[Federal Register Volume 62, Number 175 (Wednesday, September 10, 1997)]
[Rules and Regulations]
[Pages 47561-47568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23975]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185 and 186
[OPP-300549; FRL-5743-6]
RIN 2070-AB78
Triadimefon; 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 triadimefon in or on asparagus and in or on artichokes.
This action is in response to EPA's granting of an emergency exemption
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act authorizing use of the pesticide on asparagus and artichokes. This
regulation establishes maximum permissible levels for residues of
triadimefon in these food commodities pursuant to section 408(l)(6) of
the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996. These tolerances will expire and are
revoked on September 1, 1999.
DATES: This regulation is effective September 10, 1997. Objections and
requests for hearings must be received by EPA on or before November 10,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300549], 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-300549], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300549]. 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: Olga Odiott, 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) 308-9363, e-mail:
odiott.olga@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 triadimefon, in or on asparagus at 0.15 part
per million (ppm), and in or on artichokes at 0.6 ppm. These tolerances
will expire and are revoked on September 1, 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 Federal Food,
Drug, and Cosmetic Act (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.
[[Page 47562]]
II. Emergency Exemption for Triadimefon on Asparagus and Artichokes
and FFDCA Tolerances
The state of Michigan availed itself of the authority to declare a
crisis exemption to use triadimefon to control the asparagus rust
(Puccinia asparagi). EBDC fungicides are available and are effective
against the asparagus rust but processors in Michigan will not accept
asparagus treated with EBDCs, leaving the Michigan growers with no
alternative for control of the disease. Yield declines of 20 to 50% are
possible without the use of triadimefon.
The state of California stated that powdery mildew, caused by the
fungus Leveillula taurica Lev., is a relatively new disease of
artichokes that was first detected by growers in California during the
summer of 1985. It is now endemic in most artichoke growing districts,
affecting more than 65% of the artichoke acreage. Currently, there are
no registered fungicides or alternative practices available that will
control powdery mildew on artichokes. If triadimefon is not available
for use, yield losses of 30 to 50% are expected. EPA has authorized
under FIFRA section 18 the use of triadimefon on asparagus and
artichokes for control of rust in Michigan and powdery mildew in
California. After having reviewed their 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 triadimefon in or on
asparagus and in or on artichokes. In doing so, EPA considered the new
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerances 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 September 1, 1999, under FFDCA section 408(l)(5), residues
of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on asparagus and in or on artichokes after
that date will not be unlawful, provided the pesticide is applied in a
manner that was lawful under FIFRA. 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 triadimefon
meets EPA's registration requirements for use on asparagus and
artichokes or whether permanent tolerances for these uses would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serves as a basis for registration of triadimefon 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 Michigan and
California to use this pesticide on these crops 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 triadimefon, 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 percent 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.
[[Page 47563]]
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 3
