National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances per April 2019 NOSB Recommendations (Livestock and Handling), 34651-34655 [2020-11840]

Download as PDF 34651 Proposed Rules Federal Register Vol. 85, No. 110 Monday, June 8, 2020 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–19–0053; NOP–19–02] RIN 0581–AD92 National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances per April 2019 NOSB Recommendations (Livestock and Handling) 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 implement recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board (NOSB). This rule proposes to add the following substances to the National List: Oxalic acid dihydrate as a pesticide for organic apiculture; pullulan for use in organic handling in products labeled, ‘‘Made with organic (specified ingredients or food group(s))’’; and collagen gel casing as a nonorganic agricultural substance for use in organic handling when organic forms of collagen gel casing are not commercially available. DATES: Comments must be received by August 7, 2020. khammond on DSKJM1Z7X2PROD with PROPOSALS SUMMARY: 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: Robert Pooler, 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–19–0053, NOP–19–02, and/or Regulatory Information Number (RIN) 0581–AD83 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, also 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. Comments submitted in response to this proposed rule will also be available for viewing in person at USDA–AMS, National Organic Program, Room 2642—South Building, 1400 Independence Ave. SW, Washington, DC, from 9 a.m. to 12 noon and from 1 p.m. to 4 p.m. Eastern Time, Monday through Friday (except official Federal holidays). Persons wanting to ADDRESSES: visit the USDA South Building to view comments received in response to this proposed rule are requested to make an appointment in advance by calling (202) 720–3252. 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 substance allowances and the nonsynthetic substance prohibitions in organic farming. The National List also identifies synthetic and nonsynthetic nonagricultural substances and nonorganic agricultural substances that may be used in organic handling. The Organic Foods Production Act of 1990, as amended (7 U.S.C. 6501–6524) (OFPA), and the USDA organic regulations specifically prohibit the use of any synthetic substance in organic production and handling unless the synthetic substance is on the National List. Section 205.105 also requires that any nonorganic agricultural 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 proposed rule addresses NOSB recommendations to amend the National List that were submitted to the Secretary on April 26, 2019. Table 1 summarizes the proposed changes to the National List based on these NOSB recommendations. TABLE 1—SUBSTANCES BEING ADDED TO THE NATIONAL LIST OR CURRENT LISTINGS BEING AMENDED Substance National list section Oxalic acid dihydrate .................................................................................................................... Pullulan ......................................................................................................................................... Collagen gel casing ...................................................................................................................... VerDate Sep<11>2014 16:34 Jun 05, 2020 Jkt 250001 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 E:\FR\FM\08JNP1.SGM § 205.603 § 205.605 § 205.606 08JNP1 Proposed rule action Add to National List. Add to National List. Add to National List. 34652 Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Proposed Rules II. Overview of Proposed Amendments The following provides an overview of the proposed amendments to designated sections of the National List regulations: § 205.603 Synthetic Substances Allowed for Use in Organic Livestock Production Oxalic Acid Dihydrate The proposed rule would amend the National List to add oxalic acid dihydrate to § 205.603 as a synthetic substance allowed for use in livestock production. Table 2 illustrates the proposed listing. TABLE 2—PROPOSED RULE ACTION FOR OXALIC ACID DIHYDRATE Current rule: N/A Proposed rule action: Add oxalic acid dihydrate to § 205.603(b). khammond on DSKJM1Z7X2PROD with PROPOSALS On October 3, 2017, AMS received a petition to add oxalic acid dihydrate to the National List as a parasiticide treatment of Varroa destructor (‘‘Varroa’’) mites in beehives.1 Oxalic acid is a naturally occurring substance and oxalic acid dihydrate is produced through a chemical process. The EPA has approved the use of oxalic acid dihydrate to control Varroa mites (EPA Registration no. 91266–1).2 Oxalic acid dihydrate may be applied to beehives by solution or vapor treatment and to package bees by solution. According to the petition, the only treatment for controlling Varroa mite infestation in beehives that is currently available to organic honey producers is formic acid. In its recommendation to add oxalic acid dihydrate to the National List, the NOSB noted that formic acid hive fumigation may be detrimental to the bee brood. The NOSB determined that oxalic acid dihydrate would provide organic honey producers with a substance that may be an alternative to, or used in rotation with, formic acid to lessen the potential for pesticide resistance. The NOSB reviewed and considered this petition, a technical report, and public comments on oxalic acid dihydrate at its public meeting on April 26, 2019.3 4 At this meeting, the NOSB determined that adding oxalic acid dihydrate to the National List is consistent with the OFPA criteria. In its recommendation to add oxalic acid dihydrate as a pesticide in apiculture, the NOSB noted that there were no environmental concerns with this substance, it would provide additional use benefits over formic acid, and would be supported by beekeepers.5 AMS reviewed the petition, technical report, and NOSB’s recommendation for oxalic acid dihydrate. AMS concurs with the NOSB’s determination that oxalic acid dihydrate, when manufactured as described in the petition, is a synthetic substance. To address the NOSB’s recommendation, AMS is proposing to add oxalic acid dihydrate to the National List as an allowed pesticide only in apiculture. As described in the petition, the only effective Varroa mite treatment on the National List that is currently available to organic honey producers is formic acid. Sucrose octanoate esters is also on the National List as a treatment for Varroa mite infestation. However, there