[Federal Register Volume 68, Number 46 (Monday, March 10, 2003)]
[Rules and Regulations]
[Pages 11330-11335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5616]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0348; FRL-7292-6]


Aluminum tris (O-ethylphosphonate); Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of the 
fungicide aluminum tris (O-ethylphosphonate) (fosetyl-Al) in or on 
onion, green. The Interregional Research Project 4 (IR-4), 
Center for Minor Crop Management, Rutgers, The State University of New 
Jersey, 681 U. S. Highway 1 South, North Brunswick, NJ 08902-
3390 requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 
1996 (FQPA).

DATES: This regulation is effective March 10, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0348, 
must be received on or before May 9, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The North American Industrial Classification System (NAICS) codes have 
been provided to assist you and others in determining whether this 
action might apply to certain entities. Potentially affected entities 
may include, but are not limited to:
    [sbull] Crop production (NAIC code 111)
    [sbull] Animal production (NAIC code 112)
    [sbull] Food manufacturing (NAIC code 311)
    [sbull] Pesticide manufacturing (NAIC code 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. To determine whether you or your business may be affected by 
this action, you should carefully examine the applicability provisions 
in OPP-2002-0348. If you have any questions regarding the applicability 
of this action to a particular entity, consult the person listed under 
FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2002-0348. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of January 2, 2003 (68 FR 103) (FRL-7282-
5), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide petition (PP 2E6366) by IR-4, Center for Minor Crop 
Management, Rutgers, The State University of New Jersey, 681 U. S. 
Highway 1 South, North Brunswick, NJ 08902-3390. That notice 
included a summary of the petition prepared by Bayer CropScience, the 
registrant.
    The petition requested that 40 CFR 180.415 be amended by 
establishing a tolerance for residues of the fungicide fosetyl-Al, 
aluminum tris (O-ethylphosphonate), in or on onion, green at 10 parts 
per million (ppm). There were no comments received in response to the 
notice of filing.
    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) of the FFDCA 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) of the FFDCA 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....''

[[Page 11331]]

    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 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for a tolerance for residues of fosetyl-Al on 
onion, green at 10 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data on fosetyl-Al and 
considered their validity, completeness, and reliability as well as the 
relationship of the results of the studies to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by 
fosetyl-Al are discussed in the Federal Register of August 18, 2000 (65 
FR 50431) (FRL-6599-4) as well as the no-observed-adverse-effect-level 
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the 
toxicity studies reviewed. Please refer to this document should you 
desire detailed toxicological information on fosetyl-Al.

