[Federal Register Volume 62, Number 228 (Wednesday, November 26, 1997)]
[Rules and Regulations]
[Pages 62954-62961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30946]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300576; FRL-5754-9]
RIN 2070-AB78
Tefluthrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of tefluthrin and its metabolite in or on corn, grain, field and pop;
corn, forage and fodder, field, pop and sweet; and corn, fresh
(including sweet K and corn with husk removed (CWHR)) at 0.06 parts per
million (ppm). It also removes time limitations for tolerances for
residues of tefluthrin on the same commodities that expire on November
15, 1997. Zeneca Ag Products requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (Pub. L. 104-170).
DATES: This regulation is effective November 26, 1997. Objections and
requests for hearings must be received by EPA on or before January 26,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300576], 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-300576], 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-300576]. 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: Beth Edwards, 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) 305-5400, e-mail:
edwards.beth@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: On February 1, 1989 (54 FR 5080), EPA
established time limited tolerances under Section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346 a(d) and 348 for
residues of tefluthrin on corn, grain, field, and pop; corn, forage and
fodder, field and pop. As additional crop tolerances were established,
they were also made time-limited. These tolerances expire on November
15, 1997. Zeneca Ag Products, on September 15, 1997, requested that the
time limitation for tolerances established for residues of the
insecticide tefluthrin in the corn commodities mentioned above be
removed based on environmental effects data that they had submitted as
a condition of the registration. Zeneca Ag Products also submitted a
summary of its petition as required under the FFDCA as amended by the
Food Quality Protection Act (FQPA) of 1996 (Pub. L. 104-170).
In the Federal Register of September 25, 1997 (62 FR 50337) (FRL-
5748-2), 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 petitions (PP 7F3521 and 4F4406) for tolerances
by Zeneca Ag Products, P.O. Box 15458, Wilmington, DE, 19850-5458. This
notice included a summary of the petition prepared by Zeneca Ag
Products, the registrant. There were no comments received in response
to the notice of filing.
The petitions requested that 40 CFR 180.440 be amended by removing
the time-limitation for tolerances for combined residues of the
insecticide and pyrethroid tefluthrin and its metabolite (Z)-3-(2-
chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylic
acid, in or on corn, grain, field and pop; corn, forage and fodder,
field, pop and sweet; and corn, fresh (including sweet K and corn with
husk removed (CWHR)) at 0.06 part per million (ppm).
The basis for the time-limited tolerances that expire November 15,
1997, was given in the Federal Register of October 20, 1993 (58 FR
54094). These time-limited tolerances were predicated on the expiration
of pesticide product registrations that were made conditional due to
lack of certain ecological and environmental effects data. The
rationale for using time-limited tolerances was to encourage pesticide
manufacturers to comply with the conditions of registration in a timely
manner. There is no regulatory requirement to make tolerances time-
limited due to the conditional status of a product registration under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as
amended. It is current EPA policy to no longer establish time
limitations on tolerance(s) with expiration dates if none of the
conditions of registration have any bearing on human dietary risk. The
current petition action meets that condition and thus the expiration
dates associated with specific crop tolerances are being deleted.
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
[[Page 62955]]
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, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 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 ground water
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
[[Page 62956]]
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.
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
tefluthrin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for combined residues of tefluthrin
and its metabolite on corn, grain, field and pop; corn, forage and
fodder, field, pop and sweet; and corn, fresh (including sweet K and
corn with husk removed (CWHR)) at 0.06 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 tefluthrin are
discussed below.
1. Acute toxicity studies with the technical grade of the active
ingredient tefluthrin: oral LD50 in the rat is 21.8
milligrams/kilogram (mg/kg) for males and 34.6 mg/kg for females -
Toxicity Category I; dermal LD50 in the rat is 316 mg/kg in
males and 177 mg/kg in females - Toxicity Category I; acute inhalation
LC50 in the rat is 0.037 mg/l and 0.049 mg/l in male and
female rats, respectively - Toxicity Category I; the primary eye
irritation study in the rabbit was an invalid study; primary dermal
irritation study in the rabbit showed slight irritation - Toxicity
Category IV; dermal sensitization study in the guinea pig showed no
skin sensitization; and the acute delayed neurotoxicity study did not
show acute delayed neurotoxicity.
2. In an oral toxicity study, rats were dosed at 0, 25, 100, or 400
ppm (1.25, 5, or 20 milligrans/kilogram/day) (mg/kg/day) for 21 days.
The LOEL for females for this 21-day oral toxicity study is 400 ppm
(equivalent to approximately 20 mg/kg/day) based on decreased body
weight gain, decreased platelet counts, and increased WBC and
lymphocytes in the high-dose females. The NOEL for females is 100 ppm
(equivalent to approximately 5 mg/kg/day). The NOEL in males was not
observed.
3. In a subchronic oral toxicity study, rats were dosed at 0, 50,
150, or 350 ppm (2.5, 7.5, or 17.5 mg/kg/day) for 90 days. The LOEL for
this 90-day feeding study is 150 ppm (equivalent to approximately 7.5
mg/kg/day) based on changes in hemoglobin, cholesterol, and liver
weight in the mid-dose animals. The NOEL is 50 ppm (equivalent to
approximately 2.5 mg/kg/day).
