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Cyfluthrin. April 4, 2001. Pesticide Tolerance Petition. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2001/April/Day-04/p8142.htm
[Federal Register: April 4, 2001 (Volume 66, Number 65)]
[Notices]
[Page 17887-17891]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap01-65]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-1013; FRL-6772-5]
Notice of Filing a Pesticide Petition to Establish a Tolerance
for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket control number PF-1013, must be
received on or before May 4, 2001.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure
proper receipt by EPA, it is imperative that you identify docket
control number PF-1013 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@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 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/.
2. In person. The Agency has established an official record for
this action under docket control number PF-1013. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
[[Page 17888]]
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 Highway, 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.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-1013 in the subject line on the
first page of your response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by
e-mail to: opp-docket@epa.gov, or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-1013. Electronic comments may
also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI 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. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified under FOR FURTHER INFORMATION
CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in section 408(d)(2); however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data support granting of the petition. Additional data
may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: March 20, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by section 408(d)(3) of the FFDCA. The summary of the
petition was prepared by the petitioner and represents the view of the
petitioners. EPA is publishing the petition summary verbatim without
editing it in any way. The petition summary announces the availability
of a description of the analytical methods available to EPA for the
detection and measurement of the pesticide chemical residues or an
explanation of why no such method is needed.
Interregional Research Project Number 4 (IR-4)
0E6184 and 0E6075
EPA has received pesticide petitions (0E6184 and 0E6075) from the
Interregional Research Project Number 4 (IR-4), Technology Centre of
New Jersey, 681 US Highway #1 South, North Brunswick, NJ 08902-3390
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by
establishing tolerances for residues of the insecticide, cyfluthrin,
(cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropanecarboxylate in or on southern pea at 0.23 parts per
million (ppm) and dry peas (pigeon peas, chickpeas/garbanzo beans,
lentils) at 0.05 ppm. EPA has determined that the petitions contain
data or information regarding the elements set forth in section
408(d)(2) of the FFDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
support granting of the petitions. Additional data may be needed before
EPA rules on these petitions. This notice contains a summary prepared
by the registrant, Bayer Corporation, Box 4913, Kansas City, MO 64120-
0013.
A. Residue Chemistry
1. Plant metabolism. The metabolism of cyfluthrin in plants is
adequately
[[Page 17889]]
understood. The residue of concern is cyfluthrin.
2. Analytical method. Adequate analytical methodology (gas/liquid
chromatography with an electron capture detector) is available for
enforcement purposes.
3. Magnitude of residues. Complete residue data for cyfluthrin on
southern pea and dry peas have been submitted. The data support the
requested tolerances.
B. Toxicological Profile
1. Acute toxicity. The required toxicity studies for acute oral
lethal dose (LD)50 316.2 milligrams/kilograms (mg/
kg), dermal LD50 >5,000 mg/kg, inhalation lethal
concentration (LC)50 3 0.468 mg/Liter (L), primary
eye irritation (category III), primary dermal irritation (category IV),
and dermal sensitization have been conducted. Cyfluthrin is not a
dermal sensitizer.
2. Genotoxicity. Mutagenicity tests were conducted including three
reverse mutation assays (Salmonella typhimurium, E. coli and
Saccharomyces cerevisiae); one reverse mutation, mitotic recombination
and conversion assay in Saccharomyces cerevisiae; one Chinese hamster
ovary/hypoxanthine guanine phophoribosyl transferase (CHO/HGPRT) assay;
one sister chromatid exchange assay in CHO cells; and one unscheduled
DNA synthesis (UDS) assay in primary rate hepatocytes. All studies were
negative for mutagenicity.
3. Developmental and reproductive toxicity-- i.Oral developmental
study in rats/rabbits. Cyfluthrin was administered via gavage to
pregnant female rats during days 6-15 of gestation at dose levels of 0,
1, 3, or 10 mg/kg/day. The maternal lowest observed adverse effect
level (LOAEL) was not observed. The maternal no observed adverse effect
level (NOAEL) is 310 mg/kg/day. A developmental LOAEL was not
observed. The developmental NOAEL is 310 mg/kg/day.
ii. Developmental studies via inhalation in rats. In the first
study, pregnant female rats at day 0 gestation were exposed head-only
to cyfluthrin concentrations of 0, 1.1, 4.7 or 23.7 mg/m3/
day for 6 hours/day on gestation days 6-15.
