01-15296. Notice of Filing Pesticide Petitions to Establish a Tolerance 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-1026, must be received on or before July 20, 2001.

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-1026 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Treva C. 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 adress: [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” “Regulation 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 control number PF-1026. 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-1026 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-1026. 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 Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these 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 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 20, 2001.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

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 represent the views of the petitioners. EPA is publishing the petition summaries verbatim without editing them 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.

Uniqema

PP 1E6293

EPA has received a pesticide petition (1E6293) from Uniqema, 900 Uniqema Blvd, New Castle, DE 19720 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 modified acrylic polymers when used as an inert ingredient in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, or in pesticide formulations applied to animals. 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

Uniqema is petitioning that modified acrylic polymers be exempt from the requirement of a tolerance based upon their compliance with the low risk polymer criteria per 40 CFR 723.250. Therefore, an analytical method to determine residues in raw agricultural commodities has not been proposed. No residue chemistry data or environmental fate data are presented in the petition as the Agency does not generally require some or all of the listed studies to rule on the exemption from the requirement of a tolerance for a low risk polymer inert ingredient.

B. Toxicological Profile

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 relatively unreactive and stable compared to other chemical substances as well as polymers that typically are not readily absorbed. Uniqema believes that modified acrylic polymers conform to the definition of a polymer given in 40 CFR 723.250 and meet the criteria used to identify a low risk polymer. Uniqema also believes that based on these polymers, conformance to the above-mentioned criteria, no mammalian toxicity is anticipated from dietary, inhalation or dermal exposure to polymers and that these polymers will present minimal or no risk.

1. These polymers are not cationic polymers.

2. They contain as an integral part of their composition the atomic elements carbon, hydrogen, and oxygen.

3. They do not contain as an integral part of their composition, except as impurities, any elements other than those listed in 40 CFR 723.250(d)(2)(ii).

4. These polymers are not designed or reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. These polymers are not manufactured or imported from monomers and/or other reactants that are not already on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. They are not water absorbing polymers.

7. The minimum average molecular weight of the above-mentioned polymers is greater than 1,000. Substances with molecular weights greater than 400 are generally not readily absorbed through the intact skin, and substances with molecular weights greater than 1,000 are generally not absorbed through the intact gastrointestinal (GI) tract. Chemicals not absorbed through the GI tract are generally incapable of eliciting a toxic response. These polymers have an oligomer content less than 10% below molecular weight 500 and less than 25% molecular weight 1,000.

Uniqema believes sufficient information was submitted in the petition to assess the hazards of modified acrylic polymers. No toxicology data were presented in the petition as the Agency does not generally require that polymers conform to 40 CFR 723.250. Based on these polymers conforming to the definition of a polymer and meeting the criteria of a low risk polymer under 40 CFR 723.250, Uniqema believes there are no concerns for risks associated with toxicity.

8. Endocrine disrupter. There is no evidence that modified acrylic polymers are endocrine disrupters. 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 GI tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response.

The Agency at this time has not determined whether or not it will require information on the endocrine effects of this substance. Congress has allowed 3 years after August 3, 1996, for the Agency to implement a screening program with respect to endocrine effects.

C. Aggregate Exposure

1. Dietary exposure. Some modified acrylic polymers may be used in contact with food as components of containers used to manufacture, process, or store food when regulated for such use under the Federal Food, Drug, and Cosmetic Act. Modified acrylic polymers with a molecular weight greater than 1,000 daltons are not readily absorbed through the intact GI tract and are considered incapable of eliciting a toxic response.

2. Non-dietary exposure. Typical uses of modified acrylic polymers are in the paints & coatings and adhesives industries. In these uses the primary exposures are dermal, however; modified acrylic polymers with a molecular weight significantly greater than 400 are not readily absorbed through the intact skin and are considered incapable of eliciting a toxic response.

