[Federal Register Volume 64, Number 46 (Wednesday, March 10, 1999)]
[Rules and Regulations]
[Pages 11782-11789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5963]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300795; FRL-6062-5]
RIN 2070-AB78


Metolachlor; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerances for the 
combined residues of metolachlor 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 tomatoes, tomato puree, and tomato 
paste. This action is in response to EPA's granting of an emergency 
exemption under section 18 of the Federal Insecticide, Fungicide, and

[[Page 11783]]

Rodenticide Act authorizing use of the pesticide on tomatoes. This 
regulation establishes maximum permissible levels for residues of 
metolachlor in these food commodities pursuant to section 408(l)(6) of 
the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996. The tolerances will expire and are 
revoked on April 1, 2001.

DATES: This regulation is effective March 10, 1999. Objections and 
requests for hearings must be received by EPA on or before May 10, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300795], 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-300795], must also be submitted to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, bring a copy of 
objections and hearing requests to Rm. 119, Crystal Mall 2 (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 electronic 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 5.1/6.1 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket control number [OPP-300795]. 
No Confidential Business Information (CBI) should be submitted through 
e-mail. Copies of electronic objections and hearing requests on this 
rule may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Rm. 280, (CM #2), 1921 
Jefferson Davis Hwy., Arlington, VA, (703) 308-9367; 
[email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
sections 408 and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a and (l)(6), is establishing a tolerance for 
combined residues of the herbicide metolachlor 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 tomatoes 
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 are revoked on April 
1, 2001. EPA will publish a document in theFederal Register to remove 
the revoked tolerances from the Code of Federal Regulations.

I. Background and Statutory Findings

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq. The FQPA amendments went into effect immediately. Among other 
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting 
activities under a new section 408 with a new safety standard and new 
procedures. These activities are described in this preamble 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 tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemption for Metolachlor on Tomatoes and FFDCA 
Tolerances

    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 eastern black 
nightshade. Chloramben (amiben) is the most effective herbicide for 
this weed, but 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 
Applicant stated that since this weed population 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 state. EPA has authorized under FIFRA section 18 the 
use of metolachlor on tomatoes for control of nutsedge and nightshade 
in Virginia. After having reviewed the submission, EPA concurs that 
emergency conditions exist for this state.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of

[[Page 11784]]

metolachlor in or on tomatoes, tomato paste, and tomato puree. In doing 
so, EPA considered the 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 safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent non-routine situation and to ensure that the 
resulting food is safe and lawful, EPA is issuing 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 April 1, 2001, under FFDCA section 408(l)(5), 
residues of the pesticide not in excess of the amounts specified in the 
tolerances remaining in or on tomatoes, tomato paste, and tomato puree 
after that date will not be unlawful, provided the pesticide is applied 
in a manner that was lawful under FIFRA, and the residues do not exceed 
a level that was authorized by these tolerances at the time of that 
application. 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.
    Because these tolerances are being approved under emergency 
conditions 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. Under these 
circumstances, EPA does not believe that these tolerances 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 Virginia to use this pesticide on this 
crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing section 18 as identified in 40 CFR part 
166. For additional information regarding the emergency exemption for 
metolachlor, contact the Agency's Registration Division at the address 
provided under the ``ADDRESSES'' section.

III. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7) .
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
metolachlor and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
combined residues of metolachlor 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 on tomatoes at 0.1 ppm, tomato puree 
at 0.3 ppm, and tomato paste at 0.6 ppm. EPA's assessment of the 
dietary exposures and risks associated with establishing the tolerance 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by metolachlor are 
discussed in this unit.

B. Toxicological Endpoint

    1. Acute toxicity. EPA has determined that available data do not 
indicate that there is potential for adverse effects after a single 
dietary exposure. Therefore, acute risk assessments were not conducted.
    2. Short - and intermediate - term toxicity. For intermediate-term 
dermal risk assessment, the no observed adverse effect level (NOAEL) of 
100 miligrams/kilogram/day (mg/kg/day) from the 21-day dermal toxicity 
study in rats is to be used. 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 toxicity. EPA has established the Reference Dose (RfD) 
for metolachlor at 0.10 mg/kg/day. This RfD is based on the results 
from the 1-year feeding study in dogs, with a NOAEL of 9.7 mg/kg/day, 
and an uncertainty factor of 100, based on decreased body weight gain 
at the lowest observed effect level (LOEL) of 33 mg/kg/day.
    4. Carcinogenicity. Under the EPA Guidelines for Carcinogen Risk 
Assessment, metolachlor has been classified as a Group C Chemical 
(possible human carcinogen), based on increased incidence of adenomas 
and combined adenomas/carcinomas in female rats. The structural 
relationship of metolachlor to acetochlor and alachlor was of concern 
to the OPP Carcinogenicity Peer Review Committee (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 Margin of Exposure (MOE) approach for estimation of 
risk, using the NOAEL of 15.7 mg/kg/day from the 2-year rat feeding 
study.

