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Federal Register / Vol. 86, No. 56 / Thursday, March 25, 2021 / Proposed Rules
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
AMS concurs with the NOSBs 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, 1octanol, 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.
11 NOSB

recommendation for fatty alcohols, October 2019: https www.ams.usda.gov/sites/
default/files/media/CSFattyAlcoholsFinalRec_
0.pdf.

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205.605 Nonagricultural Nonorganic Substances Allowed as Ingredients in or on Processed Products Labeled as Organic or Made With Organic Specified Ingredients or Food Groups This proposed rule would remove one substance from 205.605
Nonagricultural nonorganic substances allowed as ingredients in or on processed products labeled as organic or made with organic specified ingredients or food groups.
Dairy Cultures The proposed rule would amend the National List by removing dairy cultures as a nonsynthetic nonagricultural substance listed in 205.605a 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 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.
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.
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.
6517e 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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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 6518k and 6518n 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/rulesregulations/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. 601612 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 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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