[Federal Register Volume 65, Number 178 (Wednesday, September 13, 2000)]
[Notices]
[Pages 55240-55242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23243]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-973; FRL-6738-2]


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-973, must be 
received on or before October 13, 2000.

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-973 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Vera Soltero, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9359; 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 codes         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,'' ``Regulations 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-973. 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-973 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 (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-973. 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.

[[Page 55241]]

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: August 29, 2000.

James Jones,

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 view of the 
petitioner. 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

PP 5E4430

    EPA has received a pesticide petition (PP 5E4430) from Wacker 
Silicones Corporation, 3301 Sutton Road, Adrian, Michigan 49221-9397 
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 
180.1001(c) to amend the existing exemption from the requirement of a 
tolerance for dimethylpolysiloxane in or on the raw agricultural 
commodities when used as an inert ingredient in pesticide formulations 
which were applied to the growing crop and/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 supports granting of the petition. Additional data 
may be needed before EPA rules on the petition.
    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 polymer's ability to cause adverse effects. The Agency 
believes that polymers meeting the criteria noted above will present 
minimal or no risk. Dimethylpolysiloxane 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. Dimethylpolysiloxane is not a cationic polymer, nor is it 
reasonably anticipated to become a cationic polymer in the natural 
aquatic environment.
    2. Dimethylpolysiloxane contains as an integral part of its 
composition the atomic elements carbon, hydrogen, oxygen and silicon.
    3. Dimethylpolysiloxane 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. Dimethylpolysiloxane is not reasonably anticipated to 
substantially degrade, decompose or depolymerize.
    5. Dimethylpolysiloxane 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. Dimethylpolysiloxane is not a water absorbing polymer with a 
number average molecular weight greater than or equal to 10,0000 
daltons.
    7. Dimethylpolysiloxane has a molecular weight ranging from 10,148 
daltons to 61,380 daltons. Dimethylpolysiloxane 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.

A. Aggregate Exposure

    1. Dietary exposure. Dimethylpolysiloxane is not absorbed through 
the skin or GI tract generally and is considered incapable of eliciting 
a toxic response.
    i. Food. Dimethylpolysiloxane is approved for use as a food 
additive under 21 CFR Parts 24.246, 175.105, 175.125, 175.300, 175.320, 
175.380, 175.390, 176.200, 176.170, 176.180, 176.200, 177.1200, 
177.1210, 177.1350, 177.2260, 177.2800, 178.3120, 178.3570, 178.3910, 
and 181.28.
    ii. Drinking water. Based upon the aqueous insolubility of 
dimethylpolysiloxane, there is no reason to expect human exposure to 
residues in drinking water.
    2. Non-dietary exposure. Although there may be exposures to the 
compound though dietary and non-occupational non-dietary routes, the 
chemical characteristics of the chemical are such that there is a 
reasonable certainty of no harm from aggregate exposure.

B. Cumulative Effects

    There are no data to support cumulative risk from 
dimethylpolysiloxane 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). Chemical 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. Dimethylpolysiloxane causes no safety concerns 
because it conforms to the

[[Page 55242]]

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. Dimethylpolysiloxane 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.

D. International Tolerances

    There are no CODEX Maximum Residue Limits established for 
dimethylpolysiloxane in/on any crop commodities at this time.

[FR Doc. 00-23243 Filed 9-12-00; 8:45 a.m.]
BILLING CODE 6560-50-S