Agricultural Marketing Service, USDA.
Proposed rule.
The U.S. Department of Agriculture's Agricultural Marketing Service proposes amendments to the National List of Allowed and Prohibited Substances (National List) section of the USDA's organic regulations to implement recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board (NOSB). This rule proposes the removal from the National List of several substances currently allowed for various uses in organic crop production, livestock production, and manufacture of processed products.
Send comments on or before October 25, 2021.
You may send comments on this proposed rule to the Federal eRulemaking Portal at
Jared Clark, Standards Division, National Organic Program, Telephone: (202) 720–3252.
In addition to comments about the proposed removals themselves, AMS is requesting comments about whether organic operations (producers and handlers) require time to implement the changes that would be necessary, should AMS finalize the amendments in this proposed rule. All of the substances/ingredients included in this rule have a “sunset date” of March 15, 2022, except for Turkish bay leaves and whey protein concentrate (sunset date of June 27, 2022). AMS requests comments on how much time after the sunset date is necessary, if any, for organic operations to comply with the proposed changes.
On December 21, 2000, the Secretary established the Agricultural Marketing Service's (AMS) National Organic Program and the USDA organic regulations (65 FR 80547). Within the USDA organic regulations (7 CFR part 205) is the National List of Allowed and Prohibited Substances (or “National List”). The National List identifies the synthetic substances that may be used and the nonsynthetic (natural) substances that may not be used in organic crop and livestock production. It also identifies the nonorganic substances that may be used in or on processed organic products (
To remain on the National List, substances must be: (1) Reviewed every five years by the NOSB, a 15-member Federal advisory committee; and (2) renewed by the Secretary (7 U.S.C. 6517(e)). This action of NOSB review and USDA renewal is commonly referred to as the “sunset review” or “sunset process.” AMS published information about this process in the
Through the course of the sunset review process for the substances below, the NOSB determined the substances are no longer necessary for organic production or handling or otherwise no longer comply with the criteria set forth in the Organic Foods Production Act at 7 U.S.C. 6518.
Based on recommendations submitted at the conclusion of the NOSB's sunset review process, AMS is proposing to amend the National List by removing the following synthetic substances currently allowed in organic crop and livestock production (7 CFR 205.601 and 205.603):
Additionally, AMS is proposing to amend the National List by removing the following nonorganic ingredients currently allowed in organic handling (§§ 205.605 and 205.606):
The proposed removal of these substances from the National List addresses National Organic Standards Board (NOSB) recommendations submitted to the Secretary after the conclusion of the NOSB's public meetings on October 29, 2015; November 2, 2017; October 26, 2018; and October 30, 2020.
The following provides an overview of the proposed amendments to the National List, along with the NOSB and
AMS is proposing to remove sucrose octanoate esters from the National List. Sucrose octanoate esters were added to the National List effective December 11, 2007 (72 FR 69569), were renewed through two sunset reviews, and are currently listed at §§ 205.601(e)(10) and 205.603(b)(10). The 2007 rulemaking was initiated by an NOSB recommendation in August 2005
Prior to the NOSB's 2018 Fall meeting, the NOSB received information indicating there are no current EPA registrations for sucrose octanoate esters and therefore no approved pesticide applications. Due to this information, as referenced in the published NOSB recommendations,
AMS agrees with the NOSB recommendation to remove sucrose octanoate esters from the National List at §§ 205.601(e)(10) and 205.603(b)(10). By 2019, there were no EPA approved products with legal uses corresponding to the National List allowances. (83 FR 16087, 16088, 16094). EPA's April 13, 2018, notice shows that the registrant of sucrose octanoate esters (75197–1, 75197–2) voluntarily cancelled its registrations. Since 2018, EPA's Pesticide Product and Label System
AMS agrees with the NOSB's recommendation to remove sucrose octanoate esters because this product's minimal commercial availability shows that sucrose octanoate esters are not essential for organic production. Public comments are requested on whether there is additional information available regarding the need for this substance in organic production and the availability of sucrose octanoate esters given the recent registrations.
AMS is proposing to remove Vitamin B
In support of their sunset review
AMS agrees with the NOSB recommendation to remove vitamin B
AMS is proposing to remove oxytocin from the National List. Oxytocin was added to the National List at its inception on December 21, 2000 (65 FR 80547), was renewed through several sunset reviews, and is currently listed at § 205.603(a)(22) for use in post parturition therapeutic applications.
In the sunset review, the NOSB recommended
AMS tentatively agrees with the NOSB recommendation. While the NOSB states there are other practices or materials that render oxytocin unnecessary for organic production, AMS did not find supporting comments to that effect, and NOSB did not specifically state what the alternatives are. Further, it was stated in public comment to the NOSB that while some operations still use oxytocin as a medical treatment (assisting in clearing placenta), other operations may be using it in ways inconsistent with the listing or no longer find it necessary in organic production. AMS is seeking comments on whether suitable alternatives for the use of oxytocin exist, and if so, specifically what alternative practices or materials might replace the use of oxytocin. Further, AMS seeks information on oxytocin use that may be inconsistent with the listing. If comments show that the use of oxytocin no longer meets the exemption requirements at 7 U.S.C. 6517(c)(1)(A)(ii) and (iii), AMS is
AMS is proposing to remove procaine from the National List. Procaine was added to the National List at its inception on December 21, 2000 (65 FR 80547), was renewed through several sunset reviews, and is currently listed at § 205.603(b)(8) for use as a local anesthetic.
