[Federal Register Volume 64, Number 164 (Wednesday, August 25, 1999)]
[Rules and Regulations]
[Pages 46292-46298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21832]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300905; FRL-6094-7]
RIN 2070-AB78
Pyridate; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
combined residues of pyridate (O-(6-chloro-3-phenyl-4-pyridazinyl)-S-
octyl-carbonothioate), the metabolite 6-chloro-3-phenyl-pyridazine-4-ol
and conjugates of 6-chloro-3-phenyl-pyridazine-4-ol in or on peppermint
tops (leaves and stems) and spearmint tops (leaves and stems). 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 peppermint and spearmint. This
regulation establishes a maximum permissible level for residues of
pyridate 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. The tolerances will expire and are revoked on
December 31, 2001.
DATES: This regulation is effective August 25, 1999. Objections and
requests for hearings must be received by EPA on or before October 25,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300905], 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-300905], 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 (CM #2),
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@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-300905].
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: Barbara Madden, 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. 284, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 305-6463,
Madden.Barbara@epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a,
[[Page 46293]]
is establishing tolerances for combined residues of the herbicide
pyridate (O-(6-chloro-3-phenyl-4-pyridazinyl)-S-octyl-carbonothioate,
the metabolite 6-chloro-3-phenyl-pyridazine-4-ol and conjugates of 6-
chloro-3-phenyl-pyridazine-4-ol, in or on peppermint tops (leaves and
stems) and spearmint tops (leaves and stems) at 0.3 part per million
(ppm). These tolerances will expire and are revoked on December 31,
2001. 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) (Public Law 104-170)
was signed into law August 3, 1996. FQPA amends both the 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. . . .''
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 Pyridate on Peppermint and Spearmint
and FFDCA Tolerances
Redroot pigweed and kochia have become serious pest concerns for
Idaho, Indiana, Montana, Oregon, Washington and Wisconsin mint growers.
The lack of any post-emergence chemical weed control have created an
emergency situation. Currently, terbacil is the only herbicide
registered for post-emergence weed control in mint, but resistance of
pigweed and kochia has been well documented. Not only will the presence
of these weeds result in mint yield losses but mint oil quality is
adversely effected as well. EPA has authorized under FIFRA section 18
the use of pyridate on peppermint and spearmint for control of redroot
pigweed and kochia in Idaho, Indiana, Montana, Oregon, Washington and
Wisconsin. After having reviewed the submission, EPA concurs that
emergency conditions exist for these States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of pyridate in or on
peppermint and spearmint. 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 these tolerances will expire and are revoked on
December 31, 2001, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on peppermint and spearmint 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 these tolerances earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether pyridate meets
EPA's registration requirements for use on peppermint and spearmint or
whether permanent tolerances for these uses would be appropriate. Under
these circumstances, EPA does not believe that these tolerances serve
as a basis for registration of pyridate 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 Idaho, Indiana, Montana, Oregon,
Washington and Wisconsin 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
pyridate, 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 pyridate
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for time-limited tolerances for combined residues of
pyridate (O-(6-chloro-3-phenyl-4-pyridazinyl)-S-octyl-carbonothioate),
the metabolite 6-chloro-3-phenyl-pyridazine-4-ol and conjugates of 6-
chloro-3-phenyl-
[[Page 46294]]
pyridazine-4-ol on peppermint and spearmint at 0.3 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 pyridate are
discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. An acute dietary reference dose (acute RfD) of
0.20 milligrams/kilograms/day (mg/kg/day) has been identified. The
acute RfD is derived from the systemic no observable adverse effects
level (NOAEL) of 20 mg/kg/day based on neurotoxic effects (ataxia and
emesis) seen at the lowest observable adverse effects level (LOAEL) of
60 mg/kg/day in the 90-day feeding study in dogs and an uncertainty
factor of 100 (10x for interspecies differences and 10x for
intraspecies variations). EPA has determined that the 10x factor to
account for enhanced susceptibility of infants and children, as
required by FFDCA section 408(b)(2)(C), can be removed. The acute
Population Adjusted Dose (aPAD) is a modification of the acute RfD to
accommodate the FQPA Safety Factor. The aPAD is equal to the acute RfD
divided by the FQPA Safety Factor. Therefore, since EPA has determined
that the 10x factor to account for enhanced susceptibility of infants
and children can be removed, the aPAD and acute RfD are the same (0.20
mg/kg/day).
