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Fluthiacet-methyl. December 21, 2001. Pesticide Tolerances for Corn. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2001/December/Day-21/p31497.htm
[Federal Register: December 21, 2001 (Volume 66, Number 246)]
[Rules and Regulations]
[Page 65839-65850]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21de01-12]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301184; FRL-6806-7]
RIN 2070-AB78
Fluthiacet-methyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
fluthiacet-methyl in or on field corn grain, field corn forage, field
corn stover, pop corn grain, pop corn stover, sweet corn, kernels plus
cob husk removed (K+CWHR), sweet corn forage, and sweet corn stover. K-
I Chemical, U.S.A. Inc., 11 Martine Avenue, 9th Floor, White Plains,
New York 10606 requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act
(FQPA) of 1996.
DATES: This regulation is effective December 21, 2001. Objections and
requests for hearings, identified by docket control number OPP-301184,
must be received by EPA on or before February 19, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301184 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 305-6224; and e-mail
address: miller.joanne@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS Codes Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply
[[Page 65840]]
to certain entities. If you have questions regarding the applicability
of this action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301184. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of April 14, 1997 (62 FR 18116) (FRL-5599-
7), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C.
346a as amended by the of FQPA 1996 (Public Law 104-170) announcing the
filing of a pesticide petition (PP) for tolerance by K-I Chemical
U.S.A., Inc., 11 Martine Avenue, 9th Floor, White Plains, NY 10606.
This notice included a summary of the petition prepared by K-I Chemical
U.S.A. Inc., the registrant. There were no comments received in
response to the notice of filing. In the Federal Register of October 6,
1998 (63 FR 53656) (FRL-6033-8), EPA issued a notice pursuant to the
same Acts, announcing an amendment to the petition. There were no
comments received in response to the notice of filing. Addition
tolerances for residues of fluthiacet-methyl per se in or on cottonseed
and cotton gin by products were requested; however, a revised Section F
to the petition was submitted in which these tolerances were not
requested.
The petition requested that 40 CFR 180.551 be amended by
establishing a tolerance for residues of the herbicide, fluthiacet-
methyl, acetic acid, [2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-1H,3H-
[1,3,4]thiadiazolo[3,4-a]pyridazin-1-
ylidene)amino]phenyl]thio]-methyl ester), in or on corn, field, grain
at 0.010 part per million (ppm); corn, field, forage at 0.050 ppm;
corn, field, stover at 0.050 ppm; corn, pop, grain at 0.010 ppm; corn,
pop, stover at 0.050 ppm; corn, sweet, forage at 0.050 ppm; corn,
sweet, K + CWHR at 0.010 ppm; and corn, sweet, stover at 0.050 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue''.
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961) (FRL-5754-7) November 26, 1997.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for residues of fluthacet-methyl on corn,
field, grain at 0.010 ppm; corn, field, forage at 0.050 ppm; corn,
field, stover at 0.050 ppm; corn, pop, grain at 0.010 ppm; corn, pop,
stover at 0.050 ppm; corn, sweet, forage at 0.050 ppm; corn, sweet, K +
CWHR at 0.010 ppm; and corn, sweet, stover at 0.050 ppm. EPA's
assessment of 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 fluthiacet-methyl
are discussed in the following Table 1 as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from the toxicity studies reviewed.
[[Page 65841]]
Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-day oral Rats:
Toxicity, rats and NOAEL = 6.19
mice. milligrams/
kilograms day (mg/
kg/day) in males
6.80 mg/
kg/day in females
LOAEL = 216 mg/
kg/day in males
249 mg/
kg/day in females
Mice:
NOAEL = 1.3 mg/kg/
day in males
1.6 mg/
kg/day in females
LOAEL = 66 mg/kg/
day in males
83 mg/kg/
day in females
Based on decreased
body weight gains
as well as
effects on
hematology,
clinical
chemistry,
urinalysis
parameters, liver
weights and
microscopic
pathology in
rats; and on
effects on the
erythropoietic
system and liver
in mice.
------------------------------------------------------------------------
870.3150 6-week oral NOAEL = 236 mg/kg/
toxicity in dogs day in males
77.7 mg/
kg/day in females
LOAEL = 709 mg/kg/
day in males
232 mg/
kg/day in females
based on
decreased body
weight gain.
