[Federal Register Volume 62, Number 117 (Wednesday, June 18, 1997)]
[Rules and Regulations]
[Pages 33012-33019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15981]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300504; FRL-5722-5]
RIN 2070-AB78
Metolachlor; Pesticide Tolerances for Emergency Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of the herbicide metolachlor [2-chloro-N-(2-ethyl-6-
methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide] and its
metabolites, determined as the derivatives, 2-[(2-ethyl-6-
methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-
hydroxy-5-methyl-3-morpholinone, each expressed as the parent compound,
in or on the raw agricultural commodity tomato, in tomato puree, and in
tomato paste, in connection with EPA's granting an emergency exemption
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act authorizing use of the pesticide on tomato in Ohio, Indiana,
Michigan and Pennsylvania. The tolerances will expire and are revoked
on December 31, 1998.
DATES: This regulation becomes effective June 18, 1997. Objections and
requests for hearings must be received by EPA on or before August 18,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300504], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300504], must be submitted to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, bring a copy of objections and hearing
requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300504]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Olga Odiott, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail: Crystal Mall #2, 1921 Jefferson
Davis Highway, Arlington, VA 22202. (703) 308-9363, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for
residues of the herbicide [2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-
methoxy-1-methylethyl)acetamide] and its metabolites (determined as the
derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-
ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed
as the parent compound), also referred to in this document as
metolachlor, in or on tomato at 0.1 part per million (ppm), tomato
puree at 0.3 ppm and tomato paste at 0.6 ppm. These tolerances will
expire and be revoked by EPA on December 31, 1998. After December 31,
1998, EPA will publish a document in the Federal Register to remove the
revoked tolerances from the Code of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the FFDCA, 21
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Among other things, FQPA
amends FFDCA to bring all EPA pesticide tolerance-setting activities
under section 408 with a new safety standard and new procedures. These
activities are described below and discussed in greater detail in the
final rule establishing the time-limited tolerance associated with the
emergency exemption for use of propiconazole on sorghum (61 FR 58135,
November 13, 1996) (FRL-5572-9).
New 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 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 FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166. 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.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
[[Page 33013]]
II. Emergency Exemption for Metolachlor on Tomato and FFDCA
Tolerances
The Eastern black nightshade (Solanum nigrum) is a common annual
weed found in tomato fields. Currently registered herbicides for use on
tomatoes have little or no effect in controlling the eastern black
nightshade. Chloramben (amiben) is the most effective herbicide for
this weed, but it has not been manufactured since 1991 and grower's
reserves of the herbicide have been depleted. Hand hoeing is utilized,
but it does not provide complete control and is very expensive. The
Applicants stated that since this weed is ubiquitous and hand hoeing
does not provide complete control, the weed population is increasing
and threatening the economic viability of the tomato industry in their
states. EPA has authorized under FIFRA section 18 the use of
metolachlor on tomato for control of Eastern black nightshade. After
having reviewed the submissions, EPA concurs that emergency conditions
exist for these states.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of metolachlor in or on
tomatoes. In doing so, EPA considered the new safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerances under
FFDCA section 408(l)(6) would be consistent with the new safety
standard and with FIFRA section 18. These tolerances will permit the
marketing of tomatoes treated in accordance with the provisions of the
section 18 emergency exemption. 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 these tolerances without notice and opportunity
for public comment under section 408(e), as provided in section
408(l)(6). Although these tolerances will expire and are revoked on
December 31, 1998, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on tomatoes after that date will not be unlawful,
provided the pesticide is applied during the term of, and in accordance
with all the conditions of, section 18 of FIFRA. EPA will take action
to revoke these tolerances earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
EPA has not made any decisions about whether metolachlor meets
EPA's registration requirements for use on tomatoes or whether
permanent tolerances for this use would be appropriate. These
tolerances do not serve as a basis for registration of metolachlor 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 Ohio, Indiana,
Michigan and Pennsylvania, to use this pesticide on this crop under
section 18 of FIFRA without following all provisions of section 18 as
identified in 40 CFR part 166. For additional information regarding the
emergency exemption for metolachlor, contact the Agency's Registration
Division at the address provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. For many
of these studies, a dose response relationship can be determined, which
provides a dose that causes adverse effects (threshold effects) and
doses causing no observed effects (the ``no-observed effect level'' or
``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. The TMRC is a
``worst case'' estimate since it is based on the assumptions that food
contains pesticide residues at the tolerance level and that 100% of the
crop is treated by pesticides that have established tolerances. If the
TMRC exceeds the RfD or poses a lifetime cancer risk that is greater
than approximately one in a million, EPA attempts to derive a more
accurate exposure estimate for the pesticide by evaluating additional
types of information (anticipated residue data and/or percent of crop
treated data) which show, generally, that pesticide residues in most
foods when they are eaten are well below established tolerances.