2. Short- and intermediate-term toxicity. For short- and
intermediate-term dermal and inhalation exposures, the systemic NOAEL
of 20 mg/kg/day from the 90-day feeding study in dogs based on clinical
signs of neurotoxicity at the LOAEL of 60 mg/kg/day was identified as
the short- and intermediate-term endpoint to be used in risk
assessments. Since an oral dose was selected for dermal risk
assessments, the Agency has determined that a dermal penetration factor
of 20% is appropriate. The same oral dose (20 mg/kg/day) was also
selected for inhalation risk assessments. Therefore, for inhalation
exposure the following are appropriate: (i) Converting inhalation
exposure in mg/Liter (L) to mg/kg/day (route-to-route extrapolation
using 100% inhalation absorption); (ii) combining the converted
exposure with dermal exposure (using 20% dermal absorption) and (iii)
comparing the combined total to the appropriate oral NOAEL chosen for
the short- and intermediate-term exposure scenario (NOAEL = 20 mg/kg/
day).
3. Chronic toxicity. EPA has established the chronic RfD for
pyridate at 0.11 mg/kg/day. This chronic RfD is derived from a NOAEL of
10.8 mg/kg/day based on decreased body weight gain in males seen at
67.5 mg/kg/day (LOAEL) in a 2-year feeding study in rats and an
uncertainty factor of 100 (10x for interspecies differences and 10x for
intraspecies variations). EPA has determined that the 10x factor to
account for enhanced susceptibility of infants and children, as
required by FFDCA section 408(b)(2)(C), can be removed. The chronic
Population Adjusted Dose (cPAD) is a modification of the chronic RfD to
accommodate the FQPA Safety Factor. The cPAD is equal to the chronic
RfD divided by the FQPA Safety Factor. Therefore since the EPA has
determined that the 10x factor to account for enhanced susceptibility
of infants and children can be removed, the cPAD and chronic RfD are
the same (0.11 mg/kg/day).
For chronic dermal and inhalation exposures, the NOAEL of 10.8 mg/
kg/day from a 2-year feeding study in rats based on decreased body
weight gain at the LOAEL of 67.5 mg/kg/day, was identified as the
chronic endpoint to be used in dermal and inhalation risk assessments.
Since an oral dose was selected for dermal risk assessments, the Agency
has determined that a dermal penetration rate of 20% is appropriate.
The same oral dose (20 mg/kg/day) was also selected for chronic
inhalation risk assessments. Therefore, for inhalation exposure the
following are appropriate: (i) Converting inhalation exposure in mg/L
to mg/kg/day (route-to-route extrapolation using 100% inhalation
absorption); (ii) combining the converted exposure with dermal exposure
(using 20% dermal absorption); and (iii) comparing the combined total
to the appropriate oral NOAEL chosen for the chronic exposure scenario
(NOAEL = 10.8 mg/kg/day).
4. Carcinogenicity. Pyridate has not been designated a cancer
classification by the Agency to date. However, there is no evidence of
a tumorigenic response in the 2-year rat feeding study and the mouse
carcinogenicity study with pyridate.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.462) for the combined residues of pyridate (O-(6-chloro-3-
phenyl-4-pyridazinyl)-S-octyl-carbonothioate, the metabolite 6-chloro-
3-phenyl-pyridazine-4-ol and conjugates of 6-chloro-3-phenyl-
pyridazine-4-ol, in or on cabbage, corn, and peanuts. Risk assessments
were conducted by EPA to assess dietary exposures and risks from
pyridate as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. The Dietary Exposure Evaluation Model
(DEEM) analysis evaluated the individual food consumption as reported
by respondents in the USDA 1989-91 nationwide Continuing Surveys of
Food Intake by Individuals (CSFII) and accumulated exposure to the
chemical for each commodity. At the 95th percentile exposure level,
assuming 100 percent crop treated (PCT) and tolerance level residues
for all commodities, less than 1% of the aPAD was utilized for the U.S.
