National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances per October 2020 and April 2021 NOSB Recommendations (Handling, Crop), 5424-5428 [2022-01915]

Download as PDF 5424 Federal Register / Vol. 87, No. 21 / Tuesday, February 1, 2022 / Proposed Rules DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS–NOP–21–0060; NOP–21–02] RIN 0581–AE11 National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances per October 2020 and April 2021 NOSB Recommendations (Handling, Crop) Agricultural Marketing Service, USDA. ACTION: Proposed rule. AGENCY: The U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) proposes amendments to the National List of Allowed and Prohibited Substances (National List) section of the USDA’s organic regulations to implement recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board (NOSB). This rule proposes to add lowacyl gellan gum, a food additive used as a thickener, gelling agent, and stabilizer; and paper-based crop planting aids to the National List, along with a definition of paper-based crop planting aids. If finalized, low-acyl gellan gum would be allowed as an ingredient in processed organic products, and paperbased crop planting aids would be allowed in organic crop production. The rule also proposes the correction of a spelling error on the National List to change ‘‘wood resin’’ to ‘‘wood rosin’’. DATES: Send comment on or before April 4, 2022. ADDRESSES: You may send comments on this proposed rule to the Federal eRulemaking Portal at https:// www.regulations.gov/. You can access this proposed rule and instructions for submitting public comments by searching for document number, AMS– NOP–21–0060. Comments may also be sent to Jared Clark, Standards Division, National Organic Program, AMS, USDA; 1400 Independence Ave. SW, Room 2642-So., Ag Stop 0268, Washington, DC 20250–0268, or Email: Jared.Clark@ usda.gov. Instructions: All comments received must include the docket number AMS– NOP–21–0060; NOP–21–02, and/or Regulatory Information Number (RIN) 0581–AE11 for this rulemaking. You should clearly indicate the topic and section number of this proposed rule to which your comment refers, state your position(s), offer any recommended tkelley on DSK125TN23PROD with PROPS1 SUMMARY: VerDate Sep<11>2014 16:17 Jan 31, 2022 Jkt 256001 language change(s), and include relevant information and data to support your position(s) (e.g., scientific, environmental, manufacturing, industry, or industry-impact information, etc.). All comments and relevant background documents posted to https://www.regulations.gov will include any personal information provided. FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division, National Organic Program, 202–720– 3252, Jared.Clark@usda.gov. SUPPLEMENTARY INFORMATION: I. Background On December 21, 2000, the Secretary established the Agricultural Marketing Service’s (AMS) National Organic Program and the USDA organic regulations (65 FR 80547). 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 (i.e., in organic ‘‘handling’’). The Organic Foods Production Act of 1990 (OFPA) (7 U.S.C. 6501–6524) establishes what may be included on the National List and the procedures that the USDA must follow to amend the National List (§ 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 (§ 6518(m)). Section 205.607 of the USDA organic regulations permits any person to petition to add or remove a substance from the National List. The petition process is described in further detail in the Statutory and Regulatory Authority section below. The NOSB submitted recommendations to the Secretary after the conclusion of its public meetings on October 30, 2020 and April 30, 2021. In its 2020 1 and 2021 2 recommendations, the NOSB concluded that adding paperbased crop planting aids and low-acyl gellan gum, a food additive used as a thickener, gelling agent, and stabilizer, to the National List was consistent with 1 NOSB recommendation for low-acyl gellan gum, October 30, 2020. Available at: https://www.ams. usda.gov/sites/default/files/media/HSLowAcyl GellanGumRec_webpost.pdf. 2 NOSB recommendation for paper-based crop planting aids, April 30, 2021. Available at: https:// www.ams.usda.gov/sites/default/files/media/ CSPaperBasedCropPlantingAids_FinalRec.pdf. PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 OFPA evaluation criteria (7 U.S.C. 6518(m)). This proposed rule addresses these NOSB recommendations to add low-acyl gellan gum and paper-based crop planting aids to the National List and to add a definition of paper-based crop planting aids to § 205.2 (Terms Defined). II. Overview of Proposed Amendments The following provides an overview of the proposed amendments to the National List, along with the NOSB and AMS justifications for each proposed amendment. AMS welcomes comments on each proposed amendment. Comments received during the comment period will inform AMS’s decisions for the final rule; specifically, whether the proposed amendments align with OFPA criteria and are justified. A. Low-Acyl Gellan Gum (§ 205.605(b)) AMS is proposing to add low-acyl gellan gum to the National List at § 205.605(b) as a nonagricultural, synthetic substance allowed for use in organic handling. If finalized, low-acyl gellan gum would be allowed as an ingredient in processed organic and ‘‘made with organic’’ products. This AMS proposal follows a recommendation to AMS from the NOSB. The NOSB’s recommendation was based on their review of CP Kelco’s August 2019 petition, 3 4 stakeholder comments, and a third-party technical report. Background Gellan gums are used in food products as thickeners, gelling agents, and stabilizers, and they can be used in products that require gelling, texturizing, stabilizing, suspending, film-forming, and structuring (e.g., capsules used for dietary supplements). The petitioner argues that low-acyl gellan gum is necessary in organic handling as it holds unique qualities not found in other thickener substances on the National List, including: The ability to create a stable fluid gel with suspended matter in beverages containing fruit pulp or jelly pieces; product clarity not offered by high-acyl gellan gum; heat stability in acid systems unlike carrageenan; the ability to be used in standard processing without additional steps (e.g., compared to pectin, which requires special handling in gelled confections); and 3 August 2019 low-acyl gellan gum petition: https://www.ams.usda.gov/sites/default/files/ media/PetitionLowAcylGellanGum08082019.pdf. 4 March 2020 low-acyl gellan gum petition: https://www.ams.usda.gov/sites/default/files/ media/PetitionAddendum_LAGellanGum_ ResponsetoNOSB_03062020.pdf. E:\FR\FM\01FEP1.SGM 01FEP1 Federal Register / Vol. 87, No. 21 / Tuesday, February 1, 