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 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.="" 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="" triadimefon="" and="" to="" make="" a="" determination="" on="" aggregate="" exposure,="" consistent="" with="" section="" 408(b)(2),="" for="" a="" time-limited="" tolerances="" for="" residues="" of="" triadimefon="" in="" or="" on="" asparagus="" at="" 0.15="" ppm="" and="" in="" or="" on="" artichokes="" at="" 0.6="" ppm.="" epa's="" assessment="" of="" the="" dietary="" exposures="" and="" risks="" associated="" with="" establishing="" these="" 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="" triadimefon="" are="" discussed="" below.="" triadimenol="" is="" a="" metabolite="" of="" triadimefon="" and="" is="" also="" an="" active="" ingredient="" in="" pesticide="" products="" (ex.="" baytan).="" toxicological="" endpoints="" for="" triadimefon="" and="" triadimenol="" are="" presented="" below.="" 1.="" acute="" toxicity.="" the="" noel="" of="" 20="" mg/kg/day="" from="" a="" rabbit="" developmental="" study="" was="" selected="" for="" assessing="" acute="" dietary="" risk="" from="" residues="" of="" triadimefon.="" the="" risk="" assessment="" will="" evaluate="" acute="" dietary="" risks="" for="" females="" 13+="" years="" old.="" the="" agency="" has="" determined="" that="" an="" acute="" dietary="" risk="" assessment="" is="" not="" required="" for="" triadimenol.="" this="" decision="" was="" based="" on="" the="" lack="" of="" developmental="" effects="" at="" a="" maternally="" toxic="" dose="" of="" triadimenol="" in="" a="" rabbit="" developmental="" study.="" 2.="" short="" -="" and="" intermediate="" -="" term="" toxicity.="" the="" agency="" determined="" that="" the="" noel="" of="" 20="" mg/kg/day="" from="" the="" developmental="" toxicity="" study="" in="" rabbits="" should="" be="" used="" to="" assess="" risks="" from="" short="" and="" intermediate-term="" exposures="" to="" residues="" of="" triadimefon.="" the="" agency="" determined="" that="" the="" noel="" of="" 250="" mg/kg/day="" (highest="" dose="" tested)="" from="" a="" 21-day="" dermal="" toxicity="" study="" in="" rabbits="" should="" be="" used="" to="" assess="" risks="" from="" short-="" and="" intermediate-term="" exposures="" to="" residues="" of="" triadimenol.="" 3.="" chronic="" toxicity.="" epa="" has="" established="" the="" rfd="" for="" triadimefon="" at="" 0.04="" milligrams/kilogram/day="" (mg/kg/day).="" this="" rfd="" is="" based="" on="" a="" 2-year="" dog="" feeding="" study.="" the="" noel="" for="" systemic="" toxicity="" in="" dogs="" of="" either="" sex="" was="" 11.4="" mg/kg/day="" and="" the="" loel="" was="" 33.7="" mg/kg/day="" based="" on="" decreased="" food="" intake,="" depression="" in="" weight="" gain,="" and="" significantly="" (p="">< 0.05)="" increased="" alkaline="" phosphatase="" activity="" in="" both="" sexes.="" an="" uncertainty="" factor="" (uf)="" of="" 300="" was="" applied="" to="" account="" for="" inter-species="" extrapolation="" (10),="" intra-species="" variability="" (10)="" and="" the="" lack="" of="" an="" adequate="" reproductive="" toxicity="" study="" in="" rats="" (3).="" the="" rfd="" for="" triadimenol="" was="" established="" at="" 0.038="" mg/kg/day.="" this="" rfd="" is="" based="" on="" 2-year="" and="" 6-month="" [[page="" 47564]]="" feeding="" studies="" in="" dogs="" with="" a="" noel="" of="" 3.75="" mg/kg/day="" and="" an="" uncertainty="" factor="" of="" 100="" based="" on="" changes="" in="" enzyme="" levels="" at="" the="" loel="" of="" 15.0="" mg/kg/day.="" 4.="" carcinogenicity.="" the="" agency's="" carcinogenicity="" peer="" review="" committee="" (cprc)="" has="" classified="" triadimefon="" as="" a="" group="" c="" (possible="" human="" carcinogen)="" chemical="" without="" a="">1* and recommended
using the RfD approach to assess dietary cancer risk. The
classification was based on an increase in thyroid adenomas in male
rats and an increase in hepatocellular adenomas, with a positive dose-
related trend, in both male and female mice.
The CPRC classified triadimenol as a Group C (possible human
carcinogen) chemical based on liver tumors in female mice. The
Committee recommended using the RfD approach to assess dietary cancer
risk.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.410) for the combined residues of triadimefon and its
metabolites containing chlorophenoxy and triazole moieties (expressed
as triadimefon), in or on a variety of raw agricultural commodities
ranging from 0.04 ppm in poultry meat to 145 ppm in grass seed
cleanings.