Population and children (1-6 years old), the subgroup with the highest
exposure. The results of this analysis indicate that the acute dietary
risk associated with existing uses and the proposed use of pyridate is
below the Agency's level of concern.
ii. Chronic exposure and risk. In conducting chronic dietary risk
assessments, the following conservative assumptions have been made: (a)
all of the crops having pyridate tolerances will contain pyridate
residues and (b) those residues will be at the level of the tolerance.
This results in an overestimation of human dietary exposure. Thus, in
making safety determinations for the peppermint and spearmint
tolerances, the Agency is taking into account these conservative
exposure assumptions. The combined pyridate tolerances (currently
published and the section 18 tolerances established by this action)
result in a Theoretical Maximum Residue Contribution (TMRC) that is
less than 1% of the RfD for the U.S. population and all population
subgroups, including non-nursing infants, the subgroup with the highest
exposure. The results of this analysis indicate that the chronic
dietary risk associated with existing uses and the proposed use of
pyridate is below the Agency's level of concern.
2. From drinking water. The Agency lacks sufficient water-related
exposure data to complete a comprehensive
[[Page 46295]]
drinking water exposure analysis and risk assessment for pyridate.
Because the Agency does not have comprehensive and reliable monitoring
data, drinking water concentration estimates must be made by reliance
on some sort of simulation or modeling. To date, there are no validated
modeling approaches for reliably predicting pesticide levels in
drinking water. The Agency is currently relying on Generic expected
environmental concentration (GENEEC) and EPA's Pesticide Root Zone
Model (PRZM3)/EXAMS for surface water, which are used to
produce estimates of pesticide concentrations in a farm pond and
Screening Concentration in ground water (SCI-GROW), which predicts
pesticide concentrations in ground water. None of these models include
consideration of the impact processing of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern. Based on the GENEEC and
SCI-GROW models, the acute drinking water concentration values are
estimated to be 97 parts per billion (ppb) for surface water and 4.4
ppb for ground water. The chronic drinking water concentration values
are estimated to be 25 ppb for surface water and 4.4 pbb for ground
water.
In the absence of monitoring data for pesticides, drinking water
levels of comparison (DWLOCs) are calculated and used as a point of
comparison against the model estimates of a pesticide's concentration
in water. DWLOCs are theoretical upper limits on a pesticide's
concentration in drinking water in light of total aggregate exposure to
a pesticide in food, drinking water, and residential uses. A DWLOC will
vary depending on the toxic endpoint, with drinking water consumption,
and body weights. Different populations will have different DWLOCs.
DWLOCs are used in the risk assessment process as a surrogate measure
of potential exposure associated with pesticide exposure through
drinking water. DWLOC values are not regulatory standards for drinking
water. Since DWLOCs address total aggregate exposure to pyridate they
are further discussed in the aggregate risk sections below.
3. From non-dietary exposure. Pyridate is not registered on any use
sites which would result in non-dietary, non-occupational exposure.
Therefore, EPA expects only dietary and occupational exposure from the
use of pyridate.
4. Cumulative exposure to substances with a 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 pyridate 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,
pyridate 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 pyridate 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).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. Using the exposure assumptions of 100 PCT and
tolerance level residues for all commodities, at the 95th percentile,
less than 1% of the aPAD was utilized for the U.S. Population. The
major identifiable subgroup with the highest aggregate exposure is
children, 1-6 years old (discussed below). EPA generally has no concern
for exposures below 100% of the aPAD. Despite the potential for
exposure to pyridate in drinking water, after calculating a DWLOC
(7,000 ppb) for the U.S. population and comparing it to conservative
model estimates of acute concentrations of pyridate in surface and
ground water (97 ppb and 4.4 pbb, respectively), EPA does not expect
the aggregate exposure to exceed 100% of the aPAD.
