FLUORIDE
ACTION NETWORK PESTICIDE
PROJECT
Return to
FAN's
Pesticide homepage
Return
to Chlorfenapyr
Index Page
Chlorfenapyr (BASF). September
26, 2003. Pesticide Tolerance. Final Rule. Federal
Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2003/September/Day-26/p24405.htm
[Federal Register: September 26, 2003 (Volume 68, Number 187)]
[Rules and Regulations]
[Page 55519-55527]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se03-19]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0146; FRL-7320-8]
Chlorfenapyr; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
chlorfenapyr [4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-
(trifluoromethyl)-1H-pyrrole-3-carbonitrile]
in or on vegetables,
fruiting, group 8. BASF Agro Research, now BASF Corporation 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 September 26, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0146,
must be received on or before November 25, 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: Ann Sibold, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-6502; e-mail address: sibold.ann@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you grow fruiting
vegetables in commercial greenhouses, consume vegetables that were
raised in commercial greenhouses, or provide pest control services to
commercial greenhouses. Potentially affected entities may include, but
are not limited to:
¥ Crop production (NAICS 111)
¥ Pesticide manufacturing (NAICS 32532)
¥ Other food crops grown under cover (NAICS 111419)
¥ Entomological services, agricultural; insect control for
crops (NAICS 115112)
¥ Agricultural production or harvesting crews (NAICS 115115)
This listing is not intended to be exhaustive, but rather provides
a guide
[[Page 55520]]
for readers regarding entities likely to be affected by this action.
Other types of entities not listed in this unit could also be affected.
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. 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-2003-0146. 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/. http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, 
a beta site
currently under development. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of September 13, 2000 (65 FR 55236) (FRL-
6742-3), 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 an amended pesticide petition (PP 6F4716) by BASF Agro
Research, now BASF Corporation, P.O. Box 400, Princeton, NJ 08543-0400,
now P.O. Box 13528, Research Triangle Park, NC 27709-3528. (The
original pesticide petition PP 6F4716 was filed by American Cyanamid
(now BASF Agro Research) in 1996). The 2000 notice included a summary
of the petition prepared by BASF Agro Research, the registrant. There
were no comments received in response to the notice of filing.
The petition requested that 40 CFR 180.513 be amended by
establishing a tolerance for residues of the insecticide chlorfenapyr,
[4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-
pyrrole-3-carbonitrile], in or on vegetables, fruiting, group 8 at 1.0
parts per million (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) 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. . .
.''
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 chlorfenapyr on
vegetables, fruiting, group 8 at 1.0 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 chlorfenapyr are
discussed in Table 1 of this unit as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.
[[Page 55521]]
Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
MRID No. (year)/
Guideline No. Study Type Classification/Doses Results
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity 42770219 (1993) NOAEL = 24.1 mg/kg/day
rats Acceptable/guideline... LOAEL = 48.4, based on
0, 150, 300, 600, 900, spongiform myelopathy
1,200 ppm. in the brain and spinal
0, 11.7, 24.1, 48.4, cord of male rats,
72.5, 94.5 mg/kg/day. decreased body weight
gain and increased
relative liver weight
in males and females,
increased absolute
liver weight in
females, and decreased
hemoglobin in females
----------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity 43492830 (1994) NOAEL = 27.6/40, M/F
mouse Acceptable/guideline... LOAEL = 62.6/78, M/F,
0, 40, 80, 160, 320.... based on reduced body
M: 0, 7.1, 14.8, 27.6, weights/body weight
62.6 mg/kg/day. gains, and spongiform
F: 0, 9.2, 19.3, 40, 78 encephalopathy in both
mg/kg/day. sexes
----------------------------------------------------------------------------------------
870.3150 90-Day oral toxicity 42770220 (1993) NOAEL = 3.9/4.5 mg/kg/
dog Acceptable/guideline... day, M/F
0, 60, 120,= LOAEL = 6.7/6.8 mg/kg/
247* ppm. day, M/F, based on
M: 0, 2.1, 3.9, 6.7 mg/ emaciation, decreased
kg/day. body weight gains, and
F: 0, 2.2, 4.5, 6.8 mg/ decreased food
kg/day. efficiency
*High dose animals
received 300 ppm
during days 1-15, 240
ppm during days 15-25,
and 200 ppm during
days 25-93.