are no current EPA registered products for sucrose octanoate esters, and the NOSB has recommended that sucrose octanoate esters be removed from the National List.6 AMS agrees with the NOSB recommendation that it is necessary for organic producers to have another substance, in addition to formic acid, to control Varroa mite infestation. Oxalic acid dihydrate may be used in place of formic acid because of lower toxicity to the bee brood or in rotation with formic acid to reduce the potential for pesticide resistance. Consequently, this proposed rule would allow oxalic acid dihydrate as a pesticide in organic apiculture. § 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))’’ Pullulan The proposed rule would amend the National List to add pullulan to § 205.605(a) as an ingredient allowed in products labeled, ‘‘Made with organic 4 Access 1 Oxalic acid petition: https://www.ams.usda.gov/ sites/default/files/media/OxalicAcidPetition 10032017.pdf. 2 U.S. Environmental Protection Agency, Notice of Pesticide Registration, March 10, 2015, https:// www3.epa.gov/pesticides/chem_search/ppls/ 091266-00001-20150310.pdf. 3 Technical Evaluation Report for oxalic acid dihydrate: https://www.ams.usda.gov/sites/default/ files/media/OxalicAcidTR.pdf. VerDate Sep<11>2014 18:31 Jun 05, 2020 Jkt 250001 to written and oral public comments submitted for the April 2019 NOSB meeting is available here: https://www.ams.usda.gov/event/ national-organic-standards-board-nosb-meetingseattle-wa. 5 NOSB recommendation for oxalic acid dihydrate: https://www.ams.usda.gov/sites/default/ files/media/LSOxalicAcidApril2019FinalRec.pdf. 6 NOSB recommendation (October 2018) available at: https://www.ams.usda.gov/sites/default/files/ media/LS2020SunsetFinalRecOct2018.pdf. PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 (specified ingredients or food group(s)).’’ Table 3 illustrates the proposed listing. TABLE 3—PROPOSED RULE ACTION FOR PULLULAN Current rule: Proposed rule action: N/A Add pullulan to § 205.605(a). On January 31, 2018, AMS received a petition 7 to add pullulan as a nonsynthetic substance allowed for use in organic handling as an ingredient in tablets and capsules for dietary supplements labeled ‘‘made with organic (specified ingredients or food group(s)).’’ Pullulan, as described in a technical report solicited by the NOSB, is a natural extracellular polysaccharide excretion resulting from carbohydrate fermentation by the yeast-like fungus Aureobasidium pullulans and other non-toxic fungi strains.8 The fungus A. pullulans is ubiquitous in nature and is most common in temperate zones in locations such as forest soil, freshwater, on plant leaves, and on seeds. The technical report also explains that the U.S. Food and Drug Administration (FDA) allows pullulan for use as a tablet coating, as an excipient, and as an alternative to gelatin in capsule production. Pullulan has been selfaffirmed as GRAS (Generally Recognized as Safe) for specified uses in food including as an emulsifier, nutrient supplement, thickener, and texturizer (GRN No. 99).9 At its April 26, 2019, public meeting, the NOSB considered the petition, technical report, and public comments, and determined that (1) pullulan is a nonsynthetic substance and (2) the use of pullulan as an ingredient used in tablets and capsules for dietary supplements is consistent with the OFPA evaluation criteria for National List substances. Therefore, the NOSB recommended adding pullulan to § 205.605(a) as a nonsynthetic, nonagricultural substance allowed for use in organic handling.10 AMS has reviewed the NOSB recommendation on pullulan and agrees that pullulan, as petitioned, is a nonsynthetic, nonagricultural substance 7 Pullulan petition: https://www.ams.usda.gov/ sites/default/files/media/Pullulan Petition18131.pdf. 8 Pullulan technical report: https:// www.ams.usda.gov/sites/default/files/media/ PullulanTechnicalReportFinal09072018.pdf. 9 GRAS Notice (GRN) No. 99, ‘‘Pullulan,’’ available at: https://www.accessdata.fda.gov/ scripts/fdcc/?set=GRASNotices. 10 NOSB Pullulan recommendation: https:// www.ams.usda.gov/sites/default/files/media/ HSPullullanApr2019FinalRec.pdf. E:\FR\FM\08JNP1.SGM 08JNP1 Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Proposed Rules that meets the OFPA criteria for listing as a substance allowed for use in organic handling. AMS recognizes that other manufacturing methods may yield pullulan which could be classified as agricultural and certified organic. Consistent with the NOSB recommendation, AMS proposes to amend the National List by adding pullulan for use in tablets and capsules for dietary supplements labeled ‘‘Made with organic (specified ingredients and food group(s)).’’ AMS welcomes additional information on the proposed classification of pullulan as a nonsynthetic, nonagricultural substance and whether it may be certifiable as organic. § 205.606 Nonorganically Produced Agricultural Products Allowed as Ingredients in or on Processed Products Labeled as ‘‘Organic’’ Collagen Gel Casing The proposed rule would amend the National List to add collagen gel casing as a nonorganic agricultural substance listed in § 205.606 for use in organic handling. TABLE 4—PROPOSED RULE ACTION FOR COLLAGEN GEL CASING Current rule: N/A khammond on DSKJM1Z7X2PROD with PROPOSALS Proposed rule action: Add collagen gel casing to § 205.606. On February 23, 2018, AMS received a petition to add collagen gel to the National List for use in organic handling as an ingredient in a co-extrusion organic sausage production system.11 The petition explains that in sausage production collagen gel forms an edible film that binds and forms the meat, acts as a protective barrier, and is an ingredient in the final product. Collagen gel is an alternative to natural (animal byproducts) or manufactured (cellulose) casings traditionally used in sausage production. Collagen gel, as described in the petition, is derived from animal collagen that has been subjected to a limited (partial) protein hydrolysis via acid/base treatment, and a particle size reduction through a physical sieve. Water is then added to the resulting collagen pulp and the mixture is physically agitated to produce a gel. The final step involves lowering the gel pH to a range of 2.4–2.8 with an acid treatment. At its April 26, 2019, public meeting, the NOSB considered the petition to add collagen gel to the National List for use 11 Collagen gel petition: https:// www.ams.usda.gov/sites/default/files/media/ CollagenGelPetition.pdf. VerDate Sep<11>2014 18:31 Jun 05, 2020 Jkt 250001 in organic handling. As part of its