National Organic Program (NOP): Proposed Amendments to the National List of Allowed and Prohibited Substances (Crops and Processing), 54660-54668 [05-18381]

Download as PDF 54660 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Proposed Rules Employee survey questions Employee response choices (10) Physical conditions (for example, noise level, temperature, lighting, cleanliness in the workplace) allow employees to perform their jobs well. Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree, or Do Not Know. Performance Culture (11) Promotions in my work unit are based on merit .............................. (12) In my work unit, steps are taken to deal with a poor performer who cannot or will not improve. (13) Creativity and innovation are rewarded ............................................ (14) In my work unit, differences in performance are recognized in a meaningful way. (15) My performance appraisal is a fair reflection of my performance (16) Discussions with my supervisor/team leader about my performance are worthwhile. (17) Managers/supervisors/team leaders work well with employees of different backgrounds. Strongly Agree, Agree, Neither Disagree, or Do Not Know. Strongly Agree, Agree, Neither Disagree, or Do Not Know. Strongly Agree, Agree, Neither Disagree, or Do Not Know. Strongly Agree, Agree, Neither Disagree, or Do Not Know. Strongly Agree, Agree, Neither Disagree, or Do Not Know. Strongly Agree, Agree, Neither Disagree, or Do Not Know. Strongly Agree, Agree, Neither Disagree, or Do Not Know. Agree Nor Disagree, Disagree, Strongly Agree Nor Disagree, Disagree, Strongly Agree Nor Disagree, Disagree, Strongly Agree Nor Disagree, Disagree, Strongly Agree Nor Disagree, Disagree, Strongly Agree Nor Disagree, Disagree, Strongly Agree Nor Disagree, Disagree, Strongly Leadership (18) I have a high level of respect for my organization’s senior leaders (19) In my organization, leaders generate high levels of motivation and commitment in the workforce. (20) Managers review and evaluate the organization’s progress toward meeting its goals and objectives. (21) Employees are protected from health and safety hazards on the job. (22) My organization has prepared employees for potential safety and security threats. Strongly Agree, Agree, Neither Disagree, or Do Not Know. Strongly Agree, Agree, Neither Disagree, or Do Not Know. Strongly Agree, Agree, Neither Disagree, or Do Not Know. Strongly Agree, Agree, Neither Disagree, or Do Not Know. Strongly Agree, Agree, Neither Disagree, or Do Not Know. Agree Nor Disagree, Disagree, Strongly Agree Nor Disagree, Disagree, Strongly Agree Nor Disagree, Disagree, Strongly Agree Nor Disagree, Disagree, Strongly Agree Nor Disagree, Disagree, Strongly Job Satisfaction (23) How satisfied are you with your involvement in decisions that affect your work? (24) How satisfied are you with the recognition you receive for doing a good job? (25) How satisfied are you with the policies and practices of your senior leaders? (26) How satisfied are you with the training you receive for your present job? (27) Considering everything, how satisfied are you with your job? (28) Considering everything, how satisfied are you with your pay? § 250.302 Availability of results. (a) Each agency will make the results of its annual survey available to the public and post the results on its Web site, unless the agency head determines that doing so would jeopardize or negatively impact national security. The posted survey results will include the following: (1) The agency’s evaluation of its survey results; (2) How the survey was conducted; (3) Description of the employee sample, unless all employees are surveyed; (4) The survey questions and response choices with the prescribed questions identified; (5) The number of employees surveyed and number of survey respondents; and VerDate Aug<31>2005 18:38 Sep 15, 2005 Jkt 205001 Very Satisfied, Satisfied, or Very Dissatisfied. Very Satisfied, Satisfied, or Very Dissatisfied. Very Satisfied, Satisfied, or Very Dissatisfied. Very Satisfied, Satisfied, or Very Dissatisfied. Very Satisfied, Satisfied, or Very Dissatisfied. Very Satisfied, Satisfied, or Very Dissatisfied. (6) The number of respondents for each survey question and each response choice. (b) Data must be collected by December 31 of each calendar year. Each agency must post the beginning and ending dates of its employees survey and either the survey results described in paragraph (a) or a statement noting the decision not to post no later than 120 days after the agency completes survey administration. OPM may extend this date in unusual circumstances. (c) Each agency must submit its survey results to OPM no later than 120 days after the agency completes survey administration. [FR Doc. 05–18374 Filed 9–15–05; 8:45 am] BILLING CODE 6325–39–M PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 Neither Satisfied Nor Dissatisfied, Dissatisfied, Neither Satisfied Nor Dissatisfied, Dissatisfied, Neither Satisfied Nor Dissatisfied, Dissatisfied, Neither Satisfied Nor Dissatisfied, Dissatisfied, Neither Satisfied Nor Dissatisfied, Dissatisfied, Neither Satisfied Nor Dissatisfied, Dissatisfied, DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Docket Number TM–04–01] RIN 0581–AC35 National Organic Program (NOP): Proposed Amendments to the National List of Allowed and Prohibited Substances (Crops and Processing) Agricultural Marketing Service, USDA. ACTION: Proposed rule. AGENCY: SUMMARY: This proposed rule would amend the U.S. Department of Agriculture’s (USDA) National List of Allowed and Prohibited Substances E:\FR\FM\16SEP1.SGM 16SEP1 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Proposed Rules (National List) regulations to reflect recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board (NOSB) from November 15, 2000, through March 3, 2005. Consistent with the recommendations from the NOSB, this proposed rule would add fifteen substances, along with any restrictive annotations, to the National List. This proposed rule would also amend the mailing address for where to file a Certification or Accreditation appeal. DATES: Comments must be received by November 15, 2005. ADDRESSES: Interested persons may comment on this proposed rule using the following procedures: • Mail: Comments may be submitted by mail to: Arthur Neal, Director of Program Administration, National Organic Program, USDA–AMS–TMP– NOP, 1400 Independence Ave., SW., Room 4008–So., Ag Stop 0268, Washington, DC 20250. • E-mail: Comments may be submitted via the Internet to: National.List@usda.gov. • Internet: http:// www.regulations.gov. • Fax: Comments may be submitted by fax to: (202) 205–7808. • Written comments on this proposed rule should be identified with the docket number TMD–04–01. Commenters should identify the topic and section number of this proposed rule to which the comment refers. • Clearly indicate if you are for or against the proposed rule or some portion of it and your reason for it. Include recommended language changes as appropriate. • Include a copy of articles or other references that support your comments. Only relevant material should be submitted. It is our intention to have all comments to this proposed rule, whether submitted by mail, e-mail, or fax, available for viewing on the NOP homepage. Comments submitted in response to this proposed rule will be available for viewing in person at USDA–AMS, Transportation and Marketing, Room 4008-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: Arthur Neal, Director of Program VerDate Aug<31>2005 18:38 Sep 15, 2005 Jkt 205001 Administration, Telephone: (202) 720– 3252; Fax: (202) 205–7808. SUPPLEMENTARY INFORMATION: I. Background On December 21, 2000, the Secretary established, within the NOP [7 CFR part 205], the National List regulations (§§ 205.600 through 205.607). The National List regulations identify synthetic substances and ingredients that are allowed and nonsynthetic (natural) substances and ingredients that are prohibited for use in organic production and handling. Under the authority of the Organic Foods Production Act of 1990 (OFPA), as amended, (7 U.S.C. 6501 et seq.), the National List can be amended by the Secretary based on proposed amendments developed by the NOSB. Since established, the National List has been amended twice, October 31, 2003 (68 FR 61987), and November 3, 2003 (68 FR 62215). This proposed rule would amend the National List to reflect recommendations submitted to the Secretary by the NOSB from November 15, 2000, through March 3, 2005. Between the specified time period, the NOSB has recommended that the Secretary add four substances to § 205.601 and eleven substances to § 205.605 of the National List regulations. This proposed rule would also amend the mailing address for where to file a Certification or Accreditation appeal pursuant to § 205.681(d). 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 paragraph (m)(2) of § 205.601 of the regulations by adding the following substances: Glycerine oleate (Glycerol monooleate) (CAS #s 25496–72–4; 111– 03–5; 37220–82–9)—for use only until December 31, 2006. Glycerine oleate was petitioned to be used as an antifoaming agent (defoamer) in organic crop production. Glycerine oleate is a clear amber or pale yellow liquid that is insoluble in water, slightly soluble in cold alcohol, and soluble in hot alcohol, chloroform, ether, and petroleum ether. In crop production, Glycerin oleate would be used as an anti-foaming agent (defoamer) in micronized wettable Sulfur that is used to control scab and PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 54661 mildew in the production of apples, pears, grapes, and raisins. The function of Glycerine oleate in the micronized wettable Sulfur would be to enable the product to be mixed in a tank effectively and sprayed on crops evenly. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Environmental Protection Agency (EPA) has classified Glycerine oleate as a List 3 inert (Inerts of Unknown Toxicity). Under the Food and Drug Administration (FDA), Glycerin monooleate (a synonym for Glycerin oleate) has been classified as a substance that is Generally Recognized As Safe (GRAS) for food production (21 CFR 184.1323). The NOSB, at its May 13–14, 2003, meeting in Austin, TX, recommended adding Glycerine oleate to § 205.601(m) (2) of the National List regulations. In this open meeting, the NOSB evaluated Glycerine oleate against the evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA, received public comment, and concluded that the substance is consistent with the OFPA evaluation criteria; however, it recommended that Glycerine oleate be added to the National List regulations, for use in crop production, only until December 31, 2006. The normal time period for the use of a substance under the NOP regulations is 5 years, beginning the date the substance appears in the National List regulations. The NOSB recommended the early expiration date of December 31, 2006, because of the present efforts of the Environmental Protection Agency (EPA) to reclassify inerts on List 2 (Potentially Toxic Inert Ingredients/ High Priority for Testing Inerts) and List 3 (Inerts of Unknown Toxicity) to either List 1 (Inert Ingredients of Toxicological Concern) or List 4 (Inerts of Minimal Concern) by December 31, 2006. With respect to the use of EPA regulated inert ingredients in organic crop and livestock production, only substances included on EPA’s List 4 are categorically allowed on the National List (§ 205.601(m)(i)); all other EPA inert ingredients must be listed individually. Glycerine oleate is a List 3 inert; the NOSB anticipates that EPA will conclude its reclassification of Glycerine oleate to either a List 1 or List 4 status by December 31, 2006. If Glycerine oleate is reclassified as a List 1 inert, it will be prohibited for use as an inert ingredient for organic crop production. If Glycerin oleate is reclassified as a List 4 inert, then it will automatically continue to be allowed for use in organic crop production as an inert ingredient. In addition, if EPA does not complete its reclassification of E:\FR\FM\16SEP1.SGM 16SEP1 54662 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Proposed Rules Glycerine oleate by December 31, 2006, the substance will be prohibited for use in organic crop production beginning on January 1, 2007. Therefore, in response to the NOSB recommendation regarding the use of Glycerine oleate in organic crop production, the Secretary accepts the NOSB recommendation and proposes to amend § 205.601(m)(2) of the National List regulation as follows: Glycerine oleate (Glycerol monooleate) (CAS #s 25496–72–4; 111– 03–5; 37220–82–9)—for use only until December 31, 2006. Tetrahydrofurfuryl alcohol (CAS # 97–99–4)—for use only until December 31, 2006. Tetrahydrofurfuryl alcohol was petitioned for use as an inert pesticidal ingredient for use in organic crop production. Tetrahydrofurfuryl alcohol is a clear, colorless liquid that is used extensively in various industries as a high-purity, water miscible solvent, and as a chemical intermediate. If released to soil, Tetrahydrofurfuryl alcohol is expected to exhibit high solubility. Under FIFRA, the EPA has registered Tetrahydrofurfuryl alcohol as a List 3 inert (Inerts of Unknown Toxicity). In addition, the FDA has classified Tetrahydrofurfuryl alcohol as a direct food additive in synthetic flavoring substances (21 CFR 172.515) and an indirect food additive in adhesives and the manufacture of paper and paper adjuvants (21 CFR 175.105 and 176.210). The NOSB, at its May 13–14, 2003, meeting in Austin, TX, recommended adding Tetrahydrofurfuryl alcohol to § 205.601(m)(2) of the National List regulations. In this open meeting, the NOSB evaluated Tetrahydrofurfuryl alcohol against the evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA, received public comment, and concluded that the substance is consistent with the OFPA evaluation criteria; however, it recommended that Tetrahydrofurfuryl alcohol be added to the National List regulations, for use in crop production, only until December 31, 2006. The normal time period for the use of a substance under the NOP regulations is five years, beginning the date the substance appears in the National List regulations. The NOSB recommended the early expiration date of December 31, 2006, because of the present efforts of the EPA to reclassify inerts on List 2 (Potentially Toxic Inert Ingredients/ High Priority for Testing inerts) and List 3 (Inerts of Unkown Toxicity) to either List 1 (Inert Ingredients of Toxicological Concern) or List 4 (Inerts of Minimal Concern) by December 31, 2006. With VerDate Aug<31>2005 18:38 Sep 15, 2005 Jkt 205001 respect to the use of EPA regulated inert ingredients in organic crop and livestock production, only substances included on EPA’s List 4 are categorically allowed on the National List (§ 205.601(m)(i)); all other EPA inert ingredients must be listed individually. Tetrahydrofurfuryl alcohol is a List 3 inert; the NOSB anticipates that EPA will conclude its reclassification of Tetrahydrofurfuryl alcohol to either a List 1 or List 4 status by December 31, 2006. If Tetrahydrofurfuryl alcohol is reclassified as a List 1 inert, it will be prohibited for use as an inert ingredient for organic crop production. If Tetrahydrofurfuryl alcohol is reclassified as a List 4 inert, then it will automatically continue to be allowed for use in organic crop production as an inert ingredient. In addition, if EPA does not complete its reclassification of Tetrahydrofurfuryl alcohol by December 31, 2006, the substance will be prohibited for use in organic crop production beginning on January 1, 2007. Therefore, in response to the NOSB recommendation regarding the use of Tetrahydrofurfurly alcohol in organic crop production, the Secretary accepts the NOSB recommendation and proposes to amend § 205.601(m)(2) of the National List regulation as follows: Tetrahydrofurfurly alcohol (CAS # 97–99–4)—for use only until December 31, 2006. Hydrogen chloride (CAS # 7647–01– 0)—for de-linting cotton seed for planting. Hydrogen chloride was petitioned for use as a synthetic to delint cotton seed for planting in organic crop production. Hydrogen chloride is a colorless to slightly yellow gas with a pungent, irritating odor. It is very soluble in water and readily soluble in alcohol and ether. Hydrogen chloride has been classified by the FDA as a substance that is GRAS when used as a buffer and neutralizing agent in accordance with good manufacturing or feeding practice (21 CFR 582.1057). In delinting cotton seeds intended for planting organic acreage, Hydrogen chloride is released into a delinting machine that contains linted cotton seeds. Seed is exposed to the Hydrogen chloride for about eight to ten minutes to weaken the lint and is then sent through buffers to remove the weakened lint from the seed. After delinting, a neutralizing agent (often Calcium carbonate) is used to prevent acid damage to the seed. The NOSB, at its April 28–30, 2004, meeting in Chicago, IL, recommended adding Hydrogen chloride to § 205.601 of the National List regulations. In this open meeting, the NOSB evaluated PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 Hydrogen chloride against the evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA, received public comment, and concluded that the substance is consistent with the OFPA evaluation criteria. Therefore, in response to the NOSB recommendation regarding the use of Hydrogen chloride in organic crop production, the Secretary accepts the NOSB recommendation and proposes to amend § 205.601 of the National List regulations by adding (1) a new paragraph (n), Seed preparations, and (2) Hydrogen chloride as follows: (n) Seed preparations. Hydrogen chloride (CAS # 7647–01– 0)—for de-linting cotton seed for planting. Ferric phosphate (CAS # 10045–86– 0). Ferric phosphate was petitioned for use as a pesticide (molluscicide) to bait slugs and snails in organic crop production. It is an odorless, yellowishwhite powder that is not very soluble in water. Ferric phosphate is normally applied to soil as part of a pellet that includes a wheat-based bait to attract snails and slugs. After the pellets are consumed, Ferric phosphate interferes with calcium metabolism in the digestive tract of the snails and slugs, causing them to stop eating. Shortly thereafter, the snails and slugs die. Under the FIFRA, the EPA has registered ferric phosphate as a biochemical molluscicide that targets a wide range of slugs and snails (63 FR 43936). In assessing risks to human health, EPA has concluded that there are no known or expected adverse effects to humans from the use of ferric phosphate. In assessing risks to the environment, the EPA has concluded that there are no known or expected harmful effects of the use of Ferric phosphate on the environment if users follow the application rates and use directions on the label. In addition to the assessments of the EPA, the FDA has classified Ferric phosphate as a substance that is GRAS for food use (21 CFR 184.1301). The NOSB, at its February 28–March 3, 2005, meeting in Washington, DC, recommended adding Ferric phosphate to § 205.601(h) of the National List regulations without restriction. In this open meeting, the NOSB evaluated Ferric phosphate against the evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA, received public comment, and concluded that the substance is consistent with the OFPA evaluation criteria. Therefore, in response to the NOSB recommendation regarding the use of Ferric phosphate in organic crop production, the Secretary accepts the NOSB recommendation and proposes to E:\FR\FM\16SEP1.SGM 16SEP1 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Proposed Rules amend § 205.601(h) of the National List regulations as follows: Ferric phosphate (CAS # 10045–86– 0). 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 regulations by adding the following substances: Egg white lysozyme (CAS # 9001–63– 2). Egg white lysozyme was petitioned for use as an enzyme in organic processing. It is a white powder with no distinct odor. It is readily soluble in water and practically insoluble in alcohol, chloroform, and ether. Egg white lysozyme is considered to be GRAS by the FDA for use as an antimicrobial agent in casings for frankfurters and on cooked meat and poultry products. Egg white lysozyme is used in casings for frankfurters at a concentration of 2.5 milligram (mg) lysozyme per pound (lb) of frankfurter (equivalent to 5.5 mg Lysozyme per kilogram (kg) of food) and in cooked meat and poultry products sold as ready-to-eat at a concentration of 2.0 mg of Lysozyme per lb of cooked meat or poultry product (equivalent to 4.4 mg of Lysozyme per kg of food). The FDA acknowledged in GRAS Notice No. (GRN) 000064 that it had no question, at the time of review, that Egg white lysozyme is GRAS under the intended conditions of use; provided, that the ingredient statement of food products that contain Egg white lysozyme contain the name ‘‘Egg white lysozyme’’ to identify the source of the protein. The NOSB, at its May 13–14, 2003, meeting in Austin, TX, recommended adding Egg white lysozyme to § 205.605(a) of the National List regulations without restriction. In this open meeting, the NOSB evaluated Egg white lysozyme against the evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA, received public comment, and concluded that the substance is consistent with the OFPA evaluation criteria. Therefore, in response to the NOSB recommendation regarding the use of Egg white lysozyme in organic handling, the Secretary accepts the NOSB recommendation and proposes to amend § 205.605(a) of the National List regulations as follows: Egg white lysozyme (CAS # 9001–63– 2). L-Malic acid (CAS # 97–67–6). DLMalic acid was originally petitioned for use as a synthetic processing aid in organic handling. It is a white or VerDate Aug<31>2005 18:38 Sep 15, 2005 Jkt 205001 colorless powder with no odor. It is readily biodegradable in water and in soil. DL-Malic acid is considered to be GRAS by FDA (21 CFR 184.1069). It is a processing aid that is used in bottled iced tea, dry mix beverages, carbonated beverages, bakery products, fruit juices, candies, gelatins, desserts, frozen specialties, sports drinks, and other food products. The NOSB, at its May 13–14, 2003, meeting in Austin, TX, evaluated DLMalic acid in an open meeting, received public comment, and concluded that the substance was not consistent with the evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA. This determination was made because of an identified available natural alternative, L-Malic acid. As a result of having identified a natural alternative to DL-malic acid, the NOSB asked the petitioner whether LMalic acid, a natural, could be substituted for DL-Malic acid for inclusion on the National List. The petitioner concurred and the NOSB recommended L-Malic acid for inclusion in section 205.605(a) of the National List. Therefore, in response to the NOSB recommendation regarding the use of L-Malic acid in organic handling, the Secretary accepts the NOSB recommendation and proposes to amend § 205.605 (a) of the National List regulations as follows: L-Malic acid (CAS # 97–67–6). Microorganisms—any food grade bacteria, fungi, and other microorganisms. Seed mold, a microorganism, was petitioned for use as a processing aid in organic handling. Seed mold is used as a culture starter in food processing. In the evaluation of seed mold, the NOSB recognized that they had previously evaluated and determined other types of food-grade microorganisms (e.g., dairy cultures and yeast) and certain by-products derived from them (e.g., enzymes) to be consistent with OFPA criteria and the NOP regulations. These microorganisms are already included on the National List. The NOSB acknowledged that there are many species of food-grade microorganisms that are used in food processing that could be petitioned for use in organic handling. As a result, a decision was made by the NOSB to evaluate the categorical use of foodgrade microorganisms in organic handling and recommend their inclusion in section 205.605(a) of the National List. This decision would obviate the need for future review and evaluation of other individual food grade microorganisms that exhibit similar characteristics and functions as PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 54663 those already approved for use on the National List. At its May 13–14, 2003, meeting in Austin, TX, the NOSB recommended adding microorganisms to § 205.605(a) of the National List regulations without restriction. In this open meeting, the NOSB evaluated the categorical use of microorganisms in organic handling against 7 U.S.C. 6517 and 6518 of the OFPA, received public comment, and concluded that the use of microorganisms in organic handling is consistent with the evaluation criteria. Therefore, in response to the NOSB recommendation regarding the use of microorganisms in organic handling, the Secretary accepts the NOSB recommendation and proposes to amend § 205.605(a) of the National List regulations as follows: Microorganisms—any food grade bacteria, fungi, and other microorganisms. This proposed rule would also amend § 205.605(b) of the regulations by adding the following substances: Activated charcoal (CAS #s 7440–44– 0; 64365–11–3)—only from vegetative sources; for use only as a filtering aid in handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ Activated charcoal was petitioned for use as a processing aid in organic handling. Activated charcoal is a solid, porous, black carbonaceous material that is used as a decolorizing agent, taste- and odorremoving agent, and purification agent in food processing. It is also used for the treatment of water, including potable water. Activated charcoal is acknowledged by FDA in 21 CFR 173.25(b)(1)(ii) to be an allowed substance for use in ion exchange. It is also recognized as an indirect food additive in closures with sealing gaskets for food containers (21 CFR 177.1210). At its September 17–19, 2002, meeting in Austin, TX, the NOSB recommended adding activated charcoal to § 205.605(b) of the National List regulations for organic handling, with the restrictions that the substance: (1) Comes from vegetative sources only; and (2) only be used as a filtering aid. In this open meeting, the NOSB evaluated the use of activated charcoal against the evaluation criteria of § 205.600(b) of the National List regulations, received public comment, and concluded that the use of activated charcoal in organic handling is consistent with the evaluation criteria. Therefore, in response to the NOSB recommendation regarding the use of activated charcoal in organic handling, E:\FR\FM\16SEP1.SGM 16SEP1 54664 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Proposed Rules the Secretary proposes to amend § 205.605(b) of the National List regulations to allow activated charcoal as a synthetic ingredient in or on processed products labeled as ‘‘made with organic (specified ingredients or food group(s))’’ as follows: Activated charcoal (CAS #s 7440–44– 0; 64365–11–3)—only from vegetative sources; for use only as a filtering aid in handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ Ammonium hydroxide (CAS # 1336– 21–6)—for use only as a boiler water additive until October 21, 2005. Restricted to handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ Ammonium hydroxide was petitioned as a boiler water additive in organic handling. It is a colorless liquid with an intense odor. It is used in preventing the