[Federal Register Volume 67, Number 168 (Thursday, August 29, 2002)]
[Rules and Regulations]
[Pages 55339-55347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21757]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0144; FRL-7195-1]
Fosetyl-Al; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of the
fungicide, fosetyl-Al aluminum tris (O-ethylphosphonate) in or on
bushberry subgroup, lingonberry, salal and juneberry at 40 parts per
million (ppm); turnip tops at 40 ppm; turnip roots at 15 ppm; succulent
pea at 0.3 ppm; and citrus fruit group at 5.0 ppm. The Interregional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996.
DATES: This regulation is effective August 29, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0144
must be received on or before October 28, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0144 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Sidney Jackson, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460;
telephone number: (703) 305-7610; e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0144. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity
[[Page 55340]]
Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis
Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of May 23, 2001 (66 FR 28479) (FRL-6780-2),
EPA issued a notice pursuant to section 408 of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food
Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing
the filing of pesticide petitions (PP 5E4434 and 0E6221) by IR-4,
Center for Minor Crop Management, Rutgers, The State University of New
Jersey, 681 U. S. Highway 1 South, North Brunswick, NJ 08902-
3390. This notice included a summary of the petition prepared by Rhone-
Poulenc Ag Company, Research Triangle Park, NC 27709, the registrant.
There were no comments received in response to the notice of filing.
The petition requested that 40 CFR 180.415 be amended by
establishing tolerances for residues of the fungicide fosetyl-Al,
aluminum tris (O-ethylphosphonate), in or on bushberry subgroup 13B,
lingonberry, salal and juneberry at 40 ppm: turnip tops at 40 ppm and
turnip roots at 15 ppm; succulent pea at 0.3 ppm; and citrus fruit
group 10 at 5.0 ppm. Additionally, this rule deletes the previously
established tolerance under 40 CFR 180.415(a) for citrus at 0.5 ppm.
The higher citrus fruit group tolerance was requested in support of
registration for a shorter pre-harvest interval for use of fosetyl-Al
on citrus.
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. . . .''
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).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerances for residues of fosetyl-Al on bushberry
subgroup, lingonberry, salal, and juneberry at 40 ppm; turnip tops at
40 ppm; turnip roots at 15 ppm; succulent pea at 0.3 ppm; and citrus
fruit group at 5.0 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
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 fosetyl-Al are
discussed in the Federal Register of August 18, 2000 (65 FR 50431) (
FRL-6599-4) as well as the no observed adverse effect level (NOAEL) and
the lowest observed adverse effect level (LOAEL) from the toxicity
studies reviewed.
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for fosetyl-Al used for human risk assessment is shown in the
following Table 1:
[[Page 55341]]
Table 1.--Summary of Toxicological Dose and Endpoints for Fosetyl-Al for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary Not applicable Not applicable No effects attributable
to a single exposure
(dose) were observed
from the oral toxicity
studies including
developmental toxicity
studies in rats and
rabbits.
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Chronic dietary all populations NOAEL = 250 mg/kg/day FQPA SF = 1x 2-Year chronic toxicity-
UF = 100............... cPAD = chronic RfD/FQPA dogs
Chronic RfD = 2.5 mg/kg/ SF. LOAEL = 500 mg/kg/day
day. = 2.5 mg/kg/day........ based on increased
incidence of
testicular
degeneration
----------------------------------------------------------------------------------------------------------------
Short-term (1 to 30 days) and NOAEL = 300 mg/kg/day LOC for MOE = 100 3-Generation
intermediate-term (1 to 6 months) (Residential)......... reproductive toxicity
Incidental oral...................... FQPA SF = 1x........... rat
(Residential)........................ LOAEL = 600 mg/kg/day
based on decreased
litter and pup body
weight (on day 8) in
both matings of each
generation, F1 and F2
----------------------------------------------------------------------------------------------------------------
Short- and intermediate-term dermal None Not applicable No hazard identified.
(Residential)........................ Risk assessment not
performed.
