[Federal Register Volume 63, Number 192 (Monday, October 5, 1998)]
[Rules and Regulations]
[Pages 53294-53301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26617]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300725; FRL-6031-5]
RIN 2070-AB78
Pyridaben; 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 pyridaben and its metabolites PB-7 (2-tert-butyl-
5-[4-(1-carboxy-1-methylethyl) benzylthio]-4-chloropyridazin-3 (2H)-
one) and PB-9 (2-tert-butyl-4-chloro-5-[4-(1,1-dimethyl-2-hydroxyethyl)
benzylthio]-chloropyridazin-3 (2H)-one) in or on cranberries. 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 cranberries. This regulation
establishes a maximum permissible level for residues of pyridaben in
this food commodity pursuant to section 408(l)(6) of the Federal Food,
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act
of 1996. The tolerance will expire and is revoked on December 31, 1999.
DATES: This regulation is effective October 5, 1998. Objections and
requests for hearings must be received by EPA on or before December 4,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300725], 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-300725], 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: [email protected]. 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
[[Page 53295]]
of objections and hearing requests in electronic form must be
identified by the docket control number [OPP-300725]. 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:
[email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408(e) and (l)(6) of the FFDCA, 21 U.S.C. 346a(e) and (l)(6),
is establishing a tolerance for combined residues of the insecticide
pyridaben and its metabolites PB-7 (2-tert-butyl-5-[4-(1-carboxy-1-
methylethyl) benzylthio]-4-chloropyridazin-3 (2H)-one) and PB-9 (2-
tert-butyl-4-chloro-5-[4-(1,1-dimethyl-2-hydroxyethyl) benzylthio]-
chloropyridazin-3 (2H)-one), in or on cranberries at 0.75 part per
million (ppm). This tolerance will expire and is revoked on December
31, 1999. 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 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 Pyridaben on Cranberries and FFDCA
Tolerances
The southern red mite is a sporadic but serious pest of cranberries
in Massachusetts. Until 1996, propargite (Omite) was commonly used to
control this pest. However, in 1996 propargite was voluntarily
cancelled by the product's registrant, leaving no product registered
for control of the mite species. After having reviewed the submission,
EPA concurs that emergency conditions exist for this state. EPA has
authorized under FIFRA section 18 the use of pyridaben on cranberries
for control of Southern Red Mites in Massachusetts.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of pyridaben in or on
cranberries. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment under section 408(e), as provided in section 408(l)(6).
Although this tolerance will expire and is revoked on December 31,
1999, under FFDCA section 408(l)(5), residues of the pesticide not in
excess of the amounts specified in the tolerance remaining in or on
cranberries after that date will not be unlawful, provided the
pesticide is applied in a manner that was lawful under FIFRA, and the
residues do not exceed a level that was authorized by this tolerance at
the time of that application. EPA will take action to revoke this
tolerance earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because this tolerance is being approved under emergency conditions
EPA has not made any decisions about whether pyridaben meets EPA's
registration requirements for use on cranberries or whether a permanent
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that this tolerance serves as a basis for
registration of pyridaben 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 Massachusetts to use this pesticide on this crop under
section 18 of FIFRA without following all provisions of EPA's
regulations implementing section 18 as identified in 40 CFR part 166.
For additional information regarding the emergency exemption for
pyridaben, 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
[[Page 53296]]
scientific data and other relevant information in support of this
action EPA has sufficient data to assess the hazards of pyridaben and
to make a determination on aggregate exposure, consistent with section
408(b)(2), for a time-limited tolerance for combined residues of
pyridaben and its metabolites PB-7 and PB-9 on cranberries at 0.75 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 pyridaben are
discussed below.
