[Federal Register Volume 68, Number 19 (Wednesday, January 29, 2003)]
[Rules and Regulations]
[Pages 4385-4392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1768]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0245; FRL-7199-4]


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

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY: This regulation establishes import tolerances for residues of 
4-(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane (CAS No. 71526-07-3) in 
or on corn commodities. Monsanto Company requested this tolerance under 
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the 
Food Quality Protection Act (FQPA) of 1996.

DATES: This regulation is effective January 29, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0245, 
must be received on or before March 31, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: By mail: Bipin Gandhi, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 308-8380; 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:
    [sbull] Industry, (NAICS 111, 112, 311, 32532), Crop production, 
Animal production, Food manufacturing, 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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPPT-2002-0245. The 
official public docket consists of the documents

[[Page 4386]]

specifically referenced in this action, any public comments received, 
and other information related to this action. Although a part of the 
official docket, the public docket does not include Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. The official public docket is the collection of 
materials that is available for public viewing at the EPA Docket 
Center, Rm. B102-Reading Room, EPA West, 1301 Constitution Ave., NW., 
Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding legal holidays. The EPA Docket 
Center Reading Room telephone number is (202) 566-1744 and the 
telephone number for the OPPT Docket, which is located in EPA Docket 
Center, is (202) 566-0280.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of January 28, 1998 (63 FR 4252) (FRL-5763-
6), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by the FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 5E4503) by Monsanto Company, 800 
North Lindbergh Blvd., St. Louis, MO 63167. This notice included a 
summary of the petition prepared by Monsanto Company, the petitioner. 
There were no comments received in response to the notice of filing.
    Previously, time-limited tolerances had been established (40 CFR 
180.465) for the residues of 4-(dichloroacetyl)-1-oxa-4-
azaspiro[4.5]decane, in or on corn commodities (April 14, 1993) (58 FR 
19387). These tolerances expired on January 31, 1998.
    In the above mentioned pesticide petition (5E4503) Monsanto 
Corporation requested permanent tolerances for 4-(dichloroacetyl)-1-
oxa-4-azaspiro[4.5]decane in or on corn commodities at 0.005 ppm.
    The petitioner asked in a letter dated January 15, 2002, that 40 
CFR 180.465 be amended by establishing an import tolerance for residues 
of the herbicide safener 4-(dichloroacetyl)-1-oxa-4-
azaspiro[4.5]decane, in or on corn commodities at 0.005 parts per 
million (ppm) with no U.S. registrations.
    In the United States a tolerance is the maximum residue level of a 
pesticide permitted in or on food or feed grown in the United States 
and food or feed imported into the United States from other countries. 
Typically, EPA would establish tolerance(s) or exemption(s) from the 
requirement of a tolerance at the same time that it registered the use 
of a pesticide for that commodity in the United States. Where no U.S. 
registration exists, interested persons may submit a petition 
requesting that EPA establish an import tolerance for a pesticide 
residue that would allow treated food to be legally imported into the 
United States. The term ``import tolerance'' is used as a convenience 
to refer to a tolerance that exists where there is no accompanying 
registration under the Federal Insecticide, Fungicide, Rhodenticide Act 
(FIFRA). There is no statutory or regulatory distinction between an 
``import tolerance'' and any other tolerance issued by EPA. The same 
food safety standards apply to both domestically produced and imported 
food.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that`` there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensurethat there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure topesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for a tolerance for residues of 4-
(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane on corn commodities at 
0.005 ppm. EPA's assessment of exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by 4-(dichloroacetyl)-
1-oxa-4-azaspiro[4.5]decane are discussed in the following Table 1 as 
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies 
reviewed.

[[Page 4387]]