----------------------------------------------------------------------------------------
870.3200 21/28-Day dermal 43492831 (1993) NOAEL = 100 mg/kg/day
toxicity rabbit Unacceptable/guideline LOAEL = 400 mg/kg/day,
due to incomplete for both sexes, based
histopathological on changes in liver
examination. chemistry and
0, 100, 400, 1,000 mg/ morphology
kg/day.
----------------------------------------------------------------------------------------
870.3700 Prenatal developmental 42884202 (1993) Maternal NOAEL = 25 mg/
rat Acceptable/guideline... kg/day
0, 25, 75, 225 mg/kg/ Maternal LOAEL = 75 mg/
day. kg/day, based on
decreased body weight
gain and relative food
consumption during
treatment
Developmental NOAEL
>=225 mg/kg/day
Developmental LOAEL =
not identified
----------------------------------------------------------------------------------------
870.3700 Prenatal developmental 42770222 (1993) Maternal NOAEL = 5 mg/kg/
rabbit Acceptable/guideline... day
0, 5, 15, 30 mg/kg/day. Maternal LOAEL = 15 mg/
kg/day, based on
decreased body weight
gain during treatment
Developmental NOAEL = 15
mg/kg/day
Developmental LOAEL = 30
mg/kg/day, based on
increased post
implantation loss
----------------------------------------------------------------------------------------
870.3800 2-Generation 43492836 (1994) Parental systemic NOAEL
reproduction and Acceptable/guideline... = 4.4-4.5 mg/kg/day, M
fertility effects rat 0, 60, 300, 600 ppm.... Parental systemic LOAEL
Premating doses for P1 = 22.2-22.5 mg/kg/day,
males/females: 0/0, M, based on decreased
4.5/5.0, 22.2/24.5, 44/ absolute body weight/
44.6 mg/kg/day. body weight gains of P1
Premating doses for F1 males during premating
males/females: 0/0, Offspring systemic NOAEL
4.4/5.1, 22.5/25.6, = 4.4-5.1 mg/kg/day
44.6/50.7 mg/kg/day. Offspring systemic LOAEL
= 22.2-25.6 mg/kg/day,
based on decreased pup
weights at weaning
Reproductive NOAEL >=44-
50.7 mg/kg/day
Reproductive LOAEL: not
identified
----------------------------------------------------------------------------------------
[[Page 55522]]
870.4100 Chronic toxicity dog 43492834 (1994) NOAEL = 4.0/4.5 mg/kg/
Acceptable/guideline... day, M/F
0, 60, 120, 240 ppm.... LOAEL = 8.7/10.1 mg/kg/
M: 0, 2.1, 4.0, 8.7 mg/ day, M/F, based on
kg/day. decreased body weight/
F: 0, 2.3, 4.5, 10.1 mg/ body weight gains
kg/day.
----------------------------------------------------------------------------------------
870.4200 Carcinogenicity mouse 43492838 (1994) NOAEL = 2.8/3.7 mg/kg/
Acceptable/guideline... day, M/F
0, 20, 120, 240 ppm.... LOAEL = 16.6/21.9 mg/kg/
M: 0, 2.8, 16.6, 34.5 day, M/F, based on
mg/kg/day. decreased body weight
F: 0, 3.7, 21.9, 44.5 gains, brain
mg/kg/day. vacuolation, and
scabbing of the skin
(males)
No evidence of
carcinogenicity
----------------------------------------------------------------------------------------
870.4300 Combined chronic/ 43492837 (1994) NOAEL = 15 mg/kg/day,
carcinogenicity in rat Acceptable/guideline... males
0, 60, 300, 600 ppm.... LOAEL = 30.8 mg/kg/day,
M: 0, 2.9, 15.0, 30.8 males, based on anemia
mg/kg/day. NOAEL = 3.6 mg/kg/day,
F: 0, 3.6, 18.6, 37 mg/ females
kg/day. LOAEL = 18.6 mg/kg/day,
females, based on
decreased body weight/
body weight gain
Classification:
``Suggestive Evidence
of Carcinogenicity, but
Not Sufficient to
Assess Human
Carcinogenic
Potential'' based on
significant trends in
liver tumors (adenomas
and combined adenomas/
carcinomas), malignant
histiocytic sarcomas,
and testicular cell
tumors in male rats and
uterine polyps in
female rats seen at the
highest dose
----------------------------------------------------------------------------------------
870.5100 Bacterial reverse 42770223 (1993) Negative for reverse
mutation Acceptable/Guideline... mutation in S.
