Reynoutria Sachalinensis; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

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-2004-0006, must be received on or before April 30, 2004.

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.

FOR FURTHER INFORMATION CONTACT:

Driss Benmhend, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9525; e-mail address: benmhend.driss@epa.gov.

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-2004-0006. 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, 1921 Jefferson Davis Hwy., 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 EPA's 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 photograph 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-2004-0006. 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-2004-0006. 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-2004-0006.

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, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP-2004-0006. 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.

List of Subjects

• Environmental protection
• Agricultural commodities
• Feed additives
• Food additives
• Pesticides and pests
• Reporting and recordkeeping requirements

Summary of Petition

The petitioner's 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.

Interregional Research Project Number 4 (IR-4)

PP 3E6751

EPA has received a pesticide petition (3E6751) from Interregional Research Project Number 4 (IR-4), New Jersey Agricultural Experiment Station, Technology Center of New Jersey, Technology Centre of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390, on behalf of KHH BioSci Inc., 920 Campus Drive, Suite 101, Raleigh, NC 27606 proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d) to establish a tolerance exemption for the biochemical pesticide Reynoutria sachalinensis in all food commodities.

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, the aforesaid IR-4, on behalf of KHH BioSci Inc., has submitted the following summary of information, data, and arguments in support of the pesticide petition. This summary was prepared by IR-4 on behalf of KHH BioSci Inc., 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

Reynoutria sachalinensis, is an extract of a naturally occurring plant of that botanical name, and is proposed for use to reduce the incidence of plant diseases. When applied just prior to disease incidence, Reynoutria sachalinensis induces plant defenses making treated plants more resistant to certain diseases. Reynoutria sachalinensis is applied to ornamental and food crops in a 0.5 to 1% solution at a rate of up to 100 gallons of solution per acre. The pesticide is registered for use in non-food crops (EPA Registration # 72179-2). This petition proposes to establish a permanent exemption from the requirement of a tolerance for residues of Reynoutria sachalinensis in or on all food commodities.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. The pesticide and corresponding residues are identified as Reynoutria sachalinensis, a plant extract. Residues resulting from the use of Reynoutria sachalinensis extract on food crops could be difficult to characterize since many of the same phenolic compounds promoted by Reynoutria sachalinensis extract, are already present in vegetables. A waiver has been requested for nature of the residue studies on Reynoutria sachalinensis extract.

2. Magnitude of residue at the time of harvest and method used to determine the residue. Reynoutria sachalinensis is a plant extract. An analytical method for detecting residues was not submitted as this petition proposes an exemption from the requirement of a tolerance.

3. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed. An analytical method for enforcement purposes to detect residues was not submitted as this petition proposes an exemption from the requirement of a tolerance.

C. Mammalian Toxicological Profile

Acute toxicity studies on the technical active ingredient (manufacturing use product) and formulated material have been submitted and reviewed in support of the existing product registration for greenhouse, non-food use. These studies and EPA's conclusions are summarized below.

An acute oral toxicity test was performed using the manufacturing use product, Milsana Bioprotectant (technical active ingredient). Based on a lack of mortality observed in albino rats, the oral lethal dose (LD)₅₀ of the technical active ingredient product, was >5,000 milligrams/kilogram (mg/kg); toxicity category IV.

An acute oral toxicity study of Milsana Bioprotectant Concentrate (Milsana^®, a formulated end-use product) was conducted. Based on a lack of mortality observed in albino rats, the oral LD₅₀ of the end-use product was >5,000 mg/kg; toxicity category IV.

An acute dermal toxicity study was conducted using the manufacturing use product, Milsana Bioprotectant (technical active ingredient). Based on a lack of mortality observed in albino rabbits, the LD₅₀ was >2,000 mg/kg; toxicity category III.

An acute dermal toxicity study of Milsana Bioprotectant Concentrate (Milsana^®, formulated end-use product) was conducted. Based on a lack of mortality observed in albino rabbits, the LD₅₀ was >2,000 mg/kg; toxicity category III.

An acute inhalation toxicity study of Milsana^®, a formulated end-use product was conducted in albino rats. The conclusion was that the lethal concentration (LC)₅₀ is >2.6 milligram/Liter (mg/L); toxicity category IV.

An acute eye irritation study of Milsana Bioprotectant Concentrate Milsana^®, a formulated end-use product) was conducted. The study demonstrated that a dose of 0.1 milliliter (mL) resulted in the highest average ocular irritation index was 23.3, recorded 1-hour after instillation of the test substance into the eyes of albino rabbits. This classifies Milsana^® as moderately irritating with a toxicity category II. However, when the technical grade of the active ingredient (TGAI) was used as a test material, the highest average ocular irritation recorded was 12.2, toxicity category III. Therefore, it is reasonable to conclude that the formulated end use product contains an eye irritant.

An acute dermal irritation study of Milsana Bioprotectant Concentrate (Milsana^®, formulated end-use product) was conducted in albino rabbits. The conclusion was that dermal application of 0.5 gram (g) of liquid product did not cause any dermal irritation symptoms up to 72 hours post dosing; toxicity category IV.

