National Organic Program; National List of Allowed and Prohibited Substances-Crops and Handling From October 2019 NOSB, 15800-15804 [2021-05700]

Download as PDF 15800 Proposed Rules Federal Register Vol. 86, No. 56 Thursday, March 25, 2021 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS–NOP–19–0102; NOP–19–05] RIN 0581–AD93 National Organic Program; National List of Allowed and Prohibited Substances—Crops and Handling From October 2019 NOSB Agricultural Marketing Service, USDA. ACTION: Proposed rule. AGENCY: This proposed rule would amend the National List of Allowed and Prohibited Substances (National List) section of the United States Department of Agriculture’s (USDA’s) organic regulations to add potassium hypochlorite for pre-harvest use as a sanitizer in organic crop production and fatty alcohols for sucker control in organic tobacco production. In addition, this rule proposes to remove the listing for dairy cultures, as it is redundant with an existing listing. DATES: Comments must be received by May 24, 2021. ADDRESSES: Interested persons may comment on the proposed rule using the following procedures: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: Jared Clark, Standards Division, National Organic Program, USDA–AMS–NOP, 1400 Independence Ave. SW, Room 2642–S, Ag Stop 0268, Washington, DC 20250–0268. Telephone: (202) 720–3252. Instructions: All submissions received must include the docket number AMS– NOP–19–0102, NOP–19–05, and/or Regulatory Information Number (RIN) SUMMARY: VerDate Sep<11>2014 17:19 Mar 24, 2021 Jkt 253001 0581–AD93 for this rulemaking. When submitting a comment, clearly indicate the proposed rule topic and section number to which the comment refers. In addition, comments should clearly indicate whether the commenter supports the action being proposed and clearly indicate the reason(s) for the position. Comments can also include information on alternative management practices, where applicable, that support alternatives to the proposed amendments. Comments should also offer any recommended language change(s) that would be appropriate to the position. Please include relevant information and data to support the position such as scientific, environmental, manufacturing, industry, or impact information, or similar sources. Only relevant material supporting the position should be submitted. All comments received will be posted without change to https:// www.regulations.gov. Document: To access the document and read background documents, or comments received, go to https:// www.regulations.gov (search for Docket ID AMS–NOP–19–0102). FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division, National Organic Program. Telephone: (202) 720–3252. SUPPLEMENTARY INFORMATION: I. Background On December 21, 2000, the Secretary established the National List within part 205 of the USDA organic regulations (7 CFR 205.600 through 205.607). The National List identifies the synthetic substances allowed in organic farming and the nonsynthetic substances prohibited in organic farming. The National List also identifies nonagricultural and nonorganic agricultural substances (ingredients) that may be used in organic handling. The Organic Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501–6524), and the USDA organic regulations (7 CFR part 205) specifically prohibit the use of any synthetic substance in organic production and handling unless the synthetic substance is on the National List (§§ 205.601, PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 205.603 and 205.605(b)). Section 205.105 also requires that any nonorganic agricultural substance and any nonsynthetic nonagricultural substance used in organic handling be on the National List (§§ 205.605(a) and 205.606). Under the authority of OFPA, the National List can be amended by the Secretary based on recommendations presented by the National Organic Standards Board (NOSB). Since the final rule establishing the National Organic Program (NOP) became effective on October 21, 2002, USDA’s Agricultural Marketing Service (AMS) has published multiple rules amending the National List. This proposed rule would amend the National List to reflect three recommendations submitted to the Secretary by the NOSB on October 25, 2019. This action would make the following changes to the National List based on the NOSB recommendations for three substances. Two substances are proposed to be added to the National List for use in organic crop production in response to petitions from the public. One substance is being recommended for removal from the National List because it is redundant to another listing on the National List. AMS published two notices in the Federal Register announcing the NOSB meetings and inviting public comments on the materials included in this proposed rule: November 26, 2018 (83 FR 60373) and May 22, 2019 (84 FR 23522). AMS also hosted public webinars (April 16 & 18, 2019, and October 15 & 17, 2019), to provide additional opportunities for public comment. The NOSB received additional comment during its public meetings on April 24–25, 2019,1 and October 23–24, 2019.2 Table 1 summarizes the proposed changes to the National List. 1 National Organic Standards Board (NOSB) Spring 2019 Meeting: https://www.ams.usda.gov/ event/national-organic-standards-board-nosbmeeting-seattle-wa. 2 National Organic Standards Board (NOSB) Fall 2019 Meeting: https://www.ams.usda.gov/event/ national-organic-standards-board-nosb-meetingpittsburgh-pa. E:\FR\FM\25MRP1.SGM 25MRP1 Federal Register / Vol. 86, No. 56 / Thursday, March 25, 2021 / Proposed Rules 15801 TABLE 1—PROPOSED AMENDMENTS TO THE NATIONAL LIST National list section Substance Potassium hypochlorite .............................................................. Fatty alcohols (C6, C8, C10, C12) ............................................... Dairy cultures .............................................................................. II. Overview of Proposed Amendments The following provides an overview of the proposed amendments to designated sections of the National List regulations: § 205.601 Synthetic Substances Allowed for Use in Organic Crop Production This proposed rule would add two substances to § 205.601, synthetic substances allowed for use in organic crop production. Potassium Hypochlorite The proposed rule would amend the National List to add potassium hypochlorite to § 205.601(a) as a synthetic substance allowed for use as a pre-harvest sanitizer in irrigation water in organic crop production. Table 2 illustrates the proposed listing. TABLE 2—PROPOSED AMENDMENT FOR POTASSIUM HYPOCHLORITE Proposed amendment: Add potassium hypochlorite to § 205.601(a)(2). In November 2018, AMS received a petition to add potassium hypochlorite as a synthetic substance allowed for use in organic crop production.3 4 The petition proposed to add potassium hypochlorite to § 205.601 as a type of chlorine material that can be used as a pre-harvest sanitizer. After considering the petition, the 2011 technical report on chlorine materials, and the public comments, the NOSB determined that this use of potassium hypochlorite meets the OFPA criteria for allowed synthetic substances in organic crop production.5 The NOSB 3 The initial petition for potassium hypochlorite was submitted in November 2018: https:// www.ams.usda.gov/sites/default/files/media/ PotassiumHypochloritePetition.pdf. 4 A revised petition for potassium hypochlorite was submitted in March 2019: https:// www.ams.usda.gov/sites/default/files/media/ PotassiumHypochloriteRevisedPetition 03262019.pdf. 5 Chlorine compounds technical report, 2011: https://www.ams.usda.gov/sites/default/files/ media/Chlorine%202%20TR%202011.pdf. This technical report describes the