[[Page 33014]]
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action.
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 metolachlor are
discussed below.
1. Acute toxicity. The EPA has determined that the available data
do not indicate the potential for adverse effects after a single
dietary exposure.
2. Short- and intermediate term toxicity. The EPA has determined
that a NOEL of 100 mg/kg/day from a 21-day dermal toxicity study on
rats should be used to assess risks from intermediate-term dermal
exposures. At the lowest effect level (LEL) of 1,000 mg/kg/day, there
were dose-related increases in minor histopathological alterations of
the skin, in total bilirubin (females), in absolute and relative liver
weights (males), and in relative kidney weights (females). An
inhalation exposure intermediate-term hazard was not identified. The
EPA has determined that the available data do not indicate the
potential for adverse effects from short-term dermal or inhalation
exposures.
3. Chronic risk. Based on the available chronic toxicity data, the
EPA has established the RfD for metolachlor at 0.10 mg/kg/day. The RfD
was established based on the results of a 1-year feeding study in dogs
with a NOEL of 9.7 mg/kg/day, and an uncertainty factor of 100 based on
decreased body weight gain at the LEL of 33 mg/kg/day.
4. Cancer risk. Using its Guidelines for Carcinogen Risk Assessment
published September 24, 1986 (51 FR 33992), the EPA has classified
metolachlor as a Group C, ``possible human carcinogen'', chemical. The
classification as a Group C chemical was based on the increased
incidence of adenomas and combined adenomas/carcinomas in female rats,
both by pair-wise and trend analysis and the replication of this
finding in a second study. The OPP Carcinogenicity Peer Review
Committee (CPRC) recommended the quantitation of risk by MOE estimates
using a NOEL of 15.7 mg/kg/day from a 2-year feeding study in rats. The
structural relationship of metolachlor to acetochlor and alachlor was
of concern to the CPRC. However, in light of new information on the
relative metabolism of these chemicals, and since there was no
supportable mutagenicity concern, the CPRC recommended the MOE
approach.
B. Exposures and Risks
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures from the pesticide residue
in food and all other non-occupational exposures. The primary non-food
sources of exposure the Agency looks at include drinking water (whether
from groundwater or surface water), and exposure through pesticide use
in gardens, lawns, or buildings (residential and other indoor uses). In
evaluating food exposures, EPA takes into account varying consumption
patterns of major identifiable subgroups of consumers, including
infants and children.
1. From food and feed uses. Tolerances have been established (40
CFR 180.368) for the combined residues of metolachlor [2-chloro-N-(2-
ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide] and its
metabolites, determined as the derivatives, 2-[(2-ethyl-6-
methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-
hydroxy-5-methyl-3-morpholinone, each expressed as the parent compound
in or on a variety of raw agricultural commodities at levels ranging
from 0.02 ppm in milk and numerous animal commodities to 30 ppm in
peanut forage and hay. Risk assessments were conducted by EPA to assess
dietary exposures and risks from metolachlor as follows:
i. Acute 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 one day
or single exposure. The available data for metolachlor do not indicate
the potential for adverse effects after a single dietary exposure.
ii. Chronic risk. For the chronic dietary (food only) risk
assessment OPP used percent crop-treated data for selected commodities
and assumed tolerance level residues. OPP also assumed that 100% of
tomatoes were treated. The population subgroups with the largest
percentage of the RfD occupied are non-nursing infants less than 1 year
old and children 1 to 6 years old, both at 2.3% of the RfD. This risk
estimate should be viewed as conservative; further refinement using
anticipated residue levels and additional percent crop-treated values
analysis would result in lower dietary exposure estimates. Thus, in
making a safety determination for these tolerances, EPA is taking into
account this conservative exposure assessment.
iii. Cancer risk. Based on the OPP CPRC recommendation that the MOE
approach be used to assess cancer risk, a quantitative cancer risk
assessment was not performed. Human health risk concerns due to long
term exposure to metolachlor residues are adequately addressed by the
aggregate chronic exposure analysis using the MOE approach.