Tolerances have been established (40 CFR 180.450(a)) for the
combined residues of the fungicide triadimenol (KWG-0519,-(4-
chlorophenoxy)--(1,1-dimethylethyl)-1H-1,2,4-triazol-1-
ethanol) and its butanediol metabolite (KWG-1342; 4-(4-chlorophenoxy)-
2,2-dimethyl-4-(1H-1,2,4-triazol-1-yl)-1,3-butanediol), calculated as
triadimenol, in or on various commodities including barley, oats and
wheat grain at 0.05 ppm; barley, oats and wheat forage at 2.5 ppm; and
barley, oats and wheat straw at 0.1 ppm. Tolerances have been
established (40 CFR 180.450(b)) for the combined residues of
triadimenol and its metabolites containing the chlorophenoxy moiety
(calculated as triadimenol) in or on the fat, meat, and meat by-
products of cattle, goats, hogs, horses and sheep at 0.1 ppm; milk at
0.01 ppm; the fat, meat, and meat by-products of poultry at 0.01 ppm;
and eggs at 0.01 ppm. Risk assessments were conducted by EPA to assess
dietary exposures and risks from triadimefon and triadimenol as
follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. The acute dietary (food only) risk
assessment for triadimefon used tolerance level residues and assumed
100% crop treated. For the population subgroup of concern, females 13+
years old, the resulting high-end exposure estimate of 0.05 mg/kg/day
results in a dietary (food only) MOE of 400. This MOE should be viewed
as a conservative risk estimate. Refinement of the risk assessment
using anticipated residue values and percent crop-treated data would
result in a lower acute dietary exposure estimate.
Acute dietary endpoints were not identified for triadimenol, so
this risk assessment was not conducted.
ii. Chronic exposure and risk. The chronic dietary risk assessment
for triadimefon assumed that 100% of asparagus and artichokes and all
other commodities having established and pending triadimefon tolerances
will contain triadimefon residues and those residues will be at
tolerance level, which result in an overestimate of human dietary
exposure. The existing triadimefon tolerances (published, pending, and
including the necessary Section 18 tolerances) result in a TMRC that is
equivalent to percentages of the RfD that range from 18% for the U.S.
population to 75% for non-nursing infants < 1="" year="" old.="" the="" chronic="" dietary="" risk="" assessment="" for="" triadimenol="" assumed="" that="" all="" commodities="" having="" established="" and="" pending="" triadimenol="" tolerances="" will="" contain="" triadimenol="" residues="" and="" those="" residues="" will="" be="" at="" the="" level="" of="" the="" tolerance,="" which="" result="" in="" an="" overestimate="" of="" human="" dietary="" exposure.="" thus,="" in="" making="" a="" safety="" determination="" for="" triadimenol,="" epa="" is="" taking="" into="" account="" this="" conservative="" exposure="" assessment.="" the="" existing="" triadimenol="" tolerances="" (published="" and="" pending)="" result="" in="" a="" tmrc="" that="" is="" equivalent="" to="" percentages="" of="" the="" rfd="" that="" range="" from="" 1%="" for="" the="" u.s.="" population="" to="" 3%="" for="" non-nursing="" infants="">< 1="" year="" old.="" 2.="" from="" drinking="" water.="" based="" on="" available="" data="" used="" in="" epa's="" assessment="" of="" environmental="" risk,="" triadimefon="" and="" triadimenol="" are="" mobile="" and="" have="" the="" potential="" to="" leach="" into="" ground="" water.="" there="" are="" no="" established="" maximum="" contaminant="" levels="" for="" residues="" of="" triadimefon="" or="" triadimenol="" in="" drinking="" water,="" and="" no="" health="" advisory="" levels="" for="" triadimefon="" or="" triadimenol="" in="" drinking="" water="" have="" been="" established.="" according="" to="" the="" ``pesticides="" in="" groundwater="" database'',="" epa="" 734-12-92-="" 001,="" sept="" 1992,="" 14="" wells="" in="" california="" were="" sampled="" for="" triadimefon="" from="" 1984-1989.="" no="" wells="" had="" detectable="" residues.="" there="" was="" no="" entry="" for="" triadimenol.="" because="" the="" agency="" lacks="" sufficient="" water-related="" exposure="" data="" to="" complete="" a="" comprehensive="" drinking="" water="" risk="" assessment="" for="" many="" pesticides,="" epa="" has="" commenced="" and="" nearly="" completed="" a="" process="" to="" identify="" a="" reasonable="" yet="" conservative="" bounding="" figure="" for="" the="" potential="" contribution="" of="" water-related="" exposure="" to="" the="" aggregate="" risk="" posed="" by="" a="" pesticide.