corrosion of boiler equipment used in food processing. Ammonium hydroxide is considered to be GRAS by FDA and allowed as a boiler water additive under 21 CFR 184.1139. At its October 15–17, 2001, meeting in Washington, DC, the NOSB recommended adding Ammonium hydroxide to § 205.605(b) of the National List regulations, with the restriction that it can only be used in organic handling until October 21, 2005. In this open meeting, the NOSB evaluated the use of Ammonium hydroxide against the evaluation criteria of § 205.600(b) of the National List regulations, received public comment, and concluded that the use of Ammonium hydroxide in organic handling is consistent with the evaluation criteria. Although the NOSB determined Ammonium hydroxide to be consistent with the evaluation criteria of § 205.600(b), it recommended an early expiration date of October 21, 2005, for the use of the substance, to encourage the organic processing industry to find an alternative substance to use in place of the Ammonium hydroxide. The normal time period for the use of a substance under the NOP regulations is 5 years, beginning the date the substance appears in the National List regulations. Therefore, in response to the NOSB recommendation regarding the use of Ammonium hydroxide in organic handling, the Secretary proposes to amend § 205.605(b) of the National List regulations to allow Ammonium hydroxide as a synthetic ingredient in or VerDate Aug<31>2005 18:38 Sep 15, 2005 Jkt 205001 on processed products labeled as ‘‘made with organic (specified ingredients or food group(s))’’ as follows: Ammonium hydroxide (CAS # 1336– 21–6)—for use only as a boiler water additive until October 21, 2005. Restricted to handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ Cyclohexylamine (CAS # 108–91–8)— for use only as a boiler water additive for packaging sterilization. Restricted to handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ Cyclohexylamine was petitioned as a boiler water additive in organic handling. Cyclohexylamine is a colorless to yellow liquid that has a strong, fishy odor. It is miscible with water and with common organic solvents. It is used to prevent the corrosion of boiler equipment used in food processing. Cyclohexylamine is approved for use as a secondary direct food additive and boiler water additive by FDA under 21 CFR 173.310. At its October 15–17, 2001, meeting in Washington, DC, the NOSB recommended adding Cyclohexlamine to § 205.605(b) of the National List regulations for organic handling, with the restriction that it be used as a boiler water additive for packaging sterilization only. In this open meeting, the NOSB evaluated the use of Cyclohexlamine against the evaluation criteria of § 205.600(b) of the National List regulations, received public comment, and concluded that the use of Cyclohexlamine in organic handling is consistent with the evaluation criteria. Therefore, in response to the NOSB recommendation regarding the use of Cyclohexlamine in organic handling, the Secretary proposes to amend § 205.605(b) of the National List regulations to allow Cyclohexlamine as a synthetic ingredient in or on processed products labeled as ‘‘made with organic (specified ingredients or food group(s))’’ as follows: Cyclohexylamine (CAS # 108–91–8)— for use only as a boiler water additive for packaging sterilization. Restricted to handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ Diethylaminoethanol (CAS # 100–37– 8)—for use only as a boiler water additive for packaging sterilization; restricted to handling agricultural products labeled ‘‘made with organic PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 (specified ingredients or food group(s));’’ prohibited for use in handling agricultural products labeled ‘‘organic.’’ Diethlaminoethanol was petitioned as a boiler water additive in organic handling. Diethylaminoethanol is a colorless liquid with a weak ammonia odor. It is hygroscopic soluble in water, alcohol, Acetone, Benzene, and Petroleum ether. Diethlaminoethanol inhibits corrosion in boiler chemical systems in return lines, by neutralizing Carbonic acid in steam and steam condensates, and by scavenging free Oxygen. It is used in conjunction with Cyclohexylamine, Morpholine, and Octadecylamine. Diethylaminoethanol is approved for use as a secondary direct food additive and boiler water additive by FDA under 21 CFR 173.310. At its May 6–8, 2002, meeting in Austin, TX, the NOSB recommended adding Diethylaminoethanol to § 205.605(b) of the National List regulations for organic handling, with the restriction that it be used as a boiler water additive for packaging sterilization only. In this open meeting, the NOSB evaluated the use of Diethylaminoethanol against the evaluation criteria of § 205.600(b) of the National List regulations, received public comment, and concluded that the use of Diethylaminoethanol in organic handling is consistent with the evaluation criteria. Therefore, in response to the NOSB recommendation regarding the use of Diethylaminoethanol in organic handling, the Secretary proposes to amend § 205.605(b) of the National List regulations to allow Diethylaminoethanol as a synthetic ingredient in or on processed products labeled as ‘‘made with organic (specified ingredients or food group(s))’’ as follows: Diethylaminoethanol (CAS # 100–37– 8)—for use only as a boiler water additive for packaging sterilization. Restricted to handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited for use in handling agricultural products labeled ‘‘organic.’’ Octadecylamine (CAS # 124–30–1)— for use only as a boiler water additive for packaging sterilization. Restricted to handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited for use in handling agricultural products labeled ‘‘organic.’’ Octadecylamine was petitioned for use as a boiler water additive to prevent corrosion of boiler equipment and distribution lines. Octadecylamine is an E:\FR\FM\16SEP1.SGM 16SEP1 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Proposed Rules opaque, off-white liquid with ammoniacal odor, insoluble in water but soluble in alcohol, Ether, Benzene; very soluble in Chloroform; and miscible in Acetone. Octadecylamine is approved for use as a secondary direct food additive and boiler water additive by FDA under 21 CFR 173.310. At its October 15–17, 2001, meeting in Washington, DC, the NOSB recommended adding Octadecylamine to § 205.605(b) of the National List regulations for organic handling, with the restriction that it be used as a boiler water additive for packaging sterilization only. In this open meeting, the NOSB evaluated the use of Octadecylamine against the evaluation criteria of § 205.600(b) of the National List regulations, received public comment, and concluded that the use of Octadecylamine in organic handling is consistent with the evaluation criteria. Therefore, in response to the NOSB recommendation regarding the use of Octadecylamine in organic handling, the Secretary proposes to amend § 205.605(b) of the National List regulations to allow Octadecylamine as a synthetic ingredient in or on processed products labeled as ‘‘made with organic (specified ingredients or food group(s))’’ as follows: Octadecylamine (CAS # 124–30–1)— for use only as a boiler water additive for packaging sterilization. Restricted to handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited for use in handling agricultural products labeled ‘‘organic.’’ Peracetic acid/Peroxyacetic acid (CAS # 79–21–0)—for use in wash and/or rinse water according to FDA limitations. For use as a sanitizer on food contact surfaces. Restricted to use in handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in agricultural products labeled ‘‘organic.’’ Peracetic acid was petitioned as an anti-microbial water treatment additive and/or as an equipment sanitizer or disinfectant. Its most common use in food processing and handling is as a sanitizer for food contact surfaces and as a disinfectant for fruits, vegetables, meats, and eggs. Other uses of Peracetic acid include removing deposits, suppressing odor, and stripping biofilms from food contact surfaces. Peracetic acid is a clear colorless liquid with no foaming capability, and has a strong pungent odor. It is approved by FDA as a secondary direct food additive used in the washing or peeling of fruits and vegetables (21 CFR 173.315). It is also approved for use as an indirect food VerDate Aug<31>2005 18:38 Sep 15, 2005 Jkt 205001 additive, sanitizer, under 21 CFR 178.1010. At its November 15–17, 2000, meeting in Washington, DC, the NOSB recommended adding Peracetic acid to § 205.605(b) of the National List regulations for organic handling, with the restrictions that it be allowed: (1) For direct food contact only in wash and/or rinse water; and (2) as a sanitizer on surfaces in contact with organic food. In this open meeting, the NOSB evaluated the use of Peracetic acid against the evaluation criteria of § 205.600(b) of the National List regulations, received public comment, and concluded that the use of Peracetic acid in organic handling is consistent with the evaluation criteria. In accepting the NOSB recommendation to allow Peracetic acid in organic handling, this proposed rule proposes language for including Peracetic acid on the National List that differs from the original NOSB recommendation. The original wording of the NOSB recommendation submitted to the Secretary was as follows: ‘‘Peracetic acid—for direct food contact only in wash and/or rinse water, as a sanitizer on surfaces in contact with organic food.’’ The NOP did not elect to use that language because of the confusion the language could cause when referencing the use of Peracetic acid (Peroxyacetic acid) against FDA regulations. For instance, the recommended NOSB language references ‘‘Peracetic acid’’ as the common name of the substance, but FDA regulations reference ‘‘Peroxyacetic acid,’’ in 21 CFR 173.315, for the washing or peeling of fruits and vegetables. Also, FDA regulations restrict the use of Peracetic acid/ Peroxyacetic acid on fruits and vegetables that are not raw agricultural commodities. Based on this information, the NOP determined that the original NOSB recommendation could cause handlers that use Peracetic acid/ Peroxyacetic acid to believe that the substance could be used on all agricultural products. As a result, this proposed rule attempts to limit confusion regarding the proposed use of Peracetic acid/Peroxyacetic acid in the handling of ‘‘made with * * *’’ products by including language that acknowledges the FDA use limitations. Therefore, in response to the NOSB recommendation regarding the use of Peracetic acid/Peroxyacetic acid in organic handling, the Secretary proposes to amend § 205.605(b) of the National List regulations to allow Peracetic acid/Peroxyacetic acid as a synthetic ingredient in or on processed products labeled as ‘‘made with organic PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 54665 (specified ingredients or food group(s))’’ as follows: Peracetic acid/Peroxyacetic acid (CAS # 79–21–0)—for use in wash and/or rinse water according to FDA limitations. For use as a sanitizer on food contact surfaces. Restricted to use in handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ Sodium acid pyrophosphate (CAS # 7758–16–9)—for use only as a leavening agent in agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ Sodium acid pyrophosphate was petitioned for use as a leavening agent in baked goods. It helps to control the release of Carbon dioxide that leavens baked goods. It can be either anhydrous or contain one or more molecules of water of hydration. The anhydrous forms are white, crystalline powders or granules. The hydrated forms occur as white or transparent crystals or granules. When used in accordance with good manufacturing practices, Sodium acid pyrophosphate is considered to be GRAS by FDA under 21 CFR 182.1087. At its May 13–14, 2003, meeting in Austin, TX, the NOSB recommended adding Sodium acid pyrophosphate to § 205.605(b) of the National List regulations for organic handling, with the restriction that it only be used as a leavening agent. In this open meeting, the NOSB evaluated Sodium acid pyrophosphate against the evaluation criteria of § 205.600(b) of the National List regulations, received public comment, and concluded that the use of Sodium acid pyrophosphate in organic handling is consistent with the evaluation criteria. Therefore, in response to the NOSB recommendation regarding the use of Sodium acid pyrophosphate in organic handling, the Secretary proposes to amend § 205.605(b) of the National List regulations to allow Sodium acid pyrophosphate as a synthetic ingredient in or on processed products labeled as ‘‘made with organic (specified ingredients or food group(s))’’ as follows: Sodium acid pyrophosphate (CAS # 7758–16–9)—for use only as a leavening agent in agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ Tetrasodium pyrophosphate (CAS # 7722–88–5)—for use only in meat analog products labeled ‘‘made with E:\FR\FM\16SEP1.SGM 16SEP1 54666 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Proposed Rules organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ In a proposed rule, published May 22, 2003 (68 FR 27941), § 205.605(b) of the regulations was proposed to be amended by adding Tetrasodium pyrophosphate to be used only in textured meat analog products. In response to the proposal to add Tetrasodium pyrophospate on the National List regulations, we received six public comments, three in favor of and three opposed to its inclusion. Regarding the comments that opposed the inclusion of Tetrasodium pyrophosphate on the National List regulations, commenters expressed concern that the recommended annotation was vague, confusing, undefined and needed clarification. They stated that the primary use of Tetrasodium pyrophosphate, as proposed, appeared to be to create texture that is similar to a meat product. They also asserted that such a use would be in direct conflict with the criterion in § 205.600(b)(4) of the regulations that emphasizes ‘‘the substance’s primary use is not as a preservative or to recreate or improve flavors, colors, textures, or nutritive value lost during processing, except where the replacement of nutrients is required by law.’’ Due to the merit of those comments, on March 3, 2003 (68 FR 62215), we did not add Tetrasodium pyrophosphate on the National List and referred the substance back to the NOSB for further deliberation as to whether the proposed use of Tetrasodium pyrophosphate conflicts with § 205.600 (b)(4) of the NOP regulations. Through further review and deliberation at their April 2004 meeting in Chicago, IL, the NOSB determined that the proposed use of Tetrasodium pyrophosphate did not conflict with § 205.600 (b)(4) of the NOP regulations. In response to the concerns of the commenters, the NOSB provided that the primary use of Tetrasodium pyrophosphate, as petitioned, is not to serve as a preservative, or to ‘‘recreate’’ flavor, color or texture. They acknowledged that the substance may be used to create texture; however, it is not being used to ‘‘recreate’’ texture, as is referenced in § 205.600 (b)(4) of the regulations. Rather, it is being proposed to add Tetrasodium pyrophosphate to § 205.605(b) of the National List regulations as follows: Tetrasodium pyrophosphate (CAS # 7722–88–5)—for use only in meat analog products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ VerDate Aug<31>2005 18:38 Sep 15, 2005 Jkt 205001 Section 205.681 B. Executive Order 12988 Appeals This proposed rule would amend § 205.681(d)(1) of the regulations by updating the mailing address for where to file a Certification or Accreditation appeal as follows: Administrator, USDA, AMS, c/o NOP Appeals Staff, Stop 0203, Room 3529– S, 1400 Independence Avenue, SW., Washington, DC 20250–0203. III. Related Documents Seven 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) 65 FR 64657, October 30, 2000, (Peracetic acid); (2) 66 FR 48654, September 21, 2001, (Ammonium hydroxide, Cyclohexlamine, and Octadecylamine); (3) 67 FR 19375, April 19, 2002, (Diethylaminoethanol); (4) 67 FR 54784, August 26, 2002, (Activated charcoal); (5) 68 FR 23277, May 1, 2003, (Egg white lysozyme, Glycerine oleate, L-Malic acid, Microorganisms, Sodium acid pyrophosphate and Tetrahydrofurfuryl alcohol); (6) 69 FR 18036, April 6, 2004, (Hydrogen Chloride, and Tetrasodium pyrophosphate); and (7) 70 FR 7224, February 11, 2005, (Ferric phosphate). 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 OFPA authorizes the NOSB to develop proposed amendments to the National List for submission to the Secretary and establishes 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, respectively. The National List petition process is implemented under § 205.607 of the NOP regulations. The current petition process (65 FR 43259) can be accessed through the NOP Web site at http://www.ams.usda.gov/ nop. A. Executive Order 12866 This action has been determined to be non-significant for purposes of Executive Order 12866, and therefore, has not been reviewed by the Office of Management and Budget. PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 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 section 2115 of the OFPA (7 U.S.C. 6514) from creating programs of accreditation for private persons or State officials who want to become certifying agents of organic farms or handling operations. A governing State official would have to apply to USDA to be accredited as a certifying agent, as described in section 2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under sections 2104 through 2108 of the OFPA (7 U.S.C. 6503 through 6507) from creating certification programs to certify organic farms or handling operations unless the State programs have been submitted to, and approved by, the Secretary as meeting the requirements of the OFPA. Pursuant to section 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 section 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 Environmental Protection Agency (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 E:\FR\FM\16SEP1.SGM 16SEP1 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Proposed Rules 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 Agricultural Marketing Service (AMS) performed an economic impact analysis on small entities in the final rule published in the Federal Register on December 21, 2000 (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 entirely 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 $6,000,000 and small agricultural producers are defined as those having annual receipts of less than $750,000. This proposed rule would have an impact on a substantial number of small entities. VerDate Aug<31>2005 18:38 Sep 15, 2005 Jkt 205001 The U.S. organic industry at the end of 2001 included nearly 6,600 certified crop and livestock operations, including organic production and handling operations, producers, and handlers. These operations reported certified acreage totaling more than 2.34 million acres, 72,209 certified livestock, and 5.01 million certified poultry. Data on the numbers of certified handling operations are not yet available, but likely number in the thousands, as they would include any operation that transforms raw product into processed products using organic ingredients. Growth in the U.S. organic industry has been significant at all levels. From 1997 to 2001, the total organic acreage grew by 74 percent; livestock numbers certified organic grew by almost 300 percent over the same period, and poultry certified organic increased by 2,118 percent over this time. Sales growth of organic products has been equally significant, growing on average around 20 percent per year. Sales of organic products were approximately $1 billion in 1993, but reached $15 billion in 2004. In addition, USDA has accredited 97 certifying agents who have applied to USDA to be accredited in order to provide certification services to producers and handlers. A complete list of names and addresses of accredited certifying agents may be found on the AMS NOP Web site, at http://www.ams.usda.gov/nop. AMS believes that most of these entities would be considered small entities under the criteria established by the SBA. D. Paperwork Reduction Act Pursuant to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et seq., the existing information collection requirements for the NOP are approved under OMB number 0581–0191. 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, or OMB’s implementing regulation at 5 CFR part 1320. E. General Notice of Public Rulemaking This proposed rule reflects recommendations submitted to the Secretary by the NOSB and includes an amendment to the mailing address for where to file a Certification or Accreditation Appeal. The seven substances proposed to be added to the National List were based on petitions from the industry. The NOSB evaluated each petition using criteria in the OFPA. Because these substances are critical to organic production and handling PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 54667 operations, producers and handlers should be able to use them in their operations as soon as possible. A 60-day period for interested persons to comment on this rule is provided. 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 (h). b. Revising paragraph (m)(2). c. Adding a new paragraph (n). d. Reserving paragraphs (o)–(z). The revisions and additions read as follows: § 205.601 Synthetic substance allowed for use in organic crop production. * * * * * (h) As slug or snail bait. Ferric phosphate (CAS # 10045–86–0). * * * * * (m) * * * (2) EPA List 3—Inerts of Unknown Toxicity allowed: (i) Glycerine Oleate (Glycerol monooleate) (CAS #s 25496–72–4; 111– 03–5; 37220–82–9)—for use only until December 31, 2006. (ii) Inerts used in passive pheromone dispensers. (iii) Tetrahydrofurfuryl alcohol (CAS # 97–99–4)—for use only until December 31, 2006. (n) Seed preparations. Hydrogen chloride (CAS # 7647–01–0)—for delinting cotton seed for planting. * * * * * 3. Section 205.605 is amended by: a. Adding three materials to paragraph (a). b. Adding 8 new substances to paragraph (b). The additions read as follows: § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food group(s)).’’ * * * (a) * * * * * * E:\FR\FM\16SEP1.SGM 16SEP1 * * * * 54668 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Proposed Rules Egg white lysozyme (CAS # 9001–63– 2) * * * * * L-Malic acid (CAS # 97–67–6). * * * * * Microorganisms—any food grade bacteria, fungi, and other microorganism. * * * * * (b) * * * Activated charcoal (CAS #s 7440–44– 0; 64365–11–3)—only from vegetative sources; for use only as a filtering aid in handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ * * * * * Ammonium hydroxide (CAS # 1336– 21–6)—for use only as a boiler water additive until October 21, 2005. Restricted to handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ * * * * * Cyclohexylamine (CAS # 108–91–8)— for use only as a boiler water additive for packaging sterilization. Restricted to handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ Diethylaminoethanol (CAS # 100–37– 8)—for use only as a boiler water additive for packaging sterilization. Restricted to handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited for use in handling agricultural products labeled ‘‘organic.’’ * * * * * Octadecylamine (CAS # 124–30–1)— for use only as a boiler water additive for packaging sterilization. Restricted to handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited for use in handling agricultural products labeled ‘‘organic.’’ * * * * * Peracetic acid/Peroxyacetic acid (CAS # 79–21–0)—for use in wash and/or rinse water according to FDA limitations. For use as a sanitizer on food contact surfaces. Restricted to use in handling agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ * * * * * Sodium acid pyrophosphate (CAS # 7758–16–9)—for use only as a leavening VerDate Aug<31>2005 18:38 Sep 15, 2005 Jkt 205001 agent in agricultural products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ * * * * * Tetrasodium pyrophosphate (CAS # 7722–88–5)—for use only in meat analog products labeled ‘‘made with organic (specified ingredients or food group(s));’’ prohibited in handling agricultural products labeled ‘‘organic.’’ * * * * * 4. In § 205.681, paragraph (d)(1) is revised to read as follows: § 205.681 Appeals. * * * * * (d) * * * (1) Appeals to the Administrator must be filed in writing and addressed to: Administrator, USDA, AMS, c/o NOP Appeals Staff, Stop 0203, Room 3529–S, 1400 Independence Avenue, SW., Washington, DC 20250– 0203 * * * * * Dated: September 12, 2005. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. 05–18381 Filed 9–15–05; 8:45 am] BILLING CODE 3410–02–P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA–2005–22423; Directorate Identifier 2005–NM–068–AD] RIN 2120–AA64 Airworthiness Directives; Boeing Model 747–200C and –200F Series Airplanes Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). AGENCY: SUMMARY: The FAA proposes to supersede an existing airworthiness directive (AD) that applies to certain Boeing Model 747–200C and –200F series airplanes. The existing AD currently requires repetitive inspections to find fatigue cracking in the upper chord of the upper deck floor beams, and repair if necessary. For certain airplanes, the existing AD also provides an optional repair/modification, which extends certain repetitive inspection intervals. This proposed AD would reduce the compliance time for all PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 initial inspections and reduce the repetitive interval for a certain inspection. This proposed AD is prompted by new reports of cracks in the upper deck floor beams occurring at lower flight cycles. We are proposing this AD to find and fix cracking in certain upper deck floor beams. Such cracking could extend and sever floor beams at a floor panel attachment hole location and could result in rapid decompression and loss of controllability of the airplane. DATES: We must receive comments on this proposed AD by October 31, 2005. ADDRESSES: Use one of the following addresses to submit comments on this proposed AD. • DOT Docket Web site: Go to http://dms.dot.gov and follow the instructions for sending your comments electronically. • Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your comments electronically. • Mail: Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street SW., Nassif Building, Room PL–401, Washington, DC 20590. • Fax: (202) 493–2251. • Hand Delivery: Room PL–401 on the plaza level of the Nassif Building, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. For service information identified in this proposed AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124–2207. You can examine the contents of this AD docket on the Internet at http:// dms.dot.gov, or in person at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street SW., room PL–401, on the plaza level of the Nassif Building, Washington, DC. This docket number is FAA–2005– 22423; the directorate identifier for this docket is 2005–NM–068–AD. FOR FURTHER INFORMATION CONTACT: Ivan Li, Aerospace Engineer, Airframe Branch, ANM–120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98055–4056; telephone (425) 917–6437; fax (425) 917–6590. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed under ADDRESSES. Include ‘‘Docket No. FAA– 2005–22423; Directorate Identifier 2005–NM–068–AD’’ at the beginning of your comments. We specifically invite E:\FR\FM\16SEP1.SGM 16SEP1

