This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

16371 

Vol. 87, No. 56 

Wednesday, March 23, 2022 

1 ‘‘Petition to Add Synthetic Substance to 

National List,’’ Potassium Hypochlorite Solution, 

November 2018, https://www.ams.usda.gov/sites/ 

default/files/media/ 

PotassiumHypochloritePetition.pdf. 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number AMS–NOP–19–0102; 

NOP–19–05] 

RIN 0581–AD93 

National Organic Program; National 

List of Allowed and Prohibited 

Substances—Crops and Handling 

From October 2019 NOSB 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: This rule amends the National 

List of Allowed and Prohibited 

Substances (National List) section of the 

United States Department of 

Agriculture’s (USDA) organic 

regulations to implement 

recommendations submitted to the 

Secretary of Agriculture (Secretary) by 

the National Organic Standards Board 

(NOSB). This rule allows the following 

substances for organic production: 

potassium hypochlorite to treat 

irrigation water used in organic crop 

production and fatty alcohols for sucker 

control in organic tobacco production. 

This rule also removes the listing for 

dairy cultures, as it is redundant with 

an existing listing. 

DATES: This rule is effective on April 22, 

2022. 

FOR FURTHER INFORMATION CONTACT: 

Jared Clark, Standards Division, 

National Organic Program. Telephone: 

(202) 720–3252. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 21, 2000, the Secretary 

established the Agricultural Marketing 

Service’s (AMS) National Organic 

Program (NOP) and the USDA organic 

regulations (65 FR 80547, December 21, 

2000). Within the USDA organic 

regulations (7 CFR part 205) is the 

National List of Allowed and Prohibited 

Substances (or ‘‘National List’’). The 

National List identifies the synthetic 

substances that may be used and the 

nonsynthetic (natural) substances that 

may not be used in organic crop and 

livestock production. It also identifies 

the nonorganic substances that may be 

used in or on processed organic 

products. 

AMS is finalizing three amendments 

to the National List in accordance with 

the procedures detailed in the Organic 

Foods Production Act of 1990 (OFPA) (7 

U.S.C. 6501–6524). OFPA establishes 

what may be included on the National 

List and the procedures that 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 

Handbook (document NOP 5611). The 

first sunset date for the substances 

added to the National List in this final 

rule will be five years from the effective 

date in the DATES section of this final 

rule above. 

This final rule adds potassium 

hypochlorite and fatty alcohols to the 

National List. Once the final rule 

becomes effective, producers of organic 

crops will be allowed to use these 

substances in organic production. The 

permitted use of each substance is 

discussed in detail in ‘‘Overview of 

Amendments.’’ This final rule also 

removes the listing for dairy cultures in 

7 CFR 205.605(a). This removal will not 

affect the allowance of dairy cultures in 

organic production and organic 

products as they will continue to be 

allowed under the microorganisms 

listing in 7 CFR 205.605(a). 

II. Overview of Amendments 

This rule adds potassium 

hypochlorite and fatty alcohols to the 

National List for use in organic crop 

production. This rule also removes 

dairy cultures from the National List, 

but their allowance is continued 

through the microorganisms listing. 

Additional background on the petitions 

and the NOSB’s review of the 

substances may be found in the 

proposed rule (86 FR 15800, March 25, 

2021). 

During a 60-day comment period that 

closed on May 24, 2021, AMS received 

six comments on the proposed rule. See 

below for a discussion of the comments 

received and AMS’s responses to 

comments. Comments can be viewed 

through Regulations.gov. Use the search 

area on the homepage at https://

www.regulations.gov to enter a keyword, 

title, or docket ID (the docket folder for 

this rule is AMS–NOP–19–0102). 

Potassium Hypochlorite (§ 205.601) 

The final rule amends the National 

List to add potassium hypochlorite to 7 

CFR 205.601 as a synthetic, chlorinebased sanitizer allowed for use in 

organic crop production. This 

amendment allows use of potassium 

hypochlorite in organic crop production 

for the purposes of cleaning irrigation 

equipment and treating irrigation water. 

