[Federal Register Volume 64, Number 130 (Thursday, July 8, 1999)]
[Rules and Regulations]
[Pages 36794-36801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17351]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300892; FRL-6090-3]
RIN 2070-AB78
Fosetyl-Al; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for the fungicide
fosetyl-Al (aluminum tris(O-ethyl phosphonate)) in or on the raw
agricultural commodities bananas at 3.0 parts per million (ppm),
blueberries at 40 ppm, grapes at 10 ppm, and macadamia nuts at 0.20
ppm. Rhone-Poulenc Ag Company and 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 July 8, 1999. Objections and
requests for hearings must be received by EPA on or before September 7,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300892], 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-300892], 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 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 or
[[Page 36795]]
ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300892]. 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: Cynthia Giles-Parker,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 249, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-7740; e-
mail: [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of July 7,1998 (63
FR 36s681) (FRL-5795-6) and January 29, 1999 (64 FR 4650) (FRL-6055-8),
EPA issued notices 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, 5E4559, 7E4872) for
tolerances by Interregional Research project Number 4 (IR-4), New
Jersey Agricultural Research Station, Rutgers University, New
Brunswick, New Jersey 08903, and pesticide petition (PP#8E4969) for a
tolerance by Rhone-Poulenc Ag Company, P.O. Box 12014, 2 T.W. Alexander
Drive, Research Triangle Park, NC 27709. These notices included
summaries of the petitions prepared by Rhone-Poulenc Ag Company, the
registrant. There were no comments received in response to the notices
of filing.
The petitions requested that 40 CFR 180.415 be amended by
establishing tolerances for the fungicide fosetyl-Al, in or on bananas
at 3.0 ppm, blueberries at 40 ppm, grapes at 10 ppm, and macadamia nuts
at 0.20 ppm. Since the tolerance for blueberries expired on December
31, 1998, after the notice of filing was published in the Federal
Register, this rule re-establishes the blueberry tolerance, with an
expiration date of December 31, 2000. Registration for use of fosetyl-
Al on grapes will be limited to areas east of the Rocky Mountains,
based on the geographical representation of the residue data submitted.
Persons seeking geographically broader registration should contact the
Registration Division at the address provided above.
I. Background and Statutory Findings
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 November 26, 1997 (62 FR 62961), (FRL-5754-7).
II. 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 fosetyl-
Al and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for tolerances of fosetyl-Al on bananas at 3.0 ppm,
blueberries at 40 ppm, grapes at 10 ppm, and macadamia nuts 0.20 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 fosetyl-Al are
discussed in this unit.
[Technical grade fosetyl-Al has low acute oral (IV), dermal (III),
and inhalation (III) toxicity. It is non-irritating to the skin (IV)
and severely irritating to the eyes (I). It is not a skin sensitizer.
There were no acute neurotoxicity tests performed. The acute oral
LD50 for rats is >5,000 milligrams per kilogram (mg/kg), the
acute dermal LD50 for rats is >3,000 mg/kg, and the acute
inhalation LC50 for rats is 1.73 milligrams per liter (mg/
l).
The subchronic toxicity studies included a 21-day dermal toxicity
study in rats whose no observed adverse effect level (NOAEL) was
greater than the limit dose of 1,000 milligrams per kilogram per day
(mg/kg/day). The NOAEL was 1,500 mg/kg/day, the highest dose tested
(HDT) and the lowest observed adverse effect level (LOAEL) was >1,500
mg/kg/day. The other subchronic studies were two 3-month oral toxicity
studies, one using dogs and the other using rats. Treatment-related
effects included slightly increased medullary hematopoiesis in the
spleen of rats and decreased serum potassium in dogs, both at LOAELs of
1,250 mg/kg/day. The NOAELs were 482 and 250 mg/kg/day in rats and
dogs, respectively.
