[Federal Register Volume 64, Number 101 (Wednesday, May 26, 1999)]
[Rules and Regulations]
[Pages 28377-28384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12935]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300855; FRL-6079-1]
RIN 2070-AB78
Tebuconazole; Pesticide Tolerance for Emergency Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of tebuconazole in or on garlic. 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 garlic. This regulation establishes a maximum
permissible level for residues of tebuconazole in this food commodity
pursuant to section 408(l)(6) of the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996. The
tolerance will expire and is revoked on June 30, 2000.
DATES: This regulation is effective May 26, 1999. Objections and
requests for hearings must be received by EPA on or before July 26,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300855], 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-300855], must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to Rm. 119, Crystal Mall #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@epa.gov. Copies of electronic objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket control number [OPP-300855].
No Confidential Business Information (CBI) should be submitted through
e-mail. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Stephen Schaible,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 271, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-308-9362; e-
mail: schaible.stephen@epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408 and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a and (l)(6), is establishing a tolerance for
residues of the fungicide tebuconazole, in or on garlic at 0.1 part per
million (ppm). This tolerance will expire and is revoked on June 30,
2000. EPA will publish a document in the Federal Register to remove the
revoked tolerance from the Code of Federal Regulations.
I. Background and Statutory Findings
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 in this preamble 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. . . .''
[[Page 28378]]
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 tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Tebuconazole on Garlic and FFDCA
Tolerances
While garlic rust is usually a disease of minor concern in
California, it appeared as a serious pest problem in several garlic
growing areas of the state in the 1997-98 growing season. The mild
winter that year allowed the pathogen to survive the winter and cause
infection early in the season. No fungicide is specifically registered
for control of rust on garlic. The fungicides registered for use on
garlic are not effective at controlling the disease under high pest
pressure. Data presented by the state indicate that tebuconazole is
highly effective at controlling the disease. EPA has authorized under
FIFRA section 18 the use of tebuconazole on garlic for control of
garlic rust in California. After having reviewed the submission, EPA
concurs that emergency conditions exist for this state.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of tebuconazole in or on
garlic. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the 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 this tolerance without notice and opportunity for public
comment under section 408(e), as provided in section 408(l)(6).
Although this tolerance will expire and is revoked on June 30, 2000,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerance remaining in or on garlic
after that date will not be unlawful, provided the pesticide is applied
in a manner that was lawful under FIFRA, and the residues do not exceed
a level that was authorized by this tolerance at the time of that
application. EPA will take action to revoke this tolerance earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because this tolerance is being approved under emergency conditions
EPA has not made any decisions about whether tebuconazole meets EPA's
registration requirements for use on garlic or whether a permanent
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that this tolerance serves as a basis for
registration of tebuconazole by a State for special local needs under
FIFRA section 24(c). Nor does this tolerance serve as the basis for any
State other than California to use this pesticide on this crop under
section 18 of FIFRA without following all provisions of EPA's
regulations implementing section 18 as identified in 40 CFR part 166.
For additional information regarding the emergency exemption for
tebuconazole, contact the Agency's Registration Division at the address
provided under the ``ADDRESSES'' section.
III. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7) .
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
tebuconazole and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
residues of tebuconazole on garlic at 0.1 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 tebuconazole are
discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. The acute reference dose (RfD) of 0.1
milligrams/kilogram/day (mg/kg/day) for tebuconazole was established
based on a developmental toxicity study in mice with a no observed
adverse effect level (NOAEL) of 10 mg/kg/day for developmental
toxicity. At the lowest observed adverse effect level (LOAEL) of 30 mg/
kg/day, an increased incidence of runts (fetuses weighing less than 1.3
gram) were observed. An uncertainty factor of 100 was applied to the
NOAEL to calculate the acute RfD of 0.1 mg/kg/day. EPA has determined
that the 10x factor to account for enhanced susceptibility of infants
and children (as required by FQPA) should be retained. This
determination is based on the results of the developmental toxicity
study in mice used to establish the acute RfD, other developmental
toxicity studies in mice, rats and rabbits and the structural
relationship of tebuconazole to several other triazole pesticides which
also have been shown to induce developmental toxicity in rats and/or
rabbits. For acute dietary exposure, EPA determined that the 10x safety
factor is applicable to the subpopulations females (13+ years), as well
as infants and children because the effects seen were developmental and
are presumed to occur following ``acute'' exposures. For subpopulations
other than females (13+ years), infants and children, a toxicological
endpoint was not identified. Application of the 10x safety factor for
enhanced susceptibility of infants and children to the acute RfD of 0.1
mg/kg/day results in an acceptable acute dietary exposure (food plus
water) of 10% or less of the acute RfD.
2. Short-and intermediate-term toxicity. Toxicological endpoints
for short- or intermediate-term dermal toxicity were not identified.
