[Federal Register Volume 62, Number 209 (Wednesday, October 29, 1997)]
[Rules and Regulations]
[Pages 56075-56082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28644]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300565; FRL-5750-2]
RIN 2070-AB78
4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile;
Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for 4-(2,2-difluoro-
1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile in or on potatoes . The
Ciba-Geigy Corporation submitted a petition to EPA under the Federal
Food, Drug and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (Pub. L. 104-170) requesting this tolerance.
DATES: This regulation is effective October 29, 1997. Objections and
requests for hearings must be received by EPA on or before December 29,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300565], 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-300565], 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. 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 control
number [OPP-300565]. 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: Mary L. Waller, 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) 308-9354, e-mail:
waller.mary@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 5, 1997
(62 FR 5403) (FRL-5584-1), EPA, issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
announcing the filing of a pesticide petition (PP6F4694) for tolerance
by the Ciba-Geigy Corporation, 410 Swing Road, Greensboro, NC 27401.
This notice included a summary of the petition prepared by the Ciba-
Geigy Corporation, the registrant. There were no comments received in
response to the notice of filing.
[[Page 56076]]
The petition requested that 40 CFR part 180 be amended by
establishing a tolerance for the fungicide, 4-(2,2-difluoro-1,3-
benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, in or on potatoes at 0.02
parts per million (ppm).
I. Risk Assessment and Statutory Findings
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. . . .''
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, which could occur for residential uses of a pesticide, 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,'' 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 enactment of FQPA
this risk 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 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
[[Page 56077]]
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 year="" old)="" was="" not="" regionally="" based.="" ii.="" 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="" 4-(2,2-="" difluoro-1,3-benzodioxol-4-yl)-1h-pyrrole-3-carbonitrile="" and="" to="" make="" a="" determination="" on="" aggregate="" exposure,="" consistent="" with="" section="" 408(b)(2),="" for="" a="" tolerance="" for="" 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1h-pyrrole-3-="" carbonitrile="" on="" potatoes="" at="" 0.02="" ppm.="" epa's="" assessment="" of="" the="" dietary="" exposures="" and="" risks="" associated="" with="" establishing="" the="" tolerance="" follows.="" a.="" toxicological="" profile="" epa="" has="" evaluated="" the="" available="" toxicity="" data="" and="" considered="" its="" validity,="" completeness,="" and="" reliability="" as="" well="" as="" the="" relationship="" of="" the="" results="" of="" the="" studies="" to="" human="" risk.="" epa="" has="" also="" considered="" available="" information="" concerning="" the="" variability="" of="" the="" sensitivities="" of="" major="" identifiable="" subgroups="" of="" consumers,="" including="" infants="" and="" children.="" the="" nature="" of="" the="" toxic="" effects="" caused="" by="" 4-(2,2-difluoro-="" 1,3-benzodioxol-4-yl)-1h-pyrrole-3-carbonitrile="" are="" discussed="" below.="" 1.="" a="" battery="" of="" acute="" toxicity="" studies="" placing="" technical="" fludioxonil="" in="" toxicity="" category="" iii="" for="" eye="" irritation,="" category="" iv="" for="" oral="" ld50,="" category="" iv="" for="" inhalation="" lc50="" and="" dermal="" irritation,="" and="" category="" iii="" for="" dermal="" ld50.="" 4-(2,2-difluoro-1,3-benzodioxol-4-="" yl)-1h-pyrrole-3-carbonitrile="" is="" a="" non-sensitizer.="" 2.