typhimurium strains TA
98, TA 100, TA 1535, TA
1537, TA 1538 and E.
coli strain WP2 uvrA-
exposed up to
cytotoxicity (50 [mu]g/
plate, +/- S9)
----------------------------------------------------------------------------------------
870.5300 In vitro mammalian cell 42770224, 43187601 Independently performed
gene mutation in (1993) tests were negative up
Chinese hamster ovary Acceptable/Guideline... to a cytotoxic and
cells (CHO/HGPRT) precipitating
concentration (500
[mu]g/ml) in the
presence of S9
activation or the
solubility limit (250
[mu]g/ml) without S9
activation
----------------------------------------------------------------------------------------
870.5375 In vitro mammalian 43492843 (1994) The test was negative up
chromosome aberration Acceptable............. to 100 [mu]g/ml -S9 or
(CHO) 25 [mu]g/ml +S9; higher
doses with or without
S9 activation were
cytotoxic
----------------------------------------------------------------------------------------
870.5385 In vitro chromosome 43492839 (1994) The test was negative up
aberration assay in Acceptable/Guideline... to a precipitating
Chinese hamster lung level without S9
(CHL) cells activation (225 [mu]g/
ml) or a concentration
range of 3.5-14.1 [mu]g/
ml +S9. Higher S9-
activated doses (>=28
[mu]g/ml) were
cytotoxic
----------------------------------------------------------------------------------------
870.5395 Mammalian micronucleus 42770225, 43187602 The test was negative in
(mouse) (1993, 1994) mice administered
Acceptable/Guideline... single oral gavage
doses of 7.5-30 mg/kg
(males) or 5-20 mg/kg
(females). Clinical
toxicity (deaths in
males and diarrhea in
females) was seen at
the HDT. There was,
however, no evidence of
cytotoxicity for the
target organ
----------------------------------------------------------------------------------------
870.5550 Unscheduled DNA 42770226 (1993) Negative for inducing
synthesis Acceptable/Guideline... unscheduled DNA
synthesis in primary
rat hepatocyte cultures
exposed up to severely
toxic concentrations
(>=30 [mu]g/ml)
----------------------------------------------------------------------------------------
870.6200 Acute neurotoxicity 43492829 (1994) NOAEL = 45 mg/kg/day
screening battery rat Acceptable/guideline... LOAEL = 90 mg/kg/day,
0, 45, 90, 180 mg/kg... based on lethargy in
male rats on the day of
treatment
----------------------------------------------------------------------------------------
870.6200 Chronic neurotoxicity 43492833 (1994) NOAEL = 2.6/3.4 mg/kg/
rat Acceptable/Guideline... day, M/F
0, 60, 300, 600 ppm.... LOAEL = 13.6/18 mg/kg/
M: 0, 2.6, 13.6, 28.2 day, M/F, based on the
mg/kg/day. presence of
F: 0, 3.4, 18, 37.4 mg/ myelinopathic
kg/day. alterations in the
central nervous system
(CNS) in male rats and
decreased average body
weights/body weight
gains, food efficiency,
absolute food
consumption (females)
and water consumption
(males)
----------------------------------------------------------------------------------------
[[Page 55523]]
870.7485 Metabolism and 43492844 (1994) Low recoveries of the
pharmacokinetics rat Acceptable/guideline... radioactive dose in
20, 200 mg/kg/day...... urine and tissues
indicate limited
absorption of CL
303,630 (chlorfenapyr)
by rats. The
radioactivity in urine,
as a percent of
administered dose, from
the high dosed rats was
about half that from
the single and multiple-
low dosed rats. More
than 80% of the doses
were eliminated in the
feces. Most of the
radioactivity was
eliminated in the feces
and urine within 48
hours of dosing. After
7 days, 89-121% of the
dosed radioactivity was
recovered. At
sacrifice, female rats
had greater (about
twice) recovery of
radioactivity in the
carcass, blood, and fat
at all doses than did
males. The highest
recovery of
radioactivity from a
single organ was from
the liver (0.15-0.48%
of dose)
Metabolite and parent
compound accounted for
72-91% of the
radioactive doses.
