[Federal Register Volume 63, Number 197 (Tuesday, October 13, 1998)]
[Rules and Regulations]
[Pages 54594-54599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27397]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300720; FRL-6030-3]
RIN 2070-AB78
Hexythiazox; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of hexythiazox (trans-5-(4-chlorophenyl)-N-
cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide) and its metabolite
containing (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety in or
on dates, hops, and strawberries. This action is in response to EPA's
granting of emergency exemptions under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act authorizing use of the
pesticide on dates and strawberries in California, and on hops in
Idaho, Oregon and Washington. This regulation establishes a maximum
permissible level for residues of hexythiazox in these food commodities
pursuant to section 408(l)(6) of the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996. These
tolerances will expire and be revoked on September 15, 2000.
DATES: This regulation is effective October 13, 1998. Objections and
requests for hearings must be received by EPA on or before December 14,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300720], 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-300720], 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@epamail.epa.gov.
Copies of objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption. Copies of objections and hearing requests will also be
accepted on disks in WordPerfect 5.1/6.1 file format or ASCII file
format. All copies of objections and hearing requests in electronic
form must be identified by the docket control number [OPP-300720]. 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: David Deegan, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 308-9358, e-mail:
deegan.dave@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for
combined residues of the insecticide hexythiazox in or on hops at 2.0
ppm, dates at 0.1 ppm, strawberries at 3.0 parts per million (ppm).
These tolerances will expire and be revoked on September 15, 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 Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such 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 Hexythiazox on Dates, Hops, and
Strawberries and FFDCA Tolerances
The state of California has petitioned EPA to allow the emergency
use of hexythiazox on both strawberries and
[[Page 54595]]
dates, to control various mite species. The states of Idaho, Oregon,
and Washington petitioned EPA to allow the emergency use of hexythiazox
on hops to control mites. EPA reviewed these requests, and concluded
that emergency conditions either did exist, or were likely to occur, in
each state for their subject requests. Therefore, EPA has authorized
under FIFRA section 18 the use of hexythiazox on dates, hops, and
strawberries for control of mites in California, Idaho, Oregon and
Washington.
As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of hexythiazox in or
on dates, hops, and strawberries. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerances under FFDCA section 408(l)(6) would be consistent
with the safety standard and with FIFRA section 18. Consistent with the
need to move quickly on the emergency exemptions in order to address
urgent non-routine situations, and to ensure that the resulting food is
safe and lawful, EPA is issuing these tolerances without notice and
opportunity for public comment under section 408(e), as provided in
section 408(l)(6). Although these tolerances will expire and be revoked
on September 15, 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 dates, hops, and strawberries 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 these tolerances are being approved under emergency
conditions EPA has not made any decisions about whether hexythiazox
meets EPA's registration requirements for use on dates, hops, and
strawberries or whether a permanent tolerance for this use would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of hexythiazox 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,
Idaho, Oregon, and Washington to use this pesticide on these crops
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
hexythiazox, contact the Agency's Registration Division at the address
provided above.
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
these actions. EPA has sufficient data to assess the hazards of
hexythiazox and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
combined residues of hexythiazox (trans-5-(4-chlorophenyl)-N-
cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide) and its metabolite
containing (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety on
hops at 2.0 ppm, dates at 0.1 ppm, and strawberries at 3.0 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 hexythiazox are
discussed below.
1. Acute toxicity. No appropriate endpoint attributable to a single
exposure (dose) was identified from oral toxicity studies including the
developmental rat and rabbit studies.
2. Short - and intermediate - term toxicity. For Margin of Exposure
(MOE) calculations, there are no dermal toxicity studies available. No
maternal or developmental toxicity was seen in rats (2,160 milligrams/
kilogram/day (mg/kg/day) or in rabbits (1,080 mg/kg/day). For
inhalation risk, there were no inhalation toxicity studies available.
Therefore, EPA has determined that this combined (dermal and
inhalation) risk assessment was not required. The default value of 100%
is being used for dermal penetration in the absence of data.
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for hexythiazox at 0.025 mg/kg/day. This RfD is based on a 1-year
feeding study in dogs with a no observed adverse effect level (NOAEL)
of 2.5 mg/kg/day and an uncertainty factor of 100. The lowest observe
effect level (LOEL) of 12.5 mg/kg/day was based on hypertrophy of the
adrenal cortex both sexes.
