[Federal Register Volume 62, Number 93 (Wednesday, May 14, 1997)]
[Rules and Regulations]
[Pages 26412-26416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12474]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300483; FRL-5715-5]
RIN 2070-AB78
Dimethomorph; 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
residues of the fungicide dimethomorph in or on the food 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 dimethomorph on potatoes in the states of
Alabama, California, Colorado, Delaware, Florida, Idaho, Indiana,
Maine, Maryland, Massachusetts, Michigan, Minnesota, Montana, Nebraska,
Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio,
Oregon, Pennsylvania, Virginia, Washington, and Wisconsin. The
tolerance will expire and is revoked on March 15, 1999.
DATES: This regulation is 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
doument control number,[OPP-300483], 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 document control number, [OPP-300483],
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, Crystal Mall #2, 1921 Jefferson Davis Highway, 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 document control
number [OPP-300483]. 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:
Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway,
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 dimethomorph on potatoes at 0.05 parts per
million (ppm). This tolerance will expire and is 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 FFDCA 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 chemical residue in or on a
food commodity) only if EPA determines that the tolerance is ``safe.''
Section 408(b)(2)(A)(ii) of the FFDCA 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) of the FFDCA 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
commodities 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 a 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 FFDCA section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemptions for Dimethomorph on Potatoes and FFDCA
Tolerances
EPA has authorized under FIFRA section 18 the use of dimethomorph
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
[[Page 26413]]
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 U.S. 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 dimethomorph 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
dimethomorph 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 commodity is safe and lawful, EPA is issuing this
tolerance without notice and opportunity for public comment under FFDCA
section 408(e) as provided in FFDCA section 408(l)(6). Although this
tolerance will expire and is revoked on March 15, 1999, under FFDCA
section 408(l)(5), residues of the pesticide not in excess of the
amount specified in the tolerance 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 dimethomorph 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 dimethomorph 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 of FIFRA as identified in 40 CFR
part 166. For additional information regarding the emergency exemptions
for dimethomorph, contact the Agency's Registration Division at the
address provided above in ``ADDRESSES''.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. For many
of these studies, a dose response relationship can be determined, which
provides a dose that causes adverse effects (threshold effects) and
doses causing no-observed effects (the ``no-observed-effect level'' or
``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA.
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 commodity in question,
residues in other food commodities for 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 commodity contained pesticide residues equal to the tolerance. The
TMRC is a ``worst case'' estimate since it is based on the assumptions
that food commodity 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 food commodities when they are eaten are
well below established tolerances.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. Dimethomorph is not registered by EPA for use in the
United States. Nevertheless, EPA believes it has sufficient data to
assess the hazards of dimethomorph and to make a determination on
aggregate exposure, consistent with FFDCA section 408(b)(2), for the
time-limited tolerances for residues of dimethomorph on potatoes at
0.05 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing these tolerances follows.
[[Page 26414]]
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 dimethomorph are
discussed below.
1. Chronic toxicity. Based on the available chronic toxicity data,
the Office of Pesticide Programs (OPP) has selected an RfD for
dimethomorph of 0.01 milligrams(mg)/kilogram(kg)/day. This RfD is based
on a NOEL of 10 mg/kg/day in a 2-year chronic rat study, using an
uncertainty factor of 1,000. The lowest-observed-effect level (LOEL) of
57.7 mg/kg/day was based on decreased body weight and increased
incidence of liver ``ground glass'' foci in females. The additional 10-
fold uncertainty factor was used to protect infants and children, since
data gaps consisted of rat and rabbit developmental studies and the rat
reproduction study.
2. Acute toxicity. An acute dietary risk endpoint was not
identified by OPP.
3. Short-term, non-dietary inhalation and dermal toxicity. OPP
recommends use of the developmental toxicity study in rats for short-
term, non-dietary risk calculations. The maternal NOEL was 60.0 mg/kg/
day. At the LOEL of 160 mg/kg/day there was reduced food commodity
consumption, body weights, and weight gain. Intermediate-term risk
endpoints have also been identified. The NOEL of 15 mg/kg/day in the
90-day dog feeding study has been chosen as the intermediate-term
toxicity endpoint. At the LOEL of 43 mg/kg/day, there were decreases in
the absolute and relative weights of the prostrate and possible
threshold liver effects.
4. Carcinogenicity. Dimethomorph has not been classified as to
carcinogenic potential. No cancer risks have been identified in the
available dimethomorph data evaluation records.
B. Aggregate Exposure
There are no established U.S. tolerances for dimethomorph, and
there are no registered uses for dimethomorph in the United States.
For the purpose of assessing chronic dietary exposure from
dimethomorph, EPA assumed tolerance level residues and 100% of crop
treated for the proposed use of dimethomorph. These conservative
assumptions result in overestimation of human dietary exposures.
Secondary residues of dimethomorph 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 commodities 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 dimethomorph 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 dimethomorph 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 dimethomorph 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
dimethomorph in drinking water. No drinking water health advisory
levels have been established for dimethomorph. Dimethomorph 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
dimethomorph, 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) of the FFDCA 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 dimethomorph has a common
[[Page 26415]]
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, dimethomorph 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 dimethomorph 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 dimethomorph in food commodities
from published tolerances will utilize less than 1% of the RfD for the
U.S. population. An acute-dietary-risk endpoint was not identified.