1. Acute toxicity-- i. Subpopulation females 13+ years old. NOAEL =
13 mg/kg. In a developmental toxicity study, Sprague-Dawley rats (22/
group) from Charles River, U.K., received NC-129 (Pyridaben, 98.0%
active ingredient (a.i.)) via gavage at dose levels of 0, 2.5, 5.7,
13.0, or 30.0 milligrams/kilogram/day (mg/kg/day) from gestation day 6
through 15, inclusive. Natural mating was used. Maternal toxicity,
observed at 13.0 and 30.0 mg/kg/day, consisted of decreased body
weight/weight gain and food consumption during the dosing period. Based
on these effects, the Maternal Toxicity LOEL is 13.0 mg/kg/day and the
Maternal Toxicity NOAEL is 4.7 mg/kg/day (82% of 5.7 mg/kg/day based on
concentration analysis). Developmental toxicity NOAEL is 13.0 mg/kg/day
based on observed decreased fetal body weight and increased incomplete
ossification in selected bones at 30.0 mg/kg/day (LOEL). With the 100
uncertainty factor (UF) (10X for inter-species extrapolation and 10X
for intra-species variability) the acute Reference dose (RfD) for
females 13+ is 0.13 mg/kg/day.
ii. General population including infants and children. NOAEL = 50
mg/kg. In an acute neurotoxicity study, CD Rats (10/sex/group) were
administered a single oral dose (gavage) of NC-129 in 1% aqueous
carboxymethyl cellulose of 0 (vehicle), 50, 100, and 200 mg/kg (a.i.
equivalents: 44.3, 79.6, and 190.0 mg/kg for males and 44.5, 99.7, and
190.0 mg/kg body weight for females). The animals were observed for
mortality and clinical signs of toxicity for 14 days post-dosing.
During the first 5 days, compound-related decreases in body weight gain
were noted in mid-dose males (17%) and females (36%) and high-dose
males (74%); the high-dose females lost weight (4 g) during the first 4
days of the observation period. Food consumption was low in all treated
groups on the day of dosing with severe effect seen in the high-dose
males (73% lower than controls). Dose-dependent increases in clinical
signs (piloerection, hypoactivity, tremors, and partially closed eyes)
were seen in mid-dose males and high-dose males and females. These
effects were reversible by observation Day 4. Treatment-related
findings in the functional observational battery consisted of lower
body temperature and reduced motor activity ( 44%) among the
high-dose males. No treatment-related gross or microscopic
neuropathologic findings were present. The NOAEL for systemic toxicity
is 50 mg/kg for both sexes. The LOEL of 100 mg/kg/day is based on
systemic toxicity including clinical signs and decreased food
consumption and body weight gain. With the 100 UF (10X for inter-
species extrapolation and 10X for intra-species variability) the Acute
RfD for the general population is calculated to be 0.5 mg/kg/day.
2. Short-and intermediate-term toxicity. NOAEL = 100 mg/kg/day. In
a 21-day dermal toxicity study, repeated doses of pyridaben were
applied topically to approximately 10% of the body surface area of rats
at doses of 0, 30, 100, 300, or 1,000 mg/kg/day for 21 days. Increased
squamous cell hyperplasia and/or surface accumulation of desquamated
epithelial cells were noted sporadically in the 100, 300, and 1,000 mg/
kg/day dose groups. These findings appear to be due to abrasions of the
skin when the powdered substance was applied onto the skin, rather than
a dose-related effect. No gross dermal irritation effects were noted.
Based on the results of the study, the systemic dermal toxicity NOAEL
is 100 mg/kg/day. The systemic dermal toxicity LOEL is determined to be
300 mg/kg/day based on decreased body weight in the females. The dermal
irritation NOAEL is 100 mg/kg/day. (Note: In agreement, a dermal
equivalent dose of 94 mg/kg/day is derived if the maternal oral NOAEL
of 4.7 mg/kg/day (based on decreased body weight/weight gain and food
consumption) in the rat oral developmental toxicity study is adjusted
by the proposed 5% dermal absorption rate).
3. Chronic toxicity. EPA has established the RfD for pyridaben at
0.005 mg/kg/day. This RfD is based on a 1-year feeding study in dogs
with a NOAEL of 0.5 mg/kg/day and an uncertainty factor of 100 based on
decreased body weight, emesis, and ptyalism.