review, the NOSB considered a technical report on collagen gel that described its manufacture, industry uses, chemical properties, and regulation.12 The USDA Food Safety and Inspection Service regulates collagen gel as an ingredient in meat products (9 CFR 319.104 and 319.140). After considering the petition, technical report, and public comments on collagen gel, the NOSB determined that the allowance of nonorganic collagen gel for use as an ingredient in organic handling is consistent with the OFPA evaluation criteria for National List substances.13 The NOSB handling subcommittee discussed the collagen gel manufacturing process and considered whether this process induces change in the collagen chemical structure which would classify this as a synthetic substance. The NOSB determined that it is an agricultural substance and should be listed in § 205.606 because the collagen protein is denatured, but the structure is not chemically changed. Subsequently, the NOSB recommended adding collagen gel casing to § 205.606 as a nonorganically produced agricultural product allowed as an ingredient in or on processed products labeled as ‘‘organic’’ when organic forms are not commercially available. AMS has reviewed the NOSB recommendation on collagen gel and agrees that collagen gel meets the OFPA evaluation criteria for an allowed substance on the National List. AMS is proposing to list collagen gel casing as a nonorganic agricultural ingredient allowed when an organic form is not commercially available. This action would require organic handlers to source organic forms of collagen gel before using any nonorganic source of this ingredient. If the organic form of the ingredient is not commercially available, the nonorganic form may be used.14 AMS is seeking comment on whether collagen gel is properly classified as an agricultural substance and could potentially be certified organic. According to the collagen gel petition, the manufacturing process includes a procedure that adjusts the pH of the gel to a target range between 2.4–2.8 (strongly acidic) by treating it with three acids: Acetic, lactic, and hydrochloric 12 Collagen gel technical evaluation report: https://www.ams.usda.gov/sites/default/files/ media/CollagenGelGelatinCasingsTechnical Report01282019.pdf. 13 NOSB recommendation, collagen gel: https:// www.ams.usda.gov/sites/default/files/media/ HSCollagenGelApr2019FinalRec.pdf. 14 See 7 CFR 205.606 and 7 CFR 205.2 for definition of ‘‘Commercially available.’’ PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 34653 acids. AMS welcomes additional information on whether the use of acid induces chemical change(s) in the collagen gel which should cause the substance to be classified as a nonagricultural, synthetic substance.15 III. Related Documents AMS published a notice in the Federal Register (83 FR 60373) on November 26, 2018, announcing the Spring 2019 NOSB meeting. This notice invited public comments on the NOSB recommendations on the substances addressed in this proposed 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. 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 proposal 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 15 A change in collagen gel’s chemical structure would potentially categorize it as a synthetic substance, as defined by the OFPA (7 U.S.C. 6502(22)). E:\FR\FM\08JNP1.SGM 08JNP1 khammond on DSKJM1Z7X2PROD with PROPOSALS 34654 Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Proposed Rules 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. The SBA has classified small agricultural producers that engage in crop and animal production as those with average annual receipts of less than $1,000,000. Handlers are involved in a broad spectrum of food production activities and fall into various categories in the NAICS Food Manufacturing sector. The small business thresholds for food manufacturing operations are based on the number of employees and range from 500 to 1,250 employees, depending on the specific type of manufacturing. Certifying agents fall under the NAICS subsector, ‘‘All other professional, scientific and technical services.’’ For this category, the small business threshold is average annual receipts of less than $16.5 million. AMS has considered the economic impact of this proposed rulemaking on small agricultural entities. Data collected by the USDA National Agricultural Statistics Service (NASS) and the NOP indicate most of the certified organic production operations in the United States would be considered small entities. According to the 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.16 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 $750,000 sales threshold to qualify as a small business. According to the NOP’s Organic Integrity Database, there are 19,671 organic handlers that are certified under the USDA organic regulations.17 The 16 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. 17 Organic Integrity Database: https:// organic.ams.usda.gov/Integrity/. Accessed on April 13, 2020. VerDate Sep<11>2014 16:34 Jun 05, 2020 Jkt 250001 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 $15 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 proposed rule would be to allow the use of three additional substances in organic crop production and organic handling. Adding three substances to the National List would increase regulatory flexibility and would give small entities more tools to use in day-to-day operations. AMS welcomes public comment on our assessment of costs and benefits and whether commenters have any additional information that would help establish that the action has total costs less than zero and therefore qualifies as an E.O. 13771 deregulatory action. One way to have ‘costs less than zero’ is to show that the rule allows business activity that is not allowed under the current regulations. Providing the monetary amount of such allowed business activity would be ideal. 