C. Exposures and Risks

    1.  From food and feed uses. Tolerances have been established (40 
CFR 180.368) for the combined residues of metolachlor 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, ranging 
from 0.02 ppm in various 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 exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. EPA has determined that available data 
do not indicate that there is potential for adverse effects after a 
single dietary exposure. Therefore, acute risk assessment is not 
required.
    ii. Chronic exposure and risk. In conducting this chronic dietary 
(food only) risk assessment, the Agency used percent of crop treated 
data for selected crops, and assumed tolerance level residues in all 
commodities having metolachlor tolerances. These assumptions result in 
an overestimate of human dietary exposure, and thus this risk estimate 
should be viewed as conservative; further refinement using anticipated 
residue levels and additional percent crop treated values would result 
in lower exposure estimates. Based on the given

[[Page 11785]]

assumptions, EPA has calculated that dietary exposure to metolachlor 
will utilize 1.1% of the RfD for the overall U.S. population. The major 
identifiable subgroups with the highest exposure are non-nursing 
infants <1 year old and children 1 to 6 years old, both at 2.3% of the 
RfD. This is further discussed below in the section on infants and 
children. EPA generally has no concern for exposure 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 
reasonable certainty that no harm will result from chronic aggregate 
exposure to metolachlor residues.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of food treated (PCT) for assessing chronic dietary risk 
only if the Agency can make the following findings: That the data used 
are reliable and provide a valid basis to show what percentage of the 
food derived from such crop is likely to contain such pesticide 
residue; that the exposure estimate does not underestimate exposure for 
any significant subpopulation group; and if data are available on 
pesticide use and food consumption in a particular area, the exposure 
estimate does not understate exposure for the population in such area. 
In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of percent crop treated as required by the section 408(b)(2)(F), EPA 
may require registrants to submit data on PCT.
    The Agency used percent crop treated data for selected crops, and 
assumed tolerance level residues in all commodities having metolachlor 
tolerances.
    The Agency believes that the 3 conditions, discussed in section 408 
(b)(2)(F) in this unit concerning the Agency's responsibilities in 
assessing chronic dietary risk findings, have been met. The PCT 
estimates are derived from Federal and private market survey data, 
which are reliable and have a valid basis. 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 the PCT, 
the Agency is reasonably certain that the percentage of the food 
treated is not likely to be underestimated. The regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available information on the regional consumption of food to 
which metolachlor may be applied in a particular area.
    2. From drinking water. Environmental fate studies indicate that 
metolachlor appears to be moderately persistent and ranges from being 
mobile to highly mobile in different soils. Data collected from around 
the U.S. provides evidence that metolachlor leaches into ground water, 
occasionally at levels that exceed the Lifetime Health Advisory (HA) 
level of 100 parts per billion (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 the lifetime HA of 100 ppb anywhere. Additionally, to mitigate 
risk, additional label restrictions are being required under the 
Reregistration process, designed to minimize ground and surface water 
contamination.
    Chronic exposure and risk. Because the Agency lacks sufficient 
water-related exposure data to complete a comprehensive drinking water 
risk assessment for many pesticides, EPA has commenced and nearly 
completed a process to identify a reasonable yet conservative bounding 
figure for the potential contribution of water-related exposure to the 
aggregate risk posed by a pesticide. In developing the bounding figure, 
EPA estimated residue levels in water for a number of specific 
pesticides using various data sources. The Agency then applied the 
estimated residue levels, in conjunction with appropriate toxicological 
endpoints (RfD's or acute dietary NOAEL'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 tolerance is granted.
    3. From non-dietary exposure. Metolachlor is currently registered 
for use on a number of residential non-food sites including ornamental 
plants and grasses, highway rights of way, and recreational areas. No 
indoor uses are registered.
    i. Acute exposure and risk. EPA generally will not include 
residential or other non-dietary exposures 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 aggregate 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 by 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 exposure and risk. The Agency has concluded that a 
chronic residential exposure scenario does not exist for non-
occupational uses of metolachlor.
    iii. Short- and intermediate-term exposure and risk. There are 
residential uses of metolachlor and EPA acknowledges that there may be 
short and intermediate-term non-occupational