2. From drinking water. Based on the available environmental fate
studies, metolachlor appears to be moderately persistent and ranges
from being mobile to highly mobile in different soils. Data collected
from around the United States provides evidence that metolachlor
leaches into ground water, occasionally at levels that exceed the
Lifetime Health Advisory (HA) Level of 100 ppb. The ``Pesticides in
Groundwater Database'' (EPA 734-12-92-001, Sept. 1992), indicates that
metolachlor residues were detected in wells in 20 states. Levels
exceeded the lifetime HA in three wells located in Wisconsin, New York,
and Montana. In eight other states concentrations in some well waters
exceeded 10% of the HA. Incident reports submitted under 6(a)2 of FIFRA
describe 47 detections of metolachlor in the ground water of seven
states at concentrations ranging from 0.11 ppb to 116 ppb. Metolachlor
is not yet formally regulated under the Safe Drinking Water Act;
therefore, no enforcement Maximum Contaminant Level (MCL) has been
established for it. Metolachlor also has relatively high health
advisory levels (1-10 day HA level of 2,000 ppb and lifetime HA level
of 100 ppb).
Based on available data, it appears highly unlikely that maximum or
short-term average metolachlor concentrations will exceed the 1-10 day
HA levels of 2,000 ppb or that annual average metolachlor
concentrations will exceed
[[Page 33015]]
the lifetime HA of 100 ppb anywhere. As part of the risk mitigation in
the metolachlor Reregistration Eligibility Document (RED), additional
label restrictions designed to minimize ground and surface water
contamination are required. Groundwater concerns may be mitigated by
adhering to these label restrictions and advisory statements.
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 (RfD's
or acute dietary NOEL's)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 metolachlor 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 metolachlor 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
tolerances are granted.
3. From non-dietary exposure. Metolachlor is registered for outdoor
residential lawn use, use on numerous ornamental plants and trees,
highway rights-of-way and recreational areas.
i. Acute risk. EPA generally will not include residential or other
non-dietary exposure as a component of the acute exposure assessment.
Theoretically, it is also possible that a residential, or other non-
dietary, exposure could be combined with the acute total dietary
exposure from food and water. However, the Agency does not believe that
aggregating multiple exposure to large amounts of pesticide residues in
the residential environment via multiple products and routes for a one
day exposure is a reasonably probable event. It is highly unlikely
that, in one day, an individual would have multiple high-end exposures
to the same pesticide by treating their lawn and garden, treating their
house via crack and crevice application, swimming in a pool, and be
maximally exposed in the food and water consumed. Additionally, the
concept of an acute exposure as a single exposure does not allow for
including post-application exposures, in which residues decline over a
period of days after application. Therefore, the Agency believes that
residential exposures are more appropriately included in the short-term
exposure scenario discussed below.
ii. Chronic risk. The Agency has concluded that a chronic
residential exposure scenario does not exit for non-occupational uses
of metolachlor.
iii. Short- and intermediate-term risk. There are residential uses
of metolachlor and EPA acknowledges that there may be shortand
intermediate-term non-occupational exposure scenarios. The EPA has
identified a toxicity endpoint for intermediate-term residential risks.
However, no acceptable reliable exposure data to assess the potential
risks are available at this time. Based on the high level of the
intermediate-term toxicity endpoint (NOEL = 100 mg/kg/day and lowest
observed effect level (LOEL) = 1,000 mg/kg/day), the Agency does not
expect the intermediate-term aggregate risk to exceed the level of
concern. A short-term non-dietary toxicity endpoint was not identified
for metolachlor.
C. Cumulative Exposure to Substances with 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.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
EPA does not have, at this time, available data to determine
whether metolachlor 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,
metolachlor 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 metolachlor has a common mechanism of toxicity
with other substances.
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. The available data for metolachlor do not indicate
the potential for adverse effects from acute dietary exposures. An
acute aggregate risk assessment was not conducted.
