[Federal Register Volume 67, Number 100 (Thursday, May 23, 2002)]
[Notices]
[Pages 36176-36178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12976]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0034; FRL-6834-9]


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 OPP-2002-0034, 
must be received on or before June 24, 2002.

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 OPP-2002-0034 in the subject line on the first page of 
your response.

FOR FURTHER INFORMATION CONTACT: By mail: Bipin Gandhi, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-8380; 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'' 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 OPP-2002-0034. 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 OPP-2002-0034 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

[[Page 36177]]

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 OPP-2002-0034. 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: May 10, 2002.
Debra Edwards,
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 MeadWestaco Corporation, and represents the 
view of MeadWestaco. 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.

PP 2E6411

    EPA has received a pesticide petition (2E6411) from MeadWestaco 
Corporation, 3950 Faber Place Drive, N. Charleston, SC 29405 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 2-propenoic acid, 2-methyl-, polymer with ethyl 2-
propenoate and methyl 2-methyl-2-propenoate, ammonium salt (CAS Reg. 
No. 55989-05-4) when used as an inert ingredient (encapsulating agent, 
dispensers, resins, fibers and beads) in pesticide formulations applied 
to growing crops or raw agricultural commodities after harvest, under 
40 CFR 180.1001(c) and applied to animals under 40 CFR 180.1001(e). 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. MeadWestvaco is petitioning that 2-Propenoic 
acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-
propenoate, ammonium salt 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 2-
Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 
2-methyl-2-propenoate, ammonium salt in raw agricultural commodities 
(RACs) is not required.

B. Toxicological Profile

     Acute toxicity. As part of the EPA policy statement on inert 
ingredients published in the Federal Register of April 22, 1987 (52 FR 
13305), the Agency set forth a list of studies that would generally be 
used to evaluate the risks posed by the presence of an inert ingredient 
in a pesticide formulation. However, where it can be determined without 
the data that the inert ingredient will present minimal or no risk, the 
Agency generally does not require some or all of the listed studies to 
rule on the proposed tolerance or exemption from the requirement of a 
tolerance for an inert ingredient. MeadWestvaco believes that the data 
and information described below is adequate to ascertain the toxicology 
and characterize the risk associated with the use of 2-propenoic acid, 
2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-
propenoate, ammonium salt (CAS Reg. No. 55989-05-4) as an inert 
ingredient in pesticide formulations applied to growing crops and raw 
agricultural commodities after harvest, and animals.
     In the case of certain chemical substances that are defined as 
``polymers,'' EPA has established a set of criteria that identify 
categories of

[[Page 36178]]

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. These properties generally limit a 
polymer's ability to cause adverse effects. In addition, these criteria 
exclude polymers about which little is known. EPA believes that 
polymers meeting the criteria noted below will present minimal or no 
risk.
     2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and 
methyl 2-methyl-2-propenoate, ammonium salt (CAS Reg. No. 55989-05-4) 
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. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and 
methyl 2-methyl-2-propenoate, ammonium salt is not a cationic polymer, 
nor is it reasonably anticipated to become a cationic polymer in a 
natural aquatic environment.
    2. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and 
methyl 2-methyl-2-propenoate, ammonium salt contains as an integral 
part of its composition the atomic elements carbon, hydrogen, oxygen, 
and nitrogen.
    3. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and 
methyl 2-methyl-2-propenoate, ammonium salt 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. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and 
methyl 2-methyl-2-propenoate, ammonium salt copolymer is not designed, 
nor is it reasonably anticipated to substantially degrade, decompose, 
or depolymerize.
    5. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and 
methyl 2-methyl-2-propenoate, ammonium salt is not manufactured or 
imported from monomers and/or other reactants that are not already 
included on the Toxic Substance Control Act (TSCA) Chemical Substance 
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and 
methyl 2-methyl-2-propenoate, ammonium salt is not a water-absorbing 
polymer.
    7. 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and 
methyl 2-methyl-2-propenoate, ammonium salt does not contain any group 
as reactive functional groups.
    8. The minimum number-average molecular weight of the 2-propenoic 
acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-
propenoate is listed as 18,914 daltons. 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.
    9. The 2-propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate 
and methyl 2-methyl-2-propenoate has a number-average molecular weight 
of 18,914 and contains less than 10% oligomeric material below 
molecular weight 500 and less than 25% oligomeric material below 1,000 
molecular weight.
     In addition, 2-propenoic acid, 2-methyl-, polymer with ethyl 2-
propenoate and methyl 2-methyl-2-propenoate is acceptable for use, with 
limitations, under 21 CFR for contact with food as a component in 
adhesives (21 CFR 175.105), coatings (21 CFR 175.300), and paper and 
paperboard (21 CFR 176.170). The ammonium hydroxide utilized to form 
the ammonium salt is listed in 21 CFR 184.1139 under the section, 
``Direct food substances affirmed as generally recognized as safe.''

C. Aggregate Exposure

    1. Dietary exposure. Exposure to 2-propenoic acid, 2-methyl-, 
polymer with ethyl 2-propenoate and methyl 2-methyl-2-propenoate, 
ammonium salt may occur through dietary (e.g., food wrapping containing 
copolymer) and non-occupational (e.g., printed articles) sources. The 
chemical characteristics of 2-propenoic acid, 2-methyl-, polymer with 
ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt lead 
to the conclusion that there is a reasonable certainty of no harm from 
aggregate exposure to the polymer.
    2. Non-dietary exposure. 2-propenoic acid, 2-methyl-, polymer with 
ethyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt 
formulations have been in commerce since the mid 1970's. The copolymer 
is ubiquitous in our every day environment and as it is commonly used 
in flexographic printing inks and coatings, such as on newspapers, 
corrugated boxes (e.g., pizza boxes), and disposable drinking cups.
     Given the existing widespread and historic use of 2-propenoic 
acid, 2-methyl-, polymer with ethyl 2-propenoate and methyl 2-methyl-2-
propenoate, ammonium salt, any additional exposure resulting from the 
approval of the copolymer as an inert ingredient in pesticide 
formulations for use on growing crops or to raw agricultural 
commodities after harvest should not be of concern.

D. Cumulative Effects

    At this time there is no information to indicate that any toxic 
effects produced by 2-propenoic acid, 2-methyl-, polymer with ethyl 2-
propenoate and methyl 2-methyl-2-propenoate, ammonium salt would be 
cumulative with those of any other chemical. Given the compound's 
categorization as a ``low risk polymer'' (40 CFR 723.250) and its 
proposed use as an inert ingredient in pesticide formulations, there is 
no reasonable expectation of increased risk due to cumulative exposure.

E. Safety Determination

    1. U.S. population. 2-Propenoic acid, 2-methyl-, polymer with ethyl 
2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt 
formulations have been in commerce since the mid 1970's. The copolymer 
is ubiquitous in our every day environment and as it is commonly used 
in flexographic printing inks and coatings, with no known adverse 
effects.

F. International Tolerances

    There are no CODEX Maximum Residue Limits established for 2-
Propenoic acid, 2-methyl-,polymer with ethyl 2-propenoate and methyl 2-
methyl-2-propenoate, ammonium salt in/on any crop commodities at this 
time.

 [FR Doc. 02-12976 Filed 5- 22-02; 8:45 am]
BILLING CODE 6560-50-S