                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = 48 mg/kg/day
                                          rodents                    LOAEL = 192 mg/kg/day based on decreased
                                                                      mean body weights, increased platelets ,
                                                                      changes in clinical parameters and
                                                                      histopathological findings.
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL = would be equal to or greater than
                                          nonrodents                  30 mg/kg/day
                                                                     LOAEL = not determined; but would be
                                                                      greater than 30 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 10 mg/kg/day
                                          rodents-rats (1989 study)   mg/kg/day based on decreased body weight
                                                                      gain, decreased food consumption,
                                                                      increased preimplantation loss.
                                                                     Developmental NOAEL = 75 mg/kg/day
                                                                     LOAEL = 150 mg/kg/day based on increased
                                                                      incidences of skeletal malfunctions and
                                                                      variations.
                                         Prenatal developmental in   Maternal NOAEL = 80 mg/kg/day
                                          rodents-rat (1985 study)   LOAEL = 200 mg/kg/day based on clinical
                                                                      signs (alopecia, wet fur with urinary
                                                                      staining, piloerection.
                                                                     Developmental NOAEL = 80 mg/kg/day
                                                                     LOAEL = 200 mg/kg/day based on increased
                                                                      fetal malfunctions.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 10 mg/kg/day
                                          rabbits-nonrodents         LOAEL = 30 mg/kg/day based on decreased
                                                                      body weight gain.
                                                                     Developmental NOAEL = would be equal to or
                                                                      greater than 30 mg/kg/day
                                                                     LOAEL = would be greater than 30 mg/kg/day
                                                                      .
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 6.34/7.32 male/
                                          effects                     female mg/kg/day
                                                                     LOAEL = 61.48/72.30 male/female mg/kg/day
                                                                      based on reduced body weight and body
                                                                      weight gain in P & F1a.
                                                                     Reproductive NOAEL = 6.34/7.32 male/female
                                                                      mg/kg/day
                                                                     LOAEL = 61.48/72.30 male/female mg/kg/day
                                                                      based on decreased pup body weights.
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity mice        NOAEL = 10.71/16.82 male/female mg/kg/day
                                                                     LOAEL = 107.50/166.57 male/female mg/kg/day
                                                                      based on increased absolute and relative
                                                                      liver weights as well as histopathological
                                                                      lesions in the liver, and stomach mucosa.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Chronic/Carcinogenicity     NOAEL = 2.21/2.78 male/female mg/kg/day
                                          rats                       LOAEL = 22.09/29.18 male/female mg/kg/day
                                                                      based upon histopathological changes in
                                                                      the liver and stomach including cystic
                                                                      liver degeneration, periportal
                                                                      hepatocellular vacuolation, and pyloric
                                                                      intestinal metaplasia of the stomach.
----------------------------------------------------------------------------------------------------------------
870.5300                                 Gene Mutation               In vitro gene mutation in CHO cells.
                                                                      Negative for mutagenicity.
----------------------------------------------------------------------------------------------------------------
870.5300                                 Cytogenetics                In vitro bone marrow assay did not induce a
                                                                      clastogenic response.
----------------------------------------------------------------------------------------------------------------
870.5550                                 Gene Mutation               In vitro UDS assay did not induce a
                                                                      genotoxic effect.
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene Mutation               S.typhimurium/mammalian microsome assay did
                                                                      not induce a genotoxic effect.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal penetration          There were no dermal absorption studies and
                                                                      no appropriate toxicity studies available
                                                                      to allow an estimation of the dermal
                                                                      absorption by a route-to-route comparison
                                                                      of toxicity. However, two structurally
                                                                      related chemicals, acetochlor and
                                                                      alachlor, have experimentally derived
                                                                      dermal data indicating that absorption is
                                                                      20 to 25 percent, respectively. Therefore,
                                                                      the estimated dermal absorption is 25%
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the LOAEL is sometimes 
used for risk assessment if no NOAEL was achieved in the toxicology 
study selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for intra 
species differences. An additional 3x uncertainty factor was applied 
due to the data gap for a chronic toxicity study in dogs.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to

[[Page 4388]]

account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer= point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for 4-(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane used for 
human risk assessment is shown in the following Table 2:

Table 2.--Summary of Toxicological Dose and Endpoints for 4-(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane for Use
                                            in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of  NOAEL = 10 mg/kg/day     FQPA SF = 3              Development toxicity in
 age)                                  UF = 100...............  aPAD = acute RfD/FQPA     rabbits
                                       Acute RfD = 0.1 mg/kg/    SF.                     LOAEL = 75 mg/kg/day
                                        day.                    = 0.033 mg/kg/day......   based on decreased
                                                                                          body weight gain on
                                                                                          day 3 of dosing.
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population,     NOAEL = 10 mg/kg/day     FQPA SF = 1              Development toxicity in
 including infants and children)       UF = 100...............  aPAD = acute RfD/FQPA     rabbits
                                       Acute RfD = 0.1 mg/kg/    SF.                     Material LOAEL = 75 mg/
                                        day.                    = 0.1 mg/kg/day........   kg/day based on
                                                                                          decreased body weight
                                                                                          gain on day 3 of
                                                                                          dosing.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL = 2.21 mg/kg/day   FQPA SF = 1              Chronic/Carcinogenicity
                                       UF = 300...............  cPAD = chronic RfD/FQPA   in rats
                                       Chronic RfD = 0.007 mg/   SF = 0.007 mg/kg/day.   LOAEL = 22.09 mg/kg/day
                                        kg/day.                                           based on
                                                                                          histopathological
                                                                                          changes in liver and
                                                                                          stomach including
                                                                                          cystic liver
                                                                                          degeneration,
                                                                                          periportal
                                                                                          hepatocellular
                                                                                          vacuolation, and
                                                                                          pyloric intestinal
                                                                                          metaplasia of the
                                                                                          stomach
----------------------------------------------------------------------------------------------------------------
Short-, intermediate Term Dermal       Dermal (or oral) study   LOC for MOE =            Development toxicity in
                                       NOAEL = 10 mg/kg/day     100 (Residential)......   rabbit
                                        (dermal absorption                               LOAEL = 75 mg/kg/day
                                        rate = 25 %).                                     based on decreased
                                                                                          body weight gain on
                                                                                          day 3 of dosing.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal                       Oral study NOAEL= 2.21   LOC for MOE = 100        Chronic/Carcinogenicity
                                        mg/kg/day                (Residential)            in rats
                                       (dermal absorption rate                           LOAEL = 22.09 mg/kg/day
                                        = 25 %when                                        was used for deriving
                                        appropriate).                                     the chronic RfD.
----------------------------------------------------------------------------------------------------------------
Inhalation any time period             Oral study               LOC for MOE =            Development toxicity in
                                       NOAEL = 10 mg/kg/day     100 (Residential)......   rabbit
                                        (inhalation absorption                           LOAEL = 75 mg/kg/day
                                        rate = 100%).                                     based on decreased
                                                                                          body weight gain on
                                                                                          day 3 of dosing
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)      Q1* =4.85x10-\2\ (mg/kg/                          Likely to be
                                        day)-\1\                                          carcinogenic to humans
                                                                                          (combined
                                                                                          hepatocellular adenoma
                                                                                          and /or carcinoma in
                                                                                          male mice).
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. The tolerances to be 
established are import tolerances. Thus, the only dietary exposure 
would be residues of 4-(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane, in 
imported corn commodities. Therefore, risk assessments were conducted 
by EPA to assess dietary exposures from 4-(dichloroacetyl)-1-oxa-4-
azaspiro[4.5]decane in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the acute 
exposure assessments:
    The acute dietary (food only) assessment is based on Tier 1 
assumptions (tolerance level residues, 100% crop treated). For all 
population subgroups the estimated dietary (food only) risks are less 
than 1% of the acute population-adjusted dose (PAD). This is well below 
the Agency's level of concern for the dietary exposure (100% of the 
PAD).
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1992 nationwide Continuing

[[Page 4389]]

Surveys of Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity. The following assumptions were made 
for the chronic exposure assessments:
    The chronic dietary (food only) assessment is based on Tier 2 
assumptions (tolerance-level residues and 25% crop treated estimates). 
For all population subgroups, the estimated dietary (food only) risks 
are less than 1% of the chronic PAD.
    iii. Cancer. The cancer dietary (food only) assessment is based on 
Tier 2 assumptions (tolerance-level residues and 25% crop treated 
estimates). Based on these assumptions, the estimated dietary exposure 
for the U.S. Population is 0.000013 mg/kg/day. Applying a Q\1\* of 
4.85x10-\2\ (mg/kg/day)-\1\ results in a cancer 
risk estimate of 6.5x10-\7\. Generally the Agency is not 
concerned with cancer risk less than the range of 1x10-\6\.
    iv. Anticipated residue and percent crop treated (PCT) 
information.Section 408(b)(2)(F) of the FFDCA states that the Agency 
may use data on the actual percent of food reated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on PCT.
    The Agency used PCT information as follows:
    For the acute dietary risk assessment, the Agency assumed 100% crop 
treated i.e., that the entire crop was treated. For chronic (non-cancer 
and cancer) dietary analyses it was assumed that 25% of the corn was 
treated.
     For assessing chronic dietary risk, the Agency believes that the 
three conditions listed above have been met. With respect to condition 
1, it was assumed that 25% of the corn was treated. The information was 
based on the percent crop treated data for acetochlor since 4-
(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane can be used as a safener 
with acetochlor to treat corn. This 25% crop treated estimate is likely 
to significantly overestimate the percentage of corn treated with 4-
(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane. According to information 
supplied by the USDA, Economic Research Service, the total production 
of corn in the United States. was 239.55 and 251.85 million metric tons 
for the growing seasons of 1999-2000 and 2000-2001 respectively. United 
States corn imports were 328.393 and 195.603 metric tons for the years 
1999 and 2000 respectively. Thus, treated amount of imported corn is 
less than 1% of domestic U.S. corn production.
    As to conditions 2 and 3, regional consumption information and the 
consumption information for significant subgroups is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment procedure ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue evels higher 
than those estimated by the agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food.
    2. Dietary exposure from drinking water. Residues in drinking water 
(either ground water or surface water) are not expected to result as a 
consequence of establishing an import tolerance for 4-(dichloroacetyl)-
1-oxa-4-azaspiro[4.5]decane residues in or on corn commodities. There 
are currently no registered products containing 4-(dichloroacetyl)-1-
oxa-4-azaspiro[4.5]decane being distributed or sold in the United 
States. The one registered product containing 4-(dichloroacetyl)-1-oxa-
4-azaspiro[4.5]decane is pending request for cancellation (October 16, 
2002, 67 FR 63909; FRL-7276-6). Therefore, exposure through drinking 
water is unlikely.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). 4-(dichloroacetyl)-1-
oxa-4-azaspiro[4.5]decane is not registered in the United States and 
the petition is for import tolerances only, therefore, there would be 
no residential exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning cumulative effects 
of a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether 4-(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane has a common 
mechanism of toxicity with other substances or how to include this 
pesticide in a cumulative risk assessment. Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, 4- (dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane 
does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has not assumed that 4-(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane has 
a common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 
FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. There are two developmental 
toxicity studies in the rat. In a 1995 study, fetal malfunctions were 
observed at 200 mg/kg/day in the presence of minimal maternal toxicity 
(clinical signs), Both maternal and developmental OAEL's are 80 mg/kg/
day. In a 1989 study, resorption and malfunctions were observed in the 
presence of a maternal clinical signs including decreased body

