National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances (Crops)

Summary:

This proposed rule would amend the U.S. Department of Agriculture's (USDA's) National List of Allowed and Prohibited Substances (National List) to reflect recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board (NOSB) on November 19, 2008, and May 6, 2009. The recommendations addressed in this proposed rule pertain to amending an annotation for one exempted material on the National List and establishing an exemption (use) for another material in organic crop production. Consistent with the recommendations from the NOSB, this proposed rule would amend the annotation for a listed substance and add one substance, along with any restrictive annotation, to the National List.

Table of Contents

Dates:

Comments must be received by March 15, 2010.

Addresses:

Interested persons may comment on the proposed rule using the following procedures:

Internet: http://www.regulations.gov.

Mail: Comments may be submitted by mail to: Toni Strother, Agricultural Marketing Specialist, National Organic Program, USDA-AMS-TMP-NOP, Room 2646-So., Ag Stop 0268, 1400 Independence Ave., SW., Washington, DC 20250-0268.

Written comments responding to this proposed rule should be identified with the document number AMS-NOP-09-0081; TM-09-04. You should identify the topic and section number of this proposed rule to which your comment refers. You should clearly state whether you support the amendment of the annotation for the substance on the national list and/or the exemption for the substance being proposed, with clearly indicated reason(s) for your position. You should also offer any recommended language changes that would be appropriate for your position. Please include relevant information and data to support your position (e.g. scientific, environmental, manufacturing, industry, impact information, etc.). Only relevant material supporting your position should be submitted.

It is USDA's intention to have all comments concerning this proposed rule, including names and addresses when provided, regardless of submission procedure used, available for viewing on the Regulations.gov (http://www.regulations.gov) Internet site. Comments submitted in response to this proposed rule will also be available for viewing in person at USDA—AMS, National Organic Program, Room 2646-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:

Shannon Nally, Acting Director, Standards Division, Telephone: (202) 720-3252; Fax (202) 205-7808.

Supplementary information:

I. Background

On December 21, 2000, the Secretary established, within the National Organic Program (NOP) (7 CFR part 205), the National List regulations §§ 205.600 through 205.607. This 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. 6501et seq.), (OFPA), and NOP regulations, in § 205.105, 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 the OFPA, the National List can be amended by the Secretary based on proposed amendments developed by the NOSB. Since established, the National List has been amended eleven times: October 31, 2003, (68 FR 61987); November 3, 2003,(68 FR 62215); October 21, 2005, (70 FR 61217), June 7, 2006, (71 FR 32803); September 11, 2006, (71 FR 53299); June 27, 2007, (72 FR 35137); October 16, 2007, (72 FR 58469); December 10, 2007, (72 FR 70479); December 12, 2007, (72 FR 70479); September 18, 2008, (73 FR 59479); October 9, 2008, (73 FR 59479). Additionally, a proposed amendment to the National List was published on June 3, 2009, (74 FR 26591).

This proposed rule would amend the National List to reflect two recommendations submitted to the Secretary by the NOSB on November 19, 2008, and May 6, 2009. Based upon their evaluation of petitions submitted by industry participants, the NOSB recommended that the Secretary amend § 205.601 of the National List to amend the annotation for one exempted material (tetracycline) and add one substance (sulfurous acid) for use in organic crop production. The amended annotation and the exemption for use of the added substance in organic production were evaluated by the NOSB using the criteria specified in OFPA (7 U.S.C. 6517-6518).

