National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances for April 2018 NOSB Recommendations (Crops and Handling), 4377-4381 [2019-02518]

Download as PDF 4377 Proposed Rules Federal Register Vol. 84, No. 32 Friday, February 15, 2019 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–18–0051; NOP–18–02] RIN 0581 AD80 National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances for April 2018 NOSB Recommendations (Crops 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 elemental sulfur for use as a molluscicide in organic crop production, add polyoxin D zinc salt to control fungal diseases in organic crop production, and reclassify magnesium chloride from an allowed synthetic to an allowed nonsynthetic ingredient in organic handling. DATES: Comments must be received by April 16, 2019. ADDRESSES: Interested persons may comment on the proposed rule using the following procedures: khammond on DSKBBV9HB2PROD with PROPOSALS SUMMARY: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: Valerie Frances, 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–18–0051; NOP–18–02, and/or Regulatory Information Number (RIN) 0581–XXXX 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 or not 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 http:// www.regulations.gov. Document: To access the document and read background documents, or comments received, go to http:// 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., 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: Valerie Frances, Standards Division, National Organic Program. Telephone: (202) 720–3252. SUPPLEMENTARY INFORMATION: I. Background On December 21, 2000, the Secretary established the National List within part 205 of the USDA organic regulations (7 CFR 205.600 through 205.607). The National List identifies the synthetic substances that may be used and the nonsynthetic (natural) substances that may not be used in organic production. The National List also identifies synthetic, nonsynthetic nonagricultural, and nonorganic agricultural substances that may be used in organic handling. The Organic Foods Production Act of 1990, as amended, (7 U.S.C. 6501–6522) (OFPA), and § 205.105 of 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 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 developed 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 would amend the National List to implement three NOSB recommendations. These recommendations were submitted to the Secretary on April 27, 2018. Table 1 summarizes the proposed changes to the National List based on these NOSB recommendations. TABLE 1—PROPOSED AMENDMENTS TO THE NATIONAL LIST Substance National List section Proposed rule action Elemental Sulfur ........................................................ Polyoxin D Zinc Salt .................................................. Magnesium Chloride (MgCl) ...................................... § 205.601(h) .............................................................. § 205.601(i) ............................................................... § 205.605(b) to § 205.605(a) ..................................... Add to National List. Add to National List. Reclassify listing and move within National List. VerDate Sep<11>2014 17:13 Feb 14, 2019 Jkt 247001 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 E:\FR\FM\15FEP1.SGM 15FEP1 4378 Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Proposed Rules II. Overview of Proposed Amendments The following provides an overview of the proposed amendments to designated sections of the National List regulations: § 205.601 Synthetic Substances Allowed for Use in Organic Crop Production This proposed rule would add two substances to § 205.601, synthetic substances allowed for use in organic crop production. Elemental Sulfur The proposed rule would amend the National List to add elemental sulfur to § 205.601(h) for use as a molluscicide bait to control slugs and snails. Table 2 illustrates the proposed rule action. TABLE 2—PROPOSED RULE ACTION FOR ELEMENTAL SULFUR khammond on DSKBBV9HB2PROD with PROPOSALS Current rule ... Proposed rule action. N/A. Add elemental sulfur to § 205.601(h) as slug or snail bait. On May 25, 2017, AMS received a petition 1 to add elemental sulfur to the National List in § 205.601(h) for use as a slug or snail bait. Currently, the USDA organic regulations allow elemental sulfur for use in organic crop production as an insecticide (including mite control) in § 205.601(e); as a plant disease control in § 205.601(i); and as a plant or soil amendment in § 205.601(j). At its April 2018 public meeting, the NOSB considered the petition to add elemental sulfur to the National List for use in organic crop production as a molluscicide. Increased adoption of low tillage and no tillage agricultural practices can increase the abundance of snails and slugs, which can reduce crop yields. The availability of a molluscicide as a new tool will help prevent crop losses. In its review, the NOSB considered a March 2017 technical report on elemental sulfur 2 that described its manufacture, industry uses, regulation, and chemical properties. Prior to and during this meeting, the NOSB received and considered public comment on the proposal. In consideration of the petition, technical report, and public comments, the NOSB determined that the use of 1 Elemental sulfur petition: https:// www.ams.usda.gov/rules-regulations/organic/ national-list/petitioned. Under ‘‘S.’’ 2 The technical report for elemental sulfur is available on the AMS website, organized in alphabetical order: https://www.ams.usda.gov/ rules-regulations/organic/national-list/petitioned. Under ‘‘S.’’ VerDate Sep<11>2014 17:13 Feb 14, 2019 Jkt 247001 elemental sulfur as a slug or snail bait for organic crop production satisfies OFPA evaluation criteria for National List substances and recommended adding elemental sulfur to § 205.601(h) as a slug or snail bait for organic crop production.3 AMS has reviewed and agrees that the NOSB has considered the petitions, technical report, and public comments sufficiently, and that elemental sulfur used as a slug or snail bait satisfies the OFPA criteria for National List substances. AMS proposes to address this NOSB recommendation through this proposed rule. Consistent with the NOSB recommendation, this proposed rule would amend the National List by adding elemental sulfur to § 205.601(h) as a slug or snail bait. This would permit the use of elemental sulfur-based bait, providing an additional tool to organic producers to control slugs and snails when other required preventive measures have failed to provide sufficient control (§ 205.206(e)). Polyoxin D Zinc Salt The proposed rule would amend the National List to add polyoxin D zinc salt to control fungal