[Federal Register Volume 66, Number 212 (Thursday, November 1, 2001)]
[Notices]
[Pages 55178-55180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27470]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1049; FRL-6807-7]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number PF-1049, must be 
received on or before December 3, 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-1049 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: (703) 308-8373; e-mail address: 
[email protected].

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:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS code          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 homepage at http://www.epa.gov/. 
To access this document, on the homepage 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-1049. 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-1049 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

[[Page 55179]]

(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 (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], 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-1049. 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 a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical 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 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 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: October 18, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs. 
Programs.

 Summary of Petition

     The petitioner's 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 view of the 
petitioners. EPA is publishing the petition summary verbatim without 
editing it 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.

Wacker Silicones Corporation

5E4595

     EPA has received a pesticide petition (5E4595) from Wacker 
Silicones Corporation, 3301 Sutton Road, Adrian, MI 49221-9397 
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 tetraethoxysilane polymer with hexamethyldisiloxane 
(CAS No. 104133-09-7), when used as an inert ingredient in pesticide 
formulations applied in accordance with good agricultural practice to 
growing crops and to raw agricultural commodities after harvest, and 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.
    In the case of certain substances that are defined as ``polymers,'' 
the Agency has established a set of criteria that identify categories 
of polymers that present low risk. These criteria described in 40 CFR 
723.250 identify polymers that are relatively unreactive and stable 
compounds to other chemical substances was well as polymers that 
typically are not readily absorbed. 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 will present minimal or no risk. 
Tetraethoxysilane, polymer with hexamethyldisiloxane conforms to the 
definition of polymer given in 40 CFR 723.250(b) (as amended April 11, 
1997) and meets the following criteria that are used to identify low 
risk polymers.
    1. Tetraethoxysilane, polymer with hexamethyldisiloxane is not a 
cationic polymer, nor is it reasonably anticipated to become a cationic 
polymer in the natural aquatic environment.
    2. Tetraethoxysilane, polymer with hexamethyldisiloxane contains as 
an integral part of its composition the atomic elements carbon, 
hydrogen, oxygen and silicon.
    3. Tetraethoxysilane, polymer with hexamethyldisiloxane 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. Tetraethoxysilane, polymer with hexamethyldisiloxane is not 
reasonably

[[Page 55180]]

anticipated to substantially degrade, decompose or depolymerize.
    5. Tetraethoxysilane, polymer with hexamethyldisiloxane 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. Tetraethoxysilane, polymer with hexamethyldisiloxane is not a 
water absorbing polymer with a number average molecular weight (MW) 
10,000 or greater. Tetraethoxysilane, polymer with hexamethyldisiloxane 
also meets the exemption criteria of 40 CFR 723.250(e)(1) (as amended 
April 11, 1997). Tetraethoxysilane, polymer with hexamethyldisiloxane 
has a number average MW greater than or equal to 1,000 and less than 
10,000 daltons (and oligomer content less than 10% below MW 500 and 
less than 25% below MW 1,000).

A. Aggregate Exposure

    1. Dietary exposure. Tetraethoxysilane, polymer with 
hexamethyldisiloxane is not absorbed through the skin or 
gastrointestinal (GI) tract and is generally considered incapable of 
eliciting a toxic response.
    i. Food. There are no food or food additive uses of 
tetraethoxysilane, polymer with hexamethyldisiloxane currently approved 
under 40 CFR. There are currently approved indirect food contact uses 
for tetraethoxysilane, polymer with hexamethyldisiloxane under 21 CFR 
175.300, 175.320, and 176.170.
    ii. Drinking water. Tetraethoxysilane, polymer with 
hexamethyldisiloxane is not absorbed through the skin or GI tract and 
is generally considered incapable of eliciting a toxic response.
    2. Non-dietary exposure. There are no exposures to 
tetraethoxysilane, polymer with hexamethyldisiloxane through non-
occupational, non-dietary routes.

B. Cumulative Effects

     There are no data to support cumulative risk from 
tetraethoxysilane, polymer with hexamethyldisiloxane since polymers 
with MWs greater than 400 generally are not absorbed through the intact 
skin and substances with MWs 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. 
Therefore, there is no reasonable expectation of risk due to cumulative 
exposure.

C. Safety Determination

    1. U.S. population. Tetraethoxysilane, polymer with 
hexamethyldisiloxane causes no safety concerns because it conforms to 
the definition of a low risk polymer given in 40 CFR 723.250(e)(1) and 
as such is considered incapable of eliciting a toxic response.
    2. Infants and children. Tetraethoxysilane, polymer with 
hexamethyldisiloxane 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(e)(1), and as such, is considered incapable of 
eliciting a toxic response.

D. International Tolerances

     There are no CODEX Maximum Residue Limits established for 
tetraethoxysilane, polymer with hexamethyldisiloxane in/on any crop 
commodities at this time.
[FR Doc. 01-27470 Filed 10-31-01; 8:45 am]
BILLING CODE 6560-50-S