------------------------------------------------------------------------
870.3200 28-day dermal NOAEL = 1,000 mg/
toxicity in rats kg/day, the
highest dose
tested (HDT).
------------------------------------------------------------------------
870.3700 Prenatal Maternal in rats:
developmental in NOAEL = 1,000 mg/
rats kg/day, HDT
and rabbits....... Maternal in
rabbits:
NOAEL = 1,000 mg/
kg/day, HDT
Developmental in
rabbits:
NOAEL = 300 mg/kg/
day
Developmental in
rabbits:
LOAEL of 1,000 mg/
kg/day based on
slight non-
significant
increased
incidence of
irregularly
shaped sternebrae
attributed to a
delay in fetal
development. (See
section D., 2.)
------------------------------------------------------------------------
870.3800 2-generation Parental/systemic
Reproduction and NOAEL = 1.59 mg/kg/
fertility effects. day in males
LOAEL = 31.8 mg/kg/
day in males
NOAEL = 1.73 mg/kg/
day in females
LOAEL = 35.2 mg/kg/
day in females
based on
reduction in male
body weights/
gains and hepatic
pathology
Reproductive in
males:
NOAEL = 31.8 mg/kg/
day
LOAEL =313 mg/kg/
day
Reproductive in
females:
NOAEL = 37.1 mg/kg/
day
LOAEL = 388 mg/kg/
day based on
decreases in mean
litter body
weights.
------------------------------------------------------------------------
870.4100 Chronic toxicity NOAEL in males =
dogs 57.6 mg/kg/day
LOAEL in males =
582 mg/kg/day
NOAEL in females =
30.3 mg/kg/day
LOAEL in females =
145 mg/kg/day
The LOAELs were
based on effects
observed in the
erythropoietic
system and liver.
------------------------------------------------------------------------
870.4200 Carcinogenicity NOAEL in males =
rats 2.1 mg/kg/day
LOAEL in males =
130 mg/kg/day
NOAEL in females =
2.5 mg/kg/day
LOAEL in females =
154 mg/kg/dayIn
males there were
decreased body
weight, liver
toxicity,
pancreatic
toxicity and
microcytic
anemia. In
females there
were liver
toxicity, uterine
toxicity and
slight microcytic
anemia. In males
only at 130 and
219 mg/kg/day
there was
respectively, an
increase in the
trend toward
pancreatic
exocrine adenomas
and pancreatic
islet cell
adenomas.
------------------------------------------------------------------------
[[Page 65842]]
870.4300 Carcinogenicity NOAEL in males and
mice females = 0.1 mg/
kg/day
LOAEL in males and
females = 0.1 and
1.2 mg/kg/day,
respectively,
based on non-
neoplastic liver
findings. In
males, and
possibly females,
at 10 mg/kg/day
for males and 12
mg/kg/day for
females; and at
32 gm/kg/day for
males and 37 mg/
kg/day for
females, there
was an increase
in the number of
mice with
hepatocellular
adenomas,
carcinomos and or
adenomas/
carcinomas.
------------------------------------------------------------------------
870.1000 Gene mutation Flutiacet-methyl
was negative for
mutagenic/
genotoxic effects
in bacterial or
cultured
mammalian cells
and did not cause
DNA damage in
bacterial or
primary rat
hepatocytes.
------------------------------------------------------------------------
870.5375 Cytogenetics In vitro
cytogenetic
assays performed
with two
different
mammalian cell
lines
demonstrated that
fluthiacet-methyl
is clastogenic
both in the
presence and
absence of S9
activation.
------------------------------------------------------------------------
870 Other effects Flutiacet-methyl
was negative for
micronuclei
induction in
mouse bone
marrow, a
significant
increase in
micronuclei was
seen in
stimulated rat
liver cells
following in vivo
exposure.
------------------------------------------------------------------------
870.6200 Acute NOAEL = 2,000 mg/
neurotoxicity kg/day, with no
screening battery effects at HDT
in rats
------------------------------------------------------------------------
870.6200 Subchronic NOAEL in males =
neurotoxicity 0.576 mg/kg/day
screening battery (systemic)
in rats LOAEL in males =
556 mg/kg/day
based on
decreased body
weight and food
consumption
NOAEL in females =
1,345 mg/kg/day
(HDT) (systemic)
NOAEL in males =
1,128 mg/kg/day
(neurotoxicity)
NOAEL in females =
1,345 mg/kg/day
(neurotoxicity)
------------------------------------------------------------------------
870.7485 Metabolism and Fluthiacet-methyl
pharmaco-kinetics was absorbed
in rats rapidly at both
low and high
dosages in both
male and female
rats. Repeated
oral dosing had
no effect on
extent of
absorption.