The following chronic toxicity and/or carcinogenicity studies were
performed. In a chronic toxicity feeding study using dogs, the NOAEL of
250 mg/kg/day was based on testicular degeneration (spermatocytic and/
or spermatidic giant cells in the lumen of the seminiferous tubules) at
the LOAEL of 500 mg/kg/day. In a combined chronic toxicity/
carcinogenicity study using rats, the NOAEL of 400 mg/kg/day was based
on urinary bladder pathology (tumors) and increased urine protein at
the LOAEL of 1,500 mg/kg/day. In a carcinogenicity study in mice, the
NOAEL of 409 mg/kg/day was based on a slight increase in white blood
cells at the LOAEL of 1,672 mg/kg/day. There was no evidence of
carcinogenicity in the mouse. The Agency classified fosetyl-Al as a
Group C carcinogen (possible human carcinogen). A subsequent review
concluded that fosetyl-Al was not amenable to classification using the
current Agency guidelines and determined that the tumors produced in
rats occurred under extremely high doses, under conditions not
anticipated to occur outside of the experimental lab. Therefore, it was
concluded that fosetyl-Al is not likely to pose a carcinogenic hazard
to humans.
Results from five acceptable mutagenicity studies indicate that
fosetyl-Al was not mutagenic in bacterial or cultured mammalian cells
and did not cause DNA damage in bacterial or primary rat hepatocytes.
[[Page 36796]]
Therefore, the available data indicate that fosetyl-Al is not a
mutagen.
In a developmental toxicity study using rats, maternal toxicity
occurred at four times the limit dose. The maternal LOAEL was 4,000 mg/
kg/day, based on decreased mean body weights and body weight gain, and
increased maternal mortality, and the NOAEL was 1,000 mg/kg/day (limit
dose). The developmental LOAEL was also 4,000 mg/kg/day, based on
decreased litter and mean fetal body weight, increased resorptions,
malformations, and skeletal variations, and the developmental NOAEL was
1,000 mg/kg/day (limit dose). In a developmental toxicity study using
rabbits there was no evidence of developmental toxicity at the HDT of
500 mg/kg/day, so the NOAEL is considered to be 500 mg/kg/day and the
LOAEL was not established. In this same study the maternal LOAEL was
250 mg/kg/day, based on decreased mean body weight, and the NOAEL was
125 mg/kg/day. A three-generation reproductive toxicity study using
rats did not indicate any concern for pre- or post-natal effects in
offspring or for reproductive effects. The parental/systemic LOAEL was
600 mg/kg/day, based on decreased body weight gains of the
F2b generation, and urinary tract changes in adults, and the
parental/systemic NOAEL was 300 mg/kg/day. In this same study the
reproductive (offspring) LOAEL was 600 mg/kg/day, based on decreased
litter and pup body weight (day 8) in both matings of each generation,
and the reproductive (offspring) NOAEL was 300 mg/kg/day. The in utero
(developmental) NOAEL in this study was >1,200 mg/kg/day (the HDT).
Therefore, there was no evidence of increased sensitivity due to
prenatal or postnatal exposure to fosetyl-Al.
A dermal absorption factor is required only for long-term dermal
risk assessment due to the selection of an oral value. The Agency
estimated a dermal absorption factor of 17% based on the ratio of the
oral LOAEL (250 mg/kg/day), and the dermal LOAEL (1500 mg/kg/day) in
rabbits. Two metabolism studies using rats were evaluated. The first
study showed that fosetyl-Al technical was rapidly metabolized to
carbon dioxide (60%, recovered in exhaled air), and phosphite
(phosphorous acid) (29 to 30%, excreted in the urine and feces). The
second study examined metabolism of the phosphite metabolite, showing
most of it to be excreted in the urine (59-65%) and feces (30 to 32%).
Overall, the quality of the toxicology data base is good and the
confidence in the hazard and dose responses is high. There are no
toxicology data gaps.
B. Toxicological Endpoints
1. Acute toxicity. No appropriate endpoint attributable to a single
dose exposure was identified in acute oral toxicity studies. Therefore,
an acute Reference Dose (RfD) was not established.
2. Short-and intermediate-term toxicity. In the 21-day dermal
toxicity study using rats, no dermal or systemic toxicity was seen at
the limit dose following repeated dermal applications. Therefore, no
endpoint value is calculable.
