[Federal Register: March 10, 2003 (Volume 68, Number 46)]
[Rules and Regulations]
[Page 11330-11335]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr03-5]
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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: jackson.sidney@epa.gov.
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
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
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
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
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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: griffith.francis@epa.gov.
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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov. 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