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

Published date08 June 2020
Record Number2020-11840
SectionProposed rules
CourtAgricultural Marketing Service
Federal Register, Volume 85 Issue 110 (Monday, June 8, 2020)
[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.
                ========================================================================
                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
                ----------------------------------------------------------------------------------------------------------------
                 National list
                 Substance section Proposed rule action
                ----------------------------------------------------------------------------------------------------------------
                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
                ------------------------------------------------------------------------
                 Current rule: N/A
                ------------------------------------------------------------------------
                Proposed rule action:.................. Add oxalic acid dihydrate to
                 Sec. 205.603(b).
                ------------------------------------------------------------------------
                 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.
                ---------------------------------------------------------------------------
                 \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
                ------------------------------------------------------------------------
                 Current rule: N/A
                ------------------------------------------------------------------------
                Proposed rule action:.................. Add pullulan to Sec.
                 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 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
                ------------------------------------------------------------------------
                 Current rule: N/A
                ------------------------------------------------------------------------
                Proposed rule action:.................. Add collagen gel casing to Sec.
                 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.
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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
                

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