In the second study, the dams were exposed to analytical
concentrations of 0, 0.09, 0.25, 0.59 or 4.2 mg/m3 of the
test material. The dams were sacrificed on day 20 and their pups
removed by caesarian section. Based on reduced motility, dyspnea,
piloerection, ungroomed coats and eye irritation, the maternal NOAEL
was 1.1 mg/m3 and the maternal LOAEL was 4.7 mg/
m3. The developmental NOAEL was 0.59 mg/m3 and
the developmental LOAEL was 1.1 mg/m3 based on increases in
the incidence of runts and skeletal anomalies in the sternum (at 1.1
mg/m3 (and higher)). Increases in post-implantation losses
and decreases in pup weights were observed at 4.7 mg/m3 (and
higher), and increased incidences of late embryonic deaths, in skeletal
anomalies in the extremities, pelvis, skull and microphthalmia was
observed at 23.7mg/m3.
In a third study, cyfluthrin was administered to female rats at
0.46, 2.55, 11.9 or 12.8 mg/m3 exposure levels for
gestational days 6-15 in a nose only inhalation chamber. The rats were
exposed to the test material 6 hr/day, 7 days/week. Both the maternal
NOAEL and LOAEL were <0.46 mg/m3 based on decreased body
weight gain and reduced relative food efficiency. The developmental
NOAEL and LOAEL were 0.46 mg/m3 and 2.55 mg/m3
respectively, based on reduced fetal and placental weight, reduced
ossification in the phalanx, metacarpals and vertebrae.
Cyfluthrin was administered in the diet to male and female rats in
dose levels of 0, 50, 150, or 450 ppm (actual animal intake; 0, 2.5,
7.5, or 22.5 mg/kg/day). The LOAEL for parental toxicity was 450 ppm
(22.5 mg/kg/day) based on decreased body weight gains. The NOAEL for
parental toxicity is 150 ppm (7.5 mg/kg/day). The LOAEL for
reproductive toxicity was 150 ppm (7.5 mg/kg/day) based on decreased
viability and lactational indices and decreased pup body weight gains.
The reproductive NOAEL was 50 ppm (2.5 mg/kg/day).
4. Subchronic toxicity--28 day oral toxicity studies in rats.
Cyfluthrin was administered to SPF-Wistar rats via gavage at 0, 5, 20,
or 80 (40) mg/kg/day. The high dose was 80 mg/kg/day during the first
and third weeks and 40 mg/kg/day during the second and fourth weeks.
The LOAEL was 80 (40) mg/kg/day in both sexes based on clinical signs
of nerve toxicity, decreases in body weight gain, and changes in liver
and adrenal weights. The NOAEL was 20 mg/kg/day.
Rats were dosed with cyfluthrin in the diet at 0, 100, 300, or
1,000 ppm (equivalent to 0, 5, 15,or 50 mg/kg/day). The LOAEL was 15
mg/kg/day in both sexes based on decreased blood glucose. The NOAEL was
5 mg/kg/day.
i. Three-month rat feeding study. SPF-Wistar rats were dosed with
cyfluthrin in the diet at 0, 30, 100, or 300 ppm (equivalent to 0, 1.5,
5, or 15 mg/kg/day) for 3 months. No treatment related effects were
observed at any of the levels tested, thus the NOAEL for this 3-month
rat feeding study was 15 mg/kg/day for both sexes.
ii. Six-month dog feeding study. Cyfluthrin was administered in the
diet to dogs at 0, 65, 200 or 600 ppm (equivalent to 0, 1.62, 5 or 15
mg/kg/day) for 26 weeks. The LOAEL for this study was 15 mg/kg/day for
both sexes, based on neurological effects (hindlimb abnormalities) and
gastrointestinal disturbances. The NOAEL was 5 mg/kg/day for males and
females.
iii. Twenty-one-day dermal study in rats. In a 21-day repeated dose
dermal toxicity study, male and female rats were treated with
cyfluthrin by dermal occlusion at target doses of 0, 100, 340, or 1,000
mg/kg/day for 6 hours/day (average actual dose levels were 0, 113, 376,
or 1,077 mg/kg/day). No mortality was observed, and there were no
treatment-related effects on body weight, ophthalmology, organ weights,
clinical biochemistry, or hematology. The LOAEL for dermal effects was
376 mg/kg/day for male and female Sprague-Dawley rats based on gross
and histological skin lesions. The NOAEL for dermal effects for
technical Baythroid was 113 mg/kg/day. The LOAEL for systemic effects
was 1,077 mg/kg/day based on decreased food consumption, red nasal
discharge and urine staining. The NOAEL for systemic effects was 376
mg/kg/day.
iv. Three-week inhalation toxicity studies in rats. SPF-Wistar rats
were dynamically exposed by nose-only inhalation to cyfluthrin at
concentrations of 0, 2.3, 11.5, or 69.6 mg/kg/day for 6 hours/day, 5
consecutive days/week for 3 weeks (total of 15 exposures). The LOAEL
was 2.3 mg/m3, based on the treatment-related effects on
body weight and temperature observed during the 3-week exposure period.