Parent compound was the
major radioactive
component found in
excreta, accounting for
approximately 40-70% of
the administered doses.
Minor amounts of eight
primary and conjugated
metabolites and four
unidentified isolated
components were
detected, each at less
than 10% of the dosed
radioactivity. Liver
and kidney contained
several primary and
conjugated metabolites
and only minor levels
of the parent compound
(<=8.3% of the
radioactivity in the
sample). Based on the
metabolites identified,
the major deposition
route of orally
administered
chlorfenapyr is fecal
excretion of unaltered
parent compound. Other
pathways include
cleavage of the
ethoxymethyl side-
chain, followed by de-
alkylation and ring
hydroxylation, and some
degree of conjugation
of the de-alkylated,
ring-hydroxylated
metabolite. The two
rings of the molecule
are not cleaved.
Metabolites are
excreted primarily in
urine; accumulation in
tissues is minimal
----------------------------------------------------------------------------------------------------------------
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 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. An additional safety factor (SF) may be
required if the data base is incomplete. For chlorfenapyr EPA concluded
that a developmental neurotoxicity (DNT) study is required based on the
presence of neuropathology (CNS lesions) and neurotoxic signs seen in
adult rats (males) and mice (both sexes). EPA further concluded that a
UF of 10X is required until the data are received and evaluated. EPA
does not have sufficient reliable data justifying the selection of a
factor lower than the default 10X value for the additional SF for the
protection or infants and children for this data gap.
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 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.
A summary of the toxicological endpoints for chlorfenapyr used for
human risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for chlorfenapyr for Use in Human Risk Assessment.
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk Special FQPA SF* and Study and Toxicological
Exposure Scenario Assessment, UF LOC for Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of NOAEL = 15 mg/kg Special FQPA SF = 1X Developmental toxicity
age) UF = 1,000............ aPAD = aRfD / FQPA SF. study - rabbit
aRfD = 0.015 mg/kg.... = 0.015 mg/kg......... LOAEL = 30 mg/kg/day
based on increased
post-implantation loss
-----------------------------------------------------------------------------------------
[[Page 55524]]
Acute Dietary (General population NOAEL = 45 mg/kg Special FQPA SF = 1X Acute neurotoxicity
including infants and children) UF = 1,000............ aPAD = aRfD / FQPA SF. study - rat
aRfD = 0.045 mg/kg.... = 0.045 mg/kg......... LOAEL = 90 mg/kg/day
based on lethargy in
male rats
-----------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL= 2.6 mg/kg/day Special FQPA SF = 1X Chronic neurotoxicity
UF = 1,000............ cPAD = cRfD / FQPA SF. study - rat
cRfD = 0.003 mg/kg/day = 0.003 mg/kg/day..... LOAEL = 13.6/18 mg/kg/
day, M/F, based on the
presence of
myelinopathic
alterations in the CNS
in male rats and
decreased average body
weights, body weigh
gains, food
efficiency, absolute
food consumption (F),
and water consumption
(M)
Supporting this
endpoint are similar
CNS lesions and skin
lesions observed in
the mouse
carcinogenicity study
(NOAEL = 2.8)
----------------------------------------------------------------------------------------------------------------
*The reference to the special FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Risk assessments were
conducted by EPA to assess dietary exposures from chlorfenapyr 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. The Dietary Exposure Evaluation Model (DEEM[reg])
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1994-1996 and 1998 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 acute exposure assessments: Tolerance-level residues (not
anticipated residues); 100% crop treated for all registered and
proposed commodities; and default DEEM[reg]
Version 7.76 processing
factors for all commodities. EPA selected separate acute dietary
endpoints for females 13-50 years old and the general U.S. population
(including infants and children). Therefore, two separate acute dietary
exposure assessments were performed for females 13-49 years old and for
the general U.S. population and various population subgroups. These
assessments conclude that the acute dietary exposure estimates are
below EPA's LOC (<100% aPAD) at the 95th exposure percentile for
females 13-49 years old (15% aPAD), and the general U.S. population (6%
of the aPAD) and all other population subgroups. The most highly
exposed population subgroup (other than females 13-49 years old) is
children 1-2 years old, at 12% of the aPAD.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM[reg]
analysis evaluated the individual food
consumption as reported by respondents in the USDA 1994-1996, and 1998
nationwide CSFII and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: Tolerance-level residues (not anticipated residues); 100%
crop treated for all registered and proposed commodities; and default
DEEM[reg]
Version 7.76 processing factors for all commodities. An
assessment of the general U.S. population and various population
subgroups was conducted. This assessment concludes that the chronic
dietary exposure estimates are below EPA's LOC (<100% cPAD) for the
general U.S. population (24% of the cPAD) and all population subgroups.
