[Federal Register Volume 64, Number 238 (Monday, December 13, 1999)]
[Rules and Regulations]
[Pages 69409-69415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32183]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300939; FRL-6388-4]
RIN 2070-AB78


Clomazone; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerances for 
residues of clomazone in or on rice (grain and straw). This action is 
in response to EPA's granting of an emergency exemption under section 
18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
authorizing use of the pesticide on rice. This regulation establishes a 
maximum permissible level for residues of clomazone in this food 
commodity. The tolerance will expire and is revoked on December 31, 
2001.

DATES: This regulation is effective December 13, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300939, 
must be received by EPA on or before February 11, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the ``SUPPLEMENTARY 
INFORMATION.'' To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-300939 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: David Deegan, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number: (703) 308-9358; and e-mail address: Deegan.D[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially 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            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

[[Page 69410]]

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 OPP-300939. The official record 
consists of the documents specifically referenced in this action, 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 (CM #2), 1921 Jefferson Davis Hwy., 
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.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(l)(6) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is 
establishing tolerances for residues of the herbicide clomazone, in or 
on rice, grain and in or on rice, straw at 0.05 part per million (ppm). 
These tolerances will expire and be revoked on December 31, 2001. EPA 
will publish a document in the Federal Register to remove the revoked 
tolerances from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.
    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) 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) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    Section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from 
any provision of FIFRA, if EPA determines that ``emergency conditions 
exist which require such exemption.'' This provision was not amended by 
the Food Quality Protection Act of 1996 (FQPA). EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Clomazone on Rice and FFDCA Tolerances

    Several of the rice-producing States in the southern U.S. 
petitioned EPA to authorize the use of clomazone to control barnyard 
grass in rice. The applicants chronicled an ongoing problem faced by 
rice growers, whereby control of barnyard grass is difficult with 
currently registered alternative products, either due to limited 
efficacy, resistance development, or unforseen and undesirable 
environmental repercussions due to their application. EPA has 
authorized under FIFRA section 18 the use of clomazone on rice for 
control of barnyard grass in Arkansas, Louisiana, Mississippi, 
Missouri, and Texas. After having reviewed the submissions, EPA concurs 
that emergency conditions exist in these States.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of clomazone in or on rice. 
In doing so, EPA considered the safety standard in FFDCA section 
408(b)(2), and EPA decided that the necessary tolerance under FFDCA 
section 408(l)(6) would be consistent with the safety standard and with 
FIFRA section 18. Consistent with the need to move quickly on the 
emergency exemption in order to address an urgent non-routine situation 
and to ensure that the resulting food is safe and lawful, EPA is 
issuing this tolerance without notice and opportunity for public 
comment as provided in section 408(l)(6). Although this tolerance will 
expire and is revoked on December 31, 2001, under FFDCA section 
408(l)(5), residues of the pesticide not in excess of the amounts 
specified in the tolerances remaining in or on rice after that date 
will not be unlawful, provided the pesticide is applied in a manner 
that was lawful under FIFRA, and the residues do not exceed a level 
that was authorized by this tolerance at the time of that application. 
EPA will take action to revoke this tolerance earlier if any experience 
with, scientific data on, or other relevant information on this 
pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether clomazone 
meets EPA's registration requirements for use on rice or whether 
permanent tolerances for this use would be appropriate. Under these 
circumstances, EPA does not believe that these tolerances serve as a 
basis for registration of clomazone by a State for special local needs 
under FIFRA section 24(c). Nor do these tolerances serve as the basis 
for any State other than Arkansas, Louisiana, Mississippi, Missouri, 
and Texas to use this pesticide on this crop under section 18 of FIFRA 
without following all provisions of EPA's regulations implementing 
section 18 as identified in 40 CFR part 166. For additional information 
regarding the emergency exemption for clomazone, contact the Agency's 
Registration Division at the address provided under ``FOR FURTHER 
INFORMATION CONTACT.''

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 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).
    Consistent with section 408(b)(2)(D), 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 clomazone 
and to make a determination on aggregate exposure, consistent with 
section 408(b)(2), for time-limited tolerances for residues of

[[Page 69411]]

clomazone on rice (grain and straw) at 0.05 ppm. EPA's assessment of 
the dietary 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 clomazone are 
discussed in this unit.

