[Federal Register Volume 60, Number 220 (Wednesday, November 15, 1995)]
[Proposed Rules]
[Pages 57377-57379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28182]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300401; FRL-4985-4]
RIN 2070-AC18


1,2-Ethanediamine, Polymer With Oxirane and Methyloxirane; 
Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.

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SUMMARY: This document proposes to establish an exemption from the 
requirement of a tolerance for residues of 1,2-ethanediamine, polymer 
with oxirane and methyloxirane (CAS Reg. No. 26316-40-5) when used as 
an inert ingredient (surfactant and dispersing agent) in pesticide 
formulations applied to growing crops or to raw agricultural 
commodities after harvest and to animals, under 40 CFR 180.1001 (c) and 
(e). The BASF Corp. requested this proposed regulation pursuant to the 
Federal Food, Drug and Cosmetic Act (FFDCA).
DATES: Written comments, identified by the document control number 
[OPP-300401], must be received on or before December 15, 1995.
ADDRESSES: By mail, submit written comments to Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. In person, deliver comments to: Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA 22202. Information submitted 
as a comment concerning this document may be claimed confidential by 
marking any part or all of that information as ``Confidential Business 
Information'' (CBI). Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
comment that does not contain CBI must be submitted for inclusion in 
the public record. Information not marked confidential will be included 
in the public docket by EPA without prior notice. All written comments 
will be available for public inspection in Rm. 1132 at the address 
given above, from 8 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number [OPP-300401]. No Confidential Business Information 
(CBI) should be submitted through e-mail. Electronic comments on this 
proposed rule may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found below in 
this document.
FOR FURTHER INFORMATION CONTACT: By mail: Bipin Gandhi, Registration 
Support Branch, Registration Division (7505W), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location and 
telephone number: 2800 Crystal Drive, North Tower, 6th Floor, 
Arlington, VA 22202, (703)-308-8380; e-mail: 
[email protected].
SUPPLEMENTARY INFORMATION: The BASF Corp., 3000 Continental Drive-
North, Mount Olive, NJ 07828-1234, has submitted a pesticide petition, 
PP 5E04579, to EPA requesting that the Administrator, pursuant to 
section 408(e) of the FFDCA (21 U.S.C. 346a(e)), propose to amend 40 
CFR 180.1001 (c) and (e) by exempting 1,2-ethanediamine, polymer with 
oxirane and methyloxirane (CAS Reg. No. 26316-40-5) when used as an 
inert ingredient (surfactant and dispersing agent) in pesticide 
formulations applied to growing crops or to raw agricultural 
commodities after harvest and to animals, under 40 CFR 180.1001(c) and 
(e). These inert ingredients meet the definition of polymers under 40 
CFR 723.250(b) and the criteria listed in 40 CFR 723.250(e) that define 
chemical substances that pose no unreasonable risks under section 5 of 
the Toxic Substance Control Act (TSCA). 

[[Page 57378]]