3. Chronic toxicity. EPA has established the chronic RfD for
fosetyl-Al at 2.5 mg/kg/day. This RfD is based on testicular
degeneration (spermatocytic and/or spermatidic giant cells in the lumen
of the seminiferous tubules) in 2 of 6 rats. The endpoint was observed
in the 2-year chronic toxicity using dogs. In this study the NOAEL was
250 mg/kg/day and the uncertainty factor was set at 100. The FQPA
factor was determined to be 1 x because:
(1) The toxicology data base is complete.
(2) there is no indication of increased susceptibility of rat or
rabbit fetuses to in utero and/or postnatal exposure in the
developmental and reproductive toxicity studies,
(3) a developmental neurotoxicity study is not required,
(4) food exposure estimates are unrefined (that is, tolerance level
residues and 100% crop treated assumed) and likely result in an
overestimate of the actual food exposure,
(5) the Agency models used for ground and surface drinking water
exposure estimates produce upper-bound concentration estimates,
(6) the current residential use pattern is not of concern since no
potential hazard was identified for short- or intermediate-term
exposure (no risk assessment is required) and long-term exposure is not
expected with this use. As a result of the 1x FQPA factor, the chronic
population adjusted dose (CPAD) is the same as the RfD.
4. Carcinogenicity. The Agency has determined that fosetyl-Al is
unlikely to pose a cancer hazard to humans because the effects produced
in rats occurred at extremely high doses, under conditions not
anticipated to occur outside of the laboratory. Therefore, under the
expected exposure conditions for this use, fosetyl-Al is unlikely to
pose a carcinogenic risk to humans.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.415) for residues of fosetyl-Al in or on a variety of raw
agricultural commodities. These tolerances range from 0.1 part per
million (ppm) on caneberries, fresh ginseng root, and pineapple to 100
ppm on the leafy vegetables (except brassica vegetables) group. A time-
limited tolerance for blueberries at 40 parts per million expired on
December 31, 1998. Risk assessments were conducted by EPA to assess
dietary exposures from fosetyl-Al 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. No appropriate endpoint attributable to
a single dose exposure was identified in oral toxicity studies.
Therefore, an acute RfD was not established, and there is no
expectation of acute risk.
ii. Chronic exposure and risk. Food exposure for various subgroups
of the U.S. population was estimated through the use of the Dietary
Exposure Evaluation Model (DEEM) software. The DEEM analysis evaluated
the individual food consumption as reported by respondents in the USDA
1989-1991 nationwide Continuing Surveys of Food Intake by Individuals.
As the risk estimate was low for even the most highly exposed
subpopulation, no anticipated residues were used. The Agency assumed
100% crop treated and tolerance level residues for all crops with
tolerances as well as for the crops which are being evaluated in this
action (i.e., bananas, grapes, and macadamia nuts). The most highly
exposed group, children (1-6 years), is at 6% of the chronic CPAD. Of
the female subgroups, females (13+/nursing) has the highest exposure at
4% of the CPAD. The exposure for the U.S. population is 3% of the CPAD.
Foods that contribute most to the exposure are: lettuce, apples,
tomatoes, broccoli, celery, strawberries, spinach, and cabbage.
The Agency does not consider the chronic dietary food risk to
exceed the Agency's level of concern.
iii. Short- and intermediate-term exposure and risk. Since no
dermal or systemic toxicity was seen at the limit dose following
repeated dermal applications in the 21-day toxicity study using rats,
no endpoint value was calculated and there is no expectation of short-
or intermediate-term risk.
iv. Cancer exposure and risk. Carcinogenicity risk assessments are
required for a food-use pesticide if a toxicological study has
indicated the possibility of cancer occurring as a result of an
exposure (usually chronic).
[[Page 36797]]
The Agency has concluded that fosetyl-Al is unlikely to pose a
carcinogenic hazard to humans. Therefore, this risk assessment is not
appropriate.
