[Federal Register Volume 86, Number 56 (Thursday, March 25, 2021)]
[Proposed Rules]
[Pages 15800-15804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05700]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 86, No. 56 / Thursday, March 25, 2021 /
Proposed Rules
[[Page 15800]]
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: Proposed rule.
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SUMMARY: This proposed rule would amend the National List of Allowed
and Prohibited Substances (National List) section of the United States
Department of Agriculture's (USDA's) organic regulations to add
potassium hypochlorite for pre-harvest use as a sanitizer in organic
crop production and fatty alcohols for sucker control in organic
tobacco production. In addition, this rule proposes to remove the
listing for dairy cultures, as it is redundant with an existing
listing.
DATES: Comments must be received by May 24, 2021.
ADDRESSES: Interested persons may comment on the proposed rule using
the following procedures:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Jared Clark, Standards Division, National Organic
Program, USDA-AMS-NOP, 1400 Independence Ave. SW, Room 2642-S, Ag Stop
0268, Washington, DC 20250-0268. Telephone: (202) 720-3252.
Instructions: All submissions received must include the docket
number AMS-NOP-19-0102, NOP-19-05, and/or Regulatory Information Number
(RIN) 0581-AD93 for this rulemaking. When submitting a comment, clearly
indicate the proposed rule topic and section number to which the
comment refers. In addition, comments should clearly indicate whether
the commenter supports the action being proposed and clearly indicate
the reason(s) for the position. Comments can also include information
on alternative management practices, where applicable, that support
alternatives to the proposed amendments. Comments should also offer any
recommended language change(s) that would be appropriate to the
position. Please include relevant information and data to support the
position such as scientific, environmental, manufacturing, industry, or
impact information, or similar sources. Only relevant material
supporting the position should be submitted. All comments received will
be posted without change to https://www.regulations.gov.
Document: To access the document and read background documents, or
comments received, go to https://www.regulations.gov (search for Docket
ID AMS-NOP-19-0102).
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 National List
within part 205 of the USDA organic regulations (7 CFR 205.600 through
205.607). The National List identifies the synthetic substances allowed
in organic farming and the nonsynthetic substances prohibited in
organic farming. The National List also identifies nonagricultural and
nonorganic agricultural substances (ingredients) that may be used in
organic handling.
The Organic Foods Production Act of 1990 (OFPA), as amended (7
U.S.C. 6501-6524), and the USDA organic regulations (7 CFR part 205)
specifically prohibit the use of any synthetic substance in organic
production and handling unless the synthetic substance is on the
National List (Sec. Sec. 205.601, 205.603 and 205.605(b)). Section
205.105 also requires that any nonorganic agricultural substance and
any nonsynthetic nonagricultural substance used in organic handling be
on the National List (Sec. Sec. 205.605(a) and 205.606). Under the
authority of OFPA, the National List can be amended by the Secretary
based on recommendations presented by the National Organic Standards
Board (NOSB). Since the final rule establishing the National Organic
Program (NOP) became effective on October 21, 2002, USDA's Agricultural
Marketing Service (AMS) has published multiple rules amending the
National List.
This proposed rule would amend the National List to reflect three
recommendations submitted to the Secretary by the NOSB on October 25,
2019. This action would make the following changes to the National List
based on the NOSB recommendations for three substances. Two substances
are proposed to be added to the National List for use in organic crop
production in response to petitions from the public. One substance is
being recommended for removal from the National List because it is
redundant to another listing on the National List. AMS published two
notices in the Federal Register announcing the NOSB meetings and
inviting public comments on the materials included in this proposed
rule: November 26, 2018 (83 FR 60373) and May 22, 2019 (84 FR 23522).
AMS also hosted public webinars (April 16 & 18, 2019, and October 15 &
17, 2019), to provide additional opportunities for public comment. The
NOSB received additional comment during its public meetings on April
24-25, 2019,\1\ and October 23-24, 2019.\2\ Table 1 summarizes the
proposed changes to the National List.
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\1\ National Organic Standards Board (NOSB) Spring 2019 Meeting:
https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-seattle-wa.
\2\ National Organic Standards Board (NOSB) Fall 2019 Meeting:
https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-pittsburgh-pa.
[[Page 15801]]
Table 1--Proposed Amendments to the National List
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National list
Substance section Proposed rule action
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Potassium hypochlorite............ Sec. 205.601 Add to National
List.
