[Federal Register Volume 66, Number 100 (Wednesday, May 23, 2001)]
[Notices]
[Pages 28482-28487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12904]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1023; FRL-6782-5]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
fora Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

[[Page 28483]]


ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number PF-1023, must be 
received on or before June 22, 2001.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-1023 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Joseph M. Tavano, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8375; e-mail address: 
<a href="/cdn-cgi/l/email-protection#75011403141b1a5b1f1a0610051d351005145b121a03"><span class="__cf_email__" data-cfemail="4b3f2a3d2a2524652124382e3b230b2e3b2a652c243d">[email protected]</span></a>.

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:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-1023. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-1023 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: <a href="/cdn-cgi/l/email-protection#a4cbd4d489c0cbc7cfc1d0e4c1d4c58ac3cbd2"><span class="__cf_email__" data-cfemail="bcd3cccc91d8d3dfd7d9c8fcd9ccdd92dbd3ca">[email protected]</span></a>, or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-1023. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.

[[Page 28484]]

    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: May 11, 2001.
Richard P. Keigwin, Jr., Acting,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioner. EPA is publishing the petition summary verbatim without 
editing it in any way. The petition summary announces the availability 
of a description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

Rohm and Haas Company

1F6259

    EPA has received a pesticide petition (1F6259) from Rohm and Haas 
Company, 100 Independence Mall West, Philadelphia, PA 19106-2399 
proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), 
to amend 40 CFR part 180 by establishing a tolerance for residues of 
methoxyfenozide benzoic acid, 3-methoxy-2-methyl-,2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide in or on the raw 
agricultural commodity stone fruits crop group and prunes at 5 and 7 
parts per million (ppm) respectively. EPA has determined that the 
petition contains data or information regarding the elements set forth 
in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated 
the sufficiency of the submitted data at this time or whether the data 
support granting of the petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The qualitative nature of methoxyfenozide 
residues in plants and animals is adequately understood and was 
previously published in the Federal Register of July 5, 2000 (65 FR 
41355) (FRL-6496-5).
    2. Analytical method. An high performance liquid chromotography 
using ultra-violet detection (HPLC/UV) method TR 34-00-109 for the 
enforcement of tolerances in stone fruits has been developed. 
Confirmatory method validation data have been submitted for this 
method. The validated limit of quantitation (LOQ) of the analytical 
method was 0.02 ppm in all matrices for methoxyfenozide.
    3. Magnitude of residues. Geographically representative field 
trials with methoxyfenozide 80WP and 2F formulations were conducted to 
support the proposed crop group tolerance for the stone fruit 
representative crops peaches, plums and cherries. The results of the 
field trials indicate that residues of methoxyfenozide will not exceed 
the proposed crop group tolerance of 5.0 ppm for stone fruits or 7.0 
ppm for prunes.

B. Toxicological Profile

    The toxicological profile and endpoints for methoxyfenozide which 
supports this petition to establish tolerances were previously 
published in the Federal Register of July 5, 2000 (65 FR 41355).

B. Aggregate Exposure

    1. Dietary exposure--i. Food. Acute exposure and risk. 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 1-day or single exposure. No 
appropriate toxicological endpoint attributable to a single exposure 
was identified in the available toxicology studies on methoxyfenozide 
including the acute neurotoxicity study in rats, the developmental 
toxicity study in rats and the developmental toxicity study in rabbits. 
Since no acute toxicological endpoints were established, Rohm and Haas 
considers acute aggregate risk to be negligible.
    Rohm and Haas used the Dietary Exposure Evaluation Model\TM\ (DEEM) 
V.7.075; Novigen Sciences, Washington, DC) software for conducting a 
chronic dietary (food) risk analysis. DEEM is a dietary exposure 
analysis system that is used to estimate exposure to a pesticide 
chemical in foods comprising the diets of the U.S. population, 
including population subgroups. DEEM contains food consumption data as 
reported by respondents in the USDA continuing surveys of food intake 
by individuals conducted in 1994-1996. Rohm and Haas assumed 100% of 
crops would be treated and contain methoxyfenozide residues at the 
tolerance level. The following tolerance levels were used in the 
analysis:

------------------------------------------------------------------------
                 Commodity                      Tolerance level, ppm
------------------------------------------------------------------------
Bulb vegetables                             0.1 ppm
------------------------------------------------------------------------
Corn, aspirated grain fractions             1.0 ppm
------------------------------------------------------------------------
Corn, field, forage                         15 ppm
------------------------------------------------------------------------
Corn, field, grain                          0.05 ppm
------------------------------------------------------------------------
Corn, field, stover (fodder)                105 ppm
------------------------------------------------------------------------
Corn, oil                                   0.2 ppm
------------------------------------------------------------------------
Corn, silage                                5.0 ppm
------------------------------------------------------------------------
Corn, sweet, forage                         30 ppm
------------------------------------------------------------------------
Corn, sweet (K+CWHR)                        0.05 ppm
------------------------------------------------------------------------
Corn, sweet, stover (fodder)                60 ppm
------------------------------------------------------------------------
Cotton, undelinted seed                     2.0 ppm
------------------------------------------------------------------------
Fat*                                        0.5 ppm
------------------------------------------------------------------------
Fruiting vegetables                         2.0 ppm
------------------------------------------------------------------------
Grapes                                      1.0 ppm
------------------------------------------------------------------------
Head and stem brassica (5A)                 6.5 ppm
------------------------------------------------------------------------
Herbs and spices                            8 ppm
------------------------------------------------------------------------
Leaf petioles (4B)                          10.0 ppm
------------------------------------------------------------------------
Leafy brassica greens (5B)                  20.0 ppm

[[Page 28485]]

 
------------------------------------------------------------------------
Leafy vegetables (4A)                       25 ppm
------------------------------------------------------------------------
Leaves of root and tuber vegetables         0.1 ppm
------------------------------------------------------------------------
Legume vegetables                           0.05 ppm
------------------------------------------------------------------------
Liver                                       0.4 ppm
------------------------------------------------------------------------
Meat*                                       0.02 ppm
------------------------------------------------------------------------
Meat byproducts* (except liver)             0.1 ppm
------------------------------------------------------------------------
Milk                                        0.1 ppm
------------------------------------------------------------------------
Pome fruit                                  1.5 ppm
------------------------------------------------------------------------
Prunes                                      7.0 ppm
------------------------------------------------------------------------
Raisins                                     1.5 ppm
------------------------------------------------------------------------
Root and tuber vegetables                   0.05 ppm
------------------------------------------------------------------------
Stone fruits                                5.0 ppm
------------------------------------------------------------------------
* Of cattle, goats, hogs, horses, and sheep.

    Processing factors were also applied to grape juice (1.2x), grape 
juice concentrate (3.6x), apple juice/cider (1.3x), apple juice 
concentrate (3.9x), dried apples (8x), dried pears (6.25x), tomato 
juice (1.5x), tomato puree (3.3x), tomato paste (5.4x), tomato catsup 
(2.5x), dried tomatoes (14.3x), dehydrated onions (9x), white dry 
potatoes (6.5x), sprouted soybean seeds (0.33x), corn grain sugar (high 
fructose corn syrup; 1.5x), dried beef (1.92x), dried veal (1.92x), 
dried apricots (6.0x), dried cherries (4.0x), cherry juice (1.5x), 
dried peaches (7.0x), dried plums (5.0x), and plum/prune juice (1.4x). 
The processing factors are default values from DEEM.
    As shown in the following table, the resulting dietary food 
exposures occupy up to 37.6% of the chronic population adjusted dose 
(PAD) for the most highly exposed population subgroup, children 1 to 6 
years old. These results should be viewed as conservative (health 
protective) risk estimates. Refinements such as use of percent crop-
treated information and/or anticipated residue values would yield even 
lower estimates of chronic dietary exposure.

       Summary: Chronic Dietary Exposure Analysis by DEEM (Tier 1)
------------------------------------------------------------------------
                                  Exposure milligram/
       Population subgroup         kilogram/day (mg/  Percent of chronic
                                        kg/day)               PAD
------------------------------------------------------------------------
U.S. population--48 contiguous    0.0189              18.9
 States
------------------------------------------------------------------------
All infants (<1-year)             0.0315              31.5
------------------------------------------------------------------------
Nursing infants <1-year old       0.0134              13.4
------------------------------------------------------------------------
Non-nursing infants <1-year old   0.0368              36.8
------------------------------------------------------------------------
Children 1 to 6 years old         0.0376              37.6
------------------------------------------------------------------------
Children 7 to 12 years old        0.0216              21.6
------------------------------------------------------------------------
Females 13+ (nursing)             0.0156              19.1
------------------------------------------------------------------------
U.S. population (autumn season)   0.0191              19.1
------------------------------------------------------------------------
U.S. population (spring season)   0.0190              19.0
------------------------------------------------------------------------
Northeast region                  0.0206              20.6
------------------------------------------------------------------------
Western region                    0.0210              21.0
------------------------------------------------------------------------
Hispanics                         0.0191              19.1
------------------------------------------------------------------------
Non-Hispanic/non-white/non-black  0.0249              24.8
------------------------------------------------------------------------