2022 / Proposed Rules providing a carrageenan-free, vegetarian alternative for hard and soft capsules (e.g., dietary supplements). As described in the third-party technical report,5 there are two forms of gellan gum: High-acyl and low-acyl. High-acyl gellan gum is listed on the National List (at § 205.605(a)) as a nonsynthetic, nonagricultural substance allowed in organic handling. To manufacture the low-acyl form, highacyl gellan gum is deacetylated using potassium hydroxide and heat resulting in a synthetic substance per the definition of ‘‘synthetic’’ at § 205.2. Acid is then used to lower the pH, and the low-acyl gellan gum is recovered from the solution by alcohol precipitation. tkelley on DSK125TN23PROD with PROPS1 NOSB Recommendation The NOSB recommended the addition of low-acyl gellan gum to the National List, at § 205.605(b), as a synthetic nonagricultural substance allowed in organic handling. After the NOSB reviewed the low-acyl gellan gum petition, a 2018 third-party technical report on gums, and public comments, they determined that the petitioned use of low-acyl gellan gum meets the OFPA criteria for inclusion in the National List in accordance with 7 U.S.C. 6518(m). In the rationale supporting their recommendation, the NOSB noted minimal adverse effects on the environment and distinct properties of low-acyl gellan gum, including a hard, non-elastic, brittle gel (unlike high-acyl gellan gum) and being a vegetarian option for the manufacture of capsules used for dietary supplements. The NOSB recommended that low-acyl gellan gum be classified as ‘‘synthetic,’’ as the manufacturing process includes deacetylation (the removal of acetyl group(s) from molecules), which is a chemical change. AMS Review of NOSB Recommendation AMS agrees that low-acyl gellan gum appears to meet the requirements for addition to the National List under 7 U.S.C. 6517(c)(1)(A). Public comments submitted to the NOSB and the 2018 third-party technical report indicate low-acyl gellan gum is necessary due to the apparent unavailability of wholly natural substitute products. Additionally, low-acyl gellan gum does not appear to be harmful to human health or the environment, as gellan gum is listed by the Food & Drug Administration (FDA) as a food additive permitted for direct addition to food for 5 Gums technical report, 2018: https:// www.ams.usda.gov/sites/default/files/media/ GumsTRFinal20180130.pdf. VerDate Sep<11>2014 16:17 Jan 31, 2022 Jkt 256001 human consumption at 21 CFR 172.665. Additionally, gellan gum is allowed as an inert ingredient in minimum risk pesticides (i.e., pesticide products exempt from the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act [FIFRA]) by the U.S. Environmental Protection Agency (EPA) at 40 CFR 152.25(f)(2)(iv). AMS also agrees with the NOSB’s recommendation to classify low-acyl gellan gum as a ‘‘synthetic’’ substance because the process of removing acetyl groups by the deacetylation portion meets the definition of ‘‘synthetic’’ under § 205.2. As low-acyl gellan gum appears to meet the requirements at 7 U.S.C. 6517(c)(1)(A), AMS proposes the addition of low-acyl gellan gum to the National List at 7 CFR 205.605(b) as a nonagricultural synthetic substance allowed for use in ‘‘organic’’ and ‘‘made with organic (specified ingredients or food group(s))’’ processed products. B. Paper-Based Crop Planting Aids (§ 205.601(o)(2)) AMS is proposing to add paper-based crop planting aids to the National List at § 205.601(o)(2) as a synthetic substance allowed for use in organic crop production and add a definition of paper-based crop planting aids to § 205.2 (Terms Defined). If finalized, paper-based crop planting aids would be allowed in organic crop production. This AMS proposal follows a recommendation to AMS from the NOSB from their review of Small Farm Works and Stone Circle Farm’s August 2018 petition,6 7 a third-party technical report, and public comment. Background Paper-based crop planting aids are used to transplant closely spaced crops, such as onions, beets, baby salad greens, etc. The petitioner argued that paperbased crop planting aids are necessary in organic crop production as they allow crop producers to replace the slower and more costly method of transplanting by hand. These paper-based crop planting aids, typically in the form of individual paper pots or paper chain pots, are generally used by small scale farming operations to transplant closely spaced crops using non-motorized equipment. 6 August 2018 paper planting pots petition: https://www.ams.usda.gov/sites/default/files/ media/PaperPotorContainerPetition080718.pdf. 7 August 2018 paper planting pots petition addendum: https://www.ams.usda.gov/sites/ default/files/media/PetitionAdendumPaperPots 10022018.pdf. PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 5425 As described in the 2019 Technical Report on paper-pots and containers,8 most paper-based crop planting aids contain kraft-manufactured paper, a synthetic substance. Paper-pots and other paper-based crop planting aids also contain a variety of synthetic, nonsynthetic, biobased, and/or biodegradable strengthening, adhesive and binding, fiber reinforcement, and antimicrobial additives. NOSB Recommendation The NOSB recommended the addition of paper-based crop planting aids to § 205.2 Terms Defined as well as to the National List, at § 205.601(o)(2), as a synthetic substance allowed in organic crop production. The recommended definition is: Paper-based crop planting aid. A material that is comprised of at least 60% cellulosebased fiber by weight, including, but not limited to, pots, seed tape, and collars that are placed in or on the soil and later incorporated into the soil, excluding biodegradable mulch film. Up to 40% of the ingredients can be non-synthetic, other permitted synthetic ingredients at § 205.601(j), or synthetic strengthening fibers, adhesives, or resins. Contains no less than 80% biobased content as verified by a qualified third-party assessment (e.g., laboratory test using ASTM D6866 or composition review by qualified personnel). Added nutrients must comply with § 205.105, 205.203, and 205.206. The NOSB recommended an annotated listing for paper-based crop planting aids at § 205.601(o)(2) as: Production Aids: Paper-based crop planting aids as defined in 205.2. Virgin or recycled paper without glossy paper or colored inks. After the NOSB reviewed the paperbased crop planting aid petition, a 2019 Technical Report on paper pots and containers, two January 2006 9 and January 2017 10 technical reports on newspaper, and public comments, the NOSB determined that the petitioned use of paper-based crop planting aids meets the OFPA criteria for allowed synthetic substances in organic crop production