AMS is finalizing this amendment to 

the National List, as recommended by 

the NOSB, to provide organic farmers an 

additional tool for treating irrigation 

water and cleaning irrigation 

equipment, which the U.S. Food and 

Drug Administration (FDA) requires to 

promote food safety (21 CFR part 112 

subpart E). Potassium hypochlorite 

provides an alternative to sodium 

hypochlorite, which may cause sodium 

accumulation in soil with repeated use 

(sodium hypochlorite is allowed for use 

at 7 CFR 205.601(a)(2)(iv)). 

NOSB Review and Recommendation 

Following receipt of a petition in 

November 2018,1 the NOSB 

recommended adding potassium 

hypochlorite to the National List in 


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2 ‘‘Formal Recommendation from National 

Organic Standards Board (NOSB) to the National 

Organic Program (NOP),’’ Potassium Hypochlorite, 

October 25, 2019, https://www.ams.usda.gov/sites/ 

default/files/media/CSPotassiumHypochlorite.pdf. 

3Written and oral public comments submitted for 

the Fall 2019 NOSB Meeting are available at https:// 

www.ams.usda.gov/event/national-organicstandards-board-nosb-meeting-pittsburgh-pa. 

4 ‘‘National Organic Standards Board Meeting— 

Pittsburgh, PA,’’ USDA, Agricultural Marketing 

Service, https://www.ams.usda.gov/event/nationalorganic-standards-board-nosb-meeting-pittsburghpa. 

5 ‘‘Formal Recommendation from National 

Organic Standards Board (NOSB) to the National 

Organic Program (NOP),’’ Potassium Hypochlorite, 

October 25, 2019, https://www.ams.usda.gov/sites/ 

default/files/media/CSPotassiumHypochlorite.pdf. 

6 ‘‘Green Tobacco Sickness,’’ U.S. Department of 

Labor, Occupational Safety and Health 

Administration, https://www.osha.gov/greentobacco-sickness. 

7 ‘‘Fatty Alcohols for use on Organic Tobacco 

Crops,’’ National List Petition or Petition Update, 

USDA, Agricultural Marketing Service, https://

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

RevisedPetitionNatural

FattyAlcoholsforUseonOrganicTobaccoCrops.pdf. 

8 ‘‘Formal Recommendation from National 

Organic Standards Board (NOSB) to the National 

Organic Program (NOP),’’ Fatty Alcohols, October 

25, 2019, https://www.ams.usda.gov/sites/default/ 

files/media/CSFattyAlcoholsFinalRec_0.pdf. 

9 ‘‘Fatty Alcohols (Octanol and Decanol),’’ Crops, 

Technical Report, August 1, 2016, https://

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

FattyAlcohols020217.pdf. 

10Written and oral public comments submitted 

for the Fall 2019 NOSB meeting are available at 

https://www.ams.usda.gov/event/national-organicstandards-board-nosb-meeting-pittsburgh-pa. 

October 2019.2 In their evaluation of 

potassium hypochlorite, the NOSB 

considered comments from the public 

and the petition itself. The NOSB 

discussed the petition to amend the 

National List in subcommittee calls and 

at its public meeting in October 2019.3

After their evaluation, the NOSB 

concluded that adding potassium 

hypochlorite to the National List is 

consistent with evaluation criteria in the 

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

found that use of potassium 

hypochlorite for irrigation water 

treatment and cleaning of irrigation 

equipment would be compatible with 

organic crop production, providing 

additional use benefits over sodium 

hypochlorite (e.g., no accumulation of 

sodium in soil). The NOSB noted that 

potassium hypochlorite also provides an 

additional tool for organic farmers to 

meet the requirements of the FDA Food 

Safety Modernization Act (FSMA, Pub. 

L. 111–353). 

AMS Review 

AMS concludes that the addition of 

potassium hypochlorite to the National 

List is consistent with the three 

requirements of the OFPA (7 U.S.C. 

6517(c)(1)(A)). First, when used as 

labeled for irrigation purposes, the 

substance is not harmful to human 

health or the environment. Second, it is 

necessary because of the absence of 

wholly natural substitute products. And 

third, it is consistent with organic 

farming. This amendment follows the 

NOSB recommendation according to the 

procedures established in the OFPA (7 

U.S.C. 6517(d)). 