diseases at § 205.601(i). Table 3 illustrates the proposed rule change. TABLE 3—PROPOSED RULE ACTION FOR POLYOXIN D ZINC SALT Current rule ... Proposed rule action. N/A. Add polyoxin D zinc salt to § 205.601(i) as plant disease control. Two petitions to add polyoxin D zinc salt for use in organic crop production were submitted to the National Organic Program: One in March 2012 and the other in May 2016. Both petitions and an addendum in February 2018 proposed to amend 7 CFR 205.601 to add polyoxin D zinc salt as a synthetic substance allowed for use in organic crop production.4 In consideration of the information in the March 2012 petition, the September 2012 technical report, and public comments, the NOSB determined that the use of polyoxin D zinc salt to control fungal diseases in organic crop production did not satisfy the OFPA 3 NOSB 2018 Spring meeting elemental sulfur recommendation: https://www.ams.usda.gov/sites/ default/files/media/CSSulfurMolluscicideRec.pdf. 4 Polyoxin D zinc salt 2012 and 2016 petitions along with addendums found under ‘‘P’’: https:// www.ams.usda.gov/rules-regulations/organic/ national-list/petitioned. Details regarding the consideration of the 2012 petition can be found in the April 2013 NOSB Recommendation, available here: https://www.ams.usda.gov/event/spring-nosbmeeting-2013-or. PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 evaluation criteria for National List substances and did not recommend the addition of polyoxin D zinc salt to the National List in 2013.5 However, in May 2016, a new petition brought forward new data which indicated that polyoxin D zinc salt was not harmful to beneficial soil organisms and insects. This was supported by a limited scope technical report in December 2017. The petitioner also provided an analysis of grower need for this material. On February 2, 2018, the petitioner provided an addendum that more precisely specified that the requested amendment is for 7 CFR 205.601(i). According to the 2012 and 2017 technical reports 6 and the March 2012 and May 2016 petitions, polyoxin D zinc salt is a synthetic biofungicide. The National List provides several materials that organic producers may use to control fungal diseases. However, the NOSB determined that polyoxin D zinc salt is more efficacious than other allowed materials against a broader range of fungal diseases, such as cottonball disease on cranberries; black rot, downy mildew, powdery mildew and bunch rot on grapes; mummyberry on blueberries; phomopsis leaf spot on strawberries; downy mildew on basil; and other fungal diseases on fruits. In consideration of the March 2012 and May 2016 petitions, the February 2018 addendum, the 2012 and 2017 technical reports, and public comments, the NOSB determined that the use of polyoxin D zinc salt to control fungal diseases in organic crop production satisfies OFPA evaluation criteria for National List substances and recommended adding polyoxin D zinc salt to § 205.601(i) for plant disease control in organic crop production.7 AMS has reviewed and agrees that the NOSB has considered all of the petitions, technical reports, and public comments sufficiently, and that polyoxin D zinc salt satisfies the OFPA criteria for National List substances. AMS proposes to address this NOSB recommendation through this proposed rule. Consistent with the NOSB recommendation, this proposed rule would amend the National List by 5 NOSB recommendation on the 2012 petition to add polyoxin D zinc salt to the National List: https://www.ams.usda.gov/sites/default/files/ media/Polyoxin%20D%20NOSB%20final%20 recommendation.pdf. 6 The technical report for polyoxin D zinc salt is available on the AMS website, organized in alphabetical order: https://www.ams.usda.gov/ rules-regulations/organic/national-list/petitioned. Under ‘‘P.’’ 7 NOSB Recommendations 2018 Spring Meeting: https://www.ams.usda.gov/sites/default/files/ media/CSPolyoxinDZincSaltRec.pdf. E:\FR\FM\15FEP1.SGM 15FEP1 Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Proposed Rules adding polyoxin D zinc salt to § 205.601(i) for plant disease control. This would permit the use of polyoxin D zinc salt in crop production to address fungal diseases when preventive measures have failed (§ 205.206(e)). § 205.605 Nonagricultural (Nonorganic) Substances Allowed as Ingredients in or on Processed Products Labeled as ‘‘Organic’’ or ‘‘Made With Organic (Specified Ingredients or Food Group(s))’’ This proposed rule would reclassify one substance from an allowed synthetic ingredient in § 205.605(b), to an allowed nonsynthetic ingredient in § 205.605(a). Magnesium Chloride This proposed rule would reclassify magnesium chloride as a nonsynthetic substance that may be used in organic handling. It would also remove the annotation that magnesium chloride must be ‘‘derived from sea water.’’ Table 4 illustrates the proposed rule change. TABLE 4—PROPOSED RULE ACTION FOR MAGNESIUM CHLORIDE Current rule ... khammond on DSKBBV9HB2PROD with PROPOSALS Proposed rule action. § 205.605(b) magnesium chloride—derived from sea water. Remove magnesium chloride from § 205.605(b) and insert magnesium chloride under § 205.605(a) without annotation. Magnesium chloride derived from sea water is currently listed at § 205.605(b) as a nonagricultural (nonorganic) synthetic substance allowed as an ingredient in or on processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food group(s)).’’ The primary uses of magnesium chloride in organic food processing are as a firming agent in tofu processing and as a source of the essential mineral magnesium in organic infant formula. During the NOSB’s 2015 sunset review of magnesium chloride, the Board requested public comment on whether this material should be reclassified as nonsynthetic because it can be derived from sea water by brine drying with no ancillary substances. Public comments supported the reclassification of magnesium chloride as nonsynthetic and moving it from § 205.605(b) to § 205.605(a). To consider the reclassification of magnesium chloride on the National List, the NOSB requested a technical report on magnesium which was made available in November 2016. VerDate Sep<11>2014 17:13 Feb 14, 2019 Jkt 247001 Magnesium chloride is the simple salt of the halogen chlorine and the alkaline earth metal magnesium. The November 2016 technical report describes many different sources and processes to produce nonsynthetic forms of magnesium chloride which are widely commercially available.8 This substance is nonsynthetic when derived from natural sources and manufactured in a way that does not chemically change the substance (see § 205.2 definitions of nonsynthetic (natural) and synthetic). Public comments at the April 2018 NOSB meeting supported the reclassification of magnesium