Fatty alcohols (C6, C8, C10, C12). Sec. 205.601 Add to National
List.
Dairy cultures.................... Sec. 205.605 Remove from National
List.
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II. Overview of Proposed Amendments
The following provides an overview of the proposed amendments to
designated sections of the National List regulations:
Sec. 205.601 Synthetic Substances Allowed for Use in Organic Crop
Production
This proposed rule would add two substances to Sec. 205.601,
synthetic substances allowed for use in organic crop production.
Potassium Hypochlorite
The proposed rule would amend the National List to add potassium
hypochlorite to Sec. 205.601(a) as a synthetic substance allowed for
use as a pre-harvest sanitizer in irrigation water in organic crop
production. Table 2 illustrates the proposed listing.
Table 2--Proposed Amendment for Potassium Hypochlorite
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Current rule: N/A
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Proposed amendment: Add potassium hypochlorite to
Sec. 205.601(a)(2).
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In November 2018, AMS received a petition to add potassium
hypochlorite as a synthetic substance allowed for use in organic crop
production.3 4 The petition proposed to add potassium
hypochlorite to Sec. 205.601 as a type of chlorine material that can
be used as a pre-harvest sanitizer.
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\3\ The initial petition for potassium hypochlorite was
submitted in November 2018: https://www.ams.usda.gov/sites/default/files/media/PotassiumHypochloritePetition.pdf.
\4\ A revised petition for potassium hypochlorite was submitted
in March 2019: https://www.ams.usda.gov/sites/default/files/media/PotassiumHypochloriteRevisedPetition03262019.pdf.
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After considering the petition, the 2011 technical report on
chlorine materials, and the public comments, the NOSB determined that
this use of potassium hypochlorite meets the OFPA criteria for allowed
synthetic substances in organic crop production.\5\ The NOSB concluded
that potassium hypochlorite is similar to other chlorine materials
allowed in organic crop production and allowing its use supports
compliance with the Food Safety and Modernization Act (FSMA) (21 U.S.C.
2201-2252) to sanitize irrigation water. In addition, the NOSB
indicated that potassium hypochlorite has advantages over sodium
hypochlorite, also an allowed chlorine material at Sec.
205.601(a)(2)(iv), because potassium is a plant nutrient and is
unlikely to increase soil salinization because it does not contain
sodium.
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\5\ Chlorine compounds technical report, 2011: https://www.ams.usda.gov/sites/default/files/media/Chlorine%202%20TR%202011.pdf. This technical report describes the
manufacture, industry uses, regulation, and chemical properties of
chlorine compounds. Information in this technical report is
transferable to potassium hypochlorite.
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The NOSB recommended adding potassium hypochlorite to Sec. 205.601
as a synthetic substance allowed for use as a pre-harvest sanitizer for
use in irrigation water in organic crop production. The recommendation
also specified that the concentration of potassium hypochlorite in
irrigation water should not exceed maximum residual disinfectant limits
specified under the Safe Drinking Water Act (SDWA) (42 U.S.C. 300(f) et
seq.).6 7 Notably, the recommendation also explained the
intent for a more limited allowance for potassium hypochlorite in
comparison to other allowed chlorine substances on the National List
for crop production. The recommendation specified that an allowance for
potassium hypochlorite be limited to irrigation water. Additional uses,
including post-harvest, would be prohibited.
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\6\ NOSB potassium hypochlorite recommendation: https://www.ams.usda.gov/sites/default/files/media/CSPotassiumHypochlorite.pdf.
\7\ Safe Drinking Water Act (SDWA) https://www.epa.gov/sdwa.
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AMS concurs with the NOSB's determination that potassium
hypochlorite is a synthetic substance and that the use of potassium
hypochlorite satisfies the OFPA criteria for allowed synthetic
substances in organic crop production. Consistent with the NOSB
recommendation, this proposed rule would amend the National List by
adding potassium hypochlorite to the National List as a type of
chlorine material that can be used as a pre-harvest sanitizer. Given
that the NOSB recommendation specified that potassium hypochlorite be
allowed for irrigation water only, we are proposing that potassium
hypochlorite would not be allowed for organic edible sprout production.
This would clarify how the allowance for potassium hypochlorite is
different from other allowed chlorine materials which are permitted for
use in organic edible sprout production.
Fatty Alcohols (C6, C8, C10,
C12)
The proposed rule would amend the National List to add fatty
alcohols (C6, C8, C10, C12)
to Sec. 205.601 as a synthetic substance allowed for use in crop
production. Table 3 illustrates the proposed listing.
