Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food

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:

------------------------------------------------------------------------ Examples of Categories NAICS 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 in the ``FOR FURTHER INFORMATION CONTACT'' section.

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 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 www.epa.gov/fedrgstr/. 2. In person. The Agency has established an official record for this action under docket control number PF-887. 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 (703) 305-5805.

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-887 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, 401 M St., SW., 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 (703) 305-5805. 3. Electronically. You may submit your comments electronically by E-mail to: ``opp-docket@epa.gov,'' 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 5.1/ 6.1 or ASCII file format. All comments in electronic form must be identified by docket control number PF-887. 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 in the ``FOR FURTHER INFORMATION CONTACT'' section.

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 Cosmestic 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 supports granting of the petitions. Additional data may be needed before EPA rules on the petitions.

List of Subjects

Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: August 17, 1999.

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 petitioners 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.

1. Cabot Corporation

PP 9E6017

EPA has received a pesticide petition (PP 9E6017) from Cabot Corporation, 75 State Street, Boston, MA 02109 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 dimethyl silicone polymer with silica (TS-720) when used in accordance with good agricultural practices as an inert ingredient in pesticide formulations applied to growing crops in or on the raw agricultural commodity after harvest or 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

No residue chemistry data are presented in the petition as the Agency does not generally require these data to rule on the exemption from the requirement of a tolerance for an 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 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. Cabot Corporation believes that TS-720 conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria used to identify a low risk polymer. 1. TS-720 is not a cationic polymer, nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. TS-720 contains as an integral part of its composition the atomic elements carbon, silicon, hydrogen and oxygen. 3. TS-720 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. TS-720 is not designed, nor is it reasonably anticipated to substantially degrade, decompose or depolymerize prior to, during, or after use. 5. TS-720 is not manufactured or imported from monomers and/or reactants that are not included on the Toxic Substances Control Act (TSCA) substance inventory or manufactured under an applicable TSCA section 5 exemption. 6. TS-720 is not a water absorbing polymer with a number average molecular weight greater than or equal to 10,000. 7. TS-720 has an minimum-average molecular weight of 1,100,000 daltons. 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 gastrointestinal (GI) tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response. 8. TS-720 has a minimum-average molecular weight of 1,100,000 daltons. TS-720 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. Attached is a description of the molecular weight determination of TS-720. Cabot Corporation believes that sufficient information has been submitted to assess the hazards of TS-720. No toxicology data are being submitted as the Agency does not generally require these data to rule on the exemption from the requirement of a tolerance for an inert ingredient. Because TS-720 conforms with the definition of a polymer and meets the criteria of a polymer under 40 CFR 723.250, Cabot Corporation believes there are no concerns for risks associated with toxicity.

C. Aggregate Exposure

1. Dietary exposure. TS-720 is not absorbed through the intact gastrointestinal tract and is incapable of eliciting a toxic response. 2. Drinking water. TS-720 is not soluble in water and therefore there is no reason to expect human exposure to residues in water. 3. Non-dietary exposure. For most uses of TS-720 the primary route of exposure is dermal. TS-720, with a molecular weight significantly greater than 400, is not absorbed through the intact skin.

D. Cumulative Effects

Cabot Corporation believes that sufficient information has been submitted to assess the hazards of TS-720. Because TS-720 conforms with the definition of a polymer and meets the criteria of a polymer under 40 CFR 723.250, Cabot Corporation believes there are no concerns for risks associated with cumulative effects.

E. Safety Determination

1. U.S. population. Cabot Corporation believes that sufficient information has been submitted to assess the hazards of TS-720. Because TS-720 conforms with the definition of a polymer and meets the criteria of a polymer under 40 CFR 723.250, Cabot Corporation believes there are no concerns for risks associated with any potential exposure to adults. 2. Infants and children. Cabot Corporation believes that sufficient information has been submitted to assess the hazards of TS-720. Because TS-720 conforms with the definition of a polymer and meets the criteria of a polymer under 40 CFR 723.250, Cabot Corporation believes there are no concerns for risks associated with exposure to infants and children.

2. Cabot Corporation

PP 9E6018

EPA has received a pesticide petition (PP 9E6018) from Cabot Corporation, proposing, pursuant to section 408(d) of 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for silane, dichloromethyl-, reaction product with silica (TS-610) when used in accordance with good agricultural practices as an inert ingredient in pesticide formulations applied to growing crops in or on the raw agricultural commodity after harvest or 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

No residue chemistry data are presented in the petition as the Agency does not generally require these data to rule on the exemption from the requirement of a tolerance for an 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 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. Cabot Corporation believes that TS-610 conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria used to identify a low risk polymer. 1. TS-610 is not a cationic polymer, nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. TS-610 contains as an integral part of its composition the atomic elements carbon, silicon, hydrogen and oxygen. 3. TS-610 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. TS-610 is not designed, nor is it reasonably anticipated to substantially degrade, decompose or depolymerize prior to, during, or after use. 5. TS-610 is not manufactured or imported from monomers and/or reactants that are not included on the TSCA substance inventory or manufactured under an applicable TSCA section 5 exemption. 6. TS-610 is not a water absorbing polymer with a number average molecular weight greater than or equal to 10,000. 7. TS-610 has an minimum-average molecular weight of 3,340,000 daltons. 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 gastrointestinal (GI) tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response. 8. TS-610 has a minimum-average molecular weight of 3,340,000 daltons. TS-610 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. Cabot Corporation believes that sufficient information has been submitted to assess the hazards of TS-610. No toxicology data are being submitted as the Agency does not generally require these data to rule on the exemption from the requirement of a tolerance for an inert ingredient. Because TS-610 conforms with the definition of a polymer and meets the criteria of a polymer under 40 CFR 723.250, Cabot Corporation believes there are no concerns for risks associated with toxicity.

