Source: https://www.federalregister.gov/documents/2019/10/18/2019-22639/national-organic-program-proposed-amendments-to-the-national-list-of-allowed-and-prohibited
Timestamp: 2019-11-22 02:28:38
Document Index: 388198639

Matched Legal Cases: ['§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205', '§\u2009205']

Federal Register :: National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances per October 2018 NOSB Recommendations (Crops and Handling)
A Proposed Rule by the Agricultural Marketing Service on 10/18/2019
55866-55870 (5 pages)
Document Number AMS-NOP-19-0023
NOP-19-01
0581 AD83
Blood Meal—Made With Sodium Citrate
§ 205.606 Nonorganically Produced Agricultural Products Allowed as Ingredients in or on Processed Products Labeled as “Organic.”
https://www.federalregister.gov/d/2019-22639 https://www.federalregister.gov/d/2019-22639
Start Preamble Start Printed Page 55866
Instructions: All submissions received must include the docket number AMS-NOP-19-0023, NOP-19-01, and/or Regulatory Information Number (RIN) 0581-AD83 for this rulemaking. When submitting a comment, clearly indicate the proposed rule topic and section number to which the comment refers. In addition, comments should clearly indicate whether the commenter supports the action being proposed and also clearly indicate the reason(s) for the position. Comments can also include information on alternative management practices, where applicable, that support alternatives to the proposed amendments. Comments should also offer any recommended language change(s) that would be appropriate to the position. Please include relevant information and data to support the position such as scientific, environmental, manufacturing, industry, or impact information, or similar sources. Only relevant material supporting the position should be submitted. All comments received will be posted without change to 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. Eastern Time, Monday through Friday (except official Federal holidays). Persons wanting to visit the USDA South Building to view comments received in response to this proposed rule are requested to make an appointment in advance by calling (202) 720-3252.
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 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 three NOSB recommendations to amend the National List that were submitted to the Secretary on October 26, 2018. Table 1 summarizes the proposed changes to the National List based on these NOSB recommendations.
Blood meal—made with Sodium citrate § 205.601 Add to National List.
Natamycin § 205.602 Add to National List.
Tamarind seed gum § 205.606 Add to National List.
The proposed rule would amend the National List to add blood meal—made with sodium citrate to § 205.601 as a synthetic substance allowed for use in crop production. Table 2 illustrates the proposed listing.
Table 2—Proposed Rule Action for Blood Meal Using Sodium Citrate
Proposed rule action: Add blood meal—made with sodium citrate to § 205.601(j).
On July 20, 2016, AMS received a petition [1] to add sodium citrate to the National List as an anticoagulant for spray dried blood products. The addition of sodium citrate prevents the blood from clotting and maintains the blood in a liquid state while it is processed to dried blood meal. In its natural state, blood meal is a nonsynthetic substance that may be used in organic production as a soil amendment.
The NOSB reviewed and considered this petition at its public meeting on October 26, 2018. At the conclusion of meeting, the NOSB recommended to the Secretary to add sodium citrate, for use as an anticoagulant in the production of blood meal, to the National List.[2] In its recommendation, the NOSB requested that AMS review sodium citrate to determine whether sodium citrate used to process blood meal must be on the National List in order for the resulting blood meal to be allowed in organic crop production.
AMS reviewed the NOSB's sodium citrate recommendation, the sodium citrate petition, and the sodium citrate technical report.[3] AMS concurs with the NOSB's determination that sodium citrate is a synthetic substance. Further, AMS concludes that the use of sodium citrate to manufacture blood meal means that blood meal would not qualify as a nonsynthetic substance. AMS also concurs with the NOSB's determination that the construct of the National List does not include processing aids for crop production substances; rather it includes the generic crop production substance. AMS determined that sodium citrate's use as an anticoagulant in the production of blood meal is not included within the production aid categories specified in the OFPA (7 U.S.C. 6517(c)(1)(B)).