4. Carcinogenicity. Because pyridaben has been classified by EPA as
a Group E chemical-``no evidence of carcinogenicity to humans,'' no
additional analysis is necessary regarding carcinogenicity of this
chemical.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.494) for the combined residues of pyridaben and its metabolites
PB-7 (2-tert-butyl-5-[4-(1-carboxy-1-methylethyl)benzylthio]-4-
chloropyridazin-3(2H)-one) and PB-9 (2-tert-butyl-4-chloro-5-[4-(1,1-
dimethyl-2-hydroxyethyl) benzylthio]-chloropyridazin-3(2H)-one), in or
on a variety of raw agricultural commodities, ranging from 0.05 ppm on
almonds to 10 ppm in citrus oil. Tolerances have also been established
for the combined residues of pyridaben and its metabolites PB-7 and PB-
9 in or on animal commodities at levels ranging from 0.01 in milk to
0.05 ppm in cattle commodities. Risk assessments were conducted by EPA
to assess dietary exposures and risks from pyridaben 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. In conducting this acute dietary risk
assessment, HED has made very conservative assumptions--100% of the
necessary section 18 tolerance and all commodities having published
pyridaben tolerances will contain pyridaben regulable residues, those
residues will be at the level of the tolerance, and plant residues will
be adjusted using the ratio of organosoluble residues to pyridaben (see
``Metabolism in Plants'' section below)--all of which result in an
overestimation of human dietary exposure. Thus, in making a safety
determination for this tolerance, EPA is taking into account this
conservative exposure assessment.
From the acute dietary (food only) risk assessment, the calculated
exposure yields dietary (food only) percentage of the acute RfD for
females 13+ years old ranging from 29% for females 13+ years old--not
pregnant, non-nursing, to 42% for females 13+ years old--pregnant, not
nursing. The calculated exposure yields dietary (food only) percentage
of the acute RfD for the remainder of the population ranging from 9%
for males 13-19 years old to 77% for nursing
[[Page 53297]]
infants < 1 year old. This risk estimate should be viewed as highly
conservative; refinement using anticipated residue values and percent
crop-treated data in conjunction with a Monte Carlo analysis will
result in a lower acute dietary exposure estimate.
ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, EPA has made somewhat conservative assumptions--that
100% of cranberries will contain pyridaben residues and those residues
will be at the level of the tolerance plus the ratio of organosoluble
residues to pyridaben, and all commodities having published and pending
pyridaben tolerances will contain pyridaben regulable residues, those
residues will be at the anticipated residue level for the commodity, no
percent crop treated data were used, and plant anticipated residues
will be adjusted using the ratio of organosoluble residues to pyridaben
(see ``Metabolism in Plants'' section below)--all of which result in an
overestimation of human dietary exposure. Thus, in making a safety
determination for this tolerance, EPA is taking into account this
somewhat conservative exposure assessment. The existing pyridaben
tolerances (published, pending, and including the necessary section 18
tolerance) result in an Anticipated Residue Contribution (ARC) that is
equivalent to the following percentages of the RfD:
------------------------------------------------------------------------
Subpopulation ARCfood %RfD
------------------------------------------------------------------------
U.S. Population (48 States)...................... 0.001016 20
All Infants (< 1 year old)....................... 0.003404 68
Nursing infants (< 1 year old)................... 0.00133
5 27
Non-nursing infants (< 1 year old)............... 0.004275 86
Children (1-6 years old)......................... 0.003829 77
Children (7-12 years old)........................ 0.001651 33
Males (13-19 years old).......................... 0.000528 11
Females (13+ nursing)............................ 0.001525 31
U.S. Population (Autumn)......................... 0.001203 24
U.S. Population (Winter)......................... 0.001162 23
Northeast Region................................. 0.001148 23
Pacific Region................................... 0.001211 24
Western Region................................... 0.001162 23
Non-Hispanic Whites.............................. 0.001064 21
Non-Hispanic Others.............................. 0.001178 23
------------------------------------------------------------------------
The subgroups listed above are: (1) the U.S. population (48
states); (2) those for infants and children; (3) the other subgroups
for which the percentage of the RfD occupied is greater than that
occupied by the subgroup U.S. population (48 states); and, other
populations of special interest..