at 7 U.S.C. 6518(m). Specifically, the NOSB stated that allowing paper-based crop planting aids will assist small farmers in growing organic crops that would otherwise be prohibitive to grow due to the manual 8 Paper pots and containers technical report, 2019: https://www.ams.usda.gov/sites/default/files/ media/PaperTRFinal7262019.pdf. 9 Newspaper or Other Recycled Paper, January 2006: https://www.ams.usda.gov/sites/default/files/ media/Newspaper%20TR%202006.pdf. 10 Newspaper or Other Recycled Paper, January 2017: https://www.ams.usda.gov/sites/default/files/ media/Newspaper%20TR%20Final%2001 %2011%2017.pdf. E:\FR\FM\01FEP1.SGM 01FEP1 5426 Federal Register / Vol. 87, No. 21 / Tuesday, February 1, 2022 / Proposed Rules tkelley on DSK125TN23PROD with PROPS1 labor involved in transplanting. The NOSB recommended that paper-based crop planting aids be classified as ‘‘synthetic,’’ as the manufacturing process includes acid-base chemical reactions. AMS Review of NOSB Recommendation AMS agrees with the NOSB recommendation on paper-based crop planting aids, including: The classification of paper-based crop planting aids as a ‘‘synthetic’’ substance, the recommended definition of ‘‘paperbased crop planting aid,’’ and the annotation listing at § 205.601. AMS determined that paper-based crop planting aids, as presented in the recommended definition, appear to meet the requirements for addition to the National List under 7 U.S.C. 6517(c)(1)(A). Paper-based crop planting aids are expected to readily break down in the soil and are not expected to be harmful to human health or the environment in the amounts used for this purpose. This determination is supported by the presence of paper on EPA’s list of ‘‘inert ingredients permitted in minimum risk pesticide products’’ at 40 CFR 152.25(f)(2)(iv). Further, paper-based crop planting aids appear to be necessary due to the lack of wholly natural substitute products. Public comments and a 2019 third-party technical report also found that these planting aids were consistent with organic farming, because a similar substance (newspaper) is currently allowed as a mulch and/or compost feedstock, and paper planting aids reduce plastic use. AMS agrees with the classification of paper-based crop planting aids as a ‘‘synthetic’’ substance, as the acid-base reactions included in the kraft process of manufacturing paper, as well as the inclusion of additional synthetic substances to improve performance, fit the definition of ‘‘synthetic’’ under § 205.2 and further described in NOP 5033.11 AMS reviewed public comments submitted to the NOSB prior to the October 2020 and April 2021 NOSB meetings. Many commentors requested clarification on the term ‘‘qualified personnel’’ in the proposed definition of Paper-based crop planting aid. AMS interprets ‘‘qualified personnel’’ to be a third-party (i.e., certifier or material review organization) capable and qualified to make limited biobased determinations based on productspecific formulation. AMS views this allowance as an alternative verification process when the biobased nature of the ingredients is clear (e.g., a product composed entirely of paper and coconut coir). AMS seeks comment on the interpretation of ‘‘qualified personnel’’ and the additional considerations outlined within NOSB’s recommendation. As paper-based crop planting aids appear to meet the requirements at 7 U.S.C. 6517(c)(1)(A), AMS proposes the following: An addition of a definition of ‘‘paper-based crop planting aids’’ to 7 CFR 205.2, and the addition of paperbased crop planting aids to the National List at 7 CFR 205.601(o)(ii) as a synthetic substance allowed for use in organic crop production. The addition of paper-based crop planting aids at § 205.601(o)(2) would result in a redesignation of microcrystalline cheesewax to § 205.601(o)(1), with both present under § 205.601(o) ‘‘As production aids.’’ Additionally, in support of the proposed definition, AMS will explore updating the reference to ASTM D6866–12 at § 205.3 to the current standard in a future rulemaking. C. Wood Rosin (sic. Resin; § 205.605(a)) AMS is proposing a spelling correction to ‘‘wood resin’’ listed in the definition of ‘‘waxes’’ at 7 CFR 205.605(b). In their sunset recommendation 12 for this substance, the Board noted that ‘‘wood resin’’ is the incorrect term and that the corrected listing should read ‘‘wood rosin.’’ Though it appears that resin can also refer to rosin, AMS agrees that rosin is the preferred term because it is more specific to the wood product and would provide more clarity on the substance allowed. AMS proposes amending the listing at § 205.605(a) ‘‘Waxes—nonsynthetic (Wood resin)’’ to read ‘‘Waxes— nonsynthetic (Wood rosin)’’. III. 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 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 12 Formal 11 NOP 5033—Guidance: Classification of Materials: https://www.ams.usda.gov/sites/default/ files/media/NOP-5033.pdf. VerDate Sep<11>2014 16:17 Jan 31, 2022 Jkt 256001 Recommendation, 2022 Sunset Reviews—Handling, October 30, 2020: https:// www.ams.usda.gov/sites/default/files/media/ HS2022SunsetRecs_webpost.pdf. PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 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 AMS website in ‘‘Section I Other’’ 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.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 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. 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 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. E:\FR\FM\01FEP1.SGM 01FEP1 Federal Register / Vol. 87, No. 21 / Tuesday, February 1, 2022 / Proposed Rules tkelley on DSK125TN23PROD with PROPS1 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 total sales of organic products and total farmgate sales more than $9.9 billion.14 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. According to the NOP’s Organic Integrity Database, there are 19,059 organic handlers certified under the USDA organic regulations, as of January 2021.15 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: 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. The SBA defines small agricultural service firms, which include certifying agents under the NAICS subsector ‘‘All other professional, scientific, and technical services,’’ as those having annual receipts of less than $16,500,000 (13 CFR 121.201). There are currently 77 USDA-accredited certifying agents; based on a query of the NOP certified organic operations database.16 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. The economic impact on entities affected by this rule would not be significant. The effect of this rule, if 14 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. 