05-11165. Ferric Sodium EDTA; 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-2005-0131, must be received on or before July 8, 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.

FOR FURTHER INFORMATION CONTACT:

Todd Peterson, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you 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 identification (ID) number OPP-2005-0131. 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 [phone].

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 on 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-2005-0131. 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 [e-mail], Attention: Docket ID number OPP-2005-0131. 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-2005-0131.

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-2005-0131. 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

Dated: May 24, 2005.

Janet L. Andersen,

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

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 Woodstream Corporation 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.

Woodstream Corporation

PP 5F6899

EPA has received a pesticide petition (PP 5F6899) from Woodstream Corporation, 69 N. Locust Street, Lititz, PA 17543-0327, 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 biochemical pesticide ferric sodium EDTA.

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Woodstream Corporation has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Woodstream Corporation 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

Ferric sodium EDTA (technical grade active ingredient) and slug and snail killer (end-use product). Ferric sodium EDTA is a highly efficacious replacement for metaldehyde for the control of snails and slugs. The proposed end-use product (slug and snail killer) contains 6.00% active ingredient in a flour-based pellet. All intentionally added inert ingredients are exempt from the requirement of a tolerance when used in pesticides and are on EPA's List 4. Use sites proposed include agricultural crops, turf and ornamentals and home gardens; all areas where slugs and snails are a problem. The end-use product is applied directly to the soil surface. A draft end-use product label has been submitted with the corresponding application for FIFRA section 3 registration.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. The active ingredient, ferric sodium EDTA, is comprised of iron in a sodium EDTA chelate. Ferric sodium EDTA is a commodity ingredient used in the photographic industry as a bleaching agent, used in agriculture as a micronutrient, and used in the chemical industry as a catalyst. Ferric sodium EDTA is also currently being evaluated as a way of fortifying foods to prevent anemia and iron deficiencies in developing countries. Iron is an essential element for nutrition and is listed as GRAS for direct addition to food per 21 CFR 184.1375. Sodium EDTA is a common chelating agent, which immobilizes metal ions until in an environment where they are available for uptake. Sodium EDTA is exempt per 40 CFR 180.1001 when used in pesticide formulations, and is a direct food additive per 21 CFR 172.135.

Ferric sodium EDTA has been classified as “Not a biochemical, but eligible for a reduced data set” per the Agency's letter received May 16, 2001. EPA states the classification is based on the abundance of iron in nature, its low toxicity, its use as a nutritional supplement, and it slow water solubility.

The end-use product Snail and Slug Control is formulated in pellet form with food attractants (flour-based ingredients). Snails and slugs are attracted to and ingest the pellets. When ingested, the iron in ferric sodium EDTA is available for uptake into the mollusks gut. Normally iron is prevented from passing through the gut barrier; however, the formulation of iron with the chelating agent EDTA allows for iron to pass the gut barrier. Once passed, the iron partially acidifies the mollusks copper-based blood resulting in sickness. The mollusk stops feeding and leaves the area.

2. Magnitude of residue at the time of harvest and method used to determine the residue.

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 residues is not applicable. It is expected that, when used as proposed, ferric sodium EDTA would not result in residues that are of toxicological concern.

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 (OPPTS Harmonized Guideline 870.1100): No adverse effects were seen in rats that received an oral gavage dose of 5,000 milligrams/kilogram body weight (mg/kg bwt) of the technical grade active ingredient. 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. A LD₅₀ >5,000 mg/kg was established.

2. Acute dermal toxicity (OPPTS Harmonized Guideline 870.1200): 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. A LD₅₀ >5,000 mg/kg was established.

3. Acute inhalation toxicity (OPPTS Harmonized Guideline 870.1300). No adverse effects were seen in rats that were exposed by inhalation for 4 hours to a concentration of 2.05 milligrams/Liter (mg/L) 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. A LD₅₀ >2.05 mg/L was established.

4. Primary eye irritation (OPPTS Harmonized Guideline 870.2400). In an eye irritation study on rabbits, ferric sodium EDTA was classified as mildly irritating to the eye. The active ingredient was instilled into the right eye of three healthy rabbits. Twenty four hours after instillation, conjunctivitis and corneal opacity were observed. Conjunctivitis cleared in all test animals by Day 10, and corneal opacity persisted in one test animal through Day 21. No iritis was observed in any treated eye during the study.

5. Primary Dermal Irritation (OPPTS Harmonized Guideline 870.2500). In a skin irritation study on rabbits, ferric sodium EDTA was classified as slightly irritating to the skin. The active ingredient was applied to the skin of healthy rabbits for 4 hours. No edema was noted at any test site during the study. One hour after test material application all treated sites exhibited erythema. All animals were free of dermal irritation by 24 hours.

6. Dermal sensitization (OPPTS Harmonized Guideline 870.2600). In a dermal sensitization study on guinea pigs, ferric sodium EDTA was not considered to be a contact sensitizer. The active ingredient was topically applied to test animals once a week for a 3-week induction period, and 28 days after the first induction dose as a challenge dose at the highest non-irritation concentration. No positive responses were observed.

A waiver is requested for subchronic, teratogenicity, genotoxicity and immunotoxicity data requirements. The active ingredient, ferric sodium EDTA, is comprised of iron in a sodium EDTA chelate. Ferric sodium EDTA is a commodity ingredient used in the photographic industry as a bleaching agent, used in agriculture as a micronutrient, and used in the chemical industry as a catalyst. Ferric sodium EDTA is also currently being evaluated as a way of fortifying foods to prevent anemia and iron deficiencies in developing countries. Iron is an essential element for nutrition and is listed as GRAS for direct addition to food per 21 CFR 184.1375. Sodium EDTA is a common chelating agent, which immobilizes metal ions until in an environment where they are available for uptake. Sodium EDTA is exempt per 40 CFR 180.1001 when used in pesticide formulations, and is a direct food additive per 21 CFR 172.135.