Tissue levels of
radio active
fluthiacet-methyl
in single and
repeated low dose
groups did not
exceed 0.018 ppm
in any tissue. At
the single high
dose, female rats
showed higher
levels of
radioactivity in
tissues than
males except for
muscle, brain,
fat and plasma.
Excretion in
males was
predominantly in
feces for all
dose groups, with
between 67 to 87%
of administered
radioactivity
excreted by this
route. In
females, the
percentage of
administered
radioactivity in
urine across all
dose groups 40 to
48% was
approximately
equivalent to the
percent excreted
in feces, 39 to
52%. The greater
fecal excretion
in males was
based on a
greater
percentage
excretion in bile
for males, 37%
vs. females 19%.
------------------------------------------------------------------------
870.7600 Dermal penetration No dermal
penetration
studies were
submitted.
------------------------------------------------------------------------
Special studies There were no
required special
studies
------------------------------------------------------------------------
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 LOAEL 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 intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose, (acute RfD or
chronic RfD), where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of
[[Page 65843]]
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 fluthiacet-methyl used for
human risk assessment is shown in the following Table 2:
Table 2. --Summary of Toxicological Doses and Endpoints for Fluthiacet-methyl for Use in Human Risk Assessment.
----------------------------------------------------------------------------------------------------------------
Exposure Scenario Dose (mg/kg/day) Endpoint Study
----------------------------------------------------------------------------------------------------------------
Acute Dietary None No appropriate endpoint None
attributable to a
single dose (exposure)
was identified in oral
toxicity studies.
Therefore, an acute
reference dose (RfD)
was not established.
Thus, an acute
exposure/risk
assessment was not
conducted.
----------------------------------------------------------------------------------------------------------------
NOT REQUIRED
----------------------------------------------------------------------------------------------------------------
Chronic Dietary NOAEL = 0.1 mg/kg/day Non-neoplastic liver 18-month
General population................... findings (increase in carcinogenicity in the
absolute and relative mouse
liver weights, fatty
changes, chronic
inflammation,
karyomegaly, single
cell necrosis and
ceroid/lipofuscin
pigmentation).
--------------------------------------------------
UF = 100 Chronic RfD = 0.001 mg/
FQPA SF = 1............ kg/day
Chronic PAD = 0.001 mg/
kg/day.
----------------------------------------------------------------------------------------------------------------
Short-term and intermediate-term None No dermal or systemic 28-day dermal in the
(dermal) toxicity was seen at rat
the limit-dose
following repeated
dermal applications to
rats.
----------------------------------------------------------------------------------------------------------------
Long-term (dermal) see footnote 1 NOAEL = 0.1 mg/kg/day Non-neoplastic liver 18-month
below table findings (increase in carcinogenicity in the
absolute and relative mouse
liver weights, fatty
changes, chronic
inflammation,
karyomegaly, single
cell necrosis and
ceroid/lipofuscin
pigmentation).
----------------------------------------------------------------------------------------------------------------
Inhalation (Any time period) None The LC50 for males and None
females was >5,048
± 225 mg/m3
(>5.0 mg/L). Based on
the low acute toxicity
(Toxicity Category 4),
the composition of the
end-use product
(5.36%) and the
application rate
(0.0089 lb ai/acre/
season or 4.0 g ai/
acre/season), an
inhalation exposure/
risk assessment was
not conducted.
----------------------------------------------------------------------------------------------------------------
[[Page 65844]]
Cancer (Chronic) Q1* = 2.07E-1 The HED, CARC (HED 78-week carcinogenicity
(mg/kg/day)-1.......... Cancer Assessment in the mouse
(In human equivalents). Review Committee)
recommended a linear
low-dose approach
(Q1*) for human risk
characterization and
determined that
extrapolation should
be based on the
combined
hepatocellular tumors
(adenomas and
carcinomas) in male
mice.