A NOAEL was not established; therefore this study was repeated using
lower doses.
SPF-Wistar rats were dynamically exposed by nose-only inhalation to
cyfluthrin at concentrations of 0, 0.4, 1.4, or 10.5 mg/m3
for 6 hours/day, 5 consecutive days/week for 3 weeks (total of 15
exposures). The LOAEL was 10.5 mg/m3, based on the
treatment-related behavioral effects as well as effects on body and
organ (spleen) weights. The NOAEL is 1.4 mg/m3.
v. Thirteen-week inhalation study in rats. Rats were dynamically
exposed by head-only inhalation to cyfluthrin at concentrations of 0,
0.09, 0.71, or 4.51 mg/m3 for 6 hours/day, 5 consecutive
days/week for 13 weeks. All animals survived the 13-week study, and no
treatment-related changes were observed in organ weight, gross
[[Page 17890]]
pathology and histopathology. The LOAEL was 0.71 mg/m3,
based on the treatment-related behavioral effects in females as well as
the increased urinary protein in males. The NOAEL was 0.09 mg/
m3.
5. Chronic toxicity--1-year dog study. Cyfluthrin was fed to beagle
dogs at 0, 40, 160, or 640 ppm (equivalent to 0, 1, 4, or 16 mg/kg/day)
for 52 weeks. The NOAEL was 4 mg/kg body weight/day. The LOAEL was 16
mg/kg body weight/day for both sexes, based on slight ataxia in two
dogs on single occasions, decreased body weight in males, and on
observations of increased vomiting and diarrhea at the high dose. The
NOAEL is 4 mg/kg body weight/day.
i. Chronic/carcinogenicity rat. Cyfluthrin was administered for 24
months in the diet to rats at dose levels of 0, 50, 150, or 450 ppm
(equivalent to 2.02, 6.19, or 19.20 mg/kg body weight/day in males and
2.71, 8.15, or 25.47 mg/kg/day in females based on food consumption and
body weights). The chronic LOAEL was 150 ppm (equivalent to 6.19 mg/kg/
day in males and 8.15 mg/kg/day in females) based on decreased body
weights in the high-dose animals and the mid-dose males. The chronic
NOAEL was 50 ppm (equivalent to 2.02 mg/kg/day in males and 2.71 mg/kg/
day in females). Under the conditions of this study, there was no
evidence of carcinogenic potential.
ii. Chronic/carcinogenicity mouse. Cyfluthrin was administered in
the diet for 23 months to mice at dose levels of 0, 50, 200, or 800 ppm
(equivalent to 11.6, 45.8, or 194.5 mg/kg/day in males and 15.3, 63.0,
or 259.9 in females based on food consumption and body weights). There
were no treatment related changes noted in the clinical observation,
food consumption, hematology, gross observation, organ weight, and
microscopic data. The chronic LOAEL is 50 ppm (equivalent to 11.6 mg/
kg/day in males and 15.3 mg/kg/day in females) based on increased
alkaline phosphatase activity in the dosed males. A chronic NOAEL was
not established in male and female mice. Under the conditions of this
study, there was no evidence of carcinogenic potential.
6. Animal metabolism. Metabolism studies in rats showed that
cyfluthrin is rapidly absorbed and excreted, mostly as conjugated
metabolites in the urine, within 48 hours. An enterohepatic circulation
was observed.
7. Metabolite toxicology. No toxicology data have been required for
cyfluthrin metabolites. The residue of concern is cyfluthrin.
8. Endocrine disruption. There is no evidence of endocrine effects
in any of the studies conducted with cyfluthrin, thus, there is no
indication at this time that cyfluthrin causes endocrine effects.
C. Aggregate Exposure
1. Dietary exposure. Cyfluthrin is pyrethroid insecticide currently
registered for use in alfalfa, citrus, sweet corn, cotton, sorghum,
sunflower, sugarcane, carrots, peppers, radishes, potatoes and
tomatoes. In addition, it has an import tolerance for hops. Various
formulations are registered for use in food handling establishments.
These assessments include contributions from crops with established
tolerances and proposed uses on dry peas (including pigeon peas, chick
peas/garbanzo beans, lentils) and southern peas.
i. Food. For purposes of assessing the potential acute and chronic
dietary exposure, Bayer has estimated acute and chronic exposure for
all registered crops, uses pending with the EPA for soybeans and field
corn, and new proposed uses on dry peas and southern peas.