D. Cumulative Effects

There are data to support a conclusion of negligible cumulative risk for modified acrylic polymers. 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. Therefore, there is no reasonable expectation of increased risk due to cumulative exposure. Based on these polymers conforming to the definition of a polymer and meeting the criteria of a low risk polymer under 40 CFR 723.250, Uniqema believes there are no concerns for risks associated with cumulative effects.

Uniqema

PP 1E6294

EPA has received a pesticide petition (1E6294) from Uniqema, 900 Uniqema Blvd, New Castle, DE 19720 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 vinyl acetate polymers when used as an inert ingredient in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, or in pesticide formulations applied to animals. 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

Uniqema is petitioning that vinyl acetate polymers be exempt from the requirement of a tolerance based upon their compliance with the low risk polymer criteria per 40 CFR 723.250. Therefore, an analytical method to determine residues in raw agricultural commodities has not been proposed. No residue chemistry data or environmental fate data are presented in the petition as the Agency does not generally require some or all of the listed studies to rule on the exemption from the requirement of a tolerance for a low risk polymer inert ingredient.

B. Toxicological Profile

Acute toxicity. 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 relatively unreactive and stable compared to other chemical substances as well as polymers that typically are not readily absorbed. Uniqema believes that vinyl acetate polymers conform to the definition of a polymer given in 40 CFR 723.250 and meet the criteria used to identify a low risk polymer. Uniqema also believes that based on these polymers, conformance to the above-mentioned criteria, no mammalian toxicity is anticipated from dietary, inhalation or dermal exposure to polymers and that these polymers will present minimal or no risk.

1. These polymers are not cationic polymers.

2. They contain as an integral part of their composition the atomic elements carbon, hydrogen, and oxygen.

3. They do not contain as an integral part of their composition, except as impurities, any elements other than those listed in 40 CFR 723.250(d)(2)(ii).

4. These polymer are not designed or reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. These polymers are not manufactured or imported from monomers and/or other reactants that are not already on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. They are not water absorbing polymers.

7. The minimum average molecular weight of the above-mentioned polymers are greater than 1,000. Substances with molecular weights greater than 400 are generally not readily absorbed through the intact skin, and substances with molecular weights greater than 1,000 are generally not absorbed through the intact GI tract. Chemicals not absorbed through the GI tract are generally incapable of eliciting a toxic response. These polymers have an oligomer content less than 10% below molecular weight 500 and less than 25% molecular weight 1,000.

Uniqema believes sufficient information was submitted in the petition to assess the hazards of vinyl acetate polymers. No toxicology data were presented in the petition as the Agency does not generally require that polymers conform to 40 CFR 723.250. Based on these polymers conforming to the definition of a polymer and meeting the criteria of a low risk polymer under 40 CFR 723.250, Uniqema believes there are no concerns for risks associated with toxicity.

There is no evidence that vinyl acetate polymers are endocrine disrupters. 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.

The Agency at this time has not determined whether it will require information on the endocrine effects of this substance. Congress has allowed 3 years after August 3, 1996, for the Agency to implement a screening program with respect to endocrine effects.

C. Aggregate Exposure

1. Dietary exposure. Some vinyl acetate polymers may be used in contact with food as components of containers used to manufacture, process, or store food when regulated for such use under the Federal Food, Drug, and Cosmetic Act. Vinyl acetate polymers with a molecular weight greater than 1,000 daltons are not readily absorbed through the intact GI tract and are considered incapable of eliciting a toxic response.

2. Non-dietary exposure. Typical uses of vinyl acetate polymers are in the paints & coatings and adhesives industries. In these uses the primary exposures are dermal, however; vinyl acetate polymers with a molecular weight significantly greater than 400 are not readily absorbed through the intact skin and are considered incapable of eliciting a toxic response.

D. Cumulative Effects

There are data to support a conclusion of negligible cumulative risk for vinyl acetate polymers. 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. Therefore, there is no reasonable expectation of increased risk due to cumulative exposure. Based on these polymers conforming to the definition of a polymer and meeting the criteria of a low risk polymer under 40 CFR 723.250, Uniqema believes there are no concerns for risks associated with cumulative effects.