Agencies

[Federal Register Volume 70, Number 179 (Friday, September 16, 2005)]
[Proposed Rules]
[Pages 54660-54668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18381]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Docket Number TM-04-01]
RIN 0581-AC35


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

[[Page 54661]]

(National List) regulations to reflect recommendations submitted to the 
Secretary of Agriculture (Secretary) by the National Organic Standards 
Board (NOSB) from November 15, 2000, through March 3, 2005. Consistent 
with the recommendations from the NOSB, this proposed rule would add 
fifteen substances, along with any restrictive annotations, to the 
National List. This proposed rule would also amend the mailing address 
for where to file a Certification or Accreditation appeal.

DATES: Comments must be received by November 15, 2005.

ADDRESSES: Interested persons may comment on this proposed rule using 
the following procedures:
     Mail: Comments may be submitted by mail to: Arthur Neal, 
Director of Program Administration, National Organic Program, USDA-AMS-
TMP-NOP, 1400 Independence Ave., SW., Room 4008-So., Ag Stop 0268, 
Washington, DC 20250.
     E-mail: Comments may be submitted via the Internet to: 
National.List@usda.gov.
     Internet: http://www.regulations.gov.
     Fax: Comments may be submitted by fax to: (202) 205-7808.
     Written comments on this proposed rule should be 
identified with the docket number TMD-04-01. Commenters should identify 
the topic and section number of this proposed rule to which the comment 
refers.
     Clearly indicate if you are for or against the proposed 
rule or some portion of it and your reason for it. Include recommended 
language changes as appropriate.
     Include a copy of articles or other references that 
support your comments. Only relevant material should be submitted.
    It is our intention to have all comments to this proposed rule, 
whether submitted by mail, e-mail, or fax, available for viewing on the 
NOP homepage. Comments submitted in response to this proposed rule will 
be available for viewing in person at USDA-AMS, Transportation and 
Marketing, Room 4008-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: Arthur Neal, Director of Program 
Administration, Telephone: (202) 720-3252; Fax: (202) 205-7808.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2000, the Secretary established, within the NOP [7 
CFR part 205], the National List regulations (Sec. Sec.  205.600 
through 205.607). The National List regulations identify synthetic 
substances and ingredients that are allowed and nonsynthetic (natural) 
substances and ingredients that are prohibited for use in organic 
production and handling. Under the authority of the Organic Foods 
Production Act of 1990 (OFPA), as amended, (7 U.S.C. 6501 et seq.), the 
National List can be amended by the Secretary based on proposed 
amendments developed by the NOSB. Since established, the National List 
has been amended twice, October 31, 2003 (68 FR 61987), and November 3, 
2003 (68 FR 62215).
    This proposed rule would amend the National List to reflect 
recommendations submitted to the Secretary by the NOSB from November 
15, 2000, through March 3, 2005. Between the specified time period, the 
NOSB has recommended that the Secretary add four substances to Sec.  
205.601 and eleven substances to Sec.  205.605 of the National List 
regulations. This proposed rule would also amend the mailing address 
for where to file a Certification or Accreditation appeal pursuant to 
Sec.  205.681(d).

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 paragraph (m)(2) of Sec.  205.601 of 
the regulations by adding the following substances:
    Glycerine oleate (Glycerol monooleate) (CAS s 25496-72-4; 
111-03-5; 37220-82-9)--for use only until December 31, 2006. Glycerine 
oleate was petitioned to be used as an anti-foaming agent (defoamer) in 
organic crop production. Glycerine oleate is a clear amber or pale 
yellow liquid that is insoluble in water, slightly soluble in cold 
alcohol, and soluble in hot alcohol, chloroform, ether, and petroleum 
ether. In crop production, Glycerin oleate would be used as an anti-
foaming agent (defoamer) in micronized wettable Sulfur that is used to 
control scab and mildew in the production of apples, pears, grapes, and 
raisins. The function of Glycerine oleate in the micronized wettable 
Sulfur would be to enable the product to be mixed in a tank effectively 
and sprayed on crops evenly.
    Under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), the Environmental Protection Agency (EPA) has classified 
Glycerine oleate as a List 3 inert (Inerts of Unknown Toxicity). Under 
the Food and Drug Administration (FDA), Glycerin monooleate (a synonym 
for Glycerin oleate) has been classified as a substance that is 
Generally Recognized As Safe (GRAS) for food production (21 CFR 
184.1323).
    The NOSB, at its May 13-14, 2003, meeting in Austin, TX, 
recommended adding Glycerine oleate to Sec.  205.601(m) (2) of the 
National List regulations. In this open meeting, the NOSB evaluated 
Glycerine oleate against the evaluation criteria of 7 U.S.C. 6517 and 
6518 of the OFPA, received public comment, and concluded that the 
substance is consistent with the OFPA evaluation criteria; however, it 
recommended that Glycerine oleate be added to the National List 
regulations, for use in crop production, only until December 31, 2006.
    The normal time period for the use of a substance under the NOP 
regulations is 5 years, beginning the date the substance appears in the 
National List regulations. The NOSB recommended the early expiration 
date of December 31, 2006, because of the present efforts of the 
Environmental Protection Agency (EPA) to reclassify inerts on List 2 
(Potentially Toxic Inert Ingredients/High Priority for Testing Inerts) 
and List 3 (Inerts of Unknown Toxicity) to either List 1 (Inert 
Ingredients of Toxicological Concern) or List 4 (Inerts of Minimal 
Concern) by December 31, 2006. With respect to the use of EPA regulated 
inert ingredients in organic crop and livestock production, only 
substances included on EPA's List 4 are categorically allowed on the 
National List (Sec.  205.601(m)(i)); all other EPA inert ingredients 
must be listed individually. Glycerine oleate is a List 3 inert; the 
NOSB anticipates that EPA will conclude its reclassification of 
Glycerine oleate to either a List 1 or List 4 status by December 31, 
2006. If Glycerine oleate is reclassified as a List 1 inert, it will be 
prohibited for use as an inert ingredient for organic crop production. 
If Glycerin oleate is reclassified as a List 4 inert, then it will 
automatically continue to be allowed for use in organic crop production 
as an inert ingredient. In addition, if EPA does not complete its 
reclassification of

[[Page 54662]]

