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4-(dichloroacetyl)-1-oxa-4-azospiro [4.5] decane (MON 4660) Proposed Pesticide Tolerance 3/93


40 CFR Part 180

[PP 5F03272 and 6F03381/R1186; FRL-4576-1]

RIN No. 2070-AC18

Pesticide Tolerance for 4-(Dichloroacetyl)-1-Oxa-4-Azaspiro[4.5]Decane 

AGENCY: Environmental Protection Agency. 

ACTION: Proposed rule.

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SUMMARY: This document proposes that a time-limited tolerance 
be established for residues of 4-(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane 
(CAS Reg. No. 71526-07-3) in pesticide formulations applied 
to corn fields before the corn plants emerge from the soil with 
a maximum use level of 0.4 pound of 4-(dichloroacetyl)-1-oxa-
4-azaspiro[4.5]decane per acre at a level of 0.005 ppm in or 
on corn. The proposed 
regulation to establish a maximum permissible 
level for residues of the inert ingredient in or on the commodity 
was requested by the Monsanto Co. This time-limited tolerance 
would expire on January 31, 1998. 

DATES: Comments, identified by document control number [OPP-
300280], must be received on or before May 14, 1993.

ADDRESSES: By mail, submit comments to: Public Response and 
Program Resources Branch, Field Operations Division (H7506C), 
Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, deliver comments 
to: Rm. 1128, CM 1B2, 1921 Jefferson Davis Highway, Arlington, 
VA 22202. 

   Information submitted as a comment concerning this document 
may be claimed as 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. 
The public docket is available for public inspection in Rm. 
246 at the address given above, from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. 

FOR FURTHER INFORMATION CONTACT: By mail: Kerry Leifer, Registration 
Support Branch, Registration Division (H7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm. 711L, CM 
1B2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703) 
305-5180. 

SUPPLEMENTARY INFORMATION:

I. Background

   EPA is charged with administration of section 408 of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
Section 408 authorizes the Agency to establish tolerance levels 
and exemptions from the requirements of a tolerance for residues 
of pesticide chemicals in or on raw agricultural commodities.
   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 and spreading agents; propellants in aerosol dispensers; 
and emulsifiers. The term "inert" is not intended to imply nontoxicity; 
the ingredient may or may not be chemically active.
   A policy statement on inert ingredients published in the 
Federal Register of April 22, 1987 (52 FR 13305), included data 
requirements which were to be used to evaluate the risks posed 
by the presence of an inert ingredient in a pesticide formulation. 
The minimal ("base set") data requirements for inert ingredients 
were listed in that policy statement. It was also noted that, 
based upon the results of the "base set" studies, the Agency 
may elect to require additional data such as would be required 
under 40 CFR part 158 for an active ingredient. Included among 
these additional requirements are residue chemistry data which 
would support the establishment of a finite tolerance for the 
residues of an inert ingredient in raw agricultural commodities 
and/or processed foods.
   In those cases where 
the toxicity of an inert ingredient 
is such that exposure to the inert ingredient must be restricted 
to assure that the use of the inert ingredient in a pesticide 
formulation does protect the public health, EPA will propose 
to establish a tolerance for residues of the inert ingredient 
on raw agricultural commodities.