[[Page 11786]]

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 
(NOAEL of 100 mg/kg/day, and LOEL of 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.
    4. 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.''
    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. For more information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. The available data for metolachlor do not indicate 
the potential for adverse effects from acute dietary exposures. 
Therefore, an acute aggregate risk assessment was not conducted.
    2. Chronic risk. Using the conservative exposure assumptions 
described in this unit, EPA has concluded that aggregate exposure to 
metolachlor from food will utilize 1.1% of the RfD for the U.S. 
population. The major identifiable subgroup with the highest aggregate 
exposure is non-nursing infants <1 year old, and children 1 to 6 years 
old, both at 2.3% of the RfD; this is further discussed below. 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.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure.
    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 (NOAEL and LOEL of 100 and 
1,000 mg/kg/day, respectively), 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. Since a short-term toxicity endpoint was not 
identified for metolachlor, a short-term aggregate risk assessment was 
not conducted.
    4. Aggregate cancer risk for U.S. population. 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 (food only), the calculated MOEs for 
the U.S. population and infants/children are 15,000 and 6,800, 
respectively. Other than dietary exposure, no chronic exposure 
scenarios have been identified from registered uses of metolachlor. The 
EPA believes that the potential additional exposure in drinking water 
would not significantly lower the chronic dietary MOEs. The EPA has not 
yet established what an adequate MOE should be for chemicals having a 
non-linear mechanism for carcinogenicity. At this time, and for the 
purpose of this action only, the Agency concludes that the MOEs given 
above are adequate to ensure that there is a reasonable certainty that 
no harm to the U.S. population or to infants and children, will result 
from aggregate exposure to residues of metolachlor. When the Agency 
reaches a conclusion on the science policy issue of adequate MOEs for 
non-linear carcinogens, it is possible that the risk assessment for 
metolachlor may need to be revised.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to metolachlor residues.

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

    1. Safety factor for infants and children -- i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of metolachlor, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a 2-generation 
reproduction study in the rat. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from maternal pesticide exposure during gestation. 
Reproduction studies provide information relating to effects from 
exposure to the pesticide on the reproductive capability of mating 
animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for 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 margin of exposure (MOE) analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans. EPA believes that reliable data support 
using the standard MOE and uncertainty factor (usually 100 for combined 
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.
    ii. Developmental toxicity studies. In the rat developmental study, 
the maternal NOAEL was 300 mg/kg/day; mortality, increased salivation, 
lacrimation, convulsions, reduced body weight gain, and reduced food 
consumption were observed at the LEL of 1,000 mg/kg/day. The 
developmental NOAEL was also 300 mg/kg/day, with reduced mean fetal 
body weight, reduced number of implantations, and a slight increase in 
resorptions, seen at the LEL of 1,000 mg/kg/day.
    In the rabbit developmental study, the maternal NOAEL was 120 mg/
kg/day, with lacrimation, miosis, reduced food consumption, and 
decreased body weight gain seen at the LEL of 360 mg/kg/day. No 
developmental effects were

[[Page 11787]]