="" in="" developing="" the="" bounding="" figure,="" epa="" estimated="" residue="" levels="" in="" water="" for="" a="" number="" of="" specific="" pesticides="" using="" various="" data="" sources.="" the="" agency="" then="" applied="" the="" estimated="" residue="" levels,="" in="" conjunction="" with="" appropriate="" toxicological="" endpoints="" (rfd's="" or="" acute="" dietary="" noel's)="" and="" assumptions="" about="" body="" weight="" and="" consumption,="" to="" calculate,="" for="" each="" pesticide,="" the="" increment="" of="" aggregate="" risk="" contributed="" by="" consumption="" of="" contaminated="" water.="" while="" epa="" has="" not="" yet="" pinpointed="" the="" appropriate="" bounding="" figure="" for="" exposure="" from="" contaminated="" water,="" the="" ranges="" the="" agency="" is="" continuing="" to="" examine="" are="" all="" below="" the="" level="" that="" would="" cause="" triadimefon="" and="" triadimenol="" to="" exceed="" the="" rfd="" if="" the="" tolerances="" being="" considered="" in="" this="" document="" were="" granted.="" the="" agency="" has="" therefore="" concluded="" that="" the="" potential="" exposures="" associated="" with="" triadimefon="" and="" triadimenol="" in="" water,="" even="" at="" the="" higher="" levels="" the="" agency="" is="" considering="" as="" a="" conservative="" upper="" bound,="" would="" not="" prevent="" the="" agency="" from="" determining="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" if="" the="" tolerances="" are="" granted.="" 3.="" from="" non-dietary="" exposure.="" triadimefon="" is="" currently="" registered="" for="" use="" on="" non-food="" sites="" such="" as="" ornamentals="" and="" turfgrass.="" triadimenol="" is="" currently="" registered="" for="" use="" on="" turfgrass.="" based="" on="" the="" nature="" of="" the="" outdoor="" residential="" uses,="" the="" epa="" concludes="" that="" chronic="" residential="" exposure="" scenarios="" do="" not="" exist="" for="" triadimefon.="" short="" and/="" or="" intermediate="" term="" exposure="" scenarios="" may="" exist.="" however,="" the="" agency="" currently="" lacks="" sufficient="" residential-related="" exposure="" data="" to="" complete="" a="" comprehensive="" residential="" risk="" assessment="" for="" many="" pesticides,="" including="" triadimefon.="" 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="" understanding="" common="" mechanisms="" of="" [[page="" 47565]]="" 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).="" triadimefon="" and="" triadimenol="" are="" members="" of="" the="" triazole="" class="" of="" pesticides.="" other="" members="" of="" this="" class="" include="" tebuconazole,="" propiconazole,="" cyproconazole,="" penconazole,="" myclobutanil,="" and="" difenoconazole.="" at="" this="" time,="" the="" agency="" has="" not="" made="" a="" determination="" that="" triadimefon="" and="" other="" substances="" that="" may="" have="" a="" common="" mode="" of="" toxicity="" would="" have="" cumulative="" effects,="" with="" the="" exception="" of="" triadimenol.="" a="" regulated="" metabolite="" of="" triadimefon,="" triadimenol="" is="" itself="" a="" fungicide="" active="" ingredient="" registered="" for="" use="" on="" several="" crops.="" in="" plants,="" the="" residue="" of="" concern="" for="" triadimenol="" is="" triadimenol="" and="" its="" butanediol="" metabolite.="" in="" animal="" commodities,="" the="" residue="" of="" concern="" for="" triadimenol="" is="" triadimenol="" and="" its="" metabolites="" containing="" the="" chlorophenoxy="" moiety.="" to="" estimate="" the="" cumulative="" (triadimefon="" +="" triadimenol)="" aggregate="" dietary="" exposures,="" estimates="" for="" triadimenol="" on="" its="" regulated="" commodities="" were="" added="" to="" estimates="" for="" triadimefon.="" c.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" for="" the="" population="" subgroup="" of="" concern,="" females="" 13+="" years,="" the="" calculated="" moe="" value="" for="" triadimefon="" dietary="" (food)="" exposure="" is="" 400.