[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: opp-docket@epamail.epa.gov. 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: pemberton.libby@epamail.epa.gov.
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:="">opp-docket@epamail.epa.gov
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