4. In a subchronic oral toxicity study, dogs were dosed at 0, 0.1,
0.5, or 1.5 mg/kg/day for 90 days. The LOEL for this 90-day oral
toxicity study is 1.5 mg/kg/day based on thyroid changes, and increased
levels of plasma triglycerides and aspartate transaminase observed at
the high-dose. The NOEL is 0.5 mg/kg/day.
5. In an oral toxicity study, mice were dosed at 0, 25, 75, 200, or
400 ppm (0, 3.75, 11.3, 30.0, or 60.0 mg/kg/day) for 28 days. The LOEL
is 400 ppm (equivalent to approximately 60 mg/kg/day) based on
decreased body weight gains in both sexes and final body weights in
females. The NOEL is 200 ppm (equivalent to approximately 30 mg/kg/
day).
6. In a dermal toxicity study, rats were dosed at 0, 0.1, 1.0, or
50 mg/kg. The LOEL for skin effects for this 21-day dermal toxicity
study is 50.0 mg/kg based on acanthosis, necrosis epidermis, and
inflammatory cell infiltrate dermis observed in the high-dose animals.
The NOEL for skin effects is 1.0 mg/kg). The NOEL for neurological
effects (the observed postural effects) may be between 0.025 and 0.1
mg/kg.
7. In a chronic/oncogenicity study, mice were dosed at 0, 25, 100,
or 400 ppm (actual dose levels were equivalent to 3.4, 13.5, or 54.4
mg/kg/day) for 104 weeks. The chronic LOEL is 13.5 mg/kg based on
hemangiomatous changes of the uterus and liver necrosis observed in the
mid- and high-dose females. The chronic NOEL is 3.4 mg/kg. Under the
conditions of this study, there was no evidence of carcinogenic
potential.
8. In a chronic toxicity study, dogs were dosed at dose levels of
0, 0.1, 0.5, and 2 mg/kg/day for 12 months. The LOEL for this chronic
study is 2.0 mg/kg/day based on the increased incidence of ataxia in
both sexes at the high-dose. The NOEL is 0.5 mg/kg/day.
9. In a chronic/oncogenicity study, rats were dosed for 24 months
at 0, 25, 100, or 400 ppm (actual dose levels were equivalent to 1.1,
4.6, or 18.2 mg/kg/day). The chronic LOEL is 4.6 mg/kg/day based on
decreased body weights, and neurotoxicity and clinical chemistry
changes in the mid- and high-dose animals. The chronic NOEL is 1.1 mg/
kg/day. Under the conditions of this study, there was no evidence of
carcinogenic potential.
10. In a developmental toxicity study, rats were dosed at 0, 1, 3,
or 5 mg/kg/day from days 7 through 16 of gestation. The maternal LOEL
is 3 mg/kg/day, based on treatment-related decrease body weight gains
during dosing. The maternal NOEL is 1 mg/kg/day. Developmental toxicity
was demonstrated at 5 mg/kg/day as an increase in the fetal incidence
of bilaterally unossified calcanea (92.9% vs. 87.5% in controls,
p<0.05; litter="" incidence="" was="" not="" shown)="" and="" a="" slight="" increase="" in="" the="" pes="" score="" (3.05="" vs.="" 2.96="" in="" controls)="" indicating="" slight="" inhibition="" of="" ossification="" at="" these="" sites.="" there="" were="" no="" treatment-related="" effects="" on="" the="" number,="" growth,="" and="" survival="" of="" the="" young="" in="" utero.="" in="" addition,="" the="" inter-group="" differences="" in="" the="" mean="" numbers="" of="" corpora="" lutea,="" implantations,="" pre-="" and="" post-="" implantation="" deaths,="" live="" fetuses,="" proportion="" of="" male="" fetuses,="" and="" fetal="" weights="" were="" not="" remarkable.="" the="" developmental="" loel="" is="" 5="" mg/kg/day,="" based="" on="" inhibited="" ossification.="" the="" developmental="" noel="" is="" 3="" mg/kg/day.="" 11.="" in="" a="" developmental="" toxicity="" study,="" rabbits="" were="" dosed="" at="" 0,="" 3,="" 6,="" or="" 12="" mg/kg/day="" from="" days="" 7="" through="" 19="" of="" gestation.="" the="" maternal="" loel="" is="" 3="" mg/kg/day,="" based="" on="" treatment-related="" clinical="" signs="" of="" toxicity="" (tremors).="" the="" maternal="" noel="" is=""><3 mg/kg/day.="" there="" was="" no="" developmental="" toxicity="" demonstrated="" at="" any="" dose="" level.="" there="" were="" no="" treatment-related="" effects="" on="" in="" utero="" survival="" and="" growth="" or="" on="" litter="" size="" and="" sex="" ratio="" of="" the="" fetuses.="" the="" skeletal="" variant="" data="" showed="" significant=""><0.01 or="" 0.05)="" increases="" in="" incidence="" of="" extra="" thoracic="" ribs="" and="" 27="" pre-sacral="" vertebrae="" among="" fetuses="" in="" the="" dosed="" groups;="" however,="" when="" the="" litter="" was="" used="" as="" the="" unit="" for="" comparison,="" the="" incidences="" of="" these="" respective="" variants="" were="" comparable="" between="" all="" groups.="" the="" incidences="" of="" these="" variants="" were="" not="" biologically="" significant.="" the="" noel="" for="" developmental="" toxicity="" is="" 12="" mg/kg/day.="" the="" developmental="" loel="" was="" not="" observed.="" 12.