Therefore, to address the NOSB's recommendation to allow the use of sodium citrate, AMS is proposing to add blood meal produced with sodium citrate to the National List. This determination is consistent with the current listing for liquid fish products that are pH adjusted with sulfuric, citric, or phosphoric acid and allowed in organic crop production as a plant or soil amendment (§ 205.601(j)(8)). In that case, the addition of a synthetic processing aid, i.e., the specified acids, to a nonsynthetic substance, liquid fish products, was resolved by listing as a synthetic substance liquid fish products that are pH adjusted with the specified acids. The addition of the synthetic substance, sodium citrate, in the processing of blood meal means that the final product is also synthetic and must be on the National List for use in organic crop production.[4]
In its recommendation to the Secretary, the NOSB stated that there is no concern with using sodium citrate to make dried blood meal and noted that sodium citrate is on the National List in § 205.605(b) as an allowed ingredient for use in organic processing. This proposed rule would amend the National List by adding blood meal made with sodium citrate to § 205.601(j) as a plant or soil amendment.
This proposed rule would add natamycin to § 205.602, Nonsynthetic substances prohibited for use in organic crop production.
The proposed rule would amend the National List to add natamycin to § 205.602. Table 2 illustrates the proposed listing.
Table 3—Proposed Rule Action For Natamycin
Proposed rule action: Add natamycin to § 205.602.
On September 1, 2016, AMS received a petition [5] to add natamycin as a nonsynthetic substance allowed for use in organic crop production as a post-harvest treatment to control fungal diseases. Natamycin is a naturally occurring compound produced by soil bacteria. Natamycin is used in agriculture and in food processing for its antifungal properties as either a fungicide or fungistat. These properties are effective over a wide pH range. To enhance review of this petition, the NOSB solicited a technical report on natamycin.[6] This report indicates that natamycin is regulated by both the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). Commercial applications of natamycin in crop, livestock, and food production can be grouped into three basic categories: Pre- or post-harvest agricultural fungicide; livestock medication; or as a preservative in processed foods. For example, natamycin may be used in mushroom production to control fungal diseases and in post-harvest handling treatment of raw agricultural commodities, such as fruits, to prevent spoilage. Natamycin is also used in animal health for treating ringworm and candidosis in horses and cattle. Natamycin is approved as a preservative in certain processed foods, such as cheese, yogurt, and certain beverages.
The 2016 natamycin petition is the second natamycin petition received and reviewed by the NOSB. In March 2007 the NOSB reviewed a petition on natamycin for use as a nonsynthetic, nonagricultural substance in organic processing and handling, to prevent or delay mold growth in packaged baked goods. After reviewing the 2007 petition, the NOSB considered adding natamycin to the National List in § 205.605(a), Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).” At the conclusion of the March 2007 meeting, the NOSB did not recommend adding natamycin to Start Printed Page 55868§ 205.605(a). Some comments received by the NOSB during the 2007 meeting stated opposition to allowing natamycin in organic handling because the commenters believed that natamycin is an antibiotic, and its use as a preservative would not be compatible with organic standards. In 2007, the NOSB determined natamycin to be a nonsynthetic substance and that its use, as petitioned, was not compatible with organic handling standards.
At its October 26, 2018, public meeting, the NOSB considered the second natamycin petition as a nonsynthetic substance in organic crop production and received public comment. In its review, the NOSB also considered a November 2, 2017, technical evaluation report on natamycin that described its manufacture, industry uses, regulation, and chemical properties.
After considering the petition, technical report, and public comments, the NOSB determined (1) that natamycin is a nonsynthetic substance and (2) that the use of natamycin as a post-harvest treatment on harvested crops met the OFPA criteria for prohibitions on natural substances because its use could negatively impact human health by increasing fungal resistance to natamycin. As such, its use would not be consistent with organic farming or handling. Therefore, the NOSB recommended adding natamycin to § 205.602 as a nonsynthetic substance prohibited for use in organic crop production.[7]
AMS has reviewed the NOSB recommendation on natamycin and agrees that natamycin meets the OFPA criteria for listing as a prohibited substance in organic crop production. AMS proposes addressing this NOSB recommendation through this proposed rule. Consistent with the NOSB recommendation, this proposed rule would amend the National List by adding natamycin to § 205.602 as a prohibited nonsysthetic substance. This action would prohibit any use of natamycin in organic crop production, including both pre-harvest and post-harvest treatment.
