[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