Source: https://www.federalregister.gov/documents/2003/04/16/03-9412/national-organic-program-proposed-amendments-to-the-national-list-of-allowed-and-prohibited
Timestamp: 2018-08-20 23:14:50
Document Index: 269032610

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Federal Register :: National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances
A Proposed Rule by the Agricultural Marketing Service on 04/16/2003
Comments must be received by April 28, 2003.
68 FR 18556
18556-18560 (5 pages)
Docket Number TM-02-03
03-9412
Section 205.602 Nonsynthetic Substances Prohibited for Use in Organic Crop Production
Section 205.603 Synthetic Substances Allowed for Use in Organic Livestock Production
Section 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))'
III. Request for Public Comment on the Use of Ethylene
V. Statutory and Regulatory Authority
https://www.federalregister.gov/d/03-9412 https://www.federalregister.gov/d/03-9412
Start Preamble Start Printed Page 18556
This proposed rule would amend the U.S. Department of Agriculture's (USDA) National List of Allowed and Prohibited Substances (National List) to reflect recommendations submitted to the Secretary by the National Organic Standards Board (NOSB) from June 6, 2000 through October 20, 2002. Technical corrections have also been included in this proposed rule to clarify specific sections of the National List and adequately reflect previous NOSB recommendations. Consistent with recommendations from the NOSB, this proposed rule would: add ten substances, along with any restrictive annotations, to the National List, revise the annotations of two substances, and make eight technical revisions. In addition to amending the National List, this proposed rule would offer the opportunity for public comment on the use of ethylene in organic crop production.
Mail: Comments may be submitted by mail to: Richard H. Mathews, Program Manager, National Organic Program, USDA-AMS-TMP-NOP, 1400 Independence Ave., SW., Room 4008-So., Ag Stop 0268, Washington, DC 20250.
Written comments on this proposed rule should be identified with the docket number TMD-02-03. Commenters should identify the topic and section number of this proposed rule to which the comment refers.
Toni A. Strother, Agricultural Marketing Specialist, Telephone: (202) 720-3252; Fax: (202) 205-7808.
On December 21, 2000 the Secretary established, within the National Organic Standards (NOS) [7 CFR part 205], the National List (§§ 205.600 through 205.607). The National List is the Federal list that identifies synthetic substances and ingredients that are allowed and nonsynthetic (natural) substances and ingredients that are prohibited for use in organic production and handling. Since established, the National List has not been amended. However, under the authority of the Organic Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501 et seq.), the National List can be amended by the Secretary based on proposed amendments developed by the NOSB.
This proposed rule would amend the National List to reflect recommendations submitted to the Secretary by the NOSB from June 6, 2000 through October 20, 2002. Between the specified time period, the NOSB has recommended that the Secretary add ten substances to §§ 205.601 through 205.603 of the National List based on petitions received from industry participants. These substances were evaluated by the NOSB using the criteria specified in OFPA (7 U.S.C. 6517 and 6518) and the NOS. The NOSB also recommended that the Secretary revise the annotations of two substances included within sections 205.602 and 205.605.
The NOSB has recommended that the Secretary add additional substances to sections 205.603 and 205.605 which have not been included in this proposed rule but are under review and, as appropriate, will be included in future rulemaking.
In addition to the amendments made based on June 6, 2000 through October 20, 2002 NOSB recommendations, this proposed rule would also make technical revisions to specific sections of the National List that provide clarity and adequately reflect the intent of the paragraphs identified within those sections.
The following provides an overview of the proposed amendments made to designated sections of the National List:
This proposed rule would amend the introductory paragraph of § 205.601 by adding language which clarifies that synthetic substances used in crop production must be used in a manner which does not contribute to contamination of crops, soil, or water. The proposed amendment further clarifies that synthetic substances, except those in paragraphs (c), (j), (k), and (l), may only be used when the provisions of § 205.206(a) through (d) prove insufficient to prevent or control the target pest.
This proposed rule would amend paragraph (a) of § 205.601 (as algicide, disinfectants and sanitizers, including Start Printed Page 18557irrigation cleaning systems) by adding the following materials:
Copper Sulfate, for use as an algicide, is limited to one application per field during any 24-month period. Application rates are limited to those which do not increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited certifying agent.
Ozone Gas, for use as an irrigation system cleaner only; and
Peracetic acid, for use in disinfecting equipment, seed, and asexually propagated planting material.
Paragraph (a) is proposed to be further amended by correcting the spelling of the word “demisters” contained in subparagraph (a)(4) to “demossers.”
This proposed rule would amend paragraph (e) of § 205.601 by adding the following material:
Copper Sulfate, for use as tadpole shrimp control in rice production, is limited to one application per field during any 24-month period. Application rates are limited to levels which do not increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited certifying agent.