15 Organic Integrity Database: https://organic.ams. usda.gov/Integrity/. Accessed on January 29, 2021. 16 Organic Integrity Database, Certifier Locator: https://organic.ams.usda.gov/Integrity/Certifiers/ CertifiersLocationsSearchPage.aspx. Accessed February 25, 2021. VerDate Sep<11>2014 16:17 Jan 31, 2022 Jkt 256001 implemented as final, would be to allow the use of an additional substance in organic handling. Adding a substance to the National List would increase regulatory flexibility and would give small entities more tools to use in dayto-day operations. 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 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 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 PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 5427 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: (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 proposed 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 where matters of mutual interest regarding the marketing of agricultural products are discussed. Information about the proposed changes to the regulations will be shared during an upcoming quarterly call, and tribal leaders will be informed about the proposed revisions to the regulation and the opportunity to submit comments. AMS will work with the USDA Office of Tribal Relations to ensure meaningful consultation is provided as needed with regards to the NOP regulations. E. 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. A 60day period for interested persons to comment on this rule is provided. List of Subjects in 7 CFR Part 205 Administrative practice and procedure, Agricultural commodities, Agriculture, Animals, Archives and records; Fees, Imports, Labeling, E:\FR\FM\01FEP1.SGM 01FEP1 5428 Federal Register / Vol. 87, No. 21 / Tuesday, February 1, 2022 / Proposed Rules Livestock, Organically produced products, Plants, Reporting and recordkeeping requirements, Seals and insignia, Soil conservation. For the reasons set forth in the preamble, the Agricultural Marketing Service proposes to amend 7 CFR part 205 as follows: PART 205—NATIONAL ORGANIC PROGRAM 1. The authority citation for part 205 continues to read as follows: ■ 2. Amend § 205.2 by adding, in alphabetical order, the definition for ‘‘Paper-based crop planting aid’’. ■ BILLING CODE 3410–02–P Terms Defined. * * * * Paper-based crop planting aid. A material that is comprised of at least 60% cellulose-based fiber by weight, including, but not limited to, pots, seed tape, and collars that are placed in or on the soil and later incorporated into the soil, excluding biodegradable mulch film. Up to 40% of the ingredients can be nonsynthetic, other permitted synthetic ingredients at § 205.601(j), or synthetic strengthening fibers, adhesives, or resins. Contains no less than 80% biobased content as verified by a qualified third-party assessment (e.g., laboratory test using ASTM D6866 or composition review by qualified personnel). Added nutrients must comply with §§ 205.105, 205.203, and 205.206. * * * * * ■ 3. Amend § 205.601 by revising paragraph (o) to read as follows: § 205.601 Synthetic substances allowed for use in organic crop production. tkelley on DSK125TN23PROD with PROPS1 * * * * (o) Production aids: (1) Microcrystalline cheesewax (CAS #’s 64742–42–3, 8009–03–08, and 8002– 74–2)—for use in log grown mushroom production. Must be made without either ethylene-propylene co-polymer or synthetic colors. (2) Paper-based crop planting aids as defined in § 205.2. Virgin or recycled paper without glossy paper or colored inks. * * * * * ■ 4. Amend § 205.605 by: ■ a. In paragraph (a), revising the entry for ‘‘Waxes’’. ■ b. In paragraph (b), adding, in alphabetical order, an entry for ‘‘Lowacyl gellan gum.’’. The addition and revision to read as follows: VerDate Sep<11>2014 16:17 Jan 31, 2022 Jkt 256001 * * * * (a) * * * Waxes—nonsynthetic (Wood rosin). * * * * * (b) * * * Low-acyl gellan gum. * * * * * [FR Doc. 2022–01915 Filed 1–31–22; 8:45 am] * * * Erin Morris, Associate Administrator, Agricultural Marketing Service. Authority: 7 U.S.C. 6501–6524. § 205.2 § 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)).’’ DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA–2022–0021; Project Identifier AD–2020–01283–A] RIN 2120–AA64 Airworthiness Directives; Piper Aircraft, Inc., Airplanes Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). AGENCY: The FAA proposes to adopt a new airworthiness directive (AD) for certain Piper Aircraft, Inc., (Piper) Model PA–46–600TP airplanes. This proposed AD was prompted by testing that showed that the wing splice assembly could fail before the assembly reaches its established life limit. This proposed AD would require revising the Airworthiness Limitations section of the existing maintenance manual (MM) or instructions for continued airworthiness to reduce the life limit of the wing splice assembly. The FAA is proposing this AD to address the unsafe condition on these products. DATES: The FAA must receive comments on this proposed AD by March 18, 2022. ADDRESSES: You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments. • Fax: (202) 493–2251. • Mail: U.S. Department of Transportation, Docket Operations, M– 30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE, Washington, DC 20590. SUMMARY: PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 • Hand Delivery: Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. For service information identified in this NPRM, contact Piper Aircraft, Inc., 2926 Piper Drive, Vero Beach, FL 32960; phone: (772) 299–2141; website: https:// www.piper.com. You may view the service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 901 Locust, Kansas City, MO 64106. For information on the availability of this material at the FAA, call (817) 222–5110. Examining the AD Docket You may examine the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA–2022–0021; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, any comments received, and other information. The street address for Docket Operations is listed above. FOR FURTHER INFORMATION CONTACT: John Marshall, Aviation Safety Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, GA 30337; phone: (404) 474–5524; email: john.r.marshall@faa.gov. SUPPLEMENTARY INFORMATION: Comments Invited The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES. Include ‘‘Docket No. FAA–2022–0021; Project Identifier AD– 2020–01283–A’’ at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments. Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https:// www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM. Confidential Business Information CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt E:\FR\FM\01FEP1.SGM 01FEP1

