[Federal Register Volume 64, Number 51 (Wednesday, March 17, 1999)]
[Notices]
[Pages 13192-13195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6184]



[[Page 13192]]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-864; FRL-6066-7]


ICI Surfactants; Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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 the docket control number PF-864, must 
be received on or before April 16, 1999.
ADDRESSES: By mail submit written comments to: Information and Records 
Integrity Branch, Public Information and Services Divison (7502C), 
Office of Pesticides Programs, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. In person bring comments to: Rm. 119, 
CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by following 
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential 
business information should be submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. A copy of the comment that does not contain CBI must be submitted 
for inclusion in the public record. Information not marked confidential 
may be disclosed publicly by EPA without prior notice. All written 
comments will be available for public inspection in Rm. 119 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Support 
Branch, Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW, Washington, DC 20460. 
Office location, telephone number, and e-mail address: Rm. 707A, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, 
(703) 308-8380; e-mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as 
follows proposing the establishment and/or amendment of regulations for 
residues of certain pesticide chemical 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 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 supports 
granting of the petition. Additional data may be needed before EPA 
rules on the petition.
    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number [PF-864] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1/6.1 file format or 
ASCII file format. All comments and data in electronic form must be 
identified by the docket control number [PF-864] and appropriate 
petition number. Electronic comments on this notice may be filed online 
at many Federal Depository Libraries.

List of Subjects

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

    Dated: March 3, 1999.

Peter Caulkins, 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 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.

1. ICI Surfactants

PP 6E4987

    EPA has received a pesticide petition (PP 6E4987) from ICI 
Surfactants, 3411 Silverside Road, Wilmington, DE 19803-8340, proposing 
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act, 
21 U.S.C. 346a(d), to amend 40 CFR 180.1001(c), and (e) to establish an 
exemption from the requirement of a tolerance for methyl methacrylate-
methacrylic acid-monomethoxypolyethylene glycol methacrylate copolymer 
when used as an inert ingredient in pesticide formulations applied to 
growing crops or to raw agricultural commodities 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

     Magnitude of residues. 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 an inert ingredient.

B. Toxicological Profile

    1. 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. ICI 
believes that methyl methacrylate-methacrylic acid-
monomethoxypolyethylene glycol methacrylate copolymer conforms to the 
definition of a polymer given in 40 CFR 723.250 and meet the criteria 
used to identify a low risk polymer. We also believe that based on this 
substance conformance to the above mentioned criteria, no mammalian 
toxicity is anticipated from dietary, inhalation or

[[Page 13193]]

dermal exposure to methyl methacrylate-methacrylic acid-
monomethoxypolyethylene glycol methacrylate copolymer and that methyl 
methacrylate-methacrylic acid-monomethoxypolyethylene glycol 
methacrylate copolymer will present minimal or no risk.
    i. This polymer is not a cationic substance.
    ii. It contains as an integral part of it's composition the atomic 
elements carbon, hydrogen, and oxygen.
    iii. It does not contain as an integral part of it's composition, 
except as impurities, any elements other than those listed in 40 CFR 
723.250(d)(2)(ii).
    iv. This polymer is not designed or reasonably anticipated to 
substantially degrade, decompose, or depolymerize.
    v. It is 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.
    vi. It is not a water absorbing polymer.
    vii. The minimum average molecular weight of the above mentioned 
polymer 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.
    viii. This polymer has an oligomer content less than 10% below MW 
500, and less than 25% MW 1,000. ICI believes sufficient information 
was submitted in the petition to assess the hazards of methyl 
methacrylate-methacrylic acid-monomethoxypolyethylene glycol 
methacrylate copolymer. No toxicology data were 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 an inert ingredient. Based on this polymer conforming to 
the definition of a polymer and meeting the criteria of a polymer under 
40 CFR 723.250 ICI believes there are no concerns for risks associated 
with toxicity.
    2. Endocrine disruption. ICI has no information to suggest that 
methacrylate-methacrylic acid-monomethoxypolyethylene glycol 
methacrylate copolymer will have an effect on the immune and endocrine 
systems. EPA is not requiring information on the endocrine effects of 
this substance at this time; Congress has allowed 3 years after August 
3, 1996, for the Agency to implement a screening program with respect 
to endocrine effects.

C. Cumulative Effects

    ICI believes sufficient information was submitted in the petition 
to assess the hazards of methacrylate-methacrylic acid-
monomethoxypolyethylene glycol methacrylate copolymer. Based on this 
polymer confirming to the definition of a polymer and meeting the 
criteria of a polymer under 40 CFR 723.250 ICI believes there are no 
concerns for risks associated with cumulative effects.

