National Organic Program; Amendments to the National List of Allowed and Prohibited Substances per October 2018 NOSB Recommendations (Crops and Handling), 70431-70435 [2020-22784]

Download as PDF 70431 Rules and Regulations Federal Register Vol. 85, No. 215 Thursday, November 5, 2020 This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS–NOP–19–0023; NOP–19–01] RIN 0581 AD83 National Organic Program; Amendments to the National List of Allowed and Prohibited Substances per October 2018 NOSB Recommendations (Crops and Handling) Agricultural Marketing Service, USDA. ACTION: Final rule. AGENCY: This final rule amends the National List of Allowed and Prohibited Substances (National List) section of the United States Department of Agriculture’s (USDA’s) organic regulations. This rule adds non-organic tamarind seed gum as an allowed ingredient in organic products when certified organic tamarind seed gum is not commercially available. DATES: This final rule is effective December 7, 2020. FOR FURTHER INFORMATION CONTACT: Robert Pooler, Standards Division, National Organic Program. Telephone: (202) 720–3252. SUPPLEMENTARY INFORMATION: SUMMARY: khammond on DSKJM1Z7X2PROD with RULES 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. VerDate Sep<11>2014 18:31 Nov 04, 2020 Jkt 253001 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 (7 CFR 205.601– 205.606). Section 205.105 also requires that any nonorganic agricultural substance and any nonsynthetic nonagricultural substance used in organic handling be on the National List. Under the authority of OFPA, the National List can be amended by the Secretary based on recommendations presented by the 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 final rule addresses one NOSB recommendation to amend the National List that was submitted to the Secretary on October 26, 2018. The amendment in this final rule is discussed in the section on Overview of Amendments below. II. Overview of Amendments The following provides an overview of the amendment to a designated section of the National List regulations. This rule adds tamarind seed gum to the National List. This rule does not add blood meal made with sodium citrate or natamycin to the National List, as proposed by AMS (84 FR 55866, October 18, 2019). The background information on each substance and the basis for each NOSB recommendation was addressed in the proposed rule. The NOSB evaluated each substance by applying the OFPA substance evaluation criteria to determine if the substance was compatible with organic production and handling. For each substance, AMS reviewed the recommendation submitted by the NOSB to the Secretary to determine if the OFPA evaluation criteria had been appropriately applied and whether the addition to or amendment of the National List would not supersede other federal regulations. AMS received 45 comments on the proposed rule. After considering the comments, AMS determined that the addition of nonorganic tamarind seed gum to the National List for use in organic handling will be finalized as proposed. The proposed amendments to PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 add blood meal made with sodium citrate and to prohibit the use of natamycin in organic production have not been finalized for the reasons discussed below. Section F of this final rule provides an overview of the comments received and AMS’s response to these comments. Tamarind Seed Gum This rule amends the National List to allow nonorganic tamarind seed gum (by addition to § 205.606) in organic products when organic tamarind seed gum is not commercially available. Tamarind seed gum is used as a thickener, stabilizer, emulsifier or gelling agent in processed foods. The U.S. Food and Drug Administration (FDA) has been informed that tamarind seed is Generally Recognized as Safe (GRAS) for the above uses.1 During its October 24–26, 2018, public meeting, the NOSB recommended adding tamarind seed gum as an allowed nonorganic agricultural ingredient to § 205.606 of the National List. As required by the USDA organic regulations (§ 205.606), the nonorganic form of the ingredient will only be permitted when organic tamarind seed gum is not commercially available.2 To use nonorganic forms of ingredients listed at § 205.606, organic handling operations must demonstrate and document that organic forms of the ingredient(s) are not commercially available. Certifying agents (‘‘certifiers’’) review the operation’s use of nonorganic ingredients for compliance with the regulations in the course of reviewing an organic operation’s organic system plan. Amendments Not Finalized in This Rule Based upon public comments received on the proposed rule, AMS is not finalizing the proposed amendments to (1) list blood meal made with sodium citrate as an allowed synthetic substance for organic crop production or (2) prohibit natamycin use in crop 1 Agency Response Letter GRAS Notice No. GRN 000503, August 12, 2014; https://wayback.archiveit.org/7993/20171031004449/https://www.fda.gov/ Food/IngredientsPackagingLabeling/GRAS/ NoticeInventory/ucm413748.htm. 2 The USDA organic regulations (7 CFR 205.2) define ‘‘commercially available’’ as, ‘‘The ability to obtain a production input in an appropriate form, quality, or quantity to fulfill an essential function in a system of organic production or handling, as determined by the certifying agent in the course of reviewing the organic plan.’’ E:\FR\FM\05NOR1.SGM 05NOR1 70432 Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Rules and Regulations production. A summary of the comments received on the proposed rule and AMS’s responses to these comments are included in Section F of this final rule. III. Related Documents On October 18, 2019, AMS published in the Federal Register (84 FR 55866) a proposed rule to amend the National List to include blood meal made with sodium citrate; natamycin; and nonorganic tamarind seed gum. On August 9, 2018, AMS published a Notice in the Federal Register (83 FR 39376) announcing the fall 2018 NOSB meeting. One purpose of that meeting was to deliberate recommendations for the substances addressed in this rule. khammond on DSKJM1Z7X2PROD with RULES IV. Statutory and Regulatory Authority The OFPA authorizes the Secretary to make amendments to the National List based on recommendations developed by the NOSB (7 U.S.C. 6517(d)). 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 NOP website at https://www.ams.usda.gov/rulesregulations/organic/handbook. A. Executive Orders 12866 and 13771, 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. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB’s Memorandum titled ‘‘Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled ‘Reducing Regulation and Controlling Regulatory Costs’ ’’ (February 2, 2017). 