observed at the levels tested, and therefore the developmental NOAEL 
was greater than 360 mg/kg/day the highest dose tested (HDT).
    iii. Reproductive toxicity study. In the 2-generation rat 
reproductive study, the reproductive/developmental toxicity NOAEL of 23 
mg/kg/day was less than the parental (systemic) toxicity NOAEL of >76 
mg/kg/day HDT. The reproductive/developmental NOAEL was based on 
decreased pup body weight during late lactation.
    iv. Pre- and post-natal sensitivity. Based on current toxicological 
data requirements, the database for metolachlor relative to pre- and 
post-natal toxicity is complete. The developmental toxicity NOAELs of 
300 mg/kg/day (in rats) and >360 mg/kg/day (HDT tested in rabbits) 
demonstrate that there is not 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 NOAELs are more than 30- and 37-fold higher 
in the rats and rabbits, respectively, than the NOAEL of 9.7 mg/kg/day 
from the 1-year feeding study in dogs, which is the basis of the RfD.
    In the 2-generation reproductive toxicity study in rats, the 
reproductive/developmental toxicity NOAEL of 23 mg/kg/day was less than 
the parental (systemic) toxicity NOAEL of >76 mg/kg/day. The 
reproductive/developmental NOAEL was based on decreased pup body weight 
during late lactation and the NOAEL occurred at a level which is below 
the NOAEL 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 3-fold uncertainty 
factor was added to the RfD for infants and children.
    v. Conclusion. The TMRC value for the most highly exposed infant 
and children subgroups (non-nursing infants <1 year old, and children 1 
to 6 years old) occupies 6.9% of the RfD for both groups (with the 
additional 3-fold safety factor). This estimate should be viewed as 
conservative, since it is based on percent of 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 
estimates. Therefore, this risk assessment is an over-estimate of 
dietary risk.
    2. Acute risk. The available data for metolachlor do not indicate 
the potential for adverse effects from acute dietary exposures. 
Therefore, no acute risk assessment was conducted.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to metolachlor from 
food ranges from 6.9% for non-nursing infants <1 year old, down to 1.8% 
for nursing infants <1 year old (using an additional 3 fold safety 
factor) of the RfD for infants and children. 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.
    4. Short- or 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 the 
RfD that will be utilized by aggregate exposure to residues of 
metolachlor is 6.9% (using an additional 3 fold safety factor) for non-
nursing infants <1 year old and children 1 to 6 years old (the most 
highly exposed population subgroups). Based on the low percentage of 
the RfD occupied by the chronic dietary exposure and the high level of 
the intermediate-term toxicity endpoint (NOAEL = 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.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to metolachlor 
residues.

IV. 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 Sec. 180.368)

B. 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; Gas Chromatograpy (GC) with Nitrogen 
Phosphorus Detection (NPD)) and Method II (animals; GC-Mass 
Spectroscopy).

C. Magnitude of Residues

    Residues of metolachlor are not expected to exceed 10 ppm in/on 
forage and 0.2 ppm in/on the hay of grass grown for seed, as a result 
of this section 18 use. Secondary residues in animal commodities are 
not expected to exceed existing tolerances as a result of this section 
18 use.

D. International Residue Limits

    There are no established CODEX, Canadian, or Mexican residue limits 
for metolachlor on grass commodities.

E. Rotational Crop Restrictions

    Rotational crop restrictions are stated on the Dual Magnum product 
label.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
metolachlor and its metabolites, each expressed as the parent compound 
in tomatoes at 0.1 ppm, tomato puree at 0.3 ppm, and tomato paste at 
0.6 ppm.

VI. 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 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.

[[Page 11788]]

    Any person may, by May 10, 1999, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given under the ``ADDRESSES'' section (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). EPA is authorized to waive any fee requirement 
``when in the judgement of the Administrator such a waiver or refund is 
equitable and not contrary to the purpose of this subsection.'' For 
additional information regarding tolerance objection fee waivers, 
contact James Tompkins, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 239, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
(703) 305-5697, [email protected]. Requests for waiver of tolerance 
objection fees should be sent to James Hollins, Information Resources 
and Services Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
    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 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.

VII. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-300795] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Rm. 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA.
     Objections and hearing requests may be sent by e-mail directly to 
EPA at:
    [email protected].


    E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
    The official record for this regulation, as well as the public 
version, as described in this unit 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 record which 
will also include all comments submitted directly in writing. The 
official record is the paper record maintained at the Virginia address 
in ``ADDRESSES'' at the beginning of this document.

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408 of the 
FFDCA. The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This 
final rule does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et 
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 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, since tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(l)(6), such as the 
tolerance in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency 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 
adverse economic impact. The factual basis for the Agency's generic 
certification for tolerance actions published on May 4, 1981 (46 FR 
24950), and was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of

[[Page 11789]]

Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 26, 1999.

Peter Caulkins,
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. 321(q), 346a and 371.

    2. In Sec. 180.368, paragraph (b), by revising the following 
commodities in the table to read as follows:


Sec. 180.368  Metolachlor.

*        *        *        *        *
    (b)        *        *        *

 
------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    revocation date
------------------------------------------------------------------------
 
              *        *        *        *        *
Tomato paste....................  0.6                 4/1/01
Tomato puree....................  0.3                 4/1/01
Tomatoes........................  0.1                 4/1/01
 
              *        *        *        *        *
------------------------------------------------------------------------


*        *        *        *        *

[FR Doc. 99-5963 Filed 3-9-99; 8:45 am]
BILLING CODE 6560-50-F