[Federal Register Volume 65, Number 173 (Wednesday, September 6, 2000)]
[Notices]
[Pages 54022-54024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22389]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-968; FRL-6739-7]


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-968, must be 
received on or before October 6, 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-968 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Indira Gairola, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-6379; 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-968. 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

[[Page 54023]]

imperative that you identify docket control number PF-968 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-968. 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 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 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 23, 2000.
  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 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.

Uniqema

0E6197

    EPA has received a pesticide petition (PP0E6197) from Uniqema, 900 
Uniqema Boulevard, New Castle, DE 19720 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 modified 
styrene-acrylic polymers. 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. Uniqema is petitioning that modified 
styrene-acrylic polymers be exempt from the requirement of a tolerance 
based upon their compliance with the low risk polymer criteria per 40 
CFR 723.250. Therefore, an analytical method to determine residues in 
raw agricultural commodities has not been proposed. 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 a low risk polymer 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 compared to other chemical substances as well as polymers that 
typically are not readily absorbed. Uniqema believes that modified 
styrene-acrylic polymers conform to the definition of a polymer given 
in 40 CFR 723.250 and meet the criteria used to identify a low risk 
polymer. Uniqema also believes that based on this substance's 
conformance to the above mentioned criteria, no mammalian toxicity is 
anticipated from dietary, inhalation or dermal exposure to emulsion 
polymers and that emulsion polymers will present minimal or no risk.
    1. This polymer is not a cationic substance.

[[Page 54024]]

    2. It contains as an integral part of its composition the atomic 
elements carbon, hydrogen, and oxygen.
    3. It does not contain as an integral part of its composition, 
except as impurities, any elements other than those listed in 40 CFR 
723.250(d)(2)(ii) .
    4. This polymer is not designed or reasonably anticipated to 
substantially degrade, decompose, or depolymerize.
    5. 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.
    6. It is not a water absorbing polymer.
    7. 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.
    This polymer has an oligomer content less than 10% below MW 500 and 
less than 25% MW 1,000.
    Uniqema believes sufficient information was submitted in the 
petition to assess the hazards of modified styrene-acrylic polymers. 
Based on these polymers conforming to the definition of a polymer and 
meeting the criteria of a low risk polymer under 40 CFR 723.250, 
Uniqema believes there are no concerns for risks associated with 
toxicity.

C. Endocrine Disruption

    There is no evidence that modified styrene-acrylic polymers are 
endocrine disrupters. 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 intact gastrointestinal (GI) tract. Chemicals not absorbed 
through the skin or GI tract generally are incapable of eliciting a 
toxic response.
    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.

D. Aggregate Exposure

    1. Dietary exposure. Some modified styrene-acrylic polymers may be 
used in contact with food as components of containers used to 
manufacture, process, or store food when regulated for such use under 
the FFDCA. Modified styrene-acrylic polymers with a molecular weight 
greater than 1,000 daltons are not readily absorbed through the intact 
gastrointestinal tract and are considered incapable of eliciting a 
toxic response.
    2. Non-dietary exposure. Typical uses of modified styrene-acrylic 
polymers are in the paints and coatings industries as components of 
coatings. In these uses the primary exposure used is dermal, however, 
and modified styrene-acrylic polymers with a molecular weight 
significantly greater than 400 are not readily absorbed through the 
intact skin and are considered incapable of eliciting a toxic response.

E. Cumulative Effects

    There are data to support a conclusion of negligible cumulative 
risk modified styrene-acrylic polymers. 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 intact 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 
increased risk due to cumulative exposure. Based on this polymer 
conforming to the definition of a polymer and meeting the criteria of a 
low risk polymer under 40 CFR 723.250, Uniqema believes there are no 
concerns for risks associated with cumulative effects.

F. Safety Determination

    1. U.S. population. Uniqema believes sufficient information was 
submitted in the petition to assess the hazards of modified styrene-
acrylic polymers. Based on these polymers conforming to the definition 
of a polymer and meeting the criteria of a low risk polymer under 40 
CFR 723.250, Uniqema believes there are no concerns for risks 
associated with any potential exposure to adults. There are no known 
additional pathways of exposure (non-occupational, drinking water, 
etc.) where there would be additional risk to the general population.
    2. Infants and children. Uniqema believes sufficient information 
was submitted in the petition to assess the hazards of modified 
styrene-acrylic polymers. Based on these polymers conforming to the 
definition of a polymer and meeting the criteria of a low risk polymer 
under 40 CFR 723.250, Uniqema believes there are no concerns for risks 
associated with any potential exposure to infants and children. There 
are no known pathways of exposure (non-occupational, drinking water, 
etc.) where infants and children would be at additional risk.

G. International Tolerances

    Uniqema is not aware of any country requiring a tolerance for 
modified styrene-acrylic polymers nor have there been any CODEX maximum 
residue levels established for these polymers on any food crops at this 
time.

[FR Doc. 00-22389 Filed 9-5-00; 8:45 am]
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