="" a="" subchronic="" oral="" toxicity="" study="" in="" rats="" dosed="" orally="" with="" technical="" fludioxonil="" at="" levels="" of="" 0,="" 10,="" 100,="" 1,000,="" 7,000,="" and="" 20,000="" ppm="" (0,="" 0.8,="" 6.6,="" 64,="" 428,="" and="" 1,283="" mg/kg/day="" in="" males;="" 0,="" 1.0,="" 7.1,="" 70,="" 462,="" and="" 1,288="" mg/kg/day="" in="" females)="" resulted="" in="" the="" lowest="" effect="" level="" (lel)="" of="" 428="" mg/kg/day="" in="" males="" and="" 462="" mg/kg/day="" in="" females,="" based="" on="" the="" increased="" incidence="" of="" microscopic="" pathology="" of="" the="" kidney="" and="" liver,="" and="" deceased="" body="" weight="" gain.="" the="" noel="" is="" 64="" mg/kg/day="" in="" males;="" 70="" mg/kg/day="" in="" females.="" 3.="" a="" subchronic="" oral="" toxicity="" study="" in="" dogs="" administered="" doses="" of="" 0,="" 200,="" 2,000,="" and="" 15,000/10,000="" ppm="" (15,000="" ppm="" for="" 17="" days="" and="" 10,000="" ppm="" from="" day="" 18="" until="" study="" termination)="" for="" 13="" weeks="" with="" a="" lel="" of="" 2,000="" ppm="" in="" males="" and="" females,="" based="" on="" the="" observation="" of="" diarrhea="" at="" this="" dose="" level.="" these="" dose="" levels="" correspond="" to="" nominal="" doses="" of="" 0,="" 5,="" 50,="" or="" 375/250="" mg/kg/day,="" as="" actual="" intake="" data="" were="" not="" provided.="" the="" noel="" is="" 5="" mg/kg/day="" in="" males="" and="" females.="" 4.="" a="" subchronic="" oral="" toxicity="" study="" in="" mice="" administered="" doses="" of="" 0,="" 10,="" 100,="" 1,000,="" 3,000,="" or="" 7,000="" ppm="" (0,="" 1.3,="" 13.9,="" 144,="" 445,="" or="" 1,052="" mg/kg/day="" in="" males;="" 0,="" 1.9,="" 16.8,="" 178,="" 559,="" or="" 1,307="" mg/kg/day="" in="" females)="" with="" a="" lel="" of="" 1,052="" mg/kg/day="" in="" males,="" and="" 1,307="" mg/kg/day="" in="" females="" based="" on="" decreased="" body="" weight="" gain="" in="" female="" mice,="" changes="" in="" serum="" chemistry="" in="" male="" and="" female="" mice,="" observed="" increase="" in="" liver="" to="" body="" weight="" ratio,="" and="" the="" increased="" incidence="" of="" nephropathy="" and="" centrilobular="" hypertrophy="" of="" the="" liver="" in="" both="" sexes.="" the="" noel="" is="" 445="" mg/kg/day="" in="" males="" and="" 559="" mg/kg/day="" in="" females.="" 5.="" a="" dermal="" toxicity="" test="" in="" rats="" exposed="" as="" a="" repeated="" dermal="" dose="" under="" occlusive="" dressing="" 6="" hrs/day,="" 5="" days/week,="" for="" 4="" weeks="" at="" 0,="" 40,="" 200,="" and="" 1,000="" mg/kg/day.="" for="" dermal="" irritation,="" the="" lel="" and="" noel="" are="" both="" greater="" than="" 1,000="" mg/kg="" for="" males="" and="" females.="" the="" lel="" for="" systemic="" toxicity="" for="" females="" is="" 1,000="" mg/kg="" based="" on="" increased="" ast="" and="" adrenal="" weight,="" and="" 1,000="" mg/kg="" for="" males="" based="" on="" increased="" creatinine="" and="" adrenal="" weight.="" the="" noel="" is="" 200="" mg/kg/day="" for="" males="" and="" females.="" 6.="" a="" chronic="" oral="" toxicity="" study="" in="" dogs="" dosed="" for="" 52="" weeks="" at="" 0,="" 100,="" 1,000,="" and="" 8,000="" ppm="" in="" the="" diet="" (0,="" 3.1,="" 33.1,="" and="" 297.8="" mg/kg/="" day="" in="" males;="" 3.3,="" 35.5,="" and="" 330.7="" mg/kg/day="" in="" females.="" the="" lel="" is="" 297.8="" mg/kg/day="" for="" male="" dogs="" based="" on="" decreased="" body="" weight,="" hematology="" alterations="" (increase="" in="" platelets="" and="" fibrin),="" clinical="" chemistry="" alterations="" (increase="" in="" cholesterol="" and="" alkaline="" phosphatase)="" and="" increased="" liver="" weight.="" the="" lel="" is="" 35.5="" mg/kg/day="" for="" female="" dogs="" based="" on="" a="" marked="" decrease="" in="" body="" weight="" gain="" for="" weeks="" 1="" -="" 13="" and="" weeks="" 1="" -="" 52="" of="" the="" study.="" the="" noel="" is="" 33.1="" mg/kg/day="" for="" male="" dogs="" and="" 3.3="" mg/kg/day="" in="" female="" dogs.="" 7.="" a="" combined="" chronic="" toxicity/carcinogenicity="" study="" in="" rats="" fed="" 0,="" 10,="" 30,="" 100,="" 1,000="" and="" 3,000="" ppm="" for="" either="" 12="" or="" 24="" months="" (males:="" 0,="" 0.37,="" 1.1,="" 3.7,="" 37="" and="" 113="" mg/kg/day,="" respectively;="" females:="" 0,="" 0.44,="" 1.3,="" 4.4,="" 44="" and="" 141="" mg/kg/day="" respectively).="" the="" 3,000="" ppm="" dose="" level="" is="" considered="" adequate="" for="" carcinogenicity="" testing,="" based="" on="" decreased="" body="" weight="" and="" body="" weight="" gain="" in="" both="" sexes,="" slight="" anemia="" in="" females="" at="" 12="" months,="" and="" an="" increased="" incidence="" and="" severity="" of="" liver="" histopathology="" changes="" in="" both="" sexes.