[Federal Register Volume 63, Number 121 (Wednesday, June 24, 1998)]
[Rules and Regulations]
[Pages 34304-34310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16677]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300676; FRL-5797-5]
RIN 2070-AB78
Fludioxonil; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of fludioxonil in or on apricots, nectarines, peaches and
plums. This action is in response to EPA's granting of an emergency
exemption under section 18
[[Page 34305]]
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing
use of the pesticide on stone fruit in California, Georgia and South
Carolina. This regulation establishes a maximum permissible level for
residues of fludioxonil in this food commodity pursuant to section
408(l)(6) of the Federal Food, Drug, and Cosmetic Act, as amended by
the Food Quality Protection Act of 1996. The tolerances will expire and
are revoked on December 31, 1999.
DATES: This regulation is effective June 24, 1998. Objections and
requests for hearings must be received by EPA on or before August 24,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300676], 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-300676], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, 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 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300676]. 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: Stephen Schaible,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9362; e-mail:
schaible.stephen@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 tolerances for
residues of the fungicide 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-
pyrrole-3-carbonitrile, hereafter referred to as fludioxonil, in or on
apricots, nectarines, peaches and plums at 5.0 part per million (ppm).
These tolerances will expire and are revoked on December 31, 1999. EPA
will publish a document in the Federal Register to remove the revoked
tolerances 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 . The FQPA amendments went
into effect immediately. Among other things, FQPA amends FFDCA to bring
all EPA pesticide tolerance-setting activities under a new section 408
with a new safety standard and new procedures. These activities are
described below and discussed in greater detail in the final rule
establishing the time-limited tolerance associated with the emergency
exemption for use of propiconazole on sorghum (61 FR 58135, November
13, 1996)(FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Fludioxonil on Apricots, Nectarines,
Peaches and Plums and FFDCA Tolerances
The California Department of Pesticide Regulation, South Carolina
Department of Pesticide Regulation, and Georgia Department of
Agriculture have requested the use of fludioxonil on stone fruit to
control brown rot, gray mold rot and Rhizopus rot. These fungal
pathogens cause latent infection during the period from shuck fall
through harvest. When a fruit matures its disease resistance declines
and a latent fungal infection turns into a fruit lesion. Lesioned fruit
become unmarketable. Harvested fruit were treated with the systemic
fungicide iprodione up until 1996, when the manufacturer canceled
postharvest use on stone fruit. During 1997, left over iprodione stock
was used; many packing houses packed the fruit without a fungicide
treatment, which resulted in significant yield and quality losses of
the produce. The only other registered alternative, dicloran, does not
control these fruit diseases at a commercially acceptable level.
Significant economic losses to growers are expected without the
proposed use. EPA has authorized under FIFRA section 18 the use of
fludioxonil on stone fruit for control of brown rot, gray mold rot, and
Rhizopus rot in California, Georgia and South Carolina.