4. Carcinogenicity. Hexythiazox has been classified as a Group C
chemical (possible human carcinogen), based on an increased incidence
of female mouse liver tumors. For this chemical, EPA uses the
Q1* approach. The Q1* was calculated to be 2.2 x
10-2 mg/kg/day.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.448) for the combined residues of hexythiazox (trans-5-(4-
chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide)
and its metabolite containing (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety, in or on apples (0.02 ppm) and pears (0.30 ppm).
In addition, the following time-limited tolerances have been
established related to previous section 18 exemptions that were granted
in 1997: cottonseed, undelinted (0.1 ppm, exp. date 10/1/99), cotton
gin by-products (2.0 ppm, exp. date 10/1/99), and strawberries (3.0
ppm, exp. date 7/1/98) (63 FR 17099, April 8, 1998) (FRL-5779-2). Risk
assessments were conducted by EPA to assess dietary exposures and risks
from hexythiazox 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. Because no appropriate endpoint
attributable to a single exposure (dose) was identified from oral
toxicity studies, including the developmental rat and rabbit studies,
EPA has determined that there is a reasonable certainty of no harm
resulting from risk of acute exposure to hexythiazox.
ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, EPA has made conservative assumptions -- 100% of dates
and hops, and all other commodities having hexythiazox tolerances will
contain hexythiazox residues, and those residues will be at the level
of the tolerance -- which results in an overestimation of human dietary
[[Page 54596]]
exposure. This assessment assumes that all commodities are 100% crop
treated with the exception of pears, which are 4% crop treated. Thus,
in making a safety determination for this tolerance, EPA is taking into
account this partially refined exposure assessment.
The existing hexythiazox tolerances (published, pending, and
including the necessary section 18 tolerance(s)) result in an
Anticipated Residue Contribution (ARC) that is equivalent to the
following percentages of the RfD:
------------------------------------------------------------------------
Population Subgroup ARC (mg/kg/day) %RfD
------------------------------------------------------------------------
U.S. Population (48 States)..... 0.000129.......... <1% nursing="" infants=""><1 year="" old)...="" 0.000111..........=""><1% non-nursing="" infants=""><1 year="" 0.000228..........=""><1% old).="" children="" (1-6="" years="" old)........="" 0.000230..........=""><1% children="" (7-12="" years="" old).......="" 0.000161..........=""><1% ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" states);="" and="" (2)="" those="" for="" infants="" and="" children.="" no="" other="" population="" subgroups="" utilized="" a="" greater="" percentage="" of="" the="" rfd="" than="" did="" the="" u.s.="" population="" (48="" states).="" cancer="" risk.="" using="" a="">* of 0.0222 (mg/kg/
day)-1 and the partially refined exposure estimates
described above, the cancer risk estimate for the U.S. population is
5.5x10-7. The contribution of hexythiazox exposure resulting
from these section 18 uses has been amortized for 5 years for the
purposes of this section 18 only. In addition, exposure resulting from
section 18's currently in effect for cotton and strawberries has been
amortized for 6 years for the purposes of this section 18 only. (Note:
EPA assumes a duration of 5 years for new section 18's. For repeat
18's, the number of years that previous section 18's have been granted
is added to 5 years.) This cancer risk estimate is less than the
Agency's level of concern. It is normally not the Agency's policy to
amortize exposure data for risk calculations when establishing
tolerances. However, because tolerance level residues and percent crop
treated estimates were used for this action, the Agency believes that
the cancer risk is overestimated.
2. From drinking water. Based on information available to EPA,
hexythiazox is relatively persistent and not mobile. There are no
established Maximum Contaminant Levels for residues of hexythiazox in
drinking water. No health advisory levels for hexythiazox in drinking
water have been established.
Based on the chronic dietary (food) exposure estimates, chronic
drinking water levels of concern (DWLOC) for hexythiazox were
calculated. EPA has used drinking water exposure numbers based on
generic expected environmental concentration (GENEEC) and SCIGROW
modeling using the application rate of 0.187 lb a.i./A. For surface
water, the chronic (average 56 day) value is 0.28 g/L (0.28
ppb). The groundwater screening concentration is 0.00147 g/L
(1.47 ppt).