----------------------------------------------------------------------------------------------------------------
1= Long-term dermal Since an oral study was selected and there is no dermal absorption study, a 100% dermal
absorption factor (default value) was used.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.551) for the residues of fluthiacet-methyl, in
or on a variety of raw agricultural commodities. There are presently no
tolerances established for meat, milk, poultry and eggs. Based upon the
results of a ruminant feeding study and a goat metabolism study, this
Agency concluded that there is no reasonable expectation of finite
residues in ruminant tissues and milk. Based upon the results of a
poultry metabolism study, fluthiacet-methyl and its metabolite (CGA-
300403) are unlikely to occur in poultry or eggs. Risk assessments were
conducted by EPA to assess dietary exposures from fluthiacet-methyl 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. There were no toxicological effects that could be
attributed to a single oral exposure (dose) in an appropriate
toxicological study. Thus, an acute exposure/risk assessment was not
conducted for fluthiacet-methyl.
ii. Chronic exposure. Percent crop treated (PCT), anticipated
market share percentages and tolerance level residues were used.
A chronic reference dose (RfD) (0.001 mg/kg/day) was identified for
fluthiacet-methyl, based on non-neoplastic liver findings (increase in
absolute and relative liver weights, fatty changes, chronic
inflammation, karyomegaly, single cell necrosis and ceroid/lipofuscin
pigmentation). The chronic PAD is the same as the chronic RfD since the
FQPA factor was reduced to 1X. The chronic PAD was used to assess
chronic risk.
EPA's Office of Pesticide Programs (OPP) Health Effects Division
used Dietary Exposure Evaluation Model (DEEMTM), version
7.075) software for conducting a chronic dietary (food) exposure
analysis. DEEM TM is a dietary exposure analysis system
developed by Novigen Sciences, Inc. that is used to estimate exposure
to pesticide residues in foods comprising the diets of the U.S.
population, including population subgroups. DEEMTM contains
food consumption data as reported by respondents in the USDA Continuing
Surveys of Food Intake by Individuals conducted in 1989-1992.
A Tier 2 chronic DEEMTM analysis was performed. The
assumptions of this Tier 2 analysis were tolerance level residues and
estimates of PCT for soybeans and projected market-share for corn
commodities. The following tolerance levels were used in the analysis:
soybeans at 0.01 ppm, sweet corn at 0.01 parts per million (ppm), pop
corn at 0.01 ppm, and corn grain (field corn) at 0.01 ppm. These values
were also used for corresponding processed commodities since processing
studies for soybeans and field corn showed no concentration of residues
into processed commodities. Thus, default concentration factors for
corn grain, bran; corn grain, endosperm; corn grain, oil; soybean,
other; soybeans, sprouted seeds; soybeans, flour (defatted, low fat,
and full fat); soybean, oil; and soybean, protein isolate were set to
1X. DEEMTM default processing factors for corn grain/sugar/
hfcs (1.5X), and corn grain/sugar-molasses (1.5X) were retained as
processing data for these commodities are not available. A PCT value of
1% was used for soybeans and a projected market share value of 1% was
used for all types of corn. These estimates of PCT/projected market
share were derived based on Agency analysis of information on weed-
pests for the use sites.
The chronic dietary exposure (food only) to fluthiacet-methyl for
some population subgroups are presented in Table 3. The resulting
dietary food exposures occupy <1% of the Chronic PAD for all population
subgroups included in the analysis. The results of this dietary
exposure analysis should be viewed as partially refined. Refinements
such as use of anticipated residue values may yield even lower
estimates of chronic dietary exposure.
Table 3.--Summary: Chronic Dietary Exposure Analysis by DEEM (Tier 2)
------------------------------------------------------------------------
Exposure (mg/kg/
Population Subgroup1 day) % of Chronic PAD2
------------------------------------------------------------------------
U.S. population (total) <0.000001 <1.0
------------------------------------------------------------------------
All Infants (<1 year) 0.000001 <1.0
------------------------------------------------------------------------
Children (1-6 years) <0.000001 <1.0
------------------------------------------------------------------------
Children (7-12 years) <0.000001 <1.0
------------------------------------------------------------------------
Males (20+ years) <0.000001 <1.0
------------------------------------------------------------------------
Females (13-50 years) <0.000001 <1.0
------------------------------------------------------------------------
1The subgroups listed are: (1) The U.S. population (total); (2) those
for infants and children; and, (3) the most highly exposed of the
adult females and males subgroups (in this case, females, 13 to 50
years and males 20+ years).