[[Page 34306]]
After having reviewed the submissions, EPA concurs that emergency
conditions exist for these States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of fludioxonil in or on
apricots, nectarines, peaches and plums. In doing so, EPA considered
the new safety standard in FFDCA section 408(b)(2), and EPA decided
that the necessary tolerance under FFDCA section 408(l)(6) would be
consistent with the new safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment under section 408(e),
as provided in section 408(l)(6). Although these tolerances will expire
and are revoked on December 31, 1999, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on apricots, nectarines, peaches and plums
after that date will not be unlawful, provided the pesticide is applied
in a manner that was lawful under FIFRA, and the residues do not exceed
a level that was authorized by these tolerances at the time of that
application. EPA will take action to revoke these tolerances earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions EPA has not made any decisions about whether fludioxonil
meets EPA's registration requirements for use on apricots, nectarines,
peaches and plums or whether permanent tolerances for this use would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of fludioxonil by a State
for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any State other than California,
Georgia and South Carolina 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 exemption for fludioxonil, contact the Agency's Registration
Division at the address provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and
[[Page 34307]]
presented as part of the comprehensive risk assessment/
characterization. Since the toxicological endpoint considered in this
assessment reflects exposure over a period of at least 7 days, an
additional degree of conservatism is built into the assessment; i.e.,
the risk assessment nominally covers 1-7 days exposure, and the
toxicological endpoint/NOEL is selected to be adequate for at least 7
days of exposure. (Toxicity results at lower levels when the dosing
duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (non-nursing
infants (< 1="" yr.="" old))="" was="" not="" regionally="" based.="" iv.="" aggregate="" risk="" assessment="" and="" determination="" of="" safety="" consistent="" with="" section="" 408(b)(2)(d),="" epa="" has="" reviewed="" the="" available="" scientific="" data="" and="" other="" relevant="" information="" in="" support="" of="" this="" action,="" epa="" has="" sufficient="" data="" to="" assess="" the="" hazards="" of="" fludioxonil="" and="" to="" make="" a="" determination="" on="" aggregate="" exposure,="" consistent="" with="" section="" 408(b)(2),="" for="" time-limited="" tolerances="" for="" residues="" of="" fludioxonil="" on="" apricots,="" nectarines,="" peaches="" and="" plums="" at="" 5.0="" ppm.="" epa's="" assessment="" of="" the="" dietary="" exposures="" and="" risks="" associated="" with="" establishing="" the="" tolerances="" follows.="" a.="" toxicological="" profile="" epa="" has="" evaluated="" the="" available="" toxicity="" data="" and="" considered="" its="" validity,="" completeness,="" and="" reliability="" as="" well="" as="" the="" relationship="" of="" the="" results="" of="" the="" studies="" to="" human="" risk.="" epa="" has="" also="" considered="" available="" information="" concerning="" the="" variability="" of="" the="" sensitivities="" of="" major="" identifiable="" subgroups="" of="" consumers,="" including="" infants="" and="" children.="" the="" nature="" of="" the="" toxic="" effects="" caused="" by="" fludioxonil="" are="" discussed="" below.="" 1.="" acute="" toxicity.="" no="" endpoint="" was="" identified="" for="" acute="" dietary="" exposure.="" the="" epa="" has="" concluded="" that="" the="" toxicology="" database="" does="" not="" suggest="" the="" need="" for="" this="" assessment,="" as="" no="" acute="" effects="" are="" expected="" to="" result="" from="" exposure="" to="" fludioxonil.="" 2.="" chronic="" toxicity.="" epa="" has="" established="" the="" rfd="" for="" fludioxonil="" at="" 0.03="" milligrams/kilogram/day="" (mg/kg/day).="" this="" rfd="" is="" based="" on="" a="" noel="" of="" 3.3="" mg/kg/day,="" taken="" from="" a="" chronic="" feeding="" study="" in="" dogs,="" and="" an="" uncertainty="" factor="" of="" 100.="" the="" effect="" observed="" at="" the="" lel="" of="" 35.5="" mg/="" kg/day="" was="" decreased="" body="" weight="" gain="" in="" females.="" 3.="" carcinogenicity.