Adverse systemic effects were not observed in dermal developmental
toxicity studies in mice or rats at the limit dose of 1,000
[[Page 28379]]
mg/kg/day or in a 21-day dermal toxicity study in rabbits at the limit
dose of 1,000 mg/kg/day. Therefore, risk assessments for short- or
intermediate-term dermal exposure were not conducted.
A NOAEL of 0.0106 mg/liter/day (equivalent to 2.9 mg/kg/day) was
identified as the toxicological endpoint for short- and intermediate-
term (and chronic) inhalation toxicity based on a 21-day inhalation
toxicity study in rats. At the LOAEL of 0.1558 mg/liter/day,
piloerection and increased liver O-demethylase and N-demethylase
activity were observed in both males and females. EPA determined that
the 10x safety factor to account for enhanced susceptibility of infants
and children (as required by FQPA) is not applicable for inhalation
toxicity for the currently registered residential exposures to
tebuconazole. A Margin of Exposure (MOE) of 100 or more for short- or
intermediate-term non-dietary risk is acceptable for all
subpopulations.
3. Chronic toxicity. EPA has established the RfD for tebuconazole
at 0.03 (mg/kg/day). This RfD is based on a 1-year chronic feeding
study in dogs in which the NOAEL was 100 ppm (2.96 mg/kg/day in males
and 2.94 mg/kg/day in females) and the LOAEL was 150 ppm (4.39 mg/kg/
day in males and 4.45 mg/kg/day in females), based on histopathological
changes in the adrenal gland (hypertrophy of the zona fasciculata and
fatty changes in the zona glomerulosa in both sexes and lipid
hyperplasia in the cortex in males). An uncertainty factor of 100 was
used to account for inter-species extrapolation and intra-species
variability. EPA determined that the 10x factor for enhanced
susceptibility of infants and children (as required by FQPA) is not
applicable for chronic dietary exposure. The developmental effects
which contributed to the decision to retain the 10x factor for acute
dietary exposure are considered to be acute effects; maternal effects
in those same studies were minimal. Additionally, the NOAEL on which
the RfD is based is the lowest NOAEL in the toxicology data base for
this chemical. A chronic dietary exposure (food plus water) of 100% or
less of the chronic RfD is acceptable for all subpopulations.
4. Carcinogenicity. Tebuconazole is classified as a Group C
(possible human) carcinogen. This decision was primarily based on
results in a 91-week carcinogenicity study in mice in which the
following effects were observed:
1. A statistically significant increase in the incidence of
hepatocellular adenomas, carcinomas and combined adenomas/carcinomas in
male mice at the highest dose tested (279 mg/kg/day).
2. A statistically significant increase in the incidence of
hepatocellular carcinomas and combined adenomas/carcinomas in female
mice at the highest dose tested (366 mg/kg/day). In addition,
tebuconazole is structurally related to several other triazole
pesticides that produce similar liver tumors in mice. For the purpose
of carcinogenic risk assessment, the RfD methodology is used to
estimate human risk.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.474) for the residues of tebuconazole, in or on a variety of
raw agricultural commodities. Tolerances have been established for milk
and meat byproducts in connection with use of tebuconazole under a
previous section 18. Risk assessments were conducted by EPA to assess
dietary exposures and risks from tebuconazole 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. An acute dietary endpoint of concern was
identified for subpopulations females (13+ years), as well as infants
and children.
An acute dietary (food only) probablistic risk analysis submitted
in conjunction with another action was used to estimate acute dietary
risk. The following assumptions were utilized in the Monte Carlo
analysis:
1. Percent crop treated (PCT) data were used for all commodities.
2. Maximum residue levels from crop field trials for single serving
commodities such as bananas and peaches were utilized.
3. Average residue levels from crop field trials were used for
blended commodities such as fruit juices, grains and oils.