chloride as nonsynthetic and moving it from § 205.605(b) to § 205.605(a). No public comments were received indicating any concern with procuring nonsynthetic forms of magnesium chloride.9 In consideration of the new information provided in the November 2016 technical report and the public comments provided at both the 2015 and 2018 NOSB meetings, the NOSB unanimously recommended moving magnesium chloride to § 205.605(a) to more accurately reflect that nonsynthetic forms of this material are widely available. The NOSB also recommended that the annotation ‘‘derived from seawater’’ be removed when it is moved to § 205.605(a) because natural sources of magnesium chloride can be derived from terminal lake brines, subsurface brine deposits, and mined mineral deposits as well as seawater.10 Organic handlers who use magnesium chloride will need to ensure that the product complies with the nonsynthetic classification, the regulations and the listing at § 205.605(a) by obtaining details about the source of the magnesium chloride and its full manufacturing process. The NOP Program Handbook guidance documents NOP 5033, Classification of Materials, and NOP 5033–1, the Decision Tree for the Classification of Materials as Synthetic or Nonsynthetic,11 can be used if additional clarification is needed. Synthetic forms of magnesium 8 The technical report for magnesium chloride is available on the AMS website, organized in alphabetical order under ‘‘M’’: https:// www.ams.usda.gov/rules-regulations/organic/ national-list/m. 9 https://www.ams.usda.gov/sites/default/files/ media/TranscriptsSpring2018NOSBmeeting.pdf. 10 NOSB Recommendations 2018 Spring Meeting: https://www.ams.usda.gov/sites/default/files/ media/HSMagnesiumChlorideReclassRec.pdf. 11 NOP 5033 Classification of Materials & NOP 5033–1 Decision Tree for the Classification of Materials as Synthetic or Nonsynthetic: https:// www.ams.usda.gov/sites/default/files/media/ Program%20Handbk_TOC.pdf. PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 4379 chloride would be prohibited in organic handling. AMS has reviewed and agrees that the NOSB has sufficiently considered the new information provided in the November 2016 technical report and the public comments provided at the 2015 and 2018 NOSB meetings in alignment with the OFPA criteria for National List substances and the NOP Program Handbook guidance documents NOP 5033 & NOP 5033–1.12 AMS proposes to address this NOSB recommendation through this proposed rule. Consistent with the NOSB recommendation, this proposed rule would amend § 205.605(b) by removing magnesium chloride and inserting it in § 205.605(a) to more accurately reflect that this substance is available in nonsynthetic form. This proposed rule would also remove the annotation ‘‘derived from seaweed’’. III. Related Documents On January 17, 2018, a Notice was published in the Federal Register (83 FR 2373) announcing the spring 2018 NOSB meeting. One purpose of the meeting was to deliberate on recommendations on current substances on the National List, and substances petitioned as amendments. 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 sets forth the National List petition process. The current petition process (81 FR 12680, March 10, 2016) 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 12 NOP 5033 Classification of Materials & NOP 5033–1 Decision Tree for the Classification of Materials as Synthetic or Nonsynthetic https:// www.ams.usda.gov/sites/default/files/media/ Program%20Handbk_TOC.pdf. E:\FR\FM\15FEP1.SGM 15FEP1 khammond on DSKBBV9HB2PROD with PROPOSALS 4380 Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Proposed Rules significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB’s Memorandum titled ‘‘Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled ‘Reducing Regulation and Controlling Regulatory Costs’ ’’ (February 2, 2017). The Regulatory Flexibility Act (RFA) (5 U.S.C. 601–612) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to the action. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. The Small Business Administration (SBA) sets size criteria for each industry described in the North American Industry Classification System (NAICS), to delineate which operations qualify as small businesses.13 The SBA has classified small agricultural producers that engage in crop and animal production as those with average annual receipts of less than $750,000. 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 $15 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 U.S. would be considered small entities. According to the 2016 Certified Organic NASS Survey, 13,954 certified organic farms in the U.S. reported sales of organic products and total farmgate sales in excess of $7.5 billion.14 Based 13 U.S. Small Business Administration regulations: https://www.ecfr.gov/cgi-bin/textidx?rgn=div5;node=13%3A1.0.1.1.17#se13.1.121_ 1104. 14 U.S. Department of Agriculture, National Agricultural Statistics Service. September 2017. VerDate Sep<11>2014 17:13 Feb 14, 2019 Jkt 247001 on that data, organic sales average $541,000 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 9,919 certified handlers in the U.S.15 The Organic Trade Association’s 2017 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 approximately 80 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 rule, if implemented as final, would be to allow the use of additional and widely commercially available substances in organic crop or livestock production and organic handling. This action would increase regulatory flexibility and would give small entities more tools to use in day-to-day operations. AMS concludes that the economic impact of this addition, if any, would be minimal and beneficial to small agricultural service firms. Accordingly, USDA certifies that this rule would not have a significant economic impact on a substantial number of small entities. B. Executive Order 12988 Executive Order 12988 instructs each executive agency to adhere to certain Certified Organic Survey, 2016 Summary. http:// usda.mannlib.cornell.edu/usda/current/ OrganicProduction/OrganicProduction-09-20-2017_ correction.pdf. 15 Organic Integrity Database: https:// organic.ams.usda.gov/Integrity/. Accessed on July 5, 2018. PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 requirements in the development of new and revised regulations in order to avoid unduly burdening the court system. This proposed rule is not intended to have a retroactive effect. Accordingly, to prevent duplicative regulation, states and local jurisdictions are preempted under the OFPA from creating programs of accreditation for private persons or state officials who want to become certifying agents of organic farms or handling operations. A governing state official would have to