----------------------------------------------------------------------------------------------------------------
Long-term dermal (greater than 6 Oral NOAEL = 250 mg/kg/ LOC for MOE = 100 2-Year chronic toxicity-
months) day (Residential).......... dog
(Residential)........................ LOAEL = 500 mg/kg/day
based on increased
incidence of
testicular
degeneration
----------------------------------------------------------------------------------------------------------------
Short- and intermediate-term Oral study LOC for MOE = 100 3-Generation
inhalation NOAEL= 300 mg/kg/day... (Residential).......... reproductive toxicity
(Residential)........................ rat
Parental (systemic)
LOAEL = 600 mg/kg/day
based on decreased
body weight gains of
F2b generation, and
urinary tract changes
in adults
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (several months Oral study LOC for MOE = 100 2-Year chronic toxicity
to lifetime) NOAEL = 250 mg/kg/day.. (Residential).......... - dog
(Residential)........................ LOAEL = 500 mg/kg/day
based on increased
incidence of
testicular
degeneration
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: Unlikely to pose a carcinogenic hazard to humans.
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.415) for the residues of fosetyl-Al, in or on a
variety of raw agricultural commodities. Residues of fosetyl-Al are
currently regulated under 40 CFR 180.415(a) in caneberries, fresh
ginseng root, pineapple, pineapple fodder and forage at 0.1 ppm; onions
(dry bulb) at 0.5 ppm; macadamia nuts at 0.2 ppm; citrus and cranberry
at 0.5 ppm; tomatoes and bananas at 3.0 ppm; pome fruit at 10 ppm;
cucurbit vegetables group at 15 ppm; avocados at 25 ppm; hops, dried at
45 ppm; brassica (cole) leafy vegetables group at 60 ppm; strawberries
at 75 ppm; and leafy vegetables (except brassica vegetables) group at
100 ppm. Time-limited tolerances associated with a section 18 request
for the residues of fosetyl-Al have been granted in/on peas, succulent
at 1.0 ppm under 40 CFR 180.415(b) which expired September 31, 2000.
Additionally, tolerances are established 40 CFR 180.415(c) for residues
of fosetyl-Al in/on asparagus at 0.1 ppm and grapes at 10 ppm in
conjunction with regional registrations. Risk assessments were
conducted by EPA to assess dietary exposures from fosetyl-Al in food as
follows:
i. Acute exposure. 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. No appropriate endpoint attributable to a single
exposure (dose) was identified from the oral toxicity studies including
developmental toxicity studies in rats and rabbits. Therefore, an acute
reference dose was not established and this risk assessment was not
performed.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment, the Dietary Exposure Evaluation Model (DEEMTM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the chronic
exposure assessments: The Tier 1 (assuming tolerance level residues and
100% crops treated for all commodities) chronic dietary exposure
assessment was conducted for all supported fosetyl-Al food uses.
Chronic dietary exposure estimates were provided for the general U.S.
population and various population subgroups.
iii. Cancer. The Agency concludes that pesticidal use of fosetyl-Al
is unlikely to pose a carcinogenic hazard to humans. Therefore, a
cancer dietary exposure analysis for fosetyl-Al was not performed.
[[Page 55342]]
2. Dietary exposure from drinking water. Fosetyl-Al is not expected
to reach ground or surface water under most conditions. Even if it
reaches surface water, it is expected to degrade rapidly. In ground
water, it could persist because of potentially low microbial content in
ground water. Biodegradation is the only apparent means of fosetyl-Al
dissipation. Fosetyl-Al rapidly degrades in aerobic soil (half-life < 3
hours) and in anaerobic soil (half-life ranging from 14 to 40 hours) to
degradates that are widespread in nature (Al 3+,
PO43 -, and ethanol). Under almost all uses, the
degradation is expected to be so rapid that fosetyl-Al will not have
time to move in soil despite being highly soluble in water (120 g/L)
and potentially mobile in soil. Since it is stable to abiotic
hydrolysis, fosetyl-Al could persist in pristine receiving waters with
low microbial content. Parent fosetyl-Al is the only compound included
in the Agency's assessment. The parent compound is also the residue of
concern in both plant and livestock commodities.
The Agency lacks sufficient monitoring exposure data to complete a
comprehensive dietary exposure analysis and risk assessment for
fosetyl-Al in drinking water. Because the Agency does not have
comprehensive monitoring data, drinking water concentration estimates
are made by reliance on simulation or modeling taking into account data
on the physical characteristics of fosetyl-Al.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The Screening Concentrations in Ground Water (SCI-GROW) model is used
to predict pesticide concentrations in shallow ground water. For a
screening-level assessment for surface water EPA will use FIRST (a tier
1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an
index reservoir environment, the PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to fosetyl-Al, they are further
discussed in the aggregate risk sections in Unit III.E.
