[Federal Register Volume 66, Number 216 (Wednesday, November 7, 2001)]
[Notices]
[Pages 56305-56307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27599]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1050; FRL-6807-9]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
fora 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-1050, must be 
received on or before December 7, 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-1050 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Treva C. Alston, 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 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-1050. 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-1050 in the subject line on the 
first page of your response.

[[Page 56306]]

    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-1050. 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 27, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide 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 
petitioner. 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.

Huntsman Corporation

1E6350

    EPA has received a pesticide petition (1E6350) from Huntsman 
Corporation, 3040 Post Oak Blvd., Houston, TX 77056 proposing, pursuant 
to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend the 
tolerance exemption listed under 40 CFR 180. 1,001 (c) for 1,2-
ethanediamine, polymer with methyl oxirane and oxirane to include a 
number average molecular weight of 1,100. 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. Residue Chemistry

    Analytical method. Huntsman is petitioning that 1,2-ethanediamine, 
polymer with methyl oxirane and oxirane be exempt from the requirement 
of a tolerance based upon the definition of a low risk polymer under 40 
CFR 723.250(e). Therefore, an analytical method to determine residues 
of 1,2-ethanediamine, polymer with methyl oxirane and oxirane in raw 
agricultural commodities (RACs) is not required.

B. Toxicological Profile

    In the case of certain chemical substances that are defined as 
``polymers,'' 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(e), identify polymers that are 
typically not readily absorbed, and are relatively unreactive and 
stable compounds in comparison to other chemical substances. 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 above will present minimal or no risk. 1,2-Ethanediamine, polymer 
with methyl oxirane and oxirane conforms to the definition of a polymer 
given in 40 CFR 723.250(b) and meets the following criteria that are 
used to identify low risk polymers.
    1. 1,2-Ethanediamine, polymer with methyl oxirane and oxirane is 
not a cationic polymer, nor is it capable of becoming a cationic 
polymer in the natural aquatic environment.
    2. 1,2-Ethanediamine, polymer with methyl oxirane and oxirane 
contains as an integral part of its composition, the

[[Page 56307]]

atomic elements carbon, hydrogen, nitrogen, and oxygen.
    3. 1,2-Ethanediamine, polymer with methyl oxirane and oxirane 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. 1,2-Ethanediamine, polymer with methyl oxirane and oxirane is 
not designed, nor is it reasonably anticipated to substantially 
degrade, decompose, or depolymerize.
    5. 1,2-Ethanediamine, polymer with methyl oxirane and oxirane is 
manufactured using monomers and/or reactants that are already included 
on the TSCA Chemical Substance Inventory or covered under an applicable 
TSCA section 5 exemption.
    6. 1,2-Ethanediamine, polymer with methyl oxirane and oxirane is 
not a water absorbing polymer with a number average molecular weight 
greater than or equal to 10,000 daltons.
    7. The number average molecular weight of 1,2-ethanediamine, 
polymer with methyl oxirane and oxirane is 1,100. 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 are 
generally incapable of eliciting a toxic response.
    8. 1,2-Ethanediamine, polymer with methyl oxirane and oxirane 
contains less than 10% oligomeric material below molecular weight 500 
and less than 25% oligomeric material less than molecular weight 1,000.
    9. 1,2-Ethanediamine, polymer with methyl oxirane and oxirane does 
not contain reactive functional groups.
    Endocrine disruption. There is no evidence that 1,2-ethanediamine, 
polymer with methyl oxirane and oxirane is an endocrine disrupter, 
where as 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 are 
generally incapable of eliciting a toxic response.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. 1,2-Ethanediamine, polymer with 
methyl oxirane and oxirane is not absorbed through the intact GI tract 
and is considered to be incapable of eliciting a toxic response.
    ii. Drinking water. Based upon the aqueous insolubility of 1,2-
ethanediamine, polymer with methyl oxirane and oxirane, there is no 
reason to expect human exposure to residues in drinking water.
    2. Non-dietary exposure. Although there may be exposures to 1,2-
ethanediamine, polymer with methyl oxirane and oxirane through dietary 
and or non-occupational sources, the chemical characteristics of this 
compound are such that there is reasonable certainty of no harm from 
aggregate exposure.

D. Cumulative Effects

    There is not a reasonable expectation of any increased risk due to 
cumulative expsoures to 1,2-ethanediamine, polymer with methyl oxirane 
and oxirane, since polymers with molecular weights greater than 400 
generally are not absorbed through the skin, and substances with 
molecular weights greater than 1,000 generally are not absorbed through 
the intact GI tract. Chemicals not absorbed through the skin or GI 
tract generally are incapable of eliciting a toxic response.

E. Safety Determination

    1. U.S. population. 1,2-Ethanediamine, polymer with methyl oxirane 
and oxirane 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 to be incapable of eliciting a toxic response.
    2. Infants and children. 1,2-Ethanediamine, polymer with methyl 
oxirane and oxirane 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, in considered to be incapable 
of eliciting a toxic response.

F. International Tolerances

    Huntsman is not aware of any country requiring a tolerance for 1,2-
ethanediamine, polymer with methyl oxirane and oxirane, nor have there 
been any codex maximum residue levels established for any food crops at 
this time.
[FR Doc. 01-27599 Filed 11-06-01; 8:45 am]
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