C. Aggregate Exposure

1. Dietary exposure. TS-610 is not absorbed through the intact GI tract and is incapable of eliciting a toxic response. 2. Drinking water. TS-610 is not soluble in water and therefore there is no reason to expect human exposure to residues in water. 3. Non-dietary exposure. For most uses of TS-610 the primary route of exposure is dermal. TS-610, with a molecular weight significantly greater than 400, is not absorbed through the intact skin.

D. Cumulative Effects

Cabot Corporation believes that sufficient information has been submitted to assess the hazards of TS-610. Because TS-610 conforms with the definition of a polymer and meets the criteria of a polymer under 40 CFR 723.250, Cabot Corporation believes there are no concerns for risks associated with cumulative effects.

E. Safety Determination

1. U.S. population. Cabot Corporation believes that sufficient information has been submitted to assess the hazards of TS-610. Because TS-610 conforms with the definition of a polymer and meets the criteria of a polymer under 40 CFR 723.250, Cabot Corporation believes there are no concerns for risks associated with any potential exposure to adults. 2. Infants and children. Cabot Corporation believes that sufficient information has been submitted to assess the hazards of TS-610. Because TS-610 conforms with the definition of a polymer and meets the criteria of a polymer under 40 CFR 723.250, Cabot Corporation believes there are no concerns for risks associated with exposure to infants and children.

3. Cabot Corporation

PP 9E6019

EPA has received a pesticide petition PP 9E6019 from Cabot Corporation, proposing, pursuant to section 408(d) of 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for hexamethyldisilizane, reaction product with silica (TS-530) when used in accordance with good agricultural practices as an inert ingredient in pesticide formulations applied to growing crops in or on the raw agricultural commodity after harvest or 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

No residue chemistry data are presented in the petition as the Agency does not generally require these data to rule on the exemption from the requirement of a tolerance for an 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 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. Cabot Corporation believes that TS-530 conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria used to identify a low risk polymer. 1. TS-530 is not a cationic polymer, nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. TS-530 contains as an integral part of its composition the atomic elements carbon, silicon, hydrogen and oxygen. 3. TS-530 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). 4. TS-530 is not designed, nor is it reasonably anticipated to substantially

degrade, decompose or depolymerize prior to, during, or after use. 5. TS-530 is not manufactured or imported from monomers and/or reactants that are not included on the TSCA substance inventory or manufactured under an applicable TSCA section 5 exemption. 6. TS-530 is not a water absorbing polymer with a number average molecular weight greater than or equal to 10,000. 7. TS-530 has an minimum-average molecular weight of 645,000 daltons. 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. 8. TS-530 has a minimum-average molecular weight of 645,000 daltons. TS-530 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. Attached is a description of the molecular weight determination of TS-530. Cabot Corporation believes that sufficient information has been submitted to assess the hazards of TS-530. No toxicology data are being submitted as the Agency does not generally require these data to rule on the exemption from the requirement of a tolerance for an inert ingredient. Because TS-530 conforms with the definition of a polymer and meets the criteria of a polymer under 40 CFR 723.250, Cabot Corporation believes there are no concerns for risks associated with toxicity.

C. Aggregate Exposure

1. Dietary exposure. TS-530 is not absorbed through the intact GI tract and is incapable of eliciting a toxic response. 2. Drinking water. TS-530 is not soluble in water and therefore there is no reason to expect human exposure to residues in water. 3. Non-dietary exposure. For most uses of TS-530 the primary route of exposure is dermal. TS-530 with a molecular weight significantly greater than 400 is not absorbed through the intact skin.

D. Cumulative Effects

Cabot Corporation believes that sufficient information has been submitted to assess the hazards of TS-530. Because TS-530 conforms with the definition of a polymer and meets the criteria of a polymer under 40 CFR 723.250, Cabot Corporation believes there are no concerns for risks associated with cumulative effects.

E. Safety Determination

1. U.S. population. Cabot Corporation believes that sufficient information has been submitted to assess the hazards of TS-530. Because TS-530 conforms with the definition of a polymer and meets the criteria of a polymer under 40 CFR 723.250, Cabot Corporation believes there are no concerns for risks associated with any potential exposure to adults. 2. Infants and children. Cabot Corporation believes that sufficient information has been submitted to assess the hazards of TS-530. Because TS-530 conforms with the definition of a polymer and meets the criteria of a polymer under 40 CFR 723.250, Cabot Corporation believes there are no concerns for risks associated with exposure to infants and children.

[FR Doc. 99-22049 Filed 8-24-99; 8:45 am] BILLING CODE 6560-50-F