National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances (Crops, Livestock and Processing), 69141-69146 [2011-28800]

Download as PDF 69141 Proposed Rules Federal Register Vol. 76, No. 216 Tuesday, November 8, 2011 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS–NOP–11–0058; NOP–11–09PR] RIN 0581–AD15 National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances (Crops, Livestock and Processing) Agricultural Marketing Service, USDA. ACTION: Proposed rule. AGENCY: 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 October 28, 2010, and April 29, 2011. The recommendations addressed in this proposed rule pertain to changing the annotation for one substance, tetracycline, currently allowed for use in organic crop production, and adding two substances, formic acid and attapulgite, along with any restrictive annotations, for use in organic livestock production and organic processing, respectively. DATES: Comments must be received by January 9, 2012. ADDRESSES: Interested persons may comment on the proposed rule using the following procedures: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: Toni Strother, Agricultural Marketing Specialist, National Organic Program, USDA–AMS–NOP, 1400 Independence Ave. SW. Room 2646— So., Ag Stop 0268, Washington, DC 20250–0268. Instructions: All submissions received must include the docket number AMS– NOP–11–0058; NOP–11–09PR, and/or mstockstill on DSK4VPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 16:17 Nov 07, 2011 Jkt 226001 Regulatory Information Number (RIN) 0581–AD15 for this rulemaking. You should clearly indicate the topic and section number of this proposed rule to which your comment refers. You should clearly indicate whether you support the action being proposed for the substances in this proposed rule. You should clearly indicate the reason(s) for your position. You should also supply information on alternative management practices, where applicable, that support alternatives to the proposed action. You should also offer any recommended language change(s) that would be appropriate to 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. All comments received will be posted without change to http://www.regulations.gov. Document: For access to the document to read background documents or comments received, go to http://www.regulations.gov. Comments submitted in response to this proposed rule will also be available for viewing in person at USDA–AMS, National Organic Program, Room 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: Melissa Bailey, Ph.D., 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 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 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, as amended (7 U.S.C. 6501–6522), the National List can be amended by the Secretary based on recommendations developed by the NOSB. Since established, the NOP has published multiple amendments to the National List: 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 69569); December 12, 2007 (72 FR 70479); September 18, 2008 (73 FR 54057); October 9, 2008 (73 FR 59479); July 6, 2010 (75 FR 38693); August 24, 2010 (75 FR 51919) December 13, 2010 (75 FR 77521); and March 14, 2011 (76 FR 13501). Additionally, proposed amendments to the National List were published on November 8, 2010 (75 FR 68505) and on May 5, 2011 (76 FR 25612). This proposed rule would amend the National List to reflect three recommendations submitted to the Secretary by the NOSB on October 28, 2010, and April 29, 2011. Based upon their evaluation of petitions submitted by industry participants and review of technical reports, the NOSB recommended that the Secretary revise the annotation for one substance (tetracycline) for organic crop production on § 205.601, add one substance (formic acid) to § 205.603(b) for organic livestock production, and add one substance (attapulgite) to § 205.605(a) for organic processing. The exemptions for use of each 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 E:\FR\FM\08NOP1.SGM 08NOP1 69142 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules designated sections of the National List regulations: mstockstill on DSK4VPTVN1PROD with PROPOSALS Section 205.601 Synthetic Substances Allowed for Use in Organic Crop Production This proposed rule would amend § 205.601 by changing the annotation at paragraph (i)(12) to add an expiration date and specify the permitted use for the following substance: 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. 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, the 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 fire blight are wettable powders which are spray-applied using ground or aircraft equipment on foliage at early bloom stage, when fire blight infection usually occurs. Application may also occur by injection into the tree trunks using an injection device and an aqueous solution of oxytetracycline calcium and/ or oxytetracycline hydrochloride. In addition to agronomic uses, oxytetracyclines are also antibiotics used in human and animal drugs to treat bacterial diseases.1 On July 6, 2010, AMS published a final rule (75 FR 38693), amending the listing for tetracycline to allow the use of another form of tetracycline, 1 Technical Report on Tetracycline (oxytetracycline). April 1, 2011. Available in petitioned substances database, under ‘‘T,’’ at the NOP Web site: http://www.ams.usda.gov/nop. VerDate Mar<15>2010 16:17 Nov 07, 2011 Jkt 226001 oxytetracycline hydrochloride, and adding an expiration date of October 21, 2012, in accordance with the NOSB November 2008 recommendation. In October 2010, a petition was submitted requesting the removal of the October 21, 2012 expiration date. In effect, the petitioner requested an allowance for the use of tetracycline to control fire blight in apples and pears beyond the substance’s current expiration date. The NOSB Crops Committee reviewed the October 2010 petition to remove the expiration date from the current tetracycline annotation and initially issued a Committee proposal against the petitioner’s request. The Committee referenced their concerns over antibiotic resistance and availability of fire blight resistant varieties as alternatives to tetracycline use as the basis for their proposal.2 This proposal would have, in effect, retained the October 21, 2012 expiration date for tetracycline, after which the substance could no longer be used in organic crop production. At its April 26–29, 2011, meeting in Seattle, WA, the NOSB received public comment on the Crops Committee’s proposal to reject the petitioner’s request. During the meeting, the NOSB discussed and received comments on potential alternatives to tetracycline, the challenges with the efficacy and adoption of those alternative strategies, and the potential impact of not allowing tetracycline for fire blight control after October 2012. Many commenters discussed the scope and availability of alternative methods for fire blight control including the use of fire blight resistant root stocks, biological controls, streptomycin, and apple and pear varieties that are less susceptible to fire blight. Comments from producers and researchers informed the NOSB that fire blight resistant root stocks and some biological controls are not yet commercially available.3 These commenters also stated that the efficacy of commercially available biological control products is inconsistent in reducing disease incidence, thus discouraging producers from using these products instead of tetracycline. Comments further described widespread pathogen resistance to streptomycin in certain areas of the country, such as the Pacific Northwest, which has decreased its effectiveness against fire blight. Commenters stated that this resistance to streptomycin has prompted some 2 NOSB Crops Committee Recommendation on Tetracycline. April 2011. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/ getfile?dDocName=STELPRDC5089511&acct=nosb. 3 Transcript from the April 26–29, 2011 NOSB meeting is available under the NOSB section of the NOP Web site at: http://www.ams.usda.gov/nop. PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 producers to use tetracycline as an alternative. In addition, the NOSB was informed that consumer demand is linked to apple and pear varieties which are more susceptible to fire blight. Growers in Washington State produced 88% of organic apples and 79% of organic pears harvested in the U.S. in 2008, and cultivars accounting for the highest proportion of this production are highly or moderately susceptible to fire blight.4 5 The petitioner also commented that at least 38 of 50 organic apple and pear producers surveyed in Washington State felt that if the exemption for the use of tetracycline was allowed to expire on October 21, 2012, then they would be forced to reduce their acreage of susceptible varieties or exit the organic apple and pear production industry.6 Based upon the public comments, the NOSB Crops Committee revised their proposal at the April 2011 NOSB meeting and recommended extending the allowance for the use of tetracycline to control fire blight in apples and pears until October 21, 2014. The NOSB voted on and issued a final recommendation in support of this proposal. The NOSB concluded that use of tetracycline should be permitted to continue through October 21, 2014, as options for biological controls and resistant varieties and rootstocks are further developed for commercial use. In their recommendation, the NOSB specified that the annotation include language to convey that the use of tetracycline is limited to apples and pears. The addition of ‘‘apples and pears’’ in the annotation accurately identifies the allowed use of this substance in organic production and would not change current use patterns. The NOSB recommendation also stated that the Board expects the industry to make progress in the development of alternatives for fire blight control. The NOSB recommendation conveyed this expectation in stating that, ‘‘members of the industry will collaborate and coordinate efforts in preparing for the 4 U.S. Department of Agriculture, National Agricultural Statistics Service. 2007 Census of Agriculture: Organic Production Survey: Organic Fruit and Tree Nuts Harvested from Certified Organic Farms, Table 24, 2008. Available at: http://www.agcensus.usda.gov/Publications/2007/ Online_highlights/Organics/ORGANICS.pdf. 5 The petition was submitted by the Washington State Horticultural Association, and is available from the NOP Web site in the Petitioned Substances Database, http://www.ams.usda.gov/ NOPPetitionedSubstancesDatabase. 6 Summarized from 2010 survey of organic apple and pear growers in Washington State: Organic Orchards: Needs and Priorities, conducted by David Granatstein (WSU–CSANR), Mark LaPierre, WilburEllis Co., and Nadine Lehrer, WSU–TFRC. E:\FR\FM\08NOP1.SGM 08NOP1 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules eventual removal of this material from the National List, specifically optimizing the use of resistant rootstocks and cultivars, preventive management methods, and the use of alternative, allowed biological and chemical controls whenever warranted.’’ 7 In response to the requests by the NOSB and the industry for additional resources to support research on alternatives to tetracycline in organic production, the NOP issued requests to the USDA Agricultural Research Service and the National Institute of Food and Agriculture in May of 2011 for assistance in prioritizing research in the following areas: (1) The efficacy of combinations of substances for fire blight management; (2) breeding, production, and propagation of resistant cultivars and rootstocks that are commercially viable; and (3) cultural practices, crop management, disease forecasting and other production practices that can optimize control of this disease.8 The Secretary has reviewed and proposes to accept the NOSB’s recommendation. This proposed rule would amend § 205.601(i)(12) of the National List by: (1) Inserting the qualifying words ‘‘in apples and pears’’; between the words ‘‘control’’ and ‘‘only,’’ in the current annotation and (2) replacing the current expiration date of ‘‘October 21, 2012’’ with the new expiration date, ‘‘October 21, 2014,’’ after which tetracycline may not be used in organic apple and pear crop production for fire blight control. Section 205.603 Synthetic Substances Allowed for Use in Organic Livestock Production This proposed rule would amend § 205.603 by redesignating current paragraphs (b)(2) through (b)(7) as paragraphs (b)(3) through (b)(8) for the purpose of adding the following substance as an external parasiticide at (b)(2): Formic acid (CAS #64–18–6). Formic acid was petitioned for use in May 2010, as a pesticide for suppression of Varroa mites.9 Varroa mites attach themselves to the abdomens of bees and extract mstockstill on DSK4VPTVN1PROD with PROPOSALS 7 NOSB Formal Recommendation on Tetracycline. April 29, 2011. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/ getfile?dDocName=STELPRDC5091701. 8 May 2011 Letters submitted by NOP to USDA ARS and NIFA on fire blight research. Available at the NOP Web site: http://www.ams.usda.gov/ AMSv1.0/getfile?dDocName=STELPRDC5091325. 9 The petition was submitted by the Hawaii Department of Agriculture, and is retrievable from the NOP Web site in the Petitioned Substances Database: http://www.ams.usda.gov/ NOPPetitionedSubstancesDatabase. VerDate Mar<15>2010 16:17 Nov 07, 2011 Jkt 226001 fluids from the circulatory system, causing the bees to weaken and die. Infestations can quickly destroy a hive and spread easily to nearby hives. Formic acid is a colorless liquid with a pungent odor which is miscible in water. This substance is the simplest carboxylic acid and is naturally occurring in small amounts in some insects and plants and is a natural component of honey. The manufacturing process for formic acid begins with the hydrolysis of methyl formate. Methanol and carbon monoxide are combined along with a strong base to produce methyl formate, which is then hydrolyzed to produce formic acid.10 Formic acid is considered corrosive to metals and biological tissue, and occupational exposure to these fumigant products can cause eye, skin, and mucosal irritation.11 This can be mitigated by the use of personal protective equipment. Fumigant mite control products for beehives generally consist of a gel pad impregnated with formic acid which is contained in a sealed plastic pouch. Application consists of cutting vents in the pouch and setting it in the hive, where it releases vapors that diffuse throughout the hive. The volatilization of formic acid causes mite deaths by asphyxiation generally without harm to exposed bees. It can also penetrate capped cells and sealed brood cells where mites are feeding.12 The use of synthetic formic acid is regulated by other Federal agencies. Formic acid has antibacterial properties that make it effective as a preservative, and the Food and Drug Administration (FDA) permits its use as a food additive in the feed and drinking water of animals (21 CFR 573.480). FDA also permits the use of formic acid as flavoring agent in processed foods (21 CFR 172.515). The Environmental Protection Agency (EPA) has exempted synthetic formic acid from the requirement of a tolerance in or on honey and honeycomb when used to control tracheal mites and suppress Varroa mites in bee colonies, and applied in accordance with label use directions (40 CFR 180.1178).13 The EPA has examined the potential for 10 Hazardous Substances Data Bank (HSDB). 2010. Formic Acid, CASRN: 64–18–6. Last revised 4–27–2010. Retrieved February 15, 2011, from http://toxnet.nlm.nih.gov. 11 NOAA (CAMEO Chemical), 2011. Formic Acid, Retrieved February 15, 2011 from http:// cameochemicals.noaa.gov/chemical/3513. 