    Percent chronic PAD = (Exposure divided by chronic PAD) x 100%.
    The subgroups listed are:
    1. The U.S. population (total).
    2. Those for infants and children.
    3. The other subgroup(s), if any, for which the percentage of the 
chronic PAD occupied is greater than that occupied by the subgroup U.S. 
population (total).
    4. The most highly exposed of the females subgroups (in this case, 
females, (13+ years, nursing).
    ii. Drinking water. There are no water-related exposure data from 
monitoring to complete a quantitative drinking water exposure analysis 
and risk assessment for methoxyfenozide. Generic expected environmental 
concentration (GENEEC) and/or EPA's pesticide root zone model/exposure 
analysis modeling system (PRZM/EXAMS) (both produce estimates of 
pesticide concentration in a farm pond) are used to generate estimated 
environmental concentrations (EECs) for surface water and screening 
concentration in ground water (SCI-GROW) (an empirical model based upon 
actual monitoring data collected for a number of pesticides that serve 
as benchmarks) predicts EECs in ground water. These models take into 
account the use patterns and the environmental profile of a pesticide, 
but do not include consideration of the impact that processing raw 
water for distribution as drinking water would likely have on the 
removal of pesticides from the source water. The primary use of these 
models at this stage is to provide a coarse screen for assessing 
whether a pesticide is likely to be present in drinking water at 
concentrations which would exceed human health levels of concern.
    A drinking water level of comparison (DWLOC) is the concentration 
of a pesticide in drinking water that would be acceptable as a 
theoretical upper limit in light of total aggregate exposure to that 
pesticide from food, water, and residential uses. HED uses DWLOCs 
internally in the risk assessment process as a surrogate measure of 
potential exposure associated with pesticide exposure through drinking 
water. In the absence of monitoring data for a pesticide, the DWLOC is 
used as a point of comparison against the conservative EECs provided by 
computer modeling (SCI-GROW, GENEEC, PRZM/EXAMS).
    a. Acute exposure and risk. Because no acute dietary endpoint was 
determined, Rohm and Haas concludes that there is a reasonable 
certainty of no harm from acute exposure from drinking water.
    b. Chronic exposure and risk. Tier II screening-level assessments 
can be conducted using the simulation models SCI-GROW and PRZM/EXAMS to 
generate EECs for ground and surface water, respectively. The modeling 
was conducted based on the environmental profile and the maximum 
seasonal application rate proposed for methoxyfenozide (1.0 lb ai/acre/
season). PRZM/EXAMS was used to generate the surface water EECs, 
because it can factor the persistent nature of the chemical into the 
estimates.
    The EECs for assessing chronic aggregate dietary risk used by HED 
are 6 parts per billion (ppb) (in ground water, based on SCI-GROW) and 
98.5 parts per billion (ppb) (in surface water, based on the PRZM/
EXAMS, long-term mean).The back-calculated DWLOCs for

[[Page 28486]]

assessing chronic aggregate dietary risk range from 624 ppb for the 
most highly exposed population subgroup (children 1 to 6 years old) to 
2,839 ppb for the U.S. population (48 contiguous States--all seasons).
    The SCI-GROW and PRZM/EXAMS chronic EECs are less than the Agency's 
level of comparison (the DWLOC value for each population subgroup) for 
methoxyfenozide residues in drinking water as a contribution to chronic 
aggregate exposure. Rohm and Haas thus concludes with reasonable 
certainty that residues of methoxyfenozide in drinking water will not 
contribute significantly to the aggregate chronic human health risk and 
that the chronic aggregate exposure from methoxyfenozide residues in 
food and drinking water will not exceed the Agency's level of concern 
(100% of the chronic PAD) for chronic dietary aggregate exposure by any 
population subgroup. EPA generally has no concern for exposures below 
100% of the chronic PAD, because it is a level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to the health and safety of any population subgroup. This risk 
assessment is considered high confidence, conservative, and very 
protective of human health.

                                                      DWLOC for Chronic Exposure to Methoxyfenozide
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Maximum water                           GENEEC 56-day
       Population subgroup        Chronic PAD (mg/kg/ Food exposure (mg/   exposure (mg/kg/    SCI-GROW (<greek-   Average (<greek-   DWLOC (<greek-m>g/
                                         day)               kg/day)              day)               m>g/L)              m>g/L)                L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population-48 contiguous                         0.0189              0.0811                                                      2,839
 states
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13+ (nursing)                                 0.0191              0.0809                                                      2,427
--------------------------------------------------------------------------------------------------------------------------------------------------------
Non-nursing infants <1-year old   0.10                0.0368              0.0632              6                   98.5                632
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1 to 6 years old                             0.0376              0.0624                                                      624
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 7 to 12 years old                            0.0216              0.0784                                                      784
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: Maximum water exposure (mg/kg/day) = chronic PAD (mg/kg/day) - chronic food exposure. DWLOC (<greek-m>g/L) = (Maximum water exposure (mg/kg/d) x
  body weight (kg)) divided by (1/1,000 mg/<greek-m>g x water consumed daily (L/day)). Body weights (kg) for adults is 70, for females 13+ is 60 kg and
  for all children is 10 kg. Drinking water consumption is 2 liters per day for adults and 1 liter per day for children.