2. Chronic risk. Using the TMRC exposure assumptions described
above, EPA has concluded that aggregate exposure to pyridate from food
will utilize less than 1% of the cPAD for the U.S. population. The
major identifiable subgroup with the highest aggregate exposure is non-
nursing infants (discussed below). EPA generally has no concern for
exposures below 100% of the cPAD because the cPAD 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 pyridate in drinking water, after calculating a DWLOC
(3,800 ppb) for the U.S. population and comparing it to conservative
model estimates of concentrations of pyridate in surface and ground
water (25 ppb and 4.4 pbb, respectively), EPA does not expect the
aggregate exposure to exceed 100% of the cPAD.
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 other indoor and
outdoor non-occupational exposure. Since there are no non-dietary, non-
occupational exposures expected from the use of this chemical, no
short- and intermediate-term risk assessments were conducted.
4. Aggregate cancer risk for U.S. population. Pyridate has not been
designated a cancer classification by the Agency to date. However,
there is no evidence of a tumorigenic response in the 2-year rat
feeding study and the mouse carcinogenicity study with pyridate.
Therefore, no aggregate cancer risk assessments were conducted.
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 pyridate 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 pyridate, 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 prenatal and postnatal 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
[[Page 46296]]
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 interspecies and intraspecies 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 prenatal developmental
toxicity study in rats, the maternal NOAEL was 165 mg/kg/day and the
LOAEL was 400 mg/kg/day based on mortality, significant decreases in
mean body weight and food consumption as well as clinical signs
(ventral body position, dyspnea, sedation, and loss of reaction to
external stimuli). The developmental NOAEL was 165 mg/kg/day and the
developmental LOAEL was 400 mg/kg/day, based on increased incidences of
missing and/or unossified sternebrae and a dose-related decrease in
mean fetal body weight.
In a prenatal developmental toxicity study in rabbits, the maternal
NOAEL was 300 mg/kg/day and the LOAEL was 600 mg/kg/day, based on
decreased body weight and body weight gain, decreased food consumption,
increased incidence of dried feces, and increased abortions. For
developmental toxicity, the NOAEL was equal to or greater than 600 mg/
kg/day, the highest dose tested. A developmental LOAEL was not
established.
iii. Reproductive toxicity study. In a 3-generation reproduction
study in rats, the parental systemic NOAEL was 10.8 mg/kg/day and the
LOAEL was 67.5 mg/kg/day based on depression of maternal body weight
gain. The NOAEL for offspring was 10.8 mg/kg/day and the LOAEL was 67.5
mg/kg/day based on decreased pup weight gains (at postnatal day 14 and
21 in the first litters for both generations).
iv. Prenatal and postnatal sensitivity. The toxicological data base
for evaluating prenatal and postnatal toxicity for pyridate is complete
with respect to current data requirements. There are no prenatal or
postnatal toxicity concerns for infants and children, based on the
results of the rat and rabbit developmental toxicity studies and the 2-
generation rat reproductive toxicity study.
v. Conclusion. There is a complete toxicity database for pyridate
and exposure data are complete or are estimated base on data that
reasonably accounts for potential exposures.The Agency concludes that
reliable data support use of a 100-fold margin of exposure/uncertainty
factor, rather than the standard 1,000-fold margin/factor, to protect
infants and children. Therefore, the 10x factor to account for enhanced
susceptibility of infants and children, as required by FFDCA section
408(b)(2)(C), can be removed.