12 Technical Report on Formic acid. June 1, 2011. Available in petitioned substances database, under ‘‘F,’’ at the NOP Web site: www.ams.usda.gov/nop. 13 Tracheal mites lay eggs inside bees’ tracheal tubes, and their larvae feed on the bee after the eggs hatch. PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 69143 formic acid residues to appear in beeswax and honey and concluded that residues above those found naturally are not expected when a formic acid pesticide product is used as directed.14 Synthetic formic acid is currently permitted in Canada and the European Union for use in organic apiculture to control parasitic mites. At its October 25–28, 2010, meeting in Madison, WI, the NOSB recommended adding formic acid to the National List for use in organic livestock production solely as a pesticide within honeybee hives. The NOSB evaluated formic acid against the evaluation criteria of 7 U.S.C. 6517 and 6510 of the OFPA and received public comment at this meeting.15 During the NOSB deliberations, the Board noted that they had not received any public comments against the addition of formic acid to the National List. The NOSB deliberations over the petition for this substance heavily relied upon the information provided by the petitioner. According to the formic acid petition, there are several methods for controlling mite populations in honeybee hives. These methods include those that are mechanical (e.g. trapping) and biochemical such as the use of synthetic sucrose octanoate esters (currently listed on § 205.603) for control for Varroa mites. However, data was provided by the petitioner illustrating that the allowed biochemical and mechanical control methods do not have the same efficacy as formic acid in the climatic conditions in Hawaii, one of the U.S.’s highest-producing organic honey regions.16 The information presented by the petitioner and considered by the NOSB is generally supported by a June 2011 technical report for formic acid that the NOSB Livestock Committee accepted as sufficient. During their deliberations, the NOSB also considered formic acid in the context of their final recommendations for apiculture standards from 2001 and 2010 and feedback from the Apiculture Working Group. Based upon their review of this information, the NOSB issued a final recommendation to add formic acid to the National List at 14 EPA, 2010. Formic Acid (214900) Fact Sheet, Retrieved February 15, 2011, from http:// www.epa.gov/oppbppd1/biopesticides/ingredients/ factsheets/factsheet_214900.htm. 15 The record contains acknowledgement that the Board had requested a Technical Report for formic acid. However, this report was not available for review by the October 2010 meeting. The NOSB stated that, based on the information contained in the petition, they concluded that the substance is consistent with the OFPA evaluation criteria. 16 Transcripts from the April 26–29, 2011 meeting can be retrieved from the NOSB section of the NOP Web page. E:\FR\FM\08NOP1.SGM 08NOP1 mstockstill on DSK4VPTVN1PROD with PROPOSALS 69144 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules § 205.603(b) with an annotation that would limit the substance’s use to a pesticide solely within honeybee hives. In their recommendation, the NOSB did not limit the use of formic acid only for treatment of Varroa mites, which was the use specified by the petitioner. Since EPA registers formic acid as a pesticide to control Varroa and tracheal mites, their recommendation and this proposed rule would, in effect, allow the use of formic acid to control both Varroa and tracheal mites in organic apiculture. At the October 2010 NOSB meeting, the NOP and NOSB discussed the placement of formic acid on the National List. The NOP raised the question of whether listing formic acid, a miticide, under § 205.603(b) is appropriate given that § 205.603(b) specifies that substances under this section be limited to use as ‘‘a topical treatment, external parasiticide (emphasis added) or local anesthetic as applicable’’. The NOSB explained that their research indicated that mites can be considered a parasite. The NOSB also stated that listing formic acid at § 205.603(b) would be consistent with the listing for sucrose octanoate esters, another substance in this National List section which is approved for use in apiculture to control Varroa mites. Through this proposed rule, the NOP is seeking comments on the placement of formic acid on the National List. Furthermore, the NOP may reconsider the placement of formic acid on the National List as part of any future rulemaking on organic apiculture standards. In the NOP’s consideration of the addition of formic acid to the National List, the NOP would also like to reiterate that registered pesticide products intended for use in organic production and handling must also be evaluated for compliance with EPA’s August 2004 list of inert ingredients, minus any revoked inert ingredients. The Secretary has reviewed and proposes to accept the NOSB’s recommendation. Consistent with the NOSB recommendation, this proposed rule would amend § 205.603 of the National List by adding formic acid (CAS #64–18–6) at paragraph (b)(2) as a synthetic substance allowed for use as follows: Formic acid (CAS #64–18–6)—for use as a pesticide solely within honeybee hives. VerDate Mar<15>2010 16:17 Nov 07, 2011 Jkt 226001 Section 205.605 Nonagricultural (Nonorganic) Substances Allowed as Ingredients in or on Processed Products Labeled as ‘‘Organic’’ or ‘‘Made With Organic (Specified Ingredients or Food Group(s))’’ This proposed rule would amend § 205.605(a) of the National List regulations by adding the following substance: Attapulgite. Attapulgite was petitioned for two uses: (1) As a nonsynthetic processing aid in organic handling for purifying vegetable and animal oils; and (2) as a livestock feed additive.17 Attapulgite is the product of naturally occurring attapulgus clay that is mined and subsequently dried and pulverized into a fine bluish gray powder. Fine particle size and high porosity and surface area give attapulgite the capacity to absorb and adsorb various materials such as chlorophyll, metals and other impurities to improve the appearance, flavor and stability of plant and animal oils. The clay is added to heated liquid oil, stirred, and filtered out of the oil. According to the petitioner, adverse effects to human health would not be expected from occupational exposure to this product through inhalation or ingestion when proper protective equipment is utilized.18 The FDA has listed this substance in the database, Everything Added to Food in the United States (EAFUS) (Doc. No. 1943) and references this substance among those generally regarded as safe in 21 CFR part 582.99 when used as an adjuvant for pesticide chemicals. The EPA permits attapulgite as an inert ingredient eligible in minimum risk pesticides applied for food and nonfood uses which are exempt from federal registration under Section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The EPA has determined that attapulgite is exempt from the requirement of a tolerance when used as an inert ingredient in pesticide formulations applied pre- and post-harvest per 40 CFR 180.910.19 At its April 26–29, 2011, meeting in Seattle, WA, the NOSB recommended adding attapulgite to the National List 17 Due to the nonsynthetic classification of this substance, a petition for use as an additive for organic livestock feed is not required. 18 The petition was submitted by the Oil-Dri Corporation of America, and is retrievable from the NOP Web site in the Petitioned Substances Database: http://www.ams.usda.gov/ NOPPetitionedSubstancesDatabase. 19 Technical Report on Attapulgite. February 1, 2010. A copy of this report is available in the petitioned substances database, http:// www.ams.usda.gov/ NOPPetitionedSubstancesDatabase. PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 for use as a processing aid in organic handling of plant and animal oils. The NOSB did not receive public comments against this recommendation. During their deliberations, the NOSB noted that bentonite, a material already on the National List which can serve a similar bleaching function as attapulgite, requires acid activation. The NOSB explained that, though acid activation can be used to enhance bleaching properties of attapulgite, acid activation is not required for the substance to function as a processing aid and, therefore, may be preferable to the use of bentonite. The NOSB did not, however, recommend restricting the use of attapulgite to non-acid activated forms. During this public meeting, the NOSB evaluated attapulgite against the evaluation criteria of 7 U.S.C. 6517 and 6510 of the OFPA, received public comment, and concluded the substance is consistent with the OFPA evaluation criteria. Based upon the evaluation criteria, public comment, and the petitioner’s request, the NOSB issued a final recommendation to add attapulgite to the National List. The Secretary has reviewed and proposes to accept the NOSB recommendation. Consistent with the NOSB recommendation, this proposed rule would amend § 205.605(a) of the National List by adding attapulgite as follows: Attapulgite—as a processing aid in the handling of plant and animal oils. III. Related Documents Two notices were published regarding the meetings of the NOSB and 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) 76 FR 12013, March 4, 2011, (Attapulgite and Tetracycline); (2) 75 FR 57194, September 20, 2010, (Formic acid). 