="" in="" a="" multi-generation="" reproduction="" study,="" rats="" were="" dosed="" at="" 0,="" 15,="" 50,="" or="" 250="" ppm="" (0,="" 0.75,="" 2.5,="" or="" 12.5="" mg/kg/day).="" the="" loel="" for="" parental="" toxicity="" is="" 12.5="" mg/kg/day,="" based="" on="" lowered="" body="" [[page="" 62957]]="" weight="" gains,="" and="" the="" noel="" is="" 2.5="" mg/kg/day.="" the="" loel="" for="" neurotoxic="" effects="" is="" 2.5="" mg/kg/day,="" based="" on="" abnormal,="" splayed,="" or="" high-stepping="" gait.="" the="" noel="" for="" neurotoxic="" effects="" is="" 0.75="" mg/kg/day.="" reproductive="" toxicity="" was="" demonstrated="" at="" the="" high-dose="" as="" lowered="" pup="" body="" weight="" gain="" throughout="" the="" study="" in="" all="" generations="" and="" in="" both="" sexes.="" additionally,="" total="" litter="" weight="" was="" decreased="" on="" day="" 29="" in="" all="" of="" the="" high-dose="" groups.="" the="" loel="" for="" reproductive="" toxicity="" is="" 12.5="" mg/kg/day,="" based="" on="" lowered="" pup="" body="" weight="" gains.="" the="" reproductive="" noel="" is="" 2.5="" mg/kg/day.="" 13.="" mutagenicity.="" there="" is="" no="" mutagenicity="" concern.="" the="" submitted="" studies="" satisfy="" the="" pre-1991="" mutagenicity="" test="" battery="" and="" the="" new="" mutagenicity="" testing="" requirements.="" there="" are="" seven="" acceptable="" studies:="" one="" dominant="" lethal="" study="" in="" mice;="" reverse="" mutation="" assay="" (salmonella="" typhimurium);="" one="" forward="" mutation="" assay="" in="" mammalian="" cells;="" one="" mouse="" lymphoma="" assay,="" one="" in="" vivo="" chromosomal="" aberration="" assay,="" in="" vitro="" chromosome="" aberration="" study;="" one="" uds="" assay="" in="" primary="" rat="" hepatocytes.="" all="" these="" studies="" were="" negative.="" 14.="" metabolism.="" in="" both="" rats="" and="" dogs,="" when="" given="" either="" 1="" or="" 10="" mg/kg,="" most="" of="" the="" radioactivity="" was="" found="" in="" the="" feces="" unchanged="" and="" most="" urinary="" metabolites="" were="" conjugated.="" approximately="" 30%="" of="" the="" administered="" dose="" was="" absorbed="" and="" excreted="" in="" the="" urine="" in="" both="" species.="" single="" doses="" in="" both="" rats="" and="" dogs="" were="" excreted="" within="" 48="" hours,="" 50-65%="" in="" feces="" and="" 20-30%="" in="" the="" urine.="" in="" rats,="" a="" biliary="" fistula="" experiment="" suggested="" that="" the="" radioactivity="" measured="" in="" the="" feces="" may="" be="" partially="" due="" to="" biliary="" excretion.="" studies="" also="" suggest="" that="" oxidation="" precedes="" the="" ester="" body="" cleavage.="" in="" rats,="" the="" halflife="" in="" the="" liver="" is="" 4.8="" days,="" in="" the="" fat="" is="" 13.3="" days="" and="" in="" the="" blood="" is="" 10.6="" days.="" in="" a="" study="" with="" rat="" fat,="" half="" of="" the="" radioactive="" residues="" could="" be="" attributed="" to="" the="" parent="" and="" the="" remaining="" residues="" consisted="" of="" a="" mixture="" of="" fatty="" acid="" esters="" of="" hydroxylated="" parent="" metabolites.="" 15.="" neurotoxicity.="" no="" acceptable="" mammalian="" neurotoxicity="" studies="" are="" available.="" in="" a="" supplementary="" study,="" 10="" animals/sex/group="" were="" given="" either="" vehicle,="" 2,5-hexanedione="" or="" 5="" mg/kg="" or="" 15="" mg/kg="" tefluthrin.="" the="" positive="" control,="" 2,5-hexanedione,="" elicited="" the="" appropriate="" neurotoxicological="" response.="" no="" consistent="" effects="" on="" motor="" or="" sensory="" nerve="" electrophysiology="" or="" function="" or="" clinical="" signs="" of="" neurotoxicity="" were="" evident="" in="" animals="" treated="" with="" either="" 5="" or="" 15="" mg/kg="" tefluthrin.="" a="" slight="" but="" significant="" increase="" in="" pull-up="" time="" was="" observed="" on="" day="" 12="" in="" males="" which="" was="" accompanied="" by="" a="" significant="" decrease="" in="" both="" sncv="" and="" the="" amplitude="" of="" the="" snap.="" both="" quickly="" returned="" to="" values="" similar="" to="" control="" values,="" and="" did="" not="" decrease="" again.="" neurotoxicity="" studies="" will="" be="" required="" under="" a="" special="" data="" call-in="" letter="" pursuant="" to="" section="" 3(c)(2)(b)="" of="" fifra.="" although="" these="" data="" are="" lacking,="" epa="" has="" sufficient="" toxicity="" data="" to="" support="" these="" tolerances="" and="" these="" additional="" studies="" are="" not="" expected="" to="" significantly="" change="" the="" risk="" assessment.="" b.="" toxicological="" endpoints="" 1.="" acute="" toxicity.