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 VerDate Sep<11>2014 18:31 Nov 04, 2020 Jkt 253001 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) 3 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 $1,00,000. 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 and the NOP indicate most of the certified organic production operations in the United States would be considered small entities. According to the 2017 Census of Agriculture, 18,166 organic farms in the United States reported sales of organic products and total farmgate sales in excess of $7.2 billion.4 Based on that data, organic sales average $400,000 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 19,764 organic handlers that are certified under the USDA organic regulations (10,492 of 3 North American Industry Classification System: https://www.census.gov/eos/www/naics/. 4 U.S. Department of Agriculture, National Agricultural Statistics Service. 2017 Census of Agriculture. https://www.nass.usda.gov/ Publications/AgCensus/2017/Full_Report/Volume_ 1,_Chapter_1_US/. The number of organic farms includes both certified and exempt farms. PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 these handlers are based in the U.S.).5 The Organic Trade Association’s 2018 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 USDA has 78 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 one substance in organic handling. Adding this substance to the National List would increase regulatory flexibility and would give small entities more tools to use in day-to-day operations. 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 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 5 Organic Integrity Database: https:// organic.ams.usda.gov/Integrity/. Accessed on June 15, 2020. E:\FR\FM\05NOR1.SGM 05NOR1 Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Rules and Regulations 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 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 (U.S. EPA) under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.). C. Paperwork Reduction Act No additional collection or recordkeeping requirements are imposed on the public by this rule. Accordingly, OMB clearance is not required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35. khammond on DSKJM1Z7X2PROD with RULES D. Executive Order 13175 This 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. E. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2). VerDate Sep<11>2014 18:31 Nov 04, 2020 Jkt 253001 F. Comments Received on Proposed Rule During a 60-day comment period that closed on December 17, 2019, AMS received 45 comments on the proposed rule (84 FR 55866). These comments were submitted by organic farmers and handlers, certifying agents, researchers, trade associations, nonprofit organizations, and consumers. The comments can be viewed at https:// www.regulations.gov by searching for docket ID ‘‘AMS–NOP–19–0023.’’ Comments Received on the Proposed Addition to § 205.601 AMS received several comments on the proposed amendment to add blood meal made with sodium citrate to the National List for use in organic crop production. Most of these comments opposed the proposed listing. These comments argued that classifying blood meal made with sodium citrate as a synthetic substance contradicts guidance in NOP 5033 Classification of Materials and NOP 5034–1 Materials for Organic Crop Production, which lists blood meal as a nonsynthetic substance.6 Some comments noted that the use of anticoagulants, such as sodium citrate, is part of the ‘‘standard of identity’’ of blood meal, and, therefore, blood meal made with anticoagulants should be considered a nonsynthetic substance. Some comments stated that the use of sodium citrate in the making of blood meal has no technical effect, does not transform the blood into a different substance through a chemical change, and is not present in the final product. A few comments stated that sodium citrate binds with calcium in blood, making blood meal processed with sodium citrate the same as blood meal derived from processed animal blood where no anticoagulant was used. These comments suggested that the blood meal processed with sodium citrate is not altered into a form that does not occur in nature and should be classified as nonsynthetic. A few comments expressed concern about the potential impact of adding processing aids used to manufacture crop inputs to the National List. These comments postulate that adding blood meal made with sodium citrate to the National List sets a precedent for reviewing and approving processing aids that may be used in other currently approved inputs that are considered to be nonsynthetic, such as bone meal or 6 NOP 5033 and NOP 5034–1 are available in the NOP Program Handbook: https:// www.ams.usda.gov/rules-regulations/organic/ handbook. PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 70433 feather meal, but which in turn, could become prohibited. Several comments opposed or questioned the allowance of blood meal in organic production generally. A comment indicated that blood meal can be made without the use of sodium citrate and several comments were concerned that there are no restrictions on or required information about the source of the blood meal used in organic production, for example, to prohibit blood meal from nonorganic animals. One comment was concerned about disease transmission resulting from the use of blood meal and proposed that blood meal should be added to § 205.602 as a prohibited nonsynthetic substance. AMS also received comments supporting the addition of blood meal made with sodium citrate to the National List. However, supporting comments noted concerns with potential impacts of the proposed action beyond blood meal and one suggested revising guidance as an alternative to rulemaking. One comment supported the listing with the caveat that there was public support for such action and acknowledged the potential broader implications of that action and regulatory uncertainty about reviewing substances used in the processing of inputs. Comments Received on the Proposed Addition to § 205.602 Many of the public comments addressed the proposal to list natamycin as a prohibited substance in organic crop production. Many comments opposed natamycin’s listing in § 205.602 as a prohibited nonsynthetic substance. These comments argued that the NOSB’s determination that natamycin use could increase fungal resistance is flawed and is not supported by research. Several comments also included citations to specific research findings which conclude that natamycin use does not contribute to fungal resistance. Comments also stated that natamycin has been used for many years with no documented evidence of increased fungal resistance. In addition to disputing fungal resistance, comments cited other concerns with prohibiting