="" although="" there="" is="" potential="" for="" exposure="" to="" triadimefon="" in="" drinking="" water,="" the="" agency="" does="" not="" expect="" the="" aggregate="" exposure="" (food="" plus="" water)="" to="" exceed="" the="" agency's="" level="" of="" concern.="" no="" acute="" toxicity="" endpoints="" were="" identified="" for="" triadimenol,="" therefore="" an="" acute="" aggregate="" risk="" assessment="" was="" not="" conducted.="" 2.="" chronic="" risk.="" using="" the="" tmrc="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" triadimefon="" and="" triadimenol="" from="" food="" will="" utilize="" 19%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" non-nursing="" infants="">< 1="" year="" old.="" 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.="" despite="" the="" potential="" for="" exposure="" to="" triadimefon="" and="" triadimenol="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" triadimefon="" and="" triadimenol="" residues.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" based="" on="" the="" registered="" uses="" of="" fenarimol="" short="" and/or="" intermediate="" term="" exposure="" scenarios="" may="" exist.="" however,="" the="" agency="" currently="" lacks="" sufficient="" residential-related="" exposure="" data="" to="" complete="" a="" comprehensive="" residential="" risk="" assessment="" for="" many="" pesticides,="" including="" triadimefon.="" d.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" the="" agency's="" cprc="" recommended="" the="" rfd="" approach="" for="" assessment="" of="" dietary="" cancer="" risk.="" dietary="" risk="" concerns="" due="" to="" long-term="" exposures="" to="" triadimefon="" and="" triadimenol="" residues="" are="" adequately="" addressed="" by="" the="" aggregate="" chronic="" dietary="" risk="" assessment.="" e.="" 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="" triadimefon="" and="" triadimenol,="" 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="" 100-="" fold="" safety="" factor="" (for="" combined="" inter-="" and="" intra-species="" variability)="" and="" not="" the="" additional="" tenfold="" safety="" 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="" safety="" factor.="" ii.="" developmental="" toxicity="" studies--="" a.="" rats.="" for="" triadimefon,="" the="" maternal="" systemic="" noel="" was="" 30="" mg/kg/day="" and="" the="" loel="" was="" 90="" mg/kg/day.="" effects="" seen="" at="" the="" loel="" include="" statistically="" significant="" body="" weight="" gain="" decrement="" during="" gestational="" days="" 6-15.="" the="" developmental="" noel="" was="" 30="" mg/kg/day="" and="" the="" developmental="" loel="" was="" 90="" mg/kg/day,="" based="" on="" the="" increased="" incidence="" of="" skeletal="" variations,="" unossified="" and="" incompletely="" ossified="" hyoid,="" and="" full="" and="" rudimentary="" ribs.="" for="" triadimenol,="" the="" maternal="" (systemic)="" noel="" was="" 25="" mg/kg/day,="" based="" on="" decreased="" body="" weight="" and="" food="" consumption="" at="" the="" loel="" of="" 125="" mg/kg/day.="" the="" developmental="" (fetal)="" noel="" was="" 125="" mg/kg/day="" (highest="" dose="" tested="" (hdt)).="" [[page="" 47566]]="" b.="" rabbits.="" for="" triadimefon,="" the="" maternal="" (systemic)="" noel="" was="" 50="" mg/kg/day="" and="" the="" loel="" was="" 120="" mg/kg/day.="" the="" maternal="" loel="" was="" based="" on="" increased="" clinical="" signs="" such="" as="" increased="" hyperactivity,="" reddish="" discharge,="" and="" decreased="" body="" weight="" gain="" during="" gestational="" days="" 6-10.="" the="" developmental="" noel="" was="" 20="" mg/kg/day="" and="" the="" loel="" was="" 50="" mg/kg/day,="" based="" on="" irregular="" spinous="" process="" and="" incomplete="" ossification="" of="" various="" bones.="" for="" triadimenol,="" the="" maternal="" (systemic)="" noel="" was="" 8="" mg/kg/day,="" based="" on="" decreased="" body="" weight="" and="" food="" consumption="" at="" the="" loel="" of="" 40="" mg/kg/day.="" the="" developmental="" (fetal)="" noel="" was="" 40="" mg/kg/day,="" based="" on="" post-implantation="" loss,="" decreased="" fetal="" body="" weight,="" and="" skeletal="" anomalies="" at="" the="" loel="" of="" 200="" mg/kg/day.