="" for="" acute="" dietary="" risk="" assessment,="" epa="" recommends="" use="" of="" a="" noel="" of="" 0.5="" mg/kg/day="" based="" on="" increased="" incidence="" of="" tremors="" and="" ataxia="" in="" both="" sexes="" of="" dogs="" at="" 2.0="" mg/kg/day="" (loel)="" on="" day="" 1="" of="" the="" study="" from="" the="" 1="" year="" oral="" chronic="" toxicity="" study="" in="" dogs.="" 2.="" short="" -="" and="" intermediate="" -="" term="" toxicity.="" for="" short-="" and="" intermediate="" term="" moe's,="" epa="" recommends="" use="" of="" a="" noel="" of="" 0.5="" mg/kg/day="" based="" on="" increased="" incidence="" of="" tremors="" and="" ataxia="" in="" both="" sexes="" of="" dogs="" at="" 2.0="" mg/kg/day="" (loel)="" from="" the="" one="" year="" oral="" toxicity="" study="" in="" dogs="" and="" use="" of="" a="" dermal="" absorption="" rate="" of="" 25%.="" a="" dermal="" absorption="" rate="" of="" 25%="" was="" recommended="" based="" on="" the="" weight-of-the-evidence="" available="" for="" structurally="" related="" pyrethroids.="" 3.="" chronic="" toxicity.="" epa="" has="" established="" the="" rfd="" for="" tefluthrin="" at="" 0.005="" milligrams/kilogram/day="" (mg/kg/day).="" this="" rfd="" is="" based="" on="" increased="" incidence="" of="" tremors="" and="" ataxia="" in="" both="" sexes="" of="" dogs="" in="" a="" chronic="" toxicity="" study="" and="" an="" uncertainty="" factor="" of="" 100="" to="" account="" for="" both="" interspecies="" extrapolation="" and="" intraspecies="" variability.="" 4.="" carcinogenicity.="" no="" evidence="" of="" carcinogenicity="" was="" demonstrated="" in="" studies="" conducted="" with="" mice="" or="" rats.="" c.="" exposures="" and="" risks="" 1.="" from="" food="" and="" feed="" uses.tolerances="" have="" been="" established="" (40="" cfr="" 180.440)="" for="" the="" combined="" residues="" of="" tefluthrin="" and="" its="" metabolite,="" in="" or="" on="" corn.="" risk="" assessments="" were="" conducted="" by="" epa="" to="" assess="" dietary="" exposures="" and="" risks="" from="" tefluthrin="" 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="" one="" day="" or="" single="" exposure.="" percent="" of="" crop="" treated="" data="" and="" tolerance="" values="" were="" used="" in="" conjunction="" with="" monte="" carlo.="" the="" acute="" dietary="" moe="" at="" the="" 99.9th="" percentile="" for="" the="" most="" highly="" exposed="" population="" subgroup="" (non-nursing="" infants=""><1 year="" old)="" is="" 691.="" the="" moe="" at="" the="" 99.9th="" percentile="" for="" the="" general="" u.s.="" population="" is="" 1,469.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" for="" moes="" of="" 100="" or="" greater.="" therefore,="" the="" acute="" dietary="" risk="" assessment="" for="" tefluthrin="" indicates="" a="" reasonable="" certainty="" of="" no="" harm.="" ii.="" chronic="" exposure="" and="" risk.="" the="" chronic="" dietary="" exposure="" assessment="" used="" tolerance="" values="" and="" percent="" crop="" treated="" information.="" the="" rfd="" used="" for="" the="" chronic="" dietary="" analysis="" is="" 0.005="" mg/kg/day.="" the="" risk="" assessment="" resulted="" in="" use="" of="" less="" than="" one="" percent="" (0.1%)="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" percent="" of="" the="" rfd="" used="" for="" the="" most="" highly="" exposed="" population="" subgroup="" (children="" ages="" one="" to="" six)="" is="" 0.3%.="" epa="" notes="" that="" the="" acute="" dietary="" risk="" assessments="" used="" monte="" carlo="" modeling="" (in="" accordance="" with="" tier="" 3="" of="" epa="" june="" 1996="" ``acute="" dietary="" exposure="" assessment''="" guidance="" document)="" incorporating="" tolerance="" levels="" and="" percent="" of="" crop="" treated="" refinements.="" the="" chronic="" dietary="" risk="" assessments="" used="" tolerance="" levels="" and="" percent="" crop="" treated="" information.="" section="" 408(b)(2)(e)="" authorizes="" epa="" to="" consider="" available="" data="" and="" information="" on="" the="" anticipated="" residue="" levels="" of="" pesticide="" residues="" in="" food="" and="" the="" actual="" levels="" of="" pesticide="" chemicals="" that="" have="" been="" measured="" in="" food.="" if="" epa="" relies="" on="" such="" information,="" epa="" must="" require="" that="" data="" be="" provided="" five="" years="" after="" the="" tolerance="" is="" established,="" modified="" or="" left="" in="" effect,="" demonstrating="" that="" the="" levels="" in="" food="" are="" not="" above="" the="" levels="" anticipated.="" following="" the="" initial="" data="" submission,="" epa="" is="" authorized="" to="" require="" similar="" data="" on="" a="" timeframe="" it="" deems="" appropriate.