It is current EPA policy that the following subpopulations be
addressed when calculating DWLOC: U.S. Population (48 States), any
other adult populations whose %RfD is greater than that of the U.S.
population, Males (13+ years old), Females (13+ years old), and all
infants/children. In the dietary risk evaluation system (DRES) report
these last three subpopulations are further broken down into various
subgroups. The subgroups which are listed are those which have the
highest food exposure of all the subgroups in each subpopulation.
3. Cancer risk. The cancer risk estimate (food only) of 5.5 x
10-7 does not exceed EPA's level of concern. In EPA's best
scientific judgment, considering the conservative nature of the GENEEC
surface water number of 0.28 g/L, there is not expected to be
concern for residues of hexythiazox in drinking water if actual
monitoring data were available.
4. From non-dietary exposure. Hexythiazox is not currently
registered for use on any residential non-food sites.
5. Cumulative exposure to substances with common mechanism of
toxicity. Hexythiazox is a member of the thiazolidinone class of
pesticides. There are no other members of this class of pesticides.
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 hexythiazox 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,
hexythiazox 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 hexythiazox has a 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).
[[Page 54597]]
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Chronic risk. Using the ARC exposure assumptions described
above, EPA has concluded that aggregate exposure to hexythiazox from
food will utilize <1% of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" 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.="" despite="" the="" potential="" for="" exposure="" to="" hexythiazox="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" based="" on="" risk="" estimates="" for="" food,="" epa="" calculated="" a="" drinking="" water="" level="" of="" concern="" (dwloc)="" of="" 870="">g/L. Drinking water numbers
are based on GENEEC and SCIGROW modeling. For surface water, the
chronic (average 56 day) value is 0.28 g/L (0.28 ppb). The
groundwater screening concentration is 0.00147 g/L (1.47 ppt).
These values are substantially lower than the DWLOCs calculated by EPA.
There are no registered residential uses for hexythiazox. Therefore the
aggregate risk for food + water + residential use does not exceed EPA's
level of concern.
2. Aggregate cancer risk for U.S. population. The cancer risk
estimate (food only) of 5.5 x 10-7 does not exceed EPA's
level of concern. In addition, in EPA's best scientific judgment,
considering the conservative nature of the GENEEC surface water number
of 0.28 g/L, there is not expected to be concern for residues
of hexythiazox in drinking water if actual monitoring data were
available. Furthermore, the GENEEC surface water number is lower than
the 0.71 g/L DWLOC calculated for cancer.
3. 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 hexythiazox residues.
4. 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.
D. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children-- i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of hexythiazox, 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 database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a 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 a developmental toxicity
study, 24 pregnant rats received NA-73 in gum arabic by gavage at dose
levels of 0, 240, 720 or 2,160 mg/kg/day from GD 7-17. Maternal LOEL
was 720 mg/kg/day (increased ovarian wts.). The maternal NOAEL was 240
mg/kg/day. The developmental LOEL was 720 mg/kg/day (reduced
ossification). The developmental NOAEL was 240 mg/kg/day.
iii. In a developmental toxicity study in rabbits, pregnant NZW
rabbits (12-14/dose) received NA-73 at dose levels of 0, 120, 360 or
1,080 mg/kg/day from GD 6 to 18. No maternal or developmental toxicity
was noted at 1,080 mg/kg/day (NOAEL at the Limit dose).
iv. Reproductive toxicity study. In a reproductive toxicity study,
Fisher rats (20-30/dose group) were fed NA-73 in the diet at doses of
0, 60, 400 or 2,400 ppm (0, 5, 33 or 200 mg/kg/day) for 2-generations.
No reproductive toxicity was noted. The systemic LOEL was 2,400 ppm or
200 mg/kg/day (decreased body wt. gain, food consumption and food
efficiency as well as increased liver, kidney and ovarian wts.). No
histopathological changes were noted in the ovary. The reproductive
NOAEL was 400 ppm (35 mg/kg/day). The reproductive LOEL was 2,400 ppm
(decreased pup body weight during lactation, delay in hair growth and
eye opening).
v. Pre- and post-natal sensitivity. The pre- and post-natal
toxicology data base for hexythiazox is complete with respect to
current toxicological data requirements. The results of these studies
indicate that infants and children are not more sensitive to exposure,
based on the results of the rat and rabbit developmental toxicity
studies as well as the 2-generation reproductive toxicity study in
rats. Therefore, the 10X safety factor to account for increased
sensitivity of infants and children has been removed by EPA for this
chemical.
vi. Conclusion. There is a complete toxicity database for
hexythiazox and exposure data is complete or is estimated based on data
that reasonably accounts for potential exposures.