Comments Received and AMS’s 

Response 

AMS received two comments in 

response to the proposed listing of 

potassium hypochlorite. The subjects of 

these comments and responses from 

AMS are covered in this section. AMS 

is changing the final listing of potassium 

hypochlorite in response to one of these 

comments and to better clarify its use in 

organic crop production. 

Unintentional use allowance. One 

commenter expressed concern that the 

annotation, as proposed, would allow 

additional uses outside those petitioned 

and recommended by the NOSB. Some 

additional uses identified are boot 

sanitizers, tool sanitation, cleaning of 

planting trays and pots, and reduction 

of biofilms. 

AMS did not intend for additional 

allowances beyond managing irrigation 

water and equipment. To address this, 

AMS is finalizing the addition of 

potassium hypochlorite as the NOSB 

originally proposed. The finalized 

annotation will read ‘‘for use in water 

for irrigation purposes.’’ 

Not eligible for addition. One 

commenter asserted that potassium 

hypochlorite does not meet the criteria 

outlined in OFPA for the addition of a 

synthetic substance to the National List. 

The comment states the addition of 

potassium hypochlorite poses adverse 

impacts on human health and the 

environment, is not essential in organic 

production, and is incompatible with 

organic production. 

NOSB must consider the above 

criteria when evaluating substances for 

inclusion on the National List (7 U.S.C. 

6518(m)). NOSB considered and 

discussed these criteria during their Fall 

2019 meeting 4 and in their formal 

recommendation for rulemaking.5 AMS 

must also consider similar criteria when 

adding synthetic substances to the 

National List, which AMS discussed in 

the proposed rule preceding this action 

(86 FR 15800). Both reviews by NOSB 

and AMS determined potassium 

hypochlorite meets the criteria for 

National List addition as described in 

the sections NOSB REVIEW AND 

RECOMMENDATION and AMS 

REVIEW. 

Fatty Alcohols (§ 205.601) 

This final rule amends the National 

List to add fatty alcohols (C6, C8, C10, 

and/or C12) to § 205.601(k) as a synthetic 

substance allowed for use as sucker 

(secondary stems) control in organic 

tobacco production. The fatty alcohol 

designations C6, C8, C10, and C12

correspond to 1-hexanol, 1-octanol, 1- 

decanol, and 1-dodecanol. 

Fatty alcohols can be derived from 

fats or oils (most commonly coconut oil, 

palm kernel oil, lard, tallow, rapeseed 

oil, soybean oil, and corn oil) or from 

petroleum products. Applying fatty 

alcohols to tobacco plants, generally in 

the presence of a surfactant, selectively 

kills or inhibits sucker growth. Fatty 

alcohols are necessary to provide a safer 

and effective method of de-suckering 

tobacco plants. Without an allowance 

for fatty alcohols, farmers would need to 

rely on manual sucker removal, which 

would potentially expose workers to 

nicotine poisoning.6 Removal of suckers 

facilitates growth of the harvestable 

leaves, reduces pest pressure, and 

increases crop yield. 

NOSB Review and Recommendation 

Following receipt of a petition in 

December 2018,7 the NOSB 

recommended adding fatty alcohols to 

the National List in October 2019.8 In 

the NOSB’s evaluation of fatty alcohols, 

the NOSB considered comments from 

the public, a previously commissioned 

technical report,9 and the petition itself. 

The NOSB discussed this petition in 

subcommittee calls and at its public 

meeting in October 2019.10

After their evaluation, the NOSB 

concluded that adding fatty alcohols to 

the National List is consistent with the 

evaluation criteria in the OFPA (7 

U.S.C. 6518(m)). The NOSB found that 

use of fatty alcohols for sucker removal 

is essential for organic crop production, 

providing a tool to effectively inhibit 

sucker growth without exposing 

workers to the potential health impacts 

associated with manual desuckering. 

Additionally, the NOSB acknowledged 

fatty alcohols readily break down in the 

environment. 