="" section="" 408(b)(2)(f)="" allows="" the="" agency="" to="" use="" data="" on="" the="" actual="" percent="" of="" crop="" treated="" when="" establishing="" a="" tolerance="" only="" where="" the="" agency="" can="" make="" the="" following="" findings:="" (1)="" that="" the="" data="" used="" are="" reliable="" and="" provide="" a="" valid="" basis="" for="" showing="" the="" percentage="" of="" food="" derived="" from="" a="" crop="" that="" is="" likely="" to="" contain="" residues;="" (2)="" that="" the="" exposure="" estimate="" does="" not="" underestimate="" the="" exposure="" for="" any="" significant="" subpopulation="" and;="" (3)="" where="" data="" on="" regional="" pesticide="" use="" and="" food="" consumption="" are="" available,="" that="" the="" exposure="" estimate="" does="" not="" understate="" exposure="" for="" any="" regional="" population.="" in="" addition,="" the="" agency="" must="" provide="" for="" periodic="" evaluation="" of="" any="" estimates="" used.="" the="" percent="" of="" crop="" treated="" estimates="" for="" tefluthrin="" were="" derived="" from="" federal="" and="" market="" survey="" data.="" epa="" considers="" these="" data="" reliable.="" a="" range="" of="" estimates="" [[page="" 62958]]="" are="" supplied="" by="" this="" data="" and="" the="" upper="" end="" of="" this="" range="" was="" used="" for="" the="" exposure="" assessment.="" by="" using="" this="" upper="" end="" estimate="" of="" percent="" crop="" treated,="" the="" agency="" is="" reasonably="" certain="" that="" exposure="" is="" not="" underestimate="" for="" any="" significant="" subpopulation.="" 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.="" review="" of="" this="" regional="" data="" allows="" the="" agency="" to="" be="" reasonably="" certain="" that="" no="" regional="" population="" is="" exposed="" to="" residue="" levels="" higher="" than="" those="" estimated="" by="" the="" agency.="" to="" meet="" the="" requirement="" for="" data="" on="" anticipated="" residues,="" epa="" will="" issue="" a="" data="" call-in="" (dci)="" notice="" pursuant="" to="" ffdca="" section="" 408(f)="" requiring="" submission="" of="" data="" on="" anticipated="" residues="" in="" conjunction="" with="" approval="" of="" the="" registration="" under="" the="" fifra.="" 2.="" from="" drinking="" water.="" tefluthrin="" is="" immobile="" in="" soil="" and,="" therefore,="" will="" not="" leach="" into="" ground="" water.="" additionally,="" due="" to="" the="" insolubility="" and="" lipophilic="" nature="" of="" tefluthrin,="" any="" residues="" in="" surface="" water="" will="" rapidly="" and="" tightly="" bind="" to="" soil="" particles="" and="" remain="" with="" sediment,="" therefore="" not="" contributing="" to="" potential="" dietary="" exposure="" from="" drinking="" water.="" a="" screening="" evaluation="" of="" leaching="" potential="" of="" a="" typical="" synthetic="" pyrethroid="" was="" conducted="" using="" epa's="" pesticide="" root="" zone="" model="" (przm).="" based="" on="" this="" screening="" assessment,="" potential="" concentrations="" of="" a="" pyrethroid="" in="" ground="" water="" at="" depths="" of="" 1="" to="" 2="" meters="" are="" essentially="" zero=""><0.001 ppb).="" surface="" water="" concentrations="" for="" pyrethroids="" were="" estimated="" using="" przm1="" and="" exposure="" analysis="" modeling="" systems="" (exams)="" using="" standard="" epa="" cotton="" runoff="" and="" mississippi="" pond="" scenarios.="" the="" maximum="" concentration="" predicted="" in="" the="" simulation="" pond="" was="" 0.052="" ppb.="" concentrations="" in="" actual="" drinking="" water="" would="" be="" much="" lower="" than="" the="" levels="" predicted="" in="" the="" hypothetical,="" small,="" stagnant="" farm="" pond="" model="" since="" drinking="" water="" derived="" from="" surface="" water="" would="" normally="" be="" treated="" before="" consumption.="" based="" on="" these="" analyses,="" the="" contribution="" of="" water="" to="" the="" dietary="" risk="" estimate="" is="" negligible.="" therefore,="" epa="" concludes="" that="" together="" these="" data="" indicate="" that="" residues="" are="" not="" expected="" to="" occur="" in="" drinking="" water.="" i.="" acute="" exposure="" and="" risk.="" the="" acute="" drinking="" water="" exposure="" and="" risk="" estimates="" are="" 0.000040="" mg/kg/day="" (moe="" of="" 12,362)="" and="" 0.000078="" mg/="" kg/day="" (moe="" of="" 6,439)="" for="" the="" overall="" u.s.="" population="" and="" non-nursing="" infants=""><1 year="" old,="" respectively.="" ii.="" chronic="" exposure="" and="" risk.="" the="" chronic="" drinking="" water="" exposure="" and="" risk="" estimates="" are="" 0.000000="" mg/kg/day="" (0.0%="" of="" rfd="" utilized)="" and="" 0.000002="" mg/kg/day="" (0.0%="" of="" rfd="" utilized)="" for="" the="" overall="" u.s.