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Notice

Pythium Oligandrum DV 74; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.

DATES:

Comments, identified by docket identification (ID) number OPP-2005-0121, must be received on or before June 24, 2005.

ADDRESSES:

Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

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FOR FURTHER INFORMATION CONTACT:

Tessa Milofsky, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-0455; e-mail address: milofsky.tessa@epa.gov.

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SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

  • Crop production (NAICS 111)
  • Animal production (NAICS 112)
  • Food manufacturing (NAICS 311)
  • Pesticide manufacturing (NAICS 32532)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket ID number OPP-2005-0121. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr/​.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket/​ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the Start Printed Page 30106photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.

1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/​edocket/​, and follow the online instructions for submitting comments. Once in the system, select “search,” and then key in docket ID number OPP-2005-0121. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov, Attention: Docket ID Number OPP-2005-0121. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.

2. By mail. Send your comments to: Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID Number OPP-2005-0121.

3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID Number OPP-2005-0121. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Make sure to submit your comments by the deadline in this notice.

7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

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List of Subjects

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Dated: May 16, 2005.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

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Summary of Petition

The petitioner summary of the pesticide petition is printed below as required by FFDCA section 408(d)(3). The summary of the petition was prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

Biopreparaty Co. Ltd.

PP 4F6877

EPA has received a pesticide petition (4F6877) from Biopreparaty Co., Ltd. (EPA Company No. 81606), Tylisovska 1, Prague 6, Czech Republic, proposing pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for the microbial pesticide pythium oligandrum DV 74 in or on all food commodities.

Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, Biopreparaty Co., Ltd., has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Biopreparaty Co., Ltd., and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

A. Product Name and Proposed Use Practices

Pythium oligandrum DV 74 is the active ingredient in the proposed end-use product “Polyversum.” The end-use product polyversum is for the stimulation of plant growth, the enhancement of plant strength, and the prevention of fungal attack. Polyversum mobilizes plant defense mechanisms, increases plant resistance to pathogenic fungal attack, increases rate of growth, and increases overall crop strength and yield. Polyversum can be applied as a seed dressing, pre-plant soak, overhead spray or soil drench, or irrigation application to agricultural crops, ornamental plants, and turf grasses.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Pythium oligandrum, originally described by Charles Drechsler in 1943. Isolate to be registered was discovered in 1972, in the Czech Republic. The pythium oligandrum DV 74 isolate is on deposit at the American Type Culture Collection (ATCC) as “Pythium oligandrum, ATCC 38472.” The microorganism pythium oligandrum is naturally found in soil, and is often associated with other mycoparasites and fungal species. It is widely distributed around the world, including the United States for example, pythium oligandrum was isolated from 74 of 93 soil samples collected from 40 different counties in California that represented a wide range of environmental conditions.

The pythium family has 100 varieties, of which pythium oligandrum is one of four mycoparasites. The microorganism lives parasitically on plant pathogenic fungi, and works to induce/stimulate the internal defense systems of plants. Testing has shown pythium oligandrum is parasitic to 20 species of plant pathogenic fungi, including: Alternaria, Botrytis, Fusarium, Gaeumannonyces, Ophiostoma, Phoma, Pseudocercosporella, Pythium, Sclerotinia, and Sclerotium.

The active ingredient pythium oligandrum DV 74 colonizes the surroundings of treated and sown seeds, and the rhizosphere of treated plants. Because of its strong mycoparasitical and competitive abilities, the active ingredient suppresses the growth and antagonistic effects of many soil borne pathogenic fungi, which cause damping-off and seed, and root rots such as phytophthora, rhizoctonia, fusarium, etc. The active ingredient also induces a defense reaction in the newly emerged plant, through stimulation of the phytohormones, which are involved in the resistance mechanisms of the plant against diseases. Pythium oligandrum DV 74 does not produce any antibiotics and therefore is considered a true plant growth promoter for the induction of plant resistance. The mycoparasitic action and stimulation of plant resistance by pythium oligandrum are both associated with positive effects on plant health and viability.

2. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed. An analytical method for detecting and measuring levels of pesticide residues is not applicable. It is expected that, when used as proposed, pythium oligandrum DV 74 would not result in residues that are of toxicological concern. Further, the application of pythium oligandrum DV 74 to seeds, foliage, or soil will not result in an increase in concentration in the environment. The level of pythium oligandrum DV 74 in the environment following application is expected to decrease to levels similar to naturally occurring concentrations, because the organism does not thrive in the absence of sufficient nutrients.

C. Mammalian Toxicological Profile

Studies to evaluate the safety to mammals were conducted on the technical grade active ingredient (tgai) and are summarized as follows:

1. Acute oral toxicity. No adverse effects were seen on either rats or mice that received an oral gavage dose of 5,000 milligrams/kilogram/body weight (mg/kg/bwt) of the technical grade active ingredient. No effects on appearance, behavior, or body weight were observed in any rats or mice any time after dosing. No rats or mice died during the 14-day observation period, and no gross pathological changes were found in organs in the thoracic or abdominal cavities at necropsy. An LD50 >5,000 mg/kg was established.