="" iii.="" reproductive="" toxicity="" study.="" an="" acceptable="" reproductive="" toxicity="" study="" is="" not="" available="" for="" triadimefon.="" for="" triadimenol,="" the="" maternal="" (systemic)="" noel="" from="" a="" 2-generation="" reproductive="" toxicity="" study="" in="" rats="" was="" 5.0="" mg/kg/day.="" the="" noel="" was="" based="" on="" decreased="" body="" weight="" at="" the="" loel="" of="" 25="" mg/kg/day.="" the="" developmental="" (pup)="" noel="" was="" 5.0="" mg/kg/day,="" based="" on="" decreased="" body="" weight="" at="" the="" loel="" of="" 25="" mg/kg/day.="" the="" reproductive="" noel="" was="" 25="" mg/kg/="" day="" (hdt).="" iv.="" pre-="" and="" post-natal="" sensitivity.="" the="" toxicological="" data="" base="" for="" evaluating="" pre-="" and="" post-natal="" toxicity="" for="" triadimefon="" is="" not="" complete="" with="" respect="" to="" current="" data="" requirements.="" however,="" in="" calculating="" the="" rfd,="" an="" uncertainty="" factor="" (uf)="" of="" 300="" was="" applied="" to="" account="" for="" inter-species="" extrapolation="" (10),="" intra-species="" variability="" (10),="" and="" the="" lack="" of="" an="" adequate="" reproductive="" toxicity="" study="" in="" rats="" (3).="" the="" agency="" notes="" that="" there="" is="" approximately="" a="" two-fold="" difference="" between="" the="" developmental="" noel="" of="" 20="" mg/kg/day="" from="" the="" rabbit="" developmental="" toxicity="" study="" and="" the="" noel="" of="" 11.4="" mg/kg/day="" from="" the="" 2-="" year="" dog="" feeding="" study="" which="" was="" the="" basis="" of="" the="" rfd.="" it="" is="" further="" noted="" that="" in="" the="" rabbit="" developmental="" toxicity="" study,="" the="" developmental="" noel="" of="" 20="" mg/kg/day="" (on="" which="" the="" moe="" calculations="" for="" acute="" dietary="" risks="" are="" based)="" is="" lower="" than="" the="" maternal="" systemic="" noel="" of="" 50="" mg/kg/day="" from="" the="" same="" rabbit="" developmental="" study.="" the="" agency="" believes="" that="" the="" additional="" 3x="" uncertainty="" factor,="" together="" with="" the="" very="" conservative="" assumptions="" made="" for="" the="" exposure="" assessment,="" provide="" adequate="" protection="" to="" infants="" and="" children="" from="" the="" risks="" associated="" with="" exposures="" to="" triadimefon="" residues.="" the="" toxicological="" data="" base="" for="" evaluating="" pre-="" and="" post-natal="" toxicity="" for="" triadimenol="" 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="" 2-generation="" rat="" reproductive="" toxicity="" study.="" the="" rat="" developmental="" study="" had="" no="" developmental="" effects="" up="" to="" the="" highest="" dose="" tested,="" which="" produced="" maternal="" toxicity.="" the="" rabbit="" developmental="" toxicity="" study="" demonstrated="" maternal="" toxicity="" at="" a="" dose="" at="" which="" no="" developmental="" toxicity="" was="" apparent.="" in="" the="" rat="" reproductive="" toxicity="" study,="" the="" parental="" and="" pup="" effects="" occur="" at="" the="" noels="" and="" loels="" and="" the="" same="" effect="" (decreased="" body="" weight)="" occurred="" in="" both="" pups="" and="" parental="" animals.="" v.="" conclusion.="" based="" on="" the="" above="" considerations="" and="" in="" epa's="" best="" scientific="" judgment,="" the="" application="" of="" a="" margin="" of="" exposure/="" uncertainty="" factor="" of="" 300="" provides="" adequate="" protection="" for="" infants="" and="" children="" from="" the="" risks="" associated="" with="" exposures="" to="" triadimefon="" residues.="" the="" epa="" also="" concludes="" that,="" for="" triadimenol,="" reliable="" data="" support="" use="" of="" the="" standard="" 100-fold="" margin="" of="" exposure/="" uncertainty="" factor="" and="" that="" an="" additional="" margin/factor="" is="" not="" needed="" to="" protect="" infants="" and="" children.="" 2.="" acute="" risk.="" for="" triadimefon,="" the="" acute="" dietary="" (food="" only)="" moe="" was="" calculated="" to="" be="" 400="" for="" females="" 13+="" years="" old="" (accounts="" for="" both="" maternal="" and="" fetal="" exposure),="" the="" population="" subgroup="" of="" concern.