Based on the FIRST and SCI-GROW 2 models, the EECs for fosetyl-Al
for acute exposures are estimated to be 0.0086 parts per billion (ppb)
for surface water and <0.006 ppb for ground water. The EECs for chronic
exposure are estimated to be 0.00003 ppb for surface water and less
than 0.006 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Fosetyl-Al is currently registered for use on the following
residential non-dietary sites: Lawn, turf, and ornamental plants under
the brand names CHIPO Aliette WDG and Aliette HG. CHIPO Aliette WDG is
sold to professional applicators only, which includes lawn care
operators (LCO). Because all residential uses of CHIPO Aliette WDG are
applied by the LCO, a residential applicator exposure assessment for
this product was not performed. Short- and intermediate-term dermal,
inhalation, and oral exposures to fosetyl-Al may occur from residential
handling/post-application activities.
Short-term (1 to 30 days) dermal and inhalation exposures may occur
to adult residential handlers from mixing, loading and applying
fosetyl-Al to turf. However, intermediate-term (1 to 6 months) and
long-term (more than 6 months) exposure durations are not likely based
on the use pattern. In addition, the Agency did not select applicable
short- or intermediate-term dermal endpoints. Therefore, only short-
term inhalation exposure assessments for residential handlers from
mixing, loading and applying fosetyl-Al to turf were performed. MOEs
for short-term inhalation exposures are estimated at 170,000 for mixing
loading and applying to turf with low pressure handwands and 140,000
for mixing, loading and applying to turf with hose-end sprayer. Short-
term MOEs for inhalation exposure are above 100 and do not exceed EPA's
level of concern.
There is potential dermal (adults and children) and oral exposure
(children only) during post-application activities. However, because no
dermal toxicity endpoints were identified, only incidental oral
exposure to children is assessed. The following post-application
exposure scenarios resulting from lawn treatment were assessed: (1)
Incidental non-dietary ingestion of pesticide residues on lawns from
hand-to-mouth transfer; (2) incidental non-dietary ingestion of
residues from object-to-mouth activities (pesticide-treated turfgrass);
and (3) incidental non-dietary ingestion of soil from pesticide-treated
residential areas. The exposure and risk estimates for the three
residential exposure scenarios are assessed for the day of application
(day ``0'') because it is assumed that children could contact the lawn
immediately after application. On the day of application, it was
assumed that 5% of the application rate is available from the turfgrass
as transferrable residue (20% for object-to-mouth activities). Based on
the short half-life (<3 hours in aerobic soil), intermediate-term
exposure is not expected. Risks from short-term incidental ingestion by
children is assessed by comparing these exposures to the short and
intermediate-term incidental oral endpoint (NOAEL = 300 mg/kg/day),
based on parental systemic toxicity observed in a 3-generation
reproduction study in rats. The short-term MOEs for children from post-
application exposure to treated lawns are 1,100 based on oral hand-to-
mouth activities; 4,400 from object-to-mouth (turfgrass) exposure; and
330,000 from incidental ingestion of soil from treated lawns. Short-
term MOEs are above 100 and do not exceed EPA's level of concern.
Intermediate-term exposure is not expected based on the short half-life
(less than 3 hours in aerobic soil) and long-term exposure is not
expected based on the use pattern.
Residential exposures that could reasonably be expected to occur on
the same day are combined and compared to the appropriate toxicity
endpoint. Because no dermal endpoints were identified, the only
multiple-residential exposure scenarios involve children's exposure
from oral routes following
[[Page 55343]]
turfgrass treatment. For incidental oral exposure to children in
residential settings, the three scenarios that would reasonably be
expected to occur on the same day are toddler's incidental ingestion of
residues on turf from hand-to-mouth activities, mouthing turfgrass and
eating soil. The combined short-term daily exposures total 0.34 mg/kg/
day, leading to a combined short-term toddler MOE of 880 for incidental
oral exposure. This MOE is above the target MOE of 100, and therefore
does not exceed EPA's level of concern.