Therefore, an acute-aggregate- risk assessment is not required.
Whatever reasonable bounding figure the Agency eventually decides upon
for the contribution from water, exposure to dimethomorph is not
expected to exceed the RfD. EPA concludes that there is a reasonable
certainty that no harm will result from aggregate exposure to
dimethomorph residues.
E. Determination of Safety for Infants and Children
FFDCA section 408 provides that EPA shall apply an additional 10-
fold 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 100-fold
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 100-fold margin/factor not the
additional 10-fold 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 dimethomorph relative to pre- and post-natal toxicity is
not complete.
It can not be established whether dimethomorph does or does not
demonstrate extra pre- or post-natal sensitivity for infants and
children based on the results of the rat and rabbit developmental
studies and the rat reproduction study. These studies were rated
supplementary (not acceptable). To compensate for the lack of
acceptable studies, the RfD (0.01 mg/kg/day) was calculated using an
uncertainty factor of 1,000. The additional 10-fold uncertainty factor
was added because of the data gaps and in order to protect infants and
children from possible pre-and post-natal, toxic risks from dietary
exposure to dimethomorph.
EPA has concluded that the percent of the RfD that will be utilized
by chronic dietary (food commodity) exposure to residues of
dimethomorph is less than or equal to 1% for all population subgroups
which includes nursing and non-nursing infants (<1 year="" old),="" and="" children="" (1-6="" yrs.)="" and="" (7-12="" yrs.).="" 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="" dimethomorph="" 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="" dimethomorph="" residues.="" v.="" other="" considerations="" the="" metabolism="" of="" dimethomorph="" in="" potatoes="" is="" adequately="" understood="" only="" for="" the="" purposes="" of="" this="" tolerance.="" there="" are="" no="" codex="" maximum="" residue="" levels="" established="" for="" residues="" of="" dimethomorph.="" the="" residue="" of="" concern,="" for="" the="" purposes="" of="" this="" tolerance,="" is="" dimethomorph.="" an="" adequate="" method="" is="" available="" for="" detection="" of="" the="" residues="" of="" concern="" for="" the="" purpose="" of="" this="" fifra="" section="" 18="" request.="" high="" performance="" liquid="" chromotography/ultra="" violet="" (hplc/uv)="" analytical="" method="" fams="" 002-02="" is="" adequate="" for="" detecting="" residues="" of="" dimethomorph="" in/on="" potatoes.="" this="" method="" has="" undergone="" a="" successful="" agency="" validation.="" 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="" highway,="" arlington,="" va,="" 703-305-="" 5805.="" vi.="" conclusion="" therefore,="" a="" tolerance="" in="" connection="" with="" the="" fifra="" section="" 18="" emergency="" exemptions="" is="" established="" for="" residues="" of="" dimethomorph="" in="" or="" on="" potatoes="" at="" 0.05="" ppm.="" this="" tolerance="" will="" expire="" and="" is="" revoked="" by="" epa="" on="" march="" 15,="" 1999.="" after="" that="" date,="" epa="" will="" publish="" a="" document="" in="" the="" federal="" register="" to="" remove="" the="" revoked="" tolerance="" from="" the="" code="" of="" federal="" regulations.="" vii.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" ffdca="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" ffdca="" section="" 408="" and="" in="" ffdca="" 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="" on="" 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="" in="" ``addresses''="" (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="" [[page="" 26416]]="" 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="" record="" a="" record="" has="" been="" established="" for="" this="" rulemaking="" under="" document="" control="" number="" [opp-300483].="" a="" public="" version="" of="" this="" record,="" 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="" response="" and="" program="" resources="" branch,="" field="" operations="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" the="" official="" record="" for="" this="" rulemaking,="" as="" well="" as="" the="" public="" version,="" as="" described="" above,="" is="" kept="" in="" paper="" form.="" accordingly,="" in="" the="" event="" there="" are="" objections="" and="" hearing="" requests,="" 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.="" the="" official="" rulemaking="" record="" is="" the="" paper="" record="" maintained="" at="" the="" address="" in="" ``addresses''at="" the="" beginning="" of="" this="" document.="" 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="" j.="" 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.="" 180.493="" to="" subpart="" c="" to="" read="" as="" follows:="" sec.="" 180.493="" dimethomorph;="" tolerances="" for="" residues.="" (a)="" general.="" [reserved]="" (b)="" section="" 18="" emergency="" exemptions.="" a="" time-limited="" tolerance="" is="" established="" for="" residues="" of="" the="" fungicide="" dimethomorph="" in="" connection="" with="" use="" of="" the="" pesticide="" under="" section="" 18="" emergency="" exemptions="" granted="" by="" epa.="" the="" tolerance="" is="" specified="" in="" the="" following="" table.="" this="" tolerance="" will="" expire="" and="" is="" 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.="" ------------------------------------------------------------------------="" expiration/="" commodity="" parts="" per="" revocation="" million="" date="" ------------------------------------------------------------------------="" potatoes......................................="" 0.05="" 3/15/99="" ------------------------------------------------------------------------="" (c)="" tolerances="" with="" regional="" registrations.="" [reserved]="" (d)="" indirect="" and="" inadvertent="" residues.="" [reserved]="" [fr="" doc.="" 97-12474="" filed="" 5-13-97;="" 8:45="" am]="" billing="" code="" 6560-50-f="">