2 Percent chronic PAD = (exposure chronic PAD) x 100%.
Note: There are no other subgroup(s) (other than All Infants) for which
the percentage of the Chronic PAD occupied is greater than that
occupied by the subgroup U. S. population (total).
[[Page 65845]]
iii. Cancer. Fluthiacet-methyl has been classified as ``likely to
be a human carcinogen'' by EPA. The Office of Pesticide Programs, Heath
Effects Division, Cancer Assessment Review Committee recommended a
linear low-dose approach (Q1*) for human risk
assessment. The Q1* is 0.207 (mg/kg/day)-1 in
human equivalents and is based upon the combined hepatocellular tumors
(adenomas and carcinomas) in male mice.
EPA conducted a cancer assessment analysis (food) using DEEM
software and Tier 2 chronic dietary exposure assumptions. The
assumptions of this Tier 2 chronic dietary analysis are as specified
above.
The cancer risk estimate (food only) for the U.S. population
(total) is 3.93 x 10-8. This risk estimate translates to a
dietary exposure of 1.90 x 10-7 mg/kg/day. This dietary
exposure value was back-calculated based upon the cancer risk estimate
and the Q1*. As cancer risk = Exposure x
Q1 * Thus, Exposure = cancer risk estimate/
Q1 * or Exposure = 3.93 x 10-8/0.207.
iv. Anticipated residue and PCT information. Anticipated residues
estimates were not used in the exposure analysis. Tolerance levels were
used and a projected market share estimate was used as described in the
chronic exposure section above.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F), EPA may require registrants to submit data on
PCT.
The Agency used PCT information as follows: Percent projected
market share: Corn, 1% and soybeans, 1%. Currently the largest market
share for a pesticide for control of velvetleaf in corn or cotton is
less than 20%. While the Agency does not expect the PCT to exceed 1%
for corn or soybeans, it would be highly unlikely that the PCT approach
the 20% share. EPA has determined that if PCT was to reach 20% there is
still a reasonable certainty that no harm will result to the general
population, and to infants and children from aggregate exposure to
fluthiacet-methyl residues.
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. EPA believes the PCT used in this analysis is reasonable
based on factors used in the analysis; in particular, the number of
acres of corn and soybeans currently treated for the control of the
weed pest, velvetleaf, the primary target weed pest for which
fluthiacet-methyl will be used. This analysis also included competing
currently registered herbicides for this market. EPA estimates that
currently about 25 million acres of soybeans and 50 million acres of
corn are treated for control of velvetleaf. Corn acres are treated with
41 different herbicidal active ingredients (a.i.), and soybeans acres
are treated with 34 different herbicidal a.i.. For acute dietary
exposure estimates, EPA uses an estimated maximum PCT. The exposure
estimates resulting from this approach reasonably represent the highest
levels to which an individual could be exposed, and are unlikely to
underestimate an individual's acute dietary exposure. The Agency is
reasonably certain that the percentage of the food treated is not
likely to be an underestimation. As to Conditions 2 and 3, regional
consumption information and consumption information for significant
subpopulations is taken into account through EPA's computer-based model
for evaluating the exposure of significant subpopulations including
several regional groups. Use of this consumption information in EPA's
risk assessment process ensures that EPA's exposure estimate does not
understate exposure for any significant subpopulation group and allows
the Agency to be reasonably certain that no regional population is
exposed to residue levels higher than those estimated by the Agency.
Other than the data available through national food consumption
surveys, EPA does not have available information on the regional
consumption of food to which fluthiacet-methyl may be applied in a
particular area.
1. Dietary exposure from drinking water. The Agency currently lacks
sufficient water-related exposure data from monitoring to complete a
quantitative drinking water exposure analysis and risk assessment for
fluthiacet-methyl. Therefore, the Agency is presently relying on
computer-generated estimated environmental concentrations (EECs). The
PRZM/EXAMS Index Reservoir (IR) model was used to generate EECs for
surface water and the SCI-GROW2 (an empirical model based upon actual
monitoring data collected for a number of pesticides that serve as
benchmarks) was used to predict EECs in ground water. These models take
into account the use patterns and the environmental profile of a
pesticide, but do not include consideration of the impact that
processing raw water for distribution as drinking water would likely
have on the removal of pesticides from the source water. The primary
use of these models by the Agency at this stage is to provide a coarse
screen for determining that pesticides residues (and its metabolites)
in water are not of concern.