Agencies

[Federal Register Volume 87, Number 21 (Tuesday, February 1, 2022)]
[Proposed Rules]
[Pages 5424-5428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01915]



[[Page 5424]]

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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-21-0060; NOP-21-02]
RIN 0581-AE11


National Organic Program; Proposed Amendments to the National 
List of Allowed and Prohibited Substances per October 2020 and April 
2021 NOSB Recommendations (Handling, Crop)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The U.S. Department of Agriculture's (USDA) Agricultural 
Marketing Service (AMS) proposes amendments to the National List of 
Allowed and Prohibited Substances (National List) section of the USDA's 
organic regulations to implement recommendations submitted to the 
Secretary of Agriculture (Secretary) by the National Organic Standards 
Board (NOSB). This rule proposes to add low-acyl gellan gum, a food 
additive used as a thickener, gelling agent, and stabilizer; and paper-
based crop planting aids to the National List, along with a definition 
of paper-based crop planting aids. If finalized, low-acyl gellan gum 
would be allowed as an ingredient in processed organic products, and 
paper-based crop planting aids would be allowed in organic crop 
production. The rule also proposes the correction of a spelling error 
on the National List to change ``wood resin'' to ``wood rosin''.

DATES: Send comment on or before April 4, 2022.

ADDRESSES: You may send comments on this proposed rule to the Federal 
eRulemaking Portal at https://www.regulations.gov/. You can access this 
proposed rule and instructions for submitting public comments by 
searching for document number, AMS-NOP-21-0060. Comments may also be 
sent to Jared Clark, Standards Division, National Organic Program, AMS, 
USDA; 1400 Independence Ave. SW, Room 2642-So., Ag Stop 0268, 
Washington, DC 20250-0268, or Email: [email protected].
    Instructions: All comments received must include the docket number 
AMS-NOP-21-0060; NOP-21-02, and/or Regulatory Information Number (RIN) 
0581-AE11 for this rulemaking. You should clearly indicate the topic 
and section number of this proposed rule to which your comment refers, 
state your position(s), offer any recommended language change(s), and 
include relevant information and data to support your position(s) 
(e.g., scientific, environmental, manufacturing, industry, or industry-
impact information, etc.). All comments and relevant background 
documents posted to https://www.regulations.gov will include any 
personal information provided.

FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division, 
National Organic Program, 202-720-3252, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2000, the Secretary established the Agricultural 
Marketing Service's (AMS) National Organic Program and the USDA organic 
regulations (65 FR 80547). 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 (i.e., in organic ``handling'').
    The Organic Foods Production Act of 1990 (OFPA) (7 U.S.C. 6501-
6524) establishes what may be included on the National List and the 
procedures that the USDA must follow to amend the National List (Sec.  
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 (Sec.  6518(m)). Section 205.607 of the 
USDA organic regulations permits any person to petition to add or 
remove a substance from the National List. The petition process is 
described in further detail in the Statutory and Regulatory Authority 
section below.
    The NOSB submitted recommendations to the Secretary after the 
conclusion of its public meetings on October 30, 2020 and April 30, 
2021. In its 2020 \1\ and 2021 \2\ recommendations, the NOSB concluded 
that adding paper-based crop planting aids and low-acyl gellan gum, a 
food additive used as a thickener, gelling agent, and stabilizer, to 
the National List was consistent with OFPA evaluation criteria (7 
U.S.C. 6518(m)). This proposed rule addresses these NOSB 
recommendations to add low-acyl gellan gum and paper-based crop 
planting aids to the National List and to add a definition of paper-
based crop planting aids to Sec.  205.2 (Terms Defined).
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    \1\ NOSB recommendation for low-acyl gellan gum, October 30, 
2020. Available at: https://www.ams.usda.gov/sites/default/files/media/HSLowAcylGellanGumRec_webpost.pdf.
    \2\ NOSB recommendation for paper-based crop planting aids, 
April 30, 2021. Available at: https://www.ams.usda.gov/sites/default/files/media/CSPaperBasedCropPlantingAids_FinalRec.pdf.
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II. Overview of Proposed Amendments

    The following provides an overview of the proposed amendments to 
the National List, along with the NOSB and AMS justifications for each 
proposed amendment. AMS welcomes comments on each proposed amendment. 
Comments received during the comment period will inform AMS's decisions 
for the final rule; specifically, whether the proposed amendments align 
with OFPA criteria and are justified.