Glycerine oleate by December 31, 2006, the substance will be prohibited 
for use in organic crop production beginning on January 1, 2007.
    Therefore, in response to the NOSB recommendation regarding the use 
of Glycerine oleate in organic crop production, the Secretary accepts 
the NOSB recommendation and proposes to amend Sec.  205.601(m)(2) of 
the National List regulation as follows:
    Glycerine oleate (Glycerol monooleate) (CAS s 25496-72-4; 
111-03-5; 37220-82-9)--for use only until December 31, 2006.
    Tetrahydrofurfuryl alcohol (CAS  97-99-4)--for use only 
until December 31, 2006. Tetrahydrofurfuryl alcohol was petitioned for 
use as an inert pesticidal ingredient for use in organic crop 
production. Tetrahydrofurfuryl alcohol is a clear, colorless liquid 
that is used extensively in various industries as a high-purity, water 
miscible solvent, and as a chemical intermediate. If released to soil, 
Tetrahydrofurfuryl alcohol is expected to exhibit high solubility.
    Under FIFRA, the EPA has registered Tetrahydrofurfuryl alcohol as a 
List 3 inert (Inerts of Unknown Toxicity). In addition, the FDA has 
classified Tetrahydrofurfuryl alcohol as a direct food additive in 
synthetic flavoring substances (21 CFR 172.515) and an indirect food 
additive in adhesives and the manufacture of paper and paper adjuvants 
(21 CFR 175.105 and 176.210).
    The NOSB, at its May 13-14, 2003, meeting in Austin, TX, 
recommended adding Tetrahydrofurfuryl alcohol to Sec.  205.601(m)(2) of 
the National List regulations. In this open meeting, the NOSB evaluated 
Tetrahydrofurfuryl alcohol against the evaluation criteria of 7 U.S.C. 
6517 and 6518 of the OFPA, received public comment, and concluded that 
the substance is consistent with the OFPA evaluation criteria; however, 
it recommended that Tetrahydrofurfuryl alcohol be added to the National 
List regulations, for use in crop production, only until December 31, 
2006.
    The normal time period for the use of a substance under the NOP 
regulations is five years, beginning the date the substance appears in 
the National List regulations. The NOSB recommended the early 
expiration date of December 31, 2006, because of the present efforts of 
the EPA to reclassify inerts on List 2 (Potentially Toxic Inert 
Ingredients/High Priority for Testing inerts) and List 3 (Inerts of 
Unkown Toxicity) to either List 1 (Inert Ingredients of Toxicological 
Concern) or List 4 (Inerts of Minimal Concern) by December 31, 2006. 
With respect to the use of EPA regulated inert ingredients in organic 
crop and livestock production, only substances included on EPA's List 4 
are categorically allowed on the National List (Sec.  205.601(m)(i)); 
all other EPA inert ingredients must be listed individually. 
Tetrahydrofurfuryl alcohol is a List 3 inert; the NOSB anticipates that 
EPA will conclude its reclassification of Tetrahydrofurfuryl alcohol to 
either a List 1 or List 4 status by December 31, 2006. If 
Tetrahydrofurfuryl alcohol is reclassified as a List 1 inert, it will 
be prohibited for use as an inert ingredient for organic crop 
production. If Tetrahydrofurfuryl alcohol is reclassified as a List 4 
inert, then it will automatically continue to be allowed for use in 
organic crop production as an inert ingredient. In addition, if EPA 
does not complete its reclassification of Tetrahydrofurfuryl alcohol by 
December 31, 2006, the substance will be prohibited for use in organic 
crop production beginning on January 1, 2007.
    Therefore, in response to the NOSB recommendation regarding the use 
of Tetrahydrofurfurly alcohol in organic crop production, the Secretary 
accepts the NOSB recommendation and proposes to amend Sec.  
205.601(m)(2) of the National List regulation as follows:
    Tetrahydrofurfurly alcohol (CAS  97-99-4)--for use only 
until December 31, 2006.
    Hydrogen chloride (CAS  7647-01-0)--for de-linting cotton 
seed for planting. Hydrogen chloride was petitioned for use as a 
synthetic to delint cotton seed for planting in organic crop 
production. Hydrogen chloride is a colorless to slightly yellow gas 
with a pungent, irritating odor. It is very soluble in water and 
readily soluble in alcohol and ether. Hydrogen chloride has been 
classified by the FDA as a substance that is GRAS when used as a buffer 
and neutralizing agent in accordance with good manufacturing or feeding 
practice (21 CFR 582.1057). In delinting cotton seeds intended for 
planting organic acreage, Hydrogen chloride is released into a 
delinting machine that contains linted cotton seeds. Seed is exposed to 
the Hydrogen chloride for about eight to ten minutes to weaken the lint 
and is then sent through buffers to remove the weakened lint from the 
seed. After delinting, a neutralizing agent (often Calcium carbonate) 
is used to prevent acid damage to the seed.
    The NOSB, at its April 28-30, 2004, meeting in Chicago, IL, 
recommended adding Hydrogen chloride to Sec.  205.601 of the National 
List regulations. In this open meeting, the NOSB evaluated Hydrogen 
chloride against the evaluation criteria of 7 U.S.C. 6517 and 6518 of 
the OFPA, received public comment, and concluded that the substance is 
consistent with the OFPA evaluation criteria. Therefore, in response to 
the NOSB recommendation regarding the use of Hydrogen chloride in 
organic crop production, the Secretary accepts the NOSB recommendation 
and proposes to amend Sec.  205.601 of the National List regulations by 
adding (1) a new paragraph (n), Seed preparations, and (2) Hydrogen 
chloride as follows:
    (n) Seed preparations.
    Hydrogen chloride (CAS  7647-01-0)--for de-linting cotton 
seed for planting.
    Ferric phosphate (CAS  10045-86-0). Ferric phosphate was 
petitioned for use as a pesticide (molluscicide) to bait slugs and 
snails in organic crop production. It is an odorless, yellowish-white 
powder that is not very soluble in water. Ferric phosphate is normally 
applied to soil as part of a pellet that includes a wheat-based bait to 
attract snails and slugs. After the pellets are consumed, Ferric 
phosphate interferes with calcium metabolism in the digestive tract of 
the snails and slugs, causing them to stop eating. Shortly thereafter, 
the snails and slugs die.
    Under the FIFRA, the EPA has registered ferric phosphate as a 
biochemical molluscicide that targets a wide range of slugs and snails 
(63 FR 43936). In assessing risks to human health, EPA has concluded 
that there are no known or expected adverse effects to humans from the 
use of ferric phosphate. In assessing risks to the environment, the EPA 
has concluded that there are no known or expected harmful effects of 
the use of Ferric phosphate on the environment if users follow the 
application rates and use directions on the label. In addition to the 
assessments of the EPA, the FDA has classified Ferric phosphate as a 
substance that is GRAS for food use (21 CFR 184.1301).
    The NOSB, at its February 28-March 3, 2005, meeting in Washington, 
DC, recommended adding Ferric phosphate to Sec.  205.601(h) of the 
National List regulations without restriction. In this open meeting, 
the NOSB evaluated Ferric phosphate against the evaluation criteria of 
7 U.S.C. 6517 and 6518 of the OFPA, received public comment, and 
concluded that the substance is consistent with the OFPA evaluation 
criteria. Therefore, in response to the NOSB recommendation regarding 
the use of Ferric phosphate in organic crop production, the Secretary 
accepts the NOSB recommendation and proposes to

[[Page 54663]]

amend Sec.  205.601(h) of the National List regulations as follows:
    Ferric phosphate (CAS  10045-86-0).

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 regulations 
by adding the following substances:
    Egg white lysozyme (CAS  9001-63-2). Egg white lysozyme 
was petitioned for use as an enzyme in organic processing. It is a 
white powder with no distinct odor. It is readily soluble in water and 
practically insoluble in alcohol, chloroform, and ether. Egg white 
lysozyme is considered to be GRAS by the FDA for use as an 
antimicrobial agent in casings for frankfurters and on cooked meat and 
poultry products. Egg white lysozyme is used in casings for 
frankfurters at a concentration of 2.5 milligram (mg) lysozyme per 
pound (lb) of frankfurter (equivalent to 5.5 mg Lysozyme per kilogram 
(kg) of food) and in cooked meat and poultry products sold as ready-to-
eat at a concentration of 2.0 mg of Lysozyme per lb of cooked meat or 
poultry product (equivalent to 4.4 mg of Lysozyme per kg of food). The 
FDA acknowledged in GRAS Notice No. (GRN) 000064 that it had no 
question, at the time of review, that Egg white lysozyme is GRAS under 
the intended conditions of use; provided, that the ingredient statement 
of food products that contain Egg white lysozyme contain the name ``Egg 
white lysozyme'' to identify the source of the protein.
    The NOSB, at its May 13-14, 2003, meeting in Austin, TX, 
recommended adding Egg white lysozyme to Sec.  205.605(a) of the 
National List regulations without restriction. In this open meeting, 
the NOSB evaluated Egg white lysozyme against the evaluation criteria 
of 7 U.S.C. 6517 and 6518 of the OFPA, received public comment, and 
concluded that the substance is consistent with the OFPA evaluation 
criteria. Therefore, in response to the NOSB recommendation regarding 
the use of Egg white lysozyme in organic handling, the Secretary 
accepts the NOSB recommendation and proposes to amend Sec.  205.605(a) 
of the National List regulations as follows:
    Egg white lysozyme (CAS  9001-63-2).
    L-Malic acid (CAS  97-67-6). DL-Malic acid was originally 
petitioned for use as a synthetic processing aid in organic handling. 
It is a white or colorless powder with no odor. It is readily 
biodegradable in water and in soil. DL-Malic acid is considered to be 
GRAS by FDA (21 CFR 184.1069). It is a processing aid that is used in 
bottled iced tea, dry mix beverages, carbonated beverages, bakery 
products, fruit juices, candies, gelatins, desserts, frozen 
specialties, sports drinks, and other food products.
    The NOSB, at its May 13-14, 2003, meeting in Austin, TX, evaluated 
DL-Malic acid in an open meeting, received public comment, and 
concluded that the substance was not consistent with the evaluation 
criteria of 7 U.S.C. 6517 and 6518 of the OFPA. This determination was 
made because of an identified available natural alternative, L-Malic 
acid. As a result of having identified a natural alternative to DL-
malic acid, the NOSB asked the petitioner whether L-Malic acid, a 
natural, could be substituted for DL-Malic acid for inclusion on the 
National List. The petitioner concurred and the NOSB recommended L-
Malic acid for inclusion in section 205.605(a) of the National List. 
Therefore, in response to the NOSB recommendation regarding the use of 
L-Malic acid in organic handling, the Secretary accepts the NOSB 
recommendation and proposes to amend Sec.  205.605 (a) of the National 
List regulations as follows:
    L-Malic acid (CAS  97-67-6).
    Microorganisms--any food grade bacteria, fungi, and other 
microorganisms. Seed mold, a microorganism, was petitioned for use as a 
processing aid in organic handling. Seed mold is used as a culture 
starter in food processing. In the evaluation of seed mold, the NOSB 
recognized that they had previously evaluated and determined other 
types of food-grade microorganisms (e.g., dairy cultures and yeast) and 
certain by-products derived from them (e.g., enzymes) to be consistent 
with OFPA criteria and the NOP regulations. These microorganisms are 
already included on the National List.
    The NOSB acknowledged that there are many species of food-grade 
microorganisms that are used in food processing that could be 
petitioned for use in organic handling. As a result, a decision was 
made by the NOSB to evaluate the categorical use of food-grade 
microorganisms in organic handling and recommend their inclusion in 
section 205.605(a) of the National List. This decision would obviate 
the need for future review and evaluation of other individual food 
grade microorganisms that exhibit similar characteristics and functions 
as those already approved for use on the National List.
    At its May 13-14, 2003, meeting in Austin, TX, the NOSB recommended 
adding microorganisms to Sec.  205.605(a) of the National List 
regulations without restriction. In this open meeting, the NOSB 
evaluated the categorical use of microorganisms in organic handling 
against 7 U.S.C. 6517 and 6518 of the OFPA, received public comment, 
and concluded that the use of microorganisms in organic handling is 
consistent with the evaluation criteria. Therefore, in response to the 
NOSB recommendation regarding the use of microorganisms in organic 
handling, the Secretary accepts the NOSB recommendation and proposes to 
amend Sec.  205.605(a) of the National List regulations as follows:
    Microorganisms--any food grade bacteria, fungi, and other 
microorganisms.
    This proposed rule would also amend Sec.  205.605(b) of the 
regulations by adding the following substances:
    Activated charcoal (CAS s 7440-44-0; 64365-11-3)--only 
from vegetative sources; for use only as a filtering aid in handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in handling agricultural 
products labeled ``organic.'' Activated charcoal was petitioned for use 
as a processing aid in organic handling. Activated charcoal is a solid, 
porous, black carbonaceous material that is used as a decolorizing 
agent, taste- and odor-removing agent, and purification agent in food 
processing. It is also used for the treatment of water, including 
potable water. Activated charcoal is acknowledged by FDA in 21 CFR 
173.25(b)(1)(ii) to be an allowed substance for use in ion exchange. It 
is also recognized as an indirect food additive in closures with 
sealing gaskets for food containers (21 CFR 177.1210).
    At its September 17-19, 2002, meeting in Austin, TX, the NOSB 
recommended adding activated charcoal to Sec.  205.605(b) of the 
National List regulations for organic handling, with the restrictions 
that the substance: (1) Comes from vegetative sources only; and (2) 
only be used as a filtering aid. In this open meeting, the NOSB 
evaluated the use of activated charcoal against the evaluation criteria 
of Sec.  205.600(b) of the National List regulations, received public 
comment, and concluded that the use of activated charcoal in organic 
handling is consistent with the evaluation criteria.
    Therefore, in response to the NOSB recommendation regarding the use 
of activated charcoal in organic handling,

