00-17357. Notice of Filing of Pesticide Petitions to Establish Tolerances for Certain Pesticide Chemicals in or on Food

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

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

DATES:

Comments, identified by docket control number PF-954, must be received on or before August 9, 2000.

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 control number PF-954 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Treva C. Alston, 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	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” 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 control number PF-954. 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 control number PF-954 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 control number PF-954. 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 control 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 pesticide petitions as follows proposing the establishment and/or amendment of regulations for residues of certain pesticide chemicals in or on various food commodities under section 408 of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that the petitions contain 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 petitions. 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: June 29, 2000.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

The petitioner summaries of the pesticide petitions are printed below as required by section 408(d)(3) of the FFDCA. The summaries of the petitions were prepared by the petitioner and represents the view of the petitioner. The petition summaries announce 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.

I. Huntsman Petrochemical Corporation

PP 0E6098

EPA has received a pesticide petition PP 0E6098 from Huntsman Petrochemical Corporation, 3040 Post Oak Blvd., Houston TX 77056 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 poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2- propenoic acid, 2-methyl-, methyl ester, for use as a surfactant in formulations when used in accordance with good agricultural practices as an inert ingredient in pesticide formulations applied to growing crops or on the raw agricultural commodity (RAC) after harvest. 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

Analytical method. Huntsman is petitioning that poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl-and 2-propenoic acid, 2-methyl-, methyl ester be exempt from the requirement of a tolerance based upon the definition of a low risk polymer as per 40 CFR 723.250. Therefore, an analytical method to determine residues of poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester in RACs has not been proposed.

B. Toxicological Profile

1. Acute toxicity. In the case of certain chemical substances that are defined as “polymers,” the Agency has established a set of criteria which identifies categories of polymers that present low risk. These criteria (described in 40 CFR 723.250) identify polymers that are typically not readily absorbed, and are relatively unreactive and stable compounds in comparison to other chemical substances. These properties generally limit a polymer's ability to cause adverse effects. In addition, these criteria exclude polymers about which little is known. The Agency believes that polymers meeting the criteria noted above will present minimal or no risk. Poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low risk polymers.

i. Poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester is not a cationic polymer, nor is it capable of becoming a cationic polymer in the natural aquatic environment.

ii. Poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester contains as an integral part of its composition the atomic elements carbon, hydrogen, oxygen.

iii. Poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(iii).

iv. Poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester is not designed, nor is it reasonably anticipated to substantially degrade, decompose, or depolymerize.

v. Poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester is manufactured using monomers and/or other reactants that are already included on the TSCA Chemical Substance Inventory or covered under an applicable TSCA section 5 exemption.

vi. Poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester is not a water absorbing polymer with a number average molecular weight greater than or equal to 10,000.

vii. The number average molecular weight of poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester is 3,700. Substances with molecular weights greater than 400 generally are not absorbed through the intact skin, and substances with molecular weights greater than 1,000 generally are not absorbed through the intact gastrointestinal (GI) tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response.

viii. Poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester contains approximately 0.03% oligomeric material below molecular weight 500 and approximately 0.22% oligomeric material below 1,000 molecular weight.

ix. Poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester does not contain reactive functional groups.

2. Endocrine disruption. There is no evidence that poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester is an endocrine disrupter, where as substances with molecular weights greater than 400 generally are not absorbed through the intact skin, and substances with molecular weights greater than 1,000 generally are not absorbed through the intact GI tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response.

C. Aggregate Exposure

1. Dietary exposure—i. Food. Poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester is not absorbed through the intact GI tract and is considered incapable of eliciting a toxic response.

ii. Drinking water. Based upon the aqueous insolubility of poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester, there is no reason to expect human exposure to residues in drinking water.

2. Non-dietary exposure. Although there may be exposures to the compound through dietary, and/or non-occupational sources, the chemical characteristics of this compound are such that there is reasonable certainty of no harm from aggregate exposure.

D. Cumulative Effects

There is no reasonable expectation of any increased risk due to cumulative exposure to poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester, since polymers with molecular weights greater than 400 generally are not absorbed through the intact skin, and substances with molecular weights greater than 1,000 generally are not absorbed through the intact GI tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response.

E. Safety Determination

1. U.S. population. Poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester causes no safety concerns because it conforms to the definition of a low risk polymer given in 40 CFR 723.250(b) and, as such, is considered incapable of eliciting a toxic response. Also, there are no additional pathways of exposure (non-occupational, drinking water, etc.) where there would be additional risk.

2. Infants and children. Poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester causes no additional concern to infants and children because it conforms to the definition of a low risk polymer given in 40 CFR 723.250(b) and, as such, is considered incapable of eliciting a toxic response. Also, there are no additional pathways of exposure (non-occupational, drinking water, etc.) where infants and children would be at additional risk.

F. International Tolerances

Huntsman is not aware of any country requiring a tolerance for poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-v-methoxy-, polymer with 2-propenoic acid, 2-methyl- and 2-propenoic acid, 2-methyl-, methyl ester, nor have there been any CODEX maximum residue levels established for any food crops at this time.

