[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.Dave@epa.gov.
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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov. 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