manufacture, industry uses, regulation, and chemical properties of chlorine compounds. Information in this technical report is transferable to potassium hypochlorite. VerDate Sep<11>2014 17:19 Mar 24, 2021 Jkt 253001 § 205.601 § 205.601 § 205.605 Proposed rule action Add to National List. Add to National List. Remove from National List. concluded that potassium hypochlorite is similar to other chlorine materials allowed in organic crop production and allowing its use supports compliance with the Food Safety and Modernization Act (FSMA) (21 U.S.C. 2201–2252) to sanitize irrigation water. In addition, the NOSB indicated that potassium hypochlorite has advantages over sodium hypochlorite, also an allowed chlorine material at § 205.601(a)(2)(iv), because potassium is a plant nutrient and is unlikely to increase soil salinization because it does not contain sodium. The NOSB recommended adding potassium hypochlorite to § 205.601 as a synthetic substance allowed for use as a pre-harvest sanitizer for use in irrigation water in organic crop production. The recommendation also specified that the concentration of potassium hypochlorite in irrigation water should not exceed maximum residual disinfectant limits specified under the Safe Drinking Water Act (SDWA) (42 U.S.C. 300(f) et seq.).6 7 Notably, the recommendation also explained the intent for a more limited allowance for potassium hypochlorite in comparison to other allowed chlorine substances on the National List for crop production. The recommendation specified that an allowance for potassium hypochlorite be limited to irrigation water. Additional uses, including post-harvest, would be prohibited. AMS concurs with the NOSB’s determination that potassium hypochlorite is a synthetic substance and that the use of potassium hypochlorite satisfies the OFPA criteria for allowed synthetic substances in organic crop production. Consistent with the NOSB recommendation, this proposed rule would amend the National List by adding potassium hypochlorite to the National List as a type of chlorine material that can be used as a pre-harvest sanitizer. Given that the NOSB recommendation specified that potassium hypochlorite be allowed for irrigation water only, we 6 NOSB potassium hypochlorite recommendation: https://www.ams.usda.gov/sites/default/files/ media/CSPotassiumHypochlorite.pdf. 7 Safe Drinking Water Act (SDWA) https:// www.epa.gov/sdwa. PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 are proposing that potassium hypochlorite would not be allowed for organic edible sprout production. This would clarify how the allowance for potassium hypochlorite is different from other allowed chlorine materials which are permitted for use in organic edible sprout production. Fatty Alcohols (C6, C8, C10, C12) The proposed rule would amend the National List to add fatty alcohols (C6, C8, C10, C12) to § 205.601 as a synthetic substance allowed for use in crop production. Table 3 illustrates the proposed listing. TABLE 3—PROPOSED FOR FATTY ALCOHOLS AMENDMENT (C6, C8, C10, C12) Current rule: Proposed amendment: N/A. Add fatty alcohols (C6, C8, C10, and/or C12) to § 205.601(k). AMS received a petition to add fatty alcohols (C6, C8, C10, C12) to the National List for use in organic crop production.8 9 The petition identified the intended use as sucker control in tobacco production. The petition explained that sucker control in tobacco production improves yield and quality of the plant, reduces pest pressure and supports crop rotation practices. After considering the petition, the technical report on fatty alcohols, and the public comments, the NOSB determined that this use of fatty alcohols meets the OFPA criteria for allowed synthetic substances in organic tobacco production.10 The NOSB concluded that the alternative materials for sucker control are ineffective and that fatty alcohols used for sucker 8 Fatty alcohols petition, December 10, 2018: https://www.ams.usda.gov/sites/default/files/ media/RevisedPetitionNaturalFattyAlcohols forUseonOrganicTobaccoCrops.pdf. 9 In 2015, a petition was submitted for fatty alcohols octanol-decanol mix. The NOSB did not recommend listing this substance. The 2015 fatty alcohols petition and the corresponding 2017 NOSB recommendation are available in the list of petitioned substances on the AMS website: https:// www.ams.usda.gov/rules-regulations/organic/ national-list/f. 10 Fatty alcohols technical report, 2016: https:// www.ams.usda.gov/sites/default/files/media/Fatty Alcohols020217.pdf. E:\FR\FM\25MRP1.SGM 25MRP1 15802 Federal Register / Vol. 86, No. 56 / Thursday, March 25, 2021 / Proposed Rules control are essential for organic tobacco production. Further, the NOSB also cited human health issues from manual desuckering which can cause nicotine poisoning and other health issues in workers due to heavy exposure to the nicotine present in the tobacco plant through dermal (skin) exposure. Consequently, the NOSB recommended the addition of fatty alcohols (C6, C8, C10, C12) to the National List for organic tobacco production.11 AMS concurs with the NOSB’s determination that fatty alcohols are a synthetic substance and that the use of fatty alcohols satisfies the OFPA criteria for allowed synthetic substances. Some discussion opined that the use of fatty alcohols for desuckering is primarily for economic benefit and that manual desuckering of tobacco plants, while more expensive, is the only method compatible with organic production. AMS is not persuaded by that argument because manual desuckering may pose adverse health risks to workers due to contact with tobacco plants. There are no alternative practices or allowed materials under current USDA organic regulations that perform this function. Therefore, AMS concurs that this substance is necessary for organic tobacco production and is consistent with organic farming. This proposed rule would amend the National List by adding fatty alcohols (C6, C8, C10, and/ or C12) for sucker control in organic tobacco production. The parenthetical content (C6, C8, C10, and/or C12) for the proposed listing specifies the range of alcohols that would be included in this listing. AMS is proposing that fatty alcohol products allowed for sucker control in organic production may contain either some or all of these fatty alcohols. NOP understands that referring to the carbon chain length of fatty alcohols are commonly understood by industry and regulation. In listing ‘‘C6, C8, C10, and/ or C12’’ as allowed fatty alcohols, it should be understood that these carbon chain designations refer to 1-hexanol, 1octanol, 1-decanol, and 1-dodecanol. AMS welcomes comments on whether the proposed listing provides the clarity for material reviewers to clearly determine which products would be permitted for sucker control in organic tobacco production. 11 NOSB recommendation for fatty alcohols, October 2019: https://www.ams.usda.gov/sites/ default/files/media/CSFattyAlcoholsFinalRec_ 0.pdf. VerDate Sep<11>2014 17:19 Mar 24, 2021 Jkt 253001 § 205.605 Nonagricultural (Nonorganic) Substances Allowed as Ingredients in or on Processed Products Labeled as ‘‘Organic’’ or ‘‘Made With Organic (Specified Ingredients or Food Group(s))’’ This proposed rule would remove one substance from § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food group(s)).’’ Dairy Cultures The proposed rule would amend the National List by removing dairy cultures as a nonsynthetic nonagricultural substance listed in § 205.605(a) for use in organic handling. The NOSB recommended removing dairy cultures from the National List because dairy cultures are allowed under the listing for ‘‘microorganisms’’ in § 205.605.12 The NOSB determined that dairy cultures is a redundant listing and that removing dairy cultures would have no negative impacts because these ingredients would continue to be allowed in organic handling. In addition, the NOSB indicated that permitted ancillary substances in dairy cultures would continue to be allowed under the ‘‘microorganisms’’ listing. AMS concurs that microorganisms are inclusive of dairy cultures and that listing both dairy cultures and microorganisms on the National List is redundant. AMS’ intent and belief are that current use patterns for approved dairy cultures would not be affected by the changes included in this proposed rule. Therefore, AMS is proposing to remove dairy cultures from the National List. III. Related Documents AMS published two notices in the Federal Register announcing the April 2019 and October 2019 NOSB meetings: November 26, 2018 (83 FR 60373) and May 22, 2019 (84 FR 23522). At these meetings, the NOSB deliberated on substances petitioned as amendments to the National List and substances under sunset review. 12 The NOSB recommended the removal of dairy cultures from the National List as part of its 2021 sunset review. The OFPA sunset provision (7 U.S.C. 6517(e)) requires the NOSB to review exemptions or prohibitions to the National List within 5 years of such exemption or prohibition being adopted or reviewed. The NOSB subsequently votes to remove a substance allowance or prohibition from the National List. The NOSB recommendation to remove dairy cultures is available here: https:// www.ams.usda.gov/sites/default/files/media/ HS2021SunsetReviews.pdf. PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 IV. Statutory and Regulatory Authority The OFPA authorizes the Secretary to make amendments to the National List based on recommendations developed by the NOSB. Sections 6518(k) and 6518(n) of the OFPA authorize the NOSB to develop recommendations for submission to the Secretary to amend the National List and to establish a process by which persons may petition the NOSB for the purpose of having substances evaluated for inclusion on or deletion from the National List. Section 205.607 of the USDA organic regulations permits any person to petition to add or remove a substance from the National List and directs petitioners to obtain the petition procedures from USDA. The current petition procedures published in the Federal Register (81 FR 12680, March 10, 2016) for amending the National List can be accessed through the NOP Program Handbook on the NOP website at https://www.ams.usda.gov/rulesregulations/organic/handbook. A. Executive Orders 12866 and Regulatory Flexibility Act This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) has exempted from Executive Order 12866. The Regulatory Flexibility Act (RFA) (5 U.S.C. 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 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\25MRP1.SGM 25MRP1 Federal Register / Vol. 86, No. 56 / Thursday, March 25, 2021 / Proposed Rules 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 2019 Certified Organic Survey, 16,524 organic farms in the United States reported sales of organic products and total farmgate sales in excess of $9.9 billion.14 Based on that data, organic sales average $601,000 per farm. Assuming a normal distribution of producers, we expect that most of these producers would fall under the $1,000,000 sales threshold to qualify as a small business. According to the NOP’s Organic Integrity Database, there are 19,832 organic handlers that are certified under the USDA organic regulations, of which 10,500 are based in the U.S.15 The Organic Trade Association’s 2020 Organic Industry Survey 16 has information about employment trends among organic manufacturers. The reported data are stratified into three groups by the number of employees per company: Less than 5; 5 to 49; and 50 plus. These data are representative of the organic manufacturing sector and the lower bound (50) of the range for the larger manufacturers is significantly smaller than the SBA’s small business thresholds (500 to 1,250). Therefore, AMS expects that most organic handlers would qualify as small businesses. The USDA has 77 accredited certifying agents who provide organic certification services to producers and handlers. The certifying agent that reports the most certified operations, nearly 3,500, would need to charge 14 U.S. Department of Agriculture, National Agricultural Statistics Service. 2019 Organic Survey. https://www.nass.usda.gov/Publications/ AgCensus/2017/Full_Report/Volume_1,_Chapter_1_ US/. The number of organic farms includes only certified farms. 15 Organic Integrity Database: https:// organic.ams.usda.gov/Integrity/. Accessed on August 18, 2020. 16 2020 Organic Industry Survey, Organic Trade Association. Available for purchase at https:// ota.com/organic-market-overview/organic-industrysurvey. VerDate Sep<11>2014 17:19 Mar 24, 2021 Jkt 253001 approximately $4,200 in certification fees in order to exceed the SBA’s small business threshold of $16.5 million. The costs for certification generally range from $500 to $3,500, depending on the complexity of the operation. Therefore, AMS expects that most of the accredited certifying agents would qualify as small entities under the SBA criteria. The economic impact on entities affected by this rule would not be significant. The effect of this rule, if implemented as final, would be to allow the use of two additional substances in organic crop production and remove one redundant listing from the regulations. Adding two substances to the National List would increase regulatory flexibility and would give small entities more tools to use in dayto-day operations. This action would also remove dairy cultures as a redundant listing and would have no impact on the industry. AMS reviewed comments submitted to the NOSB regarding the materials petitioned for inclusion on and recommended for removal from the National List. Therefore, AMS concludes that the economic impact of this addition, if any, would be minimal. Accordingly, USDA certifies that this rule would not have a significant economic impact on a substantial number of small entities. B. Executive Order 12988 Executive Order 12988 instructs each executive agency to adhere to certain requirements in the development of new and revised regulations in order to avoid unduly burdening the court system. This proposed rule is not intended to have a retroactive effect. Accordingly, to prevent duplicative regulation, states and local jurisdictions are preempted under the OFPA from creating programs of accreditation for private persons or state officials who want to become certifying agents of organic farms or handling operations. A governing state official would have to apply to USDA to be accredited as a certifying agent, as described in section 6514(b) of the OFPA. States are also preempted under sections 6503 through 6507 of the OFPA from creating certification programs to certify organic farms or handling operations unless the state programs have been submitted to, and approved by, the Secretary as meeting the requirements of the OFPA. Pursuant to section 6507(b)(2) of the OFPA, a state organic certification program that has been approved by the Secretary may, under certain circumstances, contain additional requirements for the production and handling of agricultural products organically produced in the state and for PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 15803 the certification of organic farm and handling operations located within the state. Such additional requirements must (a) further the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c) not be discriminatory toward agricultural commodities organically produced in other States, and (d) not be effective until