="" this="" risk="" assessment="" for="" triadimefon="" used="" tolerance="" level="" residues="" and="" assumed="" 100%="" crop="" treated.="" this="" moe="" should="" be="" viewed="" as="" a="" conservative="" risk="" estimate;="" further="" refinement="" using="" anticipated="" residue="" values="" and="" percent="" crop-treated="" data="" would="" result="" in="" a="" lower="" acute="" dietary="" exposure="" estimate.="" the="" large="" acute="" dietary="" moe="" calculated="" for="" females="" 13+="" years="" provides="" assurance="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" for="" both="" females="" 13+="" years="" and="" the="" pre-natal="" development="" of="" infants.="" despite="" the="" potential="" for="" exposure="" to="" triadimefon="" in="" drinking="" water,="" the="" agency="" does="" not="" expect="" the="" aggregate="" exposure="" (food="" +="" water)="" to="" exceed="" the="" agency's="" level="" of="" concern="" for="" acute="" dietary="" exposure.="" no="" acute="" toxicity="" endpoints="" were="" identified="" for="" triadimenol,="" so="" an="" acute="" aggregate="" risk="" assesment="" was="" not="" conducted.="" 3.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" triadimefon="" and="" triadimenol="" from="" food="" will="" utilize="" percentages="" of="" the="" rfd="" that="" range="" from="" 28%="" for="" children="" 7-12="" years="" old,="" up="" to="" 78%="" for="" non-="" nursing="" infants="" less="" than="" 1="" year="" old.="" 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.="" despite="" the="" potential="" for="" exposure="" to="" triadimefon="" and="" triadimenol="" in="" drinking="" water="" and="" from="" non-="" dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" triadimefon="" and="" triadimenol="" residues.="" 4.="" short-="" or="" intermediate-term="" risk.="" based="" on="" the="" registered="" uses="" of="" fenarimol="" short="" and/or="" intermediate="" term="" exposure="" scenarios="" may="" exist.="" however,="" the="" agency="" currently="" lacks="" sufficient="" residential-="" related="" exposure="" data="" to="" complete="" a="" comprehensive="" residential="" risk="" assessment="" for="" many="" pesticides.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" triadimefon="" residues="" in="" plants="" is="" adequately="" understood.="" the="" agency's="" metabolism="" committee="" determined="" that="" the="" residues="" of="" concern="" are="" triadimefon="" and="" its="" metabolites="" containing="" chlorophenoxy="" and="" triazole="" moieties,="" expressed="" as="" triadimefon.="" the="" nature="" of="" triadimefon="" residues="" in="" animals="" is="" not="" germane="" to="" these="" tolerances="" as="" no="" livestock="" feed="" items="" are="" involved.="" b.="" analytical="" enforcement="" methodology="" adequate="" enforcement="" methods="" (gc/ms)="" are="" published="" in="" the="" pesticide="" analytical="" manual,="" volume="" ii,="" pesticide="" reg.="" sec.="" 180.410,="" as="" methods="" i="" and="" ii.="" in="" addition,="" mobay="" method="" no.="" 80488="" has="" undergone="" a="" successful="" method="" trial="" and="" has="" been="" validated="" for="" determination="" of="" triadimefon="" and="" its="" metabolites="" relevant="" to="" 40="" cfr="" 180.410="" on="" plant="" commodities.="" c.="" magnitude="" of="" residues="" regulable="" residues="" of="" triadimefon="" are="" not="" expected="" to="" exceed="" 0.15="" ppm="" in/on="" asparagus="" and="" 0.6="" ppm="" in/on="" globe="" artichokes="" as="" a="" result="" of="" these="" section="" 18="" uses.="" secondary="" residues="" are="" not="" expected="" in="" animal="" commodities="" as="" no="" feed="" items="" are="" associated="" with="" these="" section="" 18="" uses.="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" maximum="" residue="" limits="" (mrls)="" established="" for="" residues="" of="" [[page="" 47567]]="" triadimefon="" in/on="" asparagus="" or="" in/on="" artichokes.="" vi.="" conclusion="" therefore,="" time-limited="" tolerances="" are="" established="" for="" the="" regulable="" residues="" of="" triadimefon="" in="" asparagus="" at="" 0.15="" ppm="" and="" in="" artichokes="" at="" 0.6="" ppm.