B. Toxicological Endpoint

    1. Acute toxicity. In reviews of the toxicological characteristics 
of clomazone, no toxicological endpoint was identified for acute oral 
toxicity. Therefore, no acute aggregate risk assessment is required.
    2. Short- and intermediate-term toxicity. For short- and 
intermediate-term MOE calculations, EPA has used the maternal NOAEL of 
100 mg/kg/day from the rat oral developmental toxicity study. At the 
LOAEL of 300 mg/kg/day, there were abdominal stains and decreased 
locomotion.
    3. Chronic toxicity. EPA has established the Reference Dose (RfD) 
for clomazone at 0.043 milligrams/kilograms/day (mg/kg/day). This RfD 
is based on a 2-year feeding study in rats with a NOAEL of 4.3 mg/kg/
day and an uncertainty factor of 100, based on increased liver weights 
and serum cholesterol at the LOAEL of 21.5 mg/kg/day. For this risk 
assessment, EPA has also used the chronic PAD (Population Adjusted 
Dose) of 0.0043 mg/kg/day.
    4. Carcinogenicity. Clomazone has not been classified by EPA in 
regards to carcinogenicity. However, there are no reported cancer 
concerns present at this time, and EPA has reviewed studies indicating 
that clomazone is negative for cancer in two species.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.425) for the residues of clomazone, in or on a variety of raw 
agricultural commodities, including snap beans, cottonseed, soybeans, 
peppers, sweet potatoes, and peas (succulent) at 0.05 ppm and pumpkins, 
winter and summer squash, cucumbers, and cabbage at 0.1 ppm. A time-
limited tolerance for residues of clomazone in/on watermelons at 0.1 
ppm is established in conjunction with a previous section 18 emergency 
exemption authorization. Risk assessments were conducted by EPA to 
assess dietary exposures and risks from clomazone as follows:
    i. 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. Toxicity observed in oral toxicity 
studies were not attributable to a single dose or 1 day exposure. 
Therefore, no toxicological endpoint was identified for acute toxicity 
and no acute dietary risk assessment is required.
    ii. Chronic exposure and risk. The Agency conducted a chronic 
dietary exposure analysis and risk assessment. The chronic analysis for 
exposure to clomazone residues used a chronic PAD of 0.0043 mg/kg/day. 
The analysis evaluated individual food consumption as reported by 
respondents in the USDA 1989-92 ``Continuing Surveys of Food Intake by 
Individuals'' and accumulates exposure to the chemical for each 
commodity. Tolerance level residues and 100 percent crop treated (%CT) 
assumptions were made for the proposed commodities of these emergency 
exemptions, and all other commodities with tolerances for residues of 
clomazone, in order to estimate the Theoretical Maximum Residue 
Contribution (TMRC) for the general population and subgroups of 
interest. The existing clomazone tolerances (published, pending, and 
including the necessary time-limited tolerance in support of the 
emergency exemptions related to this action) result in a TMRC that is 
equivalent to the following percentages of the chronic PAD:


                              Summary: Chronic Exposure Analysis by the DEEM System
----------------------------------------------------------------------------------------------------------------
                      Population Subgroup                         Exposure (mg/kg/day)     Percent Chronic PAD
----------------------------------------------------------------------------------------------------------------
U.S. Population (48 contiguous States)........................                 0.000079                     1.8%
All Infants (<1 year old).....................................                 0.000028                     6.6%
Nursing Infants (<1 year old).................................                 0.000044                     1.0%
Non-Nursing Infants (<1 year old).............................                  0.00039                     9.0%
Children (1-6 years old)......................................                  0.00015                     3.4%
Children (7-12 years old).....................................                 0.000095                     2.2%
----------------------------------------------------------------------------------------------------------------


    2. From drinking water. EPA conducted an assessment of Tier I 
estimated environmental concentrations (EECs) of clomazone for the 
highest registered use rate, and in this review EPA concluded that 
clomazone is metabolized slowly in soil under aerobic conditions and is 
potentially to relatively mobile. Clomazone is somewhat more labile 
under anaerobic conditions. The proposed use is expected to pose 
significant risk to surface water resources.
    i. Ground water. EPA's clomazone ground water estimated 
environmental concentration (EEC) is based upon SCI-GROW2 modeling 
(Screening Concentration In Ground Water). SCI-GROW2 is a prototype 
model for estimating ``worst case'' ground water concentrations of 
pesticides. SCI-GROW2 estimates are based on the fate properties of the 
pesticide, the application rate, and the existing body of data from 
small-scale ground water monitoring studies. The model assumes that the 
pesticide is applied at its maximum rate in areas where the ground 
water is particularly vulnerable to contamination. In most cases, a 
considerable portion of any use area will have ground water that is 
less vulnerable to contamination than the areas used to derive the SCI-
GROW2 estimates. SCI-GROW2 estimates are biased in that studies where 
the pesticide is not detected in ground water are not included in the 
data set. Thus, it is not expected that SCI-GROW2 estimates would be 
exceeded.
    The SCI-GROW2 model estimates that the concentration of clomazone 
in ground water is not likely to exceed an acute and chronic EEC of 
0.97 g/L for the proposed application rate of 0.6 pound (lb) 
active ingredient per acre (ai/acre) with a maximum of one application.
    ii. Surface water. EPA used the Generic Expected Environmental 
Concentration (GENEEC) model to determine concentrations of clomazone 
in surface water. GENEEC is used to estimate pesticide concentrations 
in