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) 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 purpose of having substances evaluated for inclusion on or deletion from the National List. The National List petition process is implemented under § 205.607 E:\FR\FM\08NOP1.SGM 08NOP1 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules 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/nop. mstockstill on DSK4VPTVN1PROD 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. 601–624), the Poultry Products Inspection Act (21 U.S.C. 451–471), or the Egg Products Inspection Act (21 U.S.C. 1031–1056), concerning meat, poultry, and egg products, nor any of the authorities of the Secretary of Health and Human VerDate Mar<15>2010 16:17 Nov 07, 2011 Jkt 226001 Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), nor the authority of the Administrator of 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 and handling. 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 and beneficial to small agricultural 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 producers, handlers, and accredited certifying agents, have been defined by the Small Business PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 69145 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. Based on USDA data from the Economic Research Service (ERS), the U.S. organic sector included nearly 13,000 certified organic crop and livestock operations at the end of 2008. These operations contained more than 4.8 million certified acres consisting of 2,665,382 acres of cropland and 2,160,577 acres of pasture and rangeland. The total acreage under organic management represents a twelve percent increase from 2007.20 AMS believes that most of the certified production and handling operations would be classified as small entities under the criteria established by the SBA. The U.S. sales of organic food and beverages have grown from $3.6 billion in 1997 to nearly $21.1 billion in 2008.21 Between 1990 and 2008, organic food sales have historically demonstrated a growth rate between 15 to 24 percent each year. In 2010, organic food sales grew 7.7%.22 In addition, USDA has accredited 93 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 the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, chapter 35. E. Executive Order 13175 This proposed rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial 20 U.S. Department of Agriculture, Economic Research Service, 2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock Numbers and Farm Operations, 1992–2008. http:// www.ers.usda.gov/Data/Organic/. 21 Dimitri, C., and L. Oberholtzer. 2009. Marketing U.S. Organic Foods: Recent Trends from Farms to Consumers, Economic Information Bulletin No. 58, U.S. Department of Agriculture, Economic Research Service, http://www.ers.usda.gov/Publications/ EIB58. 22 Organic Trade Association’s 2011 Organic Industry Survey. Available at: http://www.ota.com. E:\FR\FM\08NOP1.SGM 08NOP1 69146 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules and direct effects on Tribal governments and will not have significant Tribal implications. Attapulgite—as a processing aid in the handling of plant and animal oils. * * * * * F. General Notice of Public Rulemaking Dated: November 1, 2011. David R. Shipman, Acting Administrator, Agricultural Marketing Service. This proposed rule reflects recommendations submitted by the NOSB to the Secretary to amend the annotation for one substance and to add two substances on the National List. A 60-day period for interested persons to comment on this rule is provided and is deemed appropriate. 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: Food Safety and Inspection Service DEPARTMENT OF AGRICULTURE [Docket No. FSIS–2010–0012] 7 CFR Part 2502 RIN 0583–AD41 RIN 0503–AA49 Agricultural Career and Employment Grants Program; Withdrawal Office of Advocacy and Outreach, Departmental Management, USDA. AGENCY: SUMMARY: * * * * * (i) * * * (12) Tetracycline, for fire blight control in apples and pears only until October 21, 2014. * * * * * 3. Section 205.603 is amended by: A. Redesignating paragraphs (b)(2) through (b)(7) as paragraphs (b)(3) through (b)(8); and B. Adding new paragraph (b)(2) to read as follows: FOR FURTHER INFORMATION CONTACT: mstockstill on DSK4VPTVN1PROD with PROPOSALS * * * * (b) * * * (2) Formic acid (CAS #64–18–6)—for use as a pesticide solely within honeybee hives. * * * * * 4. In § 205.605(a), the substance ‘‘Attapulgite’’ is added in alphabetical order to read as follows: § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food groups(s)).’’ * * (a) * * * VerDate Mar<15>2010 * * 16:17 Nov 07, 2011 Jkt 226001 On October 27, 2011, USDA submitted a proposed rule concerning grants to assist agricultural employers and farm workers by improving the supply, stability, safety, and training of the agricultural labor force. The Department intended this document to be submitted as an interim rule. Therefore, the proposed rule is withdrawn. In the Rules and Regulations section of this issue of the Federal Register, USDA is publishing the interim rule. As of November 8, 2011, the proposed rule published October 27, 2011, at 76 FR 66656, is withdrawn. * * Proposed rule; withdrawal. DATES: § 205.603 Synthetic substances allowed for use in organic livestock production. 9 CFR Parts 319 and 381 Office of Advocacy and Outreach 1. The authority citation for 7 CFR part 205 continues to read as follows: § 205.601 Synthetic substances allowed for use in organic crop production. BILLING CODE P DEPARTMENT OF AGRICULTURE BILLING CODE 3410–02–P ACTION: 2. Section 205.601 paragraph (i)(12) is revised to read as follows: [FR Doc. 2011–29033 Filed 11–7–11; 8:45 am] [FR Doc. 2011–28800 Filed 11–7–11; 8:45 am] PART 205—NATIONAL ORGANIC PROGRAM Authority: 7 U.S.C. 6501–6522. Signed in Washington, DC, on November 3, 2011. Pearlie Reed, Assistant Secretary for Administration for the Office of the Secretary. Christine Chavez, Program Leader, Farmworker Coordination, Office of Advocacy and Outreach, U.S. Department of Agriculture, 1400 Independence Avenue SW., Stop 9801, Washington, DC 20250, Voice: (202) 205–4215, Fax: (202) 720–7136, Email: christine.chavez@osec.usda.gov. USDA is withdrawing its proposed rule of October 27, 2011, entitled ‘‘Agricultural Career and Employment Grants Program,’’ because it was intended to publish in the Federal Register as an interim rule. This document officially withdraws the proposed rule. The interim rule can be found in the Rules and Regulation section of this issue of the Federal Register. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 Common or Usual Name for Raw Meat and Poultry Products Containing Added Solutions—Reopening of Comment Period Food Safety and Inspection Service, USDA. ACTION: Proposed rule; reopening of comment period. AGENCY: The Food Safety and Inspection Service (FSIS) is reopening for 60 days the comment period for the proposed rule, ‘‘Common or Usual Name for Raw Meat and Poultry Products Containing Added Solutions.’’ It is also providing information concerning data used to develop the proposed rule and providing examples of labels about which FSIS has concerns. SUMMARY: The comment period for the proposed rule published July 27, 2011, at 76 FR 44855, is reopened. Submit comments by January 9, 2012. ADDRESSES: FSIS invites interested persons to submit relevant comments on the implementation of this proposed rule. Comments may be submitted by either of the following methods: • Federal eRulemaking Portal: This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the online instructions at that site for submitting comments. • Mail, including floppy disks or CD– ROMs, and hand- or courier-delivered items: Send to U.S. Department of Agriculture (USDA), FSIS, Docket Clerk, Patriots Plaza 3, 1400 Independence Avenue SW., Room 8–163A, Mailstop 3782, Washington, DC 20250–3700. Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS– 2010–0012. Comments received in response to this docket will be made available for public inspection and DATES: E:\FR\FM\08NOP1.SGM 08NOP1