="" population="" and="" non-nursing="" infants=""><1 year="" old,="" respectively.="" 3.="" from="" non-occupational="" non-dietary="" exposure.="" tefluthrin="" 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="" 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="" tefluthrin="" 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,="" tefluthrin="" 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="" tefluthrin="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" the="" acute="" aggregate="" risk="" assessment="" takes="" into="" account="" exposure="" from="" food="" and="" water.="" the="" acute="" aggregate="" moe="" calculated="" at="" the="" 99.9th="" percentile="" for="" the="" overall="" u.s.="" population="" is="" 1,316.="" the="" agency="" has="" no="" cause="" for="" concern="" if="" total="" acute="" exposure="" calculated="" for="" the="" 99.9th="" percentile="" yields="" an="" moe="" of="" 100="" or="" larger.="" therefore,="" the="" agency="" concludes="" that="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" acute="" aggregate="" exposure="" to="" tefluthrin="" residues="" in="" food="" and="" drinking="" water.="" 2.="" chronic="" risk.="" using="" the="" anticipated="" residue="" concentration="" (arc)="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" tefluthrin="" from="" food="" and="" water="" will="" utilize="" 0.1%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" children="" age="" 1-6="" years="" (discussed="" below).="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" tefluthrin="" 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="" tefluthrin="" not="" being="" registered="" for="" residential="" non-food="" sites,="" epa="" concludes="" that="" the="" aggregate="" short-="" and="" intermediate-term="" risks="" do="" not="" [[page="" 62959]]="" exceed="" levels="" of="" concern="" (moe="" less="" than="" 100),="" and="" that="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" tefluthrin="" residues.="" e.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" no="" evidence="" of="" carcinogenicity="" was="" demonstrated="" in="" studies="" conducted="" mice="" or="" rats.="" f.="" 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="" tefluthrin,="" 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="" data="" base="" unless="" epa="" determines="" that="" a="" different="" margin="" of="" safety="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" safety="" are="" incorporated="" into="" epa="" risk="" assessments="" either="" directly="" through="" use="" of="" a="" moe="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" moe="" and="" uncertainty="" factor="" (usually="" 100="" for="" combined="" inter-="" and="" intra-="" species="" variability)="" and="" not="" the="" additional="" tenfold="" moe/uncertainty="" factor="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children="" or="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" moe/safety="" factor.="" ii.="" developmental="" toxicity="" studies.="" in="" the="" prenatal="" developmental="" toxicity="" studies="" in="" rats="" and="" rabbits,="" the="" developmental="" noel="" was="" greater="" than="" the="" maternal="" noel,="" indicating="" a="" lack="" of="" sensitivity="" to="" in="" utero="" exposure.="" in="" rats,="" the="" maternal="" noel="" (1="" mg/kg/day),="" based="" on="" body="" weight="" decreases="" at="" the="" loel="" of="" 3="" mg/kg/day,="" which="" was="" based="" on="" ossification="" reductions="" in="" the="" extremities="" at="" 5="" mg/kg/day.="" in="" the="" rabbit="" study,="" maternal="" pyrethroid="" toxicity="" was="" observed="" at="" all="" dose="" levels="" (maternal="" noel=""><3 mg/kg/day),="" but="" no="" developmental="" toxicity="" was="" observed="" (developmental="" noel="">12 mg/kg/day).
iii. Reproductive toxicity study. In the two-generation
reproduction study in rats, offspring toxicity (reduced mean pup weight
gain) was observed only at the highest dose level tested (250 ppm; 12.5
mg/kg/day), while evidence of neurotoxicity in parental animals was
observed at the systemic LOEL of 50 ppm (2.5 mg/kg/day). The offspring
toxicity NOEL was 50 ppm (2.5 mg/kg/day) and the parental systemic NOEL
was 15 ppm (0.75 mg/kg/day).
iv. Pre- and post-natal sensitivity. The data demonstrated no
indication of increased sensitivity of rats or to in utero and/or
postnatal exposure with tefluthrin.
v. Conclusion. The data base related to pre- and post-natal
sensitivity is complete. Based on the above, EPA concludes that
reliable data support use of the standard 100-fold uncertainty factor,
and that an additional uncertainty factor is not needed to protect the
safety of infants and children.