="" rats="" from="" the="" control="" and="" 3,000="" ppm="" groups="" were="" fed="" the="" test="" diets="" for="" 12="" months="" and="" then="" allowed="" to="" recover="" for="" one="" month="" prior="" to="" sacrifice.="" there="" was="" no="" treatment-="" related="" effect="" on="" food="" or="" water="" consumption.="" males="" dosed="" at="" 1,000="" and="" 3,000="" ppm,="" and="" females="" dosed="" at="" 3,000="" ppm="" exhibited="" a="" number="" of="" effects="" including="" higher="" incidence="" of="" dark="" stool="" and="" urine,="" staining="" (mostly="" blue)="" around="" the="" pelvic="" region="" and="" abdomen,="" higher="" frequency="" of="" diarrhea="" (males="" only),="" and="" decrease="" body="" weight="" gain.="" females="" dosed="" at="" 3,000="" ppm="" had="" some="" evidence="" of="" slight="" anemia="" at="" the="" 12-month="" evaluation.="" at="" necropsy,="" [[page="" 56078]]="" males="" at="" the="" 3,000="" ppm="" dose="" level="" exhibited="" an="" increased="" incidence="" of="" enlarged="" livers,="" and="" kidneys="" with="" discolored="" foci="" or="" general="" discoloration="" and="" an="" increased="" severity="" of="" progressive="" nephropathy;="" kidneys="" with="" cysts="" were="" reported="" at="" both="" the="" 1,000="" and="" 3,000="" ppm="" dose="" levels.="" for="" females="" in="" the="" 1,000="" and="" 3,000="" ppm="" dose="" levels="" there="" was="" an="" increase="" incidence="" of="" general="" discoloration="" of="" the="" the="" kidneys.="" males="" and="" females="" in="" the="" 3,000="" ppm="" group="" had="" an="" increased="" incidence="" and="" more="" severe="" grade="" of="" histopathological="" changes="" in="" the="" liver.="" there="" was="" an="" increase="" incidence="" of="" hepatocellular="" tumors="" in="" both="" sexes="" of="" the="" 3,000="" ppm="" group,="" however="" the="" increase="" in="" males="" was="" not="" statistically="" significant.="" the="" statistically="" significant="" finding="" in="" females="" was="" an="" increase="" in="" combined="" adenomas="" and="" carcinomas="" (0/70,="" 1/60,="" 0/60,="" 1/60,="" 2/60="" and="" 5/70="" in="" the="" 0,="" 10,="" 30,="" 100,="" 1,000="" and="" 3,000="" ppm="" groups,="" respectively).="" males="" and="" females="" in="" the="" 3,000="" ppm="" group="" had="" an="" increased="" incidence="" of="" basophilic="" foci="" in="" the="" liver;="" males="" also="" had="" an="" increase="" in="" hepatocellular="" hypertrophy.="" the="" lel="" for="" males="" and="" females="" was="" 113="" and="" 141="" mg/kg/day,="" respectively="" (3,000="" ppm)="" based="" on="" decreased="" body="" weight="" and="" weight="" gain,="" slight="" anemia="" in="" females="" at="" 12="" months,="" and="" increased="" incidence="" and="" severity="" of="" histopathology="" changes="" in="" the="" liver.="" the="" noel="" for="" males="" and="" females="" was="" 37="" and="" 44="" mg/kg/day,="" respectively.="" 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1h-pyrrole-3-="" carbonitrile="" technical="" was="" not="" carcinogenic="" in="" male="" rats.="" there="" was="" a="" statistically="" significant="" increase="" in="" the="" incidence="" of="" combined="" adenomas="" and="" adenocarcinomas="" of="" the="" liver="" in="" female="" rats="" in="" the="" 3,000="" ppm="" dosed="" group.="" 8.="" a="" carcinogenicity="" study="" in="" mice="" administered="" in="" the="" diet="" nominal="" dose="" levels="" at="" 0,="" 10,="" 100,="" 1,000,="" and="" 3,000="" ppm="" (0,="" 1.1,="" 11.3,="" 112,="" and="" 360="" mg/kg/day="" for="" male="" mice;="" 0,="" 1.4,="" 13.5,="" 133,="" and="" 417="" mg/kg/day="" for="" female="" mice).="" male="" mice="" at="" the="" 3,000="" ppm="" level="" exhibited="" clinical="" toxicity="" in="" the="" form="" of="" an="" incidence="" of="" male="" mice="" which="" ``convulsed''="" when="" handled.="" no="" significant="" effects="" on="" body="" weight,="" weight="" gain,="" food="" consumption,="" hematology,="" or="" microscopic="" non-neoplastic="" pathology="" was="" reported="" in="" either="" sex.="" increased="" liver="" weight="" (9%)="" and="" spleen="" weight="" (34%)="" were="" observed="" in="" male="" mice="" at="" the="" 3,000="" ppm="" dose="" level,="" which="" correlated="" with="" the="" macroscopic="" observations="" of="" enlarged="" spleen="" and="" raised="" foci="" of="" their="" liver.