the use of natamycin, including reduced product shelf-life, economic loss, and fewer options for controlling diseases where options are already very limited. The comments also stated that natamycin is generally not used for treatment of human fungal infections. AMS received several comments claiming that the proposed listing to E:\FR\FM\05NOR1.SGM 05NOR1 70434 Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Rules and Regulations khammond on DSKJM1Z7X2PROD with RULES prohibit natamycin, and the deliberations on the natamycin petition, did not meet requirements for prohibiting nonsynthetic substances stipulated in OFPA (7 U.S.C. 6517). To prohibit a nonsynthetic substance in organic crop or livestock production, OFPA requires that the USDA, in consultation with the U.S. Department of Health and Human Services and the U.S. Environmental Protection Agency, determine that the substance is harmful to human health or the environment, or is inconsistent with organic farming. Comments stated that natamycin is not harmful to and has negligible impact on human health. In addition, comments argued that the NOSB did not conclude that the use of natamycin was inconsistent with organic farming. Some comments stated that the NOSB’s recommendation to prohibit natamycin because it is ‘‘non-essential for organic production’’ is not valid because essentiality is not an evaluation criterion included in 7 U.S.C. 6517(c)(2) for prohibiting nonsynthetic substances. AMS did receive some comments in support of adding natamycin to § 205.602 as a prohibited nonsynthetic substance. These comments agreed with the NOSB’s recommendation to list natamycin as a prohibited nonsynthetic because of hazards to human health and the environment, and issues with essentiality for and compatibility with organic agriculture. Some comments argued that natamycin should be categorized as a synthetic substance because of the potential for synthetic substrates to be used in the fermentation process to produce natamycin. One comment requested guidance on determining whether the use of synthetic fermentation substrates in natamycin production would result in a nonsynthetic product. Another comment supporting the listing speculated on the possible impact natamycin use could have on soil fungi. Comments Received on the Proposed Addition to § 205.606 AMS received five comments opposed to the addition of nonorganic tamarind seed gum to § 205.606 for use in organic handling. Comments argued that nonorganic ingredients should never be allowed in the processing and handling of organic products. Other comments indicated that tamarind seed gum is not essential for organic handling. Some comments argued for a focus on improved traceability of tamarind seed supply chains (as cited by the tamarind seed gum petitioner), noting that organic tamarind seed is available, but poor traceability makes confirmation of the organic status of tamarind seed gum VerDate Sep<11>2014 18:31 Nov 04, 2020 Jkt 253001 difficult. Other comments argued that the tamarind seed gum petition review process did not adequately determine whether tamarind seed gum is commercially available in organic form. One comment more broadly noted that the petition process for listing materials on § 205.606 should include a review of all barriers to the organic production and commercial availability of a substance, and that a substance should be listed only if those barriers are clearly shown to be insurmountable. This comment also challenged the NOSB review of tamarind seed gum, stating that the petition review was not robust enough. AMS Response to Comments on Blood Meal Made With Sodium Citrate and Comments on Natamycin Sodium citrate was the petitioned substance for use as a processing aid (anticoagulant) in spray-dried blood products, such as blood meal. The NOSB recommended adding sodium citrate to the National List as an allowed synthetic substance for that use and requested that AMS review sodium citrate to determine whether sodium citrate used to process blood meal must be on the National List in order for the resulting blood meal to be allowed in organic crop production. As such, AMS proposed adding blood meal made with sodium citrate as a synthetic substance to the National List for use in organic crop production. Natamycin was petitioned to be classified as an allowed nonsynthetic substance for use as a post-harvest treatment to control fungal diseases on certain commodities. The NOSB determined that natamycin is nonsynthetic and that it should be prohibited in organic crop production because it is not essential, is inconsistent with sustainable agriculture, and has the potential to contribute to fungal resistance and the associated negative effects on human health. Therefore, AMS proposed listing natamycin as a nonsynthetic substance that is prohibited in organic crop production. AMS is not adopting two amendments in the proposed rule. These amendments would have listed (1) blood meal made with sodium citrate as an allowed synthetic substance in organic crop production and (2) natamycin as a prohibited nonsynthetic in organic crop production. Commenters raised significant concerns about each of these proposals. Specifically, many comments opposed AMS’s classification of blood meal made with sodium citrate as a synthetic substance and explained that PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 there may be potential impacts of that action which had not been considered in the proposed rule. AMS does not agree that information presented in these comments conclusively shows that blood meal made with sodium citrate is a nonsynthetic substance. However, AMS does agree that classifying blood meal made with sodium citrate as synthetic may have negative implications for some other materials used in organic production and that such impacts were not anticipated or considered in the proposed rule. Further, AMS is not finalizing the proposed amendment based in part on the fact that the NOSB did not specifically recommend adding blood meal made with sodium citrate as a synthetic to the National List. The NOSB recommended adding sodium citrate for use as an anticoagulant in the processing of blood meal, but did not determine that blood meal made with sodium citrate is a synthetic substance. Based on new information received in public comments about sodium citrate’s action in blood meal, AMS determined that further discussion and deliberation by the NOSB are needed to determine whether or not the use of sodium citrate makes blood meal a synthetic substance. Therefore, in the absence of an NOSB recommendation that blood meal made with sodium citrate should be added to the National List as a synthetic substance and because information submitted in public comment raised new questions about the proposed classification