2. From drinking water. Based on information currently available to
EPA, pyridaben is immobile and thus unlikely to leach to groundwater.
There is no established Maximum Contaminant Level for residues of
pyridaben in drinking water. No health advisory levels for pyridaben in
drinking water have been established.
EPA uses the Generic expected enviromental concentration (GENEEC)
and SCI-GROW screening models to estimate surface and groundwater
concentrations for first-tier exposure assessments. As screening models
designed to estimate the concentrations found in surface and
groundwater for use in ecological risk assessment, they provide upper-
bound values on the concentrations that might be found in ecologically
sensitive environments because of the use of a pesticide.
The models predict that as much as 2.3 ppb and 0.0003 ppb of
pyridaben may be found in surface and groundwater, respectively. The
modeling data were compared to the results from modeling equations used
to calculate the acute and chronic drinking water level of concern
(DWLOC) for pyridaben in surface and ground water.
i. Acute exposure and risk. Acute drinking water levels of concern
have been calculated by EPA at the following amounts: U.S. Population->
14,000 g/L; Adult Male 20+ years old-- > 15,000 g/L;
Adult Female 13+, Pregnant, Not-nursing--> 2,200 g/L; Infant <
1, nursing-- > 1,100 g/L.
ii. Chronic exposure and risk. Chronic Drinking Water Level of
Concern have been calculated by EPA at the following amounts: U.S.
Population--140 g/L; Adult Male, 13-19 years old--160
g/L; Adult Female 13+, Nursing--100 g/L; Infant <1,
non-nursing--7 g/L.
3. From non-dietary exposure. Pyridaben is currently not registered
for use on residential non-food sites.
4. Cumulative exposure to substances with common mechanism of
toxicity. Pyridaben is structurally similar to members of the
pyridazinone class of herbicides (i.e., pyrazon and norflurazon).
Section 408(b)(2)(D)(v) of the FQPA 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 pyridaben 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,
pyridaben 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 pyridaben has a common mechanism of toxicity
with other substances. For more information regarding EPA's efforts to
determine which chemicals have a common
[[Page 53298]]
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. Acute risk. Using the published and pending tolerances, the
dietary (food only) percentage of the acute RfD range from 9% for males
13-19 years old to 77% for nursing infants < 1 year old, with the U.S.
population at 18%. This risk estimate should be viewed as highly
conservative; refinement using additional anticipated residue values
and percent crop-treated data in conjunction with Monte Carlo analysis
will result in a lower acute dietary exposure estimate. The acute
dietary exposure does not exceed EPA's level of concern.
Pyridaben is immobile and thus unlikely to leach to groundwater.
The modeling data for pyridaben in drinking water indicate levels less
than EPA's DWLOC for acute exposure. Since a refined acute risk for
food only would not exceed EPA's levels of concern for acute dietary
exposures and the monitoring and modeling levels in water are less than
the acute DWLOC, EPA does not expect aggregate acute exposure to
pyridaben will pose an unacceptable risk to human health.
2. Chronic risk. Using the somewhat conservative ARC exposure
assumptions described in Unit III.B. of this preamble, EPA has
concluded that aggregate exposure to pyridaben from food will utilize
20% 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. The
residues of pyridaben in drinking water do not exceed EPA's DWLOC.
Pyridaben does not have any residential uses. EPA does not expect the
aggregate exposure to exceed 100% of the RfD.
3. Short-and intermediate-term risk. Short-and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential uses. Since there are no residential uses, a short-or
intermediate-term aggregate risk assessment is not required.
4. Aggregate cancer risk for U.S. population. Since pyridaben has
been classified as a Group E chemical-``no evidence of carcinogenicity
to humans,'' a cancer risk assessment is not required.
5. 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 three 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.
6. 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 pyridaben residues.