The proposed rule would amend the National List to add tamarind seed gum as a non-organic agricultural substance listed in § 205.606 for use in organic handling.
Table 4—Proposed Rule Action For Tamarind Seed Gum
Proposed rule action: Add tamarind seed gum to § 205.606.
On February 13, 2017, AMS received a petition [8] to add tamarind seed gum to the National List in § 205.606 for use in organic handling as a thickener, stabilizer, or gelling agent in processed foods. Tamarind seed gum is a plant polysaccharide (polymer of carbohydrate molecules) derived from the kernel, or endosperm, of seeds of the tamarind tree. Tamarind seed gum is Generally Regarded as Safe (GRAS) for several applications as a food additive—specifically in foods such as cheese, fruit preserves, sauces, and ice cream.
To enhance its review of this petition, the NOSB solicited a technical report [9] on tamarind seed gum. This report indicated that tamarind seed gum is regulated by the FDA as a GRAS food additive and specifically, as a stabilizer and thickener as defined by 21 CFR 170.3.
At its October 26, 2018, public meeting, the NOSB considered the petition on adding tamarind seed gum to the National List for use in organic handling. As part of its review, the NOSB considered a February 21, 2018, technical report on tamarind seed gum that described its manufacture, industry uses, regulation, and chemical properties. After considering the petition, technical report, and public comments on tamarind seed gum, the NOSB determined that the allowance of non-organic tamarind seed gum for use as an ingredient in organic handling is consistent with the OFPA evaluation criteria for National List substances. The NOSB's evaluation also determined that tamarind seed gum provides different processing characteristics and texture compared to the gums currently on the National List. Subsequently, the NOSB recommended [10] adding tamarind seed gum to § 205.606 as a nonorganically produced agricultural product allowed as ingredients in or on processed products labeled as “organic.”
AMS has reviewed the NOSB recommendation on tamarind seed gum and agrees that tamarind seed gum satisfies the OFPA evaluation criteria for an allowed substance on the National List. Subsequently, AMS proposes addressing this NOSB recommendation through this proposed rule. Consistent with the NOSB recommendation, this proposed rule would amend the National List by adding tamarind seed gum to § 205.606 as a nonorganically produced agricultural product allowed as an ingredient in or on processed products labeled as “organic.” This action would require organic handlers who use tamarind seed gum to source an organic form of the ingredient 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.[11]
On August 9, 2018, a document was published in the Federal Register (83 FR 39376) announcing the fall 2018 NOSB meeting. One purpose of the meeting was to deliberate on recommendations on substances petitioned as amendments to the National List.
This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) has Start Printed Page 55869exempted from Executive Order 12866. Additionally, because this proposal does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled ‘Reducing Regulation and Controlling Regulatory Costs’ ” (February 2, 2017).
The 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 $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 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.[12] Based on that data, organic sales average $400,000 per farm. Assuming a normal distribution of producers, we expect that most of these producers would fall under the $750,000 sales threshold to qualify as a small business.
According to the NOP's Organic Integrity Database, there are 18,105 organic handlers that are certified under the USDA organic regulations (10,184 of these handlers are based in the U.S).[13] The Organic Trade Association's 2018 Organic Industry Survey has information about employment trends among organic manufacturers. The reported data are stratified into three groups by the number of employees per company: Less than 5; 5 to 49; and 50 plus. These data are representative of the organic manufacturing sector and the lower bound (50) of the range for the larger manufacturers is significantly smaller than the SBA's small business thresholds (500 to 1,250). Therefore, AMS expects that most organic handlers would qualify as small businesses.