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the lowest dose at which 
adverse effects of concern are identified (the LOAEL) is sometimes used 
for risk assessment if no NOAEL was achieved in the toxicology study 
selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for 
intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factors 
(SF) is retained due to concerns unique to the FQPA, this additional 
factor is applied to the RfD by dividing the RfD by such additional 
factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is 
a modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for fosetyl-Al used for human risk assessment is discussed in 
Unit III. B. of the final rule on fosetyl-Al tolerances published in 
the Federal Register on August 29, 2002 (67 FR 55339) (FRL-7195-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.415) for the residues of fosetyl-Al, in or on a 
variety of raw agricultural commodities. Residues of fosetyl-Al are 
currently regulated under 40 CFR 180.415(a) in bushberry subgroup, and 
juneberry, lingonberry, and salal, at 40 ppm; caneberries, fresh 
ginseng root, pineapple, pineapple fodder and forage at 0.1 ppm; onions 
(dry bulb) at 0.5 ppm, macadamia nuts at 0.2 ppm; cranberry at 0.5 ppm; 
fruit, citrus, group at 5.0 ppm; pea, succulent at 0.3 ppm; tomatoes 
and bananas at 3.0 ppm; pome fruit at 10 ppm; cucurbit vegetables group 
at 15 ppm; avocados at 25 ppm; hops, dried at 45 ppm; brassica (cole) 
leafy vegetables group at 60 ppm; strawberries at 75 ppm; turnip, roots 
at 15 ppm; turnip, tops at 40 ppm; and leafy vegetables (except 
brassica vegetables) group at 100 ppm. Time-limited tolerances 
associated with a section 18 request for the residues of fosetyl-Al 
have been granted in/on peas, succulent at 1.0 ppm under 40 CFR 
180.415(b) which expired September 31, 2000. Additionally, tolerances 
are established in 40 CFR 180.415(c) for residues of fosetyl-Al in/on 
asparagus at 0.1 ppm and grapes at 10 ppm in conjunction with regional 
registrations. Risk assessments were conducted by EPA to assess dietary 
exposures from fosetyl-Al in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. No appropriate endpoint attributable to a single 
exposure (dose) of fosetyl-Al was identified from the oral toxicity 
studies including developmental toxicity studies in rats and rabbits. 
Therefore, fosetyl-Al is not expected to pose an acute risk.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the Dietary Exposure Evaluation Model (DEEM) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: The Tier 1 (assuming tolerance level residues and 100% 
crops treated for all commodities) chronic dietary exposure assessment 
was conducted for all supported fosetyl-Al food uses. Chronic dietary 
exposure estimates were provided for the general U.S. population and 
various population subgroups.
    iii. Cancer. The Agency concludes that pesticidal use of fosetyl-Al 
is unlikely to pose a carcinogenic hazard to humans. Therefore, a 
cancer dietary exposure analysis for fosetyl-Al was not performed.
    2. Dietary exposure from drinking water. Fosetyl-Al is not expected 
to reach ground water or surface water under most conditions.

[[Page 11332]]

    Based on screening models, FQPA Index Reservoir Screening Tool 
(FIRST) and Screening Concentrations in Ground Water (SCI-GROW), the 
estimated environmental concentrations (EECs) of fosetyl-Al for acute 
exposures are estimated to be 0.0086 parts per billion (ppb) for 
surface water and 0.006 ppb for ground water. The EECs for chronic 
exposures are estimated to be 0.00003 ppb for surface water and 0.006 
ppb for ground water.
    3. From non-dietary exposure. Fosetyl-Al is currently registered 
for use on the following residential non-dietary sites: Lawn, turf, and 
ornamental plants under the brand names CHIPO[reg] Aliette WDG and 
Aliette[reg] HG. CHIPO[reg] Aliette WDG is sold to professional 
applicators only, which includes lawn care operators (LCO). Because all 
residential uses of CHIPO[reg] Aliette WDG are applied by the LCO, a 
residential applicator exposure assessment for this product was not 
performed. Short- and intermediate-term dermal, inhalation, and oral 
exposures to fosetyl-Al may occur from residential handling/
postapplication activities.
    For a detailed discussion of fosetyl-Al risk assessment, see Unit 
III. C. 3. of the final rule on fosetyl-Al tolerances published in the 
Federal Register on August 29, 2002 (67 FR 55339).
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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 (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. The developmental and 
reproductive toxicity data did not indicate increased quantitative or 
qualitative susceptibility of rats or rabbits to in utero and/or 
postnatal exposure.
    3. Conclusion. There is a complete toxicity data base for fosetyl-
Al and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. EPA determined that the 
10X safety factor to protect infants and children should be reduced to 
1X. The FQPA factor was reduced because the toxicology data base is 
complete; the developmental and reproductive toxicity data did not 
indicate increased quantitative or qualitative susceptibility of rats 
or rabbits to in utero and/or postnatal exposure; a developmental 
neurotoxicity study is not required by the Agency; and the exposure 
assessment, which assumes the theoretical maximum residue contribution 
will not underestimate the potential dietary (food and water) and non-
dietary exposures for infants and children resulting from the use of 
fosetyl-Al.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates drinking 
water level of concerns (DWLOC) which are used as a point of comparison 
against the model estimates of a pesticide's concentration in water 
(EECs). DWLOC values are not regulatory standards for drinking water. 
DWLOCs are theoretical upper limits on a pesticide's concentration in 
drinking water in light of total aggregate exposure to a pesticide in 
food and residential uses. In calculating a DWLOC, the Agency 
determines how much of the acceptable exposure (i.e., the PAD) is 
available for exposure through drinking water [e.g., allowable chronic 
water exposure (mg/kg/day) = cPAD - (average food + residential 
exposure)]. This allowable exposure through drinking water is used to 
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by EPA are used to calculate DWLOCs: 2 liter (L)/70 kg 
(adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default 
body weights and drinking water consumption values vary on an 
individual basis. This variation will be taken into account in more 
refined screening-level and quantitative drinking water exposure 
assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. The acute aggregate risk assessment takes into 
account exposure estimates from dietary consumption of fosetyl-Al (food 
and drinking water). However, no appropriate endpoint attributable to a 
single dose (exposure) was identified in oral toxicity studies for 
fosetyl-Al. Therefore, fosetyl-Al is not expected to pose an acute 
risk.
    2. Chronic risk. The chronic aggregate risk assessment takes into 
account average exposure estimates from food, drinking water, and 
residential uses. However, based on the use pattern, no chronic 
residential exposures are expected. Therefore, the chronic aggregate 
risk assessment will consider exposure from food and drinking water 
only. Chronic risk estimates resulting from aggregate exposure to 
fosetyl-Al in food and water are below Agency's LOC.
    Using the exposure assumptions described in this unit for chronic 
exposure, EPA has concluded that exposure to fosetyl-Al from food will 
utilize 4% of the cPAD for the U.S.