Spray drift is always a potential source of exposure to residents
nearby to spraying operations. This is particularly the case with
aerial application, but, to a lesser extent, could also be a potential
source of exposure from the ground application method employed for
fosetyl-Al. The Agency has been working with the Spray Drift Task
Force, EPA Regional Offices and State Lead Agencies for pesticide
regulation and other parties to develop the best spray drift management
practices. The Agency is now requiring interim mitigation measures for
aerial applications that must be placed on product labels/labeling. The
Agency has completed its evaluation of the new data base submitted by
the Spray Drift Task Force, a membership of U.S. pesticide registrants,
and is developing a policy on how to appropriately apply the data and
the AgDRIFT computer model to its risk assessments for pesticides
applied by air, orchard airblast, and ground hydraulic methods. After
the policy is in place, the Agency may impose further refinements in
spray drift management practices to reduce off-target drift and risks
associated with aerial as well as other application types where
appropriate.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether fosetyl-Al 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,
fosetyl-Al 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 fosetyl-Al has a common mechanism of toxicity
with other substances. On this basis, the petitioner must submit, upon
EPA's request and according to a schedule determined by the Agency,
such information as the Agency directs to be submitted in order to
evaluate issues related to whether fosetyl-Al shares a common mechanism
of toxicity with any other substance and, if so, whether any tolerances
for fosetyl-Al need to be modified or revoked.
For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the final rule for Bifenthrin
Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
1.In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
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.
2. Prenatal and postnatal sensitivity. The developmental and
reproductive toxicity data did not indicate increased quantitative or
qualitative susceptibility of rats or rabbits to in utero and/or
postnatal exposure.
3. Conclusion. There is a complete toxicity data base for fosetyl-
Al and exposure data are complete or are estimated based on data that
reasonably account for potential exposures.
EPA determined that the 10X safety factor to protect infants and
children should be reduced to 1X. The FQPA factor was reduced because
the toxicology data base is complete; the developmental and
reproductive toxicity data did not indicate increased quantitative or
qualitative susceptibility of rats or rabbits to in utero and/or
postnatal exposure; a developmental neurotoxicity study is not required
by the Agency; and the dietary exposure assessment, which assumes the
theoretical maximum residue contribution will not underestimate the
potential dietary (food and water) and non-dietary exposures for
infants and children resulting from the use of fosetyl-Al.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. The acute aggregate risk assessment takes into
account exposure estimates from dietary consumption of fosetyl-Al (food
and drinking water). However, no appropriate endpoint
[[Page 55344]]
attributable to a single dose (exposure) was identified in oral
toxicity studies for fosetyl-Al. Therefore, an acute RfD was not
established and no acute risk from exposure to fosetyl-Al is expected.
2. Chronic risk. The chronic aggregate risk assessment takes into
account average exposure estimates from food, drinking water, and
residential uses. However, based on the use pattern, no chronic
residential exposures are expected. Therefore, the chronic aggregate
risk assessment will consider exposure from food and drinking water
only. Chronic risk estimates resulting from aggregate exposure to
fosetyl-Al in food and water are below the Agency's level of concern.
Using the exposure assumptions described in this unit for chronic
exposure, EPA has concluded that exposure to fosetyl-Al from food will
utilize 4% of the cPAD for the U.S. population, 5% of the cPAD for
infants and 8% of the cPAD for children 1-6 years old, subpopulation at
greatest exposure. Based on the use pattern, chronic residential
exposure to residues of fosetyl-Al is not expected. In addition, there
is potential for chronic dietary exposure to fosetyl-Al in drinking
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the cPAD.
Table 2.--DWLOCs for Chronic Dietary (Non-Cancer) Exposure to Fosetyl-Al
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 2.5 4 0.00003 0.006 84,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 2.5 8 0.00003 0.006 23,000
----------------------------------------------------------------------------------------------------------------
All infants (less than 1 year old) 2.5 5 0.00003 0.006 24,000
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 2.5 3 0.00003 0.006 73,000
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). The short-term
aggregate risk assessment estimates risks likely to result from 1 to
30-day exposure to fosetyl-Al residues from food, drinking water, and
residential pesticide uses. High-end estimates of residential exposure
are used in the short-term assessment, while average values are used
for food and drinking water exposure (i.e. chronic exposures).
A short-term risk assessment is required for adults because there
is a residential handler inhalation exposure scenario. In addition, a
short-term risk assessment is required for infants and children because
there is a residential post-application oral exposure scenario. As no
short- or intermediate-term dermal endpoint was established, there is
no dermal component to these aggregate risk assessments.
