[Federal Register Volume 65, Number 68 (Friday, April 7, 2000)]
[Notices]
[Pages 18322-18324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8405]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-933; FRL-6552-9]


Notice of Filing a Pesticide Petition 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 a pesticide 
petition 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-933, must be 
received on or before May 8, 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-933 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, Ariel Rios Bldg., 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; telephone number: (703) 308-8373; and 
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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

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 PF-933. 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-933 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

[[Page 18323]]

(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, Ariel Rios Bldg., 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-933. 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 certain 
pesticide chemicals 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: March 30, 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 views 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.

Ecolab Inc.

OE6100

    EPA has received a pesticide petition (OE6100) from Ecolab Inc., 
370 N. Wabasha Street, St. Paul, MN 55102 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 1,2-ethanediamine, polymer with 
oxirane and methyloxirane (EDPOM) in or on raw agricultural 
commodities, in processed commodities, and in or on meat and meat by 
products of cattle, sheep, hogs, goats, horses, and poultry, milk, and 
dairy products, eggs, seafood and shellfish, and fruits and vegetables 
when such residues result from the use of EDPOM as a component of a 
food contact surface sanitizing solution for use in food handling 
establishments. The request is for an unlimited clearance. 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

    This is a high molecular weight alkoxylated amine polymer. 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 an 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 compounds 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. The 
Agency believes that polymers meeting the criteria noted above will 
present minimal or no risk. Ecolab Inc. believes that EDPOM conforms to 
the definition of a polymer given in 40 CFR 723.250 and meets the 
following criteria used to identify a low risk polymer.
    1. EDPOM is not a cationic polymer, nor is it reasonably 
anticipated to become a cationic polymer in a natural aquatic 
environment.

[[Page 18324]]

    2. EDPOM contains as an integral part of its composition the atomic 
elements carbon, nitrogen, hydrogen and oxygen.
    3. EDPOM 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. EDPOM is not designed, nor is it reasonably anticipated to 
substantially degrade, decompose or depolymerize prior to, during, or 
after use.
    5. EDPOM is not manufactured or imported from monomers and/or 
reactants that are not included on the Toxic Substances Control Act 
(TSCA) substance inventory or manufactured under an applicable TSCA 
section 5 exemption.
    6. EDPOM is not a water absorbing polymer.
    7. EDPOM has an minimum-average molecular weight of 25,000. 
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 generally are incapable of eliciting a toxic response.
    8. EDPOM has a minimum-average molecular weight of 25,000. EDPOM 
meets the requirements for molecular weight distribution of oligomer 
contents of less than 25% with molecular weights below 1,000 and less 
than 10% with molecular weights below 500.
    Ecolab Inc. believes that sufficient information has been submitted 
to assess the hazards of EDPOM. No toxicology data are being submitted 
as the Agency does not generally require these data to rule on 
exemptions from the requirement of a tolerance for an inert ingredient. 
Because EDPOM conforms with the definition of a polymer and meets the 
criteria of a polymer under 40 CFR 723.250, Ecolab Inc. believes there 
are no concerns for risks associated with toxicity.

C. Aggregate Exposure

    1. Dietary exposure. Acute: Due to the low toxicity, there are no 
toxicological concerns for EDPOM. An acute dietary risk assessment is 
not appropriate. Chronic: Chronic exposure would not produce any effect 
since it is not absorbed. Therefore, no concerns are warranted.
    i. Food. When EDPOM is used as a component of a food contact 
surface sanitizer, the residue that would be introduced into food will 
be insignificant. EDPOM is not absorbed from the GI tract. Based on 
this, there are no toxicological concerns resulting from exposures to 
residues of EDPOM resulting from the use of sanitizing solutions.
    ii. Drinking water. Acute: EDPOM is not expected to be introduced 
into drinking water, therefore an acute drinking water risk assessment 
is not required. Chronic: EDPOM is not expected to be introduced into 
drinking water; therefore, a chronic drinking water risk assessment is 
not required.
    2. Non-dietary exposure. EDPOM is not absorbed from the GI tract or 
through the skin. The potential for significant additional non-
occupational exposure to the general population (including children) is 
unlikely.

D. Cumulative Effects

    The amount of EDPOM exposure resulting from indirect exposure to 
sanitizing solutions will be miniscule. EDPOM is a high molecular 
weight alkoxylated amine polymer that is not absorbed by the body. 
EDPOM in the diet poses no cumulative toxicological risk. Ecolab Inc. 
believes that sufficient information has been submitted to assess the 
hazards of EDPOM. Because EDPOM conforms with the definition of a 
polymer and meets the criteria of a polymer under 40 CFR 723.250, 
Ecolab Inc. believes there are no concerns for risks associated with 
cumulative effects.

E. Safety Determination

    1. U.S. population. There are no adverse toxicological effects 
resulting from ingestion of trace amounts of EDPOM, so there is no need 
to determine aggregate risks, or to conduct a safety determination. 
EDPOM exposure due to its use as an inert ingredient in a food contact 
surface sanitizer is negligible. Ecolab Inc. believes that sufficient 
information has been submitted to assess the hazards of EDPOM. Because 
it conforms with the definition of a polymer and meets the criteria of 
a polymer under 40 CFR 723.250, there are no concerns for risks 
associated with any potential exposure to adults.
    2. Infants and children. Children are at no greater risk from 
exposure to EDPOM. Therefore, as with adults, a safety determination is 
not appropriate. Ecolab Inc. believes that sufficient information has 
been submitted to assess the hazards of EDPOM. Because it conforms with 
the definition of a polymer and meets the criteria of a polymer under 
40 CFR 723.250, there are no concerns for risks associated with any 
potential exposure to children.

E. International Tolerances

    No Codex Maximum Residue Levels have been established for EDPOM.
[FR Doc. 00-8405 Filed 4-6-00; 8:45 am]
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