[[Page 69412]]

surface water for up to 56 days after a single runoff event. GENEEC 
simulates a 1 hectare by 2 meters deep edge-of-the-field farm pond 
(with no outlet) which receives pesticide runoff from a treated 10 
hectare field. GENEEC provides an upper-bound concentration value. 
GENEEC can substantially overestimate (by a 3-fold factor) 
true pesticide concentrations in drinking water. GENEEC does have 
certain limitations and is not the ideal tool for use in drinking water 
risk assessments. However, it can be used in screening calculations and 
does provide an upper bound value for the concentration of pesticides 
that can be found in drinking water. Since GENEEC can substantially 
overestimate true drinking water concentrations, it will be necessary 
to refine the GENEEC estimate when the drinking water levels of 
comparison are exceeded. In those situations where the level of 
comparison is exceeded and the GENEEC value is a substantial part of 
the total exposure, EPA can use a variety of methods to refine the 
exposure estimates. Using the GENEEC model and available environmental 
fate data, EPA calculated the Tier 1 chronic (56-day) EEC for clomazone 
would be 16.1 g/L based on a total annual use rate of 0.6 lb 
ai/acre (i.e. 1 application at 0.6 lb ai/acre). See IV.D. for 
discussion of how these exposure values have been addressed in the risk 
assessment for this tolerance-setting action.
    iii. Chronic exposure and risk. Because the Agency lacks sufficient 
water-related exposure data to complete a comprehensive drinking water 
risk assessment for many pesticides, EPA has commenced and nearly 
completed a process to identify a reasonable yet conservative bounding 
figure for the potential contribution of water-related exposure to the 
aggregate risk posed by a pesticide. In developing the bounding figure, 
EPA estimated residue levels in water for a number of specific 
pesticides using various data sources. The Agency then applied the 
estimated residue levels, in conjunction with appropriate toxicological 
endpoints (RfDs or acute dietary no observed adverse effect levels 
(NOAELs)) and assumptions about body weight and consumption, to 
calculate, for each pesticide, the increment of aggregate risk 
contributed by consumption of contaminated water. While EPA has not yet 
pinpointed the appropriate bounding figure for exposure from 
contaminated water, the ranges the Agency is continuing to examine are 
all below the level that would cause clomazone to exceed the RfD if the 
tolerance being considered in this document were granted. The Agency 
has therefore concluded that the potential exposures associated with 
clomazone in water, even at the higher levels the Agency is considering 
as a conservative upper bound, would not prevent the Agency from 
determining that there is a reasonable certainty of no harm if the 
tolerance is granted.
    3. From non-dietary exposure. Clomazone is currently not registered 
for use on residential non-food sites. Thus, a residential exposure 
assessment for clomazone is not required.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. 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.''
    Clomazone is a member of the pyridazones/pyridinones class of 
herbicides. Other members of this class include purazon, norflurazon, 
fluridone, oxadiazon, fluorochloridone, amitrol, and dithiopyr. EPA 
does not have, at this time, available data to determine whether 
clomazone 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, clomazone 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 
clomazone has a common mechanism of toxicity with other substances. For 
more 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. Aggregate Risks and Determination of Safety for U.S. Population