AMS Review 

AMS concluded that the addition of 

fatty alcohols to the National List is 

consistent with the requirements in the 

OFPA (7 U.S.C. 6517(c)). First, when 

used as labeled for desuckering 

purposes, the substance is not harmful 

to human health or the environment. 

Second, it is necessary because of the 

absence of wholly natural substitute 

products. And third, due to its natural 

source material and being easily 


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Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations 16373 

11 ‘‘Fatty Alcohols (Octanol and Decanol),’’ Crops, 

Technical Report, August 1, 2016, Technical 

Report, lines 303–305, August 1, 2016, https://

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

FattyAlcohols020217.pdf. 

12U.S. Environmental Protection Agency, 

February 3, 2014, https://www3.epa.gov/pesticides/ 

chem_search/ppls/053575-00006-20140203.pdf. 

13 ‘‘Fatty Alcohols (Octanol and Decanol),’’ Crops, 

Technical Report, August 1, 2016, Technical 

Report, table 1, August 1, 2016, https://

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

FattyAlcohols020217.pdf. 

biodegradable, it is consistent with 

organic farming. This amendment 

follows the NOSB recommendation 

according to the procedures established 

in the OFPA (7 U.S.C. 6517(d)). 

Comments Received and AMS’s 

Response 

AMS received four comments in 

response to the proposed listing of fatty 

alcohols for sucker control. The subjects 

of these comments and responses from 

AMS are covered in this section. 

Inconsistent with organic production. 

One commenter opposed the addition of 

fatty alcohols to the National List. The 

comment stated that fatty alcohols pose 

health and environmental hazards, are 

not needed, and are inconsistent with 

organic production. 

In support of these claims, the 

comment cited several sections of the 

technical report on fatty alcohols. The 

comment stated that longer-chain fatty 

alcohols resist hydrolysis and may 

bioaccumulate and are toxic to aquatic 

organisms. The comment also quoted 

sections of the technical report referring 

to potential sublethal effects on 

Lepidopteran species. The comment 

offered an alternative to fatty alcohols— 

indoleacetic acid—for desuckering. 

Lastly, the comment asserted that fatty 

alcohols do not fall into any OFPA 

categories at 7 U.S.C. 6517(c)(1)(B)(i). 

AMS believes the information cited 

from the technical report was either 

misunderstood or misquoted. First, 

while the technical report does state 

that longer fatty alcohol chains are not 

expected to hydrolyze readily, the 

report defines these as having a carbon 

chain longer than 12.11 As this 

allowance is limited to fatty alcohols of 

carbon chain length 6, 8, 10, and 12, 

accumulation is not expected to occur. 

Second, the report does state the 

potential for sublethal effects on 

Lepidopteran species. Dodecanol (C12

fatty alcohol) is used in U.S. 

Environmental Protection Agency (EPA) 

registered products as a mating 

disruption pheromone.12 However, 

concentrations of dodecanol in mating 

disruption products (approximately 

30%) are much higher than those in 

products for sucker control (less than 

1%).13 Given the much lower 

concentration of fatty alcohols, limited 

use of fatty alcohols for sucker control, 

and quick decomposition of these 

substances, AMS does not expect this 

use of fatty alcohols will have a 

measurable effect on Lepidopterans. 

The comment also stated fatty 

alcohols do not fit into an OFPA 

category at 7 U.S.C. 6517(c)(1)(B)(i). 

AMS acknowledges that the NOSB did 

not identify an OFPA category for these 

substances. AMS views the limited use 

allowance of fatty alcohols to fall under 

the OFPA category of ‘‘production aid,’’ 

as identified in the petition. 

Desuckering is necessary plant 

maintenance in tobacco production to 

facilitate growth of the harvestable 

leaves, reduce pest pressure, and 

increase crop yield. This narrow use 

allowance of fatty alcohols aids in the 

production of organic tobacco by 

allowing farmers to perform this 

necessary maintenance task without risk 

to worker health. 

Finally, the comment offered the 

alternative substance, indoleacetic acid 

(listed as indole-3-acetic acid by the 

EPA). While indoleacetic acid may be 

naturally occurring, it appears the 

common method of production is a 

synthetic process that would not be 

permitted in organic production. 