Agencies

[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Proposed Rules]
[Pages 69141-69146]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28800]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / 
Proposed Rules

[[Page 69141]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-11-0058; NOP-11-09PR]
RIN 0581-AD15


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

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 October 28, 2010, and April 29, 2011. The 
recommendations addressed in this proposed rule pertain to changing the 
annotation for one substance, tetracycline, currently allowed for use 
in organic crop production, and adding two substances, formic acid and 
attapulgite, along with any restrictive annotations, for use in organic 
livestock production and organic processing, respectively.

DATES: Comments must be received by January 9, 2012.

ADDRESSES: Interested persons may comment on the proposed rule using 
the following procedures:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Toni Strother, Agricultural Marketing Specialist, 
National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW. Room 
2646--So., Ag Stop 0268, Washington, DC 20250-0268.
    Instructions: All submissions received must include the docket 
number AMS-NOP-11-0058; NOP-11-09PR, and/or Regulatory Information 
Number (RIN) 0581-AD15 for this rulemaking. You should clearly indicate 
the topic and section number of this proposed rule to which your 
comment refers. You should clearly indicate whether you support the 
action being proposed for the substances in this proposed rule. You 
should clearly indicate the reason(s) for your position. You should 
also supply information on alternative management practices, where 
applicable, that support alternatives to the proposed action. You 
should also offer any recommended language change(s) that would be 
appropriate to 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. All comments 
received will be posted without change to http://www.regulations.gov.
    Document: For access to the document to read background documents 
or comments received, go to http://www.regulations.gov. Comments 
submitted in response to this proposed rule will also be available for 
viewing in person at USDA-AMS, National Organic Program, Room 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: Melissa Bailey, Ph.D., 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, as amended (7 U.S.C. 6501-6522), 
the National List can be amended by the Secretary based on 
recommendations developed by the NOSB. Since established, the NOP has 
published multiple amendments to the National List: 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 69569); December 12, 2007 (72 FR 70479); September 18, 
2008 (73 FR 54057); October 9, 2008 (73 FR 59479); July 6, 2010 (75 FR 
38693); August 24, 2010 (75 FR 51919) December 13, 2010 (75 FR 77521); 
and March 14, 2011 (76 FR 13501). Additionally, proposed amendments to 
the National List were published on November 8, 2010 (75 FR 68505) and 
on May 5, 2011 (76 FR 25612).
    This proposed rule would amend the National List to reflect three 
recommendations submitted to the Secretary by the NOSB on October 28, 
2010, and April 29, 2011. Based upon their evaluation of petitions 
submitted by industry participants and review of technical reports, the 
NOSB recommended that the Secretary revise the annotation for one 
substance (tetracycline) for organic crop production on Sec.  205.601, 
add one substance (formic acid) to Sec.  205.603(b) for organic 
livestock production, and add one substance (attapulgite) to Sec.  
205.605(a) for organic processing. The exemptions for use of each 
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

[[Page 69142]]

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 by changing the 
annotation at paragraph (i)(12) to add an expiration date and specify 
the permitted use for the following substance:
    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. 
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, the 
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 fire blight are wettable powders which are spray-
applied using ground or aircraft equipment on foliage at early bloom 
stage, when fire blight infection usually occurs. Application may also 
occur by injection into the tree trunks using an injection device and 
an aqueous solution of oxytetracycline calcium and/or oxytetracycline 
hydrochloride. In addition to agronomic uses, oxytetracyclines are also 
antibiotics used in human and animal drugs to treat bacterial 
diseases.\1\
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    \1\ Technical Report on Tetracycline (oxytetracycline). April 1, 
2011. Available in petitioned substances database, under ``T,'' at 
the NOP Web site: http://www.ams.usda.gov/nop.
---------------------------------------------------------------------------

    On July 6, 2010, AMS published a final rule (75 FR 38693), amending 
the listing for tetracycline to allow the use of another form of 
tetracycline, oxytetracycline hydrochloride, and adding an expiration 
date of October 21, 2012, in accordance with the NOSB November 2008 
recommendation. In October 2010, a petition was submitted requesting 
the removal of the October 21, 2012 expiration date. In effect, the 
petitioner requested an allowance for the use of tetracycline to 
control fire blight in apples and pears beyond the substance's current 
expiration date.
    The NOSB Crops Committee reviewed the October 2010 petition to 
remove the expiration date from the current tetracycline annotation and 
initially issued a Committee proposal against the petitioner's request. 
The Committee referenced their concerns over antibiotic resistance and 
availability of fire blight resistant varieties as alternatives to 
tetracycline use as the basis for their proposal.\2\ This proposal 
would have, in effect, retained the October 21, 2012 expiration date 
for tetracycline, after which the substance could no longer be used in 
organic crop production.
---------------------------------------------------------------------------