="" female="" mice="" showed="" a="" statistically="" significant="" increase="" in="" liver="" weight="" at="" the="" 3,000="" ppm="" dose="" level,="" and="" this="" is="" also="" supported="" by="" the="" macroscopic="" observation="" of="" enlarged="" liver="" at="" the="" 3,000="" ppm="" dose="" level="" in="" female="" mice.="" other="" macroscopic="" changes="" in="" female="" mice="" were="" an="" increased="" incidence="" of="" enlarged="" thymus,="" spleen,="" mediastinal="" lymph="" node,="" and="" liver,="" and="" an="" increased="" incidence="" of="" lymphoma="" in="" these="" organs.="" the="" lel="" is="" 112="" mg/kg/day="" for="" male="" mice,="" based="" on="" the="" increased="" incidence="" of="" clinical="" toxicity="" in="" male="" mice="" (specifically,="" the="" increased="" incidence="" of="" mice="" convulsing="" when="" handled),="" and="" 417="" mg/kg/day="" for="" female="" mice,="" based="" on="" the="" increase="" in="" liver="" weight="" of="" female="" mice,="" and="" the="" increase="" in="" incidence="" of="" macroscopic="" pathology.="" the="" noel="" is="" 11.3="" mg/kg/day="" and="" 133="" mg/kg/day="" in="" male="" and="" female="" mice,="" respectively.="" there="" was="" evidence="" of="" carcinogenicity="" in="" female="" mice="" based="" on="" an="" increase="" incidence="" of="" lymphoas,="" which="" contributed="" to="" death.="" this="" effect="" was="" due="" to="" the="" early="" onset="" and="" high="" incidence="" of="" lymphoma="" at="" the="" 3,000="" ppm="" dose="" relative="" to="" the="" control="" group.="" total="" incidence="" of="" lymphoma="" was="" reported="" as="" 11/59,="" 10/59,="" 13/60,="" 12/60,="" and="" 18/60="" for="" the="" 0,="" 10,="" 100,="" 1,000,="" and="" 3,000="" ppm="" dose="" levels="" in="" female="" mice.="" this="" increase="" in="" total="" lymphoma="" was="" significant="" by="" a="" trend="" test,="" but="" not="" by="" pair="" wise="" comparison.="" whether="" an="" adequate="" dose="" level="" was="" used="" in="" this="" study="" to="" assess="" the="" carcinogic="" potential="" of="" 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1h-pyrrole-3-="" carbonitrile="" is="" complicated="" by="" the="" observation="" of="" an="" increased="" lymphoma="" incidence="" at="" the="" 3,000="" ppm="" dose="" level.="" this="" dose="" level="" produced="" some="" systemic="" effects,="" such="" as="" an="" increased="" incidence="" of="" male="" mice="" which="" `convulsed'="" when="" handle="" and="" macroscopic="" pathology="" in="" both="" sexes.="" but="" this="" dose="" level="" produced="" no="" significant="" effects="" on="" body="" weight,="" weight="" gain,="" food="" consumption,="" hematology,="" or="" microscopic="" non-neoplastic="" pathology="" in="" either="" sex.="" in="" a="" second="" carcinogenicity="" study="" in="" mice,="" 4-(2,2-difluoro-1,3-="" benzodioxol-4-yl)-1h-pyrrole-3-carbonitrile="" technical="" was="" administered="" in="" the="" diet="" at="" nominal="" dose="" levels="" of="" 0,="" 3,="" 30,="" 5,000,="" and="" 7,000="" ppm="" (0,="" 0.33,="" 3.3,="" 590,="" and="" 851="" mg/kg/="" day="" for="" male="" mice;="" 0,="" 0.41,="" 4.1,="" 715,="" and="" 1,008="" mg/kg/day="" for="" female="" mice).="" in="" male="" and="" female="" mice,="" the="" 7,000="" ppm="" dose="" level="" produced="" significant="" systemic="" effects="" in="" addition="" to="" significant="" nephropathy.="" the="" nephropathy="" in="" both="" sexes="" of="" mice="" dosed="" at="" 7,000="" ppm="" contributed="" to="" death="" in="" a="" majority="" of="" the="" mice.="" survival="" in="" female="" mice="" was="" below="" 25%,="" and="" exceeded="" the="" guideline="" criteria="" for="" survival="" in="" a="" mouse="" carcinogenicity="" study.="" changes="" in="" liver="" weights="" were="" observed="" in="" both="" sexes="" at="" the="" 5,000="" and="" 7,000="" ppm="" dose="" levels,="" but="" could="" not="" be="" related="" to="" histological="" alterations="" in="" the="" liver.="" therefore="" the="" lel="" is="" 851="" mg/kg/day="" in="" males,="" and="" 1,008="" mg/kg/day="" in="" females.="" the="" noel="" is="" 590="" mg/kg/day="" in="" males,="" and="" 715="" mg/kg/day="" in="" females.="" the="" 7,000="" ppm="" dose="" is="" adequate="" for="" testing="" carcinogenic="" potential="" in="" male="" mice,="" based="" on="" the="" significant="" systemic="" effects="" and="" nephropathy="" observed="" at="" this="" dose.