[Federal Register Volume 62, Number 93 (Wednesday, May 14, 1997)]
[Rules and Regulations]
[Pages 26407-26412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12475]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300485; FRL-5716-1]

RIN 2070-AB78]


Cymoxanil; Pesticide Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of the fungicide cymoxanil in or on the raw agricultural 
commodity potatoes in connection with EPA's granting of emergency 
exemptions under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act authorizing use of cymoxanil on potatoes in the states 
of Alabama, California, Colorado, Delaware, Florida, Idaho, Indiana, 
Maine, Massachusetts, Michigan, Minnesota, Montana, Nebraska, Nevada, 
New Jersey, New York, North Carolina, North Dakota, Oregon, 
Pennsylvania, Virginia, Washington and Wisconsin. This tolerance will 
expire and is revoked on March 15, 1999.
DATES: This regulation becomes effective May 14, 1997. Objections and 
requests for hearings must be received by EPA on or before July 14, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300485], 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-300485], must also be submitted to: Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, bring a copy of 
objections and hearing requests to Rm. 1132, CM #2, 1921 Jefferson 
Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket number 
[OPP-300485]. 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), Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Hwy., 
Arlington, VA, (703) 308-8326, 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 on potatoes at 0.05 parts per 
million (ppm). This tolerance will expire and be revoked by EPA on 
March 15, 1999. After March 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 FFDCA, 21 
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Among other things, FQPA 
amends FFDCA to bring all EPA pesticide tolerance-setting activities 
under 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 CFR 
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

[[Page 26408]]

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.
    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 Exemptions for Cymoxanil on Potatoes and FFDCA 
Tolerances

    EPA has authorized under FIFRA section 18 the use of cymoxanil on 
potatoes for control of late blight, as requested by the states 
previously listed. Recent failures to control late blight in potatoes 
as well as tomatoes 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. After having reviewed their submissions, EPA concurs that 
emergency conditions exist.
    As part of its assessment of these specific exemptions, EPA 
assessed the potential risks presented by residues of cymoxanil on 
potatoes. 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 clearly be consistent with the new safety 
standard and with FIFRA section 18. This tolerance for residues of 
cymoxanil will permit the marketing of potatoes treated in accordance 
with the provisions of the section 18 emergency exemptions. Consistent 
with the need to move quickly on these emergency exemptions 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 March 15, 1999, under FFDCA section 408(l)(5), 
residues of cymoxanil not in excess of the amount specified in these 
tolerances remaining in or on potatoes after that date will not be 
unlawful, provided the pesticide is applied during the term of, and in 
accordance with all the conditions of, section 18 of FIFRA. EPA will 
take action to revoke this tolerance earlier if any experience with, 
scientific data on, or other relevant information on this pesticide 
indicate that the residues are not safe.
    EPA has not made any decisions about whether cymoxanil meets EPA's 
registration requirements for use on potatoes or whether a permanent 
tolerance for this use would be appropriate. This tolerance does not 
serve as a basis for registration of cymoxanil by a State for special 
local needs under FIFRA section 24(c). Nor does this action serve as 
the basis for any States other than previously listed and states which 
are subsequently granted specific exemptions for this use 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. For many 
of these studies, a dose response relationship can be determined, which 
provides a dose that causes adverse effects (threshold effects) and 
doses causing no observed effects (the ``no-observed effect level'' or 
``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals, and that one person or subgroup of the population (such 
as infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100 percent or less of the 
RfD) is generally considered acceptable by EPA.
    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 margin of exposure (MOE) calculation based on the 
appropriate NOEL) will be carried out based on the nature of the 
carcinogenic response and the Agency's knowledge of its mode of action.
    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from the pesticide residue in the food in question, residues 
in other foods for

[[Page 26409]]

which there are tolerances, and other non-occupational exposures, such 
as where residues leach into groundwater or surface water that is 
consumed as drinking water. Dietary exposure to residues of a pesticide 
in a food commodity are estimated by multiplying the average daily 
consumption of the food forms of that commodity by the tolerance level 
or the anticipated pesticide residue level. The Theoretical Maximum 
Residue Contribution (TMRC) is an estimate of the level of residues 
consumed daily if each food item contained pesticide residues equal to 
the tolerance. The TMRC is a ``worst case'' estimate since it is based 
on the assumptions that food contains pesticide residues at the 
tolerance level and that 100 percent 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.