2. 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. Based on the low percentage of the RfD occupied
by the chronic dietary exposure (<3% for all population subgroups) and
the high level of the intermediate-term toxicity endpoint (NOEL = 100
mg/kg/day and LOEL = 1,000 mg/kg/day), in the best
[[Page 33016]]
scientific judgment of EPA, the intermediate-term aggregate risk will
not exceed the Agency's level of concern. Despite the potential for
exposure to metolachlor in drinking water, EPA does not expect the
aggregate exposure to exceed 100% of the RfD.
Since a short-term toxicity endpoint was not identified for
metolachlor, a short-term aggregate risk assessment was not conducted.
3. Chronic risk. Using the conservative exposure assumptions
described above, taking into account the completeness and reliability
of the toxicity data, EPA has concluded that aggregate dietary exposure
to metolachlor from food will utilize 1.1% of the RfD for the U.S.
population. EPA generally has no concern for exposures below 100% of
the RfD because the RfD 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
metolachlor in drinking water, EPA does not expect the aggregate
exposure to exceed 100% of the RfD. EPA concludes that there is a
reasonable certainty that no harm will result from aggregate exposure
to metolachlor residues.
4. Cancer risk. Based on the CPRC recommendation that the MOE
approach be used to assess cancer risk, a quantitative cancer risk
assessment was not performed. Based on the aggregate chronic dietary
analysis, the calculated MOE (food only) for the U.S. Population (48
States) is > 20,000. Other than dietary exposure, no chronic exposure
scenarios have been identified from registered uses of metolachlor. The
chronic dietary risk from the currently registered, and this proposed
Section 18 use of metolachlor, do not exceed the Agency's level of
concern. The EPA believes that the potential additional exposure in
drinking water would not significantly lower the chronic dietary MOE.
The Agency concluded that the human health risk concerns due to long-
term exposure to metolachlor residues are adequately addressed by the
aggregate chronic exposure analysis using the MOE approach.
E. Aggregate Risks and Determination of Safety for Infants and Children
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 pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a MOE analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. In either case, EPA generally defines the level of appreciable
risk as exposure that is greater than 1/100 of the NOEL in the animal
study appropriate to the particular risk assessment. EPA believes that
reliable data support using the standard MOE and uncertainty factor
(usually 100 for combined inter- and intra-species 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.
In assessing the potential for additional sensitivity of infants
and children to residues of metolachlor, EPA considered data from
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity
studies are designed to evaluate adverse effects on the developing
organism resulting from pesticide exposure during prenatal development
to one or both parents. Reproduction studies provide information
relating to effects from exposure to the pesticide on the reproductive
capability of mating animals and data on systemic toxicity.
1. Developmental toxicity studies.--i. Rat. The maternal NOEL was
300 mg/kg/day. At the maternal LEL of 1,000 mg/kg/day, there were
deaths, increased salivation, lacrimation, convulsions, reduced body
weight gain, and reduced feed consumption. The developmental NOEL was
also 300 mg/kg/day. The developmental LEL of 1,000 mg/kg/day was based
on reduced mean fetal body weight, reduced number of implantations/dam
with resulting decreased litter size, and a slight increase in
resorptions/dam with resulting increase in post-implantation loss.
ii. Rabbit. The maternal NOEL was 120 mg/kg/day. The maternal LEL
of 360 mg/kg/day was based on lacrimation, miosis, reduced food
consumption and decreased body weight gain. The developmental NOEL was
360 mg/kg/day at the highest dose tested (HDT).*
2. Reproductive toxicity study (Rat). In the two-generation
reproductive toxicity study the reproductive/ developmental toxicity
NOEL of 23 mg/kg/day was less than the parental (systemic) toxicity
NOEL of >76 mg/kg/day (HDT). The reproductive/developmental NOEL was
based on decreased pup body weight during late lactation.
3. Pre- and post-natal sensitivity. Based on current toxicological
data requirements, the data base for metolachlor relative to pre- and
post-natal toxicity is complete. The developmental toxicity NOELs of
300 mg/kg/day (in rats) and 360 mg/kg/day (HDT in rabbits)
demonstrate that there is no increased sensitivity to metolachlor by
the developing fetus (pre-natal) in the presence of maternal toxicity.