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 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 handling operations. A governing state official would have to apply to USDA to be accredited as a certifying agent, as described in section 6514(b) of the OFPA. States are also preempted under sections 6503 through 6507 of the OFPA from creating certification programs to certify organic farms or handling operations unless the state programs have been submitted to, and approved by, the Secretary as meeting the requirements of the OFPA. Pursuant to section 6507(b)(2) of the OFPA, a state organic certification program that has been approved by the Secretary may, under certain circumstances, contain additional requirements for the production and handling of agricultural products organically produced in the state and for the certification of organic farm and handling operations located within the state. Such additional requirements must (a) further the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c) not be discriminatory toward agricultural commodities organically produced in other States, and (d) not be effective until approved by the Secretary. In addition, pursuant to section 6519(c)(6) of the OFPA, this proposed rule would not supersede or alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601–624), the Poultry Products Inspection Act (21 U.S.C. 451–471), or the Egg Products Inspection Act (21 U.S.C. 1031–1056), concerning meat, poultry, and egg products, respectively, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), nor the authority of the Administrator of the EPA under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.). 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. E:\FR\FM\08JNP1.SGM 08JNP1 Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Proposed Rules F. General Notice of Public Rulemaking * This proposed rule reflects recommendations submitted by the NOSB to the Secretary to add three substances to the National List. A 60day period for interested persons to comment on this rule is provided. (d) Collagen gel casing. * * * * FOR FURTHER INFORMATION CONTACT: Bruce Summers, Administrator, Agricultural Marketing Service. [FR Doc. 2020–11840 Filed 6–5–20; 8:45 am] Administrative practice and procedure, Agricultural commodities, Agriculture, Animals, Archives and records, Fees, 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 proposed to be amended as follows: 1. The authority citation for 7 CFR part 205 continues to read as follows: 2. Amend § 205.603 by redesignating paragraphs (b)(8) through (11) as paragraphs (b)(9) through (12) and adding new paragraph (b)(8) to read as follows: ■ § 205.603 Synthetic substances allowed for use in organic livestock production. * * * * * (b) * * * (8) Oxalic acid dihydrate—for use as a pesticide solely for apiculture. * * * * * ■ 3. Amend § 205.605 in paragraph (a) by adding, in alphabetical order an entry for ‘‘Pullulan’’ to read as follows: khammond on DSKJM1Z7X2PROD with PROPOSALS § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food group(s)).’’ (a) * * * Pullulan—for use only in tablets and capsules for dietary supplements labeled ‘‘made with organic (specified ingredients or food group(s)).’’ * * * * * ■ 4. Amend § 205.606 by redesignating paragraphs (d) through (w) as paragraphs (e) through (x) and adding new paragraph (d) to read as follows: § 205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as ‘‘organic.’’ VerDate Sep<11>2014 * 16:34 Jun 05, 2020 Jkt 250001 14 CFR Part 39 [Docket No. FAA–2019–0484; Product Identifier 2019–NM–065–AD] RIN 2120–AA64 Airworthiness Directives; Airbus SAS Airplanes The FAA is withdrawing a supplemental notice of proposed rulemaking (SNPRM) that proposed to adopt a new airworthiness directive (AD) that would have applied to all Airbus SAS Model A330–200, A330– 200 Freighter, A330–300, A340–200, A340–300, A340–500, and A340–600 series airplanes. The SNPRM would have required repetitive tests of affected free fall actuators (FFAs), and replacement of any affected FFA that fails a test with a serviceable FFA; as specified in European Union Aviation Safety Agency (EASA) AD 2019–0164, dated July 11, 2019 (‘‘EASA AD 2019– 0164’’). Since issuance of the SNPRM, the FAA has determined that the SNPRM does not adequately address the identified unsafe condition. Accordingly, the SNPRM is withdrawn. DATES: As of June 8, 2020, the proposed rule, which was published in the Federal Register on January 21, 2020 (85 FR 3279), is withdrawn. ADDRESSES: SUMMARY: Authority: 7 U.S.C. 6501–6522. * Federal Aviation Administration Federal Aviation Administration (FAA), DOT. ACTION: Proposed rule; withdrawal. ■ * DEPARTMENT OF TRANSPORTATION AGENCY: PART 205—NATIONAL ORGANIC PROGRAM * Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, International Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206–231–3229. SUPPLEMENTARY INFORMATION: BILLING CODE 3410–02–P List of Subjects in 7 CFR Part 205 * 34655 Examining the AD Docket You may examine the AD docket on the internet at https:// www.regulations.gov by searching for and locating Docket No. FAA–2019– 0484; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD action, any comments received, and other information. The street address for Docket Operations is U.S. Department of Transportation, Docket Operations, M– 30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE, Washington, DC 20590. PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 Discussion The FAA issued an SNPRM that proposed to amend 14 CFR part 39 by adding an AD that would have applied to the specified products. The SNPRM was published in the Federal Register on January 21, 2020 (85 FR 3279). The SNPRM was prompted by a report that an airplane failed to extend its nose landing gear (NLG) using the free fall method, due to loss of the green hydraulic system. The SNPRM proposed to require repetitive tests of affected FFAs, and replacement of any affected FFA that fails a test with a serviceable FFA; as specified in EASA AD 2019– 0164, dated July 11, 2019 (‘‘EASA AD 2019–0164’’). Actions Since the SNPRM Was Issued Since issuance of the SNPRM, EASA AD 2019–0164 has been replaced by EASA AD 2020–0076, dated March 30, 2020 (‘‘EASA AD 2020–0076’’), and the FAA has determined that the SNPRM does not adequately address the unsafe condition. In light of these changes, the FAA is considering further rulemaking. Withdrawal of the SNPRM constitutes only such action and does not preclude the FAA from further rulemaking on this issue, nor does it commit the FAA to any course of action in the future. FAA’s Conclusions Upon further consideration, the FAA has determined that the SNPRM does not adequately address the identified unsafe condition. Accordingly, the SNPRM is withdrawn. Regulatory Findings Since this action only withdraws an SNPRM, it is neither a proposed nor a final rule. This action therefore is not covered under Executive Order 12866, the Regulatory Flexibility Act, or DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. The Withdrawal Accordingly, the supplemental notice of proposed rulemaking, Docket No. FAA–2019–0484, which was published in the Federal Register on January 21, 2020 (85 FR 3279), is withdrawn. E:\FR\FM\08JNP1.SGM 08JNP1