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 pyridaben, 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 pre-and post-natal
effects from exposure to pyridaben, 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-- a. Rats. In a developmental
toxicity study in rats, the maternal (systemic) NOAEL was 4.7 mg/kg/
day. The maternal LOEL of 13 mg/kg/day was based on decreases in body
weight, body weight gain, and food consumption during the dosing period
(GD 6-15). The developmental (fetal) NOAEL was 13 mg/kg/day. The
developmental LOEL of 30 mg/kg/day was based on decreased fetal body
weight and increased incomplete ossification in selected bones.
b. Rabbits. In an oral developmental toxicity study in rabbits, the
maternal (systemic) NOAEL was not established. The maternal LOEL of <
1.5 mg/kg/day was based on decreases in body weight gain and food
consumption. There was no developmental toxicity observed at any dose
tested. Therefore, the developmental (fetal) NOAEL is > 15 mg/kg/day at
the highest dose tested.
iii. Reproductive toxicity study--Rats. In the 2-generation
reproductive toxicity study in rats, the parental (systemic) NOAEL was
2.3 mg/kg/day. The parental(systemic) LOEL of 7 mg/kg/day was based on
decreased body weight, decreased body weight gains, and decreased food
efficiency. The reproductive (pup) NOAEL was > 7 mg/kg/day and the LOEL
was > 7 mg/kg/day at the highest dose tested.
iv. Pre-and post-natal sensitivity. The toxicological data base for
evaluating pre-and post-natal toxicity for pyridaben is complete with
respect to current data requirements. There are no pre-or post-natal
toxicity concerns for infants and children, based on the results of the
rat and rabbit developmental toxicity studies as well as the 2-
generation rat reproductive toxicity study. Based on the above, EPA has
concluded that reliable data support removing the 10X safety factor for
protection of infants and children.
v. Conclusion. There is a complete toxicity data base for pyridaben
and exposure data is complete or is estimated based on data that
reasonably accounts for potential exposures.
2. Acute risk. Using the somewhat conservative exposure assumptions
described above, the percentage of the acute RfD that will be utilized
by dietary (food) exposure to residues of pyridaben for infants and
children range from 16% for children 7-12 years old to 77% for nursing
infants < 1 year old. The acute
[[Page 53299]]
DWLOC does not exceed EPA's level of concern.
Taking into account the completeness and reliability of the
toxicity data and this conservative exposure assessment, EPA concludes
that there is a reasonable certainty that no harm will result to
infants and children from acute aggregate exposure to pyridaben
residues.
3. Chronic risk. Using the somewhat conservative exposure
assumptions described above, EPA has calculated that the percentage of
the RfD that will be utilized by dietary (food) exposure to residues of
pyridaben ranges from 27 percent for nursing infants less than 1 year
old, up to 85 percent for non-nursing infants less than 1 year old. The
chronic DWLOC does not exceed HED's level of concern. There are no
residential uses for pyridaben.
Taking into account the completeness and reliability of the
toxicity data and this conservative exposure assessment, HED concludes
that there is a reasonable certainty that no harm will result to
infants and children from chronic aggregate exposure to pyridaben
residues.
4. Short-or intermediate-term risk. Short-and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential uses. Since the chronic food and chronic DWLOC do not
exceed HED's level of concern and there are currently no indoor or
outdoor residential uses of pyridaben, the short-and intermediate-term
aggregate risk does not exceed EPA's level of concern.
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 pyridaben residues.
IV. Other Considerations
A. Metabolism in Plants and Animals
1. Metabolism in plants. The nature of the residue in plants is
adequately understood. The residue of concern is pyridaben per se as
specified in 40 CFR 180.494.
EPA has determined that the tolerance expression for plant
commodities will include residues of pyridaben per se. EPA has also
concluded that all organosoluble residues may be presumed to be of
comparable toxicity to the parent. Thus, the risk assessment for human
dietary consumption of pyridaben treated plant commodities will include
all organosoluble residues. EPA has calculated a value of 2.3 for the
ratio of organosoluble residues to pyridaben (O/P Ratio) based upon the
low dose pyridaben apple and orange metabolism studies. For dietary
risk evaluation (DRES) analyses, tolerance levels of pyridaben in/on
plant commodities will be multiplied by the ratio of organosoluble
residues to pyridaben (2.3). The use of anticipated residues for
pyridaben DRES analysis has been previously conducted.