II. Overview of Proposed Amendments

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

Section 205.601Synthetic Substances Allowed for Use in Organic Crop Production

This proposed rule would amend § 205.601 of the National List regulations by: (1) Amending the annotation of paragraph (i)(11) by eliminating the parenthetical reference to a form of the exempted material and adding an expiration date; and (2) adding new paragraph (j)(9), for the purpose of allowing the use of the following substances:

Tetracycline. Tetracycline, in the form of oxytetracycline calcium complex, was included in the National List as originally published on December 21, 2000 (FR 65 80548), for use for fire blight control only. In October 2007, a petition was submitted to add oxytetracycline hydrochloride complex for fireblight control in organic crop production. Tetracycline is a broad-spectrum antibiotic for control of bacteria, fungi and mycoplasma-like organisms which functions by inhibiting protein synthesis in bacteria and altering bacterial membranes so that vital genetic material is leaked. For regulatory purposes, Environmental Protection Agency (EPA) uses the term oxytetracycline to refer to pesticides containing either calcium oxytetracycline or hydroxytetracycline monohydrochloride (oxytetracycline hydrochloride). Oxytetracycline is registered with the EPA for the following agronomic uses: fire blight of apples, pears, peaches and nectarines; pear decline; bacterial spot on peaches and nectarines; lethal yellowing of coconut palm; and lethal decline of pritchardia palm.

Oxytetracyclines are derived from the soil bacteria, Streptomyces, by a fermentation process. Technical grade tetracycline is a pale yellow to tan crystalline powder, is freely soluble in water, and decomposes above 180 degrees Celsius. Formulated products containing the technical grade oxytetracycline calcium complex and oxytetracyline hydrochloride for fireblight are wettable powders which are spray-applied using ground or aircraft equipment at early bloom stage, when fire blight infection usually occurs. In addition to agronomic uses, oxytetracyclines are also antibiotics used in human and animal drugs.

Per the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 301et seq.), as amended by the Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170, August 3, 1996), the EPA established tolerances for residues of these oxytetracycline pesticides in or on raw apples, peaches, nectarines, and pears of 0.35 parts per million (ppm) (40 CFR 180.337). In the 2006 Tolerance Reassessment Progress and Risk Management Decision (TRED), EPA deemed that the toxicity of the oxytetracylines would be similar and thus treated oxytetracycline hydrochloride and oxytetracycline calcium as equivalent for hazard characterization. In conducting the tolerance reassessment for oxytetracycline, EPA considered the aggregate risk from exposure via food and water intake and concluded that the dietary risk for all U.S. populations was below the level of concern. In regards to ecological effects, the EPA reported the potential for terrestrial and aquatic species to be exposed to oxytetracyclines due to use patterns on food crops, and the potential for acute and/or chronic toxicity. The EPA concluded that it is unlikely that antibiotic resistance from pesticidal use of oxytetracycline would result from food exposure, but could theoretically occur among bacteria in orchards. The EPA is conducting a registration review of oxytetracycline to ensure that the intended function is achieved without unreasonable adverse effects on human health or the environment. That review is scheduled for completion in 2014.

At its November 18-20, 2008, meeting in Washington, DC, the NOSB recommended revising the tetracycline listing at 205.601(i)(11) to remove the qualifying words, “oxytetracycline calcium complex,” from the annotation and, in effect, permit the use of either form of oxytetracycline, i.e., oxytetracycline calcium complex and oxytetracycline hydrochloride until October 21, 2012. Both forms of oxytetracycline have EPA registered uses for fire blight control. In this open meeting, the NOSB evaluated the available technical forms of oxytetraclycline against the evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA, received public comment, and concluded that the two forms of tetracycline are comparable, and that allowing the use of both substances is consistent with the prior decision to allow the use of oxytetracycline calcium complex.

The NOSB, however, recommended adding an expiration date of October 21, 2012, after which no form of tetracycline could be used in organic crop production. Therefore, tetracycline will be removed from the National List by the expiration date rather than through a petition for removal or sunset. The recommendation to change the annotation for tetracycline would have reset the sunset date to 5 years from the date on which the annotation was changed through this rulemaking. The NOSB did not support prolonging the exemption for tetracycline and recommended an expiration date to prevent that occurrence. The NOSB did not find tetracycline to be essential to, nor compatible with, organic production, but approved the use of oxytetracycline hydrochloride solely on the basis that a functionally equivalent form is already allowed for use in organic crop production. The Board was informed during the meeting, and this information is supported by EPA references, that oxytetracycline calcium complex and oxytetracycline hydrochloride are the only forms of oxytetracycline that have registered agricultural uses. NOSB approval of this petition is not expected to increase the overall use of tetracycline in organic crop production, but would allow growers to substitute one form for another until October 21, 2012.