Agencies

[Federal Register Volume 85, Number 110 (Monday, June 8, 2020)]
[Proposed Rules]
[Pages 34651-34655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11840]


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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. 85, No. 110 / Monday, June 8, 2020 / Proposed 
Rules

[[Page 34651]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-19-0053; NOP-19-02]
RIN 0581-AD92


National Organic Program; Proposed Amendments to the National 
List of Allowed and Prohibited Substances per April 2019 NOSB 
Recommendations (Livestock and Handling)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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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 implement 
recommendations submitted to the Secretary of Agriculture (Secretary) 
by the National Organic Standards Board (NOSB). This rule proposes to 
add the following substances to the National List: Oxalic acid 
dihydrate as a pesticide for organic apiculture; pullulan for use in 
organic handling in products labeled, ``Made with organic (specified 
ingredients or food group(s))''; and collagen gel casing as a 
nonorganic agricultural substance for use in organic handling when 
organic forms of collagen gel casing are not commercially available.

DATES: Comments must be received by August 7, 2020.

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: Robert Pooler, 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-19-0053, NOP-19-02, and/or Regulatory Information Number 
(RIN) 0581-AD83 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, also 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. Comments 
submitted in response to this proposed rule will also be available for 
viewing in person at USDA-AMS, National Organic Program, Room 2642--
South Building, 1400 Independence Ave. SW, Washington, DC, from 9 a.m. 
to 12 noon and from 1 p.m. to 4 p.m. Eastern Time, Monday through 
Friday (except official Federal holidays). Persons wanting to visit the 
USDA South Building to view comments received in response to this 
proposed rule are requested to make an appointment in advance by 
calling (202) 720-3252.

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 substance 
allowances and the nonsynthetic substance prohibitions in organic 
farming. The National List also identifies synthetic and nonsynthetic 
nonagricultural substances and nonorganic agricultural substances that 
may be used in organic handling.
    The Organic Foods Production Act of 1990, as amended (7 U.S.C. 
6501-6524) (OFPA), and the USDA organic regulations specifically 
prohibit the use of any synthetic substance in organic production and 
handling unless the synthetic substance is on the National List. 
Section 205.105 also requires that any nonorganic agricultural 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 proposed rule addresses NOSB recommendations to amend the 
National List that were submitted to the Secretary on April 26, 2019. 
Table 1 summarizes the proposed changes to the National List based on 
these NOSB recommendations.

             Table 1--Substances Being Added to the National List or Current Listings Being Amended
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                                                National list
                 Substance                         section                     Proposed rule action
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Oxalic acid dihydrate......................      Sec.   205.603  Add to National List.
Pullulan...................................      Sec.   205.605  Add to National List.
Collagen gel casing........................      Sec.   205.606  Add to National List.
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[[Page 34652]]

II. Overview of Proposed Amendments

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

Sec.  205.603 Synthetic Substances Allowed for Use in Organic Livestock 
Production

Oxalic Acid Dihydrate
    The proposed rule would amend the National List to add oxalic acid 
dihydrate to Sec.  205.603 as a synthetic substance allowed for use in 
livestock production. Table 2 illustrates the proposed listing.