of blood meal made with sodium citrate as a synthetic substance, AMS is not adopting the proposed listing. In regards to natamycin, several public comments also presented research findings to challenge the conclusions that natamycin use in organic crop production would increase fungal resistance to antimicrobials, have negative environmental or human health impacts, and that a prohibition meets the OFPA criteria for prohibiting natural substances. AMS agrees that these research findings should be considered as part of the totality of the information considered on natamycin, and that the merits of those findings should be discussed as part of any regulatory action. AMS has not assessed the validity of the research findings presented in public comment, and AMS believes that the availability of this information warrants consideration before finalizing a prohibition on natamycin in organic production. As a result, AMS is not finalizing the proposed amendment to add natamycin E:\FR\FM\05NOR1.SGM 05NOR1 Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Rules and Regulations as a nonsynthetic substance prohibited for use in organic crop production. AMS is not finalizing the proposed amendments for blood meal with sodium citrate and natamycin for reasons discussed above. The information presented in public comments opposing the proposed actions should be assessed before any new proposal for regulatory action. AMS may invite additional input from the NOSB on these topics; the NOSB’s work may include conducting further study of the information and potential impacts and risks presented in public comments. AMS will not continue rulemaking on these two substances unless the NOSB forwards a new recommendation(s) on these topics to AMS. khammond on DSKJM1Z7X2PROD with RULES AMS Response to Comments on Tamarind Seed Gum This rule will add tamarind seed gum to the National List. AMS received few comments on tamarind seed gum. These comments expressed concern about the traceability of organic tamarind seed gum, and one comment argued that the NOSB did not conduct a robust review of the tamarind seed gum petition when determining organic tamarind seed gum availability. AMS disagrees with these comments. The NOSB comprehensively reviewed information on the potential sources of tamarind seed gum to determine if there were adequate sources of organic tamarind seed gum available to organic handlers in form, quantity, and quality. Based on the Organic INTEGRITY Database, which identifies no organic producers or handlers of tamarind seed gum, the NOSB determined there were insufficient sources of organic tamarind seed gum and recommended that tamarind seed gum be added to the National List in § 205.606. AMS agrees that the absence of organic tamarind seed gum handlers in the Organic INTEGRITY Database demonstrates that this ingredient is not currently commercially available in organic form. The USDA organic regulations require organic handlers to use organic agricultural ingredients when available before using any nonorganic agricultural ingredients that are included under § 205.606. Tamarind seed gum that is sold, labeled or represented as organic must be verified as organically produced and handled. G. General Notice of Public Rulemaking This final rule reflects recommendations submitted by the NOSB to the Secretary to add one substance to the National List. VerDate Sep<11>2014 18:31 Nov 04, 2020 Jkt 253001 List of Subjects in 7 CFR Part 205 Administrative practice and procedure, Agriculture, Animals, Archives and records, Imports, Labeling, Organically produced products, Plants, Reporting and recordkeeping requirements, Seals and insignia, Soil conservation. For the reasons set forth in the preamble, 7 CFR part 205 is amended as follows: PART 205—NATIONAL ORGANIC PROGRAM 1. The authority citation for part 205 is revised to read as follows: ■ Authority: 7 U.S.C. 6501–6522. 2. Amend § 205.606 by redesignating paragraphs (t) through (w) as paragraphs (u) through (x) and adding new paragraph (t) to read as follows: ■ § 205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as ‘‘organic.’’ * * * * * (t) Tamarind seed gum. * * * * * Bruce Summers, Administrator,Agricultural Marketing Service. [FR Doc. 2020–22784 Filed 11–4–20; 8:45 am] BILLING CODE P NUCLEAR REGULATORY COMMISSION 10 CFR Part 2 [NRC–2020–0033] RIN 3150–AK46 Non-Substantive Amendments to Adjudicatory Proceeding Requirements Nuclear Regulatory Commission. ACTION: Direct final rule. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) is amending its regulations to revise and clarify the agency’s rules of practice and procedure to reflect current Atomic Safety and Licensing Board Panel practice, Commission case law, and a decision of the Supreme Court of the United States and to enhance consistency within the NRC’s regulations. DATES: This final rule is effective January 19, 2021, unless significant adverse comments are received by December 7, 2020. If the direct final rule SUMMARY: PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 70435 is withdrawn as a result of such comments, timely notice of the withdrawal will be published in the Federal Register. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date. Comments received on this direct final rule will also be considered to be comments on a companion proposed rule published in the Proposed Rules section of this issue of the Federal Register. ADDRESSES: You may submit comments by any of the following methods: • Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC–2020–0033. Address questions about NRC dockets to Dawn Forder; telephone: 301–415–3407; email: Dawn.Forder@nrc.gov. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document. • Email comments to: Rulemaking.Comments@nrc.gov. If you do not receive an automatic email reply confirming receipt, then contact us at 301–415–1677. • Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, ATTN: Rulemakings and Adjudications Staff. For additional direction on obtaining information and submitting comments, see ‘‘Obtaining Information and Submitting Comments’’ in the SUPPLEMENTARY INFORMATION section of this document. FOR FURTHER INFORMATION CONTACT: Ian Irvin, Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington DC 20555–0001; telephone: 301–287–9193; email: 2020_Part_2_ Rulemaking@usnrc.onmicrosoft.com. SUPPLEMENTARY INFORMATION: Table of Contents I. Obtaining Information and Submitting Comments II. Rulemaking Procedure III. Background IV. Discussion V. Plain Writing VI. National Environmental Policy Act VII. Paperwork Reduction Act Act VIII. Congressional Review Act I. Obtaining Information and Submitting Comments A. Obtaining Information Please refer to Docket ID NRC–2020– 0033 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods: E:\FR\FM\05NOR1.SGM 05NOR1