The NOP engaged in consultations with the EPA and Food and Drug Administration (FDA). The EPA informed the NOP that the proposed amendment to exempt oxytetracycline hydrochloride for use in organic crops is consistent with EPA regulations. Concerning the use of tetracycline, FDA deferred to EPA as the appropriateregulatory body. Therefore, after consultation with the EPA and FDA regarding NOSB's recommendation to amend the annotation for tetracycline use in organic crops, the Secretary proposes to accept NSOB's recommendation and amend § 205.601 of the National List by: (1) Removing the qualifying words in parenthesis from the annotation at (i)(11) which currently specifies, “oxytetracycline calcium complex” to allow either form of oxyetracycline to be used; and, adding the expiration date, October 21, 2012, after which no tetracycline may be used in organic crop production for fireblight control. [1]

Sulfurous Acid (CAS #-7782-99-2). Sulfurous Acid was petitioned for use in organic crop production as a soil amendment. It functions as an acidifying agent to neutralize and reduce the excessive alkalinity (bicarbonates and carbonates) in soil or water. This substance also has transient biocide properties that contribute to keeping irrigation conveyance systems clean by suppressing growth of bacteria and pathogenic microorganisms. Sulfurous acid is a clear, nearly colorless solution (6-12%) which has a pungent odor, and is soluble in water. Sulfurous acid degrades through microbial decomposition to hydrogen ion and sulfate ion. The hydrogen ions cause the acidifying effects. The sulfate ion is a nutrient to plants and micro-organisms as long as the soil is aerobic.

Sulfurous acid is produced through natural and man-made processes by reacting sulfur dioxide with water. In nature, sulfurous acid is produced by wild fires, hydro-thermal vents on the ocean floor, vents on the earth's surface, volcanic eruptions and fumaroles emitting sulfur dioxide and reacting with water. Sulfur dioxide is also produced by burning coal to produce heat or electricity. Sulfurous acid can be manufactured by oxidizing elemental sulfur in a burner chamber with pressurized water. The sulfur dioxide that is produced is immediately captured to form an aqueous solution of sulfurous acid which can be added to the irrigation water stream for application to fields. Within hours of formation, sulfurous acid degrades to a hydrogen ion and a bi-sulfite ion and is not sufficiently stable for transporting to a farm sites for use.

The EPA does not regulate the application of sulfurous acid as a soil amendment to reduce alkalinity. Sulfurous acid can cause burns from all routes of exposure and is corrosive. Handlers should have protective clothing, eyeware and gloves, and respirators may be needed in some circumstances. Sulfurous acid should be used in a well-ventilated area. Repeated exposure may cause damage to mucous membranes, upper respiratory tract, skin and eyes.

Adverse biological or chemical reactions are not likely from the proposed use in organic crops soil amendment purposes due to the quick degradation of sulfurous acid, provided, that the sulfurous acid is applied at the intended use rate and that soil pH is closely monitored. If anaerobic conditions develop in waterlogged soil, anaerobic bacteria could convert the sulfate ion to hydrogen sulfide which would be toxic to the immediate ecosystem.

At its May 4-6, 2009, meeting in Washington, DC, the NOSB recommended adding sulfurous acid to the National List as a soil amendment for use in organic crop production, to be generated on-farm only by burning 99% pure elemental sulfur per § 205.601(j)(2), due to the transient nature of the sulfurous acid. In this open meeting, the NOSB evaluated sulfurous acid against the evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA, received public comment, and concluded that the use of the substance, as annotated, is consistent with the OFPA evaluation criteria. The NOSB explained that the on-farm generation is necessary because the short half-life of sulfurous acid would prohibit shipping from off-farm sites. Furthermore, the NOSB specified elemental sulfur at 99% purity as it is typically available in this form.

