Fosetyl-Al; Pesticide Tolerance

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

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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, [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]

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