Agencies

[Federal Register Volume 85, Number 215 (Thursday, November 5, 2020)]
[Rules and Regulations]
[Pages 70431-70435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22784]



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Rules and Regulations
                                                Federal Register
________________________________________________________________________

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

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

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Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / 
Rules and Regulations

[[Page 70431]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-19-0023; NOP-19-01]
RIN 0581 AD83


National Organic Program; Amendments to the National List of 
Allowed and Prohibited Substances per October 2018 NOSB Recommendations 
(Crops and Handling)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule amends the National List of Allowed and 
Prohibited Substances (National List) section of the United States 
Department of Agriculture's (USDA's) organic regulations. This rule 
adds non-organic tamarind seed gum as an allowed ingredient in organic 
products when certified organic tamarind seed gum is not commercially 
available.

DATES: This final rule is effective December 7, 2020.

FOR FURTHER INFORMATION CONTACT: Robert Pooler, 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 (7 CFR 205.601-205.606). Section 205.105 also requires 
that any nonorganic agricultural substance and any nonsynthetic 
nonagricultural substance used in organic handling be on the National 
List. Under the authority of OFPA, the National List can be amended by 
the Secretary based on recommendations presented by the 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 final rule addresses one NOSB recommendation to amend the 
National List that was submitted to the Secretary on October 26, 2018. 
The amendment in this final rule is discussed in the section on 
Overview of Amendments below.

II. Overview of Amendments

    The following provides an overview of the amendment to a designated 
section of the National List regulations. This rule adds tamarind seed 
gum to the National List. This rule does not add blood meal made with 
sodium citrate or natamycin to the National List, as proposed by AMS 
(84 FR 55866, October 18, 2019).
    The background information on each substance and the basis for each 
NOSB recommendation was addressed in the proposed rule. The NOSB 
evaluated each substance by applying the OFPA substance evaluation 
criteria to determine if the substance was compatible with organic 
production and handling. For each substance, AMS reviewed the 
recommendation submitted by the NOSB to the Secretary to determine if 
the OFPA evaluation criteria had been appropriately applied and whether 
the addition to or amendment of the National List would not supersede 
other federal regulations.
    AMS received 45 comments on the proposed rule. After considering 
the comments, AMS determined that the addition of nonorganic tamarind 
seed gum to the National List for use in organic handling will be 
finalized as proposed. The proposed amendments to add blood meal made 
with sodium citrate and to prohibit the use of natamycin in organic 
production have not been finalized for the reasons discussed below. 
Section F of this final rule provides an overview of the comments 
received and AMS's response to these comments.

Tamarind Seed Gum

    This rule amends the National List to allow nonorganic tamarind 
seed gum (by addition to Sec.  205.606) in organic products when 
organic tamarind seed gum is not commercially available. Tamarind seed 
gum is used as a thickener, stabilizer, emulsifier or gelling agent in 
processed foods. The U.S. Food and Drug Administration (FDA) has been 
informed that tamarind seed is Generally Recognized as Safe (GRAS) for 
the above uses.\1\ During its October 24-26, 2018, public meeting, the 
NOSB recommended adding tamarind seed gum as an allowed nonorganic 
agricultural ingredient to Sec.  205.606 of the National List. As 
required by the USDA organic regulations (Sec.  205.606), the 
nonorganic form of the ingredient will only be permitted when organic 
tamarind seed gum is not commercially available.\2\ To use nonorganic 
forms of ingredients listed at Sec.  205.606, organic handling 
operations must demonstrate and document that organic forms of the 
ingredient(s) are not commercially available. Certifying agents 
(``certifiers'') review the operation's use of nonorganic ingredients 
for compliance with the regulations in the course of reviewing an 
organic operation's organic system plan.
---------------------------------------------------------------------------

    \1\ Agency Response Letter GRAS Notice No. GRN 000503, August 
12, 2014; https://wayback.archive-it.org/7993/20171031004449/https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm413748.htm.
    \2\ The USDA organic regulations (7 CFR 205.2) define 
``commercially available'' as, ``The ability to obtain a production 
input in an appropriate form, quality, or quantity to fulfill an 
essential function in a system of organic production or handling, as 
determined by the certifying agent in the course of reviewing the 
organic plan.''
---------------------------------------------------------------------------

Amendments Not Finalized in This Rule

    Based upon public comments received on the proposed rule, AMS is 
not finalizing the proposed amendments to (1) list blood meal made with 
sodium citrate as an allowed synthetic substance for organic crop 
production or (2) prohibit natamycin use in crop

[[Page 70432]]

production. A summary of the comments received on the proposed rule and 
AMS's responses to these comments are included in Section F of this 
final rule.