The NOSB also examined whether the addition of sulfurous acid was necessary in consideration of other substances on the National List, specifically elemental sulfur and organic acids. The Board indicated that the controlled application of sulfurous acid via irrigation is preferable to broadcast applications of elemental sulfur, which acts slower and can negatively impact the microbial soil life at the application rates used. Furthermore, the Board determined that relying upon organic acids, such as citric, would require the importation and application of such large quantities as to make the use of those substances impractical.

The NOP engaged in consultations with the EPA and FDA. FDA deferred to EPA as the appropriate regulatory body. EPA concurred that the use of this substance as specified would not conflict with EPA regulations. Therefore, after consultation with the EPA and FDA regarding NOSB's recommendation to permit the use of sulfurous acid as a soil amendment in organic crop production when limited to on-farm generation by burning 99% pure elemental sulfur, the Secretary is proposing to accept the NOSB's recommendation and amend § 205.601(j) of the National List by adding sulfurous acid at new paragraph (j)(9) as follows:

Sulfurous acid (CAS #-7782-99-2)—from on-farm generation of substance, by burning only 99% elemental sulfur, exempted at (j)(2) in this section. [2]

III. Related Documents

Three 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) 73 FR 18491, April 4, 2008 (Tetracycline); (2) 73 FR 54781, September 23, 2008 (Tetracycline); (3) 74 FR 11904, March 20, 2009 (Sulfurous Acid). NOSB meetings are open to the public and allow for public participation.

IV. Statutory and Regulatory Authority

The OFPA, as amended [7 U.S.C. 6501et seq.], authorizes the Secretary to make amendments to the National List based on proposed amendments developed by the NOSB. Sections 6518(k)(2) and 6518(n) of the 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 thepurpose of having substances evaluated for inclusion on or deletion from the National List. The National List petition process is implemented under § 205.607 of the NOP regulations. The current petition process (72 FR 2167, January 18, 2007) can be accessed through the NOP Web site at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5048809acct=nopgeninfo.

A. Executive Order 12866

This action has been determined not significant for purposes of Executive Order 12866, and therefore, has not been reviewed by the Office of Management and Budget.

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.

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 § 2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under §§ 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 § 2108(b)(2) of the OFPA (7 U.S.C. 6507(b)(2)), a State organic certification program may contain additional requirements for the production and handling of organically produced agricultural products that are produced in the State and for the certification of organic farm and handling operations located within the State under certain circumstances. 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.

Pursuant to § 2120(f) of the OFPA (7 U.S.C. 6519(f)), this proposed rule would not alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601et seq.), the Poultry Products Inspections Act (21 U.S.C. 451et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031et 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. 301et seq.), nor the authority of the Administrator of the EPA under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136et seq.).

Section 2121 of the OFPA (7 U.S.C. 6520) provides for the Secretary to establish an expedited administrative appeals procedure under which persons may appeal an action of the Secretary, the applicable governing State official, or a certifying agent under this title that adversely affects such person or is inconsistent with the organic certification program established under this title. The OFPA also provides that the U.S. District Court for the district in which a person is located has jurisdiction to review the Secretary's decision.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 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. 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.

Pursuant to the requirements set forth in the RFA, the AMS performed an economic impact analysis on small entities in the final rule published in the Federal Register on December 21, 2000 (65 FR 80548). The AMS has also considered the economic impact of this action on small entities. The impact on entities affected by this proposed rule would not be significant. The effect of this proposed rule would be to allow the use of additional substances in agricultural production. This action would relax the regulations published in the final rule and would provide small entities with more tools to use in day-to-day operations. The AMS concludes that the economic impact of this addition of allowed substances, if any, would be minimal to small agricultural producers and service firms. Accordingly, USDA certifies that this rule will not have a significant economic impact on a substantial number of small entities.