2. Acute dermal toxicity. No adverse effects were seen in rats that received a dermal dose of 5,000 mg/kg/bwt of the technical grade active ingredient. No effects on appearance, behavior, or body weight were observed in any rats any time after exposure. No rats died during the 14-day observation period, and no gross pathological changes were found in organs in the thoracic or abdominal cavities at necropsy. An LD50 >5,000 mg/kg was established.

3. Acute inhalation toxicity. No adverse effects were seen in rats that were exposed by inhalation for 4 hours to a concentration of 5 mg/liters of the technical grade active ingredient. No effects on appearance, behavior, or body weight were observed in any rats any time after exposure. No rats died during the 14-day observation period, and no gross pathological changes were found in organs in the thoracic or abdominal cavities at necropsy. Histological analysis of the lungs and trachea taken from two males and two females revealed no pathogenic response to inhalation of the test article. An LD50 >5 mg/l was established.

4. Primary eye irritation. In the primary eye irritation study on the technical grade active ingredient, 3 rabbits received 100 mg of test article in 0.1 milliliter (ml) of water in the right eye. Redness of the conjunctiva and swelling of the eyelids occurred during Start Printed Page 30108the first 24-48 hours after exposure, both were rated as high as 2 on a scale of 1 to 3 in some animals. The edema resolved in all animals within 48-hours after test article administration and the redness resolved in all animals within 72 hours. No changes in the cornea or iris of any animals occurred. Pythium oligandrum DV 74 was rated “moderately irritating” to eyes.

5. Primary dermal irritation. No adverse effects were seen in rabbits that received a subcutaneous injection of an extract of the technical grade active ingredient. In this study 3 rabbits received 0.2 ml of an extract of the test article by subcutaneous injection at 2 injection sites. No reaction was observed between 45 minutes and 72 hours after the subcutaneous injection. Pythium oligandrum DV 74 was rated “non irritant” to skin.

6. Hypersensitivity incidents. The registrant has noted that no incidents of hypersensitivity or any other adverse effects have occurred through the research, develop, or testing of the active ingredient and its related end-use product. Should any incidents occur, they will be reported per the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) section 6(a)(2).

A literature search on pythium oligandrum demonstrates that this microorganism is not infective to mammals. The literature search indicated that pythium oligandrum has been studied for over 20 years, and the only biological effects attributed to the organism are parasitic effects on fungal species and stimulation of resistance to parasitic infection in plants. The mycoparasitic mode of action of pythium oligandrum is initiated by a specific affinity for the cells of the pathogenic fungus, followed by tight binding to the host hyphae and local penetration. Pythium oligandrum stimulates disease resistance in plants by production of a small proteinaceous molecule that serves as a biochemical signal in the plant. Neither the mechanism of mycoparasitic action nor the stimulation of plant resistance is associated with adverse affects in mammals.

Further, pythium oligandrum DV 74 is the active ingredient in a variety of over the counter products sold in parts of Europe (including the Czech Republic, Slovakia, and Poland). These products include: A footbath to control itching and odor (brand name: Biodeur Deodorant); a fingernail treatment preparation to control nail fungus (brand name: BioBlock); a mouthwash rinse to control yeast infections (brand name: BioPlus); and a bath additive (brand name: Biodelta) and a skin cream (brand name: Biogama) to control psoriasis and dermatitis. These products have been marketed since 1999 without reports of adverse effects.

A waiver has been requested for acute oral, dermal, pulmonary, and IV/IP toxicity/pathogenicity; dermal sensitization; and the conditionally required Tier 1 data for cell culture and immune response. In general, the waiver requests are based on the rationale that the active ingredient:

  • Produced no adverse effects in mammalian toxicity studies.
  • Is ubiquitous as a naturally occurring soil colonizer whose level in the environment will not significantly increase with the use of products that contain this strain.
  • Has modes of action that are not consistent with toxicity or pathogenicity to mammals.
  • In an extensive literature search yielded no reports of adverse effects in humans or other mammals.
  • Is marketed in Europe as the active ingredient in over the counter products, including mouth rinses, bath additives, and skin creams, with no reports of adverse effects.

The results of toxicity testing indicate there is no risk to human health or the environment from pythium oligandrum DV 74. There are no reports of ecological or human health hazards caused by pythium oligandrum in general or the strain pythium oligandrum DV 74 in specific. It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain. The limited survival of pythium oligandrum DV 74 and the lack of acute toxicity indicate that both the hazard and the exposure associated with the use of pythium oligandrum DV 74 are low. Non-dietary exposures would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern.

