05-18381. 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.

SUMMARY:

This proposed rule would amend the U.S. Department of Agriculture's (USDA) National List of Allowed and Prohibited Substances (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: [e-mail].
• Internet: http://www.regulations.gov.
• Fax: Comments may be submitted by fax to: [phone].
• 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 [phone].

FOR FURTHER INFORMATION CONTACT:

Arthur Neal, Director of Program Administration, Telephone: [phone]; Fax: [phone].

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 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 § 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 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 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 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, 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 § 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 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). 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 § 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 § 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 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 § 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, 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 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 (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 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 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 (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 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.”

Section 205.681 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.

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 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:

§ 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) * * *

* * * * *

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 § 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.