approved by the Secretary. In addition, pursuant to section 6519(c)(6) of the OFPA, this proposed rule would not supersede or alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601–624), the Poultry Products Inspection Act (21 U.S.C. 451–471), or the Egg Products Inspection Act (21 U.S.C. 1031–1056), concerning meat, poultry, and egg products, respectively, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), nor the authority of the Administrator of the Environmental Protection Agency under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.). C. Paperwork Reduction Act No additional collection or recordkeeping requirements are imposed on the public by this proposed rule. Accordingly, OMB clearance is not required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35. D. Executive Order 13175 This proposed rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on tribal governments and will not have significant tribal implications. F. General Notice of Public Rulemaking This proposed rule reflects recommendations submitted by the NOSB to the Secretary to add two substances to the National List and to remove one substance from the National List. A 60-day period for interested persons to comment on this rule is provided. List of Subjects in 7 CFR Part 205 Administrative practice and procedure, Agriculture, Archives and records, Crops, Imports, Labeling, National list, National Organic Standards Board (NOSB), Organically produced products, Plants, Reporting and recordkeeping requirements, Seals and insignia, Soil conservation, Sunset. E:\FR\FM\25MRP1.SGM 25MRP1 15804 Federal Register / Vol. 86, No. 56 / Thursday, March 25, 2021 / Proposed Rules For the reasons set forth in the preamble, AMS proposes to amend 7 CFR part 205 as follows: PART 205—NATIONAL ORGANIC PROGRAM 1. The authority citation for 7 CFR part 205 is revised to read as follows: ■ Authority: 7 U.S.C. 6501–6524. 2. Amend § 205.601 by: a. Revising paragraph (a)(2)(iv); b. Adding paragraph (a)(2)(v); and c. Revising paragraph (k). The revisions and addition to read as follows: ■ ■ ■ ■ § 205.601 Synthetic substances allowed for use in organic crop production. * * * * * (a) * * * (2) * * * (iv) Potassium hypochlorite—not allowed for edible sprout production. (v) Sodium hypochlorite. * * * * * (k) As plant growth regulators. (1) Ethylene gas—for regulation of pineapple flowering. (2) Fatty alcohols (C6, C8, C10, and/or C12)—for sucker control in organic tobacco production. * * * * * § 205.605 [Amended] 3. In § 205.605, amend paragraph (a) by removing the words ‘‘Dairy cultures’’. ■ Bruce Summers, Administrator, Agricultural Marketing Service. [FR Doc. 2021–05700 Filed 3–24–21; 8:45 am] BILLING CODE 3410–02–P DEPARTMENT OF ENERGY 10 CFR Part 430 [EERE–2019–BT–STD–0036] RIN 1904–AE82 Energy Conservation Program: Energy Conservation Standards for Consumer Products; Early Assessment Review; Boilers Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Request for information. AGENCY: The U.S. Department of Energy (DOE) is undertaking an early assessment review for consumer boilers to determine whether to amend the applicable energy conservation standards for this product. Specifically, SUMMARY: VerDate Sep<11>2014 17:19 Mar 24, 2021 Jkt 253001 through this request for information (RFI), DOE seeks data and information to evaluate whether amended energy conservation standards would result in significant savings of energy, be technologically feasible, and be economically justified. DOE welcomes written comments from the public on any subject within the scope of this document (including those topics not specifically raised in this RFI), as well as the submission of data and other relevant information concerning this early assessment review. DATES: Written comments and information are requested and will be accepted on or before April 26, 2021. ADDRESSES: Interested persons are encouraged to submit comments using the Federal eRulemaking Portal at https://www.regulations.gov. Follow the instructions for submitting comments. Alternatively, interested persons may submit comments by email to the following address: Email: ConsumerBoilers2019STD0036@ ee.doe.gov. Include ‘‘Consumer Boilers RFI’’ and docket number EERE–2019– BT–STD–0036 and/or RIN 1904–AE82 in the subject line of the message. Submit electronic comments in WordPerfect, Microsoft Word, PDF, or ASCII file format, and avoid the use of special characters or any form of encryption. Although DOE has routinely accepted public comment submissions through a variety of mechanisms, including postal mail and hand delivery/courier, the Department has found it necessary to make temporary modifications to the comment submission process in light of the ongoing Covid–19 pandemic. DOE is currently accepting only electronic submissions at this time. If a commenter finds that this change poses an undue hardship, please contact Appliance Standards Program staff at (202) 586– 1445 to discuss the need for alternative arrangements. Once the Covid–19 pandemic health emergency is resolved, DOE anticipates resuming all of its regular options for public comment submission, including postal mail and hand delivery/courier. No telefacsimiles (faxes) will be accepted. For detailed instructions on submitting comments and additional information on this process, see section III of this document (Submission of Comments). Docket: The docket for this activity, which includes Federal Register notices, comments, and other supporting documents/materials, is available for review at https:// www.regulations.gov. All documents in the docket are listed in the https:// PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 www.regulations.gov index. However, some documents listed in the index, such as those containing information that is exempt from public disclosure, may not be publicly available. The docket web page can be found at: https://www.regulations.gov/ #!docketDetail;D=EERE-2019-BT-STD0036. The docket web page contains instructions on how to access all documents, including public comments, in the docket. See section III of this document for information on how to submit comments through https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Ms. Catherine Rivest, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE–5B, 1000 Independence Avenue SW, Washington, DC 20585–0121. Telephone: (202) 586– 7335. Email: ApplianceStandardsQuestions@ ee.doe.gov. Mr. Eric Stas, U.S. Department of Energy, Office of the General Counsel, GC–33, 1000 Independence Avenue SW, Washington, DC 20585–0121. Telephone: (202) 586–5827. Email: Eric.Stas@hq.doe.gov. For further information on how to submit a comment or review other public comments and the docket, contact the Appliance and Equipment Standards Program staff at (202) 287– 1445 or by email: ApplianceStandardsQuestions@ ee.doe.gov. SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction A. Authority B. Rulemaking History II. Request for Information and Comments A. Product Classes B. Significant Savings of Energy C. Technological Feasibility D. Economic Justification III. Submission of Comments I. Introduction DOE has established an early assessment review process to conduct a more focused analysis to evaluate, based on statutory criteria, whether a new or amended energy conservation standard is warranted. Based on the information received in response to the RFI and DOE’s own analysis, DOE will determine whether to proceed with a rulemaking for a new or amended energy conservation standard. If DOE makes an initial determination that a new or amended energy conservation standard would satisfy the applicable statutory criteria or DOE’s analysis is inconclusive, DOE would undertake the E:\FR\FM\25MRP1.SGM 25MRP1