III. Related Documents

    On October 18, 2019, AMS published in the Federal Register (84 FR 
55866) a proposed rule to amend the National List to include blood meal 
made with sodium citrate; natamycin; and nonorganic tamarind seed gum. 
On August 9, 2018, AMS published a Notice in the Federal Register (83 
FR 39376) announcing the fall 2018 NOSB meeting. One purpose of that 
meeting was to deliberate recommendations for the substances addressed 
in this rule.

IV. Statutory and Regulatory Authority

    The OFPA authorizes the Secretary to make amendments to the 
National List based on recommendations developed by the NOSB (7 U.S.C. 
6517(d)). 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 
NOP website at https://www.ams.usda.gov/rules-regulations/organic/handbook.

A. Executive Orders 12866 and 13771, 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. Additionally, because this rule does not meet the definition of 
a significant regulatory action, it does not trigger the requirements 
contained in Executive Order 13771. See OMB's Memorandum titled 
``Interim Guidance Implementing Section 2 of the Executive Order of 
January 30, 2017, titled `Reducing Regulation and Controlling 
Regulatory Costs' '' (February 2, 2017).
    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) \3\ 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 $1,00,000. 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.
---------------------------------------------------------------------------

    \3\ North American Industry Classification System: https://www.census.gov/eos/www/naics/.
---------------------------------------------------------------------------

    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 2017 Census of Agriculture, 
18,166 organic farms in the United States reported sales of organic 
products and total farmgate sales in excess of $7.2 billion.\4\ Based 
on that data, organic sales average $400,000 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.
---------------------------------------------------------------------------

    \4\ U.S. Department of Agriculture, National Agricultural 
Statistics Service. 2017 Census of Agriculture. https://www.nass.usda.gov/Publications/AgCensus/2017/Full_Report/Volume_1,_Chapter_1_US/. The number of organic farms includes both 
certified and exempt farms.
---------------------------------------------------------------------------

    According to the NOP's Organic Integrity Database, there are 19,764 
organic handlers that are certified under the USDA organic regulations 
(10,492 of these handlers are based in the U.S.).\5\ The Organic Trade 
Association's 2018 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.
---------------------------------------------------------------------------

    \5\ Organic Integrity Database: https://organic.ams.usda.gov/Integrity/. Accessed on June 15, 2020.
---------------------------------------------------------------------------

    The USDA has 78 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 one substance in organic handling. Adding this 
substance to the National List would increase regulatory flexibility 
and would give small entities more tools to use in day-to-day 
operations. 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 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

[[Page 70433]]

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 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 (U.S. EPA) under the Federal 
Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.).

C. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this 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 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.

E. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this rule 
as not a major rule, as defined by 5 U.S.C. 804(2).

F. Comments Received on Proposed Rule

    During a 60-day comment period that closed on December 17, 2019, 
AMS received 45 comments on the proposed rule (84 FR 55866). These 
comments were submitted by organic farmers and handlers, certifying 
agents, researchers, trade associations, nonprofit organizations, and 
consumers. The comments can be viewed at https://www.regulations.gov by 
searching for docket ID ``AMS-NOP-19-0023.''
Comments Received on the Proposed Addition to Sec.  205.601
    AMS received several comments on the proposed amendment to add 
blood meal made with sodium citrate to the National List for use in 
organic crop production. Most of these comments opposed the proposed 
listing. These comments argued that classifying blood meal made with 
sodium citrate as a synthetic substance contradicts guidance in NOP 
5033 Classification of Materials and NOP 5034-1 Materials for Organic 
Crop Production, which lists blood meal as a nonsynthetic substance.\6\ 
Some comments noted that the use of anticoagulants, such as sodium 
citrate, is part of the ``standard of identity'' of blood meal, and, 
therefore, blood meal made with anticoagulants should be considered a 
nonsynthetic substance. Some comments stated that the use of sodium 
citrate in the making of blood meal has no technical effect, does not 
transform the blood into a different substance through a chemical 
change, and is not present in the final product. A few comments stated 
that sodium citrate binds with calcium in blood, making blood meal 
processed with sodium citrate the same as blood meal derived from 
processed animal blood where no anticoagulant was used. These comments 
suggested that the blood meal processed with sodium citrate is not 
altered into a form that does not occur in nature and should be 
classified as nonsynthetic.
---------------------------------------------------------------------------

    \6\ NOP 5033 and NOP 5034-1 are available in the NOP Program 
Handbook: https://www.ams.usda.gov/rules-regulations/organic/handbook.
---------------------------------------------------------------------------

