[Federal Register Volume 62, Number 143 (Friday, July 25, 1997)]
[Rules and Regulations]
[Pages 39950-39956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19667]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300514; FRL-5730-4]
RIN 2070-AB78


Cymoxanil; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
cymoxanil in or on tomatoes. This action is in response to EPA's 
granting of an emergency exemption under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act authorizing use of the 
pesticide on tomatoes in Florida, Maryland, and New Jersey. This 
regulation establishes a maximum permissible level for residues of 
cymoxanil in this food commodity 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 tolerance will expire and is revoked on May 
15, 1999.

DATES: This regulation is effective July 25, 1997. Objections and 
requests for hearings must be received by EPA on or before September 
23, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300514], 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-300514], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services 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-300514]. 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: Libby Pemberton, Registration 
Division 7505W, Office of Pesticide Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location, 
telephone number, and e-mail address: Crystal Mall #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, (703) 308-9364, 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 a tolerance for 
residues of the fungicide cymoxanil, in or on tomatoes at 0.05 part per 
million (ppm). This tolerance will expire and is revoked on May 15, 
1999. EPA will publish a document in the Federal Register to remove the 
revoked tolerance 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 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 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

[[Page 39951]]

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.

II. Emergency Exemption for Cymoxanil on Tomatoes and FFDCA 
Tolerances

    Recent failures to control late blight in tomatoes and potatoes 
with the registered fungicides, have been caused almost exclusively by 
immigrant strains of late blight (Phytophthora infestans), which are 
resistant to the control of choice, metalaxyl. Before the immigrant 
strains of late blight arrived, all of the strains in the United States 
were previously controlled by treatment with metalaxyl. Presently, 
there are no fungicides registered in the United States that will 
provide adequate control of the immigrant strains of late blight. EPA 
has authorized under FIFRA section 18 the use of cymoxanil on tomatoes 
for control of late blight in Florida, Maryland, and New Jersey. After 
having reviewed the submissions, EPA concurs that emergency conditions 
exist for these states.
    As part of its assessment of these emergency exemptions, EPA 
assessed the potential risks presented by residues of cymoxanil 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 tolerance 
under FFDCA section 408(l)(6) would be consistent with the new safety 
standard and with FIFRA section 18. Consistent with the need to move 
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment under section 408(e), as provided in section 
408(l)(6). Although this tolerance will expire and is revoked on May 
15, 1999, 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 in a manner that was lawful under FIFRA. EPA will take 
action to revoke this tolerance earlier if any experience with, 
scientific data on, or other relevant information on this pesticide 
indicate that the residues are not safe.
    Because this tolerance is being approved under emergency conditions 
EPA has not made any decisions about whether cymoxanil meets EPA's 
registration requirements for use on tomatoes or whether a permanent 
tolerance for this use would be appropriate. Under these circumstances, 
EPA does not believe that this tolerance serves as a basis for 
registration of cymoxanil by a State for special local needs under 
FIFRA section 24(c). Nor does this tolerance serve as the basis for any 
State other than Florida, Maryland, and New Jersey 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 exemptions for 
cymoxanil, 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. Second, 
EPA examines exposure to the pesticide through the diet (e.g., food and 
drinking water) and through exposures that occur as a result of 
pesticide use in residential settings.

A. Toxicity

    1. Threshold and non-threshold effects.  For many animal 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.
    2. Differences in toxic effect due to exposure duration.  The 
toxicological effects of a pesticide can vary with different exposure 
durations. EPA considers the entire toxicity data base, and based on 
the effects seen for different durations and routes of exposure, 
determines which risk assessments should be done to assure that the 
public is adequately protected from any pesticide exposure scenario. 
Both short and long durations of exposure are always considered. 
Typically, risk assessments include ``acute'', ``short-term'', 
``intermediate term'', and ``chronic'' risks. These assessments are 
defined by the Agency as follows.
    Acute risk, by the Agency's definition, results from 1-day 
consumption of food and water, and reflects toxicity which could be 
expressed following a single

