[Federal Register Volume 66, Number 119 (Wednesday, June 20, 2001)]
[Notices]
[Pages 33081-33084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15296]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1026; FRL-6785-9]


Notice of Filing Pesticide Petitions to Establish a Tolerance for 
Certain Pesticide Chemicals in or on Food

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 docket control number PF-1026, must be 
received on or before July 20, 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-1026 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 adress: 
[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'' ``Regulation 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-1026. 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-1026 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

[[Page 33082]]

format. All comments in electronic form must be identified by docket 
control number PF-1026. 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 pesticide petitions as follows proposing the 
establishment and/or amendment of regulations for residues of certain 
pesticide chemicals 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 these petitions contain 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: May 20, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioner and represent the views of 
the petitioners. 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.

Uniqema

PP 1E6293

    EPA has received a pesticide petition (1E6293) from Uniqema, 900 
Uniqema Blvd, New Castle, DE 19720 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 to establish an exemption from the 
requirement of a tolerance for modified acrylic polymers when used as 
an inert ingredient in pesticide formulations applied to growing crops, 
raw agricultural commodities after harvest, or in pesticide 
formulations applied 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.

A. Residue Chemistry

    Uniqema is petitioning that modified 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 
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 these polymers, conformance to the 
above-mentioned criteria, no mammalian toxicity is anticipated from 
dietary, inhalation or dermal exposure to polymers and that these 
polymers will present minimal or no risk.
    1. These polymers are not cationic polymers.
    2. They contain as an integral part of their composition the atomic 
elements carbon, hydrogen, and oxygen.
    3. They do not contain as an integral part of their composition, 
except as impurities, any elements other than those listed in 40 CFR 
723.250(d)(2)(ii).
    4. These polymers are not designed or reasonably anticipated to 
substantially degrade, decompose, or depolymerize.
    5. These polymers are 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. They are not water absorbing polymers.
    7. The minimum average molecular weight of the above-mentioned 
polymers 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. These polymers have an oligomer content 
less than 10% below

[[Page 33083]]

molecular weight 500 and less than 25% molecular weight 1,000.
    Uniqema believes sufficient information was submitted in the 
petition to assess the hazards of modified acrylic polymers. No 
toxicology data were presented in the petition as the Agency does not 
generally require that polymers conform to 40 CFR 723.250. 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.
    8. Endocrine disrupter. There is no evidence that modified 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 GI tract. Chemicals not absorbed through the 
skin or GI tract generally are incapable of eliciting a toxic response.
    The Agency at this time has not determined whether or not it will 
require information on the endocrine effects of this substance. 
Congress has allowed 3 years after August 3, 1996, for the Agency to 
implement a screening program with respect to endocrine effects.

C. Aggregate Exposure

    1. Dietary exposure. Some modified 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 Federal 
Food, Drug, and Cosmetic Act. Modified acrylic polymers with a 
molecular weight greater than 1,000 daltons are not readily absorbed 
through the intact GI tract and are considered incapable of eliciting a 
toxic response.
    2. Non-dietary exposure. Typical uses of modified acrylic polymers 
are in the paints & coatings and adhesives industries. In these uses 
the primary exposures are dermal, however; modified 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.

D. Cumulative Effects

    There are data to support a conclusion of negligible cumulative 
risk for modified 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 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 cumulative effects.

Uniqema

PP 1E6294

    EPA has received a pesticide petition (1E6294) from Uniqema, 900 
Uniqema Blvd, 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 vinyl 
acetate polymers when used as an inert ingredient in pesticide 
formulations applied to growing crops, raw agricultural commodities 
after harvest, or in pesticide formulations applied 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

    Uniqema is petitioning that vinyl acetate 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

    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. Uniqema believes that 
vinyl acetate 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 these polymers, 
conformance to the above-mentioned criteria, no mammalian toxicity is 
anticipated from dietary, inhalation or dermal exposure to polymers and 
that these polymers will present minimal or no risk.
    1. These polymers are not cationic polymers.
    2. They contain as an integral part of their composition the atomic 
elements carbon, hydrogen, and oxygen.
    3. They do not contain as an integral part of their composition, 
except as impurities, any elements other than those listed in 40 CFR 
723.250(d)(2)(ii).
    4. These polymer are not designed or reasonably anticipated to 
substantially degrade, decompose, or depolymerize.
    5. These polymers are 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. They are not water absorbing polymers.
    7. The minimum average molecular weight of the above-mentioned 
polymers are 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 GI tract. Chemicals not 
absorbed through the GI tract are generally incapable of eliciting a 
toxic response. These polymers have an oligomer content less than 10% 
below molecular weight 500 and less than 25% molecular weight 1,000.
    Uniqema believes sufficient information was submitted in the 
petition to assess the hazards of vinyl acetate polymers. No toxicology 
data were presented in the petition as the Agency does not generally 
require that polymers conform to 40 CFR 723.250. 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.
    There is no evidence that vinyl acetate 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 GI tract. Chemicals not absorbed through the skin or GI 
tract generally are incapable of eliciting a toxic response.

[[Page 33084]]

    The Agency at this time has not determined whether it will require 
information on the endocrine effects of this substance. Congress has 
allowed 3 years after August 3, 1996, for the Agency to implement a 
screening program with respect to endocrine effects.

C. Aggregate Exposure

    1. Dietary exposure. Some vinyl acetate 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 Federal 
Food, Drug, and Cosmetic Act. Vinyl acetate polymers with a molecular 
weight greater than 1,000 daltons are not readily absorbed through the 
intact GI tract and are considered incapable of eliciting a toxic 
response.
    2. Non-dietary exposure. Typical uses of vinyl acetate polymers are 
in the paints & coatings and adhesives industries. In these uses the 
primary exposures are dermal, however; vinyl acetate 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.

D. Cumulative Effects

    There are data to support a conclusion of negligible cumulative 
risk for vinyl acetate 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 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 cumulative effects.

[FR Doc. 01-15296 Filed 6-19-01; 8:45 am]
BILLING CODE 6560-50-S