    \2\ NOSB Crops Committee Recommendation on Tetracycline. April 
2011. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5089511&acct=nosb.
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    At its April 26-29, 2011, meeting in Seattle, WA, the NOSB received 
public comment on the Crops Committee's proposal to reject the 
petitioner's request. During the meeting, the NOSB discussed and 
received comments on potential alternatives to tetracycline, the 
challenges with the efficacy and adoption of those alternative 
strategies, and the potential impact of not allowing tetracycline for 
fire blight control after October 2012. Many commenters discussed the 
scope and availability of alternative methods for fire blight control 
including the use of fire blight resistant root stocks, biological 
controls, streptomycin, and apple and pear varieties that are less 
susceptible to fire blight. Comments from producers and researchers 
informed the NOSB that fire blight resistant root stocks and some 
biological controls are not yet commercially available.\3\ These 
commenters also stated that the efficacy of commercially available 
biological control products is inconsistent in reducing disease 
incidence, thus discouraging producers from using these products 
instead of tetracycline. Comments further described widespread pathogen 
resistance to streptomycin in certain areas of the country, such as the 
Pacific Northwest, which has decreased its effectiveness against fire 
blight. Commenters stated that this resistance to streptomycin has 
prompted some producers to use tetracycline as an alternative. In 
addition, the NOSB was informed that consumer demand is linked to apple 
and pear varieties which are more susceptible to fire blight. Growers 
in Washington State produced 88% of organic apples and 79% of organic 
pears harvested in the U.S. in 2008, and cultivars accounting for the 
highest proportion of this production are highly or moderately 
susceptible to fire blight.4 5 The petitioner also commented 
that at least 38 of 50 organic apple and pear producers surveyed in 
Washington State felt that if the exemption for the use of tetracycline 
was allowed to expire on October 21, 2012, then they would be forced to 
reduce their acreage of susceptible varieties or exit the organic apple 
and pear production industry.\6\
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    \3\ Transcript from the April 26-29, 2011 NOSB meeting is 
available under the NOSB section of the NOP Web site at: http://www.ams.usda.gov/nop.
    \4\ U.S. Department of Agriculture, National Agricultural 
Statistics Service. 2007 Census of Agriculture: Organic Production 
Survey: Organic Fruit and Tree Nuts Harvested from Certified Organic 
Farms, Table 24, 2008. Available at: http://www.agcensus.usda.gov/Publications/2007/Online_highlights/Organics/ORGANICS.pdf.
    \5\ The petition was submitted by the Washington State 
Horticultural Association, and is available from the NOP Web site in 
the Petitioned Substances Database, http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
    \6\ Summarized from 2010 survey of organic apple and pear 
growers in Washington State: Organic Orchards: Needs and Priorities, 
conducted by David Granatstein (WSU-CSANR), Mark LaPierre, Wilbur-
Ellis Co., and Nadine Lehrer, WSU-TFRC.
---------------------------------------------------------------------------

    Based upon the public comments, the NOSB Crops Committee revised 
their proposal at the April 2011 NOSB meeting and recommended extending 
the allowance for the use of tetracycline to control fire blight in 
apples and pears until October 21, 2014. The NOSB voted on and issued a 
final recommendation in support of this proposal. The NOSB concluded 
that use of tetracycline should be permitted to continue through 
October 21, 2014, as options for biological controls and resistant 
varieties and rootstocks are further developed for commercial use. In 
their recommendation, the NOSB specified that the annotation include 
language to convey that the use of tetracycline is limited to apples 
and pears. The addition of ``apples and pears'' in the annotation 
accurately identifies the allowed use of this substance in organic 
production and would not change current use patterns.
    The NOSB recommendation also stated that the Board expects the 
industry to make progress in the development of alternatives for fire 
blight control. The NOSB recommendation conveyed this expectation in 
stating that, ``members of the industry will collaborate and coordinate 
efforts in preparing for the

[[Page 69143]]

eventual removal of this material from the National List, specifically 
optimizing the use of resistant rootstocks and cultivars, preventive 
management methods, and the use of alternative, allowed biological and 
chemical controls whenever warranted.'' \7\
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    \7\ NOSB Formal Recommendation on Tetracycline. April 29, 2011. 
Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5091701.
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    In response to the requests by the NOSB and the industry for 
additional resources to support research on alternatives to 
tetracycline in organic production, the NOP issued requests to the USDA 
Agricultural Research Service and the National Institute of Food and 
Agriculture in May of 2011 for assistance in prioritizing research in 
the following areas: (1) The efficacy of combinations of substances for 
fire blight management; (2) breeding, production, and propagation of 
resistant cultivars and rootstocks that are commercially viable; and 
(3) cultural practices, crop management, disease forecasting and other 
production practices that can optimize control of this disease.\8\
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    \8\ May 2011 Letters submitted by NOP to USDA ARS and NIFA on 
fire blight research. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5091325.
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    The Secretary has reviewed and proposes to accept the NOSB's 
recommendation. This proposed rule would amend Sec.  205.601(i)(12) of 
the National List by: (1) Inserting the qualifying words ``in apples 
and pears''; between the words ``control'' and ``only,'' in the current 
annotation and (2) replacing the current expiration date of ``October 
21, 2012'' with the new expiration date, ``October 21, 2014,'' after 
which tetracycline may not be used in organic apple and pear crop 
production for fire blight control.

Section 205.603 Synthetic Substances Allowed for Use in Organic 
Livestock Production