This proposed rule would amend paragraph (i) of § 205.601 (as plant disease control) by adding the following substance:
Peracetic acid, for use to control fire blight bacteria when approved by the Environmental Protection Agency (EPA) under a Special Local Need (24c) registration.
This proposed rule would revise paragraph (k) of § 205.601 (as plant growth regulators) by inserting the word “gas” behind “ethylene” to be consistent with the June 2000 NOSB recommendation for the substance. Section 205.601(k) will now read “As plant growth regulators—Ethylene gas, for regulation of pineapple flowering.”
This proposed rule revises paragraph (m) of § 205.601 by inserting a new subpart (2) as follows:
This proposed rule would amend § 205.602 by adding the following substance:
Calcium chloride, except as a brine-sourced foliar spray to treat physiological disorders associated with calcium uptake.
This proposed rule revises current paragraph (h) of § 205.602 by amending its annotation to read as follows:
Sodium nitrate—unless use is restricted to no more than 20% of the crop's total nitrogen requirement; use in spirulina production is unrestricted until October 21, 2005.
This proposed rule would revise current subparagraph (4) of § 205.603 (a) by correcting the spelling of the word “chlorohexidine” to “chlorhexidine.”
This proposed rule would amend paragraph (d) of § 205.603 (as feed additives) by adding the following substances:
DL—Methionine, DL—Methionine—Hydroxy Analog, and DL—Methionine—Hydroxy Analog Calcium—for use only in organic poultry production until October 21, 2005.
This proposed rule would revise current subparagraph (1) of § 205.603 (d) by removing examples (i) and (ii), copper sulfate and magnesium sulfate, as they are both approved for use by FDA and do not need to be listed individually as examples. As currently published, subparagraphs § 205.603 (d) (1) (i) and (ii) may mislead readers to believe that the use of trace minerals are limited only to copper sulfate and magnesium sulfate. Therefore, the revision made in this proposed rule for current subparagraph (1) of § 205.603 (d) would read “Trace minerals, used for enrichment or fortification when FDA approved.”
This proposed rule would amend current paragraph (e) of § 205.603 (As synthetic inert ingredients as classified by the Environmental Protection Agency (EPA), for use with nonsynthetic substances or synthetic substances listed in this section and used as active pesticide ingredients in accordance with any limitations on the use of such substances.) by redesignating current paragraph (f) of § 205.603 as new subparagraph (1) under § 205.603 (e). While drafting § 205.603 for final publication in the Federal Register, current paragraph (f) was intended to be designated as § 205.603 (e) (1), however, its designation was not properly assigned. Therefore, this proposed rule redesignates current paragraph (f) of § 205.603 as subparagraph (e) (1) of the same section.
This proposed rule would amend current paragraph (a) of § 205.605 by adding agar-agar, carageenan and tartaric acid as technical corrections. These substances were included on the National List proposed in the Federal Register on December 16, 1997, but were inadvertently removed from the National List published in the Federal Register on March 13, 2000, proposed rule and on December 21, 2000, Final Rule (7 CFR Part 205).
This proposed rule would revise current paragraph (b) (10) of § 205.605 by amending its annotation to read as follows:
Ethylene, allowed for postharvest ripening of tropical fruit and degreening of citrus.
Ethylene, for organic crop production, was a substance that was petitioned and reviewed for inclusion onto the National List after promulgation of the proposed rule published in the Federal Register on March 13, 2000. The NOSB approved and recommended that ethylene gas be included on the National List with the annotation “for regulation of pineapple flowering.” After receiving the NOSB recommendation for the material, the NOP, while finalizing the NOS, included the material on the National List without receiving public comment on the material through the Federal rulemaking process. As a result, this proposed rule requests public comment on the use of ethylene gas for regulation of pineapple flowering.
Eight notices were published regarding the meetings of the NOSB and its deliberations on recommendations and substances petitioned for amending the National List. Substances and recommendations included in this proposed rule were announced for NOSB deliberation in the following Federal Register Notices: (1) 64 FR 54858, October 8, 1999 (Ethylene); (2) 65 FR 33802, May 25, 2000, (Ethylene gas); (3) 65 FR 64657, October 30, 2000, (Calcium borogluconate and Peracetic acid); (4) 66 FR 10873, February 20, 2001, (Poloxalene); (5) 66 FR 48654, September 21, 2001, (Calcium chloride, Copper sulfate, Methionine); (6) 67 FR 19375, April 19, 2002, (Potassium sorbate and Sodium propionate); (7) 67 FR 54784, August 26, 2002, (Ozone gas, Pheromones, Sodium (Chilean) nitrate, Propylene glycol, Magnesium hydroxide/Magnesium oxide, Kaolin pectin, Bismuth subsalicylate, Flunixin, Xylazine, Tolazoline, Butorphanol, Mineral oil, Activated charcoal, Epinephrine); and (8) 67 FR 62950, Start Printed Page 18558October 9, 2002, (Potassium sulfate and Calcium propionate).