2. From drinking water. A Drinking Water Level of Comparison
(DWLOC) is a theoretical upper limit on a pesticide's concentration in
drinking water in light of total aggregate exposure to a pesticide in
food, drinking water, and through residential uses. A DWLOC will vary
depending on the toxicological endpoint, drinking water consumption,
and body weights. Different populations will have different DWLOCs. The
Agency uses DWLOCs internally in the risk assessment process as a
surrogate measure of potential exposure associated with pesticide
exposure through drinking water. In the absence of monitoring data for
pesticides, it is used as a point of comparison against conservative
model estimates of a pesticide's concentration in water. DWLOC values
are not regulatory standards for drinking water. They do have an
indirect regulatory impact through aggregate exposure and risk
assessments.
i. Acute exposure and risk. No appropriate endpoint attributable to
a single dose exposure was identified in oral toxicity studies.
Therefore, an acute RfD was not established, and there is no
expectation of acute risk.
ii. Chronic exposure and risk. Of all of the crops for which
fosetyl-Al is registered, its use on turf produces the highest
estimated environmental concentrations (EECs). As a result, the EECs
generated from use on turf are the ones used for comparison with the
DWLOCs in this risk assessment. For surface water, the Agency's Generic
Estimated Environmental Concentration (GENEEC) model has provided a 56-
day EEC of 9 g/L. As no data were available on the aerobic
aquatic metabolism of fosetyl-Al (a GENEEC input), the aerobic soil
metabolism half-life of 3 hours (0.125 day) was multiplied by a factor
of 2 to use as a GENEEC input. Multiplying by 2 to account for a change
in medium (aerobic soil to aerobic aquatic conditions) is a standard
practice for surface water modeling in the absence of data when the
pesticide is stable to hydrolysis. For ground water, the Screening
Concentration in Ground Water (SCI-GROW2) model-derived concentration
of 4.6 x 10-3 micrograms per liter (g/L) can be
used for chronic risk assessment. For this risk assessment, the surface
water EEC of 9 g/L was compared with the DWLOCs to determine
whether or not fosetyl-Al residues in drinking water result in an
unacceptable dietary exposure. The surface water EEC was chosen because
it exceeds the ground water EEC.
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. Biodegradation is the only apparent
means of fosetyl-Al dissipation. Fosetyl-Al rapidly degrades in both
aerobic and anaerobic soil to degradates that are widespread in nature
(Al+3, phosphate, 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. As 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 EFED's
assessment. At this time the Agency has no reason to believe that there
are toxicologically significant degradates to be included in the risk
assessment.
The modeling results lead to the following maximum water exposures
and the following DWLOCs for the U.S. population and three appropriate
subgroups:
1. For the U.S. population the maximum water exposure would be 2.42
mg/kg/day and the DWLOC would be 85,000 g/L.
2. For the females (13+) subgroup, the maximum water exposure would
be 2.40 mg/kg/day and the DWLOC would be 72,000 g/L.
3. For the infants/children subgroup, the maximum water exposure
would be 2.34 mg/kg/day and the DWLOC would be 23,000 g/L.
4. For the non-Hispanic other than Black or White subgroup, the
maximum water exposure would be 2.40 mg/kg/day and the DWLOC would be
84,000 g/L.
The Agency therefore concludes that the residues in water, as
estimated by the models, are not a significant contribution to
aggregate exposure.
iii. Short- and intermediate-term toxicity. Since no dermal or
systemic toxicity was seen at the limit dose following repeated dermal
applications in the 21-day toxicity study using rats, no endpoint value
is calculable and therefore no risk analysis can be performed.
iv. Cancer exposure and risk. The Agency has concluded that
fosetyl-Al is unlikely to pose a carcinogenic hazard to humans.
Therefore, this risk assessment is not appropriate.
3. From non-dietary exposure. Fosetyl-Al is currently registered
for use on the following residential non-food sites: lawn, turf, and
ornamental plants.
i. Acute exposure and risk. No appropriate endpoint attributable to
a single dose exposure was identified in oral toxicity studies.
Therefore, an acute RfD could not be calculated, and there is no
expectation of acute risk.
ii. Chronic exposure and risk. Long-term (chronic) exposure is not
expected for residential uses. In addition, the Agency does not
consider incidental hand-to-mouth ingestion by toddlers a concern since
chronic exposure via this route is highly unlikely and because fosetyl-
Al has a relatively short half-life.
iii. Short- and intermediate-term exposure and risk. Since no
dermal or systemic toxicity was seen at the limit dose following
repeated dermal applications in the 21-day toxicity study using rats,
no endpoint value is calculable and therefore no risk analysis can be
performed.
iv. Cancer exposure and risk. The Agency has concluded that
fosetyl-Al is unlikely to pose a carcinogenic hazard to humans.