[[Page 39952]]

oral exposure to the pesticide residues. High-end exposure to food and 
water residues are typically assumed.
    Short-term risk results from exposure to the pesticide for a period 
of 1-7 days, and therefore overlaps with the acute risk assessment. 
Historically, this risk assessment was intended to address primarily 
dermal and inhalation exposure which could result, for example, from 
residential pesticide applications. However, since enaction of FQPA, 
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from 
food, water, and residential uses when reliable data are available. In 
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 3 
sources are not typically added because of the very low probability of 
this occurring in most cases, and because the other conservative 
assumptions built into the assessment assure adequate protection of 
public health. However, for cases in which high-end exposure can 
reasonably be expected from multiple sources (e.g. frequent and 
widespread homeowner use in a specific geographical area), multiple 
high-end risks will be aggregated and presented as part of the 
comprehensive risk assessment/characterization. Since the toxicological 
endpoint considered in this assessment reflects exposure over a period 
of at least 7 days, an additional degree of conservatism is built into 
the assessment; i. e., the risk assessment nominally covers 1-7 days 
exposure, and the toxicological endpoint/NOEL is selected to be 
adequate for at least 7 days of exposure. (Toxicity results at lower 
levels when the dosing duration is increased.)
    Intermediate-term risk results from exposure for 7 days to several 
months. This assessment is handled in a manner similar to the short-
term risk assessment.
    Chronic risk assessment describes risk which could result from 
several months to a lifetime of exposure. For this assessment, risks 
are aggregated considering average exposure from all sources for 
representative population subgroups including infants and children.

B. Aggregate Exposure

    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. In evaluating food 
exposures, EPA takes into account varying consumption patterns of major 
identifiable subgroups of consumers, including infants and children. 
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.
    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. For this 
pesticide, the most highly exposed population subgroup children (1-6 
years old) was not regionally based.

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, EPA has sufficient data to assess the hazards of cymoxanil 
and to make a determination on aggregate exposure, consistent with 
section 408(b)(2), for a time-limited tolerance for residues of 
cymoxanil on tomatoes at 0.05 ppm. EPA's assessment of the dietary 
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by cymoxanil are 
discussed below.
    1. Acute toxicity. Agency toxicologists have recommended that the 
acute endpoint of 10 mg/kg/day from the rat developmental toxicity 
study be used for acute dietary risk calculations. The developmental 
lowest observed effect level (LOEL) of 25 mg/kg/day is based on 
increased skeletal effects in fetuses. The population of concern for 
this risk assessment is females 13+ years old. An acute dietary food 
only MOE of 300 is required because the developmental effects occurred 
in the absence of maternal effects, suggesting a potential special pre-
natal sensitivity for infants and children.
    2. Short - and intermediate - term non-dietary toxicity.  The 
maternal NOEL of 8.0 mg/kg/day in the rabbit developmental study used 
as the short term toxicity endpoint for non-dietary risk assessment. At 
the LOEL of 16 mg/kg/day there was an increased incidence of animals 
with cold ears, reduced food consumption, decreased defecation, 
decreased weight gain. The NOEL of 5.0 mg/kg/day from the two 
generation reproduction study in the rat was used to calculate 
intermediate term MOEs. At the LOEL of 25 mg/kg/day, there were 
decreases in body weight in males and in females during growth, 
gestation and lactation.
    3.  Chronic toxicity. EPA has established the RfD for cymoxanil at 
0.02 milligrams/kilogram/day (mg/kg/day). This RfD is based on a NOEL 
of 1.6 mg/kg/day in a 1-year dog feeding study, using an uncertainty 
factor of 100. The LOEL of 3.1 mg/kg/day was based on decreased food 
consumption, decreased body weight, and decreased feed efficiency.
    4. Carcinogenicity. Cymoxanil has not been classified as to 
carcinogenic potential. No cancer risks have been identified in the 
available cymoxanil data evaluation records.

