National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances (Crops), 1555-1559 [2010-165]

Download as PDF Federal Register / Vol. 75, No. 7 / Tuesday, January 12, 2010 / Proposed Rules DHS is currently considering, however, and seeks comments on, whether it is feasible to refine existing models or develop a new model for uncontained pool fires (i.e., where the contents of one or more gasoline storage tanks escape from secondary containment), so that such a model could be used for future consequence assessments for gasoline terminals—in lieu of or in addition to the modified VCE model. IV. Issues for Commenters Comments that will provide the most assistance to DHS should address the following issues and questions. Commenters should include explanations and relevant supporting materials with their comments whenever possible. a. Comments on the inclusion of 6 CFR 27.203(b)(1)(v) (counting of Release-COI in gasoline, diesel, kerosene, or jet fuel in aboveground storage tanks) and 6 CFR 27.204(a)(2) (the flammable mixtures rule), as they apply to gasoline terminals. b. Comments on the applicability of the modified VCE model to gasoline terminals, including: whether the reduction of the vapor yield for gasoline from ten percent (as in EPA’s VCE model) to one percent reasonably reflects the potential consequences for a vapor cloud explosion from gasoline (as compared to other liquid flammable chemicals); and whether a different yield factor adjustment might better reflect the potential consequences for a vapor cloud explosion from gasoline. c. Comments on whether a reasonable model exists or should be developed for future use that would allow DHS to estimate the plausible worst-case consequences of an uncontained pool fire resulting from a successful attack on gasoline terminals. Dated: January 4, 2010. Rand Beers, Under Secretary for National Protection and Programs. [FR Doc. 2010–234 Filed 1–11–10; 8:45 am] WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS BILLING CODE P VerDate Nov<24>2008 17:46 Jan 11, 2010 Jkt 220001 DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS–NOP–09–0081; TM–09–04] RIN 0581–AC93 National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances (Crops) AGENCY: Agricultural Marketing Service, USDA. ACTION: Proposed rule. 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. DATES: Comments must be received by March 15, 2010. ADDRESSES: Interested persons may comment on the proposed rule using the following procedures: • Internet: https:// 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 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 1555 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 (https://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. 6501 et 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, E:\FR\FM\12JAP1.SGM 12JAP1 1556 Federal Register / Vol. 75, No. 7 / Tuesday, January 12, 2010 / Proposed Rules (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). WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS II. Overview of Proposed Amendments The following provides an overview of the proposed amendments to designated sections of the National List regulations: Section 205.601 Synthetic 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 broadspectrum 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 VerDate Nov<24>2008 15:05 Jan 11, 2010 Jkt 220001 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. 301 et 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. PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 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 appropriate E:\FR\FM\12JAP1.SGM 12JAP1 Federal Register / Vol. 75, No. 7 / Tuesday, January 12, 2010 / Proposed Rules WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS regulatory 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 microorganisms 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 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. https://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. https:// www.epa.gov/oppsrrd1/registration_review/ oxytetracycline/index.htm. ICF Consulting. Technical Evaluation Report Tetracycline (Oxytetracycline Calcium Complex). January 27, 2006. https://tinyurl.com/ygdtys4. National Organic Standards Board (NOSB). Final recommendation on Tetracycline. November 19, 2008, https://tinyurl.com/y9gds87. NOSB Meeting Transcripts. November 18, 2008, pp. 185–201. November 19, 2008, pp. 130–148; 191–213. https://tinyurl.com/ycaqqdq. VerDate Nov<24>2008 15:05 Jan 11, 2010 Jkt 220001 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 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 1557 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. 6501 et 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 the 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. https://tinyurl.com/yh6wsv9. NOSB Final Recommendation on sulfurous acid. May 6, 2009. https://tinyurl.com/yf9s6mb. NOSB Meeting Transcripts. May 5, 2009, pp. 163–173. May 6, 2009, pp. 34–57. E:\FR\FM\12JAP1.SGM 12JAP1 1558 Federal Register / Vol. 75, No. 7 / Tuesday, January 12, 2010 / Proposed Rules purpose 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 https:// www.ams.usda.gov/AMSv1.0/getfile? dDocName=STELPRDC5048809&acct= nopgeninfo. WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS 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. 601 et seq.), VerDate Nov<24>2008 15:05 Jan 11, 2010 Jkt 220001 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 EPA under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et 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. 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. 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 PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 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 https://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. 3501 et 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 requires E:\FR\FM\12JAP1.SGM 12JAP1 Federal Register / Vol. 75, No. 7 / Tuesday, January 12, 2010 / Proposed Rules Government 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 Synthetic substances allowed for use in organic crop production. * * * * (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). * * * * * WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS * Dated: January 5, 2010. Rayne Pegg, Administrator, Agricultural Marketing Service. [FR Doc. 2010–165 Filed 1–11–10; 8:45 am] BILLING CODE 3410–02–P VerDate Nov<24>2008 15:05 Jan 11, 2010 Jkt 220001 NUCLEAR REGULATORY COMMISSION 10 CFR Part 32 [Docket No. PRM–32–6; NRC–2009–0547] Association of State and Territorial Solid Waste Management Officials; Notice of Receipt of Petition for Rulemaking AGENCY: Nuclear Regulatory Commission. ACTION: Petition for rulemaking; Notice of receipt. SUMMARY: The Nuclear Regulatory Commission (NRC) has received and requests public comment on a petition for rulemaking dated November 6, 2009, filed by the Association of State and Territorial Solid Waste Management Officials (ASTSWMO) (petitioner). The petition was docketed by the NRC and has been assigned Docket No. PRM–32– 6. The petitioner requests that the NRC amend its regulations and/or guidance to improve the labeling and accountability of tritium exit signs. DATES: Submit comments by March 29, 2010. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date. ADDRESSES: Please include Docket ID NRC–2009–0547 in the subject line of your comments. Comments submitted in writing or in electronic form will be posted on the NRC Web site and on the Federal rulemaking Web site Regulations.gov. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. The NRC requests that any party soliciting or aggregating comments received from other persons for submission to the NRC inform those persons that the NRC will not edit their comments to remove any identifying or contact information, and therefore, they should not include any information in their comments that they do not want publicly disclosed. You may submit comments by any one of the following methods: Federal Rulemaking Web site: Go to https://www.regulations.gov and search for documents filed under Docket ID NRC–2009–0547. Comments may be submitted electronically through this Web site. Address questions about NRC dockets to Carol Gallagher 301–492– 3668; e-mail Carol.Gallagher@nrc.gov. PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 1559 Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, ATTN: Rulemakings and Adjudications Staff. E-mail comments to: Rulemaking.Comments@nrc.gov. If you do not receive a reply e-mail confirming that we have received your comments, contact us directly at 301–415–1677. Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone 301–415– 1677). You can access publicly available documents related to this document using the following methods: Federal e-Rulemaking Portal: Go to https://www.regulations.gov and search for documents filed under Docket ID NRC–2009–0547. NRC’s Public Document Room (PDR): The public may examine and have copied for a fee publicly available documents at the NRC’s PDR, Room O1 F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. NRC’s Agencywide Documents Access and Management System (ADAMS): Publicly available documents created or received at the NRC are available electronically at the NRC’s Electronic Reading Room at https://www.nrc.gov/ reading-rm/adams.html. From this page, the public can gain entry into ADAMS, which provides text and image files of NRC’s public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC’s PDR reference staff at 1–800–397–4209, 301–415–4737, or by e-mail to pdr.resource@nrc.gov. You may also obtain a copy of the petition from ADAMS under accession number ML093410012. FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Chief, Rulemaking and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001, Telephone 301–492–3663, toll free 800–368–5642, Michael.Lesar@nrc.gov. SUPPLEMENTARY INFORMATION: The Petitioner The petitioner is an organization representing the managers of solid waste, hazardous waste, remediation, and underground storage tank programs of the States and territories. The petitioner states it is tasked with identifying national level radiation issues of concern and promoting partnerships between States and Federal agencies to address these issues. The E:\FR\FM\12JAP1.SGM 12JAP1