Agencies

[Federal Register Volume 86, Number 56 (Thursday, March 25, 2021)]
[Proposed Rules]
[Pages 15800-15804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05700]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 86, No. 56 / Thursday, March 25, 2021 / 
Proposed Rules

[[Page 15800]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-19-0102; NOP-19-05]
RIN 0581-AD93


National Organic Program; National List of Allowed and Prohibited 
Substances--Crops and Handling From October 2019 NOSB

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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

SUMMARY: This proposed rule would amend the National List of Allowed 
and Prohibited Substances (National List) section of the United States 
Department of Agriculture's (USDA's) organic regulations to add 
potassium hypochlorite for pre-harvest use as a sanitizer in organic 
crop production and fatty alcohols for sucker control in organic 
tobacco production. In addition, this rule proposes to remove the 
listing for dairy cultures, as it is redundant with an existing 
listing.

DATES: Comments must be received by May 24, 2021.

ADDRESSES: Interested persons may comment on the proposed rule using 
the following procedures:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Jared Clark, Standards Division, National Organic 
Program, USDA-AMS-NOP, 1400 Independence Ave. SW, Room 2642-S, Ag Stop 
0268, Washington, DC 20250-0268. Telephone: (202) 720-3252.
    Instructions: All submissions received must include the docket 
number AMS-NOP-19-0102, NOP-19-05, and/or Regulatory Information Number 
(RIN) 0581-AD93 for this rulemaking. When submitting a comment, clearly 
indicate the proposed rule topic and section number to which the 
comment refers. In addition, comments should clearly indicate whether 
the commenter supports the action being proposed and clearly indicate 
the reason(s) for the position. Comments can also include information 
on alternative management practices, where applicable, that support 
alternatives to the proposed amendments. Comments should also offer any 
recommended language change(s) that would be appropriate to the 
position. Please include relevant information and data to support the 
position such as scientific, environmental, manufacturing, industry, or 
impact information, or similar sources. Only relevant material 
supporting the position should be submitted. All comments received will 
be posted without change to https://www.regulations.gov.
    Document: To access the document and read background documents, or 
comments received, go to https://www.regulations.gov (search for Docket 
ID AMS-NOP-19-0102).

FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division, 
National Organic Program. Telephone: (202) 720-3252.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2000, the Secretary established the National List 
within part 205 of the USDA organic regulations (7 CFR 205.600 through 
205.607). The National List identifies the synthetic substances allowed 
in organic farming and the nonsynthetic substances prohibited in 
organic farming. The National List also identifies nonagricultural and 
nonorganic agricultural substances (ingredients) that may be used in 
organic handling.
    The Organic Foods Production Act of 1990 (OFPA), as amended (7 
U.S.C. 6501-6524), and the USDA organic regulations (7 CFR part 205) 
specifically prohibit the use of any synthetic substance in organic 
production and handling unless the synthetic substance is on the 
National List (Sec. Sec.  205.601, 205.603 and 205.605(b)). Section 
205.105 also requires that any nonorganic agricultural substance and 
any nonsynthetic nonagricultural substance used in organic handling be 
on the National List (Sec. Sec.  205.605(a) and 205.606). Under the 
authority of OFPA, the National List can be amended by the Secretary 
based on recommendations presented by the National Organic Standards 
Board (NOSB). Since the final rule establishing the National Organic 
Program (NOP) became effective on October 21, 2002, USDA's Agricultural 
Marketing Service (AMS) has published multiple rules amending the 
National List.
    This proposed rule would amend the National List to reflect three 
recommendations submitted to the Secretary by the NOSB on October 25, 
2019. This action would make the following changes to the National List 
based on the NOSB recommendations for three substances. Two substances 
are proposed to be added to the National List for use in organic crop 
production in response to petitions from the public. One substance is 
being recommended for removal from the National List because it is 
redundant to another listing on the National List. AMS published two 
notices in the Federal Register announcing the NOSB meetings and 
inviting public comments on the materials included in this proposed 
rule: November 26, 2018 (83 FR 60373) and May 22, 2019 (84 FR 23522). 
AMS also hosted public webinars (April 16 & 18, 2019, and October 15 & 
17, 2019), to provide additional opportunities for public comment. The 
NOSB received additional comment during its public meetings on April 
24-25, 2019,\1\ and October 23-24, 2019.\2\ Table 1 summarizes the 
proposed changes to the National List.
---------------------------------------------------------------------------

    \1\ National Organic Standards Board (NOSB) Spring 2019 Meeting: 
https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-seattle-wa.
    \2\ National Organic Standards Board (NOSB) Fall 2019 Meeting: 
https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-pittsburgh-pa.

[[Page 15801]]



            Table 1--Proposed Amendments to the National List
------------------------------------------------------------------------
                                     National list
             Substance                  section     Proposed rule action
------------------------------------------------------------------------
Potassium hypochlorite............  Sec.   205.601  Add to National
                                                     List.
Fatty alcohols (C6, C8, C10, C12).  Sec.   205.601  Add to National
                                                     List.
Dairy cultures....................  Sec.   205.605  Remove from National
                                                     List.
------------------------------------------------------------------------

II. Overview of Proposed Amendments

    The following provides an overview of the proposed amendments to 
designated sections of the National List regulations:

Sec.  205.601 Synthetic Substances Allowed for Use in Organic Crop 
Production

    This proposed rule would add two substances to Sec.  205.601, 
synthetic substances allowed for use in organic crop production.
Potassium Hypochlorite
    The proposed rule would amend the National List to add potassium 
hypochlorite to Sec.  205.601(a) as a synthetic substance allowed for 
use as a pre-harvest sanitizer in irrigation water in organic crop 
production. Table 2 illustrates the proposed listing.