    This proposed rule would amend Sec.  205.603 by redesignating 
current paragraphs (b)(2) through (b)(7) as paragraphs (b)(3) through 
(b)(8) for the purpose of adding the following substance as an external 
parasiticide at (b)(2):
    Formic acid (CAS 64-18-6). Formic acid was petitioned for 
use in May 2010, as a pesticide for suppression of Varroa mites.\9\ 
Varroa mites attach themselves to the abdomens of bees and extract 
fluids from the circulatory system, causing the bees to weaken and die. 
Infestations can quickly destroy a hive and spread easily to nearby 
hives. Formic acid is a colorless liquid with a pungent odor which is 
miscible in water. This substance is the simplest carboxylic acid and 
is naturally occurring in small amounts in some insects and plants and 
is a natural component of honey. The manufacturing process for formic 
acid begins with the hydrolysis of methyl formate. Methanol and carbon 
monoxide are combined along with a strong base to produce methyl 
formate, which is then hydrolyzed to produce formic acid.\10\ Formic 
acid is considered corrosive to metals and biological tissue, and 
occupational exposure to these fumigant products can cause eye, skin, 
and mucosal irritation.\11\ This can be mitigated by the use of 
personal protective equipment. Fumigant mite control products for 
beehives generally consist of a gel pad impregnated with formic acid 
which is contained in a sealed plastic pouch. Application consists of 
cutting vents in the pouch and setting it in the hive, where it 
releases vapors that diffuse throughout the hive. The volatilization of 
formic acid causes mite deaths by asphyxiation generally without harm 
to exposed bees. It can also penetrate capped cells and sealed brood 
cells where mites are feeding.\12\
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    \9\ The petition was submitted by the Hawaii Department of 
Agriculture, and is retrievable from the NOP Web site in the 
Petitioned Substances Database: http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
    \10\ Hazardous Substances Data Bank (HSDB). 2010. Formic Acid, 
CASRN: 64-18-6. Last revised 4-27-2010. Retrieved February 15, 2011, 
from http://toxnet.nlm.nih.gov.
    \11\ NOAA (CAMEO Chemical), 2011. Formic Acid, Retrieved 
February 15, 2011 from http://cameochemicals.noaa.gov/chemical/3513.
    \12\ Technical Report on Formic acid. June 1, 2011. Available in 
petitioned substances database, under ``F,'' at the NOP Web site: 
www.ams.usda.gov/nop.
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    The use of synthetic formic acid is regulated by other Federal 
agencies. Formic acid has antibacterial properties that make it 
effective as a preservative, and the Food and Drug Administration (FDA) 
permits its use as a food additive in the feed and drinking water of 
animals (21 CFR 573.480). FDA also permits the use of formic acid as 
flavoring agent in processed foods (21 CFR 172.515). The Environmental 
Protection Agency (EPA) has exempted synthetic formic acid from the 
requirement of a tolerance in or on honey and honeycomb when used to 
control tracheal mites and suppress Varroa mites in bee colonies, and 
applied in accordance with label use directions (40 CFR 180.1178).\13\ 
The EPA has examined the potential for formic acid residues to appear 
in beeswax and honey and concluded that residues above those found 
naturally are not expected when a formic acid pesticide product is used 
as directed.\14\ Synthetic formic acid is currently permitted in Canada 
and the European Union for use in organic apiculture to control 
parasitic mites.
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    \13\ Tracheal mites lay eggs inside bees' tracheal tubes, and 
their larvae feed on the bee after the eggs hatch.
    \14\ EPA, 2010. Formic Acid (214900) Fact Sheet, Retrieved 
February 15, 2011, from http://www.epa.gov/oppbppd1/biopesticides/ingredients/factsheets/factsheet_214900.htm.
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    At its October 25-28, 2010, meeting in Madison, WI, the NOSB 
recommended adding formic acid to the National List for use in organic 
livestock production solely as a pesticide within honeybee hives. The 
NOSB evaluated formic acid against the evaluation criteria of 7 U.S.C. 
6517 and 6510 of the OFPA and received public comment at this 
meeting.\15\ During the NOSB deliberations, the Board noted that they 
had not received any public comments against the addition of formic 
acid to the National List. The NOSB deliberations over the petition for 
this substance heavily relied upon the information provided by the 
petitioner. According to the formic acid petition, there are several 
methods for controlling mite populations in honeybee hives. These 
methods include those that are mechanical (e.g. trapping) and 
biochemical such as the use of synthetic sucrose octanoate esters 
(currently listed on Sec.  205.603) for control for Varroa mites. 
However, data was provided by the petitioner illustrating that the 
allowed biochemical and mechanical control methods do not have the same 
efficacy as formic acid in the climatic conditions in Hawaii, one of 
the U.S.'s highest-producing organic honey regions.\16\ The information 
presented by the petitioner and considered by the NOSB is generally 
supported by a June 2011 technical report for formic acid that the NOSB 
Livestock Committee accepted as sufficient.
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    \15\ The record contains acknowledgement that the Board had 
requested a Technical Report for formic acid. However, this report 
was not available for review by the October 2010 meeting. The NOSB 
stated that, based on the information contained in the petition, 
they concluded that the substance is consistent with the OFPA 
evaluation criteria.
    \16\ Transcripts from the April 26-29, 2011 meeting can be 
retrieved from the NOSB section of the NOP Web page.
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    During their deliberations, the NOSB also considered formic acid in 
the context of their final recommendations for apiculture standards 
from 2001 and 2010 and feedback from the Apiculture Working Group. 
Based upon their review of this information, the NOSB issued a final 
recommendation to add formic acid to the National List at

[[Page 69144]]

 Sec.  205.603(b) with an annotation that would limit the substance's 
use to a pesticide solely within honeybee hives. In their 
recommendation, the NOSB did not limit the use of formic acid only for 
treatment of Varroa mites, which was the use specified by the 
petitioner. Since EPA registers formic acid as a pesticide to control 
Varroa and tracheal mites, their recommendation and this proposed rule 
would, in effect, allow the use of formic acid to control both Varroa 
and tracheal mites in organic apiculture.
    At the October 2010 NOSB meeting, the NOP and NOSB discussed the 
placement of formic acid on the National List. The NOP raised the 
question of whether listing formic acid, a miticide, under Sec.  
205.603(b) is appropriate given that Sec.  205.603(b) specifies that 
substances under this section be limited to use as ``a topical 
treatment, external parasiticide (emphasis added) or local anesthetic 
as applicable''. The NOSB explained that their research indicated that 
mites can be considered a parasite. The NOSB also stated that listing 
formic acid at Sec.  205.603(b) would be consistent with the listing 
for sucrose octanoate esters, another substance in this National List 
section which is approved for use in apiculture to control Varroa 
mites. Through this proposed rule, the NOP is seeking comments on the 
placement of formic acid on the National List. Furthermore, the NOP may 
reconsider the placement of formic acid on the National List as part of 
any future rulemaking on organic apiculture standards. In the NOP's 
consideration of the addition of formic acid to the National List, the 
NOP would also like to reiterate that registered pesticide products 
intended for use in organic production and handling must also be 
evaluated for compliance with EPA's August 2004 list of inert 
ingredients, minus any revoked inert ingredients.
    The Secretary has reviewed and proposes to accept the NOSB's 
recommendation. Consistent with the NOSB recommendation, this proposed 
rule would amend Sec.  205.603 of the National List by adding formic 
acid (CAS 64-18-6) at paragraph (b)(2) as a synthetic 
substance allowed for use as follows:
    Formic acid (CAS 64-18-6)--for use as a pesticide solely 
within honeybee hives.