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. Cymoxanil is not registered by EPA for use in the United 
States. Nevertheless, EPA believes it has sufficient data to assess the 
hazards of cymoxanil and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for the time-limited tolerances for 
residues of cymoxanil on potatoes at 0.05 ppm. EPA's assessment of the 
dietary exposures and risks associated with establishing these 
tolerances follows.

A. Toxicological Profile

    1. Chronic toxicity. Based on the available chronic toxicity data, 
the Office of Pesticide Programs (OPP) has selected an RfD for 
cymoxanil of 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 lowest observed effect level (LOEL) 
of 3.1 mg/kg/day was based on decreased food consumption, decreased 
body weight, and decreased feed efficiency.
    2. 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 
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.
    3. Short-term non-dietary inhalation and dermal toxicity. The OPP 
recommends use of the developmental toxicity study in rabbits for 
short-term non-dietary risk calculations. The maternal NOEL was 8.0 mg/
kg/day. At the LOEL of 16 mg/kg/day there was an increased incidence of 
animals with cold ears, reduced food consumption, decreased defecation, 
and decreased weight gain.
    4. Carcinogenicity. Cymoxanil has not been classified as to 
carcinogenic potential. No cancer risks have been identified in the 
available cymoxanil data evaluation records.

B. Aggregate Exposure

    There are no established U.S. tolerances for cymoxanil, and there 
are no registered uses for cymoxanil in the United States.
    For the purpose of assessing chronic dietary exposure from 
cymoxanil, EPA assumed tolerance level residues and 100% of crop 
treated for the proposed use of cymoxanil. These conservative 
assumptions result in overestimation of human dietary exposures. 
Secondary residues of cymoxanil are not expected to transfer to animal 
commodities as a result of the proposed use.
    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food and all other non-occupational exposures. The primary non-food 
sources of exposure the Agency looks at include drinking water (whether 
from groundwater or surface water), and exposure through pesticide use 
in gardens, lawns, or buildings (residential and other indoor uses).
    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 
consumption of 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 tolerances 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 tolerances are granted.
    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. Cymoxanil is not registered for any 
residential uses so no exposure from this route is expected. Because 
there are no short- or intermediate-term non-dietary, non-occupational 
exposure scenarios associated with cymoxanil, a short- or intermediate-
term aggregate risk assessment is not required.

C. Cumulative Exposure to Substances with Common Mechanism of Toxicity

    Section 408(b)(2)(D)(v) requires that, when considering whether to 
establish, modify, or revoke a tolerance, the Agency consider 
``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will

[[Page 26410]]

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.

D. Safety Determinations For U.S. Population

    Based on the completeness and reliability of the toxicity data, EPA 
has concluded that dietary exposure to cymoxanil in food from published 
tolerances will utilize less than 1 percent of the RfD for the U.S. 
population. A dietary (food only) MOE of 25,000 was calculated. This 
MOE value does not exceed the Agency's level of concern for acute 
dietary exposure. Whatever reasonable bounding figure the Agency 
eventually decides upon for the contribution from water, exposure to 
cymoxanil is not expected to exceed the RfD or to pose acute dietary 
concerns. EPA concludes that there is a reasonable certainty that no 
harm will result from aggregate exposure to cymoxanil residues.