         Table 2--Proposed Rule Action for Oxalic Acid Dihydrate
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             Current rule:                             N/A
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Proposed rule action:..................  Add oxalic acid dihydrate to
                                          Sec.   205.603(b).
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    On October 3, 2017, AMS received a petition to add oxalic acid 
dihydrate to the National List as a parasiticide treatment of Varroa 
destructor (``Varroa'') mites in beehives.\1\ Oxalic acid is a 
naturally occurring substance and oxalic acid dihydrate is produced 
through a chemical process. The EPA has approved the use of oxalic acid 
dihydrate to control Varroa mites (EPA Registration no. 91266-1).\2\ 
Oxalic acid dihydrate may be applied to beehives by solution or vapor 
treatment and to package bees by solution. According to the petition, 
the only treatment for controlling Varroa mite infestation in beehives 
that is currently available to organic honey producers is formic acid.
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    \1\ Oxalic acid petition: https://www.ams.usda.gov/sites/default/files/media/OxalicAcidPetition10032017.pdf.
    \2\ U.S. Environmental Protection Agency, Notice of Pesticide 
Registration, March 10, 2015, https://www3.epa.gov/pesticides/chem_search/ppls/091266-00001-20150310.pdf.
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    In its recommendation to add oxalic acid dihydrate to the National 
List, the NOSB noted that formic acid hive fumigation may be 
detrimental to the bee brood. The NOSB determined that oxalic acid 
dihydrate would provide organic honey producers with a substance that 
may be an alternative to, or used in rotation with, formic acid to 
lessen the potential for pesticide resistance.
    The NOSB reviewed and considered this petition, a technical report, 
and public comments on oxalic acid dihydrate at its public meeting on 
April 26, 2019.3 4 At this meeting, the NOSB determined that 
adding oxalic acid dihydrate to the National List is consistent with 
the OFPA criteria. In its recommendation to add oxalic acid dihydrate 
as a pesticide in apiculture, the NOSB noted that there were no 
environmental concerns with this substance, it would provide additional 
use benefits over formic acid, and would be supported by beekeepers.\5\
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    \3\ Technical Evaluation Report for oxalic acid dihydrate: 
https://www.ams.usda.gov/sites/default/files/media/OxalicAcidTR.pdf.
    \4\ Access to written and oral public comments submitted for the 
April 2019 NOSB meeting is available here: https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-seattle-wa.
    \5\ NOSB recommendation for oxalic acid dihydrate: https://www.ams.usda.gov/sites/default/files/media/LSOxalicAcidApril2019FinalRec.pdf.
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    AMS reviewed the petition, technical report, and NOSB's 
recommendation for oxalic acid dihydrate. AMS concurs with the NOSB's 
determination that oxalic acid dihydrate, when manufactured as 
described in the petition, is a synthetic substance.
    To address the NOSB's recommendation, AMS is proposing to add 
oxalic acid dihydrate to the National List as an allowed pesticide only 
in apiculture. As described in the petition, the only effective Varroa 
mite treatment on the National List that is currently available to 
organic honey producers is formic acid. Sucrose octanoate esters is 
also on the National List as a treatment for Varroa mite infestation. 
However, there are no current EPA registered products for sucrose 
octanoate esters, and the NOSB has recommended that sucrose octanoate 
esters be removed from the National List.\6\ AMS agrees with the NOSB 
recommendation that it is necessary for organic producers to have 
another substance, in addition to formic acid, to control Varroa mite 
infestation. Oxalic acid dihydrate may be used in place of formic acid 
because of lower toxicity to the bee brood or in rotation with formic 
acid to reduce the potential for pesticide resistance. Consequently, 
this proposed rule would allow oxalic acid dihydrate as a pesticide in 
organic apiculture.
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    \6\ NOSB recommendation (October 2018) available at: https://www.ams.usda.gov/sites/default/files/media/LS2020SunsetFinalRecOct2018.pdf.
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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))''

Pullulan
    The proposed rule would amend the National List to add pullulan to 
Sec.  205.605(a) as an ingredient allowed in products labeled, ``Made 
with organic (specified ingredients or food group(s)).'' Table 3 
illustrates the proposed listing.