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 two additional substances in organic crop production and organic handling. Adding two substances to the National List would increase regulatory flexibility and would give small entities more tools to use in day-to-day operations. This action would also prohibit the use of natamycin in organic crop production due to its possible impact on human health. AMS reviewed comments submitted to the NOSB indicating that there is little to no use of natamycin currently in organic crop production. Therefore, AMS concludes that the economic impact of this addition, if any, would be minimal because there are other practices and substances that provide effective fungal control in organic crop production. Accordingly, USDA certifies that this rule would not have a significant economic impact on a substantial number of small entities.
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 Start Printed Page 55870EPA under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.).
This proposed rule reflects recommendations submitted by the NOSB to the Secretary to add two substances to the National List and notify organic producers and certifying agents of AMS's decision not to add sodium citrate to the National List. A 60-day period for interested persons to comment on this rule is provided.
2. Amend § 205.601 by redesignating paragraphs (j)(2) through (11) as paragraphs (j)(3) through (12) and adding new paragraph (j)(2) to read as follows:
(2) Blood meal—made with sodium citrate.
3. Amend § 205.602 by redesignating paragraphs (e) through (j) as paragraphs (f) through (k) and adding new paragraph (e) to read as follows:
(e) Natamycin.
4. Amend § 205.606 by redesignating paragraphs (s) through (w) as paragraphs (t) through (x) and adding new paragraph (s) to read as follows:
(s) Tamarind seed gum.
1. Sodium citrate petition: https://www.ams.usda.gov/​sites/​default/​files/​media/​Sodium%20Citrate%20Crops%20Pet.pdf.
2. NOSB recommendation for sodium citrate: https://www.ams.usda.gov/​sites/​default/​files/​media/​CSSodiumCitratePetRecOct2018.pdf.
3. Technical Evaluation Report for sodium citrate (for used in crop production): https://www.ams.usda.gov/​sites/​default/​files/​media/​SodiumCitrateCropsTR20171218.pdf.
4. Guidance on determining whether a substance is synthetic or non-synthetic is described in document NOP 5033-1, Guidance Decision Tree for Classification of Materials as Synthetic or Nonsynthetic: https://www.ams.usda.gov/​sites/​default/​files/​media/​NOP-Synthetic-NonSynthetic-DecisionTree.pdf.
5. Natamycin petition: https://www.ams.usda.gov/​sites/​default/​files/​media/​Natamycin%20NOP%20Petition%20-%2001%20Sep%2016.pdf.
6. Natamycin Technical Evaluation Report, November 2017: https://www.ams.usda.gov/​sites/​default/​files/​media/​NatamycinTR20171102.pdf.
7. NOSB natamycin recommendation: https://www.ams.usda.gov/​sites/​default/​files/​media/​CSNatamycinPetRecOct2018.pdf.
8. Tamarind seed gum petition: https://www.ams.usda.gov/​sites/​default/​files/​media/​TamGumPetition.pdf.
9. Tamarind seed gum technical evaluation report, February 2018: https://www.ams.usda.gov/​sites/​default/​files/​media/​TamarindSeedGumTR2018221.pdf.
10. NOSB recommendation on tamarind seed gum: https://www.ams.usda.gov/​sites/​default/​files/​media/​HSTamarindSeedGumPetRecOct2018.pdf.
11. See 7 CFR 205.606 and 7 CFR 205.2 for definition of “Commercially available.”
12. U.S. Department of Agriculture, National Agricultural Statistics Service. 2017 Census of Agriculture. https://www.nass.usda.gov/​Publications/​AgCensus/​2017/​Full_​Report/​Volume_​1,_​Chapter_​1_​US/​. The number of organic farms includes both certified and exempt farms.
13. Organic Integrity Database: https://organic.ams.usda.gov/​Integrity/​. Accessed on June 7, 2019.
[FR Doc. 2019-22639 Filed 10-17-19; 8:45 am]