For any given pesticide, the SCI-GROW2 model generates a single EEC
value of pesticide concentration in ground water. That EEC is used in
assessments of both acute and chronic dietary risk. It is not unusual
for the ground water EEC to be significantly lower than the surface
water EECs. The PRZM/EXAMS IR model generates several time-based EECs
of pesticide concentration in surface water for acute exposure (upper
10th percentile of peak values), non-cancer chronic exposure
(upper 10th percentile of 90-day values), and cancer
exposure (mean annual value).
A drinking water level of comparison (DWLOC) is the concentration
of a pesticide in drinking water that would be acceptable as a
theoretical upper limit in light of total aggregate exposure to that
pesticide from food, water, and residential uses. HED 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 a pesticide, the DWLOC is
used as a point of comparison against the conservative EECs provided by
computer modeling.
[[Page 65846]]
EPA, OPP, HED back-calculates DWLOCs by a two-step process:
exposure [food + residential (if applicable)]
is subtracted from the
PAD to obtain the maximum acceptable exposure allowed in drinking
water; DWLOCs are then calculated using that value and HED default body
weight and drinking water consumption figures. In assessing human
health risk, DWLOCs are compared to EECs. When EECs are less than
DWLOCs, HED considers the aggregate risk from [food + water +
residential (if applicable) exposures]
to be acceptable.
2. Environmental profile. In soil, fluthiacet-methyl and its
metabolites are considered to be mobile and persistent (effective or
combined aerobic soil half-life of 305 days). The uncertainty of this
half-life is large as indicated by a 95% confidence range of roughly
200 to 1,100 days. Due to the large uncertainty a soil half-life of 915
days was used in the models. Fluthiacet-methyl is expected to be a
ground and surface water contaminant.
EPA, HED, Metabolism Assessment Review Committee (MARC) determined
that the residues of concern for risk assessment purposes in water are
residues that comprised greater than or equal to 10% of the total
radioactive residues in the environmental fate studies. These residues
include, but are not limited to, CGA-300402, CGA-300404, CGA-330057,
component E, CGA-300403, CGA-327066, CGA-327067, CGA-330059, A-CFPSA,
and ACA-CFPSA.
3. Estimated environmental concentrations (EECs). The modeling
results below are based on the combined concentrations of six
chemicals. These chemicals are the parent compound and metabolites CGA-
300402, CGA-300403, CGA-327066, CGA-327067, and A-CFPSA. The modeling
was conducted based on the environmental profile and two applications
at the rate of 0.0045 lbs ai/A (or a seasonal rate of 0.009 lbs ai/A).
The EECs are shown in Table 4.
Table 4.--EFED Estimated Environmental Concentrations (EECs)
------------------------------------------------------------------------
PRZM/EXAMS IR Model (µ
SCI-GROW2 (µg/L)1 g/L)
------------------------------------------------------------------------
0.08 0.8
(acute and chronic)....................... (for acute exposure)
0.5
(for chronic (non-cancer)
exposure)
0.06
(for cancer exposure)
------------------------------------------------------------------------
1 µg/L = parts per billion or ppb.
The Agency lacks sufficient monitoring exposure data to complete a
comprehensive dietary exposure analysis and risk assessment for
fluthiacet-methyl in drinking water. Because the Agency does not have
comprehensive monitoring data, drinking water concentration estimates
are made by reliance on simulation or modeling taking into account data
on the physical characteristics of fluthiacet-methyl.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The SCI-GROW model is used to predict pesticide concentrations in
shallow ground water. For a screening-level assessment for surface
water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a
tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that
uses a specific high-end runoff scenario for pesticides. While both
FIRST and PRZM/EXAMS incorporate an index reservoir environment, the
PRZM/EXAMS model includes a percent crop (PC) area factor as an
adjustment to account for the maximum PC coverage within a watershed or
drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
As the models used are considered to be screening tools in the risk
assessment process, the Agency does not use estimated environmental
concentrations (EECs) from these models to quantify drinking water
exposure and risk as a %RfD or %PAD. Instead DWLOCs are calculated and
used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Because DWLOCs address total aggregate exposure to fluthiacet-methyl
they are further discussed in the aggregate risk sections below.