II. Provisions of Proposed Rule

   The Monsanto Co., Suite 1100, 700 14th St., NW., Washington, 
DC 20005, submitted pesticide petitions (PP) 5F03272 and 6F03381 
to EPA. These petitions requested that the Administrator, pursuant 
to section 408(e) of the FFDCA, amend 40 CFR part 180 by proposing 
the establishment of an exemption from the requirement of a 
tolerance for residues of the inert ingredient 4-(dichloroacetyl)-
1-oxa-4-azaspiro[4.5]decane when used in formulations of the 
herbicides acetochlor (PP 5F03272) and alachlor (PP 6F03381) 
applied to corn fields either before the corn plants emerge 
from the soil or until the corn reaches 5 inches in height with 
a maximum of 0.4-pound inert ingredient per acre.
   EPA issued two notices, published in the Federal Register 
of August 21, 1985 (50 FR 33840) and on June 11, 1986 (51 FR 
21233), announcing receipt 
of tolerance petitions PP 5F03272 
and PP 6F03381, respectively. The petitioner amended this request 
on March 14, 1986, eliminating post-emergence treatments and 
subsequent proposed that a Sensitivity of Method (SOM) tolerance 
be established for residues of 4-(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane 
for use as an inert ingredient in pesticide formulations containing 
alachlor (November 10, 1988) or alachlor (May 30, 1990) rather 
than requesting an exemption from the requirement of a tolerance. 
Monsanto further amended these petitions on March 5, 1991, requesting 
that 4-(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane be allowed 
to be used as an inert ingredient (safener) in any pesticide 
formulation applied to corn, not specifically alachlor or acetochlor, 
thereby making the two petitions equivalent. A safener is a 
herbicidal antidote that protects desirous crops while allowing 
the herbicide to act on the intended weed targets.
   The data submitted in the petitions and other relevant material 
have been evaluated. This inert ingredient is considered useful 
for the purpose for which the tolerance is sought. The toxicological, 
ecological, and environmental fate data considered in support 
of the proposed tolerance include the following:
   1. An acute rat oral toxicity study with an acute oral LD50 
of 600 milligrams (mg)/kilogram (kg).
   2. An acute rabbit 
dermal toxicity study with an acute dermal 
LD50 of   > 5,000 mg/kg.
   3. A rabbit eye irritation study in which 4-(dichloroacetyl)-
1-oxa-4-azaspiro[4.5]decane is determined not to be an eye irritant.
   4. An acute rat inhalation toxicity study with a 4-hour inhalation 
LC50 of 0.27 mg/L.
   5. A guinea pig dermal sensitization study in which 4-(dichloroacetyl)-
1-oxa-4-azaspiro[4.5]decane is determined to be a positive sensitizer.
   6. A 90-day rat oral toxicity study with a no-observed-effect 
level (NOEL) of 120 parts per million (ppm) or 12 mg/kg/day.
   7. A 90-day oral toxicity study with a NOEL of 30 mg/kg/day 
or 1,200 ppm (highest dose tested).
   8. A rat developmental effects study with a NOEL for maternal 
toxicity of 10 mg/kg/day and developmental toxicity of 75 mg/kg/day.
   9. A rabbit developmental effects study with a NOEL for maternal 
toxicity of 10 mg/kg/day and developmental toxicity of 10 mg/kg/day.
   10. Mutagenicity studies including Salmonella typhimurium/mammalian 
plate incorporation (Ames) assay, CHO/HGPRT gene mutation assay, 
DNA repair studies (rat hepatocytes), and Salmonella/mammalian 
activation gene mutation (Ames) assay were negative with and 
without activation.
   11. Environmental fate studies including hydrolysis, photolysis, 
aerobic soil metabolism, 
leaching and soil adsorption/desorption 
and field dissipation.
   A reference dose (RfD) has not been established for this 
chemical. The theoretical worst-case maximum residue contribution 
(TMRC) from the proposed tolerance is estimated to be 0.00000166775 
mg/kg/bw (body weight)/day for the overall U.S. population.
   This tolerance is being established as a time-limited tolerance 
because the Agency does not have data from two chronic feeding/carcinogenicity 
studies which are part of the toxicology data typically required 
to be submitted in support of a tolerance request. These studies 
will be required to be submitted to the Agency by April 31, 
1997. When the Agency receives these chronic feeding/carcinogenicity 
studies it will reassess the tolerance. However, based upon 
4-(dichloroacetyl)-1-oxa-4azaspiro[4.5]decane's lack of mutagenicity 
or extraordinary adverse effects in the subchronic or developmental 
toxicity studies, the low degree of dietary exposure and the 
restriction on exposure offered by a time limitation on the 
tolerance, the Agency does not believe that this proposed tolerance 
poses significant risks.
   This tolerance will expire January 31, 1998. Residues not 
in excess of these tolerances will not be considered actionable 
if a pesticide containing this inert ingredient is legally applied 
during the term of a 
conditional registration under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended 
and in accordance with the acceptable labeling under a conditional 
registration. This tolerance will be revoked if any data indicate 
such revocation is necessary to protect the public health.
   An analytical method for determination of the nature of the 
residue, gas-liquid chromatography using an electron-capture 
detector, has been reviewed by the Agency, and upon successful 
completion of residue testing under FDA's multiresidue protocols, 
will be made available in the Pesticide Analytical Manual, Vol. 
II (PAM II), for enforcement purposes. In the interim, the method 
will be available at the address given below. By mail: Calvin 
Furlow, Public Response and Program Resources Branch, Field 
Operations Division (H7506C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm. 1128C, CM 
1B2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703) 
305-5232.
   Based upon the above information considered by the Agency, 
the regulation established for 4-(dichloroacetyl-1-oxa-4-azaspiro[4.5]decane 
would protect the public health. Therefore, it is proposed that 
the 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, 
Rodenticide, and Fungicide Act (FIFRA) as amended, which contains 
any of the ingredients listed herein, may request within 30 
days after 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 Federal Food, Drug, 
and Cosmetic Act.
   Interested persons are invited to submit written comments 
on the proposed regulation. Comments must bear a notation indicating 
the document control number, [PP 5F03272 and 6F03381/R1186]. 
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 3 of Executive Order 12291.
   Pursuant to the requirements 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 tolerances or raising 
tolerance levels or establishing exemptions from tolerance requirements 
do not have a significant 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

   Administrative practice and procedure, Agricultural commodities, 
Pesticide and pests, Recording and recordkeeping requirements.

   Dated: March 25, 1993.


Lawrence E. Culleen,
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 subpart C, by adding new 1A180.465, to read as follows:

   Tolerances, to expire January 31, 1998, are established for 
residues of 4-(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane (CAS 
Reg. No. 71526-07-3) when used as an inert ingredient (safener) 
in pesticide formulations applied to corn fields before the 
corn plants emerge from the soil with a maximum use level of 
0.4 pound per acre per year in or on the following raw agricultural 
commodities:


                                                                              
                                                                              
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                           Commodity                              Parts per   
                                                                   million    
------------------------------------------------------------------------------
                                                                              
Corn, fodder (field)...........................................        0.005  
Corn, forage 
(field)...........................................        0.005  
Corn, grain (field)............................................        0.005  
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[FR Doc. 93-8565 Filed 4-13-93; 8:45 am]
BILLING CODE 6560-50-F