="" fludioxonil="" has="" been="" classified="" as="" a="" group="" d-="" not="" classifiable="" as="" to="" human="" carcinogenicity-="" chemical="" by="" the="" cancer="" peer="" review="" committee.="" b.="" exposures="" and="" risks="" 1.="" from="" food="" and="" feed="" uses.="" a="" tolerance="" has="" been="" established="" (40="" cfr="" 180.516)="" for="" the="" residues="" of="" fludioxonil="" in="" or="" on="" potatoes="" at="" 0.02="" ppm.="" fludioxonil="" is="" currently="" registered="" for="" use="" as="" a="" seed="" treatment="" on="" potatoes,="" popcorn,="" field="" and="" sweet="" corn,="" and="" sorghum,="" as="" well="" as="" for="" use="" in="" greenhouses="" on="" nonfood="" crops.="" since="" residues="" in="" corn="" and="" sorghum="" are="" non-quantifiable,="" these="" uses="" do="" not="" require="" tolerances.="" risk="" assessments="" were="" conducted="" by="" epa="" to="" assess="" dietary="" exposures="" and="" risks="" from="" fludioxonil="" as="" follows:="" chronic="" exposure="" and="" risk.="" tolerance="" level="" residues="" and="" 100%="" crop="" treated="" were="" assumed="" to="" calculate="" tmrcs="" for="" the="" u.s.="" population="" and="" population="" subgroups="" from="" residues="" on="" potatoes="" and="" stone="" fruit.="" chronic="" exposure="" from="" food="" uses="" of="" fludioxonil="" represents="" 6%="" of="" the="" rfd="" for="" the="" u.s.="" population="" and="" 52%="" of="" the="" rfd="" for="" non-nursing="" infants=""><1yr), the="" subgroup="" most="" highly="" exposed.="" 2.="" from="" drinking="" water.="" in="" light="" of="" the="" use="" pattern,="" a="" post-harvest="" spray="" treatment="" for="" stone="" fruit="" which="" would="" occur="" indoors,="" along="" with="" the="" currently="" registered="" uses-="" seed="" treatments="" for="" potato="" and="" corn="" (field="" &="" sweet),="" popcorn,="" and="" sorghum,="" and="" ornamental="" plants="" grown="" in="" greenhouses,="" or="" other="" enclosed="" structures-="" fludioxonil="" is="" not="" expected="" to="" impact="" ground="" or="" surface="" waters.="" as="" a="" result,="" the="" likelihood="" of="" residues="" of="" fludioxonil="" in="" drinking="" water="" is="" negligible.="" therefore,="" epa="" concludes="" that="" a="" drinking="" water="" risk="" assessment="" is="" not="" required="" at="" this="" time.="" therefore,="" there="" is="" no="" drinking="" water="" risk="" assessment="" to="" aggregate="" with="" the="" chronic="" dietary="" (food="" sources)="" risk="" assessment.="" 3.="" from="" non-dietary="" exposure.="" fludioxonil="" is="" currently="" not="" registered="" for="" use="" on="" residential,="" non-food="" sites;="" therefore,="" no="" non-="" occupational,="" non-dietary="" exposure="" is="" expected.="" (please="" remove="" all="" language="" in="" this="" section="" from="" this="" point="" on).="" 4.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity.="" section="" 408(b)(2)(d)(v)="" requires="" that,="" when="" considering="" whether="" to="" establish,="" modify,="" or="" revoke="" a="" tolerance,="" the="" agency="" consider="" ``available="" information''="" concerning="" the="" cumulative="" [[page="" 34308]]="" 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="" fludioxonil="" 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,="" fludioxonil="" 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="" fludioxonil="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" c.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" chronic="" risk.="" using="" the="" tmrc="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" fludioxonil="" from="" food="" will="" utilize="" 6%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" non-nursing="" infants=""><1 yr)="" (discussed="" below).="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" given="" that="" the="" proposed="" use="" pattern="" is="" a="" postharvest="" spray="" treatment="" for="" stone="" fruit="" which="" would="" occur="" indoors,="" and="" that="" currently="" registered="" uses="" are="" for="" seed="" treatments="" at="" a="" low="" application="" rate="" and="" for="" ornamental="" plants="" grown="" in="" greenhouses="" or="" other="" enclosed="" structures,="" fludioxonil="" is="" not="" expected="" to="" impact="" ground="" or="" surface="" water;="" the="" likelihood="" of="" residues="" in="" drinking="" water="" is="" negligible.="" currently,="" there="" are="" no="" registered="" residential="" uses="" of="" fludioxonil.