D. Safety Determination

    1. U.S. population. ICI believes sufficient information was 
submitted in the petition to assess the hazards of methacrylate-
methacrylic - acid-monomethoxypolyethylene glycol methacrylate 
copolymer. Based on this polymer conforming to the definition of a 
polymer and meeting the criteria of a polymer under 40 CFR 723.250, ICI 
believes there are no concerns for risks associated with any potential 
exposure to adults.
    2. Infants and children. ICI believes sufficient information was 
submitted in the petition to assess the hazards of methacrylate-
methacrylic - acid-monomethoxypolyethylene glycol methacrylate 
copolymer. Based on this polymer conforming to the definition of a 
polymer and meeting the criteria of a polymer under 40 CFR 723.250, ICI 
believes there are no concerns for risks associated with any potential 
exposure to infants and children.

2. ICI Surfactants

PP 8E4988

    EPA has received a pesticide petition (PP 8E4988) from ICI 
Surfactants, 3411 Silverside Road, Wilmington, DE 19803-8340, proposing 
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act, 
21 U.S.C. 346a(d), to amend 40 CFR 180.1001(c) and (e) to establish an 
exemption from the requirement of a tolerance for 12-hydroxystearic 
acid-polyethylene glycol copolymer (CAS Reg. No. 70142-34-6) when used 
as an inert ingredient in pesticide formulations applied to growing 
crops or to raw agricultural commodities 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

     Magnitude of residues. 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 an inert ingredient.

B. Toxicological Profile

    1. 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. ICI 
believes that 12-hydroxystearic acid-polyethylene glycol copolymer (CAS 
Reg. No. 70142-34-6) conforms to the definition of a polymer given in 
40 CFR 723.250 and meet the criteria used to identify a low risk 
polymer. We also believe that based on this substances conformance to 
the above mentioned criteria, no mammalian toxicity is anticipated from 
dietary, inhalation or dermal exposure to 12-hydroxystearic acid-
polyethylene glycol copolymer and that 12-hydroxystearic acid-
polyethylene glycol copolymer will present minimal or no risk.
    i. This polymer is not a cationic substance.
    ii. It contains as an integral part of it's composition the atomic 
elements carbon, hydrogen, and oxygen.
    iii. It does not contain as an integral part of it's composition, 
except as impurities, any elements other than those listed in 40 CFR 
723.250 (d)(2)(ii).
    iv. This polymer is not designed or reasonably anticipated to 
substantially degrade, decompose, or depolymerize.
    v. It is 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.
    vi. It is not a water absorbing polymer.
    vii. The minimum average molecular weight of the above mentioned 
polymer 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.
    viii. This polymer has an oligomer content less than 10% below MW 
500, and less than 25% MW 1,000. ICI

[[Page 13194]]

believes sufficient information was submitted in the petition to assess 
the hazards of 12-hydroxystearic acid-polyethylene glycol copolymer 
(CAS Reg. No. 70142-34-6). No toxicology data were 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 an inert ingredient. Based on this polymer conforming to 
the definition of a polymer and meeting the criteria of a polymer under 
40 CFR 723.250 ICI believes there are no concerns for risks associated 
with toxicity.
    2. Endocrine disruption. ICI has no information to suggest that 12-
hydroxystearic acid-polyethylene glycol copolymer (CAS Reg. No. 70142-
34-6) will have an effect on the immune and endocrine systems. EPA is 
not requiring information on the endocrine effects of this substance at 
this time; Congress has allowed 3 years after August 3, 1996, for the 
Agency to implement a screening program with respect to endocrine 
effects.

C. Cumulative Effects

    ICI believes sufficient information was submitted in the petition 
to assess the hazards of 12-hydroxystearic acid-polyethylene glycol 
copolymer (CAS Reg. No. 70142-34-6). Based on this polymer conforming 
to the definition of a polymer and meeting the criteria of a polymer 
under 40 CFR 723.250 ICI believes there are no concerns for risks 
associated with cumulative effects.