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125, and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not to imply nontoxicity; the 
ingredient may or may not be chemically active.
    The data submitted in the petition and other relevant material have 
been evaluated. 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 which 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 
such 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. The Agency has decided that no 
data, in addition to that described below, for 1,2-ethanediamine, 
polymer with oxirane and methyloxirane will need to be submitted. The 
rationale for this decision is described below.
    In the case of certain chemical substances that are defined as 
``polymers,'' the Agency has established a set of criteria which 
identify 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. 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 oxirane and methyloxirane 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 oxirane and methyloxirane is not 
a cationic polymer, nor is it reasonably anticipated to become a 
cationic polymer in a natural aquatic environment.
    2. 1,2-Ethanediamine, polymer with oxirane and methyloxirane 
contains as an integral part of its composition the atomic elements 
carbon, hydrogen, oxygen, and nitrogen.
    3. 1,2-Ethanediamine, polymer with oxirane and methyloxirane 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. 1,2-Ethanediamine, polymer with oxirane and methyloxirane is not 
designed, nor is it reasonably anticipated to substantially degrade, 
decompose, or depolymerize.
    5. 1,2-Ethanediamine, polymer with oxirane and methyloxirane is not 
manufactured or imported from monomers and/or other reactants that are 
not already included on the TSCA Chemical Substance Inventory or 
manufactured under an applicable TSCA section 5 exemption.
    6. 1,2-Ethanediamine, polymer with oxirane and methyloxirane is not 
a water-absorbing polymer.
    7. The minimum number-average molecular weight of 1,2-
ethanediamine, polymer with oxirane and methyloxirane is 2,800. 
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 skin or GI 
tract generally are incapable of eliciting a toxic response.
    8. 1,2-Ethanediamine, polymer with oxirane and methyloxirane has a 
number average molecular weight in the range of 2,800 to 10,000 daltons 
and contains less than 10 percent oligomeric material below molecular 
weights 500 and less than 25 percent oligomeric material below 1,000 
molecular weight.
    9. 1,2-Ethanediamine, polymer with oxirane and methyloxirane has a 
combined (total) reactive group equivalent weight greater than or equal 
to 1,000 for amines as functional groups.
    Based on the information above and review of its uses, EPA has 
found that, when used in accordance with good agricultural practice, 
this ingredient is useful, and a tolerance is not necessary to protect 
the public health. Therefore, EPA proposes that the exemption from the 
requirement of a tolerance be established for the polymer as set forth 
below.
    Any person who has registered or submitted an application for 
registration of a pesticide, under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA) as amended, that contains the ingredient 
listed herein, may request within 30 days after the publication of this 
document in the Federal Register that this rulemaking proposal be 
referred to an Advisory Committee in accordance with section 408(e) of 
the FFDCA.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number, [OPP-300401]. All written comments filed in 
response to this petition will be available in the Public Response and 
Program Resources Branch, at the address given above, from 8 a.m. to 
4:30 p.m., Monday through Friday, except legal holidays.
    A record has been established for this rulemaking under docket 
number [OPP-300401] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed paper versions of electronic comments, which does not 
include any information claimed as CBI, is available for inspection 
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The public record is located in Room 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    opp-D[email protected]
    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed, 
paper form as they are received and will be placed in the paper copies 
of the official rulemaking record which also will include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in the ADDRESSES at the 
beginning of this document.
    The Office of Management and Budget has exempted this rule from the 
requirements of section 2 of Executive Order 12866.
    Pursuant to the requirement of the Regulatory Flexibility Act (Pub. 
L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has 
determined that regulations establishing new tolerances or raising 
tolerance levels or establishing exemptions from tolerance 

[[Page 57379]]
requirements do not have an economic impact on a substantial number of 
small entities. A certification statement to this effect was published 
in the Federal Register of May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Processed foods, 
Reporting and recordkeeping requirements.

    Dated: October 27, 1995,

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR part 180 be amended as 
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    2. In Sec. 180.1001 paragraphs (c) and (e) are amended in the 
tables therein by adding and alphabetically inserting the inert 
ingredient, to read as follows:


Sec. 180.1001   Exemptions from the requirement of a tolerance.

*        *        *        *        *
    (c) *  *  *

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       Inert ingredient             Limits                 Uses         
------------------------------------------------------------------------
                                                                        
         *        *        *        *        *        *        *        
1,2 Ethanediamine, polymer       ..............  Surfactant, dispersing 
 with oxirane and                                 agent.                
 methyloxirane (CAS Reg. No.                                            
 26316-40-5) minimum number                                             
 average molecular weight                                               
 2,800 and the range of                                                 
 number average molecular                                               
 weight is 2,800 to 10,000                                              
 daltons.                                                               
                                                                        
         *        *        *        *        *        *        *        
  (e) *  *  *                                                           
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------------------------------------------------------------------------
      Inert ingredients             Limits                 Uses         
------------------------------------------------------------------------
                                                                        
         *        *        *        *        *        *        *        
1,2 Ethanediamine, polymer       ..............  Surfactant, dispersing 
 with oxirane and                                 agent.                
 methyloxirane (CAS Reg. No.                                            
 26316-40-5) minimum number                                             
 average molecular weight                                               
 2,800 and the range of                                                 
 number average molecular                                               
 weight is 2,800 to 10,000                                              
 daltons.                                                               
                                                                        
         *        *        *        *        *        *        *        
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[FR Doc. 95-28182 Filed 11-14-95; 8:45 am]
BILLING CODE 6560-50-F