The most highly exposed population subgroup is children 1-2 years old,
at 47% of the cPAD.
2. Dietary exposure from drinking water. The registered uses of
chlorfenapyr include: Termiticide use, crack and crevice use, and use
on ornamental plants grown in greenhouses. The proposed use is for
vegetable crops grown in greenhouses. When used according to label
directions, these uses are not expected to result in contamination of
drinking water.
3. 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). Chlorfenapyr is
registered for residential crack and crevice use and in-ground termite
use. EPA has addressed the issues of possible residential exposures to
chlorfenapyr when used according to label directions, either as a
termiticide or as a crack and crevice treatment. EPA concluded that
there is essentially no incidental-oral or dermal exposures. Further,
the low vapor pressure of chlorfenapyr makes inhalation exposure
negligible.
4. Cumulative effects from 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 chlorfenapyr has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to chlorfenapyr
and any other substances and chlorfenapyr 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 chlorfenapyr has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine
[[Page 55525]]
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative/.
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. There is no evidence
(qualitative or quantitative) for increased susceptibility following in
utero exposure in the developmental toxicity studies in rats and
rabbits or prenatal/postnatal exposure in the 2-generation reproduction
study in rats. In both the rat and rabbit developmental toxicity
studies maternal toxicity included decreased body weight gain. No
developmental toxicity was noted in rats up to the highest dose tested
of 225 mg/kg/day). Developmental toxicity in rabbits (increased post
implantation loss) occurred at a higher dose than maternal toxicity. In
the 2-generation reproduction study in rats, parental and offspring
toxicity included body weight decrements at similar doses. No
reproductive effects were noted up to the highest dose tested.
3. Conclusion. EPA evaluated the potential for increased
susceptibility of infants and children from exposure to chlorfenapyr.
EPA concluded that the toxicology data base was incomplete for FQPA
purposes because a required DNT has not been submitted. The DNT was
required due to the presence of neuropathology (central nervous system
lesions) and neurotoxic signs seen in adult rats (males) and mice (both
sexes). Other than lacking the DNT study, EPA identified no residual
uncertainties for prenatal/postnatal toxicity. This decision is based
on the following:
¥ There is no evidence (qualitative or quantitative) of
increased susceptibility of rat or rabbit fetuses to in utero exposure
in developmental toxicity studies. There is no evidence (qualitative or
quantitative) of increased susceptibility of rat offspring in the
multi-generation reproduction toxicity study.
¥ There are no concerns or residual uncertainties for
prenatal and postnatal toxicity in the available developmental and 2-
generation reproduction toxicity studies.
¥ The conservative residue assumptions used in the dietary
exposure risk assessments, and the completeness of the residue
chemistry database.
EPA concluded that a FQPA SF in the form of UFDB of 10X is required
until the data from the DNT study are received and evaluated. EPA does
not have sufficient reliable data justifying the selection of a factor
lower than the default 10X value for this data gap.
