02-19805. 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-2002-0166, must be received on or before September 6, 2002.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP-2002-0166 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Treva Alston, Registration Support Branch, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

Categories	NAICS codes	Examples of potentially affected entities
Industry	111	Crop production
	112	Animal production
	311	Food manufacturing
	32532	Pesticide manufacturing

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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have 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 Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at: http://www.epa.gov/​fedrgstr/​.

2. In person. The Agency has established an official record for this action under docket ID number OPP-2002-0166. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP-2002-0166 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPP-2002-0166. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified 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 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: July 25, 2002.

Peter Caukins,

Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

The petitioner summary of the pesticide petition is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petition was prepared by the petitioner and represents the view of the petitioner. EPA is publishing the petition summary verbatim without editing it in any way. 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.

Akzo Nobel Surface Chemistry LLC

PP 7E4807

EPA has received a pesticide petition PP 7E4807 from Akzo Nobel Surface Chemistry LLC, 300 South Riverside Plaza, Chicago, IL 60606, 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 [2-ethylhexyl glucopyranoside] to be applied to growing crops only. 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 support granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The plant metabolism of 2-ethylhexyl glucopyranoside has not been investigated. However, due to the structural similarity, the metabolic pathway for 2-ethylhexyl glucopyranoside is expected to be similar to that of other alkyl glucosides which have been previously granted an exemption from the requirement of a tolerance, and also of those alkyl glucosides of similar structure that appear on EPA's current List 4B Inert Ingredient List.

2. Analytical method. The inert ingredient, impurities and oligomer distribution can be analyzed using high temperature gas chromatography with cold on column injection after derivatization with silylating reagents. Low levels of the inert ingredient can be detected by HPLC.

3. Magnitude of residues. Given the current extensive and widespread use of structurally similar nonionic surfactants in herbicide formulations, the added use of 2-ethylhexyl glucopyranoside will not significantly contribute to the total use-volume of these materials. The expected concentration of 2ethylhexyl glucopyranoside when used in an herbicide formulation will be much lower than the concentration of any co-formulated pesticide active ingredient. Therefore, the comparable application rate, on a grams/acre basis will be significantly lower than that of any co-formulated active ingredient. It is then reasonable to assume that any potential residues resulting from the use of 2-ethylhexyl glucopyranoside in a pesticide formulation would be insignificant.

B. Toxicological Profile

1. Acute toxicity. The results of acute toxicity testing for 2-ethylhexyl glucopyranoside are as follows: Acute oral LD₅₀ (rat) >2.0 gram/kilogram (g/kg); Acute dermal LD₅₀ (rat) >2.38 g/kg; moderate to severe eye irritant (rabbit); non-irritating to skin (rabbit); not a skin sensitizer (guinea pig).

2. Genotoxicty. 2-Ethylhexyl glucoside was negative in the Ames test, and did not induce chromosomal aberrations in human lymphocytes cultured in vivo.

3. Reproductive and developmental toxicity. Although the final report has not yet been issued, the preliminary results from a one-generation reproduction toxicity study with 2-ethylhexyl glucoside administered in male and female Wistar rats are available. The results indicate gavage treatment of male and female Wistar rats with 2-ethylhexyl glucoside at dose levels of 15, 150 or 750 milligram/kilogram (mg/kg) body weight/day during one generation, revealed parental toxicity in animals receiving 750 mg/kg b.w./day. Reproductive parameters and development of the pups were not affected up to 750 mg/kg b.w./day.

Parental toxicity consisted of affected mortality, clinical signs, body weights, and food consumption for animals treated at 750 mg/kg body weight/day.

Based on the results in this one-generation study, the definitive parental no observed adverse effect level (NOAEL) was established as being 150 mg/kg body weight/day. The definitive reproductive and developmental NOAEL was established as being 750 mg/kg body weight/day.

4. Subchronic toxicity. A 28-day oral toxicity study in the rat was conducted on 2-ethylhexyl glucopyranoside. The results were that in the rat, 750 mg/kg/day represents the no-observed-toxic effect level (NOTEL) and 150 mg/kg/day represents the no-observed effect level (NOEL).

5. Chronic toxicity. Based on the NOTEL and NOEL results of the 28-day study conducted on 2-ethylhexyl glucopyranoside, there are no chronic health concerns.

6. Animal metabolism. Animal metabolism studies have not been conducted on 2-ethylhexyl glucopyranoside. However, structurally similar radiolabeled alkyl glucopyranosides were studied after oral administration to mice. The results indicate that the glycosidic bond was rapidly hydrolyzed in the intestine and liver to sugars and the parent alcohol. The sugars and alcohols then entered the pathways of lipid and carbohydrate metabolism.

7. Metabolite toxicology. The metabolites of 2-ethylhexyl glucopyranoside are expected to be the cleavage products at the glycosidic bond, 2-ethylhexanol and glucose. The toxicity of these two metabolites is well known.

8. Endocrine disruption. No evidence of endocrine disruption was observed in any of the studies conducted on 2-ethylhexyl glucopyranoside, nor are there any known reports of any estrogenic and adverse effects to human population as a result of the use of 2-ethyhexyl glucopyranoside.

C. Aggregate Exposure

1. Dietary exposure. Based on the metabolism study that indicates alkyl glucopyranosides are readily metabolized in the liver and intestine to glucose and the alcohol, exposure to 2-ethylhexyl glucopyranoside should not pose a dietary risk under any foreseeable circumstances to the U.S. population including infants and children.

i. Food. Exposures to 2-ethylhexyl glucopyranoside due to ingestion of food is not expected to occur.

ii. Drinking water. Exposures to 2-ethylhexyl glucopyranoside due to ingestion of water is not expected to occur.

2. Non-dietary exposure. Structurally similar alkyl glucopyranosides are currently being used in a number of institutional and household cleaning applications. These current uses are expected to result in significantly higher exposures than exposure due to the insignificant residue levels resulting from the use under the proposed exemption from the requirement of a tolerance applied to growing crops only.

D. Cumulative Effects.

From the results of the tests conducted on 2-ethylhexyl glucopyranoside, no evidence of any specific target organ toxicity has been produced. Therefore, there is no evidence of a common mechanism of toxicity with any other substance, and there is no reason to expect that the use of 2-ethyhexyl glucopyranoside will contribute to any cumulative toxicity resulting from exposures to other substances having a common mechanism of toxicity.

E. Safety Determination

1. U.S. population. The results of the acute, genotoxic, subacute and developmental toxicity studies conducted on 2-ethylhexyl glucopyranoside indicate a relatively low order of toxicity. Structurally similar alkyl glucopyranosides currently exempted from the requirement of a tolerance, also appear on EPA's List 4B Inert List. Therefore, due to the low order of toxicity of 2-ethylhexyl glucopyranoside and the lack of known adverse human health effects associated with this class of chemicals, the exemption from the requirement of a tolerance on growing crops only is not expected to result in any new, or adverse effects to human health or the environment.

2. Infants and children. Exposure to 2-ethylhexyl glucopyranosides to infants and children is not expected to occur. The substance will be used as an inert ingredient at low levels on growing crops only, and any residual levels are expected to be insignificant and consistent with structurally similar alkyl glucopyranosides currently exempted from the requirement of a tolerance.

F. International Tolerances

No codex maximum residue levels have been established for 2-ethyhexyl glucopyranoside.