4. Anticipated residue levels for ruminant commodities were
calculated using a livestock diet constructed using anticipated residue
levels for livestock feed items. This analysis is considered to be
highly refined. This analysis was run with 2,000 iterations. The
results of the Monte Carlo analysis indicate that the percent of acute
RfD for all children and infants subgroups as well as females 13+ years
old are all below 10% of the RfD nursing infants (<1 year),="" 7%;="" non-="" nursing="" infants=""><1 year),="" 7%;="" children="" (1="" to="" 6="" years)="" 9%,="" children="" (7="" to="" 12="" years)="" 3%;="" all="" infants=""><1 year),="" 7%;="" females="" (13="" years="" plus),="" 3%.="" section="" 408(b)(2)(e)="" authorizes="" epa="" to="" use="" 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="" 5="" 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="" time="" frame="" it="" deems="" appropriate.="" as="" required="" by="" section="" 408(b)(2)(e),="" epa="" will="" issue="" a="" data="" call-in="" for="" information="" relating="" to="" anticipated="" residues="" to="" be="" submitted="" no="" later="" than="" 5="" years="" from="" the="" date="" of="" issuance="" of="" this="" tolerance.="" section="" 408(b)(2)(f)="" states="" that="" the="" agency="" may="" use="" data="" on="" the="" actual="" percent="" of="" food="" treated="" for="" assessing="" chronic="" dietary="" risk="" only="" if="" the="" agency="" can="" make="" the="" following="" findings:="" that="" the="" data="" used="" are="" reliable="" and="" provide="" a="" valid="" basis="" to="" show="" what="" percentage="" of="" the="" food="" derived="" from="" such="" crop="" is="" likely="" to="" contain="" such="" pesticide="" residue;="" that="" the="" exposure="" estimate="" does="" not="" underestimate="" exposure="" for="" any="" significant="" subpopulation="" group;="" and="" if="" data="" are="" available="" on="" pesticide="" use="" and="" food="" consumption="" in="" a="" particular="" area,="" the="" exposure="" estimate="" does="" not="" understate="" exposure="" for="" the="" population="" in="" such="" area.="" in="" addition,="" the="" agency="" must="" provide="" for="" periodic="" evaluation="" of="" any="" estimates="" used.="" to="" provide="" for="" the="" periodic="" evaluation="" of="" the="" estimate="" of="" pct="" as="" required="" by="" section="" 408(b)(2)(f),="" epa="" may="" require="" registrants="" to="" submit="" data="" on="" pct.="" the="" agency="" used="" pct="" information="" as="" follows:="" pct="" refinements="" were="" assumed="" for="" all="" commodities="" evaluated="" in="" the="" probablistic="" risk="" assessment.="" for="" published="" uses,="" pct="" data="" were="" based="" on="" information="" obtained="" from="" the="" registrant="" and="" were="" derived="" from="" doane="" marketing="" research="" and="" usda="" national="" agricultural="" statistics="" service="" (nass).="" for="" those="" commodities="" being="" requested="" under="" section="" 18,="" total="" u.s.="" acreage="" treated="" under="" section="" 18="" was="" aggregated="" for="" each="" crop="" and="" compared="" to="" total="" acreage="" grown="" in="" the="" u.s.="" to="" derive="" a="" national="" pct="" estimate.="" the="" agency="" believes="" that="" the="" three="" conditions,="" discussed="" in="" section="" 408="" (b)(2)(f)="" concerning="" the="" agency's="" responsibilities="" in="" assessing="" acute="" dietary="" risk="" findings,="" have="" been="" met.="" the="" pct="" estimates="" are="" derived="" from="" federal="" and="" private="" market="" survey="" data,="" which="" are="" reliable="" and="" have="" a="" valid="" basis.="" typically,="" a="" range="" of="" estimates="" are="" supplied="" and="" the="" upper="" end="" of="" this="" [[page="" 28380]]="" range="" is="" assumed="" for="" the="" exposure="" assessment.="" by="" using="" this="" upper="" end="" estimate="" of="" the="" pct,="" the="" agency="" is="" reasonably="" certain="" that="" the="" percentage="" of="" the="" food="" treated="" is="" not="" likely="" to="" be="" underestimated.="" the="" regional="" consumption="" information="" and="" consumption="" information="" for="" significant="" subpopulations="" is="" taken="" into="" account="" through="" epa's="" computer-based="" model="" for="" evaluating="" the="" exposure="" of="" significant="" subpopulations="" including="" several="" regional="" groups.="" use="" of="" this="" consumption="" information="" in="" epa's="" risk="" assessment="" process="" ensures="" that="" epa's="" exposure="" estimate="" does="" not="" understate="" exposure="" for="" any="" significant="" subpopulation="" group="" and="" allows="" the="" agency="" to="" be="" reasonably="" certain="" that="" no="" regional="" population="" is="" exposed="" to="" residue="" levels="" higher="" than="" those="" estimated="" by="" the="" agency.="" other="" than="" the="" data="" available="" through="" national="" food="" consumption="" surveys,="" epa="" does="" not="" have="" available="" information="" on="" the="" regional="" consumption="" of="" food="" to="" which="" tebuconazole="" may="" be="" applied="" in="" a="" particular="" area.