II. Huntsman Petrochemical Corporation

PP 0E6099

EPA has received a pesticide petition PP 0E6099 from Huntsman Petrochemical Corporation, 3040 Post Oak Blvd., Houston, TX 77056 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 2,5-furandione, polymer with (1-methylethenyl)benzene, sodium salt for use as a surfactant in formulations when used in accordance with good agricultural practices as an inert ingredient in pesticide formulations applied to growing crops or on the RAC after harvest. 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

Analytical method. Huntsman is petitioning that 2,5-furandione, polymer with (1-methylethenyl)benzene, sodium salt be exempt from the requirement of a tolerance based upon the definition of a low risk polymer as per 40 CFR 723.250. Therefore, an analytical method to determine residues of 2,5-furandione, polymer with (1-methylethenyl)benzene, sodium salt in RACs has not been proposed.

B. Toxicological Profile

1. Acute toxicity. In the case of certain chemical substances that are defined as “polymers,” the Agency has established a set of criteria which identifies categories of polymers that present low risk. These criteria (described in 40 CFR 723.250) identify polymers that typically are not readily absorbed and are relatively unreactive and stable compounds in comparison to other chemical substances. These properties generally limit a polymer's ability to cause adverse effects. In addition, these criteria exclude polymers about which little is known. The Agency believes that polymers meeting the criteria noted above will present minimal or no risk. 2,5-Furandione, polymer with (1-methylethenyl)benzene, sodium salt conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low risk polymers.

i. 2,5-Furandione, polymer with (1-methylethenyl)benzene, sodium salt is not a cationic polymer, nor is it capable of becoming a cationic polymer in the natural aquatic environment.

ii. 2,5-Furandione, polymer with (1-methylethenyl)benzene, sodium salt contains, as an integral part of its composition, the atomic elements carbon, hydrogen, oxygen and monovalent sodium.

iii. 2,5-Furandione, polymer with (1-methylethenyl)benzene, sodium salt does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250 (d)(2)(iii).

iv. 2,5-Furandione, polymer with (1-methylethenyl)benzene, sodium salt is not designed, nor is it reasonably anticipated to substantially degrade, decompose, or depolymerize.

v. 2,5-Furandione, polymer with (1-methylethenyl)benzene, sodium salt is not manufactured from monomers and/or other reactants that are not already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

vi. 2,5-Furandione, polymer with (1-methylethenyl)benzene, sodium salt is not a water absorbing polymer with a number average molecular weight greater than or equal to 10,000.

vii. The number average molecular weight of 2,5-furandione, polymer with (1-methylethenyl)benzene, sodium salt is 15,000. Substances with molecular weights greater than 400 generally are not absorbed through the intact skin, and substances with molecular weights greater than 1,000 generally are not absorbed through the intact GI tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response.

viii. 2,5-Furandione, polymer with (1-methylethenyl)benzene, sodium salt contains less than 0.1% oligomeric material below 1,000 molecular weight. The amount of oligomeric material less than 500 molecular weight is essentially nil.

ix. 2,5-Furandione, polymer with (1-methylethenyl)benzene, sodium salt does not contain reactive functional groups.

2. Endocrine disruption. There is no evidence that 2,5-furandione, polymer with (1-methylethenyl)benzene, sodium salt is an endocrine disrupter, where as substances with molecular weights greater than 400 generally are not absorbed through the intact skin, and substances with molecular weights greater than 1,000 generally are not absorbed through the intact GI tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response.

C. Aggregate Exposure

1. Dietary exposure—i. Food. 2,5-Furandione, polymer with (1-methylethenyl)benzene, sodium salt is not absorbed through the intact GI tract and is considered incapable of eliciting a toxic response.

ii. Drinking water. Based upon the aqueous insolubility of 2,5-furandione, polymer with (1-methylethenyl)benzene, sodium salt, there is no reason to expect human exposure to residues in drinking water.

2. Non-dietary exposure. Although there may be exposures to the 2,5-furandione, polymer with (1-methylethenyl)benzene, sodium salt through dietary, and/or non-occupational sources, the chemical characteristics of this compound are such that there is reasonable certainty of no harm from aggregate exposure.

D. Cumulative Effects

There is no reasonable expectation of any increased risk due to cumulative exposure to 2,5-furandione, polymer with (1-methylethenyl)benzene, sodium salt since polymers with molecular weights greater than 400 generally are not absorbed through the intact skin, and substances with molecular weights greater than 1,000 generally are not absorbed through the intact GI tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response.

E. Safety Determination

1. U.S. population. 2,5-Furandione, polymer with (1-methylethenyl)benzene, sodium salt causes no safety concerns because it conforms to the definition of a low risk polymer given in 40 CFR 723.250(b) and, as such, is considered incapable of eliciting a toxic response. Also, there are no additional pathways of exposure (non-occupational, drinking water, etc.) where there would be additional risk.

2. Infants and children. 2,5-Furandione, polymer with (1-methylethenyl)benzene, sodium salt causes no additional concern to infants and children because it conforms to the definition of a low risk polymer given in 40 CFR 723.250(b) and, as such, is considered incapable of eliciting a toxic response. Also, there are no additional pathways of exposure (non-occupational, drinking water, etc.) where infants and children would be at additional risk.

F. International Tolerances

Huntsman is not aware of any country requiring a tolerance for 2,5-furandione, polymer with (1-methylethenyl)benzene, sodium salt, nor have there been any CODEX maximum residue levels established for any food crops at this time.