General support. Two comments 

supported the addition of fatty alcohols 

to the National List. One commenter 

certifies many tobacco farms and stated 

many of their tobacco operations 

indicated that fatty alcohols are critical 

to the success of their organic farms. 

Another certifying agent commented 

they also certify several tobacco farmers, 

one of which already requested 

approval of fatty alcohols for sucker 

control. 

In addition to mentioning the support 

of certified operations, these comments 

also indicate the proposed listing is 

clear and likely will not cause 

confusion. An additional comment 

offered general support for the review 

process and an acknowledgement of the 

NOSB’s robust deliberative process of 

this substance. 

AMS appreciates public engagement 

in the rulemaking process and agrees 

with the general support noted above, 

which mirrors the recommendation by 

the NOSB. AMS is moving forward with 

adding this substance to the National 

List as proposed. 

Dairy Cultures (§ 205.605) 

This final rule amends the National 

List to remove dairy cultures from 

§ 205.605(a) as a nonsynthetic substance 

allowed for use in organic processed 

products. This removal is not expected 

to affect any currently allowed or future 

products. Any cultures allowed under 

this listing will continue to be allowed 

under the listing for microorganisms at 

§ 205.605(a). 

NOSB Review and Recommendation 

Following the sunset review of dairy 

cultures, the NOSB recommended 

removing dairy cultures 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 its recommendation, the NOSB 

stated the listing for dairy cultures was 

no longer needed, concluding that the 

allowance of microorganisms at 

§ 205.605(a) provides an alternative to 

the dairy cultures listing. This 

recommendation acknowledged the 

widespread use of dairy cultures and 

NOSB meeting participants’ comments, 

which confirmed that the removal of the 

dairy cultures listing will not affect their 

allowance. 

Comments Received and AMS’s 

Response 

Opposition. One commenter opposed 

the removal of dairy cultures from the 

National List, citing three reasons to 

maintain the listing. First, the 

commenter stated the removal of dairy 

cultures may cause consumer confusion. 

The comment stated there is potential 

for reduced transparency without a clear 

connection between ‘‘dairy cultures’’ as 

listed on product labels and the 

‘‘microorganisms’’ listing on the 

National List. Second, the comment 

identified the unique application of 

dairy cultures. While the comment 

acknowledges dairy cultures are a 

subset of microorganisms, it also stated 

a preference to maintain the listing to 

assist any future annotation. Finally, the 

comment questioned whether sunset 

review is the appropriate time for this 

removal. The comment stated this 

action should be the result of a petition 

or a separate recommendation track, not 

the product of a sunset review. 

AMS does not believe removing the 

‘‘dairy cultures’’ listing will result in 

widespread confusion or reduced 

transparency. While AMS acknowledges 

a preference to have ingredient 

declarations exactly match the National 

List allowance, many substances on the 

National List are known by multiple 

names, not all of which are listed. If 

widespread confusion occurs, AMS 


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16374 Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations 

14 ‘‘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. 

15 ‘‘2019 Organic Survey,’’ 2017 Census of 

Agriculture, USDA National Agricultural Statistics 

Service, table 1, https://www.nass.usda.gov/ 

Publications/AgCensus/2017/Online_Resources/ 

Organics/ORGANICS.pdf. 

16Organic Integrity Database, USDA, accessed 

October 27, 2021, https://organic.ams.usda.gov/ 

Integrity. 

would prefer to address the confusion 

through education rather than 

expanding the National List to include 

all possible ingredient names. 

AMS acknowledges the desire to keep 

dairy cultures for sake of flexibility. 

Regardless of whether dairy cultures 

remain on the list, any recommended 

annotation would need to come from 

the NOSB and go through the 

rulemaking process. As such, there is no 

added flexibility or resource savings in 

maintaining the listing; the process to 

add dairy cultures with an annotation is 

similar in time and resources to only 

adding the annotation. Lastly, AMS 

does not believe this action is 

inappropriate for the sunset process, 

which is intended to regularly evaluate 

National List substances against the 

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

One of these criteria is ‘‘alternatives to 

using the substance in terms of practices 

or other available materials.’’ The 

NOSB’s sunset review determined that 

there are other available materials 

(microorganisms), rendering this listing 

unnecessary. 