apply to USDA to be accredited as a certifying agent, as described in section 6514(b) of the OFPA. States are also preempted under sections 6503 through 6507 of the OFPA from creating certification programs to certify organic farms or handling operations unless the state programs have been submitted to, and approved by, the Secretary as meeting the requirements of the OFPA. Pursuant to section 6507(b)(2) of the OFPA, a state organic certification program that has been approved by the Secretary may, under certain circumstances, contain additional requirements for the production and handling of agricultural products organically produced in the state and for the certification of organic farm and handling operations located within the state. Such additional requirements must (a) further the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c) not be discriminatory toward agricultural commodities organically produced in other States, and (d) not be effective until approved by the Secretary. In addition, pursuant to section 6519(c)(6) of the OFPA, this proposed rule would not supersede or alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601–624), the Poultry Products Inspection Act (21 U.S.C. 451–471), or the Egg Products Inspection Act (21 U.S.C. 1031–1056), concerning meat, poultry, and egg products, respectively, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), nor the authority of the Administrator of the Environmental Protection Agency under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.). C. Paperwork Reduction Act No additional collection or recordkeeping requirements are imposed on the public by this proposed rule. Accordingly, OMB clearance is not required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35. E:\FR\FM\15FEP1.SGM 15FEP1 Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Proposed Rules D. Executive Order 13175 This proposed rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on tribal governments and will not have significant tribal implications. F. General Notice of Public Rulemaking This proposed rule reflects recommendations submitted by the NOSB to the Secretary to add two substances to the National List and to reclassify one substance on the National List. A 60-day period for interested persons to comment on this rule is provided. List of Subjects in 7 CFR Part 205 Administrative practice and procedure, Agriculture, Archives and records, Crops, Imports, Labeling, National List, 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, subpart G is proposed to be amended as follows: PART 205—NATIONAL ORGANIC PROGRAM Authority: 7 U.S.C. 6501–6522. 2. Amend § 205.601 as follows: a. Revise paragraph (h) and add new paragraphs (h)(1) and (h)(2), ■ b. Add new paragraph (i)(11). The revision and additions to read as follows: ■ ■ § 205.601 Synthetic substances allowed for use in organic crop production. khammond on DSKBBV9HB2PROD with PROPOSALS * * * * (h) As slug or snail bait. (1) Ferric phosphate (CAS # 10045– 86–0). (2) Elemental sulfur. * * * * * (i) * * * (11) Polyoxin D zinc salt. * * * * * ■ 3. Amend § 205.605 as follows: ■ a. In paragraph (a), add in alphabetical order, an entry for ‘‘magnesium chloride.’’ ■ b. In paragraph (b), remove the entry for ‘‘magnesium chloride—derived from seawater.’’ The addition to read as follows: VerDate Sep<11>2014 17:13 Feb 14, 2019 Jkt 247001 * * * * * (a) * * * * * * * * Magnesium chloride. * * * * * Dated: February 12, 2019. Bruce Summers, Administrator, Agricultural Marketing Service. [FR Doc. 2019–02518 Filed 2–14–19; 8:45 am] BILLING CODE 3410–02–P DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 985 [Doc. No. AMS–SC–18–0084; SC19–985–1 PR] Marketing Order Regulating the Handling of Spearmint Oil Produced in the Far West; Salable Quantities and Allotment Percentages for the 2019– 2020 Marketing Year Agricultural Marketing Service, USDA. ACTION: Proposed rule. AGENCY: This proposed rule invites comments on a recommendation from the Far West Spearmint Oil Administrative Committee (Committee) to establish salable quantities and producer allotments of Class 1 (Scotch) and Class 3 (Native) spearmint oil produced in Washington, Idaho, Oregon, and designated parts of Nevada and Utah (the Far West) for the 2019– 2020 marketing year. This proposed rule would also remove references to past volume regulation no longer in effect. DATES: Comments must be received by March 18, 2019. ADDRESSES: Interested persons are invited to submit written comments concerning this proposed rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250–0237; Fax: (202) 720–8938; or internet: http://www.regulations.gov. Comments should reference the document number and the date and page number of this issue of the Federal Register and will be made available for public inspection in the Office of the Docket Clerk during regular business hours or can be viewed at: http:// SUMMARY: 1. The authority citation for 7 CFR part 205 continues to read as follows: ■ * § 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)).’’ PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 4381 www.regulations.gov. All comments submitted in response to this proposed rule will be included in the record and will be made available to the public. Please be advised that the identity of the individuals or entities submitting the comments will be made public on the internet at the address provided above. FOR FURTHER INFORMATION CONTACT: Barry Broadbent, Marketing Specialist, or Gary Olson, Regional Director, Northwest Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (503) 326– 2724, Fax: (503) 326–7440, or Email: Barry.Broadbent@usda.gov or GaryD.Olson@usda.gov. Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250–0237; Telephone: (202) 720– 2491, Fax: (202) 720–8938, or Email: Richard.Lower@usda.gov. SUPPLEMENTARY INFORMATION: This action, pursuant to 5 U.S.C. 553, proposes to amend regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Order No. 985, as amended (7 CFR part 985), regulating the handling of spearmint oil produced in the Far West. Part 985 (referred to as the ‘‘Order’’) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601–674), hereinafter referred to as the ‘‘Act.’’ The Committee locally administers the Order and is comprised of spearmint oil producers operating within the area of production, and a public member. The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this proposed rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB’s Memorandum titled ‘‘Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled ‘Reducing Regulation and Controlling Regulatory Costs’ ’’ (February 2, 2017). This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. Under the Order now in effect, salable quantities E:\FR\FM\15FEP1.SGM 15FEP1

