Agricultural Marketing Service, USDA.
Proposed rule.
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.
Comments must be received by August 7, 2020.
Interested persons may comment on the proposed rule using the following procedures:
Robert Pooler, Standards Division, National Organic Program. Telephone: (202) 720–3252.
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.
The following provides an overview of the proposed amendments to designated sections of the National List regulations:
The proposed rule would amend the National List to add oxalic acid dihydrate to § 205.603 as a synthetic substance allowed for use in livestock production. Table 2 illustrates the proposed listing.
On October 3, 2017, AMS received a petition to add oxalic acid dihydrate to the National List as a parasiticide treatment of
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.
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
The proposed rule would amend the National List to add pullulan to § 205.605(a) as an ingredient allowed in products labeled, “Made with organic (specified ingredients or food group(s)).” Table 3 illustrates the proposed listing.
On January 31, 2018, AMS received a petition
At its April 26, 2019, public meeting, the NOSB considered the petition, technical report, and public comments, and determined that (1) pullulan is a nonsynthetic substance and (2) the use of pullulan as an ingredient used in tablets and capsules for dietary supplements is consistent with the OFPA evaluation criteria for National List substances. Therefore, the NOSB recommended adding pullulan to § 205.605(a) as a nonsynthetic, nonagricultural substance allowed for use in organic handling.
AMS has reviewed the NOSB recommendation on pullulan and agrees that pullulan, as petitioned, is a nonsynthetic, nonagricultural substance
The proposed rule would amend the National List to add collagen gel casing as a nonorganic agricultural substance listed in § 205.606 for use in organic handling.
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.
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.
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.
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.
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.
AMS published a notice in the
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
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.
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
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.
According to the NOP's Organic Integrity Database, there are 19,671 organic handlers that are certified under the USDA organic regulations.
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.
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
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.
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.
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.
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:
7 U.S.C. 6501–6522.
(b) * * *
(8) Oxalic acid dihydrate—for use as a pesticide solely for apiculture.
(a) * * *
Pullulan—for use only in tablets and capsules for dietary supplements labeled “made with organic (specified ingredients or food group(s)).”
(d) Collagen gel casing.