="" for="" female="" mice,="" the="" 7,000="" ppm="" dose="" level="" is="" considered="" excessive,="" based="" on="" the="" reduction="" in="" survival="" of="" the="" test="" animals.="" there="" was="" no="" evidence="" of="" increased="" incidence="" of="" tumors="" in="" this="" study="" for="" male="" or="" female="" mice.="" 9.="" a="" developmental="" toxicity="" study="" in="" rats="" administered="" doses="" of="" 0,="" 10,="" 100,="" and="" 1,000="" mg/kg/day="" by="" oral="" gavage="" in="" 0.5%="" carboxymethylcellulose="" to="" pregnant="" female="" rats="" on="" gestation="" days="" 6="" -="" 15="" inclusive.="" maternal="" toxicity="" was="" evident="" at="" 1,000="" mg/kg/day,="" with="" a="" 16%="" reduction="" in="" corrected="" body="" weight="" gain.="" developmental="" toxicity="" was="" evident="" at="" the="" 1,000="" mg/kg/day="" dose="" level="" with="" increased="" fetal="" and="" litter="" incidence="" of="" dilated="" renal="" pelvis="" and="" dilated="" ureter.="" based="" on="" these="" observations,="" the="" maternal="" lel="" is="" 1,000="" mg/kg/day="" and="" the="" maternal="" noel="" is="" 100="" mg/kg/day.="" the="" developmental="" toxicity="" lel="" is="" 1,000="" mg/kg/day,="" and="" the="" developmental="" toxicity="" noel="" is="" 100="" mg/kg/day.="" 10.="" a="" developmental="" toxicity="" (teratology)="" study="" in="" rabbits="" dosed="" at="" 0,="" 10,="" 100,="" and="" 300="" mg/kg/day="" in="" a="" 0.5%="" methylcellulose="" solution="" in="" distilled="" water="" by="" oral="" gavage="" from="" gestation="" days="" 6="" through="" 18,="" inclusive.="" maternal="" toxicity="" as="" less="" body="" weigh="" was="" noted="" in="" the="" mid="" and="" high="" dose="" groups="" during="" the="" dosing="" period="" (gestation="" days="" 6="" through="" 18),="" for="" the="" overall="" dosing="" plus="" post="" dosing="" periods="" (gestation="" days="" 6="" through="" 28),="" and="" for="" the="" entire="" gestation="" period;="" maternal="" toxicity="" as="" decreased="" corrected="" body="" weight="" gains="" was="" observed="" for="" the="" dosing="" plus="" post="" dosing="" periods.="" the="" high="" dose="" group="" consumed="" less="" food="" than="" the="" control="" group="" during="" the="" dosing="" period="" (gestation="" days="" 6="" -="" 18),="" the="" post="" dosing="" period="" (gestation="" days="" 19="" -28),="" the="" dosing="" plus="" post="" dosing="" period="" (gestation="" days="" 19="" -="" 28),="" and="" for="" the="" overall="" gestation="" period.="" however,="" food="" efficiency="" was="" decreased="" in="" the="" mid="" and="" high="" dosed="" groups="" during="" the="" dosing="" plus="" post="" dosing="" periods,="" and="" for="" the="" entire="" gestation="" period.="" the="" maternal="" toxicity="" lel="" is="" 100="" mg/kg/day,="" and="" the="" maternal="" toxicity="" noel="" is="" 10="" mg/kg/day="" based="" on="" decreased="" body="" weight="" gains="" and="" decreased="" food="" efficiency.="" no="" developmental="" toxicity="" was="" noted="" at="" the="" dose="" levels="" tested.="" the="" developmental="" toxicity="" lel="" is="" greater="" than="" 300="" mg/kg/day,="" and="" the="" [[page="" 56079]]="" developmental="" toxicity="" noel="" is="" equal="" to="" or="" greater="" than="" 300="" mg/kg/day.="" 11.="" a="" reproduction="" toxicity="" study="" in="" rats="" receiving="" 0,="" 30,="" 300,="" and="" 3,000="" ppm="" (equivalent="" to="" 0,="" 2.19,="" 22.13,="" and="" 221.61="" mg/kg/day="" for="" males,="" and="" 0,="" 2.45,="" 24.24,="" and="" 249.67="" mg/kg/day="" for="" females)="" fludioxonil="" technical="" in="" the="" diet="" for="" 2="" generations.="" the="" parental="" systemic="" toxicity="" lel="" is="" 221.61="" mg/kg/day="" for="" males,="" and="" 249.67="" mg/kg/="" day="" for="" females.="" the="" parental="" systemic="" toxicity="" noel="" is="" 22.13="" mg/kg/day="" for="" males,="" and="" 24.24="" mg/kg/day="" for="" females="" based="" on="" clinical="" observations,="" reduced="" body="" weight="" and="" body="" weight="" gains,="" and="" reduced="" food="" consumption.="" treatment="" related="" effects="" are="" noted="" in="" the="" high="" dose="" groups="" in="" both="" the="" f1="" and="" f2="" pups="" as="" reduced="" mean="" pup="" body="" weights="" starting="" at="" postnatal="" day="" 4="" through="" 21;="" this="" was="" considered="" a="" developmental="" toxic="" effect="" rather="" than="" a="" true="" reproductive="" toxic="" effect="" ,="" because="" the="" reduced="" mean="" pup="" body="" weights="" are="" an="" effect="" on="" the="" growth="" of="" the="" pup.