01-11521. 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-1021, must be received on or before June 8, 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-1021 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 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” “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-1021. 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-1021 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-1021. 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: April 26,2001.

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 petitioner. 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.

Stockhausen, Inc.

PP 1E6281

EPA has received a pesticide petition (1E6281) from Stockhausen, Inc., 2401 Doyle Street, Greensboro, NC 27406 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-propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) when used as an inert ingredient as a carrier in pesticide formulations that are applied to growing crops or to raw agricultural commodities before or 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. 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 compounds compared to other chemical substances as well as polymers that typically are not readily absorbed. These properties generally limit a polymer's ability to cause adverse effects. The Agency believes that polymers meeting the criteria noted above will present minimal or no risk. 2-Propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) conforms to the definition of polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low risk polymers.

1. 2-Propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) is not a cationic polymer, nor is it reasonably anticipated to become a cationic polymer in the natural aquatic environment.

2. 2-Propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) contains as an integral part of its composition the atomic elements carbon, hydrogen and oxygen.

3. 2-Propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) 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)(ii).

4. 2-Propenoic acid, sodium salt, polymer with 2-propenamide(acrylamide-sodium acrylate copolymer) is not reasonably anticipated to substantially degrade, decompose or depolymerize.

5. 2-Propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) is not manufactured or imported 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.

6. 2-Propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) is not a water absorbing polymer with a number average molecular weight greater than or equal to 10,0000 daltons.

7. 2-Propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) has an average molecular weight of 18,000 daltons. 2-Propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) meets the requirements for molecular weight distribution of oligomer contents of less than 5% with molecular weights less than 1,000 and less than 2% with molecular weights less than 500.

B. Aggregate Exposure

Dietary exposure. For the purposes of assessing potential exposure under this exemption, it is considered that 2-propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average molecular weight of 2-propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) is 18,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) conforms to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. Since there is a reasonable certainty that no harm will result from aggregate exposure to 2-propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer), a tolerance is not necessary.

C. Cumulative Effects

There are no data to support cumulative risk from 2-propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) 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 gastrointestinal tract (GI). Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response. Therefore, there is no reasonable expectation of risk due to cumulative exposure.

D. Safety Determination

1. U.S. population. 2-Propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) 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 could be additional risk.

2. Infants and children. 2-Propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) 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.

E. International Tolerances

There are no CODEX Maximum Residue Limits established for 2-propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) in/on any crop commodities at this time.

PP 1E6282

EPA has received a pesticide petition (1E6282) from Stockhausen, Inc., 2401 Doyle Street, Greensboro, NC 27406 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-propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) when used as an inert ingredient as a carrier in pesticide formulations that are applied to growing crops or to raw agricultural commodities before or 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. 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 compounds compared to other chemical substances as well as polymers that typically are not readily absorbed. These properties generally limit a polymer's ability to cause adverse effects. The Agency believes that polymers meeting the criteria noted above will present minimal or no risk. 2-Propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) conforms to the definition of polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low risk polymers.

1. 2-Propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) is not a cationic polymer, nor is it reasonably anticipated to become a cationic polymer in the natural aquatic environment.

2. 2-Propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) contains as an integral part of its composition the atomic elements carbon, hydrogen and oxygen.

3. 2-Propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) 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)(ii).

4. 2-Propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) is not reasonably anticipated to substantially degrade, decompose or depolymerize.

5. 2-Propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) is not manufactured or imported 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.

6. 2-Propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide- sodium acrylate copolymer) is not a water absorbing polymer with a number average molecular weight greater than or equal to 10,0000 daltons.

7. 2-Propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) has an average molecular weight of 18,000 daltons. 2-Propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) meets the requirements for molecular weight distribution of oligomer contents of less than 5% with molecular weights less than 1,000 and less than 2% with molecular weights less than 500.

B. Aggregate Exposure

1. Dietary exposure. For the purposes of assessing potential exposure under this exemption, it is considered that 2-propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average molecular weight of 2-propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) is 18,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) conforms to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. Since there is a reasonable certainty that no harm will result from aggregate exposure to 2-propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer), a tolerance is not necessary.

C. Cumulative Effects

There are no data to support cumulative risk from 2-propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) 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 gastrointestinal tract (GI). Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response. Therefore, there is no reasonable expectation of risk due to cumulative exposure.

D. Safety Determination

1. U.S. population. 2-Propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) 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 could be additional risk.

2. Infants and children. 2-Propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) 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.

E. International Tolerances

There are no CODEX Maximum Residue Limits established for 2-propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) in/on any crop commodities at this time.