    A few comments expressed concern about the potential impact of 
adding processing aids used to manufacture crop inputs to the National 
List. These comments postulate that adding blood meal made with sodium 
citrate to the National List sets a precedent for reviewing and 
approving processing aids that may be used in other currently approved 
inputs that are considered to be nonsynthetic, such as bone meal or 
feather meal, but which in turn, could become prohibited.
    Several comments opposed or questioned the allowance of blood meal 
in organic production generally. A comment indicated that blood meal 
can be made without the use of sodium citrate and several comments were 
concerned that there are no restrictions on or required information 
about the source of the blood meal used in organic production, for 
example, to prohibit blood meal from nonorganic animals. One comment 
was concerned about disease transmission resulting from the use of 
blood meal and proposed that blood meal should be added to Sec.  
205.602 as a prohibited nonsynthetic substance.
    AMS also received comments supporting the addition of blood meal 
made with sodium citrate to the National List. However, supporting 
comments noted concerns with potential impacts of the proposed action 
beyond blood meal and one suggested revising guidance as an alternative 
to rulemaking. One comment supported the listing with the caveat that 
there was public support for such action and acknowledged the potential 
broader implications of that action and regulatory uncertainty about 
reviewing substances used in the processing of inputs.
Comments Received on the Proposed Addition to Sec.  205.602
    Many of the public comments addressed the proposal to list 
natamycin as a prohibited substance in organic crop production. Many 
comments opposed natamycin's listing in Sec.  205.602 as a prohibited 
nonsynthetic substance. These comments argued that the NOSB's 
determination that natamycin use could increase fungal resistance is 
flawed and is not supported by research. Several comments also included 
citations to specific research findings which conclude that natamycin 
use does not contribute to fungal resistance. Comments also stated that 
natamycin has been used for many years with no documented evidence of 
increased fungal resistance.
    In addition to disputing fungal resistance, comments cited other 
concerns with prohibiting the use of natamycin, including reduced 
product shelf-life, economic loss, and fewer options for controlling 
diseases where options are already very limited. The comments also 
stated that natamycin is generally not used for treatment of human 
fungal infections.
    AMS received several comments claiming that the proposed listing to

[[Page 70434]]

prohibit natamycin, and the deliberations on the natamycin petition, 
did not meet requirements for prohibiting nonsynthetic substances 
stipulated in OFPA (7 U.S.C. 6517). To prohibit a nonsynthetic 
substance in organic crop or livestock production, OFPA requires that 
the USDA, in consultation with the U.S. Department of Health and Human 
Services and the U.S. Environmental Protection Agency, determine that 
the substance is harmful to human health or the environment, or is 
inconsistent with organic farming. Comments stated that natamycin is 
not harmful to and has negligible impact on human health. In addition, 
comments argued that the NOSB did not conclude that the use of 
natamycin was inconsistent with organic farming. Some comments stated 
that the NOSB's recommendation to prohibit natamycin because it is 
``non-essential for organic production'' is not valid because 
essentiality is not an evaluation criterion included in 7 U.S.C. 
6517(c)(2) for prohibiting nonsynthetic substances.
    AMS did receive some comments in support of adding natamycin to 
Sec.  205.602 as a prohibited nonsynthetic substance. These comments 
agreed with the NOSB's recommendation to list natamycin as a prohibited 
nonsynthetic because of hazards to human health and the environment, 
and issues with essentiality for and compatibility with organic 
agriculture. Some comments argued that natamycin should be categorized 
as a synthetic substance because of the potential for synthetic 
substrates to be used in the fermentation process to produce natamycin. 
One comment requested guidance on determining whether the use of 
synthetic fermentation substrates in natamycin production would result 
in a nonsynthetic product. Another comment supporting the listing 
speculated on the possible impact natamycin use could have on soil 
fungi.
Comments Received on the Proposed Addition to Sec.  205.606
    AMS received five comments opposed to the addition of nonorganic 
tamarind seed gum to Sec.  205.606 for use in organic handling. 
Comments argued that nonorganic ingredients should never be allowed in 
the processing and handling of organic products. Other comments 
indicated that tamarind seed gum is not essential for organic handling. 
Some comments argued for a focus on improved traceability of tamarind 
seed supply chains (as cited by the tamarind seed gum petitioner), 
noting that organic tamarind seed is available, but poor traceability 
makes confirmation of the organic status of tamarind seed gum 
difficult. Other comments argued that the tamarind seed gum petition 
review process did not adequately determine whether tamarind seed gum 
is commercially available in organic form. One comment more broadly 
noted that the petition process for listing materials on Sec.  205.606 
should include a review of all barriers to the organic production and 
commercial availability of a substance, and that a substance should be 
listed only if those barriers are clearly shown to be insurmountable. 
This comment also challenged the NOSB review of tamarind seed gum, 
stating that the petition review was not robust enough.
AMS Response to Comments on Blood Meal Made With Sodium Citrate and 
Comments on Natamycin
    Sodium citrate was the petitioned substance for use as a processing 
aid (anticoagulant) in spray-dried blood products, such as blood meal. 
The NOSB recommended adding sodium citrate to the National List as an 
allowed synthetic substance for that use and requested that AMS review 
sodium citrate to determine whether sodium citrate used to process 
blood meal must be on the National List in order for the resulting 
blood meal to be allowed in organic crop production. As such, AMS 
proposed adding blood meal made with sodium citrate as a synthetic 
substance to the National List for use in organic crop production.
    Natamycin was petitioned to be classified as an allowed 
nonsynthetic substance for use as a post-harvest treatment to control 
fungal diseases on certain commodities. The NOSB determined that 
natamycin is nonsynthetic and that it should be prohibited in organic 
crop production because it is not essential, is inconsistent with 
sustainable agriculture, and has the potential to contribute to fungal 
resistance and the associated negative effects on human health. 
Therefore, AMS proposed listing natamycin as a nonsynthetic substance 
that is prohibited in organic crop production.
    AMS is not adopting two amendments in the proposed rule. These 
amendments would have listed (1) blood meal made with sodium citrate as 
an allowed synthetic substance in organic crop production and (2) 
natamycin as a prohibited nonsynthetic in organic crop production. 
Commenters raised significant concerns about each of these proposals.
    Specifically, many comments opposed AMS's classification of blood 
meal made with sodium citrate as a synthetic substance and explained 
that there may be potential impacts of that action which had not been 
considered in the proposed rule. AMS does not agree that information 
presented in these comments conclusively shows that blood meal made 
with sodium citrate is a nonsynthetic substance. However, AMS does 
agree that classifying blood meal made with sodium citrate as synthetic 
may have negative implications for some other materials used in organic 
production and that such impacts were not anticipated or considered in 
the proposed rule.
    Further, AMS is not finalizing the proposed amendment based in part 
on the fact that the NOSB did not specifically recommend adding blood 
meal made with sodium citrate as a synthetic to the National List. The 
NOSB recommended adding sodium citrate for use as an anticoagulant in 
the processing of blood meal, but did not determine that blood meal 
made with sodium citrate is a synthetic substance. Based on new 
information received in public comments about sodium citrate's action 
in blood meal, AMS determined that further discussion and deliberation 
by the NOSB are needed to determine whether or not the use of sodium 
citrate makes blood meal a synthetic substance. Therefore, in the 
absence of an NOSB recommendation that blood meal made with sodium 
citrate should be added to the National List as a synthetic substance 
and because information submitted in public comment raised new 
questions about the proposed classification of blood meal made with 
sodium citrate as a synthetic substance, AMS is not adopting the 
proposed listing.
    In regards to natamycin, several public comments also presented 
research findings to challenge the conclusions that natamycin use in 
organic crop production would increase fungal resistance to 
antimicrobials, have negative environmental or human health impacts, 
and that a prohibition meets the OFPA criteria for prohibiting natural 
substances. AMS agrees that these research findings should be 
considered as part of the totality of the information considered on 
natamycin, and that the merits of those findings should be discussed as 
part of any regulatory action. AMS has not assessed the validity of the 
research findings presented in public comment, and AMS believes that 
the availability of this information warrants consideration before 
finalizing a prohibition on natamycin in organic production. As a 
result, AMS is not finalizing the proposed amendment to add natamycin