A. Low-Acyl Gellan Gum (Sec.  205.605(b))

    AMS is proposing to add low-acyl gellan gum to the National List at 
Sec.  205.605(b) as a nonagricultural, synthetic substance allowed for 
use in organic handling. If finalized, low-acyl gellan gum would be 
allowed as an ingredient in processed organic and ``made with organic'' 
products. This AMS proposal follows a recommendation to AMS from the 
NOSB. The NOSB's recommendation was based on their review of CP Kelco's 
August 2019 petition, 3 4 stakeholder comments, and a third-
party technical report.
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    \3\ August 2019 low-acyl gellan gum petition: https://www.ams.usda.gov/sites/default/files/media/PetitionLowAcylGellanGum08082019.pdf.
    \4\ March 2020 low-acyl gellan gum petition: https://www.ams.usda.gov/sites/default/files/media/PetitionAddendum_LAGellanGum_ResponsetoNOSB_03062020.pdf.
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Background
    Gellan gums are used in food products as thickeners, gelling 
agents, and stabilizers, and they can be used in products that require 
gelling, texturizing, stabilizing, suspending, film-forming, and 
structuring (e.g., capsules used for dietary supplements). The 
petitioner argues that low-acyl gellan gum is necessary in organic 
handling as it holds unique qualities not found in other thickener 
substances on the National List, including: The ability to create a 
stable fluid gel with suspended matter in beverages containing fruit 
pulp or jelly pieces; product clarity not offered by high-acyl gellan 
gum; heat stability in acid systems unlike carrageenan; the ability to 
be used in standard processing without additional steps (e.g., compared 
to pectin, which requires special handling in gelled confections); and

[[Page 5425]]

providing a carrageenan-free, vegetarian alternative for hard and soft 
capsules (e.g., dietary supplements).
    As described in the third-party technical report,\5\ there are two 
forms of gellan gum: High-acyl and low-acyl. High-acyl gellan gum is 
listed on the National List (at Sec.  205.605(a)) as a nonsynthetic, 
nonagricultural substance allowed in organic handling. To manufacture 
the low-acyl form, high-acyl gellan gum is deacetylated using potassium 
hydroxide and heat resulting in a synthetic substance per the 
definition of ``synthetic'' at Sec.  205.2. Acid is then used to lower 
the pH, and the low-acyl gellan gum is recovered from the solution by 
alcohol precipitation.
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    \5\ Gums technical report, 2018: https://www.ams.usda.gov/sites/default/files/media/GumsTRFinal20180130.pdf.
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NOSB Recommendation
    The NOSB recommended the addition of low-acyl gellan gum to the 
National List, at Sec.  205.605(b), as a synthetic nonagricultural 
substance allowed in organic handling. After the NOSB reviewed the low-
acyl gellan gum petition, a 2018 third-party technical report on gums, 
and public comments, they determined that the petitioned use of low-
acyl gellan gum meets the OFPA criteria for inclusion in the National 
List in accordance with 7 U.S.C. 6518(m). In the rationale supporting 
their recommendation, the NOSB noted minimal adverse effects on the 
environment and distinct properties of low-acyl gellan gum, including a 
hard, non-elastic, brittle gel (unlike high-acyl gellan gum) and being 
a vegetarian option for the manufacture of capsules used for dietary 
supplements. The NOSB recommended that low-acyl gellan gum be 
classified as ``synthetic,'' as the manufacturing process includes 
deacetylation (the removal of acetyl group(s) from molecules), which is 
a chemical change.
AMS Review of NOSB Recommendation
    AMS agrees that low-acyl gellan gum appears to meet the 
requirements for addition to the National List under 7 U.S.C. 
6517(c)(1)(A). Public comments submitted to the NOSB and the 2018 
third-party technical report indicate low-acyl gellan gum is necessary 
due to the apparent unavailability of wholly natural substitute 
products. Additionally, low-acyl gellan gum does not appear to be 
harmful to human health or the environment, as gellan gum is listed by 
the Food & Drug Administration (FDA) as a food additive permitted for 
direct addition to food for human consumption at 21 CFR 172.665. 
Additionally, gellan gum is allowed as an inert ingredient in minimum 
risk pesticides (i.e., pesticide products exempt from the requirements 
of the Federal Insecticide, Fungicide, and Rodenticide Act [FIFRA]) by 
the U.S. Environmental Protection Agency (EPA) at 40 CFR 
152.25(f)(2)(iv). AMS also agrees with the NOSB's recommendation to 
classify low-acyl gellan gum as a ``synthetic'' substance because the 
process of removing acetyl groups by the deacetylation portion meets 
the definition of ``synthetic'' under Sec.  205.2.
    As low-acyl gellan gum appears to meet the requirements at 7 U.S.C. 
6517(c)(1)(A), AMS proposes the addition of low-acyl gellan gum to the 
National List at 7 CFR 205.605(b) as a nonagricultural synthetic 
substance allowed for use in ``organic'' and ``made with organic 
(specified ingredients or food group(s))'' processed products.