A complete literature search was conducted on ferric sodium EDTA, its components and related compounds. In a safety assessment of ferric sodium EDTA (also referred to as “iron EDTA”) for Food and Drug Administration (FDA) GRAS evaluation, the ingredient is regarded as safe for use in foods to increase iron bioavailability in human diets (Heimbach et al. 2000).

The results of toxicity testing and information found in published literature indicate there is no risk to human health or the environment from ferric sodium EDTA. Both dietary and 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 ferric sodium EDTA, as proposed, is minimal. Ferric sodium EDTA is intended for application to soil surfaces in agricultural crops, turf and ornamentals, and home gardens to control slugs and snails. The product is not applied directly to fruits, vegetables, or plant surfaces.

Ferric sodium EDTA is a commodity ingredient used in the photographic industry as a bleaching agent, used in agriculture as a micronutrient, and used in the chemical industry as a catalyst. Ferric sodium EDTA is also currently being evaluated as a way of fortifying foods to prevent anemia and iron deficiencies in developing countries. The components of ferric sodium EDTA are approved as direct food additives by FDA. Acute toxicity studies have shown that ferric sodium EDTA is not toxic or irritating to mammals. Further, a published safety assessment on ferric sodium EDTA for FDA GRAS evaluation, the ingredient is regarded as safe for use in foods to increase iron bioavailability in human diets (Heimbach et al. 2000),

The results of toxicity testing and information found in published literature indicate there is no risk to human health or the environment from ferric sodium EDTA. Dietary exposures would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern.

ii. Drinking water. Similarly, exposure to humans from residues of ferric sodium EDTA in consumed drinking water would be unlikely. Potential exposure to surface water would be negligible and exposure to drinking water (well or ground water) would be impossible to measure. Ferric sodium EDTA is intended for application to soil surfaces in agricultural crops, turf and ornamentals, and home gardens to control slugs and snails. The product is not applied directly to water.

The results of toxicity testing and information found in published literature indicate there is no risk to human health or the environment from ferric sodium EDTA. Drinking water exposures would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern.

2. Non-dietary exposure. The potential for non-dietary exposure to the general population, including infants and children, is limited. Ferric sodium EDTA is intended for application to soil surfaces in agricultural crops, turf and ornamentals, and home gardens to control slugs and snails.

The results of toxicity testing and information found in published literature indicate there is no risk to human health or the environment from ferric sodium EDTA. Non-dietary exposures would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern.

E. Cumulative Exposure

It is not expected that, when used as proposed, ferric sodium EDTA would result in residues that are of toxicological concern. Ferric sodium EDTA is a commodity ingredient used in the photographic industry as a bleaching agent, used in agriculture as a micronutrient, and used in the chemical industry as a catalyst. Ferric sodium EDTA is also currently being evaluated as a way of fortifying foods to prevent anemia and iron deficiencies in developing countries. The components of ferric sodium EDTA are approved as direct food additives by FDA. Acute toxicity studies have shown that ferric sodium EDTA is not toxic or irritating to mammals. Further, a published safety assessment on ferric sodium EDTA for FDA GRAS evaluation, the ingredient is regarded as safe for use in foods to increase iron bioavailability in human diets (Heimbach et al. 2000).

Ferric sodium EDTA is intended for application to soil surfaces in agricultural crops, turf and ornamentals, and home gardens to control slugs and snails. The results of toxicity testing and information found in published literature indicate there is no risk to human health or the environment from ferric sodium EDTA.

F. Safety Determination

1. U.S. population. Ferric sodium EDTA is a commodity ingredient used in the photographic industry as a bleaching agent, used in agriculture as a micronutrient, and used in the chemical industry as a catalyst. Ferric sodium EDTA is also currently being evaluated as a way of fortifying foods to prevent anemia and iron deficiencies in developing countries. The components of ferric sodium EDTA are approved as direct food additives by FDA. Acute toxicity studies have shown that ferric sodium EDTA is not toxic or irritating to mammals. Further, a published safety assessment on ferric sodium EDTA for FDA GRAS evaluation, the ingredient is regarded as safe for use in foods to increase iron bioavailability in human diets (Heimbach et al. 2000).

When used as proposed, ferric sodium EDTA would not result in residues that are of toxicological concern. Ferric sodium EDTA is intended for application to soil surfaces in agricultural crops, turf and ornamentals, and home gardens to control slugs and snails. The results of toxicity testing and information found in published literature indicate there is no risk to human health or the environment from ferric sodium EDTA. There is a reasonable certainty of no harm to the general U.S. population from exposure to this active ingredient.

2. Infants and children. As mentioned above, it is not expected that, when used as proposed, ferric sodium EDTA would result in residues that are of toxicological concern. There is a reasonable certainty of no harm for infants and children from exposure to ferric sodium EDTA from the proposed uses.

G. Effects on the Immune and Endocrine Systems

To date there is no evidence to suggest that ferric sodium EDTA 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 ferric sodium EDTA.

I. International Tolerances

A Codex Alimentarium Commission Maximum Residue Level (MRL) is not required for ferric sodium EDTA.