2. Metabolism in animals. The nature of the residue in animals is
adequately understood. The residue of concern is pyridaben and its
metabolites PB-7 (2-tert-butyl-5-[4-(1-carboxy-1-
methylethyl)benzylthio]-4-chloropyridazin-3(2H)-one) and PB-9 (2-tert-
butyl-4-chloro-5-[4-(1,1-dimethyl-2-hydroxyethyl) benzylthio]-
chloropyridazin-3(2H)-one) as specified in 40 CFR 180.494.
For livestock commodities, EPA determined that the tolerance
expression for ruminant commodities will include pyridaben and its
metabolites PB-7 and PB-9. As all organosoluble residues are presumed
to be of comparable toxicity to the parent, the risk assessment for
human dietary consumption of commodities from livestock exposed to
pyridaben will include all organosoluble residues. As tolerance levels
for meat and milk are based upon a ruminant feeding study in which the
dose levels were exaggerated by a factor of approximately seven, it is
not necessary to further adjust the levels to be utilized in the
dietary exposure analysis.
B. Analytical Enforcement Methodology
For the purpose of the associated section 18 exemption only, the
BASF gas chromatography/electron capture (GC/EC) Method D9312 is
adequate for enforcement purposes. Adequate enforcement methodology
(example-gas chromotography) is available to enforce the tolerance
expression. The method may be requested from: Calvin Furlow, PRRIB,
IRSD (7502C), Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location and
telephone number: Rm 101FF, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA 22202, (703-305-5229).
C. Magnitude of Residues
The cranberry data supplied with the submission is minimal (a three
line summary table). The table listed an average residue of 0.28 ppm
and a maximum residue of 0.39 ppm. EPA has translated existing field
trial residue data for grapes (maximum residue = 0.68 ppm) to establish
the cranberry tolerance. Residues of pyridaben and its regulated
metabolites are not expected to exceed 0.75 ppm in/on cranberries as a
result of this section 18 use.
Applying the o/p ratio described in Unit IV.A.1 of this preamble to
the anticipated residue for pyridaben on cranberries yields 0.64 (0.28
ppm x 2.3). Since this level is lower than the proposed tolerance,
and the cranberry residue data are minimal, for this section 18, the
tolerance level has been used for the chronic and acute dietary risk
analyses. 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, Canadian, or Mexican Maximum Residue Limits
(MRL) established for pyridaben on cranberries.
E. Rotational Crop Restrictions
Since cranberries are not rotated to other crops, a discussion of
rotational crop residues is not germane to this action.
V. Conclusion
Therefore, the tolerance is established for combined residues of
pyridaben and its metabolites PB-7 (2-tert-butyl-5-[4- (1-carboxy-1-
methylethyl) benzylthio]-4-chloropyridazin-3 (2H)-one) and PB-9 (2-
tert-butyl-4-chloro-5-[4- (1,1-dimethyl-2-hydroxyethyl) benzylthio]-
chloropyridazin-3(2H)-one) in cranberries at 0.75 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 4, 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
[[Page 53300]]
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-300725] (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:
[email protected].
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
[[Page 53301]]
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: September 24, 1998.
Arnold E. Layne,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-- [AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.494, by revising paragraph (b) to read as follows:
Sec. 180.494 Pyridaben; tolerance for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the combined residues of pyridaben and its metabolites
PB-7 (2-tert-butyl-5-[4- (1-carboxy-1-methylethyl) benzylthio]-4-
chloropyridazin-3 (2H)-one) and PB-9 (2-tert-butyl-4-chloro-5-[4- (1,1-
dimethyl-2-hydroxyethyl) benzylthio]-chloropyridazin-3 (2H)-one) in
connection with use of the pesticide under section 18 emergency
exemptions granted by EPA. The tolerance is specified in the following
table:
------------------------------------------------------------------------
Parts Expiration/
Commodity per Revocation
million Date
------------------------------------------------------------------------
Cranberries....................................... 0.75 12/31/99
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-26617 Filed 10-2-98; 8:45 am]
BILLING CODE 6560-50-F