The Organic Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501 et seq.), authorizes the Secretary, at section 6517(d)(1), to make amendments to the National List based on proposed amendments developed by the NOSB. Sections 6518(k)(2) and 6518(n) of OFPA authorize the NOSB to develop proposed amendments to the National List for submission to the Secretary and establish a petition process by which persons may petition the NOSB for the purpose of having substances evaluated for inclusion onto or deletion from the National List. The National List petition process is implemented under § 205.607 of the NOS. The current petition process (65 FR 43259) can be accessed through the NOP Web site at http://www.ams.usda.gov/​nop.
This action has been determined to be non-significant for purposes of Executive Order 12866, and therefore, does not have to be reviewed by the Office of Management and Budget.
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. The final rule was reviewed under this Executive Order and no additional related information has been obtained since then. This proposed rule is not intended to have a retroactive effect.
States and local jurisdictions are preempted under section 2115 of the Organic Foods Production Act (OFPA) (7 U.S.C. 6514) 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 2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under sections 2104 through 2108 of the OFPA (7 U.S.C. 6503 through 6507) 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 2120(f) of the OFPA (7 U.S.C. 6519(f)), this regulation would not alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspections Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), concerning meat, poultry, and egg products, 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 (EPA) under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.).
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) 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 is to fit regulatory actions to the scale of businesses subject to the action.
Pursuant to the requirements set forth in the RFA, the Agricultural Marketing Service (AMS) performed an economic impact analysis on small entities in the final rule published in the Federal Register on December 21, 2000. AMS has also considered the economic impact of this action on small entities. Due to the changes reflected in this proposed rule that allow the use of additional substances in agricultural production and handling, the Administrator of AMS certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities. This action relaxes the regulations published in the final rule and provides small entities with more tools to use in day-to-day operations. Small agricultural service firms, which include producers, handlers, and accredited certifying agents, have been defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts of less than $750,000 and small agricultural producers are defined as those having annual receipts of less than $5,000,000.
The U.S. organic industry at the end of 2001 included nearly 6,600 certified crop and livestock operations, including organic production and handling operations, producers, and handlers. These operations reported certified acreage totaling more than 2.34 million acres, 72,209 certified livestock, and 5.01 million certified poultry. Data on the numbers of certified handling operations are not yet available, but likely number in the thousands, as they would include any operation that transforms raw product into processed products using organic ingredients. Growth in the U.S. organic industry has been significant at all levels. From 1997 to 2001, the total organic acreage grew by 74 percent; livestock numbers certified organic grew by almost 300 percent over the same period, and poultry certified organic increased by 2,118 percent over this time. Sales growth of organic products has been equally significant, growing on average around 20 percent per year. Sales of organic products were approximately $1 billion in 1993, but are estimated to reach $13 billion this year, according to the Organic Trade Association (the association that represents the U.S. organic industry). In addition, USDA has accredited 81 certifying agents who have applied to USDA to be accredited in order to provide certification services to producers and handlers. A complete list of names and addresses of accredited certifying agents may be found on the AMS NOP Web site, at http://www.ams.usda.gov/​nop. AMS believe that most of these entities would be considered small entities under the criteria established by the SBA.
Additional regulatory flexibility analysis beyond the regulatory flexibility analysis published in the NOP final rule on December 21, 2000, is not required for the purposes of this proposed rule. Comments from small entities affected by parts of this Start Printed Page 18559proposed rule will be considered in relation to the requirements of the RFA. These comments must be submitted separately and cite 5 U.S.C. 609 in the correspondence.
Pursuant to the Paperwork Reduction Act of 1995, the existing information collection requirements for the NOP are approved under OMB number 0581-0181. No additional collection or recordkeeping requirements are imposed on the public by this proposed rule. Accordingly, OMB clearance is not required by section 350(h) of the Paperwork Reduction Act, 44 U.S.C. 3501, et seq., or OMB's implementing regulation at 5 CFR part 1320.
This proposed rule reflects recommendations submitted to the Secretary by the NOSB. The ten substances proposed to be added to the National List were based on petitions from the industry and evaluated by the NOSB using criteria in the Act and the regulations. Because these substances are critical to organic production and handling operations, producers and handlers should be able to use them in their operations as soon as possible. Accordingly, AMS believes that a 10-day period for interested persons to comment on this rule is appropriate.