               Table 3--Proposed Rule Action for Pullulan
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             Current rule:                             N/A
------------------------------------------------------------------------
Proposed rule action:..................  Add pullulan to Sec.
                                          205.605(a).
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    On January 31, 2018, AMS received a petition \7\ to add pullulan as 
a nonsynthetic substance allowed for use in organic handling as an 
ingredient in tablets and capsules for dietary supplements labeled 
``made with organic (specified ingredients or food group(s)).'' 
Pullulan, as described in a technical report solicited by the NOSB, is 
a natural extracellular polysaccharide excretion resulting from 
carbohydrate fermentation by the yeast-like fungus Aureobasidium 
pullulans and other non-toxic fungi strains.\8\ The fungus A. pullulans 
is ubiquitous in nature and is most common in temperate zones in 
locations such as forest soil, freshwater, on plant leaves, and on 
seeds. The technical report also explains that the U.S. Food and Drug 
Administration (FDA) allows pullulan for use as a tablet coating, as an 
excipient, and as an alternative to gelatin in capsule production. 
Pullulan has been self-affirmed as GRAS (Generally Recognized as Safe) 
for specified uses in food including as an emulsifier, nutrient 
supplement, thickener, and texturizer (GRN No. 99).\9\
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    \7\ Pullulan petition: https://www.ams.usda.gov/sites/default/files/media/PullulanPetition18131.pdf.
    \8\ Pullulan technical report: https://www.ams.usda.gov/sites/default/files/media/PullulanTechnicalReportFinal09072018.pdf.
    \9\ GRAS Notice (GRN) No. 99, ``Pullulan,'' available at: 
https://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices.
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    At its April 26, 2019, public meeting, the NOSB considered the 
petition, technical report, and public comments, and determined that 
(1) pullulan is a nonsynthetic substance and (2) the use of pullulan as 
an ingredient used in tablets and capsules for dietary supplements is 
consistent with the OFPA evaluation criteria for National List 
substances. Therefore, the NOSB recommended adding pullulan to Sec.  
205.605(a) as a nonsynthetic, nonagricultural substance allowed for use 
in organic handling.\10\
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    \10\ NOSB Pullulan recommendation: https://www.ams.usda.gov/sites/default/files/media/HSPullullanApr2019FinalRec.pdf.
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    AMS has reviewed the NOSB recommendation on pullulan and agrees 
that pullulan, as petitioned, is a nonsynthetic, nonagricultural 
substance

[[Page 34653]]

that meets the OFPA criteria for listing as a substance allowed for use 
in organic handling. AMS recognizes that other manufacturing methods 
may yield pullulan which could be classified as agricultural and 
certified organic. Consistent with the NOSB recommendation, AMS 
proposes to amend the National List by adding pullulan for use in 
tablets and capsules for dietary supplements labeled ``Made with 
organic (specified ingredients and food group(s)).'' AMS welcomes 
additional information on the proposed classification of pullulan as a 
nonsynthetic, nonagricultural substance and whether it may be 
certifiable as organic.

Sec.  205.606 Nonorganically Produced Agricultural Products Allowed as 
Ingredients in or on Processed Products Labeled as ``Organic''

Collagen Gel Casing
    The proposed rule would amend the National List to add collagen gel 
casing as a nonorganic agricultural substance listed in Sec.  205.606 
for use in organic handling.

          Table 4--Proposed Rule Action for Collagen Gel Casing
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             Current rule:                             N/A
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Proposed rule action:..................  Add collagen gel casing to Sec.
                                            205.606.
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    On February 23, 2018, AMS received a petition to add collagen gel 
to the National List for use in organic handling as an ingredient in a 
co-extrusion organic sausage production system.\11\ The petition 
explains that in sausage production collagen gel forms an edible film 
that binds and forms the meat, acts as a protective barrier, and is an 
ingredient in the final product. Collagen gel is an alternative to 
natural (animal byproducts) or manufactured (cellulose) casings 
traditionally used in sausage production. Collagen gel, as described in 
the petition, is derived from animal collagen that has been subjected 
to a limited (partial) protein hydrolysis via acid/base treatment, and 
a particle size reduction through a physical sieve. Water is then added 
to the resulting collagen pulp and the mixture is physically agitated 
to produce a gel. The final step involves lowering the gel pH to a 
range of 2.4-2.8 with an acid treatment.
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    \11\ Collagen gel petition: https://www.ams.usda.gov/sites/default/files/media/CollagenGelPetition.pdf.
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    At its April 26, 2019, public meeting, the NOSB considered the 
petition to add collagen gel to the National List for use in organic 
handling. As part of its review, the NOSB considered a technical report 
on collagen gel that described its manufacture, industry uses, chemical 
properties, and regulation.\12\ The USDA Food Safety and Inspection 
Service regulates collagen gel as an ingredient in meat products (9 CFR 
319.104 and 319.140).
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    \12\ Collagen gel technical evaluation report: https://www.ams.usda.gov/sites/default/files/media/CollagenGelGelatinCasingsTechnicalReport01282019.pdf.
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    After considering the petition, technical report, and public 
comments on collagen gel, the NOSB determined that the allowance of 
nonorganic collagen gel for use as an ingredient in organic handling is 
consistent with the OFPA evaluation criteria for National List 
substances.\13\ The NOSB handling subcommittee discussed the collagen 
gel manufacturing process and considered whether this process induces 
change in the collagen chemical structure which would classify this as 
a synthetic substance. The NOSB determined that it is an agricultural 
substance and should be listed in Sec.  205.606 because the collagen 
protein is denatured, but the structure is not chemically changed. 
Subsequently, the NOSB recommended adding collagen gel casing to Sec.  
205.606 as a nonorganically produced agricultural product allowed as an 
ingredient in or on processed products labeled as ``organic'' when 
organic forms are not commercially available.
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    \13\ NOSB recommendation, collagen gel: https://www.ams.usda.gov/sites/default/files/media/HSCollagenGelApr2019FinalRec.pdf.
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    AMS has reviewed the NOSB recommendation on collagen gel and agrees 
that collagen gel meets the OFPA evaluation criteria for an allowed 
substance on the National List. AMS is proposing to list collagen gel 
casing as a nonorganic agricultural ingredient allowed when an organic 
form is not commercially available. This action would require organic 
handlers to source organic forms of collagen gel before using any 
nonorganic source of this ingredient. If the organic form of the 
ingredient is not commercially available, the nonorganic form may be 
used.\14\
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    \14\ See 7 CFR 205.606 and 7 CFR 205.2 for definition of 
``Commercially available.''
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    AMS is seeking comment on whether collagen gel is properly 
classified as an agricultural substance and could potentially be 
certified organic. According to the collagen gel petition, the 
manufacturing process includes a procedure that adjusts the pH of the 
gel to a target range between 2.4-2.8 (strongly acidic) by treating it 
with three acids: Acetic, lactic, and hydrochloric acids. AMS welcomes 
additional information on whether the use of acid induces chemical 
change(s) in the collagen gel which should cause the substance to be 
classified as a nonagricultural, synthetic substance.\15\
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    \15\ A change in collagen gel's chemical structure would 
potentially categorize it as a synthetic substance, as defined by 
the OFPA (7 U.S.C. 6502(22)).
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III. Related Documents