Table 3--Proposed Amendment for Fatty Alcohols (C6, C8, C10, C12)
------------------------------------------------------------------------
------------------------------------------------------------------------
Current rule: N/A.
Proposed amendment: Add fatty alcohols (C6, C8,
C10, and/or C12) to Sec.
205.601(k).
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AMS received a petition to add fatty alcohols (C6,
C8, C10, C12) to the National List for
use in organic crop production.8 9 The petition identified
the intended use as sucker control in tobacco production. The petition
explained that sucker control in tobacco production improves yield and
quality of the plant, reduces pest pressure and supports crop rotation
practices.
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\8\ Fatty alcohols petition, December 10, 2018: https://www.ams.usda.gov/sites/default/files/media/RevisedPetitionNaturalFattyAlcoholsforUseonOrganicTobaccoCrops.pdf.
\9\ In 2015, a petition was submitted for fatty alcohols
octanol-decanol mix. The NOSB did not recommend listing this
substance. The 2015 fatty alcohols petition and the corresponding
2017 NOSB recommendation are available in the list of petitioned
substances on the AMS website: https://www.ams.usda.gov/rules-regulations/organic/national-list/f.
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After considering the petition, the technical report on fatty
alcohols, and the public comments, the NOSB determined that this use of
fatty alcohols meets the OFPA criteria for allowed synthetic substances
in organic tobacco production.\10\ The NOSB concluded that the
alternative materials for sucker control are ineffective and that fatty
alcohols used for sucker
[[Page 15802]]
control are essential for organic tobacco production. Further, the NOSB
also cited human health issues from manual desuckering which can cause
nicotine poisoning and other health issues in workers due to heavy
exposure to the nicotine present in the tobacco plant through dermal
(skin) exposure. Consequently, the NOSB recommended the addition of
fatty alcohols (C6, C8, C10,
C12) to the National List for organic tobacco
production.\11\
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\10\ Fatty alcohols technical report, 2016: https://www.ams.usda.gov/sites/default/files/media/FattyAlcohols020217.pdf.
\11\ NOSB recommendation for fatty alcohols, October 2019:
https://www.ams.usda.gov/sites/default/files/media/CSFattyAlcoholsFinalRec_0.pdf.
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AMS concurs with the NOSB's determination that fatty alcohols are a
synthetic substance and that the use of fatty alcohols satisfies the
OFPA criteria for allowed synthetic substances. Some discussion opined
that the use of fatty alcohols for desuckering is primarily for
economic benefit and that manual desuckering of tobacco plants, while
more expensive, is the only method compatible with organic production.
AMS is not persuaded by that argument because manual desuckering may
pose adverse health risks to workers due to contact with tobacco
plants. There are no alternative practices or allowed materials under
current USDA organic regulations that perform this function. Therefore,
AMS concurs that this substance is necessary for organic tobacco
production and is consistent with organic farming. This proposed rule
would amend the National List by adding fatty alcohols (C6,
C8, C10, and/or C12) for sucker
control in organic tobacco production.
The parenthetical content (C6, C8,
C10, and/or C12) for the proposed listing
specifies the range of alcohols that would be included in this listing.
AMS is proposing that fatty alcohol products allowed for sucker control
in organic production may contain either some or all of these fatty
alcohols. NOP understands that referring to the carbon chain length of
fatty alcohols are commonly understood by industry and regulation. In
listing ``C6, C8, C10, and/or C12'' as allowed fatty alcohols, it
should be understood that these carbon chain designations refer to 1-
hexanol, 1-octanol, 1-decanol, and 1-dodecanol. AMS welcomes comments
on whether the proposed listing provides the clarity for material
reviewers to clearly determine which products would be permitted for
sucker control in organic tobacco production.
Sec. 205.605 Nonagricultural (Nonorganic) Substances Allowed as
Ingredients in or on Processed Products Labeled as ``Organic'' or
``Made With Organic (Specified Ingredients or Food Group(s))''
This proposed rule would remove one substance from Sec. 205.605
Nonagricultural (nonorganic) substances allowed as ingredients in or on
processed products labeled as ``organic'' or ``made with organic
(specified ingredients or food group(s)).''
Dairy Cultures
The proposed rule would amend the National List by removing dairy
cultures as a nonsynthetic nonagricultural substance listed in Sec.