2. Acute risk. The acute aggregate MOE calculated at the 99.9th
percentile for non-nursing infants <1 year="" old="" is="" 623.="" epa="" concluded="" that="" aggregate="" dietary="" acute="" risk="" (food="" plus="" water)="" would="" not="" exceed="" levels="" of="" concern.="" therefore,="" the="" agency="" has="" no="" acute="" aggregate="" concern="" due="" to="" exposure="" to="" tefluthrin="" through="" food="" and="" drinking="" water.="" 3.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" tefluthrin="" from="" food="" and="" water="" will="" utilize="" 0.3%="" of="" the="" rfd="" for="" children="" age="" 1-6="" years.="" 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.="" 4.="" short-="" or="" intermediate-term="" risk.="" based="" on="" tefluthrin="" not="" being="" registered="" for="" residential="" non-food="" sites,="" epa="" concludes="" that="" the="" aggregate="" short-="" and="" intermediate-term="" risks="" do="" not="" exceed="" levels="" of="" concern,="" and="" that="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" tefluthrin="" residues.="" 5.="" special="" docket.="" the="" complete="" acute="" and="" chronic="" exposure="" analyses="" (including="" dietary,="" non-dietary,="" drinking="" water,="" and="" residential="" exposure,="" and="" analysis="" of="" exposure="" to="" infants="" and="" children)="" used="" for="" risk="" assessment="" purposes="" can="" be="" found="" in="" the="" special="" docket="" for="" the="" fqpa="" under="" the="" title="" ``risk="" assessment="" for="" extension="" of="" tolerances="" for="" synthetic="" pyrethroids.''="" further="" explanation="" regarding="" epa's="" decision="" regarding="" the="" additional="" safety="" factor="" can="" also="" be="" found="" in="" the="" special="" docket.="" g.="" endocrine="" disrupter="" effects="" epa="" is="" required="" to="" develop="" a="" screening="" program="" to="" determine="" whether="" certain="" substances="" (including="" all="" pesticides="" and="" inerts)="" ``may="" have="" an="" effect="" in="" humans="" that="" is="" similar="" to="" an="" effect="" produced="" by="" a="" naturally="" occurring="" estrogen,="" or="" such="" other="" endocrine="" effect...''="" the="" agency="" is="" currently="" working="" with="" interested="" stakeholders,="" including="" other="" government="" agencies,="" public="" interest="" groups,="" industry="" and="" research="" scientists="" in="" developing="" a="" screening="" and="" testing="" program="" and="" a="" priority="" setting="" scheme="" to="" implement="" this="" program.="" congress="" has="" allowed="" 3="" years="" from="" the="" passage="" of="" fqpa="" (august="" 3,="" 1999)="" to="" implement="" this="" program.="" at="" that="" time,="" epa="" may="" require="" further="" testing="" of="" this="" active="" ingredient="" and="" end="" use="" products="" for="" endocrine="" disrupter="" effects.="" iii.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" plant="" metabolism="" studies="" indicate="" that="" tefluthrin="" per="" se="" is="" not="" translocated="" to="" plants="" but="" is="" degraded="" in="" soil="" to="" two="" principal="" metabolites="" that="" are="" capable="" of="" being="" taken="" up="" by="" plants.="" the="" metabolites="" are="" the="" products="" of="" the="" cleavage="" of="" the="" ester="" to="" the="" free="" acid="" (z)-3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-="" dimethylcyclopropane="" carboxylic="" acid="" (metabolite="" ia)="" and="" to="" 2,3,5,6-="" tetrafluoro-4-hydroxymethylbenzoic="" acid="" (metabolite="" vi).="" the="" agency="" concluded="" that="" metabolite="" vi="" need="" not="" be="" regulated.="" in="" animals,="" dosing="" with="" radioactive="" tefluthrin="" at="" level="" equivalent="" to="" 11="" ppm="" in="" feed="" resulted="" in="" identifiable="" residues="" of="" tefluthrin="" and="" its="" metabolites="" in="" tissues="" but="" at="" levels="" below="" those="" capable="" of="" detection="" by="" proposed="" enforcement="" methods.="" b.="" analytical="" enforcement="" methodology="" validated="" enforcement="" analytical="" methods="" are="" available="" for="" tefluthrin="" parent="" (method="" ppram="" no.="" 85/1,="" the="" determination="" of="" residues="" of="" tefluthrin="" in="" crops="" and="" soil-a="" gas-liquid="" chromatographic="" method)="" and="" for="" metabolite="" ia="" (method="" gram-028="" a="" gas="" chromatography="" method="" for="" the="" [[page="" 62960]]="" determination="" of="" residues="" of="" the="" tefluthrin="" metabolite="" pp890="" in="" crops="" of="" high="" and="" low="" moisture="" content).="" the="" limits="" of="" quantitation="" of="" these="" methods="" are="" 0.01="" ppm="" for="" tefluthrin="" and="" 0.05="" ppm="" for="" metabolite="" ia.="" c.="" magnitude="" of="" residues="" 1.="" plant="" commodities--="" field="" trial="" studies.="" no="" residues="" were="" detected="" in="" field="" trials="" conducted="" at="" maximum="" label="" rates="" and="" minimum="" phis.