[[Page 39953]]

B. Exposures and Risks

    1.  From food and feed uses.  Time limited tolerances have been 
established (40 CFR 180.503) for the residues of cymoxanil, in or on 
potatoes. Risk assessments were conducted by EPA to assess dietary 
exposures and risks from cymoxanil 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 one day or single exposure. The acute dietary (food only) risk 
assessment used tolerance level residues and assumed 100% crop treated 
for tomatoes. The resulting high-end exposure estimate of 0.001 mg/kg/
day, which results in a dietary (food only) MOE of 10,000 for females 
13+ years, the population sub-group of cocern, should be viewed as a 
conservative risk estimate.
    ii. Chronic exposure and risk.  For the purpose of assessing 
chronic dietary exposure from cymoxanil, EPA assumed tolerance level 
residues and 100% of crop treated for tomatoes and all other 
commodities having cymoxanil tolerances. These conservative assumptions 
result in overestimation of human dietary exposures.
    2. From drinking water.  There is no entry for cymoxanil in the 
``Pesticides in Groundwater Data Base'' (EPA 734-12-92-001, September 
1992). There is no established Maximum Concentration Level (MCL) for 
residues of cymoxanil in drinking water. No drinking water health 
advisory levels have been established for cymoxanil.
    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 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 cymoxanil 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 cymoxanil 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. 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 cymoxanil 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, 
cymoxanil 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 cymoxanil has a common mechanism of toxicity 
with other substances.

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

    1. Acute risk.  For the population subgroup of concern, females 13+ 
years, the calculated MOE value (food) is 10,000. The Agency 
acknowledges the potential for exposure to cymoxanil in drinking water, 
but does not expect that exposure would result in an aggregate MOE 
(food plus water) that would exceed the Agency's level of concern for 
acute dietary exposure. EPA concludes that there is a reasonable 
certainty that no harm will result from aggregate exposure to cymoxanil 
residues.
    2. Chronic risk.  Using the TMRC exposure assumptions described 
above, EPA has concluded that aggregate exposure to cymoxanil from food 
will utilize 0.6% of the RfD for the U.S. population. The major 
identifiable subgroup with the highest aggregate exposure is children 
1-6 years old ``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. Use the following sentence 
. Despite the potential for exposure to cymoxanil 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 from aggregate 
exposure to cymoxanil residues.
    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.

[[Page 39954]]

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

    1. Safety factor for infants and children-- a. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of cymoxanil, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. This is the case. 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.
    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. 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.
    b. Developmental toxicity studies-- Rats. In the developmental 
study in rats, the maternal (systemic) NOEL was 25 mg/kg/day, based on 
decreased feed consumption at the LOEL of 75 mg/kg/day. The 
developmental (fetal) NOEL was 10 mg/kg/day, based on increased 
skeletal findings at the LOEL of 25 mg/kg/day.
    Rabbits. In the developmental toxicity study in rabbits, the 
maternal (systemic) NOEL was 8.0 mg/kg/day, based on decreased body 
weight gain, decreased food consumption, and decreased fecal output at 
the LOEL of 16 mg/kg/day. The developmental (pup) NOEL was 32 mg/kg/
day, and was the highest dose tested. .
    c. Reproductive toxicity study-- Rats. In the 2-generation 
reproductive toxicity study in rats, the parental (systemic) NOEL was 
5.0 mg/kg/day, based on decreased body weight and food consumption at 
the LOEL of 25 mg/kg/day. The reproductive/developmental pup) NOEL was 
5.0 mg/kg/day, based on decreased survival on post-natal days 0-4 and 
decreased body weight at the LOEL of 25 mg/kg/day.
    d. Pre- and post-natal sensitivity.  The toxicological data base 
for evaluating pre- and post- natal toxicity for cymoxanil is complete 
with respect to current data requirements. Cymoxanil demonstrates extra 
pre-natal sensitivity for infants and children based on the results of 
the developmental study in rats. The developmental NOEL and the LOEL 
were 10 and 25 mg/kg/day respectively. In comparison, the parental NOEL 
and LOEL were 25 and 75 mg/kg/day respectively. This difference means 
that developmental effects (skeletal findings) occurred in the absence 
of parental effects at the 25 mg/kg/day level. Therefore, OPP 
recommended that an acute dietary risk assessment be performed for 
females 13+ years. However, the calculated MOE even without the use of 
an additional 10 fold safety factor (or less) was 10,000 which clearly 
demonstrates that the acute pre-natal risk to unborn children from 
exposure to aggregate residues of cymoxanil does not exceed the 
Agency's level of concern.
    2. Acute risk.  The acute dietary MOE (food) was calculated to be 
10,000 for females 13+ years (accounts for both maternal and fetal 
exposure). These MOE calculations were based on the developmental NOEL 
in rats of 10 mg/kg/day. This risk assessment assumed 100% crop-treated 
with tolerance level residues on all treated crops consumed, resulting 
in a significant over-estimate of dietary exposure. The large acute 
dietary MOE calculated for females 13+ years provides assurance that 
there is a reasonable certainty of no harm for both females 13+ years 
and the pre-natal development of infants to cymoxanil. The Agency 
acknowledges the potential for exposure to cymoxanil in drinking water, 
but does not expect that exposure would result in aggregate MOEs (food 
plus water) that would exceed the Agency's level of concern for acute 
dietary exposure.
    3. Chronic risk.  Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to cymoxanil 
from food will utilize from 0.6% of the RfD for non-nursing infants 
less than one year old, up to 1.3% for children 1-6 years old. 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 cymoxanil 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 cymoxanil residues.

V. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue in plants is adequately understood for 
the purpose of this tolerance. The residue of cocern, for the purpose 
of this tolerance, is cymoxanil. Secondary residues are not expected in 
animal commodities as no feed items are associated with this use.

B. Analytical Enforcement Methodology

     Methods are available for the enforcement of residues of 
cymoxanil. Available methods include Multi-Residue Protocol D and a 
method submitted by Du Pont (Analytical Method for the Determination of 
Cymoxanil in Grapes and Tomatoes Using Column Switching Liquid 
Chromatography). The latter method has undergone a successful 
independent laboratory validation (ILV) and EPA petition method 
validation (PMV). The methods are available to anyone who is interested 
in pesticide residue enforcement from: By mail, Calvin Furlow, Public 
Response and Program Resources Branch, Field Operations Division 
(7506), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location and telephone 
number: Crystal Mall #2, Rm. 1128, 1921 Jefferson Davis Hwy., 
Arlington, VA, 703-305-5805.

C. Magnitude of Residues

     Residues of cymoxanil are not expected to exceed 0.05 ppm in/on 
tomatoes as a result of this proposed use. Secondary residues are not 
expected in animal commodities as no feed items are associated with 
this use.

D. International Residue Limits

     There are no CODEX, Canadian or Mexican MRLs established for 
cymoxanil in/on tomatoes.

VI. Conclusion

    Therefore, the tolerance is established for residues of cymoxanil 
in tomatoes at 0.05 ppm.

VII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process

[[Page 39955]]

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 September 23, 1997, 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 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

    EPA has established a record for this rulemaking under docket 
control number [OPP-300514] (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 Room 1132 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7506C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [email protected].

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    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 
Virginia address in ``ADDRESSES'' at the beginning of this document.

IX. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. 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. 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, since these tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408(d), 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 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 adverse economic impact. The factual basis for the 
Agency's generic certification for tolerance acations published on May 
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for 
Advocacy of the Small Business Administration.

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 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 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: July 16, 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. In Sec. 180. 503, in paragraph (b), by revising the introductory 
text and alphabetically adding to the table the tolerance to read as 
follows:

[[Page 39956]]

Sec. 180. 503 Cymoxanil; tolerances for residues.

 *        *        *        *        *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the fungicide . cymoxanil in connection 
with use of the pesticide under section 18 emergency exemptions granted 
by EPA. The tolerances will expire and are revoked on the dates 
specified in the following table.

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
                                                                        
*                *                *                *                *   
                                  *                *                    
Tomatoes........................  0.05                May 15, 1999      
------------------------------------------------------------------------

 *        *        *        *        *

[FR Doc. 97-19667 Filed 7-24-97; 8:45 am]
BILLING CODE 6560-50-F