Agencies

[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Proposed Rules]
[Pages 4377-4381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02518]


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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. 84, No. 32 / Friday, February 15, 2019 / 
Proposed Rules

[[Page 4377]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-18-0051; NOP-18-02]
RIN 0581 AD80


National Organic Program; Proposed Amendments to the National 
List of Allowed and Prohibited Substances for April 2018 NOSB 
Recommendations (Crops 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 elemental sulfur for use as a molluscicide in organic crop 
production, add polyoxin D zinc salt to control fungal diseases in 
organic crop production, and reclassify magnesium chloride from an 
allowed synthetic to an allowed nonsynthetic ingredient in organic 
handling.

DATES: Comments must be received by April 16, 2019.

ADDRESSES: Interested persons may comment on the proposed rule using 
the following procedures:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Valerie Frances, 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-18-0051; NOP-18-02, and/or Regulatory Information Number 
(RIN) 0581-XXXX 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 
or not 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 
http://www.regulations.gov.
    Document: To access the document and read background documents, or 
comments received, go to http://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., 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: Valerie Frances, Standards Division, 
National Organic Program. Telephone: (202) 720-3252.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2000, the Secretary established the National List 
within part 205 of the USDA organic regulations (7 CFR 205.600 through 
205.607). The National List identifies the synthetic substances that 
may be used and the nonsynthetic (natural) substances that may not be 
used in organic production. The National List also identifies 
synthetic, nonsynthetic nonagricultural, and nonorganic agricultural 
substances that may be used in organic handling.
    The Organic Foods Production Act of 1990, as amended, (7 U.S.C. 
6501-6522) (OFPA), and Sec.  205.105 of 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 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 developed 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 would amend the National List to implement three 
NOSB recommendations. These recommendations were submitted to the 
Secretary on April 27, 2018. Table 1 summarizes the proposed changes to 
the National List based on these NOSB recommendations.

                                Table 1--Proposed Amendments to the National List
----------------------------------------------------------------------------------------------------------------
              Substance                National List section                 Proposed rule action
----------------------------------------------------------------------------------------------------------------
Elemental Sulfur....................  Sec.   205.601(h).....  Add to National List.
Polyoxin D Zinc Salt................  Sec.   205.601(i).....  Add to National List.
Magnesium Chloride (MgCl)...........  Sec.   205.605(b) to    Reclassify listing and move within National List.
                                       Sec.   205.605(a).
----------------------------------------------------------------------------------------------------------------


[[Page 4378]]

II. Overview of Proposed Amendments

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

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

    This proposed rule would add two substances to Sec.  205.601, 
synthetic substances allowed for use in organic crop production.
Elemental Sulfur
    The proposed rule would amend the National List to add elemental 
sulfur to Sec.  205.601(h) for use as a molluscicide bait to control 
slugs and snails. Table 2 illustrates the proposed rule action.