         Table 2--Proposed Amendment for Potassium Hypochlorite
------------------------------------------------------------------------
             Current rule:                             N/A
------------------------------------------------------------------------
Proposed amendment:                      Add potassium hypochlorite to
                                          Sec.   205.601(a)(2).
------------------------------------------------------------------------

    In November 2018, AMS received a petition to add potassium 
hypochlorite as a synthetic substance allowed for use in organic crop 
production.3 4 The petition proposed to add potassium 
hypochlorite to Sec.  205.601 as a type of chlorine material that can 
be used as a pre-harvest sanitizer.
---------------------------------------------------------------------------

    \3\ The initial petition for potassium hypochlorite was 
submitted in November 2018: https://www.ams.usda.gov/sites/default/files/media/PotassiumHypochloritePetition.pdf.
    \4\ A revised petition for potassium hypochlorite was submitted 
in March 2019: https://www.ams.usda.gov/sites/default/files/media/PotassiumHypochloriteRevisedPetition03262019.pdf.
---------------------------------------------------------------------------

    After considering the petition, the 2011 technical report on 
chlorine materials, and the public comments, the NOSB determined that 
this use of potassium hypochlorite meets the OFPA criteria for allowed 
synthetic substances in organic crop production.\5\ The NOSB concluded 
that potassium hypochlorite is similar to other chlorine materials 
allowed in organic crop production and allowing its use supports 
compliance with the Food Safety and Modernization Act (FSMA) (21 U.S.C. 
2201-2252) to sanitize irrigation water. In addition, the NOSB 
indicated that potassium hypochlorite has advantages over sodium 
hypochlorite, also an allowed chlorine material at Sec.  
205.601(a)(2)(iv), because potassium is a plant nutrient and is 
unlikely to increase soil salinization because it does not contain 
sodium.
---------------------------------------------------------------------------

    \5\ Chlorine compounds technical report, 2011: https://www.ams.usda.gov/sites/default/files/media/Chlorine%202%20TR%202011.pdf. This technical report describes the 
manufacture, industry uses, regulation, and chemical properties of 
chlorine compounds. Information in this technical report is 
transferable to potassium hypochlorite.
---------------------------------------------------------------------------

    The NOSB recommended adding potassium hypochlorite to Sec.  205.601 
as a synthetic substance allowed for use as a pre-harvest sanitizer for 
use in irrigation water in organic crop production. The recommendation 
also specified that the concentration of potassium hypochlorite in 
irrigation water should not exceed maximum residual disinfectant limits 
specified under the Safe Drinking Water Act (SDWA) (42 U.S.C. 300(f) et 
seq.).6 7 Notably, the recommendation also explained the 
intent for a more limited allowance for potassium hypochlorite in 
comparison to other allowed chlorine substances on the National List 
for crop production. The recommendation specified that an allowance for 
potassium hypochlorite be limited to irrigation water. Additional uses, 
including post-harvest, would be prohibited.
---------------------------------------------------------------------------

    \6\ NOSB potassium hypochlorite recommendation: https://www.ams.usda.gov/sites/default/files/media/CSPotassiumHypochlorite.pdf.
    \7\ Safe Drinking Water Act (SDWA) https://www.epa.gov/sdwa.
---------------------------------------------------------------------------

    AMS concurs with the NOSB's determination that potassium 
hypochlorite is a synthetic substance and that the use of potassium 
hypochlorite satisfies the OFPA criteria for allowed synthetic 
substances in organic crop production. Consistent with the NOSB 
recommendation, this proposed rule would amend the National List by 
adding potassium hypochlorite to the National List as a type of 
chlorine material that can be used as a pre-harvest sanitizer. Given 
that the NOSB recommendation specified that potassium hypochlorite be 
allowed for irrigation water only, we are proposing that potassium 
hypochlorite would not be allowed for organic edible sprout production. 
This would clarify how the allowance for potassium hypochlorite is 
different from other allowed chlorine materials which are permitted for 
use in organic edible sprout production.
Fatty Alcohols (C6, C8, C10, 
C12)
    The proposed rule would amend the National List to add fatty 
alcohols (C6, C8, C10, C12) 
to Sec.  205.601 as a synthetic substance allowed for use in crop 
production. Table 3 illustrates the proposed listing.

    Table 3--Proposed Amendment for Fatty Alcohols (C6, C8, C10, C12)
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Current rule:                            N/A.
Proposed amendment:                      Add fatty alcohols (C6, C8,
                                          C10, and/or C12) to Sec.
                                          205.601(k).
------------------------------------------------------------------------

    AMS received a petition to add fatty alcohols (C6, 
C8, C10, C12) to the National List for 
use in organic crop production.8 9 The petition identified 
the intended use as sucker control in tobacco production. The petition 
explained that sucker control in tobacco production improves yield and 
quality of the plant, reduces pest pressure and supports crop rotation 
practices.
---------------------------------------------------------------------------

    \8\ Fatty alcohols petition, December 10, 2018: https://www.ams.usda.gov/sites/default/files/media/RevisedPetitionNaturalFattyAlcoholsforUseonOrganicTobaccoCrops.pdf.
    \9\ In 2015, a petition was submitted for fatty alcohols 
octanol-decanol mix. The NOSB did not recommend listing this 
substance. The 2015 fatty alcohols petition and the corresponding 
2017 NOSB recommendation are available in the list of petitioned 
substances on the AMS website: https://www.ams.usda.gov/rules-regulations/organic/national-list/f.
---------------------------------------------------------------------------

    After considering the petition, the technical report on fatty 
alcohols, and the public comments, the NOSB determined that this use of 
fatty alcohols meets the OFPA criteria for allowed synthetic substances 
in organic tobacco production.\10\ The NOSB concluded that the 
alternative materials for sucker control are ineffective and that fatty 
alcohols used for sucker

[[Page 15802]]

control are essential for organic tobacco production. Further, the NOSB 
also cited human health issues from manual desuckering which can cause 
nicotine poisoning and other health issues in workers due to heavy 
exposure to the nicotine present in the tobacco plant through dermal 
(skin) exposure. Consequently, the NOSB recommended the addition of 
fatty alcohols (C6, C8, C10, 
C12) to the National List for organic tobacco 
production.\11\
---------------------------------------------------------------------------

    \10\ Fatty alcohols technical report, 2016: https://www.ams.usda.gov/sites/default/files/media/FattyAlcohols020217.pdf.
    \11\ NOSB recommendation for fatty alcohols, October 2019: 
https://www.ams.usda.gov/sites/default/files/media/CSFattyAlcoholsFinalRec_0.pdf.
---------------------------------------------------------------------------