[[Page 54664]]

the Secretary proposes to amend Sec.  205.605(b) of the National List 
regulations to allow activated charcoal as a synthetic ingredient in or 
on processed products labeled as ``made with organic (specified 
ingredients or food group(s))'' as follows:
    Activated charcoal (CAS s 7440-44-0; 64365-11-3)--only 
from vegetative sources; for use only as a filtering aid in handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in handling agricultural 
products labeled ``organic.''
    Ammonium hydroxide (CAS  1336-21-6)--for use only as a 
boiler water additive until October 21, 2005. Restricted to handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in handling agricultural 
products labeled ``organic.'' Ammonium hydroxide was petitioned as a 
boiler water additive in organic handling. It is a colorless liquid 
with an intense odor. It is used in preventing the corrosion of boiler 
equipment used in food processing. Ammonium hydroxide is considered to 
be GRAS by FDA and allowed as a boiler water additive under 21 CFR 
184.1139.
    At its October 15-17, 2001, meeting in Washington, DC, the NOSB 
recommended adding Ammonium hydroxide to Sec.  205.605(b) of the 
National List regulations, with the restriction that it can only be 
used in organic handling until October 21, 2005. In this open meeting, 
the NOSB evaluated the use of Ammonium hydroxide against the evaluation 
criteria of Sec.  205.600(b) of the National List regulations, received 
public comment, and concluded that the use of Ammonium hydroxide in 
organic handling is consistent with the evaluation criteria.
    Although the NOSB determined Ammonium hydroxide to be consistent 
with the evaluation criteria of Sec.  205.600(b), it recommended an 
early expiration date of October 21, 2005, for the use of the 
substance, to encourage the organic processing industry to find an 
alternative substance to use in place of the Ammonium hydroxide. The 
normal time period for the use of a substance under the NOP regulations 
is 5 years, beginning the date the substance appears in the National 
List regulations.
    Therefore, in response to the NOSB recommendation regarding the use 
of Ammonium hydroxide in organic handling, the Secretary proposes to 
amend Sec.  205.605(b) of the National List regulations to allow 
Ammonium hydroxide as a synthetic ingredient in or on processed 
products labeled as ``made with organic (specified ingredients or food 
group(s))'' as follows:
    Ammonium hydroxide (CAS  1336-21-6)--for use only as a 
boiler water additive until October 21, 2005. Restricted to handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in handling agricultural 
products labeled ``organic.''
    Cyclohexylamine (CAS  108-91-8)--for use only as a boiler 
water additive for packaging sterilization. Restricted to handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in handling agricultural 
products labeled ``organic.'' Cyclohexylamine was petitioned as a 
boiler water additive in organic handling. Cyclohexylamine is a 
colorless to yellow liquid that has a strong, fishy odor. It is 
miscible with water and with common organic solvents. It is used to 
prevent the corrosion of boiler equipment used in food processing. 
Cyclohexylamine is approved for use as a secondary direct food additive 
and boiler water additive by FDA under 21 CFR 173.310.
    At its October 15-17, 2001, meeting in Washington, DC, the NOSB 
recommended adding Cyclohexlamine to Sec.  205.605(b) of the National 
List regulations for organic handling, with the restriction that it be 
used as a boiler water additive for packaging sterilization only. In 
this open meeting, the NOSB evaluated the use of Cyclohexlamine against 
the evaluation criteria of Sec.  205.600(b) of the National List 
regulations, received public comment, and concluded that the use of 
Cyclohexlamine in organic handling is consistent with the evaluation 
criteria.
    Therefore, in response to the NOSB recommendation regarding the use 
of Cyclohexlamine in organic handling, the Secretary proposes to amend 
Sec.  205.605(b) of the National List regulations to allow 
Cyclohexlamine as a synthetic ingredient in or on processed products 
labeled as ``made with organic (specified ingredients or food 
group(s))'' as follows:
    Cyclohexylamine (CAS  108-91-8)--for use only as a boiler 
water additive for packaging sterilization. Restricted to handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in handling agricultural 
products labeled ``organic.''
    Diethylaminoethanol (CAS  100-37-8)--for use only as a 
boiler water additive for packaging sterilization; restricted to 
handling agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited for use in handling 
agricultural products labeled ``organic.'' Diethlaminoethanol was 
petitioned as a boiler water additive in organic handling. 
Diethylaminoethanol is a colorless liquid with a weak ammonia odor. It 
is hygroscopic soluble in water, alcohol, Acetone, Benzene, and 
Petroleum ether. Diethlaminoethanol inhibits corrosion in boiler 
chemical systems in return lines, by neutralizing Carbonic acid in 
steam and steam condensates, and by scavenging free Oxygen. It is used 
in conjunction with Cyclohexylamine, Morpholine, and Octadecylamine. 
Diethylaminoethanol is approved for use as a secondary direct food 
additive and boiler water additive by FDA under 21 CFR 173.310.
    At its May 6-8, 2002, meeting in Austin, TX, the NOSB recommended 
adding Diethylaminoethanol to Sec.  205.605(b) of the National List 
regulations for organic handling, with the restriction that it be used 
as a boiler water additive for packaging sterilization only. In this 
open meeting, the NOSB evaluated the use of Diethylaminoethanol against 
the evaluation criteria of Sec.  205.600(b) of the National List 
regulations, received public comment, and concluded that the use of 
Diethylaminoethanol in organic handling is consistent with the 
evaluation criteria.
    Therefore, in response to the NOSB recommendation regarding the use 
of Diethylaminoethanol in organic handling, the Secretary proposes to 
amend Sec.  205.605(b) of the National List regulations to allow 
Diethylaminoethanol as a synthetic ingredient in or on processed 
products labeled as ``made with organic (specified ingredients or food 
group(s))'' as follows:
    Diethylaminoethanol (CAS  100-37-8)--for use only as a 
boiler water additive for packaging sterilization. Restricted to 
handling agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited for use in handling 
agricultural products labeled ``organic.''
    Octadecylamine (CAS  124-30-1)--for use only as a boiler 
water additive for packaging sterilization. Restricted to handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited for use in handling 
agricultural products labeled ``organic.'' Octadecylamine was 
petitioned for use as a boiler water additive to prevent corrosion of 
boiler equipment and distribution lines. Octadecylamine is an

[[Page 54665]]

opaque, off-white liquid with ammoniacal odor, insoluble in water but 
soluble in alcohol, Ether, Benzene; very soluble in Chloroform; and 
miscible in Acetone. Octadecylamine is approved for use as a secondary 
direct food additive and boiler water additive by FDA under 21 CFR 
173.310.
    At its October 15-17, 2001, meeting in Washington, DC, the NOSB 
recommended adding Octadecylamine to Sec.  205.605(b) of the National 
List regulations for organic handling, with the restriction that it be 
used as a boiler water additive for packaging sterilization only. In 
this open meeting, the NOSB evaluated the use of Octadecylamine against 
the evaluation criteria of Sec.  205.600(b) of the National List 
regulations, received public comment, and concluded that the use of 
Octadecylamine in organic handling is consistent with the evaluation 
criteria.
    Therefore, in response to the NOSB recommendation regarding the use 
of Octadecylamine in organic handling, the Secretary proposes to amend 
Sec.  205.605(b) of the National List regulations to allow 
Octadecylamine as a synthetic ingredient in or on processed products 
labeled as ``made with organic (specified ingredients or food 
group(s))'' as follows:
    Octadecylamine (CAS  124-30-1)--for use only as a boiler 
water additive for packaging sterilization. Restricted to handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited for use in handling 
agricultural products labeled ``organic.''
    Peracetic acid/Peroxyacetic acid (CAS  79-21-0)--for use 
in wash and/or rinse water according to FDA limitations. For use as a 
sanitizer on food contact surfaces. Restricted to use in handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in agricultural products 
labeled ``organic.'' Peracetic acid was petitioned as an anti-microbial 
water treatment additive and/or as an equipment sanitizer or 
disinfectant. Its most common use in food processing and handling is as 
a sanitizer for food contact surfaces and as a disinfectant for fruits, 
vegetables, meats, and eggs. Other uses of Peracetic acid include 
removing deposits, suppressing odor, and stripping biofilms from food 
contact surfaces. Peracetic acid is a clear colorless liquid with no 
foaming capability, and has a strong pungent odor. It is approved by 
FDA as a secondary direct food additive used in the washing or peeling 
of fruits and vegetables (21 CFR 173.315). It is also approved for use 
as an indirect food additive, sanitizer, under 21 CFR 178.1010.
    At its November 15-17, 2000, meeting in Washington, DC, the NOSB 
recommended adding Peracetic acid to Sec.  205.605(b) of the National 
List regulations for organic handling, with the restrictions that it be 
allowed: (1) For direct food contact only in wash and/or rinse water; 
and (2) as a sanitizer on surfaces in contact with organic food. In 
this open meeting, the NOSB evaluated the use of Peracetic acid against 
the evaluation criteria of Sec.  205.600(b) of the National List 
regulations, received public comment, and concluded that the use of 
Peracetic acid in organic handling is consistent with the evaluation 
criteria.
    In accepting the NOSB recommendation to allow Peracetic acid in 
organic handling, this proposed rule proposes language for including 
Peracetic acid on the National List that differs from the original NOSB 
recommendation. The original wording of the NOSB recommendation 
submitted to the Secretary was as follows: ``Peracetic acid--for direct 
food contact only in wash and/or rinse water, as a sanitizer on 
surfaces in contact with organic food.'' The NOP did not elect to use 
that language because of the confusion the language could cause when 
referencing the use of Peracetic acid (Peroxyacetic acid) against FDA 
regulations.
    For instance, the recommended NOSB language references ``Peracetic 
acid'' as the common name of the substance, but FDA regulations 
reference ``Peroxyacetic acid,'' in 21 CFR 173.315, for the washing or 
peeling of fruits and vegetables. Also, FDA regulations restrict the 
use of Peracetic acid/Peroxyacetic acid on fruits and vegetables that 
are not raw agricultural commodities. Based on this information, the 
NOP determined that the original NOSB recommendation could cause 
handlers that use Peracetic acid/Peroxyacetic acid to believe that the 
substance could be used on all agricultural products. As a result, this 
proposed rule attempts to limit confusion regarding the proposed use of 
Peracetic acid/Peroxyacetic acid in the handling of ``made with * * *'' 
products by including language that acknowledges the FDA use 
limitations.
    Therefore, in response to the NOSB recommendation regarding the use 
of Peracetic acid/Peroxyacetic acid in organic handling, the Secretary 
proposes to amend Sec.  205.605(b) of the National List regulations to 
allow Peracetic acid/Peroxyacetic acid as a synthetic ingredient in or 
on processed products labeled as ``made with organic (specified 
ingredients or food group(s))'' as follows:
    Peracetic acid/Peroxyacetic acid (CAS  79-21-0)--for use 
in wash and/or rinse water according to FDA limitations. For use as a 
sanitizer on food contact surfaces. Restricted to use in handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in handling agricultural 
products labeled ``organic.''
    Sodium acid pyrophosphate (CAS  7758-16-9)--for use only 
as a leavening agent in agricultural products labeled ``made with 
organic (specified ingredients or food group(s));'' prohibited in 
handling agricultural products labeled ``organic.'' Sodium acid 
pyrophosphate was petitioned for use as a leavening agent in baked 
goods. It helps to control the release of Carbon dioxide that leavens 
baked goods. It can be either anhydrous or contain one or more 
molecules of water of hydration. The anhydrous forms are white, 
crystalline powders or granules. The hydrated forms occur as white or 
transparent crystals or granules. When used in accordance with good 
manufacturing practices, Sodium acid pyrophosphate is considered to be 
GRAS by FDA under 21 CFR 182.1087.
    At its May 13-14, 2003, meeting in Austin, TX, the NOSB recommended 
adding Sodium acid pyrophosphate to Sec.  205.605(b) of the National 
List regulations for organic handling, with the restriction that it 
only be used as a leavening agent. In this open meeting, the NOSB 
evaluated Sodium acid pyrophosphate against the evaluation criteria of 
Sec.  205.600(b) of the National List regulations, received public 
comment, and concluded that the use of Sodium acid pyrophosphate in 
organic handling is consistent with the evaluation criteria.
    Therefore, in response to the NOSB recommendation regarding the use 
of Sodium acid pyrophosphate in organic handling, the Secretary 
proposes to amend Sec.  205.605(b) of the National List regulations to 
allow Sodium acid pyrophosphate as a synthetic ingredient in or on 
processed products labeled as ``made with organic (specified 
ingredients or food group(s))'' as follows:
    Sodium acid pyrophosphate (CAS  7758-16-9)--for use only 
as a leavening agent in agricultural products labeled ``made with 
organic (specified ingredients or food group(s));'' prohibited in 
handling agricultural products labeled ``organic.''
    Tetrasodium pyrophosphate (CAS  7722-88-5)--for use only 
in meat analog products labeled ``made with

