National Organic Program; National List of Allowed and Prohibited Substances-Crops and Handling From October 2019 NOSB, 16371-16375 [2022-05870]

Agencies

• Agricultural Marketing Service
• DEPARTMENT OF AGRICULTURE

[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Rules and Regulations]
[Pages 16371-16375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05870]



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Rules and Regulations
                                                Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
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under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 

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

[[Page 16371]]



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.

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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 (Sec.  205.601)

    The final rule amends the National List to add potassium 
hypochlorite to 7 CFR 205.601 as a synthetic, chlorine-based 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

[[Page 16372]]

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\
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    \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.
    \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.
    \3\ Written and oral public comments submitted for the Fall 2019 
NOSB Meeting are available at https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-pittsburgh-pa.
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    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.
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    \4\ ``National Organic Standards Board Meeting--Pittsburgh, 
PA,'' USDA, Agricultural Marketing Service, https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-pittsburgh-pa.
    \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.
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Fatty Alcohols (Sec.  205.601)

    This final rule amends the National List to add fatty alcohols 
(C6, C8, C10, and/or C12) 
to Sec.  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.
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    \6\ ``Green Tobacco Sickness,'' U.S. Department of Labor, 
Occupational Safety and Health Administration, https://www.osha.gov/green-tobacco-sickness.
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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\
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    \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/RevisedPetitionNaturalFattyAlcoholsforUseonOrganicTobaccoCrops.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.
    \10\ Written and oral public comments submitted for the Fall 
2019 NOSB meeting are available at https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-pittsburgh-pa.
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    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

[[Page 16373]]

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.
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    \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.
    \12\ U.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.
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    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 (Sec.  205.605)

    This final rule amends the National List to remove dairy cultures 
from Sec.  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 Sec.  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 Sec.  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

[[Page 16374]]

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.
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    \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.
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    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.
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    \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.
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    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.
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    \16\ Organic Integrity Database, USDA, accessed October 27, 
2021, https://organic.ams.usda.gov/Integrity.
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    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).

[[Page 16375]]

    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

0
1. The authority citation for 7 CFR part 205 continues to read as 
follows:

    Authority: 7 U.S.C. 6501-6524.


0
2. Amend Sec.  205.601 by:
0
a. Revising paragraph (a)(2)(iv);
0
b. Adding paragraph (a)(2)(v);
0
c. Revising paragraph (k);
    The revisions and addition read as follows:


Sec.  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.
* * * * *


Sec.  205.605   [Amended]

0
3. In Sec.  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