[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