as 

described in the OFPA (7 U.S.C. 

6514(b)). States are also preempted 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 (7 U.S.C. 6503–6507). 

Pursuant to the OFPA (7 U.S.C. 

6507(b)(2)), 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 7 U.S.C. 

6519(c)(6), 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 the 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, Office of Management and 

Budget (OMB) clearance is not required 


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10938 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 

by the Paperwork Reduction Act (PRA) 

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 are 

shared during quarterly calls with Tribal 

leaders, who have the opportunity to 

submit comments. AMS works with the 

USDA 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). 

F. General Notice of Public Rulemaking 

This final rule reflects 

recommendations submitted by the 

NOSB to the Secretary to remove 

fourteen nonorganic ingredients and 

two substances from the National List. 

This final rule retains (or ‘‘renews’’) two 

substances on 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 7 CFR 

part 205 continues to read as follows: 

Authority: 7 U.S.C. 6501–6524. 

■ 2. Amend § 205.601 by revising 

paragraph (j)(9) 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 removing 

paragraph (b)(9) and redesignating 

paragraphs (b)(10) through 12 as 

paragraphs (b)(9) through (11). 

§ 205.605 [Amended] 

■ 4. Amend § 205.605(b) by removing 

the words ‘‘Alginic acid (CAS #9005– 

32–7)’’. 

■ 5. Amend § 205.606 by revising 

paragraphs (d) through (t) and removing 

paragraphs (u) through (w). 

The revisions read as follows: 

§ 205.606 Nonorganically produced 

agricultural products allowed as ingredients 

in or on processed products labeled as 

‘‘organic.’’ 

* * * * * 

(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) Cornstarch (native). 

(f) 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. 

(g) Fructooligosaccharides (CAS # 

308066–66–2). 

(h) Gelatin (CAS # 9000–70–8). 

(i) Glycerin (CAS # 56–81–5)— 

produced from agricultural source 

materials and processed using biological 

or mechanical/physical methods as 

described under § 205.270(a). 

(j) Gums—water extracted only 

(Arabic; Guar; Locust bean; and Carob 

bean). 

(k) Inulin—oligofructose enriched 

(CAS # 9005–80–5). 

(l) Lecithin—de-oiled. 

(m) Orange pulp, dried. 

(n) Orange shellac—unbleached (CAS 

# 9000–59–3). 

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

(p) Potassium acid tartrate. 

(q) Seaweed, Pacific kombu. 

(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. 2022–03851 Filed 2–25–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF AGRICULTURE 

Rural Business-Cooperative Service 

7 CFR Part 4280 

[Docket No. RBS–20–BUSINESS–0027] 

RIN 0570–AA98 

Rural Energy for America Program 

AGENCY: Rural Business-Cooperative 

Service, USDA. 

ACTION: Final rule; confirmation and 

response to comments. 

SUMMARY: The Rural BusinessCooperative Service (RBCS or the 

Agency), a Rural Development agency of 

the United States Department of 

Agriculture (USDA), is confirming the 

final rule published in the Federal 

Register on April 27, 2021, to remove 

the provisions relating to guaranteed 

loans and to make other revisions to 

enhance program delivery and customer 

service for the Rural Energy for America 

Program (REAP). This notice presents 

the opportunity for the Agency to 

provide its responses to the public 

comments received on the final rule and 

to confirm the final rule as published. 

DATES: As of February 28, 2022, the 

effective date of the final rule published 


khammond on DSKJM1Z7X2PROD with RULES