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" fludioxonil="" residues.="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" infants="" and="" children="" 1.="" safety="" factor="" for="" infants="" and="" children--="" i.="" in="" general.="" in="" assessing="" the="" potential="" for="" additional="" sensitivity="" of="" infants="" and="" children="" to="" residues="" of="" fludioxonil,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" two-="" generation="" reproduction="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" maternal="" pesticide="" exposure="" during="" gestation.="" reproduction="" studies="" provide="" information="" relating="" to="" effects="" from="" exposure="" to="" the="" pesticide="" on="" the="" reproductive="" capability="" of="" mating="" animals="" and="" data="" on="" systemic="" toxicity.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" tenfold="" margin="" of="" safety="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" to="" account="" for="" pre-and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" database="" unless="" epa="" determines="" that="" a="" different="" margin="" of="" safety="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" safety="" are="" incorporated="" into="" epa="" risk="" assessments="" either="" directly="" through="" use="" of="" a="" moe="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" moe="" and="" uncertainty="" factor="" (usually="" 100="" for="" combined="" inter-="" and="" intra-="" species="" variability))="" and="" not="" the="" additional="" tenfold="" moe/uncertainty="" factor="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children="" or="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" moe/safety="" factor.="" ii.="" developmental="" toxicity="" studies.="" in="" the="" rat="" developmental="" study,="" the="" maternal="" (systemic)="" noel="" was="" 100="" mg/kg/day,="" based="" on="" reduction="" in="" mean="" body="" weight="" gain="" in="" dams="" during="" gestation="" period="" at="" the="" lowest-="" observed-effect-level="" (loel)="" of="" 1,000="" mg/kg/day.="" the="" developmental="" (fetal)="" noel="" was="" 100="" mg/kg/day,="" based="" on="" increased="" fetal="" and="" litter="" incidence="" of="" dilated="" renal="" pelvis="" and="" dilated="" ureter="" at="" the="" loel="" of="" 1,000="" mg/kg/day.="" in="" the="" rabbit="" developmental="" toxicity="" study,="" the="" maternal="" (systemic)="" noel="" was="" 10="" mg/kg/day,="" based="" on="" decreased="" body="" weight="" gains="" and="" food="" efficiency="" at="" the="" loel="" of="" 100="" mg/kg/day.="" the="" developmental="" (pup)="" noel="" was="" 300="" mg/kg/day,="" the="" highest="" dose="" tested.="" iii.="" reproductive="" toxicity="" study.="" in="" the="" two-generation="" reproductive="" toxicity="" study="" in="" rats,="" the="" parental="" (systemic)="" noel="" was="" 22.13="" mg/kg/day="" (males)="" and="" 24.24="" mg/kg/day="" (females),="" based="" on="" clinical="" signs="" and="" decreased="" body="" weight,="" body="" weight="" gain="" and="" food="" consumption="" at="" the="" loel="" of="" 221.6="" mg/kg/day="" (males)="" and="" 249.7="" mg/kg/day="" (females).="" the="" reproductive/developmental="" (pup)="" noel="" was="" 22.13="" mg/kg/="" day="" (males)="" and="" 24.24="" mg/kg/day="" (females),="" based="" on="" reduced="" pup="" weights="" at="" the="" loel="" of="" 221.6="" mg/kg/day="" (males)="" and="" 249.7="" mg/kg/day="" (females).="" iv.="" pre-="" and="" post-natal="" sensitivity.="" the="" toxicological="" data="" base="" for="" evaluating="" pre-="" and="" post-natal="" toxicity="" for="" fludioxonil="" is="" complete="" with="" respect="" to="" current="" data="" requirements.="" there="" are="" no="" pre-="" or="" post-="" natal="" toxicity="" concerns="" for="" infants="" and="" children,="" based="" on="" the="" results="" of="" the="" rat="" and="" rabbit="" developmental="" toxicity="" studies="" and="" the="" two-="" generation="" rat="" reproductive="" toxicity="" study.="" v.="" conclusion.="" epa="" concludes="" that="" reliable="" data="" support="" the="" removal="" of="" the="" additional="" uncertainty="" factor;="" the="" standard="" hundredfold="" uncertainty="" factor="" is="" adequate="" to="" protect="" the="" safety="" of="" infants="" and="" children.="" 2.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" fludioxonil="" [[page="" 34309]]="" from="" food="" will="" utilize="" 52%="" of="" the="" rfd="" for="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" exposure="" from="" drinking="" water="" and="" residential="" uses="" is="" not="" expected.