Several other comments were neutral 

(neither in support of nor in opposition 

to the removal of the dairy cultures 

listing). One comment requested further 

examination of the allowed 

fermentation processes of 

microorganisms in general. 

AMS appreciates public engagement 

in the rulemaking process. AMS is 

moving forward with removing this 

listing from the National List as 

proposed. 

III. Related Documents 

AMS published notices in the Federal 

Register announcing the Spring 2019 

NOSB Meeting (83 FR 60373, November 

26, 2018) and announcing the Fall 2019 

NOSB meeting (84 FR 23522). These 

notices invited public comments on the 

NOSB recommendations addressed in 

this final rule. The AMS proposed rule 

that preceded this final rule was 

published on March 25, 2021 (86 FR 

15800). 

IV. Statutory and Regulatory Authority 

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 at https://

www.ams.usda.gov/rules-regulations/ 

organic/handbook. 

A. Executive Order 12866 and 

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. 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.14 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.15 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.16 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). 


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AMS does not expect the economic 

impact on entities affected by this rule 

to be significant. The effect of this final 

rule will allow the use of two additional 

substances in organic crop production 

and remove a redundant listing for one 

substance in organic handling. Adding 

two substances to the National List will 

increase regulatory flexibility and 

provide small entities with more 

options to use in day-to-day operations. 

Removal of the substance in organic 

handling will have no impact as its use 

will continue to be allowed under 

another National List allowance. 

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 

by the Paperwork Reduction Act of 

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

D. Executive Order 13175 

This final rule has been reviewed 

under Executive Order 13175— 

Consultation and Coordination with 

Indian Tribal Governments. Executive 

Order 13175 requires Federal agencies 

to consult and coordinate with tribes on 

a government-to-government basis on: 

(1) Policies that have tribal implication, 

including regulation, legislative 

comments, or proposed legislation; and 

(2) other policy statements or actions 

that have substantial direct effects on 

one or more Indian Tribes, on the 

relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the federal 

government and Indian Tribes. 

AMS has assessed the impact of this 

final rule on Indian Tribes and 

determined that this rule would not 

have tribal implications that require 

consultation under Executive Order 

13175. AMS hosts a quarterly 

teleconference with tribal leaders when 

matters of mutual interest regarding the 

marketing of agricultural products are 

discussed. Information about the 

proposed changes to the regulations are 

shared during these quarterly calls, and 

tribal leaders have the opportunity to 

comment on the proposed changes. 

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 add two 

substances to the National List and 

remove one substance from 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, 

Livestock, Organically produced 

products, Plants, Reporting and 

recordkeeping requirements, Seals and 

insignia, Soil conservation. 

For the reasons set forth in the 

preamble, AMS amends 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: 

■ a. Revising paragraph (a)(2)(iv); 

■ b. Adding paragraph (a)(2)(v); 

■ c. Revising paragraph (k); 

The revisions and addition read as 

follows: 

§ 205.601 Synthetic substances allowed 

for use in organic crop production. 

* * * * * 

(a) * * * 

(2) * * * 

(iv) Potassium hypochlorite—for use 

in water for irrigation purposes. 

(v) Sodium hypochlorite. 

* * * * * 

(k) As plant growth regulators. 

(1) Ethylene gas—for regulation of 

pineapple flowering. 

(2) Fatty alcohols (C6, C8, C10, and/ 

or C12)—for sucker control in organic 

tobacco production. 

* * * * * 

§ 205.605 [Amended] 

■ 3. In § 205.605, amend paragraph (a) 

by removing the words ‘‘Dairy 

cultures’’. 

Erin Morris, 

Associate Administrator, Agricultural 

Marketing Service. 

[FR Doc. 2022–05870 Filed 3–22–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF ENERGY 

10 CFR Part 430 

[EERE–2017–BT–TP–0028] 

RIN 1904–AE03 

Energy Conservation Program: Test 

Procedures for Water Closets and 

Urinals 

AGENCY: Office of Energy Efficiency and 

Renewable Energy, Department of 

Energy. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

test procedures for water closets and 


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