    AMS concurs with the NOSB's determination that fatty alcohols are a 
synthetic substance and that the use of fatty alcohols satisfies the 
OFPA criteria for allowed synthetic substances. Some discussion opined 
that the use of fatty alcohols for desuckering is primarily for 
economic benefit and that manual desuckering of tobacco plants, while 
more expensive, is the only method compatible with organic production. 
AMS is not persuaded by that argument because manual desuckering may 
pose adverse health risks to workers due to contact with tobacco 
plants. There are no alternative practices or allowed materials under 
current USDA organic regulations that perform this function. Therefore, 
AMS concurs that this substance is necessary for organic tobacco 
production and is consistent with organic farming. This proposed rule 
would amend the National List by adding fatty alcohols (C6, 
C8, C10, and/or C12) for sucker 
control in organic tobacco production.
    The parenthetical content (C6, C8, 
C10, and/or C12) for the proposed listing 
specifies the range of alcohols that would be included in this listing. 
AMS is proposing that fatty alcohol products allowed for sucker control 
in organic production may contain either some or all of these fatty 
alcohols. NOP understands that referring to the carbon chain length of 
fatty alcohols are commonly understood by industry and regulation. In 
listing ``C6, C8, C10, and/or C12'' as allowed fatty alcohols, it 
should be understood that these carbon chain designations refer to 1-
hexanol, 1-octanol, 1-decanol, and 1-dodecanol. AMS welcomes comments 
on whether the proposed listing provides the clarity for material 
reviewers to clearly determine which products would be permitted for 
sucker control in organic tobacco production.

Sec.  205.605 Nonagricultural (Nonorganic) Substances Allowed as 
Ingredients in or on Processed Products Labeled as ``Organic'' or 
``Made With Organic (Specified Ingredients or Food Group(s))''

    This proposed rule would remove one substance from Sec.  205.605 
Nonagricultural (nonorganic) substances allowed as ingredients in or on 
processed products labeled as ``organic'' or ``made with organic 
(specified ingredients or food group(s)).''
Dairy Cultures
    The proposed rule would amend the National List by removing dairy 
cultures as a nonsynthetic nonagricultural substance listed in Sec.  
205.605(a) for use in organic handling. The NOSB recommended removing 
dairy cultures from the National List because dairy cultures are 
allowed under the listing for ``microorganisms'' in Sec.  205.605.\12\ 
The NOSB determined that dairy cultures is a redundant listing and that 
removing dairy cultures would have no negative impacts because these 
ingredients would continue to be allowed in organic handling. In 
addition, the NOSB indicated that permitted ancillary substances in 
dairy cultures would continue to be allowed under the 
``microorganisms'' listing.
---------------------------------------------------------------------------

    \12\ The NOSB recommended the removal of dairy cultures from the 
National List as part of its 2021 sunset review. The OFPA sunset 
provision (7 U.S.C. 6517(e)) requires the NOSB to review exemptions 
or prohibitions to the National List within 5 years of such 
exemption or prohibition being adopted or reviewed. The NOSB 
subsequently votes to remove a substance allowance or prohibition 
from the National List. The NOSB recommendation to remove dairy 
cultures is available here: https://www.ams.usda.gov/sites/default/files/media/HS2021SunsetReviews.pdf.
---------------------------------------------------------------------------

    AMS concurs that microorganisms are inclusive of dairy cultures and 
that listing both dairy cultures and microorganisms on the National 
List is redundant. AMS' intent and belief are that current use patterns 
for approved dairy cultures would not be affected by the changes 
included in this proposed rule. Therefore, AMS is proposing to remove 
dairy cultures from the National List.

III. Related Documents

    AMS published two notices in the Federal Register announcing the 
April 2019 and October 2019 NOSB meetings: November 26, 2018 (83 FR 
60373) and May 22, 2019 (84 FR 23522). At these meetings, the NOSB 
deliberated on substances petitioned as amendments to the National List 
and substances under sunset review.

IV. Statutory and Regulatory Authority

    The OFPA authorizes the Secretary to make amendments to the 
National List based on recommendations developed by the NOSB. Sections 
6518(k) and 6518(n) of the OFPA authorize the NOSB to develop 
recommendations for submission to the Secretary to amend the National 
List and to establish a process by which persons may petition the NOSB 
for the purpose of having substances evaluated for inclusion on or 
deletion from the National List. Section 205.607 of the USDA organic 
regulations permits any person to petition to add or remove a substance 
from the National List and directs petitioners to obtain the petition 
procedures from USDA. The current petition procedures published in the 
Federal Register (81 FR 12680, March 10, 2016) for amending the 
National List can be accessed through the NOP Program Handbook on the 
NOP website at https://www.ams.usda.gov/rules-regulations/organic/handbook.

A. Executive Orders 12866 and Regulatory Flexibility Act

    This action falls within a category of regulatory actions that the 
Office of Management and Budget (OMB) has exempted from Executive Order 
12866.
    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires 
agencies to consider the economic impact of each rule on small entities 
and evaluate alternatives that would accomplish the objectives of the 
rule without unduly burdening small entities or erecting barriers that 
would restrict their ability to compete in the market. The purpose of 
the RFA is to fit regulatory actions to the scale of businesses subject 
to the action. Section 605 of the RFA allows an agency to certify a 
rule, in lieu of preparing an analysis, if the rulemaking is not 
expected to have a significant economic impact on a substantial number 
of small entities.
    The Small Business Administration (SBA) sets size criteria for each 
industry described in the North American Industry Classification System 
(NAICS) to delineate which operations qualify as small businesses.\13\ 
The SBA has classified small agricultural producers that engage in crop 
and animal production as those with average annual receipts of less 
than $1,000,000. Handlers are involved in a broad spectrum of food 
production activities and fall into various categories in the

[[Page 15803]]

NAICS Food Manufacturing sector. The small business thresholds for food 
manufacturing operations are based on the number of employees and range 
from 500 to 1,250 employees, depending on the specific type of 
manufacturing. Certifying agents fall under the NAICS subsector, ``All 
other professional, scientific and technical services.'' For this 
category, the small business threshold is average annual receipts of 
less than $16.5 million.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    AMS has considered the economic impact of this proposed rulemaking 
on small agricultural entities. Data collected by the USDA National 
Agricultural Statistics Service and the NOP indicate most of the 
certified organic production operations in the United States would be 
considered small entities. According to the 2019 Certified Organic 
Survey, 16,524 organic farms in the United States reported sales of 
organic products and total farmgate sales in excess of $9.9 
billion.\14\ Based on that data, organic sales average $601,000 per 
farm. Assuming a normal distribution of producers, we expect that most 
of these producers would fall under the $1,000,000 sales threshold to 
qualify as a small business.
---------------------------------------------------------------------------