E. Determination of Safety for Infants and Children.

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre- and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a MOE analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. In either case, EPA generally defines the level of appreciable 
risk as exposure that is greater than 1/100 of the NOEL in the animal 
study appropriate to the particular risk assessment. This hundredfold 
uncertainty (safety) factor/MOE (safety) is designed to account for 
combined inter- and intra-species variability. EPA believes that 
reliable data support using the standard hundredfold margin/factor not 
the additional tenfold margin/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 
margin/factor. Based on current toxicological data requirements, the 
data base for cymoxanil relative to pre- and post-natal toxicity is not 
complete.
    Cymoxanil demonstrates extra pre-natal sensitivity for infants and 
children based on the results of the developmental study in rats. The 
developmental NOEL and LOEL were 10 and 25 mg/kg/day respectively. In 
comparison, the maternal NOEL and LOEL were 25 and 75 mg/kg/day 
respectively. This difference means that developmental effects 
(skeletal findings) occurred in the absence of maternal effects at 25 
mg/kg/day. Therefore, OPP recommended that an acute dietary risk 
assessment be performed for females 13+ years. Given that the database 
is incomplete, and available data suggest extra pre-natal sensitivity, 
an extra uncertainty factor (3X) is appropriate for MOE calculations. 
That is, provided the MOE for females 13+ is greater than 300 the 
Agency would have no concerns for pre-natal exposure. The calculated 
MOE of 25,000 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.
    The results of the rabbit developmental study did not suggest any 
pre-natal toxicity concerns. The developmental NOEL was 32 mg/kg/day 
(highest dose tested) and the maternal NOEL was 8 mg/kg/day.
    The results of the rat reproduction study did not demonstrate any 
special post-natal toxicity. The parental NOEL and LOEL and the pup 
NOEL and LOEL occurred at the same dose levels (5 and 25 mg/kg/day, 
respectively). EPA has concluded that the percent of the RfD that will 
be utilized by chronic dietary (food) exposure to residues of cymoxanil 
is less than 1% for all population subgroups which includes nursing and 
non-nursing infants (<1 year old), and children (1 to 6 years old) and 
(7 to 12 years old). This calculation assumes tolerance level residues 
and is therefore an over-estimate of dietary risk. Refinement of the 
dietary risk assessment by using anticipated residue data would reduce 
dietary exposure. The addition of potential exposure from cymoxanil 
residues in drinking water is not expected to result in an exposure 
which would exceed the RfD. Therefore, 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

    The metabolism of cymoxanil in potatoes is adequately understood 
for the purposes of this tolerance. There are no Codex maximum residue 
levels established for residues of cymoxanil. The residue of concern, 
for the purposes of this tolerance, is cymoxanil. The proposed 
enforcement methods include Multi-Residue Protocol D, a method 
(adequate for generation of field trial residue data) submitted by Du 
Pont and a gas chromatography (GC) method published in the open 
literature. 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 
(7506C), 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.

VI. Conclusion

    Therefore, a tolerance in connection with the FIFRA section 18 
emergency exemptions is established for residues of cymoxanil in or on 
potatoes at 0.05 ppm.

VII. Objections and Hearing Requests

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

[[Page 26411]]

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 July 14, 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 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

    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket control 
number [OPP-300485] (including comments and data submitted 
electronically as described below). 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 official rulemaking record is located at the Virginia 
address in ``ADDRESSES''.
    Electronic comments can 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. Comment and data 
will also be accepted on disks in Wordperfect 5.1 file format or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket number [OPP-300485]. Electronic comments on 
this proposed rule may be filed online at many Federal Depository 
Libraries.

IX. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not ``a significant regulatory action'' and, since this 
action does not impose any information collection requirements as 
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is 
not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty, or contain 
any ``unfunded mandates'' as described in Title II of the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior 
consultation as specified by Executive Order 12875 (58 FR 58093, 
October 28, 1993), or special considerations as required by Executive 
Order 12898 (59 FR 7629, February 16, 1994).
    Because FFDCA section 408(l)(6) permits establishment of this 
regulation without a notice of proposed rulemaking, the regulatory 
flexibility analysis requirements of the Regulatory Flexibility Act, 5 
U.S.C. 604(a), do not apply. Nonetheless, the Agency has previously 
assessed whether establishing tolerances or exemptions from tolerance, 
raising tolerance levels, or expanding exemptions adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse impact. (46 FR 24950) (May 4, 1981).
    Under 5 U.S.C. 801(a)(1)(A) of the Small Business Regulatory 
Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-121, 110 
Stat. 847), EPA 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 the rule in today's 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: May 1, 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. By adding Sec. 180.503 to read as follows:


Sec. 180.503   Cymoxanil, tolerance for residues.

    (a)  General. [Reserved]
    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for residues of the fungicide cymoxanil in connection with 
use of the pesticide under section 18 emergency exemptions granted by 
EPA. The tolerance is specified in the following table. The tolerances 
will expire and are revoked on the dates specified in the following 
table:

------------------------------------------------------------------------
                                Parts per                               
          Commodity              million     Expiration/Revocation Date 
------------------------------------------------------------------------
 Potatoes....................         0.05             3/15/99          
------------------------------------------------------------------------


[[Page 26412]]

    (c)  Tolerances with regional registrations. [Reserved]
    (d)  Indirect or inadvertent residues. [Reserved]

[FR Doc. 97-12475 Filed 5-13-97; 8:45 am]
BILLING CODE 6560-50-F