="" ii.="" chronic="" exposure="" and="" risk.="" the="" agency="" conducted="" a="" chronic="" dietary="" exposure="" analysis="" and="" risk="" assessment.="" the="" analysis="" evaluated="" individual="" food="" consumption="" as="" reported="" by="" respondents="" in="" the="" usda="" 1977-78="" nationwide="" food="" consumption="" survey="" (nfcs)="" and="" accumulates="" exposure="" to="" the="" chemical="" for="" each="" commodity.="" in="" conducting="" the="" chronic="" dietary="" risk="" assessment,="" the="" agency="" made="" the="" very="" conservative="" assumption="" that="" 100%="" of="" every="" commodity="" evaluated="" will="" contain="" residues="" and="" those="" residues="" will="" be="" at="" tolerance="" level;="" this="" assumption="" results="" in="" an="" overestimation="" of="" human="" dietary="" exposure.="" thus,="" in="" making="" a="" safety="" determination="" for="" this="" time-limited="" tolerance,="" the="" agency="" is="" taking="" into="" account="" this="" conservative="" exposure="" assessment.="" the="" existing="" tebuconazole="" tolerances="" published,="" pending,="" and="" including="" the="" necessary="" section="" 18="" tolerance(s)="" result="" in="" a="" theoretical="" maximum="" residue="" contribution="" (tmrc)="" that="" is="" equivalent="" to="" percentages="" of="" the="" rfd="" below="" 100%="" for="" all="" subgroups="" i.e.,="" u.s.="" population,="" 11%="" and="" non-nursing="" infants=""><1 year="" old),="" the="" most="" highly="" exposed="" subgroup,="" 37%.="" 2.="" from="" drinking="" water.="" based="" on="" present="" data="" available="" to="" the="" agency,="" tebuconazole="" is="" persistent="" and="" relatively="" immobile.="" there="" are="" no="" established="" maximum="" contaminant="" level="" or="" health="" advisory="" levels="" for="" residues="" of="" tebuconazole="" in="" drinking="" water.="" monitoring="" data="" for="" residues="" of="" tebuconazole="" in="" surface="" and="" ground="" water="" are="" not="" available.="" tebuconazole="" is="" not="" included="" in="" the="" pesticides="" in="" ground="" water="" database="" (us="" epa,="" 1992),="" and="" it="" was="" not="" an="" analyte="" in="" the="" national="" pesticide="" survey="" (us="" epa,="" 1990).="" epa="" estimated="" exposure="" for="" tebuconazole="" for="" both="" surface="" and="" ground="" water="" based="" on="" available="" modeling.="" environmental="" concentrations="" for="" surface="" water="" were="" estimated="" using="" modeling="" from="" generic="" estimated="" environmental="" concentration="" (geneec).="" for="" surface="" water,="" the="" maximum="" concentrations="" were="" used="" for="" acute="" risk="" calculations,="" the="" annual="" means="" (1-10="" years)="" for="" chronic="" risk="" calculations.="" current="" agency="" policy="" allows="" that="" a="" factor="" of="" 3="" be="" applied="" to="" geneec="" model="" values="" when="" determining="" whether="" or="" not="" a="" level="" of="" concern="" has="" been="" exceeded.="" if="" the="" geneec="" model="" value="" is=""> 3 times the drinking water level of
comparison (DWLOC), the pesticide is considered to have passed the
screen. Acute and chronic ground water concentrations were estimated
using the Screening Concentration in Ground Water (SCI-GROW) model. For
the purposes of the screening level assessment, the maximum and average
annual concentrations in ground water are not believed to vary
significantly. DWLOCs will be compared directly to SCI-GROW values.
i. Acute exposure and risk. DWLOCs were calculated for acute
exposures to tebuconazole in surface and ground water for females 13+
years old and children (1-6 years old). Relative to an acute toxicity
endpoint, the acute dietary food exposure (from the probablistic
analysis) was subtracted from the ratio of the acute NOAEL to the
appropriate percentage acute RfD to obtain the acceptable acute
exposure to tebuconazole in drinking water. DWLOCs were then calculated
from this acceptable exposure using default body weights (60 kg for
females and 10 kg for children) and drinking water consumption figures
(2 liters for females 1 liter for children). Based on these
calculations EPA's DWLOC for acute dietary risk is 14 parts per billion
(ppb) for children (1-6 years old) and 200 ppb for females 13+ years
old.
Maximum concentrations of tebuconazole in surface and ground water
are estimated to be 14 ppb and 0.3 ppb, respectively. The maximum
estimated concentrations of tebuconazole in surface and ground water do
not exceed EPA's levels of concern for acute exposure in drinking water
for the females 13+ and children.
ii. Chronic exposure and risk. EPA has calculated DWLOCs for
chronic exposures to tebuconazole in surface and ground water. To
calculate the DWLOC for chronic exposures relative to a chronic
toxicity endpoint, the chronic dietary food exposure was subtracted
from the chronic RfD (0.03 mg/kg/day) to obtain the acceptable chronic
exposure to tebuconazole in drinking water. DWLOCs were then calculated
from this exposure using default body weights (70 kg for U.S.