B. Paper-Based Crop Planting Aids (Sec.  205.601(o)(2))

    AMS is proposing to add paper-based crop planting aids to the 
National List at Sec.  205.601(o)(2) as a synthetic substance allowed 
for use in organic crop production and add a definition of paper-based 
crop planting aids to Sec.  205.2 (Terms Defined). If finalized, paper-
based crop planting aids would be allowed in organic crop production. 
This AMS proposal follows a recommendation to AMS from the NOSB from 
their review of Small Farm Works and Stone Circle Farm's August 2018 
petition,6 7 a third-party technical report, and public 
comment.
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    \6\ August 2018 paper planting pots petition: https://www.ams.usda.gov/sites/default/files/media/PaperPotorContainerPetition080718.pdf.
    \7\ August 2018 paper planting pots petition addendum: https://www.ams.usda.gov/sites/default/files/media/PetitionAdendumPaperPots10022018.pdf.
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Background
    Paper-based crop planting aids are used to transplant closely 
spaced crops, such as onions, beets, baby salad greens, etc. The 
petitioner argued that paper-based crop planting aids are necessary in 
organic crop production as they allow crop producers to replace the 
slower and more costly method of transplanting by hand. These paper-
based crop planting aids, typically in the form of individual paper 
pots or paper chain pots, are generally used by small scale farming 
operations to transplant closely spaced crops using non-motorized 
equipment.
    As described in the 2019 Technical Report on paper-pots and 
containers,\8\ most paper-based crop planting aids contain kraft-
manufactured paper, a synthetic substance. Paper-pots and other paper-
based crop planting aids also contain a variety of synthetic, 
nonsynthetic, biobased, and/or biodegradable strengthening, adhesive 
and binding, fiber reinforcement, and antimicrobial additives.
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    \8\ Paper pots and containers technical report, 2019: https://www.ams.usda.gov/sites/default/files/media/PaperTRFinal7262019.pdf.
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NOSB Recommendation
    The NOSB recommended the addition of paper-based crop planting aids 
to Sec.  205.2 Terms Defined as well as to the National List, at Sec.  
205.601(o)(2), as a synthetic substance allowed in organic crop 
production. The recommended definition is:

    Paper-based crop planting aid. A material that is comprised of 
at least 60% cellulose-based fiber by weight, including, but not 
limited to, pots, seed tape, and collars that are placed in or on 
the soil and later incorporated into the soil, excluding 
biodegradable mulch film. Up to 40% of the ingredients can be non-
synthetic, other permitted synthetic ingredients at Sec.  
205.601(j), or synthetic strengthening fibers, adhesives, or resins. 
Contains no less than 80% biobased content as verified by a 
qualified third-party assessment (e.g., laboratory test using ASTM 
D6866 or composition review by qualified personnel). Added nutrients 
must comply with Sec.  205.105, 205.203, and 205.206.

    The NOSB recommended an annotated listing for paper-based crop 
planting aids at Sec.  205.601(o)(2) as:

    Production Aids: Paper-based crop planting aids as defined in 
205.2. Virgin or recycled paper without glossy paper or colored 
inks.

    After the NOSB reviewed the paper-based crop planting aid petition, 
a 2019 Technical Report on paper pots and containers, two January 2006 
\9\ and January 2017 \10\ technical reports on newspaper, and public 
comments, the NOSB determined that the petitioned use of paper-based 
crop planting aids meets the OFPA criteria for allowed synthetic 
substances in organic crop production at 7 U.S.C. 6518(m). 
Specifically, the NOSB stated that allowing paper-based crop planting 
aids will assist small farmers in growing organic crops that would 
otherwise be prohibitive to grow due to the manual

[[Page 5426]]

labor involved in transplanting. The NOSB recommended that paper-based 
crop planting aids be classified as ``synthetic,'' as the manufacturing 
process includes acid-base chemical reactions.
---------------------------------------------------------------------------

    \9\ Newspaper or Other Recycled Paper, January 2006: https://www.ams.usda.gov/sites/default/files/media/Newspaper%20TR%202006.pdf.
    \10\ Newspaper or Other Recycled Paper, January 2017: https://www.ams.usda.gov/sites/default/files/media/Newspaper%20TR%20Final%2001%2011%2017.pdf.
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AMS Review of NOSB Recommendation
    AMS agrees with the NOSB recommendation on paper-based crop 
planting aids, including: The classification of paper-based crop 
planting aids as a ``synthetic'' substance, the recommended definition 
of ``paper-based crop planting aid,'' and the annotation listing at 
Sec.  205.601.
    AMS determined that paper-based crop planting aids, as presented in 
the recommended definition, appear to meet the requirements for 
addition to the National List under 7 U.S.C. 6517(c)(1)(A). Paper-based 
crop planting aids are expected to readily break down in the soil and 
are not expected to be harmful to human health or the environment in 
the amounts used for this purpose. This determination is supported by 
the presence of paper on EPA's list of ``inert ingredients permitted in 
minimum risk pesticide products'' at 40 CFR 152.25(f)(2)(iv). Further, 
paper-based crop planting aids appear to be necessary due to the lack 
of wholly natural substitute products. Public comments and a 2019 
third-party technical report also found that these planting aids were 
consistent with organic farming, because a similar substance 
(newspaper) is currently allowed as a mulch and/or compost feedstock, 
and paper planting aids reduce plastic use.
    AMS agrees with the classification of paper-based crop planting 
aids as a ``synthetic'' substance, as the acid-base reactions included 
in the kraft process of manufacturing paper, as well as the inclusion 
of additional synthetic substances to improve performance, fit the 
definition of ``synthetic'' under Sec.  205.2 and further described in 
NOP 5033.\11\
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    \11\ NOP 5033--Guidance: Classification of Materials: https://www.ams.usda.gov/sites/default/files/media/NOP-5033.pdf.
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    AMS reviewed public comments submitted to the NOSB prior to the 
October 2020 and April 2021 NOSB meetings. Many commentors requested 
clarification on the term ``qualified personnel'' in the proposed 
definition of Paper-based crop planting aid. AMS interprets ``qualified 
personnel'' to be a third-party (i.e., certifier or material review 
organization) capable and qualified to make limited biobased 
determinations based on product-specific formulation. AMS views this 
allowance as an alternative verification process when the biobased 
nature of the ingredients is clear (e.g., a product composed entirely 
of paper and coconut coir). AMS seeks comment on the interpretation of 
``qualified personnel'' and the additional considerations outlined 
within NOSB's recommendation.
    As paper-based crop planting aids appear to meet the requirements 
at 7 U.S.C. 6517(c)(1)(A), AMS proposes the following: An addition of a 
definition of ``paper-based crop planting aids'' to 7 CFR 205.2, and 
the addition of paper-based crop planting aids to the National List at 
7 CFR 205.601(o)(ii) as a synthetic substance allowed for use in 
organic crop production. The addition of paper-based crop planting aids 
at Sec.  205.601(o)(2) would result in a redesignation of 
microcrystalline cheesewax to Sec.  205.601(o)(1), with both present 
under Sec.  205.601(o) ``As production aids.'' Additionally, in support 
of the proposed definition, AMS will explore updating the reference to 
ASTM D6866-12 at Sec.  205.3 to the current standard in a future 
rulemaking.