In support of the NOSB's sunset review of procaine, public comment was requested to determine if procaine is used in organic livestock production and whether procaine is only available in the U.S. in animal drugs compounded with antibiotics (which are not permitted in organic production) or whether procaine can be sourced by itself. The comments received indicated that procaine is rarely used, is not as effective as lidocaine (allowed in organic livestock production at § 205.603(b)(5)), and is only available in combination with prohibited antibiotics. Further comments received were in support of removing procaine from the National List. Based on the information received during the public comment period, the NOSB recommended
AMS agrees with the NOSB recommendation. Given that there is another National List material, lidocaine, that renders procaine unnecessary for organic production, procaine no longer meets the exemption requirement at 7 U.S.C. 6517(c)(1)(A)(ii). Further, the NOSB referenced in their recommendation that procaine is not available on its own (
AMS is proposing to remove alginic acid from the National List. Alginic acid was added to § 205.605(a) of the National List at its inception on December 21, 2000 (65 FR 80547), was renewed through several sunset reviews, and was reclassified as synthetic on December 27, 2018 (83 FR 66559), which moved alginic acid to its current listing at § 205.605(b) for use in organic handling.
In support of their sunset review of alginic acid, the NOSB received a third-party technical report
AMS agrees with the NOSB recommendation. Given that there were no reports of operations using alginic acid and the availability of possible alternatives on the National List (as referenced in the technical report), this substance no longer appears to meet the requirements for inclusion on the National List at 7 U.S.C. 6517(c)(1)(A)(ii). As such, AMS proposes the removal of alginic acid from the National List at § 205.605(b).
AMS is proposing to remove eight nonorganic colors from the National List at § 205.606(d):
• Black currant juice color—derived from
• Blueberry juice color—derived from blueberries (
• Carrot juice color—derived from
• Cherry juice color—derived from
• Grape juice color—derived from
• Paprika color—derived from dried powder or vegetable oil extract of
• Pumpkin juice color—derived from
• Turmeric extract color—derived from
These colors were added to the National List effective June 21, 2007 (72 FR 35137), were renewed through several sunset reviews, and are currently listed at § 205.606(d) as allowed nonorganic agricultural ingredients in organic products when organic versions are not commercially available.
The NOSB recommended
AMS is proposing to remove these colors from the National List, as recommended by the NOSB. AMS is seeking comments about whether these colors remain necessary for organic production or if there are suitable organic versions available. While public comments to the NOSB were mixed, as noted in the NOSB recommendation, most of the comments were in favor of relisting these colors. Because these colors are listed in § 205.606, certified operations are required to use organic versions of these colors unless the organic versions are not commercially available (
AMS welcomes public comments that provide more information on whether there are sufficient amounts of the organic versions of the above colors to
AMS is proposing to remove nonorganic kelp from the National List. The effect of this action is that only organic forms of kelp would be allowed in organic handling. Kelp was added to the National List at its inception on December 21, 2000 (65 FR 80547), was renewed through several sunset reviews, and is currently listed at § 205.606(k) for use only as a thickener and dietary supplement only when an organic version is not commercially available.
After the Fall 2020 meeting, the NOSB recommended
AMS agrees with the NOSB recommendation. According to the Organic Integrity Database,
AMS is proposing to remove nonorganic konjac flour from the National List. The effect of this action is that only organic forms of konjac flour would be allowed in organic handling. Konjac flour was added to the National List effective June 21, 2007 (72 FR 35137), renewed through two sunset reviews, and is currently listed at § 205.606(l). The 2007 rulemaking was initiated by an NOSB recommendation
After the Fall 2017 meeting, the NOSB recommended
AMS agrees with the NOSB recommendation. A search in the Organic Integrity Database
AMS is proposing to remove nonorganic sweet potato starch from the National List. The effect of this action is that only organic forms of sweet potato starch would be allowed in organic handling. Sweet potato starch was added to the National List effective June 21, 2007 (72 FR 35137), was renewed through two sunset reviews, and is currently listed at § 205.606(s)(2). The 2007 rulemaking was initiated by an NOSB recommendation
After the Fall 2020 meeting, the NOSB recommended
AMS agrees with the NOSB recommendation. A search in the Organic Integrity Database
AMS is proposing to remove nonorganic Turkish bay leaves from the National List. The effect of this action is that organic forms only of Turkish bay leaves would be allowed in organic handling. Turkish bay leaves were added to the National List effective June 21, 2007 (72 FR 35137), were renewed through two sunset reviews, and are currently listed at § 205.606(v). The 2007 rulemaking was initiated by an NOSB recommendation
After the Fall 2015 meeting, the NOSB recommended
AMS agrees with the NOSB recommendation. A search in the Organic Integrity Database
AMS is proposing to remove nonorganic whey protein concentrate from the National List. The effect of this action is that only organic forms of whey protein concentrate would be allowed in organic handling. Whey protein concentrate was added to the National List effective June 21, 2007 (72 FR 35137), was renewed through two sunset reviews, and is currently listed at § 205.606(x). The 2007 rulemaking was initiated by an NOSB recommendation made at the March 2007
After the Fall 2015 meeting, the NOSB recommended
AMS agrees with the NOSB recommendation. A search in the Organic Integrity Database
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 proposed rule does not meet the criteria of a significant regulatory action under Executive Order 12866 as supplemented by Executive Order 13563. Therefore, the Office of Management and Budget (OMB) has not reviewed this rule under those Orders.
