03-5751. Ultramarine Sodium Alumino Sulpho Silicate; 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 ID number OPP-2003-0055, must be received on or before April 11, 2003.

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:

Treva C. Alston, Registration Division (7505C), 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 are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111)
• Animal production (NAICS code 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS code 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-2003-0055. 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 [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. 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-2003-0055. 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-2003-0055. 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-2003-0055.

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-2003-0055. 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: February 28,2003.

Peter Caulkins,

Acting Director, Registration 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 petitioner and represents the view of the petitioner. 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. The summary of the petition 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.

Holliday Pigments Limited

PP 3E6549

EPA has received a pesticide petition (3E6549) from Holliday Pigments Limited, Morley Street, Hull, East Yorkshire, England HU8 8DN proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180. to establish an exemption from the requirement of a tolerance for ultramarine (sodium alumino sulpho silicate) when used as an inert ingredient as a dye in seed coatings. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. Ultramarine is a synthetic form of the naturally occurring semi-precious mineral Lapis Lazuli, which has been mined, processed and used for decorative purposes for thousands of years. It is a zeolitic mineral and is totally insoluble in water. As such, it is not metabolized by plants. It is stable in neutral and alkaline soils. Under acidic conditions it decomposes to give hydrogen sulphide, which is evolved as a gas together with an insoluble, inert clay-like residue, which will not be metabolized by plants.

2. Analytical method. Since this petition is for an exemption from the requirement of a tolerance, an analytical method is not required.

3. Magnitude of residues. The proposed use for ultramarine is as a seed coating to impart color for identification. It will not be metabolized and will remain in the soil. There will therefore, be no residues on the crop produced.

B. Toxicological Profile

The last of the following tests described was completed in 1981. Holliday Pigments no longer carries out tests of any of their products on animals nor do they subscribe to any form of animal testing.

1. Acute toxicity—i. Skin irritation. Albino rabbits were used for a study of irritation producted by ultramarine contact with abraded and intact skin. No irritation was found and no reactions were observed throughout the study.

ii. Skin sensitization. Skin sensitization in the guinea pig was studied using the maximization test of Magnusson and Kligman. No visible reaction was exhibited by any animal in the test or control group throughout the trials. The report concluded that there was no evidence that ultramarine acts as a sensitizer in the guinea pig.

2. Genotoxicity. Bacterial toxicity and mutagenicity were studied using two strains each of Salmonella typhimurium and Escherichia coli. These tests showed ultramarine to be non-toxic and non-mutagenic to the four strains.

3. Reproductive and developmental toxicity. Female rats were fed with diets containing up to 100,000 ppm ultramarine before and during pregnancy. There were no maternal deaths and the test report concluded that ultramarine had no teratogenic activity at levels from 100 to 100,000 ppm in the diet.

4. Subchronic toxicity—i. Fifteen—Day test. Ultramarine was administered to male mice and female rats at increasing dose levels up to the maximum that could be given in a single dose. No deaths were observed in either species over a period of 15 days. The LD₅₀ is greater than 10,000 mg/kg (rats).

ii. Ninety-Day test. In feeding trials on rats and mice, after 90 days at levels of 100,000 part per million (ppm) in the diet the effect of ultramarine was very much like that of inert clay with (LD₅₀) greater than 10,000 milligrams/kilograms (mg/kg).

5. Chronic toxicity. There are no reported studies on chronic toxicity but ultramarine has a history of well over 100 years of safe manufacture and use with no reports of ill effects of any kind. In the early years of industrial production the work force was subjected to conditions which would be totally unacceptable today. Large amounts of fine ultramarine dust were inhaled and ingested without any reported ill effects. In addition ultramarine was used as a whitening agent for sugar in many parts of the world, again with no reported ill effects. In Europe, the use of ultramarine in lipsticks has been permitted for over 50 years. Its use at levels up to 0.5% for coloring cattle salt licks where it is clearly ingested by the cattle, has been permitted for many years. Ultramarine is also permitted world-wide for use in toys and children's paints including powder and finger paints.

C. Aggregate Exposure

1. Dietary exposure. In the proposed use of ultramarine as a seed coating it will not come into contact with the grown and harvested crop. As ultramarine is insoluble, it will not be metabolized by the plants grown from the treated seed. There is therefore no risk of dietary exposure.

i. Food. For the reasons stated above there is no risk that food produced from the treated seed will contain any ultramarine.

ii. Drinking water. As ultramarine and any of its decomposition products are insoluble in water there is no danger of any leaching into water courses used for production of drinking water.

2. Non-dietary exposure. The only anticipated human exposure to ultramarine used for seed coating will be during the coating process and any handling of the coated seed. Good practice should ensure minimal contact and in any case there is no evidence of adverse health effects from exposure to ultramarine during over 100 years of production and use.

D. Cumulative Effects

As ultramarine and its decomposition products are totally insoluble and not metabolized by plants or animals there is no risk of any cumulative effect. Also, in the proposed end use there is no risk of long term exposure to humans.

E. Safety Determination

1. U.S. population. The use of ultramarine as a seed coating does not pose a safety concern for the U.S. population due to its non-toxicity and the absence of exposure.

2. Infants and children. Infants and children will not be exposed to ultramarine from its use in seed coating applications. In any case, ultramarine is permitted in the United States and world-wide for use in children's toys, modeling clay, and finger paints.

F. International Tolerances

There is no listed threshold limit value or maximum exposure limit for ultramarine. Normal practice is to consider it as a nuisance dust with threshold limit value (TLV) 10 mg/m³. The pigment is not listed as a dangerous substance in the European Community or any similar national or international classification; neither is it classified as hazardous for disposal.