Therefore, this risk assessment is not 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. 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 November 26, 1997 (62 FR 62961)
(FRL-5754-7).
D. Aggregate Risks and Determination of Safety for the U.S. Population
1. Acute risk. No appropriate endpoint attributable to a single
dose exposure was identified in oral toxicity studies. Therefore, an
acute RfD was not
[[Page 36798]]
established, and their is no expectation of acute risk.
2. Chronic risk. Chronic risk estimates associated with exposure to
fosetyl-Al in food and water do not exceed HED's level of concern. The
DEEM chronic exposure analysis showed that for the U.S. general
population, 3% of the CPAD is occupied by dietary (food) exposure. For
the most highly exposed subgroup, children 1-6 years old, 6% of the
CPAD is occupied by dietary (food) exposure. The estimated average
concentrations of fosetyl-Al in surface and ground water are less than
HED's DWLOC for fosetyl-Al as a contribution to chronic aggregate
exposure. EPA concludes that there is a reasonable certainty that no
harm will result from aggregate exposure to fosetyl-Al residues.
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 exposure.
Since no dermal or systemic toxicity was seen at the limit dose
following repeated dermal applications in the 21-day toxicity study
using rats, no endpoint value is calculable and therefore no risk
analysis can be performed.
4. Aggregate cancer risk for the U.S. population. The Agency has
concluded that fosetyl-Al is unlikely to pose a carcinogenic hazard to
humans. Therefore, this risk assessment is not appropriate.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to fosetyl-Al residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children. The Agency has
determined that the FQPA factor should be 1x because:
1. The toxicology data base is complete.
2. There is no indication of increased susceptibility of rat or
rabbit fetuses to in utero and/or postnatal exposure in the
developmental and reproductive toxicity studies.
3. A developmental neurotoxicity study is not required.
4. Food exposure estimates are expected to be unrefined (that is,
tolerance level residues and 100% crop treated assumed) and will likely
result in an overestimate of the actual dietary exposure.
5. The Agency models used for ground and surface drinking water
exposure estimates produce upper-bound concentration estimates.
6. The current residential use pattern is not of concern since no
potential hazard was identified for short- or intermediate-term
exposure (no risk assessment is required) and long-term exposure is not
expected with this use. As a result of the 1x FQPA factor, the CPAD is
the same as the RfD.
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 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 uncertainty factor (usually 100 for combined inter-
and intraspecies variability) and not the additional tenfold MOE/
uncertainty factor when EPA has a complete data base under existing
guidelines and when the severity of the effect in infants or children
or the potency or unusual toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor.
2. Acute risk. No appropriate endpoint attributable to a single
dose exposure was identified in oral toxicity studies. Therefore, an
acute RfD was not established, and there is no expectation of acute
risk.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to fosetyl-Al from food
will utilize up to 6 percent of the RfD for infants and children. EPA
generally has no concern for exposures below 100% of the RfD because
the RfD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. Despite the potential for exposure to fosetyl-Al in drinking
water and from non-dietary, non-occupational exposure, EPA does not
expect the aggregate exposure to exceed 100% of the RfD.
4. Short- and intermediate-term risk. Since no dermal or systemic
toxicity was seen at the limit dose following repeated dermal
applications in the 21-day toxicity study using rats, no endpoint value
is calculable and therefore no risk analysis can be performed.
5. Aggregate cancer risk for U.S. population. The Agency has
concluded that fosetyl-Al is unlikely to pose a carcinogenic hazard to
humans. Therefore, this risk assessment is not appropriate.
6. 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 fosetyl-Al residues.
III. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in plants is adequately understood. The
residue of concern is parent fosetyl-Al. This conclusion was based on
the results of metabolism studies performed on the following
commodities: pineapples, grape vines, tomatoes , citrus, and apples.