[[Page 4390]]

weight gain and food consumption at 150 mg/kg/day. Maternal toxicity at 
75 my/kg/day is a conservative call based on decreased food 
consumption. The susceptibility assumption is based on effects at the 
high dose.
    In a development toxicity study with rabbits there is no evidence 
of increased susceptibility since there was no evidence of 
developmental toxicity at the highest dose tested in the presence of 
maternal toxicity. In the two generation reproductive toxicity study in 
rats, there is no evidence of increased susceptibility of offspring.
    3. Conclusion. The Agency determined that the FQPA safety factor of 
10x for protection of infants and children be reduced to 3x since:
    i. The toxicity data base is complete for an FQPA assessment;
    ii. No increase in susceptibility was seen in the rabbit 
developmental study or in the 2-generation reproduction in rats;
    iii. A developmental neurotoxicity study is not required for 4-
(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane; and
    iv. The exposure data are understood and the food exposure 
assessment will not underestimate the residues resulting from the use 
of 4-(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane.

E. Aggregate Risks and Determination of Safety

    1. Aggregate risks. The Agency has concluded that exposure to 4-
(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane from food imported corn 
commodities will utilize less than 1% of the aPAD and cPAD for all 
population groups.
    The cancer risk estimates from aggregate exposure to 4-
(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane in food has also been 
assessed. For the U.S. population, the cancer dietary risk from food is 
6.5 x 10-\7\ which is below the Agency's concern for excess 
lifetime cancer risk.
    There are no uses for 4-(dichloroacetyl)-1-oxa-4-
azaspiro[4.5]decane that will result in drinking water or residential 
exposure.
    2. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to 4-(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement method (gas chromatography method using 
electron capture detection) is available to enforce the tolerance 
expression. The method may be requested from: Calvin Furlow, PRRIB, 
IRSD (7502C), Office of Pesticide Programs, Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington DC 20460-0001; 
telephone number; (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    There are no CODEX, Canadian or Mexican limits for residues of 4-
(dichloroacetyl)-1-oxa-4-azaspiro[4.5] decane in corn.

V. Conclusion

    Therefore, import tolerances are established for residues of 4-
(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane, in or on corn commodities 
at 0.005 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2002-0245 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before March 31, 
2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in

[[Page 4391]]

Unit VI.A., you should also send a copy of your request to the PIRIB 
for its inclusion in the official record that is described in Unit 
I.B.2. Mail your copies, identified by docket ID number OPP-2002-0245, 
to: Public Information and Records Integrity Branch, Information 
Resources and Services Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. In person or by courier, bring a copy to the 
location of the PIRIB described in Unit I.B.2. You may also send an 
electronic copy of your request via e-mail to: [email protected]. 
Please use an ASCII file format and avoid the use of special characters 
and any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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


    Dated: January 10, 2003.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

[[Page 4392]]


    2. Section 180.465 is revised to read as follows:


Sec.  180.465  4-(Dichloroacetyl)-1-oxa-4- azaspiro[4.5]decane.

    (a) General. Tolerances are established for the residues of 4-
(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane, (CAS No. 71526-07-3 ) 
when used as an inert ingredient (safener) in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
               Commodity\1\                       Parts per million
------------------------------------------------------------------------
Corn, field, forage                         0.005
Corn, field, grain                          0.005
Corn, field, stover                         0.005
Corn, pop, grain                            0.005
Corn, pop, stover                           0.005
------------------------------------------------------------------------
\1\There are no U.S. registered products containing 4-(dichloroacetyl)-1-
  oxa-4-azaspiro[4.5]decane as of June 17, 2002.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 03-1768 Filed 1-28-03; 8:45 am]
BILLING CODE 6560-50-S