population, 60 kg for females 10 kg for children) and drinking water
consumption figures (2 liters U.S. population females 1 liter
children). Based on these calculations EPA's DWLOCs for chronic risk
are 950 ppb for the U.S. population, 780 ppb for females and 190 ppb
for non-nursing infants (<1 year="" old).="" estimated="" annual="" average="" concentrations="" of="" tebuconazole="" in="" surface="" water="" and="" ground="" water="" are="" 10="" ppb="" and="" 0.3="" ppb,="" respectively.="" the="" estimated="" annual="" average="" concentrations="" of="" tebuconazole="" in="" surface="" and="" ground="" water="" are="" less="" than="" epa's="" levels="" of="" concern="" for="" chronic="" exposure="" in="" drinking="" water.="" 3.="" from="" non-dietary="" exposure.="" no="" short-="" or="" intermediate-term="" dermal="" toxicological="" endpoints="" were="" identified.="" tebuconazole's="" registered="" residential="" uses="" are="" for="" the="" formulation="" of="" wood-based="" composite="" products,="" wood="" products="" for="" in-ground="" contact,="" plastics,="" exterior="" paints,="" glues="" and="" adhesives.="" currently,="" the="" only="" residential="" end-use="" products="" on="" the="" market="" are="" for="" exterior="" treated="" wood="" use.="" exposure="" via="" incidental="" ingestion="" (by="" children)="" and="" inhalation="" are="" not="" a="" concern="" for="" these="" products="" which="" are="" used="" outdoors.="" no="" paints="" or="" other="" end-use="" products="" containing="" tebuconazole="" are="" available="" for="" interior="" use.="" accordingly,="" residential="" exposure="" is="" not="" expected="" at="" this="" time.="" 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.''="" epa="" does="" not="" have,="" at="" this="" time,="" available="" data="" to="" determine="" whether="" tebuconazole="" 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,="" tebuconazole="" 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="" tebuconazole="" has="" a="" [[page="" 28381]]="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" for="" more="" information="" regarding="" epa's="" efforts="" to="" determine="" which="" chemicals="" have="" a="" common="" mechanism="" of="" toxicity="" and="" to="" evaluate="" the="" cumulative="" effects="" of="" such="" chemicals,="" see="" the="" final="" rule="" for="" bifenthrin="" pesticide="" tolerances="" (62="" fr="" 62961,="" november="" 26,="" 1997).="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" a="" toxicological="" endpoint="" was="" identified="" for="" acute="" dietary="" risk="" assessments="" for="" subpopulations="" females="" (13+="" years),="" infants="" and="" children.="" the="" 10x="" safety="" factor="" for="" enhanced="" susceptibility="" of="" infants="" and="" children="" as="" required="" by="" fqpa="" is="" applicable="" for="" all="" of="" these="" subgroups.="" therefore,="" 10%="" or="" less="" of="" the="" acute="" rfd="" of="" 0.1="" mg/kg/="" day="" results="" in="" an="" acceptable="" acute="" dietary="" exposure="" (food="" plus="" water).="" an="" acute="" dietary="" (food="" only)="" probablistic="" risk="" analysis="" resulted="" in="" 3%="" of="" the="" acute="" rfd="" utilized="" for="" females="" (13+="" years).="" the="" maximum="" estimated="" concentrations="" of="" tebuconazole="" in="" surface="" and="" ground="" water="" do="" not="" exceed="" epa's="" levels="" of="" concern="" for="" acute="" exposure="" in="" drinking="" water="" for="" the="" females="" 13+.="" currently="" the="" only="" residential="" end-use="" products="" on="" the="" market="" are="" for="" exterior="" treated="" wood="" use.="" exposure="" via="" incidental="" ingestion="" (by="" children)="" and="" inhalation="" are="" not="" a="" concern="" for="" these="" products="" which="" are="" used="" outdoors.="" no="" paints="" or="" other="" end-use="" products="" containing="" tebuconazole="" are="" available="" for="" interior="" use.="" accordingly="" residential="" exposure="" is="" not="" expected="" with="" these="" uses.="" therefore,="" epa="" concludes="" with="" reasonable="" certainty="" that="" residues="" of="" tebuconazole="" do="" not="" contribute="" significantly="" to="" the="" aggregate="" acute="" risk="" at="" the="" present="" time.="" 2.="" chronic="" risk.="" using="" the="" tmrc="" exposure="" assumptions="" described="" in="" this="" unit,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" tebuconazole="" from="" food="" will="" utilize="" 11%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" non-="" nursing="" infants="">< 1="" yr.),="" discussed="" below.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" estimated="" environmental="" concentrations="" of="" tebuconazole="" in="" surface="" water="" and="" ground="" water="" do="" not="" exceed="" chronic="" dwlocs="" calculated="" by="" the="" agency;="" therefore,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 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.="" no="" short-="" or="" intermediate-term="" dermal="" toxicological="" endpoints="" were="" identified.