D. Aggregate Exposure

1. Dietary exposure—i. Food. Dietary exposure from use of pythium oligandrum DV 74, as proposed, is minimal. The major intended use of pythium oligandrum DV 74 is application to growing plants and crops for the purposes of disease control and stimulating plant defense mechanisms. Pythium oligandrum is widely distributed around the world, including the U.S. application of pythium oligandrum DV 74 to seeds, foliage, or soil will not result in a substantial increase in concentration in the environment. The level of pythium oligandrum DV 74 in the environment following application will decrease to levels similar to naturally occurring concentrations, because the organism does not thrive in the absence of sufficient nutrients. Limited survivability once its nutrient source is exhausted will limit any dietary exposure.

ii. Drinking water. Similarly, exposure to humans from residues of pythium oligandrum DV 74 in consumed drinking water would be unlikely. Pythium oligandrum DV 74 is not known to grow or thrive in aquatic environments. Potential exposure to surface water would be negligible and exposure to drinking water (well or ground water) would be impossible to measure. The major intended use of pythium oligandrum DV 74 is to treat growing plants and crops for the purpose of disease control. Pythium oligandrum DV 74 has limited survivability once its nutrient source is exhausted. The risk of the microorganism passing through the soil to ground water is minimal to unlikely. Additionally, the fungus would not tolerate the conditions water is subjected to in a drinking-water facility (including: Chlorination, pH adjustments, high temperatures, and/or anaerobic conditions).

2. Non-dietary exposure. The potential for non-dietary exposure to the general population, including infants and children, is unlikely as the proposed use sites are application to growing plants or crops. Further, pythium oligandrum DV 74 has limited survivability once its nutrient source is exhausted.

3. Conclusion. The results of toxicity testing indicate there is no risk to human health or the environment from pythium oligandrum DV 74. There are no reports of ecological or human health hazards caused by pythium oligandrum in general or the strain pythium oligandrum DV 74 in specific. It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain. The limited survival of pythium oligandrum DV 74 and the lack of acute toxicity indicate that both the hazard and the exposure associated with the use of pythium oligandrum DV 74 are low. Non-dietary exposures would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern.

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E. Cumulative Exposure

It is not expected that, when used as proposed, pythium oligandrum DV 74 would result in residues that are of toxicological concern. Pythium oligandrum DV 74 is applied to growing plants and crops for the purposes of disease control and stimulating plant resistance. Pythium oligandrum is widely distributed around the world, including the U.S. application of pythium oligandrum DV 74 to seeds, foliage, or soil will not result in a substantial increase in concentration in the environment. The level of pythium oligandrum DV 74 in the environment following application will decrease to levels similar to naturally occurring concentrations because the organism does not thrive in the absence of sufficient nutrients. The results of toxicity testing indicate there is no risk to human health or the environment from pythium oligandrum DV 74. There are no reports of ecological or human health hazards caused by pythium oligandrum in general or the strain pythium oligandrum DV 74 in specific. It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain. The limited survival of pythium oligandrum DV 74 and the lack of acute toxicity indicate that both the hazard and the exposure associated with the use of pythium oligandrum DV 74 are low.

F. Safety Determination

1. U.S. population. Acute toxicity studies have shown that pythium oligandrum DV 74 is not toxic, pathogenic, or infective to mammals. The major intended use of pythium oligandrum DV 74 is applied to growing plants and crops for the purposes of disease control and stimulating plant resistance. The level of pythium oligandrum DV 74 in the environment following application will decrease to levels similar to naturally occurring concentrations because the organism does not thrive in the absence of sufficient nutrients. The results of toxicity testing indicate there is no risk to human health or the environment from pythium oligandrum DV 74. There are no reports of ecological or human health hazards caused by pythium oligandrum in general or the strain pythium oligandrum DV 74 in specific. It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain. The limited survival of pythium oligandrum DV 74 and the lack of acute toxicity indicate that both the hazard and the exposure associated with the use of pythium oligandrum DV 74 are low. There is a reasonable certainty of no harm to the general U.S. population from exposure to this active ingredient.

2. Infants and children. It is not expected that, when used as proposed, pythium oligandrum DV 74 would result in residues that are of toxicological concern. There is a reasonable certainty of no harm for infants and children from exposure to pythium oligandrum DV 74 from the proposed uses.

G. Effects on the Immune and Endocrine Systems

To date there is no evidence to suggest that pythium oligandrum DV 74 functions in a manner similar to any known hormone, or that it acts as an endocrine disrupter.

H. Existing Tolerances

There is no EPA tolerance for pythium oligandrum DV 74.

I. International Tolerances

A Codex Alimentarium Commission Maximum Residue Level (MRL) is not required for pythium oligandrum DV 74.

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[FR Doc. 05-10340 Filed 5-24-05; 8:45 am]

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