="" tolerances="" were="" established="" at="" the="" limit="" of="" quantitation="" of="" the="" analytical="" method="" (0.06="" ppm).="" the="" 0.06="" ppm="" tolerances="" were="" used="" to="" estimate="" chronic="" and="" acute="" dietary="" exposure="" to="" potential="" residues="" of="" tefluthrin.="" 2.="" animal="" commodities.="" studies="" conducted="" indicate="" that="" no="" residues="" are="" detected="" in="" animal="" tissues,="" milk,="" and="" eggs="" and="" therefore="" secondary="" residues="" would="" not="" be="" a="" concern.="" for="" that="" reason,="" no="" tolerances="" have="" been="" established="" on="" meat,="" milk,="" and="" eggs.="" secondary="" residues="" were="" therefore="" not="" considered="" in="" these="" analyses.="" d.="" international="" residue="" limits="" there="" are="" no="" codex="" maximum="" residue="" levels="" established="" for="" tefluthrin.="" no="" canadian="" mrls="" have="" been="" established="" for="" residues="" of="" tefluthrin="" on="" corn="" commodities.="" mexico="" has="" established="" a="" tolerance="" for="" residues="" of="" tefluthrin="" on="" corn="" grain="" (0.06="" ppm)="" which="" is="" in="" harmony="" with="" the="" u.s.="" tolerance.="" iv.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" combined="" residues="" of="" tefluthrin="" and="" its="" metabolite="" in="" corn,="" grain,="" field="" and="" pop;="" corn,="" forage="" and="" fodder,="" field,="" pop="" and="" sweet;="" and="" corn,="" fresh="" (including="" sweet="" k="" and="" corn="" with="" husk="" removed="" (cwhr))="" at="" 0.06="" 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="" january="" 26,="" 1998="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" above="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" rulemaking.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" if="" a="" hearing="" is="" requested,="" the="" objections="" must="" include="" a="" statement="" of="" the="" factual="" issues="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" requestor="" (40="" cfr="" 178.27).="" a="" request="" for="" a="" hearing="" will="" be="" granted="" if="" the="" administrator="" determines="" that="" the="" material="" submitted="" shows="" the="" following:="" there="" is="" genuine="" and="" substantial="" issue="" of="" fact;="" there="" is="" a="" reasonable="" possibility="" that="" available="" evidence="" identified="" by="" the="" requestor="" would,="" if="" established,="" resolve="" one="" or="" more="" of="" such="" issues="" in="" favor="" of="" the="" requestor,="" taking="" into="" account="" uncontested="" claims="" or="" facts="" to="" the="" contrary;="" and="" resolution="" of="" the="" factual="" issues="" in="" the="" manner="" sought="" by="" the="" requestor="" would="" be="" adequate="" to="" justify="" the="" action="" requested="" (40="" cfr="" 178.32).="" information="" submitted="" in="" connection="" with="" an="" objection="" or="" hearing="" request="" may="" be="" claimed="" confidential="" by="" marking="" any="" part="" or="" all="" of="" that="" information="" as="" cbi.="" information="" so="" marked="" will="" not="" be="" disclosed="" except="" in="" accordance="" with="" procedures="" set="" forth="" in="" 40="" cfr="" part="" 2.="" a="" copy="" of="" the="" information="" that="" does="" not="" contain="" cbi="" must="" be="" submitted="" for="" inclusion="" in="" the="" public="" record.="" information="" not="" marked="" confidential="" may="" be="" disclosed="" publicly="" by="" epa="" without="" prior="" notice.="" vi.="" public="" docket="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300576]="" (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.
VII. Regulatory Assessment Requirements
This final rule establishes tolerances 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 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,
[[Page 62961]]
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: November 14, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.440 is revised to read as follows:
Sec. 180.440 Tefluthrin; tolerances for residues.
(a) General. Tolerances are established for the combined residues
of the insecticide tefluthrin (2,3,5,6 tetrafluroro-4-
methylphenyl)methyl-(1 alpha, 3 alpha)-(Z)-()-3(2-chloro-
3,3,3-trifluoro-1-propenyl)-2,2-diemthylcyclopropanecarboxylate) and
its metabolite (Z)-3-(2-chloro-3,3,3-trifluroro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylic acid in or on the following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Corn, field, fodder and forage, pop and sweet.............. 0.06
Corn, fresh (including sweet K and corn with husk removed
(CWHR).................................................... 0.06
Corn, field, grain and pop................................. 0.06
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-30946 Filed 11-25-97; 8:45 am]
BILLING CODE 6560-50-F