Novigen Sciences, Inc.'s Dietary Exposure Evaluation Model
(DEEM), which is licensed to Bayer, was used to estimate the
chronic and acute dietary exposure. This software used the food
consumption data for the 1994-1996 USDA Continuing Surveys of Food
Intake by Individuals (CSFII 1994-1996).
a. Acute. The acute dietary (food) risk assessment was conducted
using a Monte Carlo analysis (Tier 3). The anticipated residue values
used were determined from field trial data reflecting maximum
application rates and minimum preharvest intervals. Field trial residue
distributions were used in the Monte Carlo simulation for those foods
identified as single-serving commodities. For those foods considered to
be blended or processed, mean field trial residues were calculated. For
the analysis current registered uses plus the added contribution for
dry garden peas, lentils, pigeon peas, garbanzo beans/chick peas and
southern peas were used.
Bayer's acute Monte Carlo dietary exposure assessment estimated
percent of the aPAD and corresponding margins of exposure (MOE) for the
overall U.S. population, (all seasons), and the subpopulations all
infants ( 1 year), nursing infants ( 1 year), non-nursing infants (1
year), children (6-12 years), children (7-12 years), females (13-19
years) and males (13-19 years). In this acute analysis, the most highly
exposed population subgroup, non-nursing infants ( 1 year), had an
exposure equal to 2.84% of the aPAD and a MOE of 10,062 at the 99.9th
percentile. The exposure estimates in this dietary analysis are within
EPA's criteria of acceptability of the 99.9th percentile.
b. Chronic. In the analysis for the chronic dietary (food only)
risk assessment the anticipated residue values used were determined
from field trail data conducted at maximum application rates and
minimum preharvest intervals. Mean anticipated residues values were
calculated substituting half of the limit of quantitation (LOQ) for
those samples for which residues were reported below the LOQ. For the
analysis current registered uses plus the added contribution for dry
garden peas, lentils, pigeon peas, garbanzo beans/chick peas and
southern peas were used.
Bayer's chronic dietary analysis estimated the chronic population
adjusted dose (cPAD) for the overall U. S. population (all seasons) and
the subpopulations nursing infants ( 1 year), non-nursing infants ( 1
year), all infants ( 1 year), children (1-6 years), children (7-12
years), females (13-19 years), males (13-19 years). In this chronic
analysis, the most highly exposed population subgroup, children (1-6
years), the exposure was estimated to be 3.4% of the cPAD. Chronic
dietary exposure estimates for the overall U.S. population were 1.2% of
the cPAD (0.008 mg/kg bw/day).
Results from the acute and chronic dietary exposure analyses
demonstrate a reasonable certainty that no harm to the overall U. S.
population or any population subgroup will result from the use of
cyfluthrin on currently registered and the pending IR-4 uses on dry
peas, pigeon peas, chick peas/garbanzo beans, lentils, and southern
peas.
ii. Drinking water. Cyfluthrin is immobile in soil, therefore, will
not leach into groundwater. Additionally, due the insolubility and
lipophilic nature of cyfluthrin, any residues in surface water will
rapidly and tightly bind to soil particles and remain with sediment,
therefore not contributing to potential dietary exposure from drinking
water.
The EPA estimates potential concentrations of cyfluthrin in water
using the Pesticide Root Zone Model (PRZM 1) and Exposure Analysis
Modeling System (EXAMS) computer models. The estimated environmental
concentration (EECs) of cyfluthrin residues are 0.236 part per billion
(ppb) for acute surface water and 0.044 ppb for chronic surface water.