[[Page 11333]]

population, 5% of the cPAD for infants and 8% of the cPAD for children 
1-6 years old, subpopulation at greatest exposure. Based the use 
pattern, chronic residential exposure to residues of fosetyl-Al is not 
expected. In addition, there is potential for chronic dietary exposure 
to fosetyl-Al in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface water and ground water, EPA does not 
expect the aggregate exposure to exceed 100% of the cPAD, as shown in 
Table 1 of this unit:

                        Table 1.--DWLOCs for Chronic (Non-Cancer) Exposure to fosetyl-Al
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                                                                             Surface       Ground      Chronic
             Population Subgroup\1\              cPAD mg/kg/     %cPAD      Water EEC    Water EEC      DWLOC
                                                     day         (Food)      (ppb)\2\     (ppb)\2\     (ppb)\3\
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U.S. Population................................          2.5            4      0.00003        0.006       84,000
Children (1-6 years old).......................          2.5            8      0.00003        0.006       23,000
All infants (< 1 year old).....................          2.5            5      0.00003        0.006       24,000
Female (13-50 years old).......................          2.5            3      0.00003        0.006       73,000
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1 Within each of these subgroups, the subpopulation with the highest food exposurehaving an adequately
  representative number of samples was selected. Default body weights are: General U. S. population, 70 kg;
  females (13 plus years old), 60 kg; and, All Infants/Children, 10 kg.
2 Estimate for the highest use rate was chosen.
3 DWLOC ([mu]g/L) = [Maximum water exposure (mg/kg/day) X body wt (kg) divided by (10-3 mg/[mu]g) X water
  consumed daily (L/day)]. [mu]g/L = parts per billion. Default daily drinking rates are 2 L/day for Adults and
  1 L/day for Infants/Children.

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    The short-term aggregate risk assessment estimates risks likely to 
result from 1 to 30 day exposure to fosetyl-Al residues from food, 
drinking water, and residential pesticide uses. High-end estimates of 
residential exposure are used in the short-term assessment, while 
average values are used for food and drinking water exposure (i.e. 
chronic exposures).
    A short-term risk assessment is required for adults because there 
is a residential handler inhalation exposure scenario. In addition, a 
short-term risk assessment is required for infants and children because 
there is a residential post-application oral exposure scenario. As no 
short- or intermediate-term dermal endpoint was established, there is 
no dermal component to these aggregate risk assessments.
    Fosetyl-Al is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for fosetyl-Al.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 3,300 for adults, 570 for 
children ages 1-6 years old, and 650 for all infants < 1 year old. 
These aggregate MOEs do not exceed the Agency's level of concern for 
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic 
exposure of fosetyl-Al in ground water and surface water. After 
calculating DWLOCs and comparing them to the EECs for surface water and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's level of concern, as shown in Table 2 of this unit:

                    Table 2.--Aggregate Risk Assessment for Short-Term Exposure to fosetyl-Al
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                              Aggregate MOE     Level of     Surface       Ground     Short-Term
            Population Subgroup                  (Food +        Concern     Water EEC    Water EEC      DWLOC
                                             Residential)\1\    (LOC)\2\     (ppb)\3\     (ppb)\3\     (ppb)\4\
----------------------------------------------------------------------------------------------------------------
Adults.....................................          3,300            100      0.00003        0.006      102,000
Children (1-6 years old)...................            570            100      0.00003        0.006       25,000
All infants (<1 year old)..................            650            100      0.00003        0.006       25,000
----------------------------------------------------------------------------------------------------------------
1 Aggregate MOE = [NOAEL (300 mg/kg/day) / (Avg Food Exposure + Residential Exposure)]
2 The LOC is 100, based on interspecies and intraspecies safety factors totaling 100.
3 The crop producing the highest level was used.
4 DWLOC([mu]g/L) = [Maximum water exposure (mg/kg/day) x body weight (kg) / water consumption (L) x 10-3 mg/
  [mu]g]
For adults, a 70 kg body weight was used, for children, 10 kg.

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    An intermediate-term risk assessment was not performed since adult 
residential handler scenarios are not expected to occur for longer than 
a short-term timeframe (more than 30 days of continuous exposure) and 
intermediate-term exposure is not likely to occur for infants and 
children (residential post-application oral exposure scenario) because 
fosetyl-Al has a very short half-life (less than 3 hours in aerobic 
soil).
    5. Aggregate cancer risk for U.S. population. The Agency concludes 
that pesticidal uses of fosetyl-Al are not likely to pose a 
carcinogenic hazard to humans. Therefore, an aggregate cancer risk 
assessment was not performed.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to fosetyl-Al residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method is available for enforcement of the 
proposed tolerances in/on onion, green. The method is Method I in PAM 
II, which uses diazomethane as the

[[Page 11334]]

methylating agent and quantitation of fosetyl-Al by GC/FPD. The method 
may be requested from: Francis Griffith, Analytical Chemistry Branch, 
Environmental Science Center, Environmental Protection Agency, 701 
Mapes Road, Fort George G. Mead, MD 20755-5350; telephone number: (410) 
305-20905; e-mail address: [email protected].

B. International Residue Limits

    There is no established or proposed maximum residue limit (MRL) or 
tolerance for fosetyl-Al in or on onion, green for Canada, Mexico, or 
Codex.

V. Conclusion

    Therefore, the tolerance is established for residues of fosetyl-Al, 
aluminum tris (O-ethylphosphonate), in or on onion, green at 10 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2002-0348 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before May 9, 
2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2002-0348, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statuatory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any

[[Page 11335]]

unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review 
or any Agency action under Executive Order 13045, entitled Protection 
of Children from Environmental Health Risks and Safety Risks (62 FR 
19885, April 23, 1997). This action does not involve any technical 
standards that would require Agency consideration of voluntary 
consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and 
exemptions that are established on the basis of a petition under 
section 408(d) of the FFDCA, 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. 
In addition, the Agency has determined that this action will not have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 28, 2003.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. Section 180.415 is amended by alphabetically adding an entry for 
``Onion, green'' to the table in paragraph (a) to read as follows:


Sec.  180.415  Aluminum tris (O-ethylphosphonate); tolerance for 
residues.

    (a) * * *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   Revocation Date
------------------------------------------------------------------------
                                * * * * *
Onion, green......................               10.0               None
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 03-5616 Filed 3-7-03; 8:45 am]
BILLING CODE 6560-50-S