           Table 2--Proposed Rule Action for Elemental Sulfur
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Current rule..............................  N/A.
Proposed rule action......................  Add elemental sulfur to Sec.
                                               205.601(h) as slug or
                                             snail bait.
------------------------------------------------------------------------

    On May 25, 2017, AMS received a petition \1\ to add elemental 
sulfur to the National List in Sec.  205.601(h) for use as a slug or 
snail bait. Currently, the USDA organic regulations allow elemental 
sulfur for use in organic crop production as an insecticide (including 
mite control) in Sec.  205.601(e); as a plant disease control in Sec.  
205.601(i); and as a plant or soil amendment in Sec.  205.601(j).
---------------------------------------------------------------------------

    \1\ Elemental sulfur petition: https://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned. Under ``S.''
---------------------------------------------------------------------------

    At its April 2018 public meeting, the NOSB considered the petition 
to add elemental sulfur to the National List for use in organic crop 
production as a molluscicide. Increased adoption of low tillage and no 
tillage agricultural practices can increase the abundance of snails and 
slugs, which can reduce crop yields. The availability of a molluscicide 
as a new tool will help prevent crop losses. In its review, the NOSB 
considered a March 2017 technical report on elemental sulfur \2\ that 
described its manufacture, industry uses, regulation, and chemical 
properties. Prior to and during this meeting, the NOSB received and 
considered public comment on the proposal.
---------------------------------------------------------------------------

    \2\ The technical report for elemental sulfur is available on 
the AMS website, organized in alphabetical order: https://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned. 
Under ``S.''
---------------------------------------------------------------------------

    In consideration of the petition, technical report, and public 
comments, the NOSB determined that the use of elemental sulfur as a 
slug or snail bait for organic crop production satisfies OFPA 
evaluation criteria for National List substances and recommended adding 
elemental sulfur to Sec.  205.601(h) as a slug or snail bait for 
organic crop production.\3\
---------------------------------------------------------------------------

    \3\ NOSB 2018 Spring meeting elemental sulfur recommendation: 
https://www.ams.usda.gov/sites/default/files/media/CSSulfurMolluscicideRec.pdf.
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    AMS has reviewed and agrees that the NOSB has considered the 
petitions, technical report, and public comments sufficiently, and that 
elemental sulfur used as a slug or snail bait satisfies the OFPA 
criteria for National List substances. AMS proposes to address this 
NOSB recommendation through this proposed rule. Consistent with the 
NOSB recommendation, this proposed rule would amend the National List 
by adding elemental sulfur to Sec.  205.601(h) as a slug or snail bait. 
This would permit the use of elemental sulfur-based bait, providing an 
additional tool to organic producers to control slugs and snails when 
other required preventive measures have failed to provide sufficient 
control (Sec.  205.206(e)).
Polyoxin D Zinc Salt
    The proposed rule would amend the National List to add polyoxin D 
zinc salt to control fungal diseases at Sec.  205.601(i). Table 3 
illustrates the proposed rule change.

         Table 3--Proposed Rule Action for Polyoxin D Zinc Salt
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Current rule..............................  N/A.
Proposed rule action......................  Add polyoxin D zinc salt to
                                             Sec.   205.601(i) as plant
                                             disease control.
------------------------------------------------------------------------

    Two petitions to add polyoxin D zinc salt for use in organic crop 
production were submitted to the National Organic Program: One in March 
2012 and the other in May 2016. Both petitions and an addendum in 
February 2018 proposed to amend 7 CFR 205.601 to add polyoxin D zinc 
salt as a synthetic substance allowed for use in organic crop 
production.\4\
---------------------------------------------------------------------------

    \4\ Polyoxin D zinc salt 2012 and 2016 petitions along with 
addendums found under ``P'': https://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned. Details regarding the 
consideration of the 2012 petition can be found in the April 2013 
NOSB Recommendation, available here: https://www.ams.usda.gov/event/spring-nosb-meeting-2013-or.
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    In consideration of the information in the March 2012 petition, the 
September 2012 technical report, and public comments, the NOSB 
determined that the use of polyoxin D zinc salt to control fungal 
diseases in organic crop production did not satisfy the OFPA evaluation 
criteria for National List substances and did not recommend the 
addition of polyoxin D zinc salt to the National List in 2013.\5\
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    \5\ NOSB recommendation on the 2012 petition to add polyoxin D 
zinc salt to the National List: https://www.ams.usda.gov/sites/default/files/media/Polyoxin%20D%20NOSB%20final%20recommendation.pdf.
---------------------------------------------------------------------------

    However, in May 2016, a new petition brought forward new data which 
indicated that polyoxin D zinc salt was not harmful to beneficial soil 
organisms and insects. This was supported by a limited scope technical 
report in December 2017. The petitioner also provided an analysis of 
grower need for this material. On February 2, 2018, the petitioner 
provided an addendum that more precisely specified that the requested 
amendment is for 7 CFR 205.601(i).
    According to the 2012 and 2017 technical reports \6\ and the March 
2012 and May 2016 petitions, polyoxin D zinc salt is a synthetic 
biofungicide. The National List provides several materials that organic 
producers may use to control fungal diseases. However, the NOSB 
determined that polyoxin D zinc salt is more efficacious than other 
allowed materials against a broader range of fungal diseases, such as 
cottonball disease on cranberries; black rot, downy mildew, powdery 
mildew and bunch rot on grapes; mummyberry on blueberries; phomopsis 
leaf spot on strawberries; downy mildew on basil; and other fungal 
diseases on fruits.
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    \6\ The technical report for polyoxin D zinc salt is available 
on the AMS website, organized in alphabetical order: https://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned. 
Under ``P.''
---------------------------------------------------------------------------