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" fludioxonil="" residues.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" residue="" in="" stone="" fruit="" is="" adequately="" understood="" based="" on="" a="" metabolism="" study="" submitted="" for="" seed="" treatment="" use="" on="" potatoes.="" the="" residue="" of="" concern="" is="" the="" parent="" compound,="" fludioxonil,="" only.="" there="" are="" no="" livestock="" feed="" items="" associated="" with="" the="" proposed="" use="" on="" stone="" fruit.="" therefore,="" the="" nature="" of="" the="" residue="" in="" animals="" is="" not="" germane="" to="" these="" section="" 18="" requests="" or="" to="" the="" establishment="" of="" these="" tolerances.="" b.="" analytical="" enforcement="" methodology="" adequate="" enforcement="" methodology="" (gc/npd)="" was="" provided="" with="" the="" applicants'="" submissions="" to="" enforce="" the="" tolerance="" expression="" (modifications="" to="" methods="" ag-597b="" and="" ag-664).="" c.="" magnitude="" of="" residues="" residues="" of="" fludioxonil="" are="" not="" expected="" to="" exceed="" 5.0="" ppm="" in/on="" apricots,="" nectarines,="" peaches,="" and="" plums="" as="" a="" result="" of="" the="" proposed="" section="" 18="" use.="" secondary="" residues="" are="" not="" expected="" in="" animal="" commodities="" as="" there="" are="" no="" feed="" items="" associated="" with="" this="" section="" 18="" use.="" d.="" international="" residue="" limits="" no="" codex,="" canadian,="" or="" mexican="" mrls/tolerances="" have="" been="" established="" for="" residues="" of="" fludioxonil="" on="" stone="" fruit.="" e.="" rotational="" crop="" restrictions="" the="" proposed="" post-harvest="" use="" does="" not="" involve="" application="" of="" fludioxonil="" to="" fields="" of="" growing="" crops.="" therefore,="" rotational="" crop="" restrictions="" are="" not="" relevant="" to="" this="" discussion.="" vi.="" conclusion="" therefore,="" tolerances="" are="" established="" for="" residues="" of="" fludioxonil="" in="" apricots,="" nectarines,="" peaches="" and="" plums="" at="" 5.0="" ppm.="" 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="" 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="" august="" 24,="" 1998,="" 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="" record="" and="" electronic="" submissions="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300676]="" (including="" any="" comments="" and="" data="" submitted="" electronically).="" a="" public="" version="" of="" this="" record,="" including="" printed,="" paper="" versions="" of="" electronic="" comments,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8:30="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 119="" of="" the="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7502c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va.="" electronic="" comments="" may="" be="" sent="" directly="" to="" epa="" at:="">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.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section
408(l)(6) in response to a petition submitted to the Agency. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
[[Page 34310]]
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since these tolerances and exemptions that are
established under FFDCA section 408 (l)(6), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. Nevertheless, the Agency has previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
X. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 8, 1998.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-- [AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.516, by adding text to paragraph (b) to read as
follows:
Sec. 180.516 Fludioxonil; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the fungicide fludioxonil (4-(2,2-difluoro-
1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile) in connection with use
of the pesticide under section 18 emergency exemptions granted by EPA.
The tolerances will expire and are revoked on the dates specified in
the following table:
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Apricots........................ 5.0 12/31/99
Nectarines...................... 5.0 12/31/99
Peaches......................... 5.0 12/31/99
Plums........................... 5.0 12/31/99
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-16677 Filed 6-23-98; 8:45 am]
BILLING CODE 6560-50-F