="" the="" reproductive/developmental="" toxicity="" lel="" is="" 221.61="" mg/="" kg/day="" for="" males,="" and="" 249.67="" mg/kg/day="" for="" females.="" the="" reproductive/="" developmental="" toxicity="" noel="" is="" 22.13="" mg/kg/day="" for="" males,="" and="" 24.24="" mg/="" kg/day="" for="" females="" based="" on="" reduced="" pup="" body="" weights.="" 12.="" studies="" on="" gene="" mutation="" and="" other="" genotoxic="" effects:="" an="" ames="" salmonella="" assay="" which="" provided="" evidence="" of="" cytotoxicity="" at="" 1,250="">g/plate and 5,000 g/plate concentrations; an
Unscheduled DNA Synthesis Assay with apparent cytotoxicity at 313
g/ml; an In Vitro Chromosome Aberrations assay in Chinese
hamster ovary (CHO) cells, with and without S9-activation which
provided convincing evidence that technical fludioxonil is a clastogen,
and a potent inducer of polyploidy in this cultured mammalian cell
assay; an In Vitro Chromosome Aberrations assay in Chinese hamster bone
marrow cells with the occurance of hyperploidy in one mid-dose female
and trisomy in one high dose male; an In Vivo Micronucleus Assay using
rat hepatocytes, no definitive conclusions were made, and this study
should be repeated; A Dominant Lethal Assay in mice with no indication
the test material induced dominant lethal mutations in male mouse
germinal cells over the entire period of spermatogenesis; a Point
Mutation Test in CHO cells in vitro, with and without S9-activation,
with no increase in the number of thioguanine-resistant colonies,
mutation frequency, or mutation factor with or without S9-activation;
and a Mouse Micronucleus Assay in a mouse bone morrow micronucleus test
which was negative.
B. Toxicological Endpoints
1. Acute toxicity. There is no concern for an acute dietary risk.
The the available data do not indicate any evidence of significant
toxicity from one day or single event exposure by oral exposure.
2. Chronic toxicity. EPA has established the RfD for 4-(2,2-
difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile at 0.03 mg/kg/
day. This RfD is based upon the 1-year toxicity study in dogs with a
NOEL of 3.3 mg/kg/day in female dogs, and an uncertainty factor of 100
to account for both interspecies extrapolation and intraspecies
variability.
3. Carcinogenicity. This chemical has been classified as a Group D
- not classifiable as to Human Carcinogenicity. That is, the evidence
is inadequate and cannot be interpreted as showing either the presence
or absence of a carcinogenic effect. The Group D classification was
also based on the increase in liver tumors in female rats that was
statistically significant for combined adenoma/carcinoma only, the lack
of a tumorigenic response in male rats or in either sex of the mouse,
and the need for additional mutagenicity studies.The mutagenicity
studies will be required as a Condition of Registration for products
containing 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-
carbonitrile, and consists of a repeat of the in vivo rat hepatocyte
study with a primary interest in determining the mechanism (s) for
inducing genetic damage and a repeat of the bone marrow micronucleus
assay using lower doses.
C. Exposures and Risks
1. From food and feed uses. This is the first tolerance for
residues of 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-
carbonitrile, in or on a raw agricultural commodity. Risk assessments
were conducted by EPA to assess dietary exposures and risks from 4-
(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile as
follows:
Chronic exposure and risk. The RfD used for the chronic dietary
analysis is 0.03 mg/kg/day. A tolerance of 0.02 ppm in/on potatoes was
used. Tolerances in animal commodities or in potato granules/flakes are
not required for this seed piece use on potatoes. 4-(2,2-difluoro-1,3-
benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile is currently registered for
use as a seed treatment on corn and sorghum, and for use in greenhouses
on nonfood crops. Since the residues were non-quantifiable, no exposure
was assumed to result for the registered use on corn or sorghum, and
these uses did not require tolerances. Using the tolerance level
residue (0.02 ppm) and assuming that 100% of the crop is treated, the
risk assessment resulted in use of less then 1% of the RfD for the
general population and all 22 subgroups, including infants under 1 year
old and children under 13 years of age.