    In consideration of the March 2012 and May 2016 petitions, the 
February 2018 addendum, the 2012 and 2017 technical reports, and public 
comments, the NOSB determined that the use of polyoxin D zinc salt to 
control fungal diseases in organic crop production satisfies OFPA 
evaluation criteria for National List substances and recommended adding 
polyoxin D zinc salt to Sec.  205.601(i) for plant disease control in 
organic crop production.\7\
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    \7\ NOSB Recommendations 2018 Spring Meeting: https://www.ams.usda.gov/sites/default/files/media/CSPolyoxinDZincSaltRec.pdf.
---------------------------------------------------------------------------

    AMS has reviewed and agrees that the NOSB has considered all of the 
petitions, technical reports, and public comments sufficiently, and 
that polyoxin D zinc salt satisfies the OFPA criteria for National List 
substances. AMS proposes to address this NOSB recommendation through 
this proposed rule. Consistent with the NOSB recommendation, this 
proposed rule would amend the National List by

[[Page 4379]]

adding polyoxin D zinc salt to Sec.  205.601(i) for plant disease 
control. This would permit the use of polyoxin D zinc salt in crop 
production to address fungal diseases when preventive measures have 
failed (Sec.  205.206(e)).

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

    This proposed rule would reclassify one substance from an allowed 
synthetic ingredient in Sec.  205.605(b), to an allowed nonsynthetic 
ingredient in Sec.  205.605(a).
Magnesium Chloride
    This proposed rule would reclassify magnesium chloride as a 
nonsynthetic substance that may be used in organic handling. It would 
also remove the annotation that magnesium chloride must be ``derived 
from sea water.'' Table 4 illustrates the proposed rule change.

          Table 4--Proposed Rule Action for Magnesium Chloride
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Current rule..............................  Sec.   205.605(b) magnesium
                                             chloride--derived from sea
                                             water.
Proposed rule action......................  Remove magnesium chloride
                                             from Sec.   205.605(b) and
                                             insert magnesium chloride
                                             under Sec.   205.605(a)
                                             without annotation.
------------------------------------------------------------------------

    Magnesium chloride derived from sea water is currently listed at 
Sec.  205.605(b) as a nonagricultural (nonorganic) synthetic substance 
allowed as an ingredient in or on processed products labeled as 
``organic'' or ``made with organic (specified ingredients or food 
group(s)).'' The primary uses of magnesium chloride in organic food 
processing are as a firming agent in tofu processing and as a source of 
the essential mineral magnesium in organic infant formula. During the 
NOSB's 2015 sunset review of magnesium chloride, the Board requested 
public comment on whether this material should be reclassified as 
nonsynthetic because it can be derived from sea water by brine drying 
with no ancillary substances. Public comments supported the 
reclassification of magnesium chloride as nonsynthetic and moving it 
from Sec.  205.605(b) to Sec.  205.605(a). To consider the 
reclassification of magnesium chloride on the National List, the NOSB 
requested a technical report on magnesium which was made available in 
November 2016.
    Magnesium chloride is the simple salt of the halogen chlorine and 
the alkaline earth metal magnesium. The November 2016 technical report 
describes many different sources and processes to produce nonsynthetic 
forms of magnesium chloride which are widely commercially available.\8\ 
This substance is nonsynthetic when derived from natural sources and 
manufactured in a way that does not chemically change the substance 
(see Sec.  205.2 definitions of nonsynthetic (natural) and synthetic). 
Public comments at the April 2018 NOSB meeting supported the 
reclassification of magnesium chloride as nonsynthetic and moving it 
from Sec.  205.605(b) to Sec.  205.605(a). No public comments were 
received indicating any concern with procuring nonsynthetic forms of 
magnesium chloride.\9\
---------------------------------------------------------------------------

    \8\ The technical report for magnesium chloride is available on 
the AMS website, organized in alphabetical order under ``M'': 
https://www.ams.usda.gov/rules-regulations/organic/national-list/m.
    \9\ https://www.ams.usda.gov/sites/default/files/media/TranscriptsSpring2018NOSBmeeting.pdf.
---------------------------------------------------------------------------

    In consideration of the new information provided in the November 
2016 technical report and the public comments provided at both the 2015 
and 2018 NOSB meetings, the NOSB unanimously recommended moving 
magnesium chloride to Sec.  205.605(a) to more accurately reflect that 
nonsynthetic forms of this material are widely available. The NOSB also 
recommended that the annotation ``derived from seawater'' be removed 
when it is moved to Sec.  205.605(a) because natural sources of 
magnesium chloride can be derived from terminal lake brines, subsurface 
brine deposits, and mined mineral deposits as well as seawater.\10\
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    \10\ NOSB Recommendations 2018 Spring Meeting: https://www.ams.usda.gov/sites/default/files/media/HSMagnesiumChlorideReclassRec.pdf.
---------------------------------------------------------------------------

    Organic handlers who use magnesium chloride will need to ensure 
that the product complies with the nonsynthetic classification, the 
regulations and the listing at Sec.  205.605(a) by obtaining details 
about the source of the magnesium chloride and its full manufacturing 
process. The NOP Program Handbook guidance documents NOP 5033, 
Classification of Materials, and NOP 5033-1, the Decision Tree for the 
Classification of Materials as Synthetic or Nonsynthetic,\11\ can be 
used if additional clarification is needed. Synthetic forms of 
magnesium chloride would be prohibited in organic handling.
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    \11\ NOP 5033 Classification of Materials & NOP 5033-1 Decision 
Tree for the Classification of Materials as Synthetic or 
Nonsynthetic: https://www.ams.usda.gov/sites/default/files/media/Program%20Handbk_TOC.pdf.
---------------------------------------------------------------------------

