[Federal Register Volume 60, Number 85 (Wednesday, May 3, 1995)]
[Proposed Rules]
[Pages 21784-21786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10867]



[[Page 21784]]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300383; FRL-4945-6]
RIN 2070-AB78


Poly(phenylhexylurea), Cross-Linked; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This document proposes to establish an exemption from the 
requirement of a tolerance for residues of poly(phenylhexylurea), 
cross-linked, when used as an inert ingredient (encapsulating agent) in 
pesticide formulations applied to growing crops only under 40 CFR 
180.1001(d) to replace the existing exemption from the requirement of a 
tolerance for residues of cross-linked polyurea-type encapsulating 
polymer under 40 CFR 180.1082. The Monsanto Co. requested this proposed 
regulation.

DATES: Written comments, identified by the document control number, 
[OPP-300383], must be received on or before June 2, 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 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-300383]. 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: Mary Waller, 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)-308-8811; e-mail:

Waller.M[email protected].

SUPPLEMENTARY INFORMATION: The Monsanto Co., Suite 1100, 700 14th St., 
NW., Washington, DC 20005, submitted pesticide petition (PP) 4E04408 to 
EPA requesting that the Administrator, pursuant to section 408(e) of 
the Federal Food Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a(e)), 
propose to amend 40 CFR part 180 by replacing the existing exemption 
from the requirement of a tolerance for residues of cross-linked 
polyurea-type encapsulating polymer listed under 40 CFR 180.1082 with 
an exemption from the requirement of a tolerance for residues of 
poly(phenylhexylurea), cross-linked, when used as an inert ingredient 
(encapsulating agent) in pesticide formulations applied to growing 
crops only under 40 CFR 180.1001(d).
    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 
that 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 poly(phenylhexylurea), 
cross-linked, 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. Poly(phenylhexylurea), cross-linked, 
conforms to the definition of a polymer given in 40 CFR 723.250(b)(11) 
and meets the following criteria that are used to identify low-risk 
polymers.
    1. The minimum number-average molecular weight of 
poly(phenylhexylurea), cross-linked, is 36,000. 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 intact gastrointestinal 
tract. Chemicals not absorbed through skin or GI tract generally are 
incapable of eliciting a toxic response.
    2. Poly(phenylhexylurea), cross-linked, is not a cationic polymer, 
nor is it reasonably expected to become a cationic polymer in a natural 
aquatic environment.
    3. Poly(phenylhexylurea), cross-linked, does not contain less than 
32.0 percent by weight of the atomic element carbon.
    4. Poly(phenylhexylurea), cross-linked, contains as an integral 
part of its composition the atomic elements carbon, hydrogen, nitrogen, 
and oxygen.
    5. Poly(phenylhexylurea), cross-linked, 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)(3)(ii). [[Page 21785]] 
    6. Poly(phenylhexylurea), cross-linked, is not a biopolymer, a 
synthetic equivalent of a biopolymer, or a derivative or modification 
of a biopolymer that is substantially intact.
    7. Poly(phenylhexylurea), cross-linked, is not manufactured from 
reactants containing, other than impurities, halogen atoms or cyano 
groups.
    8. Poly(phenylhexylurea), cross-linked, does not contain a reactive 
functional group that is intended or reasonably expected to undergo 
further reaction.
    9. Poly(phenylhexylurea), cross-linked, is neither designed nor 
reasonably expected to substantially degrade, decompose, or 
depolymerize.
    The establishment of an exemption from the requirement of a 
tolerance for residues of poly(phenylhexylurea), cross-linked, when 
used as an inert ingredient (encapsulating agent) in pesticide 
formulations applied to growing crops only under 40 CFR 180.1001 will 
obviate the need to maintain an exemption of polyurea-type 
encapsulating polymer as listed under 40 CFR 180.1082. The polymer 
listed in 40 CFR 180.1082 is described as being ``formed by the 
reaction of polymethylene polyphenylisocyanate and hexamethylene 
diamine.'' The resultant polymer can best be described as 
poly(phenylhexylurea), cross-linked, the subject of this proposed 
regulation.
    In addition, based on the polymer's conformance to the set of 
criteria that are used to identify low-risk polymers, the additional 
use restrictions described in 40 CFR 180.1082 (i.e., use as an 
encapsulating material for formulations of alachlor (2-chloro-N-(2,6-
diethylphenyl)-N-(methoxymethyl) acetamide) for use on dry beans, lima 
beans, peas, potatoes and soybeans, when applied to the soil before 
edible portions of the crops form are no longer applicable.
    Based on the information above and review of its use, 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 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 any of the 
ingredients 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-300383]. 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 
p.m., Monday through Friday, except legal holidays.
     A record has been established for this rulemaking under docket 
number [OPP-300383] (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 place the paper copies in the 
official rulemaking record which will also include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in ``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 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 Subject in 40 CFR Part 180

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

    Dated: April 20, 1995.

Stephen L. Johnson,
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. Section 180.1001(d) is amended in the table therein by adding 
and alphabetically inserting the inert ingredient, to read as follows:


Sec. 180.1001   Exemptions from the requirement of a tolerance.

* * * * *
    (d) *  *  *

------------------------------------------------------------------------
    Inert ingredients            Limits                   Uses          
------------------------------------------------------------------------
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
Poly(phenylhexylurea),       ................  Encapsulating agent.     
 cross-linked; minimum                                                  
 average molecular weight                                               
 36,000.                                                                
                                                                        
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
------------------------------------------------------------------------

[[Page 21786]] * * * * *


Sec. 180.1082  [Removed]

    3. By removing Sec. 180.1082 Cross-linked polyurea-type 
encapsulating polymer (Alachlor); exemption from the requirement of a 
tolerance.

[FR Doc. 95-10867 Filed 5-2-95; 8:45 am]
BILLING CODE 6560-50-F