="" also,="" no="" residential="" exposure="" is="" expected="" from="" the="" current="" residential="" uses.="" thus,="" no="" risk="" assessments="" were="" conducted="" for="" residential="" exposure.="" therefore,="" epa="" concludes="" with="" reasonable="" certainty="" that="" tebuconazole="" does="" not="" contribute="" significantly="" to="" the="" aggregate="" shortand="" intermediate-term="" risk="" at="" the="" present="" time.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" tebuconazole="" is="" classified="" as="" a="" group="" c="" (possible="" human)="" carcinogen.="" since,="" for="" the="" purpose="" of="" carcinogenic="" risk="" assessment="" the="" reference="" dose="" (rfd)="" methodology="" was="" used,="" the="" discussion="" for="" chronic="" risk="" (11%="" of="" rfd="" utilized)="" above="" applies="" to="" cancer="" risk="" as="" well.="" therefore,="" epa="" concludes="" with="" reasonable="" certainty="" that="" tebuconazole="" does="" not="" contribute="" significantly="" to="" the="" aggregate="" cancer="" risk="" at="" the="" present="" time.="" 5.="" determination="" of="" safety.="" based="" on="" these="" risk="" assessments,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" tebuconazole="" residues.="" 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="" tebuconazole,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" 2-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="" 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="" margin="" of="" exposure="" (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="" two="" associated="" oral="" developmental="" toxicity="" studies="" in="" mice,="" the="" maternal="" noael="" was="" 10="" mg/="" kg/day="" and="" the="" loael="" was="" 20="" mg/kg/day,="" based="" on="" decreased="" hematocrit="" and="" effects="" in="" the="" liver.="" the="" developmental="" toxicity="" noael="" was="" 10="" mg/="" kg/day="" and="" the="" loael="" was="" 30="" mg/kg/day,="" based="" on="" increased="" numbers="" of="" runts="" (fetuses="" weighing="" less="" than="" 1.3="" gram).="" in="" addition,="" at="" 100="" mg/kg/="" day,="" frank="" malformations="" in="" the="" skull,="" brain="" and="" spinal="" column="" and="" a="" reduced="" rate="" of="" ossification="" in="" the="" cranium="" were="" observed.="" in="" a="" dermal="" developmental="" toxicity="" study="" in="" mice,="" no="" toxicologically="" significant="" maternal="" toxicity="" or="" developmental="" toxicity="" was="" observed="" at="" the="" limit="" dose="" of="" 1,000="" mg/kg/day.="" in="" an="" oral="" developmental="" toxicity="" study="" in="" rats,="" the="" maternal="" noael="" was="" 30="" mg/kg/day="" and="" the="" loael="" was="" 60="" mg/kg/day,="" based="" on="" increased="" liver="" weight.="" the="" developmental="" toxicity="" noael="" was="" 30="" mg/kg/day="" and="" the="" loael="" was="" 60="" mg/kg/day,="" based="" on="" delayed="" ossification="" of="" several="" bones="" and="" increased="" numbers="" of="" fetuses="" with="" supernumerary="" ribs.="" in="" addition,="" at="" 120="" mg/kg/day,="" increased="" resorptions,="" decreased="" fetal="" body="" weights="" and="" frank="" malformations="" in="" two="" fetuses="" (missing="" tail,="" agnatha,="" microtomia="" and="" anophthalmia)="" were="" observed.="" in="" a="" dermal="" developmental="" toxicity="" study="" in="" rats,="" no="" toxicologically="" significant="" maternal="" toxicity="" or="" developmental="" toxicity="" was="" observed="" at="" the="" limit="" dose="" of="" 1,000="" mg/kg/day.="" in="" an="" oral="" developmental="" toxicity="" study="" in="" rabbits,="" the="" maternal="" noael="" was="" 30="" mg/kg/day="" and="" the="" loael="" was="" 100="" mg/kg/day,="" based="" on="" decreased="" body="" weight="" gain="" and="" decreased="" food="" consumption="" during="" the="" dosing="" period.="" the="" developmental="" toxicity="" noael="" was="" 30="" mg/kg/day="" and="" the="" loael="" was="" 100="" mg/kg/day,="" based="" on="" increased="" postimplantation="" loss,="" increased="" frank="" malformations,="" hydrocephalus="" and="" delayed="" ossification="" of="" bones.="" in="" another="" oral="" developmental="" toxicity="" study="" in="" rabbits,="" the="" maternal="" noael="" was=""><10 [[page="" 28382]]="" mg/kg/day="" and="" the="" loael="" was="" 10="" mg/kg/day,="" based="" on="" increased="" incidences="" of="" single="" cell="" necrosis="" (minimal="" severity)="" in="" liver="" cells.="" the="" maternal="" noael="" from="" this="" study="" was="" not="" used="" to="" determine="" the="" acute="" rfd="" because="" single="" cell="" necrosis="" was="" not="" considered="" to="" result="" from="" a="" single="" exposure.="" the="" developmental="" toxicity="" noael="" was="" 30="" mg/kg/day="" and="" the="" loael="" was="" 100="" mg/kg/day,="" based="" on="" increased="" postimplantation="" loss,="" decreased="" fetal="" body="" weights,="" increased="" percentage="" of="" fetuses="" with="" abnormalities="" (including="" runts,="" hemidiaphragm,="" limb="" abnormalities="" and="" neural="" tube="" defects="" characterized="" as="" meningocoele="" and="" spina="" bifida)="" and="" delayed="" ossification="" of="" bones.