2. From drinking water. Because of the requested and currently
registered use patterns, including the treatment of potato seed pieces
at a low use rate (approximately 0.06 lbs ai/A), seed treatment of
field, sweet and popcorn, and sorghum, and ornamental plants grown in
greenhouses or other enclosed structures, 4-(2,2-difluoro-1,3-
benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile is not expected to impact
ground or surface waters. Thus the likelihood of residues of 4-(2,2-
difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile in drinking
water is considered negligible from the above mentioned use patterns.
Therefore, it is concluded that a drinking water risk assessment is not
required at this time, and there is no drinking water risk assessment
to aggregate with the chronic dietary (food sources) risk assessment.
The aggregate dietary risk is therefore the dietary risk which is less
than 1% for the general population and all 22 subgroups.
Acute exposure and risk. There is no concern for an acute dietary
exposure to fludioxonil from drinking water as stated above, and
because the available data do not indicate any evidence of significant
toxicity from a one day or single event exposure by the oral route.
Therefore, an acute exposure risk assessment is not required for 4-
(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile at this
time.
3. From non-occupational non-dietary exposure. 4-(2,2-difluoro-1,3-
benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile is currently not registered
for use on residential non-food sites, therefore no non-occupational
non-dietary exposure is expected.
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 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
[[Page 56080]]
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 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile
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, 4-(2,2-difluoro-1,3-benzodioxol-4-
yl)-1H-pyrrole-3-carbonitrile 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 4-(2,2-difluoro-
1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile has a common mechanism
of toxicity with other substances.
D. Aggregate Risks and Determination of Safety for U.S. Population
Chronic risk. Using the Theoretical Maximum Residue Contribution
(TMRC) exposure assumptions described above, EPA has concluded that
aggregate exposure to 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-
3-carbonitrile from food will utilize less then 1% of the RfD for the
U.S. population and the 22 subgroups, including 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. EPA concludes that there is a reasonable certainty that
no harm will result from aggregate exposure to 4-(2,2-difluoro-1,3-
benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile residues.
E. Aggregate Cancer Risk for U.S. Population
This chemical has been classified as Group D - not classifiable as
to Human Carcinogenicity. The available carcinogenicity studies in the
rat and mouse shows some increase in the combined tumors only in the
female rat above that in the concurrent controls. However, this
statistical increase in liver tumors in female rats was only at the
high dose. Some of this significant increase was due to the lack of any
liver tumors in the concurrent control whereas the historical control
from the same lab indicated a range of 1.4 to 15% for combined liver
tumors. Therefore based on available information, a carcinogenic risk
analysis is not appropriate. EPA believes that this pesticide does not
pose a significant cancer risk.
F. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children-- In general. In
assessing the potential for additional sensitivity of infants and
children to residues of 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-
pyrrole-3-carbonitrile, 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 pesticide
exposure during prenatal development to one or both parents.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. The toxicity
database for fludioxonil includes as acceptable two-generation
reproduction study in rats and an acceptable prenatal developmental
toxicity studies in rats and rabbits. The data did not suggest any
additional sensitivity to the embryo or neonate following in utero or
early postnatal exposure to fludioxonil. The maternal NOEL, and the
developmental (fetal and pup) Toxicity NOEL were both 100 mg/kg/day in
the rat developmental study. In the rabbit developmental study, the
maternal NOEL was 10 mg/kg/day. No developmental toxicity was noted at
any dosing level. The developmental NOEL was set equal to or greater
than 300 mg/kg/day, the highest dose tested. Results from the 2-
generation reproduction study for rats indicated a developmental/
reproduction NOEL of 22.13 mg/kg/day for males and 24.24 mg/kg/day for
females. The developmental/reproductive NOEL is at least 600 fold
higher then the RfD (0.03 mg/kg/day), and should be protective for
infants and children; no additional safety factors are warrented.
2. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to 4-(2,2-
difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile from food will
utilize less then 1% 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. EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to 4-(2,2-difluoro-1,3-
benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile residues.
III. Other Considerations
A. Metabolism In Plants and Animals
The metabolism in plants is adequately understood for this potato
seed piece treatment use. The residue of regulatory concern is the
parent compound only, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-
3-carbonitrile. Since it has been determined that secondary residues in
livestock commodities are not likely to
[[Page 56081]]
result from this use, metabolism of 4-(2,2-difluoro-1,3-benzodioxol-4-
yl)-1H-pyrrole-3-carbonitrile in animals is not relevent to this
requested use on potato seed treatment.