2. Acute risk. Using the exposure assumptions of 100 PCT and
tolerance level residues for all commodities, at the 95th percentile,
less than 1% of the aPAD was utilized for children 1-6 years old, the
subgroup with the highest aggregate exposure. EPA generally has no
concern for exposures below 100% of the aPAD. Despite the potential for
exposure to pyridate in drinking water, after calculating a DWLOC
(2,000 ppb) children 1-6 years old and comparing it to conservative
model estimates of acute concentrations of pyridate in surface and
ground water (97 ppb and 4.4 pbb, respectively), EPA does not expect
the aggregate exposure to exceed 100% of the aPAD.
3. Chronic risk. Using the TMRC exposure assumptions described
above, EPA has concluded that aggregate exposure to pyridate from food
will utilize less than 1% of the cPAD for infants and children. EPA
generally has no concern for exposures below 100% of the cPAD because
the cPAD 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 pyridate in drinking
water, after calculating a DWLOC (1,100 ppb) for non-nursing infants,
the subgroup with the highest aggregate exposure and comparing it to
conservative model estimates of concentrations of pyridate in surface
and ground water (25 ppb and 4.4 pbb, respectively), EPA does not
expect the aggregate exposure to exceed 100% of the cPAD.
4. Short- or intermediate-term risk. There are no non-dietary, non-
occupational exposures expected from the use of pyridate therefore, no
short- and intermediate-term risk assessments were conducted.
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 pyridate residues.
IV. Other Considerations
A. Metabolism in Plants and Animals
The nature of the pyridate residue in plants and ruminants is
adequately understood. The total toxic residue consists of pyridate (O-
(6-chloro-3-phenyl-4-pyridazinyl)-S-octyl-carbonothioate), its
metabolite 6-chloro-3-phenyl-pyridazine-4-ol, and conjugates of that
metabolite, all expressed as pyridate.
B. Analytical Enforcement Methodology
A total residue method using ultraviolet detection/high pressure
liquid chromatography (UV/HPLC) is available for residue data gathering
and enforcement purposes. The method has been adequately validated by
recovery data, has passed a successful method trial, and has been
forwarded to FDA for publication in PAM-II. The limit of quantitation
is 0.03 ppm. 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, CM #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5229.
C. Magnitude of Residues
Residues of pyridate, its metabolite 6-chloro-3-phenyl-pyridazine-
4-ol and conjugates of that metabolite all expressed as pyridate are
not expected to exceed 0.3 ppm in/on peppermint, tops (leaves and
stems) and spearmint, tops (leaves and stems). Secondary residues are
not expected in animal commodities as no feed items are associated with
this section 18 use.
D. International Residue Limits
There are no CODEX, Mexican, or Canadian MRLs established for
pyridate in/on mint. Therefore, no compatibility problems exist for the
proposed tolerances.
E. Rotational Crop Restrictions
A confined accumulation in rotational crops study with pyridate has
previously been reviewed. Pyridate residues metabolize rapidly in soil.
No crop rotation label restrictions are needed.
V. Conclusion
Therefore, the tolerance is established for combined residues of
pyridate (O-(6-chloro-3-phenyl-4-pyridazinyl)-S-octyl-carbonothioate),
the metabolite 6-chloro-3-phenyl-pyridazine-4-ol and conjugates of 6-
chloro-3-phenyl-pyridazine-4-ol in or on peppermint
[[Page 46297]]
tops (leaves and stems) and spearmint tops (leaves and stems) at 0.3
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 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 October 25, 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, CM #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-300905] (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 Rm. 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, CM #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) (Public Law 104-4). Nor does it require any 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
[[Page 46298]]
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 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: August 11, 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. 180.462, by adding paragraph (b) to read as follows:
Sec. 180.462 Pyridate; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. A time-limited tolerance is
established for the residue of the herbicide pyridate in connection
with use of the pesticide under section 18 emergency exemptions granted
by EPA. This tolerance will expire and is revoked on the date specified
in the following table:
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Peppermint, tops (leaves and 0.3 ppm 12/31/01
stems).
Spearmint, tops (leaves and 0.3 ppm 12/31/01
stems).
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-21832 Filed 8-24-99; 8:45 am]
BILLING CODE 6560-50-F