2. Section 205.601 is amended by:
b. Redesignating paragraphs (a)(3) and (a)(4) as paragraphs (a)(4) and (a)(7), respectively.
c. Adding new paragraphs (a)(3), (a)(5), and (a)(6).
d. Revising the word “demisters” in newly redesignated paragraph (a)(7) to read “demossers”.
e. Redesignating paragraphs (e)(3) through (e)(7) as paragraphs (e)(4) through (e)(8).
f. Adding a new paragraph (e)(3).
g. Redesignating paragraphs (i)(7) through (i)(10) as paragraphs (i)(8) through (i)(11), respectively.
h. Adding a new paragraph (i)(7).
i. Revising paragraph (k).
j. Adding new paragraph (m)(2).
In accordance with restrictions specified in this section, the following synthetic substances may be used in organic crop production: Provided, That, use of such substances do not contribute to contamination of crops, soil, or water. Substances allowed by this section, except those in paragraphs (c), (j), (k), and (l) of this section, may only be used when the provisions set forth in § 205.206(a) through (d) prove insufficient to prevent or control the target pest.
(3) Copper sulfate—for use as an algicide, is limited to one application per field during any 24-month period. Application rates are limited to those which do not increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited certifying agent.
(3) Copper Sulfate—for use as tadpole shrimp control in rice production, is limited to one application per field during any 24-month period. Application rates are limited to levels which do not increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited certifying agent.
(7) Peracetic acid—for use to control fire blight bacteria when approved by the Environmental Protection Agency (EPA) under a Special Local Need (24c) registration.
3. Section 205.602 is revised to read as follows:
§ 205.602
Nonsynthetic substances prohibited for use in organic crop production.
(g) Sodium nitrate—unless use is restricted to no more than 20% of the crop's total nitrogen requirement, or until October 21, 2005; for unrestricted use in spirulina production.
4. Section 205.603 is amended by:
b. Revising the word “chlorohexidine” in paragragh (a)(4) to read “chlorhexidine”.
c. Redesignating paragraphs (b)(1) through (b)(5) and (b)(6) as (b)(2) through (b)(6) and (b)(1), respectively.
(d) Redesignating paragraphs (d)(1) and (d)(2) as paragraphs (d)(2) and (d)(3), resepectively.
e. Adding a new paragraph (d)(1).
f. Revising newly redesignated paragraph (d)(2).
g. Redesignating paragraph (f) as paragraph (e)(1) and reserving paragraph (e)(2);
h. Reserving paragraphs (f)-(z).
(4) Chlorhexidine—Allowed for surgical procedures conducted by a veterinarian. Allowed for use as a teat dip when alternative germicidal agents and/or physical barriers have lost their effectiveness.
(5) Chlorine materials—disinfecting and sanitizing facilities and equipment. Residual chlorine levels in the water Start Printed Page 18560shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act.
(13) Parasiticides. Ivermectin—prohibited in slaughter stock, allowed in emergency treatment for dairy and breeder stock when organic system plan-approved preventive management does not prevent infestation. Milk or milk products from a treated animal cannot be labeled as provided for in subpart D of this part for 90 days following treatment. In breeder stock, treatment cannot occur during the last third of gestation if the progeny will be sold as organic and must not be used during the lactation period of breeding stock.
(1) DL—Methionine, DL—Methionine—hydroxy analog, and DL—Methionine—hydroxy analog calcium—for use only in organic poultry production until October 21, 2005.
5. Section 205.605 is revised 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)).”
Colors, nonsynthetic sources only.
Yeast—nonsynthetic, growth on petrochemical substrate and sulfite waste liquor is prohibited (Autolysate; Bakers; Brewers; Nutritional; and Smoked—nonsynthetic smoke flavoring process must be documented).
(a) Synthetics allowed:
Lecithin—bleached.
Magnesium carbonate—for use only in agricultural products labeled “made with organic (specified ingredients or food group(s)),” prohibited in agricultural products labeled “organic”.
Potassium tartrate made from tartaric acid.
Potassium hydroxide—prohibited for use in lye peeling of fruits and vegetables.
Potassium iodide—for use only in agricultural products labeled “made with organic (specified ingredients or food group(s)),” prohibited in agricultural products labeled “organic”.
6. In § 205.607, paragraph (c) is revised to read as follows:
§ 205.607
Amending the National List.
(c) A petition to amend the National List must be submitted to: Program Manager, USDA/AMS/TMP/NOP, 1400 Independence Ave., SW., Room 4008-So., Ag Stop 0268, Washington, DC 20250.
Administrator, Agricultural Marketing Services.
[FR Doc. 03-9412 Filed 4-15-03; 10:52 am]