D. Safety Determination

    1. U.S. population. ICI believes sufficient information was 
submitted in the petition to assess the hazards of 12-hydroxystearic 
acid-polyethylene glycol copolymer (CAS Reg. No. 70142-34-6). Based on 
this polymer conforming to the definition of a polymer and meeting the 
criteria of a polymer under 40 CFR 723.250 ICI believes there are no 
concerns for risks associated with any potential exposure to adults.
    2. Infants and children. ICI believes sufficient information was 
submitted in the petition to assess the hazards of 12-hydroxystearic 
acid-polyethylene glycol copolymer (CAS Reg. No. 70142-34-6). Based on 
this polymer conforming to the definition of a polymer and meeting the 
criteria of a polymer under 40 CFR 723.250 ICI believes there are no 
concerns for risks associated with any potential exposure to infants 
and children.

3. ICI Surfactants

PP 8E4989

    EPA has received a pesticide petition (PP 8E4989) from ICI 
Surfactants, 3411 Silverside Road, Wilmington, DE 19803-8340, proposing 
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act, 
21 U.S.C. 346a(d), to amend 40 CFR 180.1001(c), and (e) to establish an 
exemption from the requirement of a tolerance for polyethylene glycol-
polyisobutenyl anhydride-tall oil fatty acid copolymer when used as an 
inert ingredient in pesticide formulations applied to growing crops or 
to raw agricultural commodities 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

     Magnitude of residues. 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 an inert ingredient.

B. Toxicological Profile

    1. 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. ICI 
believes that polyethylene glycol-polyisobutenyl anhydride-tall oil 
fatty acid copolymer conforms to the definition of a polymer given in 
40 CFR 723.250 and meet the criteria used to identify a low risk 
polymer. We also believe that based on this substances conformance to 
the above mentioned criteria, no mammalian toxicity is anticipated from 
dietary, inhalation or dermal exposure to polyethylene glycol-
polyisobutenyl anhydride-tall oil fatty acid copolymer and that 
polyethylene glycol-polyisobutenyl anhydride-tall oil fatty acid 
copolymer will present minimal or no risk.
    i. This polymer is not a cationic substance.
    ii. It contains as an integral part of it's composition the atomic 
elements carbon, hydrogen, and oxygen.
    iii. It does not contain as an integral part of it's composition, 
except as impurities, any elements other than those listed in 40 CFR 
723.250(d)(2)(ii).
    iv. This polymer is not designed or reasonably anticipated to 
substantially degrade, decompose, or depolymerize.
    v. It is 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.
    vi. It is not a water absorbing polymer.
    vii. The minimum average molecular weight of the above mentioned 
polymer 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.
    viii. This polymer has an oligomer content less than 10% below MW 
500, and less than 25% MW 1,000. ICI believes sufficient information 
was submitted in the petition to assess the hazards of polyethylene 
glycol-polyisobutenyl anhydride-tall oil fatty acid copolymer. No 
toxicology data were 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 an inert ingredient. 
Based on this polymer conforming to the definition of a polymer and 
meeting the criteria of a polymer under 40 CFR 723.250 ICI believes 
there are no concerns for risks associated with toxicity.
    2. Endocrine disruption. ICI has no information to suggest that 
polyethylene glycol-polyisobutenyl anhydride-tall oil fatty acid 
copolymer will have an effect on the immune and endocrine systems. EPA 
is not requiring information on the endocrine effects of this substance 
at this time; Congress has allowed 3 years after August 3, 1996, for 
the Agency to implement a screening program with respect to endocrine 
effects.

C. Cumulative Effects

    ICI believes sufficient information was submitted in the petition 
to assess the hazards of polyethylene glycol-polyisobutenyl anhydride-
tall oil fatty acid copolymer. Based on this polymer conforming to the 
definition of a polymer and meeting the criteria of a polymer under 40 
CFR 723.250 ICI believes there are no concerns for risks associated 
with cumulative effects.

[[Page 13195]]

D. Safety Determination

    1. U.S. population. ICI believes sufficient information was 
submitted in the petition to assess the hazards of polyethylene glycol-
polyisobutenyl anhydride-tall oil fatty acid copolymer. Based on this 
polymer conforming to the definition of a polymer and meeting the 
criteria of a polymer under 40 CFR 723.250 ICI believes there are no 
concerns for risks associated with any potential exposure to adults.
    2. Infants and children. ICI believes sufficient information was 
submitted in the petition to assess the hazards of polyethylene glycol-
polyisobutenyl anhydride-tall oil fatty acid copolymer. Based on this 
polymer conforming to the definition of a polymer and meeting the 
criteria of a polymer under 40 CFR 723.250 ICI believes there are no 
concerns for risks associated with any potential exposure to infants 
and children.
[FR Doc. 99-6184 Filed 3-16-99; 8:45 am]
BILLING CODE 6560-50-F