    AMS has reviewed and agrees that the NOSB has sufficiently 
considered the new information provided in the November 2016 technical 
report and the public comments provided at the 2015 and 2018 NOSB 
meetings in alignment with the OFPA criteria for National List 
substances and the NOP Program Handbook guidance documents NOP 5033 & 
NOP 5033-1.\12\
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    \12\ NOP 5033 Classification of Materials & NOP 5033-1 Decision 
Tree for the Classification of Materials as Synthetic or 
Nonsynthetic https://www.ams.usda.gov/sites/default/files/media/Program%20Handbk_TOC.pdf.
---------------------------------------------------------------------------

    AMS proposes to address this NOSB recommendation through this 
proposed rule. Consistent with the NOSB recommendation, this proposed 
rule would amend Sec.  205.605(b) by removing magnesium chloride and 
inserting it in Sec.  205.605(a) to more accurately reflect that this 
substance is available in nonsynthetic form. This proposed rule would 
also remove the annotation ``derived from seaweed''.

III. Related Documents

    On January 17, 2018, a Notice was published in the Federal Register 
(83 FR 2373) announcing the spring 2018 NOSB meeting. One purpose of 
the meeting was to deliberate on recommendations on current substances 
on the National List, and substances petitioned as amendments.

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 
sets forth the National List petition process. The current petition 
process (81 FR 12680, March 10, 2016) 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

[[Page 4380]]

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 burdening small entities or erecting barriers that 
would restrict their ability to compete in the market. The purpose of 
the RFA is to fit regulatory actions to the scale of businesses subject 
to the action. Section 605 of the RFA allows an agency to certify a 
rule, in lieu of preparing an analysis, if the rulemaking is not 
expected to have a significant economic impact on a substantial number 
of small entities.
    The Small Business Administration (SBA) sets size criteria for each 
industry described in the North American Industry Classification System 
(NAICS), to delineate which operations qualify as small businesses.\13\ 
The SBA has classified small agricultural producers that engage in crop 
and animal production as those with average annual receipts of less 
than $750,000. 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 $15 million.
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    \13\ U.S. Small Business Administration regulations: https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=13%3A1.0.1.1.17#se13.1.121_1104.
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    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 U.S. would be considered 
small entities. According to the 2016 Certified Organic NASS Survey, 
13,954 certified organic farms in the U.S. reported sales of organic 
products and total farmgate sales in excess of $7.5 billion.\14\ Based 
on that data, organic sales average $541,000 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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    \14\ U.S. Department of Agriculture, National Agricultural 
Statistics Service. September 2017. Certified Organic Survey, 2016 
Summary. http://usda.mannlib.cornell.edu/usda/current/OrganicProduction/OrganicProduction-09-20-2017_correction.pdf.
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    According to the NOP's Organic Integrity Database, there are 9,919 
certified handlers in the U.S.\15\ The Organic Trade Association's 2017 
Organic Industry Survey has information about employment trends among 
organic manufacturers. The reported data are stratified into three 
groups by the number of employees per company: Less than 5; 5 to 49; 
and 50 plus. These data are representative of the organic manufacturing 
sector and the lower bound (50) of the range for the larger 
manufacturers is significantly smaller than the SBA's small business 
thresholds (500 to 1,250). Therefore, AMS expects that most organic 
handlers would qualify as small businesses.
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    \15\ Organic Integrity Database: https://organic.ams.usda.gov/Integrity/. Accessed on July 5, 2018.
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    The USDA has approximately 80 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 rule, if implemented as final, would be 
to allow the use of additional and widely commercially available 
substances in organic crop or livestock production and organic 
handling. This action would increase regulatory flexibility and would 
give small entities more tools to use in day-to-day operations. AMS 
concludes that the economic impact of this addition, if any, would be 
minimal and beneficial to small agricultural service firms. 
Accordingly, USDA certifies that this rule would not have a significant 
economic impact on a substantial number of small entities.

B. Executive Order 12988

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

C. Paperwork Reduction Act

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

[[Page 4381]]

D. Executive Order 13175

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

F. General Notice of Public Rulemaking

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

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agriculture, Archives and 
records, Crops, Imports, Labeling, National List, 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, subpart 
G 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.  205.601 as follows:
0
a. Revise paragraph (h) and add new paragraphs (h)(1) and (h)(2),
0
b. Add new paragraph (i)(11).
    The revision and additions to read as follows:


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

* * * * *
    (h) As slug or snail bait.
    (1) Ferric phosphate (CAS # 10045-86-0).
    (2) Elemental sulfur.
* * * * *
    (i) * * *
    (11) Polyoxin D zinc salt.
* * * * *
0
3. Amend Sec.  205.605 as follows:
0
a. In paragraph (a), add in alphabetical order, an entry for 
``magnesium chloride.''
0
b. In paragraph (b), remove the entry for ``magnesium chloride--derived 
from seawater.''
    The addition 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) * * *
* * * * *
    Magnesium chloride.
* * * * *

    Dated: February 12, 2019.
Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2019-02518 Filed 2-14-19; 8:45 am]
BILLING CODE 3410-02-P