205.605(a) for use in organic handling. The NOSB recommended removing
dairy cultures from the National List because dairy cultures are
allowed under the listing for ``microorganisms'' in Sec. 205.605.\12\
The NOSB determined that dairy cultures is a redundant listing and that
removing dairy cultures would have no negative impacts because these
ingredients would continue to be allowed in organic handling. In
addition, the NOSB indicated that permitted ancillary substances in
dairy cultures would continue to be allowed under the
``microorganisms'' listing.
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\12\ The NOSB recommended the removal of dairy cultures from the
National List as part of its 2021 sunset review. The OFPA sunset
provision (7 U.S.C. 6517(e)) requires the NOSB to review exemptions
or prohibitions to the National List within 5 years of such
exemption or prohibition being adopted or reviewed. The NOSB
subsequently votes to remove a substance allowance or prohibition
from the National List. The NOSB recommendation to remove dairy
cultures is available here: https://www.ams.usda.gov/sites/default/files/media/HS2021SunsetReviews.pdf.
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AMS concurs that microorganisms are inclusive of dairy cultures and
that listing both dairy cultures and microorganisms on the National
List is redundant. AMS' intent and belief are that current use patterns
for approved dairy cultures would not be affected by the changes
included in this proposed rule. Therefore, AMS is proposing to remove
dairy cultures from the National List.
III. Related Documents
AMS published two notices in the Federal Register announcing the
April 2019 and October 2019 NOSB meetings: November 26, 2018 (83 FR
60373) and May 22, 2019 (84 FR 23522). At these meetings, the NOSB
deliberated on substances petitioned as amendments to the National List
and substances under sunset review.
IV. Statutory and Regulatory Authority
The OFPA authorizes the Secretary to make amendments to the
National List based on recommendations developed by the NOSB. Sections
6518(k) and 6518(n) of the OFPA authorize the NOSB to develop
recommendations for submission to the Secretary to amend the National
List and to establish a process by which persons may petition the NOSB
for the purpose of having substances evaluated for inclusion on or
deletion from the National List. Section 205.607 of the USDA organic
regulations permits any person to petition to add or remove a substance
from the National List and directs petitioners to obtain the petition
procedures from USDA. The current petition procedures published in the
Federal Register (81 FR 12680, March 10, 2016) for amending the
National List can be accessed through the NOP Program Handbook on the
NOP website at https://www.ams.usda.gov/rules-regulations/organic/handbook.
A. Executive Orders 12866 and Regulatory Flexibility Act
This action falls within a category of regulatory actions that the
Office of Management and Budget (OMB) has exempted from Executive Order
12866.
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.\13\
The SBA has classified small agricultural producers that engage in crop
and animal production as those with average annual receipts of less
than $1,000,000. Handlers are involved in a broad spectrum of food
production activities and fall into various categories in the
[[Page 15803]]
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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\13\ Table of Small Business Size Standards Matched to North
American Industrial Classification System Codes, August 19, 2019:
https://www.naics.com/wp-content/uploads/2017/10/SBA_Size_Standards_Table.pdf.
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AMS has considered the economic impact of this proposed rulemaking
on small agricultural entities. Data collected by the USDA National
Agricultural Statistics Service and the NOP indicate most of the
certified organic production operations in the United States would be
considered small entities. According to the 2019 Certified Organic
Survey, 16,524 organic farms in the United States reported sales of
organic products and total farmgate sales in excess of $9.9
billion.\14\ Based on that data, organic sales average $601,000 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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\14\ U.S. Department of Agriculture, National Agricultural
Statistics Service. 2019 Organic Survey. https://www.nass.usda.gov/Publications/AgCensus/2017/Full_Report/Volume_1,_Chapter_1_US/. The
number of organic farms includes only certified farms.
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According to the NOP's Organic Integrity Database, there are 19,832
organic handlers that are certified under the USDA organic regulations,
of which 10,500 are based in the U.S.\15\ The Organic Trade
Association's 2020 Organic Industry Survey \16\ has information about
employment trends among organic manufacturers. The reported data are
stratified into three groups by the number of employees per company:
Less than 5; 5 to 49; and 50 plus. These data are representative of the
organic manufacturing sector and the lower bound (50) of the range for
the larger manufacturers is significantly smaller than the SBA's small
business thresholds (500 to 1,250). Therefore, AMS expects that most
organic handlers would qualify as small businesses.