A skin sensitization study of Milsana Bioprotectant Concentrate (Milsana^®, formulated end-use product) was conducted with albino guinea pigs. The conclusion was that the test substance is not considered to be a contact sensitizer in guinea pigs by the Buehler method.

Based on these studies, we concluded that Reynoutria sachalinensis does not present an acute toxicity risk to mammals. Since no adverse effects were observed in the Tier I acute toxicity studies, data waivers were requested for the following toxicology studies: Genotoxicity study, immune response, mutagenicity, chronic toxicity, and developmental toxicity. In addition, the following rationales were used as a basis for the data waiver requests:

1. Researchers, manufacturers, and other workers have worked with Reynoutria sachalinensis and it is currently used in greenhouse production without report of any adverse health effects.

2. Reynoutria sachalinensis is widely distributed in the environment.

3. The label will require applicators and other handlers to wear personal protective equipment (PPE), to mitigate against exposure.

D. Aggregate Exposure

1. Dietary exposure—i. Food. Dietary exposure to Reynoutria sachalinensis, should not be of concern due to the low toxicity shown in the acute toxicity studies previously submitted. In addition, Reynoutria sachalinensis is widespread throughout the United States, Europe, and Asia and is already found in foods, animals feeds, and medicines (MRID 44821916). Reynoutria sachalinensis activates phenolics in plants which can be found in a wide variety of commonly consumed vegetables and herbs. No adverse health issues for man, animals, or plants have been associated with the plant. Exposure to the active ingredient from its pesticidal use is anticipated to be very low due to the low application rate which results in negligible residues compared to consumption of Reynoutria sachalinensis as a food.

ii. Drinking water. Reynoutria sachalinensis is a naturally occurring plant that is already widespread in the environment. It commonly grows along rivers and is not considered to be a risk to drinking water. Percolation through soil and municipal treatment of drinking water would reduce the possibility of exposure of Reynoutria sachalinensis through the drinking water. The formulated end use product is an extract of this plant, and any residues that may result from its pesticidal use would be expected to behave similarly to leachates of leaf litter and plant exudates in the environment.

2. Non-dietary exposure. The potential for non-occupational, non-dietary exposure to the general population is not expected to be significant and is not expected to present any risk of adverse health effects.

E. Cumulative Exposure

There are no other products-registered for food use containing Reynoutria sachalinensis as the active ingredient, so dietary exposure from other pesticidal uses is not likely. The plant has been consumed in the human diet in Japan for generations without any known adverse effects. Researchers, manufacturers, and other workers have applied Reynoutria sachalinensis under greenhouse production without report of any adverse health effects to greenhouse workers. In addition, the label will require pesticide applicators and other handlers to wear personal protective equipment (PPE), to mitigate exposure.

F. Safety Determination

1. U.S. population. Reynoutria sachalinensis is a naturally occurring plant. This plant has low toxicity as demonstrated by the acute oral toxicity study in rats. Based on this information, IR-4 is of the opinion that the aggregate exposure to Reynoutria sachalinensis over a lifetime should not change with application of Reynoutria sachalinensis. Thus, there is a reasonable certainty that no harm will result from aggregate exposure to Reynoutria sachalinensis. The data requirements for granting the greenhouse nonfood use registration under section 3(c)(5) of FIFRA has been reviewed by BPPD. The mammalian toxicology and ecological effects data requirements for Reynoutria sachalinensis extract have been fulfilled for the nonfood greenhouse use. Additional waivers have been developed for the food use. Product analysis data requirements have adequately satisfied EPA registrations for the greenhouse, nonfood use of the end use product, (EPA Registration # 72719-2) and the manufacturing use product (EPA Registration # 72719-1) which were approved on September 29, 2000. The composition of the products in the existing registration and this registration are identical.

2. Infants and children. Based on the lack of toxicity and low exposure, there is reasonable certainty that no harm to infants, children, or adults will result from aggregate exposure to Reynoutria sachalinensis. In addition, Reynoutria sachalinensis is widespread throughout the United States, Europe, and Asia and is already found in foods, animals feeds, and in medicines (MRID 44821916). The plant has been consumed in the human diet in Japan for generations without any known adverse effects. The active components stimulated by Reynoutria sachalinensis are phenolics which have health benefits and are already present in vegetables. Exempting Reynoutria sachalinensis from the requirement of a tolerance should pose no significant risk to humans or the environment.

G. Effects on the Immune and Endocrine Systems

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

H. Efficacy

When applied to certain crop plants, this product raises the plants natural defense system by increasing the existing phenolic compounds in the leaf tissue. Current research indicates that the plant diseases affected by these natural phytoalexins are powdery mildews, gray mold, and fire blight. These diseases are economically important problems in both ornamental and food crop plants.

I. Existing Tolerances

There are no existing tolerances of any type for the extract of Reynoutria sachalinensis in the United States.

J. International Tolerances

The IR-4 program and the registrant, KHH BioSci, Inc., are not aware of any tolerances, exemptions from tolerance or maximum residue levels (MRLs) issued for the extract of Reynoutria sachalinensis outside of the United States. No MRLs have been established for the extract of Reynoutria sachalinensis by the Codex Alimentarius Commission.