C. Wood Rosin (sic. Resin; Sec.  205.605(a))

    AMS is proposing a spelling correction to ``wood resin'' listed in 
the definition of ``waxes'' at 7 CFR 205.605(b). In their sunset 
recommendation \12\ for this substance, the Board noted that ``wood 
resin'' is the incorrect term and that the corrected listing should 
read ``wood rosin.'' Though it appears that resin can also refer to 
rosin, AMS agrees that rosin is the preferred term because it is more 
specific to the wood product and would provide more clarity on the 
substance allowed.
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    \12\ Formal Recommendation, 2022 Sunset Reviews--Handling, 
October 30, 2020: https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf.
---------------------------------------------------------------------------

    AMS proposes amending the listing at Sec.  205.605(a) ``Waxes--
nonsynthetic (Wood resin)'' to read ``Waxes--nonsynthetic (Wood 
rosin)''.

III. 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 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 
AMS website in ``Section I Other'' 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.\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 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. 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

[[Page 5427]]

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 total sales of 
organic products and total farmgate sales more than $9.9 billion.\14\ 
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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    \14\ 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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    According to the NOP's Organic Integrity Database, there are 19,059 
organic handlers certified under the USDA organic regulations, as of 
January 2021.\15\ 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: 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 January 29, 2021.
---------------------------------------------------------------------------

    The SBA defines small agricultural service firms, which include 
certifying agents under the NAICS subsector ``All other professional, 
scientific, and technical services,'' as those having annual receipts 
of less than $16,500,000 (13 CFR 121.201). There are currently 77 USDA-
accredited certifying agents; based on a query of the NOP certified 
organic operations database.\16\ 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.
---------------------------------------------------------------------------

    \16\ Organic Integrity Database, Certifier Locator: https://organic.ams.usda.gov/Integrity/Certifiers/CertifiersLocationsSearchPage.aspx. Accessed February 25, 2021.
---------------------------------------------------------------------------

    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 an additional substance in organic handling. Adding 
a substance to the National List would increase regulatory flexibility 
and would give small entities more tools to use in day-to-day 
operations. 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 
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 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 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: (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 proposed 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 where matters of mutual interest 
regarding the marketing of agricultural products are discussed. 
Information about the proposed changes to the regulations will be 
shared during an upcoming quarterly call, and tribal leaders will be 
informed about the proposed revisions to the regulation and the 
opportunity to submit comments. AMS will work with the USDA Office of 
Tribal Relations to ensure meaningful consultation is provided as 
needed with regards to the NOP regulations.

E. 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. 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, Agricultural commodities, 
Agriculture, Animals, Archives and records; Fees, Imports, Labeling,

[[Page 5428]]

Livestock, Organically produced products, Plants, Reporting and 
recordkeeping requirements, Seals and insignia, Soil conservation.

    For the reasons set forth in the preamble, the Agricultural 
Marketing Service proposes to amend 7 CFR part 205 as follows:

PART 205--NATIONAL ORGANIC PROGRAM

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

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

0
2. Amend Sec.  205.2 by adding, in alphabetical order, the definition 
for ``Paper-based crop planting aid''.


Sec.  205.2  Terms Defined.

* * * * *
    Paper-based crop planting aid. A material that is comprised of at 
least 60% cellulose-based fiber by weight, including, but not limited 
to, pots, seed tape, and collars that are placed in or on the soil and 
later incorporated into the soil, excluding biodegradable mulch film. 
Up to 40% of the ingredients can be nonsynthetic, other permitted 
synthetic ingredients at Sec.  205.601(j), or synthetic strengthening 
fibers, adhesives, or resins. Contains no less than 80% biobased 
content as verified by a qualified third-party assessment (e.g., 
laboratory test using ASTM D6866 or composition review by qualified 
personnel). Added nutrients must comply with Sec. Sec.  205.105, 
205.203, and 205.206.
* * * * *
0
3. Amend Sec.  205.601 by revising paragraph (o) to read as follows:


Sec.  205.601   Synthetic substances allowed for use in organic crop 
production.

* * * * *
    (o) Production aids:
    (1) Microcrystalline cheesewax (CAS #'s 64742-42-3, 8009-03-08, and 
8002-74-2)--for use in log grown mushroom production. Must be made 
without either ethylene-propylene co-polymer or synthetic colors.
    (2) Paper-based crop planting aids as defined in Sec.  205.2. 
Virgin or recycled paper without glossy paper or colored inks.
* * * * *
0
4. Amend Sec.  205.605 by:
0
a. In paragraph (a), revising the entry for ``Waxes''.
0
b. In paragraph (b), adding, in alphabetical order, an entry for ``Low-
acyl gellan gum.''.
    The addition and revision to read as follows:


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)).''

* * * * *
    (a) * * *
    Waxes--nonsynthetic (Wood rosin).
* * * * *
    (b) * * *
    Low-acyl gellan gum.
* * * * *

Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2022-01915 Filed 1-31-22; 8:45 am]
BILLING CODE 3410-02-P


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