    2. Non-dietary exposure. Methoxyfenozide is not currently 
registered for use on any residential non-food sites. Therefore, there 
is no non-dietary acute, chronic, short- or intermediate-term exposure.

D. Cumulative Effects

    Section 408(b)(2)(D)(v) requires that, when considering whether to 
establish, modify, or revoke a tolerance, the Agency consider 
``available information'' concerning the 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 methoxyfenozide 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, 
methoxyfenozide does not appear to produce a toxic metabolite produced 
by other substances. For the purposes of this tolerance action, 
therefore, it is assumed that methoxyfenozide does not have a common 
mechanism of toxicity with other substances.

E. Safety Determination

    1. U.S. population. Using the DEEM exposure assumptions described 
in this unit, Rohm and Haas has concluded that aggregate exposure to 
methoxyfenozide from food will utilize 18.9% of the chronic PAD for the 
U.S. population. The major identifiable subgroup with the highest 
aggregate exposure is children 1 to 6 years old at 37.6% of the chronic 
PAD and is discussed below. EPA generally has no concern for exposures 
below 100% of the chronic PAD because the chronic PAD represents the 
level at or below which daily aggregate dietary exposure over a 
lifetime will not pose appreciable risks to human health. Despite the 
potential for exposure to methoxyfenozide in drinking water, the 
aggregate exposure is not expected to exceed 100% of the chronic PAD. 
Rohm and Haas concludes that there is a reasonable certainty that no 
harm will result from aggregate exposure to methoxyfenozide residues.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of methoxyfenozide, EPA 
considered data from developmental toxicity studies in the rat and 
rabbit and a 2-generation reproduction study in the rat. The 
developmental toxicity studies are designed to evaluate adverse effects 
on the developing organism resulting from maternal pesticide exposure 
during gestation. Reproduction studies provide information relating to 
effects from exposure to the pesticide on the reproductive capability 
of mating animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional ten-
fold 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 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 margin of exposure (MOE) analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans. EPA believes that reliable data support 
using the standard uncertainty factor (UF) (usually 100 for combined 
interspecies and intraspecies variability) and not the additional ten-
fold MOE/UF when EPA has a complete data base under existing guidelines 
and when the severity of the effect in infants or children or the 
potency or unusual toxic properties of a compound do not raise

[[Page 28487]]

concerns regarding the adequacy of the standard MOE/safety factor.
    The toxicology data base for methoxyfenozide included acceptable 
developmental toxicity studies in both rats and rabbits as well as a 2-
generation reproductive toxicity study in rats. The data provided no 
indication of increased sensitivity of rats or rabbits to in utero and/
or postnatal exposure to methoxyfenozide. There is a complete toxicity 
data base for methoxyfenozide and exposure data are complete or are 
estimated based on data that reasonably accounts for potential 
exposures. Based on the completeness of the data base and the lack of 
prenatal and postnatal toxicity, EPA determined that an additional 
safety factor was not needed for the protection of infants and 
children.
    Since no acute toxicological endpoints were established, acute 
aggregate risk is considered to be negligible. Using the exposure 
assumptions described in this unit, Rohm and Haas has concluded that 
aggregate exposure to methoxyfenozide from food will utilize 37.6% of 
the cPAD for infants and children. EPA generally has no concern for 
exposures below 100% of the cPAD because the cPAD represents the level 
at or below which daily aggregate dietary exposure over a lifetime will 
not pose appreciable risks to human health. Despite the potential for 
exposure to methoxyfenozide in drinking water, Rohm and Haas does not 
expect the aggregate exposure to exceed 100% of the cPAD. Short and 
intermediate term risks are judged to be negligible due to the lack of 
significant toxicological effects observed. Based on these risk 
assessments, Rohm and Haas concludes that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to methoxyfenozide residues.

F. International Tolerances

    There are no established or proposed Codex, Canadian or Mexican 
limits for residues of methoxyfenozide in/on plant or animal 
commodities. Therefore, no compatibility issues exist with regard to 
the proposed U.S. tolerances.
[FR Doc. 01-12904 Filed 5-22-01; 8:45 am]
BILLING CODE 6560-50-S


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