PMEP Home Page --> Pesticide Active Ingredient Information --> Insecticides and Miticides --> fenitrothion (Sumithion) to methyl parathion --> hexythiazox (Savey) --> hexythiazox (Savey) Pesticide Tolerance for Emergency Exemption 10/98

hexythiazox (Savey) Pesticide Tolerance for Emergency Exemption 10/98

[Federal Register: October 13, 1998 (Volume 63, Number 197)]
[Rules and Regulations]
[Page 54594-54599]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13oc98-16]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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<SUP>*</SUP> approach. The Q1<SUP>*</SUP> was 
calculated to be 2.2 x 10<SUP>-2</SUP> 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
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 old)     0.000228            <1%
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 Q1<SUP>*</SUP> of 0.0222 (mg/kg/
day)<SUP>-1</SUP> and the partially refined exposure estimates 
described above, the cancer risk estimate for the U.S. population is 
5.5x10<SUP>-7</SUP>. 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 <greek-m>g/L (0.28 
ppb). The groundwater screening concentration is 0.00147 <greek-m>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<SUP>-7</SUP> 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 <greek-m>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).
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 <greek-m>g/L. Drinking water numbers 
are based on GENEEC and SCIGROW modeling. For surface water, the 
chronic (average 56 day) value is 0.28 <greek-m>g/L (0.28 ppb). The 
groundwater screening concentration is 0.00147 <greek-m>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-<SUP>7</SUP> 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 <greek-m>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 <greek-m>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.
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 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
To Top
To Top

For more information relative to pesticides and their use, please contact the PMEP staff at: 5123 Comstock Hall
Cornell University
Ithaca, New York 14853-0901
(607)-255-1866
Last Modified: 02/17/1999
Questions regarding the development of this web site should be directed to the PMEP Webmaster.

Disclaimer: Please read the pesticide label prior to use. The information contained at this web site is not a substitute for a pesticide label. Trade names used herein are for convenience only. No endorsement of products is intended, nor is criticism of unnamed products implied.