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[Federal Register Volume 75, Number 7 (Tuesday, January 12, 2010)]
[Proposed Rules]
[Pages 1555-1559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-165]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-09-0081; TM-09-04]
RIN 0581-AC93


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

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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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.

DATES: Comments must be received by March 15, 2010.

ADDRESSES: Interested persons may comment on the proposed rule using 
the following procedures:
     Internet: https://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 (https://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 Sec. Sec.  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. 6501 et seq.), (OFPA), and NOP regulations, in Sec.  
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,

[[Page 1556]]

(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 Sec.  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 205.601 Synthetic Substances Allowed for Use in Organic Crop 
Production

    This proposed rule would amend Sec.  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. 301 
et 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 appropriate

[[Page 1557]]

regulatory 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 Sec.  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\
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    \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. https://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. https://www.epa.gov/oppsrrd1/registration_review/oxytetracycline/index.htm.
    ICF Consulting. Technical Evaluation Report Tetracycline 
(Oxytetracycline Calcium Complex). January 27, 2006. https://tinyurl.com/ygdtys4.
    National Organic Standards Board (NOSB). Final recommendation on 
Tetracycline. November 19, 2008, https://tinyurl.com/y9gds87.
    NOSB Meeting Transcripts. November 18, 2008, pp. 185-201. 
November 19, 2008, pp. 130-148; 191-213. https://tinyurl.com/ycaqqdq.
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    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 Sec.  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 Sec.  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\
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    \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. https://tinyurl.com/yh6wsv9.
    NOSB Final Recommendation on sulfurous acid. May 6, 2009. https://tinyurl.com/yf9s6mb.
    NOSB Meeting Transcripts. May 5, 2009, pp. 163-173. May 6, 2009, 
pp. 34-57.
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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. 6501 et 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 the

[[Page 1558]]

purpose of having substances evaluated for inclusion on or deletion 
from the National List. The National List petition process is 
implemented under Sec.  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 https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5048809&acct=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 Sec.  
2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under 
Sec. Sec.  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 Sec.  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 Sec.  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. 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 EPA under 
the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et 
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. 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. 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 https://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. 3501 et 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 requires

[[Page 1559]]

Government 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:


Sec.  205.601  Synthetic substances allowed for use in organic crop 
production.

* * * * *
    (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 
Sec.  205.601(j)(2).
* * * * *

    Dated: January 5, 2010.
Rayne Pegg,
Administrator, Agricultural Marketing Service.
[FR Doc. 2010-165 Filed 1-11-10; 8:45 am]
BILLING CODE 3410-02-P