    1. Drinking water assessment. In the absence of drinking water 
monitoring data, EPA assesses the aggregate dietary risk by using the 
worst-case scenario of EECs found from either ground or surface water. 
The EECs reported for clomazone residues in ground water using SCI-
GROW2 is 0.97 g/L. This is much less than the surface water 
EEC (16.1 g/L for chronic risk assessment) generated using 
GENEEC. Therefore, only the surface water EEC for clomazone will be 
used for purposes of comparing with the calculated drinking water 
levels of comparison (DWLOC).
    2. Acute risk. No toxicological endpoint was identified for acute 
oral toxicity. Therefore, no acute aggregate risk assessment is 
required.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure. No short- or intermediate-term oral toxicological 
endpoints were identified. Also, clomazone has no residential uses. 
Thus, no risk assessments were conducted for short- and intermediate-
term exposure.
    4. Chronic risk --i. Food only. Using the conservative TMRC 
exposure assumptions described above, and taking into account the 
completeness and reliability of the toxicity data, EPA has determined 
that chronic dietary exposure to clomazone residues from food will 
utilize up to a maximum of 9.0% (for the population subgroup non-
nursing infants) of the chronic PAD for subgroups including infants and 
children (see additional discussion below), and up to a maximum of 2.5% 
of the chronic PAD for subgroups including adults. Chronic dietary 
exposure to clomazone residues from food for all other population 
subgroups results in utilization of a smaller percentage of the chronic 
PAD.
    ii. Water only. Based on the chronic dietary (food only) exposure, 
chronic (non-cancer) DWLOCs were calculated. To calculate the chronic 
DWLOCs, the chronic dietary food exposure (from the DEEM analysis) was 
subtracted from the chronic PAD to give the maximum allowable exposure 
level for drinking water. DWLOCs were then calculated using the default 
body weights and drinking water consumption figures.
    iii. Food plus water. The estimated 56-day concentration of 
clomazone in surface water (16.1 g/L) is less than EPA's 
levels of comparison for clomazone in drinking water as a contribution 
to chronic aggregate exposure (1.5 x 102 g/L for adult males, 
1.3 x 102 g/L for adult females, and 39 g/L for 
infants/children). Therefore, taking into account the registered uses 
and the use proposed in the emergency exemptions resulting in this 
tolerance-setting action, EPA concludes with reasonable certainty that 
residues of clomazone in drinking water (when considered along with 
other sources of chronic exposure for which EPA has reliable data) 
would not result in unacceptable levels of chronic aggregate human 
health risk estimates

[[Page 69413]]

for adult and infants/children population subgroups at this time.
    EPA bases this determination on a comparison of estimated average 
concentrations of clomazone in surface water to back-calculated 
``levels of comparison'' for clomazone in drinking water. These levels 
of comparison in drinking water were determined after EPA has 
considered all other non-occupational human exposures for which it has 
reliable data, including all currently registered uses, and uses 
considered in this action. The estimates of clomazone in surface water 
are derived from water quality models that use conservative assumptions 
(health-protective) regarding the pesticide transport from the point of 
application to surface water. Because EPA considers the aggregate risk 
resulting from multiple exposure pathways associated with a pesticide's 
uses, levels of comparison in drinking water may vary as those uses 
change. If new uses are added in the future, EPA will reassess the 
potential impacts of clomazone in drinking water as a part of the 
chronic (non-cancer) aggregate risk assessment process.
    EPA generally has no concern for exposures below 100% of the 
chronic PAD because the chronic PAD represents the level at or below 
which average daily life-time exposure will not pose appreciable risks 
to human health. Despite the potential for exposure to clomazone in 
drinking water, EPA does not expect the chronic aggregate exposure to 
exceed 100% of the chronic PAD for population subgroups which include 
adults, infants, or children. EPA concludes that there is a reasonable 
certainty that no harm will result to adults and infants or children 
from chronic aggregate exposure to clomazone residues.
    4. Aggregate cancer risk for U.S. population. Clomazone has not 
been classified by EPA in regards to carcinogenicity. However, there 
are no reported cancer concerns at this time and clomazone is negative 
for cancer in two species studies. Thus, a cancer risk assessment was 
not performed for this chemical.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to clomazone residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children -- i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of clomazone, 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 
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 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 MOE and uncertainty factor (usually 100 for 
combined interspecies and intraspecies variability) and not the 
additional tenfold MOE/uncertainty factor 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 concerns regarding the adequacy of the standard 
MOE/safety factor.
    Information concerning the possibility of enhanced sensitivity of 
infants and children when exposed to clomazone has not yet been 
presented to, and/or reviewed by, EPA. Therefore, EPA has assumed that 
the FQPA Safety Factor (for enhanced sensitivity of infants and 
children as required by the FQPA) has been retained and is applicable 
to all oral endpoints for the purposes of this tolerance-setting 
action.
    ii. Developmental toxicity studies --a. Rat. From the rat 
developmental toxicity study, the maternal (systemic) NOAEL was 100 mg/
kg/day, based on decreased locomotion and abdominal staining at the 
LOAEL of 300 mg/kg/day. The developmental (pup) NOAEL was 100 mg/kg/
day, based on delayed ossification at the LOAEL of 300 mg/kg/day.
    b. Rabbit. From the rabbit developmental toxicity study, the 
maternal (systemic) NOAEL was 240 mg/kg/day, based on decreased body 
weight gain at the LOAEL of 700 mg/kg/day. The developmental (pup) 
NOAEL was 700 mg/kg/day at the highest dose tested.
    iii. Reproductive toxicity study -- Rat. From the rat reproductive 
toxicity study, the maternal (systemic) NOAEL was 50 mg/kg/day, based 
on decreased body weight, food consumption, clinical signs, and organ 
weight changes at the LOAEL of 100 mg/kg/day. The reproductive (pup) 
NOAEL was 5 mg/kg/ day, based on decreased pup viability, reduced 
survival, and decreased body weight at the LOAEL of 50 mg/kg/day.
    iv. Conclusion. There is a complete toxicity data base for 
clomazone and exposure data are complete or are estimated based on data 
that reasonably accounts for potential exposures.
    2. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to clomazone from food 
will utilize (no greater than 9%) 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 clomazone in 
drinking water, EPA does not expect the aggregate exposure to exceed 
100% of the cPAD.
    3. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to clomazone residues.