Residues of fosetyl-Al are not systemic; therefore, residues will be on
the surface of plants. There are no feed items associated with
preexisting tolerances or with bananas, grapes, or macadamia nuts;
therefore, the nature of the residue in animals is not germane to this
action. Section 40 CFR 180.6(a)(3) applies to this action. That is, it
is not possible to establish with certainty whether finite residues
will be incurred in animal commodities, but there is no reasonable
expectation of finite residues.
B. Analytical Enforcement Methodology
Adequate methodology is available for enforcement of the proposed
tolerances in/on bananas, blueberries, grapes, and macadamia nuts.
The gas chromatography/flame photometric detection, phosphorous-
specific (GC/FPD-P) method is adequate to enforce the proposed
tolerances on bananas and grapes. This method is an adaptation of the
tolerance enforcement method for fosetyl-Al on pineapples (Pesticide
Analytical Method (PAM) II, Food and Drug Administration, June 1986).
The limit of quantitation (LOQ) and limit of detection (LOD) for the
method are 0.10 and 0.05 ppm, respectively.
Method SOP-90113, dated 6/8/90 (a modified version of Rhone-Poulenc
method 163) is used for the blueberry analysis. The method has been
approved for publication in PAM II.
A modification of the GC/FPD-P method is adequate to enforce the
proposed tolerance on macadamia nuts. This method is similar to the
banana method in the extraction, derivitization, separation, and
detection steps. Because of the macadamia nut matrix, more-involved
cleanup steps are necessary.
[[Page 36799]]
Given the similarity of the macadamia nut method, an Agency pesticide
method validation (PMV) will not be required. The LOQ and LOD for the
method were not specified.
Adequate enforcement methodology (example--gas chromatography) 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, (703) 305-5229.
C. Magnitude of Residues
1. Bananas. With bananas, seven field trials were conducted in
Central and South America, from Mexico to Ecuador. These locations
represent the climatic regions where bananas are grown for export to
the United States. Over 96% of the bananas imported into the U.S. come
from these countries. Bananas received two types of treatment: foliar
and tree injection. In addition, bagged and unbagged samples were
treated. The unbagged samples receiving foliar applications were the
only ones with appreciable residues. Fourteen samples were treated at
the 0.9x rate. Ten of these samples had quantifiable residues. The
average of these ten samples was 0.58 ppm. Residues ranged up to 1.99
ppm. Four samples were treated at the 1.8x rate. The mean for these
samples was 0.69 ppm. Residues ranged from 0.38 to 1.22 ppm. Of the
unbagged samples receiving injection treatments (0.9x rate, 18 samples
total), all samples had residue levels at or below the LOQ of 0.10 ppm.
Four unbagged samples received a 1.8x injection treatment. Residue
levels were below the LOQ for all four of these samples, as well. Of
the 28 bagged samples, 26 had residue levels which were below the LOQ.
The other 2 had residues which were slightly over the LOQ (0.11 and
0.13 ppm). A residue decline study was also performed. Mean residues (2
samples at each PHI) in the foliar-treated unbagged samples declined as
follows: 0-day pre-harvest interval (PHI), 0.35 ppm; 3-day PHI, 0.22
ppm; 7-day PHI, 0.27 ppm; and 14-day PHI, <0.10 ppm. The Agency has a
high level of confidence in the data.
2. Blueberries. Sufficient data to support a permanent tolerance
for residues of fosetyl-Al in/on blueberries have not yet been
submitted by the registrant. However, one study that was performed on
blueberries in Michigan was submitted. This study showed a maximum
residue of 32.7 ppm of fosetyl-Al in blueberries 30 days after an
application of fosetyl-Al at the maximum label rate of 4 lb. active
ingredient per acre and supports the time-limited tolerance of 40 ppm
in/on blueberies. Two additional acceptable magnitude of residue
studies must be submitted before the time-limited tolerance can be
converted to a permanant tolerance.