[[Page 70435]]

as a nonsynthetic substance prohibited for use in organic crop 
production.
    AMS is not finalizing the proposed amendments for blood meal with 
sodium citrate and natamycin for reasons discussed above. The 
information presented in public comments opposing the proposed actions 
should be assessed before any new proposal for regulatory action. AMS 
may invite additional input from the NOSB on these topics; the NOSB's 
work may include conducting further study of the information and 
potential impacts and risks presented in public comments. AMS will not 
continue rulemaking on these two substances unless the NOSB forwards a 
new recommendation(s) on these topics to AMS.
AMS Response to Comments on Tamarind Seed Gum
    This rule will add tamarind seed gum to the National List. AMS 
received few comments on tamarind seed gum. These comments expressed 
concern about the traceability of organic tamarind seed gum, and one 
comment argued that the NOSB did not conduct a robust review of the 
tamarind seed gum petition when determining organic tamarind seed gum 
availability. AMS disagrees with these comments. The NOSB 
comprehensively reviewed information on the potential sources of 
tamarind seed gum to determine if there were adequate sources of 
organic tamarind seed gum available to organic handlers in form, 
quantity, and quality. Based on the Organic INTEGRITY Database, which 
identifies no organic producers or handlers of tamarind seed gum, the 
NOSB determined there were insufficient sources of organic tamarind 
seed gum and recommended that tamarind seed gum be added to the 
National List in Sec.  205.606. AMS agrees that the absence of organic 
tamarind seed gum handlers in the Organic INTEGRITY Database 
demonstrates that this ingredient is not currently commercially 
available in organic form. The USDA organic regulations require organic 
handlers to use organic agricultural ingredients when available before 
using any nonorganic agricultural ingredients that are included under 
Sec.  205.606. Tamarind seed gum that is sold, labeled or represented 
as organic must be verified as organically produced and handled.

G. General Notice of Public Rulemaking

    This final rule reflects recommendations submitted by the NOSB to 
the Secretary to add one substance to the National List.

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agriculture, Animals, 
Archives and records, Imports, Labeling, Organically produced products, 
Plants, Reporting and recordkeeping requirements, Seals and insignia, 
Soil conservation.

    For the reasons set forth in the preamble, 7 CFR part 205 is 
amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

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

    Authority:  7 U.S.C. 6501-6522.


0
2. Amend Sec.  205.606 by redesignating paragraphs (t) through (w) as 
paragraphs (u) through (x) and adding new paragraph (t) to read as 
follows:


Sec.  205.606   Nonorganically produced agricultural products allowed 
as ingredients in or on processed products labeled as ``organic.''

* * * * *
    (t) Tamarind seed gum.
* * * * *

Bruce Summers,
Administrator,Agricultural Marketing Service.

[FR Doc. 2020-22784 Filed 11-4-20; 8:45 am]
BILLING CODE P
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