The comparison of EECs to the back-calculated human health drinking
water levels of comparison (DWLOCs) for
[[Page 17891]]
acute and chronic exposures are summarized in the following tables 1
and 2:
Table 1.--Drinking Water Levels of Comparison for Acute Exposure to Cyfluthrin
----------------------------------------------------------------------------------------------------------------
Food Max. Water DWLOC Estimated Environmental
Population Category aPAD mg/kg/ Exposure mg/ Exposure mg/ µg/ Concentration (acute
day kg/day kg/day L Surface Water)
----------------------------------------------------------------------------------------------------------------
U.S. Population Male 0.07 0.001336 0.0687 2404 0.236
U.S. Population Female 0.07 0.001336 0.0687 2061 0.236
Infant (non-nursing, 1 yr) 0.07 0.001988 0.0501 501 0.236
----------------------------------------------------------------------------------------------------------------
Table 2: Drinking Water Level of Comparison for Chronic Exposure to Cyfluthrin
----------------------------------------------------------------------------------------------------------------
Food Max. Water DWLOC Estimated Environmental
Population Category cPAD mg/kg/ Exposure mg/ Exposure mg/ µg/ Concentration (chronic
day kg/day kg/day L Surface Water)
----------------------------------------------------------------------------------------------------------------
U.S. Population Male 0.008 0.000095 0.0079 277 0.044
U.S. Population Female 0.008 0.000095 0.0079 237 0.044
Children (1-6 yrs) 0.008 0.000271 0.0077 77 0.044
----------------------------------------------------------------------------------------------------------------
As indicated in Tables 1 and 2 above, the environmental
concentrations of cyfluthrin residues for acute and chronic surface
water are less than the calculated drinking water level of comparisons
for acute and chronic exposure and demonstrates a reasonable certainty
that no harm to the overall U. S. population or any population subgroup
will result from the use of cyfluthrin on currently registered and the
pending IR-4 uses on dry peas, and southern peas.
2. Non-dietary exposure. Non-occupational exposure to cyfluthrin
may occur as a result of inhalation or contact from indoor residential,
indoor commercial, and outdoor residential uses. Pursuant to the
requirements of FIFRA as amended by the Food Quality Protection Act of
1996 (FQPA), non-dietary and aggregate risk analyses for cyfluthrin
were conducted. The analyses include evaluation of potential non-
dietary acute application and post-application exposures. Non-
occupational, non-dietary exposure was assessed based on the assumption
that a flea infestation control scenario represents a ``worst case ''
scenario. For the flea control infestation scenario indoor fogger, and
professional residential turf same day treatments were included for
cyfluthrin. Deterministic (point values) were used to present a worse
case upper-bound estimate of non-dietary exposure. The non-dietary
exposure estimates were expressed as systemic absorbed doses for a
summation of inhalation, dermal, and incidental ingestion exposures.
These worst-case non-dietary exposures were aggregated with chronic
dietary exposures to evaluate potential health risks that might be
associated with cyfluthrin products. The chronic dietary exposures were
expressed as an oral absorbed dose to combine with the non-dietary
systemic absorbed doses for comparison to a systemic absorbed NOAEL.
Results for each potential exposed subpopulation (of adults, children
1-6 years, and infants <1 year) were compared to the systemic absorbed
dose NOAEL for cyfluthrin.
D. Cumulative Effects
Bayer will submit information for EPA to consider concerning
potential cumulative effects of cyfluthrin consistent with the schedule
established by EPA on August 4, 1997 (62 FR 42020) (FRL-5734-6) and
other EPA publications pursuant to the FQPA.
E. Safety Determination
1. U.S. population. Based on the exposure assessments described
above and on the completeness and reliability of the toxicity data, it
can be concluded that total aggregate exposure to cyfluthrin from all
label uses will utilize less than 1.2% of the cPAD for chronic dietary
exposures and that margins of exposure in excess of 1,000 exist for
aggregate exposure to cyfluthrin for non-occupational exposure. EPA
generally has no concerns for exposures below 100 percent of the
reference dose (RfD), because the RfD represents the level at or below
which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. Margins of exposure of 100 or more
(300 for infants and children) also indicate an adequate degree of
safety. Thus, it can be concluded that there is a reasonable certainty
that no harm will result from aggregate exposure to cyfluthrin
residues.
2. Infants and children. FFDCA Section 408 provides that EPA may
apply an additional safety factor for infants and children. The
additional safety factor may be used when prenatal and postnatal
threshold effects were observed in studies or to account for
incompleteness of the toxicity database.
The results of the 3-generation study in rats provided evidence
suggesting that, with respect to effects of cyfluthrin on body weight,
pups were more sensitive than adult rats. Thus, the Agency determined
that an additional 3-fold uncertainty factor (UF) should be used in
risk assessments to ensure adequate protection of infants and children.
Generally, the EPA considers margins of exposure of at least 100 to
indicate an adequate degree of safety. With an additional 3X
uncertainty factor, this would be 300 for infants and children. Using
the exposure assessments described above and based on the described
toxicity data aggregate exposure to infants and children indicate a
margin of exposure in excess of 3,800. Thus, it can be concluded that
there is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to cyfluthrin residues.
F. International Tolerances
There are Codex Maximum residue level (MRLs) for maize of 0.05 ppm,
and sweet corn of 0.02 ppm.
[FR Doc. 01-8142 Filed 4-3-01; 8:45 am]
BILLING CODE 6560-50-S