B. Analytical Enforcement Methodology
The method accepted by EPA for enforcement of 4-(2,2-difluoro-1,3-
benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile in plants is Ciba-Geigy's
Method AG-597B. A method, Ciba-Geigy's Method AG-616B (MRID#s 4360412 -
4360415), is also available for quantifying residues in meat and milk.
These methods are available from the Docket under docket control number
[OPP-300565] at the address stated above.
C. Magnitude of Residues
The submitted residue data indicate that residues of 4-(2,2-
difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile were below the
level of quantitation (LOQ), <0.01 ppm,="" in/on="" immature="" and="" mature="" potato="" tubers="" grown="" from="" seed="" pieces="" treated="" with="" 0.5%="" dust="" formulation="" of="" 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1h-pyrrole-3-carbonitrile="" at="" 1.75="" or="" 2.5="" g="" ai/100="" kg="" seed="" pieces="" (0.7x="" or="" 1x="" the="" labeled="" rate,="" respectively).="" residues="" of="" 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1h-="" pyrrole-3-carbonitrile="" in/on="" immature="" and="" mature="" tubers="" treated="" at="" a="" 2x="" application="" rate="" ranged="" from="" less="" then="" 0.01="" ppm="" to="" 0.04="" ppm.="" harvest="" times="" varied="" from="" 45="" to="" 143="" days="" after="" planting="" treated="" seed="" pieces.="" residue="" data="" was="" also="" submitted="" at="" 6x="" and="" 10x="" the="" label="" application="" rate,="" with="" reported="" residues="" ranging=""><0.01 -="" 0.06="" ppm="" and=""><0.01 -="" 0.09="" ppm="" at="" the="" 6x="" rate="" for="" immature="" and="" mature="" tubers,="" respectively;="" and=""><0.01 -="" 0.48="" ppm="" amd=""><0.01 -="" 0.06="" ppm="" at="" the="" 10x="" rate="" for="" immature="" and="" mature="" tubers,="" respectively.="" based="" on="" the="" submitted="" residue="" data,="" the="" requested="" tolerance="" of="" 0.02="" ppm="" is="" adequate="" for="" this="" potato="" seed="" piece="" use.="" potato="" processing="" studies="" were="" also="" submitted="" to="" determine="" whether="" concentration="" of="" residues="" occur="" in="" potato="" chips,="" granules,="" and="" wet="" peels="" and="" trimmings="" from="" potatoes="" grown="" from="" treated="" potato="" seed="" pieces.="" based="" on="" the="" submitted="" processing="" studies,="" concentration="" of="" the="" pesticide="" chemical="" residues="" of="" 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-="" 1h-pyrrole-3-carbonitrile="" in="" the="" processed="" foods="" is="" not="" expected="" to="" be="" greater="" than="" the="" tolerance="" of="" 0.02="" ppm="" requested="" and="" prescribed="" in="" this="" federal="" register="" document="" for="" the="" pesticide="" chemical="" residue="" in="" the="" raw="" agricultural="" commodity,="" potatoes.="" therefore,="" the="" tolerance="" of="" 0.02="" ppm="" prescribed="" for="" potatoes="" will="" also="" cover="" the="" residues="" of="" fludioxonil="" up="" to="" 0.02="" ppm="" resulting="" in="" potato="" processed="" products="" from="" this="" seed="" piece="" use.="" d.="" international="" residue="" limits="" there="" are="" currently="" no="" codex,="" canadian,="" or="" mexican="" listings="" for="" 4-="" (2,2-difluoro-1,3-benzodioxol-4-yl)-1h-pyrrole-3-carbonitrile="" residues,="" therefore="" there="" are="" no="" harmonization="" issues="" for="" this="" action.="" e.="" rotational="" crop="" restrictions="" the="" submitted="" confined="" rotation="" studies="" provided="" adequate="" results="" to="" conclude="" that="" a="" 30-day="" plantback="" interval="" is="" sufficient="" for="" all="" crops.="" iv.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" 4-(2,2-difluoro-1,3-="" benzodioxol-4-yl)-1h-pyrrole-3-carbonitrile="" in="" or="" on="" potatoes="" at="" 0.02="" ppm.="" v.="" 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="" december="" 29,="" 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.="" vi.="" public="" docket="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300565]="" (including="" any="" comments="" and="" data="" submitted="" electronically).="" a="" public="" version="" of="" this="" record,="" including="" printed,="" paper="" versions="" of="" electronic="" comments,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8:30="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 1132="" of="" the="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (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.
[[Page 56082]]
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950) and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
VIII. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 10, 1997.
Stephen L. Johnson,
Acting Director, 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. Section 180.516 is added to read as follows:
Sec. 180.516 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-
carbonitrile ; tolerances for residues.
(a) General. A tolerance is established for residues of the
herbicide, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-
carbonitrile, in or on the following food commodity:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Potatoes................................................... 0.02
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-28644 Filed 10-28-97; 8:45 am]
BILLING CODE 6560-50-F