="" in="" addition,="" because="" the="" fqpa="" eliminated="" the="" distinctions="" between="" processed="" food,="" feed="" and="" raw="" agricultural="" commodities,="" opp="" is="" transferring="" the="" tolerances="" for="" residues="" of="" triadimefon="" in="" secs.="" 185.800="" and="" 186.800="" to="" the="" table="" in="" paragraph="" (a)="" of="" sec.="" 180.410="" and="" removing="" the="" remainder="" of="" secs.="" 185.800="" and="" 186.800.="" 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="" november="" 10,="" 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="" confidential="" business="" information="" (cbi).="" information="" so="" marked="" will="" not="" be="" disclosed="" except="" in="" accordance="" with="" procedures="" set="" forth="" in="" 40="" cfr="" part="" 2.="" a="" copy="" of="" the="" information="" that="" does="" not="" contain="" cbi="" must="" be="" submitted="" for="" inclusion="" in="" the="" public="" record.="" information="" not="" marked="" confidential="" may="" be="" disclosed="" publicly="" by="" epa="" without="" prior="" notice.="" viii.="" public="" docket="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300549]="" (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="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" 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 time-limited tolerances under FFDCA
section 408(d l)(6). 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 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 acations 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 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).
[[Page 47568]]
List of Subjects
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
40 CFR Part 185
Environmental protection, Food additives, Pesticides and pests.
40 CFR Part 186
Environmental protection, Animal feeds, Pesticides and pests.
Dated: August 29, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. By amending Sec. 180.410 as follows:
i. By revising the section heading.
ii. By adding a subject heading to paragraph (a).
iii. By revising paragraphs (b) and (c).
iv. By adding and reserving paragraph (d) with a subject heading.
Sec. 180.410 Triadimefon; tolerances for residues.
(a) General . * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the combined residues of the fungicide triadimefon, 1-
(4-chlorophenoxy)-3,3-dimethyl-1(1H-1,2,4-triazol-1-yl)-2-butanone and
its metabolites containing chlorophenoxy and triazole moieties
(expressed as the fungicide) in connection with use of the pesticide
under the section 18 emergency exemptions granted by EPA. The
tolerances will expire and are revoked on the dates specified in the
following table:
------------------------------------------------------------------------
Parts
Commodity per Expiration/revocation
million date
------------------------------------------------------------------------
Artichokes........................... 0.6 September 1, 1999
Asparagus............................ 0.15 September 1, 1999
Chili peppers........................ 0.5 November 8, 1997
------------------------------------------------------------------------
(c) Tolerances with regional registrations. Tolerances with
regional registration are established for the combined residues of the
fungicide 1-(4-chlorophenoxy)-3,3-dimethyl-1(1H-1,2,4-triazol-l-yl)-2-
butanone and its metabolites containing chlorophenoxy and triazole
moieties (expressed as the fungicide) in or on the following raw
agricultural commodities:
------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
Raspberries................................................... 2.0
------------------------------------------------------------------------
(d) Indirect or inadvertent residues. [Reserved]
PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
Sec. 185.800 [Removed]
b. In Sec. 185.800 by transferring the entries in the table and
alphabetically adding them to the table in paragraph (a) of
Sec. 180.410, and by removing the remainder of Sec. 185.800.
PART 186--[AMENDED]
3. In part 186:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 342, 348, and 701.
Sec. 186.800 [Removed]
b. In Sec. 186.800 by transferring the entries in the table and
alphabetically adding them to the table in paragraph (a) of
Sec. 180.410, and by removing the remainder of Sec. 186.800.
[FR Doc. 97-23975 Filed 9-9-97; 8:45 am]
BILLING CODE 6560-50-F