3. Grapes. Four field trials were conducted in regions east of the
Rocky Mountains, 2 to 3 specimens being collected from each plot. Five
additional field trials were conducted west of the Rocky Mountains,
three specimens being collected from each of these plots. Although the
registration is for regions east of the Rocky Mountains, the tolerance
was set at a level (10 ppm) that took into account the higher values
which were obtained in the field trials that were performed west of the
Rocky Mountains. The petitioner proposed a tolerance of 10 ppm because
in extreme drought conditions residues will be higher. Although drought
conditions are rare east of the Rocky Mountains, they are still
possible. Among the 10 samples from the eastern field trials, one had a
residue level below the LOQ of 0.50 ppm and the others had residues
ranging from 0.52 to 2.45 ppm. The mean residue levels of these samples
was 1.2 ppm. Among the 15 samples from the western field trials,
residues ranged from 1.7 to 18 ppm. The Agency has a high level of
confidence in the submitted field trial data.
4. Macadamia nuts. Despite the fact that only 2 field trials were
performed and storage stability was poor, fosetyl-Al is not highly
systemic and macadamia nuts have hard, impervious shells. As a result,
no residues were expected to be detected, and none were found. Although
limited residue data were provided, the Agency is confident that
residues will not exceed a 0.20 ppm tolerance. The registrant initially
requested that this tolerance be set at 0.3 ppm.
D. International Residue Limits
There are no Codex, Canadian, or Mexican international residue
limits established for fosetyl-Al; therefore, the magnitude of the
residue is not of concern for this action.
E. Rotational Crop Restrictions
None of the crops affected by this rule is grown in rotation with
other crops. Therefore, rotational crop restrictions are unnecessary.
IV. Conclusion
Therefore, tolerances are established for residues of fosetyl-Al in
or on bananas at 3.0 ppm, blueberries at 40 ppm, grapes at 10 ppm, and
macadamia nuts at 0.20 ppm.
V. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation as was provided in
the old section 408 and in section 409. However, the period for filing
objections is 60 days, rather than 30 days. EPA currently has
procedural regulations which govern the submission of objections and
hearing requests. These regulations will require some modification to
reflect the new law. However, until those modifications can be made,
EPA will continue to use those procedural regulations with appropriate
adjustments to reflect the new law.
Any person may, by September 7, 1999, file written objections to
any aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
regulation. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697, [email protected]. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator
[[Page 36800]]
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.
VI. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300892] (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 Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at: [email protected]
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to petitions 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). 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 special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
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
[[Page 36801]]
Fairness Act of 1996, generally provides that before a rule may take
effect, the Agency promulgating the rule must submit a rule report,
which includes a copy of the rule, to each House of the Congress and
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 30, 1999.
Peter Caulkins,
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 371.
2. By revising Sec. 180.415 to read as follows:
Sec. 180.415 Aluminum tris (O-ethylphosphonate); tolerances for
residues.
(a) General. Tolerances are established for residues of the
fungicide aluminum tris(O-ethylphosphonate) in or on the following food
commodities:
------------------------------------------------------------------------
Parts per Expiration/Revocation
Commodity million Date
------------------------------------------------------------------------
Avocados.......................... 25 None
Bananas........................... 3.0 None
Blueberries....................... 40 12/31/00
Brassica (cole) leafy vegetables 60 None
group.
Caneberries....................... 0.1 None
Citrus............................ 0.5 None
Cucurbit vegetables group......... 15 None
Ginseng root, fresh............... 0.1 None
Hops, dried....................... 45 None
Leafy vegetables (except brassica 100 None
vegetables) group.
Macadamia nuts.................... 0.20 None
Pineapple......................... 0.1 None
Pineapple fodder.................. 0.1 None
Pineapple forage.................. 0.1 None
Pome fruit........................ 10 None
Onions, dry bulb.................. 0.5 None
Strawberries...................... 75 None
Tomatoes.......................... 3 None
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. Tolerances with
regional registration, as defined in Sec. 180.1(n), are established for
residues of the fungicide aluminum tris (O-ethylphosphonate) in or on
the following raw agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Asparagus.................................................... 0.1
Grapes....................................................... 10
------------------------------------------------------------------------
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 99-17351 Filed 7-7-99; 8:45 am]
BILLING CODE 6560-50-F-P