    \14\ U.S. Department of Agriculture, National Agricultural 
Statistics Service. 2019 Organic Survey. https://www.nass.usda.gov/Publications/AgCensus/2017/Full_Report/Volume_1,_Chapter_1_US/. The 
number of organic farms includes only certified farms.
---------------------------------------------------------------------------

    According to the NOP's Organic Integrity Database, there are 19,832 
organic handlers that are certified under the USDA organic regulations, 
of which 10,500 are based in the U.S.\15\ The Organic Trade 
Association's 2020 Organic Industry Survey \16\ has information about 
employment trends among organic manufacturers. The reported data are 
stratified into three groups by the number of employees per company: 
Less than 5; 5 to 49; and 50 plus. These data are representative of the 
organic manufacturing sector and the lower bound (50) of the range for 
the larger manufacturers is significantly smaller than the SBA's small 
business thresholds (500 to 1,250). Therefore, AMS expects that most 
organic handlers would qualify as small businesses.
---------------------------------------------------------------------------

    \15\ Organic Integrity Database: https://organic.ams.usda.gov/Integrity/. Accessed on August 18, 2020.
    \16\ 2020 Organic Industry Survey, Organic Trade Association. 
Available for purchase at https://ota.com/organic-market-overview/organic-industry-survey.
---------------------------------------------------------------------------

    The USDA has 77 accredited certifying agents who provide organic 
certification services to producers and handlers. The certifying agent 
that reports the most certified operations, nearly 3,500, would need to 
charge approximately $4,200 in certification fees in order to exceed 
the SBA's small business threshold of $16.5 million. The costs for 
certification generally range from $500 to $3,500, depending on the 
complexity of the operation. Therefore, AMS expects that most of the 
accredited certifying agents would qualify as small entities under the 
SBA criteria.
    The economic impact on entities affected by this rule would not be 
significant. The effect of this rule, if implemented as final, would be 
to allow the use of two additional substances in organic crop 
production and remove one redundant listing from the regulations. 
Adding two substances to the National List would increase regulatory 
flexibility and would give small entities more tools to use in day-to-
day operations. This action would also remove dairy cultures as a 
redundant listing and would have no impact on the industry. AMS 
reviewed comments submitted to the NOSB regarding the materials 
petitioned for inclusion on and recommended for removal from the 
National List. Therefore, AMS concludes that the economic impact of 
this addition, if any, would be minimal. Accordingly, USDA certifies 
that this rule would not have a significant economic impact on a 
substantial number of small entities.

B. Executive Order 12988

    Executive Order 12988 instructs each executive agency to adhere to 
certain requirements in the development of new and revised regulations 
in order to avoid unduly burdening the court system. This proposed rule 
is not intended to have a retroactive effect.
    Accordingly, to prevent duplicative regulation, states and local 
jurisdictions are preempted under the OFPA from creating programs of 
accreditation for private persons or state officials who want to become 
certifying agents of organic farms or handling operations. A governing 
state official would have to apply to USDA to be accredited as a 
certifying agent, as described in section 6514(b) of the OFPA. States 
are also preempted under sections 6503 through 6507 of the OFPA from 
creating certification programs to certify organic farms or handling 
operations unless the state programs have been submitted to, and 
approved by, the Secretary as meeting the requirements of the OFPA.
    Pursuant to section 6507(b)(2) of the OFPA, a state organic 
certification program that has been approved by the Secretary may, 
under certain circumstances, contain additional requirements for the 
production and handling of agricultural products organically produced 
in the state and for the certification of organic farm and handling 
operations located within the state. Such additional requirements must 
(a) further the purposes of the OFPA, (b) not be inconsistent with the 
OFPA, (c) not be discriminatory toward agricultural commodities 
organically produced in other States, and (d) not be effective until 
approved by the Secretary.
    In addition, pursuant to section 6519(c)(6) of the OFPA, this 
proposed rule would not supersede or alter the authority of the 
Secretary under the Federal Meat Inspection Act (21 U.S.C. 601-624), 
the Poultry Products Inspection Act (21 U.S.C. 451-471), or the Egg 
Products Inspection Act (21 U.S.C. 1031-1056), concerning meat, 
poultry, and egg products, respectively, nor any of the authorities of 
the Secretary of Health and Human Services under the Federal Food, Drug 
and Cosmetic Act (21 U.S.C. 301 et seq.), nor the authority of the 
Administrator of the Environmental Protection Agency under the Federal 
Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.).

C. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this proposed rule. Accordingly, OMB clearance is not 
required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, 
Chapter 35.

D. Executive Order 13175

    This proposed rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. The review reveals that this regulation 
will not have substantial and direct effects on tribal governments and 
will not have significant tribal implications.

F. General Notice of Public Rulemaking

    This proposed rule reflects recommendations submitted by the NOSB 
to the Secretary to add two substances to the National List and to 
remove one substance from the National List. A 60-day period for 
interested persons to comment on this rule is provided.

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agriculture, Archives and 
records, Crops, Imports, Labeling, National list, National Organic 
Standards Board (NOSB), Organically produced products, Plants, 
Reporting and recordkeeping requirements, Seals and insignia, Soil 
conservation, Sunset.

[[Page 15804]]

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

PART 205--NATIONAL ORGANIC PROGRAM

0
1. The authority citation for 7 CFR part 205 is revised to read as 
follows:

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

0
2. Amend Sec.  205.601 by:
0
a. Revising paragraph (a)(2)(iv);
0
b. Adding paragraph (a)(2)(v); and
0
c. Revising paragraph (k).
    The revisions and addition to read as follows:


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

* * * * *
    (a) * * *
    (2) * * *
    (iv) Potassium hypochlorite--not allowed for edible sprout 
production.
    (v) Sodium hypochlorite.
* * * * *
    (k) As plant growth regulators.
    (1) Ethylene gas--for regulation of pineapple flowering.
    (2) Fatty alcohols (C6, C8, C10, 
and/or C12)--for sucker control in organic tobacco 
production.
* * * * *


Sec.  205.605  [Amended]

0
3. In Sec.  205.605, amend paragraph (a) by removing the words ``Dairy 
cultures''.

Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2021-05700 Filed 3-24-21; 8:45 am]
BILLING CODE 3410-02-P