[Federal Register Volume 60, Number 8 (Thursday, January 12, 1995)]
[Proposed Rules]
[Pages 2921-2923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-818]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300374; FRL-4924-9]
RIN 2070-AC18
3,5-Bis(6-Isocyanatohexyl)-2H-1,3,5-Oxadiazine-2,4,6-(3H,5H)-
Trione, Polymer with Diethylenetriamine; 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 3,5-bis(6-isocyanatohexyl)-
2H-1,3,5-oxadiazine-2,4,6-(3H,5H)-trione, polymer with
diethylenetriamine (CAS Reg. No. 87823-33-4), when used as an inert
ingredient (encapsulating agent) in pesticide formulations applied to
growing crops. Miles, Inc., requested this proposed regulation.
DATES: Written comments, identified by the document control number
[OPP-300374], must be received on or before February 13, 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, bring 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.
FOR FURTHER INFORMATION CONTACT: Connie Welch, 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) 308-8470.
SUPPLEMENTARY INFORMATION: Miles, Inc., 8400 Hawthorn Road, P.O. Box
4913, Kansas City, MO 64120-0013, submitted pesticide petition (PP)
4E4416 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 180.1001(d) by establishing an
exemption from the requirement of a tolerance for residues of 3,5-
bis(6-isocyanatohexyl)-2H-1,3,5-oxadiazine-2,4,6-(3H,5H)-trione,
polymer with diethylenetriamine (CAS Reg. No. 87823-33-4), when used as
an inert ingredient (encapsulating agent) in pesticide formulations
applied to growing crops 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 [[Page 2922]] dispensers;
microencapsulating agents; and emulsifiers. The term ``inert'' is not
intended 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 3,5-bis(6-
isocyanatohexyl)-2H-1,3,5-oxadiazine-2,4,6-(3H,5H)-trione, polymer with
diethylenetriamine, will need to be submitted. The rationale for this
decision is described below.
1. 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. The chemical 3,5-bis(6-isocyanatohexyl)-2H-
1,3,5-oxadiazine-2,4,6-(3H,5H)-trione, polymer with diethylenetriamine,
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.
The minimum number-average molecular weight of 3,5-bis(6-
isocyanatohexyl)-2H-1,3,5-oxadiazine-2,4,6-(3H,5H)-trione, polymer with
diethylenetriamine, is listed as 1,000,000. 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. The chemical 3,5-bis(6-isocyanatohexyl)-2H-1,3,5-oxadiazine-
2,4,6-(3H,5H)-trione, polymer with diethylenetriamine, is not a
cationic polymer, nor is it reasonably expected to become a cationic
polymer in a natural aquatic environment.
3. The chemical 3,5-bis(6-isocyanatohexyl)-2H-1,3,5-oxadiazine-
2,4,6-(3H,5H)-trione, polymer with diethylenetriamine, does not contain
less than 32.0 percent by weight of the atomic element carbon.
4. The chemical 3,5-bis(6-isocyanatohexyl)-2H-1,3,5-oxadiazine-
2,4,6-(3H,5H)-trione, polymer with diethylenetriamine, contains as an
integral part of its composition the atomic elements carbon, hydrogen,
nitrogen, and oxygen.
5. The chemical 3,5-bis(6-isocyanatohexyl)-2H-1,3,5-oxadiazine-
2,4,6-(3H,5H)-trione, polymer with diethylenetriamine, 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).
6. The chemical 3,5-bis(6-isocyanatohexyl)-2H-1,3,5-oxadiazine-
2,4,6-(3H,5H)-trione, polymer with diethylenetriamine, is not a
biopolymer, a synthetic equivalent of a biopolymer, or a dervative or
modification of a biopolymer that is substantially intact.
7. The chemical 3,5-bis(6-isocyanatohexyl)-2H-1,3,5-oxadiazine-
2,4,6-(3H,5H)-trione, polymer with diethylenetriamine, is not
manufactured from reactants containing, other than impurities, halogen
atoms or cyano groups.
8. The chemical 3,5-bis(6-isocyanatohexyl)-2H-1,3,5-oxadiazine-
2,4,6-(3H,5H)-trione, polymer with diethylenetriamine, does not contain
a reactive functional group that is intended or reasonably expected to
undergo further reaction.
9. The chemical 3,5-bis(6-isocyanatohexyl)-2H-1,3,5-oxadiazine-
2,4,6-(3H,5H)-trione, polymer with diethylenetriamine, is neither
designed nor reasonably expected to substantially degrade, decompose,
or depolymerize.
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-300374]. 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.
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 Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.
Dated: December 21, 1994.
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) * * *
[[Page 2923]]
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Inert ingredients Limits Uses
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* * *
3,5-Bis(6- ................ Encapsulating agent.
isocyanatohexyl)-2H-
1,3,5-oxadiazine-2,4,6-
(3H,5H)-trione, polymer
with diethylenetriamine
(CAS Reg. No. 87823-33-
4); minimum number
average molecular weight
1,000,000.
* * * *
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[FR Doc. 95-818 Filed 1-11-95; 8:45 am]
BILLING CODE 6560-50-F