V. Other Considerations

A. Metabolism in Plants and Animals

    The nature of the residue in plants and animals is adequately 
understood. The residue of concern is clomazone per se as specified in 
40 CFR 180.425.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology (GLC/NPD or GLC/MS) are available 
(PAM II) for enforcement of clomazone residues. Additionally, clomazone 
is adequately recovered (>80%) via the FDA Multiresidue Methods of PAM 
I (Pestrak, 1990).

C. Magnitude of Residues

    1. Residues of clomazone per se are not expected to exceed 0.05 ppm 
in/on rice, grain and rice, straw. Time-limited tolerances are hereby 
being established at this level.
    2. A rice processing study has been reviewed by EPA. In this 
review, EPA has concluded that residues of clomazone do not concentrate 
when rice grain containing detectable residues is processed into 
polished rice, hulls, and

[[Page 69414]]

bran. Thus, tolerances are not required for processed rice products.
    3. A review of this use concluded that residues in meat, milk, 
poultry and, eggs are not expected.

D. International Residue Limits

    There are no Codex, Canadian or Mexican limits for clomazone in/on 
rice commodities. Therefore, compatibility problems are not expected 
from the establishment of a tolerance for clomazone on rice 
commodities.

E. Rotational Crop Restrictions

    Adequate rotational crop restrictions are included on the label for 
Command 3ME. These restrictions state that cotton, peas, peppers, 
pumpkins, soybeans, and tobacco may be rotated at anytime. After 9 
months the following crops may be rotated: cotton, dry beans, sweet 
potatoes, corn (filed, pop, seed and sweet), peanuts, tomatoes 
(transplanted), potatoes, cucurbits, rice, sugar beets, snap beans, and 
sorghum. After 12 months all crops may be rotated. The label also 
includes the statement ``do not graze or harvest for food or feed cover 
crops planted less than 9 months after Command 3ME treatment.''

VI. Conclusion

    Therefore, the tolerance is established for residues of clomazone 
in rice at 0.05 ppm.

VII. 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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 control number OPP-300939 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 February 
11, 2000.
    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 (1900), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
You may also deliver your request to the Office of the Hearing Clerk in 
Rm. M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. 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 (202) 260-4865.
    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, 401 M St., SW., Washington, DC 20460.
    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, 401 M St., SW., 
Washington, DC 20460.
    3.  Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.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 the docket control number OPP-300939, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. 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 file format 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).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408. 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). 
This final rule does not contain any information collections

[[Page 69415]]

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 
prior consultation as specified by Executive Order 13084, entitled 
Consultation and Coordination with Indian Tribal Governments (63 FR 
27655, May 19, 1998); special considerations as required by Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or require 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 FIFRA section 18 petition under FFDCA section 408, 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 FFDCA section 408(n)(4).

IX. Submission to Congress and the General Accounting Office

    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: November 24, 1999.

James Jones,
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.

    2. In Sec. 180.425, by alphabetically adding to the table in 
paragraph (b), the following commodities to read as follows:


Sec. 180.425   Clomazone; tolerances for residues.

*        *        *        *        *
    (b)    *    *    *

 
----------------------------------------------------------------------------------------------------------------
                                                                                          Expiration/revocation
                           Commodity                               Parts per million               date
----------------------------------------------------------------------------------------------------------------
Rice, grain...................................................                     0.05                 12/31/01
Rice, straw...................................................                     0.05                 12/31/01
 
                                      *        *        *        *        *
----------------------------------------------------------------------------------------------------------------

*        *        *        *        *

[FR Doc. 99-32183 Filed 12-10-99; 8:45 am]
BILLING CODE 6560-50-F