Based on the PRZM/EXAMS and SCI-GROW 2 models the estimated
environmental concentrations (EECs) of fluthiacet-methyl for acute
exposures are estimated to be 0.8 ppb for surface water and 0.08 ppb
for ground water. The EECs for chronic exposures (non-cancer) are
estimated to be 0.5 ppb for surface water and 0.08 ppb for ground
water. The EEC for chronic (cancer) exposures are estimated to be 0.08
ppb for ground water and 0.06 ppb for surface water.
4. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Fluthiacet-methyl is not registered for use on any sites that would
result in residential exposure.
5. 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 fluthiacet-methyl 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,
fluthiacet-methyl 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 fluthiacet-methyl 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
[[Page 65847]]
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There was no indication of
quantitative or qualitative increased susceptibility of rats or rabbits
to in utero and/or prenatal/postnatal exposure to fluthiacet-mthyl. In
rabbits, in utero exposure did not result in maternal toxicity at 1,000
mg/kg/day. Developmental toxicity, however, was seen at this dose
characterized as an increase in irregular sternebrae (a variation which
is reversible). The occurrence of developmental toxicity at which no
maternal toxicity was noted indicates an apparent increase in
susceptibility. The Office of Pesticide Program's Hazard Identification
Assessment Review Committee (HIARC), however, determined that the
apparent susceptibility is not convincing because of the equivocal
nature of the effect based on: (1) The increased incidence of irregular
sternebrae was not statistically significant when compared to
concurrent controls; (2) the increase occurred at the Limit-Dose (1,000
mg/kg/day; (3) it was the only anomaly seen (i.e., a single variation);
(4) the dose response was not strong because there was only a small
increase in the litter incidence between the low- (5 mg/kg/day) and the
high-dose (1,000 mg/kg/day), with the mid- and high-dose groups having
8 litters with this variation;, and (5) this endpoint is appropriate to
establish a LOAEL and not appropriate for risk assessments. Based on
these factors, the HIARC concluded that there is no increased
susceptibility in the rabbit study. Therefore, the 10X FQPA safety
factor to ensure the protection of infants and children was not applied
in the risk assessments.
3. Conclusion. There is a complete toxicity data base for
fluthiacet-methyl and exposure data are complete or are estimated based
on data that reasonably accounts for potential exposures. The 10X FQPA
safety factor to protect infants and children was removed based on the
lack of increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure to this chemical.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)]. This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. An acute dietary endpoint for fluthiacet-methyl has
not been identified; therefore, fluthiacet-methyl is not expected to
pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fluthiacet-methyl from food will utilize <1% of the cPAD for the U.S.
population, <1% of the cPAD for all infants <1 year and <1% of the cPAD
for all children. There are no residential uses for fluthiacet-methyl
that result in chronic residential exposure to fluthiacet-methyl. Based
the use pattern, chronic residential exposure to residues of
fluthiacet-methyl is not expected. In addition, there is potential for
chronic dietary exposure to fluthiacet-methyl in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 5:
Table 5.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fluthiacet-methyl
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup %cPAD Water EEC Water EEC Chronic
(Food) (ppb) (ppb) DWLOC (ppb)
---------------------------------------------------------------------------------------------------------------
U.S. population <1.0 0.5 0.08 35
----------------------------------------------------------------------------------------------------------------
All infant <1.0 0.5 0.08 1.0
----------------------------------------------------------------------------------------------------------------
Females (13-20 years) <1.0 0.5 0.08 30
----------------------------------------------------------------------------------------------------------------
[[Page 65848]]
Males (20 + years) <1.0 0.5 0.08 35
----------------------------------------------------------------------------------------------------------------
Chronic PAD (cPAD) in mg/kg/day is 0.001 for all population subgroups.
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).
Fluthiacet-methyl is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
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).
Fluthiacet-methyl is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
5. Aggregate cancer risk for U.S. population. Fluthiacet-methyl has
been classified as ``likely to be a human carcinogen'' based upon the
combined hepatocellular tumors (adenomas and carcinomas in male mice.