="" iii.="" reproductive="" toxicity="" study.="" in="" a="" 2-generation="" reproduction="" study="" in="" rats,="" the="" parental="" (systemic)="" toxicity="" noael="" was="" 15="" mg/kg/day="" and="" the="" loael="" was="" 50="" mg/kg/day,="" based="" on="" loss="" of="" hair,="" decreased="" body="" weights,="" decreased="" food="" consumption,="" increased="" severity="" of="" spleen="" hemosiderosis="" and="" decreased="" liver="" and="" kidney="" weights.="" for="" offspring="" toxicity,="" the="" noael="" was="" 15="" mg/kg/day="" and="" the="" loael="" was="" 50="" mg/kg/day,="" based="" on="" decreased="" pup="" body="" weights="" from="" birth="" through="" weeks="" 3-4="" in="" all="" litter="" groups.="" iv.="" pre-and="" postnatal="" sensitivity.="" the="" above="" studies="" meet="" the="" standard="" toxicology="" data="" requirements,="" as="" required="" for="" a="" food-use="" chemical,="" in="" 40="" cfr="" part="" 158.="" however,="" after="" evaluation="" of="" the="" findings="" in="" these="" studies,="" particularly="" with="" respect="" to="" effects="" on="" the="" fetal="" nervous="" system,="" together="" with="" a="" consideration="" of="" neurotoxic="" effects="" observed="" in="" several="" other="" developmental="" toxicity="" studies="" on="" structurally="" related="" triazole="" pesticides,="" the="" agency="" requested="" a="" postnatal="" developmental="" neurotoxicity="" study="" in="" rats="" (guideline="" 83-6)="" be="" conducted.="" the="" epa="" notes="" effects="" on="" the="" nervous="" system="" of="" fetuses="" in="" studies="" on="" tebuconazole="" occurred="" only="" at="" doses="" of="" 100="" mg/kg/day="" or="" higher--i.e.,="" at="" doses="" at="" least="" ten-fold="" higher="" than="" the="" developmental="" toxicity="" noael="" (10="" mg/kg/day)="" to="" be="" used="" for="" the="" assessment="" of="" acute="" dietary="" risk.="" on="" the="" basis="" of="" comparative="" noaels="" and="" loaels,="" it="" was="" determined="" there="" was="" no="" indication="" of="" increased="" susceptibility="" of="" the="" offspring="" of="" mice,="" rats="" or="" rabbits="" resulting="" from="" prenatal="" and/or="" postnatal="" exposure="" to="" tebuconazole.="" however,="" the="" maternal="" effects="" observed="" in="" the="" developmental="" toxicity="" studies="" at="" the="" loael="" were="" of="" minimal="" concern="" and="" did="" not="" increase="" substantially="" in="" severity="" at="" higher="" doses,="" whereas="" the="" developmental="" effects="" at="" the="" loael="" were="" pronounced="" and="" at="" higher="" doses="" were="" quite="" severe="" (including="" frank="" malformations)="" in="" mice="" (at="" 100="" mg/="" kg/day),="" rats="" (at="" 120="" mg/kg/day)="" and="" rabbits="" (at="" 100="" mg/kg/day).="" based="" on="" a="" consideration="" of="" all="" the="" above="" findings,="" the="" agency="" retained="" the="" 10x="" factor="" for="" enhanced="" susceptibility="" to="" infants="" and="" children.="" the="" 10x="" factor="" is="" applicable="" to="" acute="" dietary="" exposures="" for="" the="" subpopulations="" females="" (13+="" years),="" infants="" and="" children.="" the="" 10x="" factor="" for="" enhanced="" sensitivity="" of="" infants="" and="" children="" is="" not="" applicable="" to="" chronic="" exposure="" analysis.="" v.="" conclusion.="" there="" is="" a="" complete="" toxicity="" data="" base="" for="" tebuconazole="" and="" exposure="" data="" are="" complete="" or="" estimated="" based="" on="" data="" that="" reasonably="" accounts="" for="" potential="" exposures.="" 2.="" acute="" risk.="" an="" acute="" dietary="" (food="" only)="" probablistic="" risk="" analysis="" resulted="" in="" the="" following="" percentages="" for="" the="" acute="" rfd:="" nursing="" infants=""><1 year),="" 7%;="" non-nursing="" infants=""><1 year),="" 7%;="" children="" (1="" to="" 6="" years)="" 9%,="" children="" (7="" to="" 12="" years)="" 3%;="" and="" all="" infants=""><1 year),="" 7%.="" the="" maximum="" estimated="" concentrations="" of="" tebuconazole="" in="" surface="" and="" ground="" water="" do="" not="" exceed="" epa's="" levels="" of="" concern="" for="" acute="" exposure="" in="" drinking="" water="" for="" children.="" currently,="" the="" only="" residential="" end-use="" products="" on="" the="" market="" are="" for="" exterior="" treated="" wood="" use.="" exposure="" via="" incidental="" ingestion="" (by="" children)="" and="" inhalation="" are="" not="" a="" concern="" for="" these="" products="" which="" are="" used="" outdoors.="" no="" paints="" or="" other="" end-use="" products="" containing="" tebuconazole="" are="" available="" for="" interior="" use.="" accordingly="" residential="" exposure="" is="" not="" expected="" with="" these="" uses.="" therefore,="" epa="" concludes="" with="" reasonable="" certainty="" that="" residues="" of="" tebuconazole="" do="" not="" contribute="" significantly="" to="" the="" aggregate="" acute="" risk="" at="" the="" present.="" 3.="" chronic="" risk.