There was developmental toxicity in rats at 1,000 mg/kg/day (but not in
rabbits). The developmental NOELs are more than 30- and 37-fold higher
in the rats and rabbits, respectively, than the NOEL of 9.7 mg/kg/day
from the 1-year feeding study in dogs, which is the basis of the RfD.
In the two-generation reproductive toxicity study in rats, the
reproductive/developmental toxicity NOEL of 23 mg/kg/day was less than
the parental (systemic) toxicity NOEL of >76 mg/kg/day. The
reproductive/developmental NOEL was based on decreased pup body weight
during late lactation and the NOEL occurred at a level which is below
the NOEL for parental toxicity (>76 mg/kg/day). This finding suggests
that pups are more sensitive to metolachlor than adult animals. For
purposes of this Section 18 only, an additional 3x uncertainty factor
was added to the RfD.
The TMRC value for the most highly exposed infant and children
subgroup (non-nursing infants <1 year old) occupies 6.9% of the RfD
(with the additional 3x safety factor). This estimate should be viewed
as conservative, since is based on percent crop-treated data for
selected crops and tolerance level residues for all commodities.
Refinement of the dietary risk assessment by using additional percent
crop treated and anticipated residue data would reduce dietary
exposure. Therefore, this risk assessment is an over-estimate of
dietary risk.
4. Acute risk. The available data for metolachlor do not indicate
the potential for adverse effects from acute dietary exposures.
5. 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. A short-term non-dietary toxicity endpoint was
not identified for metolachlor. Using the conservative exposure
assumptions described above, EPA has concluded that the percent of
[[Page 33017]]
the RfD that will be utilized by aggregate exposure to residues of
metolachlor is 6.9 % (using an additional 3x safety factor) for non-
nursing infants less than 1 year old (the most highly exposed
population subgroup). Based on the low percentage of the RfD occupied
by the chronic dietary exposure and the high level of the intermediate-
term toxicity endpoint (NOEL = 100 mg/kg/day and LOEL = 1,000 mg/kg/
day), in the best scientific judgment of EPA, the intermediate-term
aggregate risk will not exceed the Agency's level of concern. Despite
the potential for exposure to metolachlor in drinking water, EPA does
not expect the aggregate exposure to exceed 100% of the RfD.
6. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that the percent of the RfD that
will be utilized by aggregate exposure to residues of metolachlor
ranges from 6.9 % for non-nursing infants less than one year old, down
to 1.8 % for nursing infants less than one year old (using an
additional 3x safety factor). EPA generally has no concern for
exposures below 100% of the RfD because the RfD 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 metolachlor in drinking water and from non-dietary, non-
occupational exposure, EPA does not expect the aggregate exposure to
exceed 100% of the RfD. EPA concludes that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to metolachlor residues.
V. Other Considerations
A. Metabolism in Plants and Animals
The nature of the residue in plants and animals is adequately
understood. Tolerances for residues of metolachlor in or on food/feed
commodities are currently expressed in terms of the combined residues
(free and bound) of the herbicide metolachlor ([2-chloro-N-(2-ethyl-6-
methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide]) and its
metabolites, determined as the derivatives, 2-[(2-ethyl-6-
methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-
hydroxy-5-methyl-3-morpholinone, each expressed as the parent compound
(40 CFR 180.368).
2. Analytical enforcement methodology. Adequate methods for
purposes of data collection and enforcement of tolerances for
metolachlor residues are available. Methods for determining the
combined residues of metolachlor and its metabolites, as the
derivatives CGA-37913 and CGA-49751, are described in PAM, Vol. II, as
Method I (plants; GC-NPD) and Method II (animals; GC-MS).
3. Magnitude of residues. Regulable residues of metolachlor are not
expected to exceed 0.1 ppm in/on tomatoes as a result of this Section
18 use. A time-limited tolerance should be established at this level.
Residues of metolachlor appear to concentrate in the tomato processed
commodities of tomato puree (3x) and paste (6x). Regulable residues of
metolachlor are not expected to exceed 0.3 ppm in tomato puree and 0.6
ppm in tomato paste a result of this Section 18 use. Time-limited
tolerances should be established at these levels. Secondary residues
are not expected in animal commodities as no feed items are associated
with this Section 18 use.
4. International residue limits. There are no CODEX or Mexican
residue limits for metolachlor on tomatoes. There is a Canadian residue
limit of 0.1 ppm for the parent compound.