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\15\ Organic Integrity Database: https://organic.ams.usda.gov/Integrity/. Accessed on August 18, 2020.
\16\ 2020 Organic Industry Survey, Organic Trade Association.
Available for purchase at https://ota.com/organic-market-overview/organic-industry-survey.
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The USDA has 77 accredited certifying agents who provide organic
certification services to producers and handlers. The certifying agent
that reports the most certified operations, nearly 3,500, would need to
charge approximately $4,200 in certification fees in order to exceed
the SBA's small business threshold of $16.5 million. The costs for
certification generally range from $500 to $3,500, depending on the
complexity of the operation. Therefore, AMS expects that most of the
accredited certifying agents would qualify as small entities under the
SBA criteria.
The economic impact on entities affected by this rule would not be
significant. The effect of this rule, if implemented as final, would be
to allow the use of two additional substances in organic crop
production and remove one redundant listing from the regulations.
Adding two substances to the National List would increase regulatory
flexibility and would give small entities more tools to use in day-to-
day operations. This action would also remove dairy cultures as a
redundant listing and would have no impact on the industry. AMS
reviewed comments submitted to the NOSB regarding the materials
petitioned for inclusion on and recommended for removal from the
National List. Therefore, AMS concludes that the economic impact of
this addition, if any, would be minimal. Accordingly, USDA certifies
that this rule would not have a significant economic impact on a
substantial number of small entities.
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 proposed rule
is not intended to have a retroactive effect.
Accordingly, to prevent duplicative regulation, states and local
jurisdictions are preempted under the OFPA from creating programs of
accreditation for private persons or state officials who want to become
certifying agents of organic farms or handling operations. A governing
state official would have to apply to USDA to be accredited as a
certifying agent, as described in section 6514(b) of the OFPA. States
are also preempted under sections 6503 through 6507 of the OFPA from
creating certification programs to certify organic farms or handling
operations unless the state programs have been submitted to, and
approved by, the Secretary as meeting the requirements of the OFPA.
Pursuant to section 6507(b)(2) of the OFPA, a state organic
certification program that has been approved by the Secretary may,
under certain circumstances, contain additional requirements for the
production and handling of agricultural products organically produced
in the state and for the certification of organic farm and handling
operations located within the state. Such additional requirements must
(a) further the purposes of the OFPA, (b) not be inconsistent with the
OFPA, (c) not be discriminatory toward agricultural commodities
organically produced in other States, and (d) not be effective until
approved by the Secretary.
In addition, pursuant to section 6519(c)(6) of the OFPA, this
proposed rule would not supersede or alter the authority of the
Secretary under the Federal Meat Inspection Act (21 U.S.C. 601-624),
the Poultry Products Inspection Act (21 U.S.C. 451-471), or the Egg
Products Inspection Act (21 U.S.C. 1031-1056), concerning meat,
poultry, and egg products, respectively, nor any of the authorities of
the Secretary of Health and Human Services under the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 301 et seq.), nor the authority of the
Administrator of the Environmental Protection Agency 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 proposed rule. Accordingly, OMB clearance is not
required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501,
Chapter 35.
D. Executive Order 13175
This proposed rule has been reviewed in accordance with the
requirements of Executive Order 13175, Consultation and Coordination
with Indian Tribal Governments. The review reveals that this regulation
will not have substantial and direct effects on tribal governments and
will not have significant tribal implications.
F. General Notice of Public Rulemaking
This proposed rule reflects recommendations submitted by the NOSB
to the Secretary to add two substances to the National List and to
remove one substance from the National List. A 60-day period for
interested persons to comment on this rule is provided.
List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agriculture, Archives and
records, Crops, Imports, Labeling, National list, National Organic
Standards Board (NOSB), Organically produced products, Plants,
Reporting and recordkeeping requirements, Seals and insignia, Soil
conservation, Sunset.
[[Page 15804]]
For the reasons set forth in the preamble, AMS proposes to amend 7
CFR part 205 as follows:
PART 205--NATIONAL ORGANIC PROGRAM
0
1. The authority citation for 7 CFR part 205 is revised 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); and
0
c. Revising paragraph (k).
The revisions and addition to read as follows:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
* * * * *
(a) * * *
(2) * * *
(iv) Potassium hypochlorite--not allowed for edible sprout
production.
(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''.
Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2021-05700 Filed 3-24-21; 8:45 am]
BILLING CODE 3410-02-P