    AMS published a notice in the Federal Register (83 FR 60373) on 
November 26, 2018, announcing the Spring 2019 NOSB meeting. This notice 
invited public comments on the NOSB recommendations on the substances 
addressed in this proposed 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. 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 proposal 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'[thinsp]'' (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

[[Page 34654]]

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. The 
SBA has classified small agricultural producers that engage in crop and 
animal production as those with average annual receipts of less than 
$1,000,000. Handlers are involved in a broad spectrum of food 
production activities and fall into various categories in the NAICS 
Food Manufacturing sector. The small business thresholds for food 
manufacturing operations are based on the number of employees and range 
from 500 to 1,250 employees, depending on the specific type of 
manufacturing. Certifying agents fall under the NAICS subsector, ``All 
other professional, scientific and technical services.'' For this 
category, the small business threshold is average annual receipts of 
less than $16.5 million.
    AMS has considered the economic impact of this proposed rulemaking 
on small agricultural entities. Data collected by the USDA National 
Agricultural Statistics Service (NASS) and the NOP indicate most of the 
certified organic production operations in the United States would be 
considered small entities. According to the 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.\16\ 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 $750,000 sales threshold to qualify as a 
small business.
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    \16\ 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.
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    According to the NOP's Organic Integrity Database, there are 19,671 
organic handlers that are certified under the USDA organic 
regulations.\17\ 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.
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    \17\ Organic Integrity Database: https://organic.ams.usda.gov/Integrity/. Accessed on April 13, 2020.
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    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 $15 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 proposed rule would be to allow the use 
of three additional substances in organic crop production and organic 
handling. Adding three substances to the National List would increase 
regulatory flexibility and would give small entities more tools to use 
in day-to-day operations.
    AMS welcomes public comment on our assessment of costs and benefits 
and whether commenters have any additional information that would help 
establish that the action has total costs less than zero and therefore 
qualifies as an E.O. 13771 deregulatory action. One way to have `costs 
less than zero' is to show that the rule allows business activity that 
is not allowed under the current regulations. Providing the monetary 
amount of such allowed business activity would be ideal.

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 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 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.

[[Page 34655]]

F. General Notice of Public Rulemaking

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

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agricultural commodities, 
Agriculture, Animals, Archives and records, Fees, Imports, Labeling, 
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 
proposed to be amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

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

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

0
2. Amend Sec.  205.603 by redesignating paragraphs (b)(8) through (11) 
as paragraphs (b)(9) through (12) and adding new paragraph (b)(8) to 
read as follows:


Sec.  205.603   Synthetic substances allowed for use in organic 
livestock production.

* * * * *
    (b) * * *
    (8) Oxalic acid dihydrate--for use as a pesticide solely for 
apiculture.
* * * * *
0
3. Amend Sec.  205.605 in paragraph (a) by adding, in alphabetical 
order an entry for ``Pullulan'' to read as follows:


Sec.  205.605  Nonagricultural (nonorganic) substances allowed as 
ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food group(s)).''

    (a) * * *
    Pullulan--for use only in tablets and capsules for dietary 
supplements labeled ``made with organic (specified ingredients or food 
group(s)).''
* * * * *
0
4. Amend Sec.  205.606 by redesignating paragraphs (d) through (w) as 
paragraphs (e) through (x) and adding new paragraph (d) to read as 
follows:


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

* * * * *
    (d) Collagen gel casing.
* * * * *

Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2020-11840 Filed 6-5-20; 8:45 am]
 BILLING CODE 3410-02-P