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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Proposed Rules A. Executive Orders 12866 and 13563
and the 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. 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.
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. 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 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.
AMS has considered the economic impact of this proposed 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 2019 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.27 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 27 U.S. Department of Agriculture, National Agricultural Statistics Service. 2019 Census of Agriculture. https www.nass.usda.gov/
Publications/AgCensus/2017/Online_Resources/
Organics/ORGANICS.pdf.

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producers would fall under the $750,000 sales threshold to qualify as a small business.
According to the NOPs Organic Integrity Database, there are 19,059
organic handlers that are certified under the USDA organic regulations.28 The Organic Trade Associations 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: 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 SBAs small business thresholds 500 to 1,250. Therefore, AMS expects that most organic handlers would qualify as small businesses.
SBA defines small agricultural service firms, which include certifying agents, as those having annual receipts of less than $8,000,000 13 CFR 121.201.
There are currently 77 USDA-accredited certifying agents; based on a query of the NOP certified organic operations database. While many certifying agents are small entities that would be affected by this proposed rule, we do not expect that these certifying agents would incur significant costs as a result of this action. Certifying agents already must comply with the current regulations, e.g., maintaining certification records for organic operations.
AMS has determined that this rule would not have a significant impact on a substantial number of small entities, as defined by SBA. The effect of this rule, if implemented as final, would be to remove the allowance of seventeen substances in organic production and organic handling. The removal of these substances, while numerous, is due to the fact that alternatives have rendered them no longer necessary, they are no longer in use, or organic versions have become available. AMS invites comments on the anticipated costs of this proposed rule, including the impacts on small businesses.
B. Executive Order 12988
Executive Order 12988 instructs each executive agency to adhere to certain requirements in the development of new and revised regulations to avoid unduly burdening the court system.
Accordingly, to prevent duplicative regulation, states and local jurisdictions are preempted under the OFPA from creating programs of accreditation for 28 Organic Integrity Database: https
organic.ams.usda.gov/Integrity/. Accessed on January 29, 2021.

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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 6514b 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 6507b2 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 6519c6 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.
601624, the Poultry Products Inspection Act 21 U.S.C. 451471, or the Egg Products Inspection Act 21
U.S.C. 10311056, 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..
This proposed rule is not intended to have a retroactive effect.
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 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:

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