5. Rotational crop restrictions. Rotational crop restrictions are
stated on the DUAL and DUAL 8E product labels.
VI. Conclusion
Therefore, tolerances in connection with the FIFRA section 18
emergency exemptions are established for residues of the herbicide [2-
chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide]
and its metabolites (determined as the derivatives, 2-[(2-ethyl-6-
methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-
hydroxy-5-methyl-3-morpholinone, each expressed as the parent compound)
also referred to in this document as metolachlor, in or on tomato at
0.1 part per million (ppm), in tomato puree at 0.3 ppm and in tomato
paste at 0.6 ppm.
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by August 18, 1997, file written objections to any
aspect of this regulation (including the revocation provision) and may
also request a hearing on those objections. Objections and hearing
requests must be filed with the Hearing Clerk, at the address given
above (40 CFR 178.20). A copy of the objections and/or hearing requests
filed with the Hearing Clerk should be submitted to the OPP docket for
this rulemaking. The objections submitted must specify the provisions
of the regulation deemed objectionable and the grounds for the
objections (40 CFR 178.25). Each objection must be accompanied by the
fee prescribed by 40 CFR 180.33(I). If a hearing is requested, the
objections must include a statement of the factual issues on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the requestor (40 CFR 178.27). A
request for a hearing will be granted if the Administrator determines
that the material submitted shows the following: There is 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 in the manner sought by the requestor
would be adequate to justify the action requested (40 CFR 178.32).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as Confidential Business Information (CBI). Information so
marked will not be disclosed except in accordance with procedures set
forth in 40 CFR part 2. A copy of the 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.
VIII. Public Docket
A record has been established for this rulemaking under docket
control number [OPP-300504]. A public version of this record, which
does not include any information claimed as CBI, is available for
inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
[[Page 33018]]
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly EPA
will transfer any copies of objections and hearing requests received
electronically into printed, paper form as they are received and will
place the paper copies in the official rulemaking record which will
also include all comments submitted directly in writing. The official
rulemaking record is the paper record maintained at the address in
``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes a time-limited tolerance under section
408 of the FFDCA and is related to EPA's granting emergency exemptions
under section 18 of the FIFRA. 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). In addition, this final rule does not contain any
information collections subject to additional 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) (Pub. L.
104-4). Nor does it require any prior consultation as specified by
Executive Order 12875, entitled Enhancing the Intergovernmental
Partnership (58 FR 58093, October 28, 1993), or 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 in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, because these tolerances are established without
notice and comment rulemaking, the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. Nonetheless,
the Agency has previously assessed whether establishing tolerances,
exemptions from tolerances, raising tolerance levels or expanding
exemptions might adversely impact small entities and concluded, as a
generic matter, that there is no significant adverse economic impact
associated with these actions (46 FR 24950, May 4, 1981). In accordance
with Small Business Administration (SBA) policy, this determination
will be provided to the Chief Counsel for Advocacy of the SBA upon
request.
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted
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 General Accounting Office prior to publication of this rule in
today's Federal Register. This 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: June 5, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.368 is amended as follows:
i. In paragraph (a) by adding the heading.
ii. In paragraph (b) by transferring and alphabetically adding the
entries in the table to the table in paragraph (a) and by removing the
remaining text.
iii. In paragraph (c) by adding the heading.
iv. By adding a heading and reserving new paragraph (d).
v. By redesignating paragraph (e) as paragraph (b) and revising
newly redesignated paragraph (b).
Sec. 180.368 Metolachlor; tolerances for residues.
(a) General. * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the combined residues (free and bound) of the herbicide
metolachlor [2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide] and its metabolites, determined as the
derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-
ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed
as the parent compound in connection with use of the pesticide under
section 18 emergency exemptions granted by EPA. The tolerance is
specified in the following table. The tolerances will expire and are
revoked on the dates specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Spinach........................... 0.3 11/15/98
Tomato paste...................... 0.6 12/31/98
Tomato puree...................... 0.3 12/31/98
Tomatoes.......................... 0.1 12/31/98
------------------------------------------------------------------------
[[Page 33019]]
(c) Tolerances with regional registrations.* * *
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-15981 Filed 6-17-97; 8:45 am]
BILLING CODE 6560-50-F