[[Page 54666]]

organic (specified ingredients or food group(s));'' prohibited in 
handling agricultural products labeled ``organic.'' In a proposed rule, 
published May 22, 2003 (68 FR 27941), Sec.  205.605(b) of the 
regulations was proposed to be amended by adding Tetrasodium 
pyrophosphate to be used only in textured meat analog products. In 
response to the proposal to add Tetrasodium pyrophospate on the 
National List regulations, we received six public comments, three in 
favor of and three opposed to its inclusion. Regarding the comments 
that opposed the inclusion of Tetrasodium pyrophosphate on the National 
List regulations, commenters expressed concern that the recommended 
annotation was vague, confusing, undefined and needed clarification. 
They stated that the primary use of Tetrasodium pyrophosphate, as 
proposed, appeared to be to create texture that is similar to a meat 
product. They also asserted that such a use would be in direct conflict 
with the criterion in Sec.  205.600(b)(4) of the regulations that 
emphasizes ``the substance's primary use is not as a preservative or to 
recreate or improve flavors, colors, textures, or nutritive value lost 
during processing, except where the replacement of nutrients is 
required by law.''
    Due to the merit of those comments, on March 3, 2003 (68 FR 62215), 
we did not add Tetrasodium pyrophosphate on the National List and 
referred the substance back to the NOSB for further deliberation as to 
whether the proposed use of Tetrasodium pyrophosphate conflicts with 
Sec.  205.600 (b)(4) of the NOP regulations. Through further review and 
deliberation at their April 2004 meeting in Chicago, IL, the NOSB 
determined that the proposed use of Tetrasodium pyrophosphate did not 
conflict with Sec.  205.600 (b)(4) of the NOP regulations. In response 
to the concerns of the commenters, the NOSB provided that the primary 
use of Tetrasodium pyrophosphate, as petitioned, is not to serve as a 
preservative, or to ``recreate'' flavor, color or texture. They 
acknowledged that the substance may be used to create texture; however, 
it is not being used to ``recreate'' texture, as is referenced in Sec.  
205.600 (b)(4) of the regulations. Rather, it is being proposed to add 
Tetrasodium pyrophosphate to Sec.  205.605(b) of the National List 
regulations as follows:
    Tetrasodium pyrophosphate (CAS  7722-88-5)--for use only 
in meat analog products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in handling agricultural 
products labeled ``organic.''

Section 205.681 Appeals

    This proposed rule would amend Sec.  205.681(d)(1) of the 
regulations by updating the mailing address for where to file a 
Certification or Accreditation appeal as follows:
    Administrator, USDA, AMS, c/o NOP Appeals Staff, Stop 0203, Room 
3529-S, 1400 Independence Avenue, SW., Washington, DC 20250-0203.

III. Related Documents

    Seven 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) 65 FR 64657, October 30, 2000, 
(Peracetic acid); (2) 66 FR 48654, September 21, 2001, (Ammonium 
hydroxide, Cyclohexlamine, and Octadecylamine); (3) 67 FR 19375, April 
19, 2002, (Diethylaminoethanol); (4) 67 FR 54784, August 26, 2002, 
(Activated charcoal); (5) 68 FR 23277, May 1, 2003, (Egg white 
lysozyme, Glycerine oleate, L-Malic acid, Microorganisms, Sodium acid 
pyrophosphate and Tetrahydrofurfuryl alcohol); (6) 69 FR 18036, April 
6, 2004, (Hydrogen Chloride, and Tetrasodium pyrophosphate); and (7) 70 
FR 7224, February 11, 2005, (Ferric phosphate).

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 
OFPA authorizes the NOSB to develop proposed amendments to the National 
List for submission to the Secretary and establishes 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, respectively. The National List petition process is implemented 
under Sec.  205.607 of the NOP regulations. The current petition 
process (65 FR 43259) can be accessed through the NOP Web site at 
http://www.ams.usda.gov/nop.

A. Executive Order 12866

    This action has been determined to be non-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 section 2115 of 
the OFPA (7 U.S.C. 6514) from creating programs of accreditation for 
private persons or State officials who want to become certifying agents 
of organic farms or handling operations. A governing State official 
would have to apply to USDA to be accredited as a certifying agent, as 
described in section 2115(b) of the OFPA (7 U.S.C. 6514(b)). States are 
also preempted under sections 2104 through 2108 of the OFPA (7 U.S.C. 
6503 through 6507) from creating certification programs to certify 
organic farms or handling operations unless the State programs have 
been submitted to, and approved by, the Secretary as meeting the 
requirements of the OFPA.
    Pursuant to section 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 section 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 
Environmental Protection Agency (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

[[Page 54667]]

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 Agricultural 
Marketing Service (AMS) performed an economic impact analysis on small 
entities in the final rule published in the Federal Register on 
December 21, 2000 (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 entirely 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 $6,000,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000. This proposed rule would have an impact on a substantial 
number of small entities.
    The U.S. organic industry at the end of 2001 included nearly 6,600 
certified crop and livestock operations, including organic production 
and handling operations, producers, and handlers. These operations 
reported certified acreage totaling more than 2.34 million acres, 
72,209 certified livestock, and 5.01 million certified poultry. Data on 
the numbers of certified handling operations are not yet available, but 
likely number in the thousands, as they would include any operation 
that transforms raw product into processed products using organic 
ingredients. Growth in the U.S. organic industry has been significant 
at all levels. From 1997 to 2001, the total organic acreage grew by 74 
percent; livestock numbers certified organic grew by almost 300 percent 
over the same period, and poultry certified organic increased by 2,118 
percent over this time. Sales growth of organic products has been 
equally significant, growing on average around 20 percent per year. 
Sales of organic products were approximately $1 billion in 1993, but 
reached $15 billion in 2004. In addition, USDA has accredited 97 
certifying agents who have applied to USDA to be accredited in order to 
provide certification services to producers and handlers. A complete 
list of names and addresses of accredited certifying agents may be 
found on the AMS NOP Web site, at http://www.ams.usda.gov/nop. AMS 
believes that most of these entities would be considered small entities 
under the criteria established by the SBA.

D. Paperwork Reduction Act

    Pursuant to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et 
seq., the existing information collection requirements for the NOP are 
approved under OMB number 0581-0191. 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, or OMB's implementing regulation at 5 CFR 
part 1320.

E. General Notice of Public Rulemaking

    This proposed rule reflects recommendations submitted to the 
Secretary by the NOSB and includes an amendment to the mailing address 
for where to file a Certification or Accreditation Appeal. The seven 
substances proposed to be added to the National List were based on 
petitions from the industry. The NOSB evaluated each petition using 
criteria in the OFPA. Because these substances are critical to organic 
production and handling operations, producers and handlers should be 
able to use them in their operations as soon as possible. A 60-day 
period for interested persons to comment on this rule is provided.

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 (h).
    b. Revising paragraph (m)(2).
    c. Adding a new paragraph (n).
    d. Reserving paragraphs (o)-(z).
    The revisions and additions read as follows:


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

* * * * *
    (h) As slug or snail bait. Ferric phosphate (CAS  10045-
86-0).
* * * * *
    (m) * * *
    (2) EPA List 3--Inerts of Unknown Toxicity allowed:
    (i) Glycerine Oleate (Glycerol monooleate) (CAS s 25496-
72-4; 111-03-5; 37220-82-9)--for use only until December 31, 2006.
    (ii) Inerts used in passive pheromone dispensers.
    (iii) Tetrahydrofurfuryl alcohol (CAS  97-99-4)--for use 
only until December 31, 2006.
    (n) Seed preparations. Hydrogen chloride (CAS  7647-01-
0)--for delinting cotton seed for planting.
* * * * *
    3. Section 205.605 is amended by:
    a. Adding three materials to paragraph (a).
    b. Adding 8 new substances to paragraph (b).
    The additions 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 group(s)).''

* * * * *
    (a) * * *
* * * * *

[[Page 54668]]

    Egg white lysozyme (CAS  9001-63-2)
* * * * *
    L-Malic acid (CAS  97-67-6).
* * * * *
    Microorganisms--any food grade bacteria, fungi, and other 
microorganism.
* * * * *
    (b) * * *
    Activated charcoal (CAS s 7440-44-0; 64365-11-3)--only 
from vegetative sources; for use only as a filtering aid in handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in handling agricultural 
products labeled ``organic.''
* * * * *
    Ammonium hydroxide (CAS  1336-21-6)--for use only as a 
boiler water additive until October 21, 2005. Restricted to handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in handling agricultural 
products labeled ``organic.''
* * * * *
    Cyclohexylamine (CAS  108-91-8)--for use only as a boiler 
water additive for packaging sterilization. Restricted to handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in handling agricultural 
products labeled ``organic.''
    Diethylaminoethanol (CAS  100-37-8)--for use only as a 
boiler water additive for packaging sterilization. Restricted to 
handling agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited for use in handling 
agricultural products labeled ``organic.''
* * * * *
    Octadecylamine (CAS  124-30-1)--for use only as a boiler 
water additive for packaging sterilization. Restricted to handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited for use in handling 
agricultural products labeled ``organic.''
* * * * *
    Peracetic acid/Peroxyacetic acid (CAS  79-21-0)--for use 
in wash and/or rinse water according to FDA limitations. For use as a 
sanitizer on food contact surfaces. Restricted to use in handling 
agricultural products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in handling agricultural 
products labeled ``organic.''
* * * * *
    Sodium acid pyrophosphate (CAS  7758-16-9)--for use only 
as a leavening agent in agricultural products labeled ``made with 
organic (specified ingredients or food group(s));'' prohibited in 
handling agricultural products labeled ``organic.''
* * * * *
    Tetrasodium pyrophosphate (CAS  7722-88-5)--for use only 
in meat analog products labeled ``made with organic (specified 
ingredients or food group(s));'' prohibited in handling agricultural 
products labeled ``organic.''
* * * * *
    4. In Sec.  205.681, paragraph (d)(1) is revised to read as 
follows:


Sec.  205.681  Appeals.

* * * * *
    (d) * * * (1) Appeals to the Administrator must be filed in writing 
and addressed to: Administrator, USDA, AMS, c/o NOP Appeals Staff, Stop 
0203, Room 3529-S, 1400 Independence Avenue, SW., Washington, DC 20250-
0203
* * * * *

    Dated: September 12, 2005.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. 05-18381 Filed 9-15-05; 8:45 am]
BILLING CODE 3410-02-P