2. Chronic risk. Using the exposure assumptions described above,
EPA has concluded that aggregate exposure to hexythiazox from food will
utilize <1% of="" the="" rfd="" for="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" hexythiazox="" in="" drinking="" water="" and="" from="" non-="" dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 3.="" 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="" hexythiazox="" residues.="" [[page="" 54598]]="" iv.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" for="" the="" purpose="" of="" this="" section="" 18="" request,="" the="" nature="" of="" the="" residue="" in="" plants="" is="" adequately="" understood.="" the="" residue="" of="" concern="" is="" hexythiazox="" and="" its="" metabolites="" containing="" the="" (4-chlorophenyl)-4-="" methyl-2-oxo-3-thiazolidine="" moiety="" as="" specified="" in="" 40="" cfr="" 180.448.="" b.="" analytical="" enforcement="" methodology="" adequate="" methods="" to="" enforce="" the="" tolerance="" expression="" have="" been="" submitted="" for="" publication="" in="" pam="" ii.="" the="" approved="" method="" is="" designated="" as="" amr="" 985-87="" which="" has="" been="" used="" in="" a="" variety="" of="" commodities.="" the="" method="" involves="" separation="" by="" high="" performance="" liquid="" chromotography="" (hplc)="" followed="" by="" ultraviolet="" (uv)="" detection="" at="" 225="" nm.="" this="" method="" is="" available="" in="" pp="" 5f3254="" and="" by="" request="" from="" u.s.="" epa,="" opp/irsd/pirib="" (7502c),="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" c.="" magnitude="" of="" residues="" residues="" of="" hexythiazox="" and="" its="" regulated="" metabolites="" are="" not="" expected="" to="" exceed="" 0.1="" ppm="" in/on="" dates,="" 2.0="" ppm="" in/on="" hops,="" or="" 3.0="" ppm="" in/on="" strawberries="" as="" a="" result="" of="" this="" section="" 18="" use.="" secondary="" residues="" are="" not="" expected="" in="" animal="" commodities="" as="" no="" feed="" items="" are="" associated="" with="" these="" section="" 18="" uses.="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" maximum="" residue="" limits="" (mrl)="" for="" hexythiazox="" on="" either="" dates="" or="" hops.="" thus,="" harmonization="" is="" not="" an="" issue="" for="" this="" section="" 18.="" e.="" rotational="" crop="" restrictions="" dates="" and="" hops="" are="" not="" routinely="" rotated="" to="" other="" crops.="" nor="" are="" strawberries="" grown="" in="" southern="" california.="" therefore,="" rotational="" crop="" restrictions="" are="" not="" applicable.="" v.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" combined="" residues="" of="" hexythiazox="" (trans-5-(4-chlorophenyl)-n-cyclohexyl-4-methyl-2-="" oxothiazolidine-3-carboxamide)="" and="" its="" metabolite="" containing="" (4-="" chlorophenyl)-4-methyl-2-oxo-3-thiazolidine="" moiety="" in/on="" hops="" at="" 2.0="" ppm,="" dates="" at="" 0.1="" ppm,="" strawberries="" at="" 3.0="" 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="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" december="" 14,="" 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.="" vii.="" public="" record="" and="" electronic="" submissions="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300720]="" (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="" highway,="" arlington,="" va.="" electronic="" comments="" may="" be="" sent="" directly="" to="" epa="" at:="">opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under FFDCA section 408
(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in
[[Page 54599]]
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
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 has previously assessed whether
establishing tolerances, exemptions from tolerances, raising tolerance
levels or expanding exemptions might adversely impact small entities
and concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance acations published on May 4, 1981 (46 FR 24950), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
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 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 to 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 to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of 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: October 1, 1998.
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. 346a and 371.
2. Section 180.448 is amended by adding alphabetically to the table
in paragraph (b) entries for ``dates,'' and ``hops,'' and by revising
the entry for ``strawberries'' to read as follows:
Sec. 180.448 Hexythiazox; tolerances for residues
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
* * * * *
Dates........................... 0.1............... 9/15/00
Hops............................ 2.0............... 9/15/00
Strawberries.................... 3.0............... 9/15/00
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-27397 Filed 10-9-98; 8:45 am]
BILLING CODE 6560-50-F