Fosetyl-Al is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for fosetyl-Al.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 3,300 for adults, 570 for
children ages 1-6 years old, and 650 for all infants (less than 1 year
old). These aggregate MOEs do not exceed the Agency's level of concern
for aggregate exposure to food and residential uses. In addition,
short-term DWLOCs were calculated and compared to the EECs for chronic
exposure of fosetyl-Al in ground and surface water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect short-term aggregate exposure to exceed the Agency's
level of concern, as shown in the following Table 3:
Table 3.--Aggregate Risk Assessment for Short-Term Exposure to Fosetyl-Al
----------------------------------------------------------------------------------------------------------------
Aggregate MOE Surface Ground Short-Term
Population Subgroup (Food + Target MOE2 Water EEC3 Water EEC3 DWLOC4
Residential)1 (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Adults 3,300 100 0.00003 0.006 102,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 570 100 0.00003 0.006 25,000
----------------------------------------------------------------------------------------------------------------
All infants (less than 1 years old) 650 100 0.00003 0.006 25,000
----------------------------------------------------------------------------------------------------------------
1Aggregate MOE = NOAEL (300 mg/kg/day) / (Average Food Exposure + Residential Exposure)
2The target MOE is 100, based on interspecies and intraspecies safety factors totaling 100.
3 The crop producing the highest level was used.
4 DWLOC([mu]g/L) = maximum water exposure (mg/kg/day) x body weight (kg)/water consumption (L) x 10-3 mg/[mu]g
For adults, a 70 kg body weight was used, for children, 10 kg.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
An intermediate-term risk assessment was not performed since adult
residential handler scenarios are not expected to occur for longer than
a short-term timeframe (more than 30 days of continuous exposure) and
intermediate-term exposure is not likely to occur for infants and
children (residential post-application oral exposure scenario) because
fosetyl-Al has a very short half-life (less than 3 hours in aerobic
soil).
[[Page 55345]]
5. Aggregate cancer risk for U.S. population. The Agency concludes
that pesticidal uses of fosetyl-Al are not likely to pose a
carcinogenic hazard to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to fosetyl-Al residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate analytical method is available for enforcement of the
proposed tolerances in/on turnips (roots and tops), succulent peas,
blueberries, and citrus. The method is Method I in PAM II, which uses
diazomethane as the methylating agent and quantitation of fosetyl-Al by
GC/FPD. The limit of quantitation (LOQ) is 0.05 ppm for turnips and
succulent peas and 0.1 ppm for citrus. The method may be requested
from: Francis Griffith, Analytical Chemistry Branch, Environmental
Science Center, Environmental Protection Agency, 701 Mapes Road, Fort
George G. Mead, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: [email protected].
B. International Residue Limits
There are no established or proposed maximum residue limits or
tolerances for fosetyl-Al in or on turnip roots and tops, succulent
peas, blueberries or citrus fruit for Canada, Mexico, or Codex.
C. Conditions
Registration for succulent pea will be conditional pending the
submission of adequate storage stability data for this crop.
V. Conclusion
Therefore, the tolerances are established for residues of fosetyl-
Al, aluminum tris (O-ethylphosphonate), in or on bushberry subgroup,
lingonberry, salal, and juneberry at 40 ppm; turnip tops at 40 ppm;
turnip roots at 15 ppm; succulent pea at 0.3 ppm; and citrus fruit
group at 5.0 ppm. Since the tolerance for the citrus fruit group at 5.0
ppm supercedes the existing tolerance under 40 CFR 180.415(a) for
citrus at 0.5 ppm, the tolerance for citrus at 0.5 ppm is deleted.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-2002-0144 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before October
28, 2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
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.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at [email protected],
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-2002-0144, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: [email protected]. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
[[Page 55346]]
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
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(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. 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). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerances 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive Order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VIII. 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 this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 16, 2002.
Debra Edwards,
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. 321(q), 346(a) and 374.
2. Section 180.415 is amended by removing the entry for ``Citrus''
and alphabetically adding the following commodities to the table in
paragraph (a) to read as follows:
Sec. 180.415 Aluminum tris (O-ethylphosphonate); tolerances for
residues.
(a) * * *
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/Revocation Date
----------------------------------------------------------------------------------------------------------------
* * * * *
Bushberry subgroup............................. 40 None
* * * * *
Fruit, citrus, group........................... 5.0 None
[[Page 55347]]
* * * * *
Juneberry...................................... 40 None
* * * * *
Lingonberry.................................... 40 None
* * * * *
Pea, succulent................................. 0.3 None
* * * * *
Salal.......................................... 40 None
* * * * *
Turnip, roots.................................. 15 None
* * * * *
Turnip, tops................................... 40 None
* * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. 02-21757 Filed 8-28-02; 8:45 am]
BILLING CODE 6560-50-S