Small agricultural service firms, which include 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 $7,000,000 and small agricultural producers are defined as those having annual receipts of less than $750,000.

According to USDA, Economic Research Service data based on information from USDA-accredited certifying agents, the U.S. organic industry included nearly 6,949 certified organic crop and livestock operations at the end of 2001. These operations reported certified acreage totaling more than 2.09 million acres of organic farm production. By the end of 2005, the number of U.S. certified organic crop and livestock operations totaled about 8,500 and certified organic acreage exceeded 4 million acres. ERS, based upon information provided by domestic accredited certifying agents, estimated the number of certified handling operations as exceeding 2,790 in 2004. AMS believes that most of these entities would be considered small entities under the criteria established by the SBA.

The U.S. sales of organic food and beverages have grown from $1 billion in 1990 to nearly $17 billion in 2006. The organic industry is viewed as the fasting growing sector of agriculture, representing almost 3 percent of overall food and beverage sales. Since 1990, organic retail sales have historically demonstrated a growth rate between 20 to 24 percent each year, including a 22 percent increase in 2006.

In addition, USDA has 100 accredited certifying agents who 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 believes that most of these accredited certifying agents would be considered small entities under the criteria established by the SBA.

D. 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 section 350(h) of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501et seq., or OMB's implementing regulation at 5 CFR part 1320.

The AMS is committed to compliance with the Government Paperwork Elimination Act (GPEA), which requiresGovernment agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.

The AMS is committed to complying with the E-Government Act to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

List of subjects in 7 cfr part 205

Administrative practice and procedure, Agriculture, Animals, Archives and records, 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, Subpart G is proposed to be amended as follows:

Part 205—national organic program

1. The authority citation for 7 CFR part 205 continues to read as follows:

Authority:

7 U.S.C. 6501-6522.

2. Section 205.601 is amended by:

A. Revising paragraph (i)(ll).

B. Adding new paragraph (j)(9).

The revision and addition read as follows:

§ 205.601 * * * * *

(i) * * *

(11) Tetracycline, for fire blight control only, and for use in organic crop production only until October 21, 2012.

* * * * *

(j) * * *

(9) Sulfurous acid (CAS #-7782-99-2) from on-farm generation of substance by burning only 99% purity elemental sulfur per § 205.601(j)(2).

* * * * *
Dated: January 5, 2010. Rayne Pegg,

Administrator, Agricultural Marketing Service.

Footnotes

1. EPA (U.S. Environmental Protection Agency). 2006. Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision (TRED) for Oxytetracycline. EPA 738-R-06-011. http://www.epa.gov/oppsrrd1/REDs/oxytetracycline_tred.pdf.

EPA. 2008. Oxytetracycline Summary Document Registration Review: Initial Docket December 2008 Case #0655. EPA-HQ-OPP-2008-0686. http://www.epa.gov/oppsrrd1/registration_review/oxytetracycline/index.htm.

ICF Consulting. Technical Evaluation Report Tetracycline (Oxytetracycline Calcium Complex). January 27, 2006. http://tinyurl.com/ygdtys4.

National Organic Standards Board (NOSB). Final recommendation on Tetracycline. November 19, 2008, http://tinyurl.com/y9gds87.

NOSB Meeting Transcripts. November 18, 2008, pp. 185-201. November 19, 2008, pp. 130-148; 191-213. http://tinyurl.com/ycaqqdq.

2. Agricultural Marketing Service Science Technology Branch. Technical Evaluation Report Sulfurous Acid. April 3, 2009.

Harmon Systems International, LLC. Petition for sulfurous acid for inclusion on the National List. July 30, 2008. http://tinyurl.com/yh6wsv9.

NOSB Final Recommendation on sulfurous acid. May 6, 2009. http://tinyurl.com/yf9s6mb.

NOSB Meeting Transcripts. May 5, 2009, pp. 163-173. May 6, 2009, pp. 34-57.

References

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