Section 205.605 Nonagricultural (Nonorganic) Substances Allowed as 
Ingredients in or on Processed Products Labeled as ``Organic'' or 
``Made With Organic (Specified Ingredients or Food Group(s))''

    This proposed rule would amend Sec.  205.605(a) of the National 
List regulations by adding the following substance:
    Attapulgite. Attapulgite was petitioned for two uses: (1) As a 
nonsynthetic processing aid in organic handling for purifying vegetable 
and animal oils; and (2) as a livestock feed additive.\17\ Attapulgite 
is the product of naturally occurring attapulgus clay that is mined and 
subsequently dried and pulverized into a fine bluish gray powder. Fine 
particle size and high porosity and surface area give attapulgite the 
capacity to absorb and adsorb various materials such as chlorophyll, 
metals and other impurities to improve the appearance, flavor and 
stability of plant and animal oils. The clay is added to heated liquid 
oil, stirred, and filtered out of the oil. According to the petitioner, 
adverse effects to human health would not be expected from occupational 
exposure to this product through inhalation or ingestion when proper 
protective equipment is utilized.\18\ The FDA has listed this substance 
in the database, Everything Added to Food in the United States (EAFUS) 
(Doc. No. 1943) and references this substance among those generally 
regarded as safe in 21 CFR part 582.99 when used as an adjuvant for 
pesticide chemicals. The EPA permits attapulgite as an inert ingredient 
eligible in minimum risk pesticides applied for food and non-food uses 
which are exempt from federal registration under Section 25(b) of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The EPA 
has determined that attapulgite is exempt from the requirement of a 
tolerance when used as an inert ingredient in pesticide formulations 
applied pre- and post-harvest per 40 CFR 180.910.\19\
---------------------------------------------------------------------------

    \17\ Due to the nonsynthetic classification of this substance, a 
petition for use as an additive for organic livestock feed is not 
required.
    \18\ The petition was submitted by the Oil-Dri Corporation of 
America, and is retrievable from the NOP Web site in the Petitioned 
Substances Database: http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
    \19\ Technical Report on Attapulgite. February 1, 2010. A copy 
of this report is available in the petitioned substances database, 
http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
---------------------------------------------------------------------------

    At its April 26-29, 2011, meeting in Seattle, WA, the NOSB 
recommended adding attapulgite to the National List for use as a 
processing aid in organic handling of plant and animal oils. The NOSB 
did not receive public comments against this recommendation. During 
their deliberations, the NOSB noted that bentonite, a material already 
on the National List which can serve a similar bleaching function as 
attapulgite, requires acid activation. The NOSB explained that, though 
acid activation can be used to enhance bleaching properties of 
attapulgite, acid activation is not required for the substance to 
function as a processing aid and, therefore, may be preferable to the 
use of bentonite. The NOSB did not, however, recommend restricting the 
use of attapulgite to non-acid activated forms. During this public 
meeting, the NOSB evaluated attapulgite against the evaluation criteria 
of 7 U.S.C. 6517 and 6510 of the OFPA, received public comment, and 
concluded the substance is consistent with the OFPA evaluation 
criteria. Based upon the evaluation criteria, public comment, and the 
petitioner's request, the NOSB issued a final recommendation to add 
attapulgite to the National List.
    The Secretary has reviewed and proposes to accept the NOSB 
recommendation. Consistent with the NOSB recommendation, this proposed 
rule would amend Sec.  205.605(a) of the National List by adding 
attapulgite as follows:
    Attapulgite--as a processing aid in the handling of plant and 
animal oils.

III. Related Documents

    Two notices were published regarding the meetings of the NOSB and 
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) 76 FR 12013, March 4, 2011, (Attapulgite 
and Tetracycline); (2) 75 FR 57194, September 20, 2010, (Formic acid).

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) 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 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

[[Page 69145]]

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/nop.

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. 601-624), the Poultry Products 
Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act 
(21 U.S.C. 1031-1056), concerning meat, poultry, and egg products, 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 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 
and handling. 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 and 
beneficial to small agricultural 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 producers, 
handlers, and accredited certifying agents, have been defined by the 
Small Business Administration (SBA) (13 CFR 121.201) as those having 
annual receipts of less than $7,000,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000.
    Based on USDA data from the Economic Research Service (ERS), the 
U.S. organic sector included nearly 13,000 certified organic crop and 
livestock operations at the end of 2008. These operations contained 
more than 4.8 million certified acres consisting of 2,665,382 acres of 
cropland and 2,160,577 acres of pasture and rangeland. The total 
acreage under organic management represents a twelve percent increase 
from 2007.\20\ AMS believes that most of the certified production and 
handling operations would be classified as small entities under the 
criteria established by the SBA.
---------------------------------------------------------------------------

    \20\ U.S. Department of Agriculture, Economic Research Service, 
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock 
Numbers and Farm Operations, 1992-2008. http://www.ers.usda.gov/Data/Organic/.
---------------------------------------------------------------------------

    The U.S. sales of organic food and beverages have grown from $3.6 
billion in 1997 to nearly $21.1 billion in 2008.\21\ Between 1990 and 
2008, organic food sales have historically demonstrated a growth rate 
between 15 to 24 percent each year. In 2010, organic food sales grew 
7.7%.\22\
---------------------------------------------------------------------------

    \21\ Dimitri, C., and L. Oberholtzer. 2009. Marketing U.S. 
Organic Foods: Recent Trends from Farms to Consumers, Economic 
Information Bulletin No. 58, U.S. Department of Agriculture, 
Economic Research Service, http://www.ers.usda.gov/Publications/EIB58.
    \22\ Organic Trade Association's 2011 Organic Industry Survey. 
Available at: http://www.ota.com.
---------------------------------------------------------------------------

    In addition, USDA has accredited 93 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 the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, 
chapter 35.

E. Executive Order 13175

    This proposed rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. The review reveals that this regulation 
will not have substantial

[[Page 69146]]

and direct effects on Tribal governments and will not have significant 
Tribal implications.
F. General Notice of Public Rulemaking
    This proposed rule reflects recommendations submitted by the NOSB 
to the Secretary to amend the annotation for one substance and to add 
two substances on the National List. A 60-day period for interested 
persons to comment on this rule is provided and is deemed appropriate.

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 paragraph (i)(12) is revised to read as follows:


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

* * * * *
    (i) * * *
    (12) Tetracycline, for fire blight control in apples and pears only 
until October 21, 2014.
* * * * *
    3. Section 205.603 is amended by:
    A. Redesignating paragraphs (b)(2) through (b)(7) as paragraphs 
(b)(3) through (b)(8); and
    B. Adding new paragraph (b)(2) to read as follows:


Sec.  205.603  Synthetic substances allowed for use in organic 
livestock production.

* * * * *
    (b) * * *
    (2) Formic acid (CAS 64-18-6)--for use as a pesticide 
solely within honeybee hives.
* * * * *
    4. In Sec.  205.605(a), the substance ``Attapulgite'' is added in 
alphabetical order to read as follows:


Sec.  205.605  Nonagricultural (nonorganic) substances allowed as 
ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food groups(s)).''

* * * * *
    (a) * * *
    Attapulgite--as a processing aid in the handling of plant and 
animal oils.
* * * * *

    Dated: November 1, 2011.
David R. Shipman,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2011-28800 Filed 11-7-11; 8:45 am]
BILLING CODE 3410-02-P