E. Aggregate Risks and Determination of Safety.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
chlorfenapyr will occupy 6% of the aPAD for the U.S. population, 15% of
the aPAD for females 13 years and older, 12% of the aPAD for children
1-2 years old and 3% of the aPAD for infants < 1 year old. As explained
in Unit III.C.2., there is no potential for acute dietary exposure to
chlorfenapyr in drinking water. EPA does not expect the aggregate
exposure to exceed 100% of the aPAD.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
chlorfenapyr from food will utilize 24% of the cPAD for the U.S.
population, 10% of the cPAD for infants < 1 year old and 47% of the
cPAD for children 1-2 years old. Based on the use pattern, chronic
residential exposure to residues of chlorfenapyr is not expected. There
is no potential for chronic dietary exposure to chlorfenapyr in
drinking water. EPA does not expect the aggregate exposure to exceed
100% of the cPAD.
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). Chlorfenapyr is
registered for use on sites that would result in negligible residential
exposure and no exposure from drinking water. Therefore, the aggregate
risk is equal to the risk from food, and does not exceed the Agency's
LOC.
IV. Other Considerations
A. Analytical Enforcement Methodology
1. Residue analytical methods. The proposed enforcement method is
M2427, a gas chromatography/electron capture detection (GC/ECD) method
with an limit of quantitation (LOQ) of 0.05 ppm. Method M2427 has been
subjected to a successful independent laboratory validation (ILV) as
well as an acceptable radiovalidation using samples obtained from
lettuce and tomato metabolism studies. A version of this method, M2284
was sent to EPA's Analytical Chemistry Branch (ACB) in Beltsville, MD
for a petition method validation (PMV) on oranges and citrus oil.
Although the PMV was successful, minor revisions were required. A new
version of analytical method M2284 with the recommended revisions has
not been submitted. The Agency's review of PP 6F4716 concluded that
method M2427 is adequate for data collection and tolerance enforcement
purposes pending submission of the rewritten method M2284. Since M2427
is similar to M2284, the petitioner was directed to rewrite Method
M2427 following the ACB comments regarding M2284. The petitioner has
submitted Method 2427.02, which contains the requested revisions.
2. Multiresidue method (MRM). The data requirement for MRM is
satisfied pending U.S. Food and Drug Administration (FDA) review and
acceptance of the MRM results. The petitioner previously submitted MRM
recovery data for chlorfenapyr through FDA Protocols A through E.
Protocols A and B were not applicable to chlorfenapyr. In Protocol C,
chlorfenapyr gave a good response with the electron capture detector on
three different GC columns. In Protocol D, using pears as a non-fatty
food representative, the 5% OV-101 column gave the greatest sensitivity
at 0.05 and 0.50 ppm. In Protocol E, chlorfenapyr eluted well on
Florisil in both the ethyl ether/petroleum ether system and the
alternate hexane/acetonitrile/methylene chloride system and gave
acceptable recovery.
Adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
[[Page 55526]]
B. International Residue Limits
There are no established Codex, Canadian, or Mexican maximum
residue levels (MRLs) for chlorfenapyr on fruiting vegetables;
therefore, harmonization of MRLs and U.S. tolerances is not an issue at
this time.
C. Conditions
The following data are required as a condition of registration: A
developmental neurotoxicity study to determine the cause/relationship
of potential central nervous system/myelinopathic alterations to
neurotoxicity in the developing young.
V. Conclusion
Therefore, the tolerance is established for residues of
chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-
(trifluoromethyl)-1H-pyrrole-3-carbonitrile, in or on vegetables,
fruiting, group 8 at 1.0 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-2003-0146 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 November
25, 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-2003-0146, 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. Statutory 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
[[Page 55527]]
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 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: September 22, 2003.
James Jones,
Director, 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. A new section heading and text are added to Sec. 180.513 to read as
follows:
Sec. 180.513 Chlorfenapyr; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide chlorfenapyr [4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-
5-(trifluoromethyl)-1H-pyrrole-3-carbonitrile]
in or on the following
raw agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Vegetables, fruiting, group 8.............................. 1.0
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 03-24405 Filed 9-25-03; 8:45 am]
BILLING CODE 6560-50-S