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.
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 2019 Census of Agriculture, 16,585 organic farms in the United States reported sales of organic products and total farmgate sales more than $9.9 billion.
According to the NOP's Organic Integrity Database, there are 19,059 organic handlers that are certified under the USDA organic regulations.
SBA defines small agricultural service firms, which include certifying agents, as those having annual receipts of less than $8,000,000 (13 CFR 121.201). There are currently 77 USDA-accredited certifying agents; based on a query of the NOP certified organic operations database. While many certifying agents are small entities that would be affected by this proposed rule, we do not expect that these certifying agents would incur significant costs as a result of this action. Certifying agents already must comply with the current regulations,
AMS has determined that this rule would not have a significant impact on a substantial number of small entities, as defined by SBA. The effect of this rule, if implemented as final, would be to remove the allowance of seventeen substances in organic production and organic handling. The removal of these substances, while numerous, is due to the fact that alternatives have rendered them no longer necessary, they are no longer in use, or organic versions have become available. AMS invites comments on the anticipated costs of this proposed rule, including the impacts on small businesses.
Executive Order 12988 instructs each executive agency to adhere to certain requirements in the development of new and revised regulations to avoid unduly burdening the court system. 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
This proposed rule is not intended to have a retroactive effect.
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 under Executive Order 13175—Consultation and Coordination with Indian Tribal Governments. Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on:
AMS has assessed the impact of this proposed rule on Indian tribes and determined that this rule would not have tribal implications that require consultation under Executive Order 13175. AMS hosts a quarterly teleconference with tribal leaders where matters of mutual interest regarding the marketing of agricultural products are discussed. Information about the proposed changes to the regulations will be shared during an upcoming quarterly call, and tribal leaders will be informed about the proposed revisions to the regulation and the opportunity to submit comments. AMS will work with the USDA Office of Tribal Relations to ensure meaningful consultation is provided as needed with regards to the NOP regulations.
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, Agriculture, Animals, Animal drugs, Dairy products, Food grades and standards, Foods, Labeling, Livestock, Meat and meat products, Organically produced products, Reporting and recordkeeping requirements, Seals and insignia.
For the reasons set forth in the preamble, AMS proposes to amend 7 CFR part 205 as follows:
7 U.S.C. 6501–6524.
The revision to read as follows:
(j) * * *
(9) Vitamins C and E.
Only the following nonorganically produced agricultural products may be used as ingredients in or on processed products labeled as “organic,” only in accordance with any restrictions specified in this section, and only when the product is not commercially available in organic form.
(a) Carnauba wax.
(b) Casings, from processed intestines.
(c) Celery powder.
(d) Colors derived from agricultural products—Must not be produced using synthetic solvents and carrier systems or any artificial preservative.
(1) Beet juice extract color—derived from
(2) Beta-carotene extract color—derived from carrots (
(3) Black/purple carrot juice color—derived from
(4) Chokeberry, aronia juice color—derived from
(5) Elderberry juice color—derived from
(6) Grape skin extract color—derived from
(7) Purple sweet potato juice color—derived from
(8) Red cabbage extract color—derived from
(9) Red radish extract color—derived from
(10) Saffron extract color—derived from
(e) Fish oil (Fatty acid CAS #'s: 10417–94–4, and 25167–62–8)—stabilized with organic ingredients or only with ingredients on the National List, §§ 205.605 and 205.606.
(f) Fructooligosaccharides (CAS # 308066–66–2).
(g) Gelatin (CAS # 9000–70–8).
(h) Glycerin (CAS # 56–81–5)—produced from agricultural source materials and processed using biological or mechanical/physical methods as described under § 205.270(a).
(i) Gums—water extracted only (Arabic; Guar; Locust bean; and Carob bean).
(j) Inulin-oligofructose enriched (CAS # 9005–80–5).
(k) Lecithin—de-oiled.
(l) Orange pulp, dried.
(m) Orange shellac-unbleached (CAS # 9000–59–3).
(n) Pectin (non-amidated forms only).
(o) Potassium acid tartrate.
(p) Seaweed, Pacific kombu.
(q) Starches.
(1) Cornstarch (native).
(2) [Reserved]
(r) Tamarind seed gum.
(s) Tragacanth gum (CAS # 9000–65–1).
(t) Wakame seaweed (