6. Cancer aggregate risk conclusions. As summarized previously, the
cancer risk estimate (food only) for the U.S. population (total) is
3.93 x 10-8. This risk estimate translates to an exposure of
1.90 x 10-7 mg/kg/day. The results of this dietary exposure
analysis should be viewed as partially refined (health protective).
Refinements such as use of anticipated residue values may yield even
lower estimates of cancer exposure.
The EECs provided by EFED for assessing cancer risk are 0.08
µg/L (for ground water, based on SCI-GROW2) and 0.06
µg/L (for surface water, based on PRZM/EXAMS IR modeling). The
back-calculated DWLOC for assessing cancer aggregate dietary risk is
0.17 µg/L for the U.S. population (total).
The SCI-GROW2 and PRZM/EXAMS cancer EECs are less than the Agency's
level of comparison for fluthiacet-methyl residues in drinking water as
a contribution to chronic (cancer) aggregate exposure. HED thus
concludes with reasonable certainty that residues of fluthiacet-methyl
in drinking water will not contribute significantly to the aggregate
cancer human health risk and that the chronic (cancer) aggregate
exposure from fluthiacet-methyl residues in food and drinking water
will not exceed the Agency's level of concern (1X 106) for
the U.S. population. EPA generally has no concern for exposures below
which result in cancer risks in the range of 1 x 10-6,
because it is a level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to the health
and safety of any population subgroup. This risk assessment is
considered high confidence, very conservative, and protective of human
health.
7. 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 fluthiacet-methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (Method AG-603B, MRID No. 442345-
02), gas-liquid chromotography with a nitrogen/phosphorus detector, is
available to enforce the tolerances for fluthiacet-methyl in or on corn
and soybean commodities. The method may be requested from: Calvin
Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.
B. International Residue Limits
There are no Codex Alimentarius Commission (Codex), Canadian, or
Mexican Maximum Residue Levels (MRLs) for fluthiacet-methyl at this
time.
C. Conditions
Conditions for registration under the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA) will include Agency monitoring
for PCT as addressed within this Final Rule.
V. Conclusion
Tolerances are established for residues of fluthiacet-methyl in or
on corn. field, grain at 0.010 ppm; corn, field, forage, at 0.050 ppm;
corn, field, stover at 0.050 ppm; corn, pop, grain at 0.010 ppm; corn,
pop, stover at 0.050 ppm; corn, sweet, stover at 0.050 ppm; corn,
sweet, forage at 0.050 ppm; and corn, sweet, K + CWHR at 0.010 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 of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301184 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 February
19, 2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by
[[Page 65849]]
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 (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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 (202) 260-4865.
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.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301184, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: 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. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any prior consultation as specified in
Executive Order 13084, entitled Consultation and Coordination with
Indian Tribal Governments (63 FR 27655, May 19, 1998); special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the 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 FFDCA section 408(n)(4).
For these same reasons, the Agency has determined that this rule does
not have any ``tribal implications'' as described in Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of
[[Page 65850]]
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, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal government and Indian tribes, or on the distribution of power
and responsibilities between the Federal government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and record
keeping requirements.
Dated: December 8, 2001.
Peter Caulkins,
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 180.551 is amended by alphabetically adding commodities
to the table in paragraph (a) to read as follows:
Sec. 180.551 Fluthiacet-methyl; tolerances for residues.
(a) General. * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Corn, field, forage 0.050
Corn, field, grain 0.010
Corn, field, stover 0.050
Corn, pop, grain 0.010
Corn, pop, stover 0.050
Corn, sweet, forage 0.050
Corn, sweet, (K + CWHR) 0.010
Corn, sweet, stover 0.050
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 01-31497 Filed 12-20-01; 8:45 am]
BILLING CODE 6560-50-S
Note from FAN:
Stedman's Medical Dictionary
Erythropoietic (e-rith«ro-poy-et«ik). Pertaining to or characterized by erythropoiesis.
Erythropoiesis (e-rith«ro-poy-e«sis). The formation of red blood cells.erythrocytopoiesis.
Clastogen (klas«to-jen). An agent (e.g., certain chemicals, x-rays, ultraviolet light) that causes
breaks in chromosomes. [G. klastos, broken, + genos, birth]