="" using="" the="" exposure="" assumptions="" described="" in="" this="" unit,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" tebuconazole="" from="" food="" will="" utilize="" up="" to="" 37%="" of="" the="" rfd="" for="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" as="" stated="" above,="" residential="" exposure="" to="" tebuconazole="" is="" not="" expected="" for="" the="" currently="" registered="" uses.="" estimated="" environmental="" concentrations="" of="" tebuconazole="" in="" surface="" water="" and="" ground="" water="" do="" not="" exceed="" chronic="" dwlocs="" calculated="" by="" the="" agency;="" therefore,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 4.="" short-="" or="" intermediate-term="" risk.="" as="" stated="" above,="" residential="" exposure="" to="" tebuconazole="" is="" not="" expected="" for="" the="" currently="" registered="" uses.="" 5.="" determination="" of="" safety.="" based="" on="" these="" risk="" assessments,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" tebuconazole="" residues.="" iv.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" residue="" in="" plants="" is="" understood="" based="" on="" metabolism="" studies="" in="" grapes,="" wheat="" and="" peanuts.="" for="" the="" purpose="" of="" this="" section="" 18="" only,="" the="" nature="" of="" the="" residue="" in="" garlic="" is="" considered="" to="" be="" adequately="" understood.="" the="" residue="" of="" concern="" in="" plants="" is="" tebuconazole="" per="" se.="" b.="" analytical="" enforcement="" methodology="" method="" 101341,="" a="" gc/npd="" method,="" is="" adequate="" to="" enforce="" the="" tolerance="" expression.="" the="" method="" may="" be="" requested="" from:="" calvin="" furlow,="" prrib,="" irsd="" (7502c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location="" and="" telephone="" number:="" rm="" 101ff,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va,="" (703)="" 305-5229.="" c.="" magnitude="" of="" residues="" no="" residue="" data="" were="" provided="" for="" garlic.="" residue="" data="" were="" translated="" from="" dry="" bulb="" onion="" data="" generated="" in="" mexico.="" based="" on="" these="" data,="" residues="" of="" tebuconazole="" are="" not="" expected="" to="" exceed="" 0.1="" ppm="" on="" garlic="" as="" a="" result="" of="" the="" proposed="" section="" 18="" use.="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" maximum="" residue="" limits="" (mrls)="" for="" residues="" of="" tebuconazole="" in/on="" garlic.="" international="" harmonization="" is="" thus="" not="" an="" issue="" for="" this="" time-limited="" tolerance.="" e.="" rotational="" crop="" restrictions="" a="" plant="" back="" interval="" of="" 120="" days="" after="" last="" application="" for="" crops="" not="" listed="" on="" the="" label="" is="" required.="" v.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" residues="" of="" tebuconazole="" in="" garlic="" at="" 0.1="" ppm.="" vi.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" 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="" [[page="" 28383]]="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" july="" 26,="" 1999,="" 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="" under="" the="" ``addresses''="" section="" (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).="" epa="" is="" authorized="" to="" waive="" any="" fee="" requirement="" ``when="" in="" the="" judgement="" of="" the="" administrator="" such="" a="" waiver="" or="" refund="" is="" equitable="" and="" not="" contrary="" to="" the="" purpose="" of="" this="" subsection.''="" for="" additional="" information="" regarding="" tolerance="" objection="" fee="" waivers,="" contact="" james="" tompkins,="" 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:="" rm.="" 239,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va,="" (703)="" 305-5697,="">tompkins.jim@epa.gov. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
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.
VII. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300855] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov.
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit 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 record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408 of the
FFDCA. 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 tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(l)(6), such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of
[[Page 28384]]
regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 12, 1999.
James Jones,
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. 321(q), 346a and 371.
2. In Sec. 180.474, by alphabetically adding the following
commodity ``garlic'' to the table in paragraph (b) to read as follows:
Sec. 180.474 Tebuconazole; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts Expiration/
Commodity per Revocation
million Date
------------------------------------------------------------------------
* * * * *
Garlic............................................ 0.1 6/30/00
* * * * *
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[FR Doc. 99-12935 Filed 5-25-99; 8:45 am]
BILLING CODE 6560-50-F
